Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Isoleucine; Leucine ; Lysine monohydrate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Glucose monohydrate; Triglycerides medium-chain ; SOYA BEAN OIL, REFINED PH. EUR.; Omega-3-acid triglycerides
B. Braun Melsungen AG
B05BA; B05BA10
Isoleucine; Leucine ; Lysine monohydrate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Glucose monohydrate; Triglycerides medium-chain ; SOYA BEAN OIL, REFINED PH. EUR.; Omega-3-acid triglycerides
0 millilitre(s)
Emulsion for infusion
Product subject to prescription which may not be renewed (A)
Solutions for parenteral nutrition; combinations
Marketed
2017-02-03
PACKAGE LEAFLET: INFORMATION FOR THE USER OMEFLEX SPECIAL WITHOUT ELECTROLYTES EMULSION FOR INFUSION 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, pharmacist or nurse. ● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. ● If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Omeflex special without electrolytes is and what it is used for 2. What you need to know before you use Omeflex special without electrolytes 3. How to use Omeflex special without electrolytes 4. Possible side effects 5. How to store Omeflex special without electrolytes 6. Contents of the pack and other information 1. WHAT OMEFLEX SPECIAL WITHOUT ELECTROLYTES IS AND WHAT IT IS USED FOR Omeflex special without electrolytes contains fluids and substances called amino acids and fatty acids that are essential for the body to grow or to recover. It also contains calories in the form of carbohydrates and fats. Omeflex special without electrolytes is given to adults. You are given Omeflex special without electrolytes when you are unable to eat food normally. There are many situations when this might be the case, for example when you are recovering from surgery, injuries, or burns, or when you are unable to absorb food from your stomach and gut. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OMEFLEX SPECIAL WITHOUT ELECTROLYTES DO NOT USE OMEFLEX SPECIAL WITHOUT ELECTROLYTES ● if you are allergic to any of the active substances, to egg, peanut, soybean or fish or to any of the other ingredients of this medicine (listed in section 6). ● This medicine must not be given to newborn infants, infants and toddlers under two years old. Also, do not Lugege kogu dokumenti
Health Products Regulatory Authority 05 January 2024 CRN009XSG Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeflex special without electrolytes emulsion for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The ready-for-use emulsion for intravenous infusion contains after mixing the chamber contents: _FROM THE TOP CHAMBER _ _(GLUCOSE SOLUTION)_ IN 1000 ML IN 625 ML IN 1250 ML IN 1875 ML Glucose monohydrate 158.4 g 99.00 g 198.0 g 297.0 g equivalent to glucose 144.0 g 90.00 g 180.0 g 270.0 g _FROM THE MIDDLE CHAMBER _ _(FAT EMULSION)_ IN 1000 ML IN 625 ML IN 1250 ML IN 1875 ML Medium-chain triglycerides 20.00 g 12.50 g 25.00 g 37.50 g Soya-bean oil, refined 16.00 g 10.00 g 20.00 g 30.00 g Omega-3-acid triglycerides 4.000 g 2.500 g 5.000 g 7.500 g _FROM THE BOTTOM CHAMBER _ _(AMINO ACID SOLUTION)_ IN 1000 ML IN 625 ML IN 1250 ML IN 1875 ML Isoleucine 3.284 g 2.053 g 4.105 g 6.158 g Leucine 4.384 g 2.740 g 5.480 g 8.220 g Lysine monohydrate 3.576 g 2.235 g 4.470 g 6.705 g equivalent to lysine 3.184 g 1.990 g 3.979 g 5.969 g Methionine 2.736 g 1.710 g 3.420 g 5.130 g Phenylalanine 4.916 g 3.073 g 6.145 g 9.218 g Threonine 2.540 g 1.588 g 3.175 g 4.763 g Tryptophan 0.800 g 0.500 g 1.000 g 1.500 g Valine 3.604 g 2.253 g 4.505 g 6.758 g Arginine 3.780 g 2.363 g 4.725 g 7.088 g Histidine 1.752 g 1.095 g 2.190 g 3.285 g Alanine 6.792 g 4.245 g 8.490 g 12.73 g Aspartic acid 2.100 g 1.313 g 2.625 g 3.938 g Glutamic acid 4.908 g 3.068 g 6.135 g 9.203 g Glycine 2.312 g 1.445 g 2.890 g 4.335 g Proline 4.760 g 2.975 g 5.950 g 8.925 g Serine 4.200 g 2.625 g 5.250 g 7.875 g IN 1000 ML IN 625 ML IN 1250 ML IN 1875 ML Amino acid content [g] 56.0 35.0 70.1 105.1 Nitrogen content [g] 8 5 10 15 Carbohydrate content [g] 144 90 180 270 Lipid content [g] 40 25 50 75 Excipient(s) with known effect: Sodium (from sodium oleate and sodium hydroxide) with max. 0.5 mmol/l in the ready to use emulsion. For the full list of excipients, see section 6.1. Health Products Regulatory Authority 05 January 2024 CR Lugege kogu dokumenti