AG-VARDENAFIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-08-2022
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Active ingredient:
VARDENAFIL (VARDENAFIL HYDROCHLORIDE)
Available from:
ANGITA PHARMA INC.
ATC code:
G04BE09
INN (International Name):
VARDENAFIL
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
VARDENAFIL (VARDENAFIL HYDROCHLORIDE) 10MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0150003002; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-01-10
Summary of Product characteristics
_AG-Vardenafil_
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PRODUCT
MONOGRAPH
PR
AG-VARDENAFIL
Vardenafil tablets
5 mg, 10 mg, 20 mg of vardenafil, as vardenafil hydrochloride
House Standard
cyclic GMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Date
of
Revision:
August 08, 2022
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3,
Canada
Submission
Control
No:
265933
_AG-Vardenafil_
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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
............................................................................................................
8
DRUG INTERACTIONS
..........................................................................................................
10
DOSAGE AND ADMINISTRATION
......................................................................................
13
OVERDOSAGE
.........................................................................................................................
14
TREATMENT OF PRIAPISM
..................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
15
STORAGE AND
STABILITY
...................................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................
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