Vaccine, bcg


Full Generic Medicine Info
Dosage/Direction for Use

Intradermal
Active immunisation against tuberculosis
Adult: 0.1 mL via slow injection into the deltoid muscle.
Child: <12 months: 0.05 mL via slow injection into the deltoid muscle.
Reconstitution: Reconstitute with appropriate volume of solvent provided.

Intravesical
Treatment of carcinoma in situ of urinary bladder
Adult: As freeze-dried BCG containing 1 to 16 x 108 colony forming units of live attenuated strain of Mycobacterium bovis: Induction: Instill 50 mL solution into the bladder, once weekly for 6 consecutive weeks, beginning min 14 days after biopsy or transurethral resection (TUR). Retain solution for up to 2 hours for Max effect. Patient may be repositioned every 15 minutes for Max area contact. Maintenance: Instill 50 mL once weekly for 3 consecutive weeks at 3, 6, 12 months after initiation of treatment.
Reconstitution: Dilute freeze-dried powder with NaCl 0.9% solution to a final concentration of 50 mL.

Intravesical
Prophylaxis of carcinoma in situ of urinary bladder
Adult: As freeze-dried BCG containing 1 to 16 x 108 colony forming units of live attenuated strain of Mycobacterium bovis: Induction: Instill 50 mL solution into the bladder, once weekly for 6 consecutive weeks, beginning min 14 days after biopsy or transurethral resection (TUR). Retain solution for up to 2 hours for Max effect. Patient may be repositioned every 15 minutes for Max area contact. Maintenance: Instill 50 mL once weekly for 3 consecutive weeks at 3, 6, 12 months after initiation of treatment.
Reconstitution: Dilute freeze-dried powder with NaCl 0.9% solution to a final concentration of 50 mL.

Intravesical
Prophylaxis of primary Ta and/or T1 papillary tumours following transurethral resection
Adult: As freeze-dried BCG containing 1 to 16 x 108 colony forming units of live attenuated strain of Mycobacterium bovis: Induction: Instill 50 mL solution into the bladder, once weekly for 6 consecutive weeks, beginning min 14 days after biopsy or transurethral resection (TUR). Retain solution for up to 2 hours for Max effect. Patient may be repositioned every 15 minutes for Max area contact. Maintenance: Instill 50 mL once weekly for 3 consecutive weeks at 3, 6, 12 months after initiation of treatment.
Reconstitution: Dilute freeze-dried powder with NaCl 0.9% solution to a final concentration of 50 mL.

Intravesical
Prophylaxis of recurrent Ta and/or T1 papillary tumours following transurethral resection
Adult: As freeze-dried BCG containing 1 to 16 x 108 colony forming units of live attenuated strain of Mycobacterium bovis: Induction: Instill 50 mL solution into the bladder, once weekly for 6 consecutive weeks, beginning min 14 days after biopsy or transurethral resection (TUR). Retain solution for up to 2 hours for Max effect. Patient may be repositioned every 15 minutes for Max area contact. Maintenance: Instill 50 mL once weekly for 3 consecutive weeks at 3, 6, 12 months after initiation of treatment.
Reconstitution: Dilute freeze-dried powder with NaCl 0.9% solution to a final concentration of 50 mL.
Contraindications
Hypersensitivity. Impaired immune response, congenital or acquired immune deficiencies (e.g. HIV-infection, leukaemia, lymphoma, cancer therapy, Hodgkin's disease), active tuberculosis, acute severe febrile illness, generalised infected skin conditions, current or previous evidence of BCG infection, urinary tract infection, gross haematuria, <14 days of biopsy, TUR, or traumatic catheterisation. Concomitant therapy with immunosuppressive agents, bone marrow depressants, radiation therapy.
Special Precautions
Patients with small bladder capacity (intravesical). Pregnancy and lactation. Monitoring Parameters Perform PPD test prior to vaccination. Monitor for anaphylaxis and syncope, 15 mins post vaccination; fever, flu-like symptoms and other adverse effects up to 3 days after treatment.
Adverse Reactions
Significant: Risk of bladder contracture (intravesical), malaise, fever and chills, flu-like symptoms. Blood and lymphatic system disorders: Anaemia. Gastrointestinal disorders: Abdominal pain, nausea, diarrhoea. General disorders and administration site conditions: Rigors. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis, myalgia. Renal and urinary disorders: Cystitis, dysuria, pollakuria, haematuria, UTI, urinary incontinence. Respiratory, thoracic and mediastinal disorders: Pneumonitis.
Potentially Fatal: Rarely, systemic granulomatous illness.
Drug Interactions
Diminished therapeutic effect with immune globulins.
Potentially Fatal: Diminished therapeutic effect with immunosuppressants, bone marrow depressants, antibiotics, radiation therapy.
Lab Interference
May diminish diagnostic effect of tuberculin skin test.
Action
BCG vaccine is an attenuated strain of bacillus Calmette-Guérin Mycobacterium bovis used as biologic response modifier. It is also used as an active immunotherapy for the treatment of bladder carcinoma in situ by causing a local, chronic inflammatory response involving macrophage and leukocyte infiltration of the bladder, resulting in the destruction of superficial tumour cells of the urothelium.
Storage
Intradermal: Store at 2-8°C. Intravesical: Store at 2-8°C.
CIMS Class
Immunological Chemotherapy / Vaccines, Antisera & Immunologicals
Disclaimer: This information is independently developed by CIMS based on vaccine, bcg from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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