Friday, October 28, 2016

Protirelin Ampoules (Cambridge Laboratories)






What you should know about Protirelin Ampoules


This leaflet contains information about Protirelin Ampoules, which are 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 or giving it to your child yourself, this leaflet contains important information to help you understand how Protirelin 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 do Protirelin Ampoules contain?


Each ampoule contains 200micrograms of Protirelin (the active ingredient) together with some other ingredients which are as follows:


Mannitol Ph.Eur, Glacial Acetic Acid Ph.Eur, Water for Injections Ph.Eur


Protirelin Ampoules, coded with orange and black colour rings contain 2ml of a solution for injections. The solution contains 100micrograms of Protirelin per ml and is supplied in packs of 10 ampoules.


Protirelin is a diagnostic agent, which means that it is used in tests rather than as a treatment for a disease. The active ingredient of Protirelin Ampoules (Protirelin, also known as TRH) is a hormone which is produced by a part of the brain called the hypothalamus and acts on the pituitary gland which is situated very close to the hypothalamus. Protirelin causes the pituitary gland to release another hormone which in turn travels round in the blood stream and acts on another gland, the thyroid gland in the neck. The thyroid gland itself produces more hormones which help to control the body's metabolism - the chemical reactions that are going on inside us all the time.


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 Protirelin used for?


Protirelin is used mainly to assess the functioning of the pituitary and thyroid glands. The test using this medicine can help to identify certain medical conditions involving these glands or, if you are already receiving treatment for such a disorder, that the correct dose of medicine is being used. In particular, Protirelin is used to test for overactivity of the thyroid, including the condition known as Grave's disease which causes the eyeballs to protrude, underactivity of the thyroid gland, underactivity of the pituitary gland and diseases of the hypothalamus.




What should I tell the doctor before the test?


You should inform the doctor if you suffer from any of the following:


  • asthma

  • any other condition causing difficulty in breathing

  • heart disease

  • any disorder of the pituitary gland

You should also tell the doctor if you are taking any medication (either prescribed or bought 'over the counter'). A number of other medicines can interfere with the results of this test, in particular the following:


  • drugs which act on the thyroid gland

  • steroids

  • oestrogens (such as are present in some contraceptive pills)

  • theophylline (a drug for asthma)

  • levodopa and bromocriptine (for Parkinson's disease)

  • major tranquillisers of the phenothiazine group (such as chlorpromazine), used for mental disorders

  • metoclopramide (for nausea and vomiting)

  • aspirin

  • amiodarone (for disorders of the heart rhythm)

  • carbamazepine (for epilepsy)

  • lithium (for mental illness)

WOMEN: Please let the doctor know if you are pregnant. Although no harmful effects on the unborn child are known, the doctor may prefer to put off the test until after the baby has been born. If you are breastfeeding, you may notice extra swelling of the breasts and leaking of milk for up to three days after the test.




How are Protirelin Ampoules used?


Please ensure that you follow any instructions given by your doctor in preparation for the test (for example, not eating anything) carefully.


A blood sample will be taken first so that the amount of thyroid hormones in the blood can be measured. An injection of Protirelin will then be given into a vein (the normal adult dose is one ampoule or 200micrograms; a lower dose of 1microgram per kilogram of bodyweight is usually used in children) and another blood sample taken twenty minutes later. A further sample may be taken an hour after the injection if necessary.




Side-effects


It is unlikely that you (or your child if he or she is having this test) will experience any side-effects from the use of Protirelin. If any do occur, they should be mild and of short duration. The most likely are nausea, a desire to pass water, a feeling of flushing, slight dizziness, a brief rise in pulse rate and blood pressure and a peculiar taste.


If these do occur and you are concerned about them, or if you think that Protirelin 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.


All medicines should be kept out of the reach of children.


Date of preparation of this leaflet: October 2002







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