PREMARIN TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

CONJUGATED ESTROGENS

มีจำหน่ายจาก:

PFIZER CANADA ULC

รหัส ATC:

G03CA57

INN (ชื่อสากล):

CONJUGATED ESTROGENS

ปริมาณ:

0.625MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

CONJUGATED ESTROGENS 0.625MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

30/100/1000

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

ESTROGENS

สรุปสินค้า:

Active ingredient group (AIG) number: 0106442006; AHFS:

สถานะการอนุญาต:

CANCELLED POST MARKET

วันที่อนุญาต:

2017-08-02

สรุปลักษณะสินค้า

_Premarin_

_ (conjugated_
_ _
_estrogens tablets, CSD) _
_Page 1 of 42_
COMPLETE PRESCRIBING INFORMATION
Pr
PREMARIN
®
(conjugated estrogens tablets, CSD)
0.3 mg, 0.625 mg, and 1.25 mg
ESTROGENIC HORMONES
® Wyeth Canada
Pfizer Canada Inc., Licensee
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
January 10, 2012
Submission Control No: 148504
_Premarin_

_ (conjugated_
_ _
_estrogens tablets, CSD) _
_Page 2 of 42_
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
....................................................................................................19
DOSAGE AND ADMINISTRATION
................................................................................22
OVERDOSAGE...................................................................................................................25
ACTION AND CLINICAL
PHARMACOLOGY...............................................................25
STORAGE AND STABILITY
............................................................................................28
SPECIAL HANDLING
INSTRUCTIONS..........................................................................28
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
....