The instruction for medical use of ИРС® 19 medicine the Trade name ИРС® 19 International unlicensed name Are not present the Dosage form Spray of nasal 20 ml Structure 100 ml of spray lysates of bacteria contain active agents: Streptococcus pneumoniae, type I of 1.11 ml Streptococcus pneumoniae, type II of 1.11 ml Streptococcus pneumoniae, type III of 1.11 ml Streptococcus pneumoniae, type V of 1.11 ml Streptococcus pneumoniae, type VIII of 1.11 ml Streptococcus pneumoniae, type XII of 1.11 ml Haemophilus influenzae, type B of 3.33 ml Klebsiella pneumoniae ss pneumoniae of 6.66 ml Staphylococcus aureus ss aureus of 9.99 ml Acinetobacter calcoaceticus of 3.33 ml Moraxella catarrhalis of 2.22 ml Neisseria subflava of 2.22 ml Neisseria perflava of 2.22 ml Streptococcus pyogenes group A of 1.66 ml Streptococcus dysgalactiae group C of 1.66 ml Enterococcus faecium of 0.83 ml Enterococcus faecalis of 0.83 ml Streptococcus group G of 1.66 ml excipients: glycine of 4.25 g no more than 1.2 mg mertiolit sodium fragrance on the basis of Nerol * 12.50 mg the water purified up to 100 ml * Composition of fragrance on the basis of Nerol: linalol, alpha terpineol, geraniol, methyl antranilat, limonene, geranilatsetat, linalyl acetate, diethylene glycol monoethyl ether, phenylethyl alcohol. The description Transparent colourless or with a yellowish shade liquid with a slight specific smell. Pharmacotherapeutic group Other drugs for treatment of diseases of respiratory organs. The ATX R07AX code the Pharmacological Pharmacokinetics Drug properties works mainly in upper airways. Action begins in 1-2 minutes after introduction and 1.5-2 hours proceed. Now there are no data on the system of absorption of drug. The pharmacodynamics ИРС® 19 increases specific and nonspecific immunity. At dispersion ИРС® 19 fine aerosol which covers a mucous membrane of a nose is formed. It leads to fast development of the local immune response, causing immediate mobilization of protective mechanisms and starting effective products of antibodies. Thanks to complex influence on the immune response of mucous membranes of upper airways ИРС® 19 has double therapeutic effect: medical and preventive. The medical effect is implemented through nonspecific factors of local protection which begin to be developed within 1 hour after use ИРС® 19 Increase in number of antiteloobrazuyushchy cells in a mucous membrane and production of specific immunoglobulins of type A (IgA) begins for 2-4 days, increases medical action and provides preventive effect ИРС® 19 which remains within 3-4 months. Prevention of chronic diseases of upper airways and bronchial tubes treatment of acute and chronic diseases of upper airways and bronchial tubes, such as rhinitis, sinusitis, laryngitis, pharyngitis, tonsillitis, tracheitis, bronchitis recovery of local immunity after the postponed flu and other viral infections preparation for planned surgery on ENT organs and in the postoperative period ИРС® 19 can appoint indications both adults, and children since 6 years. The route of administration and doses use Drug intranazalno by aerosol introduction of 1 dose (1 dose =1 short pressing of a spray). For prevention by the adult and to children since 6 years on 1 dose of drug in each nasal course 2 times a day within 2 weeks (it is recommended to begin a course of treatment in 2-3 weeks prior to the expected rise in incidence). For treatment of acute and chronic diseases of upper airways and bronchial tubes: to children since 6 years and the adult on one dose of drug in each nasal course from 2 to 5 times a day before disappearance of symptoms of an infection For recovery of local immunity to children and adults after the postponed flu and other respiratory viral infections on 1 dose of drug in each nasal course 2 times a day within 2 weeks. By preparation for planned surgery and in the postoperative period to adults and children on 1 dose of drug in each nasal course 2 times a day within 2 weeks (it is recommended to begin a course of treatment in 1 week prior to the planned surgery). Side effects attacks of bronchial asthma and cough a nasopharyngitis, sinusitis, laryngitis, bronchitis nausea, vomiting, an abdominal pain, diarrhea temperature increase (≥ 39 °C) without the visible reasons seldom: reactions of hypersensitivity (urticaria, a Quincke’s disease), skin eritemopodobny and ekzemopodobny reactions in isolated cases: the Werlhof’s disease and a knotty erythema At emergence of the above-stated symptoms is recommended to see a doctor. Contraindications hypersensitivity to drug or its components autoimmune diseases children’s age (up to 6 years) Medicinal interactions Cases of negative interaction with other medicines are unknown. In case of clinical symptoms of a bacterial infection the prescription of antibiotics against the background of the continuing use ИРС® 19 is possible. Special instructions In an initiation of treatment such reactions as the sneezing and strengthenings of discharges from a nose having short-term character can take place. If these reactions accept a heavy course, it is necessary to reduce frequency rate of administration of drug or to cancel it. In case of attacks of bronchial asthma it is recommended to turn treatment and not to accept ИРС® 19 and other drugs on the basis of bacterial lysates in the future. Temperature increase (≥39 °C) is possible, in this case treatment should be cancelled. However it is necessary to distinguish such state from the fervescence which is followed by an indisposition which can be connected with development of diseases of ENT organs. With system clinical signs of a bacterial infection it is necessary to consider expediency of purpose of system antibiotics. Very important! The device correctly functions only under following conditions: Put on a nozzle a bottle, properly establish it and it is soft, without effort press it. Now the device is ready to use. WHEN SPRAYING DRUG it is NECESSARY to KEEP the BOTTLE IN VERTICAL POSITION AND NOT to THROW BACK the HEAD. If you incline a bottle during dispersion, propellant will flow out for several seconds and the device will become useless. At regular use of drug the nozzle is not recommended to be removed. If to leave drug for long time without use, the drop of liquid can evaporate and the formed crystals will cork an exhaust outlet of a nozzle. This phenomenon occurs most often when the nozzle is removed and put in packing by the upper end near a bottle down, previously without having washed out and without having dried it. If the nozzle was corked, press it several times that liquid could pass under the influence of excessive pressure. If it does not help, lower a nozzle for several minutes in warm water. Pregnancy and the period of a lactation is not available sufficient data on potentiality of teratogenic or toxic influence on a fruit during pregnancy. Therefore use of drug during pregnancy is not recommended. Features of influence on ability to run the vehicle and potentially dangerous mechanisms Use ИРС® 19 does not influence the psychomotor functions connected with driving of the car or control of cars and mechanisms. Overdose Cases of overdose are unknown the Form of release and packing Spray nasal on 20 ml in an aerosol can from transparent glass (type III), covered with a protective layer of plastic, being under pressure of nitrogen, with the valve of continuous action, complete with a nozzle from polyethylene of high density of white color. 1 cylinder complete with a nozzle and the instruction for medical use is placed in a cardboard pack. Storage conditions In strictly vertical position at a temperature not above 25 °C. Not to freeze. To store out of children’s reach! To protect from heating over 50 °C and from hit of direct sunlight, not to puncture a bottle, not to burn a bottle even if it is empty. A period of storage 3 years it is impossible to use Drug after the expiry date specified on packing. Prescription status Without prescription the Producer Maylan Leboratories of CAC, France the Legal address: 42, Ruzhe De Lisl St., 92150 Syuren, France production Address: Ruth de Belvill, League di Mayar, 01400, Shatiyon-sur-Shalaron, France Name and country of the owner of the registration certificate of JSC Pharmstandard-Tomskkhimfarm, Russia, 634009, Tomsk, Lenin Ave., 211, ph./fax (3822) 40-28-56 Name and country of the JSC Pharmstandard-Tomskkhimfarm organization packer, Russia, 634009, Tomsk, Lenin Ave., 211, ph./fax (3822) 40-28-56 The address of the organization in the territory of the Republic of Kazakhstan: the accepting claim (offer) on quality of medicines from consumers, responsible for post-registration observation of safety of medicine of Karagandinsky pharmatsevtichesky komplex LLP, 100009, Republic of Kazakhstan, Karaganda, Botanicheskaya St., 12 Ph. / fax: +7 (7212) 437002, Ph. + 7 (7212) 507322 E-mail:
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