FrancophonIA/ELRC3.0 huggingface dataset:
English: It is available as tablets (200 mg).
Croatian: Dostupan je u obliku tableta (200 mg).
English: This finding was based on the results from 769 patients.
Croatian: Ovaj se nalaz temeljio na rezultatima prikupljenima u 769 bolesnika.
English: Nexavar is given as two tablets twice a day, without food or with a meal that is low in fat.
Croatian: Nexavar se primjenjuje kao dvije tablete dva puta dnevno, bez hrane ili uz obrok koji je siromašan mastima.
English: EPAR summary for the public sorafenib
Croatian: EPAR, sažetak za javnost sorafenib
English: To manage side effects, treatment may have to be temporarily interrupted or the dose may be reduced.
Croatian: Kako bi se upravljalo nuspojavama, liječenje se mora privremeno prekinuti ili se doza mora smanjiti.
English: Nexavar is used to treat patients who have the following diseases:
Croatian: Nexavar se koristi za liječenje bolesnika koji imaju sljedeće bolesti:
English: This means that it blocks some specific enzymes known as protein kinases.
Croatian: To znači da inhibira određene enzime poznate pod nazivom proteinske kinaze.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nexavar on 19 July 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Nexavar vrijedi na prostoru Europske unije od 19. srpnja 2006.
English: Other information about Nexavar
Croatian: Ostale informacije o lijeku Nexavar
English: This finding was based on the results from all 903 patients, including about 200 who had switched from placebo to Nexavar before the end of the study.
Croatian: Ovaj nalaz temeljio se na rezultatima prikupljenima kod svih 903 bolesnika, uključujući otprilike 200 bolesnika koji su prešli s placeba na Nexavar prije završetka ispitivanja.
English: The main measures of effectiveness were how long the patients survived or how long the patients lived without their disease getting worse.
Croatian: Glavna mjera djelotvornosti bilo je razdoblje preživljenja bolesnika ili koliko su dugo bolesnici živjeli bez pogoršanja bolesti.
English: This is a summary of the European public assessment report (EPAR) for Nexavar.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Nexavar.
English: The treatment is continued as long as the patient continues to benefit from it without too many side effects.
Croatian: Liječenje se nastavlja tako dugo dok bolesnik ima koristi od liječenja bez mnogo nuspojava.
English: Because the numbers of patients with these diseases are low, the diseases are considered ‘rare', and Nexavar was designated an ‘orphan medicine' (a medicine used in rare diseases).
Croatian: Budući da je broj bolesnika s ovim bolestima nizak, dotična se bolest smatra „rijetkom” te se Nexavar označava kao lijek za liječenje rijetkih bolesti.
English: Nexavar has been compared with placebo (a dummy treatment) in three main studies.
Croatian: Nexavar je uspoređen s placebom (liječenjem bez djelatne tvari) u tri glavna ispitivanja.
English: Treatment with Nexavar should be supervised by doctors who have experience of anticancer treatments.
Croatian: Liječenje lijekom Nexavar trebaju nadzirati liječnici koji su iskusni u liječenju raka.
English: The summaries of the opinions of the Committee for Orphan Medicinal Products for Nexavar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke bolesti o lijeku Nexavar možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation:
English: The first study involved 602 patients with hepatocellular carcinoma; the second involved 903 patients with advanced renal cell carcinoma in whom one previous anticancer treatment had stopped working; and the third study involved 417 patients with differentiated thyroid carcinoma that had progressed or spread locally or to other parts of the body and did not respond to treatment with radioactive iodine.
Croatian: Prvo je ispitivanje obuhvatilo 602 bolesnika s hepatocelularnim karcinomom; drugo je ispitivanje obuhvatilo 903 bolesnika s uznapredovanim karcinomom bubrežnih stanica u kojih je prethodno liječenje karcinoma prestalo djelovati; a treće je ispitivanje obuhvatilo 417 bolesnika s diferenciranim karcinomom štitnjače koji je napredovao ili se raširio lokalno ili u druge dijelove tijela i koji nisu odgovorili na liječenje radioaktivnim jodom.
English: The active substance in Nexavar, sorafenib, is a protein kinase inhibitor.
Croatian: Djelatna tvar lijeka Nexavar, sorafenib, je inhibitor proteinske kinaze.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nexavar.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za uporabu u ljudi (CHMP) ocijenilo lijek da bi donijelo odluku o izdavanju odobrenja za stavljanje lijeka u promet i preporučilo uvjete za njegovu uporabu.
English: • hepatocellular carcinoma (11 April 2006)
Croatian: • hepatocelularni karcinom (11. travnja 2006.)
English: The most common side effects with Nexavar are diarrhoea, rash, alopecia (hair loss), infection, hand foot skin reaction (rash and pain on the palms of the hands and soles of the feet) and fatigue (tiredness).
Croatian: Najčešće nuspojave lijeka Nexavar su proljev, osip, alopecija (gubitak kose), infekcija, reakcija kože ruku i nogu (osip i bol u dlanovima ruku i potplata na stopalima) i iscrpljenost (umor).
English: • hepatocellular carcinoma (a type of liver cancer);
Croatian: • hepatocelularni karcinom (tip raka jetre);
English: The most important serious side effects are myocardial infarction (heart attack) or ischaemia (reduced oxygen supply to the heart), gastrointestinal perforation (a hole that develops in the wall of the gut), drug-induced hepatitis (a disease of the liver), haemorrhage (bleeding) and hypertension or hypertensive crisis (high blood pressure).
Croatian: Najvažnije ozbiljne nuspojave su infarkt miokarda (srčani udar) ili ishemija (smanjena opskrba kisikom u srce), gastrointestinalna perforacija (rupa koja se razvija u stjenci crijeva), hepatitis izazvan lijekovima (bolest jetre), hemoragija (krvarenje) i preosjetljivost ili hipertenzivna kriza (visoki krvni tlak).
English: These enzymes can be found in some receptors on the surface of cancer cells, where they are involved in the growth and spread of cancer cells, and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels.
Croatian: Ovi se enzimi nalaze u određenim receptorima na površini stanica karcinoma, gdje su uključeni u rast i širenje stanica raka, te u krvnim žilama koje opskrbljuju tumore, gdje su uključeni u razvoj novih krvnih žila.
English: By blocking these enzymes, Nexavar can reduce the growth of cancer cells and cut off the blood supply that keeps cancer cells growing.
Croatian: Inhibirajući ove enzime, Nexavar može smanjiti rast stanica karcinoma i prekinuti opskrbu krvlju čime se održava rast stanica.
English: The patients taking Nexavar lived for longer without their disease getting worse (167 days, around five and a half months) than those who took placebo (84 days, around three months).
Croatian: Nexavar živjeli su duže bez pogoršanja bolesti (167 dana, otprilike pet i pol mjeseci) od onih koji su uzimali placebo (84 dana, otprilike tri mjeseca).
English: Nexavar was more effective than placebo in increasing how long the patients survived or how long the patients lived without their disease getting worse.
Croatian: Nexavar je bio djelotvorniji od placeba u produljivanju razdoblja preživljenja bolesnika ili razdoblja tijekom kojeg su bolesnici živjeli bez pogoršanja bolesti.
English: What is Nexavar?
Croatian: Što je Nexavar?
English: Why has Nexavar been approved?
Croatian: Zašto je Nexavar odobren?
English: What is the risk associated with Nexavar?
Croatian: Koji su rizici povezani s lijekom Nexavar?
English: The CHMP decided that Nexavar's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Nexavar nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: • advanced renal cell carcinoma (a type of kidney cancer) when anticancer treatment with interferon alfa or interleukin 2 has failed or cannot be used;
Croatian: • uznapredovali karcinom bubrežnih stanica (tip raka bubrega) u slučaju kada protutumorska terapija interferonom alfa ili interleukinom 2 nije bila uspješna ili se nije mogla primijeniti;
English: • renal cell carcinoma (29 July 2004)
Croatian: • karcinom bubrežnih stanica (29. srpnja 2004.)
English: • differentiated thyroid carcinoma (a type of cancer originating from the follicular cells of the thyroid gland) when the cancer has progressed or spread locally or to other parts of the body and does not respond to treatment with radioactive iodine.
Croatian: • diferencirani karcinom štitnjače (tip raka koji potječe iz folikularnih stanica štitnjače) u slučaju kada je karcinom uznapredovao ili se lokalno proširio u druge dijelove tijela i ne odgovara na liječenje radioaktivnim jodom.
English: • papillary thyroid cancer and follicular thyroid cancer (13 November 2013) The full EPAR for Nexavar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Nexavar nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For more information about treatment with Nexavar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Nexavar pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku Sažetak je posljednji put ažuriran: 05.2014.
English: In the study of hepatocellular carcinoma, the patients taking Nexavar survived for an average of 10.7 months, compared with 7.9 months in those taking placebo.
Croatian: U ispitivanju hepatocelularnog karcinoma, bolesnici koji su uzimali Nexavar preživjeli su prosječno 10,7 mjeseci u usporedbi sa 7,9 mjeseci u osoba koje su uzimale placebo.
English: For the full list of all side effects and restrictions with Nexavar, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Nexavar potražite u uputi o lijeku.
English: What benefit has Nexavar shown during the studies?
Croatian: Koje su koristi lijeka Nexavar dokazane u ispitivanjima?
English: In the study in differentiated thyroid carcinoma, the patients taking Nexavar lived for an average of 10.8 months without their disease getting worse, compared with 5.8 months in those taking placebo.
Croatian: U ispitivanju diferenciranog karcinoma štitnjače, bolesnici koji su uzimali Nexavar živjeli su prosječno 10,8 mjeseci bez pogoršanja bolesti u usporedbi s 5,8 mjeseci u onih koji su uzimali placebo.
English: Nexavar is a cancer medicine that contains the active substance sorafenib.
Croatian: Nexavar je citostatik koji sadrži djelatnu tvar sorafenib.
English: What is Nexavar used for?
Croatian: Za što se Nexavar koristi?
English: In the study of renal cell carcinoma, the patients taking Nexavar survived for an average of 19.3 months, compared with 15.9 months in those taking placebo.
Croatian: U ispitivanju karcinoma bubrežnih stanica, bolesnici koju su uzimali Nexavar preživjeli su prosječno 19,3 mjeseca u usporedbi s 15,9 mjeseci u osoba koje su uzimale placebo.
English: How is Nexavar used?
Croatian: Kako se Nexavar koristi?
English: How does Nexavar work?
Croatian: Kako djeluje Nexavar?
English: How has Nexavar been studied?
Croatian: Kako se Nexavar ispitivao?
English: Throw it away and start again from step 1.
Croatian: Odbacite je i započnite ponovno od koraka 1.
English: Date of first authorisation: 30 July 2018
Croatian: Datum prvog odobrenja: 30. srpnja 2018.
English: You will also need 2 syringes:
Croatian: Bit će Vam potrebne i 2 štrcaljke:
English: 3) Wash your hands before preparing the medicine.
Croatian: 3) Operite ruke prije pripreme lijeka.
English: A minimum clinical response is defined as at least:
Croatian: Minimalni klinički odgovor definira se najmanje kao:
English: Not known (frequency cannot be estimated from the available data):
Croatian: Nepoznato (učestalost nije moguće procijeniti iz dostupnih podataka):
English: SD = standard deviation
Croatian: SD = standardna devijacija
English: • you are pregnant
Croatian: • ste trudni
English: Generalised LD
Croatian: Generalizirani LD
English: This can help make the injections more comfortable.
Croatian: To može pomoći da primjena injekcija bude ugodnija.
English: • Then have your normal dose the next day.
Croatian: • Zatim primijenite svoju redovnu dozu sljedećeg dana.
English: Dose increases should not be made more frequently than every 4 weeks.
Croatian: Doza se ne smije povećavati češće od svaka 4 tjedna.
English: • loss of interest in food
Croatian: • gubitak interesa za hranu
English: Contact them if you are unclear about anything or if you need more information or help.
Croatian: Obratite im se ako Vam je bilo što nejasno ili ako trebate više informacija ili pomoć.
English: This improves the ability of the body to control energy levels.
Croatian: Time se poboljšava sposobnost tijela da kontrolira razine energije.
English: Contents of the pack and other information 7.
Croatian: Sadržaj pakiranja i druge informacije 7.
English: • unusually heavy or long menstrual bleeding
Croatian: • neuobičajeno obilno ili dugo menstrualno krvarenje
English: Annual reports to be submitted as part of the annual re-assessment.
Croatian: Godišnja izvješća potrebno je dostaviti u okviru godišnje revizije procjene.
English: Your doctor might need to change your treatment.
Croatian: On će Vam možda morati promijeniti liječenje.
English: Most events occurred during the initial 1-2 months of initiation of treatment.
Croatian: Većina događaja zabilježena je tijekom početnih 1-2 mjeseca od uvođenja liječenja.
English: • ‘U' means ‘Units'.
Croatian: • "U" označava "jedinice" (od engl.
English: It is anticipated that most children will require increasing per kg dose, especially as they reach puberty.
Croatian: Očekuje se da će većini djece biti potrebno povećati dozu po kg, posebno kad uđu u pubertet.
English: • swelling of your face, lips, tongue or throat
Croatian: • oticanje lica, usnica, jezika ili grla
English: 1) Get together all the materials you will need for your injection.
Croatian: 1) Pripremite sve materijale koji su Vam potrebni za injekciju.
English: The injection should be administered at the same time every day.
Croatian: Injekciju treba davati svakog dana u isto vrijeme.
English: It is also aimed to guide prescribers about the appropriate management of these risks.
Croatian: Cilj je također uputiti propisivače u pravilno upravljanje tim rizicima.
English: • 0.5% HbA1c reduction and/or 25% reduction in insulin requirements and / or
Croatian: • 0,5% smanjenje HbA1c i/ili 25% smanjenje potrebe za inzulinom i/ili
English: Overall, the safety and tolerability of metreleptin are similar in children and adults.
Croatian: Sveukupno, sigurnost i podnošljivost metreleptina slične su u odraslih i u djece.
English: Details on how to access these are available from your doctor.
Croatian: Pojedinosti o pristupu tim materijalima dostupni su kod vašeg liječnika.
English: The co-primary efficacy endpoints in this study were defined as:
Croatian: Ko-primarne mjere ishoda djelotvornosti u tom ispitivanju bile su definirane kao:
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima, osim onim navedenim u dijelu 6.6.
English: A higher accumulation is observed with higher ADA levels.
Croatian: Viša akumulacija opažena je kod viših razina ADA.
English: 1077 ZX Amsterdam The Netherlands
Croatian: 1077 ZX Amsterdam Nizozemska
English: Serious and severe infections
Croatian: Ozbiljne i teške infekcije
English: Dose decreases based on weight loss may be made weekly.
Croatian: Smanjenja doze na temelju gubitka težine mogu se uvoditi tjedno.
English: • you have ever had problems with your blood (such as a low blood count)
Croatian: • ste ikad imali problema s krvi (npr. loša krvna slika)
English: • Do not use the syringes more than once.
Croatian: • Nemojte upotrijebiti štrcaljke više od jedanput.
English: • It is important to gradually reduce the dose over two weeks because this can help prevent a sudden increase in the levels of fat (called ‘triglycerides') in your blood.
Croatian: • Važno je postupno smanjivati dozu tijekom dva tjedna jer to može pomoći da se spriječi nagli porast razina masti (koje se nazivaju trigliceridi) u krvi.
English: Your doctor may decide that you inject yourself.
Croatian: Liječnik može odlučiti da si sami dajete injekciju.
English: • feeling more hungry than normal
Croatian: • osjećaj veće gladi od uobičajenog
English: • If you forget to inject a dose, inject it as soon as you remember.
Croatian: • Ako zaboravite ubrizgati dozu, ubrizgajte je odmah čim se sjetite.
English: It is recommended that patients should use a different injection site each day when injecting in the same region.
Croatian: Preporučuje se da bolesnici koriste različito mjesto injektiranja svaki dan ako primjenjuju injekciju u isto područje.
English: If you cannot contact your doctor, you should seek emergency medical help:
Croatian: Ako ne možete stupiti u kontakt sa svojim liječnikom, potražite hitnu medicinsku pomoć u sljedećim slučajevima:
English: • 15% reduction in triglycerides (TGs)
Croatian: • 15% smanjenje triglicerida (TG-a)
English: The educational programme is aimed at increasing awareness among healthcare professionals and patients/carers about the important risks contained in the Risk Management Plan.
Croatian: Cilj je edukacijskog programa povećati svijest u zdravstvenih radnika i bolesnika/njegovatelja o važnim rizicima opisanim u Planu upravljanja rizikom.
English: • Your doctor will decide if you should use Myalepta and will monitor you during treatment.
Croatian: • Vaš će liječnik odlučiti trebate li koristiti lijek Myalepta i nadzirat će Vas tijekom liječenja.
English: - Detailed instructions for use.
Croatian: - Detaljne upute za uporabu.
English: Step G: Throwing away used materials
Croatian: Korak G: Odlaganje upotrijebljenog materijala u otpad
English: All three patients had acquired generalised LD.
Croatian: Sva tri bolesnika imala su stečeni generalizirani LD.
English: Influenza, Pneumonia
Croatian: Influenca, pneumonija
English: The final study report should be submitted by 2022.
Croatian: Završno izvješće ispitivanja treba dostaviti do 2022.
English: 1077 ZX Amsterdam The Netherlands infogroup@aegerion.com
Croatian: 1077 ZX Amsterdam Nizozemska infogroup@aegerion.com
English: • controlling how hungry you feel and your energy levels
Croatian: • kontrolu osjećaja gladi koji imate i upravljanje razinama energije
English: The medicinal product was administered subcutaneously either once daily or twice daily (in two equal doses).
Croatian: Lijek je primjenjivan supkutano jedanput ili dvaput dnevno (u dvije jednake doze).
English: Contents of the pack and other information What Myalepta contains
Croatian: Sadržaj pakiranja i druge informacije Što Myalepta sadrži
English: It can be administered any time of the day without regard to the timing of meals.
Croatian: Može se davati u bilo koje doba dana neovisno o obrocima.
English: 23) Clean the area where you will inject yourself with a clean alcohol swab and let the skin dry.
Croatian: 23) Očistite mjesto na kojem ćete si dati injekciju čistom alkoholnom blazinicom i pričekajte da se koža osuši.
English: Very common (may affect more than 1 in 10 people): • weight loss
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): • gubitak težine
English: • helping the insulin in your body manage sugar levels.
Croatian: • pomaganje inzulinu u Vašem tijelu da regulira razine šećera u Vašem tijelu.
English: Eurofins PHAST GmbH Kardinal-Wendel-Straße 16 66424 Homburg Germany
Croatian: Eurofins PHAST GmbH Kardinal-Wendel-Straße 16 66424 Homburg
English: Do not reconstitute with other diluents.
Croatian: Nemojte rekonstituirati uporabom drugih diluenata.
English: Your doctor will also ask you to follow a reduced fat diet.
Croatian: Liječnik će također tražiti da uvedete dijetu sa smanjenim udjelom masti.
English: 22) Carefully choose where you want to inject Myalepta.
Croatian: 22) Pažljivo odaberite mjesto u koje želite ubrizgati lijek Myalepta.
English: Also some other medicines can affect the way this medicine works.
Croatian: Također, neki drugi lijekovi mogu utjecati na način djelovanja ovog lijeka.
English: • you are allergic to metreleptin or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ste alergični na metreleptin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: ● Presence of diabetes mellitus, or
Croatian: Postojanje diabetesa mellitusa ili
English: Your doctor will decide if you should stop using this medicine.
Croatian: Vaš će liječnik odlučiti trebate li prestati primjenjivati ovaj lijek.
English: • Do not touch the area you have cleaned until you are injecting Myalepta.
Croatian: • Nemojte dodirivati područje koje ste očistili dok ne počnete ubrizgavati lijek Myalepta.
English: The reconstituted solution will take less than 5 minutes to become clear.
Croatian: Rekonstituiranoj otopini trebat će manje od 5 minuta da se razbistri.
English: While using this medicine, you or your child will be monitored by your doctor, who will decide the dose you or your child should use.
Croatian: Dok primjenjujete ovaj lijek, Vas ili Vaše dijete nadzirat će Vaš liječnik, koji će odlučiti o dozi za Vas ili Vaše dijete.
English: Reproductive toxicity studies have not included toxicokinetics analysis.
Croatian: Ispitivanja reproduktivne toksičnosti nisu uključila analizu toksikokinetike.
English: The final study report should be submitted by 2024.
Croatian: Završno izvješće ispitivanja treba dostaviti do 2024.
English: 25) With the other hand, hold the syringe like a pencil.
Croatian: 25) Drugom rukom držite štrcaljku poput olovke.
English: ● Fasting TG concentration > 2.26 mmol/L or postprandially elevated triglycerides
Croatian: ● Koncentracija TG-a natašte > 2,26 mmol/L ili postprandijalno povišeni trigliceridi
English: Dose adjustments in children without metabolic abnormalities should primarily be made according to weight change.
Croatian: Prilagodbe doze u djece s metaboličkim abnormalnostima prvenstveno treba vršiti u skladu s promjenom težine.
English: • The syringe you need to use to inject this medicine depends on the dose prescribed for you.
Croatian: • Koju štrcaljku trebate upotrijebiti za ubrizgavanje ovog lijeka ovisi o dozi koja Vam je propisana.
English: Pack sizes of 1 or 30 vials.
Croatian: Veličine pakiranja od 1 ili 30 bočica.
English: • Metreleptin is similar to a human hormone called leptin.
Croatian: • Metreleptin je sličan ljudskom hormonu koji se naziva leptin.
English: Your doctor will have prescribed the correct dose for you, based on the following:
Croatian: Liječnik je propisao dozu koja je za Vas ispravna na temelju sljedećih elemenata:
English: • If you weigh 40 kg or less:
Croatian: • ako težite 40 kg ili manje:
English: Advice will be provided on symptoms of an allergic reaction and action to be taken in the event of such a reaction.
Croatian: Potrebno je navesti informacije o simptomima alergijske reakcije i postupanju u slučaju takve reakcije.