Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
MEDROXYPROGESTERONE ACETATE
PFIZER CANADA ULC
G03DA02
MEDROXYPROGESTERONE
5MG
TABLET
MEDROXYPROGESTERONE ACETATE 5MG
ORAL
100
Prescription
PROGESTINS
Active ingredient group (AIG) number: 0106339005; AHFS:
APPROVED
1998-03-05
_ _ _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 ........................................................................................... Soma hati kamili