Scope and Purpose of the Medical Device:

Therapy, Otorhinolaryngology.

Indications for Use:

• Daily nasal cavity hygiene for children and infants over 1 month old.
• Cleaning the nasal cavity of thick secretions, blood clots, allergens, irritants, and foreign particles.
• Comprehensive treatment and prevention of acute (e.g., ARVI, influenza) and chronic rhinosinusitis by clearing pathogenic bacteria and viruses from the nasal mucosa.
• Moisturizing the nasal mucosa without disrupting physiological pH and restoring the natural functions of the nasal mucosa.
• Post-treatment care following medical manipulations or surgical operations in the nasopharyngeal cavity.

Title of the normative document under which the medical device was manufactured:

Manufacturer’s Specification.

Mode of Application:

Intranasal

• For children: 1-2 sprays into each nostril 2-3 times a day.
• Frequency of use may be increased or decreased as per the doctor’s recommendation.
  Do not use the nasal spray for infants under 1 month old unless prescribed by a doctor. The pressure in the NBL SOLEMAR® baby canister is semi-reduced. The spray nozzle (mist-like) should be used for one child only.

Instructions for Using the Nasal Spray:

1. Remove the protective cap. Clean the anatomical nozzle with boiled water or an ethanol solution.
2. Hold the can upright. Press the dispenser several times until the first drops appear.
3. For younger children, perform nasal rinsing in an upright position, preferably with the child sitting in front of an adult (if the child can sit). Slightly tilt the child’s head forward and to the side. Insert the anatomical nozzle into the nostril. Ensure the child’s head does not tilt backward during rinsing.
4. Press the dispenser and hold for a few seconds to rinse the nasal passage.
5. Remove any remaining rinse solution from the nasal cavity (have the child blow their nose or use an aspirator).
6. Repeat the procedure for the other nostril. If necessary, repeat the entire process.

Drug Interactions:

None observed.

Contraindications and First Aid Measures in Case of Improper Use:

• None identified.
• If you notice any allergic reaction within a few minutes of use, discontinue use immediately and thoroughly rinse the nasal cavity with clean water. Seek medical attention if necessary.
• If you observe any serious incidents associated with the use of this device, notify the authorized representative in the Republic of Kazakhstan immediately.

Special Warnings:

• Pregnancy and breastfeeding are not contraindications.
• If you are allergic to components of seawater, consult your doctor or pharmacist before use.
• Carefully read the instructions for use before applying NBL SOLEMAR® baby nasal spray.
• Do not purchase opened or damaged packaging.

Adverse Reactions:

None identified.

Information on Storage Conditions and Shelf Life of the Medical Device:

• Shelf life: 3 years.
• Store at room temperature not exceeding 25°C.
• Keep out of reach of children.
• Do not use after the expiration date.
• Do not expose the package to direct sunlight or temperatures above 50°C.
• Manufactured using “Bag-on-valve” technology, ensuring safety from fire and explosions.

Certifications and Compliance:

• Complies with ISO 13485:2016 standards for medical devices.
• Certified under EC 2195.

Information About the Manufacturer and Its Authorized Representative:

Manufacturer:
Name: Iyon Sağlık Medikal Kozmetik İth. İhr. San. Tic. A.Ş.
Legal Address: Osmangazi Mah., Battalgazi Cad., №:15/1, Sancaktepe – İstanbul, Turkey

Production Facility:
Name: Iyon Sağlık Medikal Kozmetik İth. İhr. San. Tic. A.Ş.
Legal Address: Osmangazi Mah., Battalgazi Cad., №:15/1, Sancaktepe – İstanbul, Turkey

Authorized Representative in Kazakhstan:
Name: JSC “Nobel Almaty Pharmaceutical Factory”
Address: 162E, Shevchenko St., Almaty, Republic of Kazakhstan
Phone: (+7 727) 399-50-50
Fax: (+7 727) 399-60-60
Email: nobel@nobel.kz

Consumer Complaints and Suggestions Handling Organization:
Name: JSC “Nobel Almaty Pharmaceutical Factory”
Address: 162E, Shevchenko St., Almaty, Republic of Kazakhstan
Phone: (+7 727) 399-50-50
Fax: (+7 727) 399-60-60
Email: nobel@nobel.kz

Date of Issue or Last Revision of the Instructions for Medical Use: 17.07.2023