| Code | 12478 | ||||||||
| MA number | 87/0229/00-S | ||||||||
| Product Form: | sol pnd 5x2000 ml (dvojvak+luer konektor) | ||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
| Type of procedure: | National | ||||||||
| MAH, country: | Vantive Belgium SRL, Belgium | ||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||
| ATC: |
|
||||||||
| Shelf life: | 24 | ||||||||
| Container: | bag PVC | ||||||||
| Route of admin.: | Intraperitoneal use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 28.06.2000 |
| Pediatric warnings: | Yes |
| Dokument: |
Baxter DHPC_FINAL_FINAL_clean 20 12 2010_signed.pdf
|
| Dokument: |
Baxter PD sol Endotoxin_AE reporting form active surveil.pdf
|
| PIL: |
PIL_EXTRANEAL_09.2024.pdf
|
| SPC: |
SPC_EXTRANEAL_09.2024.pdf
|
| Dokument: |
Extraneal_Upozornenie pre zdravotníckych pracovníkov.pdf
|
| Dokument: |
Extraneal_Karta pacienta.pdf
|
| Dokument: |
Extraneal_Nálepka.pdf
|
| Dokument: |
Extraneal_Zoznam glukometrov.pdf
|
| Safety feature | Yes |
| Data update: | 01.02.2022 |
