Aqualor protect (Otolaryngological product) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

YS Lab (France)

Contact Information

NIZHPHARM group of companies (Russia)

Dosage Form

Aqualor protect

Nasal irrigation solution: 30 ml can with anatomical nasal nozzle

Dosage Form, Packaging, and Product Composition

Nasal irrigation solution (spray) in the form of a transparent, colorless or slightly yellowish solution, odorless or with a slight odor.

* Sea water contains sodium, manganese, chloride, bromine, magnesium, calcium, potassium, iodine, sulfur.

Excipients : purified water – up to 100%.
Does not contain preservatives.

30 ml – polyethylene bottles (1) with a mouthpiece with a “spray” type spray – cardboard boxes.

Therapeutic Category

Medical device for moisturizing, cleansing and protecting the nasal mucosa

Properties

Aqualor protect is intended to maintain the physiological state of the nasal mucosa, which is the first barrier against the spread of respiratory infections, helps to remove mucus, reduce secretions, soften and remove crusts, reduce the risk of respiratory infections, and moisturize the nasal mucosa.

Regular use of the product helps to cleanse the nasal mucosa from pathogenic microorganisms (viral, bacterial, fungal) without disturbing the biocenosis of the mucosa, and to moisturize it.

Aqualor protect contains a hypertonic solution of sea water, which has higher concentrations of mineral salts (15 g/l) compared to the cells and intercellular space of the nasal mucosa.

Sea water is collected off the coast of Brittany, in a natural area where the water is constantly renewed due to strong currents, during high and low tides.

Thanks to the original pumping system, the sea water for Aqualor protect is collected through a sand filter, which ensures

• Natural preliminary filtration of sea water;
• Consistent quality of sea water, regardless of external factors;
• Natural richness in trace elements and minerals.

The hypertonic sea water solution helps reduce swelling of the nasal mucosa by removing excess fluid from the intercellular space due to the difference in osmotic pressure, which helps reduce nasal congestion and restore nasal breathing.

Brown algae extract supports the physiological state of the nasal mucosa: provides moisturization and regeneration (healing); helps reduce the inflammatory response and stop bleeding; creates optimal conditions for the immune system to function, namely macrophages, which are responsible for the active capture and destruction of bacteria, remnants of dead cells, and particles foreign or toxic to the body.

Sea water and brown algae extract contain iodine, which has the ability to destroy and prevent the reproduction of bacteria, viruses, and fungi.

The calcium and magnesium ions contained in sea water significantly improve the function of the ciliated epithelial cells of the nasal mucosa, normalize the rheological properties (viscosity) of mucus, and enhance resistance to the penetration of viruses and bacteria.

The sprayer creates a fine spray, allowing for gentle and safe irrigation.

The Aqualor protect nasal irrigation solution is contained in a plastic bottle equipped with a device that protects the medical device from contamination and does not require the addition of preservatives.

The average number of doses in the bottle is 214.

Scope of Application

Of the Aqualor protect product

• Prevention and complex treatment of respiratory infections (influenza, ARVI and other colds), protection of the nasal mucosa during periods of respiratory infections;
• Prevention and complex treatment of acute and chronic inflammatory diseases of the nasal cavity, paranasal sinuses and nasopharynx:
  • Acute and chronic rhinitis (runny nose);
  • Acute and chronic sinusitis (including sinusitis);
  • Acute and chronic adenoiditis;
  • Allergic and vasomotor rhinitis.
• Condition after surgical interventions in the nasal cavity and paranasal sinuses.

ICD codes

Dosage Regimen

The product is applied intranasally.

Aqualor protect is intended for children from 6 months and adults.

For prevention during periods of respiratory infections (influenza, ARVI) it is recommended to spray Aqualor protect into each nasal passage 1-2 times daily.

For inflammatory diseases of the nasal cavity, paranasal sinuses and nasopharynx it is recommended to spray Aqualor protect into each nasal passage 3-4 times daily, more often if necessary, until symptoms completely disappear.

Instructions for using the spray

During the first use, the bottle should be held in the air in a vertical position and the mouthpiece should be pressed several times to bring the device into working condition.

If possible, before using Aqualor protect, the patient should blow their nose.

When using the Aqualor protect spray, the patient should be in an upright position, with the head held straight with a slight forward tilt.

It is necessary to ensure that the head is not tilted back during the use of the spray.

1. Remove the protective cap.
2. Insert the sprayer into the right nasal passage.
3. Press the mouthpiece to obtain one dose.
4. Repeat the procedure with the left nasal passage.

Important: during the procedure, you should not inhale, talk, or shout.

After each use of the product, it is recommended to wash the sprayer with warm water and soap and then rinse it.

Side effects

None identified.

Contraindications

• Allergy, intolerance or hypersensitivity to any of the components of the product;
• Hyperthyroidism;
• Pregnancy;
• Breastfeeding period;
• Children under 6 months of age.

Use during pregnancy and lactation

Due to the lack of studies, the use of Aqualor protect is contraindicated during pregnancy and lactation.

Special instructions

Aqualor protect is not a medicinal product.

If symptoms of an acute respiratory disease persist for more than 5 days without improvement, the patient should consult a doctor.

The medical device does not require sterilization.

To avoid the risk of contamination, it is recommended

• To wash the sprayer after each use with warm water and soap and then rinse it;
• Not to share one spray with other people.

Procedure for disposal and destruction

After the expiration date, the product should be disposed of in accordance with the rules for disposal of class A medical waste.

Storage Conditions

The product should be stored in the original packaging in a place inaccessible to children at a temperature from 8°C (46.4°F) to 35°C (95°F).

Shelf Life

The shelf life is 3 years. The expiration date is indicated on the packaging.

An opened bottle should be stored until the expiration date, subject to the rules of processing.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.