RIVA-SILDENAFIL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SILDENAFIL (SILDENAFIL CITRATE)

제공처:

LABORATOIRE RIVA INC.

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:

2016-04-22

제품 특성 요약

_ _
_RIVA-SILDENAFIL - Product Monograph _
_Page 1 of 52 _
PRODUCT MONOGRAPH
PR
RIVA-SILDENAFIL
Sildenafil tablets (as sildenafil citrate)
25 mg, 50 mg and 100 mg
CGMP-SPECIFIC PHOSPHODIESTERASE TYPE 5 INHIBITOR
TREATMENT OF ERECTILE DYSFUNCTION
LABORATOIRE RIVA INC.
660 Industriel Blvd.
Blainville, Quebec
J7C 3V4
www.labriva.com
Control No.: 222945 DATE OF REVISION:
December 20, 2018
_ _
_RIVA-SILDENAFIL - Product Monograph _
_Page 2 of 52 _
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 INFORMATION
........................................................................