Fitonasal Pediatric Spray
Decongests and protects the mucosa, including in the event of a cough caused by the common cold
The entire Products section of this website is an English translation of the official Italian Aboca website. It contains the list of Aboca products marketed in Italy and their related details. Please be aware that the information contained in each product data sheet is in accordance with Italian law only and may not reflect the legislation, regulations or other requirements applicable in your country. If you would like to see the leaflets for the countries that are supported but that do not have a dedicated site, please click here.
Learn more
Fitonasal Pediatric is a decongestant specifically formulated to free children's nostrils in the event of congestion and irritation of the nasal cavities as a result of the flu, common cold, allergic rhinitis and acute or chronic sinusitis. Fitonasal Pediatric acts thanks to TANNISAL, a molecular complex with tannins and salgemma that interacts with the nasal mucosa to provide:
A decongestant effect:
- thanks to its balanced osmolarity, which helps draw water from congested tissues without irritating or drying out the mucosa.
A protective effect on the mucosa thanks to the formation of a mucoadhesive layer and to its antioxidant properties
In addition, by producing a continuous flow of nebulised material, the product has a deep cleansing effect on the nasal cavities, which removes the excess mucus along with any pathogens, irritants and allergens trapped inside (viruses, bacteria, smoke, smog, pollen grains, irritants, etc.). This effect is useful in infants who are unable to blow their noses and in children who do not blow their noses properly.
These properties make Fitonasal Pediatric suitable for coughs caused by retro-nasal drip. When mucus stagnates in the nasal cavities with microorganisms and allergens present, retro-nasal drip can trigger a cough and other problems such as a sore throat and otitis media.
Fitonasal Pediatric does not contain vasocontrictor decongestants and, thanks to its non-pharmacological mechanism of action, does not dry out or irritate the nasal mucosa and can be used frequently, including for extended periods of time. In infants and children, use of the product makes breathing easier and facilitates restful sleep.
THE PACKAGE
Fitonasal Pediatric is provided in a spray bottle equipped with “bag on valve” technology.
The advantages of the nebuliser:
1 · Practical - provides a continuous flow of material in all positions, which is especially useful for the first years of life;
2 · Ergonomic - the spray nozzle was designed with the nostrils of young children in mind.
3 · Quality - the product is contained in a bag that allows air, liquids or other residue to exit but not enter.
Read the warnings and instructions for use carefully.
Instructions for use
Use Fitonasal Pediatric at least 2 times per day, morning and evening and every time the need for the product is felt. For effective decongestant action and to protect the mucuous membrane, use Fitonasal Pediatric as indicated below:
1. From 6 months to one year of age
- Have the child lie down on one side, insert the nozzle in the upper nostril, and administer the product.
- Repeat the operation for the other nostril, having the child lie down on the other side.
2. Over one year of age
- Insert the nozzle in the nostril and press lightly for a few seconds.
- Clean the nose or, if possible, have the child blow the nose and repeat the nebulisation in the other nostril.
Rinse the nozzle after each use by placing it under a stream of hot water.
Composition
Functional ingredients: TANNISAL, a standardised molecular complex with: tannic fraction of witch hazel and halite (salt extracted by mining, not treated chemically).
Also contains: Water, plant-based glycerine, lemon juice, nahcolite (natural sodium bicarbonate).
The product does not contain preservatives.
Warnings
Do not use in case of individual hypersensitivity or allergies to one or more components. If symptoms persist seek medical advice. Use exclusively for nasal administration. Avoid contact with the eyes. If contact occurs rinse eyes with water.
Warning - Pressurised container: may explode if heated. Do not puncture or burn after use. Keep away from sources of heat, hot surfaces, sparks, open flames or other sources of ignition. Do not smoke. Protect from sunlight. Do not expose to temperatures higher than 50° C/122 °F. Keep out of reach of children.
Scientific evidence
EFFICACY TEST
STANDARDISED BIOLOGICAL EFFECT BATCH ON BATCH
Aboca has developed an innovative biological test that allows for the product to be standardised on the basis of the quantity of bradykinin sequestered:
1 millilitre of Fitonasal Pediatric causes at least 200 nanograms of bradykinin to precipitate
This test is based on the precipitation reaction described below.
Bradykinin precipitation test
The bradykinin precipitation reaction was conducted on a volume of 30 µl, obtained by combining 15 µl of Fitonasal Pediatric with 15 µl of bradykinin at a concentration of 1 ng/µl. At the same time control reactions were prepared in which:
- the inflammatory agent was replaced by 15 µl of saline (reaction between Fitonasal Pediatric and saline solution, without bradykinin);
- Fitonasal Pediatric was replaced by 15 µl of saline (reaction between saline and bradykinin, without Fitonasal Pediatric);
The reactions with the compositions described above were incubated at 37°C for 30 minutes. At the end of the incubation period the test tubes were centrifuged and the quantity of inflammatory agent that remained in solution was measured.
The quantity of bradykinin that remained in solution, and therefore the efficiency of the precipitation reaction produced by the test sample, was determined by ELISA.
MUCOADHESION TEST
The main objective of this test was to evaluate the in vitro adhesion of the Fitonasal Pediatric Medical Device on a suitable cellular model, using human buccal mucosal cells. The second objective of the test was to study the resistance over time of the bioadhesive layer (formed by the interaction of the product with the cells) to a flow of mucin solution.
The mucoadhesion of Fitonasal Pediatric was determined by evaluating the capacity of the product to adhere to the cells, impeding the bond between lectin (a chemical indicator added to the medium after the sample) and membrane glycoproteins. This indicator reacts with oxidising reagents and produces coloured products that can be quantified by a spectrophotometer. The spectrophotometric measurement provides an indirect quantitative measurement of the sites on the cells' plasma glycoproteins that are not occupied by lectin due to their being occupied by the bioadhesive product: this decreased absorbance is therefore proportional to the product's ability to adhere to the cells.
The graph that follows shows the results obtained:
show image
The results obtained show that 1:2 and 1:5 dilutions of the Medical Device show good levels of mucoadhesion (49.8% and 42.8% respectively).
The second phase of the experiment evaluated the Medical Device's ability to continue to adhere to the mucosa over time by subjecting the system to an artificial flow of artificial salivary solution.
The results obtained are shown in the graph that follows:
show image
The results obtained show that a 1:2 dilution of the Medical Device is able to maintain a good level of bioadhesion to mucosal cells up to the second hour of application (% mucoadhesion after 30 min. = 47.3%; % mucoadhesion after 1 hour = 42.2%; % mucoadhesion after 2 hours = 30.5%.
Conclusions
The results obtained support the claim that Fitonasal Pediatric shows a good level of mucoadhesion and resistance over time. It is therefore reasonable to assume that Fitonasal Pediatric is capable of serving a protective role on behalf of the cells of the mucosa.
TEST EVALUATING THE FREE RADICAL SCAVENGER EFFECT IN AN IN VITRO CELL MODEL
The antioxidant free radical scavenger effect of the Fitonasal Pediatric Medical Device was evaluated in a cell model using human fibroblasts (HuDe) exposed to an oxidant (AAPH). The activity of the product was compared to the activity of vitamin C (ascorbic acid).
The protective effect that the product has when an oxidant is present can be evaluated by incubating the cells with AAPH and either the sample or ascorbic acid (positive control) or by themselves (negative control).
The graph that follows shows the strong antioxidant effect of Fitonasal Pediatric, which is only slightly inferior to the effect of ascorbic acid:
show image
show image
SAFETY TEST
BIOCOMPATIBILITY TEST
The product was subject to the biocompatibility tests required by the applicable standard. The results are shown in the table that follows:
| Tests required by ISO 10993-1 | Reference standard | Result |
|---|---|---|
| Cytotoxicity due to direct contact with mammalian fibroblasts | ISO 10993-5:2009 | Not cytotoxic (product as is and diluted 1:2, 1:5; 1:10) |
| irritation of the nasal mucosa due to direct contact | ISO 10993-10:2010 | Non-irritating |
| Sensitization | ISO 10993-10:2010 | Non-sensitizing |
| Acute oral toxicity | ISO 10993-11:2017 | Does not cause toxic signs and satisfies the test requirements. |
