Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine Monoglutamate ; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Magnesium acetate tetrahydrate; Sodium acetate trihydrate ; Potassium dihydrogen phosphate; Potassium hydroxide; Sodium hydroxide ; Glucose monohydrate; Calcium chloride dihydrate; Histidine hydrochloride monohydrate
B. Braun Melsungen AG
V06DE
Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine Monoglutamate ; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Magnesium acetate tetrahydrate; Sodium acetate trihydrate ; Potassium dihydrogen phosphate; Potassium hydroxide; Sodium hydroxide ; Glucose monohydrate; Calcium chloride dihydrate; Histidine hydrochloride monohydrate
N/A
Solution for infusion
Product subject to prescription which may not be renewed (A)
Amino acids/carbohydrates/minerals/vitamins, combinations
Not marketed
2000-01-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NUTRIFLEX SPECIAL SOLUTION FOR INFUSION Amino acids / Glucose / Electrolytes 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 further questions, ask your healthcare professional. ● 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 healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Nutriflex special is and what it is used for 2. What you need to know before you use Nutriflex special 3. How to use Nutriflex special 4. Possible side effects 5. How to store Nutriflex special 6. Contents of the pack and other information 1. WHAT NUTRIFLEX SPECIAL IS AND WHAT IT IS USED FOR The product contains substances (nutrients) called amino acids, salts (electrolytes) and carbohydrates (glucose) which are essential for the body to grow or to recover and calories in the form of carbohydrates. You are given this product by a vein drip (infusion) because you are unable to eat adequately or cannot be fed via a tube. Nutriflex special is specifically indicated for adults and children aged 2-17 years with moderate to severe catabolism, a condition where patients are burning up their stores of energy, protein, etc. faster than they can be replaced. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRIFLEX SPECIAL DO NOT USE NUTRIFLEX SPECIAL ● if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6) ● if you have an inborn error of amino acid metabolism, where you need a special protein diet ● if you have abnormally high blood sugar levels that need more than 6 units of insulin per hour to be controlled ● if you have abnormally high levels of acidic substances in Läs hela dokumentet
Health Products Regulatory Authority 20 June 2022 CRN00CZ81 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nutriflex special Solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amounts of active substances in both the 1000 ml and 1500 ml sizes of the product are given below. COMPOSITION IN 1000 ML IN 1500 ML FROM THE UPPER CHAMBER (500 ML) FROM THE UPPER CHAMBER (750 ML ) Isoleucine 4.11 g 6.17 g Leucine 5.48 g 8.22 g Lysine hydrochloride (equivalent to lysine:) 4.97 g (3.98 g) 7.46 g (5.97 g) Methionine 3.42 g 5.13 g Phenylalanine 6.15 g 9.23 g Threonine 3.18 g 4.77 g Tryptophan 1.00 g 1.50 g Valine 4.54 g 6.81 g Arginine monoglutamate (equivalent to arginine:) (equivalent to glutamic acid:) 8.72 g (4.73 g) (3.99 g) 13.08 g (7.10 g) (5.99 g) Histidine hydrochloride monohydrate (equivalent to histidine:) 2.96 g (2.19 g) 4.44 g (3.29 g) Alanine 8.49 g 12.74 g Aspartic acid 2.63 g 3.95 g Glutamic acid 2.15 g 3.23 g Glycine 2.89 g 4.34 g Proline 5.95 g 8.93 g Serine 5.25 g 7.88 g Magnesium acetate tetrahydrate 1.08 g 1.62 g Sodium acetate trihydrate 1.63 g 2.45 g Potassium dihydrogenphosphate 2.00 g 3.00 g Potassium hydroxide 0.62 g 0.93 g Sodium hydroxide 1.14 g 1.71 g FROM THE LOWER CHAMBER (500 ML) FROM THE LOWER CHAMBER (750 ML) Glucose monohydrate (equivalent to glucose:) 264.0 g (240.0 g) 396.0 g (360.0 g) Calcium chloride dihydrate 0.60 g 0.90 g ELECTROLYTES: IN 1000 ML IN 1500 ML Sodium 40.5 mmol 60.8 mmol Potassium 25.7 mmol 38.6 mmol Magnesium 5.0 mmol 7.5 mmol Phosphate 14.7 mmol 22.1 mmol Acetate 22.0 mmol 33.0 mmol Chloride 49.5 mmol 74.3 mmol Calcium 4.1 mmol 6.2 mmol IN 1000 ML IN 1500 ML Amino acid content 70 g 105 g Nitrogen content 10 g 15 g Carbohydrate content 240 g 360 g Health Products Regulatory Authority 20 June 2022 CRN00CZ81 Page 2 of 9 IN 1000 ML IN 1500 ML Energy in the form of amino acids [kJ (kcal)] 1172 (280) 1757 (420) Energy in the form of carbohydrates [kJ (kcal)] 4017 (960) 6025 (1440) Total energy [kJ (kcal)] 5198 (1240) 7782 (1860) For Läs hela dokumentet