Finished product reference
Bcg
Injection, Powder, Lyophilized, for Suspension · Percutaneous · 1.5 mg
- List code
- 1403
- Pharmacologic class
- Live attenuated bacterial vaccine; intravesical immunotherapy
What it is and how it works
BCG (bacillus Calmette–Guérin) is a live attenuated strain of Mycobacterium bovis. Given intradermally or percutaneously it induces cell-mediated immunity against tuberculosis; instilled into the bladder it provokes a local inflammatory and immune response that destroys superficial tumour cells.
Indications
Active immunisation against tuberculosis (especially in infants and high-risk unvaccinated tuberculin-negative individuals); intravesical treatment of carcinoma in situ of the bladder and prophylaxis of recurrence of non-muscle-invasive (Ta/T1) urothelial carcinoma after transurethral resection.
Dosage and administration (summary)
Vaccine: a single dose by intradermal or percutaneous administration according to the product and age (e.g. 0.05 mL intradermally under 12 months, 0.1 mL in older children and adults for intradermal products). Intravesical: one instillation weekly for 6 weeks (induction), followed by maintenance instillations according to protocol, retained in the bladder for about 2 hours.
Contraindications
Immunodeficiency (congenital, HIV infection, immunosuppressive therapy or malignancy), pregnancy, active tuberculosis or positive tuberculin test (vaccine); for intravesical use additionally active urinary tract infection, gross haematuria and recent traumatic catheterisation or TURBT (usually wait 2 weeks).
Warnings and precautions
Local ulceration, abscess and regional lymphadenitis can follow vaccination; disseminated BCG infection is a serious risk in immunocompromised persons. Intravesical BCG commonly causes cystitis, frequency and fever, and rarely systemic BCG infection (BCG-osis) requiring anti-tuberculous therapy. Handle as biohazardous material, with appropriate disposal and patient advice on urine hygiene.
Pregnancy
Contraindicated in pregnancy.
Storage and supply
Store at 2–8 °C, protected from light; use reconstituted vaccine promptly (typically within a few hours).
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.