MYLAN-CIPROFLOXACIN XL TABLET (EXTENDED-RELEASE)

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN)

থেকে পাওয়া:

MYLAN PHARMACEUTICALS ULC

এটিসি কোড:

J01MA02

INN (International Name):

CIPROFLOXACIN

ডোজ:

1000MG

ফার্মাসিউটিকাল ফর্ম:

TABLET (EXTENDED-RELEASE)

রচনা:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN) 1000MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

Therapeutic area:

QUINOLONES

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0123207009; AHFS:

অনুমোদন অবস্থা:

CANCELLED PRE MARKET

অনুমোদন তারিখ:

2016-11-02

পণ্য বৈশিষ্ট্য

_ _
_ _
_Page 1 of 54_
PRODUCT MONOGRAPH
Pr
MYLAN-CIPROFLOXACIN XL
(Ciprofloxacin hydrochloride and Ciprofloxacin Extended Release
Tablets)
Ciprofloxacin, 500 mg, 1000 mg
Antibacterial Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
May 25, 2015
Submission Control No: 184540
_ _
_ _
_Page 2 of 54_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL INFORMATION
.................................................................................
30
CLINICAL TRIALS
...................................................