Mesna Altan 200 mg/ml solution for nebulization and for endotracheopulmonary instillation
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Mesna Altan 200 mg/ml solution for nebulisation and for endotracheopulmonary instillation
Mesna
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Mesna Altan is and what it is used for
- What you need to know before using Mesna Altan
- How to use Mesna Altan
- Possible adverse effects
- How to store Mesna Altan
- Contents of the pack and other information
1. What Mesna Altan is and what it is used for
Mesna is a mucolytic medication that binds to proteins in mucus fragments and solubilizes them, facilitating their elimination.
By nebulization it is used in:
- cystic fibrosis,
- obstructive disorders of the respiratory tree due to mucus plugs.
By endotracheal instillation it is used:
- to facilitate the aspiration and drainage of retained mucus and exudates in the respiratory tract during anesthesia or intensive care.
- in bronchoscopy, to ensure better visualization of the areas to be examined.
2. What you need to know before using Mesna Altan
Do not use Mesna Altan
If you are allergic (hypersensitive) to mesna, to other compounds containing a thiol group or sulfonamides, or to any of the other components of Mesna.
If you have asthma without mucus obstruction. Or in case of status asthmaticus.
If you have severe renal insufficiency.
If you are intolerant to aerosols.
If you are unable to cough or expectorate properly.
In children under 2 years of age.
Take special care with Mesna Altan
Mesna is intended exclusively for use via nebulizer or endotracheopulmonary instillation and must be administered only under medical supervision.
Its use is not recommended in children under 12 years of age.
In patients with asthma, the product should be administered only if there is retention of mucus and bronchial exudate, and always under the supervision of a physician or in a healthcare facility.
Any type of device may be used, provided that the circuit through which the product passes is made of plastic, glass, or stainless steel. Mesna must not come into direct contact with rubber or unprotected metal.
A whitish deposit may form in devices or circuits, which can be removed by rinsing with water.
Ideally, the solution should be administered at room temperature.
Because mesna is easily oxidizable, it is preferable to open the ampoule immediately before use. The solution may be used up to 12 hours after opening, if stored at room temperature.
Accidental intravenous injection or oral absorption does not endanger the patient. However, accidental intramuscular injection may cause local tissue necrosis (tissue death due to lack of blood supply).
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Mesna may be used simultaneously via local application with other medicines such as antibiotics (to treat infections), bronchodilators (to treat asthma-type respiratory disorders), corticosteroids (to treat inflammatory conditions), and anesthetics when administered intravenously.
It is recommended not to mix mesna in the same solution with aminoglycosides (streptomycin, kanamycin, neomycin, gentamicin), as these become inactivated. However, there is no problem with using these antibiotics systemically and mesna via local application.
Due to physicochemical incompatibility, it is recommended not to mix mesna in the same solution with:
- certain antibiotics (oxytetracycline, carbenicillin, and erythromycin)
- aminophylline (a medicine used to treat asthma)
- lipiodol (a radiological contrast medium)
- cisplatin (a medicine used to treat certain tumors)
- nitrogen gas
If you undergo a urine test, false positive results may occur in the determination of certain components (sulfites or ketones), due to the presence in urine of certain substances (disulfides or free thiol groups) after administration of mesna.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
There are insufficient data on the use of mesna in pregnant women.
Mesna must not be used during pregnancy unless clearly necessary.
Mesna should be avoided during breastfeeding or breastfeeding should be discontinued while receiving treatment with Mesna.
Driving and using machines
The influence of Mesna on the ability to drive and use machines is negligible or none.
3. How to use Mesna Altan
Follow exactly the administration instructions for Mesna as indicated by your doctor. Consult your doctor if you have any doubts.
Mesna can be administered:
By nebulization: The solution may be used undiluted, or it may be diluted with an equal volume of distilled water or physiological saline. The solution is preferably administered using a nasal piece, a mask, or via a spacer chamber.
The usual therapeutic dose is 3 ml (600 mg) to 6 ml (1200 mg) of undiluted product per day, divided into 3 to 4 doses daily.
The maximum dose is 24 ml (4.8 g) of undiluted product per day.
By endotracheal instillation: The solution must be diluted with an equal volume of distilled water or physiological saline. The solution may be administered through an endotracheal tube or tracheostomy 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 limited to the shortest possible duration, and if sufficient improvement is not achieved rapidly, the clinical situation should be re-evaluated, possibly with adjustment of therapy. In cystic fibrosis, Mesna should be administered according to symptomatology.
If you use more Mesna Altan than you should:
Cases of overdose have not been reported.
After using large volumes of solution and sudden liquefaction of mucus, partial pulmonary flooding (partial accumulation of fluid in the lungs) may occur, causing transient disturbances in ventilation. The patient should be closely monitored and symptomatic treatment provided.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone (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 using Mesna Altan:
Do not interrupt treatment with Mesna without first consulting your doctor.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Mesna Altan may cause adverse effects, although not everybody experiences them.
The adverse effects reported with Mesna Altan are:
- Chest pain
- Hypersensitivity (allergy)
- Cough
- Bronchospasm (contraction of the bronchi, causing narrowing and difficulty breathing)
- Dysgeusia (alteration of taste sensation (bad taste, bitter taste, etc.))
- Angioneurotic edema (hives or welts due to swelling under the skin)
- Erythematous rash (reddish skin eruption)
- Urticaria (itching)
Bronchospasm may occur, particularly in sensitive asthmatic patients. Especially in children, vomiting and gastrointestinal discomfort due to excessive liquefaction and swallowing of mucus may appear.
A retrosternal burning sensation (central chest area, behind the sternum) may occasionally 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 any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them directly through the national reporting system included in Appendix V*. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Mesna Altan.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Since it is a substance easily subject to oxidation, it is preferable to open the ampoule immediately before use. The solution may be used up to 12 hours after opening, if stored at room temperature.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located in the pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Mesna Altan
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The active substance is mesna. Each ml of Mesna contains 200 mg of mesna. Each 3 ml ampoule contains 600 mg of mesna.
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The other components are: disodium edetate, sodium hydroxide (for pH adjustment), and water for injections.
Appearance of the medicinal product and contents of the pack
Mesna is a clear, colourless solution.
The solution is supplied in colourless glass ampoules.
Mesna is marketed in packs containing 6 ampoules of 3 ml 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-Spain
Altan Pharmaceuticals, S.A.
Poligono Industrial s/nº (Bernedo) - 01118 – Spain
This summary of product characteristics was approved in June 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/