PB-SILDENAFIL TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

SILDENAFIL (SILDENAFIL CITRATE)

Sẵn có từ:

PB PHARMA INC

Mã ATC:

G04BE03

INN (Tên quốc tế):

SILDENAFIL

Liều dùng:

50.0MG

Dạng dược phẩm:

TABLET

Thành phần:

SILDENAFIL (SILDENAFIL CITRATE) 50.0MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2019-06-07

Đặc tính sản phẩm

_PB -SILDENAFIL _
_Page 1 of 44_
_ _
PRODUCT MONOGRAPH
PR
PB -SILDENAFIL
Sildenafil (as sildenafil citrate) tablets
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
PB PHARMA
400-3871 Belanger Street, Montréal,
DATE OF PREPARATION:
Québec, Canada.
November 01, 2013
H1X 3M7
SUBMISSION CONTROL NO: 168869
_PB -SILDENAFIL _
_Page 2 of 44_
_ _
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
....................................................................................................10
DOSAGE AND
ADMINISTRATION................................................................................13
OVERDOSAGE
..................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
..............................................................15
STORAGE AND
STABILITY............................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.........................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................18
PART II: SCIENTIFIC INFORMATION
......................................................................19
PHARMACEUTICAL
INFORMATION............................................................................1