Țară: Canada
Limbă: engleză
Sursă: Health Canada
CONJUGATED ESTROGENS
BAUSCH HEALTH, CANADA INC.
G03CA57
CONJUGATED ESTROGENS
0.625MG
TABLET
CONJUGATED ESTROGENS 0.625MG
ORAL
100/1000
Prescription
ESTROGENS
Active ingredient group (AIG) number: 0106442006; AHFS:
APPROVED
2020-09-23
PRODUCT MONOGRAPH PR C.E.S. Conjugated Estrogens Tablets, CSD 0.625 mg ESTROGEN BAUSCH HEALTH, CANADA INC. DATE OF REVISION: 2150 St-Elzear Blvd. West September 23, 2020 Laval, Quebec H7L 4A8 Control No.: 242944 _Pr_ _C.E.S._ _®_ _ Product Monograph Page 2 of 33_ 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 ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................14 DOSAGE AND ADMINISTRATION ..............................................................................16 OVERDOSAGE ................................................................................................................17 ACTION AND CLINICAL PHARMACOLOGY ............................................................18 STORAGE AND STABILITY ..........................................................................................20 SPECIAL HANDLING INSTRUCTIONS .......................................................................20 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................21 PART II: SCIENTIFIC INFORMATION ...............................................................................22 PHARMACEUTICAL INFORMATION ..........................................................................22 CLINICAL TRIALS ..........................................................................................................24 DETAIL Citiți documentul complet