LEVOFLOXACIN INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

J01MA12

INN (nume internaţional):

LEVOFLOXACIN

Dozare:

5MG

Forma farmaceutică:

SOLUTION

Compoziție:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 5MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

50/100/150ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

QUINOLONES

Rezumat produs:

Active ingredient group (AIG) number: 0131663001; AHFS:

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2017-02-09

Caracteristicilor produsului

_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
....................................................................................................