Monthly Archives: March 2014

Typos in SPC template, section 4.8

There are two spelling mistakes in the Finnish SPC, centralised template version 9, 03/2013, section 4.8, under the heading “Reporting of suspected adverse reactions” (Epäillyistä haittavaikutuksista ilmoittaminen).  I have indicated them using italics below.

English: “Reporting of suspected advers reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.”

Finnish:  “On tärkeää ilmoittaa myyntiluvan myöntämisen jälkeisistä lääkevalmisteen epäillyistä haittavaikutuksista. Se mahdollistaa lääkevalmisteenhyöty-haitta -tasapainon jatkuvan arvioinnin. Terveydenhuollon ammattilaisia pyydetään ilmoittamaan kaikista epäillyistä haittavaikutuksista liitteessä V luetellun kansallisen ilmoitusjärjestelmän kautta.”

First of all, there is a space missing between lääkevalmisteen (= medicinal product) and the following word, which is “hyöty-haitta -tasapainon” (risk/balance benefit). Secondly there should be no space after “haitta” here. The correct spelling is “hyöty-haitta-tasapainon” OR “hyöty-haittatasapainon”.

Small but annoying mistakes, as the translator has to insert comments most times she/he copies this phrase (corrected, of course) into a Finnish SPC.

“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”.