TheraCys, BCG Live (Intravesical) is a freeze-dried preparation made from the Connaught strain of Bacillus Calmette and Gu?rin, which is an attenuated strain of Mycobacterium bovis.

The BCG organisms in the product are grown on media containing potatoes, glycerine, asparagine, citric acid, potassium phosphate, magnesium sulfate, ferric ammonium citrate, calcium chloride, copper sulfate and zinc sulfate. Monosodium glutamate is added to the BCG organisms prior to freeze-drying.

Each vial of TheraCys (bcg live intravesical) contains 81 mg of freeze-dried BCG. Prior to use, each vial is reconstituted with the accompanying diluent (3 mL), which contains 0.85% w/v sodium chloride, 0.025% w/v polysorbate 80, 0.06% w/v sodium dihydrogen phosphate and 0.25% w/v disodium hydrogen phosphate. Neither the freeze-dried BCG nor the diluent contain preservative.

One dose of TheraCys (bcg live intravesical) consists of one 81mg vial of reconstituted material further diluted in 50 mL sterile, preservative-free saline.

The BCG organisms are viable upon reconstitution. In vitro potency is determined by an assay of the number of colonies grown on solid medium. The reconstituted product contains 10.5 ?± 8.7 x 10⁸ colony-forming units (CFU) per vial when resuspended in the diluent provided.

SIDE EFFECTS: Bladder irritation (e.g., difficult/painful/frequent/bloody urination), fever, or chills may occur. High/persistent fever may be a sign of an infection. Tell your doctor or pharmacist promptly if any of these effects occur, persist, or worsen. Your doctor may prescribe additional medications to help control these symptoms. Nausea, vomiting, loss of appetite, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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: muscle/joint pain, pain/swelling of the testes, unusual tiredness, fast/pounding heartbeat, shortness of breath, cough, vision changes, redness/swelling/pain in the eye, eye sensitivity to light, severe stomach/abdominal pain, yellowing skin/eyes.

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.

PRECAUTIONS: 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 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, current infection/fever (e.g., bladder infection, active tuberculosis), injury/procedure in the bladder within the last 7 days (e.g., catheterization, biopsy, signs of bloody urine).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood vessel disease (aneurysm), man-made medical devices/parts in the body (e.g., pacemakers, artificial joints, arterial grafts).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is recommended that women receiving this medication avoid pregnancy. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while receiving this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.