ACCEL-SILDENAFIL TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
27-12-2018
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
SILDENAFIL (SILDENAFIL CITRATE)
Fáanlegur frá:
ACCEL PHARMA INC
ATC númer:
G04BE03
INN (Alþjóðlegt nafn):
SILDENAFIL
Skammtar:
25MG
Lyfjaform:
TABLET
Samsetning:
SILDENAFIL (SILDENAFIL CITRATE) 25MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
4
Gerð lyfseðils:
Prescription
Lækningarsvæði:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0136261001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2018-08-03
Vara einkenni
_________________________________________________________________________________
_
_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
_________________________________________________________________________________
_
_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
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