TELZIR TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM)

Sẵn có từ:

VIIV HEALTHCARE ULC

Mã ATC:

J05AE07

INN (Tên quốc tế):

FOSAMPRENAVIR

Liều dùng:

700MG

Dạng dược phẩm:

TABLET

Thành phần:

FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM) 700MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

60

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HIV PROTEASE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0150429001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2009-12-08

Đặc tính sản phẩm

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_Page 1 of 55_
PRODUCT MONOGRAPH
PR
TELZIR
Fosamprenavir tablets 700 mg
(as fosamprenavir calcium)
Fosamprenavir oral suspension 50 mg/mL
(as fosamprenavir calcium)
Antiretroviral Agent
ViiV Healthcare ULC
245, boulevard Armand-Frappier
Laval, Quebec
H7V 4A7
Date of Revision:
July 5, 2019
Submission Control No.: 226294
© 2019 ViiV Healthcare group of companies or its licensor.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.
_ _
_Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................34
SPECIAL HANDLING INSTRUCTIONS
.......................................................................34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................36
PHARMACEUTICAL INFORM