Negara: Swedia
Bahasa: Swedia
Sumber: Läkemedelsverket (Medical Products Agency)
DL-metionin; alanin; arginin; fenylalanin; fiskolja, rik på omega-3-syror; glukosmonohydrat; glycin; histidin; isoleucin; kalciumkloriddihydrat; kaliumklorid; leucin; lysinhydroklorid; magnesiumsulfatheptahydrat; natriumacetattrihydrat; natriumglycerofosfat, hydratiserat; olivolja, raffinerad; prolin; serin; sojaolja, raffinerad; treonin; triglycerider, medellångkedjiga; tryptofan; tyrosin; valin; zinksulfatheptahydrat
Baxter Medical AB
B05BA10
DL-methionine; alanine; arginine; phenylalanine; fish oil, rich in omega-3 fatty acids; glukosmonohydrat; glycine; histidine; isoleucine; kalciumkloriddihydrat; potassium chloride; leucine; lysinhydroklorid; magnesiumsulfatheptahydrat; natriumacetattrihydrat; natriumglycerofosfat, hydrated; olive oil, refined; proline; serine; soybean oil, refined; threonine; triglycerides, medellångkedjiga; tryptophan; tyrosine; valine; zinksulfatheptahydrat
Infusionsvätska, emulsion
arginin 11,5 mg Aktiv substans; isoleucin 6 mg Aktiv substans; histidin 4,8 mg Aktiv substans; prolin 6,8 mg Aktiv substans; tryptofan 1,8 mg Aktiv substans; treonin 4,2 mg Aktiv substans; valin 5,8 mg Aktiv substans; fenylalanin 5,6 mg Aktiv substans; leucin 7,3 mg Aktiv substans; DL-metionin 4 mg Aktiv substans; serin 5 mg Aktiv substans; lysinhydroklorid 7,25 mg Aktiv substans; glukosmonohydrat 462 mg Aktiv substans; fiskolja, rik på omega-3-syror 40 mg Aktiv substans; olivolja, raffinerad 50 mg Aktiv substans; sojaolja, raffinerad 60 mg Aktiv substans; triglycerider, medellångkedjiga 50 mg Aktiv substans; glycerol Hjälpämne; natriumglycerofosfat, hydratiserat 5,92 mg Aktiv substans; tyrosin 0,4 mg Aktiv substans; kaliumklorid 4,48 mg Aktiv substans; zinksulfatheptahydrat 0,023 mg Aktiv substans; magnesiumsulfatheptahydrat 2,47 mg Aktiv substans; kalciumkloriddihydrat 0,74 mg Aktiv substans; natriumacetattrihydrat 5,62 mg Aktiv substans; glycin 10,3 mg Aktiv substans; alanin 20,7 mg Aktiv substans
Receptbelagt
Förpacknings: Trekammarpåse, 4 x 1085 ml; Trekammarpåse, 4 x 1435 ml; Trekammarpåse, 4 x 1820 ml
Godkänd
2019-01-24
PACKAGE LEAFLET: INFORMATION FOR THE USER FINOMEL EMULSION 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 nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 Finomel is and what it is used for 2. What you need to know before you use Finomel 3. How to use Finomel 4. Possible side effects 5. How to store Finomel 6. Contents of the pack and other information 1. WHAT FINOMEL IS AND WHAT IT IS USED FOR Finomel contains amino acids (components used to build proteins), glucose (carbohydrates), lipids (fat) and salts (electrolytes). Finomel is used to provide nutrition to adults when normal feeding by mouth is insufficient or not suitable. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FINOMEL DO NOT USE FINOMEL: - If you are allergic to fish, egg, soya-bean, peanut proteins, or corn/corn products (see also section “Warnings and precautions” below), or any of the other ingredients of this medicine (listed in section 6). - If you have high level of fats in your blood - If have severe problems with your liver - If you have blood coagulation problems - If you have a disorder whereby amino acids cannot be processed by the body - If you have severe problems with your kidneys - If you have too much sugar in your blood - If you have an abnormally high amount of any of the electrolytes (sodium, potassium, magnesium, calcium and/or phosphorus) in your blood - If you have problems receiving large volumes of liquids in your veins such as acute pulmonary oedema, hyperhydration and decompensated heart problems - If you have any acute and severe health problem such as Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Finomel emulsion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Finomel is presented in a 3-compartment plastic bag. Each bag contains a sterile non-pyrogenic combination of a 42% glucose solution, a 10% amino acid solution with electrolytes, and a 20% lipid emulsion. Composition of the reconstituted emulsion after mixing the content of the 3 compartments is provided in the table below: ACTIVE SUBSTANCE 1085 ML 1435 ML 1820 ML Fish oil, rich in omega-3-acids 8.24 g 10.92 g 13.84 g Olive oil, refined 10.30 g 13.65 g 17.30 g Soya-bean oil, refined 12.36 g 16.38 g 20.76 g Medium-chain triglycerides 10.30 g 13.65 g 17.30 g Alanine 11.41 g 15.09 g 19.13 g Arginine 6.34 g 8.38 g 10.63 g Glycine 5.68 g 7.51 g 9.52 g Histidine 2.64 g 3.50 g 4.44 g Isoleucine 3.31 g 4.37 g 5.54 g Leucine 4.02 g 5.32 g 6.75 g Lysine _(as Lysine hydrochloride)_ 3.20 g _(3.99 g)_ 4.23 g _(5.29 g)_ 5.36 g _(6.70 g)_ Methionine 2.20 g 2.92 g 3.70 g Phenylalanine 3.09 g 4.08 g 5.17 g Proline 3.75 g 4.96 g 6.28 g Serine 2.76 g 3.65 g 4.62 g Threonine 2.31 g 3.06 g 3.88 g Tryptophan 0.99 g 1.31 g 1.66 g Tyrosine 0.22 g 0.29 g 0.37 g Valine 3.20 g 4.23 g 5.36 g Sodium acetate trihydrate 3.10 g 4.10 g 5.19 g Potassium chloride 2.47 g 3.27 g 4.14 g Calcium chloride dihydrate 0.41 g 0.54 g 0.68 g Magnesium sulfate heptahydrate 1.36 g 1.80 g 2.28 g Sodium glycerophosphate, hydrated 3.26 g 4.32 g 5.47 g Zinc sulfate heptahydrate 0.013 g 0.017 g 0.021 g ACTIVE SUBSTANCE 1085 ML 1435 ML 1820 ML Glucose _(as Glucose monohydrate)_ 137.8 g _(151.5 g)_ 181.9 g _(200.0 g)_ 231.0 g _(254.1 g)_ Nutritional intakes of reconstituted emulsion, for each bag size: 1085 ML 1435 ML 1820 ML Nitrogen (g) 9.1 12.0 15.3 Amino acids (g) 55 73 92 Glucose (g) 138 182 231 Lipids a (g) 44 58 73 _ENERGY:_ Total calories (kcal) 1184 1567 1988 Non-protein calories (kcal) 964 1276 1619 Glucose calories (kcal) b 571 755 958 Lipid calories (kcal) c 393 521 661 Non-protein calories / nitrogen ratio (kcal/g) Baca dokumen lengkapnya