Description
Medical device containing Ectoin, a natural cytoprotective molecule, capable of reducing inflammation and stabilizing cell membranes.
Isotonic solution that can be used as a supportive treatment to reduce inflammation and alleviate symptoms of respiratory tract diseases, in cases of allergic or non-allergic asthma, bronchitis, or chronic obstructive pulmonary disease (COPD). It protects and moisturizes the respiratory tract mucosa, for example, when exposed to particulate matter, pollen, dust, or dry air from heated environments or air conditioning. Fidhalo prevents respiratory allergic symptoms of asthma induced by household dust or pollen, for example. In the prevention and supportive treatment of bronchitis symptoms, Fidhalo prevents mucosal dryness and thins thick mucus, facilitating its expectoration.
It can be administered via jet, mesh, and ultrasonic nebulizers.

Instructions for use
Inhale the contents of one single-dose vial (2.5 ml) as needed, up to twice a day, using a nebulizer device. Ensure the nebulizer is clean and free of any impurities.
Children aged 10 years or younger must be assisted during application.
1. Detach a single-dose vial from the strip and open the container by twisting the tab.
2. Hold the opening of the single-dose vial above the nebulizer's funnel.
3. Pour the entire content into the funnel, gently squeezing the vial. Due to the manufacturing method of the vial, a small amount of liquid will remain inside.
4. Use the nebulizer device according to its manufacturer's instructions.
5. Children under 2 years of age require special technical equipment (e.g., custom soft-shell masks) for inhaling FIDHALO. Use the equipment recommended by the nebulizer device manufacturer.
To ensure product sterility, each single-dose vial is intended for single use.

Components
Ectoin, water, sea salt.

Warnings
It should not be used in the presence of persistent trauma, for example, after surgical procedures on the respiratory system. It should not be used in case of hypersensitivity to Ectoin or any other ingredient. If adverse effects occur, the use of Fidhalo should be immediately discontinued. After using a single-dose vial, any remaining liquid must be discarded; it is not intended for subsequent use. Fidhalo is contained in small plastic parts that can be swallowed by small children. To avoid the risk of choking, it must be kept out of reach of children. Do not use damaged or punctured single-dose vials. Do not inhale too quickly. It should not be used after the expiry date has passed. Wait at least 15 minutes between using FIDHALO and inhaling other medical devices or other medications.

Storage
Store at a temperature between 2 °C and 25 °C.
Shelf life for intact packaging: 36 months.

Format
Pack of 10 single-dose vials of 2.5 ml.

Code. 1036110IT3