SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FISH OIL; GLUCOSE MONOHYDRATE; GLYCINE; L- ALANINE; L- ISOLEUCINE; L- LYSINE ACETATE; L- METHIONINE; L- PHENYLALANINE; L- PROLINE; L- SERINE; L- THREONINE; L- TRYPTOPHAN; L- TYROSINE; L- VALINE; L-ARGININE; L-HISTIDINE; L-LEUCINE; OLIVE OIL; SOYA BEAN OIL, REFINED; TAURINE; TRIGLYCERIDES, MEDIUM-CHAIN

Available from:

NEOPHARM (ISRAEL) 1996 LTD

Pharmaceutical form:

EMULSION FOR INFUSION

Composition:

FISH OIL 30 G / 1000 ML; OLIVE OIL 50 G / 1000 ML; TRIGLYCERIDES, MEDIUM-CHAIN 60 G / 1000 ML; SOYA BEAN OIL, REFINED 60 G / 1000 ML; GLUCOSE MONOHYDRATE 462 G / 1000 ML; L- VALINE 6.2 G / 1000 ML; L- TYROSINE 0.40 G / 1000 ML; L- TRYPTOPHAN 2 G / 1000 ML; L- THREONINE 4.4 G / 1000 ML; TAURINE 1 G / 1000 ML; L- SERINE 6.5 G / 1000 ML; L- PROLINE 11.2 G / 1000 ML; L- PHENYLALANINE 5.1 G / 1000 ML; L- METHIONINE 4.3 G / 1000 ML; L- LYSINE ACETATE 9.3 G / 1000 ML; L-LEUCINE 7.4 G / 1000 ML; L- ISOLEUCINE 5 G / 1000 ML; L-HISTIDINE 3 G / 1000 ML; GLYCINE 11 G / 1000 ML; L-ARGININE 12 G / 1000 ML; L- ALANINE 14 G / 1000 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI AB, SWEDEN

Therapeutic indications:

Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.

Authorization date:

2023-04-24

Summary of Product characteristics

1 (12)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SmofKabiven Extra Nitrogen Electrolyte Free
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven Extra Nitrogen Electrolyte Free consists of a three
chamber bag system. Each
bag contains the following partial volumes depending on the three pack
sizes.
1012 ML
1518 ML
2025 ML
PER 1000 ML
Amino acid solution 10%
662 ml
993 ml
1325 ml
654 ml
Glucose 42%
204 ml
306 ml
408 ml
202 ml
Lipid emulsion 20%
146 ml
219 ml
292 ml
144 ml
Each bag is ready for use. This corresponds to the following total
compositions:
ACTIVE INGREDIENTS
1012 ML
1518ML
2025 ML
PER 1000 ML
L-Alanine
9.3 g
14 g
19 g
9.2 g
L-Arginine
7.9 g
12 g
16 g
7.9 g
Glycine
7.3 g
11 g
15 g
7.2 g
L-Histidine
2.0 g
3.0 g
4.0 g
2.0 g
L-Isoleucine
3.3 g
5.0 g
6.6 g
3.3 g
L-Leucine
4.9 g
7.3 g
9.8 g
4.8 g
L-Lysine (as acetate)
4.4 g
6.6 g
8.7 g
4.3 g
L-Methionine
2.8 g
4.3 g
5.7 g
2.8 g
L-Phenylalanine
3.4 g
5.1 g
6.8 g
3.3 g
L-Proline
7.4 g
11 g
15 g
7.3 g
L-Serine
4.3 g
6.5 g
8.6 g
4.3 g
Taurine
0.66 g
1.0 g
1.3 g
0.65 g
L-Threonine
2.9 g
4.4 g
5.8 g
2.9 g
L-Tryptophan
1.3 g
2.0 g
2.7 g
1.3 g
L-Tyrosine
0.26 g
0.40 g
0.53 g
0.26 g
L-Valine
4.1 g
6.2 g
8.2 g
4.1 g
Glucose monohydrate
_corresponding to _
Glucose
86 g
129 g
171 g
85 g
Soya-bean oil, refined
8.8 g
13 g
18 g
8.7 g
Medium-chain triglycerides
8.8 g
13 g
18 g
8.7 g
Olive oil, refined
7.3 g
11 g
15 g
7.2 g
Fish oil, rich in omega-3-acids
4.4 g
6.6 g
8.8 g
4.3 g
Corresponding to
1012 ML
1518ML
2025 ML
PER 1000 ML
•
Amino acids
66.3 g
99.4 g
133 g
65.5 g
•
Nitrogen
10.6 g
15.9 g
21.2 g
10.5 g
•
Carbohydrates
- Glucose (anhydrous)
85.7 g
129 g
171 g
84.7 g
•
Lipids
29.2 g
43.8 g
58.4 g
28.9 g
2 (12)
•
Acetate
1)
97.2 mmol
146 mmol
194 mmol
96.0 mmol
•
Phosphate
2)
2.2 mmol
3.3 mmol
4.4 mmol
2.2 mmol
•
Energy content
- total (approx.)
900 kcal
3.8MJ
1350 kcal
5.6MJ
1800 kcal
7.5MJ
889 kcal
3.7 MJ
- non protein (approx.)
635 kcal
2.7 MJ
952 kcal
4.0 MJ
1270 kcal
5.3 MJ
627 kcal
2.6 MJ
1)
Contribution from amino acid so