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

Interactions
PK
Renal impairment
References

Hepatitis B immunoglobulin

Generic name
Hepatitis B immunoglobulin
Brand name
ATC Code
J06BB04

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

Prophylaxis for hepatitis B in newborns of HBsAg-positive mothers
  • Intramuscular
    • Term neonate
      • 150 - 180 IU/dose, once only.
        • Administer immediately after the birth combined with vaccination for hepatitis B, followed by active immunization as per the National Vaccination Programme (see the monograph on DPTP-HiB-HepB)
        • Administration can be repeated until the active production of antibodies is observed after vaccination (titre at least 10 mIU/ml)
  • Intravenous
    • Term neonate
      • Hepatect: 30 - 100 IU/kg/dose, once only.
        • In children of HBsAg-positive mothers: immediately after the birth combined with vaccination with a hepatitis B vaccine, followed by active immunization as per the National Vaccination Programme (see the monograph on DPTP-HiB-HepB)
        • Administration can be repeated until the active production of antibodies is observed after vaccination (titre at least 10 mIU/ml)
Prophylaxis for hepatitis B reinfection after liver transplant
  • Intravenous
    • 1 month up to 18 years
      [2]
      • Hepatect: Start on the day of the transplant:
        5.780.3         IU/m²/day in 1 dose once only. Then daily for 1 week and as long as necessary to achieve a serum concentration of 100-150 IU/litre in patients who are negative for HBV DNA and above 500 IU/litre in patients who are positive for HBV DNA.
    • 1 month up to 18 years
      • Hepatect: Start on the day of the transplant:
        5.780.3         IU/m²/day in 1 dose once only. Then daily for 1 week and as long as necessary to achieve a serum concentration of 100-150 IU/litre in patients who are negative for HBV DNA and above 500 IU/litre in patients who are positive for HBV DNA.
Prophylaxis for hepatitis B after accidental exposure
  • Intramuscular
    • 1 month up to 18 years

      • HEPBQUIN:

        Exposure to a SMALL quantity of HBsAg-positive blood

        • Vaccinated, titre sufficient: no action necessary

        • Vaccinated, titre < 10 mIU/ml: 8 IU/kg + booster vaccination OR 2x 8 IU/kg

        • Vaccinated, titre unknown: 8 IU/kg and determine the titre after 3 months
        • Not vaccinated: 8 IU/kg + vaccination series
        • Vaccination not possible: 8 IU/kg; repeat after 2 and 4 months

        Exposure to a LARGE quantity of HBsAg-positive blood

        • Vaccinated, titre sufficient: no action necessary
        • Vaccinated, titre < 10 mIU/ml: 50 IU/kg + booster vaccination
        • Vaccinated, titre unknown: 50 IU/kg and determine the titre after 3 months
        • Not vaccinated: 50 IU/kg + vaccination series
        • Vaccination not possible:  8 IU/kg; repeat after 2 and 4 months
Prophylaxis for hepatitis B on continuous infection risk
  • Intravenous
    • 1 month up to 18 years
      • Hepatect: 8 IU/kg/dose Repeat every 2 months.

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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

No information is present at this moment.

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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

No information available on specific warnings and precautions in 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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Immunoglobulins, normal human
J06BA02
J06BA01
Specific immunoglobulins
J06BB01
J06BB02
J06BB03
Antibacterial monoclonal antibodies
J06BC03
IMMUNOGLOBULINS, NORMAL HUMAN
J06BA02
J06BA01
Antiviral monoclonal antibodies
J06BD07
J06BD08
J06BD01

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References

  1. Sanquin, SPC HepBQuin (RVG 16926) 28-04-2014, www.geneesmiddeleninformatiebank.nl
  2. Biotest Pharma GmbH, SPC Hepatect (RVG 27115), www.cbg-meb.nl, Geraadpleegd 25/11/13, http://db.cbg-meb.nl/IB-teksten/h27115.pdf
  3. LCI, Guideline Hepatitis B, www.rivm.nl, July 2017
  4. RIVM, Draaiboek Prenatale Screening Infectieziekten en Erytrocytenimmunisatie, https://www.rivm.nl/documenten/draaiboek-prenatale-screening-infectieziekten-en-erytrocytenimmunisatie, Versie 6.0, april 2018

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Changes

Changes