natgillin/translations-raw huggingface dataset:
Theoretically this is possible by changes to the gene expression in sperm cells of adult males or by changes to the developing germ cells in the embryo. 
Teoretično je to možno zaradi sprememb pri izražanju genov v celicah spermijev odraslih moških ali sprememb razvijajočih se zarodnih celic v zarodku.
The PRAC agreed that such visual reminder on the outer carton is important to warn the patient on the risk and to prompt to consult a physician and requested the inclusion of a visual reminder on the outer packaging. 
Odbor PRAC se je strinjal, da je takšen vizualni opomnik na zunanji ovojnini pomemben za opozarjanje bolnice na tveganje in za poziv k posvetu z zdravnikom, ter je zahteval vključitev vizualnega opomnika v zunanjo ovojnino.
Therefore, this type of transmission is not likely to occur for valproate. 
Zato je malo verjetno, da bi pri valproatu prišlo do te vrste prenosa.
A survey among HCP to assess their knowledge and behaviour with regard to the new product information restrictions and whether they received the direct healthcare professional communication (DHPC) and educational materials, and another survey among patients to assess the receipt of the educational materials should be performed. 
Izvesti je treba raziskavo med zdravstvenimi delavci, da se oceni njihovo znanje in ravnanje glede novih omejitev informacij o zdravilu ter izve, ali so prejeli neposredno obvestilo za zdravstvene delavce (DHPC) in izobraževalna gradiva, ter še dodatno raziskavo med bolniki, da se oceni prejemanje izobraževalnih gradiv.
In view of the above, the PRAC recommended amendments to the product information, in particular to contraindicate its use to women of childbearing potential that do not fulfil the conditions of a pregnancy prevention program, and communication to healthcare professionals through a direct healthcare professional communication (DHPC). 
Ob upoštevanju navedenega je odbor PRAC priporočil spremembe informacij o zdravilu, še posebej s kontraindiciranjem njegove uporabe pri ženskah v rodni dobi, ki ne izpolnjujejo pogojev programa za preprečevanje nosečnosti, in komunikacijo z zdravstvenimi delavci z neposrednimi sporočili za zdravstvene delavce (DHPC).
A wide consultation was done on the request of PRAC to gather all the latest information in terms of scientific and clinical knowledge with the consultation of two scientific groups (neurology and psychiatry), and to collect information from healthcare professionals, female patients themselves as well their families, from patient organisations (public hearing, stake holders meeting) who are advocating to better characterise and increase the awareness on the risk of harm to the foetus when using valproate during pregnancy. 
Na zahtevo odbora PRAC je bilo opravljeno obsežno posvetovanje z dvema znanstvenima skupinama (s področja nevrologije in psihiatrije) za zbiranje vseh najnovejših informacij glede znanstvenega in kliničnega znanja ter zbiranje informacij zdravstvenih delavcev, bolnikov in njihovih družin ter organizacij bolnikov (prek javne obravnave, sestankov z deležniki), ki zagovarjajo boljše prepoznavanje in zavedanje tveganja poškodb ploda pri uporabi valproata med nosečnostjo.
This may be particularly important as the prescribers of IV formulations of valproate are expected to be different from the usual prescribers targeted during the implementation of additional risk minimisation measures. 
To je lahko še posebej pomembno, saj se pričakuje, da zdravniki, ki predpisujejo intravenske farmacevtske oblike valproata, niso isti kot zdravniki, ki običajno predpisujejo zdravilo in na katere se cilja med uvedbo dodatnih ukrepov za zmanjševanje tveganj.
The guide should explain the pregnancy prevention programme and the conditions to be met prior to starting treatment with valproate. 
V vodniku morajo biti pojasnjeni program preprečevanja nosečnosti in pogoji, ki jih je treba pred začetkom zdravljenja z valproatom izpolniti.
• The PRAC considered the totality of the data submitted for valproate and related substances with regard to the teratogenic and neurodevelopmental risks, the use in clinical practice and the effectiveness of the risk minimisation measures in place. 
• Odbor PRAC je upošteval vse podatke, predložene za valproat in sorodne snovi, v zvezi s teratogenimi tveganji in tveganji za razvoj živčevja, uporabo v klinični praksi in učinkovitostjo pri vzpostavljenih ukrepih za zmanjševanje tveganja.
With regards to the educational materials (i.e. HCP guide and patient guide), these are also considered relevant for the injectable forms of products containing valproate and related substances and therefore should be implemented. 
V zvezi z izobraževalnimi gradivi (npr. vodnikom za zdravstvene delavce in vodnikom za bolnike) velja, da so tudi primerni za farmacevtske oblike zdravil za injiciranje, ki vsebujejo valproat in sorodne snovi, in jih je zato treba uvesti.
Since the injectable formulations are indicated for short-term use with a short treatment duration, this annual risk acknowledgement form is not considered relevant therefore not applicable. 
Ker so farmacevtske oblike za injiciranje indicirane za kratkotrajno uporabo pri kratkotrajnem zdravljenju, ta obrazec za letno potrjevanje seznanjenosti s tveganjem ne velja za relevantnega, torej ni smiseln.
Regarding pregnancy/family planning in epilepsy, the PRAC also highlighted that, a specialist experienced in the management of epilepsy, must reassess valproate therapy and consider alternative treatment options. 
Glede nosečnosti/načrtovanja družine pri epilepsiji je odbor PRAC tudi poudaril, da mora strokovnjak z izkušnjami pri zdravljenju epilepsije ponovno oceniti zdravljenje z valproatom in pretehtati druge možnosti zdravljenja.
In order to provide adequate information, it should be tailored for different situations in the life-time of a woman and be age-appropriate: the first prescription, women continuing valproate treatment and not trying to have a child, women of childbearing potential continuing valproate treatment and considering trying to have a child, pregnant women (unplanned pregnancy) whilst continuing valproate treatment. 
Da bodo informacije ustrezne, mora biti prilagojen različnim situacijam v življenju ženske in ustrezati starosti: prvemu predpisovanju, ženskam, ki nadaljujejo zdravljenje z valproatom in ne skušajo zanositi, ženskam v rodni dobi, ki nadaljujejo zdravljenje z valproatom in razmišljajo, da bi poskusile zanositi, ter nosečnicam (nenačrtovana nosečnost), ki nadaljujejo zdravljenje z valproatom.
The CMDh therefore clarified that the amendments to the product information and the other routine measures to inform on the risk to the foetus when valproate is taken in pregnancy to all Healthcare professionals (HCP) and patients are applicable to all medicinal products containing valproate and related substances, irrespective of the route of administration. 
Zato je skupina CMDh pojasnila, da spremembe informacij o zdravilu in drugih rutinskih ukrepov za obveščanje vseh zdravstvenih delavcev in bolnikov o tveganju za plod pri jemanju valproata v nosečnosti veljajo za vsa zdravila, ki vsebujejo valproat in sorodne snovi, ne glede na pot uporabe.
In particular, experience from HCPs regarding the discontinuation of valproate or switch to other treatment was provided. 
Zlasti so bile podane izkušnje zdravstvenih delavcev s prekinitvijo uporabe valproata ali s prehodom na druga zdravila.
This patient card should be attached at the outer carton to prompt as a reminder the discussion between the pharmacist and the patient at the time of the product dispensing. 
Na zunanji ovojnini mora biti pritrjena ta kartica za bolnika, ki služi kot opomnik na razgovor med farmacevtom in bolnico v času izdajanja zdravila.
It is unknown whether slight chromosome damage might be transmitted to the offspring. 
Ni znano, ali se rahle okvare kromosomov lahko prenašajo na potomce.
The CMDh acknowledges correspondence received from a MAH (Laboratoires Aguettant, France) of medicinal products containing valproate injectable (intravenous; IV) formulations, and requesting further clarity for the implementation of the pharmacovigilance activities and risk minimization measures adopted by the PRAC for these IV formulation indicated for the temporary management of epilepsy when administration via oral route is not possible. 
Skupina CMDh potrjuje korespondenco, ki jo je prejela od imetnika dovoljenja za promet z zdravilom (Laboratoires Aguettant, Francija) za zdravila, ki vsebujejo farmacevtske oblike valproata za injiciranje (intravensko; IV), ter zahteva dodatna pojasnila za uvedbo dejavnosti na področju farmakovigilance in ukrepe za zmanjševanje tveganj, ki jih je sprejel odbor PRAC za te intravenske farmacevtske oblike, indicirane za začasno zdravljenje epilepsije, kadar peroralno dajanje ni mogoče.
• The PRAC also concluded that there was a need to update the educational materials aimed to fully inform patients and healthcare professionals on the risks to the unborn child when exposed in utero to valproate, and to implement some further risk minimisation measures such as a visual reminder on the outer packaging, a patient card and an acknowledgment form to raise awareness about the risks and the need for contraception. 
• Odbor PRAC je tudi zaključil, da obstaja potreba po posodobitvi izobraževalnih gradiv, namenjenih izčrpnem obveščanju bolnikov in zdravstvenih delavcev o tveganjih za nerojenega otroka ob izpostavljenosti valproatu in utero , ter uvajanju določenih dodatnih ukrepov za zmanjševanje tveganja, kot so vizualno opozorilo na zunanji ovojnini, kartica za bolnika ter obrazec za potrditev seznanjenosti za povečanje osveščenosti o tveganjih in potrebi po kontracepciji.
The PRAC also reviewed the annual risk acknowledgement form which should be used and documented at initiation and during each annual review of valproate treatment by a specialist. 
Odbor PRAC je pregledal tudi obrazec za letno potrditev seznanjenosti s tveganjem, ki ga mora zdravstveni delavec uporabiti in izpolniti ob začetku zdravljenja z valproatom ter ob vsakem letnem pregledu zdravljenja z valproatom.
The PRAC recommended the improvement of a HCP guide to make sure that valproate prescribers are aware of the risks associated with the use of this product in female children, women of childbearing potential and pregnant women and requested that the patients are also informed about these risks appropriately. 
Odbor PRAC je priporočil izboljšanje vodnika za zdravstvene delavce, da se bodo zdravniki, ki predpisujejo valproat, zagotovo zavedali tveganj, povezanih z uporabo tega zdravila pri deklicah, ženskah v rodni dobi in nosečnicah, ter zahteval, da so o teh tveganjih ustrezno obveščene tudi bolnice.
In cases of patients for whom treatment is initiated with IV valproate formulations and then transferred to oral forms of valproate products, the patient card will be disclosed at the time of dispensing the oral valproate-containing products. 
Pri bolnikih, pri katerih se zdravljenje začne z intravenskimi farmacevtskimi oblikami valproata in ki nato preidejo na peroralne oblike zdravil z valproatom, bo kartica za bolnika razkrita ob izdaji peroralnih zdravil, ki vsebujejo valproat.
Therefore, the adapted PASS study on the drug utilisation, the two surveys targeting HCPs or patients, the PASS from registries in order to characterise the foetal anticonvulsant syndrome in children with anti-epileptic drugs in utero exposure, the retrospective observational study on the association between paternal exposure to valproate and the risk of congenital anomalies and neurodevelopmental disorders including autism in offspring and, the observational study to evaluate and identify the best practice for discontinuation and switching of valproate treatment, are not applicable to the injectable formulations. 
Zato prilagojena študija PASS o uporabi zdravil, raziskavi, katerih ciljna skupina so bili zdravstveni delavci ali bolniki, študija PASS iz evidenc za opredelitev antikonvulzivnega sindroma pri plodu pri otrocih, izpostavljenih zdravilom proti epilepsiji in utero, retrospektivna opazovalna študija o povezavi med izpostavljenostjo valproatu prek očeta in tveganju prirojenih anomalij in motenj razvoja živčevja, vključno z avtizmom pri potomcih, ter opazovalna študija za oceno in odkrivanje dobrih praks za prekinitev zdravljenja z valproatom in prehodom z njega na druga zdravila ne veljajo za farmacevtske oblike za injiciranje.
Advice on non-interruption of treatment as well as the need to contact the doctor when a pregnancy is planned or suspected should also be included. 
Vključen mora biti tudi nasvet o neprekinitvi zdravljenja in o tem, da se je treba ob načrtovani nosečnosti ali sumu na nosečnost obrniti na zdravnika.
• The PRAC confirmed the known risk of intra-uterine exposure to valproate and related substances, associated with an increased risk of developmental disorders and congenital anomalies in the offspring. 
• Odbor PRAC je potrdil znano tveganje izpostavljenosti valproatu in sorodnim snovem v maternici, povezano s povečanim tveganjem razvojnih motenj in prirojenih anomalij pri potomcih.
The PRAC recommended that the patient guide for female children, adolescents and women who are being prescribed valproate is further developed and improved. 
Odbor PRAC je priporočil nadaljnji razvoj in izboljšavo vodnika za bolnike, namenjenega deklicam, mladostnicam in ženskam, ki jim je predpisan valproat.
Regarding the circulation of the DHPC, all MAHs are encouraged to collaborate in order to prepare and circulate a single DHPC in each Member State and all MAHs marketing products containing valproate and related substances are required to participate in the dissemination of the information, regardless of the route of administration of their medicinal product(s). 
V zvezi z razširjanjem neposrednih sporočil za zdravstvene delavce (DHPC) se vse imetnike dovoljenja za promet z zdravilom spodbuja, da v vseh državah članicah pripravijo in razširjajo enotno neposredno sporočilo za zdravstvene delavce, pri čemer se od vseh imetnikov dovoljenja za promet z zdravilom, ki tržijo zdravila, ki vsebujejo valproat in sorodne snovi, zahteva, da sodelujejo pri razširjanju informacij, ne glede na pot uporabe njihovih zdravil.
The information through the DHPC about risks and the new contraindications and other risk minimization measures is applicable to all formulations. 
Informacije, podane prek neposrednega sporočila za zdravstvene delavce, o tveganjih, novih kontraindikacijah in drugih ukrepih za zmanjševanje tveganj, veljajo za vse farmacevtske oblike.
The patient guide should provide comprehensive information on risks to the unborn child due to in utero exposure to valproate and related substances, the details of the pregnancy prevention programme to avoid valproate exposure during pregnancy and the required actions in terms of pregnancy or intention to become pregnant. 
V vodniku za bolnike morajo biti navedene obsežne informacije o tveganjih za nerojenega otroka zaradi izpostavljenosti in utero valproatu in sorodnim snovem, podrobnosti o programu za preprečevanje nosečnosti, da se prepreči izpostavljenost valproatu med nosečnostjo, ter ukrepi, ki so potrebni glede nosečnosti ali načrtovanja zanositve.
The visual reminder is considered important and required to be implemented on the outer packaging of any valproate formulation and presentation. 
Velja, da je vizualni opomnik pomemben in ga je treba uvesti na zunanjo ovojnino katere koli farmacevtske oblike valproata in v predstavitev zdravila.
The HCP guide should include the recommendation to inform the parents of young girls using valproate about the need to contact their specialist once their daughter has experienced menarche, information on need for switching when pregnancy planning, on the need to go through the risk acknowledgement form and the patient card, at least annually. 
V vodnik za zdravstvene delavce morajo biti vključeni priporočilo za obveščanje staršev deklic, ki uporabljajo valproat, o tem, da se morajo obrniti na svojega zdravnika, ko se bo pri hčeri pojavila menarha, informacije o potrebi po prehodu na drugo zdravilo ob načrtovanju nosečnosti ter informacije o potrebi po pregledovanju obrazca za potrditev seznanjenosti s tveganjem in kartice za bolnika vsaj enkrat letno.
Finally, as the patients will be transferred eventually to non-injectable form of valproate, it is considered that the annual review will be carried out as part of RMMs recommended for oral treatment where the annual risk acknowledgment form will then be used. 
Ker bodo bolnice sčasoma prešle na obliko valproata, ki ne bo namenjena za injiciranje, velja, da bo letni pregled izveden kot del ukrepov za zmanjševanje tveganj, priporočenih za peroralno zdravljenje, pri katerem bo nato uporabljen obrazec za letno potrjevanje seznanjenosti s tveganji.
In addition in an effort to increase the knowledge on the association between paternal exposure to valproate and the risk of congenital anomalies and neurodevelopmental disorders including autism in offspring, a retrospective observational study is recommended. 
Poleg tega, da je treba povečati znanje o povezavi izpostavljenosti valproatu prek očeta ter tveganja prirojenih anomalij in motenj razvoja živčevja pri potomcih, vključno z avtizmom, je priporočljiva tudi izvedba opazovalne študije.
If switching is not possible, the woman should receive further counselling regarding the valproate risks for the unborn child to support her informed decision making regarding family planning. 
Če prehod ni mogoč, je treba ženski nuditi podporo pri informiranemu odločanju glede načrtovanja družine v obliki nadaljnjega svetovanja o tveganjih valproata za nerojenega otroka.
Further, an observational study to evaluate and identify the best practice for discontinuation and switching of valproate treatment will be conducted. 
Poleg tega bo izvedena opazovalna študija za oceno in odkrivanje dobre prakse pri prekinitvi zdravljenja z valproatom in prehodom z valproata na drugo zdravilo.
To obtain additional robust information on the switch and discontinuation of valproate, the PRAC requested the conduct of an observational study to identify and evaluate the best practices for switching of valproate in clinical practice. 
Da bi pridobil dodatne realne informacije o prehodu z valproata na druga zdravila ali prekinitvi uporabe valproata, je odbor PRAC zahteval izvedbo opazovalne študije za odkrivanje dobrih praks pri prehodu z valproata na druga zdravila v klinični praksi in za oceno teh praks.
• The PRAC considered that the pregnancy prevention programme should reflect that in the indication epilepsy, if a woman is planning to become pregnant, a specialist experienced in the management of epilepsy, must reassess valproate therapy and consider alternative treatment options. 
• Odbor PRAC je menil, da mora program za preprečevanje nosečnosti pri indikaciji epilepsije izražati stališče, da mora strokovnjak, ki ima izkušnje z obravnavo epilepsije, pri ženski, ki načrtuje zanositev, znova oceniti zdravljenje z valproatom in razmisliti o drugih možnostih zdravljenja.
Indeed, the HCP guide will provide a reminder to the HCP of the conditions that apply for the administration of valproate (e.g. pregnancy prevention plan), the need to discuss the risks with the patient and check her pregnancy status. 
Vodnik za zdravstvene delavce bo dejansko vseboval opomnik za zdravstvenega delavca o pogojih, ki veljajo za uporabo valproata (npr. načrt preprečevanja nosečnosti), o potrebi po pogovoru z bolnico o tveganjih in o preverjanju njenega stanja v zvezi z nosečnostjo.
The PRAC requested the conduct of postauthorisation studies. 
Odbor PRAC je zahteval izvedbo študij po izdaji dovoljenja za promet z zdravilom.
The MAH requests CMDh to clarify the implementation of the PRAC outcome for injectable forms by further differentiating the routine/additional risk minimization activities to be considered for the noninjectable products and those also applicable to the injectable products. 
Imetnik dovoljenja za promet z zdravilom prosi skupino CMDh, da pojasni uvajanje zaključka PRAC za farmacevtske oblike za injiciranje, tako da dodatno loči dejavnosti za zmanjševanje rutinskega/dodatnega tveganja, ki jih je treba upoštevati pri zdravilih, danih brez injiciranja, in tiste, ki veljajo tudi za zdravila, dana z injiciranjem.
The CMDh, as a consequence, considers that the benefit-risk balance of medicinal products containing substances related to valproate remains favourable subject to the amendments to the product information and to the conditions described above. 
Skupina CMDh posledično meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo valproatu sorodne snovi, še naprej ugodno, če se upoštevajo zgoraj opisane spremembe informacij o zdravilu in pogojev.
It can be concluded that it is extremely unlikely that valproate, when used by a male patient, could cause adverse effects to the embryo/foetus by this route. 
Zaključiti je mogoče, da so neželeni učinki pri zarodku/plodu, ki bi jih po tej poti povzročil valproat, če ga uporablja bolnik moškega spola, zelo malo verjetni.
Information on the patient card should be brief and concise regarding the efficacy of the product but also the harm to an unborn child when taken during pregnancy. 
Informacije na kartici za bolnika glede učinkovitosti zdravila in škode za nerojenega otroka, če se zdravilo vzame med nosečnostjo, morajo biti kratke in natančne.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for medicinal products containing substances related to valproate. 
Odbor je zato priporočil spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi.
Regarding the visual reminder on the outer packaging, it is considered that it is crucial to remind to the HCPs that valproate should not be administered to women of childbearing potential (WCBP) who do not fulfil the pregnancy prevention plan requirements, or to pregnant patients, thus initiating a discussion about the risks of valproate with the patient. 
Glede vizualnega opomnika na zunanji ovojnini velja, da je ključno opozorilo zdravstvenim delavcem, da valproata ne smejo dajati ženskam v rodni dobi, ki ne izpolnjujejo pogojev načrta za preprečevanje nosečnosti, ali nosečim bolnicam, in da se morajo pogovoriti z bolnico o tveganjih jemanja valproata.
For the female patients, there may be situations in which valproate treatment is initiated with the IV formulation (before discharge on valproate oral administration). 
Pri bolnicah bo morda prišlo do situacij, pri katerih se bo zdravljenje z valproatom začelo s farmacevtsko obliko za injiciranje (pred prehodom na peroralno uporabo valproata).
• In addition, the PRAC recommended other changes to the product information such as warnings and precautions for use and updated information on the risks related to exposure during pregnancy to better inform the healthcare professionals and patients. 
• Poleg tega je odbor PRAC za boljšo poučenost zdravstvenih delavcev in bolnikov priporočil druge spremembe informacij o zdravilu, kot so opozorila in previdnostni ukrepi za uporabo, ter posodobljene informacije o tveganjih, povezanih z izpostavljenostjo med nosečnostjo.
The annual risk acknowledgement form for injectable formulations of valproate and related substances containing products is intended to act as a periodic reminder and acknowledgement of the risks of valproate for women of childbearing potential (WCBP). 
Obrazec za letno potrditev seznanjenosti s tveganjem za farmacevtske oblike zdravil za injiciranje, ki vsebujejo valproat in sorodne snovi, je namenjen rednemu opominjanju na tveganje valproata za ženske v rodni dobi in potrditvi seznanjenosti s tem tveganjem.
valproate indeed may induce transgenerational alterations of gene expression to the offspring and the types of consequent effects. 
lahko sproži transgeneracijske spremembe izražanja genov pri potomcih in vrste posledičnih učinkov, potrebnih več raziskav.