AMINOPLASMAL HEPA 10%-500ML GLASS BOTTLE

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

ALANINE; ASPARTIC ACID; ISOLEUCINE; GLUTAMIC ACID; ARGININE; LEUCINE; HISTIDINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE; LYSINE ACETATE; Acetylcysteine; GLYCINE; N- acetyl- L- tyrosine; Ornithine HCl; L-Asparagine H²O

Saatavilla:

B.BRAUN MEDICAL INDUSTRIES SDN BHD

INN (Kansainvälinen yleisnimi):

ALANINE; ASPARTIC ACID; ISOLEUCINE; GLUTAMIC ACID; ARGININE; LEUCINE; HISTIDINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE; LYSINE ACETATE; Acetylcysteine; GLYCINE; N- acetyl- L- tyrosine; Ornithine HCl; L-Asparagine H²O

Kpl paketissa:

500ml mL

Valmistaja:

B.BRAUN MELSUNGEN AG

Valmisteyhteenveto

COMPOSITION
1000 ml of solution contain
_Active ingredients:_
Isoleucine
8.80 g
Leucine
13.60 g
Lysine Acetate
10.60 g
(equivalent to Lysine, 7.51 g)
Methionine
1.20 g
Phenylalanine
1.60 g
Threonine
4.60 g
Tryptophan
1.50 g
Valine
10.60 g
Arginine
8.80 g
Histidine
4.70 g
Glycine (Aminoacetic Acid)
6.30 g
Alanine
8.30 g
Proline
7.10 g
Aspartic Acid
2.50 g
Asparagine Monohydrate
0.55 g
(equivalent to Asparagine, 0.48 g)
Acetylcysteine
0.80 g
(equivalent to Cysteine, 0.59 g)
Glutamic Acid
5.70 g
Ornithine Hydrochloride
1.66 g
(equivalent to Ornithine, 1.30 g)
Serine
3.70 g
Acetyltyrosine
0.86 g
(equivalent to Tyrosine, 0.70 g)
_Excipients:_
Disodium edetate dihydrate
0.05 g
Hydrochloric acid or sodium hydroxide
for pH adjustment, water for injections.
Total amino acids
100
g/l
Total nitrogen
15.3 g/l
a-amino nitrogen
11.2
g
Caloric value
1675 kJ/l = 400 kcal/l
Osmolarity
875 mOsm/l
_Electrolyte concentrations:_
Acetate
51 mmol/l
Chloride
10 mmol/l
PRODUCT DESCRIPTION
A clear and colourless or faintly yellow solution.
PHARMACEUTICAL FORM
Solution for infusion in glass bottles
Contents: 500 ml
PHARMACO-THERAPEUTIC GROUP
Solution for supply of amino acids
INDICATIONS
Supply of amino acids in the setting of parenteral nutrition of
patients
with severe liver insufficiency and imminent or manifest hepatic ence-
phalopathy.
CONTRAINDICATIONS
− Disorders of amino acid metabolism of other than hepatic origin,
− Severely impaired circulatory status with vital threat (shock),
− Acute pulmonary oedema,
− Acidosis,
− Hyperhydration,
− Hypokalaemia,
− Hyponatraemia,
− Hypersensitivity to any of the ingredients of Aminoplasmal® Hepa
–
10 %
No data are available on the use of Aminoplasmal® Hepa – 10 % in
children under 2 years. Therefore, administration of the solution to
such
patients cannot be recommended until relevant data become available.
Because of the particulars of its composition, Aminoplasmal® Hepa -
10
% may cause marked metabolic disturbances if given for other reasons
than stated under “Indica