- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Similar Cmax of teduglutide across age groups was demonstrated by population pharmacokinetics modelling. However, lower exposure (AUC) and shorter half-life were seen in paediatric patients 4 months to 17 years of age, as compared with adults. The pharmacokinetic profile in this paediatric population, as evaluated by clearance and volume of distribution, was different from that observed in adults after correcting for body weights. Specifically, clearance decreases with increasing age from 4 months old to adults [EPAR Revestive].
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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
| Short bowel syndrome |
|---|
|
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Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
Adjustment is not requiredGFR 30-50 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 24 uurGFR 10-30 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 24 uurGFR < 10 ml/min/1.73 m2
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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
The side effect profile in children is similar to that in adults.
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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 | ||
| A16AB04 | ||
| A16AB07 | ||
| A16AB13 | ||
| A16AB22 | ||
| A16AB17 | ||
| A16AB08 | ||
| A16AB09 | ||
| A16AB02 | ||
| A16AB05 | ||
| A16AB14 | ||
| A16AB10 | ||
| Various alimentary tract and metabolism products | ||
|---|---|---|
| A16AX10 | ||
| A16AX09 | ||
| A16AX | ||
| A16AX18 | ||
| A16AX06 | ||
| A16AX04 | ||
| A16AX07 | ||
| A16AX | ||
| A16AX07 | ||
| A16AX05 | ||
| AMINO ACIDS AND DERIVATIVES | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| A16AA04 | ||
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Reference
- Shire Pharmaceuticals Ireland Limited, SmPC Revestive (EU/1/12/787/001) Rev.22. 11-07-2023, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
