Allertek Nazo Nasal Spray is indicated for:
Active substance: mometasone furoate;
1 dose contains - 50 mcg of mometasone furoate monohydrate (in terms of the anhydrous form).
Excipients: benzalkonium chloride, glycerin, polysorbate 80, microcrystalline cellulose, sodium carmellose, citric acid, sodium, water for injection.
Hypersensitivity to the active substance or to any inactive component of the preparation.
The preparation should not be used in the presence of untreated localized infection with lesions of the nasal mucosa.
Since corticosteroids have the effect of inhibiting wound healing, patients who have recently undergone surgery in the nasal cavity or who have been injured should not use nasal corticosteroids until healing has occurred.
Treatment of seasonal or perennial allergic rhinitis. For adults (including the elderly) and children over 12 years of age, the prophylactic and therapeutic dose of the preparation is recommended for 2 injections (50 mcg each) into each nostril 1 time per day (total daily dose - 200 mcg). After achieving a therapeutic effect for maintenance therapy, it is advisable to reduce the dose to 1 injection into each nostril 1 time per day (total daily dose - 100 mcg).
If the weakening of the symptoms of the disease cannot be achieved by using the preparation in the recommended therapeutic dose, the daily dose can be increased to the maximum: 4 injections into each nostril 1 time per day (total daily dose - 400 mcg). After the symptoms of the disease have subsided, a dose reduction is recommended.
For children 2-11 years old, the recommended therapeutic dose is 1 injection (50 mcg) into each nostril 1 time per day (total daily dose - 100 mcg).
Adjunctive treatment of acute sinusitis. For adults (including the elderly) and children over 12 years of age, the recommended therapeutic dose is 2 injections (50 mcg) into each nostril 2 times a day (total daily dose - 400 mcg).
If the weakening of the symptoms of the disease cannot be achieved by using the preparation in the recommended therapeutic dose, the daily dose can be increased to 4 injections into each nostril 2 times a day (total daily dose - 800 mcg). After the symptoms of the disease have subsided, a dose reduction is recommended.
Acute rhinosinusitis. For adults and children over 12 years of age, the recommended therapeutic dose is 2 injections (50 mcg) into each nostril 2 times a day (total daily dose is 400 mcg).
Nasal polyps. For patients over 18 years of age (including the elderly), the recommended dose is 2 injections (50 mcg) into each nostril 2 times a day (total daily dose is 400 mcg). After achieving the clinical effect, it is recommended to reduce the dose to 2 injections into each nostril once a day (total daily dose - 200 mcg).
Pregnant
It is used by pregnant and breastfeeding women only if the expected benefit from its use outweighs the potential risk to the woman, fetus or infant.
Children
When conducting placebo-controlled clinical studies in children who received Allertek Nazo at a daily dose of 100 μg for a year, no growth retardation was observed.
The safety and efficacy of Allertek Nazo in the treatment of nasal polyps in children under the age of 18, symptoms of rhinosinusitis - under the age of 12, seasonal or perennial allergic rhinitis - in children under 2 years of age have not been investigated.
Due to the fact that the systemic bioavailability of the preparation is <1%, it is unlikely that in case of an overdose, other measures will be required, besides monitoring the patient's condition, followed by the use of the preparation at the recommended dose.
Inhalation or oral administration of excessive doses of corticosteroids can lead to suppression of the function of the hypothalamic-pituitary-adrenal system.
Headache (8%), nosebleeds (that is, obvious bleeding, as well as bloody mucus or blood clots) (8%), pharyngitis (4%), burning sensation in the nose (2%), irritation (2%) and ulcerative changes (1%) of the nasal mucosa.
The preparation Allertek Nazo was used simultaneously with loratadine, while there was no effect on the plasma concentration of loratadine or its main metabolite, and mometasone furoate was not detected in the blood plasma even at the minimum concentration. The joint therapy was well tolerated by the patients.
With the simultaneous use of mometasone with CYP3A inhibitors, including preparations containing cobicistat, an increased risk of systemic adverse reactions is expected. Such combinations should be avoided, unless the expected benefit of treatment outweighs the potential risk of systemic corticosteroid adverse reactions, in such cases systemic corticosteroid adverse reactions should be closely monitored.
Store in its original packaging at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life is 2 years.
The shelf life after opening is 2 months.
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