AG-SILDENAFIL TABLETS
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
12-08-2020
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Werkstoffen:
SILDENAFIL (SILDENAFIL CITRATE)
Beschikbaar vanaf:
ANGITA PHARMA INC.
ATC-code:
G04BE03
INN (Algemene Internationale Benaming):
SILDENAFIL
Dosering:
25MG
farmaceutische vorm:
TABLET
Samenstelling:
SILDENAFIL (SILDENAFIL CITRATE) 25MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0136261001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2020-08-14
Productkenmerken
PRODUCT MONOGRAPH
PR
AG-SILDENAFIL TABLETS
Sildenafil (as Sildenafil citrate)
Tablets 25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
August
12, 2020
Date of
Revision
:
Submission
Control
No.:
239723
J4B 5H3
Boucherville,
Québec
1310 rue Nobel
Angita Pharma
Inc.
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, COMPOSITION AND PACKAGING
.................................................................. 20
PART II: SCIE
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