JAMP LEVOFLOXACIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Διαθέσιμο από:

JAMP PHARMA CORPORATION

Φαρμακολογική κατηγορία (ATC):

J01MA12

INN (Διεθνής Όνομα):

LEVOFLOXACIN

Δοσολογία:

500MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 500MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

QUINOLONES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2020-11-24

Αρχείο Π.Χ.Π.

_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
...