Guidance on the correct indication of the upper limit of childhood and adolescence in Product Information
The upper age limits of childhood and adolescence are currently not presented in an uniform way in the Hungarian Product Information (PIs).
As far as adolescence is concerned, the English language text often (in most cases) contains 17 years as the upper age limit. (Until you have not reached your 18th birthday, you are 17 years old.) During the translation into Hungarian, this number in most cases will be displayed as 17 by the translator as a literal (or "word-by-word") translation. However, in the Hungarian language, the number 18 is accepted for this age limit (meaning “until 18”). Product Information not translated from English (i.e. documents submitted in Hungarian and approved in accordance with the national procedure) also indicate the number 18 as the upper limit in most cases.
As for childhood, the same is true with the number 11 versus 12.
Which interpretation (17 or 18) can be considered correct is not the right question, because there are arguments in favour of both interpretations. However, it is unacceptable that this clear limit appears in two different ways in the Hungarian PIs.
Therefore, only the following uniform presentation of upper age limit can be accepted in the Hungarian PIs:
for adolescence: „betöltött 18. életév” (“reached 18th year of age”)
for childhood: „betöltött 12. életév” (“reached 12th year of age”)
So, the number 17 indicated in the English text as the upper limit of adolescence will be changed to 18 in the Hungarian text. This is the equivalent HU translation.
So, the number 11 indicated in the English text as the upper limit of childhood will be changed to 12 in the Hungarian text. This is the equivalent HU translation.
Final common English
Pyrexia was reported more frequently for younger children 1 to 3 years of age (11%) and 4 to 11 years of age (12%) compared to children and adolescents 12 to 17 years of age (4%) and adults (7%).
Lázat gyakrabban jelentettek a fiatalabb, 1‑3 éves (11%) és 4. év és betöltött 12. év közötti gyermekeknél (12%), mint a 12 és betöltött 18. életév közötti életkorú gyermekeknél és serdülőknél (4%), illetve a felnőtteknél (7%).
The aim of this guidanceis to ensure that the Hungarian language PIs are uniform and not to be misunderstood in this matter in the future.
Hungarian PIs, currently containing numbers 11 and 17 will be corrected during the next variation (of any kind) affecting them, so no request for correction needs to be submitted.