Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
CISATRACURIUM
Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland
M03AC11
CISATRACURIUM 2 mg/ml
SOLUTION FOR INJECTION
CISATRACURIUM 2 mg/ml
POM
MUSCLE RELAXANTS
Withdrawn
2005-10-17
Summary of Product Characteristics N I M B E X ™ cisatracurium besilate 1 NAME OF THE MEDICINAL PRODUCT Nimbex 2 mg/ml, Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cisatracurium 2 mg as cisatracurium besilate 2.68 mg per 1 ml one ampoule of 2.5 ml contains 5 mg of cisatracurium one ampoule of 5 ml contains 10 mg of cisatracurium one ampoule of 10 ml contains 20 mg of cisatracurium one ampoule of 25 ml contains 50 mg of cisatracurium For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. Colourless to pale yellow or greenish yellow solution. Practically free from visible particulate matter. 4 CLINICAL PARTICULARS Nimbex is an intermediate-duration, non-depolarising neuromuscular blocking agent for intravenous administration. 4.1 THERAPEUTIC INDICATIONS Nimbex is indicated for use during surgical and other procedures and in intensive care. Nimbex can be used as an adjunct to general anaesthesia, or sedation in the Intensive Care Unit (ICU) to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Please note that Nimbex should not be mixed in the same syringe or administered simultaneously through the same needle as propofol injectable emulsion or with alkaline solutions such as sodium thiopentone (see section 6.2). Nimbex contains no antimicrobial preservative and is intended for single patient use. MONITORING ADVICE As with other neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of Nimbex in order to individualise dosage requirements. USE BY INTRAVENOUS BOLUS INJECTION DOSAGE IN ADULTS Tracheal Intubation. The recommended intubation dose of Nimbex for adults is 0.15 mg/kg (body weight). This dose produced good to excellent conditions for tracheal intubation 120 seconds after administration of Nimbex, following induction of anaesthesia with propofol. Higher doses will shorten the time to onset Baca dokumen lengkapnya
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nimbex® 2mg/ml, solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cisatracurium 2mg as cisatracurium besilate 2.68mg per 1ml One ampoule of 2.5ml contains 5mg of cisatracurium One ampoule of 5ml contains 10mg of cisatracurium One ampoule of 10ml contains 20mg of cisatracurium One ampoule of 25ml contains 50mg of cisatracurium For excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection. Colourless to pale yellow or greenish yellow solution. Practically free from visible particulate matter. 4. CLINICAL PARTICULARS Nimbex is an intermediate-duration, non-depolarising neuromuscular blocking agent for intravenous administration. 4.1 THERAPEUTIC INDICATIONS Nimbex is indicated for use during surgical and other procedures and in intensive care. Nimbex can be used as an adjunct to general anaesthesia, or sedation in the Intensive Care Unit (ICU) to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Please note that Nimbex should not be mixed in the same syringe or administered simultaneously through the same needle as propofol injectable emulsion or with alkaline solutions such as sodium thiopentone. (see section 6.2). Nimbex contains no antimicrobial preservative and is intended for single patient use. Monitoring advice Page 2 of 15 As with other neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of Nimbex in order to individualise dosage requirements. USE BY INTRAVENOUS BOLUS INJECTION DOSAGE IN ADULTS TRACHEAL Baca dokumen lengkapnya