bicaVera 1,5 % glukoze, 1,25 mmol/l kalcija, otopina za peritonejsku dijalizu
| Name | bicaVera 1,5 % glukoze, 1,25 mmol/l kalcija, otopina za peritonejsku dijalizu |
|---|---|
| Marketing Authorisation Number | HR-H-784667420 |
| Active Substance | kalcijev klorid dihidrat natrijev klorid natrijev hidrogenkarbonat magnezijev klorid heksahidrat glukoza hidrat |
| Composition | otopina pripremljena za uporabu sadrži: kalcijev klorid dihidrat 0,1838 g/l, natrijev klorid 5,786 g/l, natrijev hidrogenkarbonat 2,940 g/l, magnezijev klorid heksahidrat 0,1017 g/l, glukoza hidrat 16,5 g/l (15,0 g glukoze), što odgovara iona Ca2+ 1,25 mmol/l, iona Na+ 134 mmol/l, iona Mg 2+ 0,5 mmol/l, iona Cl- 103,5 mmol/l, iona HCO3- 34 mmol/l, glukoze 83,25 mmol/l. |
| Pharmaceutical Form | Otopina za peritonejsku dijalizu |
| Manufacturer | Fresenius Medical Care Deutschland GmbH, Bad Homburg, Njemačka
Fresenius Medical Care Deutschland GmbH, St. Wendel, Njemačka |
| Marketing Authorisation Holder | Fresenius Medical Care Deutschland GmbH, Else Kröner Str.1, Bad Homburg, Njemačka |
| Marketing Authorisation Date | 02.05.2022 |
| MA Period of Validity | 02.05.2027 |
| Classification Number | UP/I-530-09/21-01/233 |
| Registration Number | 381-12-01/154-22-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | B05DB |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
