PREMARIN TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CONJUGATED ESTROGENS

Dostupno od:

PFIZER CANADA ULC

ATC koda:

G03CA57

INN (International ime):

CONJUGATED ESTROGENS

Doziranje:

0.625MG

Farmaceutski oblik:

TABLET

Sastav:

CONJUGATED ESTROGENS 0.625MG

Administracija rute:

ORAL

Jedinice u paketu:

30/100/1000

Tip recepta:

Prescription

Područje terapije:

ESTROGENS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2017-08-02

Svojstava lijeka

_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
....