APO-MOXIFLOXACIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Sẵn có từ:

APOTEX INC

Mã ATC:

J01MA14

INN (Tên quốc tế):

MOXIFLOXACIN

Liều dùng:

400MG

Dạng dược phẩm:

TABLET

Thành phần:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

QUINOLONES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0142242001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2016-01-07

Đặc tính sản phẩm

Page 1 of 66
PRODUCT MONOGRAPH
PR
APO-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin (as moxifloxacin hydrochloride)
House Standard
Antibacterial Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
CANADA
Date of Revision:
August 31, 2020
SUBMISSION CONTROL NO: 240946
Page 2 of 66
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
6
ADVERSE REACTIONS
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
........................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
22
STORAGE AND STABILITY
.................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION .......................................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................