Avelox 400mg/250ml solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MOXIFLOXACIN

Available from:

Bayer Public Limited Company

ATC code:

J01MA14

INN (International Name):

MOXIFLOXACIN

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

MOXIFLOXACIN 400 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2010-08-05

Patient Information leaflet

v017_0
Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVELOX 400MG/250ML SOLUTION FOR INFUSION
For use in adults
Moxifloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Avelox is and what it is used for
2.
What you need to know before you are administered Avelox
3.
How to use Avelox
4.
Possible side effects
5.
How to store Avelox
6.
Contents of the pack and other information
1.
WHAT AVELOX IS AND WHAT IT IS USED FOR
Avelox contains the active substance moxifloxacin, which belongs to a
group of antibiotics
called fluoroquinolones. Avelox works by killing bacteria that cause
infections if they are
caused by bacteria that are susceptible to moxifloxacin.
Avelox is used in adults for treating the following bacterial
infections:
-
Infection of the lungs (pneumonia) acquired outside the hospital
-
Infections of the skin and soft tissue
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE ADMINISTERED AVELOX
Contact your doctor if you are not sure if you belong to a patient
group described below.
DO NOT USE AVELOX
-
If you are allergic to the active substance moxifloxacin, any other
quinolone antibiotics
or any of the other ingredients of this medicine (listed in section
6.).
-
If you are pregnant or breast-feeding.
-
If you are under 18 years of age.
-
If you have a history of tendon disease or disorder which was related
to treatment with
quinolone antibiotics (see sections
_Warnings and precautions ... _
and
_ 4. Possible side _
_effects_
).
-
If you were born with or have had any condition with abnormal heart
rhythm (seen on
ECG, electrical recording of the heart).
-
If you have salt imbalance in the blood (especially low levels of

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg/250 ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 bottle or 1 bag of 250 ml contains 400 mg moxifloxacin (as
hydrochloride).
1 ml contains 1.6 mg moxifloxacin (as hydrochloride).
Excipient with known effect: 250 ml of solution for infusion contains
787mg (34 mmol)
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avelox is indicated for the treatment of:
-
Community acquired pneumonia (CAP)
-
Complicated skin and skin structure infections (cSSSI)
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.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 400 mg moxifloxacin, infused once daily.
Initial intravenous treatment may be followed by oral treatment with
moxifloxacin 400 mg
tablets, when clinically indicated.
In clinical studies most patients switched to oral therapy within 4
days (CAP) or 6 days
(cSSSI). The recommended total duration of intravenous and oral
treatment is 7 - 14 days for
CAP and 7 - 21 days for cSSSI.
_Renal/hepatic impairment_
No adjustment of dosage is required in patients with mild to severely
impaired renal function
or in patients on chronic dialysis i.e. haemodialysis and continuous
ambulatory peritoneal
dialysis (see section 5.2 for more details).
There is insufficient data in patients with impaired liver function
(see section 4.3).
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_Other special populations_
No adjustment of dosage is required in the elderly and in patients
with low bodyweight.
_Paediatric population_
Moxifloxacin is contraindicated in children and growing adolescents.
Efficacy and safety of
moxifloxacin in children and ado