Colobreathe
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
04-10-2023
Produktets egenskaber
(SPC)
04-10-2023
Offentlige vurderingsrapport
(PAR)
07-03-2012
Aktiv bestanddel:
Colistimethate sodium
Tilgængelig fra:
Teva B.V.
ATC-kode:
J01XB01
INN (International Name):
colistimethate sodium
Terapeutisk gruppe:
Antibacterials for systemic use,
Terapeutisk område:
Cystic Fibrosis
Terapeutiske indikationer:
Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Produkt oversigt:
Revision: 16
Autorisation status:
Authorised
Autorisation dato:
2012-02-13
Indlægsseddel
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLOBREATHE 1,662,500 IU INHALATION POWDER, HARD CAPSULES
colistimethate sodium
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 Colobreathe is and what it is used for
2.
What you need to know before you use Colobreathe
3.
How to use Colobreathe
4.
Possible side effects
5.
How to store Colobreathe
6.
Contents of the pack and other information
1.
WHAT COLOBREATHE IS AND WHAT IT IS USED FOR
Colobreathe contains colistimethate sodium, a type of antibiotic
called a polymyxin.
Colobreathe is used to control persistent lung infections caused by
the bacterium
_Pseudomonas _
_aeruginosa_
in adult patients and children aged 6 years and older with cystic
fibrosis.
_Pseudomonas _
_aeruginosa_
is a very common bacterium that infects nearly all cystic fibrosis
patients at some time
during their lives. Some people will get this infection whilst very
young but for others it will be much
later. If this infection is not properly controlled it will cause
damage to the lungs.
How it works
Colobreathe works by destroying the bacterial cell membrane, having a
lethal effect on them.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COLOBREATHE
DO NOT USE COLOBREATHE
•
if you/your child are allergic to colistimethate sodium, colistin
sulphate or polymyxins.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Colobreathe.
TELL YOUR DOCTOR IF YOU/YOUR CHILD HAS EVER HAD ANY OF THE FOLLOWING
CONDITIONS
•
have reacted badly to inhaled dry powde
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Colobreathe 1,662,500 IU inhalation powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1,662,500 IU, which is approximately equal to
125 mg of colistimethate
sodium.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder)
Hard transparent PEG-gelatin capsules containing a fine white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Colobreathe is indicated for the management of chronic pulmonary
infections due to
_Pseudomonas _
_aeruginosa_
in patients with cystic fibrosis (CF) aged 6 years and older (see
section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial active
substances.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_ _
_Adults and children of 6 years of age and older _
One capsule to be inhaled twice daily.
The dose interval should be as close as possible to 12 hours.
_ _
The efficacy of Colobreathe has been demonstrated in a study of
24-weeks duration. Treatment may be
continued for as long as the physician considers that the patient is
obtaining clinical benefit.
_Renal impairment_
No dose adjustment is considered to be necessary (see section 5.2).
_Hepatic impairment_
No dose adjustment is considered to be necessary (see section 5.2).
_Paediatric population_
The safety and efficacy of Colobreathe in children under 6 years of
age have not been established. No data
are available.
Method of administration
For inhalation use only.
Colobreathe capsules are to be used only with the Turbospin powder
inhaler.
The capsules must not be swallowed.
3
To ensure proper administration of the medicinal product, the patient
should be shown how to use the
inhaler by a physician or other health professional, with the first
dose being given under medical
supervision.
If other treatments are being taken, they should be taken in the
following order:
Inhaled bronchodilators
Chest physiotherapy
Other inhaled medicinal produc
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