Dezrinitis nasal spray dosed 50mkg / dose, 140 dose

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SKU
BIDL3177615
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Expiration Date: 05/2027

Russian Pharmacy name:

Дезринит спрей назальный дозированный 50мкг/доза, 140 доз

Dezrinitis nasal spray dosed 50mkg / dose, 140 doses

- Hypersensitivity to mometasone or any of the components of the drug;

- children's age (with seasonal and year-round allergic rhinitis - up to 2 years; with acute sinusitis or exacerbations of chronic sinusitis - up to 12 years; with nasal polyposis - up to 18 years);

- recent surgery or nose injury - before the wound heals (due to the inhibitory effect of GCS on the healing process).

Carefully :

The drug Dezrinit should be used with caution in case of tuberculous infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye damage (as an exception, it is possible to prescribe the drug for the listed infections as directed by a doctor), the presence of untreated local infection involving the nasal mucosa in the process.

Intranasally. Inhalation of the suspension contained in the vial is carried out using a special dispensing nozzle on the vial.

Before using the Dezrinit nasal spray for the first time, it must be 'calibrated'.

Do not pierce the nasal applicator.

To 'calibrate', press the dispensing nozzle 10 times until splashes appear, indicating that the product is ready for use.

Tilt your head and inject the medicine into each nostril as directed by your healthcare provider.

If the drug has not been used for 14 days or more, press the dispensing nozzle 2 times until splashes appear.

Tilt your head and inject the medicine into each nostril as directed by your healthcare provider.

Cleaning the dispensing tip

It is important to clean the dispensing tip regularly to avoid malfunctioning. Remove the dust cap, then carefully remove the spray tip. Thoroughly rinse spray tip and dust cap in warm water and rinse under tap.

Do not try to open the nasal applicator with a needle or other sharp object, as this will damage the applicator and may result in the inappropriate dose of the drug.

Dry the cap and knee pad in a warm place. Then attach the spray tip to the bottle and screw the dust cap back onto the bottle. When using the nasal spray for the first time after cleaning, recalibrate by pressing the dispensing tip 2 times.

Shake the bottle vigorously before each use.

Treatment of seasonal and perennial allergic rhinitis

Adults (including the elderly) and adolescents from the age of 12

The recommended prophylactic and therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril once a day (total daily dose - 200 mcg). Upon reaching the therapeutic effect for maintenance therapy, it is possible to reduce the dose by 1 inhalation in each nostril once a day (total daily dose - 100 mcg).

If a decrease in the symptoms of the disease cannot be achieved by using the drug in the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril once a day (total daily dose - 400 mcg).

After reducing the symptoms of the disease, a dose reduction is recommended

The onset of action of the drug is usually noted clinically as early as 12 hours after the first use of the drug.

Children 2-11 years old :

The recommended therapeutic dose is 1 inhalation (50 mcg) in each nostril once a day (total daily dose is 100 mcg).

The use of the drug in young children requires adult assistance.

Adjunctive treatment of acute sinusitis or exacerbation of chronic sinusitis

Adults (including the elderly) and adolescents from the age of 12

The recommended therapeutic dose is 2 inhalations (50 mcg each) in each nostril 2 times a day (total daily dose - 400 mcg).

If a decrease in the symptoms of the disease cannot be achieved by using the drug in the recommended therapeutic dose, the daily dose of the drug can be increased to 4 inhalations in each nostril 2 times a day (total daily dose - 800 mcg). After reducing the symptoms of the disease, a dose reduction is recommended

Treating acute rhinosinusitis without evidence of severe bacterial infection

The recommended dose for adults and adolescents is 2 inhalations of 50 mcg in each nasal passage 2 times a day (total daily dose of 400 mcg). If symptoms worsen during treatment, consult a specialist.

Treatment of nasal polyposis

Adults (including the elderly) from 18 years old

The recommended therapeutic dose is 2 injections (50 mcg each) into each nostril 2 times a day (total daily dose - 400 mcg).

After reducing the symptoms of the disease, it is recommended to reduce the dose to 2 inhalations (50 mcg each) in each nostril once a day (total daily dose - 200 mcg).

1 dose contains:

active substance: mometasone furoate monohydrate (in terms of mometasone furoate) - 0.052 mg (0.050 mg);

excipients: avicel RC-591 [microcrystalline cellulose, sodium carmellose] 2.00 mg; glycerol 2.10 mg; benzalkonium chloride solution 500 g / l 0.04 mg; polysorbate-80 0.01 mg; citric acid monohydrate 0.20 mg; sodium citrate dihydrate 0.28 mg; water for injection a sufficient amount up to 100.00 mg.

- Hypersensitivity to mometasone or any of the components of the drug;

- children's age (with seasonal and year-round allergic rhinitis - up to 2 years; with acute sinusitis or exacerbations of chronic sinusitis - up to 12 years; with nasal polyposis - up to 18 years);

- recent surgery or nose injury - before the wound heals (due to the inhibitory effect of GCS on the healing process).

Carefully :

The drug Dezrinit should be used with caution in case of tuberculous infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye damage (as an exception, it is possible to prescribe the drug for the listed infections as directed by a doctor), the presence of untreated local infection involving the nasal mucosa in the process.

Active substance :

Mometasone

Dosage form:

metered dose nasal spray

Composition :

1 dose contains:

active substance: mometasone furoate monohydrate (in terms of mometasone furoate) - 0.052 mg (0.050 mg);

excipients: avicel RC-591 [microcrystalline cellulose, sodium carmellose] 2.00 mg; glycerol 2.10 mg; benzalkonium chloride solution 500 g / l 0.04 mg; polysorbate-80 0.01 mg; citric acid monohydrate 0.20 mg; sodium citrate dihydrate 0.28 mg; water for injection a sufficient amount up to 100.00 mg.

Description:

Milky-white suspension without agglomerates, placed in a white polyethylene bottle equipped with a dosing device and a transparent polypropylene cap.

Pharmacotherapeutic group:

Topical glucocorticosteroid

ATX:
R.01.AD09

Pharmacodynamics:

Mometasone is a synthetic glucocorticosteroid (GCS) for topical use. It has anti-inflammatory and anti-allergic effects. The local anti-inflammatory effect of the drug is manifested when it is used in doses at which there are no systemic effects.

Inhibits the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and, accordingly, inhibition of the synthesis of metabolic products of arachidonic acid - cyclic endoperoxides, prostaglandins. Prevents marginal accumulation of neutrophils, which reduces inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, and leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of chemotaxis substance (effect on late allergy reactions), inhibits the development of an immediate allergic reaction (by inhibiting the formation of arachidonic acid metabolites and reducing the release of inflammatory mediators from mast cells).

In studies with provocative tests with the application of antigens to the nasal mucosa, a high anti-inflammatory activity of the drug was demonstrated both in the early and late stages of an allergic reaction.

When compared with placebo, a decrease in the level of histamine and eosinophil activity was found, as well as a decrease (compared to the initial) in the number of eosinophils, neutrophils and proteins of epithelial cells.

Pharmacokinetics:

With intranasal administration, the systemic bioavailability of mometasone fuorate is <1% (with a sensitivity of the method for the determination of 0.25 pg / ml). A small amount of the active substance, which can enter the gastrointestinal tract (GIT) during intranasal administration, is absorbed to a small extent and is actively biotransformed during the 'first pass' through the liver.

Indications for use

- Seasonal and year-round allergic rhinitis in adults, adolescents and children from 2 years of age;

- acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents from 12 years old - as an auxiliary therapeutic agent in antibiotic treatment;

- acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients aged 12 years or more,

- preventive treatment of moderate and severe seasonal allergic rhinitis in adults and adolescents from 12 years of age (recommended two to four weeks before the expected start of the dusting season);

- nasal polyposis, accompanied by impaired nasal breathing and smell, in adults (over 18 years old).

Contraindications

- Hypersensitivity to mometasone or any of the components of the drug;

- children's age (with seasonal and year-round allergic rhinitis - up to 2 years; with acute sinusitis or exacerbations of chronic sinusitis - up to 12 years; with nasal polyposis - up to 18 years);

- recent surgery or nose injury - before the wound heals (due to the inhibitory effect of GCS on the healing process).

Carefully :

The drug Dezrinit should be used with caution in case of tuberculous infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye damage (as an exception, it is possible to prescribe the drug for the listed infections as directed by a doctor), the presence of untreated local infection involving the nasal mucosa in the process.

Pregnancy and lactation:

Special studies on the safety of the use of mometasone during pregnancy and during breastfeeding have not been conducted.

As with the use of other nasal corticosteroids, the drug Dezrinit should be prescribed during pregnancy and during breastfeeding only if the expected benefit from its use outweighs the potential risk to the fetus and newborn.

Newborns whose mothers used GCS during pregnancy should be carefully examined to identify possible adrenal hypofunction.

Method of administration and dosage

Intranasally. Inhalation of the suspension contained in the vial is carried out using a special dispensing nozzle on the vial.

Before using the Dezrinit nasal spray for the first time, it must be 'calibrated'.

Do not pierce the nasal applicator.

To 'calibrate', press the dispensing nozzle 10 times until splashes appear, indicating that the product is ready for use.

Tilt your head and inject the medicine into each nostril as directed by your healthcare provider.

If the drug has not been used for 14 days or more, press the dispensing nozzle 2 times until splashes appear.

Tilt your head and inject the medicine into each nostril as directed by your healthcare provider.

Cleaning the dispensing tip

It is important to clean the dispensing tip regularly to avoid malfunctioning. Remove the dust cap, then carefully remove the spray tip. Thoroughly rinse spray tip and dust cap in warm water and rinse under tap.

Do not try to open the nasal applicator with a needle or other sharp object, as this will damage the applicator and may result in the inappropriate dose of the drug.

Dry the cap and knee pad in a warm place. Then attach the spray tip to the bottle and screw the dust cap back onto the bottle. When using the nasal spray for the first time after cleaning, recalibrate by pressing the dispensing tip 2 times.

Shake the bottle vigorously before each use.

Treatment of seasonal and perennial allergic rhinitis

Adults (including the elderly) and adolescents from the age of 12

The recommended prophylactic and therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril once a day (total daily dose - 200 mcg). Upon reaching the therapeutic effect for maintenance therapy, it is possible to reduce the dose by 1 inhalation in each nostril once a day (total daily dose - 100 mcg).

If a decrease in the symptoms of the disease cannot be achieved by using the drug in the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril once a day (total daily dose - 400 mcg).

After reducing the symptoms of the disease, a dose reduction is recommended

The onset of action of the drug is usually noted clinically as early as 12 hours after the first use of the drug.

Children 2-11 years old :

The recommended therapeutic dose is 1 inhalation (50 mcg) in each nostril once a day (total daily dose is 100 mcg).

The use of the drug in young children requires adult assistance.

Adjunctive treatment of acute sinusitis or exacerbation of chronic sinusitis

Adults (including the elderly) and adolescents from the age of 12

The recommended therapeutic dose is 2 inhalations (50 mcg each) in each nostril 2 times a day (total daily dose - 400 mcg).

If a decrease in the symptoms of the disease cannot be achieved by using the drug in the recommended therapeutic dose, the daily dose of the drug can be increased to 4 inhalations in each nostril 2 times a day (total daily dose - 800 mcg). After reducing the symptoms of the disease, a dose reduction is recommended

Treating acute rhinosinusitis without evidence of severe bacterial infection

The recommended dose for adults and adolescents is 2 inhalations of 50 mcg in each nasal passage 2 times a day (total daily dose of 400 mcg). If symptoms worsen during treatment, consult a specialist.

Treatment of nasal polyposis

Adults (including the elderly) from 18 years old

The recommended therapeutic dose is 2 injections (50 mcg each) into each nostril 2 times a day (total daily dose - 400 mcg).

After reducing the symptoms of the disease, it is recommended to reduce the dose to 2 inhalations (50 mcg each) in each nostril once a day (total daily dose - 200 mcg).

Side effect

The frequency of side effects is presented in accordance with the following classification: very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01% (including isolated cases).

From the immune system : rarely - hypersensitivity reactions, including bronchospasm, shortness of breath; very rarely - anaphylaxis, angioedema.

From the side of the central nervous system : often - headache (in adults and children). The children showed growth retardation, psychomotor hyperactivity, sleep disturbance, anxiety, depression, and aggressive behavior.

From the respiratory system, chest and mediastinal organs: часто у взрослых - носовое кровотечение, жжение в полости носа, изъ¤звление слизистой оболочки полости носа, ощущение раздражени¤ слизистой оболочки полости носа, фарингит, инфекции верхних дыхательных путей; очень редко - перфораци¤ носовой перегородки. Ќосовые кровотечени¤, как правило, прекращались самосто¤тельно и не были т¤желыми; они возникали с частотой несколько большей, чем при применении плацебо (5%), но равной или меньшей, чем при применении других исследовавшихс¤ v — дл¤ интраназального применени¤, которые использовались в качестве активного контрол¤ (у некоторых из них частота носовых кровотечений составл¤ла до 15%). „астота возникновени¤ других побочных эффектов была сопоставима с таковой при применении плацебо; часто у детей - носовое кровотечение, ощущение раздражени¤ слизистой оболочки полости носа, чихание. „астота возникновени¤ всех указанных нежелательных ¤влений у детей была сравнима с частотой плацебо.

—о стороны желудочно-кишечного тракта: редко - ощущение раздражени¤ слизистой оболочки глотки; очень редко - нарушение вкуса.

ѕрочие: редко - нарушение обон¤ни¤, нарушение вкуса, глаукома, повышение внутриглазного давлени¤, катаракта.

ѕри длительном применении назальных v — в высоких дозах возможно развитие системных побочных эффектов, таких как: синдром  ушинга, характерные признаки кушингоида, подавление функции надпочечников, в том числе развитие глаукомы, катаракты, задержка роста у детей и подростков.

?ети

Ќарушение со стороны дыхательной системы, органов грудной клетки и средостени¤: носовые кровотечени¤ (6%), раздражение слизистой оболочки носа (2%), чихание (2%).

Ќарушени¤ со стороны нервной системы: головна¤ боль (3%).

„астота возникновени¤ указанных нежелательных ¤влений у детей была сопоставима с частотой их возникновени¤ при применении плацебо.

ѕередозировка :

ѕри длительном применении v — в высоких дозах, а также при одновременном применении нескольких v —, возможно угнетение функции гипоталамо-гипофизарно-надпочечниковой системы. ¬следствие малой системной биодоступности препарата (<1%, при чувствительности метода определени¤ 0,25 пг/мл) маловеро¤тно, что при случайной или намеренной передозировке потребуетс¤ прин¤тие каких-либо мер, помимо наблюдени¤ с возможным последующим возобновлением приема препарата в рекомендованной дозе.

¬заимодействие

ќдновременное применение мометазона с лоратадином не приводило к изменению концентрации лоратадина или его главного метаболита в плазме крови, при этом в плазме не определ¤лось присутствие мометазона даже в минимальной концентрации. ¬ этих исследовани¤х мометазона фуорат в плазме крови обнаружен не был (при чувствительности метода определени¤ 50 пг/мл).

ќсобые указани¤ :

 ак при любом лечении, пациенты, примен¤ющие препарат ?езринит в течение нескольких мес¤цев и дольше, должны периодически проходить осмотр у врача на предмет возможных изменений слизистой оболочки носа.

Ќеобходимо проводить мониторинг за пациентами, получающими интраназальные v — длительное врем¤. ¬озможно развитие задержки роста у детей. ¬ случае вы¤влени¤ задержки роста у детей необходимо снизить дозу интраназальных v — до наименьшей, позвол¤ющей эффективно контролировать симптомы.  роме того, следует направить пациента на консультацию к педиатру.

¬ случае развити¤ местной грибковой инфекции носа или глотки может потребоватьс¤ прекращение терапии препаратом ?езринит и проведение специального лечени¤. —охран¤ющеес¤ в течение длительного времени раздражение слизистой оболочки носа и глотки также может служить основанием дл¤ прекращени¤ лечени¤ препаратом ?езринит. ѕри проведении плацебо-контролируемых клинических исследований у детей, когда препарат ?езринит примен¤лс¤ в суточной дозе 100 мкг в течение года, задержки роста у детей не отмечалось.

ѕри продолжительном лечении препаратом ?езринит признаков подавлени¤ функции гипоталамо-гипофизарно-надпочечниковой системы не наблюдалось.

ѕациенты, которые переход¤т к лечению препаратом ?езринит после длительной терапии глюкокортикостероидами системного действи¤, требуют к себе особого внимани¤. ќтмена глюкокортикостероидов системного действи¤ у таких пациентов может привести к недостаточности функции надпочечников, последующее восстановление которой может зан¤ть до нескольких мес¤цев. ¬ случае по¤влени¤ признаков надпочечниковой недостаточности следует возобновить прием системных глюкокортикостероидов и прин¤ть другие необходимые меры.

ѕри применении интраназальных v — возможно развитие системных побочных эффектов, особенно при длительном применении в высоких дозах. ¬еро¤тность развити¤ этих эффектов значительно меньше, чем при применении пероральных v —.

—истемные побочные эффекты могут различатьс¤ как у отдельных пациентов, так и в зависимости от примен¤емого глюкокортикостероидного препарата. ѕотенциальные системные эффекты включают в себ¤ синдром  ушинга, характерные признаки кушингоида, подавление функции надпочечников, задержку роста у детей и подростков, катаракту, глаукому и реже р¤д психологических или поведенческих эффектов, включа¤ психомоторную гиперактивность, нарушение сна, тревогу, депрессию или агрессию (особенно у детей).

¬о врем¤ перехода от лечени¤ глюкокортикостероидами системного действи¤ к лечению препаратом ?езринит у некоторых пациентов могут возникнуть начальные симптомы отмены системных глюкокортикостероидов (например, боли в суставах и/или мышцах, чувство усталости и депресси¤), несмотр¤ на уменьшение выраженности симптомов, св¤занных с поражением слизистой оболочки носа. “аких пациентов необходимо специально убеждать в целесообразности продолжени¤ лечени¤ препаратом ?езринит. ѕереход от системных к местным глюкокортикостероидам может также вы¤вить уже существовавшие, но маскировавшиес¤ терапией глюкокортикостероидами системного действи¤ аллергические заболевани¤, такие как аллергический конъюнктивит и экзема.

ѕациенты, которым проводитс¤ лечение глюкокортикостероидами, обладают потенциально сниженной иммунной реактивностью и должны быть предупреждены о повышенном дл¤ них риске заражени¤ в случае контакта с больными некоторыми инфекционными заболевани¤ми (например, ветр¤ной оспой, корью), а также о необходимости врачебной консультации, если такой контакт произошел.

ѕри по¤влении признаков выраженной бактериальной инфекции (например, лихорадки, упорной и резкой боли с одной стороны лица или зубной боли, припухлости в орбитальной или периорбитальной области) требуетс¤ немедленна¤ врачебна¤ консультаци¤.

ѕри применении препарата ?езринит в течение 12 мес¤цев не возникало признаков атрофии слизистой оболочки носа.  роме того,
мометазона фуроат про¤вл¤л тенденцию способствовать нормализации гистологической картины при исследовании биоптатов слизистой носа.

Ёффективность и безопасность мометазона не изучена при лечении односторонних полипов, полипов, св¤занных с муковисцидозом и полипов, которые полностью закрывают носовую полость.

¬ случае вы¤влени¤ односторонних полипов необычной или неправильной формы, особенно изъ¤звленных или кровоточащих, необходимо провести дополнительное медицинское обследование.

¬ли¤ние на способность управл¤ть транспортным средством :

»сследований по изучению вли¤ни¤ на способность управл¤ть транспортными средствами и механизмами не проводилось.

‘орма выпуска :

—прей назальный дозированный, 50 мкг/доза.

Packing:

10 g (60 doses) or 18 g (140 doses) suspension in white polyethylene bottles equipped with a dosing device and a polyethylene cap.

1 bottle (10 g) or 1, 2, 3 bottles (18 g) together with instructions for use in a cardboard box.

Storage conditions :

Store at a temperature not exceeding 25 ? C, do not freeze.

Keep out of the reach of children.

Shelf life :

2 years.

The shelf life of an opened bottle is 2 months.

Do not use after the expiration date.

Terms of dispensing from pharmacies:

On prescription

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