Avelox 400mg/250ml solution for infusion bottles

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Moxifloxacin hydrochloride

Tilgjengelig fra:

Bayer Plc

ATC-kode:

J01MA14

INN (International Name):

Moxifloxacin hydrochloride

Dosering :

1.6mg/1ml

Legemiddelform:

Solution for infusion

Administreringsrute:

Intravenous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05011200; GTIN: 5010605250040 5010605250217

Informasjon til brukeren

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
_ _
_ _
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.
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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.

Preparatomtale

OBJECT 1
AVELOX 400 MG/250 ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 26-Sep-2017 | Bayer plc
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).
_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 adolescent