AG-SILDENAFIL TABLETS
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
12-08-2020
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Aktivní složka:
SILDENAFIL (SILDENAFIL CITRATE)
Dostupné s:
ANGITA PHARMA INC.
ATC kód:
G04BE03
INN (Mezinárodní Name):
SILDENAFIL
Dávkování:
50MG
Léková forma:
TABLET
Složení:
SILDENAFIL (SILDENAFIL CITRATE) 50MG
Podání:
ORAL
Jednotky v balení:
100
Druh předpisu:
Prescription
Terapeutické oblasti:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Přehled produktů:
Active ingredient group (AIG) number: 0136261002; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2020-08-14
Charakteristika produktu
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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