Momat Reno nasal spray 50mkg / dose, 60 dose
Expiration Date: 05/2027
Russian Pharmacy name:
Момат Рино спрей назальный 50мкг/доза, 60 доз
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 of age - 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 to 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).
Polyposis of the nose, accompanied by impaired nasal breathing and smell, in adults (over 18 years old).
Intranasalno. Inhalation of the suspension contained in the vial is carried out using a special dispensing nozzle on the vial.
Before the first use of Momat Reno nasal spray, it is necessary to УcalibrateФ it. Do not pierce the nasal applicator.
To carry out the 'calibration', you must press the dispensing nozzle 10 times until then. until splashes appear, indicating that the drug 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 nozzle.
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 an incorrect dose of the drug.
Dry the cap and tip 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, it is necessary to УcalibrateФ by pressing the dispensing nozzle 2 times.
Shake the bottle vigorously before each use.
Treatment of seasonal or perennial allergic rhinitis
Adults (including the elderly) and adolescents from 12 years of age: 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 to 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).
For the use of the drug in young children, adult assistance is required.
Adjunctive treatment of acute sinusitis or exacerbated chronic sinusitis
Adults (including the elderly) and adolescents from 12 years: The
recommended prophylactic and therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril 2 times a day (total daily dose - 400 ?g). 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 2 times a day (total daily dose - 800 mcg). After reducing the symptoms of the disease, a dose reduction is recommended.
Treatment of acute rhinosinusitis without signs of severe bacterial infection: The
recommended dose for adults and adolescents is 2 inhalations (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: The
recommended therapeutic dose of the drug is 2 inhalations (50 mcg each) in 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 spray dose contains:
Active substance:
Mometasone furoate monohydrate - 51.72 mcg, calculated as mometasone furoate -50.00 mcg;
Excipients:
Avicel RC-591 [microcrystalline cellulose, sodium carmellose] - 2.00 mg, glycerol -2.10 mg, citric acid monohydrate - 0.20 mg, sodium citrate dihydrate - 0.28 mg, polysorbate-80 - 0.01 mg , benzalkonium chloride - 0.02 mg, water for injection - up to 100 mg.
Hypersensitivity to any component of the drug.
Recent surgery or nasal trauma with damage to the nasal mucosa - before the wound heals (due to the inhibitory effect of GCS on the healing process).
Children's age (with seasonal and year-round allergic rhinitis - up to 2 years, with acute sinusitis or exacerbation of chronic sinusitis - up to 12 years, with polyposis - up to 18 years) - due to the lack of relevant data.
With caution
Tuberculous infection (active and latent) of the respiratory tract, untreated fungal. a bacterial, systemic viral infection or an infection caused by Herpes simplex with eye damage (as an exception, it is possible to prescribe the drug for these infections as directed by a doctor), the presence of an untreated local infection with the involvement of the nasal mucosa in the process.
Trade name : Momat Reno
International non-proprietary name : Mometasone
Dosage form : metered dose nasal spray
Composition:
1 spray dose contains:
Active substance:
Mometasone furoate monohydrate - 51.72 mcg, calculated as mometasone furoate -50.00 mcg;
Excipients:
Avicel RC-591 [microcrystalline cellulose, sodium carmellose] - 2.00 mg, glycerol -2.10 mg, citric acid monohydrate - 0.20 mg, sodium citrate dihydrate - 0.28 mg, polysorbate-80 - 0.01 mg , benzalkonium chloride - 0.02 mg, water for injection - up to 100 mg.
Description
From white to almost white, from translucent to opaque consistency, thick suspension.
Pharmacotherapeutic group: topical glucocorticosteroid.
Pharmacological action
Pharmacodynamics
Mometasone is a synthetic glucocorticosteroid (GCS) for topical use. It has anti-inflammatory and anti-allergic effects when used in doses that do not cause 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 (influence on 'late' allergy reactions),inhibits the development of an immediate-type allergic reaction (due to inhibition of the production of metabolites of arachidonic acid and a decrease in the release of inflammatory mediators from mast cells).
Pharmacokinetics
With intranasal administration, the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of the method of determination of 0.25 pg / ml). The suspension of mometasone is very poorly absorbed in the gastrointestinal tract, and the small amount of the suspension of mometasone that can enter the gastrointestinal tract after nasal inhalation, even before excretion in the urine or bile, undergoes active primary metabolism.
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 of age - 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 to 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).
Polyposis of the nose, accompanied by impaired nasal breathing and smell, in adults (over 18 years old).
Contraindications
Hypersensitivity to any component of the drug.
Recent surgery or nasal trauma with damage to the nasal mucosa - before the wound heals (due to the inhibitory effect of GCS on the healing process).
Children's age (with seasonal and year-round allergic rhinitis - up to 2 years, with acute sinusitis or exacerbation of chronic sinusitis - up to 12 years, with polyposis - up to 18 years) - due to the lack of relevant data.
With caution
Tuberculous infection (active and latent) of the respiratory tract, untreated fungal. a bacterial, systemic viral infection or an infection caused by Herpes simplex with eye damage (as an exception, it is possible to prescribe the drug for these infections as directed by a doctor), the presence of an untreated local infection with the involvement of the nasal mucosa in the process.
Application during pregnancy and during breastfeeding.
Appropriately planned and well-controlled studies of the drug in pregnant women have not been conducted.
As with other nasal GCS, Momat Reno should be prescribed to pregnant or breastfeeding women only if the expected benefit from prescribing the drug justifies the potential risk to the fetus or infant.
Infants whose mothers received GCS during pregnancy should be carefully examined for possible adrenal hypofunction.
Method of administration and doses
Intranasalno. Inhalation of the suspension contained in the vial is carried out using a special dispensing nozzle on the vial.
Before the first use of Momat Reno nasal spray, it is necessary to УcalibrateФ it. Do not pierce the nasal applicator.
To carry out the 'calibration', you must press the dispensing nozzle 10 times until then. until splashes appear, indicating that the drug 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 nozzle.
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 an incorrect dose of the drug.
Dry the cap and tip 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, it is necessary to УcalibrateФ by pressing the dispensing nozzle 2 times.
Shake the bottle vigorously before each use.
Treatment of seasonal or perennial allergic rhinitis
Adults (including the elderly) and adolescents from 12 years of age: 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 to 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).
For the use of the drug in young children, adult assistance is required.
Adjunctive treatment of acute sinusitis or exacerbated chronic sinusitis
Adults (including the elderly) and adolescents from 12 years: The
recommended prophylactic and therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril 2 times a day (total daily dose - 400 ?g). 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 2 times a day (total daily dose - 800 mcg). After reducing the symptoms of the disease, a dose reduction is recommended.
Treatment of acute rhinosinusitis without signs of severe bacterial infection: The
recommended dose for adults and adolescents is 2 inhalations (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: The
recommended therapeutic dose of the drug is 2 inhalations (50 mcg each) in 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 effects
Adults and adolescents.
Adverse events associated with the use of the drug (? 1%), identified in clinical trials in patients with allergic rhinitis or nasal polyposis, and during the post-marketing period of the drug, regardless of the indication for use, are presented below. Adverse reactions are listed according to the classification of the system-organ class, adverse reactions are classified according to the frequency of occurrence. Nasal bleeding, as a rule, was moderate and stopped on its own, the frequency of their occurrence was slightly higher than with placebo (5%), but equal or less than with the appointment of other intranasal corticosteroids, which were used as active control (in some of the the incidence of nosebleeds was up to 15%).The incidence of all other adverse events was comparable to that with placebo.
The frequency of adverse reactions is set as follows: very often (? 1/10); often (? 1/100, <1/10); rarely (? 1/1000, <1/100). For adverse reactions during the post-registration observation period, the frequency has not been established (cannot be determined based on the available data).
Infectious and parasitic diseases - often - pharyngitis, upper respiratory tract infections *.
Immune system disorders - frequency not established - hypersensitivity reactions, including anaphylactic reactions, angioedema, bronchospasm, shortness of breath.
Nervous system disorders - often - headache.
Violations of the organ of vision - the frequency has not been established - increased intraocular pressure, glaucoma, cataracts.
Disturbances from the respiratory system, chest and mediastinal organs - very often - nosebleeds **; - often - nosebleeds (i.e., obvious bleeding, as well as the release of blood-stained mucus or blood clots), a burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa; - frequency not established - nasal septum perforation.
Disorders from the gastrointestinal tract - often - pharyngeal irritation (sensation of irritation of the pharyngeal mucosa) **; - frequency not established - violation of taste and smell.
Note: - detected with a frequency of 'rarely' when using the drug twice a day for nasal polyposis, * - revealed when using the drug twice a day for nasal polyposis.
Children
Disorders of the respiratory system, chest and mediastinal organs : nosebleeds (6%), irritation of the nasal mucosa (2%), sneezing (2%).
Nervous system disorders: headache (3%).
The incidence of these adverse events in children was comparable to the incidence of these adverse events with placebo.
With the use of intranasal corticosteroids, systemic side effects may develop, especially with prolonged use of them in high doses.
Overdose
With prolonged use of GCS in high doses, as well as with the simultaneous use of several GCS, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system. Due to the low systemic bioavailability of the drug (<1%, with a sensitivity of the method of determination of 0.25 pg / ml), it is unlikely that in case of an accidental or intentional overdose, it will be necessary to take any measures other than monitoring with the possible subsequent resumption of taking the drug at the recommended dose.
Interaction with other medicinal products
Combination therapy with loratadine is well tolerated by patients. At the same time, no effect of the drug on the plasma concentration of loratadine or its main metabolite is noted.
ќсобые указани¤
ак и при вс¤ком долгосрочном лечении, пациенты, пользующиес¤ назальным спреем ћомат –ино в течение нескольких мес¤цев и дольше, должны периодически проходить осмотр у врача на предмет возможных изменений слизистой оболочки носа и возможного развити¤ системных побочных эффектов. ¬ случае развити¤ местной грибковой инфекции носа или глотки может потребоватьс¤ прекращение терапии назальным спреем ћомат –ино и проведение специального лечени¤. —охран¤ющеес¤ в течение длительного времени раздражение слизистой оболочки носа и глотки также может служить основанием к прекращению лечени¤ данным препаратом.
ѕациенты, которые переход¤т к лечению назальным спреем ћомат –ино после длительной терапии глюкокортикостероидами системного действи¤, требуют к себе особого внимани¤. ќтмена глюкокортикостероидов системного действи¤ у таких пациентов может привести к недостаточной 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.
¬о врем¤ перехода от лечени¤ глюкокортикостероидами системного действи¤ к лечению назальным спреем ћомат –ино 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; таких больных необходимо специально убеждать в целесообразности продолжени¤ лечени¤ назальным спреем ћомат –ино. ѕереход от системных к местным глюкокортикостероидам может, также, вызвать 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¤.
Ёффективность и безопасность мометазона не изучена при лечении односторонних полипов неправильной формы, кровоточащих полипов, полипов, св¤занных с муковисцидозом и полипов, которые полностью закрывают носовую полость. ќдносторонние полипы, которые неправильной формы или кровоточащие, следует дополнительно обследовать.
ѕри длительном применении назальных v — в высоких дозах возможно развитие системных побочных эффектов. ¬еро¤тность развити¤ этих эффектов гораздо меньше, чем при применении системных v —, и может различатьс¤ у отдельных пациентов, а также между разными v —. потенциальным системным эффектам относ¤тс¤ синдром ушинга, характерные признаки кушингоида, подавление функции надпочечников, задержка роста у детей и подростков, катаракта, глаукома и, реже, р¤д психологических или поведенческих эффектов, включа¤ психомоторную гиперактивность, нарушение сна, беспокойство, депрессию или агрессию (особенно у детей).
–екомендуетс¤ регул¤рно мониторировать рост детей, получающих длительную терапию мометазоном. ѕри замедлении роста следует пересмотреть проводимую терапию с целью снижени¤ дозы мометазона до минимальной эффективной дозы, позвол¤ющей контролировать симптомы заболевани¤. роме того, следует направить пациента на консультацию к педиатру.
Ћечение v — более высокими дозами, чем рекомендуемые, может привести к клинически значимому угнетению функции надпочечников. ?сли известно, что примен¤ютс¤ высокие дозы v — необходимо рассмотреть возможность дополнительного применени¤ системных v — в периоды стресса или планового хирургического вмешательства.
¬ли¤ние на способность управл¤ть транспортными средствами и заниматьс¤ другими видами де¤тельности
Ќет данных.
Release form
Dosed nasal spray, 50 mcg / dose.
60 or 120 doses of suspension in a high density polyethylene vial with a dispensing device and a high density polyethylene cap. 1 bottle together with instructions for medical use in a cardboard box.
Shelf life is
2 years.
Do not use the drug after the expiration date.
Storage conditions
In the dark place at a temperature of 15 to 25 ? C. Do not freeze.
Keep out of the reach of children.
Terms of dispensing
By prescription.