AVELOX IV 400 moxifloxacin 400 mg/250 mL (as hydrochloride) intravenous infusion solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

moxifloxacin, Quantity: 1.6 mg/mL (Equivalent: moxifloxacin hydrochloride, Qty 1.744 mg/mL)

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections; sodium hydroxide

Administration route:

Intravenous

Units in package:

5 bottles, 1 bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AVELOX (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions. Acute bacterial sinusitis, Community acquired pneumonia, Acute exacerbations of chronic bronchitis. AVELOX IV (moxifloxacin hydrochloride) 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. AVELOX IV (moxifloxacin hydrochloride) 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 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: Clear yellow solution; Container Type: Bottle; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2002-01-31

Patient Information leaflet

200428 AVELOX
®
IV CMI
1
AVELOX
® IV
(AV·E·LOX)
_moxifloxacin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Avelox IV.
It does not contain all of the
available information on Avelox
IV. 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 Avelox
IV 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 AVELOX IV IS
USED FOR
Avelox IV 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.
Avelox IV 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 Avelox
tablets, if you receive them,
because it may contain additional
information specific to the tablets.
Avelox IV 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.
Avelox IV will not work against
infections caused by viruses such
as colds or the flu.
Avelox IV 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 AVELOX IV
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN AVELOX IV
IF YOU HAVE AN ALLERGY TO:
• moxifloxacin, the active
ingredient in Avelox
• any of the ingredients listed at the
end of this leaflet.
• other medicines belonging to the
quinolone family (e.g.
ciprofloxacin, norfloxaci

Summary of Product characteristics

Avelox PI VX1.0; CCDS 23
1
AUSTRALIAN PRODUCT INFORMATION – AVELOX
 (MOXIFLOXACIN
HYDROCHLORIDE) TABLET AND IV SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Moxifloxacin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 436.8 mg moxifloxacin hydrochloride, equivalent
to 400 mg moxifloxacin.
Each 250 mL solution for infusion contains 436.8 mg moxifloxacin
hydrochloride, equivalent to
400 mg moxifloxacin in 0.8% sodium chloride. The solution for infusion
(250 mL) contains 34
mmoL sodium.
3
PHARMACEUTICAL FORM
Avelox 400 mg tablets are dull red, oblong, convex film-coated tablets
with BAYER on one side
and M 400 on the other.
Avelox 400mg tablets contains lactose monohydrate.
Avelox IV is a sterile, preservative free aqueous solution of
moxifloxacin hydrochloride with pH
ranging from 4.1 to 4.6. The appearance of the intravenous solution is
yellow. The colour does
not affect, nor is it indicative of, product stability.
For the full list of excipients, see Section 6.1 List of excipients.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Avelox (moxifloxacin hydrochloride) tablets are indicated for the
treatment of adults with
infections caused by susceptible organisms in the conditions:
-
Acute bacterial sinusitis
-
Community acquired pneumonia
-
Acute exacerbations of chronic bronchitis
Avelox IV (moxifloxacin hydrochloride) 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
Avelox PI VX1.0; CCDS 23
2
-
Avelox IV (moxifloxacin hydrochloride) 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