Marine water Renewal (Solution, Spray, Drops) Instructions for Use

Instructions
Dosage forms

ATC Code

R01AX10 (Other drugs)

Active Substance

Sea water (Grouping name)

Clinical-Pharmacological Group

Drug for moisturizing, cleansing, and protecting the nasal mucosa

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other preparations for topical use; other drugs for the treatment of nasal diseases

Pharmacological Action

A means for intranasal use. It helps to maintain the normal physiological state of the nasal mucosa.

It helps to thin mucus and facilitates its removal from the nose. The trace elements contained in sea water improve the function of the ciliated epithelium, which increases the resistance of the nasal mucosa to pathogenic bacteria and viruses. In allergic rhinitis, it helps to remove allergens from the nasal mucosa.

Indications

Acute and chronic inflammatory diseases of the nose, paranasal sinuses, and nasopharynx.
Prevention of infectious diseases of the nose and nasopharynx.
Allergic and vasomotor rhinitis.
Prevention of inflammatory processes after surgical interventions.
Daily hygiene of the nasal cavity to preserve the protective properties of the mucous membrane in conditions of increased dryness or air pollution.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
J00	Acute nasopharyngitis (common cold)
J01	Acute sinusitis
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)
J31.0	Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J31.1	Chronic nasopharyngitis
J32	Chronic sinusitis
Z54.0	Convalescence following surgery

ICD-11 code	Indication
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
CA08.3	Vasomotor rhinitis
CA09.0	Chronic rhinitis
CA09.1	Chronic nasopharyngitis
CA0A.Z	Chronic rhinosinusitis, unspecified
QB7Y	Other specified convalescence

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.

Apply intranasally. For therapeutic purposes, use 4-6 times per day. For hygienic purposes, use 1-4 times per day.

Use in children starting from 2 weeks of age and in adults. Select the appropriate dosage form (solution, spray, or drops) based on patient age and indication.

Adverse Reactions

Allergic reactions are possible. Discontinue use immediately if signs of hypersensitivity, such as local irritation, redness, or itching, occur.

Report any persistent or severe adverse reactions to a healthcare professional.

Contraindications

Known hypersensitivity to any component of the preparation.
Use in children under 2 weeks of age due to a lack of safety and efficacy data in this age group.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding if indicated.

Pediatric Use

There are no data on use in children under 2 weeks of age.

In children over 2 weeks of age, it is used in the appropriate dosage form.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Consultation with a doctor is required if it is necessary to use after surgery.

Drug Interactions

No clinically significant drug interactions have been reported. Can be used concomitantly with other intranasal medications.

Administer other nasal preparations at least 15-20 minutes after using this product to ensure proper absorption.

Overdose

Overdose is unlikely due to the topical nature of administration and the composition of natural sea water. No specific symptoms of overdose have been reported.

In case of accidental ingestion of a large volume, symptomatic and supportive care is recommended.

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 Disclaimer

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

Marine water Renewal [Obnovlenie Pfc, JSC (Russia)]
Nasal drops: dropper tubes 5 ml or 10 ml 1, 5, 10, or 20 pcs., 20 ml or 25 ml 1 pc.; amp. 20 ml or 25 ml 1 pc.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Sea water Renewal

Nasal drops: dropper tubes 5 ml or 10 ml 1, 5, 10, or 20 pcs., 20 ml or 25 ml 1 pc.; amp. 20 ml or 25 ml 1 pc.

Dosage Form, Packaging, and Composition

Nasal drops as a transparent or slightly opalescent, colorless solution.

	100 ml
Sea water	5 ml

Excipients: purified water – up to 100 ml.

The solution contains:
Sodium – not less than 2.5 mg/ml,
Magnesium – not less than 0.35 mg/ml,
Calcium – not less than 0.008 mg/ml,
Potassium – not less than 0.1 mg/ml,
Bicarbonates – not less than 0.03 mg/ml,
Chlorides – not less than 3.5 mg/ml,
Sulfates – not less than 1.5 mg/ml.

5 ml – dropper tubes with a valve (1) – cardboard packs.
5 ml – dropper tubes with a valve (5) – cardboard packs.
5 ml – dropper tubes with a valve (10) – cardboard packs.
5 ml – dropper tubes with a valve (20) – cardboard packs.
10 ml – dropper tubes with a valve (1) – cardboard packs.
10 ml – dropper tubes with a valve (5) – cardboard packs.
10 ml – dropper tubes with a valve (10) – cardboard packs.
10 ml – dropper tubes with a valve (20) – cardboard packs.
20 ml – dropper tubes with a screw neck (1) – cardboard packs.
25 ml – dropper tubes with a screw neck (1) – cardboard packs.
20 ml – polymer ampoules (1) complete with a bottle sealed with an attachment – cardboard packs.
25 ml – polymer ampoules (1) complete with a bottle sealed with an attachment – cardboard packs.

Marine water Renewal [Obnovlenie Pfc, JSC (Russia)]
Solution for nasal cavity irrigation: bottles 100 ml, 125 ml or 150 ml

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Sea water Renewal

Solution for nasal cavity irrigation: bottles 100 ml, 125 ml or 150 ml

Dosage Form, Packaging, and Composition

Solution for nasal cavity irrigation transparent or slightly opalescent, colorless.

	100 ml
Sea water	5 ml

Excipients: purified water – up to 100 ml.

The solution contains:
Sodium – not less than 2.5 mg/ml,
Magnesium – not less than 0.35 mg/ml,
Calcium – not less than 0.008 mg/ml,
Chlorides – not less than 3.5 mg/ml.

100 ml – aluminum aerosol cans (1) complete with a “shower” type spray nozzle – cardboard packs.
100 ml – aluminum aerosol cans (1) complete with a “stream” type spray nozzle – cardboard packs.
100 ml – aluminum aerosol cans (1) complete with a “shower” type spray nozzle and a “stream” type spray nozzle – cardboard packs.
125 ml – aluminum aerosol cans (1) complete with a “shower” type spray nozzle – cardboard packs.
125 ml – aluminum aerosol cans (1) complete with a “stream” type spray nozzle – cardboard packs.
125 ml – aluminum aerosol cans (1) complete with a “shower” type spray nozzle and a “stream” type spray nozzle – cardboard packs.
150 ml – aluminum aerosol cans (1) complete with a “shower” type spray nozzle – cardboard packs.
150 ml – aluminum aerosol cans (1) complete with a “stream” type spray nozzle – cardboard packs.
150 ml – aluminum aerosol cans (1) complete with a “shower” type spray nozzle and a “stream” type spray nozzle – cardboard packs.

Marine water Renewal [PFKO-1, LLC (Russia)]
Nasal spray 50 µl/1 ml: 20 ml or 30 ml bottle with spray nozzle