Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
SUXAMETHONIUM CHLORIDE
Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland
M03AB01
SUXAMETHONIUM CHLORIDE 50 mg/ml
SOLUTION FOR INJECTION/INFUSION
SUXAMETHONIUM CHLORIDE 50 mg/ml
POM
MUSCLE RELAXANTS
Withdrawn
2006-09-18
1 PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER ANECTINE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION (SUXAMETHONIUM CHLORIDE) 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, pharmacist or nurse. • 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. IN THIS LEAFLET: 1. What Anectine is and what it is used for 2. What you need to know before you have Anectine 3. How to have Anectine 4. Possible side effects 5. How to store Anectine 6. Contents of the pack and other information 1. WHAT ANECTINE IS AND WHAT IT IS USED FOR Anectine contains a medicine called suxamethonium chloride. This belongs to a group of medicines called muscle relaxants. Anectine is used: • to relax muscles during operations on adults and children • to help insert a tube into the windpipe (endotracheal intubation), if a person needs help to breathe • to reduce how strongly your muscles contract Ask your doctor if you would like more explanation about this medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE ANECTINE DO NOT USE ANECTINE IF: • you are allergic to suxamethonium chloride or any of the other ingredients of Anectine injection (listed in section 6). • you or a family member have reacted badly to an anaesthetic before, such as a very high body temperature (malignant hyperthermia) or a long pause in breathing (prolonged apnoea). • you have severe liver or kidney problems. • you have had a major accident, operation or severe burns within the last three months. • you have not been able to move for a long time such as to allow a broken bone to mend or a long period of bed rest. • you have high levels of potassium in your blood (hyperkalaemia). • you have recently had an eye injury. • you suffer from a problem caused by too much pr Olvassa el a teljes dokumentumot
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Anectine 50mg/ml Solution for Injection or Infusion . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2ml ampoule contains 100mg Suxamethonium Chloride For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection or infusion . A clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC I NDICATIONS Anectine Injection is an ultra-short acting, depolarising, neuromuscular blocking agent. It is used in anaesthesia as a skeletal muscle relaxant to facilitate tracheal intubation and mechanical ventilation in surgical procedures. Anectine Injection is also used to reduce the intensity of muscular contractions associated with pharmacologically or electrically-induced convulsions. 4.2 POSOLOGY AND M ETHOD OF A DMINISTRATION _INSTRUCTIONS FOR USE _ The dose of Anectine Injection is dependent on age, body weight, the degree of muscle relaxation required and the route of administration. The usual method of Anectine Injection administration is by bolus intravenous injection. _USE BY INTRAVENOUS BOLUS INJECTION _ _Dosage in adults:_ A single intravenous dose of suxamethonium chloride dihydrate of approximately 1mg/kg bodyweight will usually provide profound neuromuscular blockade and good conditions for tracheal intubation within 30-60 seconds of its administration. The duration of clinically useful neuromuscular relaxation produced by this dose is on average 2-6 minutes, although wide inter-patient variability exists. Larger single doses of Anectine Injection may slightly accelerate the speed at which neuromuscular paralysis develops, and will produce longer durations of clinically useful muscle relaxation but not in a direct dose-dependent manner; doubling the dose of Anectine Injection does not necessarily double the duration of relaxation. Supplementary intravenous doses of Anectine Injection of 50-100% of the initial dose may be administered for the maintenance of muscle relaxation during short surgical or o Olvassa el a teljes dokumentumot