ประเทศ: ไอร์แลนด์
ภาษา: อังกฤษ
แหล่งที่มา: HPRA (Health Products Regulatory Authority)
Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine hydrochloride monohydrate; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Sodium hydroxide ; Sodium chloride; Potassium acetate; Magnesium acetate tetrahydrate; Calcium chloride dihydrate; Glucose monohydrate; Sodium dihydrogen phosphate dihydrate; Zinc acetate dihydrate; Triglycerides, medium chain; Omega-3-acid triglycerides
B. Braun Melsungen AG
B05BA; B05BA10
Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine hydrochloride monohydrate; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Sodium hydroxide ; Sodium chloride; Potassium acetate; Magnesium acetate tetrahydrate; Calcium chloride dihydrate; Glucose monohydrate; Sodium dihydrogen phosphate dihydrate; Zinc acetate dihydrate; Triglycerides, medium chain; Omega-3-acid triglycerides
Unknown
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 PLUS 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 plus is and what it is used for 2. What you need to know before you use Omeflex plus 3. How to use Omeflex plus 4. Possible side effects 5. How to store Omeflex plus 6. Contents of the pack and other information 1. WHAT OMEFLEX PLUS IS AND WHAT IT IS USED FOR Omeflex plus contains fluids and substances called amino acids, electrolytes 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 plus is given to adults. You are given Omeflex plus 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 PLUS DO NOT USE OMEFLEX PLUS ● 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 use Omeflex plus if you suffer from any of the following: ● life-threatening blood circulation problems such as those that can occur if you are in a state of collapse or shock ● heart attack or stroke ● severely impaired blood clotting functio อ่านเอกสารฉบับเต็ม
Health Products Regulatory Authority 15 April 2021 CRN009ZXW Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeflex plus 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 1250 ML IN 1875 ML IN 2500 ML Glucose monohydrate 132.0 g 165.0 g 247.5 g 330.0 g equivalent to glucose 120.0 g 150.0 g 225.0 g 300.0 g Sodium dihydrogen phosphate dihydrate 1.872 g 2.340 g 3.510 g 4.680 g Zinc acetate dihydrate 5.264 mg 6.580 mg 9.870 mg 13.16 mg _FROM THE MIDDLE CHAMBER _ _(FAT EMULSION)_ IN 1000 ML IN 1250 ML IN 1875 ML IN 2500 ML Medium-chain triglycerides 20.00 g 25.00 g 37.50 g 50.00 g Soya-bean oil, refined 16.00 g 20.00 g 30.00 g 40.00 g Omega-3-acid triglycerides 4.000 g 5.000 g 7.500 g 10.00 g _FROM THE BOTTOM CHAMBER _ _(AMINO ACID SOLUTION)_ IN 1000 ML IN 1250 ML IN 1875 ML IN 2500 ML Isoleucine 2.256 g 2.820 g 4.230 g 5.640 g Leucine 3.008 g 3.760 g 5.640 g 7.520 g Lysine hydrochloride 2.728 g 3.410 g 5.115 g 6.820 g equivalent to lysine 2.184 g 2.729 g 4.094 g 5.459 g Methionine 1.880 g 2.350 g 3.525 g 4.700 g Phenylalanine 3.368 g 4.210 g 6.315 g 8.420 g Threonine 1.744 g 2.180 g 3.270 g 4.360 g Tryptophan 0.544 g 0.680 g 1.020 g 1.360 g Valine 2.496 g 3.120 g 4.680 g 6.240 g Arginine 2.592 g 3.240 g 4.860 g 6.480 g Histidine hydrochloride monohydrate 1.624 g 2.030 g 3.045 g 4.060 g equivalent to histidine 1.202 g 1.503 g 2.254 g 3.005 g Alanine 4.656 g 5.820 g 8.730 g 11.64 g Aspartic acid 1.440 g 1.800 g 2.700 g 3.600 g Glutamic acid 3.368 g 4.210 g 6.315 g 8.420 g Glycine 1.584 g 1.980 g 2.970 g 3.960 g Proline 3.264 g 4.080 g 6.120 g 8.160 g Serine 2.880 g 3.600 g 5.400 g 7.200 g Sodium hydroxide 0.781 g 0.976 g 1.464 g 1.952 g Sodium chloride 0.402 g 0.503 g 0.755 g 1.006 g Sodium acetate trihydrate 0.222 g 0.277 g 0.416 g 0.554 g Potassium acetate 2.747 g 3.434 g 5.151 g 6.868 g Magnesium acetate tetrahydrate อ่านเอกสารฉบับเต็ม