JAMP-SILDENAFIL TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

SILDENAFIL (SILDENAFIL CITRATE)

Disponible desde:

JAMP PHARMA CORPORATION

Código ATC:

G04BE03

Designación común internacional (DCI):

SILDENAFIL

Dosis:

25MG

formulario farmacéutico:

TABLET

Composición:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Vía de administración:

ORAL

Unidades en paquete:

4

tipo de receta:

Prescription

Área terapéutica:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2022-09-07

Ficha técnica

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