מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
Olive Oil, Quantity: 32 g/L; Soya Oil, Quantity: 8 g/L
Baxter Healthcare Pty Ltd
Alanine,Arginine,Aspartic acid,glucose,Glutamic acid,Glycine,Histidine,Isoleucine,Leucine,Lysine acetate,Methionine,Olive Oil,Ph
Injection, intravenous infusion
Excipient Ingredients: sodium oleate; water for injections; sodium hydroxide; egg lecithin; nitrogen; glycerol
Intravenous Infusion
1000 mL, 1500 mL, 2000 mL
Not scheduled. Not considered by committee
OLIMEL/PeriOLIMEL is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Visual Identification: smallest outside compartment containing a homogeneous liquid with a milky appearance.; Container Type: Multiple containers; Container Material: Composite plastic laminate; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-08-09
OLIMEL / PERIOLIMEL Emulsion for Intravenous Infusion CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? _ _ This leaflet answers some common questions about OLIMEL/PeriOLIMEL. It does not contain all of 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 using OLIMEL/PeriOLIMEL against the benefits he or she_ _may expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING_ _ADMINISTERED THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT OLIMEL/PERIOLIMEL IS USED FOR AND HOW IT WORKS OLIMEL/PeriOLIMEL is a sterile mixture of fat (soya_ _oil and olive oil), amino acids and glucose (with/without electrolytes depending on the formulation). It is used as a source of energy, maintaining the nitrogen/energy balance and correcting essential fatty acids deficiency. It is given as an infusion directly into your veins. OLIMEL/PeriOLIMEL is intended to provide you with nourishment (essential fatty acids, proteins, glucose) whilst you are unable to consume food by mouth. BEFORE YOU ARE GIVEN OLIMEL/PERIOLIMEL _OLIMEL/PERIOLIMEL SHOULD _ _NOT BE GIVEN TO YOU IF: _ • you have had an allergic reaction to egg or soya proteins, peanut protein, corn/corn products or to any of the active or inactive ingredients (listed at the end of this leaflet). • you have any of the following medical conditions: - problems in processing amino acids (congenital abnormalities of amino acid metabolism) - severe problems metabolising/breaking down fat resulting in abnormally high blood fat levels (severe hyperlipidaemia or hypertriglyceridaemia) - abnormally high blood sugar levels (severe hyperglycaemia) - abnormally high blood levels of the electrolytes - sodium, potassium, magnesium, calcium and/or phosphorus. • after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. OLIMEL/PeriOLIMEL should not be used for newborn ba קרא את המסמך השלם
Olimel/PeriOlimel Version 1.4 Page 1 of 24 AUSTRALIAN PRODUCT INFORMATION OLIMEL ® /PERIOLIMEL ® Emulsion for Intravenous Infusion 1. NAME OF THE MEDICINE OLIMEL/PeriOLIMEL with Electrolytes Alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, sodium acetate trihydrate, sodium glycerophosphate hydrate, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, glucose monohydrate, olive oil and soya oil. OLIMEL without Electrolytes Alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, glucose monohydrate, olive oil and soya oil. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION OLIMEL/PeriOLIMEL is presented in the form of a 3-compartment bag. The individual compartments contain a glucose solution, a lipid emulsion and an amino acid solution (with/without electrolytes). In products containing electrolytes, calcium is included in the glucose solution compartment and other electrolytes are in the amino acid solution compartment. There are 7 different formulations of OLIMEL (4 with electrolytes and 3 without electrolytes) and one formulation of PeriOLIMEL. The general composition of the formulations are summarised below: WITH ELECTROLYTES (E) WITHOUT ELECTROLYTES NITROGEN 1 AMINO ACID SOLUTION 2 GLUCOSE SOLUTION 3 LIPID EMULSION 4 PeriOLIMEL N4-600E _-_ _ _ 4.0g/L 6.3% 18.75% 15% OLIMEL N5-860E _-_ _ _ 5.2g/L 8.2% 28.75% 20% OLIMEL N7-960E OLIMEL N7-960 7.0g/L 11.1% 35% 20% OLIMEL N9-840E OLIMEL N9-840 9.0g/L 14.2% 27.5% 20% OLIMEL N12-640E OLIMEL N12-640 12g/L 14.2 % 27.5 % 17.5 % 1 prefixes N4, N5, N7, N9 refer to approx nitrogen content in g/L 2 contains 17 amino acids (and electrolytes if present) 3 contains calcium if present 4 contains refined olive oil (80%) and refined soya oil (20%) OLIMEL/PeriOLIMEL contains egg lecithi קרא את המסמך השלם