GD-SILDENAFIL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SILDENAFIL (SILDENAFIL CITRATE)

제공처:

GENMED A DIVISION OF PFIZER CANADA ULC

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:

CANCELLED POST MARKET

승인 날짜:

2015-08-03

제품 특성 요약

_ _
_GD-SILDENAFIL* (sildenafil citrate) Product Monograph _
_Page 1 of 49 _
PRODUCT MONOGRAPH
GD-SILDENAFIL *
sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Submission Control No: 193905
GenMed, a division of Pfizer Canada Inc.
17,300 TranCanada Highway
Kirkland, Quebec H9J 2M5
*TM Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee
Date of Preparation:
6 May 2016
_ _
_GD-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
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 INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
...............................