Country: Malta
Language: English
Source: Medicines Authority
suxamethonium chloride 500 mg/ml
The Wellcome Foundation
M03AB01
suxamethonium chloride
solution for injection
Authorised
2006-05-29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ANECTINE ® 50 MG / ML INJECTION SUXAMETHONIUM CHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, nurse or member of the operating theatre staff. • If you get any side effects, talk to your doctor, nurse, or member of the operating theatre staff. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Anectine is and what it is used for 2. What you need to know before you are given Anectine 3. How Anectine is given 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 ARE GIVEN ANECTINE YOU SHOULD NOT BE GIVEN ANECTINE IF: • you are allergic to suxamethonium chloride, any other muscle relaxants or any of the other ingredients of Anectine Injection (listed in section 6) • you or your family have reacted badly to an anaesthetic before such as a very high body temperature (malignant hyperthermia) • you have had a majo Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. TRADE NAME OF THE MEDICINAL PRODUCT Anectine 50 mg/ml Injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Suxamethonium chloride Injection BP 100 mg in 2 ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Used in anaesthesia as a muscle relaxant to facilitate endotracheal intubation, mechanical ventilation and a wide range of surgical and obstetric procedures. It is also used to reduce the intensity of muscular contractions associated with pharmacologically or electrically-induced convulsions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Usually by bolus intravenous injection. _Adults:_ The dose is dependent on body weight, the degree of muscular relaxation required, the route of administration, and the response of individual patients. To achieve endotracheal intubation Anectine is usually administered intravenously in a dose of 1 mg/kg. This dose will usually produce muscular relaxation in about 30 to 60 seconds and has a duration of action of about 2 to 6 minutes. Larger doses will produce more prolonged muscular relaxation, but doubling the dose does not necessarily double the duration of relaxation. Supplementary doses of Anectine of 50% to 100% of the initial dose administered at 5 to 10 minute intervals will maintain muscle relaxation during short surgical procedures performed under general anaesthesia. Page 1 of 12 For prolonged surgical procedures Anectine may be given by intravenous infusion as a 0.1% to 0.2% solution, diluted in 5% glucose solution or sterile isotonic saline solution, at a rate of 2.5 to 4 mg per minute. The infusion rate Read the complete document