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Etatsid 50 ug / dose of 140 doses of 18g nasal spray metered




The instruction for medical use of ETATsID medicine the Trade name Etatsid Mezhdunarodnoye the unlicensed name Mometazon Lekarstvennaya a form Spray the nasal Structure of 1 g of suspension dosed 0.05% 18 g / 140 doses contains active agent – a mometazon furoate of 0.5 mg, excipients: cellulose microcrystalline and sodium of a kroskarmelloz, sodium citrate, glycerin, citric acid monohydrate, polysorbate 80, a benzalkoniya chloride, water purified. Description Suspension of white or almost white color. Pharmacotherapeutic group Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Glucocorticosteroids. Mometazon. The ATX R01AD09 code the Pharmacological Pharmacokinetics At properties the correct intranasal use the system bioavailability of drug is also lt, 1%. At the same time even drug does not decide on use of hi-tech methods in blood serum. Suspension of a mometazon is very badly soaked up in digestive tract, and that small amount of suspension of a mometazon which can get into digestive tract after nasal inhalation, even before excretion with urine or bile is exposed to active primary metabolism. Mometazon’s pharmacodynamics furoate – a synthetic corticosteroid for topical administration. Has anti-inflammatory and antiallergic effect at use in doses which do not cause system effects. Mometazona furoate slows down release of mediators of inflammation, considerably reduces synthesis/release of leukotrienes from leukocytes at patients with allergic diseases. Mometazona furoate showed on the culture of cells the high potential (at least by 10 times higher activity, than other steroids, including beclomethasone Dipropionas, betamethasone, a hydrocortisone and dexamethasone) oppressions of synthesis/release of interleukins (IL-1, IL-6) and tumor necrosis factor (ФНО-α), it also substantially oppresses education T-helperami (Th2) SILT-4 and SILT-5. Mometazona furoate inhibits products of SILT-5, than beclomethasone Dipropionas and betamethasone at least 6 times more actively. Raises products of the lipomodulin which is inhibitor of a phospholipase And that causes decrease in release of arachidonic acid and, respectively, oppression of synthesis of products of metabolism of arachidonic acid – cyclic endoperoxides, prostaglandins. Indications ˗ treatment of symptoms of seasonal or year-round allergic rhinitis at adults and children are more senior than 12 years ˗ treatment of symptoms of seasonal allergic or year-round allergic rhinitis at children from 6 to 11 years ˗ prevention of allergic rhinitis of an average and heavy course (it is recommended in 4 weeks prior to the expected beginning of a season of blossoming) ˗ treatment of nasal polyps at adult patients 18 years the Route of administration and Intranazalno’s doses are more senior. To avoid hit in eyes. Before use the bottle needs to be stirred up vigorously. Before the first use of spray nasal it is necessary to carry out calibration of the portioning device (first 10 pressing). Further stereotypic supply of medicinal substance is established. If drug was not used within 14 days and more, then before the next use repeated calibration is necessary. Prevention and treatment of symptoms (congestion of a nose) of seasonal and year-round rhinitis at adults and children are more senior than 2 years: to adults and children 12 years are more senior appoint 2 injections (100 mkg) in each nasal course of 1 times a day (a daily dose – 200 mkg). To children aged from 2 up to 12 years appoint on 1 injection (50 mkg) in each nasal course of 1 times a day (a daily dose – 100 mkg). The clinical effect is noted, as a rule, within 12 hours after the first use of drug. At patients with seasonal allergic rhinitis the prevention is recommended to be begun in 2-4 weeks prior to possible emergence of clinical symptomatology. Auxiliary therapy of sharp episodes of sinusitis at adults (including advanced age) and children is more senior than 12 years: appoint in the recommended therapeutic dose – 2 injections (100 mkg) in each nasal course 2 times a day (a daily dose – 400 mkg). In case reduction of expressiveness of symptoms of a disease of use of drug in the recommended therapeutic dose does not manage to be reached, the daily dose of drug can be raised to 4 injections in each nasal course 2 times a day (a daily dose – 800 mkg). After reduction of expressiveness of symptoms of a disease the dose decline is recommended. Treatment of the sharp rinosinusit without symptoms of a heavy bacterial infection at adults and children is more senior than 12 years: the recommended therapeutic dose makes 2 injections (100 mkg) in each nasal course 2 times a day (a daily dose – 400 mkg). Treatment of nasal polyps and related symptoms, including congestion of a nose and loss of sense of smell, at patients is more senior than 18 years: appoint 2 injections (100 mkg) in each nasal course 2 times a day (a daily dose – 400 mkg). After reduction of symptoms of a disease the dose decline up to 2 injections (100 mkg) in each nasal course of 1 times a day is recommended (a daily dose – 200 mkg). Side effects In allergic rhinitis it is frequent – nasal bleeding, pharyngitis, burning, irritation and ulcer changes of a mucous membrane of a nose – a headache At a nasal polyp Is very frequent – nasal bleeding Is frequent – irritation in a throat, an upper respiratory tract infection – a headache Seldom – reactions of hypersensitivity, including a bronchospasm and dispnoe Is very rare – an anaphylaxis and a Quincke’s disease – disturbance of taste and sense of smell – perforation of a nasal partition there Are rare messages about development of glaucoma, increase in intraocular pressure, a cataract when assigning intranasal corticosteroids. Contraindications – hypersensitivity to active agent or to any of inactive components of nasal spray – presence of the undertreated localized infection with damage of a mucous membrane of a nose – recently undergone surgeries or injuries of a nasal cavity (corticosteroids slow down healing of wounds therefore it is not necessary to appoint corticosteroids for topical intranasal administration before full healing of wounds) Medicinal interactions Combination therapy with loratadiny was well transferred by patients. At the same time any influence of drug on concentration of a loratadin or its main metabolite in blood plasma was not noted. In these researches of a mometazon furoate in blood plasma was not found (at test-sensitivity of determination of 50 pg/ml). The special instructions Etatsid it has to be applied with care in tuberculosis of respiratory organs (including latent), not treated fungal, bacterial, system viral infection (including the caused Herpes simplex with damage of eyes). After 12-month treatment mometazony furoate symptoms of a mucosal atrophy of a nose did not develop, besides, a mometazona furoate contributed to normalization of a histologic picture of a mucous membrane of a nose. As well as at any other long-term treatment, the patients applying a mometazon furoate within several months and longer have to have periodically examination regarding detection of possible changes of a mucous membrane of a nose. In case of development of a local fungal infection of a nose or a throat it is necessary to stop therapy mometazony furoate or to carry out special treatment. The irritation of a mucous membrane of a nose and throat remaining for a long time can also be the indication to the treatment termination mometazony furoate. Therapy mometazony furoate provides control of nasal symptoms of a disease at most of patients, however, it is necessary to consider the possibility of additional therapy for simplification of ophthalmologic symptoms of a disease. At long-term treatment mometazony furoate of signs of oppression of function gipotalamo – the hypophysial and adrenal system was not observed. Careful medical observation of the patients passing to treatment with nasal Momester spray after long therapy by corticosteroids of systemic action is necessary. The termination of reception of corticosteroids of systemic action at such patients can result in insufficiency of function of bark of adrenal glands within several months that can demand therapy resuming by system corticosteroids and uses of other corresponding treatment. During transition from treatment by corticosteroids of systemic action to treatment mometazony furoate some patients, along with simplification of nasal symptoms, can have symptoms of cancellation of corticosteroids (for example, joint and/or muscles pain, feeling of fatigue and a depression). Change of therapy can also reveal allergic diseases (such as allergic conjunctivitis, eczema, etc.) which developed earlier and masked therapy by corticosteroids of systemic action. Now safety and efficiency of a mometazon furoate at treatment of unilateral polyps, the polyps connected with cystous fibrosis, or the polyps which are completely filling a nasal cavity are not rather studied. In the presence of the unilateral polyps having the unusual or changed outward, especially in the presence of ulcerations or bleedings it is necessary to carry out additional diagnostic methods. The patients applying corticosteroids can potentially have reduced immune responsiveness and have to be warned about the increased risk of infection in case of contact with sick some infectious diseases (for example, chicken pox, measles) and also about need of consultation of the doctor if such contact happened. There are separate messages about development of perforation of a nasal partition or increase in intraocular pressure after use of intranasal corticosteroids. Safety and efficiency mometazony furoate were not investigated at treatment of nasal polyps at children and teenagers 18 years are younger. Systemic action of nasal corticosteroids is shown, as a rule, when assigning high doses during the long periods. Similar action is less significant, than at use of oral corticosteroids and varies at different patients at use of different medicines. Systemic action of corticosteroids is shown in the form of Cushing’s syndrome, kushingnoidny symptoms, suppression of function of adrenal glands, a growth inhibition at children and teenagers, a cataract, glaucoma less often, psychological or behavioural changes, including psychomotor hyperreactivity, sleep disorders, concern, a depression or aggression (especially at children). Treatment using high doses, can lead to clinically apparent suppression of function of adrenal glands. In the presence of indications for use of higher dosages, especially during the periods of a stress or at planned surgical intervention, it is necessary to consider the possibility of combination with other system corticosteroids. Children. Use of drug for children of younger age has to be carried out only under control of adults. It is regularly recommended to check growth of the children receiving long-term treatment by nasal corticosteroids. In case of identification of delay of growth it is necessary to consider the possibility of a dose decline of a nasal corticosteroid to the lowest dose at which effective control of symptoms is supported. In a similar case of the child it is necessary to consult at the pediatrician. Pregnancy and lactation. Special researches of effect of drug at pregnant women were not conducted. However, as well as other corticosteroids furoate is applied to intranasal use, a mometazon at the pregnant women and women nursing only if the expected advantage of its use justifies potential risk for mother, a fruit or the child. Babies whose mothers during pregnancy applied corticosteroids should be examined carefully regarding a possible hypoadrenalism. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Drug does not affect ability to driving of motor transport and also performance of work, connected with the increased concentration of attention. The overdose Drug has low (& lt, 1%) system bioavailability therefore it is improbable that at overdose the acceptance of any measures, except observation and the subsequent appointment in the recommended dose will be required. At prolonged use of glucocorticosteroids in high doses or at simultaneous use of several glucocorticosteroids the oppression gipotalamo – a hypophysial and adrenal system is possible. The overdose also arises at the wrong use (ingestion) of drug. At the same time the mometazona furoate is absorbed in insignificant degree and biotransformirutsya actively at primary passing through a liver. A form of release and packing On 18 g (140 doses) of drug in a white opaque bottle from polyethyl of the high density with a capacity of 200 ml with the portioning device and a protective cap. On 1 bottle together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! Not to freeze. 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer Uorld Meditsin Ilach Sang. ve Tidzh. A.Sh., Turkey (Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K.1B Zemin 4-5-6, Istanbul) Owner of the registration certificate UORLD MEDITSIN OFTALMIX ILACHLARY LTD. STI., TURKEY the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: WM Pharma Alliance LLP, RK, Almaty, Suyunbaya Ave., 222 B Ph. / fax: +7 (727) 2529090 Address of the organization responsible for post-registration observation of safety of medicine: TROKA-S PHARMA LLP, RK, Almaty, Suyunbaya Ave., 222 B Cellular ph. +7 701 786 33 98, (24-hour access).
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