Scope of Application and Purpose of the Medical Device:

Therapy, Otorhinolaryngology

Indications:

• Daily nasal hygiene for adults and children from 2 years 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, to clear the nasal mucosa of pathogenic bacteria and viruses.
• Moisturizing the nasal mucosa without disrupting its physiological pH, restoring the natural functions of the nasal mucosa.
• Post-medical procedures and surgical operations in the nasopharyngeal cavity.

Regulatory Document for the Manufacture of the Medical Device:

Manufacturer’s Specification

Method of Use:

Intranasal application

• Adults: 3–4 times a day, 2–3 sprays in each nostril.
• Children over 2 years old: 2–3 times a day, 1–2 sprays in each nostril.
• Frequency of use may be decreased or increased upon a doctor’s recommendation.

Instructions for Using the Nasal Spray:

1. Remove the protective cap. Disinfect the nozzle with boiling water or an ethanol solution.
2. Hold the bottle upright. Press the dispenser several times until the first drops appear.
3. Maintain an upright position (sitting or standing). Tilt your head slightly forward and to the side, then insert the nozzle into the upper nasal passage.
4. Press and hold the dispenser for a few seconds to rinse the nasal passage.
5. Remove excess liquid by blowing your nose or using an aspirator (for children, if needed).
6. Repeat the procedure for the other nasal passage. If necessary, repeat the process.
   For hygienic reasons, use is recommended for individual purposes only.

Drug Interactions:

None reported.

Contraindications and First Aid Measures for Improper Use:

• Not recommended for children under 2 years old.
• If you notice any allergic reaction within minutes of use, stop usage, rinse the nose thoroughly with clean water, and seek medical assistance if necessary.
• Report any serious incidents related to the use of this device to the Authorized Representative in the Republic of Kazakhstan.

Special Instructions:

• Pregnancy and breastfeeding are not contraindications.
• If allergic to seawater components, consult a doctor or pharmacist before use.
• Carefully read the instructions before using NBL SOLEMAR® Nasal Spray.
• Do not purchase opened or damaged packaging.

Side Effects:

None identified.

Shelf Life and Storage Conditions 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.
• Avoid exposing the packaging to sunlight or temperatures above 50°C.
• Produced using “bag-on-valve” technology; fire- and explosion-safe.

Compliance Guarantees:

• Complies with ISO 13485:2016 medical device standards.
• Certified under EU Certificate No. 2195.

Manufacturer and Authorized Representative Information:

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

Production Site:
Name: Iyon Sağlık Medikal Kozmetik İth. İhr. San. Tic. A.Ş.
Address: Osmangazi Mahallesi, Battalgazi Cad., No: 15/1, Sancaktepe – İSTANBUL, Turkey

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

Instruction Issue or Revision Date: July 17, 2023