Finomel Emulsion for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Sodium acetate trihydrate ; Potassium chloride; Calcium chloride dihydrate; Magnesium sulphate heptahydrate ; Sodium Glycerophosphate Hydrate; Zinc sulphate heptahydrate; Glucose monohydrate; Soya Bean Oil, Refined Ph.Eur; Olive oil, refined; Medium chain triglycerides saturated; Fish oil, rich in omega-3 acids

Available from:

Baxter Holding B.V.

ATC code:

B05BA; B05BA01

INN (International Name):

Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Sodium acetate trihydrate ; Potassium chloride; Calcium chloride dihydrate; Magnesium sulphate heptahydrate ; Sodium Glycerophosphate Hydrate; Zinc sulphate heptahydrate; Glucose monohydrate; Soya Bean Oil, Refined Ph.Eur; Olive oil, refined; Medium chain triglycerides saturated; Fish oil, rich in omega-3 acids

Dosage:

42% +10 % + 20 percent

Pharmaceutical form:

Emulsion for infusion

Therapeutic area:

Solutions for parenteral nutrition; amino acids

Authorization status:

Marketed

Authorization date:

2019-07-19

Patient Information leaflet

Package leaflet : Information for the user
G PER 1000 ML
Tyrosine
0.20
Valine
2.95
Sodium acetate trihydrate
2.85
Potassium chloride
2.28
Calcium chloride dihydrate
0.38
Magnesium sulfate heptahydrate
1.25
Sodium glycerophosphate hydrated
3.01
Zinc sulphate heptahydrate
0.012
Glucose (as monohydrate)
139.5
Soya-bean oil, refined
11.40
Olive oil, refined
9.50
Medium-chain triglycerides
9.50
Fish oil, rich in omega-3-acids
7.60
G PER 1000 ML
Alanine
10.52
Arginine
5.84
Glycine
5.23
Histidine
2.44
Isoleucine
3.05
Leucine
3.71
Lysine (as hydrochloride)
3.68
Methionine
2.03
Phenylalanine
2.84
Proline
3.45
Serine
2.54
Threonine
2.13
Tryptophan
0.91
ADDITIVE
Nutryelt (Composition per vial: Zinc 153 µmol; Copper 4.7
µmol; Manganese 1.0 µmol; Fluorine 50 µmol; Iodine 1.0
µmol; Selenium 0.9 µmol; Molybdenum 0.21 µmol; Chromium
0.19 µmol; Iron 18 µmol)
Cernevit (Composition per vial: Vit. A (as Retinol palmitate)
3500 IU, Vit. D3 (Cholecalciferol) 220 IU, Vit. E (Alpha-
tocopherol) 11.2 IU, Vit. C (Ascorbic acid) 125 mg, Vit. B1
(Thiamine) 3.51 mg, Vit. B2 (Riboflavin) 4.14 mg, Vit. B6
(Pyridoxine) 4.53 mg, Vit. B12 (Cyanocobalamin) 6 µg, Vit.
B9 (Folic acid) 414 µg, Vit. B5 (Pantothenic acid) 17.25 mg,
Vit. B8 (Biotin) 69 µg, Vit. PP (Nicotinamide) 46mg)
Sodium
Potassium
Magnesium
Calcium
Phosphate (organic such as sodium glycerophosphate)
Or
Phosphate (mineral such as potassium phosphate)
Selenium
Zinc
a
Volume of vial: 10mL concentrate solution
b
Volume of vial: 5 mL lyophilisate
2 vials
a
/bag
2 vials
b
/bag
138 mmol/L
138 mmol/L
5 mmol/L
4.6 mmol/L
18.5 mmol/L
5.5 mmol/L
7.6 µmol/L
0.31 mmol/L
TOTAL CONTENT AFTER ADDITION
FOR ALL BAG SIZES OF FINOMEL
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
Is

Summary of Product characteristics

Health Products Regulatory Authority
05 January 2024
CRN00DGCS
Page 1 of 11
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
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 c