PROVERA 10MG TABLETS
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
21-10-2014
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ingredients actius:
MEDROXYPROGESTERONE ACETATE
Disponible des:
PFIZER CANADA ULC
Codi ATC:
G03DA02
Designació comuna internacional (DCI):
MEDROXYPROGESTERONE
Dosis:
10MG
formulario farmacéutico:
TABLET
Composición:
MEDROXYPROGESTERONE ACETATE 10MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
PROGESTINS
Resumen del producto:
Active ingredient group (AIG) number: 0106339006; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
1998-03-05
Fitxa tècnica
_ _
_PROVERA (medroxyprogesterone acetate) Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
PROVERA*
(medroxyprogesterone acetate tablets USP)
2.5 mg, 5 mg and 10 mg tablets
PROGESTIN
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
29 September 2014
SUBMISSION CONTROL NO: 176877
* TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2014
_ _
_PROVERA (medroxyprogesterone acetate) Product Monograph _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
...........................................................................................
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