modalités d’utilisation

English translation: (conditions of) use

13:44 Jan 25, 2021
French to English translations [PRO]
Medical - Medical: Pharmaceuticals
French term or phrase: modalités d’utilisation
Court case about a proprietary medicinal product manufactured by a company, AAA.

"- d’appréciation des modalités d’utilisation du médicament, ni estimation du nombre de patients relevant des indications thérapeutiques."

"3° Une appréciation sur les modalités d'utilisation du médicament et notamment sur les durées de traitement, la posologie et les autres indications utiles à une bonne prescription du médicament ; ces modalités sont précisées à l'égard de chacune des indications thérapeutiques proposées ; à l'occasion du renouvellement de l'inscription, les modalités réelles d'utilisation et les indications thérapeutiques constatées sont comparées aux modalités d'utilisation et aux indications thérapeutiques retenues lors des avis précédents ;"

"Si la requérante fait grief à l’avis de n’avoir pas apporté de commentaire particulier quant aux modalités d’utilisation du médicament « en cohérence avec les tailles de conditionnement proposées par AAA », elle ne précise pas en quoi, en l’espèce, ces tailles de conditionnement (boîtes de 25 gélules, au dosage identique) auraient dû en susciter en-dehors de toute exigence réglementaire de principe."

"De sorte que l’allégation selon laquelle la commission n’aurait pas suffisamment apprécié les modalités d’utilisation du médicament manque manifestement en fait."


I'm just wondering what expression occurs to English-language medics: my stab would be "way it is used" (though sometimes this won't quite fit for all the above instances). I'd therefore be inclined to put "actual ways it is used" or "ways it is actually used" for modalités réelles d'utilisation.

Maybe there's a much better medical expression.
Mpoma
United Kingdom
Local time: 21:35
English translation:(conditions of) use
Explanation:
I'd say 'use', quite simply.
Or 'conditions of use', if you prefer.
Selected response from:

Barbara Schmidt, M.A. (X)
Germany
Local time: 22:35
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2(conditions of) use
Barbara Schmidt, M.A. (X)
4Instructions for Use (IFU)
Drmanu49
3administration modes
Patricia Fierro, M. Sc.
3terms of use
liz askew


Discussion entries: 1





  

Answers


12 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
administration modes


Explanation:
Maybe "actual administration modes". When dealing with pharmaceutical products, "administration" is used.

Patricia Fierro, M. Sc.
Ecuador
Local time: 16:35
Native speaker of: Native in SpanishSpanish, Native in EnglishEnglish
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24 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
Instructions for Use (IFU)


Explanation:
www.fda.gov › patients › learn-abo...
Traduire cette page
8 janv. 2018 — Patient Package Inserts (PPI), Medication Guides (MG), and Instructions for Use (IFU) are paper handouts that come with many prescription ...

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Note added at 25 minutes (2021-01-25 14:09:08 GMT)
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FDA Publishes Guidance on Instructions for Use in Patient ...
www.pharmtech.com › view › fda-p...
Traduire cette page
2 juil. 2019 — ... content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination ...

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Note added at 2 heures (2021-01-25 15:56:47 GMT)
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Instructions for use and observance for modalités réelles d'utilisation.

Drmanu49
France
Local time: 22:35
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 1131
Notes to answerer
Asker: Thanks, but are you sure? How does "modalités réelles d'utilisation" work in that case, which concerns the way people are using this medicinal product in the real world...

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3 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
(conditions of) use


Explanation:
I'd say 'use', quite simply.
Or 'conditions of use', if you prefer.

Barbara Schmidt, M.A. (X)
Germany
Local time: 22:35
Works in field
Native speaker of: German
PRO pts in category: 16
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  philgoddard: But I don't agree with "conditions of", which sounds like a legal requirement. You could also say " how the drug is used ".
17 mins
  -> Thank you, Phil!

agree  liz askew: Terms of use?
18 hrs
  -> Thank you, Liz!
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22 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
terms of use


Explanation:

Legal Information On Medicine Manipulation For Health ...www.rosemontpharma.com › health-professionals › leg...
Right medicine is given to the; Right patient, at the; Right time, using the; Right ... The summary of product characteristics defines the terms of use, outlining the ...

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Note added at 22 hrs (2021-01-26 12:28:02 GMT)
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What is the meaning of summary of product characteristics ...nckpharma.com › what-is-the-meaning-of-summary-of...
28 Oct 2014 — A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the ...

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Note added at 22 hrs (2021-01-26 12:31:50 GMT)
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A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively. Abbreviated as SmPC.


so

conditions of use
terms of use
how to use

liz askew
United Kingdom
Local time: 21:35
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 465
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