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

Interactions
PK
Renal impairment
References

Fibrinogen

Generic name
Fibrinogen
Brand name
ATC Code
B02BB01

Pharmacokinetics in children

In adolescents between 12 and under 18 years of age, a small difference was observed in half-life (n=5, 72.8 ± 16,5 h) compared to adults (n=16, 76.9 ± 26,1 h). 
Clearance was nearly identical in both age groups and was 0.68 ± 0.18 mL/h/kg and 0.66 ± 0.21 mL/h/kg, respectively [SmPC Fibryga].

The following pharmacokinetic parameters were determined in children under 12 years of age with congenital fibrinogen deficiency (n=13, dose: 70 mg/kg i.v. single dose) [SmPC Fibryga]:

parameter mean ± SD range
T1/2 (h) 63,3 ± 12,0 45,6 – 91,6
Cmax (mg/dL) 107,2 ± 16,8 93,0 – 154,0
Cl (mL/h/kg) 0,8 ± 0,2 0,5 – 1,0
VdSS (mL/kg) 67,6 ± 7,1 52,8 – 76,8

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Available formulations

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Dosages

Treatment of bleeding
  • Intravenous
    • 1 month up to 18 years
      • Depending on the clinical necessity, usually 20 - 30 mg/kg/dose, as required.
      • Directions for administration:

        Administer slowly, max. 5 ml/min.
Prophylaxis in case of congenital hypo-dysia or afibrinogenaemia and known bleeding tendency
  • Intravenous
    • 1 month up to 12 years

      • Dose (mg/kg) = [Target level (g/L) – measured level (g/L] / 0,014 (g/L per mg/kg bodyweight)

    • Term neonate

      • Dose (mg/kg) = [Target level (g/L) – measured level (g/L] / 0,014 (g/L per mg/kg bodyweight)

    • 12 years up to 18 years

      • Dose (mg/kg) = [Target level (g/L) – measured level (g/L] / 0,018 (g/L per mg/kg bodyweight)

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

The overall safety profile does not differ between adults, adolescents and children.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Interactions

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

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Vitamin K
B02BA01
Local hemostatics
B02BC30
Blood coagulation factors
B02BD08
B02BD04
B02BD02
B02BD01
Other systemic hemostatics
B02BX05
B02BX06
B02BX04
Blood coagulation factors
B02BD08
B02BD04
B02BD02
B02BD01

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

References

  1. CSL Behring, SmPC Heamocomplettan (RVG 16996) 01-03-2020, www.geneesmiddeleninformatiebank.nl
  2. Octapharma GmbH, SmPC Fibryga (RVG 126548) 30-11-2021, www.geneesmiddeleninformatiebank.nl
  3. Laboratoire français du Fractionnement et des Biotechnologies, SmPC Fibclot (RVG 116873) 20-09-2020, www.geneesmiddeleninformatiebank.nl

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Changes

Changes