What is Nordimet and Metrotressato used for?
Nordimet is a medicine used to treat the inflammatory conditions described below:
- active rheumatoid arthritis, a disease that involves inflammation of the joints;
- juvenile idiopathic arthritis (JIA) in severe form, a joint pathology in children in the event of an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs);
- crippling psoriasis in severe form, a disease that causes reddish and scaly foci when there is no adequate response to other forms of therapy;
- Severe psoriatic arthritis, a joint inflammation that occurs in psoriasis patients.
Nordimet is a "hybrid" medicine. This means that it is similar to a "reference medicine" (in this case Lantarel FS) containing the same active ingredient (methotrexate). The difference between Nordimet and Lantarel FS is that Nordimet is available in a greater number of dosages.
How is Nordimet - Metrotressato used?
Nordimet is available as a solution in different dosages and should be administered by subcutaneous injection once a week, on the same day. The dose depends on the condition being treated, from the patient's response to treatment and, in the case of children, from the body surface. In most cases, Nordimet is used in long-term treatment.
Incorrect dose or timing of injections can cause serious side effects. Nordimet should only be prescribed by doctors experienced in the use of methotrexate and who are well aware of the mechanism of action. The medicine can only be obtained with a prescription.
For more information on how to use Nordimet, see the package leaflet.
How does Nordimet - Metrotressato work?
The active ingredient in Nordimet, the methotrexate, prevents the cells from growing too quickly by interfering with the production of DNA. The reason why this action is good for patients with arthritis and psoriasis is not entirely known, however it is believed that the benefits of methotrexate are due to its ability to reduce inflammation and suppress the function of an overactive immune system
What benefits has Nordimet - Metrotressato shown during the studies?
The company presented data on Nordimet taken from the scientific literature. No further studies were needed because Nordimet is a hybrid medicine given by injection and contains the same active ingredient as the reference medicine, Lantarel FS.
Since Nordimet has the same composition as the reference medicine, Lantarel FS, its benefits and risks are considered to be the same as those of Lantarel FS.
What are the risks associated with Nordimet - Metrotressato?
Since Nordimet has the same composition as the reference medicine, Lantarel FS, its benefits and risks are considered to be the same as those of Lantarel FS.
Why has Nordimet - Metrotressato been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Nordimet has been shown to have qualities comparable to the reference medicine. Therefore, the CHMP considered that, as in the case of the reference medicine, the benefits outweighed the identified risks and recommended approving the use of Nordimet in the EU.
What measures are being taken to ensure the safe and effective use of Nordimet - Metrotressato?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nordimet have been included in the summary of product characteristics and the package leaflet.
More information on Nordimet - Metrotressato
For the full version of Nordimet EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Nordimet therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
