País: Malta
Idioma: anglès
Font: Medicines Authority
ATRACURIUM BESILATE
Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland
M03AC04
ATRACURIUM BESILATE 10 mg/ml
SOLUTION FOR INJECTION/INFUSION
ATRACURIUM BESILATE 10 mg/ml
POM
MUSCLE RELAXANTS
Authorised
2005-11-25
Package leaflet: Information for the patient TRACRIUM 10 MG/ML SOLUTION FOR INJECTION OR INFUSION ATRACURIUM BESILATE 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, 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. WHAT IS IN THIS LEAFLET: 1. What Tracrium is and what it is used for 2. What you need to know before you use Tracrium 3. How to use Tracrium 4. Possible side effects 5. How to store Tracrium 6. Contents of the pack and other information 1. WHAT TRACRIUM IS AND WHAT IT IS USED FOR Tracrium contains a medicine called atracurium besilate. This belongs to a group of medicines called muscle relaxants. Tracrium is used: • to relax muscles during operations on adults and children over 1 month of age • 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 USE TRACRIUM DO NOT USE TRACRIUM IF: • you are allergic to atracurium besilate, cisatracurium (another muscle relaxant) or any of the other ingredients in Tracrium (listed in Section 6) • you have reacted badly to an anaesthetic before. Do not use Tracrium if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you use Tracrium. WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or pharmacist before using this medicine if: • you are allergic to any other muscle relaxant • you have muscle weakness, tiredness or difficulty in co-ordinating your movements (myasthenia gravis) • you have a neuromuscular disease, such as a muscle wasting disease, paralysis, motor neurone disease or cerebral palsy • you have a severe electrolyte imbalance • yo Llegiu el document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tracrium 10 mg/ml, Solution for Injection or Infusion, ampoules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 10 mg of atracurium besilate. _ _ Each 2.5 ml ampoule contains 25 mg of atracurium besilate. Each 5 ml ampoule contains 50 mg of atracurium besilate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion. A clear, colorless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tracrium is a highly selective, competitive or non-depolarising neuromuscular blocking agent, which is used as an adjunct to general anaesthesia to enable tracheal intubation to be performed and to relax skeletal muscles during surgery or controlled ventilation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Injection: _ Tracrium is administered by intravenous injection.The dosage range for adults is 0.3 to 0.6 mg/kg (depending on the duration of full block required) and will provide adequate relaxation for 15 to 35 minutes. Endotracheal intubation can usually be accomplished within 90 seconds from the intravenous injection of 0.5 to 0.6 mg/kg. Full block can be prolonged with supplementary doses of 0.1 to 0.2 mg/kg as required. Successive supplementary dosing does not give rise to accumulation of neuromuscular blocking effect. _Caesarean Section_ : Tracrium is suitable for maintenance of muscle relaxation during Caesarean section as it does not cross the placenta in clinically significant amounts following recommended doses (0.3-0.6 mg/kg). Spontaneous recovery from the end of full block occurs in about 35 minutes as measured by the restoration of the tetanic response to 95% of normal neuromuscular function. 2 The neuromuscular block produced by Tracrium can be rapidly reversed by standard doses of anticholinesterase agents, such as neostigmine and edrophonium, accompanied or preceded by atropine, with no evidence of recurarisation. _Continuous infusion_ : Normothermia: Af Llegiu el document complet