Cayston 75 mg powder and solvent for nebuliser solution

Cayston is an antibiotic used to suppress chronic lung infection caused by the bacteria Pseudomonas aeruginosa in adult patients 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.

Do not take Cayston

• if you are allergic (hypersensitive) to aztreonam or any of the other ingredients of Cayston.

Take special care with Cayston

Your doctor needs to know:

• 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 any of these apply to you tell your doctor before using Cayston.

Cayston is not for use in children under the age of 18.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

It is important to tell your doctor if you are breast-feeding, if you are pregnant or planning to become pregnant, or when you think you are pregnant. Your doctor will help you decide what is best for you and your child.

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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Cayston is not expected to affect your ability to drive or use machines.

Always take Cayston exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• Take Cayston 3 times a day for the 28-day treatment course. Each of the three doses should be taken by inhalation at least four hours apart, using an Altera Nebuliser Handset. You can use either an Altera Control Unit or an eFlow rapid Control Unit with the Altera Handset.
• 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 therapies to treat cystic fibrosis, the recommended order is as follows:

1. bronchodilator

2. dornase alfa (a medicine that helps to dissolve the thick mucous produced in the lungs)

3. chest physiotherapy

4. any other inhaled medicines and finally:

5. Cayston.

Do not mix Cayston with any other medicines in the Altera Nebuliser Handset.

• 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.

How to take Cayston using the Altera Nebuliser Handset

You will need the following:
One amber-coloured vial of Cayston
One plastic ampoule of solvent (0.17% w/v sodium chloride)
An Altera Nebuliser Handset containing an Altera Aerosol Head connected to an Altera Control Unit (678G) or an eFlow rapid Control Unit (178G)

You must use the Cayston specific Altera Nebuliser Handset containing an Altera Aerosol Head. Do not try to take Cayston using any other type of nebuliser handset (including the eFlow rapid handset).

Check that your nebuliser works properly before starting your treatment with Cayston. Read the manufacturer?s instructions for use provided with your Altera Nebuliser System carefully.

Preparing your Cayston for inhalation

• 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.

1. Take one amber vial of Cayston and one ampoule of solvent from the box. Solvent ampoules must be separated by gently pulling them apart.

2. Gently tap the amber vial containing the Cayston so that the powder settles at the bottom. This helps to ensure that you get the proper dose of medicine.

3. Open the amber vial by lifting up the metal flap on the top (Figure 1a) and pulling down (Figure 1b) to carefully remove the entire metal ring and overcap from the vial (Figure 1c). Safely dispose of the ring. Carefully remove the rubber stopper.

4. Open the ampoule of solvent by twisting off the tip. Squeeze out the contents completely into the vial (Figure 1d). Next, gently swirl the vial until the powder has completely dissolved and the liquid is clear.

It?s best to use Cayston immediately after you have made up the solution. But, if you cannot use the prepared dose straight away, replace the stopper in the vial and store in a refrigerator. Use the prepared solution within 8 hours.

Preparing the Altera Nebuliser to take your Cayston

1. Make sure the AlteraNebuliser Handset is on a flat, stable surface.

2. Remove the medicine cap by twisting anticlockwise.

3. Pour all of the prepared Cayston from the vial into the Altera Nebuliser Handset medicine reservoir (Figure 2a). Be sure to completely empty the vial. Gently tap the vial against the side of the medicine reservoir if necessary.

4. Close the medicine reservoir by aligning the tabs of the medicine cap with the slots on the reservoir. Press down and turn the cap clockwise as far as it will go (Figure 2b).

Figure 2a Figure 2b

Using the Altera Nebuliser to take your Cayston

1. Begin your treatment. Sit in a relaxed, upright position. Hold the handset level and place the mouthpiece in your mouth and close your lips around it (Figure 3).

Figure 3

Keep the handset level.

2. Press and hold the On/Off button on the Control Unit for a few seconds. You will hear one ?beep? and the status light will turn green.

3. After a few seconds, an aerosol mist will begin to flow into the Aerosol Chamber of the Altera Nebuliser Handset. If aerosol mist does not begin to flow, please refer to the Altera manual for information.

4. Breathe normally (inhale and exhale) through the mouthpiece. Avoid breathing through your nose. Continue to inhale and exhale comfortably until the treatment is finished.

5. When all of the medicine has been delivered, you will hear a tone that means ?treatment complete? (2 beeps).

6. When treatment is complete, open the medicine cap to ensure that all medicine has been used. 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 Control Unit 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 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.

Replacing the Altera Nebuliser Handset

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 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 want to 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 product, ask your doctor or pharmacist.

Like all medicines, Cayston 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.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).

Very common side effects

• Cough
• Wheezing
• Sore throat
• Blocked nose
• High temperature

Common side effects

• Difficulty breathing
• Runny nose
• Rash
• Chest discomfort

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Cayston 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 Cayston 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 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Cayston and the solvent contain

• The powder vial contains 75 mg aztreonam (which is the active substance) as lysine.
• The solvent ampoule contains water for injections and sodium chloride.

What Cayston looks like and contents of the pack

Cayston is a sterile, white to off-white, lyophilised powder.

Cayston is contained in a 2 ml amber glass vial with a grey rubber stopper and aluminium tear-off overseal.

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 and Manufacturer

Marketing Authorisation Holder:

Gilead Sciences International Limited
Granta Park
Abington
Cambridge
CB21 6GT
United Kingdom

Manufacturer:

Gilead Sciences Limited
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Gilead Sciences Belgium SPRL-BVBA TélTel 32 0 2 401 3550 LuxembourgLuxemburg Gilead Sciences Belgium SPRL-BVBA TélTel 32 0 2 401 3550

Gilead Sciences International Ltd Te. 44 0 20 7136 8820 Magyarország Gilead Sciences International Ltd Tel 44 0 20 7136 8820

eská republika Gilead Sciences International Ltd Tel 44 0 20 7136 8820 Malta Gilead Sciences International Ltd Tel 44 0 20 7136 8820

Danmark Gilead Sciences Sweden AB Tlf 46 0 8 5057 1849 Nederland Gilead Sciences Netherlands B.V. Tel 31 0 20 718 3698

Deutschland Gilead Sciences GmbH Tel 49 0 89 899890-0 Norge Gilead Sciences Sweden AB Tlf 46 0 8 5057 1849

Eesti Gilead Sciences International Ltd Tel 44 0 20 7136 8820 Österreich Gilead Sciences GesmbH Tel 43 1 260 830

Gilead Sciences .. 30 210 8930 100 Polska Gilead Sciences International Ltd Tel 44 0 20 7136 8820

España Gilead Sciences, S.L. Tel 34 91 378 98 30 Portugal Gilead Sciences, Lda. Tel 351 21 7928790

France Gilead Sciences Tél 33 0 1 42 73 70 70 România Gilead Sciences International Ltd Tel 44 0 20 7136 8820

Ireland Gilead Sciences Ltd Tel 44 0 1223 897555 Slovenija Gilead Sciences International Ltd Tel 44 0 20 7136 8820

Ísland Gilead Sciences Sweden AB Sími 46 0 8 5057 1849 Slovenská republika Gilead Sciences International Ltd Tel 44 0 20 7136 8820

Italia Gilead Sciences S.r.l. Tel 39 02 439201 SuomiFinland Gilead Sciences Sweden AB PuhTel 46 0 8 5057 1849

Gilead Sciences .. 30 210 8930 100 Sverige Gilead Sciences Sweden AB Tel 46 0 8 5057 1849

Latvija Gilead Sciences International Ltd Tel 44 0 20 7136 8820 United Kingdom Gilead Sciences Ltd Tel 44 0 1223 897555

Lietuva

Gilead Sciences International Ltd
Tel: + 44 (0) 20 7136 8820

This leaflet was last approved in {MM/YYYY}.

This medicine has been given ?conditional approval?.
This means that there is more evidence to come about this medicine.
The European Medicines Agency will review new information on the medicine every year and this leaflet will be updated as necessary.