País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
L-leucine; L-phenylalanine; L-methionine; L-lysine; L-isoleucine; L-valine; L-histidine; L-threonine; L-tryptophan; L-alanine; L-arginine; Glycine; L-proline; L-serine; L-tyrosine; Sodium acetate trihydrate ; Dibasic potassium phosphate ; Sodium chloride; Magnesium chloride hexahydrate; Glucose; Calcium chloride dihydrate
Baxter Holding B.V.
B05BA; B05BA01
L-leucine; L-phenylalanine; L-methionine; L-lysine; L-isoleucine; L-valine; L-histidine; L-threonine; L-tryptophan; L-alanine; L-arginine; Glycine; L-proline; L-serine; L-tyrosine; Sodium acetate trihydrate ; Dibasic potassium phosphate ; Sodium chloride; Magnesium chloride hexahydrate; Glucose; Calcium chloride dihydrate
Solution for infusion
Solutions for parenteral nutrition; amino acids
Marketed
1996-04-30
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: BE-30-03-500 Date: 09 SEPT 2021 Proofread No.: 04 Designer: DFO Page: 1 of 06 Colour Reference: BLACK BE-30-03-500 1 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 doctoror 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 tha Leia o documento completo
Health Products Regulatory Authority 03 December 2021 CRN009SMZ Page 1 of 12 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 N14G30Eis the following: 8.5% AMINO ACID SOLUTION WITH ELECTROLYTES 30% GLUCOSE SOLUTIONWITH CALCIUM ACTIVE INGREDIENTS L-Leucine L-Phenylalanine L-Methionine L-Lysine (as L-Lysine hydrochloride) L-Isoleucine L-Valine L-Histidine L-Threonine L-Tryptophan L-Alanine L-Arginine Glycine L-Proline L-Serine L-Tyrosine Sodium acetate, 3H2O Dibasic potassium phosphate Sodium chloride Magnesium chloride, 6H2O Glucose (as monohydrate glucose) Calcium chloride, 2H2O 6.21 g/l 4.76 g/l 3.40 g/l 4.93 g/l (6.16 g/l) 5.10 g/l 4.93 g/l 4.08 g/l 3.57 g/l 1.53 g/l 17.60 g/l 9.78 g/l 8.76 g/l 5.78 g/l 4.25 g/l 0.34 g/l 5.94 g/l 5.22 g/l 1.54 g/l 1.02 g/l 300 g/l (330 g/l) 0.66 g/l For the full list of excipients, see section 6.1. After mixing of the contents of both compartments, the composition of the binary mixture, for all the available bag sizes, is the following: N14G30E 1 L N14G30E 1.5 L N14G30E 2 L Nitrogen (g) Amino acids (g) Glucose (g) 7.0 43 10.5 64 14.0 85 Health Products Regulatory Authority 03 December 2021 CRN009SMZ Page 2 of 12 150 225 300 Total calories (kcal) Glucose calories (kcal) 770 600 1155 900 1540 1200 Sodium (mmol) Potassium (mmol) Magnesium (mmol) Calcium (mmol) Acetate (mmol) Chloride (mmol) Phosphate as HPO4 2- (mmol) 35 30 2.5 2.3 70 40 15 53 45 3.8 3.4 105 60 23 70 60 5. Leia o documento completo