ABOUT COMPANY PRODUCTS INSTRUCTIONS ARTICLES CONTACTS VACANCIES We deliver products to any region of Russia! RUS / ENG Products CATALOG ALLERGENS FOOD / HOME. VEGETABLE ALLERGENS DIAGNOSTICS IMMUNOBIOLOGY MEDICINES AND MEDICAL GOODS CULTURE MEDIA TEST SYSTEMS BACTERIAL ALLERGENS SERUMS SSI COMPONENT OF CULTURE MEDIA ORDERING GOODS (PEGASUS PROGRAM) QUALITY DOCUMENTS ON FTP SERVER New items in the catalog TICK-E-VAK TICK-E-VAK LAIS GRASS (BEGINNER COURSE) LAIS GRASS (MAINTENANCE COURSE) LAIS DERMATOPHAGOIDES (INITIAL COURSE) LAIS DERMATOPHAGOIDES (MAINTENANCE COURSE) ULTRIX Home :: Products :: Catalog :: Immunobiology Immunobiology Vaccine for tick-borne encephalitis cultural purified concentrated inactivated dry 1 dose / amp No. 5 + 5 sol. Product code: 7051 Unit of measure: pack. Country: Russia Manufacturer: Chumakov PIPVE Instructions APPROVED Chief State Sanitary Doctor of the Russian Federation G.G. Onishchenko August 22, 2004 No. 01-11 / 18-04 INSTRUCTIONS * on the use of "Tick-borne encephalitis vaccine cultured purified concentrated inactivated dry", lyophilisate for preparing a suspension for intramuscular administration Tick-borne encephalitis vaccine is a lyophilized purified concentrated suspension of tick-borne encephalitis virus (TBE) inactivated by formalin. The viral suspension is obtained by reproduction of the TBE virus in a primary trypsinized chicken embryo cell culture. The active principle of the TBE vaccine is the specific antigen of the TBE virus (strain "Sof'in" or "205"). The CE vaccine is a porous white mass, hygroscopic. One inoculation dose (0.5 ml) of the drug contains: specific antigen of the TBE virus - an active component; donor human albumin - 250 + 50 μg (stabilizer); sucrose - 37.5 + 0.5 mg (stabilizer); gelatin - 5 + 0.5 mg (shaper); bovine serum albumin - no more than 0.5 μg; protamine - sulfate - no more than 5 mcg. The vaccine does not contain formaldehyde, antibiotics or preservatives. The solvent is an aluminum hydroxide gel, a homogeneous suspension of white color without foreign particles (inclusions), which separates into two layers upon settling: a colorless transparent supernatant liquid and a loose white precipitate, which does not give non-developing flakes and conglomerates when shaken. Immunological properties The vaccine stimulates the production of cellular and humoral immunity to the tick-borne encephalitis virus. After two injections of the drug (vaccination course), virus-neutralizing antibodies are detected in at least 90% of the vaccinated. Purpose Specific prophylaxis of tick-borne encephalitis for children from 3 years of age and adults, immunization of donors in order to obtain specific immunoglobulin. Contingents subject to vaccination: The population living in areas enzootic for tick-borne encephalitis, as well as persons arriving in these areas, performing the following work: 1. Agricultural, irrigation and drainage, construction, excavation and movement of pounds, procurement, fishing, geological, exploration, expedition , deratization and disinfestation. 2. Logging, clearing and landscaping of forests, health improvement and recreation areas of the population. 3. Persons working with live cultures of tick-borne encephalitis pathogen. 4. Persons visiting areas endemic for tick-borne encephalitis for the purpose of recreation, tourism, work in summer cottages and garden plots. Method of administration and dosage 1. Prophylactic vaccination. The vaccination course consists of two intramuscular injections of 1 dose (0.5 ml) with an interval of 1-7 months. The vaccination course (two vaccinations) can be carried out throughout the year, including in the summer period (epidemiological season), but no later than 2 weeks before visiting the TBE outbreak. The most optimal is the interval between the first and second vaccinations of 5-7 months (autumn - spring). Revaccination is carried out once in a dose of 0.5 ml 1 year after the completion of the vaccination course. Subsequent remote revaccinations are performed once every three years. Vaccination is carried out with strict adherence to the rules of asepsis and antiseptics. The vaccine is dissolved in the supplied solvent at the rate of 0.5 ml per dose. The ampoule with the solvent is shaken vigorously, the necks of the ampoules are treated with alcohol, opened, the solvent is drawn into a syringe and introduced into the ampoule with a dry vaccine. The contents of the ampoule with the vaccine are intensively mixed for 3 minutes until the vaccine is completely dissolved, drawing it several times into a syringe without foaming. The vaccine should form a homogeneous suspension within 3 minutes when the solvent for the vaccine is added to the ampoule (0.5 ml for 1 dose and 1.0 ml for 2 doses). Before each injection, the contents of the ampoule are stirred, since during settling, the suspension is divided into a colorless transparent supernatant and a loose white precipitate, the inoculation is carried out immediately after the inoculation dose is set into the syringe. The vaccine dissolved in an ampoule cannot be stored. The drug is not suitable in ampoules with impaired integrity, labeling, when foreign inclusions are detected, when the physical properties change (strong deformation of the tablet - a porous white mass becomes translucent and swollen in shape, discoloration, the presence of large unbreakable conglomerates in the solvent after shaking it) , in case of expired shelf life, in violation of the temperature regime of storage or transportation. The drug is injected intramuscularly into the area of the deltoid muscle of the shoulder . The vaccinations carried out are recorded in the established registration forms, indicating the name of the drug, the date of the vaccination, the dose, the batch number, and the reaction to the vaccination. 2. Vaccination of donors. The course of vaccination is two injections of 0.5 ml with an interval of 5-7 months or three injections at doses of 0.5 ml for the first and 1.0 ml for the second and third with an interval of 3-5 weeks between vaccinations. The first scheme provides the best immunization effect. Revaccination - with a dose of 0.5 ml in 6-12 months. The route of administration is similar to the route of administration for prophylactic vaccination. The first blood sampling from donors is carried out 14-30 days after the vaccination course. Injection reactions After the introduction of the vaccine, in some cases, local and general reactions may develop. Local reactions are expressed in redness, swelling, pain at the injection site, and the development of infiltration. A slight increase in regional lymph nodes is possible. The duration of local reactions does not exceed 3 days. General reactions can develop in the first two days after vaccination and are expressed in a rise in temperature, headache, malaise, their duration does not exceed 48 hours. The frequency of reactions with temperatures over 37.5 ° C should not exceed 7%. In extremely rare cases, vaccinations may be accompanied by the development of immediate allergic reactions, in connection with which the vaccinated must be under medical supervision within 30 minutes after vaccination. Vaccination sites should be provided with anti-shock and anti-allergic therapy. Contraindications to use 1. Acute infectious and non-infectious diseases - vaccinations are carried out no earlier than 1 month after recovery. 2. Chronic diseases in the acute stage. 3. Severe allergic reactions in history to food (especially chicken egg protein), drugs, bronchial asthma, systemic connective tissue diseases. 4. Severe reaction (temperature rise above 40 ° C, at the injection site - edema, hyperemia more than 8 cm in diameter) or complication to the previous dose of the vaccine. 5. Pregnancy. When vaccinating donors, the contraindications listed above, as well as contraindications related to the selection of donors, should be taken into account. In each case of a disease that is not included in this list of contraindications, vaccination is carried out with the permission of a doctor, based on the state of health of the vaccinated person and the risk of infection with TBE. In order to identify contraindications, the doctor (paramedic) conducts a survey and examination of the vaccinated person on the day of vaccination with mandatory thermometry. Vaccination against TBE is carried out no earlier than 1 month after vaccination against another infectious disease. It is allowed to vaccinate against TBE at the same time (on the same day) with other vaccinations with inactivated vaccines (except for rabies) of the National calendar of preventive vaccinations and the calendar of preventive vaccinations for epidemic indications. Release form Vaccine 1 dose (0.5 ml) or 2 doses (1.0 ml) in an ampoule. Solvent 0.65 ml in an ampoule for a single-dose vaccine or 1.2 ml in an ampoule for a two-dose vaccine, respectively. Produced in sets. Kit No. 1 consists of 1 ampoule containing 1 dose (0.5 ml) of the vaccine and 1 ampoule containing 0.65 ml of solvent. The pack contains 5 sets. Kit No. 2 consists of 1 ampoule containing 2 doses (1.0 ml) of the vaccine and 1 ampoule containing 1.2 ml of solvent. The pack contains 5 sets. Storage and transportation conditions The drug is stored and transported in accordance with SP 3. 3. 2. 1248-03 at a temperature of 2 to 8 ° C. Do not freeze. Transportation is allowed at temperatures from 9 to 25 ° C for 2 days. Over long distances - only by air. Shelf life Shelf life - 3 years. Complaints for the drug should be sent to the State Research Institute for Standardization and Control of Medical Immunobiological Preparations named after V.I. L. A. Tarasevich of the Ministry of Health of Russia (119002, Moscow, Sivtsev Vrazhek, 41, tel. (095) 241-39-22) and to the address of the manufacturer of the Federal State Unitary Enterprise “Enterprise for the production of bacterial and viral preparations of the Institute of Poliomyelitis and Viral Encephalitis named after ML Chumakova RAMS "(142782, Moscow region, Leninsky district, p / o Institute of Poliomyelitis (tel. (095) 439-90-02). Cases of increased reactogenicity or the development of post-vaccination complications should be reported by phone or telegraph with the subsequent submission of medical documentation Director of the State Institution IPHE named after M.P. Chumakov RAMS Academician of RAMS July 1, 2004 * instead of the Instruction approved on March 17, 2003 by the Ministry of Health of Russia [ back ] Company vacancies We invite you to work: Specialist in registration of medicines and medical devices XIV International Congress "Modern Problems of Immunology, Allergology and Immunopharmacology" From 22 to 24 March 2017, the XIV International Congress "Modern Problems of Immunology, Allergology and Immunopharmacology" will be held in the building of the Moscow Government on Novy Arbat Happy New Year, kids! We gave the children warm clothes and shoes. The new version of the Charter and the new name of the Company A new edition of the Charter of JSC "Trading House Allergen" was registered Научно-практическая конференция с международным участием "Ринит, синусит, астма: высокие технологии в диагностике и лечении" 8 апреля 2016 г. в Москве состоялась Научно-практическая конференция с международным участием "Ринит, синусит, астма: высокие технологии в диагностике и лечении". VIII Ежегодный всероссийский конгресс по инфекционным болезням с международным участием. 28 - 30 марта 2016 г. в Москве проходил VIII Ежегодный Всероссийский Конгресс по инфекционным болезням с международным участием. Conference "Allergology and Immunology: Clinical Recommendations in a Doctor's Practice" On February 25-26, 2016, the All-Russian Conference "Allergology and Immunology: Clinical Recommendations in a Doctor's Practice" was held in Moscow . News archive Actual Advertising Our Facebook page Individuals can purchase our products by prior arrangement. 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