JAMP-SILDENAFIL TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SILDENAFIL (SILDENAFIL CITRATE)

Dostępny od:

JAMP PHARMA CORPORATION

Kod ATC:

G04BE03

INN (International Nazwa):

SILDENAFIL

Dawkowanie:

100MG

Forma farmaceutyczna:

TABLET

Skład:

SILDENAFIL (SILDENAFIL CITRATE) 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

4

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0136261003; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2022-09-07

Charakterystyka produktu

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