Država: Izrael
Jezik: angleščina
Source: Ministry of Health
CALCIUM CHLORIDE DIHYDRATE; GLUCOSE AS MONOHYDRATE; GLYCINE; L- ALANINE; L- ISOLEUCINE; L- LEUCINE; L- LYSINE AS HYDROCHLORIDE; L- METHIONINE; L- PHENYLALANINE; L- PROLINE; L- SERINE; L- THREONINE; L- TRYPTOPHAN; L- TYROSINE; L- VALINE; L-ARGININE; L-HISTIDINE; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUM CHLORIDE; REFINED SOYA-BEAN OIL; SODIUM ACETATE TRIHYDRATE; SODIUM GLYCEROPHOSPHATE PENTAHYDRATE
TEVA MEDICAL MARKETING LTD.
N/A
EMULSION FOR INFUSION
REFINED SOYA-BEAN OIL 200.00 G / 1000 ML; CALCIUM CHLORIDE DIHYDRATE 0.74 G / 1000 ML; GLUCOSE AS MONOHYDRATE 250.00 G / 1000 ML; MAGNESIUM CHLORIDE HEXAHYDRATE 1.12 G / 1000 ML; POTASSIUM CHLORIDE 4.47 G / 1000 ML; SODIUM GLYCEROPHOSPHATE PENTAHYDRATE 5.36 G / 1000 ML; SODIUM ACETATE TRIHYDRATE 6.12 G / 1000 ML; L- VALINE 4.06 G / 1000 ML; L- TYROSINE 0.28 G / 1000 ML; L- TRYPTOPHAN 1.26 G / 1000 ML; L- THREONINE 2.94 G / 1000 ML; L- SERINE 3.50 G / 1000 ML; L- PROLINE 4.76 G / 1000 ML; L- PHENYLALANINE 3.92 G / 1000 ML; L- METHIONINE 2.80 G / 1000 ML; L- LYSINE AS HYDROCHLORIDE 4.06 G / 1000 ML; L- LEUCINE 5.11 G / 1000 ML; L- ISOLEUCINE 4.20 G / 1000 ML; L-HISTIDINE 3.36 G / 1000 ML; GLYCINE 7.21 G / 1000 ML; L-ARGININE 8.05 G / 1000 ML; L- ALANINE 14.49 G / 1000 ML
I.V
Required
BAXTER S.A., BELGIUM
Parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
2013-09-30
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת _________ APRIL 27, 2014 __ םש רישכת תילגנאב רפסמו םושירה _____________ OLICLINOMEL N5-800E: 139 41 30707 21 םש לעב םושירה _ עבט לקידמ קוויש םיגרואה ,מ"עב 8 דודשא , 77100 _ ___ ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח INDICATION CONTRAINDICATIONS POSOLOGY, DOSAGE & ADMINISTRATION SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as sweating, fever, chills, headache, skin rashes or) develop. This medicinal product contains soybean oil and egg phosphatide. Soybean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between soybean and peanut proteins have been observed. Fat overload syndrome has been reported with similar products. Reduced ability to remove the lipids contained in Oliclinomel may result in a "fat overload syndrome" which may be caused by overdose, however, the signs and symptoms but may also occur when the product is administered according to instructions (see also section 4.8). Hepatic Insufficiency Use with caution in patients with hepatic insufficiency because of the risk of developing or worsening neurological disorders associated with hyperammonaemia. Regular clinical and laboratory tests are required particularly , blood glucose, electrolytes and triglycerides. The infusion must be stopped immediately if any signs or symptoms of an allergic reaction (such as sweating, fever, chills, headache, skin rashes or dyspnea or bronchospasm) develop. This medicinal product contains soybean oil and egg phosphatide. Soybean and egg proteins may cause hypersensitivity reactions. Cross-allergic reactions between Preberite celoten dokument
Oliclinomel N5-800E , 9. 6. 2015, RH ."רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ" ינוי :רשואמ ןולע 2015 “This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved.” Date of approval: June 2015. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT OLICLINOMEL N5-800E, EMULSION FOR INFUSION. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION This medicinal product is presented in the form of a 3-compartment bag. There are four different bag sizes, with the following volumes : COMPARTMENT 1000 ML 1500 ML 2000 ML 2500 ML lipid emulsion 200 ml 300 ml 400 ml 500 ml amino acid solution 400 ml 600 ml 800 ml 1000 ml glucose solution 400 ml 600 ml 800 ml 1000 ml Composition of a 1000 ml bag ACTIVE SUBSTANCES 20% LIPID EMULSION COMPARTMENT (CORRESPONDING TO 20G/100ML) (200 ML) 7% AMINO ACID SOLUTION COMPARTMENT (CORRESPONDING TO 7G/100ML) (400 ML) 25% GLUCOSE SOLUTION COMPARTMENT (CORRESPONDING TO 25G/100ML) (400 ML) Refined olive oil + refined soya oil* 40.00 g Alanine 5.80 g Arginine 3.22 g Glycine 2.89 g Histidine 1.34 g Isoleucine 1.68 g Leucine 2.05 g Lysine 1.62 g (As lysine hydrochloride) (2.03g) Methionine 1.12 g Phenylalanine 1.57 g Proline 1.90 g Serine 1.40 g Threonine 1.18 g Tryptophan 0.50 g Tyrosine 0.11 g Valine 1.62 g Sodium Acetate, 3H 2 O 2.45 g Sodium glycerophosphate, 5H 2 O 2.14 g Potassium chloride 1.79 g Magnesium chloride, 6H 2 O 0.45 g Anhydrous glucose 100.00g (As glucose monohydrate) (110.00 g) Calcium chloride, 2H 2 O 0.30 g * Mixture of refined olive oil (approximately 80%) and refined soya oil (approximately 20%) For full list of excipients, see section 6.1. Oliclinomel N5-800E , 9. 6. 2015, RH Page 2 sur 13 2 After the contents of the three compartments have been mixed, the ternary mixture for each of the bag presentations provides the following: PER BAG 1 LITRE 1.5 LITRES 2 LITRES 2.5 LITRES Nitrogen (g) 4.6 6.9 9.2 11.6 Amino acids (g) 28 42 56 70 Gluc Preberite celoten dokument