Monthly Archives: March 2015

A strip – repäisypakkaus or läpipainolevy?

The standard term for “strip” is “repäisypakkaus”. This Finnish term actually covers many different kind of packages that you can open by tearing; the word “repäisy” means “tearing”. (E.g. a tear-off cap = repäisykansi.) Thus the Finnish term has a quite wide sphere of application; you can check this by doing a Google image search using the word “repäisypakkaus”. However, I understand “repäisypakkaus” would also logically be the smallest part of blister pack, a part that can be easily torn off and that usually contains only one tablet.
However, the templates (Annex III, Labelling) use the word “levy” for the strip: the heading MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS has been translated as
LÄPIPAINOPAKKAUKSISSA TAI LEVYISSÄ ON OLTAVA VÄHINTÄÄN SEURAAVAT MERKINNÄT.
(Actually I suppose there is a hyphen missing in front of the word “levyissä”; I understand strip to be läpipainolevy (“a press-through sheet”)

Often in SPCs  the word “blister strip” has also been translated as “läpipainoliuska”.

So, which word to use for “strip”, the standard term “repäisypakkaus” or the PL term “läpipainolevy”?

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New PRAC recommendations cause changes in SPC wordings

There is a rather new EMA document containing wording that must be updated to product information of certain medicinal products: “Signaaleihin perustuvat PRACin suositukset valmistetietojen päivittämistä varten” / “PRAC recommendations on signals for update of the product information” (Hyväksytty 6.–9. tammikuuta 2015 PRACin kokouksessa).

You can find the document in Finnish here, and by changing the language code “fi_FI” to “en-GB” you get the English document.
The medicinal products concerned by this document are (in Finnish):
Atorvastatiini, fluvastatiini, lovastatiini, pitavastatiini,pravastatiini, simvastatiini; gadodiamidi; gadopenteettihappo,  gadoversetamidi, litium, paroksetiini, valoproaatti ja vastaavat lääkeaineet.
PRAC (Pharmacovigilance Risk Assessment Committee)  is “lääketurvatoiminnan riskinarviointikomitea” in Finnish.