Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Fish oil - rich in Omega-3 acids, Quantity: 30 g/L; medium chain triglycerides, Quantity: 60 g/L; Olive Oil, Quantity: 50 g/L; Soya Oil, Quantity: 60 g/L
Fresenius Kabi Australia Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: dl-alpha-tocopherol; egg lecithin; glycerol; sodium oleate; sodium hydroxide; water for injections
Intravenous Infusion
1 x 1400 mL, 4 x 1400 mL
Not scheduled. Not considered by committee
Parenteral nutrition for adult patients and paediatric patients aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.
Visual Identification: White homogeneous emulsion; Container Type: Bag; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-08-27
CMI - SmofKabiven Low Osmo 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 no Lesen Sie das vollständige Dokument
AUSTRALIAN PRODUCT INFORMATION – SMOFKABIVEN LOW OSMO (AMINO ACIDS 2.5%, ELECTROLYTES 0.4%, LIPIDS 3.5% AND GLUCOSE 6.8%) Page 1 of 24 1. NAME OF THE MEDICINE SmofKabiven Low Osmo is a three chamber bag system of amino acid solution with electrolytes, glucose solution and lipid emulsion for intravenous infusion. The active ingredients are: AMINO ACIDS 2.5%: Alanine, Arginine, Glycine, Histidine, Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Proline, Serine, Taurine, Threonine, Tryptophan, Tyrosine, Valine. ELECTROLYTES 0.4%: Calcium chloride dihydrate, Sodium glycerophosphate hydrate, Magnesium sulfate heptahydrate, Potassium chloride, Sodium acetate trihydrate, Zinc sulfate heptahydrate. LIPIDS 3.5%: Soya oil, Fish oil - rich in Omega-3 acids, Medium-chain triglycerides, Olive oil. GLUCOSE 6.8%: Glucose monohydrate. 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 acetate _corresponding to_ Lysine 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 1 The total volume for bags is shown as the sum of the non-rounded cha Lesen Sie das vollständige Dokument