Država: Singapur
Jezik: engleski
Izvor: HSA (Health Sciences Authority)
GLUCOSE (as GLUCOSE MONOHYDRATE) (In Compartment 3); GLYCINE (In Compartment 2); L-ALANINE (In Compartment 2); L-ARGININE (In Compartment 2); L-HISTIDINE (In Compartment 2); L-ISOLEUCINE (In Compartment 2); L-LEUCINE (In Compartment 2); L-LYSINE (as HCl) (In Compartment 2); L-METHIONINE (In Compartment 2); L-PHENYLALANINE (In Compartment 2); L-PROLINE (In Compartment 2); L-SERINE (In Compartment 2); L-THREONINE (In Compartment 2); L-TRYPTOPHAN (In Compartment 2); L-TYROSINE (In Compartment 2); L-VALINE (In
BAXTER HEALTHCARE (ASIA) PTE LTD
B05BA10
176.00 g/l
EMULSION
GLUCOSE (as GLUCOSE MONOHYDRATE) (In Compartment 3) 176.00 g/l; GLYCINE (In Compartment 2) 4.12 g/l; L-ALANINE (In Compartment 2) 8.28 g/l; L-ARGININE (In Compartment 2) 4.60 g/l; L-HISTIDINE (In Compartment 2) 1.92 g/l; L-ISOLEUCINE (In Compartment 2) 2.40 g/l; L-LEUCINE (In Compartment 2) 2.92 g/l; L-LYSINE (as HCl) (In Compartment 2) 2.90 g/l; L-METHIONINE (In Compartment 2) 1.60 g/l; L-PHENYLALANINE (In Compartment 2) 2.24 g/l; L-PROLINE (In Compartment 2) 2.72 g/l; L-SERINE (In Compartment 2) 2.00 g/l; L-THREONINE (In Compartment 2) 1.68 g/l; L-TRYPTOPHAN (In Compartment 2) 0.72 g/l; L-TYROSINE (In Compartment 2) 0.16 g/l; L-VALINE (In Compartment 2) 2.32 g/l; REFINED SOYA BEAN OIL + REFINED OLIVE OIL (In Compartment 1) 40.00 g/l
INTRAVENOUS
General Sale List
BAXTER SA
ACTIVE
2004-05-06
1. SUMMARY OF PRODUCT CHARACTERISTICS OliClinomel N7-1000, emulsion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This medicinal product is presented in the form of a 3‐compartment bag. There are four presentations, which have the following different volumes: COMPARTMENT 1000 ML 1500 ML 2000 ML 2500 ML Lipid emulsion Amino acid solution Glucose solution 200 ml 400 ml 400 ml 300 ml 600 ml 600 ml 400 ml 800 ml 800 ml 500 ml 1000 ml 1000 ml Composition of a 1000ml bag: _ _ _ _ _ _ ACTIVE SUBSTANCES 20% LIPID EMULSION COMPARTMENT (CORRESPONDING TO 20G/100ML) (200ML) 10% AMINO ACID SOLUTION COMPARTMENT (CORRESPONDING TO 10G/100ML) (400ML) 40% GLUCOSE SOLUTION COMPARTMENT (CORRESPONDING TO 40G/100ML) (400ML) Refined olive oil _ _ 40.00 g + refined soya bean oil * Alanine 8.28 g Arginine 4.60 g Glycine 4.12 g Histidine 1.92 g Isoleucine 2.40 g Leucine 2.92 g Lysine 2.32 g (As Lysine hydrochloride) (2.90 g) Methionine 1.60 g Phenylalanine 2.24 g Proline 2.72 g Serine 2.00 g Threonine 1.68 g Tryptophan 0.72 g Tyrosine 0.16 g Valine 2.32 g Glucose 160.00 g (As Glucose monohydrate) (176.00) g * Mixture of refined olive oil (approximately 80%) and refined soya bean oil (approximately 20%) For full list of the excipients, see section 6.1 After the contents of the three compartments have been mixed, the ternary mixture for each of the bag Bar code provides the following: PER BAG 1 LITRE 1.5 LITRE 2 LITRES 2.5 LITRES Nitrogen (g) 6.6 9.9 13.2 16.5 Amino acids (g) 40 60 80 100 Glucose (g) 160 240 320 400 Lipids(g) 40 60 80 100 Total calories (kcal) 1200 1800 2400 3000 Non‐protein calories (kcal) 1040 1560 2080 2600 Glucose calories (kcal) 640 960 1280 1600 Lipid calories (kcal) 400 600 800 1000 Non‐protein calorie/nitrogen ratio 158 158 158 158 (kcal/g N) Phosphate (mmol)** 3 4.5 6 7.5 Acetate (mmol) 37 56 74 93 Chloride (mmol) 16 24 32 40 pH 6 6 6 6 Osmolarity (mOsmol/l) 1400 1400 1400 1400 ** Including phosphates provided by the lipid emulsion. 3. PHARMACEUTICAL FORM After reconstitution: Emulsion for infusion Pročitajte cijeli dokument