PREMARIN TABLET (EXTENDED-RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CONJUGATED ESTROGENS

Dostopno od:

PFIZER CANADA ULC

Koda artikla:

G03CA57

INN (mednarodno ime):

CONJUGATED ESTROGENS

Odmerek:

0.3MG

Farmacevtska oblika:

TABLET (EXTENDED-RELEASE)

Sestava:

CONJUGATED ESTROGENS 0.3MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

ESTROGENS

Povzetek izdelek:

Active ingredient group (AIG) number: 0106442002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2013-10-18

Lastnosti izdelka

_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