Tag Archives: template

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

SPC section 4.2 : safety and efficacy have/has (not) (yet) been established

A client asked me to check a phrase I had translated. The client had noticed that the word I had used,  “on“,  is not included in the Finnish centralised template (Version 9, 03/2013).


EN: Safety and efficacy have been established in patients with a Body Mass Index) > 30 kg/m2

FI: Turvallisuus ja teho on varmistettu potilailla, joiden painoindeksi (BMI) > 30 kg/m2.

EN template: < The <safety> <and> <efficacy>  of {X} in children aged {x to y} <months> <years> [or any other relevant subsets, e.g. weigt, pubertal age, gender] <has> <have>  not  <yet> been established.

FI template: <{X-valmisteen} <turvallisuutta> <ja> <tehoa> {x-y} <vuoden> <kuukauden> ikäisten {tai mitkä hyvänsä muut sopivat määreet, kuten paino, puberteetti-ikä, sukupuoli} lasten hoidossa ei ole <vielä> varmistettu.

My comment:  The FI template has only the negative form “ei ole” (has/have not). The affirmative verb form “on” (has/have)  is not present in the FI template.  However, I think the original EN template phrase is meant to be negative only (there are no less than/greater than signs around the word “not”.)

Another note:  the EN template has <months> <years>, whereas the FI template has <vuoden> <kuukauden> (the other way round; vuoden = year(s),  kuukauden= month(s)).

Why “naisia” instead of the template word “naisten” (women)?

I made a SPC update (decentralized procedure) including some sentences in section 4.6, Fertility, pregnancy and lactation (Hedelmällisyys, raskaus ja imetys). Some of the phrases must be taken directly from  Appendix I, “Pregnancy and Lactation” (Raskaus ja imetys). There was a phrase  “Women of childbearing potential should be advised to avoid becoming pregnant during treatment“. I had translated it as follows: “Naisia, jotka voivat tulla raskaaksi, on neuvottava välttämään raskaaksi tulemista hoidon aikana.” ( the parts that can be taken directly from Appendix I are in italics here).

After delivery, I got a question from the translation agency:  Why did I write “naisia” and not “naisten” as in the template. Was there a grammatical reason for that?

Yes, the reason is grammatical. Finnish nouns can have hundreds or thousands different forms. The reason for this change is the change of the verb structure in the sentence.

The template phrase ( Pregnancy, [3], third phrase) is as follows (only relevant parts copied here):

  • Women of childbearing potential have to use effective contraception during treatment.
  • Naisten, jotka voivat tulla raskaaksi, on käytettävä tehokasta ehkäisyä hoidon aikana.

In Finnish, the verb structure “have to use” (on käytettävä) requires a different case form in the preceding noun than the verb structure “should be advised to avoid” (on neuvottava välttämään).

The plural basic (nominative) form of “nainen” (woman) is “naiset” (women).  Case endings are used in Finnish to replace the preposions of the Indo-European languages (at, on, in, with, from, for, etc). So, the plural form of “women” can be anything of the following: naiset (nominative), naisten/naisien (genitive, two alternative forms are possible), naisia (partitive), naisina (essive), naisiksi (translative), naisissa (inessive), naisista (elative), naisiin (illative), naisilla (adessive), naisilta (ablative), naisille (allative). In addition, there are three other cases but I list them here as they are of minor importance (practically not used with the word “woman”). And there is one more case that is common, accusative, but it always looks like either a) nominative, b) partitive, so there is no separate form for it.

And this was only the plural. The corresponding singular forms for the word “nainen” (nominative for a woman) are nainen, naisen, naista, naisena, naiseksi, naisessa, naisesta, naiseen, naisella, naiselta, naiselle. When comparing these with the plural forms, one can see that the plural marker in Finnish often is the letter in the middle of the word. The plural marker in the nominative is, however, -t in the end of the word.

Besides, many other endings can be attached to nouns to give further meanings to the word.  E. g.  “also” (-kin) can be added as follows: (singular) nainenkin (also a woman), naisenkin (genitive, also of a woman), naistakin, naisenakin, naiseksikin, naisessakin, naisestakin, naiseenkin, naisellakin, naiseltakin, naisellekin. The corresponding plurals are naisetkin, naistenkin/naisienkin, naisiakin, naisinakin, naisiksikin, naisissakin, naisistakin, naisiinkin, naisillakin, naisiltakin, naisillekin.