LEVOFLOXACIN INJECTION SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

J01MA12

INN (Jina la Kimataifa):

LEVOFLOXACIN

Kipimo:

5MG

Dawa fomu:

SOLUTION

Tungo:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 5MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

50/100/150ML

Dawa ya aina:

Prescription

Eneo la matibabu:

QUINOLONES

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED PRE MARKET

Idhini ya tarehe:

2017-02-09

Tabia za bidhaa

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