Aborted Fetal Tissue: MMR LIVE Vaccine/Mosby's

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Rubella portion in MMR same as Rubella vax sent earlier...

At 08:32 PM 04/26/2000 -0700, you wrote:

>Mosby's GenRx®, 10th ed.

>Copyright © 2000 Mosby, Inc.

>

> ------------------------------------------------------------------------

>

>Measles, Mumps and Rubella Virus Vaccine Live (001704)

>

>CATEGORIES:

>

> Indications: Immunization, measles; Immunization, mumps; Immunization,

> rubella

>

> Pregnancy Category C

>

> WHO Formulary

>

> FDA Pre 1938 Drugs

>

>FDA DRUG CLASS: Vaccines/Antisera

>

>BRAND NAMES: Imovax-ROR (Greece); MMR II (Hong-Kong, Philippines, Taiwan,

>South-Africa); M.M.R. II (Israel); M.M.R. Vaccine (Korea); M-M-R II (US);

>M-M-R Vax (Germany, Austria); Morupar (Philippines); Mumeru Vax

>(Philippines, Korea); Pluserix (Benin, Burkina-Faso, Ethiopia, Gambia,

>Ghana, Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania,

>Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone,

>Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe, Germany, Belgium,

>Greece); R.O.R. Vax (France); Trimovax (Bulgaria, Italy, Hong-Kong,

>Thailand, Taiwan); Triviraten Berna (Hong-Kong, Malaysia, Philippines,

>Thailand);

>(International brand names outside U.S. in italics)

>

>DESCRIPTION:

>

>M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) is a live virus

>vaccine for immunization against measles (rubeola), mumps and rubella

>(German measles).

>

>M-M-R II is a sterile lyophilized preparation of (1) Attenuvax (Measles

>Virus Vaccine Live), a more attenuated line of measles virus, derived from

>Enders' attenuated Edmonston strain and grown in cell cultures of chick

>embryo; (2) Mumpsvax (Mumps Virus Vaccine Live), the Jeryl Lynn (B level)

>strain of mumps virus grown in cell cultures of chick embryo; and (3)

>Meruvax II (Rubella Virus Vaccine Live), the Wistar RA 27/3 strain of live

>attenuated rubella virus grown in human diploid cell (WI-38) culture.1,2The

>vaccine viruses are the same as those used in the manufacture of Attenuvax

>(Measles Virus Vaccine Live), Mumpsvax (Mumps Virus Vaccine Live) and

>Meruvax II (Rubella Virus Vaccine Live). The three viruses are mixed before

>being lyophilized. The product contains no preservative.

>

>The reconstituted vaccine is for subcutaneous administration. When

>reconstituted as directed, the dose for injection is 0.5 ml and contains

>not less than the equivalent of 1,000 TCID50 (tissue culture infectious

>doses) of the U.S. Reference Measles Virus; 20,000 TCID50of the U.S.

>Reference Mumps Virus; and 1,000 TCID50of the U.S. Reference Rubella Virus.

>Each dose contains approximately 25 mcg of neomycin. The product contains

>no preservative. Sorbitol and hydrolyzed gelatin are added as stabilizers.

>

>CLINICAL PHARMACOLOGY:

>

>Clinical studies of 279 triple seronegative children, 11 months to 7 years

>of age, demonstrated that M-M-R II is highly immunogenic and generally well

>tolerated. In these studies, a single injection of the vaccine induced

>measles hemagglutination-inhibition (HI) antibodies in 95 percent, mumps

>neutralizing antibodies in 96 percent, and rubella HI antibodies in 99

>percent of susceptible persons.

>

>The RA 27/3 rubella strain in M-M-R II elicits higher immediate

>postvaccination HI, complement-fixing and neutralizing antibody levels than

>other strains of rubella vaccine3-9 and has been shown to induce a broader

>profile of circulating antibodies including anti-theta and anti-iota

>precipitating antibodies.10,11 The RA 27/3 rubella strain immunologically

>simulates natural infection more closely than other rubella vaccine

>viruses.11-13 The increased levels and broader profile of antibodies

>produced by RA 27/3 strain rubella virus vaccine appear to correlate with

>greater resistance to subclinical reinfection with the wild virus,11,13-15

>and provide greater confidence for lasting immunity.

>

>Vaccine induced antibody levels following administration of M-M-R II have

>been shown to persist up to 11 years without substantial decline.16,43

>Continued surveillance will be necessary to determine further duration of

>antibody persistence.

>

>INDICATIONS AND USAGE:

>

>M-M-R II is indicated for simultaneous immunization against measles, mumps,

>and rubella in persons 15 months of age or older. A second dose of M-M-R II

>or monovalent measles vaccine is recommended (see Revaccination.)17,18,19

>

>Infants who are less than 15 months of age may fail to respond to the

>measles component of the vaccine due to presence in the circulation of

>residual measles antibody of maternal origin, the younger the infant, the

>lower the likelihood of seroconversion. In geographically isolated or other

>relatively inaccessible populations for whom immunization programs are

>logistically difficult, and in population groups in which natural measles

>infection may occur in a significant proportion of infants before 15 months

>of age, it may be desirable to give the vaccine to infants at an earlier

>age. Infants vaccinated under these conditions at less than 12 months of

>age should be revaccinated after reaching 15 months of age. There is some

>evidence to suggest that infants immunized at less than one year of age may

>not develop sustained antibody levels when later reimmunized. The advantage

>of early protection must be weighed against the chance for failure to

>respond adequately on reimmunization.20

>

>Previously unimmunized children of susceptible pregnant women should

>receive live attenuated rubella vaccine, because an immunized child will be

>less likely to acquire natural rubella and introduce the virus into the

>household.

>

>Individuals planning travel outside the United States, if not immune, can

>acquire measles, mumps or rubella and import these diseases to the United

>States. Therefore, prior to International travel, individuals known to be

>susceptible to one or more of these diseases can receive either a single

>antigen vaccine (measles, mumps or rubella), or a combined antigen vaccine

>as appropriate. However, M-M-R II is preferred for persons likely to be

>susceptible to mumps and rubella; and if single-antigen measles vaccine is

>not readily available, travelers should receive M-M-R II regardless of

>their immune status to mumps or rubella.21,22,23

>

>Non-Pregnant Adolescent and Adult Females: Immunization of susceptible

>non-pregnant adolescent and adult females of childbearing age with live

>attenuated rubella virus vaccine is indicated if certain precautions are

>observed (see below and PRECAUTIONS). Vaccinating susceptible postpubertal

>females confers individual protection against subsequently acquiring

>rubella infection during pregnancy, which in turn prevents infection of the

>fetus and consequent congenital rubella injury.24

>

>Women of childbearing age should be advised not to become pregnant for

>three months after vaccination and should be informed of the reasons for

>this precaution.*

>

>It is recommended that rubella susceptibility be determined by serologic

>testing prior to immunization.** If immune, as evidenced by a specific

>rubella antibody titer of 1:8 or greater (hemagglutination-inhibition

>test), vaccination is unnecessary. Congenital malformations do occur in up

>to seven percent of all live births.25 Their chance appearance after

>vaccination could lead to misinterpretation of the cause, particularly if

>the prior rubella-immune status of vaccinees is unknown.

>

>Postpubertal females should be informed of the frequent occurrence of

>generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks

>after vaccination (see ADVERSE REACTIONS.)

>

>Postpartum Women: It has been found convenient in many instances to

>vaccinate rubella susceptible women in the immediate postpartum period.

>(See Nursing Mothers.)

>

>Revaccination: Children first vaccinated when younger than 12 months of age

>should be revaccinated at 15 months of age.

>

>The American Academy of Pediatrics (AAP), the Immunization Practices

>Advisory Committee (ACIP), and some state and local health agencies have

>recommended guidelines for routine measles revaccination and to help

>control measles outbreaks.26.27***

>

>*NOTE: The Immunization Practices Advisory Committee (ACIP) has recommended

> " In view of the importance of protecting this age group against rubella,

>reasonable precautions in a rubella immunization program include asking

>females if they are pregnant, excluding those who say they are, and

>explaining the theoretical risk to the others. " 24

>

>**NOTE: The Immunization Practices Advisory Committee (ACIP)) has stated

> " When practical, and when reliable laboratory services are available,

>potential vaccinees of childbearing age can have serologic tests to

>determine susceptibility to rubella.... However, routinely performing

>serologic tests for all females of childbearing age to determine

>susceptibility so that vaccine is given only to proven susceptibles is

>expensive and has been ineffective in some areas. Accordingly, the ACIP

>believes that rubella vaccination of a woman who is not known to be

>pregnant and has no history of vaccination is justifiable without serologic

>testing. " 24

>

>***NOTE: A primary difference among these recommendations is the timing of

>revaccination: the ACIP recommends routine revaccination at entry into

>kindergarten or first grade, whereas the AAP recommends routine

>revaccination at entrance to middle school or junior high school. In

>addition, some public health jurisdictions mandate the age for

>revaccination. The complete text of applicable guidelines should be

>consulted.26,27

>

>Vaccines available for revaccination include monovalent measles vaccine

>(Attenuvax (Measles Virus Vaccine Live)) and polyvalent vaccines containing

>measles (e.g., M-M-R II, M-R-VAX II (Measles and Rubella Virus Vaccine

>Live)). If the prevention of sporadic measles outbreaks is the sole

>objective, revaccination with a monovalent measles vaccine should be

>considered (see appropriate product circular). If concern also exists about

>immune status regarding mumps or rubella, revaccination with appropriate

>monovalent or polyvalent vaccine should be considered after consulting the

>appropriate product circulars. Unnecessary doses of a vaccine are best

>avoided by ensuring that written documentation of vaccination is preserved

>and a copy given to each vaccinee's parent or guardian.

>

>Use with other Vaccines

>

>Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV

>(oral poliovirus vaccine) concomitantly with measles, mumps, and rubella

>vaccines is not recommended because there are limited data28relating to the

>simultaneous administration of these antigens. M-M-R II should be given one

>month before or after administration of other vaccines.

>

>However, other schedules have been used. For example, the American Academy

>of Pediatrics has noted that when the patient may not return, some

>practitioners prefer to administer DTP, OPV, and M-M-R II on a single day.

>If done, separate sites and syringes should be used for DTP and M-M-R

>II.29The Immunization Practices Advisory Committee (ACIP) recommends

>routine simultaneous administration of M-M-R II, DTP and OPV or inactivated

>polio vaccine (IPV) to all children [image] 15 months who are eligible to

>receive these vaccines on the basis that there are equivalent antibody

>responses and no clinically significant increases in the frequency of

>adverse events when DTP, M-M-R II and OPV (or IPV are administered either

>simultaneously at different sites or separately.* Administration of M-M-R

>II at 15 months followed by DTP and OPV (or IPV) at 18 months remains an

>acceptable alternative, especially for children with caregivers known to be

>generally compliant with other health-care recommendations.

>

>*NOTE: The Immunization Practices Advisory Committee (ACIP) recommends

>administering M-M-R II concomitantly with the fourth dose of DTP and the

>third dose of OPV to children 15 months of age or older providing that 6

>months have elapsed since DTP-3; or, if fewer than three DTPs have been

>received, at least 6 weeks have elapsed since the last dose of DTP and OPV.

>

>CONTRAINDICATIONS:

>

>Do not give M-M-R II to pregnant females; the possible effects of the

>vaccine on fetal development are unknown at this time. If vaccination of

>postpubertal females is undertaken, pregnancy should be avoided for three

>months following vaccination. See PRECAUTIONS, Pregnancy.

>

>Anaphylactic or anaphylactoid reactions to neomycin (each dose of

>reconstituted vaccine contains approximately 25 mcg of neomycin).

>

>History of anaphylactic or anaphylactoid reactions to eggs (see WARNINGS,

>Hypersensitivity To Eggs.)

>

>Any febrile respiratory illness or other active febrile infection.

>

>Active untreated tuberculosis.

>

>Patients receiving immunosuppressive therapy. This contraindication does

>not apply to patients who are receiving corticosteroids as replacement

>therapy, e.g., for 's disease.

>

>Individuals with blood dyscrasias, leukemia, lymphomas of any type, or

>other malignant neoplasms affecting the bone marrow or lymphatic systems.

>

>Primary and acquired immunodeficiency states, including patients who are

>immunosuppressed in association with AIDS or other clinical manifestations

>of infection with human immunodeficiency viruses;30,31cellular immune

>deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states.

>

>Individuals with a family history of congenital or hereditary

>immunodeficiency, until the immune competence of the potential vaccine

>recipient is demonstrated.32

>

>WARNINGS:

>Hypersensitivity To Eggs

>

>Live measles vaccine and live mumps vaccine are produced in chick embryo

>cell culture. Persons 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

>should not be vaccinated. Evidence indicates that persons are not at

>increased risk if they have egg allergies that are not anaphylactic or

>anaphylactoid in nature. Such persons may be vaccinated in the usual

>manner. There is no evidence to indicate that persons with allergies to

>chickens or feathers are at increased risk of reaction to the vaccine.20

>

>PRECAUTIONS:

>General

>

>Adequate treatment provisions including epinephrine, should be available

>for immediate use should an anaphylactic or anaphylactoid reaction occur.

>

>Due caution should be employed in administration of M-M-R II to persons

>with a history of cerebral injury, individual or family histories of

>convulsions, or any other condition in which stress due to fever should be

>avoided. The physician should be alert to the temperature elevation which

>may occur following vaccination. (See ADVERSE REACTIONS.)

>

>Children and young adults who are known to be infected with human

>immunodeficiency viruses but without overt clinical manifestations of

>immunosuppression may be vaccinated; however, the vaccinees should be

>monitored closely for vaccine-preventable diseases because immunization may

>be less effective than for uninfected persons.30,31

>

>Vaccination should be deferred for at least 3 months following blood or

>plasma transfusions, or administration of human immune serum globulin.

>

>Excretion of small amounts of the live attenuated rubella virus from the

>nose or throat has occurred in the majority of susceptible individuals 7-28

>days after vaccination. There is no confirmed evidence to indicate that

>such virus is transmitted to susceptible persons who are in contact with

>the vaccinated individuals. Consequently, transmission through close

>personal contact, while accepted as a theoretical possibility, is not

>regarded as a significant risk.24 However, transmission of the rubella

>vaccine virus to infants via breast milk has been documented (see Nursing

>Mothers.)

>

>There are no reports of transmission of live attenuated measles on mumps

>viruses from vaccinees to susceptible contacts.

>

>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 test is to be done

>it should be administered either before or simultaneously with M-M-R II.

>

>Children under treatment for tuberculosis have not experienced exacerbation

>of the disease when immunized with live measles virus vaccine;33 no studies

>have been reported to date of the effect of measles virus vaccines on

>untreated tuberculous children.

>

>As for any vaccine, vaccination with M-M-R II may not result in

>seroconversion in 100% of susceptible persons given the vaccine.

>

>Pregnancy Category C

>

>Animal reproduction studies have not been conducted with M-M-R II. It is

>also not known whether M-M-R II can cause fetal harm when administered to a

>pregnant woman or can affect reproduction capacity. Therefore, the vaccine

>should not be administered to pregnant females; furthermore, pregnancy

>should be avoided for three months following vaccination (see

>CONTRAINDICATIONS.)

>

>In counseling women who are inadvertently vaccinated when pregnant or who

>become pregnant within 3 months of vaccination, the physician should be

>aware of the following: (1) In a 10 year survey involving over 700 pregnant

>women who received rubella vaccine within 3 months before or after

>conception (of whom 189 received the Wistar RA 27/3 strain), none of the

>newborns had abnormalities compatible with congenital rubella syndrome;34

>(2) Although mumps virus is capable of infecting the placenta and fetus,

>there is no good evidence that it causes congenital malformations in

>humans. Mumps vaccine virus also has been shown to infect the placenta, but

>the virus has not been isolated from the fetal tissues from susceptible

>women who were vaccinated and underwent elective abortions;35 and (3)

>Reports have indicated that contracting of natural measles during pregnancy

>enhances fetal risk. Increased rates of spontaneous abortion, stillbirth,

>congenital defects and prematurity have been observed subsequent to natural

>measles during pregnancy. There are no adequate studies of the attenuated

>(vaccine) strain of measles virus in pregnancy. However, it would be

>prudent to assume that the vaccine strain of virus is also capable of

>inducing adverse fetal effects.

>

>Nursing Mothers

>

>It is not known whether measles or mumps vaccine virus is secreted in human

>milk. Recent studies have shown that lactating postpartum women immunized

>with live attenuated rubella vaccine may secrete the virus in breast milk

>and transmit it to breast-fed infants.36In the infants with serological

>evidence of rubella infection, none exhibited severe disease; however, one

>exhibited mild clinical illness typical of acquired rubella.37,38 Caution

>should be exercised when M-M-R II is administered to a nursing woman.

>

>ADVERSE REACTIONS:

>

>Burning and/or stinging of short duration at the injection site have been

>reported.

>

>The adverse clinical reactions associated with the use of M-M-R II are

>those expected to follow administration of the monovalent vaccines given

>separately. These may include malaise, sore throat, cough, rhinitis,

>headache, dizziness, fever, rash, nausea, vomiting or diarrhea; mild local

>reactions such as erythema, induration, tenderness and regional

>lymphadenopathy; parotitis, orchitis, nerve deafness, thrombocytopenia and

>purpura; allergic reactions such as wheal and flare at the injection site

>or urticaria; polyneuritis; and arthralgia and/or arthritis (usually

>transient and rarely chronic).

>

>Anaphylaxis and anaphylactoid reactions have been reported.

>

>Vasculitis has been reported rarely.

>

>Otitis media and conjunctivitis have been reported.

>

>Moderate fever (101-102.9°F (38.3-39.4°C)) occurs occasionally, and high

>fever (above 103°F (39.4°C)) occurs less commonly. On rare occasions,

>children developing fever may exhibit febrile convulsions. Afebrile

>convulsions or seizures have occurred rarely following vaccination with

>live attenuated measles vaccine. Syncope, particularly at the time of mass

>vaccination, has been reported. Rash occurs infrequently and is usually

>minimal, but rarely may be generalized. Erythema multiforme has also been

>reported rarely.

>

>Forms of optic neuritis, including retrobulbar neuritis, papillitis, and

>retinitis may infrequently follow viral infections, and have been reported

>to occur 1 to 3 weeks following inoculation with some live virus vaccines.

>

>Clinical experience with live attenuated measles, mumps and rubella virus

>vaccines given individually indicates that encephalitis and other nervous

>system reactions have occurred very rarely. These might occur also with

>M-M-R II.

>

>Experience from more than 80 million doses of all live measles vaccines

>given in the U.S. through 1975 indicates that significant central nervous

>system reactions such as encephalitis and encephalopathy, occurring within

>30 days after vaccination, have been temporally associated with measles

>vaccine very rarely.39 In no case has it been shown that reactions were

>actually caused by vaccine. The Center for Disease Control has pointed out

>that " a certain number of cases of encephalitis may be expected to occur in

>a large childhood population in a defined period of time even when no

>vaccines are administered " . However, the data suggest the possibility that

>some of these cases may have been caused by measles vaccines. The risk of

>such serious neurological disorders following live measles virus vaccine

>administration remains far less than that for encephalitis and

>encephalopathy with natural measles (one per two thousand reported cases).

>

>There have been rare reports of ocular palsies, Guillain-Barre syndrome, or

>ataxia occurring after immunization with vaccines containing live

>attenuated measles virus. The ocular palsies have occurred approximately

>3-24 days following vaccination. No definite causal relationship has been

>established between these events and vaccination. Isolated reports of

>polyneuropathy including Guillain-Barre syndrome have also been reported

>after immunization with rubella-containing vaccines.

>

>There have been reports of subacute sclerosing panencephalitis (SSPE) in

>children who did not have a history of natural measles but did receive

>measles vaccine. Some of these cases may have resulted from unrecognized

>measles in the first year of life or possibly from the measles vaccination.

>Based on estimated nationwide measles vaccine distribution, the association

>of SSPE cases to measles vaccination is about one case per million vaccine

>doses distributed. This is far less than the association with natural

>measles, 6-22 cases of SSPE per million cases of measles. The results of a

>retrospective case-controlled study conducted by the Center for Disease

>Control suggest that the overall effect of measles vaccine has been to

>protect against SSPE by preventing measles with its inherent higher risk of

>SSPE.40

>

>Local reactions characterized by marked swelling, redness and vesiculation

>at the injection site of attenuated live measles virus vaccines, and

>systemic reactions including atypical measles, have occurred in persons who

>received killed measles vaccine previously. M-M-R II was not given under

>this condition in clinical trials. Rarely, more severe reactions that

>require hospitalization, including prolonged high fevers and extensive

>local reactions, have been reported.41Panniculitis has been reported rarely

>following administration of measles vaccine.42

>

>Arthralgia and/or arthritis (usually transient and rarely chronic), and

>polyneuritis are features of natural rubella and vary in frequency and

>severity with age and sex, being greatest in adult females and least in

>prepubertal children. This type of involvement as well as myalgia and

>paresthesia, have also been reported following administration of Meruvax II

>(Rubella Virus Vaccine Live).

>

>Chronic arthritis has been associated with natural rubella infection and

>has been related to persistent virus and/or viral antigen isolated from

>body tissues. Only rarely have vaccine recipients developed chronic joint

>symptoms.

>

>Following vaccination in children, reactions in joints are uncommon and

>generally of brief duration. In women, incidence rates for arthritis and

>arthralgia are generally higher than those seen in children (children:

>0-3%; women: 12-20%),43 and the reactions tend to be more marked and of

>longer duration. Symptoms may persist for a matter of months or on rare

>occasions for years. In adolescent girls, the reactions appear to be

>intermediate in incidence between those seen in children and in adult

>women. Even in older women (35-45 years), these reactions are generally

>well tolerated and rarely interfere with normal activities.

>

>DOSAGE AND ADMINISTRATION:

>FOR SUBCUTANEOUS ADMINISTRATION

>

>Do not inject intravenously

>

>The dosage of vaccine is the same for all persons. Inject the total volume

>of the single dose vial (about 0.5 ml) or 0.5 ml of the 10 dose vial of

>reconstituted vaccine subcutaneously, preferably into the outer aspect of

>upper arm. Do not give immune globulin (IG) concurrently with M-M-R II.

>

>During shipment, to insure that there is no loss of potency, the vaccine

>must be maintained at a temperature of 10°C (50°F) or less.

>

>Before reconstitution, store M-M-R II at 2-8°C (36-46°F).Protect from light

>.

>

>CAUTION: A sterile syringe free of preservatives, antiseptics, and

>detergents should be used for each injection and/or reconstitution of the

>vaccine because these substances may inactivate the live virus vaccine. A

>25 gauge, 5/8 " needle is recommended.

>

>To reconstitute, use only the diluent supplied, since it is free of

>preservatives or other antiviral substances which might inactivate the

>vaccine.

>

>Single Dose Vial --First withdraw the entire volume of diluent into the

>syringe to be used for reconstitution. Inject all the diluent in the

>syringe into the vial of lyophilized vaccine, and agitate to mix

>thoroughly. Withdraw the entire contents into a syringe and inject the

>total volume of restored vaccine subcutaneously.

>

>It is important to use a separate sterile syringe and needle for each

>individual patient to prevent transmission of hepatitis B and other

>infectious agents from one person to another.

>

>10 Dose Vial (available only to government agencies/institutions) Withdraw

>the entire contents (7 ml) of the diluent vial into the sterile syringe to

>be used for reconstitution, and introduce into the 10 dose vial of

>lyophilized vaccine. Agitate to ensure thorough mixing. The outer labeling

>suggests " For Jet Injector or Syringe Use " . Use with separate sterile

>syringes is permitted for containers of 10 doses or less. The vaccine and

>diluent do not contain preservatives; therefore, the user must recognize

>the potential contamination hazards and exercise special precautions to

>protect the sterility and potency of the product. The use of aseptic

>techniques and proper storage prior to and after restoration of the vaccine

>and subsequent withdrawal of the individual doses is essential. Use 0.5 ml

>of the reconstituted vaccine for subcutaneous injection.

>

>It is important to use a separate sterile syringe and needle for each

>individual patient to prevent transmission of hepatitis B and other

>infectious agents from one person to another.

>

>Each dose contains not less than the equivalent of 1,000 TCID50of the U.S.

>Reference Measles Virus, 20,000 TCID50 of the U.S. Reference Mumps Virus

>and 1,000 TCID50 of the U.S. Reference Rubella Virus.

>

>Parenteral drug products should be inspected visually for particulate

>matter and discoloration prior to administration. M-M-R II, when

>reconstituted, is clear yellow.

>

>Storage

>

>It is recommended that the vaccine be used as soon as possible after

>reconstitution. Protect vaccine from light at all times, since such

>exposure may inactivate the virus. Store reconstituted vaccine in the

>vaccine vial in a dark place at 2 - 8°C (36 - 46°F) and discard if not used

>within 8 hours.

>

>REFERENCES:

>

>1) Plotkin, S. A.; Cornfeld, D.; Ingalls, T. H.: Studies of immunization

>with living rubella virus: Trials in children with a strain cultured from

>an aborted fetus, Am. J. Dis. Child. 110: 381-389, 1965. 2) Plotkin, S. A.;

>Farquhar, J.; Katz, M.; Ingalls, T. H.: A new attenuated rubella virus

>grown in human fibroblasts: Evidence for reduced nasopharyngeal excretion,

>Am. J. Epidemiol. 86: 468-477,1967. 3) Fogel, A.; Moshkowitz, A.; Rannon,

>L.; Gerichter, Ch. B.: Comparative trials of RA 27/3 and Cendehill rubella

>vaccines in adult and adolescent females, Am. J. Epidemiol. 93: 392-393,

>1971. 4) Andzhaparidze, O. G.; Desyatskova, R. G.; Chervonski, G. I.;

>Pryanichnikova, L. V.: Immunogenicity and reactogenicity of live attenuated

>rubella virus vaccines, Am. J. Epidemiol. 91: 527-530, 1970. 5) Freestone,

>D. S.; Reynolds, G. M.; McKinnon, J. A.; Prydie, J.: Vaccination of

>schoolgirls against rubella. Assessment of serological status and a

>comparative trial of Wistar RA 27/3 and Cendehill strain live attenuated

>rubella vaccines in 13-year-old schoolgirls in Dudley, Br. J. Prev. Soc.

>Med. 29: 258-261, 1975. 6) Grillner. L.; Hedstrom, C. E.; Bergstrom, H.;

>Forssman, L.; Rigner, A.; Lycke, E.: Vaccination against rubella of newly

>delivered women,Scand. J. Infect. Dis. 5: 237-241, 1973. 7) Grillner, L.:

>Neutralizing antibodies after rubella vaccination of newly delivered women:

>a comparison between three vaccines, Scand. J. Infect. Dis. 7: 169-172,

>1975. 8) Wallace, R. B.; Isacson, P.: Comparative trial of HPV-77, DE-5 and

>RA 27/3 live-attenuated rubella vaccines, Am. J. Dis. Child. 124: 536-538,

>1972. 9) Lalla, M.; Vesikari, T.; Virolainen, M.: Lymphoblast proliferation

>and humoral antibody response after rubella vaccination, Clin. Exp.Immunol.

>15: 193-202, 1973. 10) LeBouvier, G. L.; Plotkin, S. A.: Precipitin

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>from the files of Merck Sharp and Dohme Research Laboratories.

>

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