Tag Archives: Appendix II

Esiintymistiheydet ja välilyönnit / Frequencies and spaces

There are still small – but very annoying – mistakes in the Finnish part of the current Appendix II that was last updated in June 2018. The Appendix is called ‘Appendix II – Medical Dictionary for Regular Activities (Version 21.0) terminology to be used in Section 4.8 ‘undesirable effects’ of the summary of product characteristics’ and it can be downloaded here.

In Finnish:

  • there is a space between a mathematical symbol like ≥ and the preceding or following number or word;
  • there is no decimal comma in thousands; instead, a space or a full stop is used.

So the Finnish translator who is working with SmPCs, labels and PLs must correct these and leave a comment for the client.

Frequencies:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)

Esiintymistiheydet:
Hyvin yleinen (≥ 1/10)
Yleinen (≥ 1/100, < 1/10)
Melko harvinainen (≥ 1/1 000, < 1/100)
Harvinainen (≥ 1/10 000, < 1/1 000)
Hyvin harvinainen (≥ 1/10 000)
Tuntematon (koska saatavissa oleva tieto ei riitä esiintyvyyden arviointiin)

(please also note that the word ‘esiintyvyyden’ was added to this template wording in the June 2018 update)