SmofKabiven Central emulsion for infusion

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

23-04-2021

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Principio attivo:

I camera: L-alanine, L-arginine, glycine, L-histidine, L-isoleucine, L-leucine, L-lysine (lysine acetate), L-methionine, L-phenylalanine, L-proline, L-serine, taurine, L-threonine, L-tryptophan, L-tyrosine, L-valine, calcium chloride (calcium chloride dihydrate), sodium glycerophosphate (sodium glycerophosphate hydrate), magnesium sulphate (magnesium sulphate heptahydrate), potassium chloride, sodium acetate (sodium acetate trihydrate), zinc sulphate (zinc sulphate heptahydrate), II camera: glucose (glucose monohydrate), III camera: soya-bean oil, triglycerides, olive oil, fish oil (rich in omega-3 acids)

Commercializzato da:

Fresenius Kabi AB

Codice ATC:

B05BA10

INN (Nome Internazionale):

Dosaggio:

I camera: 14mg/ml+ 12mg/ml+ 11mg/ml+ 3mg/ml+ 5mg/ml+ 7,4mg/ml+ 6,6mg/ml+ 4,3mg/ml+ 5,1mg/ml+ 11,2mg/ml+ 6,5mg/ml+ 1mg/ml+ 4,4mg/ml+ 2mg/ml+ 0,4mg/ml+ 6,2mg/ml+ 0,56mg/ml+ 4,2mg/ml+ 1,2mg/ml+ 3,4mg/ml+ 0,013mg/ml, II camera: 419,5mg/ml, III camera: 60mg/ml+ 60mg/ml+ 50mg/ml+ 30mg/ml

Forma farmaceutica:

emulsion for infusion

Confezione:

(4/4x1/) plastic camera set 986ml (camera I 500ml+camera II 298ml+camera III 188ml), (4/4x1/) plastic camera set 1477ml (camera I 750ml+camera II 446ml+camera III 281ml), (4/4x1/) plastic camera set 1970ml (camera I 1000ml+camera II 595ml+camera III 375ml)

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2021-04-23

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SmofKabiven Central emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven consists of a three chamber bag system. Each bag contains
the following partial
volumes depending on the five pack sizes.
493 ML
986 ML
1477 ML
1970 ML
2463 ML
PER 1000 ML
Amino acid solution with
electrolytes
250 ml
500 ml
750 ml
1000 ml
1250 ml
508 ml
Glucose 42%
149 ml
298 ml
446 ml
595 ml
744 ml
302 ml
Lipid emulsion
94 ml
188 ml
281 ml
375 ml
469 ml
190 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
493 ML
986 ML
1477ML
1970 ML
2463 ML
PER 1000 ML
Alanine
3.5 g
7.0 g
10.5 g
14.0 g
17.5 g
7.1 g
Arginine
3.0 g
6.0 g
9.0 g
12.0 g
15.0 g
6.1 g
Glycine
2.8 g
5.5 g
8.2 g
11.0 g
13.8 g
5.6 g
Histidine
0.8 g
1.5 g
2.2 g
3.0 g
3.7 g
1.5 g
Isoleucine
1.3 g
2.5 g
3.8 g
5.0 g
6.2 g
2.5 g
Leucine
1.9 g
3.7 g
5.6 g
7.4 g
9.4 g
3.8 g
Lysine (as acetate)
1.7 g
3.3 g
5.0 g
6.6 g
8.4 g
3.4 g
Methionine
1.1 g
2.2 g
3.2 g
4.3 g
5.4 g
2.2 g
Phenylalanine
1.3 g
2.6 g
3.8 g
5.1 g
6.4 g
2.6 g
Proline
2.8 g
5.6 g
8.4 g
11.2 g
14.0 g
5.7 g
Serine
1.6 g
3.2 g
4.9 g
6.5 g
8.1 g
3.3 g
Taurine
0.25 g
0.50 g
0.75 g
1.0 g
1.2 g
0.5 g
Threonine
1.1 g
2.2 g
3.3 g
4.4 g
5.4 g
2.2 g
Tryptophan
0.5 g
1.0 g
1.5 g
2.0 g
2.5 g
1.0 g
Tyrosine
0.10 g
0.20 g
0.30 g
0.40 g
0.49 g
0.20 g
Valine
1.6 g
3.1 g
4.6 g
6.2 g
7.6 g
3.1 g
Calcium chloride
0.14 g
0.28 g
0.42 g
0.56 g
0.69 g
0.28 g
(as dihydrate)
Sodium glycerophosphate
1.1 g
2.1 g
3.1 g
4.2 g
5.2 g
2.1 g
(as hydrate)
Magnesium sulphate
0.30 g
0.60 g
0.90 g
1.2 g
1.5 g
0.61 g
(as heptahydrate)
Potassium chloride
1.1 g
2.2 g
3.4 g
4.5 g
5.7 g
2.3 g
Sodium acetate
0.9 g
1.7 g
2.6 g
3.4 g
4.2 g
1.7 g
(as trihydrate)
Zinc sulphate
0.0033 g 0.0065 g
0.0097 g
0.013 g
0.016 g
0.0066 g
(as heptahydrate)
Glucose
63 g
125 g
187 g
250 g
313 g
127 g
(as monohydrate) Soya-
bean oil, refined Medium-
chain triglycerides
5.6 g
11.3 g
16.9 g
22.5 g
28.1 g
11.4 g
5.6 g
11.3 g
16.9 g
22.5 g
28.1 g
11.4 g
Olive oil, refined

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