The reason there aren't so many vampyres
around these days is they don't like TV hype
and the intrusions of TV news crews. It transpires
that vampyres prefer late hours and like low light levels
because they're egregarious and don't like to be seen inebrious
in the middle of their heinous, intravenous revels.
Also, unfavorable reviews about transfusions
and the confusion caused by AIDS, at this juncture,
has definitely reduced the appeal of being seduced
by some crazed and gurgling Transylvanian
bloodsucker lusting to puncture the jugular,
or any other available vein again,
especially when you don't know if they've disinfected their fangs
or only licked them after draining their last victim.

After all, vampyres were brought up in castles
when there weren't antiseptics for gargles
and they haven't been taught prophylactic criteria
against such apocalyptic viral bacteria.
And if you've ever seen vampyres with condoms
on their teeth, you'll know what I mean.  
It's a scream. Everyone finds them hilarious. It'd be easier
to die laughing than to go down with anemia.
Also, like everyone else, vampyres hate ridicule.
No-one likes being seen as the fool.
  
And the other reason vampyres are scarce now
is that there are so many genuine muggers, hoods, crims,
druggies, financial leeches, homicidal maniacs,
psychopathic liars and genocidal tendencies to conjure up real fears
out there, that there's not much room left for quaint old-fashioned vampyres, poor dears.  

But do you know something? Even though they were naughty,
I miss their occasional ****. I know it was gory,
but those kisses, oh boy. We got into the femoral artery inside the thigh. It was *****. But when AIDs came along,
that was it.  Definitely bye-bye. Nobody wanted to die.  
These are the facts.  
So these vampyres were starving and they reverted to bats.  
Did a midnight flit,
and that's the end of my story.

It's like when you have the stomach flu,
and the first thing you toss up is your favorite,
homemade, blueberry muffins. How after that,
even though you've eaten them for 19 years,
just the thought of violet-speckled, baked goods
makes you want to hunch over the nearest toilet.

I don't remember when I stopped being able
to stomach irony.

All I know is I spend every morning gargling
minty antiseptics, trying to rid my mouth from
the aftertaste of dreams, but still its ghost lingers
in the back of my throat. I try to wash it down with the
taste of his ****, and the smell of his cologne. Thinking,
I guess, that one day I'll be able to love him like he deserves.

As opposed to wondering what happened between us.

Your catchphrase was," There's nothing to say."
It wasn't until now that I understood.  I wanted so
badly to find the right words. Wanted so bad to mend
what was  irreparably broken.  But you knew that every
time you opened your mouth, you were in danger
of coughing out your heart. Of spewing out a ******
mess of feelings that I didn't yet understand.

Now, as you come to me with olive branches, all I can
do is choke on my own aorta. So understand when I sound
like your broken record, that I'm just trying to hold it together.

Rucksack – Duffle bag – Backpack
                       Packed
Note books – Journal books – Poetry books
                    Book books
Tin cans – Pots and pans
         First aid – Survival kit
Complete with fishhooks, fishing line,
            Lighter, matches
  of the waterproof kind
                 Even a sewing kit
                                        Equipped
With extra sewing needles,
                       black thread, safety pins,
          Buttons,
                         Band-aids, gauze,
                antiseptics,
                        Burn cream
Just in case
                  it's ever needed
      Bucket hat Stuffed
              down somewhere deep
A handkerchief –
                          bandana too
      Flannels and sweater
                                       For cool weather
Tennis shoes
          For when hiking boots
     Get too hot
               A few days worth of food
     Vegetarian – salmon jerky – chocolate protein bars
                            Sleeping bag rolled tightly
            All slung heavily over my shoulder

“One fast move or I’m gone”
           Kerouac once said
   As he tried to run away from
     Crashing waves of stardom
        I just want to get away
      From crashing city noise
            And live life like a
              Dharma ***

And other countries. We get a check from the bottom of the floor.
This is important for women, for example, if you think about it.
I could eat *******, red, black or white, because I bought prostitutes.
I worked for a long time. But girls, Russians, Russians, Russians,
Bernard and civilians were soldiers and warriors and others. Kenya,
Uganda, pigs, dogs, women and adults who are good. In the world
of struggle, happiness, adultery and goals. Paris, Hawaii, Carrots,
Austria, Honduras and Ireland. Do not clean the device. Land known
from 100%. Says Yitzhak: "Be kind and angry." This applies to all.
You have to imagine the new home in nature. The best schools in
Russia, Russia, Russia and Russia are two, three and three spaces.
Kenya, a woman 60 years in the United States. Finn Christian
Armstrong, Austria, Italy, Ireland, Netherlands, Australia. Serbia,
Belgium is based on the information you receive. 1. Employees
and female supporters of whites. Need Russia, Russia, France,
world 2? Kenya, Uganda, pigs, cats and various varieties
for adults. Australia today in Honduras and prostitutes
in Ireland. Many are Spanish users. First of all, I want
you to know. Free and Alabama. And now check your
mobile phone information. Women, antiseptics, many men.
In the east of Russia. Women from more than 60 women
in Kenya. "You want to be a good person." Some reports
of war, especially in Russia, the Middle East and Europe.
2000 people (140) 41. Wise people and other areas.
The summer of the week is red and white, regardless
of [**** and white on white ****] for many years. I worked
for a long time. However, they have been charged in Russia
and other countries. Kenya, Uganda,
pigs, dogs, women and adults who are good.
In light, the joys, the friends and your goals.
Paris, Hawaii, Carrots, Austria, Honduras
and Ireland. To support the fact that customers
can feel the penalty later, the holy letter.
The first is 100% clear. Says Yitzhak:
"Be kind and angry." This applies to all.
Most changes in the new home.
The best students in two countries.
In Kenya, women in the United States
are sixty. Finn Christian Armstrong,
Austria, Italy, Ireland, Netherlands,
Australia. Serpent is true. This book
contains information and evidence
of the message .1. Tell women for many
years. Why not work hard? 2. Kenya,
Uganda, pigs, babies and adults
are different. Austria, Honduras
and Irish minerals. Many users can listen
to the Spanish. First of all, you want
to warn that Bush is this. Growth
in general and collection. Now check
your mobile phone. The women,
the drugs and the many men with her.
Now it is east of Russia. More than
60 women lost their children. "You want
to be a good person." There are wars
between Russia and Russia. (140) 41,000
people; Kenya is most Uganda,
competitive blood, some. and other areas
of the ashes of sunshine.

barely living things
wrapped in bandages
and doused in antiseptics
kept alive by food tubes
and oxygen pumped through heaving lungs

almost cadavers, broken dreams
shattered hopes and in-betweens
unanswered phone calls to heaven
and a hundred not yets

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to us e
M-M-R II safely and effectively. See full prescribing information
for M-M-R II.
M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live)
Suspension for subcutaneous injection
Initial U.S. Approv al: 1978
-------------------------------INDICATIONS AND USAGE-------------------------------
M-M-R II is a vaccine indicated for active immunization for the
prevention of measles, mumps, and rubella in individuals 12 months of
age and older. (1)
-------------------------- DOSAGE AND ADMINISTRATION--------------------------
Administer a 0.5-mL dose of M-M-R II subcutaneously. (2.1)
• The first dose is administered at 12 to 15 months of age. (2.1)
• The second dose is administered at 4 to 6 years of age. (2.1)
------------------------DOSAGE FORMS AND STRENGTHS -----------------------
Suspension for injection (0.5-mL dose) supplied as a lyophilized
vaccine to be reconstituted using accompanying sterile diluent. (3)
---------------------------------- CONTRAINDICATIONS ----------------------------------
• Hypersensitivity to any componentof the vaccine. (4.1)
• Immunosuppression. (4.2)
• Moderate or severe febrile illness. (4.3)
• Active untreated tuberculosis. (4.4)
• Pregnancy. (4.5, 8.1)
-------------------------- WARNINGS AND PRECAUTIONS --------------------------
• Use caution when administering M-M-R II to individuals with a
history of febrile seizures. (5.1)
• Use caution when administering M-M-R II to individuals with
anaphylaxis or immediate hypersensitivity following egg ingestion.
(5.2)
• Use caution when administering M-M-R II to individuals with a
history of thrombocytopenia. (5.3)
• Immune Globulins (IG) and other blood products should not be
given concurrently with M-M-R II. (5.4, 7.2)
----------------------------------ADVERSE REACTIONS----------------------------------
See full prescribing information for adverse reactions occurring duri ng
clinical trialsor the post-marketing period. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-8 7 7 -
888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
-----------------------------------DRUG INTERACTIONS----------------------------------
• Administration of immune globulins and other blood products
concurrently with M-M-R II vaccine may interfere with the
expected immune response. (7.2)
• M-M-R II vaccination may result in a temporary depression of
purified protein derivative (PPD) tuberculin skin sensitivity. (7.3)
-------------------------- USE IN SPECIFIC POPULATIONS--------------------------
• Pregnancy: Do not administer M-M-R II to females who are
pregnant. Pregnancy should be avoided for 1 month following
vaccination with M-M-R II. (4.5, 8.1, 17)
See 17 for PATIENT COUNSELING INFORMATION and FDA
approv ed patient labeling.
Rev ised: 06/2020
FULL PRESCRIBING INFORMATION: CONTENTS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose and Schedule
2.2 Preparation andAdministration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Immunosuppression
4.3 Moderate or Severe Febrile Illness
4.4 Active Untreated Tuberculosis
4.5 Pregnancy
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
5.2 Hypersensitivity to Eggs
5.3 Thrombocytopenia
5.4 Immune Globulins and Transfusions
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
7.2 Immune Globulinsand Transfusions
7.3 Tuberculin Skin Testing
7.4 Use with Other Live Viral Vaccines
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.6 Persistence of Antibody Responses After Vaccination
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Clinical Efficacy
14.2 Immunogenicity
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Sections or subsections omitted from the full prescribing info rma tion
are not listed.
2
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
M-M-R® II is a vaccine indicated for active immunization for the prevention of measles, mumps, and
rubella in individuals 12 months of age and older.
2 DOSAGE AND ADMINISTRATION
For subcutaneous use only.
2.1 Dose and Schedule
Each 0.5 mL dose is administered subcutaneously.
The first dose is administered at 12 to 15 months of age. A second dose is administered at 4 to 6
years of age.
The second dose may be administered prior to 4 years of age, provided that there is a minimum
interval of one month between the doses of measles, mumps and rubella virus vaccine, live {1-2}.
Children who received an initial dose of measles, mumps and rubella vaccine prior to their first
birthday should receive additional doses of vaccine at 12-15 months of age and at 4-6 years of age to
complete the vaccination series [see Clinical Studies (14.2)].
For post-exposure prophylaxis for measles, administer a dose of M-M-R II vaccine within 72 hours
after exposure.
2.2 Preparation and Administration
Use a sterile syringe free of preservatives, antiseptics, and detergents for each injection and/or
reconstitution of the vaccine because these substances may inactivate the live virus vaccine. To
reconstitute, use only the diluent supplied with the vaccine since it is free of preservatives or other
antiviral substances which might inactivate the vaccine.
Withdraw the entire volume of the supplied diluent from its vial and inject into lyophilized vaccine vial.
Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved.
Withdraw the entire volume of the reconstituted vaccine and inject subcutaneously into the outer
aspect of the upper arm (deltoid region) or into the higher anterolateral area of the thigh.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit. Visually inspect the vaccine before and after
reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a light yellow
compact crystalline plug, when reconstituted, is a clear yellow liquid. Discard if particulate matter or
discoloration are observed in the reconstituted vaccine.
To minimize loss of potency, administer M-M-R II as soon as possible after reconstitution. If not used
immediately, the reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from
light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours.
3 DOSAGE FORMS AND STRENGTHS
M-M-R II vaccine is a suspension for injection supplied as a single dose vial of lyophilized vaccine to
be reconstituted using the accompanying sterile diluent [see Dosage and Administration (2.2) and How
Supplied/Storage and Handling (16)]. A single dose after reconstitution is 0.5 mL.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component
of the vaccine (including gelatin) {3} or who have experienced a hypersensitivity reaction following
administration of a previous dose of M-M-R II vaccine or any other measles, mumps and rubellacontaining vaccine. Do not administer M-M-R II vaccine to individuals with a history of anaphylaxis to
neomycin [see Description (11)].
4.2 Immunosuppression
Do not administer M-M-R II vaccine to individuals who are immunodeficient or immunosuppressed due
to disease or medical therapy. Measles inclusion body encephalitis {4} (MIBE), pneumonitis {5} and death
as a direct consequence of disseminated measles vaccine virus infection have been reported in
3
immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In this
population, disseminated mumps and rubella vaccine virus infection have also been reported.
Do not administer M-M-R II to individuals with a family history of congenital or hereditary
immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
4.3 Moderate or Severe Febrile Illness
Do not administer M-M-R II vaccine to individuals with an active febrile illness with fever >101.3F
(>38.5C).
4.4 Active Untreated Tuberculosis
Do not administer M-M-R II vaccine to individuals with active untreated tuberculosis (TB).
4.5 Pregnancy
Do not administer M-M-R II to individuals who are pregnant or who are planning on becoming
pregnant within the next month [see Use in Specific Populations (8.1) and Patient Counseling Information
(17)].
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization with
M-M-R II vaccine. For children who have experienced a previous febrile seizure (from any cause) and
those with a family history of febrile seizures there is a small increase in risk of febrile seizure following
receipt of M-M-R II vaccine [see Adverse Reactions (6)].
5.2 Hypersensitivity to Eggs
Individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives,
swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion
may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving M-M-R II vaccine
.The potential risks and known benefits should be evaluated before considering vaccination in these
individuals.
5.3 Thrombocytopenia
Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles,
mumps and rubella vaccine. Carefully evaluate the potential risk and benefit of vaccination in children
with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous
dose of measles, mumps, and rubella vaccine {6-8} [see Adverse Reactions (6)].
5.4 Immune Globulins and Transfusions
Immune Globulins (IG) and other blood products should not be given concurrently with M-M-R II [see
Drug Interactions (7.2)]. These products may contain antibodies that interfere with vaccine virus
replication and decrease the expected immune response.
The ACIP has specific recommendations for intervals between administration of antibody containing
products and live virus vaccines.
6 ADVERSE REACTIONS
The following adverse reactions include those identified during clinical trials or reported during postapproval use of M-M-R II vaccine or its individual components.
Body as a Whole
Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.
Cardiovascular System
Vasculitis.
Digestive System
Pancreatitis; diarrhea; vomiting; parotitis; nausea.
Hematologic and Lymphatic Systems
Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.
Immune System
Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or ****** edema) and
bronchial spasm.
Musculoskeletal System
Arthritis; arthralgia; myalgia.
4
Nervous System
Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing
panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM);
transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis;
polyneuropathy; ocular palsies; paresthesia.
Respiratory System
Pneumonia; pneumonitis; sore throat; cough; rhinitis.
Skin
Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schönlein purpura;
erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema,
swelling and vesiculation).
Special Senses — Ear
Nerve deafness; otitis media.
Special Senses — Eye
Retinitis; optic neuritis; papillitis; conjunctivitis.
Urogenital System
Epididymitis; orchitis.
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
M-M-R II vaccine should not be administered to individuals receiving immunosuppressive therapy,
including high dose corticosteroids. Vaccination with M-M-R II vaccine can result in disseminated disease
due to measles vaccine in individuals on immunosuppressive drugs [see Contraindications (4.2)].
7.2 Immune Globulinsand Transfusions
Administration of immune globulins and other blood products concurrently with M-M-R II vaccine may
interfere with the expected immune response {9-11} [see Warnings and Precautions (5.4)]. The ACIP has
specific recommendations for intervals between administration of antibody containing products and live
virus vaccines.
7.3 Tuberculin Skin Testing
It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually
may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin skin test with
tuberculin purified protein derivative (PPD) is to be done, it should be administered before, simultaneously
with, or at least 4 to 6 weeks after vaccination with M-M-R II vaccine.
7.4 Use with Other Live Viral Vaccines
M-M-R II vaccine can be administered concurrently with other live viral vaccines. If not given
concurrently, M-M-R II vaccine should be given one month before or one month after administration of
other live viral vaccines to avoid potential for immune interference.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
M-M-R II vaccine is contraindicated for use in pregnant women because infection during pregnancy
with the wild-type viruses has been associated with maternal and fetal adverse outcomes.
Increased rates of spontaneous abortion, stillbirth, premature delivery and congenital defects have
been observed following infection with wild-type measles during pregnancy. {12,13} Wild-type mumps
infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.
Infection with wild-type rubella during pregnancy can lead to miscarriage or stillbirth. If rubella infection
occurs during the first trimester of pregnancy, it can result in severe congenital defects, Congenital
Rubella Syndrome (CRS). Congenital rubella syndrome in the infant includes but is not limited to eye
manifestations (cataracts, glaucoma, retinitis), congenital heart defects, hearing loss, microcephaly, and
intellectual disabilities. M-M-R II vaccine contains live attenuated measles, mumps and rubella viruses. It
is not known whether M-M-R II vaccine can cause fetal harm when administered to pregnant woman.
There are no adequate and well-controlled studies of M-M-R II vaccine administration to pregnant
women.
5
All pregnancies have a risk of birth defect, loss or other adverse outcomes. In the US general
population, the estimated background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Available data suggest the rates of major birth defects and miscarriage in women who received
M-M-R II vaccine within 30 days prior to pregnancy or during pregnancy are consistent with estimated
background rates (see Data).
Data
Human Data
A cumulative assessment of post-marketing reports for M-M-R II vaccine from licensure 01 April 1978
through 31 December 2018, identified 796 reports of inadvertent administration of M-M-R II vaccine
occurring 30 days before or at any time during pregnancy with known pregnancy outcomes. Of the
prospectively followed pregnancies for whom the timing of M-M-R II vaccination was known, 425 women
received M-M-R II vaccine during the 30 days prior to conception through the second trimester. The
outcomes for these 425 prospectively followed pregnancies included 16 infants with major birth defects, 4
cases of fetal death and 50 cases of miscarriage. No abnormalities compatible with congenital rubella
syndrome have been identified in patients who received M-M-R II vaccine. Rubella vaccine viruses can
cross the placenta, leading to asymptomatic infection of the fetus. Mumps vaccine virus has also been
shown to infect the placenta {14}, but there is no evidence that it causes congenital malformations or
disease in the fetus or infant .
The CDC established the Vaccine in Pregnancy registry (1971-1989) of women who had received
rubella vaccines within 3 months before or after conception. Data on 1221 inadvertently vaccinated
pregnant women demonstrated no evidence of an increase in fetal abnormalities or cases of Congenital
Rubella Syndrome (CRS) in the enrolled women {15}.
8.2 Lactation
Risk Summary
It is not known whether measles or mumps vaccine virus is secreted in human milk. Studies have
shown that lactatingpostpartum women vaccinated with live attenuated rubella vaccine may secrete the
virus in breast milk and transmit it to breast-fed infants.{16,17} In the breast-fed infants with serological
evidence of rubella virus vaccine strain antibodies, none exhibited severe disease; however, one
exhibited mild clinical illness typical of acquired rubella.{18,19}
The developmental and health benefits of breastfeeding should be considered along with the mother’s
clinical need for M-M-R II, and any potential adverse effects on the breastfed child from M-M-R II or from
the underlying maternal condition. For preventive vaccines, the underlying maternal condition is
susceptibility to disease prevented by the vaccine.
8.4 Pediatric Use
M-M-R II vaccine is not approved for individuals less than 12 months of age. Safety and effectiveness
of measles vaccine in infants below the age of 6 months have not been established [see Clinical Studies
(14)]. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have
not been established.
8.5 Geriatric Use
Clinical studies of M-M-R II did not include sufficient numbers of seronegative subjects aged 65 and
over to determine whether they respond differently from younger subjects.
11 Description
M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated
line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo
cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in
chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated
rubella virus propagated in WI-38 human diploid lung fibroblasts. {20,21} The cells, virus pools,
recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and
determined to be free of adventitious agents.
After reconstitution, each 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious
doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus.
Each dose is calculated to contain sorbitol (14.5 mg), sucrose(1.9 mg), hydrolyzed gelatin (14.5 mg),
recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin
and other buffer and media ingredients. The product contains no preservative.
6
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
M-M-R II vaccination induces antibodies to measles, mumps, and rubella associated with protection
which can be measured by neutralization assays, hemagglutination-inhibition (HI) assays, or enzyme
linked immunosorbent assay (ELISA) tests. Results from efficacy studies or effectivenes s studies that
were previously conducted for the component vaccines of M-M-R II were used to define levels of serum
antibodies that correlated with protection against measles, mumps, and rubella [see Clinical Studies (14)].
12.6 Persistence of Antibody Responses After Vaccination
Neutralizing and ELISA antibodies to measles, mumps, and rubella viruses are still detectable in 95-
100%, 74-91%, and 90-100% of individuals respectively, 11 to 13 years after primary vaccination. {22-28}
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
M-M-R II vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of
fertility.
14 CLINICAL STUDIES
14.1 Clinical Efficacy
Efficacy of measles, mumps, and rubella vaccines was established in a series of double-blind
controlled trials. {29-34} These studies also established that seroconversion in response to vaccination
against measles, mumps and rubella paralleled protection. {35-38}
14.2 Immunogenicity
Clinical studies enrolling 284 triple seronegative children, 11 months to 7 years of age, demonstrated
that M-M-R II vaccine is immunogenic. In these studies, a single injection of the vaccine induced measles
HI antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of
susceptible individuals.
A study of 6-month-old and 15-month-old infants born to mothers vaccinated with a measles vaccine in
childhood, demonstrated that, following infant and toddler vaccination with Measles Virus Vaccine, Live
(previously US-licensed, manufactured by Merck), 74% of the 6-month-old infants developed detectable
neutralizing antibody titers while 100% of the 15-month-old infants vaccinated with Measles Virus
Vaccine, Live or M-M-R II vaccine developed neutralizing antibodies {39}. When the 6-month-old infants
of immunized mothers were revaccinated at 15 months with M-M-R II vaccine, they developed antibody
titers similar to those of toddlers who were vaccinated previously at 15-months of age.
15 REFERENCES
1. General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices, MMWR
43(RR-1): 1-38, January 28, 1994.
2. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, a n d Co n g e nita l Ru b e lla
Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practice s (ACIP), M M WR
47(RR-8): May 22, 1998.
3. Kelso, J.M.; Jones, R.T.; Yunginger, J.W.: Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gel atin , J.
Allergy Clin. Immunol. 91: 867-872, 1993.
4. Bitnum, A.; et al: Measles Inclusion Body Encephalitis Caused by the Vaccine Strain of Measles Virus. Cl i n . In fect. Di s. 2 9 :
855-861, 1999.
5. Angel, J.B.; et al: Vaccine Associated Measles Pneumonitis in an Adult with AIDS. Annals of Internal Medicine, 129: 1 0 4 -1 06 ,
1998.
6. Cecinati V, et al. Vaccine administration and the development of immune thrombocyto pe ni c p urp u ra i n ch i ld re n. Hu m an
Vaccines & Immunotherapeutics 9:5, 2013.
7. Mantadakis E, Farmaki E, Buchanan GR. Thrombocytopenic Purpura after Measles-Mumps-Rubella Vaccination: A Systematic
Review of the Literature and Guidance for Management. J Ped 156(4): 2010.
8. Andrews N, Stowe J, Miller E, Svanstrom H, Johansen K, Bonhoeffer J, et al. A collaborative approach to investigating th e ri sk
of thrombocytopenic purpura after measles-mumps-rubella vaccination in England and Denmark. Vaccine. 2012;30:3042‐6.
9. Rubella Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP), MM WR 3 9 (RR-1 5 ): 1 -1 8 ,
November 23, 1990.
7
10. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatri cs,
344-357, 1997.
11. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22,
December 29, 1989.
12. Eberhart-Phillips, J.E.; et al: Measles in pregnancy: a descriptive study of 58 cases. Obstetrics and Gynecology, 82(5): 797-801,
November 1993.
13. Jespersen, C.S.; et al: Measles as a cause of fetal defects: A retrospective study of ten measles epidemics in Greenland. Acta
Paediatr Scand. 66: 367-372, May 1977.
14. Yamauchi T, Wilson C, Geme JW Jr. Transmission of live, attenuated mumps virus to the hu m a n p l ace n ta . N En g l J M e d .
1974;290(13):710‐712.
15. Rubella Vaccination during Pregnancy —United States, 1971-1988. JAMA. 1989;261(23):3374–3383.
16. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. II.
Maternal-neonatal interactions, J. Infect. Dis. 145: 661-666,1982.
17. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. I.
Development and characterization of specific immunologic reactivity in breast milk, J. Infect. Dis. 145: 654-660, 1982.
18. Landes, R.D.; Bass, J.W.; Millunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal i mm un izatio n , J.
Pediatr. 97: 465-467, 1980.
19. Lerman, S.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 98: 668, 1981. (Letter)
20. Plotkin, S.A.; Cornfeld, D.; Ingalls, T.H.: Studiesof immunization with living rubella virus: Trialsin children with a strain culture d
from an aborted fetus, Am. J. Dis. Child. 110: 381-389, 1965.
21. Plotkin, S.A.; Farquhar, J.; Katz, M.; Ingalls, T.H.: A new attenuated rubella virus grown in human fi bro b la sts: Evi d e n ce fo r
reduced nasopharyngeal excretion, Am. J. Epidemiol. 86: 468-477, 1967.
22. Weibel, R.E.; Carlson, A.J.; Villarejos, V.M.; Buynak, E.B.; McLean, A.A.; Hilleman, M.R.: Clinical and Labo ra tory Stu d ie s o f
Combined Live Measles, Mumps, and Rubella Vaccines Using the RA 27/3 Rubella Virus, Proc. So c. Exp . Bi ol. M e d. 1 6 5 :
323-326, 1980.
23. Watson, J.C.; Pearson, J.S.; Erdman, D.D.; et al: An Evaluation of Measles RevaccinationAmong School-Entry Age Ch i ld re n,
31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Abstract #268, 143, 1991.
24. Unpublished data from the files of Merck Research Laboratories.
25. Davidkin, I.; Jokinen, S.; Broman, M. et al.: Persistence of Measles, Mumps, and Rubella Antibodies in a n M M R -Va ccina ted
Cohort: A 20-Year Follow-up, JID 197:950–6, April 2008.
26. LeBaron, W.; Beeler J.; Sullivan, B.; et al.: Persistence of Measles Antibodies After 2 Doses of Measles Vaccine in a
Postelimination Environment, Arch Pediatr Adolesc Med. 161:294-301, March 2007.
27. LeBaron, C.; Forghani, B.; Beck, C. et al.: Persistence of Mumps Antibodies after 2 Doses of Measles-Mumps-Rubella Vaccine,
JID 199:552– 60 , February 2009.
28. LeBaron, W.; Forghani, B.; Matter, L. et al.: Persistence of Rubella Antibodies after 2 Doses of Measles-Mumps-Rubella
Vaccine, JID 200:888–99, September 2009.
29. Hilleman, M.R.; Buynak, E.B.; Weibel, R.E.; et al: Development and Evaluation of the Moraten MeaslesVirusVa cci n e , JAM A
206(3): 587-590, 1968.
30. Weibel, R.E.; Stokes, J.; Buynak, E.B.; et al: Live, Attenuated Mumps Virus Vaccine 3. Clinical and Serologic Aspects in a Fiel d
Evaluation,N. Engl. J. Med. 276: 245-251, 1967.
31. Hilleman, M.R.; Weibel, R.E.; Buynak, E.B.; et al:Live, Attenuated Mumps VirusVaccine 4. ProtectiveEfficacy as Measure d i n
a Field Evaluation, N. Engl. J. Med. 276: 252-258, 1967.
32. Cutts, F.T.; Henderson, R.H.; Clements, C.J.; et al: Principles of measles control, Bull WHO 69(1): 1-7, 1991.
33. Weibel, R.E.; Buynak, E.B.; Stokes, J.; et al: Evaluation Of Live Attenuated Mumps Virus Vaccine, Strain Jeryl Lynn, First
International Conference on VaccinesAgainst Viral and Rickettsial Diseases of Man, World Health Organization, No. 147, M a y
1967.
34. Leibhaber, H.; Ingalls, T.H.; LeBouvier, G.L.; et al: Vaccination With RA 27/3 Rubella Vaccine, Am. J. Dis. Child. 123: 133-1 3 6,
February 1972.
35. Rosen, L.: Hemagglutination and Hemagglutination-Inhibition with Measles Virus, Virology 13: 139-141, January 1961.
36. Brown, G.C.; et al: Fluorescent-Antibody Marker for Vaccine-Induced Rubella Antibodies, Infection and Immunity 2(4): 360-363,
1970.
8
37. Buynak, E.B.; et al: Live Attenuated Mumps Virus Vaccine 1. Vaccine Development, Proceedings of the Society for
Experimental Biology and Medicine, 123: 768-775, 1966.
38. Hilleman M.R., Studies of Live Attenuated Measles Virus Vaccine in Man: II. Appraisal of Efficacy. Amer. J. o f Pu b l ic He a lth ,
52(2):44-56, 1962.
39. Johnson, C.E.; et al: Measles Vaccine Immunogenicity in 6- Versus 15-Month-Old Infants Born to Mothers in the Measles
Vaccine Era, Pediatrics, 93(6): 939-943, 1994.
16 HOW SUPPLIED/STORAGE AND HANDLING
No. 4681 ⎯ M-M-R II vaccine is supplied as follows:
(1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00
(2) a box of 10 vials of diluent (package B)
Exposure to light may inactivate the vaccine viruses.
Before reconstitution, refrigerate the lyophilized vaccine at 36°F to 46°F, (2°C to 8°C).
Store accompanying diluent in the refrigerator with the lyophilized vaccine or separately at room
temperature (68° to 77°F, 20° to 25°C). Do not freeze the diluent.
Administer M-M-R II vaccine as soon as possible after reconstitution. If not administered immediately,
reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8
hours. Discard reconstituted vaccine if it is not used within 8 hours.
For information regarding the product or questions regarding storage conditions, call 1-800-
MERCK-90 (1-800-637-2590).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Package Insert).
Discuss the following with the patient:
• Provide the required vaccine information to the patient, parent, or guardian.
• Inform the patient, parent, or guardian of the benefits and risks associated with vaccination.
• Question the patient, parent, or guardian about reactions to a previous dose of M-M-R II vaccine
or other measles-, mumps-, or rubella-containing vaccines.
• Question females of reproductive potential regarding the possibility of pregnancy. Inform female
patients to avoid pregnancy for 1 month following vaccination [see Contraindications (4.5) and
Use in Specific Populations (8.1)].
• Inform the patient, parent, or guardian that vaccination with M-M-R II may not offer 100%
protection from measles, mumps, and rubella infection.
• Instruct patients, parents, or guardians to report any adverse reactions to their health-care
provider. The U.S. Department of Health and Human Services has established a Vaccine
Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events
after the administration of any vaccine, including but not limited to the reporting of events required
by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine
reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at
https://www.vaers.hhs.gov.
For patent information: www.merck.com/product/patent/home.html
Copyright © 1978-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
uspi-v205c-i-2006r009
Product patents - Merck.com
merck.com
Product patents - Merck.com
Merck US has many products enjoying exclusive patent rights. Click here to access a full list of Merck US patents.

I trusted you,
Took you as unknowing of your faults.
Thought I could believe you,
Confide in you my thoughts.

My heart still clings to you,
All of your aesthetic charms.
My mind and soul are hot coals,
Burning with anger and wanting vengeance.

All this time I thought you had seen me,
You had looked forward through a window.
You are truly a man of mirrors though,
Seen because I stood behind you,
No matter how much I wanted to be beside you.
Even now you can't see past yourself,
Oblivious to the fires burning around you,
You'll remain like this until it's you they consume.

Broken again,
I hate you for this.
I wanted you because you were a cure.
Now I'm left to the old antiseptics,
Music, movies and sympathetic friends.
They dull pain until I can find time to stand in the rain,
Find the time to confront this pain and banish these demons.

All my "thank you"s become regrets,
All the electricity grounded and gone.

Sometimes we don't realize a bond until it's gone.
Sometimes we don't seek healing until a wound becomes a scar
Like when a cut runs deep
And then it closes but wasn't treated properly when it was open.
The bodies natural reaction is to create infection
Effects that alert the body, its need for antiseptics
Antibiotics cannot disguise the pain
Feelings are shown on one's  face
And cannot be duplicated no matter the advancements in robotics
So let the tears flood
Tucks overflow like a kid filling up a tub
That forgot to turn it off
We all inhale life and exhale time
We're all a bunch of watches under the sun.
A moment of eclipse and then we turn off
Death no matter how it's sliced, given or served
It's a dish that's hard to stomach
But God endowed all of us with enough strength so in grief we don't plummet
With enough grace so when death surrounds we learn from it
Learn to love greater
Love can fill voids the size of canyons
Learn to love our neighbors
A conversation can provide food for thought when souls are  famished
Learn love through the  lens  of scripture
Because there's no pain we've went through that Jesus cannot  fathom
For us he hung on a cross like a fixture
Died so when can live
Then rose to bring life and it abundantly
Learn from death to live life with purpose
Not coast through like tumbleweeds
Live life.
We all should live life on purpose

"No one wants to be a great *******." - Eli Simple

Red and white, black, [white and black prostitutes]
in recent years. I worked for a long time. However,
Bernard struggles with citizen ****** and soldiers,
Russia, Russia, Russia, Russia and other countries.
Kenya, Uganda, pigs, dogs, good women and adults.
In the world, fight, happiness, prostitutes and goals.
Paris, Hawaii, carrots, Austria, Honduras
and Ireland. This helps users to perceive the sacred
source or the device they can contract to recognize
one. The first is a 100% clean floor. Yitzhak said:
"They are beautiful, they are angry." These rules
apply to everyone. You have to change the characteristics
of the new homes. The best schools in Russia, Russia,
Russia and Russia are two, three aces and three putas.
Kenya, women in the United States are sixty years
old. Finn, Christian Armstrong, Austria, Italy,
Ireland, Dutch ******, ****** and Australia. BE.
Belgium is wrong. It contains tense time
and the testimony of the information received
from the editor. 1. White prostitutes for years.
Why not work so much in Russia,
Russia, Russia, Russia, France, France
and World War II? Kenya, Uganda, pigs,
cats, older adults who find differences.
Austria today in the dog garden of ******
in Honduras and Ireland have said.
Many users can listen in Spanish. First of all,
I would like to remind you that Bush
was like that. Generally for the prostitutes
of Alabama. Now check the registration
of your mobile phone. Women, antiseptic,
many men. Now, three years closer
to prove that I am the East of Russia.
Women have more than 60 women,
including women, families, and communities
mainly in Austria, Italian prostitutes
of North America, prostitutes of Kenya
who have lost. "And what you do not want
is to be great." Some reports about the war
in Russia, the Middle East and the prostitutes
at war in Europe. 140,041 2,000 people.
Kenya is a large part of Uganda, the blood
of aircraft, as targets, wars, Russia, Russia,
prostitutes in other countries. Dreams of the Sun
Red ****** and white, black, [white and black
******] in recent years. I worked for a long time.
However, Bernard struggles with civilians
and military, Russia, Russia, Russia, Russia
and other countries. Kenya, Uganda, pigs,
dogs, good women and adults. In the world
of ardor and happiness, ****** are goals.
Paris, Hawaii, carrots, Austria, Honduras
and Ireland. This helps users feel the sacred
source, or on the device they can receive
and recognize one.
The first is 100% clear terrain. Yitzhak said:
"They are beautiful, they are angry." These
rules apply to everyone. You have to change
the characteristics of the new houses. The best
schools are in Russia, Russia, *****, Russian
****** and Russia are two, three *******
and three. Kenya, women in the United States
there are sixty. Finn, Christian Armstrong,
Austria, Italy, Ireland, Dutch ******
and Australia. BE. Belgium is in error.
It contains the testimonial letters of a puta
and the testimony of the information
obtained from the editor. 1. White *****
and ****** for years. Why do not you
work so hard? Russia, Russia, Russia, Russia,
Russia, France, ****** and in World War II.
Kenya, Uganda, pigs, cats, older adults
who find differences. Austria today in the garden
dog and Honduras and Ireland have said.
Many users can listen in Spanish. First of all,
I would like to remind you that Bush
was like that. Generally ******* and growing
in Alabama. Now check your mobile phone.
Women are antiseptic to too many men. Now,
three years closer to prove that I am the Lord of
East of Russia. Women have more than 60
women, including women, families
and communities,  mainly in Austria, Italy,
in ****** and in North America, ******
and Kenya who have lost. "And what you do
want to be is great." Some reports about the war
in Russia, Russia, the Middle East and ******
in Europe. 140,041 2,000 people; Kenya
is a large part of Uganda, the blood of aircraft,
as targets, wars, Russia, Russia, Russia
and other countries. Dreams of the sun...
Red and white, black, [white and black
prostitutes] in recent years. I worked for a long time.
However, Bernard struggles with citizen ******
and soldiers, Russia, Russia, Russia, Russia
and other countries. Kenya, Uganda, pigs, dogs,
good women and adults. In the world, fight,
happiness, prostitutes and goals. Paris, Hawaii,
carrots, Austria, Honduras and Ireland.
This helps users to perceive the sacred source
or the device they can contract to recognize one.
The first is a 100% clean floor. Yitzhak said:
"They are beautiful, they are angry." These rules
apply to everyone. You have to change
the characteristics of the new homes. The best
schools in Russia, Russia, Russia and Russia
are two, three aces and three *******. Kenya,
women in the United States are sixty years old.
Finn, Christian Armstrong, Austria, Italy, Ireland,
Dutch ****** ****** and Australia. BE.
Belgium is wrong. It contains tense time
and the testimony of the information received
from the editor. 1. White and white prostitutes
for years. Why not work so much Russia, Russia,
Russia, France, France and World War II?
Kenya, Uganda, pigs, cats, older adults
who find differences. Austria today in the dog
garden of ****** and Honduras and Ireland
have said. Many users can listen in Spanish.
First of all, I would like to remind you that Bush
was like that. Generally for the prostitutes
of Alabama. Now check the registration
of your mobile phone. Women, antiseptic,
many men. Now, three years closer
to prove that I am the King of the East of Russia.
Women have more than 60 women,
including women, families and communities
mainly in Austria and Italian prostitutes
in North America, prostitutes in Kenya
who have lost. "And what you do not
want is to be great." Some reports about
the war in Russia, the Middle East
and prostitutes in Europe. 140,041 2,000
people. Kenya is a large part of Uganda,
the blood of aircraft, as targets, wars,
Russia, Russia, prostitutes in other countries.
Dreams of the Sun Red ****** and white,
black, [white and black ******] in recent years.
I worked for a long time. However, Bernard
struggles with civilians and military, Russia,
Russia, Russia, Russia and other countries.
Kenya, Uganda, pigs, dogs, good women
and adults. In the world, ardor, happiness,
****** and goals. Paris, Hawaii, carrots,
Austria, Honduras and Ireland. This helps
users feel the sacred source, or the device
they can receive, recognize one. The first
is 100% clear terrain. Yitzhak said:
"They are beautiful, they are angry."
These rules apply to everyone. You have
to change the characteristics of the new
houses. The best schools are in Russia,
Russia, ***** Russian ****** and Russia
are two, three ******* and three. Kenya,
women in the United States there are sixty.
Finn, Christian Armstrong, Austria, Italy,
Ireland, Dutch ****** and Australia. BE.
Belgium is in error. It contains the testimonial
letters and the testimony of the information
obtained from the editor. 1. White ***** and
****** for years. Why do not you work
so hard? Russia, Russia, Russia, Russia, France,
****** and in World War II. Kenya, Uganda,
pigs, cats, older adults who find the differences
intriguing. Austria today is in the garden of dogs
and Honduras and Ireland have said. Many users
can listen in Spanish. First of all, I would like
to remind you that Bush was like that. General
in ******* and growing in Alabama. Now check
your mobile phone. Women, antiseptics, many
men. Now, three years closer to prove that I am
in the East of Russia. Women have more than
60 women, including women, families
and communities, mainly in Austria, Italy,
****** in North America, ****** in Kenya
who have lost. "And what you do not want
is to be great." Some reports about the war
in Russia, Russia, the Middle East
and ****** in Europe. 140,041 2,000 people;
Kenya is a large part of Uganda, the blood of aircraft,
as targets, wars, Russia, Russia, Russia
and other countries. Dreams of the sun ...

Yaserevai Q.bi found the mood of Starbucks;            Talk to adults in Caltech
Support each other; Lighthouse Owenvaniya Hati Lait Yuvao Chacho
Kiryat Yarim, (2000-2015) Rules for the use of the terms of use of the library. Vanidi Lejhi Sundar Gabrique, he is.           destiny;
enya neberiku
golden golden eggs
                                    Measure the product. For good news
Lettte Street, Vanderil Liuchi.                    Technology, 3-libigigiriwi work it ikiti inudiniyiyiyigigelu within Metalechi
This knowledge is Imphiligelu baby Shotochi.
ECB Challenge, Starbucks?
Twenty
With Kyle-A
Amen ____ Devotion is not shy
Capital point
See the fields of precious stones.
Jesus went to Jerusalem for the Easter festival.
Yanasiladki Lewit, student name, Pothi Dyeri,
No application Gilead, Gilaad, part of Paradise,
with Kille-A and Gilead.       Here, the Lord says here that all leaders do not condemn themselves for believing in the darkness of sin.
Even then: they are not married.
From the table of the homepage in English.
Today, in the North, Starbucks Disfir.
See tabs get satellites and satellites;     See Yannery's products immediately verses of the heavenly Spirit
I do not remember enough space.
Change in real time Love for readers, love, love,
Despite the fraud, the behavior is not outside the criteria.
The parents of the child, I am happy with the parents.
When they hear, they are enemies.
Australia have represented many organizations.                       n4 comments
Karl changes the dialogue of 3 lines
that will change the enemy and other popular Kebkiiboni. The death of my mother. Do I want women and men
            to meet at the ECB meeting, Starbucks?
Breakfast:           We have seen our community.
Candidate;       Afghan on Saturday of marriage
The first man,                             General Bruno,
After deleting the last proposal,
The study focused on many investigations,
Changes in the nose and death.
His mandate is not difficult                                           for the child of Libya,
and the young ēdišenišitemi should use,
magnet, to ask the elderly parents.    I went to a country and I heard a voice. Drivers and antiseptics. Our characteristics
and participation in four germs show that vitamins derived from vitamin B by Elchev, the bill is considered a charity.
Beta break break
Here is a kind of separation.
We have to make efforts without changing the city.      ECB response from tomorrow, Starbucks Disfire
We brilliant steal curiosity; satellite
cemetery                                            And immediately ask Nirrin Products;
Spell speaks of the spirit of heaven
I forgot the coffee grounds, changed it
The changes in real mode.
For the love of a partner
for the reader of the same out of water,
Txawmlicaslos, the nature of the jitters cannot be found
Son. Parents, working parents. I was happy.
They are the enemies of themselves when they hear this.
Australia; There are many trade unions       4 Comments
Changes in the Economy;        Wanting to change
the threat to the Kooiritim
and popularize some other local, in the 3D chat. |
                      My mother dies.       I want women.
ECB meeting, Starbucks?
Breakfast weekend,                      |          He asked for our cyclone animation;
Unnamed V. runner Afoga lady Saturday
Nirin primary variation
General In Brody,                                After the collapse of the last sentence;
yezarēwi ī.bī. Millie, Starbucks Dispersion
Caltech. Chat with adults in cell
Support one another
Owenwaniya Hanti Lati Yuuwuo Chucho.
The lighthouse of Kiriath Jearim,
(2000-2015)                                Library of Regulations Useful Terms of Use
wenidi liji Beautiful gabiaki, that is. desitenya neberiku. Golden golden egg.
Measure Product; For Good News
Lietti street, Wenderegel Leuichi;
In šeledewi-art, 3-libigigiriwi worikiti
inudiniyiyiyiligigelus. Inatra motalechi
the knowledge is ifeligalehu baby sētochi.
                        ECB Challenge, Starbucks?
t'ewati
With Kile-a
Amen;                        shy without lyuneti's
chapter sign,
See the gem of the field.
                    And he went out before the feast,
yenasiladikī lewit'i,                                        student name motidiresi,
No one is in the application. With Kile-a. In Gilead,
Gilead, Gilead, the paradis part. Behold, the Lord spake here,
saying that the judges of a deacon of all their own
did not believe in sinners to meet with sinners
about all who oppose him.
Yet: They are not married.
From the table to the English homepage.
Today, EB Answers, Starbucks Disfir
We see the light of the eyes.         Get satellites and satellite immediately see yenireni product,                                             letters about the heavenly spirits;                                               I do not remember the coffee place
[Change in real time].       Love for the reader is love in love, affection,
While fraud, the behavior outside the yardstick
                  has not been found
The boy. Parents, with parents. I'm happy.              When they hear,
                                                         they are enemies.
Australia; There are many organizations represented by 4 comments -
The changes in the Karolithi $ 3-line dialogue
that would change the enemy and other popular ākebebochini.
My mother dies. I want women and men.
ECB meeting, Starbucks?
Breakfast Breakfast
We have watched our community.
Unnamed V. Marriage for Afoga Saturday
Neri's First Person
General Bruno,
After the last sentence was deleted,
The study focused on many research,
The change of nose, and death,
His command is not difficult to libiya boy,
and ēdišenišitemi should use young men,
Imam, to ask elderly parents.                                       I went to a country,
and I heard a voice. Drivers and antiseptics;
Our features and four of the membership evidence of bacteria infected
                                                              in­to water bemifek'ediblechewy,
the invoice is considered a charitable organization.
Beta version break.
Here, some separation is unbelief
We must strive in the city, without change. Focused on a range of legal research;
Nasljaddiki's change, and even to death,
It is difficult for the commandment
of the products of the morning in the Susanny Liibob,
Edensteintoto lay for men to use it, Iamanth;     Y asks the old man's parents. And participated in a national newspaper,
and I heard a sharp voice. Rifles and drugs trafficking;         Australia, three-dimensional and four acts of ownership
for the approval of bacteria flowing into the water,                            flowing,
                                       is shown as the Connick of charity.
Scareware jet version infringement of the price,     \                          it is said.
Some of them are Gentiles,   they release slŭnchevo
We need to take a look into the city,       there is no change.

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to us e
M-M-R II safely and effectively. See full prescribing information
for M-M-R II.
M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live)
Suspension for subcutaneous injection
Initial U.S. Approv al: 1978
-------------------------------INDICATIONS AND USAGE-------------------------------
M-M-R II is a vaccine indicated for active immunization for the
prevention of measles, mumps, and rubella in individuals 12 months of
age and older. (1)
-------------------------- DOSAGE AND ADMINISTRATION--------------------------
Administer a 0.5-mL dose of M-M-R II subcutaneously. (2.1)
• The first dose is administered at 12 to 15 months of age. (2.1)
• The second dose is administered at 4 to 6 years of age. (2.1)
------------------------DOSAGE FORMS AND STRENGTHS -----------------------
Suspension for injection (0.5-mL dose) supplied as a lyophilized
vaccine to be reconstituted using accompanying sterile diluent. (3)
---------------------------------- CONTRAINDICATIONS ----------------------------------
• Hypersensitivity to any componentof the vaccine. (4.1)
• Immunosuppression. (4.2)
• Moderate or severe febrile illness. (4.3)
• Active untreated tuberculosis. (4.4)
• Pregnancy. (4.5, 8.1)
-------------------------- WARNINGS AND PRECAUTIONS --------------------------
• Use caution when administering M-M-R II to individuals with a
history of febrile seizures. (5.1)
• Use caution when administering M-M-R II to individuals with
anaphylaxis or immediate hypersensitivity following egg ingestion.
(5.2)
• Use caution when administering M-M-R II to individuals with a
history of thrombocytopenia. (5.3)
• Immune Globulins (IG) and other blood products should not be
given concurrently with M-M-R II. (5.4, 7.2)
----------------------------------ADVERSE REACTIONS----------------------------------
See full prescribing information for adverse reactions occurring duri ng
clinical trialsor the post-marketing period. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-8 7 7 -
888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
-----------------------------------DRUG INTERACTIONS----------------------------------
• Administration of immune globulins and other blood products
concurrently with M-M-R II vaccine may interfere with the
expected immune response. (7.2)
• M-M-R II vaccination may result in a temporary depression of
purified protein derivative (PPD) tuberculin skin sensitivity. (7.3)
-------------------------- USE IN SPECIFIC POPULATIONS--------------------------
• Pregnancy: Do not administer M-M-R II to females who are
pregnant. Pregnancy should be avoided for 1 month following
vaccination with M-M-R II. (4.5, 8.1, 17)
See 17 for PATIENT COUNSELING INFORMATION and FDA
approved patient labeling.
Revised: 06/2020
FULL PRESCRIBING INFORMATION: CONTENTS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose and Schedule
2.2 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Immunosuppression
4.3 Moderate or Severe Febrile Illness
4.4 Active Untreated Tuberculosis
4.5 Pregnancy
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
5.2 Hypersensitivity to Eggs
5.3 Thrombocytopenia
5.4 Immune Globulins and Transfusions
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
7.2 Immune Globulinsand Transfusions
7.3 Tuberculin Skin Testing
7.4 Use with Other Live Viral Vaccines
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.6 Persistence of Antibody Responses After Vaccination
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Clinical Efficacy
14.2 Immunogenicity
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Sections or subsections omitted from the full prescribing info rma tion
are not listed.
2
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
M-M-R® II is a vaccine indicated for active immunization for the prevention of measles, mumps, and
rubella in individuals 12 months of age and older.
2 DOSAGE AND ADMINISTRATION
For subcutaneous use only.
2.1 Dose and Schedule
Each 0.5 mL dose is administered subcutaneously.
The first dose is administered at 12 to 15 months of age. A second dose is administered at 4 to 6
years of age.
The second dose may be administered prior to 4 years of age, provided that there is a minimum
interval of one month between the doses of measles, mumps and rubella virus vaccine, live {1-2}.
Children who received an initial dose of measles, mumps and rubella vaccine prior to their first
birthday should receive additional doses of vaccine at 12-15 months of age and at 4-6 years of age to
complete the vaccination series [see Clinical Studies (14.2)].
For post-exposure prophylaxis for measles, administer a dose of M-M-R II vaccine within 72 hours
after exposure.
2.2 Preparation and Administration
Use a sterile syringe free of preservatives, antiseptics, and detergents for each injection and/or
reconstitution of the vaccine because these substances may inactivate the live virus vaccine. To
reconstitute, use only the diluent supplied with the vaccine since it is free of preservatives or other
antiviral substances which might inactivate the vaccine.
Withdraw the entire volume of the supplied diluent from its vial and inject into lyophilized vaccine vial.
Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved.
Withdraw the entire volume of the reconstituted vaccine and inject subcutaneously into the outer
aspect of the upper arm (deltoid region) or into the higher anterolateral area of the thigh.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit. Visually inspect the vaccine before and after
reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a light yellow
compact crystalline plug, when reconstituted, is a clear yellow liquid. Discard if particulate matter or
discoloration are observed in the reconstituted vaccine.
To minimize loss of potency, administer M-M-R II as soon as possible after reconstitution. If not used
immediately, the reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from
light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours.
3 DOSAGE FORMS AND STRENGTHS
M-M-R II vaccine is a suspension for injection supplied as a single dose vial of lyophilized vaccine to
be reconstituted using the accompanying sterile diluent [see Dosage and Administration (2.2) and How
Supplied/Storage and Handling (16)]. A single dose after reconstitution is 0.5 mL.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component
of the vaccine (including gelatin) {3} or who have experienced a hypersensitivity reaction following
administration of a previous dose of M-M-R II vaccine or any other measles, mumps and rubellacontaining vaccine. Do not administer M-M-R II vaccine to individuals with a history of anaphylaxis to
neomycin [see Description (11)].
4.2 Immunosuppression
Do not administer M-M-R II vaccine to individuals who are immunodeficient or immunosuppressed due
to disease or medical therapy. Measles inclusion body encephalitis {4} (MIBE), pneumonitis {5} and death
as a direct consequence of disseminated measles vaccine virus infection have been reported in
3
immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In this
population, disseminated mumps and rubella vaccine virus infection have also been reported.
Do not administer M-M-R II to individuals with a family history of congenital or hereditary
immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
4.3 Moderate or Severe Febrile Illness
Do not administer M-M-R II vaccine to individuals with an active febrile illness with fever >101.3F
(>38.5C).
4.4 Active Untreated Tuberculosis
Do not administer M-M-R II vaccine to individuals with active untreated tuberculosis (TB).
4.5 Pregnancy
Do not administer M-M-R II to individuals who are pregnant or who are planning on becoming
pregnant within the next month [see Use in Specific Populations (8.1) and Patient Counseling Information
(17)].
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization with
M-M-R II vaccine. For children who have experienced a previous febrile seizure (from any cause) and
those with a family history of febrile seizures there is a small increase in risk of febrile seizure following
receipt of M-M-R II vaccine [see Adverse Reactions (6)].
5.2 Hypersensitivity to Eggs
Individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives,
swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion
may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving M-M-R II vaccine
.The potential risks and known benefits should be evaluated before considering vaccination in these
individuals.
5.3 Thrombocytopenia
Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles,
mumps and rubella vaccine. Carefully evaluate the potential risk and benefit of vaccination in children
with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous
dose of measles, mumps, and rubella vaccine {6-8} [see Adverse Reactions (6)].
5.4 Immune Globulins and Transfusions
Immune Globulins (IG) and other blood products should not be given concurrently with M-M-R II [see
Drug Interactions (7.2)]. These products may contain antibodies that interfere with vaccine virus
replication and decrease the expected immune response.
The ACIP has specific recommendations for intervals between administration of antibody containing
products and live virus vaccines.
6 ADVERSE REACTIONS
The following adverse reactions include those identified during clinical trials or reported during postapproval use of M-M-R II vaccine or its individual components.
Body as a Whole
Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.
Cardiovascular System
Vasculitis.
Digestive System
Pancreatitis; diarrhea; vomiting; parotitis; nausea.
Hematologic and Lymphatic Systems
Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.
Immune System
Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or ****** edema) and
bronchial spasm.
Musculoskeletal System
Arthritis; arthralgia; myalgia.
4
Nervous System
Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing
panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM);
transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis;
polyneuropathy; ocular palsies; paresthesia.
Respiratory System
Pneumonia; pneumonitis; sore throat; cough; rhinitis.
Skin
Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schönlein purpura;
erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema,
swelling and vesiculation).
Special Senses — Ear
Nerve deafness; otitis media.
Special Senses — Eye
Retinitis; optic neuritis; papillitis; conjunctivitis.
Urogenital System
Epididymitis; orchitis.
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
M-M-R II vaccine should not be administered to individuals receiving immunosuppressive therapy,
including high dose corticosteroids. Vaccination with M-M-R II vaccine can result in disseminated disease
due to measles vaccine in individuals on immunosuppressive drugs [see Contraindications (4.2)].
7.2 Immune Globulinsand Transfusions
Administration of immune globulins and other blood products concurrently with M-M-R II vaccine may
interfere with the expected immune response {9-11} [see Warnings and Precautions (5.4)]. The ACIP has
specific recommendations for intervals between administration of antibody containing products and live
virus vaccines.
7.3 Tuberculin Skin Testing
It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually
may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin skin test with
tuberculin purified protein derivative (PPD) is to be done, it should be administered before, simultaneously
with, or at least 4 to 6 weeks after vaccination with M-M-R II vaccine.
7.4 Use with Other Live Viral Vaccines
M-M-R II vaccine can be administered concurrently with other live viral vaccines. If not given
concurrently, M-M-R II vaccine should be given one month before or one month after administration of
other live viral vaccines to avoid potential for immune interference.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
M-M-R II vaccine is contraindicated for use in pregnant women because infection during pregnancy
with the wild-type viruses has been associated with maternal and fetal adverse outcomes.
Increased rates of spontaneous abortion, stillbirth, premature delivery and congenital defects have
been observed following infection with wild-type measles during pregnancy. {12,13} Wild-type mumps
infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.
Infection with wild-type rubella during pregnancy can lead to miscarriage or stillbirth. If rubella infection
occurs during the first trimester of pregnancy, it can result in severe congenital defects, Congenital
Rubella Syndrome (CRS). Congenital rubella syndrome in the infant includes but is not limited to eye
manifestations (cataracts, glaucoma, retinitis), congenital heart defects, hearing loss, microcephaly, and
intellectual disabilities. M-M-R II vaccine contains live attenuated measles, mumps and rubella viruses. It
is not known whether M-M-R II vaccine can cause fetal harm when administered to pregnant woman.
There are no adequate and well-controlled studies of M-M-R II vaccine administration to pregnant
women.
5
All pregnancies have a risk of birth defect, loss or other adverse outcomes. In the US general
population, the estimated background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Available data suggest the rates of major birth defects and miscarriage in women who received
M-M-R II vaccine within 30 days prior to pregnancy or during pregnancy are consistent with estimated
background rates (see Data).
Data
Human Data
A cumulative assessment of post-marketing reports for M-M-R II vaccine from licensure 01 April 1978
through 31 December 2018, identified 796 reports of inadvertent administration of M-M-R II vaccine
occurring 30 days before or at any time during pregnancy with known pregnancy outcomes. Of the
prospectively followed pregnancies for whom the timing of M-M-R II vaccination was known, 425 women
received M-M-R II vaccine during the 30 days prior to conception through the second trimester. The
outcomes for these 425 prospectively followed pregnancies included 16 infants with major birth defects, 4
cases of fetal death and 50 cases of miscarriage. No abnormalities compatible with congenital rubella
syndrome have been identified in patients who received M-M-R II vaccine. Rubella vaccine viruses can
cross the placenta, leading to asymptomatic infection of the fetus. Mumps vaccine virus has also been
shown to infect the placenta {14}, but there is no evidence that it causes congenital malformations or
disease in the fetus or infant .
The CDC established the Vaccine in Pregnancy registry (1971-1989) of women who had received
rubella vaccines within 3 months before or after conception. Data on 1221 inadvertently vaccinated
pregnant women demonstrated no evidence of an increase in fetal abnormalities or cases of Congenital
Rubella Syndrome (CRS) in the enrolled women {15}.
8.2 Lactation
Risk Summary
It is not known whether measles or mumps vaccine virus is secreted in human milk. Studies have
shown that lactating postpartum women vaccinated with live attenuated rubella vaccine may secrete the
virus in breast milk and transmit it to breast-fed infants. {16,17} In the breast-fed infants with serological
evidence of rubella virus vaccine strain antibodies, none exhibited severe disease; however, one
exhibited mild clinical illness typical of acquired rubella. {18,19}
The developmental and health benefits of breastfeeding should be considered along with the mother’s
clinical need for M-M-R II, and any potential adverse effects on the breastfed child from M-M-R II or from
the underlying maternal condition. For preventive vaccines, the underlying maternal condition is
susceptibility to disease prevented by the vaccine.
8.4 Pediatric Use
M-M-R II vaccine is not approved for individuals less than 12 months of age. Safety and effectiveness
of measles vaccine in infants below the age of 6 months have not been established [see Clinical Studies
(14)]. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have
not been established.
8.5 Geriatric Use
Clinical studies of M-M-R II did not include sufficient numbers of seronegative subjects aged 65 and
over to determine whether they respond differently from younger subjects.
11 Description
M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated
line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo
cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in
chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated
rubella virus propagated in WI-38 human diploid lung fibroblasts. {20,21} The cells, virus pools,
recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and
determined to be free of adventitious agents.
After reconstitution, each 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious
doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus.
Each dose is calculated to contain sorbitol (14.5 mg), sucrose(1.9 mg), hydrolyzed gelatin (14.5 mg),
recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin
and other buffer and media ingredients. The product contains no preservative.
6
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
M-M-R II vaccination induces antibodies to measles, mumps, and rubella associated with protection
which can be measured by neutralization assays, hemagglutination-inhibition (HI) assays, or enzyme
linked immunosorbent assay (ELISA) tests. Results from efficacy studies or effectivenes s studies that
were previously conducted for the component vaccines of M-M-R II were used to define levels of serum
antibodies that correlated with protection against measles, mumps, and rubella [see Clinical Studies (14)].
12.6 Persistence of Antibody Responses After Vaccination
Neutralizing and ELISA antibodies to measles, mumps, and rubella viruses are still detectable in 95-
100%, 74-91%, and 90-100% of individuals respectively, 11 to 13 years after primary vaccination. {22-28}
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
M-M-R II vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of
fertility.
14 CLINICAL STUDIES
14.1 Clinical Efficacy
Efficacy of measles, mumps, and rubella vaccines was established in a series of double-blind
controlled trials. {29-34} These studies also established that seroconversion in response to vaccination
against measles, mumps and rubella paralleled protection. {35-38}
14.2 Immunogenicity
Clinical studies enrolling 284 triple seronegative children, 11 months to 7 years of age, demonstrated
that M-M-R II vaccine is immunogenic. In these studies, a single injection of the vaccine induced measles
HI antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of
susceptible individuals.
A study of 6-month-old and 15-month-old infants born to mothers vaccinated with a measles vaccine in
childhood, demonstrated that, following infant and toddler vaccination with Measles Virus Vaccine, Live
(previously US-licensed, manufactured by Merck), 74% of the 6-month-old infants developed detectable
neutralizing antibody titers while 100% of the 15-month-old infants vaccinated with Measles Virus
Vaccine, Live or M-M-R II vaccine developed neutralizing antibodies {39}. When the 6-month-old infants
of immunized mothers were revaccinated at 15 months with M-M-R II vaccine, they developed antibody
titers similar to those of toddlers who were vaccinated previously at 15-months of age.
15 REFERENCES
1. General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices, MMWR
43(RR-1): 1-38, January 28, 1994.
2. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella
Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practice s (ACIP), M M WR
47(RR-8): May 22, 1998.
3. Kelso, J.M.; Jones, R.T.; Yunginger, J.W.: Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gelatin , J.
Allergy Clin. Immunol. 91: 867-872, 1993.
4. Bitnum, A.; et al: Measles Inclusion Body Encephalitis Caused by the Vaccine Strain of Measles Virus. Cl i n . In fect. Di s. 2 9 :
855-861, 1999.
5. Angel, J.B.; et al: Vaccine Associated Measles Pneumonitis in an Adult with AIDS. Annals of Internal Medicine, 129: 1 0 4 -1 06 ,
1998.
6. Cecinati V, et al. Vaccine administration and the development of immune thrombocyto pe ni c p urp u ra i n ch i ld re n. Hu m an
Vaccines & Immunotherapeutics 9:5, 2013.
7. Mantadakis E, Farmaki E, Buchanan GR. Thrombocytopenic Purpura after Measles-Mumps-Rubella Vaccination: A Systematic
Review of the Literature and Guidance for Management. J Ped 156(4): 2010.
8. Andrews N, Stowe J, Miller E, Svanstrom H, Johansen K, Bonhoeffer J, et al. A collaborative approach to investigating th e ri sk
of thrombocytopenic purpura after measles-mumps-rubella vaccination in England and Denmark. Vaccine. 2012;30:3042‐6.
9. Rubella Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP), MM WR 3 9 (RR-1 5 ): 1 -1 8 ,
November 23, 1990.
7
10. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatri cs,
344-357, 1997.
11. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22,
December 29, 1989.
12. Eberhart-Phillips, J.E.; et al: Measles in pregnancy: a descriptive study of 58 cases. Obstetrics and Gynecology, 82(5): 797-801,
November 1993.
13. Jespersen, C.S.; et al: Measles as a cause of fetal defects: A retrospective study of ten measles epidemics in Greenland. Acta
Paediatr Scand. 66: 367-372, May 1977.
14. Yamauchi T, Wilson C, Geme JW Jr. Transmission of live, attenuated mumps virus to the hu m a n p l ace n ta . N En g l J M e d .
1974;290(13):710‐712.
15. Rubella Vaccination during Pregnancy —United States, 1971-1988. JAMA. 1989;261(23):3374–3383.
16. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. II.
Maternal-neonatal interactions, J. Infect. Dis. 145: 661-666,1982.
17. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. I.
Development and characterization of specific immunologic reactivity in breast milk, J. Infect. Dis. 145: 654-660, 1982.
18. Landes, R.D.; Bass, J.W.; Millunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal i mm un izatio n , J.
Pediatr. 97: 465-467, 1980.
19. Lerman, S.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 98: 668, 1981. (Letter)
20. Plotkin, S.A.; Cornfeld, D.; Ingalls, T.H.: Studiesof immunization with living rubella virus: Trialsin children with a strain culture d
from an aborted fetus, Am. J. Dis. Child. 110: 381-389, 1965.
21. Plotkin, S.A.; Farquhar, J.; Katz, M.; Ingalls, T.H.: A new attenuated rubella virus grown in human fi bro b la sts: Evi d e n ce fo r
reduced nasopharyngeal excretion, Am. J. Epidemiol. 86: 468-477, 1967.
22. Weibel, R.E.; Carlson, A.J.; Villarejos, V.M.; Buynak, E.B.; McLean, A.A.; Hilleman, M.R.: Clinical and Labo ra tory Stu d ie s o f
Combined Live Measles, Mumps, and Rubella Vaccines Using the RA 27/3 Rubella Virus, Proc. So c. Exp . Bi ol. M e d. 1 6 5 :
323-326, 1980.
23. Watson, J.C.; Pearson, J.S.; Erdman, D.D.; et al: An Evaluation of Measles RevaccinationAmong School-Entry Age Ch i ld re n,
31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Abstract #268, 143, 1991.
24. Unpublished data from the files of Merck Research Laboratories.
25. Davidkin, I.; Jokinen, S.; Broman, M. et al.: Persistence of Measles, Mumps, and Rubella Antibodies in a n M M R -Va ccina ted
Cohort: A 20-Year Follow-up, JID 197:950–6, April 2008.
26. LeBaron, W.; Beeler J.; Sullivan, B.; et al.: Persistence of Measles Antibodies After 2 Doses of Measles Vaccine in a
Postelimination Environment, Arch Pediatr Adolesc Med. 161:294-301, March 2007.
27. LeBaron, C.; Forghani, B.; Beck, C. et al.: Persistence of Mumps Antibodies after 2 Doses of Measles-Mumps-Rubella Vaccine,
JID 199:552– 60 , February 2009.
28. LeBaron, W.; Forghani, B.; Matter, L. et al.: Persistence of Rubella Antibodies after 2 Doses of Measles-Mumps-Rubella
Vaccine, JID 200:888–99, September 2009.
29. Hilleman, M.R.; Buynak, E.B.; Weibel, R.E.; et al: Development and Evaluation of the Moraten MeaslesVirusVa cci n e , JAM A
206(3): 587-590, 1968.
30. Weibel, R.E.; Stokes, J.; Buynak, E.B.; et al: Live, Attenuated Mumps Virus Vaccine 3. Clinical and Serologic Aspects in a Fiel d
Evaluation,N. Engl. J. Med. 276: 245-251, 1967.
31. Hilleman, M.R.; Weibel, R.E.; Buynak, E.B.; et al:Live, Attenuated Mumps VirusVaccine 4. ProtectiveEfficacy as Measure d i n
a Field Evaluation, N. Engl. J. Med. 276: 252-258, 1967.
32. Cutts, F.T.; Henderson, R.H.; Clements, C.J.; et al: Principles of measles control, Bull WHO 69(1): 1-7, 1991.
33. Weibel, R.E.; Buynak, E.B.; Stokes, J.; et al: Evaluation Of Live Attenuated Mumps Virus Vaccine, Strain Jeryl Lynn, First
International Conference on VaccinesAgainst Viral and Rickettsial Diseases of Man, World Health Organization, No. 147, M a y
1967.
34. Leibhaber, H.; Ingalls, T.H.; LeBouvier, G.L.; et al: Vaccination With RA 27/3 Rubella Vaccine, Am. J. Dis. Child. 123: 133-1 3 6,
February 1972.
35. Rosen, L.: Hemagglutination and Hemagglutination-Inhibition with Measles Virus, Virology 13: 139-141, January 1961.
36. Brown, G.C.; et al: Fluorescent-Antibody Marker for Vaccine-Induced Rubella Antibodies, Infection and Immunity 2(4): 360-363,
1970.
8
37. Buynak, E.B.; et al: Live Attenuated Mumps Virus Vaccine 1. Vaccine Development, Proceedings of the Society for
Experimental Biology and Medicine, 123: 768-775, 1966.
38. Hilleman M.R., Studies of Live Attenuated Measles Virus Vaccine in Man: II. Appraisal of Efficacy. Amer. J. o f Pu b l ic He a lth ,
52(2):44-56, 1962.
39. Johnson, C.E.; et al: Measles Vaccine Immunogenicity in 6- Versus 15-Month-Old Infants Born to Mothers in the Measles
Vaccine Era, Pediatrics, 93(6): 939-943, 1994.
16 HOW SUPPLIED/STORAGE AND HANDLING
No. 4681 ⎯ M-M-R II vaccine is supplied as follows:
(1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00
(2) a box of 10 vials of diluent (package B)
Exposure to light may inactivate the vaccine viruses.
Before reconstitution, refrigerate the lyophilized vaccine at 36°F to 46°F, (2°C to 8°C).
Store accompanying diluent in the refrigerator with the lyophilized vaccine or separately at room
temperature (68° to 77°F, 20° to 25°C). Do not freeze the diluent.
Administer M-M-R II vaccine as soon as possible after reconstitution. If not administered immediately,
reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8
hours. Discard reconstituted vaccine if it is not used within 8 hours.
For information regarding the product or questions regarding storage conditions, call 1-800-
MERCK-90 (1-800-637-2590).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Package Insert).
Discuss the following with the patient:
• Provide the required vaccine information to the patient, parent, or guardian.
• Inform the patient, parent, or guardian of the benefits and risks associated with vaccination.
• Question the patient, parent, or guardian about reactions to a previous dose of M-M-R II vaccine
or other measles-, mumps-, or rubella-containing vaccines.
• Question females of reproductive potential regarding the possibility of pregnancy. Inform female
patients to avoid pregnancy for 1 month following vaccination [see Contraindications (4.5) and
Use in Specific Populations (8.1)].
• Inform the patient, parent, or guardian that vaccination with M-M-R II may not offer 100%
protection from measles, mumps, and rubella infection.
• Instruct patients, parents, or guardians to report any adverse reactions to their health-care
provider. The U.S. Department of Health and Human Services has established a Vaccine
Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events
after the administration of any vaccine, including but not limited to the reporting of events required
by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine
reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at
https://www.vaers.hhs.gov.
For patent information: www.merck.com/product/patent/home.html
Copyright © 1978-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
uspi-v205c-i-2006r009
Product patents - Merck.com
merck.com
Product patents - Merck.com
Merck US has many products enjoying exclusive patent rights. Click here to access a full list of Merck US patents.