Елена Матвеева, Автор в Национальный научный центр Фармаконадзора

Hydrochlorothiazide/Spironolactone: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — PSUSA / 00001662/202101

Елена Матвеева2021-11-19T13:48:11+03:00

Given the available data from the literature on acute respiratory toxicity, including acute respiratory distress syndrome, as well as spontaneous reports with some cases of close temporal relationship, positive recall, and given a plausible mechanism of action, PRAC reviews the causal relationship between hydrochlorothiazide/spironolactone and acute respiratory distress syndrome, and medical professionals should be warned [...]

Hydrochlorothiazide/Spironolactone: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — PSUSA / 00001662/202101Елена Матвеева2021-11-19T13:48:11+03:00

Changes were made to the list of activities carried out by the National Center for Expertise of Medicines and Medical Devices

Елена Матвеева2021-11-17T17:36:20+03:00

By Order No. KP DSM-107 of the Minister of Health of the Republic of Kazakhstan dated October 19, 2021, changes were made to the list of activities technologically related to services performed by a subject of state monopoly. According to the new Order, paragraph 4 is added to the following activities: Pharmaceutical inspection for compliance [...]

Changes were made to the list of activities carried out by the National Center for Expertise of Medicines and Medical DevicesЕлена Матвеева2021-11-17T17:36:20+03:00

Pharmacovigilance: on the formation of periodic updated safety reports

Елена Матвеева2021-11-17T17:20:15+03:00

Currently, the development of analytical databases on the Internet makes it possible to determine the relevance of certain keywords. Among others, "pharmacovigilance, cheap" and "full range of pharmacovigilance services" occupy quite high positions. And this is a fairly new trend. So what do users who search for "pharmacovigilance, cheap" or "full-service pharmacovigilance" on Internet search [...]

Pharmacovigilance: on the formation of periodic updated safety reportsЕлена Матвеева2021-11-17T17:20:15+03:00

82.8% of infectious disease beds occupied for patients with COVID-19

Елена Матвеева2021-11-17T17:01:47+03:00

As of the morning of November 9, 82.8% of infectious disease beds for patients with COVID-19 were occupied in Russia, Deputy Prime Minister Tatyana Golikova said at a meeting with President Vladimir Putin. She noted that of particular concern is the continued increase in mortality among patients with coronavirus infection. Currently, there are 301.5 thousand [...]

82.8% of infectious disease beds occupied for patients with COVID-19Елена Матвеева2021-11-17T17:01:47+03:00

Gender peculiarities in the development of adverse reactions of medicinal products

Елена Матвеева2021-11-17T16:58:01+03:00

Matveev A.V., Krasheninnikov A.E., Egorova E.A., Konyaeva E.I., Bekirova E.Yu.National Scientific Center for Pharmacovigilance, S.I. Georgievsky Medical Academy of the Crimean Federal University named after V.I. Vernadsky, Moscow, Simferopol. At the present stage of healthcare development, the study of gender peculiarities of the onset and course of various diseases, as well as the variability [...]

Gender peculiarities in the development of adverse reactions of medicinal productsЕлена Матвеева2021-11-17T16:58:01+03:00

Гендерные особенности развития нежелательных реакций леркарственных

Елена Матвеева2021-11-13T18:26:51+03:00

Матвеев А.В., Крашенинников А.Е., Егорова Е.А., Коняева Е.И., Бекирова Э.Ю.Национальный научный центр фармаконадзора, Медицинская академия им. С.И. Георгиевского Крымского федерального университета им. В.И. Вернадского, Москва, Симферополь На современном этапе развития здравоохранения все боль-шее значение приобретает изучение гендерных особенностей возникновения и протекания различных заболеваний, а также изменчивости фармакологического ответа пациентов разного пола при применении отдельных [...]

Гендерные особенности развития нежелательных реакций леркарственныхЕлена Матвеева2021-11-13T18:26:51+03:00

Lizdexamfetamine dimesylate: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — EMEA / H / N / PSR / S / 0033

Елена Матвеева2021-11-16T20:55:47+03:00

Although the overall study results provide no evidence of increased cardiovascular risk, these overall estimates are derived from the study population, in which most patients had short-term LDX exposure. In an analysis of long-term LDX use, there was a higher estimated risk of MACE among LDX users compared to what was observed in the overall [...]

Lizdexamfetamine dimesylate: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — EMEA / H / N / PSR / S / 0033Елена Матвеева2021-11-16T20:55:47+03:00

Amitriptyline, amitriptyline/amitriptyline oxide, amitriptyline oxide: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — PSUSA / 00010374/202101

Елена Матвеева2021-11-16T20:53:27+03:00

Given the available data on interactions with duloxetine, childhood intoxication, and Brugada syndrome, PRAC considers the causal relationship between amitriptyline, amitriptyline/amitriptylinoxide, amitriptylinoxide and these risks at least a reasonable possibility. PRAC concluded that information about products containing amitriptyline, amitriptyline/amitriptylinoxide, and amitriptylinoxide should be changed accordingly. data source and details

Amitriptyline, amitriptyline/amitriptyline oxide, amitriptyline oxide: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — PSUSA / 00010374/202101Елена Матвеева2021-11-16T20:53:27+03:00

Амитриптилин, амитриптилин/амитриптилиноксид, амитриптилиноксид: CMDh Научные выводы и основания для изменений, поправки к информации о продукте и график внедрения — PSUSA / 00010374/202101

Елена Матвеева2021-11-14T23:18:08+03:00

Принимая во внимание доступные данные о взаимодействии с дулоксетином, детской интоксикации и синдромом Бругада, PRAC рассматривает причинную связь между амитриптилином, амитриптилином / амитриптилиноксидом, амитриптилиноксидом и этими рисками, по крайней мере, разумной возможностью. PRAC пришел к выводу, что информация о продуктах, содержащих амитриптилин, амитриптилин / амитриптилиноксид, амитриптилиноксид, должна быть изменена соответствующим образом. источник данных и подробная [...]

Амитриптилин, амитриптилин/амитриптилиноксид, амитриптилиноксид: CMDh Научные выводы и основания для изменений, поправки к информации о продукте и график внедрения — PSUSA / 00010374/202101Елена Матвеева2021-11-14T23:18:08+03:00

Лиздексамфетамин димезилат: CMDh Научные выводы и основания для изменений, поправки к информации о продукте и график внедрения — EMEA / H / N / PSR / S / 0033

Елена Матвеева2021-11-14T23:16:45+03:00

Хотя общие результаты исследования не предоставляют доказательств повышенного риска сердечно-сосудистых заболеваний, эти общие оценки получены из исследуемой популяции, в которой большинство пациентов имели кратковременное воздействие LDX. При анализе длительного использования LDX был выявлен более высокий оценочный риск MACE среди пользователей LDX по сравнению с тем, что наблюдалось в общей популяции исследования. Акцент на повышенном относительном [...]

Лиздексамфетамин димезилат: CMDh Научные выводы и основания для изменений, поправки к информации о продукте и график внедрения — EMEA / H / N / PSR / S / 0033Елена Матвеева2021-11-14T23:16:45+03:00

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