ISTENDO 1 g/5 ml S inst ETB en ampoule 6Amp/5ml

Acetylcysteine................................................................................................................. 1,00000 g

For 1 ampoule of 5 ml of solution

Care of tracheostomized patients: treatment of airway obstruction by local instillation.

Dosage

1 to 2 ml of solution diluted in an equal quantity of physiological saline or distilled water, instilled via the tracheostomy cannula.

Method of administration

Endotracheal route.

Do not inject.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

There is a risk of sudden liquefaction of bronchial secretions which may lead to bronchial flooding and may, in this case, require emergency bronchial aspiration.

ISTENDO 1 g/5 ml should be used with caution in subjects with a history of asthma or bronchospasm.

After local administration of the product, it should be ensured that secretions are evacuated.

Many patients with bronchospasm are rapidly relieved by the use of a bronchodilator in nebulised form. If the bronchospasm progresses, ISTENDO 1 g/5 ml must be stopped immediately.

The data available to date do not suggest the existence of clinically significant interactions.

Pregnancy

Animal studies have not shown a teratogenic effect. The clinical data available in pregnant women with acetylcysteine are limited. Nevertheless, given the mode of administration of ISTENDO by endotracheobronchial instillation, the risk of impact on an ongoing pregnancy is unlikely.

Breast-feeding

It is possible to breastfeed during treatment with this medicine.

• Bronchospasm,
• Bronchial flooding,
• Tracheal burning sensation or irritating cough (particularly if the product is insufficiently diluted or used neat),
• Hypersensitivity reactions with possible anaphylactic shock, anaphylactoid reactions, angioedema, skin rashes,
• Cases of rhinorrhoea, drowsiness, sweating, chest tightness have been reported.

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 the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.signalement-sante.gouv.fr.

No cases of overdose have been reported; however, a possible overdose may lead to an exacerbation of undesirable effects.

Pharmacotherapeutic class: mucolytic (R: respiratory system)

Mechanism of action

Acetylcysteine is a mucomodifier of the mucolytic type. It acts on the gel phase of mucus, probably by breaking the disulfide bridges of glycoproteins, and thus facilitates the liquefaction of secretions.

As N-acetylcysteine is a reducing agent:

• Certain materials (for example: rubber and certain metals, in particular iron and copper) may react with ISTENDO 1 g/5 ml. Therefore, do not bring ISTENDO 1 g/5 ml into contact with these materials.
• There is a probability of physicochemical incompatibilities with antibiotics or corticosteroids. Therefore, do not mix ISTENDO 1 g/5 ml with these products in the same container.

3 years.

Once the ampoule is opened: the product must be used immediately.

No special precautions for storage.

No particular requirements