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.

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