Descriptive sheet IALOCLEAN
SOLUTION TO BE NEBULIZED
Description
CE Medical Device (Dir. 93/42/EEC) Class IIa.
Indicated in the adjuvant treatment of respiratory tract conditions such as: tonsillitis, laryngitis, pharyngitis, rhinitis, tracheobronchitis and bronchitis, both acute and chronic; hoarseness; inflammation of the vocal cords with and without dysphonia; irritant, post-viral or environmental pollutant-induced cough; flu-like or cold-like syndromes; post-operative ENT conditions; outcomes of extraesophageal manifestations of gastric reflux affecting the upper respiratory tract (dysphagia, chronic laryngitis and pharyngitis, aphonia, irritable cough).
How to use
Adults and children over 6 years of age: one single-dose container per session twice a day.
Children aged 2-6 years: half the contents of a single-dose container per session twice a day.
The container has a graduation corresponding to half the dose. Do not exceed the recommended dose. Administer the solution using aerosol therapy devices (piston-based only, not ultrasonic).
Wash your hands and do the following:
1. Flex the single-dose container in both directions and detach it from the strip to which it is welded.
2. Shake the single-dose container lightly before use.
3. Open the single-dose container by rotating the flap.
4. By applying moderate pressure to the walls of the single-dose container, dispense the indicated amount of solution and pour it into the nebulizer bulb.
5. If using half a dose, the container can be resealed by turning it upside down and pressing the cap. The resealed single-dose container should be stored at 2°C to 8°C (in the refrigerator) and the remaining amount should be used within 24 hours of opening.
Add saline solution in a 1:1 ratio.
IALOCLEAN nebulizer solution can be used at any time of day without any particular time or schedule restrictions. The duration of use depends on the evolution of symptoms; if necessary for symptom improvement, IALOCLEAN nebulizer solution can be taken for extended periods.
Components
Hyaluronic acid sodium salt, chamomile extract, EDTA, N-acetylcysteine, sodium chloride, sodium hydroxide, sodium phosphate monobasic dihydrate, sodium phosphate dibasic heptahydrate, water.
Warnings
Keep out of reach of children. Avoid contact with eyes. The presence of a sulfurous odor does not indicate any alterations to the preparation, but is characteristic of a component of the formulation.
Use, especially if prolonged, of all topical products may cause sensitization. If you experience these or other side effects, discontinue use and inform your doctor or pharmacist.
Contraindicated for use in children under two years of age. Do not use if you are hypersensitive to any of the product's components. If you are pregnant or breastfeeding, consult your doctor.
There are no known interactions with other products. IALOCLEAN nebulizer solution can be used in combination with other medical devices or medications after consulting a doctor.
Conservation
Single-dose containers must be stored in the protective pouch, away from light and heat. If using a half dose, the resealed single-dose container should be stored at a temperature between 2°C and 8°C (in the refrigerator).
Shelf life in unopened packaging: 36 months.
Format
15 single-dose vials of 2 ml.
Code 14