BCG vaccine

Generic name
BCG vaccine
Brand name
ATC Code
J07AN01
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BCG vaccine

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Active immunization against tuberculosis
  • Intracutaneous
    • < 1 year
      [1]
      • 0.05 ml/dose, once only.
    • ≥ 1 year
      [1]
      • 0.1 ml/dose, once only.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Very preterm infants(born ≤ 28 weeks gestation) have a potential risk of apnea. Consider monitoring of respiratory function for 48-72 hours, particularly for children with an incompletely developed respiratory system in the history. Since the benefit of vaccination is high in this group of children, vaccination should not be withheld or delayed.

Cases of immune reconstitution inflammatory syndrome (IRIS) have been reported after initiation of antiretroviral therapy in HIV-infected children or after initiation of treatment for other severe immune deficiencies in children who had previously received BCG vaccination. Symptoms such as adenitis, pusy discharge, ulcerations and abscesses of the skin, and fever may occur within weeks to months after initiation of immunotherapy.

Live vaccines (e.g., BCG vaccine) should not be given to infants after in utero exposure to infliximab for 12 months after birth. Administration of a live vaccine to a breastfed infant while the mother is receiving infliximab is not recommended unless infant infliximab serum levels are undetectable. These infants may be at increased risk of infection, including serious disseminated infection that can become fatal. [DHPC]

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

BACTERIAL VACCINES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Cholera vaccines
J07AE01
Haemophilus influenzae B vaccines
J07AG01
Meningococcal vaccines
J07AH09
J07AH07
J07AH08
Pertussis vaccines
J07AJ52
Pneumococcal vaccines
J07AL02
Typhoid vaccines
J07AP03
J07AP01

Reference

  1. Statens Serum Institut, SmPC BCG Vaccin (RVG 17661) 06-08-2015, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose