NOLVADEX TAB 10MG TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

TAMOXIFEN (TAMOXIFEN CITRATE)

Saadav alates:

ASTRAZENECA CANADA INC

ATC kood:

L02BA01

INN (Rahvusvaheline Nimetus):

TAMOXIFEN

Annus:

10MG

Ravimvorm:

TABLET

Koostis:

TAMOXIFEN (TAMOXIFEN CITRATE) 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

60

Retsepti tüüp:

Prescription

Terapeutiline ala:

ANTINEOPLASTIC AGENTS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2003-04-01

Toote omadused

PRODUCT
MONOGRAPH
NOLVADEX
®
(tamoxifen citrate)
Tablets 10 mg
NOLVADEX
®
-
D
(tamoxifen citrate)
Tablets 20 mg
Antineoplastic Agent
AstraZeneca Canada Inc.
DATE OF PREPARATION:
1004 Middlegate Road
May 2, 2000
Mississauga, Ontario
L4Y 1M4
DATE OF REVISION:
August 25, 2003
Control # 079989
NOLVADEX
®
is a trademark, the property of the AstraZeneca group.
PRODUCT
MONOGRAPH
NAME
OF
DRUG
NOLVADEX
®
(tamoxifen citrate)
Tablets 10 mg
NOLVADEX
®
-
D
(tamoxifen citrate)
Tablets 20 mg
THERAPEUTIC
CLASSIFICATION
Antineoplastic Agent (non-steroidal antiestrogen)
- 2 -
NOLVADEX 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 NOLVADEX
FOR BREAST CANCER PREVENTION IS NOT AN APPROVED INDICATION IN
CANADA. IN THE NSABP P-1 TRIAL, THE RELATIVE RISK OF NOLVADEX
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 NOLVADEX THERAPY AND SHOULD
DISCUSS THEN WITH THEIR PATIENTS.
THE BENEFITS OF NOLVADEX 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, 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 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.
- 3 -
In cytosols de