Levofloxacin 5mg/ml solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVOFLOXACIN

Available from:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC code:

J01MA12

INN (International Name):

LEVOFLOXACIN 5 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

LEVOFLOXACIN 5 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2009-10-21

Patient Information leaflet

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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 tongue
 You have ever had epi

Summary of Product characteristics

MT Levofloxacin SmPC
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Levofloxacin 5mg/ml solution for infusion.
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 3.5 mg of sodium per
ml.
For a 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
MT Levofloxacin SmPC
Page 2 of 21

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 as cons