Finomel Peri Emulsion for Infusion

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

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

Saatavilla:

Baxter Holding B.V.

ATC-koodi:

B05BA; B05BA01

INN (Kansainvälinen yleisnimi):

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

Annos:

13 %+ 10 % +20 percent

Lääkemuoto:

Emulsion for infusion

Terapeuttinen alue:

Solutions for parenteral nutrition; amino acids

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2019-07-19

Pakkausseloste

G PER 1000 ML
Tyrosine
0.13
Valine
1.83
Sodium acetate trihydrate
1.77
Potassium chloride
1.41
Calcium chloride dihydrate
0.23
Magnesium sulfate heptahydrate
0.78
Sodium glycerophosphate hydrated
1.87
Zinc sulphate heptahydrate
0.007
Glucose (as monohydrate)
77.8
Soya-bean oil, refined
8.46
Olive oil, refined
7.05
Medium-chain triglycerides
7.05
Fish oil, rich in omega-3-acids
5.64
G PER 1000 ML
Alanine
6.52
Arginine
3.62
Glycine
3.24
Histidine
1.51
Isoleucine
1.89
Leucine
2.30
Lysine (as hydrochloride)
2.28
Methionine
1.26
Phenylalanine
1.76
Proline
2.14
Serine
1.58
Threonine
1.32
Tryptophan
0.57
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: of 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
9.2 mmol/L
7.6 µmol/L
0.31 mmol/L
TOTAL CONTENT AFTER ADDITION
FOR ALL BAG SIZES OF FINOMEL PERI
ACTIVE SUBSTANCE
1085 ML
1450 ML
2020 ML
Fish oil, rich in omega-3-acids
6.12 g
8.16 g
11.40 g
Olive oil, refined
7.65 g
10.20 g
14.25 g
Soya-bean oil, refined
9.18 g
12.24 g
17.10 g
Medium-chain triglycerides
7.65 g
10.20 g
14.25 g
Alanine
7.08 g
9.46 g
13.17 g
Arginine
3.93 g
5.26 g
7.31 g
Glycine
3.52 g
4.71 g
6.55 g
Histidine
1.64 g
2.19 g
3.05 g
Isoleucine
2.05 g
2.74 g
3.82 g
Leucine
2.50 g

Valmisteyhteenveto

Health Products Regulatory Authority
05 January 2024
CRN00DGCS
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Finomel Peri Emulsion for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Finomel Peri is presented in a 3-compartment plastic bag. Each bag
contains a sterile non-pyrogenic combination of a 13%
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
1450 ML
2020 ML
Fish oil, rich in omega-3-acids
6.12 g
8.16 g
11.40 g
Olive oil, refined
7.65 g
10.20 g
14.25 g
Soya-bean oil, refined
9.18 g
12.24 g
17.10 g
Medium-chain triglycerides
7.65 g
10.20 g
14.25 g
Alanine
7.08 g
9.46 g
13.17 g
Arginine
3.93 g
5.26 g
7.31 g
Glycine
3.52 g
4.71 g
6.55 g
Histidine
1.64 g
2.19 g
3.05 g
Isoleucine
2.05 g
2.74 g
3.82 g
Leucine
2.50 g
3.34 g
4.64 g
Lysine
_(as Lysine hydrochloride)_
1.98 g
_(2.48 g)_
2.65 g
_(3.31 g)_
3.69 g
_(4.61 g)_
Methionine
1.37 g
1.83 g
2.54 g
Phenylalanine
1.92 g
2.56 g
3.56 g
Proline
2.33 g
3.11 g
4.32 g
Serine
1.71 g
2.29 g
3.18 g
Threonine
1.44 g
1.92 g
2.67 g
Tryptophan
0.62 g
0.82 g
1.14 g
Tyrosine
0.14 g
0.18 g
0.25 g
Valine
1.98 g
2.65 g
3.69 g
Sodium acetate trihydrate
1.92 g
2.57 g
3.57 g
Potassium chloride
1.53 g
2.05 g
2.85 g
Calcium chloride dihydrate
0.25 g
0.34 g
0.47 g
Magnesium sulfate heptahydrate
0.84 g
1.13 g
1.57 g
Sodium glycerophosphate, hydrated
2.03 g
2.71 g
3.77 g
Zinc sulfate heptahydrate
0.008 g
0.011 g
0.015 g
Glucose
_(as Glucose monohydrate)_
76.7 g
_(84.4 g)_
102.6 g
_(112.8 g)_
142.9 g
_(157.2 g)_
Nutritional intakes of reconstituted emulsion, for each bag size:
1085 ML
1450 ML
2020 ML
Nitrogen (g)
5.6
7.5
10.5
Amino acids (g)
34
46
64
Glucose (g)
77
103
143
Lipids
a
(g)
32
43
60
_ENERGY:_
Total calories (kcal)
751
1003
1398
Non-protein calories (kcal)
614
820
1144
Glucose calories (kcal)
b
322
431
600
Lipid calories (kcal)
c
292
389
544
Non-protein calo