FTPR 70

Ipertonic nasal spray
MDR MEDICAL DEVICE CE

PRODUCT REFERENCE FTPR 70

PRODUCT REFERENCE: FTPR 70 – CE 0477

Medical Device (class IIa)

Properties:

Ipertonic nasal spray is a 3% hypertonic saline solution with Hyaluronic Acid. It is intended for cleaning the stuffy nose and as adjuvant in the treatment of early cooling symptoms and in cases of sinusitis, rhinitis and rhinosinusitis.

It has a decongestant action, due to its osmolarity promotes the recall of water from congested tissues. It also forms a mucoadhesive layer that helps to maintain hydration of the irritated nasal mucosa by performing a soothing action.

The product, thanks to its continuous-flow nebulized jet, deeply cleanses the nasal cavities by removing excess mucus and impurities such as pollen, dust, allergens, pollutants and smoke.

Ipertonic nasal spray is indicated   for children (1+), adolescents and adults.

 

Posology and instructions for use:

  1. Remove the protective capsule from the cylinder and insert the dispenser button on the valve, insert the anatomical dispenser very gently into the nostril, pressing gently to dispense the product. At the end of use, clean and dry the dispenser.
  2. Nebulization takes place in any position the bottle is held; however, it is advisable to slightly tilt the head to one side and spray for 2 seconds in the nostril of the opposite side (eg head tilted to the right and product sprayed into the left nostril). Repeat the operation in both nostrils.
  3. One nostril spray up to 3 times a day.

At the end of use, clean and dry the dispenser.

Warnings:

  • Do not take it if you are allergic, intolerant or hypersensitive to any component.
  • The use of the same cylinder by several subjects can facilitate the transmission of infections: a strictly personal use of the product is recommended.
  • Keep out of the reach of children.
  • Pressure vessel.
  • Protect from sunlight and do not expose to a temperature above 50°C.
  • Do not use for purposes other than that for which the product is intended.
  • No side effects associated by used the device have been observed. If you notice the appearance of side effects, inform your doctor.
  • Do not use if the cylinder is damaged. Once the product is exhausted, do not pierce or burn the cylinder. Once used, remove the cylinder and the dispenser following the normal rules of urban waste.
  • Expiry date refers to the product in its intact packaging, and properly stored.
  • Do not exceed the recommended daily dose
  • Even if no side effects are known, it is recommended not to use the product in children under 1 year. In any case, consult your doctor before taking it.
  • In the event of concomitant pharmacological treatment, although no interactions with drugs are known, it is advisable to take the product one hour before or after other medicines.

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the Competent Autorithy. In case of any undesired event always seek for medical advice.

Do not use in case the package is not intact.

Store in its original package at room temperature, place away from heat sources and direct sunlight.

Composition: Hyaluronic acid sodium (0,02%), Purified water, Sodium chloride (3%), Bibasic potassium phosphate E340(ii), Monobasic potassium phosphate E340(i).

Content total SALE: A bag-on-valve cylinder containing 100 ml of solution + 1 dispenser for nasal use.

Others optional information:

3% hypertonic saline solution with Hyaluronic Acid (Sodium Hyaluronate)

Nose decongestion for adults, adolescent and children (1+).

BAG ON VALVE system: does not pollute the atmosphere because air is used as the propellant.

ESSENTIAL FORMULA: without preservatives, the possibility of developing allergic reactions is reduced.

EASY and PRACTICAL use.

Alcohol-free.

Preservative-free

PROPELLANT GAS: Air.

 

Manufacturer: Labomar S.p.A., Via N. Sauro 35/I, Istrana (TV) Italy.

Revision: November 2024.