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In the U.S.—

Meruvax II

In Canada—

Meruvax II

• Immunizing agent, active

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

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. While immunization against rubella is recommended for everyone, it is especially important for women of child-bearing age.

Immunization against rubella is also important for employees in medical facilities, adolescents and adult men, persons traveling outside the U.S., and all children 12 months of age and older, including school-aged children.

Immunization against rubella is not recommended for infants less than 12 months of age, because antibodies they received from their mothers before birth may interfere with the effectiveness of the vaccine. Children who were immunized against rubella before 12 months of age should be immunized again.

You can be considered immune to rubella only if you received rubella vaccine on or after your first birthday and have the medical record to prove it, or if you have had a blood test showing immunity to rubella. A past history of having a rubella infection does not prove immunity, because the signs of rubella infection are not reliable enough to be certain that you have had the disease.

Since vaccination with rubella vaccine may not provide protection for everyone, you may want to ask your doctor to check your immunity to the rubella virus 6 to 8 weeks following your vaccination. This may be especially important if you are a woman of child-bearing age who is likely to become pregnant in the future.

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. and Canada)

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 vaccine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to rubella vaccine, 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. Vaccination during pregnancy or within 3 months of pregnancy is not recommended.

Breast-feeding—Rubella vaccine may pass into the breast milk. However, studies have not shown that this causes any problems.

Children—Use is not recommended for infants less than 12 months of age. This medicine has been tested in older infants and children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

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 vaccine, it is especially important that your health care professional know if you have received any of the following:

• Cancer medicines or
• Corticosteroids (e.g., cortisone-like medicines) or
• Radiation therapy—May reduce the useful effect of the vaccine

Other medical problems—The presence of other medical problems may affect the use of rubella vaccine. 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

Dosing—

The dose of rubella vaccine will be different for different patients. The following information includes only the average dose of rubella vaccine.

• For injection dosage form:
  • For prevention of rubella:
    • 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.

Do not become pregnant for 3 months after receiving rubella vaccine without first checking with your doctor. There is a chance that this vaccine may cause birth defects.

Tell your doctor that you have received this vaccine:

• 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.
• if you are to receive blood transfusions or other blood products within 2 weeks after receiving this vaccine.
• if you are to receive gamma globulin or other immune globulins within 2 weeks after receiving 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.

Get emergency help immediately if any of the following side effects occur:

• Symptoms of allergic reaction
  • Difficulty in breathing or swallowing;  hives;  itching, especially of feet or hands;  reddening of skin, especially around ears;  swelling of eyes, face, or inside of nose;  unusual tiredness or weakness (sudden and severe) 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Pain or tenderness of eyes 
  
  

• Rare
  • Bruising or purple spots on skin;  confusion ;  convulsions (seizures);  headache (severe or continuing);  pain, numbness, or tingling of hands, arms, legs, or feet;  stiff neck;  unusual irritability;  vomiting 
  
  

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:

• More common
  • Burning or stinging at place of injection;  skin rash;  swelling of glands in neck 
  
  

• Less common
  • Aches or pain in joints;  headache (mild), sore throat, runny nose, or fever;  itching, swelling, redness, tenderness, or hard lump at place of injection;  nausea;  vague feeling of bodily discomfort 
  
  

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

Some of the above side effects may not occur until 1 to 4 weeks after immunization and usually last less than 1 week. Aches or pain in joints may not occur until 1 to 10 weeks after immunization, and usually lasts less than 1 week. Check with your doctor if this side effect continues or is bothersome.

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

Revised: 07/23/1997