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Aqua Maris® Strong (Spray) Instructions for Use

ATC Code

R02A (Preparations for the treatment of throat diseases)

Clinical-Pharmacological Group

Agent for cleansing and protecting the mucous membrane of the pharynx and larynx

Pharmacotherapeutic Group

Remedy for throat conditions

Pharmacological Action

The drug is based on a sterile hypertonic solution of sea water. It is used for therapeutic, prophylactic, and hygienic purposes to cleanse, relieve irritation, and protect the mucous membrane of the pharynx and larynx.

The trace elements included in the drug’s composition enhance the resistance of the pharyngeal mucosa to pathogenic bacteria and viruses and contribute to increasing local immunity.

Pharmacokinetics

Pharmacokinetic data for Aqua Maris® Strong are not provided.

Indications

  • For the prevention and complex treatment of acute and chronic infectious and inflammatory diseases of the pharynx and larynx (tonsillitis, adenoiditis, pharyngitis, laryngitis);
  • For the prevention and complex treatment of acute respiratory viral infections (including during pregnancy and lactation);
  • Dryness of the mucous membrane of the posterior pharyngeal wall due to increased air dryness (central heating, air conditioning) or air pollution – to preserve the physiological characteristics of the pharyngeal mucosa in altered microclimatic conditions.

ICD codes

ICD-10 code Indication
J02 Acute pharyngitis
J03 Acute tonsillitis
J04 Acute laryngitis and tracheitis
J06.9 Acute upper respiratory infection, unspecified
J31 Chronic rhinitis, nasopharyngitis and pharyngitis
J35.0 Chronic tonsillitis
J35.8 Other chronic diseases of tonsils and adenoids
J37 Chronic laryngitis and laryngotracheitis
Z58.1 Exposure to air pollution
Z58.8 Other problems related to physical environmental factors
ICD-11 code Indication
CA02.Z Acute pharyngitis, unspecified
CA03.Z Acute tonsillitis, unspecified
CA05 Acute laryngitis or tracheitis
CA07.0 Acute upper respiratory tract infection of unspecified site
CA09 Chronic rhinitis, nasopharyngitis or pharyngitis
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
CA0F.Z Chronic diseases of tonsils and adenoids, unspecified
CA0G Chronic laryngitis or laryngotracheitis
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

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.

Use the spray for topical application only.

Administer 3-4 sprays per application, directing the sprayer towards the posterior wall of the pharynx.

Apply the spray 4-6 times daily for both adults and children.

Before each use, turn the sprayer to a horizontal position.

Prime the pump before first use by pressing the cap several times until a fine mist is produced.

For prevention of acute respiratory viral infections, use the spray 2-3 times daily.

For complex treatment of inflammatory throat conditions, adhere to the standard dosage of 4-6 times daily.

Use the spray to alleviate dryness of the pharyngeal mucosa as needed throughout the day.

Continue use for the duration prescribed by a physician or until symptoms resolve.

Do not exceed the recommended daily frequency of applications.

Adverse Reactions

Allergic reactions are possible.

Contraindications

  • Hypersensitivity to the components of the drug.

Use with caution in children under 1 year of age.

Use in Pregnancy and Lactation

Aqua Maris® Strong can be used during pregnancy and lactation (breastfeeding) as indicated.

Pediatric Use

Use with caution in children under 1 year of age.

Special Precautions

Effect on the ability to drive vehicles and machinery

No data.

Overdose

No cases of overdose have been reported.

Drug Interactions

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

It can be used with other medicines used to treat inflammatory diseases of the pharynx and larynx.

Storage Conditions

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

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the packaging.

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® Strong Nasal spray: bottle 30 mL 1 pc. with spray device

Dosage Form, Packaging, and Composition

Nasal spray in the form of a colorless transparent solution with a faint specific odor.

1 bottle
Sterile hypertonic solution of Adriatic sea water (100%) incl.
   Na+ Not less than 7.5 mg/ml
   Ca2+ Not less than 0.25 mg/ml
   K+ Not less than 0.2 mg/ml
   Mg2+ Not less than 1 mg/ml
   Cl Not less than 16.5 mg/ml
   SO42- Not less than 1.8 mg/ml
   HCO3 Not less than 0.1 mg/ml
   Br Not less than 0.04 mg/ml

Does not contain preservatives.

30 ml – dark glass bottles (1) with a spray device – 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® Strong Topical spray: bottle 30 mL 1 pc. with spray device

Dosage Form, Packaging, and Composition

Topical spray in the form of a colorless transparent solution with a faint characteristic sea smell.

1 bottle
Sterile hypertonic solution of Adriatic sea water (100%), with natural salts and trace elements incl.
   Na+ Not less than 7.5 mg/ml
   Ca2+ Not less than 0.25 mg/ml
   K+ Not less than 0.2 mg/ml
   Mg2+ Not less than 1 mg/ml
   Cl Not less than 16.5 mg/ml
   SO42- Not less than 1.8 mg/ml
   HCO3 Not less than 0.1 mg/ml
   Br Not less than 0.04 mg/ml

Does not contain preservatives.

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

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