PATIENT INFORMATION LEAFLET

tinzaparin sodium

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.

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.

The inactive ingredients are: sodium citrate, sodium chloride, sodium metabisulphite and water for injections. The solution does not contain preservative.

It is made by Leo Pharmaceutical Products, Ballerup, Denmark. The Product Licence Holder is Leo Laboratories Limited, Longwick Road, Princes Risborough. Bucks. HP27 9RR.

This product belongs to a group of medicines called anti-thrombotic agents which help to stop the blood from cloning in the blood vessels.

Your medicine is used to prevent blood clotting in the dialysis machine of patients with kidney problems who are receiving haemodialysis.

1. 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.
1. 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.)

Remember, if 1 or 2 applies to you, tell your Doctor or nurse.

Tell the doctor if you have:

• liver disease
• a history of asthma caused by sodium metabisulphite

These may affect whether you are given this medicine. Speak to your doctor about these, before you are given Innohep.

Innohep should not be injected into the muscle.

Tell your Doctor if you are taking drugs which affect the cells in your blood. e.g. aspirin, vitamin K antagonists (warfarin) and dextran.

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.

The same dosage should be used as for Adults.

Tell your doctor BEFORE you are given this product if you are pregnant, might be pregnant or you are breast feeding.

Most people receiving this medicine may have regular tests to check the level of tinzaparin sodium in their blood.

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.

It is usually administered by a health care professional either into the arterial side of the dialyser or intravenously.

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.

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.

The bolus dose may be adjusted until a satisfactory response is obtained.

Additional Innohep may be given if blood transfusions are given during dialysis.

The dose of this product may be monitored by laboratory tests.

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.

Your medicine can sometimes have side effects but these are rare.

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.

Innohep should be stored at room temperature (below 25°C) in a safe place out of the reach of children.

Do not use after the expiry date given on the label.