FrancophonIA/ELRC3.0 huggingface dataset:
English: Except in life-threatening situations (e.g. unconsciousness, collapse, etc) infusion rates of Flolan should be adjusted only under the direction of a physician.
Slovenian: Hitrost infundiranja zdravila Flolan se sme prilagoditi le pod nadzorom zdravnika; izjema so smrtno nevarne okoliščine (npr. nezavest, kolaps ipd.).
English: • tenderness
Slovenian: • občutljivost,
English: • redness.
Slovenian: • driska,
English: Each vial contains either:
Slovenian: Ena viala vsebuje
English: • overactive thyroid gland
Slovenian: • čezmerno dejavna žleza ščitnica,
English: • 5,000 nanogram/mL - One vial containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
Slovenian: • 5.000 nanogramov/ml - Ena viala z 0,5 mg zdravila Flolan, pripravljenega in razredčenega na celotno količino 100 ml v vehiklu.
English: 15,000 nanograms/mL - 1.5 mg Flolan reconstituted and diluted to a total volume of 100mL in solvent.
Slovenian: • 15.000 nanogramov/ml - 1,5 mg zdravila Flolan, pripravljenega in razredčenega na celotno količino 100 ml v vehiklu.
English: • 15,000 nanogram/mL - One vial containing 1.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
Slovenian: • 15.000 nanogramov/ml - ena viala z 1,5 mg zdravila Flolan, pripravljenega in razredčenega v celotni količini 100 ml vehikla.
English: • 10,000 nanogram/mL - Two vials containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
Slovenian: • 10.000 nanogramov/ml - Dve viali z 0,5 mg zdravila Flolan, pripravljenega in razredčenega na celotno količino 100 ml v vehiklu.
English: Pallor
Slovenian: Odmerjanje
English: 3 Bradycardia, sometimes accompanied by orthostatic hypotension, has occurred in healthy volunteers at doses of Flolan greater than 5 nanograms/kg/min.
Slovenian: 3 Pri zdravih prostovoljcih so pri odmerkih zdravila Flolan, večjih od
English: • joint pain
Slovenian: • bolečine,
English: • burning
Slovenian: • bruhanje,
English: Marketing Authorisation Holder and Manufacturer
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Prilogo I - izpolni država članica] {Ime in naslov} <{tel.}> <{faks}> <{e-pošta}>
English: • swelling
Slovenian: NSPVZ),
English: • chest pain
Slovenian: • bolečine v prsih,
English: • One vial containing sterile, freeze-dried Flolan equivalent to 0.5 mg Flolan, supplied with one or two
Slovenian: • Ena viala s sterilnim liofiliziranim zdravilom Flolan, kolikor ustreza 0,5 mg zdravila Flolan, z eno ali dvema 50-ml vialama vehikla in filtrirno enoto.
English: Methotrexate is authorised in the European Union since the 1960s.
Slovenian: Metotreksat je v Evropski uniji odobren od 60. let 20. stoletja.
English: T. 2018 Apr;43(4):191-248.
Slovenian: P T. 2018 Apr;43(4):191-248.
English: It was also noted that current European guidelines do not mention the possibility of dividing the dose.
Slovenian: Ugotovljeno je bilo tudi, da trenutne evropske smernice ne omenjajo možnosti delitve odmerka.
English: These risk minimisation measures should be reflected in a risk management plan.
Slovenian: Te ukrepe za zmanjšanje tveganja je treba vključiti v načrt za obvladovanje tveganj;
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products containing methotrexate;
Slovenian: • Odbor za oceno tveganja na področju farmakovigilance (PRAC) je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo metotreksat;
English: Each group of indications has a different administration schedule:
Slovenian: Vsaka skupina indikacij ima drugačen urnik uporabe metotreksata:
English: The PRAC adopted a recommendation on 11 July 2019 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Slovenian: Odbor PRAC je 11. julija 2019 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnaval odbor CHMP.
English: Methotrexate-containing products are authorised in all EU Member States, and either oral or parenteral formulation or both pharmaceutical formulations are available.
Slovenian: Zdravila, ki vsebujejo metotreksat, so odobrena v vseh državah članicah EU, na voljo pa so v obliki peroralne ali parenteralne formulacije ali v obeh farmacevtskih formulacijah.
English: This included the responses submitted by the marketing authorisation holders in writing as well as the views of patients and healthcare professionals;
Slovenian: To je vključevalo odzive, ki so jih pisno predložili imetniki dovoljenja za promet z zdravilom, ter stališča bolnikov in zdravstvenih delavcev;
English: Overall, it was considered that such practice may generate more confusion and lead to more medication errors and should therefore not be recommended.
Slovenian: Na splošno je bilo ocenjeno, da lahko takšna praksa povzroči več zmede in pripelje do več napak pri uporabi zdravila, zato se ne sme priporočati.
English: Any reference to dividing the dose in the product information should therefore be deleted.
Slovenian: Vsakršno sklicevanje na delitev odmerka v informacijah o zdravilu je torej treba izbrisati.
English: Taking into account that such replacement may require several technical changes and not to jeopardize the availability of methotrexate formulations in some Member States, the PRAC agreed to an implementation period of up to 4 years after finalisation of this procedure.
Slovenian: Glede na to, da bo takšna nadomestitev morda zahtevala več tehničnih sprememb, in da ne bi ogrozili razpoložljivosti formulacij metotreksata v nekaterih državah članicah, se je odbor PRAC strinjal z največ štiriletnim obdobjem uvajanja po koncu tega postopka.
English: In addition, splitting the dose in multiple intakes should no longer be recommended;
Slovenian: Poleg tega se delitev odmerka na jemanje v več delih ne sme več priporočati;
English: In addition, bulk packaging bear the risk of losing warning information at the time of repackaging which is e.g. common practice in medical centres/hospitals.
Slovenian: Poleg tega zbirna ovojnina pomeni tveganje za izgubo opozorilnih informacij ob prepakiranju, kar je npr. pogosta praksa v zdravstvenih centrih/bolnišnicah.
English: The feedback received from healthcare professional organisations also provided further insight on the root causes for errors.
Slovenian: Tudi povratne informacije, ki so jih posredovale zdravstvene organizacije, so zagotovile dodaten vpogled v ključne vzroke za napake.
English: • A direct healthcare professionals communication was also agreed, together with a communication plan;
Slovenian: • sprejet je bil dogovor o neposrednem obvestilu za zdravstvene delavce, skupaj z načrtom obveščanja;
English: Systematic review by Saedder and colleagues (2014)1 revealed that 47% of all serious medication errors were caused by only seven drug classes, with methotrexate topping the list in percentage of incidents.
Slovenian: Saedder in sodelavci (2014)1 so s sistematičnim pregledom odkrili, da 47 % vseh resnih napak pri uporabi zdravila izhaja iz samo sedmih razredov zdravil, pri čemer je metotreksat prvi na seznamu glede na odstotek incidentov.
English: The case report analyses showed that the elderly patient population was more predisposed for inadvertent daily use of methotrexate, with more than half of the cases reporting elderly population (65 or over).
Slovenian: Analize poročil o primerih so pokazale, da je populacija starejših bolnikov bolj nagnjena k nenamerni uporabi metotreksata enkrat na dan, saj je več kot polovica sporočenih primerov zadevala starejšo populacijo (65 let ali več).
English: In addition, the PRAC requested the development of a patient card to be inserted inside or attached to the outer packaging.
Slovenian: Poleg tega je odbor PRAC zahteval pripravo bolnikove kartice, ki bo vstavljena v zunanjo ovojnino ali pritrjena nanjo.
English: In the context of this review, the PRAC discussed, in consultation with patients and healthcare professionals, how the risk minimisation measures already in place could be further strengthen and if further measures should be implemented.
Slovenian: V sklopu tega pregleda je odbor PRAC po posvetovanju z bolniki in zdravstvenimi delavci razpravljal o tem, kako bi lahko nadalje okrepili že vzpostavljene ukrepe za zmanjšanje tveganja in ali bi bilo treba uvesti dodatne ukrepe.
English: In view of the differences, the PRAC recommended an increased consistency in the implementation of this measure by defining clear, concise and unambiguous warnings for the outer and inner packaging of these products.
Slovenian: Glede na razlike je odbor PRAC priporočil povečano skladnost pri izvajanju tega ukrepa, in sicer z opredelitvijo jasnih, natančnih in nedvoumnih opozoril za zunanjo in notranjo ovojnino teh zdravil.
English: • For the treatment of cancer, various administration schedules including daily dosage may be used;
Slovenian: • pri zdravljenju raka se lahko uporabljajo različni urniki uporabe, vključno z odmerjanjem enkrat na dan;
English: In particular, it was reported that bulk packaging such as bottles or tubes does not allow tracking, i.e. easy counting, of the remaining tablets, making it difficult both for patients and caregivers to notice the error.
Slovenian: Poročali so zlasti, da zbirna ovojnina, kot so stekleničke ali epruvete, ne omogoča sledenja, tj. preprostega štetja preostalih tablet, kar bolnikom in negovalcem otežuje, da bi opazili napako.
English: Furthermore, of the 74 articles that met the review's inclusion criteria, 73 contained information about a serious adverse reaction caused by methotrexate-related medication error (found in the FDA Adverse Event Reporting System).
Slovenian: Nadalje je 73 od 74 člankov, ki so izpolnjevali vključitvena merila za pregled, vsebovalo informacije o resnem neželenem učinku, ki ga je povzročila napaka pri uporabi zdravila, povezana z metotreksatom (najdeno v sistemu za poročanje o neželenih učinkih agencije FDA).
English: Medication errors were also associated with the use of bulk packaging.
Slovenian: Napake pri uporabi zdravila so bile povezane tudi z uporabo zbirne ovojnine.
English: Lack of knowledge and clarity on the weekly dosing schedule in some indications was also recurring feature and not limited to patient level.
Slovenian: Tudi pomanjkanje poznavanja in jasnosti glede odmerjanja enkrat na teden pri nekaterih indikacijah je bil ponavljajoč se razlog, ki ni bil omejen samo na raven bolnika.
English: A direct healthcare professional communication was also agreed, together with a communication plan, to inform relevant healthcare professionals of the new recommendations and risk minimisation measures agreed.
Slovenian: Dogovorjeno je bil tudi neposredno obvestilo za zdravstvene delavce, skupaj z načrtom obveščanja, za seznanjanje zadevnih zdravstvenih delavcev z novimi priporočili in dogovorjenimi ukrepi za zmanjšanje tveganja.
English: On 22 March 2018 Spain therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the root causes and the impact of the risk of medication errors on the benefit-risk balance of oral formulation of methotrexate and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Slovenian: Zato je Španija 22. marca 2018 na podlagi farmakovigilančnih podatkov sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor PRAC zaprosila, naj oceni ključne vzroke za napačno uporabo zdravila in vpliv teh napak na razmerje med koristmi in tveganji peroralne formulacije metotreksata, ter izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno umakniti ali ukiniti.
English: It is indicated in the treatment of cancers such as acute lymphoblastic leukaemia (ALL) and various inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, and psoriatic arthritis and as steroid sparing adjunctive therapy in Crohn's disease.
Slovenian: Indiciran je za zdravljenje določenih vrst raka, kot je akutna limfoblastna levkemija (ALL), in različnih vnetnih stanj, vključno z revmatoidnim artritisom, juvenilnim idiopatskim artritisom, psoriazo in psoriatičnim artritisom, ter kot dopolnilno zdravljenje za varčevanje s steroidi pri Crohnovi bolezni.
English: 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.
Slovenian: 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.
English: The educational material should also include a reminder for the pharmacist to counsel the patient about the inadvertent daily instead of once-weekly dosing.
Slovenian: To izobraževalno gradivo mora vključevati tudi opomnik za farmacevta, naj bolnika pouči o nenamernem odmerjanju enkrat na dan namesto enkrat na teden.
English: • 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.
Slovenian: • 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.
English: Different reasons for the occurrence of medication error have been identified.
Slovenian: Ugotovili so različne razloge za pojav napak pri uporabi zdravila.
English: In EU/EEA, despite the risk minimisation measures in place, cases of medication errors are still occurring.
Slovenian: V EU/EGP kljub vzpostavljenim ukrepom za zmanjšanje tveganja še vedno prihaja do napak pri uporabi zdravila.
English: It was also agreed that for all tablet formulations of methotrexate, bottles and tubes currently used as immediate packaging should be replaced by blisters.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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;
Slovenian: • 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;
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: Despite additional risk minimisation measures having already been put in place, reports continued to be received.
Slovenian: Kljub dodatno vzpostavljenim ukrepom za zmanjšanje tveganja o takih primerih še vedno poročajo.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.