Levofloxacin Ibigen 5 mg/ml solution for infusion (100ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVOFLOXACIN

Available from:

Ibigen S.r.L Via Fossignano, 2, 04011 Aprilia (LT), Italy

ATC code:

J01MA12

INN (International Name):

LEVOFLOXACIN 500 mg

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

LEVOFLOXACIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2012-02-29

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN IBIGEN 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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 Ibigen solution for infusion is and what it is used
for
2.
What you need to know before you are given Levofloxacin Ibigen
solution for infusion
3.
How Levofloxacin Ibigen solution for infusion is given
4.
Possible side effects
5.
How to store Levofloxacin Ibigen solution for infusion
6.
Contents of the pack and other information
1.
WHAT LEVOFLOXACIN IBIGEN SOLUTION FOR INFUSION IS AND WHAT IT IS USED
FOR
The name of your medicine is Levofloxacin Ibigen solution for
infusion. Levofloxacin Ibigen
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 IBIGEN 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.
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2.
WHAT YOU NEED TO KNOW BEFORE

Summary of Product characteristics

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of
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levofloxacin Ibigen 5 mg/ml solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 ml vial (5 mg/ml solution) contains 250 mg of levofloxacin as
levofloxacin hemihydrate.
Each 100 ml vial (5 mg/ml solution) contains 500 mg of levofloxacin as
levofloxacin hemihydrate.
Excipients with known effect:
50 ml of solution for infusion contain 7.7 mmol (177 mg) sodium
100 ml of solution for infusion contain 15.4 mmol (354 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear greenish-yellow isotonic solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levofloxacin Ibigen 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
In complicated skin and soft tissue infections Levofloxacin Ibigen
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: post exposure prophylaxis and curative treatment
(see section 4.4)
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Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage depends on the type and severity of the infection and the
susceptibility of the presumed
causative
pathogen.
Treatment
with
Levofloxacin
Ibigen
after
initial
use
of
the
intravenous
preparation may be completed with an appropriate oral presentation
according to the SPC of an
appropriate oral presentation and as considered appropriate for the
individual patient. Given the
bioequivalence of the parenteral and oral forms, the same dosage can
be used.
_ _
The following dose recommendations can be give