Ciprofloksacin Sandoz 200 mg/100 ml otopina za infuziju
| Name | Ciprofloksacin Sandoz 200 mg/100 ml otopina za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-364139536 |
| Active Substance | ciprofloksacinklorid |
| Composition | svaka bočica od 100 ml otopine za infuziju sadrži 200 mg ciprofloksacina u obliku ciprofloksacinklorid hidrata |
| Pharmaceutical Form | otopina za infuziju |
| Manufacturer | Salutas Pharma GmbH, Barleben, Njemačka
Sandoz GmbH, Kundl, Austrija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 13.12.2019 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/532 |
| Registration Number | 381-12-01/70-19-03 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J01MA02 |
| Medicinal product marketed in the Croatia | Nestašica |
| SmPC | download |
| PL | download |
| Summary of risk management plan | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku od regurgitacije/insuficijencije srčanih zalistaka uz primjenu fluorokinolona za sustavnu i inhalacijsku primjenu | 29.10.2020 | Alkaloid d.o.o, Sandoz d.o.o, Jadran Galenski laboratorij d.d., Belupo lijekovi i kozmetika d.d., Alpha-Medical d.o.o., KRKA-FARMA, d.o.o., PharmaS d.o.o., Alvogen d.o.o., Fresenius Kabi d.o.o., Pliva Hrvatska d.o.o. |
