AMINOSTERIL N-HEPA 8%

Country: Malaysia

Language: English

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

Active ingredient:

AMINOACETIC ACID; ARGININE; L-LYSINE MONOACETATE; L-METHIONINE; GLACIAL ACETIC ACID; L-phenylalanine; L-SERINE; L-Alanine; L-Proline; L-Leucine; L-Valine; Acetylcysteine USP; L-Tryptophan; L-Histidine; L-ISOLEUCINE; L-Threonine

Available from:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (International Name):

AMINOACETIC ACID; ARGININE; L-LYSINE MONOACETATE; L-METHIONINE; GLACIAL ACETIC ACID; L-phenylalanine; L-SERINE; L-Alanine; L-Proline; L-Leucine; L-Valine; Acetylcysteine USP; L-Tryptophan; L-Histidine; L-ISOLEUCINE; L-Threonine

Units in package:

500ml10Units mL

Manufactured by:

FRESENIUS KABI AUSTRIA GMBH

Summary of Product characteristics

M089128/03 EXP
COMPOSITION
1000 ml contains:
L-Isoleucine
10.40 g
L-Leucine
13.09 g
L-Lysine monoacetate
9.71 g
= L-Lysine 6.88 g
L-Methionine
1.10 g
Acetylcysteine
0.70 g
= L-Cysteine 0.52 g
L-Phenylalanine
0.88 g
L-Threonine
4.40 g
L-Tryptophan
0.70 g
L-Valine
10.08 g
Arginine
10.72 g
L-Histidine
2.80 g
Aminoacetic acid
5.82 g
L-Alanine
4.64 g
L-Proline
5.73 g
L-Serine
2.24 g
Glacial acetic acid
4.42 g
Total nitrogen content 12.9 g/l
INDICATIONS
Parenteral amino acid supply in severe forms of
hepatic failure (liver insufficiency) with and without
encephalopathy.
CONTRAINDICATIONS
Disturbance
of
amino
acid
metabolism,
metabolic acidosis, fluid overload, hyponatremia,
hypokalemia, renal insufficiency, decompensated
cardiac insufficiency, shock, hypoxia.
_REMARK_:
No specific studies have been performed to assess
the safety of Aminosteril N-Hepa 8% in pregnancy
and lactation.
SIDE EFFECTS
_REMARK:_
Due to the special composition of this preparation,
use in indications other than those recommended
may result in amino acid imbalances and severe
metabolic disorders.
DOSAGE AND APPLICATION
For intravenous infusion.
1.0 to 1.25 ml/kg b.w./h.
Max. dosage:
1.5 g amino acids/kg b.w./day = 1300 ml/day at
70 kg b.w.
_REMARK:_
Constant
checking
of
serum
electrolytes,
fluid
balance and acidbase balance is mandatory.
LENGTH OF APPLICATION
AMINOSTERIL
® N-HEPA 8% IS USED AS LONG AS
REQUIRED BY THERAPY.
INTERACTIONS WITH OTHER MEDICAMENTS
Because of the increased risk of microbiological
contamination
and
incompatibilities,
amino
acid
solutions should not be mixed with other drugs.
Should it become necessary to add other nutrients
like carbohydrates, lipid emulsions, electrolytes,
vitamins or trace elements to Aminosteril
®
N-Hepa
8% for complete nutrition, care should be given to
hygienic admixing, good blending and, in particular,
to compatibility.
Aminosteril
®
N-Hepa 8% should not be stored after
the addition of other components.
STORAGE CONDITIONS
DO NOT STORE ABOVE 30°C
DO NOT FREEZE!
PRECAUTIONS
DO NOT USE AMINOSTERIL