MOXIFLOXACIN KABI moxifloxacin (as hydrochloride) 400mg/250mL intravenous infusion injection bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

moxifloxacin hydrochloride, Quantity: 1.75 mg/mL

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

moxifloxacin hydrochloride

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium sulfate; sulfuric acid; sodium acetate trihydrate; water for injections

Administration route:

Intravenous

Units in package:

1, 10, 20, 25 and 40

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Moxifloxacin Kabi intravenous solutions are indicated for treatment of adults who require initial IV therapy for the treatment of infections in the conditions:,- Community acquired pneumonia (caused by susceptible organisms),- Acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics,- Moxifloxacin Kabi intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents, (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin.,Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with Moxifloxacin Kabi may be initiated, in some conditions, before results of these tests are known. Once results become available, therapy should be continued with the most appropriate antibiotic therapy.

Product summary:

Visual Identification: The appearance of the intravenous solution is yellow.; Container Type: Bottle; Container Material: Plastic; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-05-09

Patient Information leaflet

CMI for Moxifloxacin Kabi
Jul
2018
Page 1 of 4
MOXIFLOXACIN KABI
Moxifloxacin Hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Moxifloxacin Kabi.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
receiving
Moxifloxacin
Kabi
against
the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE,
EVEN
AFTER
YOUR
TREATMENT
IS
FINISHED.
You may need to read it again.
WHAT MOXIFLOXACIN KABI
IS USED FOR
Moxifloxacin
Kabi
is
a
sterile
intravenous antibiotic used in adults
for
the
treatment
of
serious
infections of the lungs and airways.
It can also be used to treat severe,
complicated skin and skin structure
infections.
Moxifloxacin Kabi is used to start
the treatment and then your doctor
may prescribe tablets to complete
the course.
Remember to read the Consumer
Medicine
Information
for
Moxifloxacin tablets, if you receive
them,
because
it
may
contain
additional information specific to the
tablets.
Moxifloxacin
Kabi
contains
the
active
ingredient,
moxifloxacin,
which is an antibiotic belonging to a
group
of
medicines
called
quinolones. These antibiotics work
by
killing
the
bacteria
that
are
causing your infection.
Moxifloxacin
Kabi
will
not
work
against infections caused by viruses
such as colds or the flu.
Moxifloxacin
Kabi
is available by
prescription only, and is used in a
hospital environment only.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE GIVEN
MOXIFLOXACIN KABI
_WHEN YOU MUST NOT BE GIVEN IT _
YOU
MUST
NOT
BE
GIVEN
MOXIFLOXACIN KABI IF YOU HAVE AN
ALLERGY TO:
•
moxifloxacin,
the
active
ingredient
in
Moxifloxacin
Kabi
•
any of the ingredients listed
at the end of this leafl

Summary of Product characteristics

Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION-
MOXIFLOXACIN KABI (MOXIFLOXACIN HYDROCHLORIDE)
1.
NAME OF MEDICINE
Moxifloxacin hydrochloride.
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Moxifloxacin
Kabi
is
available
in
ready-to-use
250
mL
(containing
400
mg
of
moxifloxacin) FREE_flex_
_®_
bags or KabiPac infusion bottles, as a sterile, preservative
free aqueous solution of moxifloxacin hydrochloride with pH ranging
from 5.0 to 6.0.
The appearance of the intravenous solution is yellow. The colour does
not affect, nor
is it indicative of, product stability. The inactive ingredients are
sodium acetate
trihydrate, sodium sulfate, sulfuric acid and Water for Injections.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Moxifloxacin
Kabi
(moxifloxacin
hydrochloride)
is
a
synthetic
broad
spectrum
antibacterial agent and is available as Moxifloxacin Kabi IV infusion
solution for
intravenous administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moxifloxacin Kabi intravenous solutions are indicated for treatment of
adults who
require initial IV therapy for the treatment of infections in the
conditions:
−
Community acquired pneumonia (caused by susceptible organisms)
−
Acute
exacerbations
of
chronic
bronchitis
when
caused
by
organisms
bacteriologically proven to be resistant to other classes of
antibiotics or when
there is intolerance to other antibiotics
−
Moxifloxacin Kabi intravenous solutions are indicated for treatment of
adults
with severe and complicated skin and skin structure infections who
require
initial parenteral therapy, and who have intolerance to alternative
agents,
(especially penicillin allergy), and when caused by organisms known to
be
susceptible to moxifloxacin.
Appropriate culture and susceptibility tests should be performed
before treatment in
order to isolate and identify organisms causing infection and to
determine their
susceptibility to moxifloxacin. Therapy with Moxifloxacin Kabi may be
initiated, in
some conditions, before results of