Factive film-coated tablet 320 mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Gemifloxacin Mesylate

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

Gemifloxacin Mesylate

Unit dalam pakej:

5tablet Tablets; 7tablet Tablets

Dikeluarkan oleh:

LG CHEM LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FACTIVE FILM-COATED TABLET
_GEMIFLOXACIN MESYLATE (320 MG) _
1
Confidential
ⓒ
2023 LG Chem, Ltd. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What FACTIVE is used for
2.
How FACTIVE works
3.
Before you use FACTIVE
4.
How to use FACTIVE
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
FACTIVE
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
WHAT FACTIVE IS USED FOR
FACTIVE
is
a
fluoroquinolone
antibiotic
medicine
used
to
treat
certain infections caused by certain
germs called bacteria in adults 18
years or older.
HOW FACTIVE WORKS
FACTIVE
works
by
inhibiting
topoisomerase IV and topoisomerase
II (DNA gyrase) enzymes that are
involved
in
the
uncoiling
and
supercoiling
of
DNA
during
replication.
BEFORE YOU USE FACTIVE
-
_When you must not use it_
_ _
_DO NOT TAKE FACTIVE_ _IF YOU_:
-
have
ever
had
a
severe
allergic
reaction to an antibiotic known as
a fluoroquinolone, or are allergic
to
any
of
the
ingredients
in
FACTIVE
(listed
in
Product
Description)
-
are
PREGNANT
OR
PLANNING
to
become pregnant
-
are breast-feeding or planning to
breast-feed
-
are children or adolescents, less
than 18 years of age
-
have a history of fluoroquinolone-
associated
tendonitis
and
tendon
rupture
-
_Before you start to use it_
_ _
Tell your healthcare provider about
all
your
medical
conditions,
including if you:
-
have tendon problems
-
have a disease that causes muscle
weakness (myasthenia gravis)
-
have tendon problems have central
nervous system problems (such as
epilepsy)
-
have nerve problems
-
have or anyone in your family has
an irregular heartbeat, especially a
condition
called
“QT
prolongation”
-
have
been
diagnosed
with
an
enlargement or “bulge” of a large
blood vessel (aortic aneurysm or
large vessel peripheral aneurysm).
-
have
experienced
a
previous
episode of aortic dissection (a tear
in the aorta wall).
-
have
a
family
history
of
aortic
aneurysm or aortic dissection or
other risk factors or predis

Ciri produk

FACTIVE
® 320MG
GEMIFLOXACIN MESYLATE FILM-COATED TABLET
_PACKAGE INSERT _
1/20
ⓒ
2023 LG Chem, Ltd. All rights reserved.
1. NAME OF THE MEDICINAL PRODUCT
Factive
F
ilm-coated tablet
320 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains gemifloxacin mesylate equivalent to 320 mg
gemifloxacin.
3. PHARMACEUTICAL FORM
A white to off-white oval-shaped film-coated tablet with breaklines on
both faces debossed
with LG 320 on both faces.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
Factive is indicated for the treatment of infections caused by
susceptible strains of the
designated microorganisms in the conditions listed below.
COMMUNITY-ACQUIRED PNEUMONIA (of mild to moderate severity) caused by
_ Streptococcus _
_pneumoniae_ (including multi-drug resistant strains [MDRSP])*, _
Haemophilus influenzae, _
_Moraxella _
_catarrhalis, _
_Mycoplasma _
_pneumoniae, _
_Chlamydia _
_pneumonia, _
_or _
_Klebsiella _
_pneumonia. _
*MDRSP:
multi-drug
resistant
_Streptococcus _
_pneumoniae,_
includes
isolates
previously
known as PRSP (penicillin resistant _ Streptococcus pneumonia_), and_
_ are strains resistant to
two or more of the following antibiotics: penicillin (MIC
≥
2
㎍
/mL), 2
nd
generation
cephalosporins
(e.g.,
cefuroxime),
macrolides,
tetracyclines
and
trimethoprim/sulfamethoxazole.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Factive and other antibacterial drugs, Factive should be used only to
treat infections that are
proven
or
strongly
suspected
to
be
caused
by
susceptible
bacteria.
When
culture
and
susceptibility information are available, they should be considered in
selecting or modifying
antibacterial therapy, In the absence of such data, local epidemiology
and susceptibility
patterns may contribute to the empiric selection of therapy.
4.2 DOSAGE AND ADMINISTRATION
Factive can be taken with or without food and should be swallowed
whole with a l