Riik: Iirimaa
keel: inglise
Allikas: 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 ; Sodium dihydrogen phosphate dihydrate; Potassium hydroxide; Sodium hydroxide ; Glucose monohydrate; Calcium chloride dihydrate; Histidine hydrochloride monohydrate
B. Braun Melsungen AG
B05BA; B05BA10
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 ; Sodium dihydrogen phosphate dihydrate; Potassium hydroxide; Sodium hydroxide ; Glucose monohydrate; Calcium chloride dihydrate; Histidine hydrochloride monohydrate
Unknown
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions for parenteral nutrition; combinations
Not marketed
2000-01-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NUTRIFLEX PLUS 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 plus is and what it is used for 2. What you need to know before you use Nutriflex plus 3. How to use Nutriflex plus 4. Possible side effects 5. How to store Nutriflex plus 6. Contents of the pack and other information 1. WHAT NUTRIFLEX PLUS 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 plus is specifically indicated for adults and children aged 2-17 years with moderately 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 PLUS DO NOT USE NUTRIFLEX PLUS ● 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 the blood (acidosis) ● if Lugege kogu dokumenti
Health Products Regulatory Authority 20 June 2022 CRN00CZ81 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nutriflex plus Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amounts of active substances in both the 1000 ml and 2000 ml sizes of the are given below. COMPOSITION IN 1000 ML IN 2000 ML FROM THE UPPER CHAMBER (400 ML) FROM THE UPPER CHAMBER (800 ML ) Isoleucine 2.82 g 5.64 g Leucine 3.76 g 7.52 g Lysine hydrochloride (equivalent to lysine:) 3.41 g (2.73 g) 6.82 g (5.46 g) Methionine 2.35 g 4.70 g Phenylalanine 4.21 g 8.42 g Threonine 2.18 g 4.36 g Tryptophan 0.68 g 1.36 g Valine 3.12 g 6.24 g Arginine monoglutamate (equivalent to arginine:) (equivalent to glutamic acid:) 5.98 g (3.24 g) (2.74 g) 11.96 g (6.48 g) (5.48 g) Histidine hydrochloride monohydrate (equivalent to histidine:) 2.03 g (1.50 g) 4.06 g (3.00 g) Alanine 5.82 g 11.64 g Aspartic acid 1.80 g 3.60 g Glutamic acid 1.47 g 2.94 g Glycine 1.98 g 3.96 g Proline 4.08 g 8.16 g Serine 3.60 g 7.20 g Magnesium acetate tetrahydrate 1.23 g 2.46 g Sodium acetate trihydrate 1.56 g 3.12 g Sodium dihydrogen phosphate dihydrate 3.12 g 6.24 g Potassium hydroxide 1.40 g 2.80 g Sodium hydroxide 0.23 g 0.46 g FROM THE LOWER CHAMBER (600 ML) FROM THE LOWER CHAMBER (1200 ML) Glucose monohydrate (equivalent to glucose:) 165.0 g (150.0 g) 330.0 g (300.0 g) Calcium chloride dihydrate 0.53 g 1.06 g ELECTROLYTES: IN 1000 ML IN 2000 ML Sodium 37.2 mmol 74.4 mmol Potassium 25.0 mmol 50.0 mmol Magnesium 5.7 mmol 11.4 mmol Phosphate 20.0 mmol 40.0 mmol Acetate 22.9 mmol 45.8 mmol Chloride 35.5 mmol 71.0 mmol Calcium 3.6 mmol 7.2 mmol IN 1000 ML IN 2000 ML Amino acid content 48 g 96 g Nitrogen content 6.8 g 13.6 g Health Products Regulatory Authority 20 June 2022 CRN00CZ81 Page 2 of 9 Carbohydrate content 150 g 300 g IN 1000 ML IN 2000 ML Energy in the form of amino acids [kJ (kcal)] 803 (192) 1607 (384) Energy in the form of carbohydrates [kJ (kcal)] 2510 (600) 5021 (1200) Total energy [kJ (kcal)] 3313 (792) 6628 (1584) For Lugege kogu dokumenti