Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: 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
Alanine,Arginine,Fish oil - rich in Omega-3 acids,glucose,Glycine,Histidine,Isoleucine,Leucine,Lysine acetate,medium chain trigl
Injection, intravenous infusion
Excipient Ingredients: egg lecithin; glycerol; sodium oleate; water for injections; sodium hydroxide; dl-alpha-tocopherol
Intravenous Infusion
1 x 2463 mL, 3 x 2463 mL (Biofine bag), 1 x 2463 mL, 2 x 2463 mL (Excel bag)
Not scheduled. Not considered by committee
Parenteral nutrition for adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.
Visual Identification: White homogenous emulsion.; Container Type: Bag; Container Material: Composite plastic laminate; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-01-09
Page 1 of 2 SMOFKABIVEN ® ELECTROLYTE FREE Amino acids 5.1%, lipids 3.8% & glucose 12.7% CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SmofKabiven Electrolyte Free. 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 Electrolyte Free 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 ELECTROLYTE FREE USED FOR SmofKabiven Electrolyte Free 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) and lipids (fat) in a plastic bag. A health care professional will give you SmofKabiven Electrolyte Free when other forms of feeding are not good enough or have not worked. BEFORE YOU ARE GIVEN SMOFKABIVEN ELECTROLYTE FREE You must NOT use this product: if you are allergic (hypersensitive) to any of the ingredients of SmofKabiven Electrolyte Free if you are allergic to fish or egg if you are allergic to peanuts, soya or corn (maize) as SmofKabiven Electrolyte Free 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 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 syst Կարդացեք ամբողջական փաստաթուղթը
AUSTRALIAN PRODUCT INFORMATION - SMOFKABIVEN ® ELECTROLYTE FREE (AMINO ACIDS 5.1%, LIPIDS 3.8%, GLUCOSE 12.7%) Page 1 of 17 1 NAME OF MEDICINE _ _ _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 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SmofKabiven is a three chamber bag system of amino acid solution, 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 (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 1477ML 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 acetate _corresponding to_ Lysine 3.3 5.0 6.6 8.4 3.4 Methionine 2.2 3.2 4.3 5.4 2.2 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 Glucose monohydrate _corresponding to _ Glucose (anhydrous)_ _ 125 187 250 313 127 Page 2 of 17 ACTIVE INGREDIENTS (G) 986 ML 1477ML 1970 ML 2463 ML PER 1000 ML Soya oil 11.3 16.9 22.5 28.1 11.4 Medium chain triglycerides 11.3 16.9 22.5 28.1 11.4 Olive oil 9.4 14.1 18.8 23.4 9.5 Fish oil - rich in Omega-3 acids 5.6 8.4 11.3 14.0 5.7 Corresponding to: 986 ML 1477 ML 1970 ML 2463 ML PER 1000 ML Amino acids (g) 50 75 100 125 51 Nitrogen (g) 8 12 16 20 8 Lipids (g) 38 56 75 94 38 Carbohydrates - Glucose (an Կարդացեք ամբողջական փաստաթուղթը