Category Archives: SPC section 4.8

“Tabulated list of adverse reactions” in Finnish

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Several different Finnish translations are used for the phrase “Tabulated list of adverse reactions“, that is used as a heading in the SPC section 4.8. This heading is not part of any template but can be translated freely (so far), and I have come across at least the following wordings:

  • haittavaikutustaulukko
  • taulukoitu luettelo haittavaikutuksista
  • taulukoitu yhteenveto haittavaikutuksista
  • taulukkomuotoinen luettelo haittavaikutuksista
  • haittavaikutukset esitettynä yhteenvetona taulukkomuodossa
  • taulukko haittavaikutuksista
  • luettelo haittavaikutuksista

“To tabulate” means “taulukoida, esittää taulukossa” (source: English-Finnish dictionaries) or in English “to set out, arrange, or write in a tabular form” (source: The Collins English Dictionary).

Would you rather write  “Luettelo osallistujista”  or “Osallistujaluettelo” (both mean ‘list of participants’, “Taulukko arvosanoista”  or “Arvosanataulukko” (both mean ‘table of grades’)?

The English-Finnish Technical Dictionary “Enteka” gives the following example. “The results are tabulated below.” = “Tulokset on esitetty taulukossa alla.”

Which one of the above do you think is best – or do you still have another suggestion?

 

“Healthcare professional” in Finnish

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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?

QRD Appendix V – the Finnish wording for “Reporting of side effects”

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Recently I did some small jobs where the the phrases in the section 4.8 of SPC  , under the heading “Reporting of suspect adverse reactions” (Epäillyistä haittavaikutuksista ilmoittaminen)  and in the section 4 of the PL, under the heading “Reporting of side effects” (Haittavaikutuksista ilmoittaminen), were amended to include the contact information of the national authority.

Adding the address requires some wording changes in the template phrases (at least for Finnish).  The phrases to be used can be found in the Fimea document “The national translations, QRD Appendix V“.