PREMARIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CONJUGATED ESTROGENS

제공처:

PFIZER CANADA ULC

ATC 코드:

G03CA57

INN (International Name):

CONJUGATED ESTROGENS

복용량:

1.25MG

약제 형태:

TABLET

구성:

CONJUGATED ESTROGENS 1.25MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

ESTROGENS

제품 요약:

Active ingredient group (AIG) number: 0106442003; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2017-08-02

제품 특성 요약

_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
....