GD-SILDENAFIL TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

SILDENAFIL (SILDENAFIL CITRATE)

זמין מ:

GENMED A DIVISION OF PFIZER CANADA ULC

קוד ATC:

G04BE03

INN (שם בינלאומי):

SILDENAFIL

כמות:

50MG

טופס פרצבטיות:

TABLET

הרכב:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

4/8

סוג מרשם:

Prescription

איזור תרפויטי:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2015-08-03

מאפייני מוצר

_ _
_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
...............................