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seguridad de uso

English translation: User safety

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:seguridad de uso
English translation:User safety
Entered by: Dr. Andrew Frankland
Options:
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- Include in personal glossary

18:27 Nov 3, 2007
Spanish to English translations [PRO]
Medical - Medical: Pharmaceuticals / expert report
Spanish term or phrase: seguridad de uso
Context: Datos sobre ***seguridad de uso*** y conclusiones incluyendo propuestas para el control de los riesgos incluyendo valoración de la idoneidad de las frases con implicaciones de seguridad incluidas u omitidas en el SPC.

This is from an expert report regarding the licencing of a new antibiotic formulation for use in pigs. My brain has gone completely dead so any suggestions will be much appreciated. Thanks in advance.
Dr. Andrew Frankland
Spain
Local time: 06:08
User safety
Explanation:
Here's section from an Expert Report template used at the company I work at:

PART III.A.5: USER SAFETY

Expert’s comments and conclusions on User Safety:

As this is a generic application, I agree with the applicant when he states that this application is outside the scope of the guideline EMEA/CVMP/543/03-Final, Guideline on user safety for pharmaceutical veterinary medicinal products.

Although no proprietary studies concerning User Safety have been carried out, the applicant submits a brief assessment of each of the following parts:

Exposure during manufacturing: During the handling of raw materials and the manufacturing process, personnel are protected by standard measures including gauze masks, goggles and gloves.
Inherent toxicity of xxx is referred to in part 3.A.3. Moreover, the applicant points out that excipients included in the formula of this product do not have any important inherent toxicity.
Selected response from:

John Cutler
Spain
Local time: 06:08
Grading comment
Despite another answer getting more "agrees", the context of the explanation given here fits perfectly. Many thanks.

PS Any chance you can send me that template you mention?
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +2safety dataRobert Anderson
3 +1use safety
Maria
4User safety
John Cutler
3safety of useNeil Mann


  

Answers


4 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
use safety


Explanation:
one option... the safety involved in using the product.


Maria
Local time: 23:08
Native speaker of: Native in SpanishSpanish
PRO pts in category: 4

Peer comments on this answer (and responses from the answerer)
agree  Maria523
8 days
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13 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
safety of use


Explanation:
how safe it is for use on the pigs

Neil Mann
United States
Local time: 00:08
Native speaker of: English
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31 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
safety data


Explanation:
In keeping with the customary conciseness of such documents, I think you could simply say "Safety data and conclusions...

Robert Anderson
Local time: 22:08
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 12

Peer comments on this answer (and responses from the answerer)
agree  Giovanni Rengifo: This is what they usually call it
24 mins
  -> Thank you, Giovanni.

agree  trnet: Si.
3 hrs
  -> Gracias, trnet.
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1 day1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
User safety


Explanation:
Here's section from an Expert Report template used at the company I work at:

PART III.A.5: USER SAFETY

Expert’s comments and conclusions on User Safety:

As this is a generic application, I agree with the applicant when he states that this application is outside the scope of the guideline EMEA/CVMP/543/03-Final, Guideline on user safety for pharmaceutical veterinary medicinal products.

Although no proprietary studies concerning User Safety have been carried out, the applicant submits a brief assessment of each of the following parts:

Exposure during manufacturing: During the handling of raw materials and the manufacturing process, personnel are protected by standard measures including gauze masks, goggles and gloves.
Inherent toxicity of xxx is referred to in part 3.A.3. Moreover, the applicant points out that excipients included in the formula of this product do not have any important inherent toxicity.


John Cutler
Spain
Local time: 06:08
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 67
Grading comment
Despite another answer getting more "agrees", the context of the explanation given here fits perfectly. Many thanks.

PS Any chance you can send me that template you mention?
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