CAYSTON 75 mg Inhalation Powder

Зміст інструкції

1. Cayston 75 mg powder and solvent for nebulizer solution
   1. What is Cayston and what is it used for
   2. What you need to know before you take Cayston
   3. How to take Cayston
   4. Possible side effects
   5. How to store Cayston
   6. Contents of the pack and other information

Cayston 75 mg powder and solvent for nebulizer solution

aztreonam

Read this leaflet carefully before you start to take this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Cayston is and what it is used for
• 2. What you need to know before you take Cayston
• 3. How to take Cayston
• 4. Possible side effects
• 5. How to store Cayston
• 6. Contents of the pack and other information

1. What is Cayston and what is it used for

Cayston contains the active substance aztreonam. Cayston is an antibiotic used to suppress chronic lung infections due to the bacterium Pseudomonas aeruginosain patients aged 6 years and older with cystic fibrosis. Cystic fibrosis, also known as mucoviscidosis, is a life-threatening hereditary disease that affects the mucous glands of internal organs, especially the lungs, but also the liver, pancreas and digestive system. Cystic fibrosis of the lungs causes their obstruction by thick and sticky mucus. Due to the mucus, the patient has difficulty breathing.

2. What you need to know before you take Cayston

Do not take Cayston

• if you are allergicto aztreonam or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Cayston:

• if you are allergic to other antibiotics(such as e.g. penicillins, cephalosporins and/or carbapenems)
• if you do not tolerate other inhaled medicines or experience chest tightness after using them
• if you have kidney problems
• if you have coughed up blood
• if you have had abnormal results of lung function testsIf you have any of these conditions, tell your doctorbefore using Cayston.

As an inhaled medicine, Cayston may cause you to cough, and this cough may be
accompanied by blood. If you have coughed up blood, you should only use Cayston
if your doctor believes that the benefits of taking this medicine outweigh the risk of
coughing up blood.
During treatment with Cayston, a temporary worsening of lung function test results may occur, but this effect is usually not lasting.

Children
The use of Cayston is not indicated in children under 6 years of age.

Other medicines and Cayston
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor for advice before taking this medicine.
There are no clinical data regarding the use of Cayston in pregnant women, therefore you should not take
Cayston during pregnancy unless this has been expressly discussed with your doctor.
If you are planning to breastfeed, ask your doctor for advice before taking
Cayston. You can breastfeed during treatment with Cayston, as the amount of Cayston that can
be passed on to the baby during breastfeeding is extremely low.

Driving and operating machinery
No effects of Cayston on the ability to drive or operate machinery are expected.

3. How to take Cayston

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:

• Take Cayston 3 times a day in repeated cycles of 28 days of therapy followed by 28 dayswithout therapy with Cayston.The three doses must be inhaled at intervals of at least four hours from each other using a portable Altera nebulizer. With the portable Altera nebulizer, you can use both an eBase Controller control unit and an eFlow rapid control unit.
• Each dose consists of a vial of Cayston mixed with a vial of solvent. Cayston must be mixed with a solvent before being inhaled with the Altera nebulizer.

Place the previously prepared Cayston solution into the portable Altera nebulizer (see
below). Each inhalation lasts approximately 2-3 minutes.
Use a bronchodilator before each dose of Cayston. Short-acting bronchodilators
can be used from 15 minutes to 4 hours before each dose of Cayston and long-acting bronchodilators
can be used from 30 minutes to 12 hours before.
If you are using other inhalation therapies for cystic fibrosis, the recommended timing
for use is as follows:

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

Do not mix Cayston with other medicinesin the portable Altera nebulizer.

• Do not pour other medicines into the portable Altera nebulizer.
• Do not pour the aztreonam formulation for intravenous (injectable) administration into the portable Altera nebulizer. Injectable aztreonam is not suitable for inhalation.

How to take Cayston with the portable Altera nebulizer
Materials needed:

• an amber vial of Cayston with a blue closing cap.
• a plastic vial containing the solvent (sodium chloride 0.17% w/v). The information on the solvent vial is provided in English only (see section 6).
• a portable Altera nebulizer containing an Altera aerosol generator connected to an eFlow type 178 (eFlow rapid) or type 678 (eBase Controller) control unit.

You must use the specific portable Altera nebulizer for Cayston containing an Altera
aerosol generator.Do not attempt to take Cayston with another type of portable nebulizer (including
eFlow rapid).

Check that the nebulizer is working correctlybefore starting treatment with Cayston.
Read the instructions for use provided by the manufacturer with the Altera nebulizer system carefully.

How to prepare Cayston for inhalation

• Do not prepare Cayston until you are ready to administer a dose.
• Do not use Cayston if you notice that the packaging has been tampered with.
• Do not use Cayston if it has been stored outside the refrigerator for more than 28 days.
• Do not use the solvent or previously prepared Cayston solution if it is cloudy or if it contains particles in solution.
• 1. Take an amber vial of Cayston and a vial containing the solvent from the box.The solvent vials must be separated from each other by pulling them slightly.
• 2. Tap the amber vialcontaining Cayston gently to settle the powder at the bottom. This helps to ensure that the correct dose of the medicine is administered.

• 3. Follow steps A to D in Figure 1, below, to openthe amber vial:

Step A: With the tab of the blue closing cap facing you, place the
vial on a flat surface. Hold the vial firmly with one hand and with
the other slowly lift the blue closing cap.
Step B: Pull the blue closing cap down to the horizontal position
(with the bottom of the blue closing cap facing up) to remove the
metal ring. Do not tear off the metal ring completely.

Step C: Continue to hold the vial firmly with one hand and with the other pull
the blue closing cap slowly in a counterclockwise direction. Do not bend the blue closing
cap.
Step D: When the metal ring opens, continue to pull the blue closing cap slowly in a counterclockwise direction until
completely removing the metal ring.
Figure 1

• 4. Dispose of the metal ring safely. Carefully remove (without throwing away) the rubber stopper.
• 5. Open the vial containing the solventby bending the tip. Pour the entire contents into the vial (Figure 2), then gently shake the vial until the powder is completely dissolved and the liquid is clear.

It is recommended to use Cayston immediately after preparing the solution.If, however, you
cannot use the prepared dose immediately, close the vial with the stopper and store it in the refrigerator.
Use the prepared solution within 8 hours.

Figure 2

How to prepare the Altera nebulizer to take Cayston

• 1. Checkthat the portable Alteranebulizer is placed on a stable flat surface.
• 2. Remove the medicine coverby rotating it counterclockwise.
• 3. Pour the entire Cayston solution, prepared previously, from the vialinto the medicine container of the portable Altera nebulizer (Figure 3a). Make sure to empty the vial completely. If necessary, tap the vial gently against the side of the medicine container.
• 4. Close the medicine containerby aligning the guide noses of the medicine cover with the grooves on the container. Press and rotate the cover completely clockwise (Figure 3b).

Figure 3a Figure 3b

How to use the Altera nebulizer to take Cayston

• 1. Start of treatment.Sit in a relaxed position keeping your shoulders straight. Hold the portable nebulizer upright and place the mouthpiece between your teeth, clamping it with your lips (Figure 4).

Figure 4

Hold the portable nebulizer upright.

• 2. Press and hold the On/Off buttonon the control unit for a few seconds. You will hear a beep and the light will turn green.
• 3. After a few seconds,a cloud of aerosol will begin to flow into the chamber of the portable Altera nebulizer. If the aerosol cloud does not flow, refer to the Altera manual for more information.
• 4. Breathe normally(inhale and exhale) through the mouthpiece. Avoid breathing through your nose. Continue to inhale and exhale calmly until the end of the treatment.
• 5. When all the medicine has been released,you will hear a beep indicating the end of the treatment (double beep).
• 6. At the end of the treatment,open the cover of the medicine container to make sure that all the medicine has been used. Some drops of medicine are likely to remain in the container at the end of the treatment. If more than a few drops remain, close the cover of the medicine container and restart the treatment.
• 7. At the end of the treatment,disconnect the control unit from the portable Altera nebulizer to clean and disinfect it. Refer to the instructions for use provided with the portable Altera nebulizer for detailed cleaning and disinfection instructions.

What to do if I have to stop treatment prematurely?

• 8. If, for any reason, you have to stop the treatment prematurely, press and hold the On/Off button for one second. To restart the treatment, press and hold the On/Off button for one second and restart the treatment.

Replacement of the portable Altera nebulizer
The portable Altera nebulizer is intended to be used for three 28-day cycles, if used
correctly. After this period, replace the portable Altera nebulizer including the aerosol generator. If you notice a change in the performance of the device before completing the three cycles
(e.g. if the time it takes to produce the aerosol cloud increases to more than 5 minutes), refer to the
instructions for use of the Altera nebulizer.

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

If you forget to take Cayston
If you forget a dose, you can always take all 3 daily doses, provided that at least 4 hours elapse between doses. If you cannot allow a 4-hour interval to elapse, simply skip
the missed dose.

If you stop taking Cayston
Do not stop taking Cayston without consulting your doctor.
If you have any doubts about 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 a skin rash appears, tell your doctor immediately,as this may be a sign
of an allergic reaction to Cayston.
Very common side effects (affect more than 1 in 10 people)

• cough
• nasal congestion
• wheezing
• sore throat
• shortness of breath
• fever. This effect may be more common in children than in adults.

Common side effects (affect 1 to 10 users out of 100)

• difficulty breathing
• chest discomfort
• runny nose
• coughing up blood
• skin rash
• joint pain
• worsening of lung function test results

Uncommon side effects (affect 1 to 10 users out of 1000)

• joint swelling

The following side effects have been observed following the use of aztreonam injectable, but not
after the use of Cayston: swelling of the face, lips, tongue and/or throat, with difficulty swallowing or breathing,
sweating, skin irritation and scaling, itchy rash, redness, small
red spots and, very rarely, blisters on the skin. All of these can be signs of an allergic
reaction.
Tell your doctor if you notice any of these disorders.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell
your doctor or pharmacist. You can also report side effects directly through the national reporting system
described in Annex V. By reporting side effects you can help to 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 label of the vial, on the
solvent vial and on the carton. The expiry date refers to the last day of that month.
Powder vial and solvent vial:
Store in a refrigerator (2°C-8°C). The unopened vial can also be stored outside the
refrigerator, at a temperature below 25°C, for a maximum of 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 packaging has been tampered with.
Do not use this medicine if it has been stored outside the refrigerator for more than 28 days.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This 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 of aztreonam (as lysine).
• The solvent vial contains water for injections and sodium chloride. The vial is printed exclusively in English. The information reported on the vial is presented here below:

Solvent for Cayston
Sodium chloride 0.17%
For inhalation use only
1 ml
GILEAD SCIENCES

Description of the appearance of Cayston and contents of the pack
Cayston consists of a powder from white to off-white in colour and a solvent for solution for
nebulizer.
Cayston is contained in a 2 ml amber glass vial with a grey rubber stopper and a tear-off aluminium
cap with a blue sealing cap.
The solvent (1 ml) is contained in a plastic vial.
Each pack of Cayston for 28 days contains 84 vials of Cayston lyophilized and 88 vials of
solvent. The four additional solvent vials are provided as a reserve in case of
spillage.
The following packs are available:

• pack of Cayston for 28 days
• pack containing a pack of Cayston for 28 days and an Altera portable nebulizer

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 further information on this medicinal product, 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

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113700

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.