RATIO-SILDENAFIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SILDENAFIL (SILDENAFIL CITRATE)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

G04BE03

DCI (Dénomination commune internationale):

SILDENAFIL

Dosage:

25MG

forme pharmaceutique:

TABLET

Composition:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Mode d'administration:

ORAL

Unités en paquet:

4/8/30/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2015-11-25

Résumé des caractéristiques du produit

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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
.............................................