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Sanorin 0.1% 10 ml Nasal Drops


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The instruction for medical use of SANORIN medicine the Trade name Sanorin the International unlicensed name Naphazoline Dosage Form of the Drop in a nose of 0.1%. The structure of 1 ml of solution contains active agent – naphazoline nitrate of 0.001 g excipients: boric acid, ethylene diamine, methylparahydroxybenzoate, the water purified. Description flavourless Colourless transparent solution Pharmacotherapeutic group Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Sympathomimetics. Naphazoline. The ATX R01AA08 code the Pharmacological Pharmacokinetics Data properties about distribution, metabolism and elimination of naphazoline are not known. At topical administration the vasoconstrictive effect occurs in 5-10 minutes and proceeds from 4 to 6 hours. It is absorbed in a system blood stream and can have systemic action. The pharmacodynamics Sanorin contains the naphazoline which is the system sympathomimetic operating on alpha adrenoceptors. Renders expressed and the continuing vasoconstrictive action on vessels of mucous membranes is long. At intranasal use, naphazoline narrows vessels, reduces exudation, facilitating, thus, nasal breath and reducing puffiness mucous at inflammations of upper airways. Indications – for simplification of congestion of a nose – acute rhinitis – sinusitis – for removal of a rhinedema at diagnostic and therapeutic interventions the Route of administration and doses Solution of 0.1% to Adults and teenagers are more senior than 15 years – on 1-3 drops of solution in each nasal course, put 2-3 times, with an interval not less than 6 hours. Drug is dug in in each nostril, the head has to be inclined back. During instillation in the left nostril it is reasonable to turn slightly the head to the left, at instillation in the right nostril, to turn the head to the right. Drug should be used during the short span. It should not be applied within more than 3 days. Therapy can be stopped earlier if the congestion of a nose is eliminated. Drug can be used repeatedly only in several days after the treatment termination. Side effects At use in the recommended doses drug usually well is transferred. Seldom: – nausea, a headache, nervousness, a tremor – tachycardia, increase in arterial blood pressure, heartbeat – a reactive hyperemia, the increased sweating – burning sensation or dryness in a nose – hypostasis of a mucous membrane of a nasal cavity (at use more than 7 days) – atrophic rhinitis Very seldom: – the intensive congestion of a nose, after weakening of effect of drug can result Too frequent use in the dependence accompanied with the intensive hypostasis of a mucous membrane occurring during rather short time after use. Prolonged use of drug can lead to disturbance of an epithelium of a mucous membrane, inhibition of tsiliarny activity and to lead to irreversible injury of a mucous membrane and development of dry rhinitis of the Contraindication – hypersensitivity to drug components – an arterial hypertension, tachycardia, the profound atherosclerosis – a serious illness of eyes – a hyper thyroidism – urination disturbances – diabetes – closed-angle glaucoma – prostate diseases – dry rhinitis – chronic rhinitis (atrophic type) – children’s age up to 15 years With care – pregnancy and the period of a lactation (strictly on doctor’s orders, only in case of emergency). Medicinal interactions Drug should not be used along with monoaminooxidase inhibitors, tricyclic antidepressants and Maprotilinum as there can be a disturbance of a warm rhythm and increase in arterial blood pressure. It is necessary to appoint the special instructions Drug carefully in diseases of a cardiovascular system (hypertension, coronary heart disease), a pheochromocytoma or with potentially hypertensive drugs. At prolonged use the expressiveness of vasoconstrictive action gradually decreases (the tachyphylaxis phenomenon), in communication with what no more than 3 days are recommended to use drug. Not to exceed the recommended dose. It is necessary to be careful during the general anesthesia by means of anesthetics which increase sensitivity of a myocardium to sympathomimetics (for example, a halothane), at patients with bronchial asthma. It is necessary to avoid prolonged use and overdose. Prolonged use of the medicines intended for removal of hypostasis of a mucous membrane can lead to hypostasis and the subsequent mucosal atrophy of a nose. This medicine contains methylparaben which can cause allergic reactions (perhaps, the slowed-down type). Pregnancy and the period of a lactation are Not enough information on ability of naphazoline to get through a placenta and to be allocated in breast milk. Therefore pregnant women or the feeding women need to consider potential risks and advantages of treatment before administration of drug, to appoint drug, only in case of emergency. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. Drug does not affect ability to run motor transport or potentially dangerous mechanisms. Overdose Symptoms: the headache, a tremor, tachycardia, heartbeat or a hypertension can lead accidental consumption of drug to emergence of system undesirable reactions, such as nervousness, the increased sweating. Possible symptoms of overdose are provided by nausea, cyanosis, fever, spasms, cardiac arrest, a fluid lungs and respiratory or psychiatric problems. Besides, it is possible to notice the oppression of the central nervous system accompanied with drowsiness, decrease in body temperature, bradycardia, sweating, shocklike hypotension, an apnoea or a coma. Treatment: symptomatic. The risk of overdose is higher at children as they are more susceptible to adverse effects, than adults. A form of release and packing On 10 ml in the bottle of brown glass supplied with a dropper with a cover from polyethylene with control of the first opening. Each bottle supplied with the label together with the instruction for medical use in the state and Russian languages is put in a box of cardboard. To Store storage conditions in the place protected from light, at a temperature from 10 s to +25C. To protect from freezing. To store out of children’s reach! 4 years not to apply a period of storage after an expiration date. Prescription status Without prescription the Producer Teva Czech Industries s.r.o., the Czech Republic Teva the Czech Enterprises of neuter of the lake, the Czech Republic the Owner of the registration certificate of Ksantis Pharm Ltd, Cyprus the Address of the organization accepting claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine in the territory of the Republic of Kazakhstan of limited liability partnership Xantis Pharma (Ksantis of Pharm), Kazakhstan 050008, Kazakhstan, Almaty, Auezov St. 48, 3 the floor, office 3/2

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