Nazione: Canada
Lingua: inglese
Fonte: Health Canada
CONJUGATED ESTROGENS; MEDROXYPROGESTERONE ACETATE
PFIZER CANADA ULC
G03FA12
MEDROXYPROGESTERONE AND ESTROGEN
0.625MG; 10MG
KIT
CONJUGATED ESTROGENS 0.625MG; MEDROXYPROGESTERONE ACETATE 10MG
ORAL
42
Prescription
ESTROGENS
Active ingredient group (AIG) number: 0242061003; AHFS:
CANCELLED PRE MARKET
2019-11-06
_Premplus _ ® _ and Premplus Cycle_ ® _ _ _Page 1 of 49_ PRODUCT MONOGRAPH Pr PREMPLUS ® conjugated estrogens tablets CSD 0.625 mg and medroxyprogesterone acetate tablets USP 2.5 mg, 5.0 mg (Continuous therapy) Pr PREMPLUS CYCLE ® conjugated estrogens tablets CSD 0.625 mg and medroxyprogesterone acetate tablets USP 10.0 mg (Cyclic therapy) Estrogenic Hormones/Progestin ® Wyeth LLC Pfizer Canada Inc., Licensee 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of Revision: DECEMBER 8, 2010 Submission Control No: 141329 _Premplus _ ® _ and Premplus Cycle_ ® _ _ _Page 2 of 49_ 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 ....................................................................................................14 DRUG INTERACTIONS ..................................................................................................22 DOSAGE AND ADMINISTRATION ................................................................................23 OVERDOSAGE...................................................................................................................24 ACTION AND CLINICAL PHARMACOLOGY...............................................................25 STORAGE AND STABILITY ............................................................................................30 SPECIAL HANDLING INSTRUCTIONS..........................................................................30 DOSAGE FORMS, COMPOSITION AND PACKAGING................................................30 P Leggi il documento completo