AURO-SILDENAFIL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

SILDENAFIL (SILDENAFIL CITRATE)

Tilgjengelig fra:

AURO PHARMA INC

ATC-kode:

G04BE03

INN (International Name):

SILDENAFIL

Dosering :

50MG

Legemiddelform:

TABLET

Sammensetning:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Administreringsrute:

ORAL

Enheter i pakken:

4/8/30/100/1000

Resept typen:

Prescription

Terapeutisk område:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2013-10-16

Preparatomtale

Page 1 of 52
PRODUCT MONOGRAPH
PR
AURO-SILDENAFIL
sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Auro Pharma Inc. DATE OF REVISION:
3700 Steeles Avenue West, Suite # 402 June 10, 2019.
Woodbridge, Ontario, L4L 8K8
CANADA
SUBMISSION CONTROL NO: 227781
Page 2 of 52
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..............................……………................
11
DOSAGE AND ADMINISTRATION.............…............................
14
OVERDOSAGE.......................................………….........................
15
ACTION AND CLINICALPHARMACOLOGY…..........................
16
STORAGE AND STABILITY
........................................……..........
19
SPECIAL HANDLING INSTRUCTIONS ......................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING ……….. 19
PART II:
SCIENTIFIC
INFORMATION.........................…………….….......
20
PHARMACEUTICAL INFORMATION .........................….............
20
CLINICAL
TRIALS...............................................……………......
21
DETAILED PHARMACOLOGY..............................……………..
24
TOXICOLOGY.............................…………………………............
27
REFERENCES....................................………………………….....
39
PART III:
CONSUMER
INFORMATION....................…………………..........
44
Page 3 of 52
PR
AURO-SILDENAFIL
Sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
PART I: HEALTH PROFESSI