75 mg of powder and solvent for nebuliser 
aztreonam

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Cayston is and what it is used for 
2. What you need to know before you use Cayston 
3. How to use Cayston 
4. Possible side effects 
5. How to store Cayston 
6. Contents of the packaging and other information 

1. What Cayston is and what it is used for

Cayston contains the active substance aztreonam. Cayston is an antibiotic used to inhibit chronic lung infection caused by the bacterium Pseudomonas aeruginosa in cystic fibrosis in patients from 6 years of age. Cystic fibrosis, also called mucoviscidosis, is a life-threatening, hereditary disease that affects the mucous glands in internal organs, especially the lungs, but also the liver, pancreas, and gastrointestinal tract. Cystic fibrosis of the lungs causes the lungs to become clogged with thick, sticky mucus. This makes it difficult to breathe.

2. What you need to know before using Cayston

Do not use Cayston

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

Warnings and cautions

Talk to your doctor before using Cayston:

  • if you are allergic to any other antibiotic (such as penicillins, cephalosporins, and/or carbapenems)
  • if you do not tolerate or experience tightness in the chest when taking other inhaled medicines
  • if you have kidney problems
  • if you have ever coughed up blood
  • if you have ever had low values ​​in lung function tests

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

Because Cayston is medicine for inhalation , Cayston can cause coughing and this can lead to bloody coughs. If you have ever coughed up blood, you should only use Cayston if your doctor thinks that the benefit of taking this medicine outweighs the risk of bloody cough.

During treatment with Cayston, the results of lung function tests may temporarily deteriorate but the effect is usually not long-lasting.

Children

Cayston should not be used in children under 6 years of age.

Other drugs 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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

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

If you are planning to breast-feed, ask your doctor for advice before taking Cayston. You can breastfeed during treatment with Cayston because the amount of Cayston that is likely to pass to your baby during breastfeeding is extremely small.

Driving and using machines

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

3. How to use Cayston

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

  • Use Cayston 3 times daily in repeated cycles of 28 days with treatment followed by 28 days without treatment. Each of the three dose engines to be at least 4 hours apart by inhalation using an Altera nebulizer. You can use either an erase Controller or an eFlow rapid controller with the Altera nebulizer.
  • Each dose consists of a vial of Cayston mixed with one ampoule of liquid. Cayston must be mixed with liquid before inhalation through the Altera nebulizer.

Pour the reconstituted Cayston solution into the Altera nebulizer (see below). Each treatment takes about 2-3 minutes to inhale.

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

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

  • 1. bronchodilator
  • 2. expectorant (a drug that helps to dissolve the thick mucus produced in the lungs)

and finally:

  • 3. Cayston.

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

  • Do not put other medicines in the Altera nebulizer.
  • Do not inject intravenous (injectable) aztreonam into the Altera nebulizer. Intravenous aztreonam is not suitable for inhalation.

How to use Cayston with the Altera nebulizer

You need the following:

  • A yellow-brown vial of Cayston with a blue cap.
  • A plastic ampoule containing liquid (0.17% v / v sodium chloride). The information on the ampoules with liquid is given in English only (see section 6).
  • An Altera nebulizer with an Altera Aerosol connected to an eFlow controller type 178 (eFlow rapid) or type 678 (eBase Controller).

You must use the Cayston-specific Altera nebulizer with Altera aerosol generator. Do not attempt to use Cayston with any other type of nebulizer (including the eFlow rapid nebulizer).

Check that the nebulizer is working properly before starting treatment with Cayston. Carefully read the manufacturer’s manual that comes with your Altera nebulizer system.

Prepare Cayston for inhalation

  • Do not prepare Cayston until you have finished administering a dose.
  • Do not use Cayston if you notice that the packaging is not intact.
  • Do not use Cayston if it has been stored outside the refrigerator for more than 28 days.
  • Do not use the liquid or reconstituted Cayston solution if it is cloudy or if there are particles in the solution.

1. Take a yellow-brown vial of Cayston and a cartridge of liquid from the carton. You must separate the ampoules with liquid by gently pulling them apart.

2. Gently tap the amber vial containing Cayston so that the powder falls to the bottom. This helps ensure that you get the right dose of medication.

3. Follow steps A to D in Figure 1 below to open the amber vial:

Step A: Place the vial on a flat surface with the blue cap pointing towards you. Hold the vial firmly with one hand and slowly fold up the blue cap with the other hand. Step B: Pull the blue cover down in an even (horizontal) position (with the bottom of the blue cover facing up) to prepare for the removal of the metal tab. Do not tear off the metal tab completely.
Step C: Continue to hold the vial firmly and slowly pull the blue cap counterclockwise with your other hand. Do not turn the blue cover. Step D: Continue to slowly pull the blue cover counterclockwise as the metal tab opens until the metal tab is completely removed.

Figure 1

4. Dispose of the metal tab safely. Carefully remove (but do not discard) the rubber stopper.

5. Open the ampoule one with liquid by turning off the tip. Squeeze all the contents into the vial (figure 2). Then gently rotate the vial until the powder has completely dissolved and the liquid is clear.

It is best to use Cayston immediately after preparing the solution. However, if you can not use the reconstituted dose immediately, put the stopper back in the vial and store it in the refrigerator. Use the reconstituted solution within 8 hours.

Fig. 2


Figure 2

Prepare the Altera nebulizer to use Cayston

  1. Make sure that the Altera nebulizer is on a flat, stable surface.
  2. Remove the medicine cap by turning it counterclockwise.
  3. Pour all reconstituted Cayston from the vial into the medicine container of the Altera nebulizer (Figure 3a). Be sure to empty the vial completely. Gently tap the vial against the side of the medicine container if necessary.
  4. Close the medicine container by fitting the medicine lid wedges into the wedge grooves on the container. Press down and turn the cover clockwise until it stops (figure 3b).
Figure 2a Figure 2b

Figure 3a Figure 3b

How to use the Altera nebulizer to use Cayston

1. Start treatment. Sit relaxed with your back straight. Hold the nebulizer horizontally and insert the nozzle into your mouth and close your lips around it (Figure 4).

Figure 3

Figure 4

Hold the nebulizer horizontally.

2. Press and hold the On / Off button on the control unit for a few seconds. You hear a tone and the status light glows green.

3. After a few seconds aerosol mist will begin to flow into the Altera nebulizer nebuliseringskammare. If aerosol mist does not start to flow, see the Altera manual for information.

4. Inhale as usual (inhale and exhale) through the mouthpiece. Avoid breathing through your nose. Continue to breathe calmly in and out until the treatment is completed.

5. When the medicine runs out , you will hear a beep indicating “treatment completed” (2 tones).

6. Open the medicine cap when the treatment is completed to check that all the medicine has been used. A few drops of medicine may remain in the container after the end of treatment. If there are more than a few drops of fluid left, replace the medicine cap, and restart treatment.

7. When the treatment is complete, disconnect the control unit and disassemble the Altera nebulizer for cleaning and disinfection. For complete information on cleaning and disinfection, see the manufacturer’s manual that comes with the Altera nebulizer.

What happens if you need to stop treatment before it is completed?

8. If for any reason you need to stop the treatment before it is completed, press the On / Off button for a full second. Restart the treatment by pressing the On / Off button for a full second and then restart the treatment.

Replacing the Altera Nebulizer

The Altera nebulizer is designed to withstand three 28-day courses of Cayston provided it is used in accordance with the instructions for use. After this time, replace the Altera nebulizer, including the aerosol generator. If you notice that performance has changed before this time has elapsed (eg if it takes longer to produce fog, more than 5 minutes), see the Altera Nebulizer Instructions for Use.

If you use too much Cayston 

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

If you forget to use Cayston

If you miss a dose, you can still take all 3 daily doses for as long as 4 hours pass between each dose . If it is not possible to take 3 doses at 4-hour intervals, you may skip the missed dose.

If you stop using Cayston

Do not stop using Cayston without talking to your doctor first.

If you have any further questions on the use of this product, 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, as this may mean that you have an allergic reaction to Cayston.

Very common side effects (may affect more than 1 user in 10)

  • Cough
  • Nasal congestion
  • Wheezing
  • Sore throat
  • Respiratory distress
  • Fever. This may be more common in children than in adults.

Common side effects (may affect up to 1 to 10 users)

  • Breathing difficulties
  • Discomfort in the chest
  • Runny nose
  • Bloody vomiting
  • Rash
  • Joint pain
  • Low values ​​in lung function tests

Uncommon side effects (may affect up to 1 in 100 people)

  • Joint swelling

The following side effects have been observed after using aztreonam for injection, but not after using Cayston: swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing, sweating, skin irritation and flaking of the skin, itchy rash, redness of the skin, small red spots and, in very rare cases, blisters on the skin. All this can be a sign of an allergic reaction.

Tell your doctor if you experience any of these side effects.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Cayston

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

Use before the expiry date which is stated on the vial label, one ampoule of liquid, and the carton. The expiration date is the last day of the specified month.

Vial of powder and ampoule of liquid:

Store in a refrigerator (2 ° C-8 ° C). The unopened vials can also be stored outside the refrigerator but below 25 ° C for up to 28 days.

Use this medicine immediately after reconstitution. If the reconstituted solution is not used immediately, it 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 is not intact.

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

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.

6. Contents of the packaging and other information

Content declaration

  • The powder vial contains 75 mg of aztreonam (as lysine ).
  • Ampoule one with liquid contains water for injections and sodium chloride. The text on the ampoules is in English only. The information on the ampoules is shown below:

Liquid for a solution to CaystonSodium chloride 0.17%
For inhalation use only
1 ml
GILEAD SCIENCES

What the medicine looks like and the contents of the pack

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

Cayston is supplied in 2 ml vials of yellow-brown glass with a gray rubber stopper and a removable aluminum cap with a blue cap.

1 ml of liquid is delivered in a plastic ampoule.

Each 28-day pack of Cayston contains 84 vials of lyophilized Cayston and 88 ampoules of liquid. The four extra ampoules with liquid are included with regard to possible spills.

The following pack sizes are available:

  • 28-day pack with Cayston
  • A package containing a 28-day pack of Cayston plus an Alterane nebulizer

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Contact the representative of the marketing authorization holder to find out more about this medicine.

Muhammad Nadeem

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