Avelox IV 400

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Moxifloxacin hydrochloride 436.8mg equivalent to 400 mg moxifloxacin

Available from:

Bayer New Zealand Limited

INN (International Name):

Moxifloxacin hydrochloride 436.8 mg (equivalent to 400 mg moxifloxacin)

Dosage:

400 mg

Pharmaceutical form:

Solution for infusion

Composition:

Active: Moxifloxacin hydrochloride 436.8mg equivalent to 400 mg moxifloxacin Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Units in package:

Bag, plastic, Polyolefin, infusion, 250 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Avelox tablets and solution for infusion is indicated for the treatment of the following bacterial infections caused by susceptible strains: · Complicated intra-abdominal infections including polymicrobial infections such as abscesses

Product summary:

Package - Contents - Shelf Life: Bag, plastic, Polyolefin, infusion - 250 mL - 36 months from date of manufacture stored at or below 30°C. Do not store below 15°C. Do not refrigerate. - Bottle, glass, Type 2, chlorobutyl or bromobutyl rubber stopper - 250 mL - 60 months from date of manufacture stored at or below 30°C. Do not store below 15°C. Do not refrigerate.

Authorization date:

2001-03-16

Patient Information leaflet

AVELOX
®
IV NZ CMI – CCDS22
Page 1 of 4
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
infections of the lungs, airways
and sinuses. Avelox IV can also
be used to treat severe and
complicated skin and skin
structure infections, and
complicated infections within
the abdomen.
Your doctor may choose to
prescribe tablets to finish the
course rather than keep you on
Avelox IV for the whole
treatment period.
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
fluoroquinolones. 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 IV
•
any of the ingredients listed
at the

Summary of Product characteristics

191001 Avelox Data Sheet
Page 1 of 26
NEW ZEALAND DATA SHEET
AVELOX® (MOXIFLOXACIN)
1
PRODUCT NAME
AVELOX 400 mg moxifloxacin film coated tablet
AVELOX 400 mg moxifloxacin solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 436.8 mg moxifloxacin hydrochloride, equivalent
to 400 mg
moxifloxacin.
Excipient
with
known
effect:
The
film-coated
tablet
contains
68
mg
lactose
monohydrate (= 66.56 mg lactose)
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.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The film coated tablets are dull red, oblong and convex, 17 x 7 mm
with 10 mm
radius of curvature weighing 693.8 – 699.8 mg. They are marked
“Bayer” on one
side and “M 400” on the other side.
The IV infusion is available in either a polyolefin flexible bag or a
glass bottle filled
with a minimum of 250 mL clear, yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avelox tablets and solution for infusion are indicated for the
treatment of the
following bacterial infections caused by susceptible strains:

Bronchitis (acute exacerbations of chronic bronchitis)

Pneumonia (community acquired)

Sinusitis (acute)

Complicated skin and skin structure infections (including diabetic
foot infections)

Complicated intra-abdominal infections including polymicrobial
infections such
as abscesses
Avelox tablets are indicated for the treatment of the following
bacterial infections
caused by susceptible strains:

Uncomplicated pelvic inflammatory disease (i.e. infections of female
upper
genital tract, including salpingitis and endometritis)
191001 Avelox Data Sheet
Page 2 of 26
Consideration should be given to available official guidance on the
appropriate use
of antibacterial agents.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dose for Avelox is 400 mg onc