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

Interactions
PK
Renal impairment
References

Bromelaïnen

Generic name
Bromelaïnen
Brand name
ATC Code
D03BA03

Pharmacokinetics in children

Age n Tmax (h) Cmax (ng/ml)
< 2 years 2 2 200
4-11 years 5 4 (2-4) 205 ± 169
12-18 years 3 4 (2-4) 180 ± 114

Elimination
A majority of patients had no quantifiable concentration of the drug after 48 hours; no patients had a quantifiable concentration after 72 hours

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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

Removal of dead tissue in burn wounds
  • Cutaneous
    • 0 years up to 18 years
        • apply 2 g of powder in 20 g of gel or 5 g of powder in 50 g of gel to the burn area;
          • in children 4-18 years, a wound area of up to 15% of the total BSA can be treated,
          • in children 0-3 years it is up to 10% of the total BSA. 
        • start pain relief at least 15 min before the start of treatment;
        • apply the gel to a clean, keratin-free and moist wound area with a thickness of 1.5-3 mm and cover it with a bandage;
        • leave it in place for 4 hours, then remove the gel and loosened dead tissue;
        • apply an antibacterial dressing for 2 hours before applying the gel as well as after removing it.

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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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Reference

  1. MediWound Ltd., SmPC NexoBrid (EU/1/12/803/001) 1-2-2024, www.geneesmiddelinformatiebank.nl

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Changes

Changes