M-M-R II VACCINE

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD PHARMA (SINGAPORE) PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, FOR SOLUTION

**DOSAGE AND ADMINISTRATION** FOR 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 0.5 mL administered subcutaneously, preferably into the outer aspect of the upper arm. 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. 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 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.