Land: Canada
Språk: engelsk
Kilde: Health Canada
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN)
MYLAN PHARMACEUTICALS ULC
J01MA02
CIPROFLOXACIN
1000MG
TABLET (EXTENDED-RELEASE)
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN) 1000MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0123207009; AHFS:
CANCELLED PRE MARKET
2016-11-02
_ _ _ _ _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 ................................................... Les hele dokumentet