Friday, October 28, 2016

Edrophonium Injection BP 10mg / 1ml (Cambridge Laboratories)






What you should know about Edrophonium Injection BP


This leaflet contains information about Edrophonium Injection BP, which is administered by a doctor or nurse as part of the test you are about to have done. Although you will not be taking this medicine yourself, this leaflet contains important information to help you understand how Edrophonium is used. If there is anything you do not understand, please ask a doctor or nurse.


This leaflet is written for the patient who is to have the test. If you are the parent of a child who is going to have the test, then of course the information should be read as applying to the child.





What does Edrophonium Injection BP contain?


Each ampoule contains 10mg of Edrophonium chloride (the active ingredient) together with some other ingredients which are as follows:


  • Sodium Citrate BP

  • Sodium Sulphite

  • Citric Acid BP

  • Water for Injections BP

Edrophonium Injection BP is supplied in packs of 10 ampoules, each ampoule coded with orange and emerald green colour rings contains 1ml.




What does Edrophonium Injection BP do?


Edrophonium is a diagnostic agent, which means that it is used in tests rather than as a treatment for a disease. The active ingredient of Edrophonium Injection BP is a drug which prevents the action of one of the body's enzymes. The enzyme (known as cholinesterase) destroys a substance (acetylcholine) which is involved with many bodily functions, including the contraction of muscle. By preventing the destruction of acetylcholine, Edrophonium helps the muscles to respond to nerve impulses which tell them to contract.


The holder of the product licence for this medicine is



Cambridge Laboratories Limited

Deltic House

Kingfisher Way

Silverlink Business Park

Wallsend

Tyne & Wear
NE28 9NX


The ampoules are made by



BCM Limited

1 Thane Road

Nottingham

NG2 3AA




What is Edrophonium Injection BP for?


Edrophonium is mainly used in a diagnostic test for the disease known as myasthenia gravis. This is a chronic disease in which the muscles are weak and tire easily because the nerve impulses are not transmitted properly to them.




Before taking your medicine



What should I tell the doctor before the test?


If you have had this test before and experienced an unpleasant reaction, please tell the doctor about this. If you have ever had a reaction to any of the ingredients, tell your doctor. As Edrophonium should not be given to patients with intestinal or urinary obstruction, please tell the doctor if you think you have had a blockage in your gut or in your waterworks.


Please also tell the doctor if you are taking any medication or if you have or have ever had any of the following conditions:


Asthma, any heart problems, low blood pressure, epilepsy, Parkinson's disease or a stomach ulcer.


Edrophonium may interact with certain anaesthetics and drugs used to produce muscle relaxation during surgery. If you are about to have an operation your anaesthetist will be aware of this and will treat you accordingly but please do not hesitate to ask him for further information.


WOMEN: Please let the doctor know if you are pregnant or breastfeeding. Although no harmful effects on the unborn or breast-fed child are known, the doctor may prefer to put off the test until after the baby has been born or weaned.





How is Edrophonium Injection BP used?


Edrophonium is given by injection into a vein or muscle. Sometimes part of the dose is given first and the remainder thirty seconds later. The effect of the injection on muscular strength depends upon the exact purpose of the test. The usual doses are as follows:


  • As a test for myasthenia gravis: 2mg into a vein followed if there has been no response by the remaining 8mg thirty seconds later. Alternatively, the whole 10mg may be injected into a muscle.




  • To tell whether your existing treatment is too weak or too strong: 2mg given one hour after the last dose of a medicine for myasthenia gravis.




  • For diagnosis of prolonged breathing difficulties after certain muscle relaxant drugs: 10mg injected into a vein.




  • To reverse the effects of muscle relaxant drugs: 0.5 - 0.7mg for each kilogram of bodyweight is usually given slowly into a vein, together with another drug called atropine.




  • Children's doses: For diagnostic tests the dose is usually 0.1mg for each kilogram of bodyweight, with one-fifth of the dose being given first and the remainder thirty seconds later if there has been no response. Children are given the same dose as adults for reversal of the effects of muscle relaxant drugs.

If you think you have been given too much medicine, tell your doctor. The likely signs of an overdose are a slow or irregular heartbeat, feeling faint, difficulty in breathing, perspiration, upset stomach and visual disturbances. If you would like any other information about the use of Edrophonium, please ask your doctor or nurse.




Side-effects


It is possible that you (or your child if he or she is having the test) may have nausea and vomiting, increased salivation, diarrhoea and abdominal pains.


If you think that Edrophonium has caused any other side-effect, please tell your doctor or nurse about it.


This medicine should not be used after the expiry date that is shown on the carton. Your doctor should have checked this.


Edrophonium Injection should be protected from light and kept out of the reach of children.


Date of preparation of this leaflet: May 2002







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