AG-SILDENAFIL TABLETS

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Preparatomtale Preparatomtale (SPC)
12-08-2020

Aktiv ingrediens:

SILDENAFIL (SILDENAFIL CITRATE)

Tilgjengelig fra:

ANGITA PHARMA INC.

ATC-kode:

G04BE03

INN (International Name):

SILDENAFIL

Dosering :

50MG

Legemiddelform:

TABLET

Sammensetning:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0136261002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2020-08-14

Preparatomtale

                                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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