MED-MOXIFLOXACIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Sẵn có từ:

GENERIC MEDICAL PARTNERS 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:

30

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:

2016-12-12

Đặc tính sản phẩm

_Page 1 of 72_
PRODUCT MONOGRAPH
PR
MED-MOXIFLOXACIN
Moxifloxacin tablets
400 mg
(as moxifloxacin
hydrochloride)
Manufacturer’s Standard
Antibacterial Agent
Generic Medical Partners Inc.
1500 Don Mills Road, Suite 711
Toronto, Ontario
M3B 3K4
Date of Revision:
March 23, 2022
Submission
Control No: 255995
_Page 2 of 72_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT
INFORMATION...........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
....................................................................................................
5
WARNINGS AND
PRECAUTIONS....................................................................................
5
ADVERSE REACTIONS
...................................................................................................15
DRUG INTERACTIONS
....................................................................................................19
DOSAGE AND ADMINISTRATION
.................................................................................22
OVERDOSAGE
.................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
................................................................24
STORAGE AND STABILITY
............................................................................................31
SPECIAL HANDLING
INSTRUCTIONS...........................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................31
PART II : SCIENTIFIC INFORMATION
........................................................................
33
PHARMACEUTICAL INFORMATION
.............................................................................33
CLINICAL TRIALS
....................................