Kraj: Kanada
Język: angielski
Źródło: Health Canada
MEDROXYPROGESTERONE ACETATE
PRO DOC LIMITEE
G03DA02
MEDROXYPROGESTERONE
2.5MG
TABLET
MEDROXYPROGESTERONE ACETATE 2.5MG
ORAL
100/500
Prescription
PROGESTINS
Active ingredient group (AIG) number: 0106339004; AHFS:
CANCELLED POST MARKET
2020-07-17
Page 1 of 39 PRODUCT MONOGRAPH Pr MEDROXY-2,5 Pr MEDROXY-5 (MEDROXYPROGESTERONE ACETATE TABLETS USP) 2.5 MG, 5 MG PROGESTIN PRO DOC LTÉE Date of Revision: 2925, boul. Industriel 1 February 2018 Laval, Quebec H7L 3W9 Control No.: 212978 Page 2 of 39 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 ....................................................................................................... 13 DRUG INTERACTIONS ....................................................................................................... 15 DOSAGE AND ADMINISTRATION ................................................................................... 17 OVERDOSAGE ...................................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY.................................................................. 19 STORAGE AND STABILITY ............................................................................................... 22 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 23 PART II: SCIENTIFIC INFORMATION ............................................................................. 24 PHARMACEUTICAL INFORMATION ............................................................................... 24 CLINICAL TRIALS ............................................................................................................... 24 DETAILED PHARMACOLOGY .............................. Przeczytaj cały dokument