Europe — EMA
Onko Bcg 100
Live BCG Bacilli (Bacillus Calmette‑Guerin) Brazilian Moreau strain, the active ingredient in Onko Bcg 100, is a BCG vaccine presented as a live bacterial suspension for intravesical use.
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What is Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain?
Live BCG Bacilli (Bacillus Calmette‑Guerin) Brazilian Moreau strain, the active ingredient in Onko Bcg 100, is a BCG vaccine presented as a live bacterial suspension for intravesical use. It is employed in immunotherapy for bladder cancer and related urological indications.
GNH USA supplies Onko Bcg 100 as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain used for?
Onko Bcg 100 is a BCG‑based immunotherapy that acts on the urothelial carcinoma pathway. - Non‑muscle‑invasive bladder cancer: reduces the risk of tumour recurrence and progression. - High‑risk carcinoma in situ of the bladder: induces durable remission remission remission. - Recurrent superficial bladder tumours: helps prevent recurrence after transurethral resection.
What are the side effects of Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain?
Adverse reactions to intravesical BCG are generally related to local bladder irritation and systemic immune activation.
Common Side Effects: - Dysuria: mild burning sensation during urination. - Hematuria: presence of blood in urine. - Urinary frequency: increased urge to void. - Low‑grade fever: transient temperature rise. - Fatigue: mild tiredness. - Irritative cystitis symptoms: urgency and suprapubic pain.
Serious or Rare Side Effects: - BCG‑induced sepsis: systemic infection with fever and hypotension. - Disseminated mycobacterial infection: involvement of liver, lungs, or bone. - Severe allergic reactions: anaphylaxis or urticaria. - Persistent high‑grade fever lasting >48 h. - Granulomatous prostatitis: prostate inflammation with pain. - Renal involvement leading
What precautions apply to Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain?
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