Rubella Virus Vaccine, Live Solution for injection

What is this medicine?

RUBELLA VIRUS VACCINE LIVE (roo BEL uh VAHY ruhs vak SEEN lahyv) is used to prevent infections with the rubella virus (German measles).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• fever or infection

• immune system problems

• low blood counts, like low white cell, platelet, or red cell counts

• tuberculosis

• an unusual or allergic reaction to vaccines, neomycin, albumin, gelatin, sorbitol, beef products, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This vaccine is for injection under the skin. It is given by a health care professional.

A copy of Vaccine Information Statements will be given before each vaccination. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 months old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep all appointments for follow up doses. Your health care provider will tell you when to return for the next vaccine. Ask your health care professional for advice if you are unable to keep an appointment or miss a scheduled dose.

What may interact with this medicine?

• adalimumab

• anakinra

• immunoglobulins

• infliximab

• medicines that suppress your immune system

• medicines to treat cancer

• steroid medicines like prednisone or cortisone

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Contact your doctor or health care professional and seek emergency medical care if any serious side effects occur.

This vaccine, like all vaccines, may not fully protect everyone.

Do not have a tuberculin skin test and this vaccination at the same time. This vaccine can reduce skin reactions to the tuberculin test. Do not receive this vaccination within 3 months of blood or plasma transfusions or immunoglobulin injections; these can block the effects of the vaccine.

This medicine is made from human blood. It may be possible to pass an infection in this medicine. Talk to your doctor about the risks and benefits of this medicine.

Do not become pregnant for 3 months after taking this vaccine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• arthritis pain

• breathing problems

• changes in hearing

• changes in vision

• extreme changes in behavior

• feeling faint or lightheaded, falls

• fever over 102 degrees F

• pain, tingling, numbness in the hands or feet

• unusual bruising or bleeding

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches or pains

• bruising, pain, swelling at site where injected

• diarrhea

• low-grade fever under 102 degrees F

• nausea, vomiting

• runny nose, cough, sore throat

• swollen glands

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.