AG-SILDENAFIL TABLETS

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SILDENAFIL (SILDENAFIL CITRATE)

Tersedia dari:

ANGITA PHARMA INC.

Kode ATC:

G04BE03

INN (Nama Internasional):

SILDENAFIL

Dosis:

50MG

Bentuk farmasi:

TABLET

Komposisi:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-08-14

Karakteristik produk

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