Land: Malta
Sprache: Englisch
Quelle: Malta Medicines Authority
MIVACURIUM
Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland
M03AC10
MIVACURIUM 2 mg/ml
SOLUTION FOR INJECTION
MIVACURIUM 2 mg/ml
POM
MUSCLE RELAXANTS
Authorised
2006-11-23
Package Leaflet: Information for the User MIVACRON 2 MG/ML SOLUTION FOR INJECTION mivacurium (as mivacurium chloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING 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 pharmacist. • If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Mivacron is and what it is used for 2. What you need to know before you have Mivacron 3. How to have Mivacron 4. Possible side effects 5. How to store Mivacron 6. Contents of the pack and other information 1. WHAT MIVACRON IS AND WHAT IT IS USED FOR Mivacron contains a medicine called mivacurium. This belongs to a group of medicines called muscle relaxants. Mivacron is used: • to relax muscles during operations on adults and children 2 months of age and over, including heart surgery • to help insert a tube into the windpipe (tracheal intubation), if a person needs help to breathe Ask your doctor if you would like more explanation about this medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE MIVACRON DO NOT HAVE MIVACRON IF: • you are allergic to mivacurium or any of the other ingredients in Mivacron (listed in Section 6) • you have been diagnosed as having a genetically determined abnormal cholinesterase • you or your family have reacted badly to an anaesthetic before Do not have Mivacron if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you have Mivacron. WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or pharmacist before having this medicine if: • you have muscle weakness, tiredness or difficulty in co-ordinating your movements (myasthenia gravis) or other form of neuromuscular disease • you have a burn which requires medical treatment • you have ever had an allergic reaction to any muscle rel Lesen Sie das vollständige Dokument
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mivacron 2mg/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2mg mivacurium (as mivacurium chloride) Each 5ml ampoule contains 10mg mivacurium. (As mivacurium chloride) Each 10ml ampoule contains 20mg mivacurium. (As mivacurium chloride) For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. (Short term: Injection) A clear, pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mivacron is a highly selective, short-acting, non-depolarising neuromuscular blocking agent with a fast recovery profile. Mivacron is indicated as an adjunct to general anaesthesia to relax skeletal muscles and to facilitate tracheal intubation and mechanical ventilation in adults, children and infants 2 months and over. This formulation contains no antimicrobial preservative and is intended for single patient use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Use by injection in adults:_ Mivacron is administered by intravenous injection. The mean dose required to produce 95% suppression of the adductor pollicis single twitch response to ulnar nerve stimulations (ED 95 ) is 0.07 mg/kg (range 0.06 to 0.09) in adults receiving narcotic anaesthesia. The following dose regimens are recommended for tracheal intubation:- i._ _ A dose of 0.2 mg/kg, administered over 30 seconds, produces good to excellent conditions for tracheal intubation within 2 to 2.5 minutes. ii._ _ A dose of 0.25 mg/kg administered as a divided dose (0.15 mg/kg followed 30 seconds later by 0.1 mg/kg), produces good to excellent conditions for tracheal intubation within 1.5 to 2.0 minutes of completion of administration of the first dose portion. The recommended bolus dose range for healthy adults is 0.07 to 0.25_ _mg/kg. The duration of neuromuscular blockade is related to the_ _dose. Doses of 0.07, 0.15, 0.20 Page 2 of 12 and 0.25 mg/kg produce clinically effective block for approximately 13, 16, 20 a Lesen Sie das vollständige Dokument