Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data Sheet
File ref: TT50-2184/18
Trade NameDose FormStrengthIdentifier
Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL)Solution for infusion(Baxter)
SponsorApplication dateRegistration situationClassification
Baxter Healthcare Ltd
P O Box 14062
Panmure
AUCKLAND 1741
29/9/1980Consent given
Approval date: 29/9/1980
General sale
 

Composition

ComponentIngredientManufacturer
solution for infusionActive 
 Potassium chloride 0.15% w/v
 Sodium chloride 0.9% w/v
 Excipient 
 Water for injection

Production

Manufacturing stepManufacturer
Manufacture of Final Dose FormBaxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie
NSW 2146
Australia
PackingBaxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie
NSW 2146
Australia
NZ Site of Product ReleaseBaxter Healthcare Ltd
33 Vestey Drive
Mt Wellington
AUCKLAND

Packaging

PackageContentsShelf Life
Bag, Viaflex, 1000 mL24 months from date of manufacture stored at or below 30°C

Indications

Indicated as a source of water and to restore electrolyte balance as required by the patient's clinical condition, such as hypokalaemia.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
24/4/2018Changed Medicine NotificationFinished product manufacturing process - Grade 1; Administrative fee (CMN)Granted 2/8/201811/5/2018 
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