FrancophonIA/ELRC3.0 huggingface dataset:
English: Increases in postimplantation loss, reduced foetal body weights and decreased litter sizes together with increases in the number of malformations (gross external, soft tissue) and skeletal alterations (including retarded ossification) were reported in rats receiving doses which produced approximately 2 to 3 fold the clinical exposure (54 mg/m2/day) and in rabbits receiving 12 mg/m 2/day clofarabine.
Slovenian: Pri podganah, ki so prejemale odmerke, ki so bili približno 2- do 3-krat večji od klinične izpostavljenosti (54 mg/m2/dan), ter pri kuncih, ki so prejemali 12 mg klofarabina/m2/dan, so poročali o povečanju postimplantacijske izgube, zmanjšanju telesne mase ploda in zmanjšanju velikosti mladičev, skupaj s povečanjem števila malformacij (zunanje, mehka tkiva) ter spremembami na skeletu (vključno z zaostalo osifikacijo).
English: Other medicines and Evoltra
Slovenian: Shranjevanje zdravila Evoltra
English: Evoltra 1 mg/ml concentrate for solution for infusion clofarabine
Slovenian: Evoltra 1 mg/ml koncentrat za raztopino za infindiranje klofarabin
English: Each 20 ml vial contains 20 mg of clofarabine
Slovenian: Ena 20 ml viala vsebuje 20 mg klofarabina
English: Plasma protein binding Serum albumin Elimination:  half-life of clofarabine
Slovenian: Vezava na beljakovine v plazmi Serumski albumin
English: Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine
Slovenian: Predlagane razredčitve za priporočeni odmerek 52 mg klofarabina/m2/dan Telesna površina (m2)
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Stopnja skupne remisije (SR)
English: Twentythree patients out of 115 experienced a vascular disorder considered to be related to clofarabine, the most frequently reported being flushing (13 events; not serious) and hypotension (5 events; all of which were considered to be serious; see section 4.4).
Slovenian: Najpogosteje so poročali o oblivanju (13 dogodkov; niso bili resni) in hipotenziji (5 dogodkov; vsi so bili ocenjeni kot resni; glejte poglavje 4.4).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: What Evoltra contains
Slovenian: Kaj vsebuje zdravilo Evoltra
English: • Recovery of peripheral counts (platelets  100 x 10
Slovenian: • periferna obnovitev števila krvnih celic (trombociti  100 x 109/l in ANC  1,0 x 109/l)
English: Patients who did not undergo transplant CR
Slovenian: bolniki brez presaditve
English: Each ml of concentrate contains 1 mg of clofarabine.
Slovenian: En ml koncentrata vsebuje 1 mg klofarabina.
English: Renal failure or acute renal failure have been observed as a consequence of infections, sepsis and tumour lysis syndrome (see section 4.8).
Slovenian: Kot posledico okužb, sepse in sindroma lize tumorja so opazili odpoved ledvic ali akutno odpoved ledvic (glejte poglavje 4.8).
English: The liver is a potential target organ for clofarabine toxicity and 25.2% of patients experienced at least one hepato-biliary disorders adverse event (see sections 4.3 and 4.4).
Slovenian: Pri 25,2 % bolnikov je prišlo do vsaj enega neželenega dogodka bolezni jeter, žolčnika in žolčevodov (glejte poglavji 4.3 in 4.4).
English: Clofarabine should be discontinued immediately if substantial increases in creatinine, liver enzymes and/or bilirubin are observed.
Slovenian: Če opazite znatno povečanje kreatinina, jetrnih encimov in/ali bilirubina, morate zdravljenje s klofarabinom takoj prekiniti.
English: Occurrences of enterocolitis, including neutropaenic colitis, caecitis, and C. difficile colitis have been reported during treatment with clofarabine.
Slovenian: Med zdravljenjem s klofarabinom so poročali o pojavih enterokolitisa, vključno z nevtropeničnim kolitisom, tifilitisom in kolitisom zaradi C. difficile.
English: Evoltra 1 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Evoltra 1 mg/ml koncentrat za raztopino za infundiranje
English: Special precautions for administration
Slovenian: Posebni pogoji za ravnanje
English: Τηλ: +30 210 900 1600
Slovenian: Sanofi-Aventis AEBE Τηλ: +30 210 900 1600
English: What Evoltra looks like and contents of the pack Evoltra is a concentrate for solution for infusion.
Slovenian: Zdravilo Evoltra je koncentrat za raztopino za infundiranje.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 20 mg/20 ml
English: Severe bone marrow suppression, including neutropaenia, anaemia and thrombocytopaenia have been observed in patients treated with clofarabine.
Slovenian: Pri bolnikih, ki so jih zdravili s klofarabinom, so opazili hudo supresijo kostnega mozga, vključno z nevtropenijo, anemijo in trombocitopenijo.
English: Neoplasms benign and malignant (including cysts and polyps) and Immune systems disorders Administration of clofarabine results in a rapid reduction in peripheral leukaemia cells.
Slovenian: Benigne in maligne novotvorbe (vključno s cistami in polipi) in bolezni imunskega sistema
English: The active substance is clofarabine.
Slovenian: Zdravilna učinkovina je klofarabin.
English: Children and adolescents (≥ 1 year old) The recommended dose in monotherapy is 52 mg/m of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Slovenian: Priporočeni odmerek za monoterapijo je 52 mg/m2 telesne površine, dane v obliki intravenske infuzije;
English: CR
Slovenian: DR
English: Further to that the results of the SALT study became available.
Slovenian: Po tem so postali razpoložljivi tudi rezultati študije SALT.
English: This referral procedure was concluded in 2004 (European Commission decision issued on 26 April 2004) and the product information was subsequently updated.
Slovenian: Napotitveni postopek je bil zaključen leta 2004 (Evropska komisija je izdala odločbo dne 26. aprila 2004), informacije o zdravilu pa so bile naknadno posodobljene.
English: This signal could possibly be due to environmental, genetic factors involved and it remains to be explained.
Slovenian: Ta znak bi bil morda lahko posledica okoljskih ali genskih dejavnikov in ga je treba še pojasniti.
English: Nimesulide-containing medicinal products for systemic use are currently authorised in 17 Member States on prescription only and marketed in 15 Member States (Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia).
Slovenian: Zdravila, ki vsebujejo nimesulid za sistemsko uporabo, so trenutno odobrena v 17 državah članicah samo na recept, tržijo pa se v 15 državah članicah (Bolgarija, Češka, Ciper, Francija, Grčija, Madžarska, Italija, Latvija, Litva, Malta, Poljska, Portugalska, Romunija, Slovaška in Slovenija).
English: In the remaining Member States the exposure appears relatively stable over time.
Slovenian: V ostalih državah je izpostavljenost v tem času relativno stabilna.
English: However, it must be noted that no direct comparisons are available, and confidence intervals are overlapping considerably.
Slovenian: Treba je tudi upoštevati, da ni na voljo nobenih neposrednih primerjav, intervali zaupanja pa se pomembno prekrivajo.
English: It was noted that the majority of hepatic disorders (56%) occurred after two weeks of treatment.
Slovenian: Ugotovljeno je bilo, da se je večina jetrnih motenj (56 %) pojavila dva tedna po zdravljenju.
English: Patient's exposure has been decreasing over the recent years following the outcomes of the previous reviews under Article 31 and Article 107.
Slovenian: Izpostavljenost bolnikov se je v zadnjih letih po izidih preteklih pregledov v skladu s členom 31 in členom 107 zmanjševala.
English: Nevertheless, the SALT study did confirm the signal seen in Ireland which was not seen in any other country involved in the study.
Slovenian: Kljub temu pa je študija SALT potrdila opozorilni znak, ki so ga opazili na Irskem in ni bil opažen v nobeni drugi državi, ki je bila vključena v študijo.
English: The absolute risk for acute liver failure indicated for transplantation is 5.64 [2.43-11.11] per million person-years and 5.90 per billion DDDs (defined daily doses).
Slovenian: Absolutno tveganje za akutno odpoved jeter, pri kateri je potrebna presaditev, je 5,64 [2,4311,11] na milijon oseb/let in 5,90 na milijardo DDO (določenih dnevnih odmerkov).
English: The CHMP reviewed the data submitted by the marketing authorisation holders from clinical and non-clinical studies, epidemiological studies and spontaneous reports.
Slovenian: CHMP je preučil podatke, ki so jih predložili imetniki dovoljenj za promet z zdravili, iz kliničnih in nekliničnih študij, epidemioloških študij in spontanih poročil.
English: In this regard the SALT study was a key piece of data expected to provide further insight.
Slovenian: V tem smislu naj bi študija SALT zagotovila ključne podatke za nadaljnji vpogled.
English: Overall summary of the scientific evaluation of nimesulide-containing medicinal products for systemic use (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil za sistemsko uporabo, ki vsebujejo nimesulid (glejte Dodatek I)
English: The absolute risk for hospital admission for hepatoxicity is approximately 30-35 per 100,000 person-years and the absolute risk for abnormal liver function tests is approximately 1%.
Slovenian: Absolutno tveganje za sprejem v bolnišnico zaradi toksičnosti jeter je med 30-35 na 100 000 oseb/let, absolutno tveganje za neobičajne vrednosti preiskav jetrne funkcije pa je približno 1 %.
English: Restriction of the maximum dose to 100 mg twice daily (with withdrawal of the marketing authorisations for the 200 mg), restriction of the therapeutic indications to the three above mentioned and warnings, precaution for use and contraindications were introduced.
Slovenian: Omejitev največjega odmerka na 100 mg dvakrat na dan (z umikom dovoljenj za promet z zdravilom za odmerek 200 mg), omejitev terapevtskih indikacij na tri zgoraj navedene, sprejeta pa so bila opozorila, previdnostni ukrepi pri uporabi in kontraindikacije.
English: Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with preferred COX-2 inhibition authorised in Europe since 1985.
Slovenian: Nimesulid je nesteroidno protivnetno zdravilo (NSAID), selektivni zaviralec COX-2, ki je v Evropi odobreno od leta 1985.
English: On 19 January 2010, the European Commission triggered a referral under Article 31 of Directive 2001/83/EC requesting the CHMP to give its opinion on whether the marketing authorisations for medicinal products containing nimesulide for systemic use should be maintained, varied, suspended or withdrawn.
Slovenian: Evropska komisija je dne 19. januarja 2010 sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES, s katero je CHMP zaprosila, naj poda mnenje, ali naj se dovoljenja za promet z zdravili, ki vsebujejo nimesulid za sistemsko uporabo, ohranijo, spremenijo, začasno umaknejo ali prekličejo.
English: Poland, France and Greece.
Slovenian: Največja izpostavljenost je opažena v Italiji, na Poljskem, v Franciji in Grčiji.
English: It is noted that 23% of the hepatic cases reported for nimesulide involved patients treated for more chronic indications.
Slovenian: Ugotovljeno je bilo, da so v 23 % primerov v zvezi z jetri, o katerih so poročali pri uporabi nimesulida, bolnike zdravili za bolj kronične indikacije.
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, for medicinal products containing nimesulide for systemic use.
Slovenian: • Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo nimesulid za sistemsko uporabo.
English: Nimesulide efficacy in the treatment of pain associated with several inflammatory and painful disorders has been shown in mostly short-term studies (up to four weeks) with limited numbers of patients.
Slovenian: Učinkovitost nimesulida pri zdravljenju bolečine, povezane z različnimi vnetji in bolečimi motnjami, je bila dokazana v večinoma kratkotrajnih študijah (do štiri tedne) z omejenim številom bolnikov.
English: It is indicated as second line treatment for acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea.
Slovenian: Indicirano je kot zdravilo drugega izbora za zdravljenje akutne bolečine, simptomatično zdravljenje bolečega osteoartritisa in primarne dismenoreje.
English: • The Committee considered all the available data submitted on the safety and the efficacy of nimesulide-containing products for systemic use.
Slovenian: • Odbor je upošteval vse razpoložljive podatke, predložene glede varnosti in učinkovitosti zdravil, ki vsebujejo nimesulid, za sistemsko uporabo.
English: Therefore the committee concluded that nimesulide use should be restricted to acute conditions only i.e. treatment of acute pain and primary dysmenorrhoea.
Slovenian: Zato je odbor sklenil, da je treba uporabo nimesulida omejiti na akutna stanja, to je samo za zdravljenje akutne bolečine in primarne dismenoreje.
English: As discussed throughout the assessment report, the SALT study presented several limitations such as small number of identified cases, all severe cases are of acute liver failure and very wide confidential intervals making the results not being robust.
Slovenian: V študiji SALT je bilo predstavljenih več omejitev, kot je na primer majhno število ugotovljenih primerov; vsi hudi primeri so akutne okvare jeter in zelo široki intervali zaupanja, kar je bilo navedeno tudi v celotnem poročilu o oceni in zaradi česar rezultati niso trdni.
English: Nimesulide is associated with an increased risk of hepatotoxicity versus no-use or past use.
Slovenian: Nimesulid se povezuje s povečanim tveganjem toksičnosti za jetra v primerjavi z njegovo neuporabo ali uporabo v preteklosti.
English: Furthermore, the limitations of the current available data lead to uncertainties on hepatotoxicity, and concerns remain especially with prolonged use of nimesulide.
Slovenian: Omejenost trenutno razpoložljivih podatkov sproža negotovosti glede toksičnosti za jetra in zato ostajajo zadržki predvsem pri podaljšani uporabi nimesulida.
English: The risk of gastrointestinal complications due to nimesulide is lower than for ketorolac, piroxicam, indomethacin and azopropazone, but not proven to be consistently different from other NSAIDs such as celecoxib, ibuprofen, naproxen, ketoprofen, diclofenac, sulindac and meloxicam.
Slovenian: Tveganje za zaplete v prebavilih zaradi nimesulida je nižje kot pri ketoralaku, piroksikami, indometacinu in azoproprazonu, vendar se dokazano ne razlikuje od drugih nesteroidnih protivnetnih zdravil, kot so celekoksib, ibuprofen, naproksen, ketoprofen, diklofenak, sulindak in meloksikam.
English: The recommended dosage is 100 mg twice daily and the maximum duration of treatment is 15 days with the shortest duration of treatment recommended to minimise the occurrence of side effects.
Slovenian: Priporočeni odmerek je 100 mg dvakrat na dan, zdravljenje pa lahko traja največ 15 dni, pri čemer je priporočeno kar najkrajše zdravljenje za zmanjšanje pojavljanja neželenih učinkov.
English: • Considering the maximum duration of 15 days of treatment to minimise the risk for hepatotoxicity and aiming a further minimisation of the risks associated with nimesulide, the Committee considered that nimesulide use should be restricted to acute conditions only i.e. treatment of acute pain and primary dysmenorrhoea.
Slovenian: • Ob upoštevanju najdaljšega časa zdravljenja 15 dni za čim večje zmanjšanje tveganja toksičnosti za jetra in z namenom nadaljnjega zmanjševanja tveganj, povezanih z nimesulidom, je Odbor menil, da je treba uporabo nimesulida omejiti samo na akutna stanja, to je za zdravljenje akutne bolečine in primarne dismenoreje.
English: Data available including a new epidemiological study (FVG GI study) confirms that all NSAIDs can induce damage to the gastroduodenal mucosa and increase the risk of upper gastrointestinal complications (UGIC).
Slovenian: Razpoložljivi podatki, vključno z rezultati nove epidemiološke študije (študija FVG GI), potrjujejo, da lahko vsa nesteroidna protivnetna zdravila povzročijo poškodbe sluznice želodca in dvanajstnika ter povečano tveganje za zaplete v zgornjih prebavilih (UGIC).
English: In May 2007, following new information regarding cases of fulminant hepatic failure associated with the use of nimesulide, Ireland suspended the marketing authorisations for all systemic medicinal products containing nimesulide and a procedure under Article 107 was started.
Slovenian: Maja 2007 je Irska po novih informacijah o primerih fulminantne odpovedi jeter, povezanih z uporabo nimesulida, začasno umaknila dovoljenja za promet z vsemi sistematskimi zdravili, ki vsebujejo nimesulid, in sprožen je bil postopek v skladu s členom 107.
English: The hepatotoxic profile compared to ibuprofen varies from worse in spontaneous reports, to comparable with respect to hospitalisations for liver injury or slightly better with respect to severe liver injury requiring transplant.
Slovenian: Profil toksičnosti za jetra je v primerjavi z ibuprofenom različen; v spontanih poročilih je slabši, medtem ko je primerljiv glede na hospitalizacije zaradi poškodb jeter ali celo boljši glede na hude okvare jeter, ki zahtevajo presaditev.
English: Although there are some results of clinical studies that may suggest rapid onset of analgesic action associated with the use of nimesulide compared with other NSAIDs, the clinical relevance of the measured differences in onset of pain relief is doubtful.
Slovenian: Čeprav nekateri rezultati kliničnih študij morda nakazujejo hiter začetek protibolečinskega delovanja, povezanega z uporabo nimesulida, v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili, pa je klinični pomen ugotovljenih razlik glede ublažitve bolečin vprašljiv.
English: Overall nimesulide is at least as effective as other NSAIDs in short-term use indications for pain.
Slovenian: Na splošno je nimesulid najmanj tako učinkovit kot druga nesteroidna protivnetna zdravila pri indikacijah za kratkotrajno uporabo za lajšanje bolečin.
English: • The Committee considered that evidence of the clinically efficacy of nimesulide-containing products for systemic use in the indications for short-term treatment has been shown.
Slovenian: • Odbor je menil, da je bila klinična učinkovitost zdravil, ki vsebujejo nimesulid, za sistemsko uporabo pri indikacijah za kratkotrajno zdravljenje, dokazana.
English: It was concluded that the risk-benefit balance remained positive subject to amendments to the Marketing Authorisations, including introduction of restrictions for the safe use of the products.
Slovenian: Sklenjeno je bilo, da razmerje med koristmi in tveganjem ostane pozitivno, vendar z dopolnili dovoljenj za promet z zdravilom, vključno z novimi omejitvami za varno uporabo zdravil.
English: Scientific conclusions and grounds for the amendments of the Summary of Product Characteristics and Package Leaflet presented by the EMA
Slovenian: Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodil za uporabo, ki jih je predstavila Evropska agencija za zdravila
English: Data suggests that that the renal safety for nimesulide is comparable to other NSAIDs and also comparable or slightly favourable with regards to skin, immunological and nervous system safety.
Slovenian: Podatki kažejo, da je varnost za ledvice pri nimesulidu primerljiva z drugimi nesteroidnimi protivnetnimi zdravili, prav tako pa je primerljiva ali nekoliko boljša varnost za kožo ter za imunski in živčni sistem.
English: The hepatoxicity of nimesulide was previously assessed under the Article 107 procedure triggered by the new information regarding cases of fulminant hepatic failure associated with its use in Ireland and the consequent suspension of the marketing authorisations for nimesulide in that Member State.
Slovenian: Toksičnost nimesulida za jetra je bila predhodno ocenjena v postopku v skladu s členom 107, ki so ga sprožile nove informacije o primerih fulminantnih okvar jeter, povezanih z njegovo uporabo na Irskem in posledičnim začasnim umikom dovoljenj za promet z zdravili, ki vsebujejo nimesulid, v tej državi članici.
English: Therefore, the CHMP recommended the variation to the terms of the Marketing Authorisations for nimesulide-containing medicinal products for systemic use referred in Annex I, subject to the conditions set out in Annex IV and for which the amendments of the Summary of Product Characteristics and Package Leaflet are set out in Annex III.
Slovenian: Zato je Odbor priporočil spremembo pogojev za dovoljenja za promet z zdravili, ki vsebujejo nimesulid in so navedena v Dodatku I, za sistemsko uporabo v skladu s pogoji, navedenimi v Dodatku IV, in za katere so dopolnitve za povzetek glavnih značilnosti zdravila in navodila za uporabo navedeni v Dodatku III.
English: Further to consideration of all data available at that time, it was concluded that the incidence of hepatic reactions associated with nimesulide treatment was slightly higher when compared to other NSAIDs but that there was no increased incidence in severe hepatic reactions.
Slovenian: Po preučitvi vseh podatkov, ki so bili takrat na voljo, je bilo ugotovljeno, da je pojavnost jetrnih reakcij, povezanih z zdravljenjem z nimesulidom, nekoliko večja v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili, ni pa bilo povečane pojavnosti pri hudih jetrnih reakcijah.
English: Moreover, considering that the review and assessment of the available data for nimesulide under the Article 107 focused on the hepatic safety of nimesulide and that only limited information regarding the gastrointestinal toxicity profile of nimesulide was considered, it was agreed that a full risk-benefit assessment should be conducted in the framework an Article 31 procedure, where the risks of nimesulide should be weighted vis-à-vis the gastrointestinal risks of other NSAIDs.
Slovenian: Ob upoštevanju, da so se v pregledu in oceni razpoložljivih podatkov za nimesulid v skladu s členom 107 osredotočili posebno na varnost nimesulida za jetra ter da so bile obravnavane samo omejene informacije glede toksičnega profila nimesulida za prebavila, je bilo sklenjeno, da se celovita ocena razmerja med koristmi in tveganjem izvede po postopku v skladu s členom 31, pri čemer je treba tveganja, povezana z nimesulidom, pretehtati glede na tveganja za prebavila pri drugih nesteroidnih protivnetnih zdravilih.
English: • The Committee, in light of the above, considered that there is a risk of chronic use of nimesulide in “symptomatic treatment of painful osteoarthritis” and concludes that the riskbenefit balance of nimesulide-containing medicinal products for systemic use is no longer favourable in this indication.
Slovenian: • Ob upoštevanju navedenega je Odbor menil, da obstaja tveganje pri kronični uporabi nimesulida pri „simptomatskem zdravljenju bolečega osteoartritisa“, in sklenil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo nimesulid za sistemsko uporabo, za to indikacijo ni več ugodno.
English: No unequivocal and clinically meaningful advantage over other NSAIDs has been demonstrated and, therefore the Committee considered the efficacy of nimesulide to be similar to other NSAIDs available.
Slovenian: Dokazana ni bila nobena nedvoumna in klinično pomembna prednost v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili in zato je Odbor menil, da je učinkovitost nimesulida podobna učinkovitosti drugih nesteroidnih protivnetnih zdravil, ki so na voljo.
English: There is an increased risk of hepatoxicity associated with nimesulide whose magnitude still raises uncertainties.
Slovenian: Obstaja povečano tveganje toksičnosti za jetra, povezano z nimesulidom, obseg tveganja pa je še vedno negotov.