APO-ZIDOVUDINE-LAMIVUDINE-NEVIRAPINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

NEVIRAPINE; ZIDOVUDINE; LAMIVUDINE

Sẵn có từ:

APOTEX INC

Mã ATC:

J05AR05

INN (Tên quốc tế):

ZIDOVUDINE, LAMIVUDINE AND NEVIRAPINE

Liều dùng:

200MG; 300MG; 150MG

Dạng dược phẩm:

TABLET

Thành phần:

NEVIRAPINE 200MG; ZIDOVUDINE 300MG; LAMIVUDINE 150MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

60

Loại thuốc theo toa:

Prescription

Khu trị liệu:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0351645001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2016-05-30

Đặc tính sản phẩm

Page 1 of 78
PRODUCT MONOGRAPH
P
Pr
P
Apo-Zidovudine-Lamivudine-Nevirapine
ZIDOVUDINE, LAMIVUDINE AND NEVIRAPINE TABLETS
300 MG/ 150 MG/ 200 MG
ANTIRETROVIRAL AGENT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
MAY 30, 2016
WESTON, ONTARIO
M9L 1T9
CONTROL # 103156 & 193373
Page 2 of 78
U
TABLE OF CONTENTS
PART I: HEALTH PROFFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
0BADVERSE REACTIONS
..................................................................................................
18
DRUG INTERACTIONS
.......................................................................................................
27
DOSAGE AND ADMINISTRATION
...................................................................................
42
OVERDOSAGE
......................................................................................................................
44
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 45
STORAGE AND STABILITY
...............................................................................................
53
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 53
PART II: SCIENTIFIC INFORMATION
..............................................................................
54
PHARMACEUTICAL INFORMATION
...............................................................................
54
CLINICAL TRIALS
...............................................................................................................
56
VIROLOGY
.......