국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Soya oil 20%{relative}; ;
Fresenius Kabi New Zealand Limited
Soya oil 20% w/v
20 %
Solution for infusion
Active: Soya oil 20%{relative} Excipient: Egg lecithin Glycerol Water for injection
Bag, Excel, 100 mL
General sale
General sale
Fresenius Kabi AB
Part of the intravenous diet in all parenteral nutrition indications including: - Preoperative and postoperative nutritional disturbances where an improved nitrogen balance is required; - Nutritional disorders or disturbances of nitrogen balance due to inadequate or failing intestinal absorption caused by tumours in the gastrointestinal tract, acute or chronic intestinal diseases (peritonitis, ulcerative colitis, terminal ileitis); - Burns, to reduce the frequently excessive nitrogen losses; - Prolonged unconsciousness, eg following cranial trauma or poisoning in cases where enteral feeding is inappropriate or impossible; - Impaired renal function where a concentrated source of energy may be indicated to reduce protein breakdown; - Cachexia and - Patients with Essential Fatty Acid Deficiency who cannot maintain or restore a normal essential fatty acid pattern by oral intake.
Package - Contents - Shelf Life: Bag, plastic, Biofine-1 - 100 mL - 24 months from date of manufacture stored at or below 25°C - Bag, plastic, Biofine-1 - 500 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 100 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 250 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 500 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - 1000 mL - 24 months from date of manufacture stored at or below 25°C
1969-12-31
NEW ZEALAND CMI Page 1 of 2 INTRALIPID ® 10%, 20% & 30% Sterile fat emulsions containing soya oil, egg lecithin and glycerol CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Intralipid. 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 taking Intralipid against any benefits they expect it will have for you. Please read this leaflet carefully before using Intralipid 10%, 20% and 30%. If you have any questions or are unsure about anything, please ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. _ _ WHAT IS INTRALIPID USED FOR AND HOW DOES IT WORK? Intralipid is a sterile fat emulsion, which provides your body with energy and fatty acids. The active ingredient in Intralipid is soya oil. Soya oil consists of a mixture of mainly polyunsaturated fatty acids. It also contains egg lecithin as an emulsifier, which is isolated from egg yolk. It is available in 3 strengths namely 10%, 20% and 30%. 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. It is usually given together with carbohydrates, amino acids, salts, trace elements and vitamins to provide a complete intravenous diet. BEFORE YOU ARE GIVEN INTRALIPID You should not be given Intralipid if You have an allergy to soya oil, eggs, peanuts or any of the ingredients listed at the end of this leaflet. You have an inability to break down fats If you are not sure whether any of these apply to you, check with your doctor. You should tell your doctor BEFORE using Intralipid if the answer to any of t 전체 문서 읽기
NEW ZEALAND DATA SHEET Page 1 of 11 1 PRODUCT MEDICINE Intralipid ® 10%, 20% and 30%, intravenous infusion for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Soya oil is a mixture of triglycerides, i.e. triacylglycerols. The triglycerides, triacylglycerols, are fatty acid triesters of glycerol (propane-1, 2, 3-triol). The main fatty acids are linoleic acid (C18:2), oleic acid (C18:1) and palmitic acid (C16:0). The number of double bonds in the different fatty acids can vary from zero (saturated) to three (unsaturated). As with most vegetable oils, the saturated acids are preferably esterified in sn-1 and sn-3 position. The molecular structure is well known from general literature on lipid chemistry. Soya oil structural formula. General structure of a triglyceride, R1, R2 and R3 are long-chain alkyl groups. Molecular weight: 871 g/mol (typical mean value, the molecular weight depends on the fatty acid pattern of the triglyceride). CAS number 8001-22-7. Sterile fat emulsions for intravenous infusion containing: Content per 1000 mL Intralipid 10% Intralipid 20% Intralipid 30% Active Soya oil 100 g 200 g 300 g Osmolality (mOsmol/kg water) 300 350 310 Energy Content kcal (kJ) 1100 (4600) 2000 (8400) 3000 (12600) For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Intravenous infusion for Injection. A milky white liquid. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Part of the intravenous diet in all parenteral nutrition indications including: 1) Preoperative and postoperative nutritional disturbances where an improved nitrogen balance is required; 2) Nutritional disorders or disturbances of nitrogen balance due to inadequate or failing intestinal absorption caused by tumours in the gastrointestinal tract, acute or chronic intestinal diseases (peritonitis, ulcerative colitis, terminal ileitis); 3) Burns, to reduce the frequently excessive nitrogen losses; NEW ZEALAND DATA SHEET Page 2 of 11 4) Prolonged unconsciousness, eg following cranial trauma or poisoning in case 전체 문서 읽기