PHL-MOXIFLOXACIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Sẵn có từ:

PHARMEL 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:

10/30/100/500

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:

2017-09-13

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
PHL-MOXIFLOXACIN
Moxifloxacin tablets
400 mg
(as moxifloxacin hydrochloride)
ANTIBACTERIAL AGENT
PHARMEL INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
December 23, 2016
Montréal, Quebec, Canada
H4P 2T4
SUBMISSION CONTROL NO:
120275
_ _
_phl-MOXIFLOXACIN Product Monograph _
_Page 2 of 67 _
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
.........................................................................................
21
OVERDOSAGE
...........................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................................................
23
STORAGE
AND
STABILITY
.....................................................................................................
31
SPECIAL
HANDLING
INSTRUCTIONS
..................................................................................
31
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ........................................................ 32
PART II: SCIENTIFIC INFORMATION
..................................................................................
33
PHARMACEUTICAL
INFORMATION
....