BCG Vaccine, Live Attenuated

Registered South African indications:

• Immunisation against tuberculosis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Immunocompromised patients
• Acute, severe febrile illness
• Generalised infected skin conditions
• Coadministration with immunosuppressive treatment

Cautions

• Pregnancy
• Breastfeeding
• Elderly
• Premature infants  

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

Active immunisation against tuberculosis

• Intradermal (inj): 0.1ml

Must be given into the upper layer of skin of the right arm in the region of the deltoid muscle

DO NOT admin via IM, IV or SC routes

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

EPI Schedule 2016

Active immunisation against tuberculosis

Younger than 1 year

• Intradermal (inj): 0.05ml

Older than 1 year

• See adult dosage

Must be given into the upper layer of skin of the right arm in the region of the deltoid muscle

DO NOT admin via IM, IV or SC routes

Pregnancy

• Caution;
• Animal reproduction studied have not been performed
• Due to a theoretical risk to the foetus, avoid using live, attenuated virus vaccines in pregnant women. Conception should be avoided for 4 weeks following vaccination with live vaccines

Breastfeeding

• Caution; not recommended
• It is unknown whether BCG vaccine is excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to avoid use of BCG vaccine taking into account the benefit of breastfeeding for the child and the benefit of vaccination for the woman

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Possibly porphyrinogenic (PSP) 

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache

Musculoskeletal Disorders

• Osteitis

Skin and Subcutaneous Tissues Disorders

• Lupus-like reactions
• Keloid formation
• Injection site pain and swelling
• Injection site ulcer
• Injection site absces

Immune, Blood and Lymphatic System Disorders

• Enlargement of regional lymph nodes
• Suppurative lymphadenitis  
• Osteomyelitis
• Suppurative lymphadenitis
• Anaphylactic reaction 
• Allergic reaction
• Fever

• Immunosuppressive agents
• Antimicrobials

None routine

BCG vaccine is an attenuated, live culture preparation of Mycobacterium bovis, which is used to prevent tuberculosis and other mycobacterial infections.

Injection (per ml) 0.75mg

• BCG vaccine SSI (The Biovac) originator
• BCG  Cipla/SII ( The Biovac Institute)