TAMOFEN 20 TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TAMOXIFEN (TAMOXIFEN CITRATE)

Disponibil de la:

SANOFI-AVENTIS CANADA INC

Codul ATC:

L02BA01

INN (nume internaţional):

TAMOXIFEN

Dozare:

20MG

Forma farmaceutică:

TABLET

Compoziție:

TAMOXIFEN (TAMOXIFEN CITRATE) 20MG

Calea de administrare:

ORAL

Unități în pachet:

30/60

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0131293002; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2011-01-14

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
TAMOFEN
®
(Tamoxifen Citrate)
10 and 20 mg Tablets
Antineoplastic
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
May 31, 2006
Laval, Quebec H7L 4A8
Submission Control No. 106131
s-a Version 1.0 dated
2
NAME OF DRUG
TAMOFEN
®
tamoxifen citrate tablets 10 mg and 20 mg
THERAPEUTIC CLASSIFICATION
Antineoplastic (non-steroidal antiestrogen)
T
AMOXIFEN THERAPY WAS ASSOCIATED WITH SERIOUS AND LIFE
-
THREATENING EVENTS INCLUDING UTERINE
MALIGNANCIES
,
STROKE
,
PULMONARY EMBOLISM
,
AND DEEP VEIN THROMBOSIS IN THE
N
ATIONAL
S
URGICAL
A
DJUVANT
B
REAST AND
B
OWEL
P
ROJECT
(NSABP)
P-1
BREAST CANCER PREVENTION TRIAL
.
T
HE USE OF
TAMOXIFEN FOR BREAST CANCER PREVENTION IS NOT AN APPROVED INDICATION
IN
C
ANADA
.
T
HE
FOLLOWING RISKS ASSOCIATED WITH TAMOXIFEN THERAPY HAVE BEEN ESTIMATED
FROM THE
NSABP
P-1
BREAST CANCER PREVENTION TRIAL
.
T
HE RELATIVE RISK OF TAMOXIFEN 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
.
T
HESE EVENTS WERE FATAL IN SOME PATIENTS
.
H
EALTH
CARE PROVIDERS SHOULD BE AWARE OF THE POSSIBLE RISKS ASSOCIATED WITH
TAMOXIFEN THERAPY AND
SHOULD DISCUSS THEM WITH THEIR PATIENTS
.
T
HE BENEFITS OF TAMOXIFEN THERAPY OUTWEIGH THE RISKS IN THE MAJORITY OF
WOMEN BEING TREATED
ACCORDING TO THE APPROVED
C
ANADIAN INDICATION FOR THE TREATMENT OF BREAST CANCER
(see
WARNINGS
).
ACTIONS AND CLINICAL PHARMACOLOGY
Tamoxifen is a nonsteroidal agent which has demonstrated potent
antiestrogenic properties in
animal test systems. The antiestrogenic effects are related to is
ability to compete with estrogen
for binding sites in target tissues such as breast and uterus.
Tamoxifen inhibits the induction of rat
mammary carcinoma induced by dimethylbenzanthracene (DMBA) and causes
the regression of
already established DMBA-induced tumors. In this rat model tamoxifen
appears to exert its
antitumor effects by binding to estrogen receptors.
In cytosols derived from human endo