Medicinal Products

Volulyte 6% otopina za infuziju

Name Volulyte 6% otopina za infuziju
Marketing Authorisation Number HR-H-474984793
Active Substance hidroksietilškrob (130/0.4)
natrijev acetat trihidrat
natrijev klorid
kalijev klorid
magnezijev klorid heksahidrat
Composition 1000 ml otopine za infuziju sadrži: 60,00 g hidroksietilškroba, 4,63 g natrijevog acetat trihidrata, 6,02 g natrijevog klorida, 0,30 g kalijevog klorida, 0,30 g magnezijevog klorid heksahidrata
Pharmaceutical Form otopina za infuziju
Manufacturer Fresenius Kabi Deutschland GmbH, Bad Homburg, Njemačka
Fresenius Kabi France, Louviers, Francuska
Fresenius Kabi Deutschland GmbH, Bad Homburg, Njemačka
Marketing Authorisation Holder Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska
Marketing Authorisation Date 20.09.2017
MA Period of Validity unlimited
MA Revocation Date 17.07.2023*
Classification Number UP/I-530-09/16-02/487
Registration Number 381-12-01/30-17-09
Prescription Medicinal product subject to medical prescription
Type of prescription ograničeni recept
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code B05AA07
SmPC download
PL download
Educational materials
for healthcare professionals
Edukacija za zdravstvene radnike, verzija 1

*Note

Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.

Packaging

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o daljnjim mjerama za jačanje postojećih ograničenja primjene otopina za infuziju koje sadrže hidroksietil škrob 12.04.2019 Fresenius Kabi
Pismo zdravstvenim radnicima o novim mjerama za jačanje postojećih restrikcija u primjeni otopina za infuziju koje sadrže hidroksietil škrob (HES) 28.08.2018 B. Braun Adria d.o.o. i Fresenius Kabi d.o.o.
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