JAMP LEVOFLOXACIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

J01MA12

INN (Nama Internasional):

LEVOFLOXACIN

Dosis:

500MG

Bentuk farmasi:

TABLET

Komposisi:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 500MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

QUINOLONES

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-11-24

Karakteristik produk

_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
...