- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The following pharmacokinetic parameters were found in 15 children aged 8,5-16 years (weight 27.1-64.9 kg) receiving a dose of 1 mg/kg once every 2 weeks [SmPC]
| Initial value | After IgG-seroconversion | |
| Cl | 77 ml/min | 35 ml/min |
| Vd in steady state | 2.6 L | 5.4 L |
| t1/2 | 55 min | 240 min |
The following pharmacokinetic parameters were found in 30 children aged 5-18 years [SmPC]
| Initial value | After IgG-seroconversion | |
| Dose 0,5 mg/kg once every 2 weeks | ||
| Cl | 4,6 ml/min/kg | 5,7 ml/min/kg |
| Vd in steady state | 0,27 l/kg | 0,49 l/kg |
| t1/2 | 88 min | |
| Dose 1 mg/kg once every 4 weeks | ||
| Cl | 2,3 ml/min/kg | 2,8 ml/min/kg |
| Vd in steady state | 0,22 l/kg | 0,48 l/kg |
| t1/2 | 107 min |
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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
| Fabry’s disease |
|---|
|
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Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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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
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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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| Amino acids and derivatives | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| A16AA04 | ||
| Enzymes | ||
|---|---|---|
| A16AB03 | ||
| A16AB07 | ||
| A16AB13 | ||
| A16AB22 | ||
| A16AB17 | ||
| A16AB08 | ||
| A16AB09 | ||
| A16AB02 | ||
| A16AB05 | ||
| A16AB14 | ||
| A16AB10 | ||
| Various alimentary tract and metabolism products | ||
|---|---|---|
| A16AX10 | ||
| A16AX09 | ||
| A16AX | ||
| A16AX18 | ||
| A16AX06 | ||
| A16AX04 | ||
| A16AX07 | ||
| A16AX | ||
| A16AX08 | ||
| A16AX07 | ||
| A16AX05 | ||
| AMINO ACIDS AND DERIVATIVES | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| A16AA04 | ||
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References
- Genzyme Europe B.V., SmPC Fabrazyme (EU/1/01/188/001-006) 10-10-2014 , www.geneesmiddeleninformatiebank.nl
- Genzyme Europe B.V., SmPC Fabrazyme (EU/1/01/188/001-006) 10-10-2014, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
