Quinsair

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

levofloxacin

Beschikbaar vanaf:

Chiesi Farmaceutici S.p.A

ATC-code:

J01MA12

INN (Algemene Internationale Benaming):

levofloxacin

Therapeutische categorie:

Antibacterials for systemic use,

Therapeutisch gebied:

Cystic Fibrosis; Respiratory Tract Infections

therapeutische indicaties:

Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Product samenvatting:

Revision: 15

Autorisatie-status:

Authorised

Autorisatie datum:

2015-03-25

Bijsluiter

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUINSAIR 240 MG NEBULISER SOLUTION
levofloxacin
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Quinsair is and what it is used for
2.
What you need to know before you use Quinsair
3.
How to use Quinsair
4.
Possible side effects
5.
How to store Quinsair
6.
Contents of the pack and other information
1.
WHAT QUINSAIR IS AND WHAT IT IS USED FOR
Quinsair contains an antibiotic medicine called levofloxacin. It
belongs to the group of antibiotics
called fluoroquinolones.
Quinsair is used to treat LUNG INFECTIONS caused by _Pseudomonas_
_aeruginosa _in adults with CYSTIC
FIBROSIS. It is an antibiotic medicine that is breathed (inhaled)
directly into the lungs where it kills the
bacteria causing the infection. This helps to improve breathing in
people with cystic fibrosis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE QUINSAIR
DO NOT USE QUINSAIR:
-
if you are ALLERGIC to LEVOFLOXACIN, to any other QUINOLONE
ANTIBIOTICS, such as moxifloxacin,
ciprofloxacin or ofloxacin, or to any of the other ingredients of this
medicine (listed in
section 6)
-
if you have ever had a problem with your tendons (INFLAMMATION of a
TENDON or a RUPTURED
TENDON) during treatment with a QUINOLONE OR FLUOROQUINOLONE
ANTIBIOTIC
-
if you suffer

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Quinsair 240 mg nebuliser solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of nebuliser solution contains levofloxacin hemihydrate
equivalent to 100 mg of
levofloxacin. Each ampoule contains 240 mg of levofloxacin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nebuliser solution.
Clear, pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quinsair is indicated for the management of chronic pulmonary
infections due to _Pseudomonas _
_aeruginosa_ in adult patients with cystic fibrosis (CF, see section
5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial medicinal
products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is 240 mg (one ampoule) administered by
inhalation twice daily (see
section 5.2). The doses should be inhaled as close as possible to 12
hours apart.
Quinsair is taken in alternating cycles of 28 days on treatment
followed by 28 days off treatment.
Cyclical therapy may be continued for as long as the physician
considers that the patient is obtaining
clinical benefit.
If a dose is missed, it should be taken as soon as the patient
remembers providing that at least an 8-
hour interval is allowed before inhaling the next dose. Patients
should not inhale the contents of more
than one ampoule to compensate for the missed dose.
If acute symptomatic bronchospasm occurs after receiving Quinsair,
patients may benefit from the use
of a short-acting inhaled bronchodilator at least 15 minutes to 4
hours prior to subsequent doses (see
sections 4.4 and 4.8).
_Elderly patients_
_(≥_
_ 65 years old)_
The safety and efficacy of Quinsair in elderly patients wi