MOXIFLOXACIN-BAXTER moxifloxacin (as hydrochloride) 400 mg/250 mL solution for intravenous infusion bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

moxifloxacin hydrochloride, Quantity: 1.74 mg/mL

Disponible des:

Baxter Healthcare Pty Ltd

Designació comuna internacional (DCI):

moxifloxacin hydrochloride

formulario farmacéutico:

Injection, intravenous infusion

Composición:

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

Vía de administración:

Intravenous Infusion

Unidades en paquete:

1 x 250 mL

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

MOXIFLOXACIN-BAXTER is indicated for treatment of adults who require initial I.V. 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-BAXTER is 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-BAXTER 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.

Resumen del producto:

Visual Identification: Clear, greenish yellow solution, essentially free from visible particles; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2016-08-30

Informació per a l'usuari

MOXIFLOXACIN-CLARIS
_moxifloxacin hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about MOXIFLOXACIN-CLARIS
It does not contain all of the available information on
MOXIFLOXACIN-CLARIS. 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-
CLARIS 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-CLARIS IS USED FOR
MOXIFLOXACIN-CLARIS 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-CLARIS is used to start the treatment and then your
doctor may prescribe tablets to complete the
course.
MOXIFLOXACIN-CLARIS 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-CLARIS will not work against infections caused by viruses
such as colds or the flu.
MOXIFLOXACIN-CLARIS 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-CLARIS
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN MOXIFLOXACIN-CLARIS IF YOU HAVE AN ALLERGY TO:
• moxifloxacin, the active ingredient in MOXIFLOXACIN-CLARIS
• any of the ingredients listed at the end of this leaflet.
• other medicines belonging to the quinolone family (e.g.
ciprofloxacin, norfloxacin, nalidixic acid)
Some of the symptoms of an allergic reaction may includ

Fitxa tècnica

PRODUCT INFORMATION
MOXIFLOXACIN-CLARIS
CLARIS LIFESCIENCES AUSTRALIA PTY LTD
NAME OF THE MEDICINE
Moxifloxacin (as hydrochloride) 400 mg/250 mL solution for infusion.
T h e
c h e m i c a l
n a m e
i s
1-cyclopropyl-7-{(_S,S_)-2,8-
diaza-bicyclo[4.3.0]non-8-yl}-6-fluoro-8-
methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid hydrochloride and
t h e chemical structure is:
The CAS number is 186826-86-8
The empirical formula is C
21
H
23
FN
3
O
4
.HCl
The molecular weight is 437.9
DESCRIPTION
Moxifloxacin hydrochloride is a light yellow or yellow powder or
crystals.
Moxifloxacin-Claris
is
a
sterile,
clear,
greenish-yellow
aqueous
solution
containing
moxifloxacin
hydrochloride equivalent to moxifloxacin 400 mg/250 mL with sodium
chloride in water for injections.
The pH is adjusted to 4.1 – 4.6 with hydrochloric acid or sodium
hydroxide.
PHARMACOLOGY
Oral moxifloxacin is unavailable in this brand however is available in
other brands. Pharmacokinetic
information obtained using oral moxifloxacin is also included in the
following sub-sections for completion
and for information of the prescribers.
PHARMACOKINETICS
Absorption
Following oral administration, moxifloxacin is absorbed rapidly and
almost completely with an absolute
bioavailability of approximately 90%. Concomitant administration of
moxifloxacin together with food
slightly prolongs the time to reach peak concentrations by
approximately 2 hours and slightly reduced
peak concentrations by approximately 16%. Extent of absorption
remained unchanged. As AUC/MIC is
most predictive for antimicrobial efficacy of quinolones, this effect
is clinically not relevant. Therefore,
moxifloxacin can be administered independent from meals.
The mean (+SD) C
max
and AUC values following single and multiple doses of 400 mg
moxifloxacin given
orally or by 1 hour I.V. infusion are summarised below.
C
MAX
(MG/L)
AUC
HALF-LIFE (HR)
Single Dose Oral
Healthy (n = 372)
3.1 + 1.0
36.1 + 9.1
11.5 - 15.6*
Single Dose I.V.
Healthy young (n = 56)
Patients (n = 118)
Male (n = 64)
Female (n = 5