May 14 08:28
17 days ago
18 viewers *
Italiano term
PM sosp
Da Italiano a Inglese
Medico/Sanitario
Medicina: Strumentazione
infusion
Durante infusione di PM sosp comparsa di fastidio, dolore in sede di somministrazione per stravaso di PM sosp, per problema di dispositivo medico PICC Port - sospetta lesione/ rottura
Proposed translations
(Inglese)
| 4 +3 | suspected medicinal product |
Emily Gilby
|
References
| https://www.gmp-compliance.org/gmp-news/... |
JudyC
|
Proposed translations
+3
4 min
Emily Gilby
Regno Unito
Regno Unito
Native in Inglese
Specializes in field
Regno Unito
Medical translator, 9 years' experience
Native in: Inglese (Variants: Wales / Welsh, British, Scottish, UK) 
Works in: Da Francese a Inglese, Da Italiano a Inglese, Inglese
Related KudoZ points
:
4
Selected
suspected medicinal product
PM sosp = prodotto medicinale sospetto = suspected medicinal product
"I farmaci sospetti sono quei medicinali assunti dal paziente e sospettati dal segnalatore di avere determinato la reazione avversa."
The medicinal product suspected of having caused an adverse reaction.
--------------------------------------------------
Note added at 2 hrs (2024-05-14 10:34:14 GMT)
--------------------------------------------------
Page 19 - https://www.ulh.nhs.uk/wp-content/uploads/2016/10/SOP03_AE_A...
--------------------------------------------------
Note added at 2 hrs (2024-05-14 10:35:04 GMT)
--------------------------------------------------
https://www.ema.europa.eu/en/documents/regulatory-procedural...
"I farmaci sospetti sono quei medicinali assunti dal paziente e sospettati dal segnalatore di avere determinato la reazione avversa."
The medicinal product suspected of having caused an adverse reaction.
--------------------------------------------------
Note added at 2 hrs (2024-05-14 10:34:14 GMT)
--------------------------------------------------
Page 19 - https://www.ulh.nhs.uk/wp-content/uploads/2016/10/SOP03_AE_A...
--------------------------------------------------
Note added at 2 hrs (2024-05-14 10:35:04 GMT)
--------------------------------------------------
https://www.ema.europa.eu/en/documents/regulatory-procedural...
4 KudoZ points awarded for this answer.
Comment: "thanks"
Reference comments
2 ore
Reference:
https://www.gmp-compliance.org/gmp-news/new-fda-guidance-whe...
https://www.tracelink.com/resources/resource-center/dscsa-20...
ema:
urly.it/3_yj6
--------------------------------------------------
Note added at 6 ore (2024-05-14 14:59:53 GMT)
--------------------------------------------------
The previous EMA link doesn't work - try this one:
https://www.ema.europa.eu/en/documents/scientific-guideline/...
where you'll find:
3. Minimum criteria for reporting
Information for final description and evaluation of a case report may not be available within the required time frames for reporting outlined above. Nevertheless, for regulatory purposes, initial reports should be submitted within the prescribed time as long as the following minimum criteria are met: an identifiable patient; a suspect medicinal product; an identifiable reporting source; and an event or outcome that can be identified as serious and unexpected, and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. Follow-up information should be actively sought and submitted as it becomes available.
https://www.tracelink.com/resources/resource-center/dscsa-20...
ema:
urly.it/3_yj6
--------------------------------------------------
Note added at 6 ore (2024-05-14 14:59:53 GMT)
--------------------------------------------------
The previous EMA link doesn't work - try this one:
https://www.ema.europa.eu/en/documents/scientific-guideline/...
where you'll find:
3. Minimum criteria for reporting
Information for final description and evaluation of a case report may not be available within the required time frames for reporting outlined above. Nevertheless, for regulatory purposes, initial reports should be submitted within the prescribed time as long as the following minimum criteria are met: an identifiable patient; a suspect medicinal product; an identifiable reporting source; and an event or outcome that can be identified as serious and unexpected, and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. Follow-up information should be actively sought and submitted as it becomes available.
Something went wrong...