FrancophonIA/ELRC3.0 huggingface dataset:
English: Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are non-cancerous (benign) tumours of the womb, in women who have not reached the menopause.
Croatian: Lijek Esmya odobren je u EU-u 2012. za liječenje umjerenih do teških simptoma mioma maternice, nekanceroznih (benignih) tumora maternice u žena koje još nisu u menopauzi.
English: These recommendations are temporary measures to protect patients' health, pending the conclusion of the review of Esmya which started on 30 November 2017.
Croatian: Te su preporuke privremene mjere za zaštitu zdravlja bolesnica do zaključka ocjenjivanja lijeka Esmya, koje je započelo 30. studenoga 2017.
English: • If you were about to start treatment with Esmya or start a new course of treatment, your doctor will put your treatment on hold until EMA's review of the medicine is complete.
Croatian: • Ako trebate započeti liječenje lijekom Esmya ili novi ciklus liječenja, vaš će liječnik odgoditi liječenje do završetka ocjenjivanja EMA-e.
English: It is used for up to 3 months before women undergo surgery to remove the fibroids and can also be used long-term but with treatment breaks in other women.
Croatian: Primjenjuje se do tri mjeseca prije operacije kojom se uklanjaju miomi, a može se primjenjivati i u dugotrajnom liječenju u drugih žena, ali s prekidima.
English: Following reports of liver injury and hepatic failure with Esmya, EMA has made the following temporary recommendations:
Croatian: Nakon prijavljenih oštećenja jetre i zatajenja jetre pri liječenju lijekom Esmya, EMA je izdala sljedeće privremene preporuke:
English: • Perform liver function tests at least once a month for all patients taking Esmya.
Croatian: • Barem jedanput mjesečno provodite test jetrene funkcije svih bolesnica koje uzimaju lijek Esmya.
English: A link between Esmya and cases of serious liver injury is under review.
Croatian: Ocjenjuje se povezanost između lijeka Esmya i slučajeva ozbiljnih oštećenja jetre.
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
Croatian: Ocjenjivanje provodi Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za ocjenu pitanja u pogledu sigurne primjene lijekova za humanu uporabu, koji će iznijeti niz preporuka.
English: • As a precaution, while taking Esmya you will be required to have blood tests to check that your liver is working well.
Croatian: • Kao mjera opreza, za vrijeme uzimanja lijeka Esmya morat ćete obavljati krvne pretrage radi praćenja ispravnog rada jetre.
English: The PRAC is also recommending that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being.
Croatian: PRAC ujedno preporučuje da se zasad ne započinje s liječenjem novih bolesnica lijekom Esmya te da bolesnice koje su dovršile ciklus liječenja ne započinju s novim.
English: • Do not start new patients on Esmya or new treatment courses in patients who have already completed a previous one.
Croatian: • Nemojte započinjati s liječenjem novih bolesnica lijekom Esmya ni s novim ciklusom liječenja u bolesnica koje su dovršile prethodni ciklus.
English: • For any patient with signs or symptoms consistent with liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice), check transaminase levels immediately.
Croatian: • Odmah provjerite razine transaminaze u svih bolesnica sa znakovima ili simptomima koji upućuju na oštećenje jetre (kao što su mučnina, povraćanje, bol u desnoj hipohondrijskoj regiji, anoreksija, astenija, žutica).
English: Liver tests should be repeated 2 to 4 weeks after stopping treatment.
Croatian: Testove jetrene funkcije treba ponoviti dva do četiri tjedna nakon prekida liječenja.
English: Liver test should be repeated 2 to 4 weeks after stopping treatment.
Croatian: Test jetrene funkcije treba ponoviti dva do četiri tjedna nakon prekida liječenja.
English: If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient.
Croatian: Ako testovi pokazuju abnormalne vrijednosti (razine jetrenih enzima dvostruko više od gornje granice normalne razine), zdravstveni radnik mora prekinuti liječenje i pomno pratiti bolesnicu.
English: As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids.
Croatian: Kao privremenu mjeru tijekom ocjenjivanja PRAC je preporučio redovito praćenje rada jetre u žena koje uzimaju lijek Esmya za liječenje mioma maternice.
English: • Esmya, used to treat uterine fibroids, is being reviewed because cases of serious liver problems have occurred in women taking the medicine.
Croatian: • Ocjenjivanje lijeka Esmya, koji se primjenjuje za liječenje mioma maternice, provodi se zbog toga što su se u žena koje uzimaju taj lijek pojavili ozbiljni problemi s jetrom.
English: These recommendations are temporary measures, pending the conclusion of an ongoing EMA review of Esmya.
Croatian: Ove su preporuke privremene mjere do zaključka ocjenjivanja lijeka Esmya koje EMA trenutačno provodi.
English: If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient.
Croatian: Ako je razina transaminaze dvostruko viša od gornje granice normalne razine, prekinite liječenje i pomno pratite bolesnicu.
English: If the patient develops transaminase levels more than 2 times the upper limit of normal, stop treatment and monitor the patient closely.
Croatian: Ako razina transaminaze u bolesnice poraste na razinu dvostruko višu od gornje granice normalne razine, prekinite liječenje i pomno pratite bolesnicu.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation.
Croatian: Nakon prijavljenih ozbiljnih oštećenja jetre, uključujući zatajenje jetre koje je dovelo do transplantacije, Odbor za procjenu rizika u području farmakovigilancije (PRAC) pri EMA-i trenutačno ocjenjuje koristi i rizike lijeka Esmya.
English: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).Avoid the use of abbreviations].
Croatian: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).
English: On the basis of the scientific conclusions for {name of active substance(s)} the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing {name of active substance(s)} is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za {naziv djelatne(ih) tvari}, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) {naziv djelatne(ih) tvari} nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {name of active substance(s)}, the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za {naziv djelatne(ih) tvari}, znanstveni zaključci CHMP-a su sljedeći:
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
Croatian: I RAZLOZI ZA IZMJENU UVJETA
English: OF THE MARKETING AUTHORISATION(S)
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: • The other ingredients are:
Croatian: · Drugi sastojci su:
English: ● At the request of the European Medicines Agency
Croatian: • na zahtjev Europske agencije za lijekove;
English: Including fatalities.
Croatian: uključujući smrtne slučajeve.
English: Best Overall Response Rate (CR/PR)
Croatian: Najbolja ukupna stopa odgovora (CR/PR)
English: The treatment with this medicine is not recommended for children and adolescents.
Croatian: Liječenje ovim lijekom ne preporučuje se djeci i adolescentima.
English: Plasma protein binding is approximately 95%.
Croatian: Vezanje za proteine plazme iznosi otprilike 95%.
English: What Tarceva is and what it is used for
Croatian: Što je Tarceva i za što se koristi
English: The benefit is mostly driven by the presence of a low pain intensity score.
Croatian: Korist uglavnom proizlazi iz prisutnosti slabog intenziteta boli.
English: Demographic characteristics were well balanced between the two treatment groups.
Croatian: Demografske karakteristike bile su dobro uravnotežene između dvije skupine.
English: Caution should be exercised in such situations.
Croatian: U takvim slučajevima potreban je oprez.
English: See also section 4 “Possible side effects”.
Croatian: Pogledajte i dio 4 “Moguće nuspojave”.
English: This protein is known to be involved in the growth and spread of cancer cells.
Croatian: Poznato je da taj protein sudjeluje u rastu i širenju stanica raka.
English: There was no change to Tmax or half-life.
Croatian: Nije bilo promjena vrijednosti Tmax ni poluvijeka.
English: Other forms of interactions
Croatian: Ostali oblici interakcija
English: Second and Further Line Treatment
Croatian: Druga i daljnje linije liječenja
English: It can also be prescribed if previous chemotherapy has not helped to stop your disease.
Croatian: Također može biti propisan ako prethodna kemoterapija nije uspjela zaustaviti Vašu bolest.
English: Tell your doctor if you have severe pain in your abdomen.
Croatian: Recite svom liječniku ako imate jaku bol u trbuhu.
English: The clinical relevance of these differences is unclear.
Croatian: Klinička važnost ovih razlika nije jasna.
English: Tell your doctor or pharmacist if you are taking, have recently taken any other medicines or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: - corresponds to percentage below threshold.
Croatian: - označava postotak ispod praga
English: The effect on overall survival was explored across different patient subsets.
Croatian: Učinak na ukupno preživljenje istražen je u različitim podskupinama bolesnika.
English: If you take more Tarceva than you should
Croatian: Ako uzmete više lijeka Tarceva nego što ste trebali
English: Talk to your doctor, he will need to regularly monitor you with some blood tests.
Croatian: Obratite se svom liječniku koji će morati redovito pratiti Vaše krvne nalaze.
English: Symptoms started from a few days to several months after initiating Tarceva therapy.
Croatian: Simptomi su se počeli pojavljivati od nekoliko dana do nekoliko mjeseci od početka liječenja lijekom Tarceva.
English: It is not known whether Tarceva has a different effect if your liver or kidneys are not functioning normally.
Croatian: Nije poznato ima li Tarceva različit učinak ako jetra ili bubrezi ne rade normalno.
English: See also below “Other medicines and Tarceva”
Croatian: Pogledajte također niže “Drugi lijekovi i Tarceva”.
English: Patients in this study were not selected based on EGFR mutation status.
Croatian: Bolesnici u ovom ispitivanju nisu odabirani na temelju statusa mutacije EGFR-a.
English: Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
Croatian: Liječenje trudnica treba nastaviti samo ako je potencijalna korist za majku veća od rizika za plod.
English: Based on population pharmacokinetic analysis, the presence of an opioid appeared to increase exposure by about 11%.
Croatian: Na temelju farmakokinetičke populacijske analize, čini se da je prisutnost opioida povećala izloženost za oko 11%.
English: PFS (median in months)
Croatian: PFS (medijan u mjesecima)
English: This disease can also be linked to the natural progression of your medical condition and can have a fatal outcome in some cases.
Croatian: Ta bolest može biti povezana s prirodnim tijekom Vaše bolesti i u nekim slučajevima može imati smrtni ishod.
English: The safety and efficacy of erlotinib in the approved indications has not been established in patients under the age of 18 years.
Croatian: Sigurnost i djelotvornost erlotiniba u odobrenim indikacijama nisu ustanovljene u bolesnika mlađih od 18 godina.
English: Less than 2% of the orally administered dose is excreted as parent substance.
Croatian: Manje od 2% peroralno primijenjene doze izlučuje se kao osnovna supstanca.
English: Contact your doctor or pharmacist immediately.
Croatian: Odmah se obratite liječniku ili ljekarniku.
English: The median duration of response was 34.3 weeks, ranging from 9.7 to 57.6+ weeks.
Croatian: Medijan trajanja odgovora iznosio je 34,3 tjedna, krećući se u rasponu od 9,7 do 57,6+ tjedana.
English: Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%.
Croatian: Pokazalo se da pušenje cigareta smanjuje izloženost erlotinibu za 50 do 60%.
English: Other medicines and Tarceva
Croatian: Drugi lijekovi i Tarceva
English: Tarceva has not been studied in patients under the age of 18 years.
Croatian: Tarceva nije ispitana u bolesnika mlađih od 18 godina.
English: If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment.
Croatian: Ako krvne pretrage upućuju na teške promjene u funkciji jetre, možda će Vaš liječnik morati prekinuti Vaše liječenje.
English: No studies have been conducted to assess the impact of Tarceva on milk production or its presence in breast milk.
Croatian: Nisu provedena ispitivanja koja bi ocijenila utjecaj lijeka Tarceva na proizvodnju mlijeka ili njegovu prisutnost u majčinu mlijeku.
English: PVC blister sealed with aluminium foil containing 30 tablets.
Croatian: PVC blister zatvoren aluminijskom folijom sadrži 30 tableta.
English: EGFR is expressed on the cell surface of normal cells and cancer cells.
Croatian: EGFR je izražen na površini normalnih stanica i stanica raka.
English: If you become pregnant while you are being treated with Tarceva, immediately inform your doctor who will decide if the treatment should be continued.
Croatian: Ako zatrudnite tijekom liječenja lijekom Tarceva, odmah obavijestite liječnika koji će odlučiti treba li liječenje nastaviti.
English: (months)
Croatian: (mjeseci)
English: Also, tell your doctor if you had peptic ulcers or diverticular disease in the past, as this may increase this risk.
Croatian: Također recite svom liječniku ako se imali peptički vrijed (čir) ili divertikularnu bolest, jer to može povećati rizik.
English: Psychiatric disorders Depression very common
Croatian: Psihijatrijski poremećaji Depresija vrlo često
English: The efficacy results are summarized in Table 3.
Croatian: Rezultati djelotvornosti sažeto su prikazani u Tablici 3.
English: The clinical relevance of this increase has not been established.
Croatian: Klinička važnost tog povećanja nije utvrđena.
English: What Tarceva looks like and contents of the pack:
Croatian: Kako Tarceva izgleda i sadržaj pakiranja
English: Results are shown in the table below (results for the group of metastatic and locally advanced patients are derived from exploratory subgroup analysis).
Croatian: Rezultati su prikazani u sljedećoj tablici (rezultati za grupu bolesnika s metastatskom i lokalno uznapredovalom bolešću izvedeni su iz eksploratorne analize podgrupa).
English: Pharmacokinetics in special populations
Croatian: Farmakokinetička svojstva u posebnim populacijama
English: Placebo (months)
Croatian: Placebo (mjeseci)
English: Potential interactions may occur with active substances which are metabolised by, or are inhibitors or inducers of, these enzymes.
Croatian: Potencijalne interakcije mogu se pojaviti s aktivnim supstancama koje metaboliziraju te enzime ili su pak njihovi inhibitori ili induktori.
English: If necessary the dose of erlotinib should be reduced, particularly if toxicity is observed.
Croatian: Po potrebi se doza erlotiniba može smanjiti, osobito ako se primijeti toksičnost.
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Croatian: Dijagnosticira li se keratitis, treba pažljivo razmotriti koristi i rizike nastavka liječenja.
English: When dose adjustment is necessary, the dose should be reduced in 50 mg steps (see section 4.4).
Croatian: Kada je potrebna prilagodba doze, treba ju postupno smanjivati za 50 mg (vidjeti dio 4.4).
English: Independent Review **
Croatian: Nezavisna procjena **
English: 90% of patients on Tarceva developed rash within the first 44 days.
Croatian: U 90% bolesnika koji su primali lijek Tarceva osip se razvio u prva 44 dana.
English: EGFR mutations may lead to constitutive activation of anti-apoptotic and proliferation signaling pathways.
Croatian: EGFR mutacije mogu dovesti do konstitutivne aktivacije antiapoptotskih i proliferativnih signalnih putova.
English: In some cases dose reduction may be necessary.
Croatian: U nekim slučajevima potrebno je smanjiti dozu.
English: If you miss one or more doses of Tarceva, contact your doctor or pharmacist as soon as possible.
Croatian: Ako preskočite jednu ili više doza lijeka Tarceva, obratite se liječniku ili ljekarniku što je brže moguće.
English: See also section 3 ‘How to take Tarceva'
Croatian: Pogledajte i dio 3 „Kako uzimati lijek Tarceva“.
English: They are present in plasma at levels that are <10% of erlotinib and display similar pharmacokinetics as erlotinib.
Croatian: Oni su prisutni u plazmi u razinama koje su < 10% razine erlotiniba i pokazuju sličnu farmakokinetiku kao erlotinib.
English: What Tarceva is and what it is used for What you need to know before you take Tarceva How to take Tarceva
Croatian: Što je Tarceva i za što se koristi Što morate znati prije nego počnete uzimati lijek Tarceva Kako uzimati lijek Tarceva
English: Elderly population There have been no specific studies in elderly patients.
Croatian: Ne postoje posebne studije u starijih bolesnika.
English: No new covariate effects were identified.
Croatian: Nisu otkriveni novi učinci kovarijanti.
English: 5 Including increased alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin.
Croatian: 5 uključujući povišenje alanin aminotransferaze [ALT], aspartat aminotransferaze [AST], bilirubina.
English: In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.
Croatian: U bolesnika s tumorima bez aktivirajućih mutacija EGFR-a, Tarceva je indicirana kada se druge opcije liječenja ne smatraju prikladnima.
English: Although statistically significant, the magnitude of this difference is not considered to be clinically relevant.
Croatian: Iako je statistički značajna, ta se razlika ne smatra klinički bitnom.
English: Current smokers should be advised to stop smoking (see sections 4.4, 4.5, 5.1 and 5.2).
Croatian: Pušačima treba savjetovati da prestanu pušiti (vidjeti dijelove 4.4, 4.5, 5.1 i 5.2).
English: The consequences of this interaction for e.g. CNS toxicity have not been established.
Croatian: Posljedice takve interakcije za npr. toksična oštećenja SŽS još uvijek nisu utvrđene.
English: A higher incidence has been observed in patients in Japan (see section 4.4).
Croatian: Veća incidencija je uočena među bolesnicima u Japanu (vidjeti dio 4.4)
English: The inhibition of glucuronidation may cause interactions with medicinal products which are substrates of UGT1A1 and exclusively cleared by this pathway.
Croatian: Inhibicija glukuronidacije može dovesti do interakcije s lijekovima koji su supstrati UGT1A1 i koji se uklanjaju isključivo tim putem.
English: The exposure after an oral dose may be increased by food.
Croatian: Izloženost nakon peroralne primjene može se povećati uzimanjem hrane.
English: The study did not meet its primary endpoint.
Croatian: Ispitivanje nije postiglo primarnu mjeru ishoda.
English: However, an adverse effect on the fertility can not be excluded as animal studies have shown effects on reproductive parameters (see section 5.3).
Croatian: Međutim, štetan učinak na plodnost ne može biti isključen obzirom da su ispitivanja na životinjama pokazala učinak na reproduktivne parametre (vidjeti dio 5.3).
English: The treatment with this medicine is not recommended if you have a severe liver disease or severe kidney disease.
Croatian: Liječenje ovim lijekom ne preporučuje se ako imate tešku bolest jetre ili tešku bolest bubrega.
English: * Severe infections, with or without neutropenia, have included pneumonia, sepsis, and cellulitis.
Croatian: * Teške infekcije, s neutropenijom ili bez nje, obuhvaćale su upalu pluća, sepsu i celulitis.
English: A higher incidence of ILD (approximately 5% with a mortality rate of 1.5%) is seen among patients in studies conducted in Japan.
Croatian: Veća incidencija IBP-a (oko 5% sa stopom smrtnosti od 1,5%) uočena je među bolesnicima u ispitivanjima provedenima u Japanu.
English: In clinical practice, there may be other co-factors leading to an increased exposure to carboplatin like renal impairment.
Croatian: U kliničkoj praksi mogu postojati drugi pridruženi čimbenici koji uzrokuju povećanu izloženost karboplatinu, poput narušene funkcije bubrega.
English: Survival was evaluated in the intent-to-treat population based on follow-up survival data.
Croatian: Preživljenje je procijenjeno na populaciji predviđenoj za liječenje (intent-to-treat) na temelju podataka preživljenja prikupljenih tijekom praćenja.
English: Persistent and severe diarrhoea may lead to low blood potassium and impairment of your kidney function, particularly if you receive other chemotherapy treatments at the same time.
Croatian: Dugotrajan i težak proljev može uzrokovati nisku razinu kalija u krvi i poremećaj funkcije bubrega, osobito ako istodobno primate i druge oblike kemoterapije.
English: In general, rash manifests as a mild or moderate erythematous and papulopustular rash, which may occur or worsen in sun exposed areas.
Croatian: Općenito, osip se manifestira kao blagi do umjereni eritematozni i papulopustulozni osip, koji se može pojaviti ili pogoršati na područjima izloženim suncu.
English: Overall Survival (OS) (months)
Croatian: Ukupno preživljenje (OS) (mjeseci)
English: • if you have diarrhoea because your doctor may need to treat you with anti-diarrhoeal (for example loperamide);
Croatian: · ako imate proljev, jer će Vam liječnik možda morati propisati antidijaroik (na primjer, loperamid),
English: Tarceva (months)
Croatian: Tarceva (mjeseci)
English: Tarceva or placebo was taken orally once daily until disease progression or unacceptable toxicity.
Croatian: Tarceva ili placebo uzimani su peroralno, jedanput dnevno, do progresije bolesti ili neprihvatljive toksičnosti.
English: Your doctor might avoid treating you with these medicines while you are receiving Tarceva.
Croatian: Možda će liječnik izbjegavati liječenje tim lijekovima dok primate lijek Tarceva.
English: A study in normal healthy volunteers provided an estimate of the absolute bioavailability of 59%.
Croatian: Ispitivanjem provedenim u zdravih dobrovoljaca dobivena je procjena apsolutne biodostupnosti od
English: It can be prescribed as initial therapy or as therapy if your disease remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations.
Croatian: Može Vam biti propisan kao početno liječenje ili kao liječenje nakon početne kemoterapije ako je bolest nakon nje ostala uglavnom nepromijenjena, pod uvjetom da stanice Vašega raka imaju specifične mutacije EGFR-a.
English: These findings were observed at clinically relevant exposures.
Croatian: Ti su učinci opaženi pri klinički relevantnim izloženostima.
English: Studies in animals have shown no evidence of teratogenicity or abnormal parturition.
Croatian: Ispitivanja na životinjama nisu pokazala znakove teratogenosti ili abnormalnosti pri porodu.