Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
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
FRESENIUS KABI MALAYSIA SDN. BHD
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
500ml10Units mL
FRESENIUS KABI AUSTRIA GMBH
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 Læs hele dokumentet