What is Thorinane - Enoxaparin sodium used for and what is it used for?
Thorinane is an anticoagulant (a medicine to prevent blood clots). It is used in adults for:
- the prevention of venous thromboembolism (clots that form inside the veins obstructing blood circulation), particularly in patients undergoing surgery or who are at greater risk of developing clots because they are bedridden because of an illness;
- the treatment of conditions associated with blood clots such as deep vein thrombosis (where the clot forms in a deep vein, usually in the leg);
- the treatment of unstable angina (a type of severe chest pain caused by a problematic flow of blood to the heart);
- the treatment of certain types of myocardial infarction (heart attack);
- prevention of clot formation when blood is circulated through a hemodialysis machine to remove toxic substances.
In the treatment of unstable angina and heart attacks Thorinane is given in combination with aspirin (acetylsalicylic acid).
The active substance in Thorinane is enoxaparin sodium.
Thorinane is a "biosimilar medicine". This means that it is very similar to a biological medicine (the "reference medicine") that is already authorized in the European Union (EU). The reference medicine for Thorinane is Clexane. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Thorinane - Enoxaparin sodium used?
Thorinane is available as a solution for injection in pre-filled syringes. It is usually given as a subcutaneous injection; however, in the treatment of a type of heart attack called acute myocardial infarction with ST segment elevation (STEMI) is first administered as an injection into a vein and, to prevent clots in hemodialysis machines, is injected directly into the tube where blood passes. The dose and duration of treatment, as well as its possible administration in combination with other medicines, depend on the condition to be prevented or treated. Dose adjustment is necessary in patients with severely reduced kidney function.
The medicine can only be obtained with a prescription. For more information, see the package leaflet.
How does Thorinane - Enoxaparin sodium work?
The formation of blood clots inside the blood vessels can reduce the blood supply to the organs, including the heart. The active substance in Thorinane, enoxaparin, belongs to a group of anticoagulant medicines called "low molecular weight heparins." Enoxaparin enhances the effect of antithrombin III, a natural substance that controls blood clotting factors helping to prevent blood clotting. coagulation inside the body This helps to stop the formation of new clots and to control the existing ones.
What benefit has Thorinane - Enoxaparin sodium shown during the studies?
Large-scale laboratory studies that compared Thorinane and Clexane have shown that Thorinane is very similar to Clexane in terms of structure, purity and biological activity.
Furthermore, a study of 20 healthy subjects showed that the same doses of these two drugs given by subcutaneous injection produced similar effects on blood clotting factors. The study made use of different measurement methods, corresponding to the way the medicine works in the body.
The company also presented data derived from published studies that highlight the benefits of enoxaparin in the prevention and treatment of blood clots.
What are the risks associated with Thorinane - Enoxaparin sodium?
The most common side effect of Thorinane (which may affect more than 1 in 10 people) is bleeding (bleeding): severe bleeding occurred in about 4 out of 100 people who were given Thorinane to prevent the formation of blood clots during surgery. Furthermore, it is very common (with more than 1 in 10 people) to increase the levels of liver enzymes in the blood (a sign of possible liver problems).
For the full list of all side effects reported with Thorinane, see the package leaflet.
Thorinane should not be used in patients with major prior bleeding, severe bleeding problems, or diseases that increase the risk of or resulting in bleeding, such as stomach ulcers or strokes. For the full list of limitations, see the package leaflet
Why has Thorinane - Enoxaparin sodium been approved?
Studies have shown that Thorinane has a biological structure and activity very similar to Clexane and has the same effect on blood clotting factors. The safety profiles of the two medicines were also considered similar, based on laboratory tests.
Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically significant differences between Thorinane and Clexane in terms of efficacy and safety and that, as with Clexane, the benefits outweigh the identified risks. The Committee therefore recommended that Thorinane be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Thorinane - Enoxaparin sodium?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thorinane have been included in the summary of product characteristics and the package leaflet.
More information on Thorinane - Enoxaparin sodium
For the full EPAR for Thorinane, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Thorinane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
