Notice Type
Departmental
Notice Title

Corrigendum—Consent to the Distribution of New Medicines

In the notice with the above heading, published in the New Zealand Gazette, 22 April 2021, Notice No. 2021-go1438. This corrigendum amends the notice by replacing the entry:

Schedule

Product:
Amino acid component:
Active Ingredients:
SmofKabiven Low Osmo

Alanine 14g/L
Arginine 12g/L
Calcium chloride dihydrate 0.74g/L equivalent to calcium chloride 0.56g/L
Glycine 11g/L
Histidine 3g/L
Isoleucine 5g/L
Leucine 7.4g/L
Lysine acetate 9.3g/L equivalent to L-Lysine 6.6g/L
Magnesium sulfate heptahydrate 2.47g/L equivalent to magnesium sulfate 1.2g/L
Methionine 4.3g/L
Phenylalanine 5.1g/L
Potassium chloride 4.48g/L
Proline 11.2g/L
Serine 6.5g/L
Sodium acetate trihydrate 5.62g/L equivalent to sodium acetate 3.4g/L
Sodium glycerophosphate 4.18mg/L
Taurine 1g/L
Threonine 4.4g/L
Tryptophan 2g/L
Tyrosine 0.4g/L
Valine 6.2g/L
Zinc sulfate heptahydrate 0.023g/L equivalent to zinc sulfate 0.0129g/L
Dosage Form: Solution for infusion
Glucose component:
Active Ingredient:

Glucose monohydrate 130g/L equivalent to glucose 118g/L
Dosage Form: Solution for infusion
Lipid component:
Active Ingredients:

Fish oil 30g/L
Medium-chain triglycerides 60g/L
Olive oil 50g/L
Soya oil 60g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden

With:

Product:
Amino acid component:
Active Ingredients:
SmofKabiven Low Osmo

Alanine 14g/L
Arginine 12g/L
Calcium chloride dihydrate 0.74g/L equivalent to calcium chloride 0.56g/L
Glycine 11g/L
Histidine 3g/L
Isoleucine 5g/L
Leucine 7.4g/L
Lysine acetate 9.3g/L equivalent to L-Lysine 6.6g/L
Magnesium sulfate heptahydrate 2.47g/L equivalent to magnesium sulfate 1.2g/L
Methionine 4.3g/L
Phenylalanine 5.1g/L
Potassium chloride 4.48g/L
Proline 11.2g/L
Serine 6.5g/L
Sodium acetate trihydrate 5.62g/L equivalent to sodium acetate 3.4g/L
Sodium glycerophosphate 4.18g/L
Taurine 1g/L
Threonine 4.4g/L
Tryptophan 2g/L
Tyrosine 0.4g/L
Valine 6.2g/L
Zinc sulfate heptahydrate 0.023g/L equivalent to zinc sulfate 0.0129g/L
Dosage Form: Solution for infusion
Glucose component:
Active Ingredient:

Glucose monohydrate 130g/L equivalent to glucose 118g/L
Dosage Form: Solution for infusion
Lipid component:
Active Ingredients:

Fish oil 30g/L
Medium-chain triglycerides 60g/L
Olive oil 50g/L
Soya oil 60g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden


Dated this 5th day of July 2021.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).