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indications réglementaires

English translation: labeled indications/legally approved indications / FDA-approved indications (USA)

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:indications réglementaires
English translation:labeled indications/legally approved indications / FDA-approved indications (USA)
Entered by: Piotr Fras
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21:49 Oct 21, 2007
French to English translations [PRO]
Medical - Medical (general)
French term or phrase: indications réglementaires
In this medical context:

http://www.adiph.org/bonusage/INDUCTOS_bon_usage_CHU_0107.pd...
Piotr Fras
Poland
labeled indications / FDA-approved indications (USA)
Explanation:
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...
Selected response from:

Isabelle Berquin
Local time: 12:10
Grading comment
Thanks
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +6labeled indications / FDA-approved indications (USA)
Isabelle Berquin
4 +2legal indications or guidelines
Drmanu49
3prescribed safety guidelines/marksliz askew


Discussion entries: 1





  

Answers


7 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
prescribed safety guidelines/marks


Explanation:
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...

liz askew
United Kingdom
Local time: 17:10
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 2124
Login to enter a peer comment (or grade)

7 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
legal indications or guidelines


Explanation:
More context???

--------------------------------------------------
Note added at 29 mins (2007-10-21 22:18:45 GMT)
--------------------------------------------------

After reading your explanation I would use guidelines or recommendations.

Drmanu49
France
Local time: 18:10
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 3989
Notes to answerer
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 comments on this answer (and responses from the answerer)
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.
Login to enter a peer comment (or grade)

30 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +6
labeled indications / FDA-approved indications (USA)


Explanation:
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...

Isabelle Berquin
Local time: 12:10
Specializes in field
Native speaker of: Native in FrenchFrench
PRO pts in category: 48
Grading comment
Thanks

Peer comments on this answer (and responses from the answerer)
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 day16 hrs
  -> Thanks, Helen!

agree  liz askew: Oh yes! I see, now that the full context has been given.
1 day21 hrs
  -> Thanks, Liz!
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