Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Soya Oil, Quantity: 200 g/L
Fresenius Kabi Australia Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: glycerol; egg lecithin; water for injections
Intravenous
500mL x 12
Medicine Registered
Not scheduled. Not considered by committee
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; 4. prolonged unconsciousness, eg. following cranial trauma or poisoning in cases where enteral feeding is inappropriate or impossible; 5.impaired renal function where a concentrated source of energy may be indicated to reduce protein breakdown; 6. cachexia; 7. patients with essential fatty acid deficiency who cannot maintain or restore a normal essential fatty acid pattern by oral intake.
Visual Identification: Milky white liquid; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-03-08
JULY 2016 CMI FOR INTRALIPID Filename: Page 1 of 2 Change: 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 Intra Prečítajte si celý dokument
AUSTRALIAN PRODUCT INFORMATION - INTRALIPID ® (SOYA OIL) Page 1 of 10 1 NAME OF MEDICINE Soya oil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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; 4) Prolonged unconsciousness, e.g. following cranial trauma or poisoning in cases where enteral feeding is inappropriate or impossible; 5) Impaired renal function where a concentrated source of energy may be indicated to reduce protein breakdown; 6) Cachexia and 7) Patients with Essential Fatty Acid Deficiency who cannot maintain or restore a normal essential fatty acid pattern by oral intake. 4.2 DOSE AND METHOD OF ADMINISTRATION Intralipid 30% is particularly suitable for patients on fluid restriction due to its more concentrated form. This also provides an advantage in patients with a high energy requirement. A lower phospholipid/triglyceride ratio provides less phospholipids than the same amount of energy from Intralipid 100 mg/mL and Intralipid 200 mg/mL. About 60% of the fatty acids in Intralipid are essential fatty acids. Page 2 of 10 Adult dosage and infusion rate _Intralipid 10% and 20% _ The quantity of Intralipid given Prečítajte si celý dokument