AG-SILDENAFIL TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

SILDENAFIL (SILDENAFIL CITRATE)

Pieejams no:

ANGITA PHARMA INC.

ATĶ kods:

G04BE03

SNN (starptautisko nepatentēto nosaukumu):

SILDENAFIL

Deva:

25MG

Zāļu forma:

TABLET

Kompozīcija:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

4

Receptes veids:

Prescription

Ārstniecības joma:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0136261001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2022-11-15

Produkta apraksts

_Pr_
_AG-SILDENAFIL_
_Page 1 of 43_
PRODUCT MONOGRAPH
PR
AG-SILDENAFIL
sildenafil (as sildenafil citrate) tablets
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Date of Revision:
August 28, 2018
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Quebec
J4B 5H3
SUBMISSION CONTROL NO.: 214622
_Pr_
_AG-SILDENAFIL_
_Page 2 of 43_
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
DOSAGEAND
ADMINISTRATION...................................................................................
14
OVERDOSAGE
....................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................
16
STORAGE AND
STABILITY..............................................................................................
19
SPECIAL HANDLING
INSTRUCTIONS...........................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................
19
PART II: SCIENTIFIC INFORMATION
............................................................................
20
PHARMACEUTICAL
INFORMATION......................................................