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SUGGESTIONS FOR PREVENTING UNDESIRED REACTIONS AT APPLICATION IMMUNOBIOLOGICAL MEDICINAL PRODUCTS IN THE RUSSIAN FEDERATION

Abstract

The authors prepared proposals for preventing undesired reactions at application immunobiological medicinal products in the Russian Federation. Given the significant number of osteitis when carrying out vaccination against tuberculosis in a nursing home as BCG and BCG-vaccine, it is proposed to consider with experts of the respective profiles of the question of the possible adjustments in the existing system of prevention of tuberculosis. To ensure timely diagnosis "BCG-ASTIC and destination specific treatment of the disease to carry out consultation with the coordinators of all children under the age of 5 years with a diagnosis of "octet" regardless of the localization of the inflammatory process. When exercising pharmacovigilance for side effects of vaccination against tuberculosis note that unlike bone tuberculosis caused by virulent bacteria, and striking in most cases, the spine, BCG osteitis virtually no this localization, and strike thigh 21, 2% of cases, tibia and fibula - 20%, sternum - 15, 6%, humerus and 11.6%, the bones of the foot is 9, 3%, fin - 8, 5%. It is considered necessary to conduct a complete replacement drugs heterologous sera, especially tetanus toxoid and rabies immunoglobulin from the serum of a horse, on preparations of human serum, as it is implemented in all developed countries. This event will lead to the exclusion of the possibility of allergic reactions of immediate type, including anaphylactic shock, when an emergency prophylaxis of these infections. Registration sterile abscesses after application of drugs DTP vaccine and the absence of such complications after the use of other adsorbed preparations (for example hepatitis In vaccines and vaccine encephalitis) do not exclude the possibility of communication first with the quality of the used sorbent and this allows us to recommend further study and evaluation of physicochemical parameters of the series of sorbent, used in the production of adsorbed vaccine containing the pertussis component.

About the Authors

N. A. Ozeretskovsky
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of the Russian Federation
Russian Federation


K. E. Zatolochina
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of the Russian Federation
Russian Federation


I. I. Snegireva
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of the Russian Federation
Russian Federation


References

1. Harmonization of information on identified in Russia unwanted side reactions with the results of monitoring drug safety, conducted by WHO and other intern ation al organizations: research report (intermediate) / FSBI "SCEEMP" of Ministry of Health of the Russian Federation; Mironov A.N.; Romanov B.K. [et al.]. M., 2013. 189 p. SR № 01201275291. Inv. № DC 643 980 (in Russian).

2. Scientific an alysis of information on adverse drug reactions (ADR) on the use of drugs in medical practice and identify the causes of the NDP, aassociated not only with the properties of drugs themselves, but also with the characteristics of the patient: research report (intermediate). / FSBI "SCEEMP" of Ministry of Health of the Russian Federation; Mironov A.N.; Romanov B.K. [et al.]. M., 2012. 50 p. SR № 01201275291. Inv. № DC 643 970 (in Russian).

3. Vaccine prophylaxis. Monitoring of postvaccin ation complications and their prevention: guidelines MU 3.3.1.1123-02. M .: Federal Center for Sanitary Inspection of Ministry of Health of Russia, 2002. 28 p (in Russian).

4. Immunization of Infectious Diseases. Investigation of post-vaccin ation complications: Guidelines MU 3.3.1879-04. M .: Federal Center for Sanitary Inspection Ministry of Health of Russia, 2004. 13 p (in Russian).

5. Vaccin ation complications (clinical features, diagnosis, treatment, prevention): A guide for practitioners / E.A. Lakotkin a, S.N. Harith, T.V. Chernyaeva [et al.] / Ed. Corresponding member of RAMS, prof. V.V. Ivanova. St. Petersburg: St. Petersburg Medical Information and An alytical Center, 2004. 79 p (in Russian).


Review

For citations:


Ozeretskovsky N.A., Zatolochina K.E., Snegireva I.I. SUGGESTIONS FOR PREVENTING UNDESIRED REACTIONS AT APPLICATION IMMUNOBIOLOGICAL MEDICINAL PRODUCTS IN THE RUSSIAN FEDERATION. Safety and Risk of Pharmacotherapy. 2015;(1):25-29. (In Russ.)

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ISSN 2312-7821 (Print)
ISSN 2619-1164 (Online)