Glossary entry (derived from question below)
French term or phrase:
hors cadre
English translation:
off-label use
Added to glossary by
Louise Etheridge
Sep 10, 2015 12:25
9 yrs ago
11 viewers *
French term
hors cadre
French to English
Medical
Medical (general)
Information leaflet
The above terms appears several times throughout an information leaflet for a medicinal product.
Here are a couple of examples:
C’est un usage hors cadre pour lequel la prescription reste à la discrétion du praticien hospitalier.
L’usage en onco-pédiatrie relève d'une utilisation hors cadre de l'X.
While I realise that the general meaning is about a 'use beyond the the scope of/outside the context of', I wondered whether there was a more specific set term in the medical field?
Many thanks.
Here are a couple of examples:
C’est un usage hors cadre pour lequel la prescription reste à la discrétion du praticien hospitalier.
L’usage en onco-pédiatrie relève d'une utilisation hors cadre de l'X.
While I realise that the general meaning is about a 'use beyond the the scope of/outside the context of', I wondered whether there was a more specific set term in the medical field?
Many thanks.
Proposed translations
(English)
| 4 +1 | off-label use |
liz askew
|
| 4 | exceptional |
kashew
|
Proposed translations
+1
22 mins
Selected
off-label use
Médicaments - Pharmacie des hôpitaux universitaires de ...
pharmacie.hug-ge.ch/ens/.../cf_util_hors_indic_2004....
Translate this page
25 Mar 2004 - UTILISATION HORS INDICATION DES ... hors indication. Prescription en dehors du cadre de l'AMM ... manner in which a physician may use an approved drug. Once a ... unapproved » or, more precisely, « unlabeled » uses ...
Cadre Noir - Wikipedia, the free encyclopedia
https://en.wikipedia.org/wiki/Cadre_Noir
Today, there are about 50 horses and a team of elite riders, usually limited to 22. ... The Cadre Noir mainly uses Thoroughbreds, Anglo-Arabians, Hanoverians ...
English - John Libbey Eurotext
www.jle.com/en/.../jpc/...hors.../article.phtml?... - Translate this page
Les prescriptions hors AMM, c'est-à-dire ne respectant pas une ou plusieurs ... termes unlabeled use, off-label use, out of label use, usage outside of labeling pour ... milieu hospitalier dans le cadre de patients ambulatoires [25, 77, 78, 85, 93].
--------------------------------------------------
Note added at 23 mins (2015-09-10 12:49:16 GMT)
--------------------------------------------------
Updated Physician's Guide to the Off-label Uses of Oral ...
www.ncbi.nlm.nih.gov/pubmed/24765227
by SB Nickle - 2014 - Cited by 2 - Related articles
J Clin Aesthet Dermatol. 2014 Apr;7(4):22-34. Updated Physician's Guide to the Off-label Uses of Oral Isotretinoin. Nickle SB(1), Peterson N(2), Peterson M(3).
[PDF]Position Statement - Isotretinoin - American Academy of ...
https://www.aad.org/forms/policies/uploads/ps/ps-isotretinoi...
The Association is committed to the safe and responsible use of isotretinoin. ... use of isotretinoin in such off-label indications should make the patient aware that ...
--------------------------------------------------
Note added at 24 mins (2015-09-10 12:50:30 GMT)
--------------------------------------------------
http://www.leem.org/sites/default/files/CP-Efpia-RTU-vFran-9...
L’Assemblée nationale a voté hier, mardi 8 juillet 2014, son projet de loi de Sécurité Sociale rectificatif, qui pourrait autoriser
les médecins à prescrire des médicaments hors du cadre des indications de leur AMM, même dans le cas où il existe sur le
marché un médicament disponible dans ces indications. Ce projet de loi doit passer en deuxième lecture au Sénat et
probablement devant le Conseil constitutionnel.
--------------------------------------------------
Note added at 26 mins (2015-09-10 12:52:20 GMT)
--------------------------------------------------
OR
indications outside the scope of marketing authorisation
Guide to EU Pharmaceutical Regulatory Law
https://books.google.co.uk/books?isbn=904112845X
Sally Shorthose - 2010 - Law
If the Marketing Authorisation application has alreadybeen granted, ... apply for a separate Marketing Authorisation for indications outside the scope of the ODR.
--------------------------------------------------
Note added at 27 mins (2015-09-10 12:53:42 GMT)
--------------------------------------------------
hors cadre - WordReference.com
www.wordreference.com/fren/hors cadre
Forums pour discuter de hors cadre, voir ses formes composées, des exemples et ... hors cadre, outside the framework, outside the context, beyond the scope ...
--------------------------------------------------
Note added at 28 mins (2015-09-10 12:54:24 GMT)
--------------------------------------------------
Off-Label Use - MeSH Result
www.ncbi.nlm.nih.gov/mesh?term=Off-Label Use
1: Off-Label Use The practice of prescribing or using a drug outside the scope of the ... Entry Terms: Off Label Use Off-Label Uses Use, Off-Label Uses, Off-Label ...
pharmacie.hug-ge.ch/ens/.../cf_util_hors_indic_2004....
Translate this page
25 Mar 2004 - UTILISATION HORS INDICATION DES ... hors indication. Prescription en dehors du cadre de l'AMM ... manner in which a physician may use an approved drug. Once a ... unapproved » or, more precisely, « unlabeled » uses ...
Cadre Noir - Wikipedia, the free encyclopedia
https://en.wikipedia.org/wiki/Cadre_Noir
Today, there are about 50 horses and a team of elite riders, usually limited to 22. ... The Cadre Noir mainly uses Thoroughbreds, Anglo-Arabians, Hanoverians ...
English - John Libbey Eurotext
www.jle.com/en/.../jpc/...hors.../article.phtml?... - Translate this page
Les prescriptions hors AMM, c'est-à-dire ne respectant pas une ou plusieurs ... termes unlabeled use, off-label use, out of label use, usage outside of labeling pour ... milieu hospitalier dans le cadre de patients ambulatoires [25, 77, 78, 85, 93].
--------------------------------------------------
Note added at 23 mins (2015-09-10 12:49:16 GMT)
--------------------------------------------------
Updated Physician's Guide to the Off-label Uses of Oral ...
www.ncbi.nlm.nih.gov/pubmed/24765227
by SB Nickle - 2014 - Cited by 2 - Related articles
J Clin Aesthet Dermatol. 2014 Apr;7(4):22-34. Updated Physician's Guide to the Off-label Uses of Oral Isotretinoin. Nickle SB(1), Peterson N(2), Peterson M(3).
[PDF]Position Statement - Isotretinoin - American Academy of ...
https://www.aad.org/forms/policies/uploads/ps/ps-isotretinoi...
The Association is committed to the safe and responsible use of isotretinoin. ... use of isotretinoin in such off-label indications should make the patient aware that ...
--------------------------------------------------
Note added at 24 mins (2015-09-10 12:50:30 GMT)
--------------------------------------------------
http://www.leem.org/sites/default/files/CP-Efpia-RTU-vFran-9...
L’Assemblée nationale a voté hier, mardi 8 juillet 2014, son projet de loi de Sécurité Sociale rectificatif, qui pourrait autoriser
les médecins à prescrire des médicaments hors du cadre des indications de leur AMM, même dans le cas où il existe sur le
marché un médicament disponible dans ces indications. Ce projet de loi doit passer en deuxième lecture au Sénat et
probablement devant le Conseil constitutionnel.
--------------------------------------------------
Note added at 26 mins (2015-09-10 12:52:20 GMT)
--------------------------------------------------
OR
indications outside the scope of marketing authorisation
Guide to EU Pharmaceutical Regulatory Law
https://books.google.co.uk/books?isbn=904112845X
Sally Shorthose - 2010 - Law
If the Marketing Authorisation application has alreadybeen granted, ... apply for a separate Marketing Authorisation for indications outside the scope of the ODR.
--------------------------------------------------
Note added at 27 mins (2015-09-10 12:53:42 GMT)
--------------------------------------------------
hors cadre - WordReference.com
www.wordreference.com/fren/hors cadre
Forums pour discuter de hors cadre, voir ses formes composées, des exemples et ... hors cadre, outside the framework, outside the context, beyond the scope ...
--------------------------------------------------
Note added at 28 mins (2015-09-10 12:54:24 GMT)
--------------------------------------------------
Off-Label Use - MeSH Result
www.ncbi.nlm.nih.gov/mesh?term=Off-Label Use
1: Off-Label Use The practice of prescribing or using a drug outside the scope of the ... Entry Terms: Off Label Use Off-Label Uses Use, Off-Label Uses, Off-Label ...
Note from asker:
| Thanks for your answer Liz, that sounds right! |
Peer comment(s):
| agree |
Charles Davis
: Yes, this is the term. (In Spanish, "fuera de ficha técnica", but they often seem to use the English term "off-label").
28 mins
|
|
Thank you!
|
4 KudoZ points awarded for this answer.
Comment: "Many thanks again Liz!"
16 mins
exceptional
Non-standard
Note from asker:
| Thanks for your answer Kashew! |
Discussion
En général, on parle d’une prescription «hors AMM», «hors notice», «hors cadre réglementaire » ou «off-label» lorsqu’un médicament autorisé est utilisé en dehors des indications validées et énoncées dans la notice"
http://www.synopsys.be/opendocs/Neuron FR extern/Prescriptio...