RATIO-SILDENAFIL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

SILDENAFIL (SILDENAFIL CITRATE)

Disponible des:

TEVA CANADA LIMITED

Codi ATC:

G04BE03

Designació comuna internacional (DCI):

SILDENAFIL

Dosis:

25MG

formulario farmacéutico:

TABLET

Composición:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Vía de administración:

ORAL

Unidades en paquete:

4/8/30/100

tipo de receta:

Prescription

Área terapéutica:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED PRE MARKET

Data d'autorització:

2015-11-25

Fitxa tècnica

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_ratio-SILDENAFIL Tablets 25 mg, 50 mg and 100 mg _
_Page 1 of 49_
PRODUCT MONOGRAPH
PR
RATIO-SILDENAFIL
Sildenafil Citrate
25 mg, 50 mg and 100 mg of sildenafil (as sildenafil citrate)
Film Coated Tablets
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
ratiopharm inc.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
DATE OF PREPARATION:
NOVEMBER 8, 2012
SUBMISSION CONTROL NO: 121353, 129879, 158416
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_ratio-SILDENAFIL Tablets 25 mg, 50 mg and 100 mg _
_Page 2 of 49_
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
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
21
PHARMACEUTICAL INFORMATION
.............................................