DOM-SILDENAFIL TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

SILDENAFIL (SILDENAFIL CITRATE)

Prieinama:

DOMINION PHARMACAL

ATC kodas:

G04BE03

INN (Tarptautinis Pavadinimas):

SILDENAFIL

Dozė:

50MG

Vaisto forma:

TABLET

Sudėtis:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

4/8/30

Recepto tipas:

Prescription

Gydymo sritis:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Produkto santrauka:

Active ingredient group (AIG) number: 0136261002; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2013-06-26

Prekės savybės

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