Category Archives: EMA templates

Months in Finnish (and how to write the date)

The months in Finnish are the following (English names in brackets):

  • tammikuu (January)
  • helmikuu (February)
  • maaliskuu (March)
  • huhtikuu (April)
  • toukokuu (May)
  • kesäkuu (June)
  • heinäkuu (July)
  • elokuu (August)
  • syyskuu (September)
  • lokakuu (October)
  • marraskuu (November)
  • joulukuu (December).

The date is normally expressed in the following ways:

  • 6.12.2015 = 6. joulukuuta 2015
  • 29.11.1962 = 29. marraskuuta 1962
  • 15.6.2016 = 15. kesäkuuta 2016

Please note that in the date expression where the month name is written out, there is a full stop after the number indicating the day,  and the ending ‘- ta’ must be added to the month name.

Shortening of the month names is done by dropping  the “kuu” part out of the word (kuu =month):  tammi, helmi, maalis etc.

In Finnish texts, dates are commonly written with numbers only:  3.1.2015. In more solemn texts, month names are used: 3. tammikuuta 2015.

In the Finnish templates, e.g. QRD template version 10.1 , SPC sections 9 and 10 (see below),  the expression ‘PP kuukausi VVVV’ is not correct – the date must be expressed PP. kuukautta VVVV. 

  1. MYYNTILUVAN MYÖNTÄMISPÄIVÄMÄÄRÄ/UUDISTAMISPÄIVÄMÄÄRÄ

<Myyntiluvan myöntämisen päivämäärä: {PP kuukausi VVVV}>(My note: the spelling of the date is wrong)

<Viimeisimmän uudistamisen päivämäärä: {PP kuukausi VVVV}> (My note: the spelling of the date is wrong)

  1. TEKSTIN MUUTTAMISPÄIVÄMÄÄRÄ

{KK/VVVV}>

<{PP.KK.VVVV}>

<{PP kuukausi VVVV}> (My note: the spelling of the date is wrong)

———————————

Month names can have other endings, too (e.g. in July = heinäkuussa),  so if you have to insert a month name in Finnish in the text but you don’t know Finnish, it is wise to ask a person who knows Finnish to check your insertion.

 

“Healthcare professional” in Finnish

 

The term “healthcare professional(s)” is common in EMA texts. It is used in templates, e.g in the decentralised template (v.4.0, 02/2016) as follows:

  • in the beginning of the SPC:  “Healthcare professionals are asked to report any suspected adverse reactions.” (Terveydenhuollon ammattilaisia pyydetään ilmoittamaan epäillyistä lääkkeen haittavaikutuksista.)
  • in the SPC section 4.8. “Healthcare professionals are asked to report any suspected adverse reactions….) (Terveydenhuollon ammattilaisia pyydetään ilmoittamaan kaikista epäillyistä haittavaikutuksista…)
  • in the end of PIL: “The following information is intended for healthcare professionals only:” (Seuraavat tiedot on tarkoitettu vain hoitoalan ammattilaisille:)

OK, here we have a problem. (Besides the fact that sentence “Healthcare professionals are asked to report any suspected adverse reactions” has been translated in two different ways into Finnish). The templates are using two different terms for “healthcare professional” in Finnish: terveydenhoidon ammattilainen and  hoitoalan ammattilainen.  – Which one to choose when my client (who does not speak Finnish)  asks me to translate “Your healthcare professional” using “the template term”.  If I could translate freely,  would say “sinua hoitava henkilökunta”, but now I have to choose from the two mentioned above. This task is further complicated by the fact that one cannot really translate “your” directly into Finnish here, or else one gets a strange phrase in Finnish, “Sinun terveydenhoidon ammattilaisesi”,  that would give an impression that you have someone working privately (only) for you…) . Instead of “sinun” (your) one should say “sinua hoitava” (the one/ those who are taking care of you”).

The translation of “your healthcare professional” would thus be”sinua hoitava terveydenhoidon ammattilainen” or “sinua hoitava hoitoalan ammattilainen”. Or do you have any better suggestions?

“Ohjeet antamisesta”, “ohjeet antamiseen or “antamisohjeet”?”

I often see the following type of translation in SPCs:

Comprehensive instructions for administration are given in the package leaflet, section 7, “Instructions for use”

Yksityiskohtaiset ohjeet XYZ-valmisteen antamisesta löytyvät pakkausselosteesta kohdasta 7, ”Käyttöohjeet”.

But one should translate “instructions for administration” using the structure “ohjeet antamiseen” or “antamisohjeet”. Think about “Instructions for making coffee”. In idiomatic Finnish. one doesn’t say “Ohjeet kahvin keittämisestä” but either “Kahvin keittämisohjeet” or “Ohjeet kahvin keittämiseen”. Do you agree?

This kind of a structure should be corrected in the templates, too, if present there.

“Above” translated as “below” in FI vet template!

In the Finnish veterinary template Version 8, 10/2012, Pakkausseloste (PL), section 11. Säilytysolosuhteet (Special storage precautions):

“Älä säilytä alle …” should be “Älä säilytä yli…” In English it says “Do not store above…”
This is actually the worst typo I have seen in these templates. The translator must keep on eye on this in order not to make a mistake here, and a comment must always be added so that the client understands why the translation is not according to the template.
In the SPC and label parts this has been translated correctly (“Älä säilytä yli”)

In the human product information templates, this expression has actually been translated the other way round: “Säilytä alle” – consistency between the templates is missing, which causes confusion and extra work.

Excipient(s) with known effect / Apuaine(et), jonka (joiden) vaikutus tunnetaan

Once again I came across of one the many flaws in the Finnish templates; once again I had to add a comment for the client about this, so that they won’t complain that I haven’t followed the template.

Centralized template 06/2015: SPC, section 2.2.
Excipient(s) with known effect / Apuaine(et), joiden vaikutus tunnetaan

“Jonka” is missing in this template phrase. Jonka is the singular form of the template word “joiden”. When the word for excipient (apuaine) is in singular, one cannot use “joiden”.

The correct template wording would thus be:
Excipient(s) with known effect / Apuaine(et), jonka (joiden) vaikutus tunnetaan

Not all nurses are “sairaanhoitaja” – a template problem!

A client asked me to correct my SPC translation about “the nurse / healthcare professional who is taking the x-ray” so that it includes the template term for nurse, “sairaanhoitaja”.

OK, I changed it but the problem is that not all nurses are “sairaanhoitaja” (“Level One Nurse”), some are e.g. ”lähihoitaja” (Level Two Nurse) or “terveydenhoitaja” (Public Health Nurse) or others,  and in this case (taking x-rays), I think the correct term is  “röntgenhoitaja” (a radiographer).

Not all Finnish nurses are allowed to use the title “sairaanhoitaja”.  Dear Fimea, wouldn’t it be better to change the template word “sairaanhoitaja” to mere “hoitaja” (a nurse, a carer)? That would save me time when working on these translations.

New Centralised Template (Version 9.1., 06/2015) published

EMA has published updated templates of the centralised template on their website.

At a quick glance, it seems to me that the quality of the Finnish template has not been improved, but here is the general description of the update from the EMA website:

Latest update: June 2015 (version 9.1)

  • Addition of guidance on the acceptance of combined summaries of product characteristics (SmPCs) for different strengths of the same pharmaceutical form.
  • Revision of guidance on the dates to be recorded in section 9 of the SmPC (i.e. date of first authorisation and date of latest renewal).
  • Revision of guidance and new standard statements in Annex II.
  • New guidance for the inclusion of quick response (QR) codes on the labelling and package leaflet.
  • Revision of guidance on the list of local representatives in the package leaflet as a result of the revised European Commission (EC) Guideline on the packaging information of medicinal products for human use (i.e. no need to have the whole list of local representatives in the actual printed package leaflet).
  • Improvements in most language versions. 

A strip – repäisypakkaus or läpipainolevy?

The standard term for “strip” is “repäisypakkaus”. This Finnish term actually covers many different kind of packages that you can open by tearing; the word “repäisy” means “tearing”. (E.g. a tear-off cap = repäisykansi.) Thus the Finnish term has a quite wide sphere of application; you can check this by doing a Google image search using the word “repäisypakkaus”. However, I understand “repäisypakkaus” would also logically be the smallest part of blister pack, a part that can be easily torn off and that usually contains only one tablet.
However, the templates (Annex III, Labelling) use the word “levy” for the strip: the heading MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS has been translated as
LÄPIPAINOPAKKAUKSISSA TAI LEVYISSÄ ON OLTAVA VÄHINTÄÄN SEURAAVAT MERKINNÄT.
(Actually I suppose there is a hyphen missing in front of the word “levyissä”; I understand strip to be läpipainolevy (“a press-through sheet”)

Often in SPCs  the word “blister strip” has also been translated as “läpipainoliuska”.

So, which word to use for “strip”, the standard term “repäisypakkaus” or the PL term “läpipainolevy”?

New PRAC recommendations cause changes in SPC wordings

There is a rather new EMA document containing wording that must be updated to product information of certain medicinal products: “Signaaleihin perustuvat PRACin suositukset valmistetietojen päivittämistä varten” / “PRAC recommendations on signals for update of the product information” (Hyväksytty 6.–9. tammikuuta 2015 PRACin kokouksessa).

You can find the document in Finnish here, and by changing the language code “fi_FI” to “en-GB” you get the English document.
The medicinal products concerned by this document are (in Finnish):
Atorvastatiini, fluvastatiini, lovastatiini, pitavastatiini,pravastatiini, simvastatiini; gadodiamidi; gadopenteettihappo,  gadoversetamidi, litium, paroksetiini, valoproaatti ja vastaavat lääkeaineet.
PRAC (Pharmacovigilance Risk Assessment Committee)  is “lääketurvatoiminnan riskinarviointikomitea” in Finnish.

“To take” is not always “ottaa” in Finnish

Sometimes it is better to translate “take” (a tablet / a medicine etc.) by the word that actually means “use” in Finnish.  In EMA templates these two verbs go often as a pair:

(PIL, section 3:)

How to <take> <use> X  / Miten X:ää <otetaan> <käytetään>

Always <take> <use> this medicine exactly as … / <Ota> <Käytä> tätä lääkettä juuri siten kuin…

If you<take> <use>  more X than you should / Jos <otat> <käytät> enemmän X:ää kuin sinun pitäisi

If you forget to <take> <use>  X / Jos unohdat <ottaa> <käyttää> X:ää

If  you stop <taking> <using> X / Jos lopetat X:n <oton> <käytön>

However, translating “use” -> “käyttää”, “take” ->  “ottaa” automatically is not wise.

Here is a example:

ORIGINAL TEXT: The XYZ tablets are sometimes taken with another medicine, called ABC.

If you translate it literally into Finnish, the result is ” XYZ-tabletteja otetaan toisinaan toisen lääkkeen, ABC:n, kanssa.”

However, in Finnish,  “otetaan” in this context implies questions: when and why it is taken, who takes it? The verb “ottaa” in this phrase gives the impression that someone can just pluck these tablets every now and then, when they wish and if they wish.

When you change the verb, the meaning becomes much clearer:

XYZ-tabletteja käytetään toisinaan toisen lääkkeen, ABC:n, kanssa.

Now the phrase implies that the use of ZYZ is prescribed and supervised by the doctor, taking of it is more or less regular, and the course lasts at least for some days.

Another example:  the phrase “You should not breast-feed while you are taking this medicine” translated as “Älä imetä ottaessasi tätä lääkettä” may imply the thought that one should not breast-feed at the moment when one is just swallowing the tablet (but two minutes or half an hour after having taken the tablet, one could continue with breast-feeding?). It is better to say “Älä imetä käyttäessäsi tätä lääkettä.” The word “käyttäessäsi” implies the entire treatment course –  several weeks or months perhaps.

In the templates, this mistake of too direct a translation has been avoided at least in the PL section 2:  “If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your <doctor> or <pharmacist> for advice before taking this medicine.” The Finnish template has “Jos olet raskaana tai imetät, epäilet olevasi raskaana tai jos suunnittelet lapsen hankkimista, kysy <lääkäriltä> tai <apteekista> neuvoa ennen tämän lääkkeen käyttöä.