Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Kabiven Peripheral
Active Ingredient: Glucose monohydrate 12.1% equivalent to 11% glucose anhydrous
Dosage Form: (Glucose component) Solution for injection
Active Ingredients: Alanine 1.6%
Arginine 1.13%
Aspartic acid 0.34%
Calcium chloride dihydrate 0.074%
Glutamic acid 0.56%
Glycine 0.79%
Histidine 0.68%
Isoleucine 0.56%
Leucine 0.79%
Lysine hydrochloride 0.9%
Magnesium sulphate 0.16%
Methionine 0.56%
Phenylalanine 0.79%
Potassium chloride 0.597%
Proline 0.68%
Serine 0.45%
Sodium acetate trihydrate 0.49%
Sodium glycerophosphate 0.54%
Threonine 0.56%
Tryptophan 0.19%
Tyrosine 0.023%
Valine 0.73%
Dosage Form: (Vamin 18 Novum component) Solution for injection
Active Ingredient: Soya oil 20%
Dosage Form: (Intralipid component) Emulsion for injection
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden
Product: Kabiven
Active Ingredients: Glucose monohydrate 20.9 equivalent to 19% glucose anhydrous
Dosage Form: (Glucose component) Solution for injection
Active Ingredients: Alanine 1.6%
Arginine 1.13%
Aspartic acid 0.34%
Calcium chloride dihydrate 0.074%
Glutamic acid 0.56%
Glycine 0.79%
Histidine 0.68%
Isoleucine 0.56%
Leucine 0.79%
Lysine hydrochloride 0.9%
Magnesium sulphate 0.16%
Methionine 0.56%
Phenylalanine 0.79%
Potassium chloride 0.597%
Proline 0.68%
Serine 0.45%
Sodium acetate trihydrate 0.49%
Sodium glycerophosphate 0.54%
Threonine 0.56%
Tryptophan 0.19%
Tyrosine 0.023%
Valine 0.73%
Dosage Form: (Vamin 18 Novum component) Solution for injection
Active Ingredient: Soya oil 20%
Dosage Form: (Intralipid component) Emulsion for injection
New Zealand Sponsor: Fresenius Medical Care New Zealand
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden
Dated this 19th day of June 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).