Label: Information for the User

Cayston 75 mg Powder and Diluent for Inhalation Solution for Nebulizer

Aztreonam

Read the entire label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Cayston contains the active ingredient aztreonam. Cayston is an antibiotic used for the treatment of chronic respiratory infections caused by the Pseudomonas aeruginosa bacteria in patients 6 years of age or older with cystic fibrosis. Cystic fibrosis, also known as mucoviscidosis, is a potentially fatal hereditary disease that affects the mucous glands of internal organs, especially the lungs, but also the liver, pancreas, and digestive system. In the lungs, cystic fibrosis causes congestion with sticky mucus. This produces difficulty breathing.

Do not use Cayston

- if you are allergic to aztreonamor to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use Cayston:

• if you areallergic to any other antibiotics(such as penicillins, cephalosporins, and/or carbapenems)
• if you do not tolerate or feel chest tightness when taking other inhaled medications
• if you havekidney problems
• if you havehemoptysisat any time
• if you have hadlow pulmonary function testsat any time.

If you find yourself in any of the above circumstances,inform your doctorbefore using Cayston.

Since it is an inhaled medication, Cayston may cause you to cough, which could cause hemoptysis. If you have hemoptysis at any time, you should only use Cayston if your doctor believes that the benefits of taking this medication outweigh the risk of hemoptysis.

During treatment with Cayston, you may experience a temporary decrease in pulmonary function tests, but this is generally not a persistent effect.

Children

Cayston should not be administered to children under 6 years old.

Other medications and Cayston

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

There are no clinical data on the use of Cayston in pregnant women, therefore, do not use Cayston during pregnancy, unless you have discussed this specifically with your doctor.

If you plan to breastfeed your baby, consult your doctor before using Cayston. You can breastfeed during treatment with Cayston, as the amount of medication that is likely to pass to your baby during breastfeeding will be extremely small.

Driving and operating machinery

It is not expected that Cayston will affect your ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Use Cayston 3 times a day in repeated cycles of 28 days of therapy followed by 28 days without Cayston therapy.Each of the three doses must be administered by inhalation with an interval of at least four hours, using a handheld nebulizer Altera device. You can use an eBase Controller or an eFlow rapid command unit with the handheld Altera device.

• Each dose consists of a Cayston vial that is mixed with the contents of the ampoule of solvent. It is necessary to mix Cayston with a solvent before inhaling it using the Altera nebulizer.

Insert the prepared Cayston solution into the handheld Altera nebulizer (see below). Each treatment takes around 2 to 3 minutes to inhale.

Use a bronchodilator before each dose of Cayston. Short-acting bronchodilators can be used between 15 minutes and 4 hours before each dose of Cayston, and long-acting bronchodilators between 30 minutes and 12 hours before.

If you are using other inhalation therapies to treat cystic fibrosis, the recommended order of use is as follows:

1. bronchodilator
2. mucolytics (a medication that helps to dissolve the thick mucus produced in the lungs) and finally:
3. Cayston.

Do not mix Cayston with any other medicationin the handheld Altera nebulizer.

• Do not introduce other medications into the handheld Altera nebulizer.
• Do not introduce aztreonam for intravenous administration (injectable) into the handheld Altera nebulizer. Intravenous aztreonam is not suitable for inhalation.

How to administer Cayston using the handheld Altera nebulizer

You will need the following items:

• A yellow-colored vial of Cayston with a blue-capped closure.
• A plastic ampoule of solvent (sodium chloride 0.17% w/v). The information on the ampoule of solvent is only in English (see section 6).
• A handheld Altera nebulizer device with an Altera aerosol generator connected to an eFlow rapid command unit of type 178 (eFlow rapid) or type 678 (eBase Controller).

You must use the specific handheld Altera nebulizer device for Cayston, with the Altera aerosol generator.Do not attempt to use Cayston with any other type of handheld nebulizer (even the eFlow rapid handheld device).

Check that the nebulizer is working properlybefore starting treatment with Cayston. Read the manufacturer's instructions provided with the Altera nebulizer system carefully.

Cayston preparation for inhalation

- Do not prepare Cayston until you are ready to administer the dose.

- Do not use Cayston if you observe that the packaging has been manipulated.

- Do not use Cayston if it has been stored outside the refrigerator for more than 28 days.

- Do not use the solvent or prepared Cayston if it appears turbid or if particles are observed in the solution.

1. Remove a yellow-colored vial of Cayston and a solvent ampoulefrom the box. The solvent ampoules must be separated by gently pulling them.

1. Gently tap the yellow-colored vialof Cayston, so that the powder settles at the bottom. This helps to ensure that the administered dose is correct.

1. Follow the steps A to D in Figure 1 below to open the yellow-colored vial:

1. Dispose of the metal closure safely. Carefully remove (but do not discard yet) the rubber stopper.
2. Twist the solvent ampoule to extract its contents. Squeeze the ampoule to transfer its entire contents to the vial (Figure 2). Then, gently shake the vial in a circular motion until the powder has completely dissolved and the liquid appears clear.

It is best to use Cayston immediately after preparing the solution.However, if you cannot use the prepared dose immediately, replace the rubber stopper on the vial and store it in the refrigerator. Use the prepared solution within a maximum of 8 hours.

Preparation of the Altera nebulizer for Cayston administration

1. Ensure that the handheld Altera nebulizeris placed on a flat and stable surface.

1. Remove the medication container capby turning it counterclockwise.

1. Pour the prepared Cayston from the vialinto the medication container of the handheld Altera nebulizer (Figure 3a). Make sure to empty the vial completely. Gently tap the vial against the side of the medication container, if necessary.

1. Close the medication containerby aligning the cap guides with the container ridges. Press down and turn the cap clockwise until it reaches the top (Figure 3b).

Using the Altera nebulizer for Cayston administration

1. Start the treatment.Sit comfortably with your back straight. Hold the handheld device horizontally, insert the mouthpiece into your mouth, and close your lips around it (Figure 4).

Keep the handheld device in a horizontal position.

1. Press and hold the On/Off buttonfor a few seconds. You will hear a sound and the status light will turn green.

1. After a few seconds, a mist of aerosol will start flowing into the nebulizer chamber of the handheld Altera nebulizer. If the mist does not start flowing, consult the Altera nebulizer user manual for information.

1. Breathe normally(inhale and exhale) through the mouthpiece. Avoid breathing through your nose. Continue inhaling and exhaling comfortably until the treatment is complete.

1. When the entire medication has been administered, you will hear a sound indicating "treatment complete" (2 beeps).

1. When the treatment is complete, open the medication container cap to ensure that the medication has been used entirely. There may be some remaining medication in the container after the treatment is complete. If there is more than a few drops of liquid remaining, replace the medication container cap and restart the treatment.

1. Once the treatment is complete, disconnect the command unit and set aside the handheld Altera nebulizer for cleaning and disinfection. For detailed information on cleaning and disinfection procedures, consult the manufacturer's instructions provided with the handheld Altera nebulizer.

What if I need to interrupt the treatment before it is complete?

1. If, for any reason, you need to interrupt the treatment before it is complete, press and hold the On/Off button for a complete second. To restart the treatment, press and hold the On/Off button for a complete second and restart the treatment.

Replacement of the handheld Altera nebulizer

The handheld Altera nebulizer is designed to last for three cycles of 28 days of treatment with Cayston when used according to the provided instructions. Once this time has elapsed, replace your handheld Altera nebulizer, including the aerosol generator. If you notice any changes in its functioning before this time (for example, if it takes longer to generate the mist, more than five minutes), consult the Altera nebulizer user manual.

If you use more Cayston than you should

If you have used more Cayston than you should, consult your doctor or pharmacist immediately.

If you forget to use Cayston

If you forget a dose, you can continue to administer the 3 daily doses, leaving an interval of at least 4 hours between them. If you cannot leave a 4-hour gap, omit the missed dose.

If you interrupt Cayston treatment

Do not interrupt Cayston treatment without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

If a rash appears, consult your doctor immediately,as it may indicate that you are suffering an allergic reaction to Cayston.

Very common adverse effects (affect more than 1 in 10 patients)

• Coughing
• Nasal congestion
• Wheezing
• Sore throat
• Shortness of breath
• Fever. It may be more frequent in children than in adults.

Common adverse effects (affect between 1 and 10 in 100 patients)

• Difficulty breathing
• Chest discomfort
• Nasal discharge
• Blood-stained sputum

• Rash
• Joint pain
• Lowered lung function test results

Uncommon adverse effects (affect between 1 and 10 in 1,000 patients)

• Swelling of the joints

The following adverse effects have been observed after the use of aztreonam injectable, but not after administration of Cayston: swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing, sweating, skin irritation, and peeling, skin rash with itching, redness, small red spots, and, very rarely, skin blisters. All these signs may indicate an allergic reaction.

Inform your doctor if you experience any of these effects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendixVBy reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial label, the solvent ampule label, and the packaging. The expiration date is the last day of the month indicated.

Vial of powder and solvent ampule:

Store in refrigerator (between 2°C and 8°C). Unopened vials can also be stored outside the refrigerator, but at a temperature below 25°C for a maximum of 28 days.

Use this medication immediately after preparation. If not used immediately, the prepared solution must be stored between 2°C and 8°C and used within a maximum of 8 hours. Do not prepare more than one dose at a time.

Do not use this medication if you observe that the packaging has been manipulated.

Do not use this medication if it has been stored outside the refrigerator for more than 28 days.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Cayston and the solvent

• The vial of powder contains 75 mg of aztreonam (as lysine).
• The ampoule of solvent contains water for injection and sodium chloride. The ampoule is printed in English only. The information on the ampoule is presented below:

Appearance of the product and contents of the package

Cayston is a white to off-white powder and solvent for inhalation solution for nebulizer.

Cayston is found inside a 2 ml amber glass vial with a grey rubber stopper and an aluminum desiccant with a blue closure.

The solvent (1 ml) is found inside a plastic ampoule.

Each package of Cayston for 28 days contains 84 vials of lyophilized Cayston and 88 ampoules of solvent. Four additional ampoules of solvent are provided in case of spills.

This medication is available in:

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible for manufacturing:

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu.