FrancophonIA/ELRC3.0 huggingface dataset:
English: It is acknowledged that the majority of cases included concomitant medication known to have potential for hepatic adverse reactions and that the combination of COX-2 inhibitors or NSAIDs with flupirtine may significantly increase the severity of the hepato-biliary reactions.
Slovenian: Ugotovljeno je bilo, da je večina primerov vključevala sočasno uporabo drugih zdravil z znanim tveganjem za neželene učinke na jetra in da lahko kombinacije zaviralcev COX-2 ali nesteroidnih protivnetnih zdravil in flupirtina znatno povečajo intenzivnost neželenih učinkov na jetra, žolčnik in žolčevode.
English: Overall conclusion and conditions to the Marketing Authorisations Having considered the overall submitted data provided by the MAHs in writing and in the oral explanation, the PRAC concluded that: a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study; b. the marketing authorisation holders should implement risk minimisation measures;
Slovenian: Splošni zaključki in pogoji dovoljenj za promet z zdravili Po preučitvi vseh podatkov, ki so jih v obliki pisne dokumentacije in ustnih obrazložitev predložili imetniki dovoljenj za promet z zdravili, je PRAC zaključil, da: a. morajo imetniki dovoljenj za promet z zdravili sponzorirati študijo o varnosti zdravila v obdobju trženja in nadaljnje vrednotenje rezultatov študije; b. morajo imetniki dovoljenj za promet z zdravili izvajati ukrepe za zmanjšanje tveganja; c. so potrebne spremembe dovoljenj za promet z zdravili.
English: Data from the literature as well as data from randomised clinical trials,,, showed an increment of markers for hepato-biliary impairment associated with the treatment of flupirtine.
Slovenian: Tako podatki iz literature kot tudi podatki iz randomiziranih kliničnih preskušanj1,2,3,4 so pokazali porast označevalcev bolezni jeter, žolčnika in žolčevodov, povezanih z zdravljenjem s flupirtinom.
English: Open study over 12 months, single blind subsequent observation period of 14 days (including an „Additional evaluation about a group of very old patients > 80 years“) Degussa-Report No. D-09998 / 75 057 C, (for publication see also below)
Slovenian: Open study over 12 months, single blind subsequent observation period of 14 days (including an „Additional evaluation about a group of very old patients > 80 years“).
English: 1 Li C, Ni J, Wang Z et al. Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial.
Slovenian: Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial.
English: Moreover, liver function should be kept under closely monitoring i.e. weekly during the treatment with flupirtine which should be discontinued upon symptoms and signals of liver disorders.
Slovenian: Prav tako je treba skrbno pregledovati delovanje jeter, in sicer enkrat na teden v času zdravljenja s flupirtinom, ki ga je treba ob pojavu simptomov in znakov bolezni jeter prekiniti.
English: The PRAC concluded that the benefit-risk balance for flupirtine containing medicinal products remains favourable in the treatment of acute pain subject to the agreed restrictions, contraindications, warnings, other changes to the product information and additional risk minimisation measures.
Slovenian: PRAC je zaključil, da je razmerje med tveganji in koristmi za zdravila, ki vsebujejo flupirtin, pri zdravljenju akutnih bolečin še vedno pozitivno, če se upoštevajo dogovorjene omejitve, kontraindikacije, opozorila, druge spremembe informacij o zdravilu in dodatni ukrepi za zmanjšanje tveganja.
English: A total of 330 hepatic and biliary disorders were reported post-marketing, of which 49 involved liver failure and 15 had a fatal outcome or resulted in liver transplantation.
Slovenian: V obdobju trženja so poročali o skupno 330 primerih bolezni jeter, žolčnika in žolčevodov; v 49 primerih je prišlo do odpovedi jeter, 15 pa se jih je končalo s smrtnim izidom ali presaditvijo jeter.
English: The amendments aim to reflect the restricted use of maximum of two weeks of treatment, consequently only for use in acute pain and when other analgesics are contraindicated.
Slovenian: na največ dva tedna ter posledično uporabo samo pri akutnih bolečinah in v primerih, ko so ostali analgetiki kontraindicirani.
English: Direct healthcare professional communication were agreed, together with the timelines for distribution and that a postauthorisation safety study as well as a drug utilisation study should be conducted.
Slovenian: Odbor se je dogovoril o neposrednem obvestilu zdravstvenim delavcem in rokih za njegovo razdelitev ter določil, da je treba izvesti študijo varnosti v obdobju trženja ter tudi študijo uporabe zdravila;
English: Since no cases of hepatotoxicity including cases with fatal outcome or which resulted in liver transplantation have been identified so far in the first two weeks of treatment, PRAC concluded that flupirtine use should be restricted to a maximum of two weeks.
Slovenian: Ker do sedaj v prvih dveh tednih zdravljenja niso zabeležili nobenih primerov hepatotoksičnosti, ki bi se končali s smrtnim izidom ali presaditvijo jeter, je PRAC zaključil, da bi moralo biti zdravljenje s flupirtinom omejeno na največ dva tedna.
English: If you observe any symptoms that may indicate hepatic damage during treatment with <Product Name> (e.g. loss of appetite, nausea, vomiting, abdominal discomfort, fatigue, dark urine, jaundice,
Slovenian: Če v času zdravljenja z zdravilom <ime zdravila> opazite katere koli simptome, ki bi lahko kazali na okvaro jeter (npr. izguba teka, slabost, bruhanje, nelagodje v trebuhu, utrujenost, temen urin, zlatenica, pruritus), morate prenehati jemati/uporabljati zdravilo <ime zdravila> in se takoj posvetovati z zdravnikom.
English: In view of the hepatotoxicity and very limited efficacy PRAC concluded that the benefit/risk for flupirtine containing medicinal products in the management of chronic pain is no longer favourable.
Slovenian: Ob upoštevanju hepatotoksičnosti in zelo omejene učinkovitosti je PRAC zaključil, da razmerje med tveganji in koristmi za zdravila, ki vsebujejo flupirtin, pri obvladovanju kroničnih bolečin ni več pozitivno.
English: [Oral pharmaceutical forms and suppositories] Do not <take><use><Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Slovenian: [Peroralne farmacevtske oblike in svečke] Ne <jemljite><uporabljajte> zdravila <ime zdravila>, če: - imate že obstoječo bolezen jeter;
English: In addition, patients should have their liver function monitored after each full week of treatment and treatment should be stopped if there are signs of liver problems.
Slovenian: Poleg tega bi bilo treba v času zdravljenja vsak teden pregledati delovanje bolnikovih jeter in prekiniti zdravljenje, če bi se pojavili znaki težav z jetri;
English: [All pharmaceutical forms]
Slovenian: Opozorila in previdnostni ukrepi [Vse farmacevtske oblike]
English: The PRAC concluded that the risk-benefit balance of flupirtine containing medicinal product(s) in the treatment of acute pain remains favourable subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Slovenian: PRAC je zaključil, da je razmerje med tveganji in koristmi zdravil(a) z vsebnostjo flupirtina pri zdravljenju akutnih bolečin še vedno pozitivno, če se upoštevajo dogovorjene omejitve, opozorila, druge spremembe informacij o zdravilu, dodatne dejavnosti farmakovigilance in dodatni ukrepi za zmanjšanje tveganja.
English: In addition, treatment with flupirtine is not recommended in patients with pre-existing liver disease or taken concomitantly other medication known to cause drug liver injury.
Slovenian: Poleg tega zdravljenje s flupirtinom ni priporočljivo pri bolnikih z že obstoječo boleznijo jeter ali bolnikih, ki sočasno uporabljajo druga zdravila, ki povzročajo okvare jeter.
English: In view of this and of the very limited efficacy of flupirtine in the management of chronic pain, PRAC concluded that the benefit-risk balance of flupirtine containing medicinal products in the management of chronic pain was no longer favourable.
Slovenian: Zaradi tega dejstva in zelo omejene učinkovitosti flupirtina pri obvladovanju kroničnih bolečin je PRAC zaključil, da razmerje med tveganji in koristmi za zdravila, ki vsebujejo flupirtin, pri obvladovanju kroničnih bolečin ni več pozitivno.
English: • The PRAC considered that flupirtine containing medicinal products only show very limited efficacy in the management of chronic pain.
Slovenian: • PRAC je menil, da je učinkovitost zdravil, ki vsebujejo flupirtin, pri obvladovanju kroničnih bolečin zelo omejena.
English: The protocol of drug utilisation study in order to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription should be also be submitted as part of the RMP.
Slovenian: V okviru RMP je treba predložiti tudi protokol študije uporabe zdravila, s katero bi razjasnili prakse pri predpisovanju teh zdravil med običajno klinično uporabo pri reprezentativni skupini zdravstvenih delavcev, ki predpisujejo ta zdravila, in opredelili glavne razloge za predpisovanje.
English: In addition, treatment with flupirtine is contraindicated in patients with pre-existing liver disease or taken concomitantly other medication known to cause drug liver injury.
Slovenian: Poleg tega je zdravljenje s flupirtinom kontraindicirano pri bolnikih z že obstoječo boleznijo jeter in bolnikih, ki sočasno uporabljajo druga zdravila, ki povzročajo okvare jeter.
English: The PRAC reviewed the data submitted by the marketing authorisation holders and other stakeholders from clinical and non-clinical studies, epidemiological studies, spontaneous reports and published literature.
Slovenian: Odbor PRAC je pregledal podatke iz kliničnih in predkliničnih študij, epidemioloških študij, spontanih poročil in objavljene literature, ki so jih predložili imetniki dovoljenj za promet z zdravili in druge zainteresirane strani.
English: Overall, the duration of treatment is recommended to be established individually by the prescriber.
Slovenian: Največji dnevni odmerek ne sme preseči 600 mg. Na splošno je priporočljivo, da trajanje zdravljenja določi zdravnik, ki bo predpisal zdravilo, za vsakega bolnika posebej.
English: With regards to the management of chronic pain PRAC concluded that the benefit-risk in this indication is no longer favourable.
Slovenian: Glede razmerja med tveganji in koristmi pri obvladovanju kroničnih bolečin je PRAC zaključil, da razmerje pri tej indikaciji ni več pozitivno.
English: A total of 570 serious (421) and non-serious (149) flupirtine hepatic case reports have been reported up to 28 March 2013, accordingly to the market leader MAH's safety database.
Slovenian: Glede na bazo podatkov o varnosti imetnika dovoljenja za promet z zdravilom, ki je vodilni na trgu, so do 28. marca 2013 poročali o skupno 570 primerih bolezni jeter, povezanih s flupirtinom, med katerimi je bilo 421 resnih in 149 takih, ki niso bili resni.
English: Therefore, the PRAC considered that flupirtine containing medicinal products only show very limited efficacy in the management of chronic pain.
Slovenian: Zato je odbor menil, da je učinkovitost zdravil, ki vsebujejo flupirtin, pri obvladovanju kroničnih bolečin zelo omejena.
English: In order to ensure a favourable benefit/risk in this indication, PRAC concluded that treatment should be restricted to a maximum of 2 weeks.
Slovenian: PRAC je zaključil, da je treba za zagotovitev pozitivnega razmerja med tveganji in koristmi pri tej indikaciji zdravljenje omejiti na največ 2 tedna.
English: c. the marketing authorisations should be varied.
Slovenian: b. naj imetniki dovoljenj za promet z zdravili izvajajo ukrepe za zmanjšanje tveganja;
English: Do not use <Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Slovenian: Ne uporabljajte zdravila <ime zdravila>, če: - imate že obstoječo bolezen jeter;
English: The PRAC in accordance with Article 107j(3) of Directive 2001/83/EC, recommended by a majority that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study, as well as a drug utilisation study (see Annex IV - Conditions of marketing Authorisations); b. the marketing authorisation holders should implement risk minimisation measures; c. the marketing authorisations of flupirtine containing medicinal products (see Annex I) should be varied (in accordance with changes to the product information as set out in Annex III).
Slovenian: a. naj imetniki dovoljenj za promet z zdravili sponzorirajo študijo varnosti zdravila v obdobju trženja in nadaljnje vrednotenje rezultatov študije ter tudi študijo uporabe zdravila (glejte Prilogo IV - Pogoji dovoljenj za promet z zdravili);
English: Supportive measures should be provided as necessary.
Slovenian: Po potrebi se uvedejo podporni ukrepi.
English: You may also need other treatments.
Slovenian: Morda boste potrebovali tudi druga zdravila.
English: However, no unacceptable risks appear to be present in this patient group.
Slovenian: Vendar ne kaže, da bi bilo v tej skupini bolnikov prisotno kakršnokoli nesprejemljivo tveganje.
English: Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Slovenian: Kapsule vzemite na prazen želodec, na primer vsaj eno uro, preden nameravate zajtrkovati.
English: • which days are your dosing days.
Slovenian: • kateri dnevi so dnevi odmerjanja.
English: In 43 patients stable disease was reported.
Slovenian: Pri 43 bolnikih so poročali o stabilni bolezni.
English: • how many capsules you need to take every dosing day.
Slovenian: • koliko kapsul morate vzeti vsak dan odmerjanja.
English: Elderly patients (> 70 years of age)
Slovenian: Starejši bolniki (nad 70 let)
English: Each one lasts 28 days.
Slovenian: Vsako bo trajalo 28 dni.
English: After Day 28, the next cycle will begin.
Slovenian: Po 28. dnevu se bo začel nov cikel.
English: This latency period is very short even for an alkylating agent.
Slovenian: Ta latentna doba je zelo kratka celo za alkilirajočo učinkovino.
English: Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega, razen če vam tako naroči zdravnik.
English: Achieving a radiological objective response or maintaining progression-free status was strongly associated with maintained or improved quality of life.
Slovenian: Dosega radiološko objektivnega odziva ali vzdrževanje stanja brez napredovanja bolezni sta bila močno povezana z ohranjeno ali izboljšano kakovostjo življenja.
English: In the event of an overdose, haematological evaluation is needed.
Slovenian: V primeru prevelikega odmerka je potrebna hematološka preiskava.
English: Ask your doctor or pharmacist to write it down (including the colour).
Slovenian: Prosite zdravnika ali farmacevta, da vam to napiše (vključno z barvo kapsul);
English: For the eligible histology population, the efficacy results were similar.
Slovenian: V populaciji, primerni za histološko preiskavo, so bili rezultati učinkovitosti podobni.
English: Median overall survival was 14.6 months.
Slovenian: Srednje skupno preživetje je bilo 14,6 meseca.
English: Your doctor will work out your exact dose.
Slovenian: Zdravnik vam bo izračunal natančni odmerek.
English: Keep the bottle tightly closed in order to protect from moisture.
Slovenian: Steklenička mora biti dobro zaprta za zagotovitev zaščite pred vlago.
English: During treatment a complete blood count should be obtained weekly.
Slovenian: Med zdravljenjem je treba vsak teden narediti celotno krvno sliko.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake “EXP”.
English: Tolerance to TMZ is similar to adults.
Slovenian: Toleranca za TMZ je bila podobna kot pri odraslih.
English: TMZ demonstrates low protein binding (10% to 20%), and thus it is not expected to interact with highly protein-bound substances.
Slovenian: TMZ se veže na beljakovine v majhni meri (10 do 20 %), zato ni pričakovati medsebojnega delovanja s snovmi, ki se obsežno vežejo na beljakovine.
English: Haupt Pharma Amareg GmbH Donaustaufer Straβe 378 93055 Regensburg Germany
Slovenian: Haupt Pharma Amareg GmbH Donaustaufer Straβe 378 93055 Regensburg Nemčija
English: The half-life (t1/2) in plasma is approximately 1.8 hours.
Slovenian: Izločanje Razpolovni čas (t1/2) v plazmi je približno 1,8 ure.
English: - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na temozolomid ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: - if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Slovenian: - če ste kdaj imeli alergijsko reakcijo na dakarbazin (zdravilo proti raku, ki ga včasih imenujemo
English: TMZ is more toxic to the rat and dog than to humans, and the clinical dose approximates the minimum lethal dose in rats and dogs.
Slovenian: TMZ je bolj toksičen za podgane in pse kot za ljudi; klinični odmerek približno ustreza najmanjšemu smrtnemu odmerku za podgane in pse.
English: Administration of TMZ with food resulted in a 33% decrease in Cmax and a 9% decrease in area under the curve (AUC).
Slovenian: Vnos TMZ s hrano je povzročil 33 odstotno zmanjšanje vrednosti Cmax in 9 odstotno zmanjšanje površine pod krivuljo (AUC).
English: Temozolomide Teva treatment can cause a reduction in certain kinds of blood cells.
Slovenian: Uporaba zdravila Temozolomide Teva lahko povzroči zmanjšanje števila nekaterih vrst krvnih celic.
English: TMZ dose levels are listed in Table 2.
Slovenian: Ravni odmerkov TMZ so navedene v razpredelnici 2.
English: If a full day has gone by, check with your doctor.
Slovenian: Če je pretekel ves dan, se posvetujte z zdravnikom.
English: There are no data in pregnant women.
Slovenian: O uporabi zdravila pri nosečnicah ni podatkov.
English: The incidence of severe nausea and vomiting was 4%.
Slovenian: Incidenca hude navzeje in bruhanja je bila 4-odstotna.
English: The following side effects may occur, and may require medical attention.
Slovenian: Lahko se pojavijo naslednji neželeni učinki, zaradi katerih boste morda potrebovali zdravniško pomoč.
English: Errors in how you take this medicine may have serious health consequences.
Slovenian: Če se pri jemanju zdravila zmotite, s tem tvegate hude zdravstvene posledice.
English: In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
Slovenian: Če zdravilo tako vpliva na vas, ne smete voziti in uporabljati orodij ali strojev ali se voziti s kolesom, dokler ne ugotovite, kako to zdravilo vpliva na vas (glejte poglavje 4).
English: The presence of thrombocytopenia may increase the risk of bleeding, and the presence of neutropenia or leukopenia may increase the risk of infection.
Slovenian: Prisotnost trombocitopenije lahko poveča tveganje za krvavitve, medtem ko lahko prisotnost nevtropenije ali levkopenije poveča tveganje za okužbo.
English: Colour/marking
Slovenian: jakost barva/oznake
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks.
Slovenian: Mielosupresija je bila predvidljiva (ponavadi v prvih nekaj ciklih zdravljenja, z najnižjimi vrednostmi med 21. in 28. dnem), okrevanje pa hitro, ponavadi v enem do dveh tednih.
English: Rats appear to be particularly sensitive to oncogenic effects of TMZ, with the occurrence of first tumours within 3 months of initiating dosing.
Slovenian: Kaže, da so podgane še posebej občutljive za onkogene učinke TMZ - prvi tumorji se pojavijo v treh mesecih po začetku odmerjanja.
English: This is bedcause you must not be treated with Temozolomide Teva during pregnancy unless clearly indicated by your doctor.
Slovenian: To morate storiti zato, ker se med nosečnostjo ne smete zdraviti z zdravilom Temozolomide Teva, razen če vam je to izrecno predpisal vaš zdravnik.
English: TMZ + concomitant RT n=288*
Slovenian: TMZ + sočasno obsevanje n = 288*
English: Therefore, special care should be taken when TMZ is administered in elderly patients.
Slovenian: Zato je potrebna posebna previdnost, kadar se TMZ daje starejšim bolnikom.
English: Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Slovenian: Sočasno uporabo z valprojsko kislino so povezali z majhnim, vendar statistično pomembnim zmanjšanjem očistka TMZ.
English: You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Slovenian: Ta odmerek boste jemali 42 dni (do 49 dni) vsak dan, v kombinaciji z obsevanjem.
English: In very rare cases, patients taking Temozolomide Teva and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Slovenian: Pri zelo redkih bolnikih, ki uporabljajo Temozolomide Teva in podobna zdravila, obstaja majhno tveganje za razvoj sekundarnega raka, tudi levkemije.
English: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Slovenian: Menijo, da je citotoksičnost MTIC predvsem posledica alkilacije DNA, v glavnem na položajih gvanina O6 in N7.
English: Recurrent anaplastic astrocytoma
Slovenian: Ponavljajoč se anaplastični astrocitom
English: TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see sections 4.8).
Slovenian: TMZ ima blag vpliv na sposobnost vožnje in upravljanja s stroji zaradi utrujenosti in zaspanosti (glejte poglavje 4.8).
English: If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Slovenian: Če se odmerek ni povečal v drugem ciklu, se ne sme niti v naslednjih.
English: However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
Slovenian: Vendar, ker se TMZ ne presnavlja v jetrih in ker se v majhni meri veže na beljakovine, ni verjetno, da bi vplival na farmakokinetiko drugih zdravil (glejte poglavje 5.2).
English: A treatment cycle with Temozolomide Teva lasts 28 days.
Slovenian: Cikel zdravljenja z zdravilom Temozolomide Teva obsega 28 dni.
English: There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Slovenian: PCP je lahko pogostejša, če se TMZ uporablja v daljšem režimu odmerjanja.
English: Dose levels include 100 mg/m², 150 mg/m², and 200 mg/m².
Slovenian: Ravni odmerkov vključujejo 100 mg/m², 150 mg/m² in 200 mg/m².
English: Most of the toxicity showed evidence of reversibility, except for adverse events on the male reproductive system and retinal degeneration.
Slovenian: Za večino toksičnih učinkov so našli dokaze o reverzibilnosti, razen za neželene učinke na moške razmnoževalne organe in za degeneracijo mrežnice.
English: If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Slovenian: Če je treba pretehtati možnost uporabe med nosečnostjo, mora biti bolnica seznanjena z morebitnim tveganjem za plod.