Glossary entry

German term or phrase:

Fach- und Patienteninformation

English translation:

SPC / PIL

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?
Change log

Jul 27, 2014 07:16: Harald Moelzer (medical-translator) Created KOG entry

Discussion

Lirka (asker) Dec 24, 2009:
I checked with the client and they wanted me to use THEIR versions, not the official EMEA versions, after all.

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...
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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...
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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 ...) ;-)
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!
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