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 |
| Packaging [MA Number for Packaging] | 500 ml otopine u vreći, 20 vreća u kutiji [HR-H-474984793-01] |
| 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 | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B05AA07 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
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. |
