Glossary entry

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

Discussion

Piotr Fras (asker) Oct 21, 2007:
More context: 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.

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...
Peer comment(s):

agree Michael Lotz : exactly correct.
46 mins
Thank you, Michael!
agree MatthewLaSon : You got it!
3 hrs
Thank you, Matthew!
agree sktrans
3 hrs
Thanks, sktrans!
agree Diane de Cicco : legally approved indications, yes
9 hrs
Thanks, Diane!
agree Helen Genevier
1 day 16 hrs
Thanks, Helen!
agree liz askew : Oh yes! I see, now that the full context has been given.
1 day 21 hrs
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...
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+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.
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
Thank you DDDC.
agree cjohnstone
10 hrs
Thank you Catherine.
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