The instruction for medical use of RINOZOL® medicine Trade name РИНОЗОЛ® the International unlicensed name Is not present the Dosage form Spray Structure, nasal for children of 10 ml, 1 ml of solution contain active agents: Neomycinum sulfate of 1.0 mg, difengidramina hydrochloride of 1.0 mg, naphazoline hydrochloride of 0.25 mg excipients: sodium chloride, polyvinyl alcohol, a benzalkoniya chloride (in terms of 100% substance), phosphate dinatrium dodecahydrate, dihydrophosphate sodium a dihydrate, Trilonum B, water for injections the Description Transparent colourless or slightly yellow liquid. Weak opalescence of solution Pharmacotherapeutic group the Respiratory system is allowed. Nasal drugs. Antikongenstanta and other nasal drugs for topical administration. Sympathomimetics, combinations, excepting corticosteroids. The ATX R01AB code the Pharmacological Pharmacokinetics Therapeutic Effect properties of naphazoline develops in 5 min. after intranasal use of drug and proceeds up to 8 h, at frequent use of drug duration of action can be reduced to 6 h. At topical administration, naphazoline can be soaked up in a system blood stream and have systemic action. Development of system effects in children up to 6 years and elderly people is the most probable. At topical administration system absorption of a difengidramin and Neomycinum low. A pharmacodynamics the Combined drug possessing vasoconstrictive, anti-inflammatory, antimicrobial and antiallergenic action. It is caused by existence of a sympathomimetic, vasoconstrictive component of naphazoline of a hydrochloride (Naphthyzinum), active agent with antihistaminic properties - a difengidramina of a hydrochloride (Dimedrol) and an antibiotic of a broad spectrum of activity from group of aminoglycosides – sulfate Neomycinum. Naphazoline the alpha stimulates 2 adrenoceptors that leads to narrowing of peripheral blood vessels, increases arterial blood pressure, expands pupils. Owing to vasoconstrictive action drug reduces puffiness, hyperaemia, exudation. Difengidramin is an antagonist of H1 receptors 1 generations. By competitive blockade histamine H1 receptors drug slows down development of such allergic symptoms as expansion and increase in permeability of blood vessels (in particular connected with release of a histamine), has antiallergic effect, reducing hypostasis, an itching and dacryagogue. Neomycinum has bactericidal effect. The mechanism of action is connected with direct influence on ribosomes and oppression of synthesis of protein of a bacterial cell. Shigella spp., Proteus spp., Staphylococcus aureus, Streptococcus pneumoniae is active concerning many gram-negative and gram-positive microorganisms, including concerning Esherichia coli. It is a little active concerning Pseudomonas aeruginosa and Streptococcus spp. It is not active concerning a pathogenic fungi, viruses, anaerobic bacteria. Resistance of microorganisms to Neomycinum develops slowly and in small degree. Indications - rhinitises, antritises and sinusitis of infectious and inflammatory origin (including with the accompanying allergic manifestations) the Route of administration and doses to Children at the age of 2 years are also more senior on 1-2 dose of spray in each nasal course 3-4 times a day within 5-7 days. It is not recommended to use drug without consultation of the attending physician, longer than an established period. The opened packing Naphazoline is slow to use no more than 4 weeks Side effects - quickly passing feeling of pain or burning in a nasopharynx (in the first seconds after intranasal use) - a reactive hyperemia, swelling of a mucous membrane of a nose, light dryness of a mucous membrane of a nasal cavity, the strengthened growth of microorganisms, including mushrooms, irresponsive to an antibiotic (at long use) Contraindications - the increased individual sensitivity to drug and its making chronic rhinitis - atrophic rhinitis - a concomitant use of monoamine oxidase inhibitors or tricyclic antidepressants and the period up to 14 days after their cancellation - children's age up to 2 years Medicinal interactions absorption of mestnoanesteziruyushchy means (extends their action when carrying out surface anesthesia). It is incompatible with tricyclic antidepressants (Maprotilinum) and MAO inhibitors (Nialamidum, befol) - increase in arterial blood pressure is possible that is caused by release of the deposited catecholamines under the influence of naphazoline. Strengthens action of stimulators of the central nervous system. Reduces therapeutic activity of the antihypertensives appointed orally. Perhaps mutual reduction of effects of a difengidramin and the medicines stimulating the central nervous system. System absorption of Neomycinum after topical administration so low that risk of any interaction minimum. At the accompanying therapy using ophthalmologic drugs it is necessary to adhere to an interval of 10-15 min. between their use. Special instructions in order to avoid solution pollution, you store a bottle densely closed and avoid contact of a tip with any surface. Prolonged use of drug as it can lead to the strengthened growth of microorganisms, irresponsive to an antibiotic, including mushrooms is not recommended. Use in pediatrics the Data on efficiency and safety of medicine at children up to 2 years are absent. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. Does not influence. Overdose At the recommended mode of topical administration of overdose it was not noted so far. The form of release and packing On 10 ml spill polyethylene in spray bottles. On 1 spray bottle together with the instruction for medical use in the state and Russian languages place in a pack cardboard with control of the first opening. To Store storage conditions at a temperature from 15 wasps up to 25 wasps, in the place protected from light. To store out of children's reach! A period of storage 2 years a drug Period of storage after opening of a bottle - 4 weeks. Not to apply after an expiration date Prescription status Without prescription LeKos LLP Producer, Republic of Kazakhstan 050000, Almaty, Kabangbai St. of the batyr, 114-13, ph.: 308-10-67. The owner of the registration certificate of LeKos LLP, the Republic of Kazakhstan the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine the Republic of Kazakhstan, Almaty region, Karasaysky district, the settlement of Kemertogan, ph.: 308-10-67, mobile phone number: +7 777 788 3809
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