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NUMETAH G13% E PREMATURES (ternary mixture)
NUTRITION - New medicinal product
Opinions on drugs -
Posted on
Nov 04 2016
Reason for request
Inclusion
- NUMETAH G13% E PRETERM has Marketing Authorisation in parenteral nutrition in preterm newborns when oral nutrition or enteral nutrition is impossible, insufficient or contraindicated.
- Owing to the suspension of the Marketing Authorisation for NUMETAH G13%E in December 2013, following cases of hypermagnesaemia, the magnesium concentration was modified; it is now 0.47 mmoL Mg per 300 mL. This new proprietary pharmaceutical product is called NUMETAH G13% E PRETERM.
- In light of this new composition, of the lack of new efficacy data, of the tolerability data for NUMETAH G13%E, and of the recommendation to use as first-line product with Marketing Authorisation for parenteral nutrition, in particular in newborns, NUMETAH G13% E PRETERM retains the same benefit as the old formulation in the management of preterm babies when parenteral nutrition is necessary.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| minor |
- |
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