Review of EMA Approved French Translation for Hepcludex

The following segments need review. They are presented as they appear as of December 21 2020 in the texts approved by the European Medicines Agency.

Do you need to translate Hepcludex into French? Download the translation memory for the English French product information texts.

English Product Information Text

Other information about Hepcludex Hepcludex received a conditional marketing authorisation valid throughout the EU on 31 July 2020.

Further information on Hepcludex can be found on the Agency’s website:
This overview was last updated in 07-2020.

French Product Information

Translation Autres informations relatives à Hepcludex:
Des informations sur Hepcludex sont disponibles sur le site web de l’Agence, sous:


Bolded sentences of the English original are missing from the translation into French. Documents concerned: hepcludex-epar-medicine-overview_en and hepcludex-epar-medicine-overview_fr

English Product Information Text Powder for solution for injection (powder for injection).

French Product Information Translation Poudre pour solution injectable.

Reason Text in parentheses “(powder for injection)” missing from translation into French

English Product Information Text The most frequently reported adverse reactions were asymptomatic, dose dependent and reversible (after
discontinuation of treatment) increase in bile salts (very common) and injection site reactions (common)
(see section 4.4).

French Product Information Translation Les effets indésirables les plus fréquemment rapportés ont été une élévation asymptomatique des sels
biliaires, dose-dépendante et réversible (après l’arrêt du traitement), et des réactions au site d’injection
(fréquentes) (voir rubrique 4.4).

Reason “(very common)” – missing from translation into French

English Product Information Text In this limited dataset, the efficacy and safety profiles were not substantially different than for patients treated for 24

French Product Information Translation Les profils d’efficacité et de sécurité de ce groupe limité de patients n’ont pas été
significativement différents de ceux des patients traités pendant 24 semaines.

Reason Translation into French needs rewriting. The safety and efficacy profile is a property of the medicine, not of the patients.

English Product Information Text In vitro plasma protein binding
is high with >99% of bulevirtide bound to plasma proteins.

French Product Information Translation In vitro, la fixation protéique dans le plasma est élevée, avec > 99 % du bulévirtide qui se lie aux protéines plasmatiques.

Reason French translation needs review

qui se lie > se liant

English Product Information Text Colourless glass vial with bromobutyl rubber stopper, sealed with a flip off cap (aluminium with plastic disc)

French Product Information Translation Flacon en verre incolore, muni d’un bouchon en caoutchouc bromobutyle et d’une capsule flip-off (en aluminium avec un disque en plastique).

Reason French text needs review, there is a French equivalent for “flip-off” – “capsule amovible”.

English Product Information Text The bulevirtide vial should be taken from the refrigerator shortly before the injection and the blue flipoff cap has to be removed.

French Product Information Translation Sortir le flacon de bulévirtide du réfrigérateur peu de temps avant l’injection et retirer la capsule flip-off bleue.

Reason French text needs review, there is a French equivalent for “flip-off” – “capsule amovible”.

English Product Information Text This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:

French Product Information Translation Une autorisation de mise sur le marché «conditionnelle» ayant été accordée, et conformément à l’article 14 bis du règlement (CE) n° 726/2004, le titulaire de l’autorisation de mise sur le marché doit mener à son terme, selon le calendrier indiqué, les mesures suivantes:

Reason “paragraphe 4” missing from French translation

English Product Information Text HDV uses a particular protein in liver cells to enter the cells.

French Product Information Translation Le VHD se sert d’une protéine particulière située dans les cellules du foie pour pénétrer dans ces cellules.

Reason French translation needs review: the protein is not inside the cells if it transports the virus into liver cells; the English text refers to the specificity of the protein to liver cells, as opposed to proteins specific to other organs.

English Product Information Text If less than 4 hours have passed since your missed dose of Hepcludex, take the missing dose as soon as possible and take your next scheduled dose at the usual time.

French Product Information Translation Si moins de 4 heures se sont écoulées depuis votre dose oubliée d’Hepcludex, prenez la dose manquante dès que possible et prenez votre dose suivante à l’heure habituelle.

Reason Both English and French texts need review; the dose is not missing – it is missed.