Levofloxacin 5mg/ml Solution for infusion, glass bottle

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Levofloxacin hemihydrate

Prieinama:

Baxter Holding B.V.

ATC kodas:

J01MA; J01MA12

INN (Tarptautinis Pavadinimas):

Levofloxacin hemihydrate

Dozė:

5 milligram(s)/millilitre

Vaisto forma:

Solution for infusion

Recepto tipas:

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

Gydymo sritis:

Fluoroquinolones; levofloxacin

Autorizacija statusas:

Marketed

Leidimo data:

2012-09-28

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVOFLOXACIN 5 MG/ML SOLUTION FOR INFUSION
LEVOFLOXACIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, nurse, or
pharmacist.
•
If you get any side effects, talk to your doctor, nurse, or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Levofloxacin Solution for infusion is and what it is used for
2.
What you need to know before you use Levofloxacin Solution for
infusion
3.
How to use Levofloxacin Solution for infusion
4.
Possible side effects
5.
How to store Levofloxacin Solution for infusion
6.
Contents of the pack and other information
1. WHAT LEVOFLOXACIN 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 USE LEVOFLOXACIN SOLUTION FOR
INFUSION
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic to levofloxacin, any other quinolone antibiotic such
as moxifloxacin, ciprofloxacin or
ofloxacin or any of the othe

Prekės savybės

Health Products Regulatory Authority
04 November 2022
CRN00D0Y2
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin 5mg/ml Solution for infusion, glass bottle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 5 mg levofloxacin (as 5.12
mg of levofloxacin hemihydrate).
100 ml of solution for infusion contains 500 mg of levofloxacin as
levofloxacin hemihydrate.
Excipients with known effect:
This medicinal product contains 354 mg sodium per 100 ml of solution
of infusion.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Levofloxacin 5 mg/ml Solution for infusion is a clear yellow to
greenish-yellow solution with pH ranging from 3.80 to 5.80 and
osmolality ranging from 270 to 340 mOsmol/kg
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):

Acute pyelonephritis and complicated urinary tract infections (see
section 4.4)

Chronic bacterial prostatitis

Inhalation Anthrax: post exposure prophylaxis and curative treatment
(see section 4.4).
In the below-mentioned infections levofloxacin should be used only
when it is considered inappropriate to use other
antibacterial agents that are commonly recommended for the treatment
of these infections.

Community-acquired pneumonia

Complicated skin and soft tissue infections
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 completed with an
appropriate oral presentation according to the SPC for the
film-coated tablets and as co