PMS-SILDENAFIL R TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

SILDENAFIL (SILDENAFIL CITRATE)

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

C02KX

INN (Nama Antarabangsa):

ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION

Dos:

20MG

Borang farmaseutikal:

TABLET

Komposisi:

SILDENAFIL (SILDENAFIL CITRATE) 20MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

90/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2013-09-11

Ciri produk

PRODUCT MONOGRAPH
PR
PMS-SILDENAFIL R
Sildenafil
Tablets
20 mg sildenafil (as sildenafil
citrate)
BP Standard
CGMP-SPECIFIC PHOSPHODIESTERASE TYPE 5 INHIBITOR
TREATMENT OF PULMONARY ARTERIAL HYPERTENSION
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
June 8, 2021
Submission
Control No: 252093
_pms-SILDENAFIL R Product Monograph _
_Page 2 of 55_
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............................................................................................
10
DRUG INTERACTIONS
............................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................
21
OVERDOSAGE
.........................................................................................................
22
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
22
STORAGE AND STABILITY
....................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
................................................................... 26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 27
PART II: SCIENTIFIC INFORMATION
..........................................................................
28
PHARMACEUTICAL INFORMATION
.....................................................................
28
CLINICAL TRIALS
...............................