Mastodon

Aqua Maris® (Spray, Drops, Aerosol) Instructions for Use

ATC Code

R01AX10 (Other drugs)

Clinical-Pharmacological Group

Drug for moisturizing, cleansing, and protecting the nasal mucosa

Pharmacotherapeutic Group

Remedy for nasal conditions

Pharmacological Action

Sterilized isotonic sea water helps maintain the normal physiological state of the nasal mucosa.

The drug helps to thin mucus and normalize its production in the goblet cells of the nasal mucosa.

The trace elements included in the drug improve the function of the ciliated epithelium and have an anti-inflammatory, cleansing, stimulating, restorative effect on the nasal mucosa.

In allergic and vasomotor rhinitis, the drug helps to wash away and remove allergens and haptens from the nasal mucosa, reducing the local inflammatory process.

Aqua Maris®, used for hygienic purposes, helps cleanse the mucous membrane of street and room dust.

Pharmacokinetics

Pharmacokinetic data for the drug Aqua Maris® are not provided.

Indications

  • Acute and chronic inflammatory diseases of the nasal cavity, paranasal sinuses and nasopharynx;
  • Adenoiditis;
  • Postoperative period after surgical interventions on the nasal cavity;
  • Allergic and vasomotor rhinitis (especially in persons with increased sensitivity to drugs or a predisposition to it, including during pregnancy and lactation);
  • Prevention and treatment (as part of complex therapy) of nasal cavity infections in the autumn-winter period (including during pregnancy and lactation);
  • Dryness of the nasal mucosa; preservation of the physiological characteristics of the nasal mucosa in altered microclimatic conditions – in persons living and working in rooms with air conditioning and/or central heating, in people whose mucous membrane of the upper respiratory tract is constantly exposed to harmful effects (in smokers, vehicle drivers, people working in hot and dusty workshops, living in regions with harsh climatic conditions).

ICD codes

ICD-10 code Indication
J00 Acute nasopharyngitis (common cold)
J01 Acute sinusitis
J02 Acute pharyngitis
J03 Acute tonsillitis
J06.9 Acute upper respiratory infection, unspecified
J30.0 Vasomotor rhinitis
J30.1 Allergic rhinitis due to pollen
J30.3 Other allergic rhinitis (perennial allergic rhinitis)
J31 Chronic rhinitis, nasopharyngitis and pharyngitis
J32 Chronic sinusitis
J35.0 Chronic tonsillitis
J35.8 Other chronic diseases of tonsils and adenoids
Z54.0 Convalescence following surgery
Z57.3 Occupational exposure to other air contaminants
Z58.1 Exposure to air pollution
Z58.8 Other problems related to physical environmental factors
ICD-11 code Indication
CA00 Acute nasopharyngitis
CA01 Acute rhinosinusitis
CA02.Z Acute pharyngitis, unspecified
CA03.Z Acute tonsillitis, unspecified
CA07.0 Acute upper respiratory tract infection of unspecified site
CA08.00 Allergic rhinitis due to pollen
CA08.03 Other allergic rhinitis
CA08.3 Vasomotor rhinitis
CA09 Chronic rhinitis, nasopharyngitis or pharyngitis
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
QD70.1 Problems related to exposure to polluted air
QD70.Z Problems related to the natural environment or anthropogenic changes in the environment, unspecified
QD7Z Problems related to the environment, unspecified
QD84.Y Other specified exposure to occupational risk factors

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.

Spray

For treatment, Aqua Maris® metered nasal spray is prescribed for children aged 1 to 7 years, 2 sprays into each nostril 4 times/day; for children aged 7 to 16 years – 2 sprays into each nostril 4-6 times/day, for adults – 2-3 sprays into each nostril 4-8 times/day.

The duration of the course of therapy is 2-4 weeks (at the discretion of the attending physician). It is recommended to repeat the course after one month.

For prevention, Aqua Maris® metered nasal spray is used in children aged 1 to 7 years, 1-2 sprays into each nostril 1-2 times/day; for children aged 7 to 16 years – 2 sprays into each nostril 2-4 times/day, for adults – 2-3 sprays into each nostril 3-6 times/day.

For softening and removing contaminant accumulations and nasal secretions, Aqua Maris® is sprayed into each nostril as much as the situation requires, removing excess fluid with cotton wool or a handkerchief. The procedure can be repeated many times until the accumulations of contaminating particles are successfully softened or removed.

Drops

For treatment, Aqua Maris® nasal drops are prescribed to children from the 1st day of life, 2 drops into each nostril 4 times/day.

The duration of the course of therapy is 2-4 weeks. It is recommended to repeat the course after one month.

For prevention, it is recommended to perform a toilet in the form of instilling Aqua Maris® nasal drops for children from the 1st day of life, 1-2 drops into each nostril 2-3 times/day.

For softening and removing contaminant accumulations and nasal secretions, Aqua Maris® is instilled into each nostril as much as the situation requires, removing excess fluid with cotton wool or a handkerchief. The procedure can be repeated many times until the accumulations of contaminating particles are successfully softened or removed.

Aerosol

The product is used every time the child has excessive mucous discharge from the nose. Before using the nasal aspirator, it is recommended to rinse the nose with a sea water solution.

Side effects

When used according to the instructions, no side effects have been identified.

Contraindications

No known contraindications.

Use during pregnancy and lactation

Can be used during pregnancy and lactation.

Special instructions

After use, the nasal aspirator should be rinsed with running water.

Adverse Reactions

Possible allergic reactions.

Contraindications

  • Children under 1 year of age (for metered nasal spray);
  • Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug Aqua Maris® can be used during pregnancy and lactation (breastfeeding) according to indications.

Pediatric Use

Contraindicated for use in children under 1 year of age.

Special Precautions

Effect on the ability to drive vehicles and operate machinery

No data.

Overdose

No cases of overdose have been reported.

Drug Interactions

The drug does not have a systemic effect on the body, so no interactions with other drugs have been noted.

Can be used with other drugs that are used to treat rhinitis.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

After opening the bottle, the drug should be used within 45 days.

Dispensing Status

The drug is available without a prescription.

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 Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

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

Contact Information

JADRAN-GALENSKI LABORATORIJ a.o. (Croatia)

Dosage Form

Bottle OTC Icon Aqua Maris® Nasal spray, metered: bottle 30 mL with dosing device

Dosage Form, Packaging, and Composition

Metered nasal spray in the form of a colorless transparent solution without odor.

100 ml
Adriatic Sea water with natural trace elements 30 ml,
   Na+ Not less than 2.5 mg/ml
   Ca2+ Not less than 0.08 mg/ml
   Mg2+ Not less than 0.35 mg/ml
   Cl Not less than 5.5 mg/ml
   SO42- Not less than 0.6 mg/ml
   HCO3 Not less than 0.03 mg/ml

Excipients: purified water – 70 ml.

Does not contain preservatives.

30 ml (30.36 g) – dark glass bottles (1) with a dosing device with a spray head – cardboard packs.

Marketing Authorization Holder

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

Contact Information

JADRAN-GALENSKI LABORATORIJ a.o. (Croatia)

Dosage Form

Bottle OTC Icon Aqua Maris® Nasal drops for children: 10 ml dropper bottle.

Dosage Form, Packaging, and Composition

Nasal drops for children in the form of a colorless transparent solution without odor.

100 ml
Adriatic Sea water with natural trace elements 30 ml,
   Na+ Not less than 2.5 mg/ml
   Ca2+ Not less than 0.08 mg/ml
   Mg2+ Not less than 0.35 mg/ml
   Cl Not less than 5.5 mg/ml
   SO42- Not less than 0.6 mg/ml
   HCO3 Not less than 0.03 mg/ml

Excipients: purified water – 70 ml.

Does not contain preservatives.

10 ml – polyethylene dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

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

Manufactured By

Pharmalink, S.L. (Spain)

Dosage Form

Bottle OTC Icon Aqua Maris® Nasal aspirator for children: case incl. 4 replacement nozzles or box with 3 replacement nozzles

Dosage Form, Packaging, and Composition

Nasal aspirator for children consists of a central rigid body, a flexible tube, a mouthpiece for aspiration, a replaceable disposable nozzle with an anatomically shaped tip and an absorbent filter.

The aspirator is supplied in a plastic case with 4 replacement nozzles.

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