M-M-R II

It works by causing your body to produce its own protection (antibodies) against the virus.

Measles (also known as coughing measles, hard measles, morbilli, red measles, rubeola, and 10-day measles) is an infection that is easily spread from one person to another. Infection with measles can cause serious problems, such as stomach problems, pneumonia, ear infections, sinus problems, convulsions (seizures), brain damage, and possibly death. The risk of serious complications and death is greater for adults and infants than for children and teenagers.

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 (miscarriage) in women during the first 3 months of pregnancy.

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 measles, mumps, and rubella 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 measles, mumps, and rubella vaccine is to be given to a child, the child should be at least 12 months of age. This is to make sure the measles vaccine is effective . In a younger child, antibodies from the mother may interfere with the effectiveness of the vaccine .

This vaccine should be administered only by or under the supervision of your doctor or other health care professional .

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use is not recommended for infants younger than 12 months of age, unless the risk of measles infection is high . Waiting until children are at least 12 months of age is important because antibodies that infants receive from their mothers before birth may interfere with the effectiveness of the vaccine . There may be special reasons why children between 6 months and 12 months of age also may require measles vaccination.

Pregnancy

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aclarubicin


• Adalimumab


• Aldesleukin


• Alemtuzumab


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Azacitidine


• Azathioprine


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Certolizumab Pegol


• Chlorambucil


• Cisplatin


• Cladribine


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etanercept


• Etoposide


• Floxuridine


• Fludarabine


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Golimumab


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Meningococcal Vaccine


• Mercaptopurine


• Methotrexate


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Mycophenolic Acid


• Oxaliplatin


• Paclitaxel


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Procarbazine


• Raltitrexed


• Rilonacept


• Rituximab


• Sirolimus


• Streptozocin


• Tacrolimus


• Teceleukin


• Tegafur


• Temsirolimus


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Trimetrexate


• Trofosfamide


• Uracil Mustard


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept


• Leflunomide

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine . Make sure you tell your doctor if you have any other medical problems, especially:

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

• Severe illness with fevera€”The symptoms of the condition may be confused with the possible side effects of the vaccine

Proper Use

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  
  
  • For prevention of measles, mumps, and rubella:
    
    
    
    • Adults and children 12 months of age and oldera€”One dose injected under the skin .
    
    
    • Children up to 12 months of agea€”Use is not recommended .
    
    
    
    
  
  
  
  

Precautions

Do not become pregnant for 3 months after receiving measles, mumps, and rubella vaccine . 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 8 weeks after receiving this vaccine . The results of the test may be affected by this vaccine .


• If you are to receive any other live virus vaccines within 1 month after receiving 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 globulins within 2 weeks after receiving this vaccine .

Side Effects

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

Check with your doctor 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:

More common

• Fever higher than 103 A°F (39.4 A°C)

Less common

• Pain or tenderness of eyes

Rare

• Bruising or purple spots on skin


• Confusion


• Convulsions (seizures)


• Double vision


• Headache (severe or continuing)


• Irritability


• Pain, numbness, or tingling of hands, arms, legs, or feet


• Pain, tenderness, or swelling in testicles and scrotum


• Stiff neck


• Vomiting

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning or stinging at place of injection


• Fever between 100 and 103 A°F (37.7 and 39.4 A°C)


• Skin rash


• Swelling of glands in neck

Less common

• Aches or pain in joints


• Headache (mild)


• Itching, swelling, redness, tenderness, or hard lump at place of injection


• Nausea


• Runny nose


• Sore throat


• Vague feeling of bodily discomfort

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

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.