Levofloxacin 5mg/ml solution for infusion, LDPE bottles

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levofloxacin

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

J01MA; J01MA12

INN (International Name):

Levofloxacin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Fluoroquinolones; levofloxacin

Authorization status:

Marketed

Authorization date:

2009-07-24

Patient Information leaflet

UK-IE PIL Levofloxacin 5mg/ml V010
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN 5MG/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, 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 is and what it is used for
2.
What you need to know before you are given Levofloxacin
3.
How to use Levofloxacin
4.
Possible side effects
5.
How to store Levofloxacin
6.
Contents of the pack and other information
1.
WHAT LEVOFLOXACIN IS AND WHAT IT IS USED FOR
The name of your medicine is Levofloxacine. Levofloxacin 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 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 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
DO NOT HAVE 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 other ingredients of this
medicine (listed in section 6)
•
Signs of an allergic reactivon include: a rash, swallowing or
breathing problems, swelling of
your lips, face, throat or ton

Summary of Product characteristics

Health Products Regulatory Authority
14 September 2023
CRN00DMMY
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin 5mg/ml solution for infusion, LDPE bottles
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
50 ML FILLED IN 100 ML BOTTLE/BAGS:
Each ml of solution for infusion contains 5 mg levofloxacin (as
levofloxacin hemihydrate).
50 ml of solution for infusion contains 250 mg of levofloxacin as
active substance.
100 ML FILLED IN 100 ML BOTTLE/BAGS:
Each ml of solution for infusion contains 5 mg levofloxacin (as
levofloxacin hemihydrate).
100 ml of solution for infusion contains 500 mg of levofloxacin as
active substance.
Excipient(s) with known effect: The medicinal product contains 3.54 mg
of sodium per ml
_For the full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Solution for infusion.
Yellow to greenish yellow solution
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: postexposure 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
p