Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
Olive Oil, Quantity: 50 g/L; Fish oil - rich in Omega-3 acids, Quantity: 30 g/L; medium chain triglycerides, Quantity: 60 g/L; Soya Oil, Quantity: 60 g/L
Fresenius Kabi Australia Pty Ltd
Alanine,Arginine,calcium chloride dihydrate,Fish oil - rich in Omega-3 acids,glucose,Glycine,Histidine,Isoleucine,Leucine,Lysine
Injection, intravenous infusion
Excipient Ingredients: water for injections; dl-alpha-tocopherol; sodium oleate; sodium hydroxide; egg lecithin; glycerol
Intravenous Infusion
1 x 1447mL, 4x 1447 mL (Biofine bag)
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 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 ® 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 Lue koko asiakirja
AUSTRALIAN PRODUCT INFORMATION - SMOFKABIVEN ® (AMINO ACIDS 5.1%, LIPIDS 3.8%, GLUCOSE 12.7% & ELECTROLYTES 0.7%) Page 1 of 21 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 _ELECTROLYTES 0.7% _ Calcium chloride dihydrate Magnesium sulfate heptahydrate Potassium chloride Sodium acetate trihydrate Sodium glycerophosphate hydrate 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 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 Page 2 of 21 ACTIVE INGREDIENTS (G) 986 ML 1477ML 1970 ML 2463 ML PER 1000 ML 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 dihydrate _corresponding to _ Calcium chloride 0.28 0.42 0.56 0.69 0.28 Sodium glycerophosphate hydrate _corresponding to_ Sodium glycerophosphate 2.1 3.1 4.2 5.2 2.1 Magnesium sulfate heptahydrate _corresponding Lue koko asiakirja