Sensitive Nazivin 22.5g / 10 ml dose nasal spray metered

The instruction for medical use of Sensitiv Torgovoye Nazivin medicine a name of Nazivin Sensitiv the International unlicensed name Oxymetazoline Dosage Form Spray the nasal Structure of 1 ml of solution dosed 22.5 mkg / a dose contains active agent - oxymetazoline a hydrochloride of 0.500 mg excipients: citric acid monohydrate, citrate sodium a dihydrate, glycerin (85%), the water purified the Description Transparent or almost transparent solution from colourless till weak-yellow color Pharmacotherapeutic group Nasal drugs. Antikongenstanta and other nasal drugs for topical administration. Sympathomimetics. Oxymetazoline the ATX R01AA05 Code the Pharmacological Pharmacokinetics At properties topical intranasal administration drug does not possess systemic action. After injection in a nose the effect of oxymetazoline comes quickly: - for a form of 0.05% within several seconds (on average 20 seconds) Duration of effect of drug till 12 o'clock. Elimination half-life of oxymetazoline at its intranasal introduction makes 35 h 2.1% of oxymetazoline also about 1.1% with a stake are removed with urine. After intranasal use the absorbed amount of medicine can cause system impacts, for example, on the central nervous system and a cardiovascular system. The pharmacodynamics of Nazivin® Sensitiv (oxymetazoline) does not contain preservatives. Has vasoconstrictive effect, is a sympathomimetic, with direct promoting effect on alfa2-adrenoceptors. At topical administration of spray for a nose there is a narrowing of blood vessels of a mucous membrane of a nose, hypostasis and hyperaemia of a mucous membrane of a nasopharynx is eliminated. Nasal breath in rhinitises is facilitated. After removal of hypostasis of a mucous membrane the removing channels for aeration of adnexal bosoms of a nose, an acoustical pipe open and extend. It stimulates drainage function of nasal cavities and prevents development of bacterial complications. Antiviral, immunomodulatory and antioxidant effect of active agent is proved. Antiviral effect of oxymetazoline, is confirmed with researches with use of the cultivated cells infected with viruses (therapeutic approach). This cause and effect mechanism of action was shown by means of suppression of activity of the viruses causing cold and cold with use of the test of reduction of plaques, determination of residual infectivity of viruses (titration of viruses) and also the test of inhibition of virus cytopathic action (CPD/zpE). Thus, treatment of 0.05% oxymetazoline solution for nasal use, in comparison with normal saline solution, considerably reduced cold duration, on average from 6 to 4 days (p & lt, 0.001). Indications - acute respiratory diseases with the phenomena of rhinitis (cold) - allergic rhinitis - vasomotorial rhinitis - improvement of a drainage of secretion at inflammation of adnexal bosoms of a nasal cavity (sinusitis) - the eustachitis associated by rhinitis - elimination of hypostasis before diagnostic procedures the Route of administration and doses of Nazivin® Sensitiv of 0.05% (1 dose of spray (45 mkl) contains 22.5 mkg of oxymetazoline in a mucous membrane of a nasal cavity) spray nasal is intended for use in a nose. Nazivin® Sensitiv of 0.05% spray nasal is appointed to adults and children 6 years on 1 injection in each nasal course 2 – 3 times a day are more senior. It is impossible to apply the nasal sprays containing oxymetazoline longer than 7 days if it is not appointed differently the attending physician. The period without treatment which is several days has to precede any repeated course of use of drug. Doses, above recommended, can be applied only under observation of the doctor. Side effects Often (from ≥ 1% to & lt, 10%): - burning sensation or xeromycteria - sneezing, especially at sensitive patients. Infrequently (from ≥ 0.1% to & lt, 1%): - hypostasis of a mucous membrane (feeling of congestion of a nose) can become more intensive (reactive hyperemia), nasal bleeding - hypersensitivity reactions (Quincke's disease, rash, an itching). Seldom (from ≥ 0.01% to & lt, 0.1%): - cardiopalmus, increase of pulse and increase in arterial blood pressure. Very seldom & lt, 0.01% and isolated cases: - concern, insomnia, fatigue (drowsiness, sedative action), a headache, hallucinations (especially at children) - arrhythmias - an apnoea at babies and newborns - Contraindication spasms - hypersensitivity or to any excipient - atrophic rhinitis - Nazivin® Sensitiv of 0.05% spray nasal should not be applied to oxymetazoline at children up to 6 years - states after transsphenoidal hypophysectomy or other surgical interventions on a firm meninx Medicinal interactions the Combined (simultaneous) use of oxymetazoline and - tricyclic antidepressants - monoamine oxidase inhibitors of traniltsiprominovy type - hypertensive means can lead to increase in arterial blood pressure. Therefore, if perhaps, it is at the same time undesirable to use these drugs. Special instructions In the following cases this drug can be used only after careful assessment of risk and advantage of its use: - the increased intraocular pressure, especially a narrow angle glaucoma - a serious cardiovascular illness (for example, a coronary disease) and hypertensia - a pheochromocytoma - metabolic disorders (for example, a hyperthyroidism, diabetes) - a prostate hyperplasia - a porphyria - the patients undergoing treatment by monoamine oxidase inhibitors (MAO inhibitors) and other drugs which have potential ability to increase arterial blood pressure At prolonged use of nasal means from cold or at their overdose their efficiency can go down. The wrong use of nasal means from cold can cause: - a reactive hyperemia (resuming of symptoms after drug withdrawal) - chronic hypostasis of a mucous membrane of a nasal cavity (rhinitis medicamentosa) - a mucosal atrophy. Pregnancy and a lactation At use during pregnancy or breastfeeding it is not necessary to exceed the recommended dosage. The data obtained at the limited number of the women receiving this drug during the first trimester of pregnancy did not show development of any adverse reactions owing to effect of oxymetazoline which could influence pregnancy or health of the fruit/newborn. Researches on animals showed reproductive toxicity concerning the doses exceeding range therapeutic the dosed Drug Nazivin® Sensitiv it is necessary to use during pregnancy after careful assessment of a ratio of advantage/risk. During pregnancy it is not necessary to exceed the recommended dose as the overdose can make an adverse effect on blood circulation of a fruit. The lactation period the Drug Nazivin® Sensitiv should be used during breastfeeding only after careful assessment of a ratio of advantage/risk. During breastfeeding it is not necessary to exceed the recommended dose in connection with influence of drug on amount of milk. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms After prolonged use of Nazivina® Sensitiv, in the dosages exceeding recommended it is impossible to exclude the general influence on a cardiovascular system and the central nervous system. In these cases the ability to run the vehicle or the equipment can decrease. Overdose Symptoms: when exceeding the recommended doses or accidental intake the following symptoms can appear: mydriasis, nausea, vomiting, cyanosis, temperature increase, tachycardia, arrhythmia, collapse, oppression of warm activity, arterial hypertension, fluid lungs, respiratory disorders. Besides, there can be mental disorders and also the oppression of functions of the central nervous system which is followed by drowsiness, fall of temperature of a body, bradycardia, arterial hypotension, spasms, an apnoea and possible development of a coma. Treatment: intake of activated carbon, gastric lavage, ventilation of the lungs by oxygen. For lowering of blood pressure – phentolamine of 5 mg in saline (physiological) solution slowly in/in or 100 mg orally. Use of angiotonic means is contraindicated. In case of need means for decrease in symptoms of fever and anticonvulsant therapy. The form of release and packing On 10 ml of drug place in the bottles from polyethylene supplied with portioning devices and a protective cover from polyethylene. The bottle together with the instruction for medical use in the state and Russian languages is placed in a box cardboard by Storage conditions to Store at a temperature not higher than 30 wasps. To store out of children's reach! 3 years the use Period after the first opening of 12 months not to use a period of storage after expiry date. Prescription status Without prescription the Producer/packer Famar Hels Keyr Servises Madrid, S.A. U., Spain the Name and the country of the owner of the registration certificate of Merck Zelbstmedikation GmbH, Germany the Name and the country of the organization - the releasing quality control Famar Hels Keyr Servises Madrid, S.A. U., Spain the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) 050057 Almaty, 22nd Line St., 45, 8 (727) 3941699, 8 (727) 3941689, 87017633805, fax: 3941294 (110), maira70@mail.ru the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety medicinal sredstvadr. Reddy’s Laboratories Ltd, 050057 Almaty, 22nd Line St., 45, 8 (727) 3941699, 8 (727) 3941689, 87017633805, fax: 3941294 (110)
to Develop maira70@mail.ru