AMINOPLASMAL B. BRAUN 10% E

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

ARGININE; ASPARTIC ACID; DISODIUM PHOSPHATE DODECAHYDRATE; GLUTAMINE; GLYCINE; HISTIDINE; ISOLEUCINE; L- ALANINE; LEUCINE; LYSINE AS ACETATE; MAGNESIUM CHLORIDE HEXAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM ACETATE; PROLINE; SERINE; SODIUM ACETATE TRIHYDRATE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE

Доступна з:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

Код атс:

B05CB10

Фармацевтична форма:

SOLUTION FOR INFUSION

Склад:

ISOLEUCINE 5.00 G/L; LEUCINE 8.9 G/L; METHIONINE 4.40 G/L; PHENYLALANINE 4.70 G/L; THREONINE 4.20 G/L; TRYPTOPHAN 1.60 G/L; VALINE 6.20 G/L; ARGININE 11.50 G/L; HISTIDINE 3.00 G/L; GLYCINE 12.00 G/L; L- ALANINE 10.50 G/L; PROLINE 5.50 G/L; ASPARTIC ACID 5.60 G/L; GLUTAMINE 7.20 G/L; SERINE 2.30 G/L; TYROSINE 0.40 G/L; POTASSIUM ACETATE 2.453 G/L; SODIUM ACETATE TRIHYDRATE 2.858 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.508 G/L; LYSINE AS ACETATE 8.56 G/L; DISODIUM PHOSPHATE DODECAHYDRATE 3.581 G/L

Адміністрація маршрут:

I.V

Тип рецепту:

Required

Виробник:

B.BRAUN MELSUNGEN AG, GERMANY

Терапевтична области:

COMBINATIONS

Терапевтичні свідчення:

Supply of amino acids and a limited amount of electrolytes for parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contraindicated. For adults, adolescents and children over 2 years of age.

Дата Авторизація:

2018-10-31

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aminoplasmal B. Braun 10 % E
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution for infusion contains:
Per 1 mL
Per 250 mL
Per 500 mL
Per 1000
mL
Isoleucine
5.00
mg
1.25
g
2.50
g
5.00
g
Leucine
8.90
mg
2.23
g
4.45
g
8.90
g
Lysine hydrochloride
8.56
mg
2.14
g
4.28
g
8.56
g
(
≙
Lysine)
(6.85
mg)
(1.71
g)
(3.43
g)
(6.85
g)
Methionine
4.40
mg
1.10
g
2.20
g
4.40
g
Phenylalanine
4.70
mg
1.18
g
2.35
g
4.70
g
Threonine
4.20
mg
1.05
g
2.10
g
4.20
g
Tryptophan
1.60
mg
0.40
g
0.80
g
1.60
g
Valine
6.20
mg
1.55
g
3.10
g
6.20
g
Arginine
11.50
mg
2.88
g
5.75
g
11.50
g
Histidine
3.00
mg
0.75
g
1.50
g
3.00
g
Alanine
10.50
mg
2.63
g
5.25
g
10.50
g
Glycine
12.00
mg
3.00
g
6.00
g
12.00
g
Aspartic acid
5.60
mg
1.40
g
2.80
g
5.60
g
Glutamic acid
7.20
mg
1.80
g
3.60
g
7.20
g
Proline
5.50
mg
1.38
g
2.75
g
5.50
g
Serine
2.30
mg
0.58
g
1.15
g
2.30
g
Tyrosine
0.40
mg
0.10
g
0.20
g
0.40
g
Sodium acetate trihydrate
2.858
mg
0.715
g
1.429
g
2.858
g
Potassium acetate
2.453
mg
0.613
g
1.227
g
2.453
g
Sodium hydroxide
0.360
mg
0.090
g
0.180
g
0.360
g
Magnesium chloride hexahydrate
0.508
mg
0.127
g
0.254
g
0.508
g
Disodium phosphate dodecahydrate
3.581
mg
0.895
g
1.791
g
3.581
g
_EleCtrolyte concentrations: _
_mmol/l _
Sodium
50
Potassium
25
Magnesium
2.5
Acetate
46
Chloride
52
Phosphate
10
Citrate
1.0 - 2.0
Amino acid content
100 g/l
Nitrogen content
15.8 g/l
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless or faintly straw-coloured solution, free from
particles.
Energy [kJ/l (kcal/l)] 1675 (400)
Theoretical osmolarity [mOsm/] 1021
Acidity (titration to pH 7.4) [mmol NaOH/l] approx. 26
pH 5.7
–
6.3
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supply of amino acids and a limited amount of electrolytes for
parenteral nutrition, when
oral or enteral nutrition is impossible, insufficient or
contraindicated. For adults, adolescents
and children over 2 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
P