This vaccine is used to help prevent tuberculosis (TB). It is recommended for people who have not been infected with the disease but are at an increased risk of getting it. Those at increased risk include certain health care personnel and children who live with or spend much time with people with tuberculosis.

This vaccine contains live bacteria that have been weakened. It works by increasing the body's natural defense (immunity) against the bacteria.

Vaccines may not fully protect everyone who receives them.

This form of the vaccine is not used to treat or prevent bladder cancer.

This vaccine is given by injection into the skin by a health care professional. It is given in the upper arm area. After injection, the injection site should be loosely covered and kept dry for 24 hours.

This vaccine may be given at the same time as other vaccines.

Pain at the injection site, muscle aches, fever, or swollen lymph nodes may occur. If any of these effects last or get worse, tell your health care professional promptly.

Small red bumps may occur at the injection site. These bumps will later crust and fall off 6 to 10 weeks later. A small, flat scar may remain.

Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.

Remember that this vaccine has been prescribed because your health care professional has judged that the benefit to you is greater than the risk of side effects. Many people using this vaccine do not have serious side effects.

Tell your health care professional right away if you have any serious side effects, including:

• sores/pus at the injection site
• bone pain
• high fever (103 degrees F/39 degrees C or higher)

A very serious allergic reaction to this vaccine is rare. However, get medical help right away 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 health care professional.

Contact the health care professional 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 call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

Before you receive this vaccine, tell the health care professional 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 health care professional for more details.

Before receiving this vaccine, tell your health care professional your medical history, especially of:

• current fever/illness
• positive tuberculin skin test
• immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment)
• burns or skin disease over large area of skin
• vaccination history (including previous reactions to any vaccines)

This vaccine is not recommended for use during pregnancy. Consult your health care professional for more details.

It is unknown if this vaccine passes into breast milk. Consult your health care professional before breastfeeding.

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 health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this vaccine are:

• antibiotics (such as drugs to treat tuberculosis including isoniazid, rifampin, ethambutol, pyrazinamide)
• drugs that weaken the immune system (such as cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone)
• mefloquine

This vaccine may interfere with certain lab tests (such as TB skin test), possibly causing false test results. Make sure lab personnel and all your doctors know you recently received this vaccine.

Not applicable.

Keep all medical and lab appointments.

Keep vaccine records for yourself and your children and provide them to the health care professionals to prevent unnecessary re-vaccinations.

Not applicable.

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.