PATIENT INFORMATION LEAFLET

Fragmin® 2,500 IU/0.2 ml

Fragmin® 5,000 IU/0.2 ml
Pharmacia
dalteparin sodium

Solution for Injection

WHAT IS YOUR MEDICINE FOR?

Fragmin acts on substances present in the blood which cause clotting. Fragmin syringes are used to prevent blood clots forming after an operation or if you are bedridden due to illness.

BEFORE USING YOUR MEDICINE -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 have suffered from a stroke in the past three months.
• 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 have ever had an operation to insert artificial heart valves, (because it is uncertain how safe or effective Fragmin will be in this situation).
• 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 easily). 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 pregnant, or breast feeding and have an artificial heart valve, the usual dose might not be enough to prevent a blood clot, your doctor will discuss this with you.
• 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 YOUR MEDICINE 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 dose given depends on the risk of a clot forming and the type of operation you are having.

 

For patients who only have a moderate risk of developing a clot, the usual dose is 2,500 IU one to two hours before the operation, then 2,500 IU each morning. This is continued for five to seven days, or until you are fully able to move about.

Other patients may have a greater risk of developing a clot, for example those who have had clots in the past. For this type of patient, the usual dose is 2,500 IU one to two hours before the operation, the same dose 8 to 12 hours later, then 5,000 IU each morning. As an alternative, 5,000 IU may be given the evening before the operation, then 5,000 IU on following evenings. Your first dose (2500 IU) may also be given as soon as possible after your operation. Again, this is continued for five to seven days, or until you are able to move about.

After a hip operation, your doctor may decide to continue treating you with Fragmin for five weeks using a dose of 5,000 IU every evening. If you have an artificial heart valve, the normal dose for prevention of blood clots is not sufficient. Your doctor will discuss this with you.

The maximum dose in a 12 hour period is 10,000 IU.

If you are bedridden due to illness, the dose of Fragmin given will be 5,000 IU daily. The length of treatment will be up to 14 days, depending on your illness.

These are typical doses for adults, including elderly patients.

Fragmin is not suitable for children.

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

WHAT IF TOO MUCH IS GIVEN?

If too much Fragmin is given by mistake, tell your doctor immediately. Your doctor may want to give you an injection of protamine as an antidote.

WHEN SHOULD FRAGMIN NOT BE USED?

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

WHAT SIDE EFFECTS MIGHT HAPPEN WHILE YOU ARE USING YOUR MEDICINE?

• You may start bleeding, although this is rare when the normal doses are given.
• Certain substances produced by your liver may increase, but this has not been shown to cause you any harm.
• If you have an artificial heart valve, treatment with Fragmin might not be sufficient to prevent a blood clot, and you might develop a clot in the heart valve.
• 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 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
• In rare cases there may be a 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 syringes should not be stored above 25 °C and they should be used before the expiry date printed on the label.