Salin (Spray) Instructions for Use

Marketing Authorization Holder

Sagmel Inc. (USA)

ATC Code

R01AX10 (Other drugs)

Active Substance

Sodium chloride (Ph.Eur. European Pharmacopoeia)

Dosage Form

Salin

Nasal spray 0.65%: bottle 44 ml with sprayer

Dosage Form, Packaging, and Composition

Nasal spray 0.65% in the form of a clear, colorless liquid with a faint almond odor.

Excipients: benzyl alcohol, purified water, sodium hydrogen phosphate, sodium dihydrogen phosphate, benzalkonium chloride.

44 ml – low-density polyethylene bottles (1) with a sprayer – cardboard packs.

Clinical-Pharmacological Group

Drug for moisturizing, cleansing, and protecting the nasal mucosa

Pharmacotherapeutic Group

Remedy for nasal conditions

Pharmacological Action

It effectively moisturizes the nasal mucosa, thins thick mucus, softens dry crusts in the nose, and facilitates their easy removal.

The pH of the solution is close to the pH of the natural secretory fluid of the nasal mucosa.

Indications

• Administer for hygienic care of the nasal cavity in infants.
• Use in children and adults to cleanse the nasal cavity of accumulated mucus and crusts associated with dry nasal mucosa.
• Apply as part of the management regimen for rhinitis of various etiologies.

This preparation is indicated for conditions including acute nasopharyngitis, allergic rhinitis (both seasonal and perennial), and chronic rhinitis forms such as atrophic or hypertrophic rhinitis.

ICD codes

Dosage Regimen

Administer intranasally three to four times per day, or as needed for symptomatic relief.

The typical course for both prevention and treatment lasts from two to four weeks. For young children, ensure an age-appropriate dosage form is used to guarantee safe and effective administration.

Adverse Reactions

Monitor for allergic reactions, which are possible following administration.

These may include localized symptoms such as irritation, redness, or itching at the application site. Discontinue use immediately if any signs of hypersensitivity develop and seek medical advice.

Contraindications

• Do not use in patients with a known hypersensitivity to sodium chloride or any of the excipients, including benzyl alcohol and benzalkonium chloride.

This product is contraindicated in individuals who have experienced previous allergic reactions to any component of the formulation.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding.

Use in Hepatic Impairment

The drug is approved for use in patients with impaired liver function.

Use in Renal Impairment

The drug is approved for use in patients with impaired renal function.

Pediatric Use

The drug is approved for use in children and adolescents under the age of 18.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

When used as part of complex therapy, other medicinal products should be administered intranasally after cleansing the nasal cavity – 10-15 minutes after spraying.

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.