AVELOX TABLET

国: マレーシア

言語: 英語

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

有効成分:

MOXIFLOXACIN HCL

から入手可能:

BAYER CO. (MALAYSIA) SDN. BHD.

INN（国際名）:

MOXIFLOXACIN HCL

パッケージ内のユニット:

5Tablet Tablets

製:

BAYER HEALTHCARE MANUFACTURING S.R.L

情報リーフレット

AVELOX
®
Moxifloxacin (400 mg film-coated tablets)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Avelox_
is used for
2.
How
_Avelox_
works
3.
Before you use
_Avelox_
4.
How to use
_Avelox_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Avelox_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT _AVELOX_ IS USED FOR
Avelox is used for treating the following
bacterial infections when caused by
bacteria against which moxifloxacin is
active:
-
Infections of the respiratory tract:
Sudden worsening of long term
inflammation
of
the
airways
(chronic bronchitis), infection of
the
lungs
(pneumonia)
acquired
outside
the
hospital,
or
acute
infection of the sinuses
-
Mild to moderate infections of the
female upper genital tract (pelvic
inflammatory disease), including
infections of the fallopian tubes
and
infections
of
the
uterus
mucous membrane.
-
Severe infections of the skin and
associated soft tissues (e.g. major
abscesses,
infected
burns
and
ulcers,
infected
bite
wounds,
diabetic foot infections)
-
Severe
infections
of
the
abdominal
cavity
such
as
abscesses
HOW _AVELOX_ WORKS
Avelox
contains
the
active
substance
moxifloxacin which belongs to a group
of
antibiotics
called
fluoroquinolones.
Avelox
works
by
killing
bacteria
that
cause infections.
BEFORE YOU USE _AVELOX _
- When you must not use it
DO NOT TAKE _AVELOX_
-
If you are allergic to the active
substance moxifloxacin, any
other quinolone antibiotics or
any of the other ingredients of
this medicine
-
If you are pregnant or breast-
feeding.
DO NOT TAKE AVELOX AND TELL YOUR
DOCTOR
if any of these apply to you.
- Before you start to use it
You should not take fluoroquinolone
antibacterial medicines, including
Avelox, if you have experienced any
serious adverse reaction in the past when
taking a fluoroquinolone (see section
Things to be careful of and Side effects).
In this situation, you should inform your
healthcare providers as soon as possibl

製品の特徴

Reference : Moxifloxacin/ Film-coated Tablets / Solution for Infusion
/ CCDS / Version 23 /January 2021
AVELOX ®
NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg film-coated tablets
Avelox 400 mg solution for infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film-coated tablet
1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).
Solution for infusion
1 bottle or bag contains 250 mL solution for infusion containing 400
mg moxifloxacin
(as hydrochloride).
PHARMACEUTICAL FORM
Film-coated tablet
Dull red film-coated tablet with an oblong, convex shape with facet, a
dimension of 17x7
mm with 10 mm radius of curvature and a weight of
693.8-699.8mg.“Bayer”on one side
and “M 400” on the other side.
Dull red film-coated tablet with an oblong, convex shape with facet, a
dimension of 17x7
mm with 10 mm radius of curvature and a weight of
693.8-699.8mg.“blanc”on one side
and “M 400” on the other side.
Solution for infusion
250 mL polyolefine flexible bag filled with minimum 250 mL clear,
yellow solution.
250 mL glass bottle with clear, yellow solution filled with minimum
250 mL.
INDICATIONS
Avelox tablets are indicated for the treatment of adults (> 18 years
of age) with the
following bacterial infections caused by susceptible strains:
•
Acute sinusitis
•
Acute exacerbations of chronic bronchitis
_ _
•
Community acquired pneumonia
•
Mild to moderately severe inflammatory pelvic diseases (i.e.
Infections of the
upper female genital tract, including salpingitis and endometritis),
without an
associated tubo-ovarian or pelvic abscess.
Avelox 400 mg film-coated tablets are not recommended for monotherapy
of mild
to moderately severe inflammatory pelvic diseases. Preferably, they
should be
administered in combination with another suited antibiotic (such as
cephalosporin), due to the increasing resistance of
_Neisseria gonorrhoeae_
to
Reference : Moxifloxacin/ Film-coated Tablets / Solution for Infusion
/ CCDS / Version 23 /January 2021
moxifloxacin; that is, unless moxifloxacin-resistant
_Neiss