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|BIAVAX II

RUBELLA AND MUMPS VIRUS VACCINE LIVE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• BIAVAX II

† Not commercially available in Canada.

Category

• Immunizing agent, active

Description

Rubella (rue-BELL-a) and mumps virus vaccine live is an active immunizing agent used to prevent infection by the rubella and mumps viruses. It works by causing your body to produce its own protection (antibodies) against the virus.

Rubella (also known as German measles) is a serious infection that causes miscarriages, stillbirths, or birth defects in unborn babies when pregnant women get the disease.

Mumps is an infection that can cause serious problems, such as encephalitis and meningitis, which affect the brain. In addition, adolescent boys and men are very susceptible to a condition called orchitis, which causes pain and swelling in the testicles and scrotum and, in rare cases, sterility. Also, mumps infection can cause spontaneous abortion in women during the first 3 months of pregnancy.

While immunization against rubella and mumps is recommended for all persons 12 months of age and older, it is especially important for women of childbearing age and persons traveling outside the U.S.

If rubella and mumps virus vaccine live is to be given to a child, the child should be at least 12 months of age. This is to make sure the vaccine is effective. In a child less than 12 months of age, antibodies from the mother may prevent the vaccine from working.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional. It is available in the following dosage form:

• Parenteral
• Injection (U.S.)

Before Receiving This Vaccine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rubella and mumps virus vaccine live, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to rubella and mumps virus vaccine live, to the antibiotic neomycin, or to gelatin. Also tell your health care professional if you are allergic to any other substances, such as preservatives.

Pregnancy—Tell your doctor if you are pregnant or if you may become pregnant within 3 months after receiving this vaccine. Although adequate studies have not been done in either humans or animals and problems have not been shown to occur, use of rubella and mumps virus vaccine live during pregnancy, or becoming pregnant within 3 months after receiving rubella and mumps virus vaccine live, is not recommended. Rubella vaccine virus crosses the placenta. However, the Centers for Disease Control and Prevention monitored more than 200 women who received the vaccine within 3 months before or after becoming pregnant and those women gave birth to normal babies. Mumps vaccine virus may infect the placenta, although the vaccine has not been shown to infect the fetus or to cause birth defects.

Breast-feeding—Rubella vaccine virus may pass into breast milk. However, this vaccine has not been reported to cause problems in nursing babies.

Children—Use of this vaccine is not recommended for infants younger than 12 months of age. Children who received the vaccine when younger than 12 months of age should receive another dose of vaccine at 12 to 15 months of age.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Before you receive rubella and mumps virus vaccine live, it is especially important that your health care professional know if you have received any of the following:

• Cancer medicines or
• X-ray treatment—May reduce the useful effect of the vaccine

Other medical problems—The presence of other medical problems may affect the use of rubella and mumps virus vaccine live. Make sure you tell your doctor if you have any other medical problems, especially:

• Immune deficiency condition (or family history of)—Condition may increase the chance and severity of side effects of the vaccine and/or may decrease the useful effects of the vaccine

• Severe illness with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine

Proper Use of This Vaccine

Dosing—The following information includes only the average dose of rubella and mumps virus vaccine live.

• For injection dosage form:
  • For prevention of rubella and mumps:
    • Adults and children 12 months of age and older—One dose injected under the skin.
    • Children up to 12 months of age—Use is not recommended.

Precautions After Receiving This Vaccine

Do not become pregnant for 3 months after receiving rubella and mumps virus vaccine live without first checking with your doctor . There may be a chance that this vaccine can cause birth defects.

Tell your doctor that you have received this vaccine:

• If you are to receive blood products or immune globulins within 14 days of receiving this vaccine
• If you are to receive this vaccine within 3 months of receiving blood products or immune globulin
• If you are to receive a tuberculin skin test within 4 to 6 weeks after receiving this vaccine. The results of the test may be affected by this vaccine.

Side Effects of This Vaccine

Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. However, check with your doctor if any of the following side effects continue or are bothersome:

The above side effects (especially aches or pain in joints) are more likely to occur in adults, particularly women.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 04/29/1997

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