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BCG (Bacillus Calmette-Guerin) Vaccine

BCG (Bacillus Calmette-Guerin) Vaccine is used for:

Treating cancer of the bladder.

BCG (Bacillus Calmette-Guerin) Vaccine is a strain of bacteria. How it works is not fully known. It is thought to stimulate the immune system.

Do NOT use BCG (Bacillus Calmette-Guerin) Vaccine if:

• you are allergic to any ingredient in BCG (Bacillus Calmette-Guerin) Vaccine
• you have a history of sepsis, urinary tract infections or a large amount of blood in the urine, or HIV- or AIDS-related conditions
• you are receiving cancer therapy (eg, cytotoxic medicines, radiation therapy) or are taking medicines that suppress the immune system (eg, corticosteroids [eg, hydrocortisone])
• you have active tuberculosis (TB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using BCG (Bacillus Calmette-Guerin) Vaccine :

Some medical conditions may interact with BCG (Bacillus Calmette-Guerin) Vaccine . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you recently had urinary tract surgery or a you have a weakened immune system

Some MEDICINES MAY INTERACT with BCG (Bacillus Calmette-Guerin) Vaccine . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cancer therapy (eg, cytotoxic medicines, radiation therapy) or corticosteroids (eg, hydrocortisone) because the risk of serious, life-threatening infections is increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if BCG (Bacillus Calmette-Guerin) Vaccine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use BCG (Bacillus Calmette-Guerin) Vaccine :

Use BCG (Bacillus Calmette-Guerin) Vaccine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• BCG (Bacillus Calmette-Guerin) Vaccine is usually administered by catheter through the urinary tract at your doctor"s office, hospital, or clinic. If you are using BCG (Bacillus Calmette-Guerin) Vaccine at home, carefully follow the injection procedures taught to you by your health care provider. Ask your doctor or pharmacist any questions that you may have about BCG (Bacillus Calmette-Guerin) Vaccine .
• Fluid intake should be increased in order to "flush" the bladder in the hours following treatment with BCG (Bacillus Calmette-Guerin) Vaccine . Ask your doctor or pharmacist for instructions.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• After you receive BCG (Bacillus Calmette-Guerin) Vaccine , lay on your back, front, and each side for 15 minutes each while retaining the solution in your bladder. You may then stand up, but try to retain the solution for another 60 minutes before emptying your bladder. After retaining the solution for 2 hours, all patients should sit down to urinate.
• Dilute all urine for up to 6 hours after receiving BCG (Bacillus Calmette-Guerin) Vaccine with an equal amount of household bleach. Wait 15 minutes before flushing.
• If you miss a dose of BCG (Bacillus Calmette-Guerin) Vaccine , contact your doctor right away.

Ask your health care provider any questions you may have about how to use BCG (Bacillus Calmette-Guerin) Vaccine .

Important safety information:

• BCG (Bacillus Calmette-Guerin) Vaccine may lower your resistance to infection. Prevent infection by avoiding contact with people who have an infection. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first.
• The use of birth control is recommended while you or your sexual partner is using BCG (Bacillus Calmette-Guerin) Vaccine . Do not become pregnant while using BCG (Bacillus Calmette-Guerin) Vaccine .
• BCG (Bacillus Calmette-Guerin) Vaccine is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using BCG (Bacillus Calmette-Guerin) Vaccine during pregnancy. It is unknown if BCG (Bacillus Calmette-Guerin) Vaccine is excreted in breast milk. Do not breast-feed while taking BCG (Bacillus Calmette-Guerin) Vaccine .

Possible side effects of BCG (Bacillus Calmette-Guerin) Vaccine :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; increased pain or frequency of urination; loss of appetite; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; burning or pain when urinating; chills; cough; fever; flu-like symptoms; frequent or urgent urination; general feeling of discomfort; joint pain; tiredness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

BCG (Bacillus Calmette-Guerin) Vaccine is usually handled and stored by a health care provider. If you are using BCG (Bacillus Calmette-Guerin) Vaccine at home, store BCG (Bacillus Calmette-Guerin) Vaccine as directed by your pharmacist or health care provider. Keep BCG (Bacillus Calmette-Guerin) Vaccine out of the reach of children and away from pets.

General information:

• If you have any questions about BCG (Bacillus Calmette-Guerin) Vaccine , please talk with your doctor, pharmacist, or other health care provider.
• BCG (Bacillus Calmette-Guerin) Vaccine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about BCG (Bacillus Calmette-Guerin) Vaccine . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.