PMS-SILDENAFIL TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
24-08-2016
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Aktiv bestanddel:
SILDENAFIL (SILDENAFIL CITRATE)
Tilgængelig fra:
PHARMASCIENCE INC
ATC-kode:
G04BE03
INN (International Name):
SILDENAFIL
Dosering:
100MG
Lægemiddelform:
TABLET
Sammensætning:
SILDENAFIL (SILDENAFIL CITRATE) 100MG
Indgivelsesvej:
ORAL
Enheder i pakken:
4/30
Recept type:
Prescription
Terapeutisk område:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0136261003; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2012-11-13
Produktets egenskaber
PRODUCT MONOGRAPH
PR PMS-SILDENAFIL
Sildenafil tablets (as sildenafil citrate)
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
August 9, 2016
Montreal, Quebec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 196963
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_pms-SILDENAFIL 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
..............................................................................................................
13
DOSAGE AND ADMINISTRATION
..........................................................................................
16
OVERDOSAGE
.............................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
18
STORAGE AND STABILITY
......................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
21
DOSAGE FORMS, COMPOSITION AND
PACKAGING.......................................................... 21
PART II: SCIENTIFIC INFORMATION
..............
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