국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
cisatracurium besilate, Quantity: 2.68 mg/mL (Equivalent: cisatracurium, Qty 2 mg/mL)
Aspen Pharmacare Australia Pty Ltd
Injection, solution
Excipient Ingredients: benzenesulfonic acid; water for injections
Intravenous
5 X 10mL
(S4) Prescription Only Medicine
Nimbex injection is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the Intensive Care Unit.
Visual Identification: Colourless to pale yellow or greenish yellow solution, practically free from visible particulate matter.; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
1996-09-13
1 AUSTRALIAN PRODUCT INFORMATION NIMBEX (CISATRACURIUM BESILATE) INJECTION 1 NAME OF THE MEDICINE Cisatracurium besilate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nimbex injection is supplied in two strengths, either 2 mg or 5 mg of cisatracurium besilate per mL. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Nimbex injection is a colourless to pale yellow or greenish solution, practically free from visible particulate matter. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Nimbex injection is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit. 4.2 D OSE AND METHOD OF ADMINISTRATION Nimbex injection contains no antimicrobial preservative and is intended for single patient use. _ _ USE BY INTRAVENOUS BOLUS INJECTION DOSAGE IN ADULTS _Tracheal intubation_. The recommended intubation dose of Nimbex injection for adults is 0.15 mg/kg bodyweight. This dose produces good to excellent conditions for tracheal intubation 120 seconds following injection. Higher doses will shorten the time to onset of neuromuscular block. The following table, Table 1, summarises mean pharmacodynamic data when Nimbex injection was administered at doses of 0.1 to 0.4 mg/kg bodyweight to healthy adult patients during opioid (thiopentone/fentanyl/midazolam) or propofol anaesthesia. 2 TABLE 1 INITIAL NIMBEX INJECTION DOSE (MG/KG BODYWEIGHT) ANAESTHETIC BACKGROUND TIME TO 90% T 1 ® SUPPRESSION (MIN) TIME TO MAXIMUM T 1 ® SUPPRESSION (MIN) TIME TO SPONTANEOUS T 1 ® RECOVERY (MIN) 0.1 Opioid 3.4 4.8 45 0.15 Propofol 2.6 3.5 55 0.2 Opioid 2.4 2.9 65 0.4 Opioid 1.5 1.9 91 ® Single twitch response as well as the first component of the Train-of-Four response of the adductor pollicis muscle following the supramaximal electrical stimulation of the ulnar nerve Enflurane or isoflurane anaesthesia may 전체 문서 읽기