Protrombinecomplex

Generic name
Protrombinecomplex
Brand name
ATC Code
B02BD01
Compare …

Protrombinecomplex

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

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

Deficiency of vitamin K dependent clotting factors
  • Intravenous
    • 1 month up to 18 years
      • (Cofact) Based on Factor IX: 100 IU/kg/day in 1 dose. Max: 2.500 IU/dose. Infuse at a rate of 2 ml/min.
        • The dose depends on the INR before treatment (measured as shortly as possible before administration), the desired INR and body weight.
        • After consultation of paediatric haematologist

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

No information is present at this moment.

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

Closely monitoring is indicated due to the risk of thromboembolic events. No data are available on use in perinatal bleeding due to vitamine K deficiency in neonates. 

Interactions

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

VITAMIN K AND OTHER HEMOSTATICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Vitamin K
B02BA01
Fibrinogen
B02BB01
Local hemostatics
B02BC30
Blood coagulation factors
B02BD08
B02BD04
B02BD02
Other systemic hemostatics
B02BX05
B02BX06
B02BX04
Blood coagulation factors
B02BD08
B02BD04
B02BD02

References

  1. Octapharma GmbH, SmPC Octaplex (RVG 30499) 26-08-2019, www.geneesmiddeleninformatiebank.nl
  2. Peters, M. et al, NVK werkboek kinderhematologie - Stollingsstoornis op basis van Vitamine K deficiëntie, https://hematologienederland.nl/wp-content/uploads/2020/04/KSS-Vitamine-K-deficientie.pdf, 2018
  3. Prothya Biosolutions Netherlands B.V., SmPC Cofact (RVG 17060) 21-11-2024, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose