Extraneal otopina za peritonejsku dijalizu
| Name | Extraneal otopina za peritonejsku dijalizu |
|---|---|
| Marketing Authorisation Number | HR-H-928997385 |
| Active Substance | ikodekstrin natrijev klorid natrijev (S)-laktat, otopina kalcijev klorid dihidrat magnezijev klorid heksahidrat |
| Composition | 1000 ml otopine sadrži 75 g ikodekstrina, 5,4 g natrijvog klorida, 4,5 g natrijevog S-laktata, 0,257 g kalcijevog klorida dihidrata i 0,051 g magnezijevog klorida heksahidrata |
| Pharmaceutical Form | otopina za peritonejsku dijalizu |
| Manufacturer | Vantive Manufacturing Limited, Castlebar, County Mayo, Irska |
| Marketing Authorisation Holder | Vantive Belgium SRL, Boulevard d'Angleterre 2, Braine-l'Alleud, Belgija |
| Marketing Authorisation Date | 08.11.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/225 |
| Registration Number | 381-12-01/70-24-72 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | B05DA |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Educational materials for healthcare professionals |
Popratno pismo za zdravstvene radnike, verzija 2 |
| Educational materials for patients / caregivers |
Kartica za bolesnika, verzija 5 Naljepnica za dokumentaciju, verzija 5 Omotnica za dokumentaciju, verzija 5 |
