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PATIENT INFORMATION LEAFLET innohep
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5,000 anti-Factor Xa IU / 5 ml tinzaparin sodium
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This leaflet gives some helpful information about Innohep 5,000 anti-Factor Xa lU/5ml. Read the leaflet carefully. This medicine is usually administered by a member of the health care profession. If you are a patient and have questions about this leaflet, ask your doctor, nurse or pharmacist.
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What is Innohep?
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Innohep contains tinzaparin sodium (low molecular weight heparin), the active ingredient, in a sterile solution for injection. Each ampoule contains tinzaparin sodium 1,000 anti-Factor Xa IU in 1ml. Packs of 10 x 5ml ampoules are available.
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The inactive ingredients are: sodium citrate, sodium chloride, sodium metabisulphite and water for injections. The solution does not contain preservative.
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Who makes Innohep?
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It is made by Leo Pharmaceutical Products, Ballerup, Denmark. The Product Licence Holder is Leo Laboratories Limited, Longwick Road, Princes Risborough. Bucks. HP27 9RR.
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How does Innohep work?
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This product belongs to a group of medicines called anti-thrombotic agents which help to stop the blood from cloning in the blood vessels.
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What is Innohep used for?
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Your medicine is used to prevent blood clotting in the dialysis machine of patients with kidney problems who are receiving haemodialysis.
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Before Administration of Innohep
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Is Innohep right for you?
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You should not have this product if you have ever had an allergy or bad reaction to any medicine containing tinzaparin sodium or any other ingredient in Innohep.
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You should not have it if you have a tendency to bleed or if your blood pressure is difficult to control. You should also avoid Innohep if you have a stomach ulcer or an infection in the lining of your heart (Your doctor will tell you this.)
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Remember, if 1 or 2 applies to you, tell your Doctor or nurse.
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Do you have any other illnesses?
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Tell the doctor if you have:
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liver disease
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a history of asthma caused by sodium metabisulphite
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These may affect whether you are given this medicine. Speak to your doctor about these, before you are given Innohep.
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Innohep should not be injected into the muscle.
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What other medicines are you taking?
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Tell your Doctor if you are taking drugs which affect the cells in your blood. e.g. aspirin, vitamin K antagonists (warfarin) and dextran.
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Innohep does not appear to affect drugs used for kidney failure e.g. vitamin B and C supplements, calcium supplements, iron, folic acid, aluminium hydroxide, alfacalcidol, ranitidine, nifedipine, erythropoietin and azatidine.
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Always tell your doctor and pharmacist about all the other medicines you are taking, including the ones that you have bought yourself <CB n=2>
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Special Advice Children
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There is no experience of use in children. Therefore, it should not be used in children.
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Elderly
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The same dosage should be used as for Adults.
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Pregnancy
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Tell your doctor BEFORE you are given this product if you are pregnant, might be pregnant or you are breast feeding.
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What medical checks will you have?
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Most people receiving this medicine may have regular tests to check the level of tinzaparin sodium in their blood.
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If you have blood tests for other reasons, tell your Doctor or nurse that you are receiving Innohep. It could affect the results Do not miss appointments with your Doctor.
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Injecting Innohep
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It is usually administered by a health care professional either into the arterial side of the dialyser or intravenously.
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In adults with severe kidney disease, a bolus dose of 2,000 to 2,500 anti Factor Xa IU is given into the dialyser (or intravenously), for dialysis of up to 4 hours.
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For dialysis of more than 4 hours, a bolus dose of 2,500 anti Factor Xa IU is given into the dialyser (or intravenously) followed by 750 anti-Factor Xa lU/hour infused into the dialysis machine.
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The bolus dose may be adjusted until a satisfactory response is obtained.
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Additional Innohep may be given if blood transfusions are given during dialysis.
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The dose of this product may be monitored by laboratory tests.
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What if you are given too much Innohep?
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This may result in bleeding which can be reversed by giving an injection of protamine sulphate. This will usually be given by a health care professional.
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Does Innohep have side effects?
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Your medicine can sometimes have side effects but these are rare.
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The most serious is blood in your urine or bowel motions or bleeding from your nose which is due to a decrease of cells in your blood. Bleeding may occur when large doses are used. However, at the usual doses, this should not happen. Allergic reactions such as hot flushes, difficulty in breathing, skin itching and redness may also occur. Like other agents which stop the blood from clotting, it also increases the incidence of bleeding. Frequently there is an increase in an enzyme level in your blood (transaminase) but this does not usually mean that you have to stop your treatment.
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If you feel unwell or notice anything unusual or which you do not understand. tell your doctor as soon as possible.
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Remember, this treatment is for you. Only a doctor can prescribe it for you. Do not let other people use your medicine.
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Storing Innohep
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Innohep should be stored at room temperature (below 25°C) in a safe place out of the reach of children.
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Do not use after the expiry date given on the label.
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Date Leaflet Last Revised: November 1995
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  Registered Trade Mark
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