Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cisatracurium besilate
Hospira UK Ltd
M03AC11
Cisatracurium besilate
2mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 15010500
Page 1 of 5 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 USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. 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 This medicine belongs to a group of medicines called muscle relaxants. The full name of this medicine is Cisatracurium solution for injection/infusion but for ease of reference it will be referred to as Cisatracurium throughout the leaflet. Cisatracurium is used - During surgery and other procedures and in intensive care - With general anaesthesia, or sedation in the Intensive Care Unit to relax muscles - To help insert a tube into the windpipe (tracheal intubation) if a person needs help to breathe (with or without a machine). Cisatracurium is used in adults and in children over 1 month of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CISATRACURIUM DO NOT USE CISATRACURIUM - If you are allergic (hypersensitive) to cisatracurium besilate, atracurium, or any of the ingredients in this medicine (listed in section 6) WARNINGS AND PRECAUTIONS Talk to your doctor before using this medicine if you: - have a neuromuscular disease, such as a muscle wasting disease, paralysis, motor neurone disease, cerebral palsy or myasthenia gravis - have a burn which requires medical treatment - ha Olvassa el a teljes dokumentumot
OBJECT 1 CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/INFUSION Summary of Product Characteristics Updated 10-Apr-2018 | Hospira UK Ltd 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 2.7 mg per 1 ml One vial of 2.5 ml contains 5 mg of cisatracurium as cisatracurium besilate 6.7 mg One vial of 5 ml contains 10 mg of cisatracurium as cisatracurium besilate 13.4 mg One vial of 10 ml contains 20 mg of cisatracurium as cisatracurium besilate 26.8 mg 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 pH: 3.0 – 3.7 Osmolarity: 8 mOsmol/l 4. Clinical particulars 4.1 Therapeutic indications Cisatracurium is indicated for use during surgical and other procedures and in intensive care in adults and children aged 1 month and over. It 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. 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 requirements. USE BY INTRAVENOUS BOLUS Olvassa el a teljes dokumentumot