scholarly journals Safety of Remdesivir and Tocilizumab in COVID-19 Treatment

2020 ◽  
Vol 8 (3) ◽  
pp. 160-162
Author(s):  
Article Editorial
Keyword(s):  
Adverse Reactions ◽  
Safety Data ◽  
Individual Case ◽  
Federal State ◽  
Symptomatic Therapy ◽  
Medicinal Products ◽  
Treatment Protocols ◽  
Global Database ◽  
Life Threatening ◽  
The Russian Federation

An important part of treating patients infected with SARS-CoV-2 is to ensure effective pathogenetic and symptomatic therapy before life-threatening complications, such as pneumonia, acute respiratory distress syndrome, or sepsis begin to develop. Current COVID-19 treatment protocols often use remdesivir and tocilizumab, though safety data on these drugs are insufficient. Therefore, experts of the Centre for Evaluation of Medicinal Products’ Safety of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation studied adverse reactions to remdesivir and tocilizumab, which are registered in the VigiBase (as of August 27, 2020), the global database of individual case safety reports.

scholarly journals Recommendations for the Contents of the “Glycan Profile” Part of a Product Specification File

2021 ◽  
Vol 11 (4) ◽  
pp. 273-275
Author(s):  
O. A. Vaganova
Keyword(s):  
Test Procedure ◽  
Federal State ◽  
Expert Evaluation ◽  
Medicinal Products ◽  
Active Ingredients ◽  
Glycan Profile ◽  
Additional Information ◽  
Batch Release ◽  
The Russian Federation ◽  
Product Specification

“Glycan Profile” is a necessary part of manufacturers’ product specification files for monoclonal antibody active ingredients or final products and erythropoietin active ingredients. The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products.

Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients

1982 ◽  
Vol 10 (5) ◽  
pp. 306-324 ◽  
Author(s):  
G Bruni ◽  
M Lavezzari ◽  
A Perbellini ◽  
A Battaglia ◽  
A Emanueli
Keyword(s):  
Adverse Reactions ◽  
Phase 1 ◽  
Safety Data ◽  
Intestinal Bleeding ◽  
Clear Cut ◽  
Parenteral Route ◽  
The Third ◽  
Life Threatening ◽  
Laboratory Changes ◽  
Reaction Profile

Safety data on indoprofen are presented, deriving from three sources: the first was a phase 4 multicentre clinical study based on 4042 patients suffering from osteoarthritis and treated with 400–800 mg daily by mouth for about 4 weeks; the second was a survey based on a heterogeneous series of 2722 subjects belonging to phase 1, 2 and 3 investigations, and treated with 200 to 1200 mg daily by the oral and/or parenteral route for from 1 to more than 180 days; the third was a safety laboratory study conducted in 472 patients, most of whom had participated in the first study, while the remainder were included in the second. Adverse events of any type occurred in 22% of patients in the first study and in 13% in the second, but treatment had to be withdrawn for drug-related reasons in less than 5% in both. Potentially life-threatening events were rare, overall including 16 instances of clinically overt gastro-intestinal bleeding and 2 anaphylactic reactions. Unfavourable laboratory changes, i.e. shifting from normal to abnormal values, were recorded in about 10% of the series studied. The adverse reaction profile of indoprofen was similar to that of most NSAIDs, with gastro-intestinal troubles prevailing over the other events, a distribution which, however, was clear-cut only with oral indoprofen. Tolerability problems appeared to be dose-related up to some point between 400 and 600 mg daily plateauing thereafter, and were less frequent following parenteral than following oral administration.

scholarly journals Signal Messages in Pediatric Practice

2018 ◽  
Vol 6 (4) ◽  
pp. 180-186
Author(s):  
G. V. Kutekhova ◽  
E. O. Zhuravleva ◽  
M. A. Darmostukova ◽  
I. I. Snegireva ◽  
N. Yu. Velts ◽  
...  
Keyword(s):  
Weight Gain ◽  
Adverse Reactions ◽  
Control Program ◽  
Individual Case ◽  
Pediatric Practice ◽  
Global Database ◽  
Spontaneous Reports ◽  
Post Marketing ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee

Abstract. Detection and analysis of drug safety signals in children is a mandatory part of pharmacovigilance. The criteria for evaluating signals of adverse effects were considered. Spontaneous reports databases as a source for detecting signaling information about adverse reactions, including in children were used. More than 17.5 million cases of adverse reactions identified in WHO global database of individual case safety reports — VigiBase which was detected since 1968 in 120 countries — members of the WHO Drug Treatment Control Program. Of these, 1.5 million cases of adverse reactions occur in childhood. Objective: search and analysis for signal information in the post-marketing period of the use of drugs in children to increase the safety of pharmacotherapy in pediatric practice. Results: а causal relationship between desloratadine and weight gain was detected. Desloratadine is an active metabolite of loratadine so the researchers have considered reports on desloratadine and also on loratadine. In VigiBase there are reports of weight gain when taking desloratadine (44 messages) and loratadine (115 messages) in 2016. Among them, 22 reports on weight gain in children from 2 to 11 years. The Pharmacovigilance Risk Assessment Committee of the European Medical Agency (PRAC EMA) recommended marketing authorization holders to add an information about weight gain in children in prescribing information of drugs which contains desloratadine and loratadine. In September 2017, the Committee on Drugs for Human Use, following a review and analysis of VigiBase, approved the recommendations of PRAC EMA. Appropriate changes were made to the instructions for medical use for loratadine tablets. Conclusions. These results confirm the importance of long post-marketing studies, the results of which will provide significant assistance in improving the safety of pharmacotherapy in children.

scholarly journals Recommendations for the Contents of the “Peptide Mapping” Part of a Product Specification File

2021 ◽  
Vol 11 (4) ◽  
pp. 276-277
Author(s):  
O. A. Vaganova
Keyword(s):  
Monoclonal Antibodies ◽  
Peptide Mapping ◽  
Test Procedure ◽  
Federal State ◽  
Expert Evaluation ◽  
Medicinal Products ◽  
Additional Information ◽  
Batch Release ◽  
The Russian Federation ◽  
Product Specification

‘Identification. Peptide mapping’ is a necessary part of manufacturers’ product specification files for therapeutic proteins (active ingredients and final products of monoclonal antibodies, filgrastims, erythropoietins). The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products.

MONITORING OF ADVERSE REACTIONS ON MEDICINES IN CHILDREN IN THE RUSSIAN FEDERATION

2017 ◽  
Vol 96 (3) ◽  
pp. 152-159
Author(s):  
A. R. Titova ◽  
◽  
I. L. Asetskaya ◽  
V. A. Polivanov ◽  
S. K. Zyryanov ◽  
...  
Keyword(s):  
Russian Federation ◽  
Adverse Reactions ◽  
The Russian Federation

Evaluating the efficiency of the environmental security policy in the Russian regions

2020 ◽  
Vol 19 (4) ◽  
pp. 633-649
Author(s):  
G.T. Shkiperova ◽  
P.V. Druzhinin
Keyword(s):  
Environmental Policy ◽  
Russian Federation ◽  
Security Policy ◽  
Quantitative Methods ◽  
Federal District ◽  
Environmental Security ◽  
Environmental Indicators ◽  
Federal State ◽  
Environmental Situation ◽  
The Russian Federation

Subject. Considering the existing environmental situation, it becomes especially important for the State to regulate the anthropogenic footprint on the environment in the Russian Federation. Current amendments to the legislative framework for environmental security are intended to ensure the innovative development of regions concurrently with a reduction in adverse environmental effects and more active environmental policy. Objectives. The research is to devise methodological tools to evaluate the efficiency of environmental policy in regions. Methods. The research employs qualitative and quantitative methods of economic analysis, including statistical and content analysis, rating, matrix zoning. The dataset proceeds from the Federal State Statistics Service, governmental reports on the current environmental situation and environmental protection in the Russian Federation. Results. We propose our own approach to evaluating the efficiency of environmental policy. It may help trace the correlation between the quality of strategic documents and changes in environmental indicators for a certain period, flag the challenging areas in terms of the environmental policy implementation and outline possible development paths. The approach extends the list of quantification indicators in line with those ones adopted internationally and presented in the Environmental Security Strategy of the Russian Federation up to 2025. We evaluated the efficiency of the environmental policy referring to the regions of the Northwestern Federal District for the period from 2012–2016. Conclusions. Having analyzed the evaluation results, most of the Northwestern regions tend to be controversial and ambivalent in setting environmental goals and achieving them. The findings may prove useful as the analytical and data basis for articulating the environmental and economic policy of the regions.

THE PRINCIPLES AND ACTIVITIES OF THE NATIONAL SCIENTIFIC DEVELOPMENT STRATEGY IN THE ARCTIC ZONE OF THE RUSSIAN FEDERATION

2017 ◽  
Author(s):  
Mikhail Bubynin ◽  
Mikhail Bubynin ◽  
Valery Abramov ◽  
Valery Abramov ◽  
Gennady Zabolotnikov ◽  
...  
Keyword(s):  
Development Strategy ◽  
Russian Federation ◽  
National Policy ◽  
Scientific Research ◽  
Point Of View ◽  
The Arctic ◽  
Scientific Development ◽  
Federal State ◽  
Arctic Zone ◽  
The Russian Federation

The paper considers the priorities of the state policy of the Russian Federation in the Arctic, from the point of view of the development of scientific research, identified by the main strategic documents of national policy and security in the Arctic zone of the Russian Federation. Measures for implementation of priorities in the development of scientific research in the Arctic can be divided into three main sections: 1. Scientific projects and expeditions in the Arctic; 2. International activities; 3. Coordination and implementation of integrated research in the Arctic. Note that currently the Ministry of education and science of the Russian Federation develops the Analytical Coordination Program “Comprehensive research of the Arctic and Antarctic”, in cooperation with the federal state bodies and Governance of the Subjects of the Arctic zone of the Russian Federation. The mechanism of the Program will ensure coordination between state bodies for integrated scientific researches in the Arctic in the interests of economic and scientific development of the region, and the creation of the scientific, technical and technological reserve in order to ensure of national security in the Arctic zone of the Russian Federation.

Features of The Proceedings on Administrative Offenses Initiated for Violation of Fire Safety Requirements

2019 ◽  
pp. 100-104
Author(s):  
A. K. Sabirova
Keyword(s):  
Russian Federation ◽  
Fire Safety ◽  
Federal State ◽  
Safety Requirements ◽  
Administrative Legislation ◽  
Administrative Punishment ◽  
The Russian Federation ◽  
Administrative Proceedings ◽  
Made In

The article is devoted to the analysis of the features of administrative proceedings instituted for violations of fire safety requirements, including important changes made in the relevant area of the administrative legislation of the Russian Federation, as well as the analysis of the legislative possibility of applying administrative punishment in the form of administrative suspension of activities for non-compliance with the requirements of the federal state firefighters oversight (including named changes).

scholarly journals Case Series of Three Patients with Rifampicin-Induced Thrombocytopenia

2020 ◽  
Author(s):  
Chandramouli M.T
Keyword(s):  
Pulmonary Tuberculosis ◽  
Adverse Reactions ◽  
Rare Complication ◽  
Case Series ◽  
Tuberculosis Treatment ◽  
Effective Drug ◽  
Antitubercular Drugs ◽  
Short Course ◽  
Life Threatening

AbstractLife-threatening adverse reactions of antitubercular drugs are uncommon; however, thrombocytopenia is one such rare complication encountered with rifampicin, isoniazid, ethambutol, and pyrazinamide. Rifampicin is the most effective drug and its use in the tuberculosis treatment led to the emergence of modern and effective short-course regimens. I am reporting case series of three patients with pulmonary tuberculosis presented with rifampicin-induced thrombocytopenia.

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