Levofloxacin 5mg/ml solution for infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Levofloxacin

Verfügbar ab:

Hikma Farmacêutica (Portugal) S.A.

ATC-Code:

J01MA; J01MA12

INN (Internationale Bezeichnung):

Levofloxacin

Dosierung:

5 milligram(s)/millilitre

Darreichungsform:

Solution for infusion

Verschreibungstyp:

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

Therapiebereich:

Fluoroquinolones; levofloxacin

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2012-04-20

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN 5MG/ML SOLUTION FOR INFUSION
Levofloxacin
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 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
BEFORE TAKING THIS MEDICINE
You should not take fluoroquinolone/quinolone antibacterial medicines,
including Levofloxacin,
if you have experienced any serious adverse reaction in the past when
taking a

Fachinformation

Health Products Regulatory Authority
23 February 2022
CRN00C830
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin 5mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 5 mg of levofloxacin (as
hemihydrate).
100 ml glass vials:
Each 100ml vial of solution for infusion contains 500mg of
levofloxacin (as hemihydrate)
Excipients with known effect:
This medicinal product contains 16.2 mmol of sodium per 100ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear greenish-yellow solution free from particles.
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 previously indicated 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.

Acute 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
solution for infusion 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 considered
appropriate for the individual patient. Given the
bioequivalence of the parenteral and oral forms, the same dosage can
be u