দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
TYROSINE, ISOLEUCINE, LEUCINE, LYSINE HYDROCHLORIDE, METHIONINE, ACTIVE, PHENYLALANINE, THREONINE, TRYPTOPHAN, L-, VALINE, ARGININE, HISTIDINE, ALANINE, AMINOACETIC ACID, PROLINE, SERINE, TAURINE, GLUCOSE MONOHYDRATE, SODIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, ZINC CHLORIDE
Fresenius Kabi Limited
B05BA10
TYROSINE, ISOLEUCINE, LEUCINE, LYSINE HYDROCHLORIDE, METHIONINE, ACTIVE, PHENYLALANINE, THREONINE, TRYPTOPHAN, L-, VALINE, ARGIN
3.5 Per Cent
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Solutions for parenteral nutrition
Authorised
1999-11-26
M0xxxxx-xx IE PACKAGE LEAFLET: INFORMATION FOR THE USER AMINOVEN 3.5% GLUCOSE/ELECTROLYTES SOLUTION 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 or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Aminoven 3.5% is and what it is used for 2. What you need to know before you receive Aminoven 3.5% 3. How you are given Aminoven 3.5% 4. Possible side effects 5. How to store Aminoven 3.5% 6. Contents of the pack and other information 1. WHAT AMINOVEN 3.5% IS AND WHAT IT IS USED FOR Aminoven 3.5% provides nourishment into your blood stream when you cannot eat normally. It provides amino acids which your body will use to make proteins (to build and repair muscles, organs, and other body structures) together with energy (glucose) and salts. Aminoven 3.5% is typically mixed with vitamins, lipids and carbohydrates which together provide your complete nutritional needs. may be possible to continue with a reduced dosage. There is no specific antidote for overdose. Infusion should be stopped immediately in such cases. Emergency procedures should be general supportive measures, with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring would be essential and specific abnormalities treated appropriately. STORAGE Do not store above 25°C. Keep container in the outer carton. Do not freeze. Storage precautions after mixing with other components: Aminoven 3.5% Glucose/Electrolytes may be aseptically admixed with other nutrients such as fat emulsions, carbohydrates and electrolytes. Chemical and physical stability data for a number of admixtures stored at 4°- 8° C for up সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aminoven 3.5% Glucose/Electrolytes solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml solution for infusion contains: Tyrosine 0.14 g Isoleucine 1.75 g Leucine 2.59 g Lysine hydrochloride (= 2.31 g Lysine) 2.885 g Methionine 1.505 g Phenylalanine 1.785 g Threonine 1.54 g Tryptophan 0.70 g Valine 2.17 g Arginine 4.20 g Histidine 1.05 g Alanine 4.90 g Glycine 3.85 g Proline 3.92 g Serine 2.275 g Taurine 0.35 g Glucose monohydrate (= 50 g Glucose anhydrous) 55.0 g Sodium chloride 1.169 g Calcium chloride dihydrate (= 0.222 g calcium chloride, anhydrous) 0.294 g Magnesium chloride hexahydrate (= 0.286 g magnesium chloride, anhydrous) 0.61 g Zinc chloride 0.00545 g Sodium glycerophosphate, hydrated (= 3.241 g sodium glycerophosphate, anhydrous) 4.592 g Potassium hydroxide (= 1.68 g potassium hydroxide, anhydrous) 1.98 g Electrolytes: Na+ 50 mmol/l K+ 30 mmol/l Ca++ 2 mmol/l Mg++ 3 mmol/l Zn++ 0.04 mmol/l Cl- 46.7 mmol/l Glycerophosphate-- 15 mmol/l H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _2_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _1_ _5_ _7_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for infusion The solution is clear and colourless to slightly yellow. pH: 4.5 - 5.5 Theoretical osmolarity: 768.54 mosm/l. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aminoven 3.5% Glu সম্পূর্ণ নথি পড়ুন