Category Archives: Package Leaflet

TBE Vaccine Product Information out of Date

The vaccination schedule mentioned  in the TicoVac package leaflet  is out of date. The same applies to Encepur. These two are vaccines against tick-borne encephalitis.  The Finnish National Institute for Health and Welfare (THL) has given new vaccination schedule recommendations in 2017; however, the revaccination intervals mentioned in the vaccine package leaflets have not been updated. THL has come into conclusion that because the level of antibodies remains rather high for many years after vaccination, there is no need for booster vaccinations as often as it was earlier thought.

Ns. punkkirokotteen ottaminen on Suomessa yhä yleisempää punkkien eli puutiaisten yleistyessä. Rokotteella ehkäistään TBE:tä (puutiaisaivokuume, puutiaisaivotulehdus, Kumlingen tauti).  Yleisesti aikuisille käytetty rokote on nimeltään TicoVac ja alle 16-vuotiaille käytetty TicoVac Junior. Aiemmin tehosterokote suositeltiin annettavaksi kuten TicoVacin pakkausselosteessa kerrotaan, mutta THL (Terveyden ja hyvinvoinnin laitos) muutti vuonna 2017 suositustaan, koska tutkimusten mukaan rokotuksen jälkeen vasta-aineet pysyvätkin koholla veressä pitempään kuin aiemmin on arvioitu. Tehosterokotusta ei näin ollen tarvitse ottaa niin usein.  THL kertoo asiasta sivuillaan.

Toinen Suomessa käytössä oleva TBE:n ehkäisemiseen tarkoitettu rokote on kauppanimeltään Encepur.

Non-breaking spaces (sitovat välilyönnit)

When translating or editing product information, one is often asked to use non-breaking spaces(ctrl/shift/space). But where to use them? The answer (or perhaps rather the ‘minimum requirements’) can be found in the EMA document called “Compilation of QRD decisions on stylistic matters in product information“. The following guidance has been copied from it:

  • Degrees: There should be a non-breaking space (ctrl/shift/space) between the figure and the º symbol, and no space between the º symbol and the indicator of scale used; e.g. 10 ºC
  •  Numbers (figures) + unit/symbol: There should be a non-breaking space (ctrl/shift/space) between the figure and the unit or symbol, e.g. 100 ml, > 10, etc.
  • If a space is used between thousands. In Finnish both ways of writing are possible:   1 000,00* or 1000,00 (*non-breaking space (ctrl/shift/space)

“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?

“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.

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. 

Appendix V updated in January 2014

The EMA Appendix V was updated on 1st Dec, 2014. The downloadable Appendix V  version 09 includes a change of Fimea address: what was before “FI-00034 Fimea” is now “00034 FIMEA”.

In the SPC, the correct wording is now:

Epäillyistä haittavaikutuksista ilmoittaminen (NB. this title should be underlined)
On tärkeää ilmoittaa myyntiluvan myöntämisen jälkeisistä lääkevalmisteen epäillyistä haittavaikutuksista. Se mahdollistaa lääkevalmisteen hyöty-haitta-tasapainon jatkuvan arvioinnin. Terveydenhuollon ammattilaisia pyydetään ilmoittamaan kaikista epäillyistä haittavaikutuksista seuraavalle taholle:

Lääkealan turvallisuus- ja kehittämiskeskus Fimea
Lääkkeiden haittavaikutusrekisteri
PL 55
00034 FIMEA

and in the PL it can be e.g. as follows:

(…)  Voit ilmoittaa haittavaikutuksista myös suoraan seuraavalle taholle:

Lääkealan turvallisuus- ja kehittämiskeskus Fimea
Lääkkeiden haittavaikutusrekisteri
PL 55
00034 FIMEA

Ilmoittamalla haittavaikutuksista voit auttaa saamaan enemmän tietoa tämän lääkevalmisteen turvallisuudesta.

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

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“.