What is Temozolomide Sun - temozolomide?
Temozolomide Sun is a medicine that contains the active substance temozolomide. It is available in capsule form (5, 20, 100, 140, 180 and 250 mg).
Temozolomide Sun is a 'generic medicine'. which means that Temozolomide Sun is similar to a 'reference medicine' already authorized in the European Union (EU) called Temodal.
What is Temozolomide Sun used for?
Temozolomide Sun is an anticancer medicine. It is indicated for the treatment of malignant gliomas (brain tumors) in the following patient groups:
adults with newly diagnosed glioblastoma multiforme (a type of aggressive brain tumor). Temozolomide Sun is used first in conjunction with radiotherapy and then alone;
adults and children from three years of age with a malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumor has reappeared or got worse after standard treatment. Temozolomide Sun is used alone in these patients.
The medicine can only be obtained with a prescription.
How is Temozolomide Sun used - temozolomide?
Treatment with Temozolomide Sun should be prescribed by a doctor who has experience in the treatment of brain tumors.
The dosage of Temozolomide Sun depends on the body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square meter, once a day. The dosage and number of doses depend on the type of tumor to be treated. treat, whether the patient has been previously treated, whether Temozolomide Sun is used alone or with other therapies, and the patient's response to treatment. Temozolomide Sun should be taken between meals.
Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sun. Temozolomide Sun should be used with caution in patients with severe liver or kidney problems.
For more information, see the Summary of Product Characteristics (included in the EPAR).
How does Temozolomide Sun work - temozolomide?
The active substance in Temozolomide Sun, temozolomide, belongs to a group of anticancer medicines called alkylating agents. In the body, temozolomide is converted into another compound called MTIC. MTIC binds to the DNA of cells during the reproductive phase, thereby blocking cell division. As a result, cancer cells cannot reproduce and tumor growth is slowed down.
How has Temozolomide Sun - temozolomide been studied?
Because Temozolomide Sun is a generic medicine, the patient studies have been limited to evidence to show that the medicine is bioequivalent to the reference medicine, Temodal. Two medicines are considered bioequivalent when they produce the same levels of the active substance in the body.
What are the benefits and risks associated with Temozolomide Sun - temozolomide?
Because Temozolomdie Sun is a generic medicine, bioequivalent to the reference medicine, the benefits and risks are taken to be the same as the reference medicine.
Why has Temozolomide Sun - temozolomide been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Temozolomide has been shown to have comparable quality and to be bioequivalent to the reference medicine. Therefore, it is the view of the CHMP that, as in the case of Temodal, the benefits outweigh the identified risks The Committee therefore recommended that Temozolomide Sun be given a Marketing Authorization.
Other information about Temozolomide Sun - temozolomide
The European Commission granted a "Marketing Authorization" for Temolozomide Sun, valid throughout the European Union on 13 July 2011. For more information on Temozolomide Sun therapy, please read the package leaflet (included with the EPAR) or consult your doctor or pharmacist.
The full EPAR version of the reference medicine can be found on the Agency's website.
Last update of this summary: 06-2011.
The information on Temozolomide Sun - temozolomide published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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