Country: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Alanine 14 g/L; ; ; Arginine 12 g/L; ; ; Calcium chloride dihydrate 0.74 g/L equivalent to calcium chloride 0.56 g/L; ; Glycine 11 g/L; ; ; ; Histidine 3 g/L; ; ; ; Isoleucine 5 g/L; ; ; ; Leucine 7.4 g/L; ; ; ; Lysine acetate 9.3 g/L equivalent to L-Lysine 6.6 g/L; ; ; Magnesium sulfate heptahydrate 2.47 g/L equivalent to magnesium sulfate 1.2 g/L; ; Methionine 4.3 g/L; ; ; Phenylalanine 5.1 g/L; ; ; Potassium chloride 4.48 g/L; ; Proline 11.2 g/L; ; Serine 6.5 g/L; ; ; ; Sodium acetate trihydrate 5.62 g/L equivalent to sodium acetate 3.4 g/L; ; ; ; Sodium glycerophosphate 4.18 g/L; Sodium glycerophosphate hydrate equivalent to sodium glycerophosphate 4.18g/L; ; Taurine 1 g/L; ; Threonine 4.4 g/L; ; ; ; Tryptophan 2 g/L; ; ; Tyrosine 0.4 g/L; ; Valine 6.2 g/L; ; ; ; ; Zinc sulfate heptahydrate 0.023 g/L equivalent to zinc sulfate 0.0129 g/L; ; Glucose monohydrate 130 g/L equivalent to glucose 118 g/L; ; ; Fish oil 30 g/L; Medium-chain triglycerides 60 g/L; ; Olive oil 50 g/L; ; Soya oil 60 g/L;
Fresenius Kabi New Zealand Limited
Emulsion for infusion
Active: Alanine 14 g/L Arginine 12 g/L Calcium chloride dihydrate 0.74 g/L equivalent to calcium chloride 0.56 g/L Glycine 11 g/L Histidine 3 g/L Isoleucine 5 g/L Leucine 7.4 g/L Lysine acetate 9.3 g/L equivalent to L-Lysine 6.6 g/L Magnesium sulfate heptahydrate 2.47 g/L equivalent to magnesium sulfate 1.2 g/L Methionine 4.3 g/L Phenylalanine 5.1 g/L Potassium chloride 4.48 g/L Proline 11.2 g/L Serine 6.5 g/L Sodium acetate trihydrate 5.62 g/L equivalent to sodium acetate 3.4 g/L Sodium glycerophosphate 4.18 g/L Sodium glycerophosphate hydrate equivalent to sodium glycerophosphate 4.18g/L Taurine 1 g/L Threonine 4.4 g/L Tryptophan 2 g/L Tyrosine 0.4 g/L Valine 6.2 g/L Zinc sulfate heptahydrate 0.023 g/L equivalent to zinc sulfate 0.0129 g/L Excipient: Acetic acid Nitrogen Water for injection Active: Glucose monohydrate 130 g/L equivalent to glucose 118 g/L Excipient: Nitrogen Water for injection Active: Fish oil 30 g/L Medium-chain triglycerides 60 g/L Olive oil 50 g/L Soya oil 60 g/L Excipient: Egg lecithin Glycerol Nitrogen Sodium hydroxide Sodium oleate Tocoferols Water for injection
General sale
Parenteral nutrition for adult patients and paediatric patients aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated
Package - Contents - Shelf Life: Bag, plastic, Biofine 3-chamber bag, 5 x 850 mL - 850 mL - 24 months from date of manufacture stored at or below 25°C. Store in overpouch 36 hours opened stored at or below 25°C. Store in overpouch - Bag, plastic, Biofine 3-chamber bag, 4 x 1400 mL - 1400 mL - 24 months from date of manufacture stored at or below 25°C. Store in overpouch 36 hours opened stored at or below 25°C. Store in overpouch - Bag, plastic, Biofine 3-chamber bag, 4 x 1950 mL - 1950 mL - 24 months from date of manufacture stored at or below 25°C. Store in overpouch 36 hours opened stored at or below 25°C. Store in overpouch - Bag, plastic, Biofine 3-chamber bag, 3 x 2500 mL - 2500 mL - 24 months from date of manufacture stored at or below 25°C. Store in overpouch 36 hours opened stored at or below 25°C. Store in overpouch
2020-04-01
Page 1 of 2 SMOFKABIVEN LOW OSMO Amino acids 2.5%, Lipids 3.5%, Glucose 6.8% & Electrolytes 0.4% CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SmofKabiven Low Osmo. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you given SmofKabiven Low Osmo against any benefits they expect it will have for you. PLEASE READ THIS LEAFLET CAREFULLY. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT ANYTHING, PLEASE ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet. You may need to read it again. WHAT IS SMOFKABIVEN LOW OSMO USED FOR SmofKabiven Low Osmo is an emulsion for infusion given into your blood by a drip (intravenous infusion). The product contains amino acids (components used to build proteins), glucose (carbohydrates), lipids (fat) and salts (electrolytes) in a plastic bag. A health care professional will give you SmofKabiven Low Osmo when other forms of feeding are not good enough or have not worked. BEFORE YOU ARE GIVEN SMOFKABIVEN LOW OSMO You must NOT use this product: if you are allergic (hypersensitive) to any of the ingredients of SmofKabiven Low Osmo if you are allergic to fish or egg if you are allergic to peanuts, soya or corn (maize) as SmofKabiven Low Osmo contains soya oil if you have too much fat in the blood (hyperlipidaemia) if you have serious liver disease if you have blood clotting problems (coagulation disorders) if your body has problems using amino acids if you have serious kidney disease without access to dialysis if you are in acute shock if you have too much sugar in your blood (hyperglycaemia) which is uncontrolled if you have high blood (serum) levels of the salts (electrolytes) if you have fluid in the lungs (acute pulmonary oedema) if you have too much body fluid (hyperhydrated) if you have heart failure that is not treated if you have a Lestu allt skjalið
NEW ZEALAND DATA SHEET Page 1 of 21 1. PRODUCT NAME SmofKabiven Low Osmo (Infusion, emulsion). Amino acids 2.5%, Electrolytes 0.4%: Lipids 3.5% and Glucose 6.8%. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SmofKabiven Low Osmo consists of a three chamber bag system. Each bag contains the following partial volumes depending on the four pack sizes. 850 ML 1 1400 ML 1950 ML 2500 ML 1 PER 1000 ML Amino acid solution 10% with electrolytes 213 mL 350 mL 488 mL 625 mL 250 mL Glucose 11.8% 489 mL 805 mL 1121 mL 1438 mL 575 mL Lipid emulsion 20% 149 mL 245 mL 341 mL 438 mL 175 mL This corresponds to the following total compositions: ACTIVE INGREDIENTS 850 ML 1400 ML 1950 ML 2500 ML PER 1000 ML Alanine 3.0 g 4.9 g 6.8 g 8.8 g 3.5 g Arginine 2.6 g 4.2 g 5.9 g 7.5 g 3.0 g Glycine 2.3 g 3.9 g 5.4 g 6.9 g 2.8 g Histidine 0.64 g 1.1 g 1.5 g 1.9 g 0.75 g Isoleucine 1.1 g 1.8 g 2.4 g 3.1 g 1.3 g Leucine 1.6 g 2.6 g 3.6 g 4.6 g 1.9 g Lysine (as acetate) 1.4 g 2.3 g 3.2 g 4.1 g 1.7 g Methionine 0.92 g 1.5 g 2.1 g 2.7 g 1.1 g Phenylalanine 1.1 g 1.8 g 2.5 g 3.2 g 1.3 g Proline 2.4 g 3.9 g 5.5 g 7.0 g 2.8 g Serine 1.4 g 2.3 g 3.2 g 4.1 g 1.6 g Taurine 0.21 g 0.35 g 0.49 g 0.63 g 0.25 g Threonine 0.94 g 1.5 g 2.1 g 2.8 g 1.1 g Tryptophan 0.43 g 0.70 g 0.98 g 1.3 g 0.50 g Tyrosine 0.085 g 0.14 g 0.20 g 0.25 g 0.10 g Valine 1.3 g 2.2 g 3.0 g 3.9 g 1.6 g Calcium chloride dihydrate _corresponding to_ Calcium chloride 0.12 g 0.20 g 0.27 g 0.35 g 0.14 g Sodium glycerophosphate (hydrate) _corresponding to_ Sodium glycerophosphate 0.89 g 1.5 g 2.0 g 2.6 g 1.0 g Magnesium sulphate heptahydrate _corresponding to _ Magnesium sulphate_ _ 0.26 g 0.42 g 0.59 g 0.75 g 0.30 g 1 The total volume for bags is shown as the sum of the non-rounded chamber volumes Page 2 of 21 ACTIVE INGREDIENTS 850 ML 1400 ML 1950 ML 2500 ML PER 1000 ML Potassium chloride 0.95 g 1.6 g 2.2 g 2.8 g 1.1 g Sodium acetate trihydrate _corresponding to_ Sodium acetate 0.72 g 1.2 g 1.7 g 2.1 g 0.85 g Zinc sulphate heptahydrate _corresponding to_ Zinc sulphate 0.0027 g 0.0045 g 0.0 Lestu allt skjalið