Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Alanine 14 g/L; ; ; Arginine 12 g/L; ; ; Calcium chloride dihydrate 0.56 g/L (as dihydrate. Equivalent to 0.74 g/L calcium chloride dihydrate); ; 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 1.2 g/L (as heptahydrate. Equivalent to 2.47 g/L magnesium sulphate heptahydrate); ; ; 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 3.4 g/L (as trihydrate. Equivalent to sodium acetate trihydrate 5.62 g/L); ; ; ; Sodium glycerophosphate 4.18 g/L (as hydrate. Amount added corrected for actual water content of substance); ; 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 0.023 g/L (as heptahydrate. Equivalent to zinc sulphate 0.0129 g); ; Glucose monohydrate 462 g/L equivalent to glucose (anhydrous) 420 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
Alanine 14 g/L
Emulsion for infusion
Active: Alanine 14 g/L Arginine 12 g/L Calcium chloride dihydrate 0.56 g/L (as dihydrate. Equivalent to 0.74 g/L calcium chloride dihydrate) 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 1.2 g/L (as heptahydrate. Equivalent to 2.47 g/L magnesium sulphate heptahydrate) 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 3.4 g/L (as trihydrate. Equivalent to sodium acetate trihydrate 5.62 g/L) Sodium glycerophosphate 4.18 g/L (as hydrate. Amount added corrected for actual water content of substance) 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 0.023 g/L (as heptahydrate. Equivalent to zinc sulphate 0.0129 g) Excipient: Glacial acetic acid Nitrogen Water for injection Active: Glucose monohydrate 462 g/L equivalent to glucose (anhydrous) 420 g/L Excipient: Hydrochloric acid 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: dl-Alpha tocopherol Egg lecithin Glycerol Nitrogen Sodium hydroxide Sodium oleate Water for injection
Bag, plastic, Biofine 3-chamber bag, 986mL, 1 dose unit
General sale
General sale
Kyowa Hakko Bio Co., Ltd
Parenteral nutrition for adults and children 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, 2463mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber bag, 1970mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber bag, 1477mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber bag, 986mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber bag, 2463mL - 3 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber bag, 1970mL - 4 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber bag, 1477mL - 4 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Bag, plastic, Biofine 3-chamber bag, 986mL - 4 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze
2012-05-18
Page 1 of 2 SMOFKABIVEN ® Amino acids 5.1%, lipids 3.8%, glucose 12.7% & electrolytes 0.7% CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SmofKabiven. 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 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 USED FOR SmofKabiven 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 when other forms of feeding are not good enough or have not worked. BEFORE YOU ARE GIVEN SMOFKABIVEN You must NOT use this product: if you are allergic (hypersensitive) to any of the ingredients of SmofKabiven if you are allergic to fish or egg if you are allergic to peanuts, soya or corn (maize) as SmofKabiven 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 defect in your blood clotting system (haemophagocytotic syndrome) if you Les hele dokumentet
NEW ZEALAND DATA SHEET Page 1 of 23 1. PRODUCT NAME SmofKabiven ® (Infusion, emulsion) _AMINO ACIDS 5.1% _ Alanine, Arginine, Glycine, Histidine, Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Proline, Serine, Taurine, Threonine, Tryptophan, Tyrosine, Valine _LIPIDS 3.8% _ Soya oil Fish oil - rich in Omega-3 acids Medium chain triglycerides Olive oil _GLUCOSE 12.7% _ Glucose monohydrate _ELECTROLYTES 0.7% _ Calcium chloride dihydrate Magnesium sulfate heptahydrate Potassium chloride Sodium acetate trihydrate Sodium glycerophosphate Zinc sulfate heptahydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SmofKabiven is a three chamber bag system of amino acid solution with electrolytes, glucose solution and lipid emulsion for intravenous infusion. Each bag contains the following partial volumes depending on the four pack sizes. 986 ML 1477 ML 1970 ML 2463 ML PER 1000 ML Amino acid solution with electrolytes (mL) 500 750 1000 1250 508 Glucose 42% (mL) 298 446 595 744 302 Lipid emulsion (mL) 188 281 375 469 190 This corresponds to the following total compositions: ACTIVE INGREDIENTS (G) 986 ML 1477 ML 1970 ML 2463 ML PER 1000 ML Alanine 7.0 10.5 14.0 17.5 7.1 Arginine 6.0 9.0 12.0 15.0 6.1 Glycine 5.5 8.2 11.0 13.8 5.6 Histidine 1.5 2.2 3.0 3.7 1.5 Isoleucine 2.5 3.8 5.0 6.2 2.5 Leucine 3.7 5.6 7.4 9.4 3.8 Lysine (as acetate) 3.3 5.0 6.6 8.4 3.4 Methionine 2.2 3.2 4.3 5.4 2.2 NEW ZEALAND DATA SHEET Page 2 of 23 ACTIVE INGREDIENTS (G) 986 ML 1477 ML 1970 ML 2463 ML PER 1000 ML Phenylalanine 2.6 3.8 5.1 6.4 2.6 Proline 5.6 8.4 11.2 14.0 5.7 Serine 3.2 4.9 6.5 8.1 3.3 Taurine 0.50 0.75 1.0 1.2 0.50 Threonine 2.2 3.3 4.4 5.4 2.2 Tryptophan 1.0 1.5 2.0 2.5 1.0 Tyrosine 0.20 0.30 0.40 0.49 0.20 Valine 3.1 4.6 6.2 7.6 3.1 Calcium chloride (as dihydrate) 0.28 0.42 0.56 0.69 0.28 Sodium glycerophosphate (as hydrate) 2.1 3.1 4.2 5.2 2.1 Magnesium sulfate (as heptahydrate) _ _ 0.60 0.90 1.2 1.5 0.61 Potassium chloride 2.2 3.4 4.5 5.7 2.3 Sodium acetate (as trihydrate) 1.7 2.6 3.4 4.2 1.7 Zinc sulfate (as _ _ hep Les hele dokumentet