Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Cisatracurium
Noridem Enterprises Limited
M03AC; M03AC11
Cisatracurium
2 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Other quaternary ammonium compounds; cisatracurium
Not marketed
2013-07-12
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/INFUSION cisatracurium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse . This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. THE NAME OF YOUR MEDICINE IS CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/INFUSION _In the rest of this leaflet Cisatracurium 2 mg/ml Solution for Injection/Infusion is called _ _Cisatracurium._ WHAT IS IN THIS LEAFLET : 1. What Cisatracurium is and what it is used for 2. What you need to know before you use Cisatracurium 3. How to use Cisatracurium 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 The active substance is cisatracurium besilate, which 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 USE CISATRACURIUM DO NOT USE CISATRACURIUM IF YOU: • are allergic (hypersensitive) to the active substance, any other muscle relaxant or any of the other ingredients in this medicine (listed in section 6). • have reacted badly to an anaesthetic before. Do not receive Cisatracurium if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you receive Cisatracurium Lugege kogu dokumenti
Health Products Regulatory Authority 12 August 2021 CRN00CGPT Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cisatracurium 2 mg/ml solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 ml contains cisatracurium besilate corresponding to 2 mg Cisatracurium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. Colourless to pale yellow or greenish yellow solution. 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 in order to individualise dosage requirements. USE BY INTRAVENOUS BOLUS INJECTIO Lugege kogu dokumenti