Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cisatracurium besilate
Viatris UK Healthcare Ltd
M03AC11
Cisatracurium besilate
2mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 15010500; GTIN: 5016695005317
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/INFUSION CISATRACURIUM 5 MG/ML SOLUTION FOR INJECTION/INFUSION Cisatracurium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What CISATRACURIUM is and what it is used for 2. What you need to know before you are given Cisatracurium 3. How Cisatracurium is given 4. Possible side effects 5. How to store Cisatracurium 6. Contents of the pack and other information 1. WHAT CISATRACURIUM IS AND WHAT IT IS USED FOR Cisatracurium contains a medicine called cisatracurium. This belongs to a group of medicines called muscle relaxants. Cisatracurium 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 DO NOT USE CISATRACURIUM if you are allergic (hypersensitive) to cisatracurium, any other muscle relaxant or any other ingredients in Cisatracurium (listed in section 6); if you have reacted badly to an anaesthetic before. Do not have Cisatracurium if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you take Cisatracurium. WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or pharmacist before you are given this medicine if: you h Lestu allt skjalið
OBJECT 1 CISATRACURIUM 2MG/ML SOLUTION FOR INJECTION/INFUSION Summary of Product Characteristics Updated 18-May-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Cisatracurium 2mg/ml solution for injection/infusion 2. Qualitative and quantitative composition Cisatracurium 2 mg as cisatracurium besylate 2.68 mg per 1 ml One ampoule of 2.5ml 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 Excipient(s): For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection/infusion. Colourless to pale yellow or greenish yellow clear solution. The pH is between 3.25 and 3.65 4. Clinical particulars 4.1 Therapeutic indications Cisatracurium is an intermediate-duration, non-depolarising neuromuscular blocking agent for intravenous administration. Cisatracurium is indicated for use during surgical and other procedures and in intensive care in adults and children aged 1 month and over. 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). Cisatracurium 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 Lestu allt skjalið