Cayston
aztreonam
aztreonam
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 Cayston is and what it is used for
What you need to know before you take Cayston
How to take Cayston
Possible side effects
How to store Cayston
Contents of the pack and other information
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.
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 tests.
If any of these apply to you tell your doctor before using Cayston.
As an inhaled medicine, Cayston could cause you to cough and this could lead to coughing up blood. If you have ever coughed up blood you should only use Cayston if your doctor thinks the benefit of taking this medicine outweighs the risk of coughing up blood.
You may get a temporary lowering of lung function test result during treatment with Cayston, but this is typically not a lasting effect.
Cayston is not for use in children under the age of 6 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
There are no clinical data on the use of Cayston in pregnant women, therefore you should not take Cayston during pregnancy unless specifically discussed with your doctor.
If you plan to breast-feed ask your doctor for advice before taking Cayston. You can breast-feed during treatment with Cayston because the amount of Cayston likely to be passed to your child during breast-feeding will be extremely small.
Cayston is not expected to affect your ability to drive or use machines.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Each dose consists of one vial of Cayston mixed with one ampoule of solvent. Cayston needs to be mixed with a solvent before being inhaled through the Altera Nebuliser.
Put the prepared Cayston solution in the Altera Nebuliser Handset (see below). Each treatment takes about 2 to 3 minutes to inhale.
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.
If you are using other inhaled therapies to treat cystic fibrosis, the recommended order of use is as follows:
bronchodilator
mucolytics (a medicine that helps to dissolve the thick mucous produced in the lungs) and finally:
Cayston.
Do not put other medicines in the Altera Nebuliser Handset.
Do not put the intravenous (injectable) form of aztreonam in the Altera Nebuliser Handset.
Intravenous aztreonam is not suitable for inhalation.
You will need the following:
One amber-coloured vial of Cayston with a blue cap.
One plastic ampoule of solvent (0.17% w/v sodium chloride). The information that appears on the solvent ampoule is provided in English only (see section 6).
An Altera Nebuliser Handset containing an Altera Aerosol Head connected to an eFlow Control
Unit of the type 178 (eFlow rapid) or type 678 (eBase Controller).
Do not prepare Cayston until you are ready to administer a dose.
Do not use Cayston if you notice that the package has been tampered with.
Do not use Cayston if it has been stored outside a refrigerator for more than 28 days.
Do not use the solvent or prepared Cayston if it is cloudy or if there are particles in the solution.
This helps to ensure that you get the proper dose of medicine.
Step A: With the blue cap tab facing toward you, place the vial on a flat surface. Using one hand to hold the vial steady, use the other hand to slowly flip up the blue cap.
Step B: Pull the blue cap down to a flat (horizontal) position (where the bottom of the blue cap faces up), to prepare the metal seal for removal. Do not completely tear through the metal seal.
Step C: While continuing to hold the vial steady with one hand, use the other hand to slowly pull the blue cap in a counterclockwise direction. Do not twist the blue cap.
Step D: When the metal seal opens, continue to slowly pull on the blue cap in a counterclockwise direction until the metal seal is completely removed.
Figure 1
Safely dispose of the metal seal. Carefully remove (but do not yet discard) the rubber stopper.
Figure 2
Figure 3a Figure 3b
Figure 4
A few drops of medicine may remain in the reservoir at the end of treatment. If there is more than a few drops of liquid left, replace the medicine cap and restart treatment.
If for any reason you must stop the treatment before you have finished, press and hold the On/Off button for one full second. To re-start the treatment, press and hold the On/Off button
for one full second and then restart the treatment.
The Altera Nebuliser Handset is designed to last for three 28-day courses of Cayston when used as directed. After this time replace your Altera Nebuliser Handset, including the aerosol head. If you notice that the performance has changed before this time (for instance, if it takes longer to produce a mist, more than 5 minutes), please refer to the Altera Nebuliser instructions for use.
If you have taken more Cayston than you should, talk to a doctor or pharmacist immediately.
If you miss a dose, you can still take all 3 daily doses as long as they are at least 4 hours apart. If you can’t leave a gap of 4 hours just skip the missed dose.
Do not stop taking Cayston without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (affects more than 1 user in 10)
Cough
Blocked nose
Wheezing
Sore throat
Shortness of breath
High temperature. This may be more common in children than in adults.
Common side effects (affects 1 to 10 users in 100)
Difficulty breathing
Chest discomfort
Runny nose
Coughing up blood
Rash
Joint pain
Lower lung function test results
Uncommon side effects (affects 1 to 10 users in 1000)
Joint swelling
The following side effects have been observed after the use of aztreonam for injection, but not after taking Cayston: swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing, sweating, skin irritation and flaking, itchy rash, flushing, small red spots and very rarely, blistering of the skin. All these may be signs of an allergic reaction.
Tell your doctor if you have any of these effects.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety
of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label, solvent ampoule and the carton. The expiry date refers to the last day of that month.
Powder vial and solvent ampoule:
Store in a refrigerator (2°C - 8°C). The unopened vials may also be stored outside the refrigerator but below 25°C for up to 28 days.
Use this medicine immediately after preparation. If not used immediately, the prepared solution must be stored at 2°C - 8°C and used within 8 hours. Do not prepare more than one dose at a time.
Do not use this medicine if you notice that the package has been tampered with.
Do not use this medicine if it has been stored outside a refrigerator for more than 28 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The powder vial contains 75 mg aztreonam (as lysine).
The solvent ampoule contains water for injections and sodium chloride. The ampoule is imprinted in English only. The information that appears on the ampoule is presented below:
Solvent for Cayston Sodium Chloride 0.17% |
Inhalation use only |
1 ml |
GILEAD SCIENCES |
Cayston is a white to off-white powder and solvent for nebuliser solution.
Cayston is contained in a 2 ml amber glass vial with a grey rubber stopper and aluminium tear-off overseal with a blue cap.
The 1 ml solvent is contained in a plastic ampoule.
Each 28-day pack of Cayston contains 84 vials of lyophilised Cayston and 88 solvent ampoules. The four additional solvent ampoules are provided in case of spillage.
The following pack sizes are available:
28-day pack of Cayston
Pack containing one 28-day pack of Cayston plus one Altera Nebuliser Handset Not all pack sizes may be marketed.
Gilead Sciences Ireland UC Carrigtohill
County Cork, T45 DP77 Ireland
Gilead Sciences Ireland UC
IDA Business & Technology Park Carrigtohill
County Cork Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Gilead Sciences Belgium SRL-BV Tél/Tel: + 32 (0) 2 401 35 50
Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
Gilead Sciences Ireland UC
Teл.: + 353 (0) 1 686 1888
Gilead Sciences Belgium SRL-BV Tél/Tel: + 32 (0) 2 401 35 79
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0
Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849
Gilead Sciences Ελλάς Μ.ΕΠΕ. Τηλ: +30 210 8930 100
Gilead Sciences GesmbH Tel: + 43 1 260 830
Gilead Sciences, S.L. Tel: + 34 91 378 98 30
Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00
Gilead Sciences, Lda. Tel: + 351 21 7928790
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences Ireland UC Tel: +353 (0) 214 825 999
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences Sweden AB Sími: + 46 (0) 8 5057 1849
Gilead Sciences Slovakia s.r.o Tel: + 421 232 121 210
Gilead Sciences S.r.l. Tel: + 39 02 439201
Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
Gilead Sciences Ελλάς Μ.ΕΠΕ. Τηλ: + 30 210 8930 100
Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1849
Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
Gilead Sciences Ireland UC Tel: + 44 (0) 8000 113700