JAMP-VARDENAFIL ODT TABLET (ORALLY DISINTEGRATING)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE TRIHYDRATE)

Sẵn có từ:

JAMP PHARMA CORPORATION

Mã ATC:

G04BE09

INN (Tên quốc tế):

VARDENAFIL

Liều dùng:

10MG

Dạng dược phẩm:

TABLET (ORALLY DISINTEGRATING)

Thành phần:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE TRIHYDRATE) 10MG

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: 0150003002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-06-05

Đặc tính sản phẩm

_JAMP-VARDENAFIL ODT Product Monograph_
_Page 1 of 48_
PRODUCT MONOGRAPH
PR
JAMP-VARDENAFIL ODT
Vardenafil Hydrochloride Orally Disintegrating Tablets
10 mg of vardenafil, as vardenafil hydrochloride trihydrate
cyclic GMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Date of Preparation:
March 9, 2021
Submission Control No: 249164
_JAMP-VARDENAFIL ODT Product Monograph_
_Page 2 of 48_
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
DRUG INTERACTIONS
..............................................................................................
11
DOSAGE AND ADMINISTRATION
...........................................................................
15
OVERDOSAGE
............................................................................................................
16
TREATMENT OF PRIAPISM
.......................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.......................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFO