SMOFKABIVEN PERIPHERAL

Nazione: Indonesia

Lingua: indonesiano

Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Scheda tecnica Scheda tecnica (SPC)
01-01-2020

Principio attivo:

ALANINE, ARGININE, GLYCINE, HISTIDINE, ISOLEUCINE, LEUCINE, METHIONINE, PHENYLALANINE, PROLINE, SERINE, TAURINE, THREONINE, TRYPTOPHAN, TYROSINE, VALINE, SODIUM GLYCEROPHOSPHATE HYDRATED, MAGNESIUM SULFATE HEPTAHYDRATE, CALCIUM CHLORIDE DIHYDRATE, POTASSI

Commercializzato da:

FRESENIUS KABI COMBIPHAR - Indonesia

INN (Nome Internazionale):

ALANINE, ARGININE, GLYCINE, HISTIDINE, ISOLEUCINE, LEUCINE, METHIONINE, PHENYLALANINE, PROLINE, SERINE, TAURINE, THREONINE, TRYPTOPHAN, TYROSINE, VALINE, SODIUM GLYCEROPHOSPHATE HYDRATED, MAGNESIUM SULFATE HEPTAHYDRATE, CALCIUM CHLORIDE DIHYDRATE, POTASSI

Dosaggio:

6.4 G /5.5 G /5.1 G /1.3 G /2.3 G /3.3 G /1.9 G /2.3 G /5.1 G /3.0 G /0.46 G /2.0 G /0.91 G /0.17 G

Forma farmaceutica:

INFUS

Confezione:

CHAMBER BAG(BIOFINE BAG) @1448 ML

Prodotto da:

FRESENIUS KABI AB - Sweden

Data dell'autorizzazione:

2019-12-02

Scheda tecnica

                                SMOFKABIVEN PERIPHERAL
EMULSION FOR INFUSION
COMPOSITION
SmofKabiven
Peripheral
consists
of
a
three
chamber
bag
system.
Each
bag
contains
the
following partial volumes depending on the two
pack sizes.
1448ML
1904ML
PER 1000 ML
Glucose 13%
788 ml
1036ml
544 ml
Amino acid
solution with
electrolytes
456 ml
600 ml
315 ml
Lipid
emulsion
204 ml
268 ml
141 ml
This corresponds to the following total
compositions:
ACTIVE INGREDIENTS
1448
ML
1904
ML
PER 1000
ML
Glucose (as
monohydrate)_ _
103 g
135 g
71 g
Alanine
6.4 g
8.4 g
4.4 g
Arginine
5.5 g
7.2 g
3.8 g
Glycine
5.1 g
6.6 g
3.5 g
Histidine
1.3 g
1.8 g
0.93 g
Isoleucine
2.3 g
3.0 g
1.6 g
Leucine
3.3 g
4.4 g
2.3 g
Lysine (as acetate)
3.0 g
4.0 g
2.1 g
Methionine
1.9 g
2.6 g
1.3 g
Phenylalanine
2.3 g
3.1 g
1.6 g
Proline
5.1 g
6.7 g
3.5 g
Serine
3.0 g
3.9 g
2.1 g
Taurine
0.46 g
0.60 g
0.32 g
Threonine
2.0 g
2.6 g
1.4 g
Tryptophan
0.91 g
1.2 g
0.63 g
Tyrosine
0.17 g
0.24 g
0.12 g
Valine
2.9 g
3.7 g
2.0 g
Calcium chloride (as
dihydrate)
0.26 g
0.34 g
0.18 g
Sodium
glycerophosphate (as
hydrate)
1.9 g
2.5 g
1.3 g
Magnesium sulphate
(as heptahydrate)_ _
0.55 g
0.72 g
0.38 g
Potassium chloride
2.0 g
2.7 g
1.4 g
Sodium acetate (as
trihydrate)
1.6 g
2.0 g
1.1 g
Zinc sulphate (as_ _
heptahydrate)
0.006 g
0.008 g
0.004 g
Soya-bean oil, refined
12.3 g
16.1 g
8.5 g
Medium-chain
triglycerides
12.3 g
16.1 g
8.5 g
Olive oil, refined
10.1 g
13.4 g
7.0 g
Fish oil, rich in omega-
3-acids
6.1 g
8.0 g
4.2 g
Corresponding to
1448 ML
1904 ML
PER 1000 ML

Carbohydrates
- Glucose
(anhydrous)
103 g
135 g
71 g

Amino acids
46 g
60 g
32 g

Nitrogen
7.4 g
9.8 g
5.1 g

Lipids
41 g
54 g
28 g

Energy content
- total (approx.)
1000 kcal
4.0 MJ
1300 kcal
5.4 MJ
700 kcal
2.9 MJ
- non protein
(approx.)
800 kcal
3.5 MJ
1100 kcal
4.6 MJ
600 kcal
2.5 MJ

Electrolytes
- sodium
36 mmol
48 mmol
25 mmol
- potassium
28 mmol
36 mmol
19 mmol
- magnesium
4.6 mmol
6.0 mmol
3.2 mmol
- calcium
2.3 mmol
3.0 mmol
1.6 mmol
- phosphate
1
11.9 mmol
15.6 mmol
8.2 mmol
- zinc
0.03 mmol
0.05 mmol
0.02 mmol
- sul
                                
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