Teysuno 20 Mg

1. Medicinal Product Name
Teysuno 20 mg / 5.8 mg / 15.8 mg hard capsule

2. Qualitative and Quantitative Composition
Each hard capsule contains 20 mg of tefur, 5.8 mg of gemerasil and 15.8 mg of ocerasil (as monopassium).

Excellent to known effect

Each hard capsule contains 93.6 mg of lactose monohydrate.

For a complete list of excitements, see Section 6.1.

3. Pharmaceutical form Hard capsule (capsule). The capsule has an opaque white body and the opaque white cap in gray is inscribed "TC442".
4. Diagnostic Details
4.1 Medical indications
Tysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).

4.2 Psychology and method of administration
Teysuno should only be prescribed by a qualified physician experienced in treating cancer patients with anti-neoplastic medicinal products.

Posology

When administered in combination with cisplatin, the recommended standard dose of Tysuno is 25 mg / m2 (expressed as tegfur content) taken twice a day in the morning and evening for 21 days after 7 consecutive days of rest (1 treatment cycle). . This treatment cycle is repeated every 4 weeks.

Standard and low Teysuno and Cisplatin doses and calculations according to body surface area (BSA) for Teysuno supplements given in combination with cisplatin are provided in Table 1 and Table 2, respectively. The patient's BSA should be recalculated and adjusted accordingly if the patient's weight increases or decreases by ses10% from the one used for the previous calculation of the BSA and the change is clearly not related to fluid retention. is.

The recommended dose of cisplatin with this diet is 75 mg / m2 by intravenous infusion taken once every 4 weeks. Cisplatin should be discontinued after 6 cycles without Tysuno's withdrawal. If cisplatin is discontinued before 6 cycles, Tysuno treatment can be resumed when the criteria for resuming it are met.

Laboratory tests including hematology, liver function, renal function, and serum electrolytes should be closely monitored, often performed in patients treated with teisuno in combination with cisplatin. If progressive disease or intolerable toxicity is observed, treatment should be discontinued.

See the cisplatin summary of product characteristics (SmPC) for preinstruction hyperhydration.

Patients should be provided outpatient prescriptions for anti-emetic and anti-diarrheal medicinal products.

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