JAMP LEVOFLOXACIN TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

MAH:

JAMP PHARMA CORPORATION

ATC_code:

J01MA12

INN:

LEVOFLOXACIN

dosage:

500MG

pharmaceutical_form:

TABLET

composition:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 500MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

QUINOLONES

leaflet_short:

Active ingredient group (AIG) number: 0131663004; AHFS:

authorization_status:

APPROVED

authorization_date:

2020-11-24

SPC

_JAMP Levofloxacin_
_Page 1 of 68_
PRODUCT MONOGRAPH
PR
JAMP LEVOFLOXACIN
Levofloxacin Tablets, USP
250 mg, 500 mg and 750 mg Levofloxacin
as Levofloxacin Hemihydrate
Antibacterial Agent
JAMP Pharma Corporation
Date of Approval: November 23, 2020
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Submission Control No: 232133
_JAMP Levofloxacin_
_Page 2 of 68_
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
........................................................................................................
12
DRUG INTERACTIONS
........................................................................................................
16
DOSAGE AND ADMINISTRATION
........................................................................................
18
OVERDOSAGE
.....................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
21
STORAGE AND STABILITY
..................................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 25
PART II: SCIENTIFIC
INFORMATION......................................................................................
27
PHARMACEUTICAL INFORMATION
....................................................................................
27
CLINICAL TRIALS
...