JAMP-SILDENAFIL TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

SILDENAFIL (SILDENAFIL CITRATE)

Tilgængelig fra:

JAMP PHARMA CORPORATION

ATC-kode:

G04BE03

INN (International Name):

SILDENAFIL

Dosering:

25MG

Lægemiddelform:

TABLET

Sammensætning:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Indgivelsesvej:

ORAL

Enheder i pakken:

4

Recept type:

Prescription

Terapeutisk område:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0136261001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2022-09-07

Produktets egenskaber

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