MoRu

MoRu-Viraten BERNA™

Berna Products

Measles and Rubella Virus Vaccine, Live, Attenuated

Active Immunizing Agent

Action And Clinical Pharmacology: MoRu-Viraten Berna is a live virus vaccine for immunization against measles (rubeola) and rubella (German measles).

A single dose of MoRu-Viraten Berna vaccine was administered to 26 children, 15 months to 9 years of age, who were seronegative [a rubella hemagglutination-inhibition (HI) titer of 256). The viral vaccine strains that comprise MoRu-Viraten Berna vaccine have also been administered to children 15 months to 14 years of age, together with a live attenuated mumps virus vaccine in the form of a trivalent vaccine, Triviraten Berna vaccine. In comparative studies involving 349 seronegative children, the seroconversion rate was 97% for measles and 100% for rubella. In noncomparative studies in 529 seronegative children, the seroconversion rate was 98% for measles and 99% for rubella. The persistence of vaccine-induced antibodies is unknown.

Indications And Clinical Uses: Children: For the simultaneous immunization against measles and rubella in individuals 12 to 15 months of age or older. A booster dose of either MoRu-Viraten Berna vaccine, monovalent measles vaccine or trivalent measles, mumps and rubella vaccine is recommended (see Reimmunization).

It is recommended that children less than 12 to 15 months of age not be immunized as they may not mount a protective immune response to the measles component. This is due to the inhibitory activity of persisting antimeasles maternal antibodies. In general, the younger the child is at the time of immunization the less likely they are to mount a protective immune response. In certain circumstances it may be desirable to vaccinate children less than 12 months of age. This would include groups with a high risk of acquiring measles at an age less than 12 months or populations difficult to vaccinate due to geographical isolation. Children falling into these categories who are vaccinated at less than 12 months of age should be revaccinated after reaching their 15th month of life. Data exist to indicate that children vaccinated at less than 12 months of age may not adequately respond to a booster dose of vaccine administered subsequent to their 15th month of life. Therefore, the potential advantages of vaccination at an early age must be weighed against the possibility of an inadequate immune response upon revaccination.

Children with no history of immunization against rubella residing with a susceptible pregnant woman should be immunized with a live attenuated rubella vaccine in an effort to reduce the risk of introducing wild-type rubella virus into the household.

Nonpregnant Adolescent and Adult Females: Susceptible nonpregnant adolescent and adult females of childbearing age should be immunized with a vaccine containing live attenuated rubella virus as long as certain precautions are observed (see Precautions). Immunization of this susceptible population is warranted due to the fact that protection is conferred against rubella infection during pregnancy, which prevents fetal infection with attendant congenital rubella syndrome.

Women of childbearing age who are immunized with a vaccine containing live attenuated rubella vaccine should be counseled and be advised not to become pregnant for at least 3 months following vaccination (see Contraindications).

Postpubertal females should be informed of the frequent occurrence of self-limiting arthralgia, arthritis or both syndromes with an onset 2 to 4 weeks postvaccination (see Adverse Effects).

Postpartum Women: Rubella-susceptible women may also be vaccinated with a live attenuated rubella vaccine immediately postpartum (see Precautions, Lactation).

Reimmunization: Children younger than 12 months of age when first vaccinated should be revaccinated at 15 months of age followed by another at 4 to 6 years of age. Revaccination may be accomplished by the administration of the following vaccines: monovalent measles vaccine when the sole concern is to augment protection against measles; bivalent measles and rubella vaccine where enhanced protection is desired against both measles and rubella; and trivalent measles, mumps and rubella vaccine when there is concern relating to the immune status against all 3 viral pathogens.

Children vaccinated at 12 to 15 months of age are recommended for revaccination at the age of 4 to 6 years or at the age of 11 to 12 years when a combined measles, mumps, rubella vaccine is usually administered.

Use in Combination with Other Vaccines and Immune Globulin: The simultaneous administration of diphtheria, tetanus and pertussis vaccines and/or oral polio vaccine with MoRu-Viraten Berna vaccine is not recommended due to insufficent data on the effect of such a combined administration on the immune response to the individual vaccine antigens. MoRu-Viraten Berna vaccine should be administered no sooner than 30 days before or after the receipt of other viral vaccines.

Antibodies present in immune globulin preparations, blood or plasma may suppress the immune response to live attenuated measles and rubella vaccines. Vaccination should be delayed for at least 3 months after the receipt of such products. If such preparations are administered within 2 weeks of vaccination it is recommended that the immune status to measles and rubella be determined by appropriate serological tests 3 months after vaccination or, if not feasible, to repeat the vaccination with MoRu-Viraten Berna vaccine.

Contra-Indications: Hypersensitivity to any component of the vaccine.

Pregnancy: MoRu-Viraten Berna vaccine should not be administered to pregnant women as its effects on fetal development have not been studied. Following vaccination, women of childbearing age should avoid becoming pregnant for 3 months (see Precautions, Pregnancy).

Vaccination should be delayed in the face of a febrile illness or in persons with active tuberculosis. Congenital or acquired humoral or cellular immunodeficiency states, including patients receiving treatment with immunosuppressvive or antimitotic drugs, hypogammaglobulinemia and dysgammaglobulinemia. Patients with leukemia, lymphoma, malignant neoplasia of the bone marrow or lymphatic systems. This contraindication does not extend to patients receiving corticosteroids as replacement therapy such as for Addison’s disease.

Precautions: General: The vaccine should not be administered in the face of an acute febrile illness or to persons with active tuberculosis. MoRu-Viraten Berna vaccine should not be administered to persons with a known hypersensitivity to any vaccine component. Appropriate therapy, such as epinephrine, should be available to treat any anaphylactic or anaphylactoid reaction.

Caution should be exercised when MoRu-Viraten Berna vaccine is to be administered to individuals with a known or suspected cerebral injury, individual or familial history of convulsions or seizures or any other conditions known to be aggravated by elevated fever. The attending physician should be aware of the fact that an elevation in body temperature often follows immunization (see Adverse Effects).

Individuals known to be infected with human immunodeficiency viruses without overt symptoms associated with immunosuppression may be vaccinated. However, such individuals may fail to mount a protective immune response at a higher rate than noninfected subjects.

Immunization should be delayed for at least 3 months following the receipt of immune globulin, blood or plasma.

The majority of vaccinated individuals will secrete live attenuated rubella virus in nasal or throat secretions for up to 1 month postimmunization. Although the possibility exists that transmission to susceptible close contacts may occur, this has yet to be conclusively demonstrated and is therefore considered a minimal risk. Transmission of rubella virus to nursing infants via breast milk has been documented (see Lactation).

There have been no confirmed reports of transmission of measles virus from vaccinated individuals to seronegative contacts.

Vaccination with measles and/or rubella viruses can temporarily suppress tuberculin skin reactivity. If a tuberculin skin test is to be performed, it should be done before or concurrently with vaccination. Immunization with MoRu-Viraten Berna vaccine may not engender a 100% seroconversion rate in susceptible individuals.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals with MoRu-Viraten Berna vaccine have not been performed to evaluate carcinogenic potential, mutagenic potential or impairment of fertility.

Pregnancy: Category C: Animal reproductive studies have not been conducted with MoRu-Viraten Berna vaccine. It is not known whether this vaccine can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Therefore, the vaccine should not be administered to pregnant women. In addition, pregnancy should be avoided for a period of 3 months following vaccination (see Contraindications).

Lactation: It is not known if measles virus is excreted in human milk. Studies have shown that lactating women who have been immunized with live rubella virus vaccine can secrete the virus in breast milk and transmit it to breast-feeding infants. Therefore, caution should be exercised when MoRu-Viraten Berna vaccine is administered to nursing mothers.

Adverse Reactions: The adverse events reported with the administration of MoRu-Viraten Berna vaccine are similar to those associated with the use of the individual vaccine components, or with the use of a combined measles, mumps and rubella vaccine.

Local: Local reactions reported include tenderness at the injection site, erythema, swelling, induration, a wheal and flare reaction or urticaria at the injection site. Rash is an infrequent reaction and is usually localized but can be generalized in rare cases.

Systemic: Systemic reactions are characterized by moderate fever (38.3 to 39.4°C), which is an occasional occurrence. High fever (>39.4°C) is a far less common reaction. Rarely will children who develop fever present with convulsions. Malaise, headache, nausea, runny nose, conjunctivitis, sore throat, respiratory tract symptoms, localized lymphadenopathy, rash, deafness, purpura and thrombocytopenia have also been associated with MoRu-Viraten Berna vaccine, the individual vaccine components or similar vaccines.

Natural rubella infection is characterized by transient or intermittent arthritis, arthralgia and polyneuritis. The appearance and severity of such symptoms are dependent upon both age and sex, being most pronounced in adult females and least severe in prepubertal children. A similar syndrome, which also includes myalgia and paresthesia, has been reported following the administration of live attenuated rubella virus vaccine. Chronic arthritis is often associated with natural rubella infection. Similar symptomatology is rarely observed in recipients of live attenuated rubella virus vaccines.

Children: Immunized children infrequently present with joint symptomatology, which is usually transient.

The incidence of joint symptoms, such as arthralgia and arthritis, is higher among women than children. In general, such reactions are more severe and of a longer duration in women than in children. The severity and persistence of such symptoms appear to be intermediate in adolescent girls. In all age groups of females, joint symptoms are rarely debilitating.

CNS Involvement: Optic neuritis, papillitis and retinitis may be associated with naturally acquired viral infections. These symptoms have also been reported approximately 1 to 4 weeks following immunization with some types of live attenuated viral vaccines.

Encephalitis, in addition to other CNS reactions, has been reported as a very rare occurrence associated with the use of live attenuated measles and rubella vaccine. Such reactions may also occur following immunization with MoRu-Viraten Berna vaccine.

Clinical experience in the U.S. through 1975, involving more than 80 million doses of live attenuated measles vaccine, has shown that a single case of significant CNS involvement occurring within 30 days of vaccination has been temporally associated with the administration of 1 million doses of vaccine. In no instance was the cause of such reactions identified as the vaccine. The U.S. Centers for Disease Control has stated 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, there are data to indicate that 1 or more of these cases may have been caused by measles vaccines. The risk of such serious CNS disorders associated with the use of live attenuated measles vaccines is much less than for encephalitis and encephalopathy associated with natural measles (1/1 000 cases reported). Cases of subacute sclerosing panencephalopathy (SSPE) have been reported in children who have received measles vaccine. These children had no history of having had naturally acquired measles. The association of SSPE to measles vaccination is approximately 1 case/million doses of measles vaccine distributed in the U.S. Following natural measles infection, it is estimated that 6 to 22 cases of SSPE will occur per million cases of measles. The U.S. Centers for Disease Control has reported that data from a retrospective case-controlled study has shown that the use of measles vaccine has reduced the overall risk of SSPE by preventing natural measles infections with their inherent higher risk of subsequent SSPE.

Dosage And Administration: The dose for all ages is the same, being 0.5 mL of reconstituted vaccine.

Prior to administration, the skin at the injection site should be cleansed with a suitable germicide. The vaccine is to be administered s.c. preferably at the deltoid region of the upper arm. After insertion of the needle, aspirate to prevent accidental injection into a blood vessel. Do not administer by either the i.m. or intradermal route.

Do not administer immune globulin simultaneously with MoRu-Viraten Berna vaccine.

A separate sterile needle and syringe should be used to administer each dose of vaccine to prevent the spread of adventitious infectious agents.

Stability and Storage Recommendations: Store refrigerated at 2 to 8°C away from freezer compartment. Do not freeze. Protect from light.

Reconstitution: Prior to reconstitution the appearance of each vial of vaccine and diluent (sterile water for injection, USP) should be checked. The vaccine should appear as a white to off-white powder, while the diluent should appear as a clear liquid. Only the diluent supplied should be used for reconstitution of the vaccine. The cap of the vaccine and diluent vials should be removed and the top cleaned with a suitable germicide. The entire contents of the diluent vial should be transferred to the vaccine vial using a sterile needle and syringe. The vaccine vial should then be gently rotated to dissolve the lyophilized vaccine. The reconstituted vaccine should be red to yellow-reddish in color and clear. Discard if it appears otherwise.

Immediately prior to use, the vial should be inspected for particulate matter and discoloration. The entire contents of the vial should be used within 1 hour of reconstitution since no preservative is included.

Availability And Storage: Each sterile, lyophilized preparation, contains: 31 000 TCID50 (tissue culture infectious dose) of each vaccine virus. Antibiotic-, avian protein- and preservative-free. Single dose vials of 0.5 mL. Boxes of 1, 10 and 50, together with 1, 10 and 50 vials of diluent respectively. Each diluent vial contains 0.5 mL of sterile water for injection, USP.

MoRu-Viraten BERNA™ Berna Products Measles and Rubella Virus Vaccine, Live, Attenuated Active Immunizing Agent

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