Quinsair 240mg nebuliser solution ampoules

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Levofloxacin hemihydrate

Dostupno od:

Chiesi Ltd

INN (International ime):

Levofloxacin hemihydrate

Doziranje:

100mg/1ml

Farmaceutski oblik:

Nebuliser liquid

Administracija rute:

Inhalation

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 05011200; GTIN: 5060415920060

Uputa o lijeku

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
. If the infection is not properly treated it will continue to damage
the lungs, causing further
problems with breathing.
_ _
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
BROKEN
TENDON
) during treatment with another
QUINOLONE ANTIBIOTIC
-
if you suffer from
EPILEPSY
-
if you are
PREGNANT
or BREAST-FEEDING
WARNINGS AND PRECAUTIONS
TELL YOUR DOCTOR BEFO

Svojstava lijeka

OBJECT 1
QUINSAIR 240 MG NEBULISER SOLUTION
Summary of Product Characteristics Updated 13-Jun-2018 | Chiesi
Limited
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 agents.
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).
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.
The doses should be inhaled as close as possible to 12 hours apart.
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 s