Aminoplasmal B. Braun 10% Solution for Intravenous Infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ALANINE; ASPARTIC ACID; ISOLEUCINE; GLUTAMIC ACID; TYROSINE; ARGININE; LEUCINE; HISTIDINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE; LYSINE ACETATE; GLYCINE; LYSINE MONOHYDRATE

Available from:

B.BRAUN MEDICAL INDUSTRIES SDN BHD

INN (International Name):

ALANINE; ASPARTIC ACID; ISOLEUCINE; GLUTAMIC ACID; TYROSINE; ARGININE; LEUCINE; HISTIDINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE; LYSINE ACETATE; GLYCINE; LYSINE MONOHYDRATE

Units in package:

500ml mL

Manufactured by:

B. BRAUN MELSUNGEN AG.

Summary of Product characteristics

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451/12609999/0920
COMPOSITION
1000 ml solution for infusion contains
_Active substances:_
Isoleucine
5.00 g
Leucine
8.90 g
Lysine acetate
5.74 g
(equivalent to lysine, 4.07 g)
Lysine monohydrate
3.12 g
(equivalent to lysine, 2.78 g)
Methionine
4.40 g
Phenylalanine
4.70 g
Threonine
4.20 g
Tryptophan
1.60 g
Valine
6.20 g
Arginine
11.50 g
Histidine
3.00 g
Alanine
10.50 g
Glycine
12.00 g
Aspartic acid
5.60 g
Glutamic acid
7.20 g
Proline
5.50 g
Serine
2.30 g
Tyrosine
0.40 g
Electrolyte concentrations:
_Excipients:_
Acetylcysteine
Citric acid monohydrate
Water for injections
PHARMACEUTICAL FORM
Solution for infusion
Amino acid content
100 g/l
Nitrogen content
15.8 g/l
Energy
1675 kJ/l Ⳏ 400 kcal/l
Theoretical osmolarity:
864 mOsm/l
Titration acidity (to pH 7.4), approximately
20 mmol/l
pH
5.7 – 6.3
PRODUCT DESCRIPTION
Clear, colourless or faintly straw-coloured solution
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Solutions for parenteral nutrition,
ATC-Code B05B
A01.
The aim of parenteral nutrition is the supply of all nutrients
necessary for the
growth, maintenance and regeneration of body tissues etc.
Amino acids are of special importance as they partly are essential for
protein
synthesis. Intravenously administered amino acids are incorporated in
the
respective intravascular and intracellular amino acid pools. Both
endogenous
and exogenous amino acids serve as substrate for the synthesis of
functional
and structural proteins.
To prevent the metabolisation of amino acids for energy production,
and also
to fuel the other energy consuming processes in the organism,
simultaneous
energy supply (in the form of carbohydrate or fat) is necessary.
PHARMACOKINETIC PROPERTIES
Because Aminoplasmal B. Braun 10% is infused intravenously, the
bio-avail-
ability of the amino acids contained in the solution is 100 %.
The composition of Aminoplasmal B. Braun 10% is based upon the results
of
clinical investigations of the metabolism if intravenously
administered amino
acids