DOM-SILDENAFIL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SILDENAFIL (SILDENAFIL CITRATE)

제공처:

DOMINION PHARMACAL

ATC 코드:

G04BE03

INN (International Name):

SILDENAFIL

복용량:

50MG

약제 형태:

TABLET

구성:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

관리 경로:

ORAL

패키지 단위:

4/8/30

처방전 유형:

Prescription

치료 영역:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0136261002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2013-06-26

제품 특성 요약

PRODUCT MONOGRAPH
PR
DOM-SILDENAFIL
Sildenafil Citrate Tablets
25 mg, 50 mg and 100 mg sildenafil (as sildenafil citrate)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
DOMINION PHARMACAL
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
June 5, 2013
Montreal, Quebec
H4P 2T4
SUBMISSION CONTROL NO: 164964
_ _
_Dom-SILDENAFIL Product Monograph _
_Page 2 of 46 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
......................................................................................................
3
WARNINGS AND PRECAUTIONS
.....................................................................................
4
ADVERSE REACTIONS
......................................................................................................
7
DRUG INTERACTIONS
.....................................................................................................
11
DOSAGE AND ADMINISTRATION
.................................................................................
14
OVERDOSAGE
...................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 16
STORAGE AND STABILITY
.............................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 19
PART II: SCIENTIFIC INFORMATION
.....................................................................................
20
PHARMACEUTICAL INFORMATION
.............................................................................
20
CLINICAL TRIALS
........................