LEVOFLOXACIN TEVA 5 Mg/Ml Solution for Infusion

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

LEVOFLOXACIN

Dostupné s:

Teva Pharma B.V.

ATC kód:

J01MA12

INN (Mezinárodní Name):

LEVOFLOXACIN

Dávkování:

5 Mg/Ml

Léková forma:

Solution for Infusion

Druh předpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Fluoroquinolones

Stav Autorizace:

Authorised

Datum autorizace:

2009-11-27

Informace pro uživatele

Levofloxacin 5 mg/ml Solution for infusion
UK/H/1311/01/DC
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN TEVA 5 MG/ML SOLUTION FOR INFUSION
Levofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 LEVOFLOXACIN TEVA SOLUTION FOR INFUSION IS AND WHAT IT IS USED
FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LEVOFLOXACIN TEVA SOLUTION
FOR INFUSION
3.
HOW LEVOFLOXACIN TEVA SOLUTION FOR INFUSION IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LEVOFLOXACIN TEVA SOLUTION FOR INFUSION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT LEVOFLOXACIN TEVA SOLUTION FOR INFUSION IS AND WHAT IT IS USED
FOR
The name of your medicine is Levofloxacin solution for infusion.
Levofloxacin solution for infusion
contains a medicine called levofloxacin. This belongs to a group of
medicines called antibiotics.
Levofloxacin is a ‘quinolone’ antibiotic. It works by killing the
bacteria that cause infections in your body.
Levofloxacin solution for infusion can be used to treat infections of
the:

Lungs, in people with pneumonia

Urinary tract including your kidneys or bladder

Prostate gland, where you have a long lasting infection

Skin and underneath the skin, including muscles. This is sometimes
called ‘soft tissue’
In some special situations, Levofloxacin solution for infusion may be
used to lessen the chances of getting a
pulmonary disease named anthrax or worsening of the disease after you
are exposed to the bacteria causing
anthrax.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LEVOFLOXACIN TEVA SOLUTION
FOR INFUSION
DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF:

You are allergic to levofloxacin,

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin Teva 5 mg/ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Solution for Infusion contains 5 mg of levofloxacin (as
hemihydrate).
Each 50 ml bag of Solution for Infusion contains 250 mg of
levofloxacin (as hemihydrate).
Each 100 ml bag of Solution for Infusion contains 500 mg of
levofloxacin (as hemihydrate).
Excipients with known effect:
Each ml of Solution for Infusion contains 0.15 mmol (3.546 mg) sodium
(as chloride)
50 ml Solution for Infusion contains 7.6 mmol (177.3 mg) sodium (as
chloride)
100 ml Solution for Infusion contains 15.2 mmol (354.6 mg) sodium (as
chloride)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear greenish-yellow solution
pH: 4.3-5.3; osmolarity: 285-325 mosmol/L
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levofloxacin solution for infusion is indicated in adults for the
treatment of the following infections (see sections 4.4
and 5.1):
Community-acquired pneumonia.
Complicated skin and soft tissue infections.
For the above-mentioned infections Levofloxacin should be used only
when it is considered inappropriate to use
antibacterial agents that are commonly recommended for the initial
treatment of these infections.
Pyelonephritis and complicated urinary tract infections (see section
4.4).
Chronic bacterial prostatitis.
Inhalation Anthrax: postexposure prophylaxis and curative treatment
(see section 4.4).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Levofloxacin solution for infusion is administered by slow intravenous
infusion once or twice daily. The dosage
depends on the type and severity of the infection and the
susceptibility of the presumed causative pathogen. Treatment
with Levofloxacin after initial use of the intravenous preparation may
be co