Glossary entry (derived from question below)
Deutsch term or phrase:
Fachinformation
Englisch translation:
summary of product characteristics; package insert
Added to glossary by
Rowan Morrell
Jan 11, 2003 09:31
22 yrs ago
86 viewers *
Deutsch term
Neuseeland
Committed to the Customer
Native in: Englisch (Variant: New Zealand) 
Works in: Französisch > Englisch, Deutsch > Englisch, Spanisch > Englisch
Fachinformation
Deutsch > Englisch
Medizin
Medizin: Pharmazie
Medical Devices Vigilance System
"Verdachtsfälle unerwarteter Nebenwirkungen
"Nebenwirkungen, deren Art, Ausmaß oder Ergebnis von der Zusammenfassung der Erzeugnismerkmale ('Fachinformation) abweicht."
Talking about various kinds of incidents that can be reported with drugs.
"Fachinformation" is the info on the drug bottle, basically. I just can't think of the English word, and incredibly, the dictionaries don't have it. Yet I know there's a simple answer. It won't come to me though. TIA for helping me clear this up. Hopefully it won't take long.
"Nebenwirkungen, deren Art, Ausmaß oder Ergebnis von der Zusammenfassung der Erzeugnismerkmale ('Fachinformation) abweicht."
Talking about various kinds of incidents that can be reported with drugs.
"Fachinformation" is the info on the drug bottle, basically. I just can't think of the English word, and incredibly, the dictionaries don't have it. Yet I know there's a simple answer. It won't come to me though. TIA for helping me clear this up. Hopefully it won't take long.
Proposed translations
(Englisch)
Change log
Nov 24, 2010 16:08: Steffen Walter changed "Field (specific)" from "(none)" to "Medizin: Pharmazie"
Proposed translations
2 Stunden
Jonathan MacKerron
Native in Englisch
Specializes in field
Retired as of Jan 2019!
Native in: Englisch
Works in: Deutsch > Englisch, Französisch > Englisch
Related KudoZ points
:
180
Selected
Additional information
As far as I understand the pharmaceutical industry, the package insert reflects the information of the Summary of Product Characteristics, an official document that is submitted to health authorities by the drug companies. Unfortunately, sometimes the Fachinformation is used to denote both of these documents. Does your context refer directly to the package insert itself or to the specifications laid down in the SmPC?
4 KudoZ points awarded for this answer.
Comment: "I'm giving Jonathan the points not just for the comments in his answer, but for some of his peer grade remarks, which I also found helpful. Lisa's comments were of assistance to me as well, but Jonathan has provided the term "package insert", which seems to be fairly official along with "summary of product characteristics". I think I might use "package insert" for "Fachinformation" on this occasion, although I have noted what both Jonathan and Lisa said about "Fachinformation" referring to both the summary of product characteristics and the package insert. I wish I could give Lisa points as well, but at least I can give her some kudos if not KudoZ! :-) Thank you both for your help, and thanks also to the others, who offered reasonable suggestions as well."
+1
2 Min.
Norbert Hermann
Native in Deutsch
&
Englisch
YOUR COMPETITIVE EDGE - over 40 YEARS!
Native in: Englisch 
, Deutsch
Works in: Englisch > Deutsch, Deutsch > Englisch, Portugiesisch > Deutsch, and 3 more.
Related KudoZ points
:
8
authorative information
maybe
--------------------------------------------------
Note added at 2003-01-11 09:46:49 (GMT)
--------------------------------------------------
specific product information
maybe
--------------------------------------------------
Note added at 2003-01-11 10:58:49 (GMT)
--------------------------------------------------
looking at the other suggestions I would say
(specific) product related information
--------------------------------------------------
Note added at 2003-01-11 09:46:49 (GMT)
--------------------------------------------------
specific product information
maybe
--------------------------------------------------
Note added at 2003-01-11 10:58:49 (GMT)
--------------------------------------------------
looking at the other suggestions I would say
(specific) product related information
Peer comment(s):
| agree |
jerrie
: I must've been googling when you added this! It wasn't there when I was proposing : - ))
33 Min.
|
|
that's alright - no probs - i always guess first, then i google :-)
|
21 Min.
Edith Kelly
Schweiz
Schweiz
Native in Deutsch
&
Englisch
Specializes in field
Schweiz
Professional conference interpreter
Native in: Deutsch , Englisch
Works in: Deutsch > Englisch, Englisch > Deutsch, Niederländisch > Deutsch, and 4 more.
Related KudoZ points
:
286
patient information
on my package of PARALIEF Paracetamol.
by
Clonmel Healthcare Ltd.
The leaflet provides a summary of the information available on your medicine.
by
Clonmel Healthcare Ltd.
The leaflet provides a summary of the information available on your medicine.
Peer comment(s):
| neutral |
Jonathan MacKerron
: known as "package insert" from a pharmaceutical company point of view
2 Stunden
|
+4
31 Min.
product information
This seems to get thousands of Google hits in the context of side effects etc
hth
hth
Peer comment(s):
| agree |
Norbert Hermann
: yours looks quite similar to my suggestion above ;-)
2 Min.
|
|
It is! OK, I'll say 'Patient Product Information'....vive la difference : - ))
|
|
| agree |
Martina Keskintepe
: I like this translation best. Not only 'patients' might want to be informed about this product but others as well.
5 Min.
|
|
Thanks
|
|
| neutral |
Edith Kelly
: I'm not too happy about it as you would have in the above context product properties or whatever followed by (product information) in the above context.
10 Min.
|
| agree |
Olaf
1 Stunde
|
| neutral |
Jonathan MacKerron
: still, "Summary of Product Characteristics" is what the industry and regulatory authorities call it
1 Stunde
|
| agree |
gangels (X)
5 Stunden
|
+1
45 Min.
summary of product characteristics
This is what EC directives use for your German senctence (see link below):
unexpected adverse reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics. But in German "Fachinformation" seems to be the same as "Zusammenfassung der Produkteigenschaften", i.e. "summary of product characteristics". So its more or less redundant. See http://www.pei.de/professionals/remicade_info.htm. With a click on "European Public Assessment Report" you will find more detailed documents. You might leave the brackets out or leave it in German, if it fits into the context.
unexpected adverse reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics. But in German "Fachinformation" seems to be the same as "Zusammenfassung der Produkteigenschaften", i.e. "summary of product characteristics". So its more or less redundant. See http://www.pei.de/professionals/remicade_info.htm. With a click on "European Public Assessment Report" you will find more detailed documents. You might leave the brackets out or leave it in German, if it fits into the context.
Reference:
http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&numdoc=300L0038&lg=EN
Peer comment(s):
| agree |
Jonathan MacKerron
: I think Rowan's context refers to the SmPC, and not to the package insert
1 Stunde
|
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