国家: 亚美尼亚
语言: 英文
来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
atracurium (atracurium besylate)
Kalceks JSC
M03AC04
atracurium (atracurium besylate)
10mg/ml
solution for injection/infusion
(5) ampoules 5ml
Prescription
Registered
2019-03-11
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atracurium Besilate 10 mg/ml Solution for Injection/Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 10 mg of atracurium besilate. Each ampoule (2.5 ml) contains 25 mg of atracurium besilate. Each ampoule (5 ml) contains 50 mg of atracurium besilate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Clear colourless or yellowish solution, free from visible particles. pH of solution is 3.30 to 3.65 and osmolality is 10 – 30 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is used as an adjunct to general anaesthesia to facilitate tracheal intubation, to relax skeletal muscles during surgery or controlled ventilation, and to facilitate mechanical ventilation of patients in the intensive care unit. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ _ _ _Dosage by intravenous injection _ Atracurium besilate is administered by intravenous injection. The usual dose for adults ranges from 0.3 to 0.6 mg/kg of body weight (depending on the required duration of full block) and provides adequate relaxation for 15 to 35 minutes. Endotracheal intubation can usually be accomplished within 90 seconds from the intravenous injection of 0.5 to 0.6 mg/kg. Full block can be prolonged with supplementary doses of 0.1 to 0.2 mg/kg as required. Successive supplementary dosing does not give rise to accumulation of neuromuscular blocking effect. Caesarean Section: Atracurium besilate is suitable for maintenance of muscle relaxation during Caesarean section as it does not cross the placenta in clinically significant amounts following recommended doses (0.3-0.6 mg/kg). Spontaneous recovery of normal muscle tone occurs after approximately 35 minutes when neuromuscular function restored to 95 % of its baseline (measured by the restoration of the tetanic response). The neuromuscular block produced by atracurium besilate can be rapidly reversed by standa 阅读完整的文件