PMS-SILDENAFIL TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

SILDENAFIL (SILDENAFIL CITRATE)

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

G04BE03

INN (Tên quốc tế):

SILDENAFIL

Liều dùng:

25MG

Dạng dược phẩm:

TABLET

Thành phần:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

4

Loại thuốc theo toa:

Prescription

Khu trị liệu:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2012-11-13

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR PMS-SILDENAFIL
Sildenafil tablets (as sildenafil citrate)
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
August 9, 2016
Montreal, Quebec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 196963
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_pms-SILDENAFIL Product Monograph _
_Page 2 of 49_
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
..............................................................................................................
13
DOSAGE AND ADMINISTRATION
..........................................................................................
16
OVERDOSAGE
.............................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
18
STORAGE AND STABILITY
......................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
21
DOSAGE FORMS, COMPOSITION AND
PACKAGING.......................................................... 21
PART II: SCIENTIFIC INFORMATION
..............