Bcg vaccine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing Mycobacterium bovis BCG (Bacillus Calmette-Guerin)
Drugs List
Therapeutic Indications
Uses
Tuberculosis - prophylaxis
Active immunisation against tuberculosis.
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book#the-green-book
Dosage
National recommendations should be consulted regarding the need for tuberculin testing before administration of BCG vaccine.
Adults
0.1ml by intradermal injection.
Children
Children aged 12 months and older
0.1ml by intradermal injection.
Infants aged less than 12 months
0.05ml by intradermal injection.
Administration
For intradermal injection only in the arm over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).
Contraindications
Children under 2 years old in a household with known or suspected active TB
Immunosuppressive treatment including radiotherapy
Infants born to HIV-positive mothers
Infants under 6 months exposed to immunosuppressive biological in utero
Prophylactic doses of anti-tuberculous medication
Severe febrile conditions
Tuberculin positive individuals
Immunodeficiency syndromes
Malignant neoplasm
Skin infection
Precautions and Warnings
Infants exposed to immunosuppressive biological therapy via breast milk
Neonates exposed to immunosuppressive treatment in pregnancy/breastfeeding
Neonates exposed to TNF-alfa or other biological medicine in utero
Within 4 weeks of other live vaccines
Breastfeeding
Pregnancy
Live vaccine must not be given during/within 6 months of chemotherapy
Live vaccine must not be given during/within 6 months of radiotherapy
Postpone immunisation if there is active or suspected infection
Before vaccination check tuberculin status following national guidelines
Vaccine may not be effective in 100% of patients
Avoid administration to eczematous or inflamed skin
Do not mix with other drugs or substances
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Reconstitute only with the solvent supplied by the manufacturer
Resuscitation facilities must be immediately available
Avoid deep or misplaced injections
Risk of apnoea in premature infants - monitor respiration for 72 hours
Follow national immunisation guidelines
Avoid further vaccination in arm used for vaccination for at least 3 months
Pregnancy and Lactation
Pregnancy
BCG vaccine should be used with caution during pregnancy.
The manufacturer does not recommend the use of BCG vaccine during pregnancy.
Although no harmful effects to the foetus have been associated with the BCG vaccine, vaccination is not routinely recommended during pregnancy particularly during the first trimester. However, in areas with high risk of tuberculosis infection, BCG vaccine may be given during pregnancy if the benefit outweighs the risk. A further tuberculin test may be required if more than three months has elapsed since the test on which a recommendation for BCG vaccination was based.
Lactation
Use BCG vaccine with caution in breastfeeding.
The manufacturer does not recommend the use of BCG vaccine during breastfeeding.
Although no harmful effects to the nursing infant have been associated with the BCG vaccine, vaccination is not routinely recommended during breastfeeding. However, in areas with high risk of tuberculosis infection, BCG vaccine may be given during breastfeeding if the benefit outweighs the risk.
Side Effects
Abscess
Discharge (injection site)
Erythema
Fever
Headache
Hypersensitivity reactions including anaphylaxis
Induration (injection site) followed by local lesion
Local tenderness (application site)
Lymph node enlargement
Osteitis
Osteomyelitis
Suppurative lymphadenitis
Ulceration (injection site)
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2013
Reference Sources
Immunisation against infectious diseases: 'The Green Book', Department of Health.
Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book#the-green-book
Last accessed: 20 August 2019.
MHRA Drug Safety Update April 2016
Available at: https://www.gov.uk/drug-safety-update/live-attenuated-vaccines-avoid-use-in-those-who-are-clinically-immunosuppressed#fatal-bcg-infection-in-neonates-after-in-utero-exposure-to-tnf-antagonist
Last accessed: 20 August 2019.
Summary of Product Characteristics: BCG vaccine. Statens Serum Institut. Revised November 2011.
Summary of Product Characteristics: BCG Vaccine AJV powder and solvent for suspension for injection. AJ Vaccines. Revised May 2018.
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