C.E.S. TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

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제품 특성 요약 제품 특성 요약 (SPC)
23-09-2020

유효 성분:

CONJUGATED ESTROGENS

제공처:

BAUSCH HEALTH, CANADA INC.

ATC 코드:

G03CA57

INN (International Name):

CONJUGATED ESTROGENS

복용량:

0.625MG

약제 형태:

TABLET

구성:

CONJUGATED ESTROGENS 0.625MG

관리 경로:

ORAL

패키지 단위:

100/1000

처방전 유형:

Prescription

치료 영역:

ESTROGENS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2020-09-23

제품 특성 요약

                                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
                                
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