ACCEL-SILDENAFIL TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
27-12-2018
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유효 성분:
SILDENAFIL (SILDENAFIL CITRATE)
제공처:
ACCEL PHARMA INC
ATC 코드:
G04BE03
INN (International Name):
SILDENAFIL
복용량:
100MG
약제 형태:
TABLET
구성:
SILDENAFIL (SILDENAFIL CITRATE) 100MG
관리 경로:
ORAL
패키지 단위:
4/8
처방전 유형:
Prescription
치료 영역:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0136261003; AHFS:
승인 상태:
APPROVED
승인 날짜:
2018-08-03
제품 특성 요약
_________________________________________________________________________________
_
_ACCEL-SILDENAFIL (sildenafil citrate) Product Monograph _
_Page 1 of 49_
PRODUCT MONOGRAPH
PR
ACCEL-SILDENAFIL
sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
House Standard
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Accel Pharma Inc.
99 Place Frontenac
Pointe-Claire, Quebec
H9R 4Z7
Date of Revision:
December 27, 2018
SUBMISSION CONTROL NO: 222236
_________________________________________________________________________________
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_ACCEL-SILDENAFIL (sildenafil citrate) Product Monograph _
_Page 2 of 49_
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
................................................................................
15
OVERDOSAGE
..................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 17
STORAGE AND STABILITY
............................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
20
DOSAGE FORMS, CO
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