APO-SILDENAFIL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SILDENAFIL (SILDENAFIL CITRATE)

제공처:

APOTEX INC

ATC 코드:

G04BE03

INN (International Name):

SILDENAFIL

복용량:

25MG

약제 형태:

TABLET

구성:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

관리 경로:

ORAL

패키지 단위:

4

처방전 유형:

Prescription

치료 영역:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0136261001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2012-11-09

제품 특성 요약

_ _
_APO-SILDENAFIL (sildenafil citrate) _
_–_
_ Product Monograph _
_Page 1 of 57_
PRODUCT MONOGRAPH
PR
APO-SILDENAFIL
Sildenafil Tablets
Tablets, 25 mg, 50 mg and 100 mg sildenafil (as sildenafil citrate)
Apotex Standard
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
April 5, 2023
Submission Control No: 268822
_APO-SILDENAFIL (sildenafil citrate) _
_–_
_ Product Monograph _
_Page 2 of 57_
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
...........................................................................................................7
DRUG INTERACTIONS
.........................................................................................................12
DOSAGE AND ADMINISTRATION
.....................................................................................16
OVERDOSAGE
........................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
....................................................................18
STORAGE AND STABILITY
.................................................................................................21
SPECIAL HANDLING INSTRUCTIONS
...............................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................21
PART II: SCIENTIFIC IN