Aqua Maris® (Otolaryngological product) Instructions for Use
Therapeutic Category
Medical device for moisturizing, cleansing, and protecting the nasal mucosa
Properties
Isotonic sea water helps maintain the normal physiological state of the nasal mucosa, promotes mucus thinning, and normalizes its production in the goblet cells of the nasal mucosa.
After using this product, the therapeutic effectiveness of medications applied to the nasal mucosa is increased, and the duration of respiratory diseases is reduced.
The product for washing and irrigating the nasal cavity reduces the risk of infection spreading to the sinuses and the ear cavity (sinusitis, frontal sinusitis, otitis).
It reduces the risk of local complications and accelerates healing processes after surgical interventions (including adenoid removal, polyp removal, septoplasty) on the nasal cavity.
It relieves irritation of the nasal cavity in individuals whose upper respiratory tract mucosa is constantly exposed to harmful effects (smokers, drivers of motor vehicles, people living and working in rooms with air conditioning and/or central heating, working in hot and dusty workshops, as well as those in regions with harsh climatic conditions).
Scope of Application
As part of complex therapy for acute and chronic inflammatory diseases of the nasal cavity, paranasal sinuses, and nasopharynx (acute and chronic rhinitis; acute and chronic sinusitis; acute and chronic adenoiditis; allergic rhinitis; atrophic rhinitis); ARVI and influenza.
Prevention of ARVI and influenza during an epidemic.
Nasal cavity care: after surgical interventions; cleansing from bacteria, viruses, dust, pollen, smoke; for preparing the mucosa for the application of medications; long-term therapy with topical corticosteroids.
ICD codes
| ICD-10 code | Indication |
| J00 | Acute nasopharyngitis (common cold) |
| J01 | Acute sinusitis |
| J06.9 | Acute upper respiratory infection, unspecified |
| J10 | Influenza due to identified seasonal influenza virus |
| J30.1 | Allergic rhinitis due to pollen |
| J30.3 | Other allergic rhinitis (perennial allergic rhinitis) |
| J31.0 | Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis) |
| J32 | Chronic sinusitis |
| J35.0 | Chronic tonsillitis |
| J35.8 | Other chronic diseases of tonsils and adenoids |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| Z54.0 | Convalescence following surgery |
| ICD-11 code | Indication |
| 1E30 | Influenza due to identified seasonal influenza virus |
| CA00 | Acute nasopharyngitis |
| CA01 | Acute rhinosinusitis |
| CA07.0 | Acute upper respiratory tract infection of unspecified site |
| CA08.00 | Allergic rhinitis due to pollen |
| CA08.03 | Other allergic rhinitis |
| CA09.0 | Chronic rhinitis |
| CA0A.Z | Chronic rhinosinusitis, unspecified |
| CA0F.Y | Other specified chronic diseases of the palatine tonsils and adenoids |
| CA0F.Z | Chronic diseases of tonsils and adenoids, unspecified |
| QB7Y | Other specified convalescence |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Otolaryngological product
The product is applied intranasally.
For therapeutic purposes, wash each nasal passage 4-6 times/day, daily; for prevention – 2-4 times/day; for hygienic purposes – 1-2 times/day (more frequently if necessary).
Side effects
When used according to the instructions, no side effects have been identified.
Contraindications
Hypersensitivity to sea water.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding are not contraindications for use.
Special instructions
Consultation with a doctor is necessary if the product is used after surgery.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Product for washing and irrigating the nasal cavity: 50 ml or 150 ml canisters with nozzle
Marketing Authorization Holder
Jadran-Galenski Laboratorij, D.D. (Croatia)
Dosage Form
 |
Aqua Maris® Baby intensive washing | Product for washing and irrigating the nasal cavity: 50 ml or 150 ml canisters with nozzle |
Dosage Form, Packaging, and Composition
Product for washing and irrigating the nasal cavity (isotonic sea water solution) in the form of a transparent colorless liquid with a slightly salty taste.
| 100 ml | |
| Sea water* | 27.1±3.0 ml |
| With an isotonic NaCl concentration – not less than 9 g/l | |
* natural water of the Adriatic Sea, which is part of the solution, contains ions Cl–, Na+, SO42-, Mg2+, Ca2+, K+, HCO3–, Br–, as well as trace elements Zn, Se, I, Fe, Mn, etc.
Excipients: purified water – up to 100 ml.
Does not contain chemical additives or preservatives.
50 ml – metal canisters (1) with nozzle – cardboard packs.
150 ml – metal canisters (1) with nozzle – cardboard packs.
Product for washing and irrigating the nasal cavity: 50 ml or 150 ml canisters with nozzle
Marketing Authorization Holder
Jadran-Galenski Laboratorij, D.D. (Croatia)
Dosage Form
|
Aqua Maris® Norm intensive washing | Product for washing and irrigating the nasal cavity: 50 ml or 150 ml canisters with nozzle |
Dosage Form, Packaging, and Composition
Product for washing and irrigating the nasal cavity (isotonic sea water solution) in the form of a transparent colorless liquid with a slightly salty taste.
| 100 ml | |
| Sea water* | 27.1±3.0 ml |
| With an isotonic NaCl concentration – not less than 9 g/l | |
* natural water of the Adriatic Sea, which is part of the solution, contains ions Cl–, Na+, SO42-, Mg2+, Ca2+, K+, HCO3–, Br–, as well as trace elements Zn, Se, I, Fe, Mn, etc.
Excipients: purified water – up to 100 ml.
Does not contain chemical additives or preservatives.
50 ml – metal canisters (1) with nozzle – cardboard packs.
150 ml – metal canisters (1) with nozzle – cardboard packs.
![Aqua Maris® [Otolaryngological product] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Aqua Maris® [Otolaryngological product] 2")