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PRODUCT DETAIL

EXTRANEAL

Code 9567D
MA number 87/0229/00-S
Product Form: sol pnd 5x2500 ml (dvojvak+spike 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:
B BLOOD AND BLOOD FORMING ORGANS
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B05D PERITONEAL DIALYTICS
B05DA Isotonic solutions
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  
Dokument: Extraneal_Karta pacienta.pdf  
Dokument: Extraneal_Upozornenie pre zdravotníckych pracovníkov.pdf  
Dokument: Extraneal_Zoznam glukometrov používaných v danej krajine.pdf  
PIL: PIL_EXTRANEAL_09.2024.pdf  
SPC: SPC_EXTRANEAL_09.2024.pdf  
Safety feature Yes
Data update: 01.02.2022
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