Country: Mesir
Bahasa: Inggeris
Sumber: EDA (Egyptian Drug Authority)
OTSUKA EGYPT
infusion
500 ml
OTSUKA EGYPT
2009-03-19
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 Baca dokumen lengkap