This medication is a vaccine used to prevent tuberculosis (TB) in people who have not been infected with the disease but are at a high risk of getting it. This medication is not used to treat tuberculosis.
This medication contains live bacteria that have been weakened. It works by causing the body to produce its own protection (antibodies) against the bacteria that causes tuberculosis.
This form of the medication is not used to treat or prevent bladder cancer.
Dosage is based on your age.
Pain at injection site or swollen lymph nodes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
A small red bump may occur at the injection site. This bump will later crust and fall off 6 to 10 weeks later. A small, flat scar may remain.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: skin sores/bumps, pus at injection site.
Tell your doctor immediately if any of these rare but very serious side effects occur: bone pain, signs of infection (e.g., persistent fever).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.
Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as monosodium glutamate, polysorbate 80, latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: immune system problems (e.g., HIV, certain cancers such as leukemia/lymphoma), radiation treatment, burns or skin disease over large area of skin, positive tuberculin skin test.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infection/fever.
This medication is not recommended for use during pregnancy. Consult your doctor for more details.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: antibiotics (such as drugs to treat tuberculosis including isoniazid, rifampin, ethambutol, pyrazinamide), drugs that weaken the immune system (such as abatacept, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone), mefloquine.
Other vaccines may be given at the same time as this vaccine, but they should be given with separate syringes and at different injection sites. If the BCG vaccine cannot be given at the same time as other live vaccines, then it should be given at least 4 weeks later.
This medication may interfere with the tuberculin skin test, possibly causing false test results. Before having this skin test, make sure that your doctor knows that you have received this vaccine.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
As with any vaccine, this vaccine may not fully protect everyone who receives it.
Keep vaccine records for yourself and all of your children, and provide them to their doctors and to your children after they are grown. This will prevent unnecessary re-vaccinations.
Store in the refrigerator. Do not freeze. Protect from light. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised July 2014. Copyright(c) 2014 First Databank, Inc.
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