MESNA ALTAN 200mg/mL SOLUTION FOR NEBULIZATION AND FOR ENDOTRACHEOPULMONARY INSTILLATION

2. What you need to know before taking Mesna Altan

Do not use Mesna Altan

If you are allergic (hypersensitive) to mesna, other compounds with a thiol group or sulfonamides, or any of the other components of Mesna.

If you have asthma without mucous obstruction. Or in case of asthmatic status.

If you have severe renal insufficiency.

If you have intolerance to aerosols.

If you are unable to cough or expectorate properly.

In children under 2 years of age.

Be careful with Mesna Altan

Mesna is exclusively for use via nebulizer or endotracheal instillation and should only be administered under medical supervision.

It is not recommended for use in children under 12 years of age.

In asthmatic patients, the product should only be administered if there is retention of mucus and bronchial secretions and always in the presence of a doctor or in a healthcare center.

Any type of device can be used, provided that the circuit through which the product must pass is made of plastic, glass, or stainless steel. Mesna should not come into direct contact with rubber or unprotected metal.

A white deposit may form in the devices or circuits, which can be eliminated by rinsing with water.

Ideally, the solution should be administered at room temperature.

As it is a easily oxidizable product, it is preferable to open the ampoule at the time of use. The solution can be used up to 12 hours after opening, stored at room temperature.

Accidental intravenous injection or oral absorption does not pose a risk to the patient. However, accidental intramuscular injection can cause local tissue necrosis (tissue death due to lack of blood flow).

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Mesna can be used simultaneously with local application of other medications such as antibiotics (to treat infections), bronchodilators (to treat respiratory disorders of an asthmatic type), corticosteroids (to treat inflammatory processes), and anesthetics when these are administered intravenously.

It is recommended not to mix Mesna in the same solution with aminoglycosides (streptomycin, kanamycin, neomycin, gentamicin), as they are inactivated. However, there is no problem with the use of all these antibiotics via systemic route and Mesna via local application.

Due to physicochemical incompatibility, it is recommended not to mix Mesna in the same solution with:

• certain types of antibiotics (oxytetracycline, carbenicillin, and erythromycin)
• aminophylline (medication for asthma)
• lipiodol (radiological contrast medium)
• cisplatin (medication for certain tumors)
• nitrogen gas

If you undergo a urine test, false positive results may appear in the determination of certain components (sulfites or ketones) due to the presence in the urine of certain substances (disulfides or free thiol groups) after administration of mesna.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

There is insufficient data on the use of mesna in pregnant women.

Mesna should not be used during pregnancy except if it is clearly necessary.

Mesna should be avoided during breastfeeding or breastfeeding should be interrupted while receiving treatment with Mesna.

Driving and using machines

Mesna has no or negligible influence on the ability to drive and use machines.

3. How to take Mesna Altan

Follow the administration instructions of Mesna indicated by your doctor. Consult your doctor if you have any doubts.

Mesna can be administered:

Via nebulization:The solution can be used pure or diluted with distilled water or physiological serum. The solution can be administered preferably with a nasal piece, a mask, or under a chamber.

The usual therapeutic dose is 3 ml (600 mg) to 6 ml (1200 mg) of the undiluted product per day, divided into 3 to 4 times a day.

The maximum dose is 24 ml (4.8 g) of pure product per day.

Via endotracheal instillation:The solution should be diluted with distilled water or physiological serum. The solution can be administered via endotracheal tube or tracheotomy cannula.

The usual therapeutic dose is 1 ml or 2 ml of 10% diluted solution per hour.

The maximum dose is 24 ml (4.8 g) per day.

Treatment should be reduced to the shortest possible period, and if there is no sufficiently rapid improvement, the clinical situation should be reevaluated with possible adjustment of treatment. In cystic fibrosis, Mesna will be administered according to symptoms.

If you use more Mesna Altan than you should:

No cases of overdose have been reported.

After using large volumes of solution and sudden liquefaction of mucus, partial pulmonary congestion (partial accumulation of fluid in the lungs) may occur, causing transient ventilation disorders. The patient should be closely monitored and symptomatic treatment should be performed.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone (91) 562 04 20.

If you forget to use Mesna Altan:

Do not use a double dose to make up for forgotten doses.

If you stop treatment with Mesna Altan:

Do not stop treatment with Mesna without consulting your doctor first.

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

4. Possible side effects

Like all medications, Mesna Altan can have side effects, although not everyone experiences them.

The side effects described with Mesna Altan are:

- Chest pain

- Hypersensitivity (allergy)

- Cough

- Bronchospasm (contraction of the bronchi, causing narrowing and difficulty breathing)

• Disgeusia (alteration in the sense of taste (bad taste, bitter taste,...))

- Angioneurotic edema (hives or swelling under the skin)

- Erythematous rash (red skin rash)

- Urticaria (itching)

There is a possibility of bronchospasm, particularly in sensitive asthmatic patients. Vomiting and digestive discomfort caused by excessive fluidification and ingestion of mucus may occur, especially in children.

Sometimes, a sensation of retrosternal burning (central chest area, behind the sternum) may occur with the solution at a concentration of 200 mg/ml (in this case, the solution should be diluted to 100 mg/ml).

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

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

5. Storage of Mesna Altan

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

As it is a easily oxidizable product, it is preferable to open the ampoule at the time of use. The solution can be used up to 12 hours after opening, stored at room temperature.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Mesna Altan

• The active ingredient is mesna. Each ml of Mesna contains 200 mg of mesna. Each 3 ml ampoule contains 600 mg of mesna.

• The other components are: disodium edetate, sodium hydroxide (for pH adjustment), and water for injectable preparations.

Appearance of the product and package contents

Mesna is a clear and colorless solution.

The solution is supplied in a colorless glass ampoule.

Mesna is marketed in packages containing 6 ampoules of 3 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Altan Pharmaceuticals, S.A. Cólquide, 6 Portal 2, 1º-Ofic. F

28230 Las Rozas (Madrid)

Spain

Manufacturer:

Altan Pharmaceuticals S.A.

Avda. de la Constitución, 198-199,

Polígono Industrial Monte Boyal, Casarrubios del Monte, 45950 Toledo-España

Altan Pharmaceuticals, S.A.

Poligono Industrial s/nº (Bernedo) - 01118 – España

This package leaflet was approved in June 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.es/