Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Aztreonam lysine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Cayston contains the active substance aztreonam. Caystonis an antibiotic used to suppress chronic lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older 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. 2.
e Cayston
Do not take Cayston –
if you are allergic to 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 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 you have ever coughed up any blood if you have ever had low lung function tests. If any of these apply to you tell your doctor before using Cayston. As an inhaled medicine, Cayston could cause you to cough and this could lead to coughing up blood. If you have ever coughed up blood you should only use Cayston if your doctor thinks the benefit of taking this medicine outweighs the risk of coughing up blood. You may get a temporary lowering of lung function test result during treatment with Cayston, but this is typically not a lasting effect. 1
Children Cayston is not for use in children under the age of 6 years. Other medicines and Cayston Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding 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 taking this medicine. 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. Driving and using machines Cayston is not expected to affect your ability to drive or use machines. 3.
How to take Cayston
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: –
Take Cayston 3 times a day in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy. 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 eBase Controller or an eTrack Controller with the Altera Nebuliser Handset.
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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 inhaled therapies to treat cystic fibrosis, the recommended order of use is as follows: 1. bronchodilator 2. mucolytics (a medicine that helps to dissolve the thick mucous produced in the lungs) and finally: 3. Cayston.
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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.
Cayston using the Altera Nebuliser Handset You will need the following: ▪ One amber-coloured vial of Cayston with a blue cap. ▪ One plastic ampoule of solvent (0.17% w/v sodium chloride). The information that appears on the solvent ampoule is provided in English only (see section 6). ▪ An Altera Nebuliser Handset containing an Altera Aerosol Head connected to an eBase Controller or eTrack Controller. 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. 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. Follow Step A to D in Figure 1 below to open the amber vial:
Step A: With the blue cap tab facing toward you, place the vial on a flat surface. Using one hand to hold the vial steady, use the other hand to slowly flip up the blue cap.
Step B: Pull the blue cap down to a flat (horizontal) position (where the bottom of the blue cap faces up), to prepare the metal seal for removal. Do not completely tear through the metal seal.
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Step C: While continuing to hold the vial Step D: When the metal seal opens, continue steady with one hand, use the other hand to to slowly pull on the blue cap in a slowly pull the blue cap in a counterclockwise direction until the metal counterclockwise direction. Do not twist the seal is completely removed. blue cap. Figure 1 4. Safely dispose of the metal seal. Carefully remove (but do not yet discard) the rubber stopper. 5. Open the ampoule of solvent by twisting off the tip. Squeeze out the contents completely into the vial (Figure 2). 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.
Figure 2 Preparing the Altera Nebuliser to take your Cayston 1. Make sure you have an eBase or eTrack Controller to connect to the Altera Nebuliser Handset. 2. Make sure the Altera Nebuliser Handset is on a flat, stable surface. 3. Remove the medicine cap by twisting anticlockwise. 4. Pour all of the prepared Cayston from the vial into the Altera Nebuliser Handset medicine reservoir (Figure 3a). Be sure to completely empty the vial. Gently tap the vial against the side of the medicine reservoir if necessary. 5. 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 3b).
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Figure 3a
Figure 3b
Using the Altera Nebuliser to take your Cayston 1. Begin your treatment. Sit in a relaxed, upright position. Hold the nebuliser handset level and place the mouthpiece in your mouth and close your lips around it (Figure 4).
Figure 4 Keep the nebuliser handset level. 2. Turn on the controller. Press and hold the ON/OFF button. You will hear one "beep" and the eFlow® Technology logo will appear on the display. Select the treatment mode by pressing the OK button when using the eTrack Controller. 3. 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) and the dose complete checkmark will appear briefly on the display.
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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 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.
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 6
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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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine. 5.
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.
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6.
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 Ltd 280 High Holborn London WC1V 7EE United Kingdom 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: Gilead Sciences Ltd. Tel: + 44 (0)8000 113 700
This leaflet was last revised in 03/2026 8
Cayston 75 mg powder and solvent for nebuliser solution comes as inhaler containing 75mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Cayston 75 mg powder and solvent for nebuliser solution is aztreonam lysine.
This leaflet reproduces the patient information leaflet approved for Cayston 75 mg powder and solvent for nebuliser solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
Patients should 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.
For patients taking multiple inhaled therapies, the recommended order of administration is as follows:
1. bronchodilator
2. mucolytics
3. and lastly, Cayston.
Adults and children 6 years and older
The recommended dose for adults is 75 mg three times per 24 hours for 28 days.
Doses should be taken at least 4 hours apart.
Cayston may be taken in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy.
The dosing in children aged 6 years and older is the same as for adults.
Elderly
Clinical studies of Cayston did not include Cayston-treated patients aged 65 years and older to determine whether they respond differently from younger patients. If Cayston is to be prescribed to the elderly then the posology is the same as for adults.
Renal impairment
Aztreonam is known to be excreted renally and therefore administration of Cayston in patients with renal impairment (serum creatinine > 2 times upper limit of normal) should be undertaken with caution. No dose adjustment is necessary in cases of renal impairment since the systemic concentration of aztreonam following inhaled administration of Cayston is very low (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection).
Hepatic impairment
There are no data on the use of Cayston in patients with severe hepatic impairment (ALT or AST greater than 5 times the upper limit of normal). No dose adjustment is necessary in cases of hepatic impairment.
Paediatric population
The safety and efficacy of Cayston in children younger than 6 years of age have not been established. Currently available data are described in section 5.1 but no recommendation on posology can be given.
Method of administration
For inhalation use.
Cayston should only be used with the Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eTrack Controller. For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Allergic reactions
If an allergic reaction to aztreonam does occur, stop administration of the medicinal product and initiate treatment as appropriate. The occurrence of rash may be indicative of an allergic reaction to aztreonam.
Cross-reactivity may occur in patients with a history of allergy to beta‑lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems. Animal and human data demonstrate low risk of cross-reactivity between aztreonam and beta-lactam antibiotics. Aztreonam, a monobactam, is only weakly immunogenic. Caution is advised when administering Cayston to patients if they have a history of beta-lactam allergy.
The following rare and severe adverse reactions have been reported after parenteral use of other aztreonam containing products: toxic epidermal necrolysis, anaphylaxis, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis.
Bronchospasm
Bronchospasm (an acute reduction of ≥ 15% in FEV1) is a complication associated with nebulised therapies. Bronchospasm has been reported after Cayston administration (see section 4.8). Patients should use a bronchodilator before each dose of Cayston. If a case of bronchospasm is suspected to be part of an allergic reaction appropriate measures should be taken (see “allergic reactions” paragraph above).
Haemoptysis
Inhalation of nebulised solutions may induce a cough reflex. The use of Cayston in paediatric CF patients has been associated with haemoptysis during treatment cycles and could have aggravated underlying conditions. Administration of Cayston in CF patients with active haemoptysis should be undertaken only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Other precautions
Efficacy has not been established in patients with FEV1 > 75% predicted. Patients with Burkholderia cepacia isolated from sputum within the previous 2 years were excluded from the clinical studies.
Aztreonam for injection must not be used in the Altera or other nebulisers. Aztreonam for injection has not been formulated for inhalation, and contains arginine, a substance known to cause pulmonary inflammation.
Resistance to aztreonam, other antibiotics and treatment-emergent microorganisms
The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy. Development of resistance during inhaled aztreonam therapy could limit treatment options during acute exacerbations. A decrease in P. aeruginosa susceptibility to aztreonam and other beta-lactam antibiotics was observed in clinical studies of Cayston. In a 24-week active-controlled clinical study of Cayston therapy, increases were observed in the MIC90 for all P. aeruginosa isolates as well as in the percentages of patients with P. aeruginosa resistant (MIC above the parenteral breakpoint) to aztreonam, to at least 1 beta-lactam antibiotic, and to all 6 beta-lactam antibiotics tested (see section 5.1). However, decreased P. aeruginosa susceptibility was not predictive of clinical efficacy of Cayston during the study. Among patients with multidrug-resistant P. aeruginosa, improvements in respiratory symptoms and pulmonary function were observed following treatment with Cayston. The emergence of parenteral P. aeruginosa resistance to aztreonam or other beta-lactam antibiotics may have potential consequences for the treatment of acute pulmonary exacerbations with systemic antibiotics.
An increased prevalence of methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), Aspergillus and Candida species was observed over time in patients treated with several Cayston treatment courses. An association between persistent isolation of MRSA and worse clinical outcome has been reported in the literature. During clinical studies of Cayston, isolation of MRSA did not result in worsening of lung function.
No interaction studies have been performed. However, no evidence of any drug interactions with aztreonam were identified from clinical studies in which Cayston was taken concomitantly with bronchodilators, dornase alfa, pancreatic enzymes, azithromycin, tobramycin, oral steroids (less than 10 mg daily/20 mg every other day) and inhaled steroids.
Pregnancy
There are no data from the use of aztreonam in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Systemic concentration of aztreonam following inhaled administration of Cayston is low compared to a standard dose of aztreonam for injection (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection).
Cayston should not be used during pregnancy unless the clinical condition of the woman requires treatment with aztreonam.
Breast-feeding
Following administration of aztreonam for injection, aztreonam is excreted in human milk at very low concentrations. Systemic concentration of aztreonam following inhaled administration of Cayston is approximately 1% of the concentration resulting from a standard dose of aztreonam for injection. Therefore, and because of low oral absorption, aztreonam exposure in breast-fed infants due to mothers receiving Cayston is likely to be extremely low.
Cayston can be used during breast-feeding.
Fertility
Non-clinical data for aztreonam for injection about fertility do not indicate any adverse effects.
Cayston has no or negligible influence on the ability to drive or use machines.
Summary of the safety profile
Assessment of adverse reactions is based on experience in four Phase 3 clinical studies involving CF patients with chronic P. aeruginosa infection and post-marketing spontaneous reporting.
In the two Phase 3 placebo-controlled clinical studies where patients received Cayston for 28 days, the most frequently occurring adverse reactions to Cayston were cough (58%), nasal congestion (18%), wheezing (15%), pharyngolaryngeal pain (13.0%), pyrexia (12%) and dyspnoea (10%).
An acute reduction of ≥ 15% in FEV1 is a complication associated with nebulised therapies, including Cayston (see section 4.4).
Tabulated summary of adverse reactions
The adverse reactions considered at least possibly related to treatment from clinical study and post-marketing experience are listed below by body system organ class and frequency.
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100).
Respiratory, thoracic and mediastinal disorders:
Very common:
cough, nasal congestion, wheezing, pharyngolaryngeal pain, dyspnoea
Common:
bronchospasm1, chest discomfort, rhinorrhoea, haemoptysis1
Skin and subcutaneous tissue disorders:
Common:
rash1
Musculoskeletal and connective tissue disorders:
Common:
arthralgia
Uncommon:
joint swelling
General disorders and administration site conditions:
Very common:
pyrexia
Investigations:
Common:
lung function test decreased1
1 See section Description of selected adverse reactions
Description of selected adverse reactions
Bronchospasm
Nebulised therapies, including Cayston, may be associated with bronchospasm (an acute reduction of ≥ 15% in FEV1). Refer to section 4.4.
Haemoptysis
Inhalation of nebulised solutions may induce a cough reflex which could aggravate underlying conditions (see section 4.4).
Allergic reactions
Rash has been reported with the use of Cayston and may be indicative of an allergic reaction to aztreonam (see section 4.4).
Lung function test decreased
Lung function test decreased has been reported with use of Cayston, but was not associated with a sustained decrease in FEV1 (see section 5.1).
The following rare and severe adverse reactions have been reported after parenteral use of other aztreonam containing products: toxic epidermal necrolysis, anaphylaxis, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis.
Paediatric population
A total of 137 paediatric patients aged 6 to 17 years with chronic P. aeruginosa infection and FEV1 ≤ 75% predicted have received Cayston in Phase 2 and Phase 3 clinical studies (6‑12 years, n = 35; 13‑17 years, n = 102).
Pyrexia was observed at a higher incidence rate in paediatric patients aged 6 to 17 years compared to adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store
Adverse reactions specifically associated with overdose of Cayston have not been identified. Since the plasma concentration of aztreonam following administration of Cayston (75 mg) is approximately 0.6 µg/ml, compared to serum levels of 54 µg/ml following administration of aztreonam for injection (500 mg), no safety issues associated with aztreonam overdose are anticipated.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Aztreonam lysine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Aztreonam lysine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Cayston 75 mg powder and solvent for nebuliser solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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