Patient Information Leaflet

Fragmin Graduated Syringe

10,000 IU/ml Solution for Injection

PHARMACIA

dalteparin sodium

WHAT YOU SHOULD KNOW ABOUT FRAGMIN GRADUATED SYRINGES

Please read this carefully before you use your medicine. This leaflet provides useful information for you on your medicine. If you have any questions or are not sure about anything, please ask your doctor or pharmacist.

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

WHAT IS IN FRAGMIN GRADUATED SYRINGES?

The active ingredient in Fragmin Graduated Syringes is dalteparin sodium. Each syringe contains 10,000 IU (units) of dalteparin sodium as a sterile solution for injection.

The syringes also contain Water for Injections Ph. Eur., sodium chloride Ph. Eur. and either sodium hydroxide or hydrochloric acid (to balance the acidity of the injection). Each box contains 5 syringes.

HOW DOES FRAGMIN WORK?

Fragmin acts on substances present in the blood which cause clotting.

WHAT ARE FRAGMIN GRADUATED SYRINGES FOR?

The low molecular weight heparin in these syringes given concurrently with aspirin are used to treat a condition known as unstable angina and non-Q wave myocardial infarction (unstable coronary artery disease).

In coronary artery disease, the coronary arteries (blood vessels to the heart) are furred up and narrowed by patches of fatty deposits.

Unstable coronary artery disease means that a furred up bit of the artery has ruptured and a clot has formed on it, reducing the flow of blood to the heart. Patients with this condition may be more likely to go on to have a heart attack without treatment with blood thinning drugs such as Fragmin.

BEFORE USING FRAGMIN -TELL YOUR DOCTOR

• If you have had an allergic reaction after being given Fragmin (or a similar product) in the past.
• If you have a stomach ulcer.
• If you have suffered from a brain haemorrhage (bleeding).
• If you suffer from any condition which may cause you to bleed more easily. Ask your doctor if you are unsure.
• If you have a condition called endocarditis (an inflammation of the lining of the heart and heart valves.) Your doctor will have told you if you have this.
• If you are taking any other medicines. Certain medicines may increase the effect of Fragmin e.g. aspirin*, dipyridamole and warfarin (used to thin your blood), anti inflammatories such as indomethacin, some medicines for gout, ethacrynic acid (a medicine known as a diuretic which increases the amount of urine produced), dextrans (solutions given to increase the blood volume), and medicines known as cytostatics (used in cancer treatment). Other medicines may make Fragmin less effective, e.g. antihistamines (often used for allergies or hay fever), the heart drugs digoxin or digitoxin, antibiotics known as tetracyclines, and vitamin C.
• If you have an injury to, or are about to have an operation involving your spine, head, eyes or ears.
• If you are suffering from thrombocytopenia (a condition where there are fewer clotting cells known as platelets in the blood, causing you to bruise and bleed more easlily). Your doctor will have told you if you have this.
• If you have problems with your liver you may need a smaller dose.
• If you are breast feeding.
• If you have diabetes, kidney disease or have been told that you have a lot of potassium in your blood.
• If you are receiving Fragmin for the prevention of blood clots and you have to have a spinal or epidural anaesthetic as special care may be needed.

HOW IS FRAGMIN GIVEN?

Fragmin is given as a subcutaneous injection, which means it is injected beneath the skin. It is usually injected into a skin fold in your abdomen (stomach), or the upper part of your thigh.

The usual dose used to treat unstable coronary artery disease is 120 IU (units) for every kilogram you weigh, given every 12 hours.

 

Doses are usually given for between 5 and 8 days.The maximum dose in a 12 hour period is 10,000 IU.

Extended use

If your doctor has recommended a special procedure to restore the blood supply to your heart (angiography or coronary artery surgery), it may be necessary to continue to administer Fragmin for up to 45 days.

In this case, the dose should be either 5,000 IU (women < 80 kg and men < 70 kg) or 7,500 IU (women ≥ 80 kg and men ≥ 70 kg) 12 hourly.

These are typical doses for adults, including elderly patients. Fragmin is not suitable for children.

Your doctor will work out the right dose for you. Some of the liquid in the syringe may have to be expelled before the injection is given.

Medical staff may take blood samples during your treatment to monitor the effects of Fragmin.

WHAT SIDE EFFECTS MIGHT HAPPEN WHILE YOU ARE USING FRAGMIN?

You may start bleeding, although this is rare when the normal doses are given.

Liver enzymes produced by the liver may increase, but this has not been shown to cause you any harm.

Special care is needed (make sure your doctor knows) if you are receiving Fragmin for the prevention of blood clots and you have to have a spinal or epidural anaesthetic.

You may develop a bruise where you have been injected. Very rarely, when Fragmin is used at the same time as spinal anaesthesia or puncture, bruising of the spine may occur. Tell your doctor or nurse IMMEDIATELY, if you notice any of the following symptoms so this can be treated:

• back pain
• tingling, numbness or weakness in the legs
• bowel or bladder problems

If you are receiving Fragmin to treat blood clots, you should not have a spinal or epidural anaesthetic.

In rare cases there may be a immunological medicated decrease in the number of clotting cells (platelets) in your blood.

Allergic reactions can occur rarely (some patients have reported slight hair loss, rashes or itching). Severe allergic reactions have only occurred in a few cases.

Osteoporosis (a reduction in bone density leading to bones which may fracture easily) has occurred after long term treatment with a similar medicine called heparin. It is possible that this could happen with Fragmin.

Medicines like Fragmin can rarely cause temporary muscle weakness, loss of feeling or changes in your heartbeat. It is important to tell the medical staff looking after you if you notice any of these changes.

If you suffer from any unwanted effects whilst using your medicine, please tell your doctor or pharmacist.

STORING YOUR MEDICINE

Fragmin Graduated Syringes should not be stored above 25°C and should be used before the expiry date printed on the label.