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 … Continue reading Excipient(s) with known effect / Apuaine(et), jonka (joiden) vaikutus tunnetaan
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 … Continue reading SPC section 4.2 : safety and efficacy have/has (not) (yet) been established
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". … Continue reading Why “naisia” instead of the template word “naisten” (women)?