ISOPEDIA, electrolytes and glucose
PAEDIATRIC INTENSIVE CARE - New medicinal product
Opinions on drugs -
Posted on
Jul 07 2017
Reason for request
Inclusion
No clinical benefit demonstrated in the therapeutic strategy of its different indications
- ISOPEDIA, solution for infusion, has Marketing Authorisation in newborns and children up to 14 years of age, in the following cases:
- Perioperative plasma-isotonic fluid and electrolyte replacement with partial coverage of carbohydrate requirements,
- Short-term intravascular fluid replacement,
- Treatment of isotonic dehydration,
- Use as carrier solution for compatible electrolyte concentrates and medicinal products.
- This ready-to-use injectable solution has a composition suitable for paediatric use.
- Its isotonic nature and its composition could help to prevent the occurrence of serious and irreversible neurological complications due to perioperative dilutional hyponatraemia in children.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |
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