AMINOLEBAN EN sachets

Country: Egypt

Language: English

Source: EDA (Egyptian Drug Authority)

Available from:

OTSUKA EGYPT

Pharmaceutical form:

sachet

Units in package:

1 sachet

Manufactured by:

OTSUKA PHARMACEUTICAL-JAPAN

Authorization date:

2002-05-21

Summary of Product characteristics

EGYPT OTSUKA PHARMACEUTICAL CO.,S.A.E.
1
1.
NAME OF THE MEDICINAL PRODUCT .
AMINOLEBAN
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
8% Amino Acid infusion
3. PHARMACEUTICAL FORM
AMINOLEBAN
®
is a clear and colorless or slightly yellow solution for intravenous
infusion.
pH range (5-7)
Osmotic pressure ratio (relative to physiological saline): Approx. 3
4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS
Treatment of hepatic encephalopathy in patients with chronic liver
disease.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The usual adult dose of AMINOLEBAN
®
500–1000 mL per dose, infused via a
peripheral vein. The usual peripheral infusion rate is 500 mL over
180–300 min in adults.
For total parenteral nutrition, 500–1000 mL of AMINOLEBAN
®
should be combined
with glucose or other solutions and administered over 24 hours via a
central vein. The
dosage should be adjusted according to the patient’s age, symptoms,
and body weight. PRECAUTIONS >
AMINOLEBAN
® CONTAINS ABOUT 12 MEQ/L OF SODIUM AND 94 MEQ/L OF CHLORIDE.
CONCOMITANT USE WITH AN ELECTROLYTE SOLUTION OR ADMINISTRATION OF A
LARGE DOSE
REQUIRES CAREFUL MONITORING OF ELECTROLYTE BALANCE.
Ingredient
100 mL
L-Threonine
0.45 g
L-Serine
0.5 g
L-Proline
0.8 g
L-Cysteine Hydrochloride Hydrate
0.04 g
L-Glycine
0.9 g
L-Alanine
0.75 g
L-Valine
0.84 g
L-Methionine
0.1g
L-Isoleucine
0.9 g
L-Leucine
1.1 g
L-Phenylalanine
0.1 g
L-Tryptophan
0.07 g
L-Lysine Hydrochloride
0.76 g
L-Histidine Hydrochloride Hydrate
0.32 g
L-Arginine Hydrochloride
0.730 g
EGYPT OTSUKA PHARMACEUTICAL CO.,S.A.E.
2 4.3. CONTRAINDICATIONS
(AMINOLEBAN
® IS CONTRAINDICATED IN THE FOLLOWING PATIENTS.)
(1)
Patients with serious renal disorder (patients on dialysis or
hemofiltration are excluded)
[Urea and other amino acid metabolites may be retained, which may
worsen the
patient’s clinical condition.[See (3 in section 1) & (Section 2) in
4.4 Special warnings
and precautions for use].
(2)
Patients
with
abnormal
amino
acid
metabolism
[Because the infused amino acids are not adequately meta