Mycobacterium Bovis BCG Culture

Registered South African indications:

• Instillation in the urinary tract after transurethral resection
• Immunoprophylaxis in primary or recurrent grade Ta or T1 superficial bladder cancer
• Immunotherapy treatment of non-invasive carcinoma in-situ of the bladder

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Clinically verified or suspected active tuberculosis. Active tuberculosis should be excluded in patients with a positive Mantoux test before beginning treatment
• Treatment with anti-tuberculosis medicines such as isoniazid, rifampicin, and ethambutol
• Reduced immune response, including active HIV disease, regardless of whether congenital or triggered by illness, medication, or other treatment, e.g., high-dose systemic corticosteroid therapy
• Pregnancy
• Breastfeeding
• Medical history including radiation therapy of the bladder

Cautions

• Renal impairment
• Hepatic impairment
• Elderly
• Urinary tract infection
• Unexplained fever
• Traumatised urothelium

Forms avail. in SA and covered in this monograph: inj

Used for the treatment of

Instillation in the urinary tract after transurethral resection
Immunoprophylaxis in primary or recurrent grade Ta or T1 superficial bladder cancer
Immunotherapy treatment of non-invasive carcinoma in-situ of the bladder

Consult specialist for dosages and regimens

No information available

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Malaise

Genitourinary Disorders

• Increased urinary frequency
• Cystitis
• Haematuria
• Bladder contraction 
• Temporary urethral obstructions

Musculoskeletal Disorders

• Myalgia
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Rash

Immune, Blood and Lymphatic System Disorders

• Mild systemic influenza-like reactions
• Fever 
• Chills
• Allergic reactions

• Immuno-suppressive drugs
• Systemic corticosteroid therapy
• Anti-mycobacterial agents
• Anti-tuberculosis agents
• Aminoglycosides 
• Fluoroquinolones

None routine

The effect of BCG against carcinoma is not completely understood. It may be related to an inflammatory response and possibly also to an immune response. Intravesical BCG suspension produces a granulomatous response locally and in regional lymph nodes; the inflammatory response stimulates production of macrophages that have tumoricidal effects. However, the relationship of these effects to the antineoplastic effect of BCG is unknown.

Injection (per vial) 30mg

• BCG Culture SSI (Litha) originator