aztreonam: package leaflet

place the mouthpiece in your mouth and close your lips around it (Figure 4).

Keep the nebuliser handset level.

eFlow® Technology logo will appear on the display. Select the treatment mode by pressing the OK button when using the eTrack Controller.

aerosol mist does not begin to flow, please refer to the instructions for use of the Altera Nebuliser Handset. .

nose. Continue to inhale and exhale comfortably until the treatment is finished.

complete” (2 beeps) and the dose complete checkmark will appear briefly on the display.

Figure 4

Figure 3a

Figure 3b

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.

7.
Once treatment is complete, disconnect the eBase Controller or the eTrack Controller and take apart the Altera Nebuliser Handset for cleaning and disinfecting. For complete details on cleaning and disinfecting refer to the manufacturer’s instructions for use provided with your Altera Nebuliser Handset.

What if I need to stop my treatment before I’ve finished?
8.
If for any reason you must stop the treatment before you have finished, press the ON/OFF button. To restart the treatment, press the ON/OFF button again and restart the treatment.
Replacing the Altera Nebuliser Handset

Refer to the Altera Nebuliser Handset instructions for use for guidance on when to replace the handset.
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 take more Cayston than you should

If you have taken more Cayston than you should, talk to a doctor or pharmacist immediately.

If you forget to take Cayston

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.

If you stop taking Cayston

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.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get a rash, tell your doctor immediately because this could mean that you have an allergic reaction to Cayston.

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.

Reporting of side 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.

5.
How to store Cayston

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.

6.
Contents of the pack and other information

What Cayston and the solvent contain

• 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

What Cayston looks like and contents of the pack

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.

Marketing Authorisation Holder:

Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

Manufacturer:

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:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 2 401 35 50

Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

България
Gilead Sciences Ireland UC
Teл.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 2 401 35 79

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf.: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: +30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

România
Gilead Sciences (GSR) S.R.L.
Tel: +40 31 631 18 00

Ireland
Gilead Sciences Ireland UC
Tel: +353 (0) 214 825 999

Slovenija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.