natgillin/translations-raw huggingface dataset:
Other subgroups of patients were also identified at risk such as patients with impaired memory and cognitive functions, patients with visual impairment, patients who have difficulties to follow written instructions, patients who split their weekly oral methotrexate dose, patients with co-morbidities and co-medications. 
Kot ogrožene so bile prepoznane tudi druge podskupine bolnikov, na primer bolniki z motnjami spomina in kognitivnih funkcij, bolniki z motnjami vida, bolniki, ki imajo težave pri upoštevanju pisnih navodil, bolniki, ki delijo svoj tedenski peroralni odmerek metotreksata ter bolniki s sočasnimi boleznimi in sočasnimi zdravili.
The educational material should also include a reminder for the pharmacist to counsel the patient about the inadvertent daily instead of once-weekly dosing. 
To izobraževalno gradivo mora vključevati tudi opomnik za farmacevta, naj bolnika pouči o nenamernem odmerjanju enkrat na dan namesto enkrat na teden.
• For the treatment of autoimmune diseases, which require immunosuppressive therapy like rheumatoid arthritis, psoriasis, Crohn's disease and other autoimmune diseases, it is prescribed as a single low-dose, once a week. 
• pri zdravljenju avtoimunskih bolezni, ki zahtevajo imunosupresivno zdravljenje, kot so revmatoidni artritis, psoriaza, Crohnova bolezen in druge avtoimunske bolezni, se zdravilo predpisuje v obliki enkratnega majhnega odmerka enkrat na teden.
Different reasons for the occurrence of medication error have been identified. 
Ugotovili so različne razloge za pojav napak pri uporabi zdravila.
In EU/EEA, despite the risk minimisation measures in place, cases of medication errors are still occurring. 
V EU/EGP kljub vzpostavljenim ukrepom za zmanjšanje tveganja še vedno prihaja do napak pri uporabi zdravila.
It was also agreed that for all tablet formulations of methotrexate, bottles and tubes currently used as immediate packaging should be replaced by blisters. 
Dogovorili so se tudi, da je treba pri vseh formulacijah metotreksata v obliki tablet stekleničke in epruvete, ki se trenutno uporabljajo kot stična ovojnina, nadomestiti s pretisnimi omoti.
Extensive assessment of spontaneously reported post-marketing cases has been performed by the PRAC and although some relevant data might not have been provided in all spontaneously reported post-marketing cases, the root cause analysis was further substantiated by the assessment of literature data, which provided more detailed description of methotrexate medication error cases. 
Odbor PRAC je opravil obširno oceno spontano sporočenih primerov iz obdobja trženja, in čeprav nekateri pomembni podatki niso bili navedeni v vseh spontano sporočenih primerih iz obdobja trženja, je bila analiza ključnih vzrokov nadalje podprta z oceno podatkov iz literature, ki je zagotovila podrobnejši opis primerov napak pri uporabi zdravila z metotreksatom.
To address this issue, the PRAC recommended that for all tablet formulations of methotrexate, bulk packaging such as bottles or tubes should be replaced by blisters. 
Za obravnavo te težave je odbor PRAC priporočil, da pri vseh formulacijah metotreksata v obliki tablet zbirno ovojnino, kot so stekleničke ali epruvete, nadomestijo pretisni omoti.
It was noted that many different wordings and styles of warnings have been implemented, from very small information on one side of the packaging in black to large red framed information on several sides of the outer packaging, inclusion of a calendar or place to mark the day of intake as well as different texts for the warning. 
Ugotovljeno je bilo, da so uvedena opozorila vsebovala zelo različna besedila in sloge, od informacij v zelo drobnih črnih črkah na eni strani ovojnine, do velikih, rdeče uokvirjenih informacij na več straneh zunanje ovojnine, vključitve koledarja ali mesta za označitev dneva jemanja ter različnih besedil opozorila.
The PRAC further agreed during its April 2018 plenary meeting to extend the scope to include also parenteral formulations of methotrexate, in view of a number of cases reported with these formulations as well, and due to the fact that for a high number of cases reported as “incorrect schedule of dose administration” with methotrexate, the route of administration and the pharmaceutical form had not been specified. 
Odbor PRAC je med svojim plenarnim zasedanjem aprila 2018 nadalje soglašal, da bo obseg napotitve razširil in vanjo vključil tudi parenteralne formulacije metotreksata, in sicer zaradi števila primerov, o katerih so poročali tudi s temi formulacijami, ter zaradi dejstva, da pri številnih primerih, pri katerih so poročali o „napačnem urniku uporabe“ metotreksata, način uporabe in farmacevtska oblika nista bila navedena.
• The PRAC investigated the root causes for the abovementioned risk of medication errors and noted that these can occur at all stages of the medication process; 
• odbor PRAC je preučil ključne vzroke za zgoraj navedeno tveganje za napake pri uporabi zdravila in opozoril, da se lahko pojavijo v vseh fazah postopka zdravljenja;
Admission to hospital and transfer of care between institutions and physicians was also noted as a root cause due to poor or a lack of communication between patient/physician, physician/physician, physician/nurse. 
Kot ključni vzrok sta bila ugotovljena tudi sprejem v bolnišnico in prenos oskrbe med ustanovami in zdravniki, in sicer zaradi slabe komunikacije ali odsotnosti komunikacije med bolnikom in zdravnikom, med enim in drugim zdravnikom ter med zdravnikom in medicinsko sestro.
• In addition, the PRAC also recommended other changes to the product information of all methotrexate-containing products with at least one indication requiring once weekly dosing to include that only physicians with expertise in using methotrexate-containing medicines should prescribe them and that healthcare professionals should ensure that patients or their carers will be able to follow the once weekly dosing schedule. 
• poleg tega je odbor PRAC priporočil tudi vključitev drugih sprememb v informacije o zdravilu za vsa zdravila, ki vsebujejo metotreksat in imajo vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden, in sicer da jih smejo predpisovati samo zdravniki s strokovnim znanjem o uporabi zdravil, ki vsebujejo metotreksat, in da morajo zdravstveni delavci zagotoviti, da bodo bolniki ali njihovi negovalci zmožni upoštevati urnik odmerjanja enkrat na teden.
Despite additional risk minimisation measures having already been put in place, reports continued to be received. 
Kljub dodatno vzpostavljenim ukrepom za zmanjšanje tveganja o takih primerih še vedno poročajo.
Based on the available data, the PRAC noted that the abovementioned risk of medication errors can occur at all stages of the medication process, from prescription to administration. 
Odbor PRAC je na podlagi razpoložljivih podatkov ugotovil, da se zgoraj navedeno tveganje za napake pri uporabi zdravila lahko pojavi v kateri koli fazi postopka zdravljenja, od predpisovanja do uporabe.
• The PRAC considered the totality of the data submitted for methotrexate-containing products with regard to the important identified risk of medication errors when methotrexate intended for once weekly use is taken daily by mistake, the root causes for this risk and the effectiveness of the risk minimisation measures in place. 
• odbor PRAC je ocenil vse predložene podatke o zdravilih, ki vsebujejo metotreksat, kar zadeva pomembno ugotovljeno tveganje za napake pri uporabi zdravila, kadar se metotreksat, ki je predviden za uporabo enkrat na teden, pomotoma jemlje vsak dan, ključne vzroke za to tveganje in vzpostavljene ukrepe za zmanjšanje tveganja.
The risks associated with inappropriate use of methotrexate daily instead of weekly make methotrexate one of the most known high-risk medications prone to medication errors. 
Zaradi tveganj, povezanih z nepravilno uporabo metotreksata enkrat na dan namesto enkrat na teden, je metotreksat eno najbolj znanih zdravil z visokim tveganjem za napake pri uporabi zdravila.
The risk of medication errors due to inadvertent daily instead of once weekly dosing is an important identified risk and all methotrexate-containing products for which additional risk minimisation measures are required to address this risk (i.e. replacement of bottles/tubes by blisters, implementation of educational material and patient card), should have a risk management plan (RMP) in place listing all pharmacovigilance activities and risk minimisation measures agreed. 
Tveganje za napake pri uporabi zdravila zaradi nenamernega odmerjanja enkrat na dan namesto enkrat na teden je pomembno ugotovljeno tveganje, in vsa zdravila, ki vsebujejo metotreksat, za katera so za obravnavo te težave zahtevani dodatni ukrepi za zmanjšanje tveganja (tj. nadomestitev stekleničk/epruvet s pretisnimi omoti, uvedba izobraževalnih gradiv in bolnikove kartice), morajo imeti vzpostavljen načrt za obvladovanje tveganja (RMP), v katerem so navedene vse farmakovigilančne dejavnosti in dogovorjeni ukrepi za zmanjšanje tveganja.
Similarly, the boxed warning in SmPC section 4.2 already agreed to be added to the product information of the oral formulations as outcome of the PSUSA should be also reflected in the product information of methotrexate parenteral formulations. 
Podobno je treba uokvirjeno opozorilo v poglavju 4.2 povzetka glavnih značilnosti zdravila, za katero je kot izid postopka PSUSA že dogovorjeno, da bo vključeno v informacije o zdravilu za peroralne formulacije, navesti tudi v informacijah o zdravilu za parenteralne formulacije metotreksata.
For this reason, the PRAC was of the view that the visual reminder agreed for the outer packaging of the oral formulations of methotrexate should also be implemented on the outer packaging of the parenteral formulations of methotrexate with at least one indication requiring once weekly dosing, and that the shorter warning agreed for the immediate packaging of the oral formulations should be implemented on the intermediate (where applicable) and immediate packaging of the parenteral formulations. 
Zato je odbor PRAC menil, da je treba vidni opomnik, dogovorjen za zunanjo ovojnino peroralnih formulacij metotreksata, uvesti tudi na zunanji ovojnini parenteralnih formulacij metotreksata z vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden, in da je treba krajše opozorilo, dogovorjeno za stično ovojnino peroralnih formulacij, uvesti tudi na vmesni (kjer je ustrezno) in stični ovojnini parenteralnih formulacij.
In order to assess the root causes and the impact of the risk of medication errors due to inadvertent daily dosing instead of weekly dosing, the PRAC considered the analyses of cases report of inadvertent daily instead of weekly usage of methotrexate-containing products, including reports without adverse events, for the period 1 January 2013 until 31 March 2018 from the EudraVigilance database as well as from the data provided by the MAHs of methotrexate-containing products which included analyses of the medication error case reports from the companies' pharmacovigilance databases and in the literature. 
Da bi ocenil ključne vzroke in vpliv tveganja za napake pri uporabi zdravila zaradi nenamernega odmerjanja enkrat na dan namesto enkrat na teden, je odbor PRAC upošteval analize poročil o primerih nenamerne uporabe zdravil, ki vsebujejo metotreksat, enkrat na dan namesto enkrat na teden, vključno s poročili brez neželenih učinkov, za obdobje od 1. januarja 2013 do 31. marca 2018 iz zbirke podatkov EudraVigilance ter podatke, ki so jih predložili imetniki dovoljenj za promet z zdravilom za zdravila, ki vsebujejo metotreksat, kar je vključevalo analize poročil o primerih napak pri uporabi zdravila iz farmakovigilančnih zbirk podatkov podjetij in literature.
The day of the week methotrexate treatment should be taken should be written on the card by the patient. 
Bolnik mora na kartico zapisati dan v tednu, ko mora vzeti metotreksat.
• The PRAC concluded that there is a need to further strengthen the current risk minimisation measures by adding warnings in the product information and visual reminders on the outer, intermediate and immediate packaging of methotrexate-containing medicinal products with at least one indication requiring a once weekly dosing, for both oral and parenteral use; 
• odbor PRAC je zaključil, da je treba trenutne ukrepe za zmanjšanje tveganja dodatno okrepiti, in sicer z vključitvijo opozoril v informacije o zdravilu in vidnih opomnikov na zunanjo, vmesno in stično ovojnino zdravil, ki vsebujejo metotreksat in imajo vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden, za peroralno in parenteralno uporabo;
• Considering the number of reported inadvertent daily administration of methotrexate oral formulations, the PRAC concluded that for these products educational materials for healthcare professionals should be developed or updated, if already in place, in accordance with the key elements agreed, as well as a patient card to be provided with the medicinal product, to further increase awareness. 
• odbor PRAC je glede na število sporočenih primerov nenamernega dajanja peroralnih formulacij metotreksata enkrat na dan presodil, da je treba za ta zdravila pripraviti ali posodobiti (če so že na voljo) izobraževalna gradiva za zdravstvene delavce v skladu s ključnimi dogovorjenimi elementi ter zdravilu priložiti bolnikovo kartico za nadaljnje povečanje ozaveščenosti.
Dispensing errors have also been reported. 
Poročali so tudi o primerih napak pri izdaji zdravila.
This card was considered a necessary tool to remind patients to take the product only once weekly, inform on serious adverse effects that may be fatal, on the symptoms of overdose and steps to be taken should symptoms arise, and recommend patients to show the card and alert any healthcare professionals not familiar with their methotrexate treatment about their once weekly dosing schedule (e.g. on hospital admission, change of care). 
Ocenili so, da je kartica potrebno orodje za opominjanje bolnikov, da morajo zdravilo jemati samo enkrat na teden, za obveščanje o resnih neželenih učinkih, ki so lahko usodni, o simptomih prevelikega odmerjanja in ukrepih v primeru pojava simptomov ter za opozarjanje bolnikov, naj zdravstvenim delavcem, ki niso seznanjeni z njihovim zdravljenjem z metotreksatom, pokažejo kartico in jih opozorijo na svoj urnik odmerjanja enkrat na teden (npr. ob sprejemu v bolnišnico, spremembi oskrbe).
• The PRAC noted that severe, life-threatening and fatal cases of overdose due to medication errors with methotrexate-containing medicinal products continue to be reported and that the risk minimisation measures in place have not been sufficiently effective to prevent medication errors, in particular with the oral formulations of methotrexate; 
• odbor PRAC je opozoril, da pri zdravilih, ki vsebujejo metotreksat, še naprej poročajo o resnih, smrtno nevarnih in usodnih primerih prevelikega odmerjanja zaradi napak pri uporabi zdravila in da vzpostavljeni ukrepi za zmanjšanje tveganja niso dovolj učinkoviti za preprečevanje napak pri uporabi zdravila, zlasti pri peroralnih formulacijah metotreksata;
While daily instead of once weekly use of methotrexate was mainly reported with oral dosage forms in non-oncologic indications, predominantly rheumatoid arthritis and psoriasis, there were also cases with the use of parenteral formulations, as well as many reports which did not specify the route of administration. 
O uporabi metotreksata enkrat na dan namesto enkrat na teden so v glavnem poročali pri peroralnih farmacevtskih oblikah pri neonkoloških indikacijah, večinoma pri revmatoidnem artritisu in psoriazi, bili pa so tudi primeri z uporabo parenteralnih formulacij ter poročila, v katerih način uporabe ni naveden.
To gain further knowledge on the reasons leading to medication errors and prevent them adequately, as well as in support of the measurement of the effectiveness of the agreed risk minimisation measures, all MAHs are requested to implement and use a targeted follow-up questionnaire, as agreed by PRAC, for all medication errors reported with methotrexate and resulting in overdose. 
Za poglobitev znanja o razlogih, ki privedejo do napak pri uporabi zdravila, in njihovo preprečevanje ter kot podpora pri ugotavljanju učinkovitosti dogovorjenih ukrepov za zmanjšanje tveganja se od vseh imetnikov dovoljenj za promet z zdravilom zahteva, da uvedejo in uporabljajo namenski vprašalnik za spremljanje, dogovorjen z odborom PRAC, za vse napake pri uporabi zdravila, o katerih se poroča pri metotreksatu in ki privedejo do prevelikega odmerjanja.
In addition, although the number of cases reporting medication errors with parenteral formulations was smaller than with oral formulations, the risk of medication error by daily intake/use rather than once weekly is considered a general problem for all methotrexate-containing products with at least one indication that requires once a week dosing. 
Ne glede na dejstvo, da je število primerov napačne uporabe parenteralnih formulacij manjše kot pri peroralnih formulacijah, velja, da je tveganje za napako pri uporabi zdravila enkrat na dan namesto enkrat na teden splošna težava pri vseh zdravilih, ki vsebujejo metotreksat in imajo vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden.
To minimise the risk of prescribing errors due to lack of knowledge by the prescriber of the weekly dosing schedule of methotrexate for the treatment of auto-immune diseases, the PRAC was of the view that methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. 
Da bi zmanjšali tveganje za napake pri predpisovanju zaradi pomanjkanja seznanjenosti predpisovalca z odmerjanjem metotreksata pri zdravljenju avtoimunskih bolezni enkrat na teden, je odbor PRAC menil, da smejo metotreksat predpisovati samo zdravniki s strokovnim znanjem o uporabi metotreksata in celovitim razumevanjem tveganj zdravljenja z metotreksatom.
The CHMP, as a consequence, considers that the benefit-risk balance of methotrexate-containing medicinal products remains favourable subject to the amendments to the product information and to the conditions described above. 
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo metotreksat, še naprej ugodno, če se upoštevajo zgoraj opisane spremembe informacij o zdravilu in pogojev.
To increase awareness of HCPs on the risk of medication errors and their possible consequences, it was considered that for methotrexate oral formulations, educational materials for healthcare professionals should be developed or updated, if already in place, to inform them on the potential for fatal overdose due to medication errors (ME), including daily instead of once weekly use, highlight the need to inform patients and relatives/carers about the once weekly dosing, and provide information on the importance to fill in prescriptions with clear instructions about once weekly dosing, defined day of intake, and to not use abbreviations. 
Da bi povečali ozaveščenost zdravstvenih delavcev o tveganju za napake pri uporabi zdravila in njihovih morebitnih posledicah, je bilo ocenjeno, da je treba za peroralne formulacije metotreksata pripraviti oziroma posodobiti (če so že na voljo) izobraževalna gradiva za zdravstvene delavce ter tako te seznaniti z možnostjo za usodno preveliko odmerjanje zaradi napak pri uporabi zdravila, vključno z uporabo enkrat na dan namesto enkrat na teden, poudariti potrebo po seznanjanju bolnikov in njihovih sorodnikov/negovalcev z odmerjanjem enkrat na teden ter zagotoviti informacije o odmerjanju enkrat na teden, opredeljenem dnevnem vnosu in neuporabi okrajšav.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for methotrexate-containing medicinal products. 
Odbor posledično priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo metotreksat.
An update of the product information of all methotrexate products with at least one indication requiring a once weekly dosing schedule was recommended accordingly. 
V skladu s tem je bila priporočena posodobitev informacij o zdravilu za vsa zdravila z metotreksatom, ki imajo vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden.
To increase awareness and remind healthcare professionals and patients of the weekly dosing schedule required for the treatment of some conditions, the MAHs for oral methotrexate-containing products with at least an indication requiring dosing once a week had been requested, as outcome of the PSUSA (EMEA/H/C/PSUSA/00002014/201706), to implement a visual reminder on the outer and immediate packaging to warn patients to take the product once a week for those indications requiring dosing once a week. 
Da bi povečali ozaveščenost ter zdravstvene delavce in bolnike opomnili na odmerjanje enkrat na teden, ki je potrebno pri zdravljenju določenih bolezni, je kot izid pregleda PSUSA (EMEA/H/C/PSUSA/00002014/201706) od imetnikov dovoljenj za promet z zdravilom za zdravila z vsaj
Since early 1996, harmful or fatal errors with low dose oral methotrexate have been reported to the Institute for Safe Medication Practices (ISMP) and published in more than 50 of its newsletters, but in spite of this and numerous risk minimization measures, methotrexate continues to be subject in documented serious medication errors (Grissinger, 20182). 
inštituta, vendar je metotreksat kljub temu in kljub številnim ukrepom za zmanjšanje tveganja še naprej predmet dokumentiranih resnih napak pri uporabi zdravila (Grissinger, 20182).
Dividing the prescribed dose in multiple intakes was reported as a risk factor for medication error and no robust evidence could be provided to support the effectiveness of this regimen or identify patient groups for whom benefits of dividing the dose would outweigh the risk of medication errors. 
Robustnih dokazov v podporo učinkovitosti te sheme ali za identifikacijo bolnikov, pri katerih bi delitev odmerka odtehtala tveganje za napake pri uporabi zdravila, ni bilo mogoče zagotoviti.
• The PRAC finally agreed on targeted follow-up questionnaires should be used for all cases of medication errors reported with methotrexate and resulting in overdose. 
• odbor PRAC se je dogovoril tudi, da je treba pri vseh primerih napak pri uporabi zdravila, o katerih poročajo z metotreksatom in ki privedejo do prevelikega odmerjanja, uporabljati namenske vprašalnike za spremljanje.
In addition, as understanding of the once weekly dosing schedule of methotrexate is essential to avoid dosing errors by the patients or their carer and for the adherence to this special treatment schedule, an update of the product information of methotrexate products with at least one indication requiring a once weekly dosing schedule was considered necessary to alert healthcare professionals to restrict the use of oral methotrexate to patients/carers who are able to comply with the once weekly dosing schedule. 
Ker je seznanjenost z odmerjanjem metotreksata enkrat na teden ključnega pomena za preprečevanje napak pri odmerjanju in za ravnanje v skladu s tem posebnim urnikom zdravljenja, je bila posodobitev informacij o zdravilu za zdravila z metotreksatom z vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden, ocenjena kot potrebna za opozarjanje zdravstvenih delavcev, da morajo omejiti uporabo peroralnega metotreksata na bolnike/negovalce, ki so urnik odmerjanja enkrat na teden zmožni upoštevati.
The data showed that severe, life-threatening and fatal cases of overdose due to medication errors with methotrexate-containing medicinal products continue to be reported despite the risk minimisation measures in place. 
Podatki so pokazali, da kljub uvedenim ukrepom za zmanjšanje tveganja še naprej poročajo o resnih, smrtno nevarnih in usodnih primerih prevelikega odmerjanja, ki so posledica napak pri uporabi zdravil, ki vsebujejo metotreksat.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for methotrexate-containing medicinal products. 
Zato priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo metotreksat.