NEO ESTRONE TAB 1.25MG TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ESTERIFIED ESTROGENS

Pieejams no:

NEOLAB INC

ATĶ kods:

G03CA

SNN (starptautisko nepatentēto nosaukumu):

NATURAL AND SEMISYNTHETIC ESTROGENS, PLAIN

Deva:

1.25MG

Zāļu forma:

TABLET

Kompozīcija:

ESTERIFIED ESTROGENS 1.25MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/500

Receptes veids:

Prescription

Ārstniecības joma:

ESTROGENS

Produktu pārskats:

Active ingredient group (AIG) number: 0106444001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2008-04-02

Produkta apraksts

- 1 -
PRODUCT MONOGRAPH
NEO-ESTRONE
ESTERIFIED ESTROGEN
TABLETS
1.25mg, 0.625mg, 0.3mg
ESTROGEN
NEOLAB INC.
Date of Preparation: January 30, 2004
5476 Upper Lachine Road MG-101-D
Montréal, Québec
Control Number
: 085532
H4A 2A4
- 2 -
PRODUCT MONOGRAPH
NEO-ESTRONE
ESTERIFIED ESTROGEN
TABLETS
1.25mg, 0.625mg, 0.3mg
PHARMACOLOGIC CLASSIFICATION
ESTROGEN
Warning
As the Women’s Health Initiative (WHI) study results indicated
increased risk of myocardial infarction
(MI),stroke, invasive breast cancer , pulmonary emboli, and deep
venous thrombosis in postmenopausal
women receiving treatment with combined conjugated equine estrogens
and medroxyprogesterone acetate
compared to those receiving placebo tablets, the following should be
highly considered:
. Estrogens with or without progestins should not be prescribed for
primary or secondary prevention of
cardiovascular diseases.
. Estrogens with or without progestins should be prescribed at the
lowest effective dose for the
approved indication.
. Estrogens with or without progestins should be prescribed for the
shortest period possible for the
recognized indication.
- 3 -
ACTIONS AND CLINICAL PHARMACOLOGY
NEO-ESTRONE TABLETS contain a sulphate ester form of estrone used in
relieving the menopausal
and post-menopausal symptoms of naturally or surgically induced
estrogen deficiency states.
In general, estrogens are of importance in the development and
maintenance of the female reproductive
system as well as secondary sexual characteristics. After menopause
the ovarian follicle produces less
and less estradiol to convert to estrone. Whereas the ratio of
circulating estradiol to estrone was close to
equal before menopause, after menopause most of the endogenous
circulating hormone is the sulphate ester
form of estrone coming from the conversion of androstendione secreted
by the adrenal cortex. Metabolic
conversion occurring mostly in the liver creates an equilibrium of
various forms of estrogen through
interconversions. Sulfated forms of estrone create a reservoir for
deriv