Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
LEUCINE ; PHENYLALANINE ; L-METHIONINE ; L-LYSINE ; ISOLEUCINE ; VALINE ; HISTIDINE ; THREONINE ; TRYPTOPHAN, L- ; ALANINE ; ARGININE ; AMINOACETIC ACID ; PROLINE ; SERINE ; TYROSINE ; SODIUM ACETATE TRIHYDRATE ; POTASSIUM PHOSPHATE DIBASIC ; SODIUM CHLORIDE ; MAGNESIUM CHLORIDE HEXAHYDRATE ; GLUCOSE ; CALCIUM CHLORIDE DIHYDRATE
Baxter Healthcare Limited
B05BA01
LEUCINE ; PHENYLALANINE ; L-METHIONINE ; L-LYSINE ; ISOLEUCINE ; VALINE ; HISTIDINE ; THREONINE ; TRYPTOPHAN, L- ; ALANINE ; ARGININE ; AMINOACETIC ACID ; PROLINE ; SERINE ; TYROSINE ; SODIUM ACETATE TRIHYDRATE ; POTASSIUM PHOSPHATE DIBASIC ; SODIUM CHLORI
8.5/30 %v/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
amino acids
Marketed
1996-04-30
Package leaflet: Information for the patient CLINIMIX N14G30E, SOLUTION FOR INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS ADMINISTERED, 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What CLINIMIX is and what it is administered for 2. What you need to know before CLINIMIX is administered 3. How CLINIMIX is administered 4. Possible side effects 5. How to store CLINIMIX 6. Contents of the pack and other information 1. WHAT CLINIMIX IS AND WHAT IT IS ADMINISTERED FOR CLINIMIX is a solution for infusion. It is supplied in a bag with 2 chambers. One chamber contains an amino acid solution with electrolytes and the second contains a glucose solution with calcium chloride. The chambers are separated by a non-permanent seal. Just before administration, the contents of the chambers are mixed together by rolling the top of the bag to open the seals. CLINIMIX is administered to provide nutrition in adults and children by a tube into a vein when normal feeding by mouth is not suitable. CLINIMIX must only be administered under medical supervision. 2. WHAT YOU NEED TO KNOW BEFORE CLINIMIX IS ADMINISTERED CLINIMIX SHALL NOT BE ADMINISTERED IF - you are allergic to any of the ingredients of this medicine (listed in section 6). - your body has problems using certain amino acids. - you have too much sugar in your blood (severe hyperglycaemia), - your blood is excessively acid (metabolic acidosis due to an excess of lactate), - your blood level of sodium, potassium, magnesium, calcium and/or phosphorus is too high (hypernatraemia, hyperkalemia, hypermagnesemia, hypercalcemia and/or hyperphosphatemia) - In children less than 28 days of age , ceftriaxone must not be co-administered with calcium- containing IV solutions, becaus Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CLINIMIX N14G30E, solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CLINIMIX N14G30E is packaged in a dual compartment plastic bag containing respectively an amino acid solution with electrolytes and a glucose solution with calcium. The injectable amino acid solution contains 15 L-amino acids (8 essential amino acids) needed for the protein synthesis. The amino acid profile is the following: - Essential amino acids/Total amino acids = 41.3 % - Essential amino acids/Total nitrogen = 2.83 - Branched chain amino acids/Total amino acids = 19 % The quantitative composition of CLINIMIX N14G30E is the following: For the full list of excipients, see section 6.1. 8.5% Amino acid solution with electrolytes 30% Glucose solution with calcium ACTIVE INGREDIENTS L-Leucine 6.20 g/l L-Phenylalanine 4.76 g/l L-Methionine 3.40 g/l L-Lysine 4.93 g/l (as L-Lysine hydrochloride) (6.16 g/l) L-Isoleucine 5.10 g/l L-Valine 4.93 g/l L-Histidine 4.08 g/l L-Threonine 3.57 g/l L-Tryptophan 1.53 g/l L-Alanine 17.6 g/l L-Arginine 9.78 g/l Glycine 8.76 g/l L-Proline 5.78 g/l L-Serine 4.25 g/l L-Tyrosine 0.34 g/l Sodium acetate, 3H 2 O 5.94 g/l Dibasic potassium phosphate 5.22 g/l Sodium chloride 1.54 g/l Magnesium chloride.6H 2 0 1.02 g/l Glucose 300 g/l (as monohydrate glucose) (330 g/l) Calcium chloride, 2H 2 0 0.66 g/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_ _ _ _1_ _8_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ Baca dokumen lengkapnya