DOM-SILDENAFIL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SILDENAFIL (SILDENAFIL CITRATE)

Commercializzato da:

DOMINION PHARMACAL

Codice ATC:

G04BE03

INN (Nome Internazionale):

SILDENAFIL

Dosaggio:

25MG

Forma farmaceutica:

TABLET

Composizione:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Via di somministrazione:

ORAL

Confezione:

4/8/30

Tipo di ricetta:

Prescription

Area terapeutica:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-06-26

Scheda tecnica

PRODUCT MONOGRAPH
PR
DOM-SILDENAFIL
Sildenafil Citrate Tablets
25 mg, 50 mg and 100 mg sildenafil (as sildenafil citrate)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
DOMINION PHARMACAL
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
June 5, 2013
Montreal, Quebec
H4P 2T4
SUBMISSION CONTROL NO: 164964
_ _
_Dom-SILDENAFIL Product Monograph _
_Page 2 of 46 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL 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
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 19
PART II: SCIENTIFIC INFORMATION
.....................................................................................
20
PHARMACEUTICAL INFORMATION
.............................................................................
20
CLINICAL TRIALS
........................