APO-SILDENAFIL R TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

SILDENAFIL (SILDENAFIL CITRATE)

Saadav alates:

APOTEX INC

ATC kood:

C02KX

INN (Rahvusvaheline Nimetus):

ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION

Annus:

20MG

Ravimvorm:

TABLET

Koostis:

SILDENAFIL (SILDENAFIL CITRATE) 20MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0136261004; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2013-12-17

Toote omadused

Page 1 of 54
PRODUCT MONOGRAPH
Pr
APO-SILDENAFIL R
SILDENAFIL TABLETS USP
20 MG SILDENAFIL (AS SILDENAFIL CITRATE)
CGMP-SPECIFIC PHOSPHODIESTERASE TYPE 5 INHIBITOR
TREATMENT OF PULMONARY ARTERIAL HYPERTENSION
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE
FEBRUARY 11, 2019
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO:
224315
Page 2 of 54
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
...........................................................................................................
9
DOSAGE AND ADMINISTRATION
.......................................................................................
20
OVERDOSAGE
......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
21
STORAGE AND STABILITY
..................................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 25
PART II: SCIENTIFIC INFORMATION ...................................................................................
26
PHARMACEUTICAL INFORMATION
...................................................................................
26
CLINICAL TRIALS
..............................