Letro - Denk 2.5 Tablet, Film-coated 2.5 mg

Land: Tanzania

Språk: engelska

Källa: Tanzania Medicinces & Medical Devices Authority

Aktiva substanser:

Letrozole

Tillgänglig från:

Denk Pharma GmbH & Co. KG, GERMANY

ATC-kod:

Hormone antagonists and related agents?

INN (International namn):

Letrozole

Dos:

2.5 mg

Läkemedelsform:

Tablet, Film-coated

Tillverkad av:

HAUPT PHARMA MUNSTER GMBH, GERMANY

Produktsammanfattning:

Physical description: Yellow to dark yellow, round, biconvex, film coated tablets; Local technical representative: Talemwa Investment Consulting Co., Ltd (44520)

Bemyndigande status:

Registered/Compliant

Tillstånd datum:

2021-03-29

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Letrozole Denk 2.5
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: letrozole
Each film-coated tablet contains 2.5 mg letrozole.
Excipient with known effect:
Each tablet contains 61.5 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FROM
Film-coated tablet
Yellow to dark yellow, round, biconvex, film-coated, tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Adjuvant treatment of postmenopausal women with hormone receptor
positive invasive
early breast cancer.
•
Extended
adjuvant
treatment
of
hormone-dependent
invasive
breast
cancer
in
postmenopausal women who have received prior standard adjuvant
tamoxifen therapy for 5
years.
•
First-line treatment in postmenopausal women with hormone-dependent
advanced breast
cancer.
•
Advanced breast cancer after relapse or disease progression, in women
with natural or
artificially induced postmenopausal endocrine status, who have
previously been treated with
anti-oestrogens.
•
Neo-adjuvant treatment of postmenopausal women with hormone receptor
positive, HER-2
negative breast cancer where chemotherapy is not suitable and
immediate surgery not
indicated.
Efficacy has not been demonstrated in patients with hormone receptor
negative breast cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult and elderly patients_
The recommended dose of letrozole is 2.5 mg once daily. No dose
adjustment is required for
elderly patients.
In patients with advanced or metastatic breast cancer, treatment with
letrozole should continue
until tumour progression is evident.
2
In the adjuvant and extended adjuvant setting, treatment with
letrozole should continue for 5
years or until tumour relapse occurs, whichever is first.
In the adjuvant setting a sequential treatment schedule (letrozole 2
years followed by tamoxifen
3 years) could also be considered (see sections 4.4 and 5.1).
In the neoadjuvant setting, treatment with letrozole could b