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Glossary entry

Dutch term or phrase:

bijsluiterteksten

English translation:

patient information leaflet texts (EU) package insert texts (USA)

Added to glossary by Textpertise
Sep 2, 2013 12:25
10 yrs ago
3 viewers *
Dutch term

bijsluiterteksten

Dutch to English Medical Medical (general)
It is about a text giving the right to a medicine to be sold in a country.

here the sentence :

De bijsluiterteksten, die in een andere taal dan de Nederlandse zijn opgesteld, moeten een juiste en voledige vertaling van de Nederlandse tekst omvatten

Thanks
Proposed translations (English)
4 +4 patient information leaflet texts
4 +3 package insert text
References
in a legal context but medical terminology
Change log

Sep 2, 2013 12:41: writeaway changed "Field" from "Law/Patents" to "Medical" , "Field (specific)" from "Law (general)" to "Medical (general)"

Sep 9, 2013 13:01: Textpertise Created KOG entry

Sep 9, 2013 13:02: Textpertise changed "Edited KOG entry" from "<a href="/profile/924884">Textpertise's</a> old entry - "bijsluiterteksten"" to ""patient information leaflet texts (EU) package insert text (USA)""

Discussion

Barend van Zadelhoff Sep 2, 2013:
It seems to me just obvious that this phrase Bij deze vergunning voor parallelinvoer worden de bijsluiterteksten gevoegd, zoals die bij de vergunning werden aanvaard. De bijsluiterteksten, die in een andere taal dan de Nederlandse zijn opgesteld, moeten een juiste en volledige vertaling van de Nederlandse tekst omvatten.

applies to both human medicines and veterinary medicines.

The fact that writeaway mentions 'diergeneesmiddel' is just because of the document he clicked on.

You should have a look here as well: http://tinyurl.com/p2udxuk
Michael Beijer Sep 2, 2013:
@Isabelle: Are we perhaps talking about veterinary medicine here?
Michael Beijer Sep 2, 2013:
@Textpertise I have changed my answer to 'package leaflet', as we are apparently dealing with veterinary medicine.
Textpertise Sep 2, 2013:
Haven't got time to investigate this now Michael, I am not ignoring you. Just don't have time to investigate this now. To the best of my recollection, having worked both sides of the pond, it is called the same there too but I would need to check this and I simply don't have the time to do it right now. I am not saying that yours is wrong and it may very well be that this is EU/UK only. I cannot yet say.
Michael Beijer Sep 2, 2013:
from http://en.wikipedia.org/wiki/Package_insert: ‘In addition to the obvious use of inclusion with medications, package inserts have been used or provided in other forms. In the United States, the package inserts for thousands of prescription medicines are compiled into a reference book called the Physicians' Desk Reference, better known as the PDR. South Africa has taken the initiative of making all package inserts available electronically via the internet, listed by trade name, generic name, and classification, and Canada is working on a similar capability. The UK-based electronic Medicines Compendium provides freely-available online access to both Patient Information Leaflets (intended for consumers) and Summary of Product Characteristics (aimed at healthcare professionals) for products available in the UK.’

Would these 'Patient Information Leaflets', aimed at consumers, then correspond to 'consumer information leaflet' (listed in my answer)?
Michael Beijer Sep 2, 2013:
PIL = European version of the 'Package insert'? The Wikipedia article says:

PIL is the European version of the Package insert. The PIL is written by the manufacturing pharmaceutical company and is a patient friendly version of the Summary of Product Characteristics. All licenced medicines need to carry such a leaflet. There are guidelines that must be followed for producing this document, drawn up by the European Medicines Agency of the EU.

I have no medical training, so I wonder what a 'package insert' is then. Would this be a PIL, but then for countries outside of the EU? What about the UK? Is the UK covered by the EMA?
Michael Beijer Sep 2, 2013:
@Textpertise: So are you saying that:

package insert text,
information insert text,
text of the information insert, or
text of the package insert

are all wrong here, and that it should be: 'patient information leaflet texts'?
Barend van Zadelhoff Sep 2, 2013:
Textpertise I see in Michael's reference:

A package insert or prescribing information (in Europe, Patient information leaflet for human medicines or Package Leaflet for veterinary medicines) is a document provided along with a prescription medication to provide additional information about that drug.

http://en.wikipedia.org/wiki/Package_insert
Textpertise Sep 2, 2013:
You cannot market a medicine without legalities The whole field of pharmacology is about compliance with legal requirements. The two are inextricably related.
Isabelle Barth-O'Neill (asker) Sep 2, 2013:
Thank.
In fact I put my question as a law question, because the document is giving the rights and the rules for the said-medicines to be sold in such a country.
Textpertise Sep 2, 2013:
But you are dealing with a medicine In the industry which supplies medicines, a bijsluiter is called a patient information leaflet.
Isabelle Barth-O'Neill (asker) Sep 2, 2013:
I am looking for a law term and not a medical term
Thank
Isabelle Barth-O'Neill (asker) Sep 2, 2013:
My text is a law document and not a medical document
Thank

Proposed translations

+4
33 mins
Selected

patient information leaflet texts

In a medical and pharmacological context, a "bijsluiter" is called a "patient information leaflet", often abbreviated as PIL. See for example http://www.bad.org.uk/site/792/default.aspx
You will be able to find countless other examples.
Peer comment(s):
agree writeaway : yes. absolutely. this is what it is.
11 mins
neutral Michael Beijer : this would seem to be correct (for the EU and UK), but not for the US? (or am I wrong?) ~~~ I have changed my answer to 'package leaflet', as we are apparently dealing with veterinary medicine.
1 hr
agree 11thmuse
1 hr
agree Marijke Singer
3 hrs
agree Anne Schulz : also used as an "official" technical term in Europe (besides "package leaflet")
3 hrs
Something went wrong...
4 KudoZ points awarded for this answer.
+3
6 mins

package insert text

or information insert text, text of the information insert/package insert, etc.

--------------------------------------------------
Note added at 8 mins (2013-09-02 12:34:00 GMT)
--------------------------------------------------

Groot Woordenboek Industrie & Techniek (GWIT): bijsluiter = package insert, information insert, prescribing information

Onroerend Goed Lexicon : bijsluiter = package insert, package leaflet, instruction leaflet, consumer information leaflet

--------------------------------------------------
Note added at 1 hr (2013-09-02 14:24:29 GMT)
--------------------------------------------------

✪✪✪✪ I wish to change my answer to 'package leaflet', as we are apparently dealing with veterinary medicine.

See, e.g.:

'A package insert or prescribing information (in Europe, Patient information leaflet for human medicines or Package Leaflet for veterinary medicines) is a document provided along with a prescription medication to provide additional information about that drug.' (http://en.wikipedia.org/wiki/Package_insert )
Reference:

http://en.wikipedia.org/wiki/Package_insert

http://nl.wikipedia.org/wiki/Bijsluiter

Peer comment(s):
agree freekfluweel : wel handig om te weten wat je vertaalt ;-)
1 min
Bedankt!
agree Barend van Zadelhoff : medical: PIL = Patient Information Leaflet
24 mins
Thanks Barend! I am a little puzzled though. Is the term 'PIL' preferred in a medical context, or just in a European/UK context (but not in the US)? ~~~ I have changed my answer to 'package leaflet', as we are apparently dealing with veterinary medicine.
agree Anne Schulz : "package leaflet" for human medicines as well (see templates on EMA website)
3 hrs
Thanks Anne!
Something went wrong...

Reference comments

1 hr
Reference:

in a legal context but medical terminology

Het invoeren van dit geneesmiddel is afhankelijk gesteld van volgende voorwaarden:

Bij deze vergunning voor parallelinvoer worden de bijsluiterteksten gevoegd, zoals die bij de vergunning werden aanvaard. De bijsluiterteksten, die in een andere taal dan de Nederlandse zijn opgesteld, moeten een juiste en volledige vertaling van de Nederlandse tekst omvatten.

Het diergeneesmiddel is ingevoerd uit:

Het Belgische referentiegeneesmiddel is (vergunningsnr).
ontwerp vergunning voor parallelinvoer (DOC, 726 Kb) - afmps
www.fagg-afmps.be/.../VHB voor parallelinvo...‎
Feb 21, 2013 - De bijsluiterteksten, die in een andere taal dan de Nederlandse zijn opgesteld, moeten een juiste en volledige vertaling van de Nederlandse
Peer comments on this reference comment:
agree Michael Beijer
45 mins
Something went wrong...
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