LETROZOL AMAROX 2.5MG FTA Amarox

6,71 20,13 

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Description

Method of administration and dosage

Adults and elderly patients. The recommended dose of letrozole is 2.5 mg once daily. In adjuvant and extended adjuvant therapy Letrozole-Teva treatment should be continued for 5 years or until relapse of the disease. In patients with metastases, letrozole therapy should be continued until signs of disease progression become evident.

In the adjuvant setting, sequential therapy (letrozole for 2 years followed by tamoxifen for 3 years) should also be considered.

In the neoadjuvant setting, letrozole therapy should be continued for 4-8 months to achieve optimal tumour reduction. If the response to treatment is insufficient, letrozole therapy should be discontinued and planned surgery should be scheduled and/or further treatment options should be discussed with the patient.

During the preoperative treatment period, regular monitoring of disease progression is recommended. No dose adjustment is required in elderly patients. Available data on patients with renal insufficiency with creatinine clearance <10 ml/min or severe hepatic dysfunction are insufficient. Patients with severe hepatic dysfunction (Child-Pugh class C) require close monitoring.

Patients with hepatic and/or renal impairment. In patients with mild to moderate hepatic impairment (Child-Pugh class A and B) or renal impairment (creatinine clearance ³ 10 ml/min) no dose adjustment is required

Additional information

substance active

letrozole

Amount of substance, mg

2.5

formulaire de discharge

compressed

1 compressed, mg

2.5

Plaquettes thermoformed by package, pieces

3

manufacturer

AMAROX PHARMA GmbH

volume de commande

1 blister of 10 compresses, 1 pack (3 blisters)

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