Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Soybean oil; Triglycerides, medium chain; Refined olive oil; Purified fish oil
Fresenius Kabi Deutschland GmbH
B05BA; B05BA02
Soybean oil; Triglycerides, medium chain; Refined olive oil; Purified fish oil
200 milligram(s)/millilitre
Emulsion for infusion
Solutions for parenteral nutrition; fat emulsions
Marketed
2004-10-27
PACKAGE LEAFLET: INFORMATION FOR THE USER SMOFLIPID 200 MG/ML, EMULSION FOR INFUSION Soya-bean oil, medium chain triglycerides, olive oil, fish oil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What SMOFlipid is and what it is used for 2. What you need to know before you are given SMOFlipid 3. How you are given SMOFlipid 4. Possible side effects 5. How to store SMOFlipid 6. Contents of the pack and other information 1. WHAT SMOFLIPID IS AND WHAT IT IS USED FOR SMOFlipid contains four different lipids (fats); soya-bean oil, medium chain triglycerides, olive oil and fish oil which is rich in omega-3 fatty acids. The liquid is a mixture of fats and water which is called a ‘lipid emulsion’. - It works by providing energy and fatty acids for your body - It is put into your blood by a drip or an infusion pump A health care professional will give you SMOFlipid when other forms of feeding are not good enough or have not worked. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SMOFLIPID YOU SHOULD NOT BE GIVEN SMOFLIPID: - if you are allergic to soya-bean oil, medium-chain tryglycerides, olive oil, fish oil or any of the other ingredients of this medicine (listed in section 6). - if you are allergic (hypersensitive) to any other products containing fish, egg, soy or peanut. - if you have too much fat in the blood (called ‘severe hyperlipemia’). - if you have serious kidney or liver problems. - if you have severe blood clotting problems (called ‘coagulation disorders’). - if you are in acute shock. - f you have fluid in the lungs (called ‘pulmonary oedema’) , too much body fluid (called ‘hyperhydration’) or have heart failure (due to too much body fl Прочетете целия документ
Health Products Regulatory Authority 28 May 2020 CRN009CYW Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SMOFlipid 200 mg/ml emulsion for infusion, glass bottle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml of emulsion for infusion contain: Soya-bean oil, refined 60.0 g Triglycerides, medium-chain 60.0 g Olive oil, refined 50.0 g Fish oil, rich in omega-3-acids 30.0 g Total energy: 8.4 MJ/l (= 2000kcal/l) pH-value: approx. 8 Osmolality approx. 380 mosm/kg Excipients with known effect: 1000 ml emulsion contains up to 5 mmol sodium (as sodium hydroxide and sodium oleate). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Emulsion for infusion. White homogenous emulsion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Supply of energy and essential fatty acids and omega-3 fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient’s ability to eliminate the fat infused, should govern the dosage and infusion rate, see section 4.4. _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. _PAEDIATRIC POPULATION_ 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. It is recommended not to exceed a daily dose of 3 g fat/kg b.w./d, 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 about 24 hours. Health Products Regulatory Authority 28 May 2020 CRN009CYW Page 2 of 7 Children It is rec Прочетете целия документ