Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)
TEVA CANADA LIMITED
J01MA12
LEVOFLOXACIN
5MG
SOLUTION
LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 5MG
INTRAVENOUS
50/100/150ML
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0131663001; AHFS:
CANCELLED PRE MARKET
2017-02-09
_Page 1 of 71_ PRODUCT MONOGRAPH Pr TEVA-LEVOFLOXACIN (levofloxacin) 250 mg, 500 mg and 750 mg Tablets and Pr LEVOFLOXACIN INJECTION (levofloxacin) Sterile 5 mg/mL in 5% dextrose Antibacterial Agent Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Canada www.tevacanada.com Submission Control No: 188951 Date of Revision: February 22, 2016 _Page 2 of 71_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................... 3 SUMMARY PRODUCT INFORMATION......................................................................... 3 INDICATIONS AND CLINICAL USE .............................................................................. 3 CONTRAINDICATIONS .................................................................................................... 5 WARNINGS AND PRECAUTIONS .................................................................................. 5 ADVERSE REACTIONS .................................................................................................. 11 DRUG INTERACTIONS .................................................................................................. 15 DOSAGE AND ADMINISTRATION .............................................................................. 17 OVERDOSAGE ................................................................................................................. 21 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 21 STORAGE AND STABILITY .......................................................................................... 26 DOSAGE FORMS, COMPOSITION AND PACKAGING.............................................. 26 PART II: SCIENTIFIC INFORMATION ............................................................................... 28 PHARMACEUTICAL INFORMATION .......................................................................... 28 CLINICAL TRIALS .................................................................................................... Διαβάστε το πλήρες έγγραφο