Glossary entry (derived from question below)
Spanish term or phrase:
fuera de ficha técnica
English translation:
outside the Summary of Product Characteristics / off-label
Added to glossary by
Charles Davis
Dec 3, 2016 12:13
7 yrs ago
23 viewers *
Spanish term
fuera de ficha técnica
Spanish to English
Medical
Medical (general)
Clinical trial of a medicinal product
Hello,
I do not what this means - unauthorised use/off-label use, but wondered how to fit this in with "Summary of Product Characteristics". See context below:
A todos los pacientes se les solicitó firma previa de los consentimientos informados de la aplicación de parche en régimen de hospital de día y firma por parte del paciente del consentimiento para realizar el tratamiento fuera de ficha técnica.
Thank you for any suggestions.
I do not what this means - unauthorised use/off-label use, but wondered how to fit this in with "Summary of Product Characteristics". See context below:
A todos los pacientes se les solicitó firma previa de los consentimientos informados de la aplicación de parche en régimen de hospital de día y firma por parte del paciente del consentimiento para realizar el tratamiento fuera de ficha técnica.
Thank you for any suggestions.
Proposed translations
(English)
Change log
Dec 8, 2016 09:14: Charles Davis Created KOG entry
Proposed translations
+1
1 hr
Selected
outside the Summary of Product Characteristics
I think you can say it like this, Liz.
This is from the UK Dept of Health's Independent Health Care: National Minimum Standards (2002):
"C22.10 Medicines are used as specificed in the Summary of Product Characteristics, unless there is a body of evaluated evidence to support any use outside this licence, in which case patients are informed that the medicine is used outside the Summary of Product Characteristics."
https://books.google.es/books?id=94kU8j_PoScC&pg=PP40&lpg=PP...
"In exceptional circumstances, Non-Medical Prescribers may be authorised to prescribe medicines used outside the Summary of Product Characteristics. This is considered individually."
http://www.boltonft.nhs.uk/wp-content/uploads/2014/12/Medici... (p. 30)
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Note added at 1 hr (2016-12-03 13:29:22 GMT)
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After all, that's what "off-label" actually means (i.e., use for conditions or in ways that do not conform to the SPC), so it's not out of place at all.
This is from the UK Dept of Health's Independent Health Care: National Minimum Standards (2002):
"C22.10 Medicines are used as specificed in the Summary of Product Characteristics, unless there is a body of evaluated evidence to support any use outside this licence, in which case patients are informed that the medicine is used outside the Summary of Product Characteristics."
https://books.google.es/books?id=94kU8j_PoScC&pg=PP40&lpg=PP...
"In exceptional circumstances, Non-Medical Prescribers may be authorised to prescribe medicines used outside the Summary of Product Characteristics. This is considered individually."
http://www.boltonft.nhs.uk/wp-content/uploads/2014/12/Medici... (p. 30)
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Note added at 1 hr (2016-12-03 13:29:22 GMT)
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After all, that's what "off-label" actually means (i.e., use for conditions or in ways that do not conform to the SPC), so it's not out of place at all.
Note from asker:
| This is what I have in my translation too, for the moment. |
4 KudoZ points awarded for this answer.
Comment: "This is what I had put provisionally, so this is what I went with."
+1
1 hr
Muriel Vasconcellos
United States
United States
Native in English
Specializes in field
United States
Each translation a gem!
Native in: English (Variant: US) 
Works in: Spanish to English, Portuguese to English
Related KudoZ points
:
1508
[consent to treatment using an application] not recognized in the ...
I hid my first answer because I didn't understand what you meant about working it in with the Summary of Product Characteristics.
I think addition information is needed to make the idea clear, hence my more lengthy suggestion.
I think addition information is needed to make the idea clear, hence my more lengthy suggestion.
Peer comment(s):
| agree |
Neil Ashby
: I think it's a great solution Muriel, or maybe simply "not specified in the SmPC".
1 day 19 hrs
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Thanks, Neil. I also like "outside the conditions of," recently posted in the Discussion.
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+2
2 hrs
off-label
I am not sure why you would be reluctant to use off-label. After all, a drug's 'label' is just that: the information on its use as specified in the Summary of Product Characteristics.
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Note added at 4 hrs (2016-12-03 17:06:16 GMT)
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Sorry liz, it seems I was not clear enough: off = fuera, (drug) label = ficha técnica/Resumen de las características del producto. You would not need any additional "in the Summary of Product Characteristics", it is implied in "label".
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Note added at 4 hrs (2016-12-03 17:06:16 GMT)
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Sorry liz, it seems I was not clear enough: off = fuera, (drug) label = ficha técnica/Resumen de las características del producto. You would not need any additional "in the Summary of Product Characteristics", it is implied in "label".
Note from asker:
| My point is that "off-label in the Summary of Product Characteristics" doesn't sound right to my ears, Charles' contribution does. |
Peer comment(s):
| agree |
Joseph Tein
: Hi Anne. I agree with you. I think this is the most straightforward way of saying this.
37 mins
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Thank you Joseph :-)
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| agree |
neilmac
: May sound a bit jargony though... (look who's talking)
1 day 6 hrs
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Thanks neilmac – medical jargon it is :-)
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1 day 8 hrs
beyond (the) technical specifications
Boilerplate, maybe too broad in scope?
See Charles for a proper explanation :-)
See Charles for a proper explanation :-)
Discussion
http://ec.europa.eu/health/files/pharmacos/docs/doc2005/10_0...