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

Interactions
PK
Renal impairment
References

Hepatitis B vaccine

Generic name
Hepatitis B vaccine
Brand name
ATC Code
J07BC01

Pharmacokinetics in children

No information

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

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Available formulations

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Dosages

NATIONAL VACCINATION PROGRAMME for HepB: only for children of HBsAg-positive mothers
  • Intramuscular
    • 0 days up to 2 days
      [1] [2] [3] [4]
      • First vaccination at birth (within 48 hours after birth), preferably concomitantly with hepatitis B immunoglobulin:
        HBvaxPRO: 5 mcg/dose once only. Combined with hepatitis B immunoglobulines.

      • Follow-on vaccinations with combined DPTP-HiB-HepB vaccine at 2-3-5-11 months

Hepatitis B vaccination
  • Intramuscular
    • 0 years up to 16 years
      [2] [3]
      • ENGERIX: 10 mcg/dose
        HBVAXPRO: 5 mcg/dose

      • VACCINATION SCHEDULE:
        First vaccination: at any time, not related to the age
        Second vaccination: 1 month after the first vaccination
        third vaccination: 6 months after the first vaccination

        Accelerated schedule:
        First vaccination: at any time, not related to the age
        Second vaccination: 1 month after the first vaccination
        third vaccination: 2 months after the first vaccination
        fourth vaccination: 12 months after the first vaccination

        Administer the vaccine in adults and children intramuscularly in the deltoid. Administer intramuscularly in neonates, infants and young children (< 3 yrs) in the anterolateral thigh.

    • 16 years up to 18 years
      [2] [3]
      • ENGERIX: 20 mcg/dose
        HBVAXPRO: 10 mcg/dose

      • VACCINATION SCHEDULE:
        First vaccination: at any time, not related to the age
        Second vaccination: 1 month after the first vaccination
        third vaccination: 6 months after the first vaccination

        Accelerated schedule:
        First vaccination: at any time, not related to the age
        Second vaccination: 1 month after the first vaccination
        third vaccination: 2 months after the first vaccination
        fourth vaccination: 12 months after the first vaccination

        Administer the vaccine in adults and children intramuscularly in the deltoid

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

Side effects in children

In very premature children (≤ 28 weeks pregnancy): apnoea.
 

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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

In primary immunization of very premature children (≤ 28 weeks of pregnancy), take account of the risk of apnoea and the need to monitor respiratory function for 48-72 hours, especially in children whose anamnesis includes a respiratory system that was not yet fully developed. Given the importance of vaccinating, the vaccination should however not be postponed or withheld from these children.

 

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Interactions

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

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References

  1. GlaxoSmithKline BV, SPC Engerix B Junior RVG 24290, www.cbg-meb.nl, (geraadpleegd 30 okt 2009), http://db.cbg-meb.nl/IB-teksten/h24290.pdf
  2. RIVM , Richtlijn hepatitis B, Juli 2023, https://lci.rivm.nl/richtlijnen/hepatitis-b
  3. MSD Vaccins, SPC HBVAXPRO (EU/1/01/183/001;007;008;018;019) 30-03-2017, www.ema.europa.eu
  4. RIVM, Bevolkingsonderzoek Prenatale Screening Infectieziekten en Erytrocytenimmunisatie, www.rivm.nl, april 2021

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Changes

Changes