Yabro Spray-sol IBSA 10 Ampoules

Yabro Spray-sol IBSA - Medical Device

Hyaluronic acid is universally recognized as the main molecular component of the extracellular matrix. In the respiratory system, it is synthesized by the fibroblasts of the nasopharynx and the pulmonary interstitium, by the glands of the tracheo-bronchial submucosa, and by the goblet cells of the lining epithelium that add it to the mucus that covers and protects the respiratory system. Thanks to this distribution, hyaluronic acid plays a central role in respiratory physiology by intervening in multiple homeostatic mechanisms.

Nebulized hyaluronic acid rapidly penetrates and integrates into the lung interstitium, preventing the spread of macromolecules and regulating the migration of cell populations involved in inflammatory reactions. Its high hydrophilicity also allows to hydrate the entire respiratory tree, facilitating the removal of catabolites and allergens. Thanks to its ability to integrate into the glycoprotein component that covers the pre-respiratory mucosa, it intervenes in the regulation of ciliary mucus clearance by interfering with potentially disturbing allergenic or inflammatory, environmental or endogenous factors.

It allows the nebulization of the product vial, through the Spray-sol device. It is a medical device specifically designed to perform topical treatments of the nasal and sinus cavities , and allows rapid administration of the solution by nebulisation in particles of 10 to 20 microns, ideal for upper airway therapy. Thanks to its conical shape, it fits ergonomically to the nostril of adults and children.

Consisting of:

• the body of the device
• a colored dispenser mounted interlocking on the body of the device

The body of the product is in turn composed of two chambers:

• the first, a hollow and transparent cylindrical chamber with a solid and colored internal part, is intended for the passage of the solution to be nebulized;
• the second, consisting of a small container with a transparent corolla, is intended for the collection solution.

Indicated in the adjuvant treatment of upper respiratory tract diseases such as: tonsillitis, laryngitis, pharyngitis, nasopharyngitis, sinusitis, rhinitis, tracheitis, both in acute and chronic phases; hoarseness; inflammation of the vocal cords with and without dysphonia; in improving the restoration of mucosal function in the post-operative phase of endonasal interventions.
It adds to and does not replace other therapeutic treatments that may be prescribed to patients.

DOSAGE

We recommend 1 vial of 5 ml once or twice a day according to medical advice, for a time of not less than 2 weeks.

HOW TO USE

1. Open the single-dose vial by breaking the neck along the marked line.
2. Firmly screw the needle cannula to the Luer-type locking collar of the syringe, both included in the package, and aspirate the solution to be nebulized.
3. Unscrew the needle cannula and, after having hooded it, put it back in the appropriate package.
4. Place the syringe, filled with the solution to be nebulized, in the specific inlet nozzle of the product. Secure the syringe by screwing its Luer-type collar firmly to the product inlet nozzle.
5. Insert the regulator into one nostril as shown in Fig. 5 to prepare for nebulization.
During the nebulization it is recommended to keep the torso in an upright position and not to recline the head in any direction.
6. Breathe in and gently push on the plunger of the syringe to atomize the solution.
7. Release the plunger of the syringe before exhaling.
8. Repeat the operations from point 5 to point 7 also for the other nostril, trying to divide the solution contained in the syringe equally between the two nostrils.

Indicated for single patient use, but can be used multiple times. For this reason, it is very important to carefully clean the device after each use in order to ensure its durability and good functioning. Wash the product under lukewarm running water, possibly adding a little neutral soap (non-abrasive) or wash in the dishwasher with a hot cycle. Before storing the product, dry it thoroughly with a soft cloth or a jet of hot air.

WARNINGS

Do not use after the expiry date stated on the package.
Do not use if the packaging is open or damaged.
Keep away from hot surfaces and protect from sunlight.
Store in a dry place, between 0 ° and 25 ° C. Do not freeze.
For correct use, the patient must have his torso in an upright position.
Do not recline your head in any way or lie down to use the product.
The vials are sterile and intended for single use only. Do not reuse to avoid any risk of contamination and do not sterilize again.
Once opened, the vials must be used immediately and discarded after use.
Before each use, check that the device is not damaged; if it is damaged, do not use it for nebulization.
Intended for one patient only, but can be reused for multiple nebulisations. For re-use, clean following the instructions given in the "CLEANING" paragraph.
The device must be used for no more than 100 sprays and in any case for no more than one month. The cannula needle and syringe are intended for multipurpose use.After each use, cap the cannula needle and put it back together with the syringe in the special package.
The use of the product by children or non self-sufficient people must be under the supervision of an adult who has read these instructions for use.
Additional treatment and does not replace other treatments prescribed by your doctor.
It is advisable to consult your doctor before using it.
Smoking compromises the protective effect of hyaluronic acid on alveolar function.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

INTERACTIONS

No interactions between the product and any concomitant therapies are currently known.
However, being made up of physiological solution and hyaluronic acid, a natural constituent of human tissues, such interactions are, in principle, to be excluded.
Device not suitable for use in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide.

CONTRAINDICATIONS AND SIDE EFFECTS

There are currently no contraindications to the use of the product nor have any side effects been reported, however the product should not be used in case of known hypersensitivity to sodium hyaluronate or to the other components. If unwanted effects occur, it is advisable to stop the treatment and consult your doctor.

FORMAT

The package contains:

• 10 sterile disposable vials of 5 ml each Each vial contains: sodium hyaluronate (Hyaluronic Acid Sodium Salt), water, sodium chloride.
• 1 device for nebulization - Spray-sol.
• 1 5ml Luer Lock Syringe -SOFT-JECT SYRINGE.
• 1 Needle-cannula - Needle 18G X 2 ".