How does it work?

Fragmin injection contains the active ingredient dalteparin sodium, which is type of medicine called a low molecular weight heparin. It is used to stop blood clots forming within the blood vessels.

Blood clots normally only form to stop bleeding that has occurred as a result of injury to the tissues. The clotting process is complicated and begins when blood cells called platelets clump together and produce chemicals that activate the clotting process. The final part of this process involves a substance called thrombin being activated to produce a protein called fibrin. Fibrin binds the platelets together, forming a blood clot. This is the body’s natural way of repairing itself.

Sometimes, however, a blood clot can form abnormally within the blood vessels. This is known as a thrombus. It can be dangerous because the clot may detach and travel in the bloodstream, where it becomes known as an embolus. The embolus may eventually get lodged in a blood vessel, thereby blocking the blood supply to a vital organ such as the heart, brain or lungs. This is known as a thromboembolism.

Some people have an increased tendency for blood clots to form within the blood vessels. This is usually due to a disturbance in the blood flow within the blood vessels. For example, in coronary artery disease, fatty deposits (atherosclerosis) on the walls of the coronary arteries can disrupt the blood flow, giving a tendency for platelets to clump together and start off the clotting process. Unstable coronary artery disease means that a furred up bit of the arteryhas ruptured and a clot has formed on it, reducing the flow of blood tothe heart. This causes chest pain (angina) and can result in a heart attack.

Slow blood flow in the leg and pelvic veins can also result in clots forming (deep vein thrombosis). These clots can break off and travel to the lungs (pulmonary embolism). Being immobile for long periods of time, for example due to a severe medical condition or following surgery, can increase the risk of these types of blood clot.

Dalteparin is used to prevent and treat these types of abnormal blood clots. It works by inactivating thrombin in the clotting process described above. This stops the formation of fibrin, the essential component of blood clots.

What is it used for?

• Treatment and prevention of blood clots in the veins of the leg (deep vein thrombosis)
• Treatment and prevention of blood clots that travel to the lungs (pulmonary embolism)
• Treating blood clots in the coronary arteries in unstable angina and unstable coronary artery disease
• Preventing blood from clotting when it is filtered through an 'artificial kidney' (haemodialysis) machine as part of the management of kidney failure

Warning!

• This medicine should not be injected into a muscle (intramuscular injection).
• During treatment you should have regular blood tests to monitor the numbers of blood cells called platelets in your blood.

Use with caution in

• People who have had recent surgery, bleeding or major injury
• People currently taking anticoagulant tablets, eg warfarin, or antiplatelet tablets, eg dipyridamole
• Reduced platelet count in the blood (thrombocytopenia)
• Recent stroke caused by bleeding in the brain (haemorrhagic stroke)
• Severe liver failure
• Severe kidney failure
• Uncontrolled high blood pressure (hypertension)
• Eye disorder caused by diabetes (diabetic retinopathy) or high blood pressure (hypertensive retinopathy)
• Diabetes
• High levels of potassium in the blood (hyperkalaemia)
• Increase in the acidity of the blood (metabolic acidosis)
• People having spinal or epidural anaesthesia

Not to be used in

• People who have previously developed a reduced platelet count due to treatment with heparin or low molecular weight heparin (heparin-associated thrombocytopenia)
• People who are more prone to bleeding than normal, eg due to the blood clotting disorder haemophilia
• Bleeding in the brain (cerebral haemorrhage)
• Peptic ulcer
• Inflammation of the heart valves and sac surrounding the heart (endocarditis)
• People who have had recent injury or surgery to the brain, spinal cord, eyes or ears

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• There are no known harmful effects when this medicine is used during pregnancy.
• It is not known if this medicine passes into breast milk or is safe for use by women who are breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Bleeding
• Bruising (haematoma) at injection site
• Decrease in the number of platelets in the blood (thrombocytopenia)
• Increased amount of potassium in the blood (hyperkalaemia)
• Allergic skin reactions, such as rash, itching or hair loss
• An extreme allergic reaction (anaphylaxis)
• Blood clots in the spinal cord (intraspinal haematoma) in people also having spinal or epidural anaesthesia
• 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.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to ensure that the combination is safe.

There may be an increased anti-blood-clotting effect, which can result in an increased risk of bleeding or increased time taken to stop bleeding, if this medicine is used in combination with any of the following medicines:

• antiplatelet ('blood-thinning') medicines, such as aspirin, dipyridamole, clopidogrel
• clot-busting medicines (fibrinolytics) such as streptokinase, alteplase
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac, naproxen
• oral anticoagulants, such as warfarin, nicoumalone, phenindione
• probenecid.

Your doctor or pharmacist will adjust the doses of your medicines so that the appropriate effect on your blood clotting time is achieved.

There may be an increased risk of a rise in the amount of potassium in your blood if this medicine is used in combination with any of the following medicines:

• ACE inhibitors, eg captopril, lisinopril
• ciclosporin
• potassium-sparing diuretics, eg spironolactone, triamterene, amiloride
• potassium supplements
• potassium-containing salt substitutes.

The amount of potassium in your blood should be regularly monitored if you are taking any of these during treatment with this medicine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain dalteparin as the active ingredient.