Aqua Maris^® Leyka (Nasal irrigation device) Instructions for Use

Marketing Authorization Holder

Jadran-Galenski Laboratorij, D.D. (Croatia)

Dosage Form

Aqua Maris® Leyka

Individual otorhinolaryngological device for nasal mucosa irrigation

Dosage Form, Packaging, and Composition

Individual otorhinolaryngological device for nasal mucosa irrigation is a plastic container with a volume of 330 ml for preparing a nasal irrigation solution, supplied as a set with Aqua Maris^® irrigation products (30 sachets with Adriatic Sea salt*).

* 1 sachet contains 2.97 g of sea salt.

Therapeutic Category

Medical device for moisturizing, cleansing, and protecting the nasal mucosa

Properties

The device, as part of a set with irrigation products, is used for the treatment and prevention of various inflammatory diseases of the nasopharynx.

The device allows for convenient and safe nasal irrigation along the entire length of the nasal passages. The irrigation fluid enters the nasal cavity by gravity flow, i.e., without additional pressure, which helps to avoid complications such as middle ear inflammation (otitis). The procedure is simple and safe even for children, pregnant women, and breastfeeding women.

When irrigating the nasal cavity using this device, pathological contents are removed from the surface of the nasal mucosa along with viruses, bacteria, allergens, and dust; swelling and inflammation are reduced; and capillary tone is improved.

Scope of Application

The nasal irrigation device provides effective and gentle clearance of the nasopharynx from mucus and foreign particles and is recommended for use in: acute and chronic rhinitis; acute respiratory viral infections (ARVI); allergic rhinitis; acute and chronic sinusitis, frontal sinusitis, ethmoiditis; adenoiditis; increased dryness of the nasal mucosa and crust formation; frequently ill patients; after surgical intervention in the nasal cavity (as recommended by a doctor).

ICD codes

Dosage Regimen

The device is recommended for individual use at home by adults and children from 3 years of age.

Side Effects

No side effects have been identified when used according to the instructions.

Contraindications

Acute otitis media and exacerbation of chronic otitis media; frequent nosebleeds; benign and malignant neoplasms in the nasal cavity; complete obstruction of the nasal passages; children under 3 years of age; individual intolerance to the components of the irrigation product.

Use During Pregnancy and Breastfeeding

Can be used during pregnancy and breastfeeding.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.