Gazette.govt.nzPursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
| Product: | Dianeal 1mmol/L Calcium with 1.5% w/v glucose monohydrate |
| 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, Sydney, Australia |
| Note: This renewed consent is valid for two years from 12 September 2021. | |
| Product: | Dianeal 1mmol/L Calcium with 2.5% w/v glucose monohydrate |
| 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, Sydney, Australia |
| Note: This renewed consent is valid for two years from 12 September 2021. | |
| Product: | Dianeal 1mmol/L Calcium with 4.25% w/v glucose monohydrate |
| 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, Sydney, Australia |
| Note: This renewed consent is valid for two years from 12 September 2021. | |
| Product: | Dianeal PD4 with 0.55% w/v glucose monohydrate |
| 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, Sydney, Australia |
| Note: This renewed consent is valid for two years from 12 September 2021. | |
Dated this 6th day of September 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).