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real sea Agua de Mar Natural en Spray Nasal

Natural Sea Water Nasal Spray

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SCIENTIFIC ABSTRACT

REAL SEA® is an approved class II Medical Device in the UK, Europe (CE mark) and other countries

The sea water for REAL SEA® is collected from depth in a particular area of the Atlantic Ocean, selected for the water purity and richness of trace elements. It is purified by micro filtration and diluted to form an isotonic 0.9% solution with distilled water, and then filled using inner bag with anti-reflux valve technology under pharmaceutical hygienic conditions.

The sea water in the ocean is normally around 3.5% de NaCl (salt). For this reason natural sea water requires dilution to the same percentage of salt present in human cells (0.9%), so that once in the product, this can be used without undesirable discomfort while retaining the cleansing efficiency of natural sea water.

This dilution creates a natural sea water solution at 0.9%, the same percentage used in sterile physiological salt solutions in hospitals.

The diluted sea water of REAL SEA® is propelled by pressurized nitrogen which is an inert non-flammable gas, producing a fine spray through the specially designed nozzle .The design of the inner bag with anti-reflux valve ensures that nitrogen is not in contact with the solution, and permits zero entry of air or other matter.

The sophisticated technology of the inner bag with anti-reflux valve, ensures that ONLY the diluted sea water of REAL SEA® is in its fine spray when is applied.

REAL SEA® is free of preservatives and does not contain medicine or any other ingredient that is not found in naturally in the sea water. Therefore it can be used safely in infants, children, during pregnancy and old age, in addition to having no known interaction with any other medication which may be prescribed by the physician.

The spray of REAL SEA® can be applied with the can in upright or any other position . Its fine pressurized spray is particularly useful for daily nasal hygiene of the whole family. The unique design of the applicator, helps in the prevention on nasal lesions in elderly and young babies.

The nasal applicator may be removed for easy cleaning.

REAL SEA® because of its fine pressurized spray, helps clear excess and dried mucus during nasal hygiene, as well as other impurities present in the surface of the nasal cavity.

Trace Elements in sea water

The sea water contains many elements in minute quantities, including the following, which have specific natural curative properties:

  • Copper: Natural anti-inflammatory and antimicrobial
  • Manganese: Natural anti-allergic.
  • Silver: Natural antiseptic.

SUMMARY OF CLINICAL STUDIES

  • The efficacy of nasal irrigation with processed sea water from the Atlantic as contained in REAL SEA® contributes to the rapid remission of rhinological symptoms, reduced use of concomitant medication and improved health status in pediatric patients with common cold or flu.(26)
  • The effective nasal wash system through fine pressurized spray like REAL SEA®, helps eliminate crusts and secretions post nasal surgery being superior to other methods of irrigation with chemicals (14)

FINAL CONCLUSION

Based on the clinical evidence, is clear that saline nasal sprays particularly those containing sea water such as REAL SEA® relieve symptoms, help as an adjunct to the treatments and are well tolerated by the vast majority of patients.

Medical Director, Medisante, 2014

CLINICAL REFERENCES

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  14. Pigret, D. & Jankowski, R. Management of post-ethmoidectomy crust formation: randomized single-blind clinical trial comparing pressurized seawater versus antiseptic/mucolytic saline. Rhinology 34, 38-40 (1996).
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  16. Bachmann, G., Hommel, G. & Michel, O. Effect of irrigation of the nose with isotonic salt solution on adult patients with chronic paranasal sinus disease. Eur Arch Otorhinolaryngol 257, 537-541 (2000).
  17. Rabago, D., Zgierska, A., Mundt, M., Barrett, B., et al. Efficacy of daily hypertonic saline nasal irrigation among patients with sinusitis: a randomized controlled trial. J Fam Pract 51, 1049-1055 (2002).
  18. Süslü, N., Bajin, M. D., Süslü, A. E. & Ogretmenoglu, O. Effects of buffered 2.3%, buffered 0.9%, and non-buffered 0.9% irrigation solutions on nasal mucosa after septoplasty. Eur Arch Otorhinolaryngol 266, 685-689 (2009).
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  20. European Chemicals Website: http://echa.europa.eu/
  21. MHRA – 5- Guidance on the Biological Safety Assessment of Medical Devices (January 2006)
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  24. European Council Directive 93/42/EEC concerning medical devices.
  25. MEDDEV . 2.7.1 Rev.3 December 2009. Guidelines on medical devices. Clinical evaluation: A guide for manufacturers and notified bodies.
  26. Efficacy in Isotonic Nasal Washing (Sea water) in the tratment and prevention of rhinitis in pediatric patients
    Dr. Ivo Slapak; Dra. Jana Skoupa; Dr. Petr Strnad; Dr. Pavel Hornik (Print) Arch Otolaryngol Head Neck Surg/Vol. 134   (NO. I ), Jan 2008 WWW. ARCHOTO.COM 70