Hepatitis B vaccine

Generic name
Hepatitis B vaccine
Brand name
ATC Code
J07BC01
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Hepatitis B vaccine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

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

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

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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.
 

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.

 

Interactions

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

VIRAL 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.

Encephalitis vaccines
J07BA02
J07BA01
Influenza vaccines
J07BB02
Hepatitis vaccines
J07BC20
J07BC02
Measles vaccines
J07BD52
Poliomyelitis vaccines
J07BF03
Rabies vaccines
J07BG01
Rota virus diarrhea vaccines
J07BH01
Varicella zoster vaccines
J07BK01
Yellow fever vaccines
J07BL01
Papillomavirus vaccines
J07BM03
J07BM02
Other viral vaccines
J07BX04

References

  1. RIVM , Richtlijn hepatitis B, Juli 2023, https://lci.rivm.nl/richtlijnen/hepatitis-b
  2. 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
  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

Changes

Therapeutic Drug Monitoring


Overdose