DOM-SILDENAFIL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SILDENAFIL (SILDENAFIL CITRATE)

Tersedia dari:

DOMINION PHARMACAL

Kode ATC:

G04BE03

INN (Nama Internasional):

SILDENAFIL

Dosis:

50MG

Bentuk farmasi:

TABLET

Komposisi:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Rute administrasi :

ORAL

Unit dalam paket:

4/8/30

Jenis Resep:

Prescription

Area terapi:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2013-06-26

Karakteristik produk

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