GlunebBiomedica Foscama Group markets also medical devices. Among these are included those substances used in humans the purpose of which is diagnosis, prevention, monitoring, treatment or alleviation of disease, whose main action, in the human body, is not exercised by pharmacological, immunological or metabolic means. Medical devices are ruled by Legislative Decree No 46 of 1997 and they are divided into four classes: Class I, IIa, IIb and III.
Powder and solvent for solution for nebuliser
- INDICATIONS: Through a mechanical action, Gluneb facilitates removal of mucus with subsequent reduction of viscosity and infections and thus it helps to prevent bronchopulmonary obstruction.
- INSTRUCTIONS FOR USE: Reconstitute the solution in the powder vial by withdrawing the water of the ampoule of solvent by means of a syringe with an appropriate needle. Remove the aluminium seal of the vial and wipe closures with disinfectant, then insert the needle of the syringe in the vial through the centre of the rubber closure and direct the flow of water toward the glass wall of the vial. Gently shake to ensure the complete solubilisation, then transfer the thus obtained solution in a proper nebulizer ampoule , suitable to achieve particles having an average diameter of about 5 microns (eg. Equal or similar). Do not reuse the product once opened.
- POSOLOGY: Children: the recommended dose is 1 reconstituted vial , twice a day or according to medical prescription. Adults: the recommended dose is 2 reconstituted vials, twice a day or according to medical prescription.
- WARNINGS: Keep out of the reach and sight of children. Store in a cool, dry place, away from heat. Do not use the product after the expiry date printed on the package. Do not use this product if the package is not intact. The expiry date refers with package integrity and correctly stored. Do not use in cases of allergy or hypersensitivity to the components. keep physician informed if any adverse event should occur.
- COMPOSITION: one powder vial contains: Glutathione sodium salt, 323 mg lyophilized powder (300 mg of Glutathione). One ampoule of solvent contains: water for solution for nebuliser
- PACKAGING: 30 vials lyophilized powder + 30 solvent ampoules
- CLASS: Class IIa disposable Medical Device