PREMARIN TABLETS 0.9MG

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CONJUGATED ESTROGENS

Commercializzato da:

WYETH CANADA

Codice ATC:

G03CA57

INN (Nome Internazionale):

CONJUGATED ESTROGENS

Dosaggio:

0.9MG

Forma farmaceutica:

TABLET

Composizione:

CONJUGATED ESTROGENS 0.9MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

ESTROGENS

Dettagli prodotto:

Active ingredient group (AIG) number: 0106442007; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2007-08-13

Scheda tecnica

_Premarin_
®
_ (conjugated_
_ _
_estrogens tablets, CSD) _
_Page 1 of 42_
PRODUCT MONOGRAPH
Pr
PREMARIN
®
(conjugated estrogens tablets, CSD)
0.3 mg, 0.625 mg, 0.9 mg, and 1.25 mg
ESTROGENIC HORMONES
©
Wyeth Canada.
1025 Marcel Laurin Blvd.
St. Laurent (Montreal), Quebec
Canada H4R 1J6
Date of Revision:
June 01, 2007
Submission Control No: 109700
_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..................................................................................5
ADVERSE
REACTIONS..................................................................................................13
DRUG INTERACTIONS
................................................................................................18
DOSAGE AND
ADMINISTRATION..............................................................................21
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND
STABILITY..........................................................................................26
SPECIAL HANDLING INSTRUCTIONS
.......................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
...................................................................28
PHARMACEUTICAL
INFORMATION.......................................................................