Levofloxacin 5mg/ml Solution for Infusion (50ml vial)

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

LEVOFLOXACIN

Prieinama:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC kodas:

J01MA12

INN (Tarptautinis Pavadinimas):

LEVOFLOXACIN 5 mg/ml

Vaisto forma:

SOLUTION FOR INFUSION

Sudėtis:

LEVOFLOXACIN 5 mg/ml

Recepto tipas:

POM

Gydymo sritis:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorizacija statusas:

Withdrawn

Leidimo data:

2010-04-29

Pakuotės lapelis

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN 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.
-
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 are given Levofloxacin solution for
infusion
3.
How Levofloxacin solution for infusion is given
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 ARE GIVEN LEVOFLOXACIN SOLUTION FOR
INFUSION
DO NOT HAVE LEVOFLOXACIN SOLUTION FOR INFUSION
-
if you are allergic to levofloxacin, any other quinolone antibiotic
such as moxifloxacin,
ciprofloxacin or ofloxacin or any of the othe

Prekės savybės

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levofloxacin 5 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 5 mg of Levofloxacin (as
hemihydrate).
Each 50 ml vial of solution for infusion contains 250 mg of
levofloxacin (as hemihydrate).
Each 100 ml vial of solution for infusion contains 500 mg of
levofloxacin (as hemihydrate).
Excipient(s) with known effect:
Each ml of solution for infusion contains 0.15 mmol (3.54 mg) sodium
(as chloride).
50 ml of solution for infusion contains 7.70 mmol (177.10 mg) sodium
(as chloride).
100 ml of solution for infusion contain 15.40 mmol (354.20 mg) sodium
(as chloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
A clear greenish-yellow solution, free from foreign particles.
pH: 4.5 – 5.1
Osmolality: 290 mOsmol/Kg ± 5%
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.
Page 2 of 16
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 ma