ACCEL-SILDENAFIL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SILDENAFIL (SILDENAFIL CITRATE)

Tersedia dari:

ACCEL PHARMA INC

Kode ATC:

G04BE03

INN (Nama Internasional):

SILDENAFIL

Dosis:

100MG

Bentuk farmasi:

TABLET

Komposisi:

SILDENAFIL (SILDENAFIL CITRATE) 100MG

Rute administrasi :

ORAL

Unit dalam paket:

4/8

Jenis Resep:

Prescription

Area terapi:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0136261003; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-08-03

Karakteristik produk

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_ACCEL-SILDENAFIL (sildenafil citrate) Product Monograph _
_Page 1 of 49_
PRODUCT MONOGRAPH
PR
ACCEL-SILDENAFIL
sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
House Standard
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Accel Pharma Inc.
99 Place Frontenac
Pointe-Claire, Quebec
H9R 4Z7
Date of Revision:
December 27, 2018
SUBMISSION CONTROL NO: 222236
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_ACCEL-SILDENAFIL (sildenafil citrate) Product Monograph _
_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
....................................................................................................
12
DOSAGE AND ADMINISTRATION
................................................................................
15
OVERDOSAGE
..................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 17
STORAGE AND STABILITY
............................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
20
DOSAGE FORMS, CO