Glossary entry (derived from question below)
French term or phrase:
indications réglementaires
English translation:
labeled indications/legally approved indications / FDA-approved indications (USA)
Added to glossary by
Piotr Fras
Oct 21, 2007 21:49
16 yrs ago
6 viewers *
French term
indications réglementaires
French to English
Medical
Medical (general)
Proposed translations
(English)
4 +6 | labeled indications / FDA-approved indications (USA) | Isabelle Berquin |
4 +2 | legal indications or guidelines | Drmanu49 |
3 | prescribed safety guidelines/marks | liz askew |
Proposed translations
+6
30 mins
Selected
labeled indications / FDA-approved indications (USA)
Is your target audience in the US? If so, I would use FDA-approved indications (as opposed to off-label indication). See web site extract below:
In medical terminology, an "indication" for a drug refers to the use of that drug for treating a particular disease. For example, diabetes is an indication for insulin. Another way of stating this relationship is that insulin is indicated for the treatment of diabetes. Drugs often have more than one indication, which means that there is more than one disease for which it is used. The Food and Drug Administration (FDA) classifies indications for drugs in the United States. Indications for drugs can be classified in two categories:
FDA-approved, also called labeled indications, and
Non FDA-approved, also called off-label indications.
If the FDA determines that there is enough evidence to approve the drug for the indication (treatment of the disease), the indication becomes a labeled indication for the drug. The approval by the FDA means that the company can include the information in their package insert (product label) regarding the use of the drug for that indication.
Once a drug has been approved by the FDA for an indication and then marketed for that indication, physicians are allowed to prescribe the drug for any other indication (treatment for other diseases or conditions) if there is reasonable scientific evidence that the drug is effective for that indication. These uses that have not been approved by the FDA are the off-label indications.
http://www.medicinenet.com/script/main/art.asp?articlekey=20...
In medical terminology, an "indication" for a drug refers to the use of that drug for treating a particular disease. For example, diabetes is an indication for insulin. Another way of stating this relationship is that insulin is indicated for the treatment of diabetes. Drugs often have more than one indication, which means that there is more than one disease for which it is used. The Food and Drug Administration (FDA) classifies indications for drugs in the United States. Indications for drugs can be classified in two categories:
FDA-approved, also called labeled indications, and
Non FDA-approved, also called off-label indications.
If the FDA determines that there is enough evidence to approve the drug for the indication (treatment of the disease), the indication becomes a labeled indication for the drug. The approval by the FDA means that the company can include the information in their package insert (product label) regarding the use of the drug for that indication.
Once a drug has been approved by the FDA for an indication and then marketed for that indication, physicians are allowed to prescribe the drug for any other indication (treatment for other diseases or conditions) if there is reasonable scientific evidence that the drug is effective for that indication. These uses that have not been approved by the FDA are the off-label indications.
http://www.medicinenet.com/script/main/art.asp?articlekey=20...
Peer comment(s):
agree |
Michael Lotz
: exactly correct.
46 mins
|
Thank you, Michael!
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agree |
MatthewLaSon
: You got it!
3 hrs
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Thank you, Matthew!
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agree |
sktrans
3 hrs
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Thanks, sktrans!
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agree |
Diane de Cicco
: legally approved indications, yes
9 hrs
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Thanks, Diane!
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agree |
Helen Genevier
1 day 16 hrs
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Thanks, Helen!
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agree |
liz askew
: Oh yes! I see, now that the full context has been given.
1 day 21 hrs
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Thanks, Liz!
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4 KudoZ points awarded for this answer.
Comment: "Thanks"
7 mins
prescribed safety guidelines/marks
I was unable to open your site, but found the latter on a Canadian site:
http://64.233.183.104/search?q=cache:aGfWG5j4kAgJ:www.gov.yk...
http://64.233.183.104/search?q=cache:aGfWG5j4kAgJ:www.gov.yk...
+2
7 mins
legal indications or guidelines
More context???
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Note added at 29 mins (2007-10-21 22:18:45 GMT)
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After reading your explanation I would use guidelines or recommendations.
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Note added at 29 mins (2007-10-21 22:18:45 GMT)
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After reading your explanation I would use guidelines or recommendations.
Note from asker:
RECOMMANDATIONS DE BON USAGE GROUPE I : Indications réglementaires · Ce médicament est indiqué dans le traitement des fractures du tibia chez l'adulte, en tant que complément au traitement standard comprenant la réduction de la fracture ouverte et la fixation par enclouage centromédullaire. |
Peer comment(s):
agree |
Diane de Cicco
: legally approved indications, yes. the answere lies between yours and Isabelle's, I think
10 hrs
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Thank you DDDC.
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agree |
cjohnstone
10 hrs
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Thank you Catherine.
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Discussion
· Ce médicament est indiqué dans le traitement des fractures du tibia chez l'adulte, en tant que complément au traitement standard comprenant la réduction de la fracture ouverte et la fixation par enclouage centromédullaire.