Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
ATROPINE SULFATE
Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland
A03BA01
ATROPINE SULFATE 600 µg/ml
SOLUTION FOR INJECTION
ATROPINE SULFATE 600 µg/ml
POM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Withdrawn
2006-08-31
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 pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. The name of your medicine is Atropine Sulphate 600 micrograms/ml Solution for Injection. It will be referred to as Atropine Sulphate Injection for ease hereafter. WHAT IS IN THIS LEAFLET: 1. What Atropine Sulphate Injection is and what it is used for 2. What you need to know before you are given Atropine Sulphate Injection 3. How you are given Atropine Sulphate Injection 4. Possible side effects 5. How to store Atropine Sulphate Injection 6. Contents of the pack and other information 1. WHAT ATROPINE SULPHATE INJECTION IS AND WHAT IT IS USED FOR Atropine Sulphate Injection contains the active substance Atropine Sulphate which belongs to a group of medicines called cholinesterase inhibitors. It has the effect of reversing the action of certain muscle-relaxing drugs. The effects of atropine include an increase in heart rate, a decrease in production of saliva, sweat, bronchial and intestinal secretions, and a decrease in the movements of the intestine. Atropine Sulphate Injection is used in the following conditions: • during anaesthesia to dry up secretions in the mouth and chest and to keep heart beat normal • in the treatment of poisoning caused by certain substances like pesticides • to reverse the effects of certain drugs given during surgery to relax muscles • to prevent slowing of the heartbeat during CPR (emergency procedure undertaken to revive the heart when it has suddenly stopped) • to reverse over activity of certain substances (cholinergic crises) Citiți documentul complet
Page 1 of 10 1 NAME OF THE MEDICINAL PRODUCT Atropine Sulphate 600 micrograms/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of solution contains 600 micrograms of Atropine Sulphate B.P. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Clear, colourless, sterile, aqueous solution intended for parenteral administration to human beings. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS 1) In anaesthesia, to reduce the risk of vagal inhibition of the heart and to reduce salivary and bronchial secretions. 2) In the treatment of cholinergic crisis of myasthenia gravis. 3) In conjunction with neostigmine used to reverse the effects of non-depolarising muscle relaxants. 4) In the treatment of poisoning by certain cholinesterase inhibitors e.g. organo- phosphorous compounds. 5) During cardiopulmonary resuscitation to counteract excessive vagal tone on the heart. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY 1) Use in Anaesthesia Adults (including older people) : The usual dose is 0.3 to 0.6mg (300 micrograms to 600 micrograms). _Paediatric population_: Premature Infants : 65 micrograms Page 2 of 10 Full-term Infants : 100 micrograms 6 months - 1 year : 200 micrograms Over one year : 10 - 20 micrograms/kg bodyweight 2) Treatment of cholinergic crisis of myasthenia gravis Adults : The usual dose is 0.4 to 2.0mg intravenously, which may be increased according to patients response. 3) In conjunction with neostigmine used to reverse the effects of non-depolarising muscle relaxants Adults : The usual dose is 0.6 to 1.2mg given by slow intravenous injection. Atropine should be administered before neostigmine. 4) Treatment of poisoning by certain cholinesterase inhibitors Adults : From 1.2mg, increased according to patients response. 5) Use during Cardiopulmonary Resuscitation Adults : A dose of 0.2 to 0.5mg may be given intravenously and repeated if necessary. Persistent bradycardia should be controlled by the insertion of a pacemaker as soon as possible. Method of Citiți documentul complet