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

Interactions
PK
Renal impairment
References

Immunoglobulin, normal SUBCUTANEOUS use

Generic name
Immunoglobulin, normal SUBCUTANEOUS use
Brand name
ATC Code
J06BA01

Pharmacokinetics in children

No data known on use in children.

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Primary immunodeficiency; hypogammaglobulinaemia.
  • Subcutaneous
    • 0 years up to 18 years
      [1] [2]

      • a loading dose if necessary of at least 200-500 mg/kg bodyweight spread over several days with a maximum daily dose of 100-150 mg/kg bodyweight; maintenance dose 400-800 mg/kg bodyweight per month in split doses, generally with a weekly dosing interval;
Immunomodulating therapy in chronic inflammatory demyelinizing polyneuropathy (CIDP)
  • Subcutaneous
    • 0 years up to 18 years
      [3]
      • Start 1 week after last IVIg dose. The final 3-weekly IVIg dose can be converted 1:1 to a weekly SC dose, usually 0.2 - 0.4 g/kg/dose once a week. . 1 g/kg IVIg every 3 weeks is for example 0.33 g/kg/week after conversion..

      • The weekly dose can be split up into smaller doses and given in the desired number per week. The weekly dose can also be doubled and then only needs to be given once every 2 weeks.

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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

Clinical studies with Hizentra demonstrated a similar overall safety profile in pediatric patients and adult patients with PID

 

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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
Specific immunoglobulins
J06BB02
IMMUNOGLOBULINS, NORMAL HUMAN
J06BA02

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References

  1. OCTAPHARMA GmbH, SmPC Gammanorm (RVG30505)21-12-2017
  2. Sanquin, SmPC Gammaquin (RVG 16941) 03-05-2013, www.cbg-meb.nl
  3. CSL Behring GmbH, SmPC Hizentra (EU/1/11/687) 28-01-2020, www.geneesmiddeleninformatiebank.nl

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Changes

Changes