M-M-R II VACCINE [SIN02056P]

Product Info

M-M-R II VACCINE

[SIN02056P]

INDICATIONS

M-M-R II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older (see DOSAGE AND ADMINISTRATION).

There is some evidence to suggest that infants who are born to mothers who had wild-type measles and who are vaccinated at less than one year of age may not develop sustained antibody levels when later revaccinated. The advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunization.

Infants who are less than 12 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 wild-type 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 12 to 15 months of age.

DOSAGE AND ADMINISTRATION

FOR INTRAMUSCULAR OR SUBCUTANEOUS ADMINISTRATION Do not inject intravascularly.

Do not give immune globulin (IG) concurrently with M-M-R II. (See DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)

The dose for any age is approximately 0.5 mL administered intramuscularly or subcutaneously, preferably into the outer aspect of the upper arm.

The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.

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.

To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Before reconstitution, the lyophilized vaccine is a light yellow compact crystalline plug. M-M-R II, when reconstituted, is clear yellow.

RECOMMENDED VACCINATION SCHEDULE

Individuals first vaccinated at 12 months of age or older should be revaccinated at 4 to 6 years of age since increased risk of exposure typically occurs around elementary school entry. Revaccination is intended to seroconvert those who do not respond to the first dose.

[Note: Local vaccination schedules may be substituted for the above recommendations as dictated by local authorities.]

MEASLES OUTBREAK SCHEDULE

Infants Between 6 to 12 Months of Age

Local health authorities may recommend measles vaccination of infants between 6 to 12 months of age in outbreak situations. This population may fail to respond to the components of the vaccine. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established. The younger the infant, the lower the likelihood of seroconversion. Such infants should receive a second dose of M-M-R II at 12 to 15 months of age followed by revaccination at 4 to 6 years of age.

MUMPS OUTBREAK SCHEDULE

Local health authorities may recommend mumps vaccination in a mumps outbreak situation.

OTHER VACCINATION CONSIDERATIONS

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 PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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.

Women of childbearing age should be advised not to become pregnant for one month after vaccination and should be informed of the reasons for this precaution (see PRECAUTIONS, Pregnancy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If it is practical and if reliable laboratory services are available, women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. However, with the exception of premarital and prenatal screening, routinely performing serologic tests for all women of childbearing age to determine susceptibility (so that vaccine is given only to proven susceptible women) can be effective but is expensive. Also, 2 visits to the health-care provider would be necessary – one for screening and one for vaccination. Accordingly, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing and may be preferable, particularly when costs of serology are high and follow-up of identified susceptible women for vaccination is not assured.

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 SIDE EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Postpartum Women

It has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period (see PRECAUTIONS, Nursing Mothers – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

OTHER POPULATIONS

Previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine (such as that contained in monovalent rubella vaccine or in M-M-R II) to reduce the risk of exposure of the pregnant woman.

Individuals planning travel abroad, if not immune, can acquire measles, mumps, or rubella and import these diseases to their country. Therefore, prior to international travel, individuals known to be susceptible to one or more of these diseases can receive either a monovalent vaccine (measles, mumps, or rubella), or a combination vaccine as appropriate. However, M-M-R II is preferred for persons likely to be susceptible to mumps and rubella; and if monovalent measles vaccine is not readily available, travelers should receive M-M-R II regardless of their immune status to mumps or rubella.

Vaccination has been recommended for susceptible individuals in high-risk groups such as college students, health-care workers, and military personnel.

POST-EXPOSURE VACCINATION

Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours of exposure. If, however, vaccine is given a few days before exposure, substantial protection may be afforded. There is no conclusive evidence that vaccination of individuals recently exposed to wild-type mumps or wild-type rubella will provide protection.

USE WITH OTHER VACCINES

M-M-R II should be given one month before or after administration of other live viral vaccines.

M-M-R II has been administered concurrently with live attenuated varicella and inactivated Haemophilus influenzae type b (Hib) conjugate vaccines using separate injection sites and syringes. No impairment of immune response to individually tested vaccine antigens was demonstrated. The type, frequency, and severity of adverse experiences observed with M-M-R II were similar to those seen when each vaccine was given alone.

Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps, and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens.

However, other schedules have been used. Data from published studies concerning the simultaneous administration of the entire recommended vaccine series (i.e., DTaP [or DTwP], IPV [or OPV], Hib with or without Hepatitis B vaccine, and varicella vaccine), indicate no interference between routinely recommended childhood vaccines (either live, attenuated, or killed).

SINGLE DOSE VIAL

If the prevention of sporadic measles outbreaks is the sole objective, revaccination with a measles-containing vaccine should be considered (see appropriate product circular). If concern also exists about immune status regarding mumps or rubella, revaccination with appropriate mumps- or rubella-containing vaccine should be considered after consulting the appropriate product circulars.

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. If the lyophilized vaccine cannot be dissolved, discard. Withdraw the entire contents into a syringe and inject the total volume of reconstituted vaccine intramuscularly or 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. M-M-R II when reconstituted is clear yellow.

CONTRAINDICATIONS

Hypersensitivity to any component of the vaccine, including gelatin.

Do not give M-M-R II to pregnant females. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for one month following vaccination (see PRECAUTIONS, Pregnancy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 mcg of neomycin).

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 Addison’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; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis (MIBE), pneumonitis and death as a direct consequence of disseminated measles vaccine virus infection have been reported in severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine.

Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.