Bentrio

Bentrio is a gel emulsion which is sprayed into the nasal cavity to form a protective barrier against airborne particles.
Bentrio is free of any medications such as antihistamines or steroids and does not contain preservatives.

The nasal cavities are lined with mucosa which serves as the body's first line of defence against inhaled particles such as pollen, house dust mites, animal dander or viruses. The nasal mucosa acts as a protective barrier against these particles; it secrets mucus which traps particles for clearance via the throat. Its protective function may be compromised by nasal dryness or irritation (e.g. due to low air humidity, certain nasal sprays) or mucosal damage. Also, it may be overwhelmed by the quantity or infectiousness of inhaled particles. Bentrio protects the nasal mucosa in three ways: forms a thin protective layer on the nasal mucosa; binds inhaled particles through electrostatic effects; humidifies the mucosa and thus aids its functionality.
The gel formulation of Bentrio has been designed for extended residence time within the nose. Upon shaking of the spray bottle, it turns liquid which allows for spraying into the nose. After contact with the nasal mucosa, the formulation returns to its gel state and creates the protective barrier.
Bentrio is cleared from the nasal cavities over time into the throat and eliminated via the digestive tract.

It is intended to trap allergens and viruses which might be inhaled through the nose. This will help alleviate symptoms caused by these inhaled allergens and viruses.
Bentrio is suitable for adults and children from 6 years of age under supervision of parents or other caretakers.

Apply 1-2 sprays per nostril 3 times per day or as needed (not more than 8 sprays per nostril and day) for not more than 30 days in a row.
Bentrio has been shown to provide clinically relevant protection against pollen for at least 3 hours.
Apply Bentrio prior to potential exposure to airborne allergens and viruses.
Blow the nose gently. Shake the bottle vigorously five times up and down.
Remove protective cap. Prime pump prior to first use by actuating it repeatedly (point away, in the air or towards a tissue) until a full spray appears.
Bend head slightly forward, insert spray tip as far as possible and hold bottle upright while actuating firmly 1 or 2 times.
Repeat application in the other nostril. Wipe spray tip and put on cap.
Upon application of Bentrio the patient may feel a slight, transient sensation of a congested nose. Later, the patient may feel a slight, transient sensation of the formulation in the throat as Bentrio is cleared from the nasal cavities.
If the patient blow his/her nose or if he/she sneezes, Bentrio should be re-applied. If using a medicated nasal spray, use prior to Bentrio.

Do not use Bentrio if the patient has an allergic reaction to any of the ingredients or if has a wound or ulcers in the nose.

Bentrio has no pharmacological, immunologic or metabolic effects.
All ingredients have a well-established safety profile and have been used for many years in other medical devices or drug products.
Clinical testing confirmed that Bentrio is well tolerated.
In case of side effects, the patient should discontinue treatment immediately; if symptoms persist medical treatment should be sought.

Store between 8°C and 30°C. May be stored at up to 30°C/75% relative humidity for up to 18 months. When stored refrigerated, warm up prior to use. Do not freeze.
Use within 6 months of first use and before the expiry date shown on the spray bottle.

Instructions for safe use: After each use, wipe the spray tip thoroughly with a clean, dry, unused tissue and put on the protective cap. Do not share Bentrio with other users to avoid potential contamination.
Do not use if tamper-evident seal is broken or missing.

Nasal Decongestants & Other Nasal Preparations

R01AX10 - various ; Belongs to the class of other nasal preparations for topical use.

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