IntradermalActive immunisation against tuberculosisAdult: 0.1 mL via slow injection into the deltoid muscle.
Child: <12 months 0.05 mL via slow injection into the deltoid muscle.
IntravesicalProphylaxis of carcinoma in situ of urinary bladder, Prophylaxis of primary Ta and/or T1 papillary tumours following transurethral resection, Prophylaxis of recurrent Ta and/or T1 papillary tumours following transurethral resection, Treatment of carcinoma in situ of urinary bladderAdult: 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.
|
Intradermal: Reconstitute with appropriate volume of solvent provided. Intravesical: Dilute freeze-dried powder with NaCl 0.9% solution to a final concentration of 50 mL.
|
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, antibiotics, radiation therapy.
|
Patient with small bladder capacity (intravesical). Pregnancy and lactation.
|
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.
|
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.
|
Diminished therapeutic effect with immune globulins.
Potentially Fatal: Diminished therapeutic effect with immunosuppressants, bone marrow depressants, antibiotics, radiation therapy.
|
May diminish diagnostic effect of tuberculin skin test.
|
Description: 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.
|
|
|
|
|
L03AX03 - BCG vaccine ; Belongs to the class of other immunostimulants.
|
Anon. BCG (Intravesical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/07/2018. Anon. BCG Vaccine (Immunization). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/07/2018. Anon. BCG Vaccine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/07/2018. BCG Vaccine Substrate Tice Live Antigen Injection, Powder, Lyophilized, for Solution (Organon USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/07/2018. Buckingham R (ed). BCG Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/07/2018. Joint Formulary Committee. Bacillus Calmette-Guérin Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/07/2018. Sequiriz (NZ) Ltd. BCG Vaccine SSI Powder and Solvent for Suspension for Injection data sheet 14 March 2018. Medsafe. http://www.medsafe.govt.nz/. Accessed 03/07/2018. Tice BCG Powder, for Suspension (Organon USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/07/2018.
|
Sign Out
