Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
ATRACURIUM BESILATE
HOSPIRA UK Ltd
ATRACURIUM BESILATE
10 Micromol
Solution for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER ATRACURIUM BESILATE 10 MG/ML SOLUTION FOR INJECTION The active substance is atracurium besilate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - 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. IN THIS LEAFLET: 1. What Atracurium Besilate Solution for Injection is and what it is used for 2. Before you are given Atracurium Besilate Solution for Injection 3. How you are given Atracurium Besilate Solution for Injection 4. Possible side effects 5. How to store Atracurium Besilate Solution for Injection 6. Further information 1. WHAT ATRACURIUM BESILATE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR Atracurium Besilate Solution for Injection is a medicine which acts as a muscle relaxant. Atracurium Besilate Solution for Injection is used during surgery to relax muscles and to assist with inserting a breathing tube and with artificial breathing. It is also used to help with artificial breathing in patients in intensive care. 2. BEFORE YOU ARE GIVEN ATRACURIUM BESILATE SOLUTION FOR INJECTION YOU WILL NOT BE GIVEN ATRACURIUM BESILATE SOLUTION FOR INJECTION - IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO ATRACURIUM BESILATE or any of the other ingredients of this drug (see section 6) TAKE SPECIAL CARE WITH ATRACURIUM BESILATE SOLUTION FOR INJECTION IF YOU - are pregnant or breast-feeding (see Pregnancy and breast-feeding) - have HEART OR CIRCULATION PROBLEMS - have PROBLEMS WITH YOUR LUNGS - have a HISTORY OF ALLERGY OR ASTHMA - suffer from MYASTHENIA GRAVIS, EATON-LAMBERT SYNDROME OR OTHER NEUROMUSCULAR DISEASES (these may result in muscle weakness) - have SEVERE Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atracurium Besilate 10 mg/ml Solution for Injection, ampoules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Atracurium besilate 10 mg/ml (equivalent to atracurium 7.5 mg/ml) 2.5 ml of solution contains 25 mg atracurium besilate 5 ml of solution contains 50 mg atracurium besilate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection A clear colourless or faint yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atracurium Besilate Injection is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles, and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION USE AS AN ADJUNCT TO GENERAL ANAESTHESIA Atracurium Besilate Injection should only be administered by intravenous injection. DO NOT GIVE ATRACURIUM BESILATE INJECTION INTRAMUSCULARLY since this may result in tissue irritation and there are no clinical data to support this route of administration. To avoid distress to the patient, Atracurium Besilate Injection should not be administered before unconsciousness has been induced. Atracurium Besilate Injection should not be mixed in the same syringe, or administered simultaneously through the same needle, with alkaline solutions (e.g. barbiturate solutions). In common with all neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of Atracurium Besilate Injection in order to individualise dosage requirements. Initial bolus doses for intubation An initial atracurium besilate dose of 0.3 to 0.6 mg/kg (depending on the duration of full block required), gi Preberite celoten dokument