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This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.


Aspen

Aspen
12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland
Telephone: +44 1748 828 798
Medical Information Direct Line: 0080000404142 - Freephone
Medical Information e-mail: aspenglobal@professionalinformation.co.uk


Patient Information Leaflet last updated on medicines.ie: 01/06/2011
XPIL Imuran Injection

Table of Contents

  • Patient Information Leaflet
  • What is Imuran Powder for Injection or Infusion 50mg for?
  • Is it alright for me to have Imuran?
  • How is Imuran Powder for Injection or Infusion 50mg given?
  • Does Imuran Powder for Injection or Infusion 50mg have side effects?
  • Storing your Imuran Powder for Injection or Infusion 50mg
  • Further Information

Patient Information Leaflet

Imuran TM Powder for Solution for Injection or Infusion 50mg

(azathioprine)

Please read this carefully before you start to take your medicine.

Keep it safe, as you may want to read it again.

This leaflet contains important information about your Imuran Powder for Injection or Infusion 50mg. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.

What is in Imuran Powder for Injection or Infusion 50mg?

Imuran Powder of Injection or Infusion 50mg is a powder for solution for injection or infusion, it contains azathioprine sodium equivalent to 50mg of the active ingredient, azathioprine, as a freeze-dried powder. The product also contains sodium hydroxide.

Before injection, it is dissolved in sterile water.

Each 50mg vial contains approximately 4.5mg (0.2mmol) sodium.

This should be included in the daily allowance of patients on sodium restricted diets.

Imuran Powder for Injection or Infusion 50mg is packed in single vials.

Who makes Imuran Powder for Injection or Infusion 50mg?

Imuran Powder for Injection or Infusion 50mg is manufactured by

GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana 90
43056 San Polo di Torrile
Parma
Italy

The Product Authorisation is held by

Aspen Pharma Trading Limited
12/13 Exchange Place
I.F.S.C
Dublin 1
Ireland
Service-Tel:+800 00404142
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What is Imuran Powder for Injection or Infusion 50mg for?

Imuran belongs to a group of medicines called immunosuppressives.

This means that it reduces the strength of your immune system.

Immunosuppressive medicines are sometimes necessary to help your body accept an organ transplant, or to treat some diseases where your immune system is reacting against your own body (autoimmune diseases).

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Is it alright for me to have Imuran?

This medicine suits most people but there are a few people who should not take it. Ask yourself these questions to check whether Imuran is right for you:

  • Have you ever had an allergy (e.g. rash, itchness, shortness of breath) or bad reaction to Imuran, azathioprine or mercaptopurine ?
  • Are you pregnant or breast-feeding?
  • Are you planning to have a baby? This question is for both men and women. As Imuran can damage the foetus, adequate contraceptive precautions should be taken if either partner is taking Imuran. This is to prevent the possibility of a pregnancy during treatment.
  • Are you taking or likely to be taking any of the following medicines (Please check with your doctor if you are not sure):
    • allopurinol, oxipurinol or thiopurinol (used mainly to treat gout),
    • tubocurarine, succinylcholine (used mainly during surgical operations),
    • penicillamine (used mainly in the treatment of rheumatoid arthritis),
    • captopril, (use mainly to treat high blood pressure),
    • frusemide (used mainly to help reduce fluids),
    • warfarin (used to prevent blood clots),
    • cimetidine (used to treat stomach ulcers and indigestion),
    • indomethacin (used as a pain killer and anti-inflammatory),
    • cytostatic drugs (includes some antibiotics and also drugs used to treat various types of cancer),
    • olsalazine, mesalazine, sulphasalazine (mainly used in the treatment of ulcerative collitis).
  • Do you need, or are going to have, a vaccination while you are on Imuran Powder for Injection or Infusion 50mg?
  • Do you suffer from liver or kidney disease?
  • Do you have a rare hereditary condition, where you have too little of the natural body chemical thiopurine methyltransferase (TPMT) enzyme in your body? If you are unsure, ask your doctor.
  • Do you suffer from the condition known as Lesch-Nyhan Syndrome?
  • Have you ever suffered from chickenpox or shingles?

If you answer "YES" to any of these questions, tell your doctor.

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How is Imuran Powder for Injection or Infusion 50mg given?

The dosage is very variable and it may be changed from time to time by your doctor. The usual daily dosage of Imuran is from 1-5mg per kilogram bodyweight for adults and children. The usual dosage for elderly patients and those with liver or kidney disease should be at the lower end of the dosage range for adults.

Imuran Powder for Injection or Infusion may only be given intravenously (into a vein) as an injection or an infusion. Your doctor will discuss the best method of treatment for you.

While you are on Imuran, your doctor will want you to have a blood test from time to time to check the blood count and to adjust the dosage if necessary.

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Does Imuran Powder for Injection or Infusion 50mg have side effects?

This medicine may cause side effects in some people. Some people can be allergic to medicines. If you have any of the following symptoms soon after receiving Imuran STOP taking this medicine and tell your doctor immediately or go to the nearest casualty (accident and emergency department).

  • You develop bad diarrhoea and/or abdominal pain
  • You develop jaundice (skin or whites of the eyes turn yellow)
  • You develop muscle and bone pain
  • You develop kidney problems
  • You start feeling faint especially on standing up
  • You develop a serious skin reaction (e.g. blistering and/or peeling).

Patients taking immunosuppressive medicines may have an increased risk of developing tumors including skin cancer. Therefore while receiving Imuran treatment you should avoid too much exposure to sunlight. You are advised to wear protective clothing and to use sunscreen with a high protection factor. Infection with chickenpox or shingles can become severe in patients taking immunosuppressive medicine. Therefore you should avoid contact with anyone suffering from chickenpox or shingles.

Tell your doctor immediately if any of the following happen to your while you are taking Imuran.

  • You start to notice any signs of a fever or an infection.
  • You have any unexpected bruising or bleeding.
  • If you develop any new marks on your skin or any change to marks that you may have had previously.
  • You develop a cough or difficulty breathing similar to a chest infection.
  • You have nausea and vomiting.
  • You feel tired, dizzy or generally unwell.
  • You come into contact with anyone who is suffering from chickenpox or shingles.

You may notice some hair loss while taking Imuran. Often hair does grow again, even if you carry on taking Imuran. If you are worried ask your doctor.

Tell your pharmacist or doctor if you notice any other side effects from your medicine which are not mentioned here.

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Storing your Imuran Powder for Injection or Infusion 50mg

  • Do not store above 25°C and Keep the vial in the outer carton. Keep out of the reach and sight of children.
  • The doctor or nurse will make sure that this medicine is not used after the expiry date shown on the vial or carton.

Remember

This medicine is for YOU. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

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Further Information

This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who has the information you need and will advise you.

You may need to read this leaflet again. Please do not throw it away until you have finished your medicine.

The information in this leaflet applies only to Imuran Powder for Injection or Infusion 50mg.

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Date of last revision: January 2011.

Imuran is a registered trademark of Aspen.

All rights reserved.

10000000094411



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Active Ingredients

 
   azathioprine sodium

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