FrancophonIA/ELRC3.0 huggingface dataset:
English: In relation to lactation, information on the fact that etoposide is excreted in the milk (Medications and Mothers' Milk: Thomas W. Hale) has been added.
Croatian: U pogledu dojenja, dodana je informacija o činjenici da se etopozid izlučuje u mlijeko (Thomas W. Hale: Lijekovi i majčino mlijeko).
English: The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
Croatian: Sljedeća posebna upozorenja i mjere opreza pri uporabi usklađeni su u dijelu 4.4., u koji su već bili uvršteni u nekim ili većini nacionalnih SmPC-ova: mijelosupresija, sekundarna leukemija, preosjetljivost, reakcija na mjestu primjene injekcije, niska razina serumskog albumina, oštećena funkcija bubrega i jetre, sindrom lize tumora i mutageni potencijal.
English: In renal impairment (creatinine clearance (CrCl) 15-50 mL/min) a dose reduction of 25% is recommended.
Croatian: Kod oštećene funkcije bubrega (klirens kreatinina (CrCl) 15-50 mL/min) preporučuje se smanjenje doze za 25 %.
English: Paediatric indications were agreed in the following indications:
Croatian: Indikacije za pedijatrijsku populaciju usuglašene su za sljedeće indikacije:
English: Kintzel PE, Dorr RT. Anticancer drug reanl toxicity and elimination: dosing guidelines for altered renal function.
Croatian: Anticancer drug reanl toxicity and elimination: dosing guidelines for altered renal function.
English: In paediatric patients diagnosed with Hodgkin's lymphoma, non-Hodgkin's lymphoma or acute myeloid leukaemia, the CHMP recommended the range of 75 to 150 mg/ m2/day for 2 to 5 days in combination with other antineoplastic agents as supported in studies conducted by major international groups such as The German Society of Paediatric Oncology and Haematology Hodgkin's Disease, The Children's Cancer Group and The European Organization of Research and Treatment of Cancer Children Leukaemia Group among others.
Croatian: Kod pedijatrijskih bolesnika kojima je dijagnosticiran Hodgkinov limfom, ne-Hodgkinov limfom ili akutna mijeloična leukemija, CHMP preporučuje primjenu lijeka u rasponu od 75 do 150 mg/m2/dan kroz 2 do 5 dana u kombinaciji s drugim antineoplastičnim lijekovima, što potkrijepljuju ispitivanja koja su provela velika međunarodna udruženja, kao što su Njemačko društvo za pedijatrijsku onkologiju i hematološku Hodgkinovu bolest, Udruženje za djecu oboljelu od raka, Europska organizacija za istraživanje i liječenje raka, Udruženje za djecu oboljelu od leukemije.
English: - Ovarian cancer: non-epithelial ovarian cancer and platinum-resistant/refractory epithelial ovarian cancer
Croatian: - rak jajnika: ne-epitelijalni karcinom jajnika i rak jajnika otporan na platinu / refraktorni epitelijalni karcinom jajnika
English: Etoposide is a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals.
Croatian: Etopozid je polusintetički derivat podofilotoksina koji raskida dvolančanu DNK interakcijom s DNKtopoizomerazom tipa II ili stvarajući slobodne radikale.
English: The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Etopophos and associated names (see Annex I).
Croatian: CHMP je preporučio izmjene uvjeta za izdavanje odobrenja za stavljanje lijeka u promet, za koje su informacije o lijeku utvrđene u Prilogu III. za lijek Etopophos i srodne lijekove (vidjeti Prilog I.).
English: - Gestational trophoblastic neoplasia
Croatian: - gestacijska trofoblastična neoplazija
English: This has been addressed by a warning in section 4.2 of the SmPC.
Croatian: Na to se već poziva upozorenje u dijelu 4.2. SmPC-a.
English: • The scope of the referral was the harmonisation of the product information,
Croatian: • Područje primjene upućivanja bilo je usklađivanje informacija o lijeku.
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC
Croatian: Direktive 2001/83/EZ.
English: In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[1][2][3][4][5].
Croatian: Kod bolesnika s oštećenjem funkcije bubrega, CHMP se složio da se ne preporučuje smanjenje doze ako je klirens kreatinina > 50 mL/min što je potkrijepljeno u dostupnoj literaturi1][2][3][4][5].
English: The data in literature for patients with CrCl less than 15 mL/min and on dialysis strongly suggest that further dose reduction is required in these patients as reviewed by Inoue et al. (2004)[6].
Croatian: Podatci iz literature za bolesnike s CrCl-om manjim od 15 mL/min i na dijalizi, jasno sugeriraju dodatno smanjenje doze prema reviziji koju su izradili Inoue i suradnici. (2004.)[6].
English: The MAH also discussed a dose reduction for patients with end stage renal disease (CrCl < 15mL/min).
Croatian: Podnositelj zahtjeva također je raspravljao o smanjenju doze za bolesnike u terminalnoj fazi bolesti bubrega (CrCl < 15 mL/min).
English: As regards the posology, section 4.2 of the SmPC, the doses were harmonised for all indications and patient populations - adult and paediatric.
Croatian: U pogledu dijela 4.2. SmPC-a „Doziranje i način primjene”, doze su usklađene za sve indikacije i populacije bolesnika, odrasle i pedijatrijske.
English: As immunosuppression is a very common side effect of etoposide, concomitant use of live vaccines has been added as a contraindication, which is in line as well with the guideline on SmPC.
Croatian: S obzirom na to da etopozid vrlo često ima imunosupresivno djelovanje, istodobna primjena živih cjepiva dodana je kao kontraindikacija, što je u skladu sa smjernicama o SmPC-u.
English: • The Committee considered the divergences identified in the notification for Etopophos and associated names, as well as the remaining sections of the product information.
Croatian: • Odbor je u obzir uzeo utvrđene razlike u prijavi za lijek Etopophos i srodne lijekove, kao i u preostalim dijelovima informacija o lijeku.
English: However, the treatment regimen and posology in these paediatric indications should be chosen according to the local standard of care.
Croatian: Međutim, plan liječenja te doziranje i način primjene kod pedijatrijskih bolesnika potrebno je uskladiti s lokalnim standardima zdravstvene zaštite.
English: Journal of Clinical Oncology 1986; 4(11): 1690-1695.
Croatian: Journal of Clinical Oncology 1986.; 4(11): 1690-1695 3 Toffoli G., Corona G., Basso B. et al.
English: Etopophos and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC.
Croatian: Lijek Etopophos i srodni lijekovi uvršteni su na popis lijekova za usklađivanje sažetaka opisa svojstava lijeka (SmPC), koji sastavlja Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), u skladu s člankom 30. stavkom 2. Direktive 2001/83/EZ.
English: With regards to fertility, pregnancy and lactation section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included.
Croatian: U pogledu plodnosti, trudnoće i dojenja, u dio 4.6. SmPC-a uvrštene su informacije koje se odnose na žene u reproduktivnoj dobi u pogledu kontracepcije kod muškaraca i žena.
English: Etoposide phosphate injection is supplied as a nonpyrogenic lyophilized powder intended for reconstitution and/or dilution with a suitable parenteral vehicle prior to intravenous (IV) administration and is available as 114 mg etoposide phosphate (100 mg etoposide equivalent) single dose sterile vial and 1140 mg etoposide phosphate (1000 mg etoposide equivalent) pharmacy bulk vial (Germany only).
Croatian: Injekcija etopozid fosfata izdaje se u obliku nepirogenog liofiliziranog praška namijenjenoga za rekonstituciju ili razrjeđivanje s kompatibilnim parenteralnim sredstvom prije intravenozne (IV) primjene i dostupna je u jednodoznoj sterilnoj bočici koja sadrži 114 mg etopozid fosfata (što odgovara količini od 100 mg etopozida) i farmaceutskoj višedoznoj bočici koja sadrži 1140 mg etopozid fosfata (što odgovara količini od 1000 mg etopozida) (samo u Njemačkoj).
English: Finally, lactation has also been included as a contraindication with a reference to section 4.6 of the SmPC where lactation is further described.
Croatian: Konačno, dojenje je također uneseno kao kontraindikacija upućivanjem na dio 4.6. SmPC-a u kojem je dojenje detaljno opisano.
English: Hypersensitivity has been added as contraindication in section 4.3 of the SmPC in line with the guideline on SmPC.
Croatian: Preosjetljivost je dodana kao kontraindikacija u dio 4.3. SmPC-a u skladu sa smjernicama o SmPC-u.
English: Etopophos contains etoposide phosphate, a pro-drug of etoposide which is rapidly converted to etoposide in vivo.
Croatian: Lijek Etopophos sadržava etopozid fosfat, prolijek etopozida koji se in vivo brzo pretvara u etopozid.
English: The CHMP as a consequence, concluded that the benefit-risk balance of Etopophos and associated names remains favourable, subject to the agreed changes to the product information.
Croatian: CHMP slijedom toga zaključuje da omjer koristi i rizika za lijek Etopophos ostaje povoljan pod uvjetom da se u informacije o lijeku unesu dogovorene izmjene.
English: • The committee agreed on a harmonised product information for Etopophos and associated names.
Croatian: • Odbor se usuglasio oko usklađenih informacija o lijeku za lijek Etopophos i srodne lijekove.
English: As breastfeeding women could replace breastfeeding by dairy products to feed their child the text has been amended accordingly.
Croatian: Tekst je izmijenjen s obzirom na činjenicu da dojilje mogu zamijeniti dojenje mliječnim pripravcima pri hranjenju svog djeteta.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Etopophos and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU.
Croatian: Zbog različitih odluka na nacionalnoj razini koje su donijele države članice u pogledu odobrenja za ovaj proizvod, Europska je komisija 14. listopada 2015. obavijestila CHMP / Europsku agenciju za lijekove o pokretanju službenog postupka upućivanja za lijek Etopophos i srodne lijekove u skladu s člankom 30.
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Croatian: Izmjene sažetka opisa svojstava lijeka koje su bitne za korisnike navedene su i u uputi o lijeku te ih je podržao CHMP.
English: • The Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Croatian: • Odbor je ponovno pregledao sve podatke koje je u prilog predloženog usklađenja informacija o lijeku dostavio nositelj odobrenja za stavljanje lijeka u promet.
English: The recommended dose in adult patients is 50 to 100 mg/m2/day on days 1 to 5 in line with the current clinical practice guidelines, however when administered on three days (e.g. days 1, 3, and 5) the daily dose that is most commonly used can be either 100 to 120 mg/m2 every 3 to 4 weeks in combination with other drugs indicated in the disease to be treated.
Croatian: Preporučena doza za odrasle bolesnike iznosi od 50 do 100 mg/m2/dan od 1. do 5. dana u skladu s postojećim smjernicama kliničke prakse, međutim kada se primjenjuje kroz tri dana (npr. 1., 3. i 5.
English: Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
Croatian: Izmjene sažetka opisa svojstava lijeka dosljedno su se odražavale u označivanju gdje je to bitno, međutim, sadržaj većine
English: Fissell WH, IV, Earl M. Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
Croatian: Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
English: Kreusser W, Herrmann R, Tschope W, et al. Nephrological complications of cancer therapy.
Croatian: Kreusser W., Herrmann R., Tschope W., et al.
English: Etopophos is currently approved in DE, FR, SE and UK.
Croatian: Prvi je put odobren u Švedskoj 12. travnja 1996. Lijek Etopophos trenutačno je odobren u Njemačkoj, Francuskoj, Švedskoj i Ujedinjenoj Kraljevini.
English: 2 Arbuck SG, Douglass HO, Crom WR et al. Etoposide Pharmacokinetics in Patients With Normal and Abnormal Organ
Croatian: 2 Arbuck S.G., Douglass H.O., Crom W.R. et al.
English: Ann. Oncol.
Croatian: Ann.
English: Minor changes were included in the remaining sections of the SmPC.
Croatian: U ostale dijelove sažetka opisa svojstava lijeka unesene su manje izmjene.
English: 3 Toffoli G, Corona G, Basso B et al. Pharmacokinetic Optimisation of Treatment with Oral Etoposide.
Croatian: Pharmacokinetic Optimisation of Treatment with Oral Etoposide.
English: (Invented) name Strength Pharmaceutical form
Croatian: (Zaštićeno)ime Doza
English: (PAOD Stage II)
Croatian: (PAOD stupanj II)
English: The publications on clinical data are old (from 1971 up to 1995).
Croatian: Publikacije o kliničkim podacima su zastarjele (od 1971. do 1995.).
English: Available data is in fact indicative of such causal relationship.
Croatian: Dostupni podaci zapravo ukazuju na takvu uzročnu vezu.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Croatian: Istaknuta je ozbiljnost takvih štetnih događaja i njihov mogući smrtni ishod.
English: The scales used were largely based on subjective assessment rather than formal testing.
Croatian: Korištene ljestvice uvelike su se temeljile na subjektivnoj procjeni, a ne na formalnom testiranju.
English: All these old studies suffered from methodological flaws.
Croatian: Sva ova stara ispitivanja sadržavala su metodološke nedostatke.
English: It therefore remains uncertain whether the studied population in the selected clinical studies is representative of the proposed indication.
Croatian: Stoga je i dalje nejasno je li ispitana populacija u odabranim kliničkim ispitivanjima reprezentativna za predloženu indikaciju.
English: In addition, the CHMP convened another meeting of the scientific advisory group (SAG) that took place on 16 October 2013.
Croatian: Nadalje, CHMP je sazvao novi sastanak znanstvene savjetodavne skupine (SAG-a) koji je održan 16. listopada 2013.
English: Thus the demonstrated benefit for patients in the proposed indication does not outweigh the above identified risk.
Croatian: Stoga, demonstrirana korist za bolesnike u predloženoj indikaciji ne nadmašuje prethodno utvrđeni rizik.
English: In addition, both included a small number of patients (n=48 and n=62), both were short-term studies (1-5 months and 8 months, respectively) which short term duration is considered inappropriate to evaluate the outcome of slow progressing diseases.
Croatian: Uz to, oba su ispitivanja uključila mali broj bolesnika (n=48 i n=62), i oba su bila kratkotrajna ispitivanja (1-5 mjeseci, odnosno 8 mjeseci), čije se kratko trajanje smatra neprimjerenim za evaluaciju ishoda bolesti spore progresije.
English: In others, only certain points of the scale to assess efficacy were significantly improved.
Croatian: U drugima su pak značajno poboljšane samo određene točke ljestvice za procjenu djelotvornosti.
English: The MAH submitted a number of papers with efficacy clinical studies, 2 reviews (the medical letter, 1974, Mc Donald, 1979) and one Cochrane review (2009).
Croatian: Nositelji odobrenja dostavili su niz dokumenata vezanih uz klinička ispitivanja djelotvornosti, dva pregleda (liječničko pismo, 1974., Mc Donald, 1979.) i jedan Cochraneov pregled (2009.).
English: Indeed, the heterogeneity of the studies submitted is such that no firm conclusions can be drawn.
Croatian: Uistinu, heterogenost dostavljenih ispitivanja je takva da se ne mogu izvući nikakvi zaključci.
English: Following the adoption of the CHMP opinion during the June 2013 CHMP meeting, a re-examination request was received from one of the MAH involved in the procedure.
Croatian: Nakon usvajanja mišljenja CHMP-a tijekom sastanka CHMP-a u lipnju 2013., zaprimljen je zahtjev za ponovni pregled koji je dostavio jedan od nositelja uključenih u postupak.
English: Diagnostic and determination of the origin of cognitive impairments are difficult tasks for the modern medicine.
Croatian: Dijagnostika i utvrđivanje porijekla kognitivnih oštećenja teški su zadaci moderne medicine.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
Croatian: • Povjerenstvo je razmotrilo postupak u skladu s člankom 31. Direktive 2001/83/EZ za lijekove koji sadrže derivate ergota u dotičnim indikacijama.
English: These studies were of poor methodological quality: uncontrolled, open designed and without any well-defined primary efficacy endpoint.
Croatian: Ova su ispitivanja bile slabe metodološke kvalitete: nekontrolirana, otvorenog dizajna i bez bilo kakvih dobro definiranih krajnjih točaka primarne djelotvornosti.
English: Furthermore, the fact that these studies have been performed many years ago raises methodological concerns given advances in clinical research methods and the changes in the definition of dementia/ pre-dementia conditions over time.
Croatian: Nadalje, činjenica da su ova ispitivanja provedena prije mnogo godina daje povoda za metodološku zabrinutost uzimajući u obzir napredak u metodama kliničkog ispitivanja i promjene koje su nastupile tijekom vremena u definiciji demencije/stanja koja prethode demenciji.
English: Issues such as a high dropout level, unclear or subjective evaluation criterions and low number of patients also preclude a conclusion on efficacy based on these data.
Croatian: Problemi poput velikog broja odustajanja, nejasnih ili subjektivnih evaluacijskih kriterija i malog broja bolesnika također isključuju zaključak o djelotvornosti na temelju ovih podataka.
English: The Cochrane review is not relevant for the assessment as it focuses on dementia and symptoms consistent with dementia.
Croatian: Cochraneov pregled nije od značaja za procjenu jer se usredotočio na demencije i simptome konzistentne s demencijom.
English: A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Croatian: Pregled svih drugih dostupnih podataka (primjerice podataka iz literature, predkliničkih podataka i drugih kliničkih podataka uključujući podatke iz epidemioloških ispitivanja) koji su bili relevantni za procjenu rizika od fibroze prikazan je tamo gdje je bilo moguće.
English: • The Committee considered the overall submitted data and grounds provided by the MAHs and the outcome of the scientific advisory groups.
Croatian: • Povjerenstvo je uzelo u obzir ukupne podatke koje su podnijeli nositelji odobrenja i ishod vijećanja znanstvenih savjetodavnih skupina.
English: Therefore, concerns about heterogeneity of the studied population remain.
Croatian: Slijedom navedenog, i dalje ostaje zabrinutost u pogledu heterogenosti ispitane populacije.
English: The primary mechanism of action of dihydroergotoxine and other ergoloids is unclear at the present time.
Croatian: U ovom trenutku nije jasan primarni mehanizam djelovanja dihidroergotoksina i drugih ergoloida.
English: Moreover, three out of the nine cases were reported during the French Pharmacovigilance survey that was conducted in 2011 which shows that the risk minimisation measures that are currently in place are not sufficient to prevent the risk of fibrotic reactions.
Croatian: Nadalje, prijavljena su tri na devet slučaja tijekom francuskog ispitivanja na području farmakovigilancije koje je provedeno 2011., što dokazuje da trenutno primjenjive mjere za smanjivanje rizika nisu dostatne kako bi se spriječio rizik od fibrotičkih reakcija.
English: In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the medicinal product outweigh the risk.
Croatian: Kako bi se ukinula suspenzija, nositelji odobrenja moraju utvrditi specifičnu populaciju bolesnika za koje dobrobiti premašuju rizik.
English: The SAG unanimously agreed that there is no distinct clinical entity for cognitive impairment no dementia (CIND), the diagnostic criteria and definitions have changed over time and this wording does not correspond to a current clinically defined group.
Croatian: SAG se jednoglasno složio da ne postoji distinktivan klinički entitet za kognitivno oštećenje bez demencije (CIND), te da su se dijagnostički kriteriji i definicije promijenile tijekom vremena, a da ova formulacija ne odgovara trenutnoj klinički definiranoj grupi.
English: Based on the overall documentation provided, the CHMP concluded that the studies suffer from substantial methodological deficiencies which preclude any conclusion on the efficacy of the product.
Croatian: Na temelju sveukupne dostavljene dokumentacije, CHMP je zaključio da su ispitivanja sadržavala značajne metodološke nedostatke koji isključuju bilo kakav zaključak o djelotvornosti proizvoda.
English: Moreover the severity of such adverse effects, their possible fatal outcome and the raised risk for patient to develop a fibrotic disorder with long term use according to the authorised indications should be underlined.
Croatian: Štoviše, potrebno je istaknuti težinu takvih štetnih događaja, njihov potencijalno smrtonosni ishod i povećani rizik za bolesnike od razvoja fibrotičkog poremećaja uz dugotrajnu primjenu u skladu s odobrenim indikacijama.
English: In addition, severe cases of peripheral vasoconstrictive symptoms were reported in the literature.
Croatian: Nadalje, u literaturi su prijavljeni ozbiljni slučajevi perifernih vazokonstriktivnih simptoma.
English: The majority of the papers are not relevant (publications not submitted, studies were open-label, not placebo-controlled and/or with intravenous use of dihydroergotoxine mesilate).
Croatian: Većina publikacija nije relevantna (publikacije nisu dostavljene, ispitivanja su bila otvorena, nisu bila kontrolirana placebom i/ili su koristila intravenoznu primjenu dihidroergotoksin mezilata).
English: Furthermore, those reporting positive results are claiming improvement in different parameters in scales intended to capture important aspects of impaired cognition.
Croatian: Nadalje, ispitivanja koja navode pozitivne rezultate tvrde da postoji poboljšanje u različitim parametrima ljestvica čija je namjena vrednovanje važnih aspekata oštećene kognicije.
English: Five were uncontrolled, open designed, without any well-defined primary efficacy objective, and they were conducted in patients with heterogeneous ocular disorders.
Croatian: Pet ispitivanja bilo je nekontrolirano, otvorenog dizajna, bez bilo kakve dobro definirane objektivne primarne djelotvornosti, te su provedeni na bolesnicima s heterogenim poremećajima oka.
English: It acts as an agonist to dopaminergic and serotonergic receptors and an antagonist for alpha-adrenoreceptors.
Croatian: Djeluje kao agonist na dopaminergičke i serotonergičke receptore, te kao antagonist za alfaadrenoreceptore.