MYLAN-CIPROFLOXACIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

Sẵn có từ:

MYLAN PHARMACEUTICALS ULC

Mã ATC:

J01MA02

INN (Tên quốc tế):

CIPROFLOXACIN

Liều dùng:

250MG

Dạng dược phẩm:

TABLET

Thành phần:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 250MG

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: 0123207006; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2018-07-12

Đặc tính sản phẩm

Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLAN-CIPROFLOXACIN
CIPROFLOXACIN TABLETS, USP
250 MG AND 500 MG
(AS CIPROFLOXACIN HYDROCHLORIDE)
ANTIBACTERIAL AGENT
MYLAN PHARMACEUTICALS ULC
85 Advance Road
Etobicoke, Ontario
Canada
M8Z 2S6
DATE OF REVISION: May 3, 2019
Control No.: 227162
Page 2 of 58
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
....................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
6
WARNINGS
AND
PRECAUTIONS
.............................................................................................
7
ADVERSE
REACTIONS
.............................................................................................................
13
DRUG
INTERACTIONS
.............................................................................................................
16
DOSAGE
AND
ADMINISTRATION
.........................................................................................
23
OVERDOSAGE
...........................................................................................................................
26
ACTION
AND
CLINICAL
PHARMACOLOGY
........................................................................
26
STORAGE
AND
STABILITY
.....................................................................................................
29
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ......................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL
INFORMATION
.....................................................................................
30
CLINICAL
TRIALS
.......