Onco Bcg 40Mg Dry Vial Of 1 Powder For Vaccine

• For flat urothelial cell carcinoma in situ (CIS) of the bladder
• As adjunct therapy following transurethral resection (TUR) of primary or recurrent superficial papillary urothelial cell carcinoma (stage Ta, T1)

• In people who are immunosuppressed or who have congenital or acquired immune deficiency, whether due to a disease such as HIV/AIDS, leukaemia or lymphoma, or due to cancer treatment such as cytotoxic medicines or radiation, or due to immunosuppressive treatment such as corticosteroids
• In people with active tuberculosis. Active tuberculosis should be ruled out in anyone who is PPD positive before treatment is started
• In people with a concurrent infection
• Treatment must be postponed until a fever, urinary tract infection or visible blood in the urine has resolved
• Treatment must be postponed for a period after bladder biopsy, transurethral resection or a traumatic catheterisation, as instillation onto actively bleeding bladder lining may promote body-wide BCG infection

• Painful or burning urination (dysuria)
• Increased frequency of urination
• Flu-like symptoms such as malaise, fever and chills
• Blood in the urine (haematuria)
• Fever
• Tiredness and general unwellness
• Inflammation of the bladder (cystitis)
• Urgency to pass urine
• Passing urine at night (nocturia)
• Cramps or pain
• Rigors (shivering)
• Nausea and vomiting
• Joint pain or muscle pain
• Headache and dizziness
• Loss of urinary control (incontinence)
• Loss of appetite and weight loss
• Debris in the urine
• Allergic reactions
• Inflammation or abscess of the genitals
• Urinary tract infection
• Abdominal pain
• Serious but less common effects include BCG sepsis and infection spreading to other organs such as the lung, liver, bone, bone marrow, kidney, lymph nodes and prostate; inflammation of the testicle or epididymis; hepatitis; pneumonitis; low blood counts; and a contracted bladder

Other General Warnings

• You develop a fever with flu-like symptoms that lasts more than a few days, a high fever, or symptoms that get worse with each instillation, as these may suggest a body-wide BCG infection.
• You develop pain or swelling of the testicle, epididymis or prostate that lasts more than two to three days, as this may suggest active infection.
• You have severe burning or pain on passing urine, urgency, increased frequency, or blood in the urine.
• You develop joint pain, cough or a skin rash.
• You have or have had tuberculosis, or you have a positive tuberculin (PPD) skin test. Your tuberculin reactivity should be checked before treatment is started, because this treatment can itself cause tuberculin sensitivity.
• You have any condition or take any medicine that lowers your immunity, or you are in a group at high risk of HIV infection.
• You have a small bladder capacity, as this has been associated with a higher risk of severe local reactions.
• You are being treated with antibiotics for any other infection.
• Treatment should be stopped and you should be assessed immediately if you develop a persistent fever or an acute feverish illness consistent with BCG infection. Treating such infection requires long-term treatment with more than one antibiotic, under specialist care.
• Safety and effectiveness in children have not been established.

• Onco Bcg Powder For Vaccine is given by a doctor or trained nurse in a hospital or clinic. It is instilled into the bladder through a catheter by gravity flow.
• It must never be injected under the skin or into a vein.
• Do not drink fluids for the period before treatment advised by your doctor, and empty your bladder before the instillation.
• While the medicine is held in the bladder you may be asked to change position, lying on your left side, right side, back and front in turn, so that the whole bladder lining is exposed to it.
• Hold the medicine in the bladder for the time your doctor advises and then pass urine. Tell the staff if you cannot hold it for that long.
• Pass urine sitting down after treatment to avoid splashing.
• For the period advised by your hospital, disinfect the urine you pass with an equal volume of household bleach before flushing.
• Increase your fluid intake afterwards to flush the bladder. You may feel burning when you first pass urine after treatment.

• Intact vials are stored refrigerated at 2–8°C.
• This medicine contains live bacteria and must be protected from direct sunlight.
• It is prepared, handled and disposed of as biohazardous material by trained healthcare staff. All equipment and containers that come into contact with it are discarded as biohazardous waste.
• Do not use it after the expiry date printed on the label.
• Keep it out of the reach of children and pets.

Overdose

Missed a Dose

Interactions with other medicines

• Medicines that suppress the immune system, medicines that depress the bone marrow, and radiation interfere with the development of the immune response and should not be used together with Onco Bcg Powder For Vaccine.
• Antimicrobial (antibiotic) treatment for other infections may interfere with how well this medicine works, so instillations are postponed during antibiotic treatment.
• Antituberculosis medicines such as isoniazid should not be used to prevent or treat the local bladder irritation caused by this treatment.
• BCG is sensitive to commonly used antituberculous agents such as isoniazid, rifampicin and ethambutol, but is not sensitive to pyrazinamide. This matters if treatment for a BCG infection becomes necessary.
• Tell your doctor about all prescription medicines, over-the-counter medicines, supplements and herbal products you take.

Interactions with food items

• There are no specific food interactions with Onco Bcg Powder For Vaccine. However, you should not drink fluids for the period before the instillation advised by your doctor, and you should increase your fluid intake afterwards to help flush the bladder.