FrancophonIA/ELRC3.0 huggingface dataset:
English: Panniculitis*
Croatian: često panikulitis*
English: • If asymptomatic: Binimetinib should be withheld for up to 4 weeks.
Croatian: • Prva pojava nuspojava stupnja 4 Treba prekinuti binimetinib u razdoblju do 4 tjedna.
English: Probability of Overall Survival (%)
Croatian: Broj događaja (%)
English: • feeling dizzy, tired or lightheaded
Croatian: • osjećaj omaglice, umora ili ošamućenosti • nedostatak zraka
English: Renal dysfunction
Croatian: Oštećenje jetrene funkcije
English: Table 4:
Croatian: Tablica 4 i slika 1
English: The first dose is taken in the morning and the second dose in the evening around 12 hours later.
Croatian: Prva doza uzima se ujutro, a druga doza navečer, otprilike 12 sati kasnije.
English: Further information on Zelboraf can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Zelboraf možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This overview was last updated in 02-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 02. 2018.
English: The recommended dose is 960 mg (four tablets) twice daily.
Croatian: Preporučena je doza 960 mg (četiri tablete) dvaput dnevno.
English: Each dose can be taken with or without food, but Zelboraf should be taken in the same way day-to-day.
Croatian: Svaka se doza može uzimati s hranom ili bez nje, ali način svakodnevnog uzimanja lijeka Zelboraf mora biti isti.
English: What is Zelboraf and what is it used for?
Croatian: Što je Zelboraf i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Zelboraf?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zelboraf?
English: The main measures of effectiveness were how long the patients lived (overall survival) and how long they lived without their disease getting worse (progression-free survival).
Croatian: Glavne mjere djelotvornosti bile su duljina života bolesnika (ukupno preživljenje) i vrijeme koje su bolesnici preživjeli bez pogoršanja bolesti (preživljenje bez progresije bolesti).
English: Zelboraf is available as tablets (240 mg).
Croatian: Lijek Zelboraf dostupan je u obliku tableta (240 mg).
English: Zelboraf received a marketing authorisation valid throughout the EU on 17 February 2012.
Croatian: Lijek Zelboraf dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 17. veljače 2012.
English: Other information about Zelboraf
Croatian: Ostale informacije o lijeku Zelboraf
English: The most common side effects with Zelboraf (which may affect more than 3 in 10 patients) include arthralgia (joint pain), tiredness, rash, photosensitivity reaction (sunburn-like reactions following exposure to light), nausea and vomiting (feeling sick and being sick), alopecia (hair loss), diarrhoea, headache, pruritus (itching), skin papilloma (warts) and hyperkeratosis (thickening and toughening of the skin).
Croatian: Najčešće nuspojave lijeka Zelboraf (koje se mogu javiti u više od 3 na 10 osoba) uključuju artralgiju (bol u zglobovima), umor, osip, fotosenzitivne reakcije (reakcije slične opeklinama od sunca nakon izlaganja svjetlu), mučninu i povraćanje (osjećaj slabosti i povraćanje), alopeciju (gubitak kose), proljev, glavobolju, pruritus (svrbež), papilome kože (bradavice) i hiperkeratozu (zadebljanje i očvršćivanje kože).
English: What are the risks associated with Zelboraf?
Croatian: Koji su rizici povezani s lijekom Zelboraf?
English: As for all medicines, data on the use of Zelboraf are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Zelboraf kontinuirano se prate.
English: Zelboraf can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.
Croatian: Zelboraf se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik specijalist s iskustvom u liječenju raka.
English: By blocking the action of the abnormal BRAF, Zelboraf helps to slow down the growth and spread of the cancer.
Croatian: Blokiranjem djelovanja abnormalnog BRAF-a Zelboraf pomaže usporiti rast i širenje raka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zelboraf have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zelboraf nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The study showed that patients taking Zelboraf lived on average for 13.2 months compared with 9.9 months for patients on dacarbazine, and it took on average 5.3 months for the disease to worsen in the Zelboraf group compared with 1.6 months in the dacarbazine group.
Croatian: U ispitivanju se pokazalo da su bolesnici koji su uzimali lijek Zelboraf živjeli u prosjeku 13,2 mjeseca, u usporedbi s 9,9 mjeseci u slučaju bolesnika koji su liječeni dakarbazinom, a pogoršanje bolesti nastupilo je u prosjeku nakon 5,3 mjeseca u skupini koja je uzimala lijek Zelboraf, u usporedbi s 1,6 mjeseci u skupini koja je uzimala dakarbazin.
English: Side effects reported with Zelboraf are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zelboraf pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Treatment should be continued until the disease worsens or the side effects become too severe.
Croatian: Liječenje treba nastaviti sve dok se bolest ne pogorša ili dok nuspojave ne postanu preozbiljne.
English: Why is Zelboraf authorised in the EU?
Croatian: Zašto je lijek Zelboraf odobren u EU-u?
English: Zelboraf was shown to be effective at prolonging patients' lives and delaying the worsening of the disease.
Croatian: Lijek Zelboraf pokazao se učinkovitim u produljenju života bolesnika i u usporavanju pogoršanja bolesti.
English: The Agency considered the side effects to be manageable and included recommendations for doctors to help reduce the risks in the product information.
Croatian: Agencija smatra da je moguće kontrolirati nuspojave te je u informacije o lijeku uvrstila preporuke za liječnike, što će pomoći u smanjenju rizika.
English: Before starting treatment a test must be carried out to make sure that the patient's tumours have the BRAF V600 mutation.
Croatian: Prije početka liječenja potrebno je provesti ispitivanje kako bi se utvrdilo da tumori bolesnika imaju mutaciju BRAF V600.
English: Zelboraf is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.
Croatian: Zelboraf je lijek protiv raka koji se koristi za liječenje odraslih osoba s melanomom (vrsta raka kože) koji se proširio na druge dijelove tijela ili se ne može kirurški odstraniti.
English: An overview of Zelboraf and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zelboraf i zašto je odobren u EU-u
English: The European Medicines Agency decided that Zelboraf's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Zelboraf nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Zelboraf is only for patients whose melanoma tumour cells have a specific mutation (genetic change) called ‘BRAF V600'.
Croatian: Zelboraf je namijenjen samo bolesnicima čije tumorske stanice melanoma imaju specifičnu mutaciju (genetsku promjenu) koja se naziva BRAF V600.
English: The most common serious side effects include another type of skin cancer called ‘cutaneous squamous cell carcinoma', which is commonly treated by local surgery, keratoacanthoma (benign skin tumour), rash, arthralgia and change in liver test results (increased gamma-glutamyltransferase [GGT]).
Croatian: Najčešće ozbiljne nuspojave uključuju drugi oblik raka kože naziva planocelularni karcinom kože, koji se uglavnom liječi lokalnim kirurškim zahvatom, keratoakantom (benigni tumor kože), osip, artralgiju i promjene rezultata testova jetrene funkcije (povišena razina gamaglutamiltransferaze (GGT)).
English: How is Zelboraf used?
Croatian: Kako se Zelboraf koristi?
English: Zelboraf contains the active substance vemurafenib.
Croatian: Zelboraf sadrži djelatnu tvar vemurafenib.
English: With regard to its risks, in the main study around half of the patients taking Zelboraf experienced a severe side effect and about one fifth developed cutaneous squamous cell carcinoma.
Croatian: U pogledu rizika lijeka, otprilike polovica bolesnika koji su uzimali lijek Zelboraf u okviru glavnog ispitivanja imala je ozbiljne nuspojave, a u otprilike jedne petine bolesnika razvio se planocelularni karcinom kože.
English: For more information about using Zelboraf, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Zelboraf pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: What benefits of Zelboraf have been shown in studies?
Croatian: Koje su koristi lijeka Zelboraf dokazane u ispitivanjima?
English: In melanoma tumours with the BRAF V600 mutation, an abnormal form of BRAF is present which plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
Croatian: U melanomskih tumora s mutacijom BRAF V600 prisutan je abnormalni oblik BRAF-a koji djeluje na razvoj raka omogućivanjem nekontrolirane diobe stanica tumora.
English: How does Zelboraf work?
Croatian: Kako djeluje Zelboraf?
English: The Agency noted that Zelboraf had been convincingly shown to improve overall survival and to delay the worsening of ‘BRAF V600 positive' melanoma which has spread or cannot be surgically removed.
Croatian: Agencija je nepomenula da je uvjerljivo dokazano da liječenje lijekom Zelboraf poboljšava ukupan vijek preživljenja i usporava pogoršanje melanoma pozitivnog na mutaciju BRAF V600 koji se proširio ili se ne može kirurški odstraniti.
English: Patients were to receive either medicine until their disease got worse or their
Croatian: Bolesnici su trebali dobivati jedan od lijekova dok ne dođe do pogoršanja bolesti ili dok liječenje ne postane previše toksično za njih.
English: The active substance in Zelboraf, vemurafenib, is an inhibitor of BRAF, a protein involved in stimulating cell division.
Croatian: Djelatna tvar lijeka Zelboraf, vemurafenib, inhibitor je BRAF proteina koji potiče diobu stanica.
English: Zelboraf was compared with the cancer medicine dacarbazine in a main study involving 675 patients with melanoma containing the BRAF V600 mutation whose tumours had spread or could not be surgically removed.
Croatian: Lijek Zelboraf uspoređen je s lijekom protiv raka dakarbazinom u glavnom ispitivanju kojim je obuhvaćeno 675 bolesnika s melanomom s mutacijom BRAF V600 u kojih su se tumori proširili ili se
English: For the full list of side effects and restrictions with Zelboraf, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Zelboraf potražite u uputi o lijeku.
English: The preliminary review was concluded on 8th of February 2018.
Croatian: Preliminarni pregled zaključen je 8. veljače 2018.
English: Three out of those four cases of serious liver injury were reported to the competent authorities before November 2017.
Croatian: Tri od četiri slučaja ozbiljne ozljede jetre prijavljena su nadležnim tijelima prije studenoga 2017.
English: However, there are a few cases of serious hepatic injury, where no other obvious explanation has been identified, despite uncertainty in relation to possible confounding.
Croatian: Međutim, postoji nekoliko slučajeva ozbiljnih ozljeda jetre za koje nije pronađeno očito objašnjenje, unatoč nesigurnosti u pogledu mogućih zbunjujućih čimbenika.
English: Among those, there are positive de-challenge cases.
Croatian: Među tim slučajevima postoje i slučajevi pozitivnog prekida primjene.
English: In addition, PRAC considers that involvement of Esmya in at least two of the four transplantation cases reported and in two additional less serious cases, is at least plausible.
Croatian: Osim toga, PRAC smatra da je uključenost lijeka Esmya u najmanje dva od četiri zabilježena slučaja transplantacije i u dva dodatna manje ozbiljna slučaja barem vjerojatna.
English: Although firm conclusions cannot be drawn that these cases were caused by Esmya, the available data raise serious concerns.
Croatian: Iako se ne mogu donijeti čvrsti zaključci o tome da su ti slučajevi uzrokovani lijekom Esmya, dostupni podatci izazivaju ozbiljnu zabrinutost.
English: A fourth case of hepatic liver failure leading to transplantation was reported on 30th of January 2018.
Croatian: Četvrti slučaj zatajenja jetre koje je dovelo do transplantacije zabilježen je 30. siječnja 2018.
English: No signal of hepatic toxicity was identified during the review of non-clinical or clinical trials of Esmya inducing hepatic toxicity.
Croatian: Nisu utvrđeni znakovi toksičnog hepatitisa tijekom pregleda nekliničkih ili kliničkih ispitivanja lijeka Esmya u pogledu induciranja toksičnog hepatitisa.
English: An in depth assessment is needed to firmly establish factors that may have caused the reported serious hepatic injuries.
Croatian: Potrebna je dubinska procjena kako bi se utvrdili čimbenici koji su mogli uzrokovati zabilježene ozbiljne ozljede jetre.
English: The absence of findings in clinical trials has to be interpreted with caution as abnormal values of ALT/AST was an exclusion criterion as per protocols
Croatian: Nedostatak otkrića u kliničkim ispitivanjima treba oprezno tumačiti jer su abnormalne vrijednosti ALT-a/AST-a bile kriterij za isključenje prema planu ispitivanja
English: The impact of the new safety findings in the currently authorised indications of Esmya cannot be evaluated with certainty at present in view of the limited data available.
Croatian: Utjecaj novih sigurnosnih dokaza u trenutačno odobrenim indikacijama lijeka Esmya trenutačno se ne mogu sigurno procijeniti jer su dostupni podatci ograničeni.
English: Acknowledging the uncertainty regarding background incidence and the information in the reported cases, the seriousness of the reported cases raises concern.
Croatian: Uzimajući u obzir nesigurnost u pogledu prethodne učestalosti i informacija u zabilježenim slučajevima, ozbiljnost zabilježenih slučajeva razlog je za zabrinutost.
English: While the magnitude and nature (e.g. pattern of hepatotoxicity and possible mechanism of action) of the risk are being reviewed in depth, having considered the seriousness of the risk, the PRAC considered that the above raised a reasonable doubt that justifies adopting provisional measures in the meantime.
Croatian: Iako se priroda i opseg (npr. uzorak hepatoksičnosti i mogući mehanizam djelovanja) rizika dubinski analiziraju, PRAC smatra da prethodno navedena razumna sumnja, uzimajući u obzir ozbiljnost rizika, opravdava usvajanje privremenih mjera u međuvremenu.
English: Even though it is unclear at this stage whether monitoring of transaminases would necessarily prevent further severe cases, liver function monitoring is expected to be an important measure to detect liver injury during treatment, and likely reduce the incidence of severe cases.
Croatian: Iako u ovoj fazi nije jasno bi li praćenje transaminaze spriječilo buduće teške slučajeve, smatra se da praćenje funkcije jetre treba biti važna mjera za otkrivanje ozljeda jetre tijekom liječenja i očekuje se da će vjerojatno smanjiti učestalost ozbiljnih slučajeva.
English: These investigations should occur immediately in case a patient shows signs or symptoms compatible with liver injury.
Croatian: Te bi se pretrage trebale odmah izvršiti ako bolesnik pokazuje znakove ili simptome koji ukazuju na ozljedu jetre.
English: • PRAC recommended monitoring of the liver function at least monthly of patients under treatment as well as up to four weeks after the discontinuation of the treatment.
Croatian: • PRAC preporučuje praćenje funkcije jetre barem jednom mjesečno u bolesnika tijekom primanja terapije, kao i četiri tjedna nakon prekida terapije.
English: The PRAC considered the potential risk of hepatotoxicity of the product, together with the fact that Esmya is a symptomatic treatment and not curative, that has the potential to reduce the need for surgical intervention.
Croatian: PRAC je u obzir uzeo potencijalni rizik od hepatoksičnosti proizvoda, kao i činjenicu da Esmya služi za simptomatsko, a ne kurativno liječenje koje može smanjiti potrebu za kirurškim zahvatom.
English: In addition to these, a preliminary assessment of a recently reported case of liver transplantation with fatal outcome was performed.
Croatian: Osim toga, provedena je preliminarna procjena nedavno zabilježenog slučaja transplantacije jetre sa smrtnim ishodom.
English: Liver monitoring should also be performed up to four weeks after the discontinuation of the treatment.
Croatian: Praćenje jetre treba se izvršiti četiri tjedna nakon prekida liječenja.
English: • The PRAC recommends that no new patients should be treated with the medicinal product while the review is ongoing.
Croatian: • PRAC preporučuje da se novi bolesnici ne liječe ovim lijekom dok je procjena u tijeku.
English: Patients overcoming such threshold should be closely monitored after discontinuation of the treatment.
Croatian: Bolesnike koji prelaze tu granicu treba pažljivo pratiti nakon prekida liječenja.
English: The PRAC considered the duration of treatment with Esmya, the timelines of the current scientific evaluation and the patients that are currently under treatment.
Croatian: PRAC je razmotrio trajanje liječenje lijekom Esmya, vremenske okvire trenutačne znanstvene procjene i bolesnike koji se trenutačno liječe.
English: The current recommendation relates only to provisional measures recommended by the PRAC for Esmya based on the preliminary data available at this time.
Croatian: Sadašnje se preporuka odnosi samo na privremenu mjeru koju preporučuje PRAC za lijek Esmya na temelju trenutačno dostupnih preliminarnih podataka.
English: This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) No 726/2004.
Croatian: Ova preporuka ne dovodi u pitanje konačne zaključke postupka koji je u tijeku temeljem članaka 20 Uredbe (EZ) br. 726/2014.
English: In addition, for patients currently under treatment, a monitoring of serum transaminases levels should to be performed at least monthly and immediately in case of incidence of signs and symptoms of liver injury.
Croatian: Nadalje, u bolesnika koji trenutačno primaju terapiju potrebno je uvesti praćenje razine transaminaze u serumu barem jednom mjesečno i odmah nakon pojavljivanja znakova i simptoma ozljede jetre.
English: Taking into account this new case and the totality of the reported cases, a preliminary review and assessment of all the data available was performed by PRAC, to consider if provisional measures were needed while the issue is being furtherly reviewed.
Croatian: Uzimajući u obzir taj novi slučaj i ukupan broj prijavljenih slučajeva, PRAC je izvršio preliminarnu procjenu i pregled svih dostupnih podataka kako bi se razmotrilo jesu li potrebne privremene mjere tijekom dodatne procjene problema.
English: Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Croatian: Esmya (ulipristal acetat, 5 mg) lijek je odobren centraliziranim postupkom koji je indiciran za preoperativno liječenje, kao i liječenje s prekidima umjerenih do ozbiljnih simptoma mioma maternice kod odraslih žena reproduktivne dobi.
English: On 30 November 2017 the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Esmya and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Croatian: Uredbe (EZ) br. 726/2004 koji je proizašao iz podataka o farmakovigilanciji, te je od PRAC-a zatražila procjenu učinka gore navedenih problema na omjer koristi i rizika za lijek Esmya i izdavanje preporuke o tome trebaju li odgovarajuća odobrenja za stavljanje u promet biti zadržana, izmijenjena, obustavljena ili uskraćena.
English: It is therefore too early to conclude that the risk of hepatotoxicity is associated with the use of Esmya for all cases.
Croatian: Stoga je prerano za donošenje zaključaka o tome da su u svim slučajevima rizici za hepatotoksičnost jetre povezani s uporabom lijeka Esmya.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Esmya (Ulipristal acetate), in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) N0 726/2004.
Croatian: Uredbe (EZ) br. 726/2004 koji je proizašao iz podataka o farmakovigilanciji, naročito u odnosu na potrebu donošenja privremenih mjera u skladu s člankom 20. stavkom 3. Uredbe (EZ) br. 726/2004 za lijek Esmya (ulipristal acetat).
English: PRAC concluded that the use of Esmya could potentially be associated with a risk of serious liver injury.
Croatian: PRAC je zaključio da bi primjena lijeka Esmya mogla biti povezana s rizikom od ozbiljne ozljede jetre.
English: The possible causal relationship between Esmya and acute liver failure of those three cases prompted an in-depth investigation of this risk and its impact on the benefit risk balance of Esmya is warranted.
Croatian: Moguća uzročna veza između lijeka Esmya i akutnog zatajenja jetre u ta tri slučaja dovela je do dubinske istrage tog rizika i njegova utjecaja na omjer koristi i rizika lijeka Esmya.
English: The threshold of transaminases elevation for patients not included in clinical trials, which is two times the upper limit of normal, should be considered as the threshold in which the discontinuation of treatment is recommended.
Croatian: Granica povišene razine transaminaze (dvaput veća od normalne) u bolesnika koji nisu uključeni u klinička ispitivanja treba se smatrati granicom pri kojoj se preporučuje prekid liječenja.
English: Given the estimated exposure to Esmya of approximately 175,000 patient years, the number of cases of subacute severe liver impairment leading to liver transplantation with Esmya is higher than expected (4 transplantation cases among 175,000 patient years - a total of 7 cases with severe liver impairment among 175,000 patient years; although causality is uncertain for some of these cases).
Croatian: Uzimajući u obzir procijenjenu izloženost lijeku Esmya od približno 175.000 bolesnika u odnosu na godine liječenja, broj slučajeva subakutnog ozbiljnog oštećenja jetre koje dovodi do transplantacije jetre nakon primjene lijeka Esmya čini se višim od očekivanoga (4 slučaja transplantacije od 175.000 bolesnika u odnosu na godine liječenja - ukupno 7 slučajeva s teškim oštećenjem jetre od 175.000 bolesnika u odnosu na godine liječenja, iako učestalost nije poznata za neke od tih slučajeva).
English: Considering all these factors, in order to recommend the measure that would be the most proportionate, the PRAC concluded to provisionally limit the use of the medicinal product to patients that are currently under therapeutic treatment.
Croatian: Uzimajući u obzir sve navedene čimbenike, kako bi preporučio najprikladniju mjeru, PRAC je odlučio privremeno ograničiti primjenu lijeka na bolesnike koji trenutačno primaju terapiju.
English: The Committee, as a consequence, recommends the variations of the terms of the marketing authorisation for Esmya.
Croatian: Shodno tomu, Odbor preporučuje izmjene uvjeta odobrenja za stavljanje u promet lijeka Esmya.