PREMARIN VAGINAL CREAM

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CONJUGATED ESTROGENS

Verfügbar ab:

PFIZER CANADA ULC

ATC-Code:

G03CA57

INN (Internationale Bezeichnung):

CONJUGATED ESTROGENS

Dosierung:

0.625MG

Darreichungsform:

CREAM

Zusammensetzung:

CONJUGATED ESTROGENS 0.625MG

Verabreichungsweg:

VAGINAL

Einheiten im Paket:

162

Verschreibungstyp:

Prescription

Therapiebereich:

ESTROGENS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0106442005; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2010-09-17

Fachinformation

_Premarin_
_®_
_ Vaginal Cream _
_Page 1 of 40 _
COMPLETE PRESCRIBING INFORMATION
Pr
PREMARIN
®
Vaginal Cream
(Conjugated Estrogens CSD, 0.625 mg/g)
ESTROGENIC HORMONES
®
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, QC H9J 2M5
Date of Revision:
June 2, 2017
Submission Control No: 204671
_Premarin_
_®_
_ Vaginal Cream _
_Page 2 of 40 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................3
INDICATIONS AND CLINICAL USE
................................................................................3
CONTRAINDICATIONS
......................................................................................................3
WARNINGS AND PRECAUTIONS
....................................................................................4
ADVERSE REACTIONS
....................................................................................................13
DOSAGE AND ADMINISTRATION
................................................................................20
OVERDOSAGE
...................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
...............................................................22
STORAGE AND STABILITY
............................................................................................24
SPECIAL HANDLING INSTRUCTIONS
..........................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
............................................................................26
CLINICAL TRIALS
............................................................................................................27
DETAILED