Category Archives: SPCs

Avoiding adessive (the -lla ending)

I have learnt that this kind of a structure:

“The most commonly reported advers reactions with Abcxyz are headache, pruritus and rash.”

is best translated by

“Yleisimmin raportoidut haittavaikutukset Abcxyz-valmistetta käytettäessä ovat päänsärky, kutina ja ihottuma.”  (literally translated: when Abcxyz is being used)

The same can be expressed … Abcxyz-valmisteen käytön yhteydessä… (…in connection with the use of Abcxyz...)

So one shouldn’t use the adessive case here:  Abczyz-valmisteella...   That is not good Finnish.

The medical writing handbook Lääketieteen kieliopas (published by Duodecim in 1994)  gives instructions on how to avoid the excessive use of adessive (pages 115 to 116).  According to it, one could also say e.g.

Abcxyc-valmistetta käyttävillä potilailla … (in patients who are using Abcxyz)

So, there are several alternatives to the -lla ending (adessive), which is not appropriate in these kind of expressions.

“Tradenamex kovat kapselit” or “kovat Tradenamex-kapselit”?

“Tradenamex kovat kapselit” (Tradenamex hard capsules) – is this good Finnish?  In my opinion it isn’t – nor is this name type:

“Tradenamex Medium 500 mg poretabletti”  (Tradenamex Medium 200 mg effervescent tablet). (“Tradenamex” and “Tradenamex Medium” present trade names here).

I think the correct forms would be as follows:

“Kovat Tradenamex-kapselit”  and

“500 mg:n Tradenamex Medium -poretabletti” / “Tradenamex Medium 500 mg -poretabletit”.

I would like to hear what Finnish language specialists think about this name problem.

Another thing that regularly annoys me is the following. Here are some Standard Terms:

Capsule, hard = Kapseli, kova
Capsule, soft = Kapseli, pehmeä
Chewable capsule, soft = Purukapseli, pehmeä
However, when you use this kind of a Standard Term in an entire phrase, I m puzzled what to do with the adjective, that cannot be left in the basic form in Finnish:
 Blisters contain 14, 21 or 56 capsules, hard.
-> Läpipainopakkaukset sisältävät 14, 21 tai 56 kapselia, kovaa (or kovia?).
My question is which form I should use here?  The simplest solution would be to write “… 56 kovaa kapselia”, but that is not an option here, as the Standard Term has to be kept as it is…?  Any advice is welcome.

“CYP3A4:n estäjä” or “CYP3A4-estäjä”?

One sees both “CYP3A4-estäjä” and “CYP3A:n estäjä” as translations for “CYP3A4 inhibitor”. Which one is correct, or are they both correct? Which one should I use?

A Fimea article about translations from Dec 2, 2008 (which unfortunately seems to have disappeared from the Fimea website by now) prefers the form “CYP3A4:n estäjä”. The person who has written the article doesn’t  mention this specific term, but “CYP:n estäjä, ACE:n estäjä, COX:n estäjä are recommended instead of “CYP-estäjä”, ACE-estäjä, COX-estäjä”.

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.