JAMP-SILDENAFIL TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

SILDENAFIL (SILDENAFIL CITRATE)

זמין מ:

JAMP PHARMA CORPORATION

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

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:

2022-09-07

מאפייני מוצר

_Jamp-SILDENAFIL (Sildenafil Citrate Tablets) 25 mg, 50 mg, 100 mg _
_Page 1 of 44_
_ _
PRODUCT MONOGRAPH
PR JAMP-SILDENAFIL
sildenafil (as sildenafil citrate) tablets
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
SPONSOR:
Jamp Pharma Corporation
DATE OF PREPARATION:
1380-203 Newton
April 24, 2013
Boucherville, Québec
J4B 5H2
SUBMISSION CONTROL NO: 163804
_Jamp-SILDENAFIL (Sildenafil Citrate Tablets) 25 mg, 50 mg, 100 mg _
_Page 2 of 44_
_ _
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
....................................................................................................10
DOSAGE AND
ADMINISTRATION................................................................................13
OVERDOSAGE
..................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
..............................................................15
STORAGE AND
STABILITY............................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.........................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................18
PART II: SCIENTIFIC INFORMATION
.....................................................................