Ingredients for 6-8 people
• 4 egg whites
• 2 egg yolks
• 100 g (1/2 cup) of sugar or 5 tablespoons of fruit sugar (alter to your own preference)
• 500 g (2 1/2 cups) of mascarpone cheese
• 4 small coffee cups of espresso coffee
• marsala wine (or brandy or cognac)
• 400 g of savoiardi or lady fingers (sponge cake fingers)
• dark chocolate powder
Preparation
1. Make espresso coffee, sweeten, and add the marsala wine (or cognac) to it. Let it cool a bit.
2. Separate the egg yolks and the whites of two eggs in two bowls.
3. Beat sugar into the egg yolks.
4. Beat the mascarpone into the sweetened yolks.
5. Add two more egg whites to the other two and whisk until they form stiff peaks.
6. Fold gently egg whites into mascarpone mixture.
7. Quickly dip both sides of the ladyfingers in the espresso mixture.
8. Layer soaked ladyfingers and mascarpone in a large bowl or pan (start with fingers, finish with mascarpone).
9. Sprinkle dark chocolate powder on top.
10. Refrigerate for one hour.

You opened my jar.
Stuck, so you ran it under warm water,
banged it on the counter, and leaned
your full body over it and strained to
free it from its lid.

You scooped me out.
I was luke warm and spicy salsa.
Cold, watery hominy.
Salty greens.
Fermented sugar cabbage.
Smelly and raw.

You ate a little of me every day,
tried to make the contents last.
The jar had been in your cabinet for a long time.
You almost donated me,
but you forgot.

You stored me in your refrigerator,
I got cold, stagnant.
I loved when you poured out my contents
and warmed them up on the stove
and ate me in front of the window on a mild day.

I loved when you seasoned me and made me new.

poetic poultice.

Take this salve;
this balm and unction,
apply around valve
n up yer junction,
refrigerate;
and best kept cool,
to thicken up
loose water stool,
please don't fret
n do not fear,
'tis but poetic,
diarrhea..

Turn the lights out

Touch me in the dark

kiss me at midnight

and taste the whiskey on my tongue

pour wine all over my body

and taste it with your warm soft lips

kiss me gently in my neck

as your fingers are dancing under my clothes

making me crave you more and more

dont say anything

your lips on mine say much more

no ocean can extenguish our burning hearts

no freezer can refrigerate this hot desire

I don't know life nor death

day nor night, right nor wrong

I only know that I want you so bad right now

everything else is irrelevant and forgotten

This happy mind
Set high up in the sky
An elevation conquered through such smiles
These well-embarked nights
Too sweet like sugared lime
We're gallivanting urban streets for miles

This life is gold
Wrapped memories in foil
To save, refrigerate, and sit and wonder
Street light, lightning poles
Electrified shoe soles
Northbound on a bridge, we stand and ponder

This city street
The trees have lost their leaves
But warm food paired with milkshakes stifles chills
Each touch ignites the breeze
Bad jokes, good laughs with ease
Casting spells unknown through each unopened thrill

(20 minute poetry)

When it's done and you're on a run to the cryogenic laboratory
I hope you think of me as I think of all humanity.

Once wasted twice
dry, ice us
and we'll live fiercer than forever could ever be.

I'll return only when the house of clowns burns down and I'll dance in the smoke, but it's mirrors I see in the eyes, are we ever really
free?

If death untied is true
where and when and what would be the point to hide in the nib of a pen? only flowing when the lights are low and the type in the margins is green inked to go?

I know no more than the kiss that brings me alive.

I can see the Eastern night even when the light is low and I didn't know how sweet it looked and all they want is to
refrigerate you.

I think if this is the farewell kiss I'll miss it all.

I've been
getting
tired

since
1954

when my father was
born

since when
we would
begin
beginning

to eventually
end
and anyways

I don't have insomnia
but I do watch
wildly

with my lower spine
and whine

and refrigerate
my mind

and he there,
that one

looks into
my eyes
as if

I've been
kicking him
since he was
a child

and
keeps it
up

i. WATER: straightforward enough just make sure she can breathe still; not just the kind in her throat, she needs the ocean, a spirit somehow both constant and ever-changing; you may try to hand her the umbrella but it'll never work, she'd rather drink the sky and wear it in her hair than anything else

ii. FOOD: keep it on hand; lemonade, strawberries, coffee and donuts, pasta; don't get it confused with thought, don't refrigerate a monet, don't put haring in the cabinet; she'll drag you to the museums but i swear it'll be worth it when you see her full and bright and alive against those canvases

iii. WARMTH: wrap her up in your arms every second you see her; wear your favorite cologne and i guarantee she will notice every time; she rises for the sun but lives for the stars, don't forget about the way she turns her face to the sky every time she goes outside; her glow is strong but every so often she'll need a little bit of yours to stay alive

jealousy ponders its self worth
ugly and repetitive
the next phase is mimesis
synthetic fabrics collapse
the space-time diamond lattice
our sporadic garments
now garden themselves
we refrigerate our castles
while the frigid dawn insists
on spinning its web
next to your bed
friends dance in symphonic threads
musical souls and down tempos
our elbows and our noses
pressing a little closer to each other
as i am moving beyond myself
turning into nothing
the hourglass masquerades
and we become two sedated slaves
who increase the treasury of saponification
to be fair the soapiest stations
do provide clean clothes to the drowning
so we disrobed and then dressed ourselves again
in colors borrowed from the rainbow
the favor of the demigods may be wavering
but forever is abiding here and now
as we return each others surreptitious looks
from out the corners of our eyes
that must signify our wish to smother
the forlorn teenagers who are now wagering again
upon race-car drivers swerving around our fallen idols

The first of October again?
I said that last time it came,

October, best before end of
May, once opened, refrigerate
and use within thirty-one days.

jeez,
this will be like death row,
the
waiting for October to go,

heating on and
teetering on the edge of a drink
think I'll go to bed instead
with a cup of cocoa.

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
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Why do so many people
Want to have their picture taken
And posted online
All over the internet
For your eyes only
Personally I find it discordant
And a little disorienting
We deceive our friends
And pretend we are not lonely
Mostly lost and a little distorted
Forced to refrigerate
Our lack of moral attunement
Our only hope is not to give a ****
We never did fit in anyway
So let’s play the game
Where we never say we're sorry

Twig by twig
we built our home
like birds

in the winter
we froze
together in a
raindrop

our faces
suspended forever
inside a tear

branches sway
in the breeze and
we fight

to remain

here

in the air

where we can
refrigerate
our hearts

pretending not to
feel the wind
ripping our skin
apart

and the rot
that grows
in the cracks

Heather's tight bikini ******* intrigued Roger like she was from another century. He'd give a million dollars to feel her soft nether portions against his ***** thrill-hammer, but she was the wife of his ****-buddy Jeff who was likely a homosexual. If only Heather & Jeff weren't siblings? But there was nothing to be done, except extract vital D.N.A. hormones from either of them or both to create a better version: a 𝘣𝘳𝘪𝘴𝘵𝘦𝘳 or a 𝘴𝘰𝘵𝘩𝘦𝘳 (or a brother/sister hybrid). "Look out there!" Roger demanded as he stuffed his peanut butter sandwich with a jellyfish. "Where?!" Heather exclaimed. 10 days after that a large gynecologist was found dead in the river. He'd been doing gynecological work when the Mafia killed him for reasons unknown.
   With ******-hardening projection Lenny Bruce injected morphia into his left ****** and it hurt worse than anything the Beatles ever did to each other. Later, elephants in pink mini-skirts appeared to dance on ice in a rink plated with stainless steel that glistened brighter than 100 trillion midgets eating tuna sandwiches in a replica of the 𝘛𝘪𝘵𝘢𝘯𝘪𝘤 even though it was the 𝘖𝘭𝘺𝘮𝘱𝘪𝘤 because the ships were switched for insurance fraud purposes.
   Sandy took the submarine sandwich and hid it quickly in her purse before Rambo knew what was what. Let's amscray," she whispered to Tony. "Right," he whimpered back. After an hour of walking along the tracks, Sandy suggested that they share the food in her purse. "Where'd you get a purse like that? It's cold enough to refrigerate sandwiches yet hot enough fashionably to be accepted by young fashion models who possess a keen sense of style," Tony observed. "Why don't you just shut up before I plant my foot up your gerbil-warming ******?" Sandy asked. "Fair enough," Tony replied with a grin that made his ******-gerbil scratch fiercely.