Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ATRACURIUM BESILATE
MITSUBISHI TANABE PHARMA INDONESIA - Indonesia
ATRACURIUM BESILATE
25 MG
INJEKSI
DUS, 5 AMPUL @ 2.5 ML
ASPEN SVP (PTY) LTD - South Africa
2021-12-23
TRACRIUM ATRACURIUM BESYLATE INJECTION 10MG/ML 1. QUALITATIVE AND QUANTITATIVE COMPOSITION _INJECTION:_ A sterile solution containing 10 mg atracurium besylate per mL, without an antimicrobial preservative, supplied in ampoules. 2. PHARMACEUTICAL FORM Solution for injection or infusion. 3. CLINICAL PARTICULARS 3.1 INDICATIONS _TRACRIUM_ is a highly selective, competitive or non-depolarising neuromuscular blocking agent which is used as an adjunct to general anaesthesia to enable tracheal intubation. _TRACRIUM_ injection is also used to be performed and to relax skeletal muscles during surgery or controlled ventilation, and to facilitate mechanical ventilation in Intensive Care Unit (ICU) patients. 3.2 DOSAGE AND ADMINISTRATION In common with all neuromuscular blocking agents monitoring of neuromuscular function is recommended during the use of _TRACRIUM_ in order to individualise dosage requirements. • USE BY INJECTION IN ADULTS _TRACRIUM_ is administered by intravenous (i.v.)_ _injection. The dosage range for adults is 0.3 to 0.6 mg/kg (depending on the duration of full block required) and will provide adequate relaxation for 15 to 35 minutes. Endotracheal intubation can usually be accomplished within 90 seconds from the i.v. injection of 0.5 to 0.6 mg/kg. Full block can be prolonged with supplementary doses of 0.l to 0.2 mg/kg as required. Successive supplementary dosing does not give rise to accumulation of neuromuscular blocking effect. Spontaneous recovery from the end of full block occurs in about 35 minutes as measured by the restoration of the tetanic response to 95% of normal neuromuscular function. The neuromuscular block produced by _TRACRIUM_ can be rapidly reversed by standard doses of anticholinesterase agents, such as neostigmine and edrophonium, accompanied or preceded by atropine, with no evidence of recurarisation. • USE AS AN INFUSION IN ADULTS After an initial bolus dose of 0.3 to 0.6 mg/kg, _TRACRIUM_ can be used to maintain neuromuscular block during long surgical procedures by administr Baca dokumen lengkapnya