Country: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
CONJUGATED ESTROGENS
PFIZER CANADA ULC
G03CA57
CONJUGATED ESTROGENS
0.625MG
CREAM
CONJUGATED ESTROGENS 0.625MG
VAGINAL
162
Prescription
ESTROGENS
Active ingredient group (AIG) number: 0106442005; AHFS:
APPROVED
2010-09-17
_Premarin_ _®_ _ Vaginal Cream _ _Page 1 of 40 _ COMPLETE PRESCRIBING INFORMATION Pr PREMARIN ® Vaginal Cream (Conjugated Estrogens CSD, 0.625 mg/g) ESTROGENIC HORMONES ® Pfizer Canada Inc. 17,300 Trans-Canada Highway Kirkland, QC H9J 2M5 Date of Revision: June 2, 2017 Submission Control No: 204671 _Premarin_ _®_ _ Vaginal Cream _ _Page 2 of 40 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ...........................................................................3 INDICATIONS AND CLINICAL USE ................................................................................3 CONTRAINDICATIONS ......................................................................................................3 WARNINGS AND PRECAUTIONS ....................................................................................4 ADVERSE REACTIONS ....................................................................................................13 DOSAGE AND ADMINISTRATION ................................................................................20 OVERDOSAGE ...................................................................................................................21 ACTION AND CLINICAL PHARMACOLOGY ...............................................................22 STORAGE AND STABILITY ............................................................................................24 SPECIAL HANDLING INSTRUCTIONS ..........................................................................24 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................24 PART II: SCIENTIFIC INFORMATION ...............................................................................26 PHARMACEUTICAL INFORMATION ............................................................................26 CLINICAL TRIALS ............................................................................................................27 DETAILED সম্পূর্ণ নথি পড়ুন