PREMARIN TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CONJUGATED ESTROGENS

Saatavilla:

PFIZER CANADA ULC

ATC-koodi:

G03CA57

INN (Kansainvälinen yleisnimi):

CONJUGATED ESTROGENS

Annos:

0.625MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

CONJUGATED ESTROGENS 0.625MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ESTROGENS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0106442006; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2013-10-18

Valmisteyhteenveto

_PREMARIN (conjugated_
_ _
_estrogens sustained release tablets) _
_Page 1 of 46_
PRODUCT MONOGRAPH
Pr
PREMARIN
®
(conjugated estrogens sustained release tablets)
0.3 mg, 0.625 mg, and 1.25 mg
ESTROGENIC HORMONES
® Wyeth Canada
Pfizer Canada Inc., Licensee
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
December 1, 2014
Submission Control No: 177429
_PREMARIN (conjugated_
_ _
_estrogens sustained release tablets) _
_Page 2 of 46_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................3
INDICATIONS AND CLINICAL USE
................................................................................3
CONTRAINDICATIONS
......................................................................................................4
WARNINGS AND PRECAUTIONS
....................................................................................4
ADVERSE REACTIONS
....................................................................................................14
DRUG INTERACTIONS
....................................................................................................20
DOSAGE AND ADMINISTRATION
................................................................................23
OVERDOSAGE
...................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
...............................................................25
STORAGE AND STABILITY
............................................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
............................................................................30
CLINICAL TRIALS