Glossary entry (derived from question below)
German term or phrase:
Fach- und Patienteninformation
English translation:
SPC / PIL
Added to glossary by
Harald Moelzer (medical-translator)
Dec 22, 2009 15:44
14 yrs ago
21 viewers *
German term
Fach- und Patienteninformation [sowie Packungstexte]
German to English
Medical
Medical: Pharmaceuticals
Context: a letter to the authorities confirming that the above pharmaceutical texts have been updated according to the EMEA requirements.
Now, my problems is the following: The client wants me to use the EMEA terminology and at the same time they provided me with some terms I should use. Their terms are as follows:
1. Fachinformation=Information for professionals
2. Patient information- Information for the patients
3. Packungstexts= no proposal
I fear that if I used the above terms, someone [perhaps the proofreader or the final client may end up objecting that that's not EMEA terminology. For Fachinfo I usually use "Summary of Product Characteristics" and for Patient info "Patient information leaflet (PIL)."
What do you think of this? What terms would you use?
Now, my problems is the following: The client wants me to use the EMEA terminology and at the same time they provided me with some terms I should use. Their terms are as follows:
1. Fachinformation=Information for professionals
2. Patient information- Information for the patients
3. Packungstexts= no proposal
I fear that if I used the above terms, someone [perhaps the proofreader or the final client may end up objecting that that's not EMEA terminology. For Fachinfo I usually use "Summary of Product Characteristics" and for Patient info "Patient information leaflet (PIL)."
What do you think of this? What terms would you use?
Proposed translations
(English)
4 | correct... | Harald Moelzer (medical-translator) |
4 | package inserts | Antoinette-M. Sixt Ruth |
4 | (see below!) | MMUlr |
Change log
Jul 27, 2014 07:16: Harald Moelzer (medical-translator) Created KOG entry
Proposed translations
26 mins
Selected
correct...
..according to EMEA
short/alternative names would be:
- prescribing information
- package leaflet/information for the user
- labelling (for text on packages)
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Note added at 28 Min. (2009-12-22 16:13:09 GMT)
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...To make it absolutely clear:
YOUR suggestions are correct!!!
"Summary of Product Characteristics"
"Patient information leaflet (PIL)"
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Note added at 30 Min. (2009-12-22 16:15:03 GMT)
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e.g. see here:
http://www.emea.europa.eu/humandocs/Humans/EPAR/refludan/ref...
4 KudoZ points awarded for this answer.
Comment: "Thanks, Harald!"
11 mins
German term (edited):
Packungstexte
package inserts
I can help you with Packungstexte. The term "package inserts" is used widely by one of my clients (a medical translation agency). Personally, I don't think it is ideal; but they have used it for years.
Note from asker:
Really? I though that Packungstexte refers to the texts that are stamped on the packaging, not the "internal" texts. Package insert is the PIL as far as I know... |
32 mins
(see below!)
terms found in this EMEA document (-> http://www.emea.europa.eu/pdfs/human/pcwp/10997406en.pdf - See page 4)
Fachinformation -> Summary of Product Characteristics (SPC)
Patienteninformation (this is actually *Gebrauchsinformation* in Germany, an insert) -> Package Leaflet (PL)
see also: http://www.eudrac.com/glossary/Summary-of-Product-Characteri...
Wikipedia article: http://de.wikipedia.org/wiki/Zusammenfassung_der_Merkmale_de...
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Note added at 33 mins (2009-12-22 16:18:24 GMT)
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@lirka, just as *you* mentioned above (sorry, I noticed it only now ...) ;-)
Fachinformation -> Summary of Product Characteristics (SPC)
Patienteninformation (this is actually *Gebrauchsinformation* in Germany, an insert) -> Package Leaflet (PL)
see also: http://www.eudrac.com/glossary/Summary-of-Product-Characteri...
Wikipedia article: http://de.wikipedia.org/wiki/Zusammenfassung_der_Merkmale_de...
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Note added at 33 mins (2009-12-22 16:18:24 GMT)
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@lirka, just as *you* mentioned above (sorry, I noticed it only now ...) ;-)
Peer comment(s):
neutral |
Harald Moelzer (medical-translator)
: ...genau, ganz meine Meinung... ;-)
27 mins
|
klar, Harald - s. oben! :-) lirka wird's schon gemerkt haben, dass du eher dran warst!
|
Discussion