Kinolox 400mg Tablets

国家: 马来西亚

语言: 英文

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

有效成分:

MOXIFLOXACIN HCL

可用日期:

NOVUGEN PHARMA SDN. BHD.

INN（国际名称）:

MOXIFLOXACIN HCL

每包单位数:

7 Tablets; 5 Tablets; 10 Tablets; 14 Tablets

厂商:

PHARMANIAGA MANUFACTURING BERHAD

资料单张

1 KINOLOX 400MG FILM COATED TABLETS
Moxifloxacin (400mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Kinolox is used for
2.
How Kinolox works
3.
Before you use Kinolox
4.
How to use Kinolox
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Kinolox
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT KINOLOX IS USED FOR
Kinolox is used in patients aged 18 years
and above to treat infections caused by
certain bacteria which include:
•
Infections of the sinuses.
•
Sudden worsening of long-term
inflammation of the airways
•
Infection
of
the
lower
respiratory
tract (pneumonia) acquired outside
hospital.
•
Mild to moderate infections of the
female
upper
genital
tract
(pelvic
inflammatory
disease),
including
infections of the fallopian tubes and
uterus mucous membrane.
Kinolox
is
not
sufficient
on
its
own
for
treating this kind of infection hence
another
antibiotic
in
addition
to
Kinolox
should
be
prescribed
by
your doctor for treatment of these
infections.
•
Infection of the skin, soft tissue and
infection
occurring
within
the
abdomen.
HOW MAXIFLOXACIN WORKS
Kinolox works by killing bacteria that
cause infections.
BEFORE YOU USE KINOLOX
-
_When you must not take it _
Do not take this medicine
•
If you have an allergy to Kinolox,
other quinolone antibiotics or any of
the other ingredients listed at the end
of this leaflet
•
If you have serious adverse reactions
in the past when using quinolones or
fluroquinolone containing products
•
If you are pregnant or breast-feeding
•
If you are under 18 years of age
•
If you previously had problems with
your tendons related to treatment with
quinolone antibiotics
•
If you are born with or have
-
Any
condition
with
abnormal
heart rhythm (as in ECG)
-
Salt
imbalance
in
the
blood
(especially
low
levels
of
potassium in the blood)
-
A
very
slow
heart
rhythm
(bradycardia)
-
A weak heart (heart failure)
-
A
history
of
abnormal
heart
rhythms

产品特点

KINOLOX 400MG FILM COATED TABLETS
NAME OF THE MEDICINAL PRODUCT
Moxifloxacin 400 mg film coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 436.34 mg Moxifloxacin Hydrochloride
(as monohydrate),
equivalent to 400mg Moxifloxacin.
PHARMACEUTICAL FORM
Orange coloured, oval shaped biconvex film-coated tablet debossed with
“N” on one side and
“400” on other side.
INDICATIONS
Kinolox 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.
Kinolox 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 moxifloxacin; that is, unless moxifloxacin-resistant
_Neisseria gonorrhoeae_
can be ruled out.
•
Complicated skin and skin structure infections
•
Complicated intra-abdominal infections including polymicrobial
infections such as
abscesses
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
DOSAGE AND METHOD OF ADMINISTRATION
DOSE (ADULTS)
The recommended dose for Kinolox is 400 mg once daily (1 film coated
tablet) for the above-
mentioned indications and should not be exceeded.
DURATION OF TREATMENT
The duration of treatment should be determined by the severity of the
indication or clinical
response. The following general recommendations for the treatment of
upper and lower
respiratory tract infections are made:
Bronchitis: acute exacerbation of chronic bronchitis: 5 days
Pneumonia: community acquired pneumon