KudoZ home » Spanish to English » Medical (general)

fuera de ficha técnica

English translation: outside the Summary of Product Characteristics / off-label

Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs
(or are passionate about them). Participation is free and the site has a strict confidentiality policy.
GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:fuera de ficha técnica
English translation:outside the Summary of Product Characteristics / off-label
Entered by: Charles Davis
Options:
- Contribute to this entry
- Include in personal glossary

12:13 Dec 3, 2016
Spanish to English translations [PRO]
Medical - Medical (general) / Clinical trial of a medicinal product
Spanish term or phrase: fuera de ficha técnica
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.
liz askew
United Kingdom
Local time: 03:26
outside the Summary of Product Characteristics
Explanation:
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)

--------------------------------------------------
Note added at 1 hr (2016-12-03 13:29:22 GMT)
--------------------------------------------------

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.
Selected response from:

Charles Davis
Spain
Local time: 04:26
Grading comment
This is what I had put provisionally, so this is what I went with.
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2off-label
Anne Schulz
4beyond (the) technical specifications
neilmac
3 +1[consent to treatment using an application] not recognized in the ...
Muriel Vasconcellos
3 +1outside the Summary of Product Characteristics
Charles Davis


Discussion entries: 1





  

Answers


1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
outside the Summary of Product Characteristics


Explanation:
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)

--------------------------------------------------
Note added at 1 hr (2016-12-03 13:29:22 GMT)
--------------------------------------------------

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.

Charles Davis
Spain
Local time: 04:26
Native speaker of: Native in EnglishEnglish
PRO pts in category: 664
Grading comment
This is what I had put provisionally, so this is what I went with.
Notes to answerer
Asker: This is what I have in my translation too, for the moment.


Peer comments on this answer (and responses from the answerer)
agree  neilmac
1 day 7 hrs
  -> Cheers, Neil ;)
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
[consent to treatment using an application] not recognized in the ...


Explanation:
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.

Muriel Vasconcellos
United States
Local time: 19:26
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 1342

Peer comments on this answer (and responses from the answerer)
agree  Neil Ashby: I think it's a great solution Muriel, or maybe simply "not specified in the SmPC".
1 day 19 hrs
  -> Thanks, Neil. I also like "outside the conditions of," recently posted in the Discussion.
Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
off-label


Explanation:
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.

--------------------------------------------------
Note added at 4 hrs (2016-12-03 17:06:16 GMT)
--------------------------------------------------

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".



Anne Schulz
Germany
Local time: 04:26
Specializes in field
Native speaker of: German
PRO pts in category: 114
Notes to answerer
Asker: My point is that "off-label in the Summary of Product Characteristics" doesn't sound right to my ears, Charles' contribution does.


Peer comments on this answer (and responses from the answerer)
agree  Joseph Tein: Hi Anne. I agree with you. I think this is the most straightforward way of saying this.
37 mins
  -> Thank you Joseph :-)

agree  neilmac: May sound a bit jargony though... (look who's talking)
1 day 6 hrs
  -> Thanks neilmac – medical jargon it is :-)
Login to enter a peer comment (or grade)

1 day 8 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
beyond (the) technical specifications


Explanation:
Boilerplate, maybe too broad in scope?
See Charles for a proper explanation :-)


    Reference: http://www.linguee.com/english-spanish/translation/beyond+th...
neilmac
Spain
Local time: 04:26
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 574
Login to enter a peer comment (or grade)




Return to KudoZ list


Changes made by editors
Dec 8, 2016 - Changes made by Charles Davis:
Created KOG entryKudoZ term » KOG term


KudoZ™ translation help
The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.



See also:



Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search