Warnings and precautions: 

• All administration operations must be performed gently, avoiding inserting the tip of the dispenser too deeply into the nostrils and maintaining an upright position during use. 
• Close the bottle tightly after each application. 
• Store the product away from light and direct heat sources. Do not refrigerate. 
• Do not use the product for more than 20 consecutive days per month. 
• If persistent or severe side effects occur, discontinue use and consult a physician or pharmacist. 
• For children, use must be supervised by an adult. 

Contraindications: 

• Hypersensitivity (allergy) to any component of the product. 
• Use in subjects with untreated viral or bacterial infections of the upper respiratory tract. 
• Use in children below the indicated age or in conditions requiring specific medical evaluation. 

CELMAST is indicated for non-allergic cell-mediated vasomotor rhinitis and rhinosinusitis (NARNE, NARES, NARMA, and NARESMA), mild to moderate IgE-mediated allergic vasomotor rhinitis and rhinosinusitis, as well as in patients who have undergone FESS surgery (Functional Endoscopic Sinus Surgery), to create a protective effect on the respiratory mucosa and promote tissue repair both anatomically and functionally.  

It is useful in the treatment of the vasomotor rhinitis and rhinosinusitis listed above when watery rhinorrhea is present associated with one or more of the following symptoms: 

• sneezing (even without mucus) 
• stuffy nose in both nostrils 
• nasal itching 
• conjunctivitis with red or itchy eyes.

15 ml nasal sprays 

Children: CELMAST Nasal Spray Children (ages 3–12) 
Adults: CELMAST Nasal Spray Adult (>12 years) 

Aerosol therapy solution 3 ml/dose 

Children: CELMAST Nebules Children (ages 3–12) 
Adults: CELMAST Nebules Adult (>12 years) 

Functional substances: 

Sodium hyaluronate 350–1150 KDa at 0.3% (Hyaluronic acid sodium salt), Palmitoylethanolamide. 

Excipients: 

Purified water FU, Ethyl alcohol, Mint flavoring, Eucalyptol, Methylparaben, Propylparaben, Polysorbate 80, Sodium chloride, Monosodium sodium phosphate dihydrate (or Citric Acid monohydrate), Sodium disodium phosphate dodecahydrate (or Sodium Citrate dihydrate).

In the presence of both allergic (IgE mediated) and non-allergic cell-mediated vasomotor rhinopathies (NARNE, NARES, NARMA and NARESMA), an excessive production of neutrophils, mast cells and eosinophils occurs in the nasal mucosa. These cells produce substances that damage the respiratory mucosa, generating a vicious circle that intensifies symptoms such as: nasal congestion, watery rhinorrhea, repeated sneezing, conjunctivitis with red and itchy eyes, nasal itching and burning.  

CELMAST exerts a protective action on the respiratory mucosa through the barrier effect provided by high and low molecular weight hyaluronic acid, interrupting the vicious circle described above and promoting tissue repair. Furthermore, it has a protective action on mast cells by reducing their sensitized reactivity and decreases the production and migration of eosinophils and neutrophils responsible for inflammation, damage to the mucosa and the onset of the symptoms described above. 

For children (ages 3–12): 

Nasal spray: 1 or 2 sprays per nostril twice daily (morning & evening). Minimum duration: at least 10 days; can be extended up to twenty days per month over three consecutive months. 

Aerosol therapy: nebulize 3 ml of the solution into both nostrils using a micronized nasal shower. The treatment should be performed twice a day (morning and evening) for ten consecutive days; it can be extended up to twenty consecutive days per month for three months. 

For adults (>12 years): 

Nasal spray: 2 sprays per nostril twice daily (morning & evening). Minimum duration: at least 10 days; can be extended up to twenty days per month over three months. 

Aerosol therapy: As for children: using a micronized nasal shower, nebulize 3 ml of solution in both nostrils, twice a day for at least ten days. Treatment can be extended up to twenty days per month over three consecutive months. 

Additional note: 

The duration of treatment can be adjusted based on clinical response and symptoms; however, a minimum of ten days is required. Shorter treatments do not guarantee a tangible effect.

For nasal spray (children and adults): 

1. Blow your nose to remove mucus or residues to allow the product to reach nasal areas. 
2. Shake before use. 
3. Remove the dispenser safety and protective cap. 
4. Prime the pump by pressing 2–3 times until a steady spray is obtained. 
5. Gently insert the dispenser into one nostril, keeping your head upright and slightly tilted forward. 
6. Spray once while inhaling slowly through your nose. 
7. Repeat in the other nostril following the same procedure. 

For aerosol therapy (children and adults):  

1. Blow your nose to remove mucus or residues to allow the product to reach nasal areas. 
2. Ensure bottle is intact and properly sealed before opening. 
3. Shake before use. 
4. Open by turning counterclockwise then break tamper-proof seal. 
5. Draw up 3 ml using supplied syringe—if you prefer half dose (~1.5 ml), do so accordingly. 
6. Insert liquid into micronized nasal shower as per nebulizer device instructions. 
7. Nebulize into both nostrils until all liquid is used up in the ampoule of the micronized nasal shower. 

Note: 

Do not exhale nor blow your nose immediately after application to avoid dispersing the product (wait 10-15 minutes). Use in children must be supervised or assisted by an adult. 

• Hypersensitivity to any component of CELMAST. 
• Use in subjects with untreated viral or bacterial infections of upper respiratory tracts. 
• Use in children below the indicated age or conditions requiring specific medical assessment.

Common adverse effects: 

• Burning sensation in nostrils immediately after administration;  

Also may occur: 

• Throat & palate irritation; 
• Sneezing & tearing;  

Rare adverse effects: 

• Small blood streaks in mucus (epistaxis), especially in nasal vascular fragility cases. 

Overdose increases likelihood of adverse effects described above - if persistent or severe side effects occur, discontinue use and consult a healthcare professional. 

All operations should be performed gently: avoid inserting too deeply into nostrils; maintain an upright position during application. 

After each administration: 

• Close bottle tightly; 
• Keep away from direct light; 
• Store out of reach of children; 
• Do not refrigerate. 

Specific warnings: 

• Aerosol solution must only be administered via appropriate micronized nasal showers—not via masks or oral nebulizers designed for lower airways! 
• Do not use after expiration date printed on packaging! 
• CELMAST solution is not sterile nor injectable! 
• Keep out of reach of children! 
• Do not use if bottle is damaged or not properly sealed! 

You can receive real-time support on how to use CELMAST by scanning the QR code below: 

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Online assistance is provided by Nevia Biotech’s artificial intelligence system, monitored by a human supervisor who is an expert on the product and will intervene within 24 hours if necessary. 

Store at a temperature between +10°C and +30°C, away from direct light and heat sources; keep out of reach of children; do not store in the refrigerator, do not use beyond two months after opening or after the expiration date indicated on the packaging.

Last revision: June/2025 

Version: 2.0