Morskaya voda bufus (Drops) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

R01AX10 (Other drugs)

Active Substance

Sea water (Grouping name)

Dosage Form

Sea water bufus

Nasal drops: tube-dropper 2 ml 1, 10, or 20 pcs., tube-dropper 5 ml 5, 10, or 20 pcs., tube-dropper 10 ml 1, 5, 10, or 20 pcs., tube-dropper 15 ml or 20 ml 1 pc.

Dosage Form, Packaging, and Composition

Nasal drops as a transparent or slightly opalescent colorless solution.

Excipients: purified water up to 100 ml.

2 ml – polyethylene tube-droppers (1) with a valve – cardboard packs.
2 ml – polyethylene tube-droppers (10) with a valve – cardboard packs.
5 ml – polyethylene tube-droppers (5) with a valve – cardboard packs.
5 ml – polyethylene tube-droppers (10) with a valve – cardboard packs.
5 ml – polyethylene tube-droppers (20) with a valve – cardboard packs.
10 ml – polyethylene tube-droppers (5) with a valve – cardboard packs.
10 ml – polyethylene tube-droppers (10) with a valve – cardboard packs.
10 ml – polyethylene tube-droppers (20) with a valve – cardboard packs.
10 ml – tube-droppers (1) – cardboard packs.
15 ml – tube-droppers (1) – cardboard packs.
20 ml – tube-droppers (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for moisturizing, cleansing, and protecting the nasal mucosa

Pharmacotherapeutic Group

Nose diseases treatment

Pharmacological Action

It helps to maintain the normal physiological state of the nasal mucosa, as well as to thin mucus and normalize its production by goblet cells of the mucous membrane.

The microelements that are part of the sea water have an anti-inflammatory effect, stimulate reparative processes, and improve the function of the ciliated epithelium, which increases the resistance of the mucous membrane to the penetration of pathogenic bacteria and viruses and promotes its cleansing.

Indications

• Adenoids;
• Acute, allergic, vasomotor rhinitis;
• Chronic diseases of the nasal cavity, nasopharynx, paranasal sinuses, including those accompanied by dryness of the nasal mucosa;
• Prevention of nasal cavity infections in the autumn-winter period, when climatic conditions change (rooms with air conditioning and/or central heating), in the presence of polluted atmospheric air (smokers, vehicle drivers, hot and dusty workshops);
• Washing of wounds of the nasal cavity and paranasal sinuses before and after surgical interventions;
• Hygienic procedures of the nasal cavity (including in infants).

ICD codes

Dosage Regimen

The drug should be applied intranasally.

For therapeutic purposes (treatment of diseases of the nasal mucosa, paranasal sinuses, nasopharynx)

• children under 1 year (infants) – 1-2 drops into each nasal passage 1-3 times a day;
• children from 1 year to 7 years – 2 drops into each nasal passage 4 times a day;
• children from 7 to 16 years – 2 drops into each nasal passage 4-6 times a day;
• adults – 2-3 drops into each nasal passage 4-8 times a day.

The course of treatment is 2-4 weeks; if necessary, the course of treatment is repeated after 1 month.

For prophylactic purposes

• children under 1 year (infants) – using turundas moistened with the drug, 2 times a day, or by instillation of 1-2 drops into each nasal passage 2-3 times a day;
• children from 1 year to 7 years – 1-2 drops into each nasal passage 1-3 times a day;
• children from 7 to 16 years – 2 drops into each nasal passage 2-4 times a day;
• adults – 2-3 drops into each nasal passage 3-6 times a day.

For hygienic purposes to soften and remove nasal discharge, the drug is instilled repeatedly (removing excess fluid with cotton wool or a handkerchief) into each nasal passage until the discharge is completely softened and removed.

For children under 2 years of age, nasal cavity lavage should be performed in a lying position.

The child’s head should be turned to the side, the upper nasal passage should be washed, then the procedure should be repeated with the other nasal passage.

Sit the child up, wipe the nasal discharge.

For children over 2 years of age and adults, the head should be tilted to the side, the upper nasal passage should be washed, and the procedure should be repeated with the other nasal passage.

Adverse Reactions

A feeling of discomfort in the nasal cavity at the beginning of use; allergic reactions are possible.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug can be used during pregnancy and breastfeeding according to indications.

Pediatric Use

Used in accordance with the dosage regimen.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

Not described.

Overdose

Cases of overdose have not been noted.

Drug Interactions

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

It can be used with other drugs used to treat the common cold.

Storage Conditions

In a place protected from light at a temperature from 0 to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

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.