Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution 2.5%w/v
Active Ingredients: Calcium chloride dihydrate 0.1455g/L
Glucose monohydrate 24.75g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Note: This consent is valid for two years from the date of publication of this notice.
Product: Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution 1.5%w/v
Active Ingredients: Calcium chloride dihydrate 0.1455g/L
Glucose monohydrate 14.85g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Note: This consent is valid for two years from the date of publication of this notice.
Product: Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution 4.25%w/v
Active Ingredients: Calcium chloride dihydrate 0.1455g/L
Glucose monohydrate 42.08g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Note: This consent is valid for two years from the date of publication of this notice.
Product: Dianeal PD-4 Peritoneal Dialysis Solution
Active Ingredients: Calcium chloride dihydrate 0.181g/L
Glucose monohydrate 5.45g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 5th day of September 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).