MYLAN-TAMOXIFEN TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

TAMOXIFEN (TAMOXIFEN CITRATE)

Mevcut itibaren:

MYLAN PHARMACEUTICALS ULC

ATC kodu:

L02BA01

INN (International Adı):

TAMOXIFEN

Doz:

10MG

Farmasötik formu:

TABLET

Kompozisyon:

TAMOXIFEN (TAMOXIFEN CITRATE) 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

10/30/60/250

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0131293001; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2017-01-09

Ürün özellikleri

PRODUCT MONOGRAPH
PR
MYLAN-TAMOXIFEN
Tamoxifen Citrate Tablets, BP
10 MG AND 20 MG TAMOXIFEN (AS TAMOXIFEN CITRATE)
Antineoplastic Agent
MYLAN PHARMACEUTICALS ULC
Date of Revision:
85 Advance Road
February 6, 2014
Etobicoke, Ontario
M8Z 2S6
Control No.: 171511
2
NAME OF DRUG
PR
MYLAN-TAMOXIFEN
(Tamoxifen Citrate Tablets, BP)
10 mg and 20 mg tamoxifen (as tamoxifen citrate)
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent (non-steroidal antiestrogen)
TAMOXIFEN CITRATE THERAPY WAS ASSOCIATED WITH SERIOUS AND
LIFE-THREATENING EVENTS
INCLUDING UTERINE MALIGNANCIES, STROKE, PULMONARY EMBOLISM, AND DEEP
VEIN THROMBOSIS
IN THE NSABP P-1 TRIAL FOR THE PREVENTION OF BREAST CANCER. THE USE OF
TAMOXIFEN CITRATE
FOR BREAST CANCER PREVENTION IS NOT AN APPROVED INDICATION IN CANADA.
IN THE NSABP P-1
TRIAL, THE RELATIVE RISK OF TAMOXIFEN CITRATE COMPARED TO PLACEBO WAS
3.1 FOR ENDOMETRIAL
CANCER, 4.0 FOR UTERINE SARCOMAS, 1.6 FOR STROKE, 3.0 FOR PULMONARY
EMBOLISM, AND 1.6 FOR
DEEP VEIN THROMBOSIS. THESE EVENTS WERE FATAL IN SOME PATIENTS. HEALTH
CARE PROVIDERS
SHOULD BE AWARE OF THE POSSIBLE RISKS ASSOCIATED WITH TAMOXIFEN
CITRATE THERAPY AND
SHOULD DISCUSS THEM WITH THEIR PATIENTS.
THE BENEFITS OF TAMOXIFEN CITRATE THERAPY OUTWEIGH THE RISKS
IN
THE
MAJORITY
OF
WOMEN
BEING
TREATED
ACCORDING
TO
THE
APPROVED CANADIAN INDICATION FOR THE TREATMENT OF BREAST
CANCER.
ACTIONS AND CLINICAL PHARMACOLOGY
Tamoxifen citrate, the active ingredient, is a non-steroidal agent
which has demonstrated potent
antiestrogenic properties in animal test systems. The antiestrogenic
effects are related to its ability
to compete with estrogen for binding sites in target tissues such as
breast and uterus. Tamoxifen
citrate inhibits the induction of rat mammary carcinoma induced by
dimethylbenzanthracene
(DMBA) and causes the regression of already established DMBA-induced
tumours. In this rat
model, tamoxifen citrate appears to exert its antitumour effects by
binding to estrogen receptors.
In cytosols derived from human endometrium and human breast and
ute