Cayston
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
03-03-2023
Valmisteyhteenveto
(SPC)
03-03-2023
Julkisesta arviointikertomuksesta
(PAR)
13-09-2012
Aktiivinen ainesosa:
aztreonam lysine
Saatavilla:
Gilead Sciences Ireland UC
ATC-koodi:
J01DF01
INN (Kansainvälinen yleisnimi):
aztreonam
Terapeuttinen ryhmä:
Antibacterials for systemic use,
Terapeuttinen alue:
Cystic Fibrosis; Respiratory Tract Infections
Käyttöaiheet:
Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Tuoteyhteenveto:
Revision: 20
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2009-09-21
Pakkausseloste
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAYSTON 75 MG POWDER AND SOLVENT FOR NEBULISER SOLUTION
aztreonam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Cayston is and what it is used for
2.
What you need to know before you take Cayston
3.
How to take Cayston
4.
Possible side effects
5.
How to store Cayston
6.
Contents of the pack and other information
1.
WHAT CAYSTON IS AND WHAT IT IS USED FOR
Cayston contains the active substance aztreonam. Caystonis an
antibiotic used to suppress chronic
lung infection caused by the bacteria
_Pseudomonas aeruginosa_
in patients aged 6 years and older with
cystic fibrosis. Cystic fibrosis, also known as mucoviscidosis, is a
life-threatening inherited disease
that affects the mucus glands of internal organs, especially the
lungs, but also of the liver, pancreas,
and the digestive system. Cystic fibrosis in the lungs leads to
clogging them with thick sticky mucus.
This makes it hard to breathe.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAYSTON
DO NOT TAKE CAYSTON
-
IF YOU ARE ALLERGIC
to aztreonam or any of the other ingredients of this medicine (listed
in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Cayston:
-
if you are
ALLERGIC TO ANY OTHER ANTIBIOTICS
(such as penicillins, cephalosporins, and/or
carbapenems)
-
if you do not tolerate or have chest tightness from taking other
inhaled medicines
-
if you have
KIDNEY PROBLEMS
-
if you have ever
COUGHED UP ANY BLOOD
-
if you have ever had
LOW LUNG FUNCTION TEST
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cayston 75 mg powder and solvent for nebuliser solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains aztreonam lysine equivalent to 75 mg aztreonam.
After reconstitution the nebuliser
solution contains 75 mg aztreonam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for nebuliser solution.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cayston is indicated for the suppressive therapy of chronic pulmonary
infections due to
_Pseudomonas _
_aeruginosa_
in patients with cystic fibrosis (CF) aged 6 years and older.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients should use a bronchodilator before each dose of Cayston.
Short acting bronchodilators can be
taken between 15 minutes and 4 hours and long acting bronchodilators
can be taken between
30 minutes and 12 hours prior to each dose of Cayston.
For patients taking multiple inhaled therapies, the recommended order
of administration is as follows:
1.
bronchodilator
2.
mucolytics
3.
and lastly, Cayston.
_Adults and children 6 years and older _
The recommended dose for adults is 75 mg three times per 24 hours for
28 days.
Doses should be taken at least 4 hours apart.
Cayston may be taken in repeated cycles of 28 days on therapy followed
by 28 days off Cayston
therapy.
The dosing in children aged 6 years and older is the same as for
adults.
3
_Elderly _
_ _
Clinical studies of Cayston did not include Cayston-treated patients
aged 65 years and older to
determine whether they respond differently from younger patients. If
Cayston is to be prescribed to
the elderly then the posology is the same as for adults.
_Renal impairment _
Aztreonam is known to be excreted renally and therefore administration
of Cayston in patients with
renal impairment (serum creatinine > 2 times upper limit of normal)
sh
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