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smeltparel
Oct 20, 2015 19:47
8 yrs ago
2 viewers *
Dutch term

toebehoren

Dutch to English Medical Medical: Pharmaceuticals
België: Verpakking met verpakkingsmateriaal en aanwezigheid van toebehoren: blisterverpakking.

In a document approving a homeopathic pill in a blister.
Technically 'accessories' or 'devices'. I don't see what this could be in a pharmaceutical context...

Thanks in advance for any ideas!
Proposed translations (English)
4 +2 associated items
3 +2 devices
3 +1 paraphernalia
References
pagina 4
'devices' according to fagg-afmps.be
Devices
Change log

Oct 20, 2015 20:45: Stieneke Hulshof changed "Term asked" from "toebehoeren" to "toebehoren"

Discussion

Kitty Brussaard Oct 20, 2015:
@Barend Useful information, thanks for sharing.
Barend van Zadelhoff Oct 20, 2015:
@Kitty See added note.

http://tinyurl.com/nbmoky4

This is a template phrase:

Primaire verpakking, verpakkingsmateriaal en aanwezigheid van toebehoren:

Below this you insert the information applicable to a specific product.
Kitty Brussaard Oct 20, 2015:
@CMarc It seems that the part before the colon should be seen (and read) as a generic/standard/official name or description for a specific product information category (here: packaging information). (NL: rubrieknaam, see Barend's reference comment). This means that only the information following after the colon is product-specific.

Proposed translations

+2
16 hrs
Selected

associated items

Or related items, or accessories.
Reference:

http://www.mijnwoordenboek.nl/vertaal/NL/EN/toebehoren

Peer comment(s):
agree Richard Purdom : presumably bijsluiter enzo
55 mins
agree David Walker (X)
18 hrs
Something went wrong...
4 KudoZ points awarded for this answer.
+1
16 hrs

paraphernalia


paraphernalia - miscellaneous articles, especially the equipment needed for a particular activity.

paraphernalia - (sometimes used with a singular verb) equipment, apparatus, or furnishing used in or necessary for a particular activity: a skier's paraphernalia

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Note added at 16 hrs (2015-10-21 12:36:11 GMT)
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'aanwezigheid' in 'aanwezigheid van toebehoren' might be translated as 'possible'

...and possible paraphernalia.

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Note added at 17 hrs (2015-10-21 12:49:23 GMT)
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Verpakking met verpakkingsmateriaal en aanwezigheid van toebehoren: blisterverpakking

Possibly:

Immediate packaging, packaging materials and possible paraphernalia: blister.

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Note added at 17 hrs (2015-10-21 13:47:29 GMT)
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11.Discard medication paraphernalia.
12. Rewash the hands.
13. Confirm that medication was administered.
14. Record the medication administration in the partient's chart

http://tinyurl.com/p7koakv
Peer comment(s):
neutral philgoddard : This is inappropriately colloquial for the context in my opinion, and has slightly dismissive connotations. For example, in your example of "skier's paraphernalia", the implication is "assorted junk".
15 mins
I was not aware of a negative connotation in this context of course. And in fact I don't believe this is necessarily so: An electric kettle and all the paraphernalia for making tea and coffee. What is negative about this?
neutral Richard Purdom : most common use: drugs paraphenalia. Not right here
1 hr
I opted for this from the perspective of "especially the equipment needed for a particular activity", which seemed to fit in this particular context.// See just a random example above for the use of 'paraphernalia'.
neutral David Walker (X) : Not exactly a word that would be used in normal English
18 hrs
See above. Also, 1840 G-hits for "medication paraphernalia". Also, not unsual in a pharmacological context.
agree Kitty Brussaard : An agree to underpin that this would be perfectly idiomatic English - and, in fact, is used - in closely related contexts. See f.i. the Peninsulas EMS Council: http://tinyurl.com/ojxj7aq. Here, however, I would opt for devices as used by EMA.
1 day 1 hr
Thank you, Kitty, for looking into this as well. I see many things that confirm nothing is wrong with 'paraphernalia'. I agree EMA must be followed and I would really appreciate it if you posted devices as an answer.
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+2
1 day 21 hrs

devices

Taking into account the relevant background information which has been provided in the various reference comments, I think it would be safest to follow the terminology used by EMA in this regard: devices. As used by the Belgian Federal Agency for Medicines and Health Products (see reference comments), it seems to refer specifically to measuring and administration devices which may be included in the packaging of the product.

More fully, I would translate aanwezigheid van toebehoren either as the presence of devices (see Sindy's reference) or use something along the lines of any devices included (which seems to be in line with IDMP terminology) or any available devices (as suggested by Barend).
Peer comment(s):
agree Barend van Zadelhoff : I do PILs/ SmPCs /Labels. EMA templates and EMA terminology must be followed (and there are many good reasons for it). This means: Immediate packaging, packaging materials and any devices included.
13 mins
Dank voor deze aanvulling!
agree Marijke Singer
2 days 3 hrs
Dank je wel, Marijke
Something went wrong...

Reference comments

21 mins
Reference:

pagina 4

Derhalve zal de benaming van deze rubriek gewijzigd worden naar "primaire verpakking, verpakkingsmateriaal en aanwezigheid van toebehoren" (maat- en toedieningstoebehoren)

http://www.fagg-afmps.be/nl/binaries/OZB-522-2008-06_tcm290-...

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Note added at 1 hr (2015-10-20 21:36:02 GMT)
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See this document:

Primaire verpakking, verpakkingsmateriaal en aanwezigheid van toebehoren:

http://tinyurl.com/nbmoky4

Yes, this is what happens when using templates with standard phrases.

Everything you mention in the standard phrase may not be applicable to each individual product.



--------------------------------------------------
Note added at 23 hrs (2015-10-21 19:14:58 GMT)
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Just another example.

DISPENSING MEDICATION AT SCHOOL

Dispensing of medication is not a typical function of the school and it must be given whenever possible by parents at home. However, if a student must take medication during school hours in order to assume full participation in the school program, the school nurse, by discretion as outlined in the Utah Nurse Practice Act, may designate a school employee for this task.

The medication, paraphernalia, the doctor’s statement requesting such action and proper instructions to the employee are the responsibility of the parent or guardian.

http://irondistrict.org/handbook/policy-handbook-table-conte...
Peer comments on this reference comment:
agree Kitty Brussaard : Accessories for dosage and application? / Much better indeed. As far as I can see, only part of this 'official' category name is used in asker's source text and only the information following after the colon seems to be product-specific.
49 mins
Thank you, Kitty. I was thinking something like it but used 'dosing and administration'. // See above.
Something went wrong...
1 day 1 min
Reference:

'devices' according to fagg-afmps.be

The translation by fagg-afmps.be of the omzendbrief which Barend refers to in his answer can be found here

http://www.fagg-afmps.be/fr/binaries/circular-522-2008-06-EN...

The sentence
"Derhalve zal de benaming van deze rubriek gewijzigd worden naar 'primaire verpakking, verpakkingsmateriaal en aanwezigheid van toebehoren' (maat- en toedienings toebehoren [sic])

on page 4 has been translated as follows:

p.3: "Therefore the name of this section will be changed into 'primary packaging, packaging material and presence of devices' (both measuring and administration devices).
Peer comments on this reference comment:
agree Barend van Zadelhoff : Goed snuffelwerk, Sindy. Moeten we ons houden aan de bestaande vertaling? Anyway, 'primaire verpakking' = 'immediate packiging' acc. to EMA templates.//Schept zeker duidelijkheid. De vertaling is 'letterlijk'. Ik begrijp dat je wel N-E doet?//Okay.
10 mins
Niet mijn vakgebied en ik ben geen Anglo, dus ik waag me niet aan een vertaling. Ik wilde uitsluitend aangeven hoe de bevoegde Belgische overheid het woord 'toebehoren' vertaalt; dat schept wellicht wat duidelijkheid./Jur only & met backup van 'n Anglo
agree Kitty Brussaard : Devices (measuring/administration devices) is in fact also used by EMA, see pp. 21-23 of http://www.ema.europa.eu/docs/en_GB/document_library/Scienti...
3 hrs
Something went wrong...
1 day 16 hrs
Reference:

Devices

In its Guideline on pharmaceutical development of medicines for paediatric use, EMA uses devices as a generic term for all common types of measuring/administration devices (note that these terms are used interchangeably by EMA in this specific context) and any other specific devices (f.i. face masks and nebulisers).

See Chapter 11: Container closure system, measuring device, administration device and packaging (pp. 21-24)
http://www.ema.europa.eu/docs/en_GB/document_library/Scienti...

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Note added at 1 day18 hrs (2015-10-22 13:56:44 GMT)
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The third group (green outline) is any Devices included for Administration (e.g., spoons, syringes) or integrated with the medication (e.g., inhalers). Devices also have Physical and Other Characteristics of their own, which are separate from the packaging’s characteristics, plus Nomenclature, their own Batch IDs, and a Manufacturer/Establishment.
http://blogs.csc.com/2015/06/17/idmp-lessons-packaging/
Peer comments on this reference comment:
agree Barend van Zadelhoff : Als EMA dat gebruikt is er geen verdere discussie nodig: Immediate packaging (EMA), packaging materials and any available devices. Wat denk jij over 'aanwezigheid' ?// Dat is rond dan. De toelichting moet worden weggelaten in de template phrase.
1 hr
Dit lijkt me prima, ook dat any available devices. Ik was zelf uitgekomen bij (...) and any devices included (for measuring/administration). Zie ook de link die ik zojuist hierboven heb toegevoegd.
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