Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cisatracurium besilate
Accord-UK Ltd
M03AC11
Cisatracurium besilate
2mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 15010500; GTIN: 5055565714898
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/ INFUSION CISATRACURIUM 5 MG/ML SOLUTION FOR INJECTION/ INFUSION Cisatracurium The name of your medicine are “Cisatracurium 2 mg/ml Solution for injection/ infusion” and “Cisatracurium 5 mg/ml Solution for injection/ infusion” but in the rest of the leaflet it will be called “Cisatracurium Injection 2 mg/ml” and “Cisatracurium Injection 5 mg/ml”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Cisatracurium Injection is and what it is used for 2. What you need to know before you are given Cisatracurium Injection 3. How Cisatracurium Injection is given 4. Possible side effects 5. How to store Cisatracurium Injection 6. Contents of the pack and other information 1. WHAT CISATRACURIUM INJECTION IS AND WHAT IT IS USED FOR Cisatracurium Injection contains a medicine called cisatracurium. This belongs to a group of medicines called muscle relaxants. Cisatracurium is an intermediate-duration, non-depolarising neuromuscular blocking agent for intravenous administration. Cisatracurium Injection is used: to relax muscles during operations on adults and children over 1 month of age, including heart surgery to help insert a tube into the windpipe (tracheal intubation), if a person needs help to breathe to relax the muscles of adults in intensive care. Ask your doctor if you would like more explanation about this medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CISATRACURIUM INJECTION DO NOT USE CISATRACURIUM INJECTION IF: you are allergic (hypersensitive) to cisatracurium, any other muscle relaxant or any of the other ingredients Les hele dokumentet
OBJECT 1 CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/INFUSION Summary of Product Characteristics Updated 04-Oct-2017 | Accord Healthcare Limited 1. Name of the medicinal product Cisatracurium 2 mg/ml Solution for injection/infusion 2. Qualitative and quantitative composition Cisatracurium 2 mg as cisatracurium besilate 2.68 mg per 1 ml • One vial of 2.5 ml contains 5 mg of cisatracurium • One vial of 5 ml contains 10 mg of cisatracurium • One vial of 10 ml contains 20 mg of cisatracurium • One vial of 25 ml contains 50 mg of cisatracurium For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection/infusion. A clear colourless to slightly yellow or greenish yellow solution. 4. Clinical particulars 4.1 Therapeutic indications Cisatracurium is indicated for use during surgical and other procedures in adults and children aged 1 month and over. Cisatracurium is also indicated for use in adults requiring intensive care. Cisatracurium 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 Cisatracurium 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 Cisatracurium 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). This medicinal product 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 Cisatracurium in order to individualise dosage re Les hele dokumentet