PREMARIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CONJUGATED ESTROGENS

Saatavilla:

PFIZER CANADA ULC

ATC-koodi:

G03CA57

INN (Kansainvälinen yleisnimi):

CONJUGATED ESTROGENS

Annos:

1.25MG

Lääkemuoto:

TABLET

Koostumus:

CONJUGATED ESTROGENS 1.25MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ESTROGENS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0106442003; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2017-08-02

Valmisteyhteenveto

_Premarin_

_ (conjugated_
_ _
_estrogens tablets, CSD) _
_Page 1 of 42_
COMPLETE PRESCRIBING INFORMATION
Pr
PREMARIN
®
(conjugated estrogens tablets, CSD)
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:
January 10, 2012
Submission Control No: 148504
_Premarin_

_ (conjugated_
_ _
_estrogens tablets, CSD) _
_Page 2 of 42_
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
....................................................................................................19
DOSAGE AND ADMINISTRATION
................................................................................22
OVERDOSAGE...................................................................................................................25
ACTION AND CLINICAL
PHARMACOLOGY...............................................................25
STORAGE AND STABILITY
............................................................................................28
SPECIAL HANDLING
INSTRUCTIONS..........................................................................28
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
....