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Dianeal PD4 Glucose 2.27 % w/v (22.7 mg/ml), Solution for peritoneal dialysis



Baxter Holding B.V.PA2299/015/002

Main Information

Trade NameDianeal PD4 Glucose 2.27 % w/v (22.7 mg/ml), Solution for peritoneal dialysis
Active SubstancesSodium chloride
Sodium lactate
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Glucose anhydrous
Glucose monohydrate
Dosage FormSolution for peritoneal dialysis
Licence HolderBaxter Holding B.V.
Licence NumberPA2299/015/002

Group Information

ATC CodeB05DB Hypertonic solutions

Status

License statusAuthorised
Licence Issued03/06/1993
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceParametric Release for Sterility approved on 21st December 2004 in accordance with CPMP/QWP/3015/00, Note for Guidance on Parametric Release and Annex 17 to the EU guide on Good Manufacturing Practice provided the following conditions apply: 1.The approval is valid only for the Baxter Healthcare SA, Breaffy Road, Castlebar, Co Mayo, Ireland and Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom (MHRA approved 10th February 2004) manufactured in Viaflex bags only. 2.No double sterilization cycle is covered by this variation. Therefore any cycle aborted prior to completion and subjected to a second sterilization cycle is not covered by this variation. 3.In accordance with European Pharmacopoeia general monograph on parenteral products, which includes the requirements that “Parenteral products comply with the test for sterility’, so the sterility test remains a requirement for all sterilised products even where parametric release is approved, and should therefore be retained
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
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