Finomel Infusionsvätska, emulsion

Land: Sverige

Sprog: svensk

Kilde: Läkemedelsverket (Medical Products Agency)

Aktiv bestanddel:

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

Tilgængelig fra:

Baxter Medical AB

ATC-kode:

B05BA10

INN (International Name):

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

Lægemiddelform:

Infusionsvätska, emulsion

Sammensætning:

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

Recept type:

Receptbelagt

Produkt oversigt:

Förpacknings: Trekammarpåse, 4 x 1085 ml; Trekammarpåse, 4 x 1435 ml; Trekammarpåse, 4 x 1820 ml

Autorisation status:

Godkänd

Autorisation dato:

2019-01-24

Indlægsseddel

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

Produktets egenskaber

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)