MYLAN-MOXIFLOXACIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Sẵn có từ:

MYLAN PHARMACEUTICALS ULC

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:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

QUINOLONES

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2017-01-11

Đặc tính sản phẩm

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_Page 1 of 61_
PRODUCT MONOGRAPH
Pr
MYLAN-MOXIFLOXACIN
Moxifloxacin Hydrochloride Tablets
400 mg Moxifloxacin (as Moxifloxacin Hydrochloride)
Antibacterial Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
November 15, 2016
Submission Control No: 199712
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_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
12
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 28
PART II: SCIENTIFIC INFORMATION
..............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
.........................................................................................................
31
DETAILED PHARMACOLOGY
....................................................................................
40
MICROBIOLOGY
.......................................................