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PRODUCT DETAIL

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ ml

Code 08336
MA number 87/0114/00-S
Product Form: sol pnd 5x2000 ml (dvojvak PVC)
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
B05DB Hypertonic solutions
Shelf life: 24 (12)
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: 13.04.2000
Pediatric indication: Yes
Pediatric posology: 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_Dianeal PD4 Glucose_09.2024.pdf  
SPC: SPC_Dianeal PD4 Glucose_09.2024.pdf  
Safety feature Yes
Data update: 28.05.2018
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