Apr 16, 2020 04:00
4 yrs ago
17 viewers *
Russian term
Russian Federation
Native Russian speaker
Native in: Russian 
Works in: Russian to English, English to Russian
превышение ожидаемой частоты развития серьезных нежелательных реакций
Russian to English
Medical
Medical: Pharmaceuticals
pharmacovigilance
Срочному предоставлению в течение 15 календарных дней в регуляторные органы подлежит следующая информация по безопасности, которая может свидетельствовать об изменениях в соотношении «польза – риск» лекарственного препарата:
- превышение ожидаемой частоты развития серьезных нежелательных реакций;
- ограничения в распространении лекарственного препарата, отзыв лекарственного препарата с рынка, непродление, аннулирование или приостановка действия регистрационных удостоверений (разрешений на маркетинг) на территориях других государств по причинам, связанным с безопасностью и эффективностью лекарственного препарата;
- [..]
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I'm unsure how to translate "превышение". Exceedance? Sounds quaint.
- превышение ожидаемой частоты развития серьезных нежелательных реакций;
- ограничения в распространении лекарственного препарата, отзыв лекарственного препарата с рынка, непродление, аннулирование или приостановка действия регистрационных удостоверений (разрешений на маркетинг) на территориях других государств по причинам, связанным с безопасностью и эффективностью лекарственного препарата;
- [..]
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I'm unsure how to translate "превышение". Exceedance? Sounds quaint.
Proposed translations
(English)
Proposed translations
+1
4 hrs
Dylan Edwards
United Kingdom
United Kingdom
Native in English
Works in field
United Kingdom
Native in: English (Variant: British) 
Works in: Greek to English, Czech to English, Slovak to English, and 1 more.
Related KudoZ points
:
36
Selected
a higher-than-expected incidence of serious adverse reactions
Myasthenia gravis: a higher than expected incidence in ... - NCBI
www.ncbi.nlm.nih.gov › pubmed
2003 Mar 25;60(6):1024-6. Myasthenia gravis: a higher than expected incidence in the elderly. Aragonès JM(1), Bolíbar I, Bonfill X, Bufill E, Mummany A, Alonso ...
Amyotrophic lateral sclerosis: A higher than expected ... - NCBI
www.ncbi.nlm.nih.gov › pubmed
25 Μαΐ 2016 - Amyotrophic lateral sclerosis: A higher than expected incidence in people ...
Higher-Than-Expected Incidence of Marrow Neoplasms After ...
www.ascopost.com › may-25-2015 › hi...
.. higher-than-expected incidence of marrow neoplasms in patients receiving adjuvant radiation therapy or chemotherapy for breast cancer.1.
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Note added at 4 hrs (2020-04-16 08:59:58 GMT)
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A similar phrase here - "a higher-than-expected rate":
https://abcnews.go.com/Health/SwineFlu/vaccine-experts-urge-...
Nov. 25, 2009— -- A higher-than-expected rate of serious adverse events resulting from a batch of H1N1 vaccine in Canada should be no cause for public alarm, vaccine experts said – adding that these events may be a chance occurrence, and do not necessarily point to safety issues with the new shot.
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Note added at 5 hrs (2020-04-16 09:03:20 GMT)
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"частоты развития", "frequency of development", I take to be equivalent to "frequency of occurrence". With reference to a specific length of time, this is "incidence".
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Note added at 5 hrs (2020-04-16 09:09:11 GMT)
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- and serious adverse reactions are often referred to as SARs.
More about SARs, SAEs etc. here:
https://www.ulh.nhs.uk/content/uploads/2016/10/SOP03_AE_AR_S...
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Note added at 12 hrs (2020-04-16 16:25:52 GMT)
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Serious adverse reaction
An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.
https://www.ema.europa.eu/en/glossary/serious-adverse-reacti...
An SAE that occurs during research with a medicinal product may be a SAR or a SUSAR.
https://english.ccmo.nl/investigators/during-and-after-the-r...
4 KudoZ points awarded for this answer.
Comment: "Thank you!"
10 mins
Ravindra Godbole
India
India
Native in English
Specializes in field
India
Punctuality and Quality
Native in: Marathi , English
Works in: English to Marathi, Marathi to English, English to Hindi, and 3 more.
Related KudoZ points
:
74
increase in expected frequency growth of undesirable serious reactions
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35 mins
Carole Wolfe
United States
United States
Native in English
Specializes in field
United States
Accuracy, Integrity, Promptness
Native in: English (Variant: US)
Works in: Russian to English, Spanish to English, English
Related KudoZ points
:
44
It exceeds the expected frequency growth of undesirable serious reactions;
I cannot think of a suitable noun either.
My solution is to change the grammatical form of the first words of each item in the list. You can use
It + verb: for example, -It exceeds... -It restricts...
Just be sure to parallel this form when you start every item in the list.
My solution is to change the grammatical form of the first words of each item in the list. You can use
It + verb: for example, -It exceeds... -It restricts...
Just be sure to parallel this form when you start every item in the list.
-1
56 mins
Turdimurod Rakhmanov
Kyrgyzstan
Kyrgyzstan
Specializes in field
Kyrgyzstan
Education, Legal, Technical & Medical
Native in: Uzbek (Variants: Tashkent, Ferghana valley, Samarkand-Bukhara, Khorezm) , Kirghiz
Works in: English to Uzbek, English to Kirghiz, English to Kazakh, and 26 more.
Related KudoZ points
:
44
increase in frequency of a serious, but expected adverse reaction
I would use "adverse reaction" rather than "undesirable",
increase in frequency of a serious, but expected adverse reaction
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Note added at 57 mins (2020-04-16 04:57:51 GMT)
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in plural:
adverse reactions
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Note added at 1 hr (2020-04-16 05:13:16 GMT)
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Of course, in Russian expected comes before frequency,
increase in expected frequency of serious adverse reactions might work, but my first version is logically correct and sounds better.
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Note added at 1 hr (2020-04-16 05:33:04 GMT)
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Regulations require that serious, but expected adverse reactions be reported within 15-days (15-days alert reports) to...for
....-increase in frequency of a serious, but expected adverse reaction
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Note added at 1 hr (2020-04-16 05:44:05 GMT)
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Or in this context, the word order:
Regulations require that 15-days alert reports for
....-increase in frequency of a serious, but expected adverse reaction
be submitted to ...
Срочному предоставлению в течение 15 календарных дней в регуляторные органы подлежит следующая информация по безопасности, которая может свидетельствовать об изменениях в соотношении «польза – риск» лекарственного препарата:
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Note added at 1 hr (2020-04-16 05:50:04 GMT)
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be immediately submitted to ...(here control authorities)
increase in frequency of a serious, but expected adverse reaction
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Note added at 57 mins (2020-04-16 04:57:51 GMT)
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in plural:
adverse reactions
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Note added at 1 hr (2020-04-16 05:13:16 GMT)
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Of course, in Russian expected comes before frequency,
increase in expected frequency of serious adverse reactions might work, but my first version is logically correct and sounds better.
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Note added at 1 hr (2020-04-16 05:33:04 GMT)
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Regulations require that serious, but expected adverse reactions be reported within 15-days (15-days alert reports) to...for
....-increase in frequency of a serious, but expected adverse reaction
--------------------------------------------------
Note added at 1 hr (2020-04-16 05:44:05 GMT)
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Or in this context, the word order:
Regulations require that 15-days alert reports for
....-increase in frequency of a serious, but expected adverse reaction
be submitted to ...
Срочному предоставлению в течение 15 календарных дней в регуляторные органы подлежит следующая информация по безопасности, которая может свидетельствовать об изменениях в соотношении «польза – риск» лекарственного препарата:
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Note added at 1 hr (2020-04-16 05:50:04 GMT)
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be immediately submitted to ...(here control authorities)
Peer comment(s):
| disagree |
Boris Shapiro
: Do Google SARs next time you decide to swap things up to make them 'sound better'.
9 hrs
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