Momester 50 ug / dose to 60 doses of 20 ml nasal spray metered

The instruction for medical use of Momester Torgovoye medicine a name Momester Mezhdunarodnoye the unlicensed name Mometazona furoate the Dosage form spray the nasal Structure dosed 50 mkg / a dose, suspension of 60 doses, 120 doses and 140 doses Structure on 100 g of drug: active agent – a mometazona of furoate of monohydrate of 0.05173 g (it is equivalent a mometazona to furoate) 50 mkg / a dose. Excipients: a benzalkoniya chloride, glycerin, polysorbate 80, cellulose microcrystalline and croscarmellose sodium (Avitsel RC591), citric acid monohydrate, sodium citrate, water the White or almost white viscous suspension purified the Description Pharmacotherapeutic group Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Glucocorticosteroids. Mometazon ATH R01A D09 Code the Pharmacological Mometazon's Pharmacodynamics properties furoate – a synthetic corticosteroid for topical administration which has anti-inflammatory effect. This action is shown in doses at which there are no system effects. Antiallergenic and anti-inflammatory action of a mometazon of furoate is connected with its ability to oppress release of mediators of allergic reactions. Mometazona furoate significantly slows down release of leukotrienes from leukocytes of patients with allergic diseases. On the culture of cells of a mometazon furoate showed high efficiency in inhibition of synthesis and release of IL-1, IL-5, IL-6 and TNFα, mometazon furoate is, also, active inhibitor of products of leukotrienes. Besides, substance is active inhibitor of products of Th2-cytokines, IL-4 and IL-5 from human CD4+ of T-cells. In the researches using intranasal antigen challenge, a mometazon furoate showed anti-inflammatory activity both in early, and in a late stage of allergic reaction. Action was confirmed with decrease (in comparison with placebo) to histamine and eosinophilic activity and also reduction of level (in comparison with basic data) eosinophils, neutrophils and proteins of adhesion of epithelial cells. The pharmacokinetics At intranasal use of a mometazon of furoate its system bioavailability makes also lt, 0.1%: at the same time the mometazona furoate practically does not decide in blood plasma, even when using highly sensitive methods of definition on a threshold of sensitivity of 50 pg/ml, therefore, there are no relevant pharmacokinetic data for such dosage. Suspension of a mometazon of furoate is very poorly absorbed in a GIT, and the insignificant quantity which can be swallowed by the patient and which can be soaked up biotransformirutsya actively at primary passing in a liver before removal with urine and bile. 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 doses Before the first use of nasal Momester spray are more senior it is necessary to carry out its calibration by 10 pressing of the portioning device. After calibration the stereotypic supply of medicinal substance at which to each pressing there is an emission about 100 mg of the suspension containing 50 mkg of a mometazon is established. If nasal spray was not used within 14 days or longer, then repeated calibration by 2 pressing is necessary, uniform spraying of spray will not be observed yet. Seasonal or year-round allergic rhinitis At teenagers is aged more senior than 12 years and adults, including elderly patients, the recommended dose of drug makes 2 injections (on 50 mkg everyone) in each nostril of 1 times/days (the general daily dose makes 200 mkg of drug). After achievement of positive clinical effect as maintenance therapy the decrease in a dosage to 1 injection in each nostril is recommended (the general daily dose - 100 mkg). If weakening of symptoms of a disease does not manage to be reached, the dose can be increased to the maximum daily dose and make 4 injections in each nostril of 1 times/days (the general daily dose - 400 mkg). After weakening of symptoms of a disease the dose decline is recommended. At children aged from 6 to 11 years the recommended dose makes 1 injection (on 50 mkg everyone) in each nostril of 1 times/days (the general daily dose - 100 mkg). At some patients with seasonal allergic rhinitis the beginning of clinical effect can be observed in the first 12 hours after the beginning of therapy though full action can be reached only in 48 hours. Therefore for achievement of full clinical effect it is important to use medicine regularly. Nasal polyps the Recommended initial dose at nasal polyps makes 2 injections (on 50 mkg everyone) in each nostril of 1 times/days (the general daily dose - 200 mkg). If after 5 - 6 weeks of therapy of weakening of symptoms of a disease it is not possible to reach, the dosage can be increased up to 2 injections in each nostril of 2 times/days (the general daily dose - 400 mkg). The dose should be lowered to the lowest dose at which disease symptoms are effectively controlled. If after 5 - 6 weeks of therapy when assigning 2 times/days the improvement of symptoms is not observed, it is necessary to consider alternative methods of therapy. nasal Momester spray was effective and safe at therapy of nasal polyps within four months. Before each use it is necessary to stir up a spray bottle vigorously. The bottle with spray becomes unsuitable after the specified number of injections or 2 months later after the first use. 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 It is necessary to observe special precautionary measures when using corticosteroids of systemic action. At a research of clinical interaction with loratadiny interaction is not revealed. Special instructions of Mometazon furoate should be applied with care or not to apply absolutely at patients with an active or latent tuberculosis infection of a respiratory path and also in an uncured fungal, bacterial infection, a system viral infection or in herpes simplex infection 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 In the recommended dose Momester spray does not affect ability to run transport or potentially dangerous mechanisms. The overdose Owing to small (≤0.1%) system bioavailability mometazony furoate overdose is improbable (when using a sensitive method of definition with a threshold of sensitivity of 0.25 pg/ml). In case of overdose the observation of the patient with the subsequent use of drug in the recommended dose is necessary. Inhalation or intake of high doses of corticosteroids can lead to suppression gipotalamo - a hypophysial and adrenal system. A form of release and packing On 20 ml of drug in bottles from PETF. Bottles fill 10 g of suspension (a dosage form on 60 pressing), 16 g of suspension (a dosage form on 120 pressing) and 18 g of suspension (a dosage form on 140 pressing). On each bottle paste the label. On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions in the place protected from light at a temperature not above 25ºС. To store out of children's reach. A period of storage 2 years the Period of storage after opening of primary packing 2 months. Not to use after an expiration date. Prescription status According to the prescription the Name and the country of the organization producer/packer of Farmea Bosch Toma 10 St., Z.A.K darzhemon, 49000 Angers, France the Name and the country of the owner of the registration certificate of JSC Khimfarm, the Republic of Kazakhstan
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Khimfarm, Shymkent, Republic of Kazakhstan, Rashidov St., 81 the Name, the address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of JSC Khimfarm Republic of Kazakhstan, Shymkent, Rashidov St., 81