Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cisatracurium besilate
GlaxoSmithKline UK Ltd
M03AC11
Cisatracurium besilate
2mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 15010500
- 1 - [ASPEN LOGO] INFORMATION FOR THE PHYSICIAN NIMBEX CISATRACURIUM PLEASE REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS (SPC) FOR FURTHER DETAILS ON THIS PRODUCT. TRADE NAME OF THE MEDICINAL PRODUCT Nimbex 2 mg/ml solution for injection/infusion Nimbex Forte 5 mg/ml solution for injection/infusion QUALITATIVE AND QUANTITATIVE COMPOSITION Nimbex 2 mg/ml, solution for injection: Cisatracurium 2 mg as cisatracurium besilate 2.68 mg per 1 ml one ampoule of 10 ml contains 20 mg of cisatracurium one ampoule of 25 ml contains 50 mg of cisatracurium Nimbex Forte 5 mg/ml, solution for injection: Cisatracurium 5 mg as cisatracurium besilate 6.70 mg per 1 ml one vial of 30 ml contains 150 mg of cisatracurium PHARMACEUTICAL FORM Solution for injection/infusion. Colourless to pale yellow or greenish yellow solution. Practically free from visible particulate matter. THERAPEUTIC INDICATIONS Nimbex is indicated for use during surgical and other procedures in adults and children aged 1 month and over. Nimbex is also indicated for use in adults requiring 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. POSOLOGY AND METHOD OF ADMINISTRATION Nimbex should be only administered by or under the supervision of anaesthetists or other clinicians who are familiar with the use and action of neuromuscular blocking agents. Facilities for tracheal intubation, and maintenance of pulmonary ventilation and adequate arterial oxygenation have to be available. 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. Nimbex contains no antimicrobial preservative and is intended for single patient use. - 2 - MONITORING ADVICE As with other neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of Ni Read the complete document
OBJECT 1 NIMBEX INJECTION 2MG/ML Summary of Product Characteristics Updated 03-Aug-2017 | Aspen 1. Name of the medicinal product Nimbex 2mg/ml solution for injection/infusion. 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 the full list of excipients, see Section 6.1. 3. Pharmaceutical form Solution for injection/infusion. 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 in adults and children aged 1 month and over. Nimbex is also indicated for use in adults requiring 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 Nimbex should only be administered by or under the supervision of anaesthetists or other clinicians who are familiar with the use and action of neuromuscular blocking agents. Facilities for tracheal intubation, and maintenance of pulmonary ventilation and adequate arterial oxygenation have to be available. 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 i Read the complete document