Orgaran

How does it work?

Danaparoid sodium is an anti-clotting (anticoagulant) medicine belonging to a class of medicines called heparinoids. Heparinoids are similar in structure to heparin, which is a commonly used and naturally occurring anti-clotting agent. Thrombin is a chemical substance, which plays an important role in the blood clotting process. Danaparoid acts by inactivating thrombin, and so preventing the formation of blood clots. Danaparoid is given by injection or infusion and is used to prevent the formation of blood clots following surgery. It is also used for the treatment of blood clotting disorders in individuals who cannot be given heparin due to a history of a reduction in the number of platelets in the blood caused by the use of heparin (heparin-induced thrombocytopenia).

What is it used for?

Prevention of blood clot formation in the veins after surgery

Treatment of blood clotting disorders (thromboembolic disorders) in individuals who develop or have a history of reduced platelet cells in the blood resulting from the use of heparin (Heparin Induced Thrombocytopenia)

Warning!

This medicine should not be injected into the muscle (intra-muscular injection)

This medicine contains sodium sulphite and should not be used in individuals who are allergic to sulphites (e.g. asthmatics).

Danaparoid has a lower potential of causing a reduction of platelets in the blood as compared to normal heparin. Even though the risk is small, it is advisable to check blood platelet levels regularly whilst using this medicine.

Use with caution in

Asthma

Individuals weighing over 90 kg. Monitoring is recommended.

Moderately decreased kidney function

Moderately reduced liver function

Peptic ulcers

Sensitisation to heparin

Stroke that is not associated with internal bleeding of the brain

Not to be used in

Active uncontrolled bleeding disorders

Allergy to sulphites

Bacterial infection of the heart valves and the lining surrounding the heart (bacterial endocarditis)

Bleeding in the brain (cerebral haemorrhage)

Blood clotting disorder (haemophilia)

Children

Diabetes affecting the eyes

Reduced platelets in the blood (thrombocytopenia) as a result of using danaparoid

Reduced platelets in the blood of unknown cause (idiopathic thrombocytopenia), unless the individual has reduced platelets caused by heparin use (heparin-induced thrombocytopenia) and no alternative treatment is available

Severe liver and renal function, unless there is a history of reduced platelets caused by heparin use (heparin induced thrombocytopenia)and no alternative treatment is available

Very high blood pressure

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.

The safety of this medicine during pregnancy and breastfeeding is not established. It is not recommended for use during pregnancy or breastfeeding. Consult your doctor for further advice.

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.

Allergy to active ingredients (hypersensitivity)

Alteration in results of liver function tests

Bleeding (haemorrhage)

Bruising or pain at injection site

Thinning of the bones (osteoporosis) with long term use

Decrease in the number of platelets in the blood (thrombocytopenia)

Localised collection of blood (usually clotted) due to a break in the blood vessel wall (haematoma)

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.

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