国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
Olive Oil, Quantity: 50 g; Fish oil - rich in Omega-3 acids, Quantity: 30 g; medium chain triglycerides, Quantity: 60 g; Soya Oil, Quantity: 60 g
Fresenius Kabi Australia Pty Ltd
Fish oil - rich in Omega-3 acids,medium chain triglycerides,Olive Oil,Soya Oil
Injection, intravenous infusion
Excipient Ingredients: glycerol; sodium oleate; dl-alpha-tocopherol; water for injections; egg lecithin; sodium hydroxide
Intravenous
10 x 100mL bags, 20 x 100 mL bags
Not Scheduled after consideration by Committee
Supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.
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
2015-12-14
Page 1 of 2 SMOFLIPID ® 20% Emulsion for intravenous infusion CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SMOFlipid. 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 SMOFlipid against any benefits they expect it will have for you. IF YOU HAVE ANY QUESTIONS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS SMOFLIPID USED FOR SMOFlipid is a sterile emulsion which provides your body with nutrition by the intravenous route. When the intake of nutrients or food into the mouth or directly into the gut is not possible, or it is not enough to supply the body’s needs, then intravenous nutrients or foods can be given. This is especially important for people whose bodies are under physical stress from illness or recent surgery. During illness or after surgery the body requires nutrition or food. SMOFlipid contains Soya oil, Medium chain triglycerides, Olive oil and Fish oil. SMOFlipid is usually given together with carbohydrates, amino acids and salts to provide an intravenous diet. BEFORE YOU ARE GIVEN SMOFLIPID _WHEN YOU MUST NOT TAKE IT _ If you have had an allergic reaction like fever, shivering, rash or breathing difficulties to fish, egg-yolk containing foods, peanut or soy products. If you are allergic to any of the ingredients in this medicine. If you have an inability to break down fats If you have severe liver failure. If you have severe kidney failure (when dialysis facilities are not available). If you are suffering from a very serious problem with your blood circulation. If you have too much fluid in your body. If you have too much acid in your blood, also called metabolic acidosis. If you have a build up of fluid in your lungs and If you have certain untreated heart problem 完全なドキュメントを読む
AUSTRALIAN PRODUCT INFORMATION - SMOFLIPID ® (FISH OIL-RICH IN OMEGA-3 ACIDS, MEDIUM CHAIN TRIGLYCERIDES, OLIVE OIL, SOYA OIL) Page 1 of 14 1 NAME OF MEDICINE Fish oil - rich in Omega-3 acids Medium chain triglycerides Olive oil Soya oil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SMOFlipid emulsion for infusion is a white homogenous emulsion. Each 1000 mL contains: Soya oil 60 g Medium chain triglycerides 60 g Olive oil 50 g Fish oil - rich in Omega-3 acids 30 g Total energy: 8400 kJ (2000kcal) pH: approx. 8 Osmolality: 380 mOsm/kg water Excipients with known effect: Egg lecithin For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM SMOFlipid is a white homogenous emulsion for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contraindicated. 4.2 DOSE AND METHOD OF ADMINISTRATION The patient’s ability to eliminate the fat infused should govern the dosage and infusion rate. Please see section 4.4 Special warnings and precautions for use. Adults The standard dose is 1.0 - 2.0 g fat/kg body weight (b.w)/day, corresponding to 5 - 10 mL/kg b.w/day. The recommended infusion rate is 0.125 g fat/kg b.w/hour, corresponding to 0.63 mL SMOFlipid/ kg b.w/hour, and should not exceed 0.15 g fat/kg b.w/hour, corresponding to 0.75 mL SMOFlipid/kg b.w/hour. Neonates and infants The initial dose should be 0.5 - 1.0 g fat kg b.w/day followed by a successive increase by 0.5 - 1.0 g fat/kg b.w/day up to 3.0 g fat/kg b.w/day. Page 2 of 14 It is recommended not to exceed a daily dose of 3 g fat/kg b.w/day, corresponding to 15 mL SMOFlipid/kg b.w/day. The rate of infusion should not exceed 0.125 g fat/kg b.w/hour. In premature and low birth weight neonates, SMOFlipid should be infused continuously over around 24 hours. Children It is recommended not to exceed a daily dose of 2 g fat/kg b.w/day, corresponding to 10 mL SMOFlipid/k 完全なドキュメントを読む