Moflox 400 Tablets

देश: तंज़ानिया

भाषा: अंग्रेज़ी

स्रोत: Tanzania Medicinces & Medical Devices Authority

सक्रिय संघटक:

Moxifloxacin

थमां उपलब्ध:

Future Pharmaceuticals Industries (FPi), EGYPT

ए.टी.सी कोड:

ANTIBACTERIALS FOR SYSTEMIC USE

INN (इंटरनेशनल नाम):

Moxifloxacin

डोज़:

400

फार्मास्यूटिकल फॉर्म:

Tablets

द्वारा बनाया गया:

Future Pharmaceutical Industries (FPi), EGYPT

उत्पाद समीक्षा:

Physical description: Pink to dark buff, oblong, biconvex film coated tablets with pale yellow core, engraved with FPI on one side and plain on the other side; Local technical representative: GAMA PHARMACEUTICALS (T) LIMITED

प्राधिकरण का दर्जा:

Registered/Compliant

प्राधिकरण की तारीख:

2022-01-10

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Moflox 400 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg Moxifloxacin equivalent to
436.33 mg
Moxifloxacin HCl.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pinkish red, oblong, biconvex.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Moflox 400 mg film-coated tablets are indicated for the treatment of
the following
bacterial infections in patients of 18 years and older caused by
bacteria susceptible to
Moxifloxacin (see sections 4.4, 4.8 and 5.1). Moxifloxacin should be
used only when it
is
considered
inappropriate
to
use
antibacterial
agents
that
are
commonly
recommended for the initial treatment of these infections or when
these have failed:
-
Acute bacterial sinusitis (adequately diagnosed)
-
Acute exacerbations of chronic bronchitis (adequately diagnosed)
-
Community acquired pneumonia, except severe cases
-
Mild to moderate pelvic inflammatory disease (i.e. infections of
female upper
genital tract, including salpingitis and endometritis), without an
associated tubo-
ovarian or pelvic abscess.
Moflox 400 mg film-coated tablets are not recommended for use in
monotherapy of mild
to moderate pelvic inflammatory disease but should be given in
combination with
another
appropriate
antibacterial
agent
(e.g.
a
cephalosporin)
due
to
increasing
Moxifloxacin
resistance
of
_Neisseria _
_gonorrhoeae _
unless
Moxifloxacin-
resistant
_Neisseria gonorrhoeae _can be excluded (see sections 4.4 and 5.1).
Moflox 400 mg film-coated tablets may also be used to complete a
course of therapy
in patients who have shown improvement during initial treatment with
intravenous
Moxifloxacin for the following indications:
-
Community-acquired pneumonia
-
Complicated skin and skin structure infections
Moflox 400 mg film-coated tablets should not be used to initiate
therapy for any
type
of
skin
and
skin structure
infection
or
in
severe
community-acquired
pneumonia.
Co