CAYSTON

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AZTREONAM

Available from:

GILEAD SCIENCES ISRAEL LTD

ATC code:

J01DF01

Pharmaceutical form:

LYOPHILIZED POWDER FOR NEBULISER SOLUTION

Composition:

AZTREONAM 75 MG/VIAL

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

GILEAD SCIENCES IRELAND UC, IRELAND

Therapeutic area:

AZTREONAM

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.

Authorization date:

2019-02-28

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is to be supplied upon physician’s prescription only
CAYSTON
®
Powder and solvent for nebuliser solution
ACTIVE INGREDIENTS - each vial contains Aztreonam 75mg
Inactive ingredients and allergens: See section 6 “_Additional
information_”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains summary information about this medicine. If you have any
further questions,
refer to the physician or the pharmacist.
This medicine has been prescribed for treating your illness. Do not
pass it on to others.
It may harm them, even if it seems to you that their illness is
similar.
The medicine is not intended for children under the age of 6 years.
1. WHAT IS CAYSTON INTENDED FOR?
Cayston is used to suppress chronic lung infection caused by the
bacteria
_Pseudomonas aeruginosa_ in patients aged 6 years and older with
cystic fibrosis.
THERAPEUTIC GROUP: antibiotic.
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. BEFORE TAKING CAYSTON
.X. DO NOT USE THIS MEDICINE IF:
•
You are sensitive
(
allergic) to the active ingredient or to any of the other
ingredients that this medicine contains (see section 6).
.!. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
BEFORE USING CAYSTON, TELL YOUR PHYSICIAN IF:
•
you are ALLERGIC TO ANY OTHER ANTIBIOTICS (such as penicillins,
cephalosporins,
and/or carbapenems).
•
you do not tolerate or have chest tightness from taking other inhaled
medicines.
•
you have KIDNEY PROBLEMS.
•
you have ever COUGHED UP ANY BLOOD.
•
you have ever had LOW LUNG FUNCTION TESTS.
If any of these apply to you TELL YOUR DOCTOR before using Cayston.
As an inhaled medicine, Cayston could cau

Summary of Product characteristics

1
The format of this leaflet was defined by the Ministry of Health and
its content was checked
and approved by the Ministry of Health in March 2014 and updated
according to the
guidelines of the Ministry of Health in November 2019.
Cayston
®
1.
NAME OF THE MEDICINAL PRODUCT
Cayston
®
.
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.
2
The dosing in children aged 6 years and older is the same as for
adults.
_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