Kabiven emulzija za infuziju
| Name | Kabiven emulzija za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-708415004 |
| Active Substance | sojino ulje, rafinirano glukoza hidrat alanin arginin aspartatna kiselina glutamatna kiselina glicin histidin izoleucin leucin lizinklorid metionin fenilalanin prolin serin treonin triptofan tirozin valin kalcijev klorid dihidrat natrijev glicerofosfat, bezvodni magnezijev sulfat heptahidrat kalijev klorid natrijev acetat trihidrat |
| Composition | 1 plastična vrećica sastoji se od odjeljka sa 526 ml 19% glukoze, odjeljka sa 300 ml aminokiselina i elektrolita (Vamin 18 Novum) i odjeljka sa 200 ml emulzije masti (Intralipid 20%), ukupni volumen pripremljene mješavine je 1026 ml; 1 plastična vrećica sastoji se od odjeljka sa 790 ml 19% glukoze, odjeljka sa 450 ml aminokiselina i elektrolita (Vamin 18 Novum) i odjeljka sa 300 ml emulzije masti (Intralipid 20%), ukupni volumen pripremljene mješavine je 1540 ml |
| Pharmaceutical Form | emulzija za infuziju |
| Manufacturer | Fresenius Kabi AB, Uppsala, Švedska |
| Marketing Authorisation Holder | Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
| Marketing Authorisation Date | 29.06.2018 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 17.01.2024* |
| Classification Number | UP/I-530-09/16-02/252 |
| Registration Number | 381-12-01/70-18-10 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B05BA10 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| SmPC | download |
| PL | download |
*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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
