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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Nasal spray: bottle 30 mL 1 pc. with spray device
Marketing Authorization Holder
Jadran-Galenski Laboratorij, D.D. (Croatia)
Contact Information
JADRAN-GALENSKI LABORATORIJ a.o. (Croatia)
Dosage Form
| 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.
Topical spray: bottle 30 mL 1 pc. with spray device
Marketing Authorization Holder
Jadran-Galenski Laboratorij, D.D. (Croatia)
Contact Information
JADRAN-GALENSKI LABORATORIJ a.o. (Croatia)
Dosage Form
| 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.
