FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Stivarga?
Croatian: Koji su rizici povezani s lijekom Stivarga?
English: Supportive care included treatments like pain relief, antibiotics, and blood transfusions that help the patient but without treating the cancer.
Croatian: Potporna skrb uključivala je terapije poput ublažavanja boli, antibiotike i transfuziju krvi, koje su pomogle bolesnicima, ali nisu djelovale na rak.
English: • gastrointestinal stromal tumour (GIST, a cancer of the stomach and bowel) that has spread or cannot be surgically removed;
Croatian: • gastrointestinalni stromalni tumor (GIST, rak želuca i crijeva) koji se proširio ili se ne može odstraniti operacijom;
English: Stivarga had been shown to delay the worsening of the disease in these patients.
Croatian: Dokazano je da lijek Stivarga odgađa pogoršanje bolesti u tih bolesnika.
English: With regard to GIST and HCC, the Committee noted that the outlook is poor for patients whose disease gets worse despite previous treatment.
Croatian: U pogledu GIST-a i HCC-a, Odbor je napomenuo da bolesnici čija se bolest pogoršava unatoč prethodnom liječenju nemaju dobru perspektivu.
English: Why is Stivarga approved?
Croatian: Zašto je lijek Stivarga odobren?
English: Stivarga is used in patients who have already been treated with, or who cannot be given, other available treatments.
Croatian: Lijek Stivarga primjenjuje se u bolesnika koji su već liječeni ili se ne mogu liječiti drugim dostupnim mogućnostima liječenja.
English: The company that markets Stivarga will carry out studies to look for ways of identifying patients who are more likely to respond to treatment.
Croatian: Tvrtka koja stavlja na tržište lijek Stivarga provest će ispitivanja u kojima će se istraživati načini utvrđivanja bolesnika za koje postoji veća vjerojatnost da će imati pozitivan odgovor na liječenje.
English: For more information about treatment with Stivarga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Stivarga pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svojem liječniku ili ljekarniku.
English: How is Stivarga used?
Croatian: Kako se Stivarga koristi?
English: The active substance in Stivarga, regorafenib, is a ‘protein kinase inhibitor'.
Croatian: Djelatna tvar lijeka Stivarga, regorafenib, inhibitor je protein-kinaze.
English: However, given the side effects, the CHMP considered it important to find ways to identify any subgroups of patients who are more likely to respond to Stivarga.
Croatian: Međutim, s obzirom na nuspojave, CHMP je zaključio da je važno pronaći načina za utvrđivanje svih podskupina bolesnika za koje postoji veća vjerojatnost da će imati pozitivan odgovor na liječenje lijekom Stivarga.
English: Stivarga is a cancer medicine that contains the active substance regorafenib.
Croatian: Stivarga je lijek za liječenje raka koji sadrži djelatnu tvar regorafenib.
English: In another main study, Stivarga was compared with placebo in 199 patients with GIST that had spread or was inoperable and who were also given best supportive care.
Croatian: U drugom glavnom ispitivanju lijek Stivarga uspoređen je s placebom u liječenju 199 bolesnika s GISTom koji se proširio ili se nije mogao kirurški odstraniti i koji su također dobili najbolju moguću potpornu skrb.
English: The study showed that Stivarga with supportive care was effective at prolonging the length of time patients lived without their disease getting worse.
Croatian: Ispitivanje je pokazalo da je liječenje lijekom Stivarga i potpornom skrbi bilo djelotvorno u produljenju životnog vijeka bolesnika bez pogoršanja bolesti.
English: Patients treated with Stivarga lived on average for 4.8 months without their disease getting worse compared with 0.9 months for patients taking placebo and supportive care.
Croatian: Bolesnici koji su liječeni lijekom Stivarga živjeli su u prosjeku 4,8 mjeseci bez pogoršanja bolesti, u usporedbi s 0,9 mjeseci u bolesnika koji su primali placebo i potpornu skrb.
English: What benefits of Stivarga have been shown in studies?
Croatian: Koje su koristi lijeka Stivarga dokazane u ispitivanjima?
English: In a main study involving 760 patients with metastatic colorectal cancer which had progressed after standard therapy, Stivarga was compared with placebo (a dummy treatment) and the main measure of effectiveness was overall survival (the length of time that patients lived).
Croatian: U glavnom ispitivanju koje je obuhvatilo 760 bolesnika s metastaziranim kolorektalnim karcinomom koji je napredovao nakon standardne terapije, lijek Stivarga uspoređen je s placebom (prividno liječenje), a glavno mjerilo djelotvornosti bila je ukupna stopa preživljavanja (koliko su dugo bolesnici živjeli).
English: For patients with HCC, this led to an improvement in the length of time patients lived.
Croatian: U bolesnika oboljelih od HCC-a to je dovelo do produljenja životnog vijeka bolesnika.
English: For practical information about using Stivarga, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Stivarga bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: In a main study involving 573 patients with HCC that had worsened after treatment with sorafenib, Stivarga was compared with placebo and the main measure of effectiveness was overall survival.
Croatian: U glavnom ispitivanju koje je obuhvatilo 573 bolesnika oboljelih od HCC-a koji se pogoršao nakon liječenja sorafenibom, lijek Stivarga uspoređen je s placebom, a glavno mjerilo djelotvornosti bila je ukupna stopa preživljavanja.
English: The side effects of Stivarga are manageable.
Croatian: Nuspojave lijeka Stivarga mogu se kontrolirati.
English: Patients with GIST should have tried treatment with imatinib and sunitinib and patients with HCC should have tried sorafenib before starting treatment with Stivarga.
Croatian: Prije početka liječenja lijekom Stivarga, bolesnici oboljeli od GIST-a trebali su pokušati liječenje imatinibom i sunitinibom, a bolesnici oboljeli od HCC-a trebali su pokušati liječenje sorafenibom.
English: The study showed that Stivarga improved survival, with treated patients living for 6.4 months on average, compared with 5 months for those given placebo.
Croatian: Ispitivanje je pokazalo da je liječenje lijekom Stivarga dovelo do poboljšanja preživljavanja bolesnika koji su u prosjeku živjeli 6,4 mjeseci, u usporedbi s 5 mjeseci u onih koji su primali placebo.
English: The study showed that Stivarga increased the length of time that patients lived overall, with patients treated with Stivarga living for 10.6 months on average, compared with 7.8 months for those given placebo.
Croatian: Ispitivanje je pokazalo da je liječenje lijekom Stivarga produljilo životni vijek bolesnika te su bolesnici u prosjeku živjeli 10,6 mjeseci, u usporedbi s 7,8 mjeseci u onih koji su primali placebo.
English: For the full list of all restrictions and side effects with Stivarga, see the package leaflet.
Croatian: Potpuni popis ograničenja i nuspojava zabilježenih pri primjeni lijeka Stivarga potražite u uputi o lijeku.
English: This will help protect them against leptospirosis.
Croatian: Ovo pomaže pri njihovoj zaštiti od leptospiroze.
English: Responses in puppies were lower than adult dogs in some cases, because of antibodies inherited from their mothers.
Croatian: U pojedinim slučajevima odgovor u štenadi bio je manji nego u odraslih pasa, budući da se protutijela nasljeđuju od majki.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus L4 on 31 July 2014.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Versican Plus L4 od 31. srpnja 2014.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus L4 exceed the risks for the approved indication and recommended that Versican Plus L4 be given a marketing authorisation.
Croatian: Odbor za veterinarsko- medicinske proizvode (CVMP) zaključio je da koristi lijeka Versican Plus L4 nadmašuju rizike za odobrene indikacije i preporučilo je izdavanje odobrenja za stavljanje u promet VMP-a Versican Plus L4.
English: The effectiveness of Versican Plus L4 was investigated in a field study involving 129 dogs.
Croatian: Djelotvornost cjepiva Versican Plus L4 ispitana je terenskim ispitivanjem koje je obuhvatilo 129 pasa.
English: The field study showed that after vaccination with Versican Plus L4 the percentage of dogs with protective levels of antibodies for leptospira ranged from 59 to 96%.
Croatian: Terenskim je ispitivanjem dokazano da se nakon cijepljenja cjepivom Versican Plus L4 postotak pasa s zaštitnim razinama protutijela za leptospiru kretao od 59 do 96%.
English: For revaccination a single dose of Versican Plus L4 is required annually.
Croatian: Za docjepljivanje potrebna je jedna doza cjepiva Versican Plus L4 godišnje.
English: The strains of Leptospira bacteria in Versican Plus L4 are killed (inactivated) so that they do not cause disease.
Croatian: Sojevi bakterije Leptospira u cjepivu Versican Plus L4 su ubijeni (inaktivirani) tako da ne uzrokuju bolest.
English: Versican Plus L4 is a veterinary vaccine that contains inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa).
Croatian: Versican Plus L4 je veterinarsko cjepivo koje sadrži inaktivirane (ubijene) sojeve bakterije Leptospira (Icterohaemorrhagiae, Canicola, Bratislava i Grippotyphosa).
English: When Versican Plus L4 is given to dogs the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Croatian: U slučaju kada se Versican Plus L4 primjenjuje u pasa, imunosni sustav životinje prepoznaje bakterije kao „strane” i proizvodi protutijela protiv virusa.
English: Versican Plus L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Croatian: Versican Plus L4 sadrži adjuvans (aluminijev hidroksid) kako bi se pojačao imunološki odgovor.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus L4 is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Croatian: Najčešće nuspojave (kod 1 od 100 pasa) lijeka Versican Plus L4 je kratkotrajno oticanje do 5 cm koje može nastupiti u mjestu injekcije nakon cjepiva.
English: the future, if the animals are exposed to these Leptospira bacteria the immune system will be able to respond more quickly.
Croatian: životinje izlože ovim bakterijama Leptospira, imunosni sustav će brže stvarati protutijela.
English: Versican Plus L4 is used to protect dogs against leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation).
Croatian: Versican Plus L4 se koristi za zaštitu pasa od leptospiroze, bakterijske bolesti koja se može prenijeti putem zaraženog urina, a rezultira krvarenjem, hepatitisom (upalom jetre) i žuticom ili nefritisom (upalom bubrega).
English: The vaccine is given to puppies from six weeks of age as an injection, under the skin, and repeated three to four weeks later.
Croatian: Cjepivo se primjenjuje u štenadi u dobi od šest tjedana u obliku supkutane injekcije i ponavlja se nakon četiri tjedna.
English: In
Croatian: Ubuduće ako se
English: Versican Plus L4 is a vaccine.
Croatian: Versican Plus L4 je cjepivo.
English: Other information about Versican Plus L4:
Croatian: Druge informacije o Versican Plus L4:
English: What is the risk associated with Versican Plus L4?
Croatian: Koji su rizici povezani s Versican Plus L4?
English: Versican Plus L4 is available as a suspension for injection.
Croatian: Dostupan je kao suspenzija za injekciju.
English: Why has Versican Plus L4 been approved?
Croatian: Zašto je Versican Plus L4 odobren?
English: What is Versican Plus L4?
Croatian: Što je Versican Plus L4?
English: What benefit has Versican Plus L4 shown during the studies?
Croatian: Koje koristi Versican Plus L4 su utvrđene tijekom ispitivanja?
English: What is Versican Plus L4 used for?
Croatian: Za što se Versican Plus L4 koristi?
English: How has Versican Plus L4 been studied?
Croatian: Kako se Versican Plus L4 ispitivao?
English: How does Versican Plus L4 work?
Croatian: Na koji način Versican Plus L4 djeluje?
English: ≥ 40 to < 50
Croatian: ≥ 40 do < 50
English: Date of first authorisation: 20 June 2019
Croatian: Datum prvog odobrenja: 20. lipnja 2019
English: Do not give Doptelet to people less than 18 years old.
Croatian: Nemojte davati Doptelet osobama mlađim od 18 godina.
English: Results are shown in Table 2.
Croatian: Rezultati su prikazani u Tablici 2.
English: The next dose should be taken at the usual time the next day.
Croatian: Sljedeću dozu treba uzeti u uobičajeno vrijeme sljedećeg dana.
English: EU/1/19/1373/001 EU/1/19/1373/002
Croatian: EU/1/19/1373/002
English: * Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.
Croatian: * Medicinski rječnik za regulatorne poslove (MedDRA) verzija 19.1.
English: • Your doctor or pharmacist will tell you how many tablets to take and when to take them.
Croatian: • Vaš će Vam liječnik ili ljekarnik reći koliko tableta trebate uzeti i kada.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke .
English: • Swallow the tablets whole, once daily with food.
Croatian: • Tabletu progutajte cijelu, jedanput dnevno, s hranom.
English: Effect of transporting proteins
Croatian: Učinci transportnih proteina
English: System organ class (MedDRA terminology*)
Croatian: Klasifikacija organskih sustava (MedDRA terminologija*)
English: Reproductive and Developmental Toxicity
Croatian: Reproduktivna i razvojna toksičnost
English: If you take more Doptelet than you should
Croatian: Ako uzmete više Dopteleta nego što ste trebali
English: The safety and effectiveness of this medicine in this age group is not known.
Croatian: Sigurnost i djelotvornost ovog lijeka u toj dobnoj skupini nisu poznate.
English: Excretion in Milk
Croatian: Izlučivanje u mlijeku
English: Do not stop taking Doptelet unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Doptelet osim ako Vam tako ne kaže liječnik.
English: What Doptelet is and what it is used for
Croatian: Što je Doptelet i za što se koristi
English: Doptelet contains lactose (a type of sugar).
Croatian: Doptelet sadrži laktozu (vrsta šećera).
English: This adverse reaction was assessed as non-serious.
Croatian: Procijenjeno je da ta nuspojava nije ozbiljna.
English: • low red blood cell count (anaemia)
Croatian: • nizak broj crvenih krvnih zrnaca (anemija)
English: This effect was not associated with inflammatory response or any evidence of erosion or ulcer formation.
Croatian: Ovaj učinak nije bio povezan s upalnim odgovorom ni bilo kojim dokazom erozije ili stvaranja ulkusa.
English: Doptelet is for oral use, and the tablets should be taken once daily with food (see section 5.2).
Croatian: Doptelet je namijenjen za peroralnu primjenu, a tablete treba uzimati jednom dnevno s hranom (vidjeti dio 5.2).
English: Other medicines and Doptelet
Croatian: Drugi lijekovi i Doptelet
English: What Doptelet looks like and contents of the pack
Croatian: Kako Doptelet izgleda i sadržaj pakiranja
English: A total of 24.8% of patients were ≥ 65 years of age, 4.6% ≥ 75 years of age, and only 1 (0.2%) ≥ 85 years of age.
Croatian: Ukupno je 24,8% bolesnika bilo ≥ 65 godina, 4,6% ≥ 75 godina, a samo 1 (0,2%) ≥ 85 godina.
English: Take Doptelet for as long as your doctor tells you.
Croatian: Doptelet uzimajte onoliko dugo koliko Vam kaže liječnik.
English: • Start taking Doptelet 10 to 13 days before your planned medical procedure.
Croatian: • Počnite uzimati Doptelet 10 do 13 dana prije planiranog medicinskog postupka.
English: • Take your missed dose as soon as you remember, then take your next dose at the usual time.
Croatian: • Propuštenu dozu uzmite čim se sjetite, a sljedeću dozu uzmite u uobičajeno vrijeme.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Croatian: Učestalost je definirana kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: Talk to your doctor or pharmacist before taking Doptelet if: - you are at risk of blood clots in your veins or arteries, or members of your family have had blood clots.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Doptelet ako: kod Vas postoji rizik od stvaranja krvnih ugrušaka u venama ili arterijama ili ako su članovi vaše obitelji imali ugruške.
English: Platelets are blood cells that help the blood to clot and so reduce or prevent bleeding.
Croatian: Trombociti su krvne stanice koje pomažu u zgrušavanju krvi, pa time smanjuju ili sprječavaju krvarenje.
English: Co-administration with interferon preparations
Croatian: Istodobna primjena s pripravcima interferona
English: Dosing should begin 10 to 13 days prior to the planned procedure.
Croatian: Doziranje treba započeti 10 do 13 dana prije planiranog postupka.
English: Your doctor will help you decide whether the benefit of breast-feeding outweighs any possible risks to your baby while you are breast-feeding.
Croatian: Vaš će Vam liječnik pomoći odlučiti jesu li koristi od dojenja veće od mogućeg rizika za Vaše dijete dok dojite.
English: The tablets are supplied in cartons containing one aluminium blister.
Croatian: Tablete se isporučuju u kutijama koje sadrže po jedan aluminijski blister.
English: If a dose is missed, it should be taken as soon as it is remembered.
Croatian: Ako se doza propusti, treba je uzeti čim prije.
English: This medicine can pass into breast milk.
Croatian: Ovaj se lijek može prenijeti u majčino mlijeko.
English: • Talk to a doctor or pharmacist straight away.
Croatian: • Odmah razgovarajte s liječnikom ili ljekarnikom.
English: * at steady state, except for cyclosporine which was administered as a single dose
Croatian: * u stanju dinamičke ravnoteže, osim za ciklosporin koji je primjenjen u jednoj dozi
English: Doptelet works by helping to increase the number of platelets in the blood.
Croatian: Doptelet djeluje tako što pomaže povećati broj trombocita u krvi.
English: A risk to the breast-feeding child cannot be excluded.
Croatian: Ne može se isključiti rizik za dijete koje se doji.
English: The mean plasma elimination half-life (%CV) of avatrombopag is approximately 19 hours (19%).
Croatian: Srednja vrijednoist poluvijeka eliminacije avatrombopaga iz plazme (%CV) je približno 19 sati (19%).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Doptelet therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja Dopteletom, uzimajući u obzir koristi dojenja za dijete i korist liječenja za ženu.
English: Category
Croatian: Kategorija
English: - you are allergic to avatrombopag or any of the other ingredients of this medicine (listed in section 6).
Croatian: ako ste alergični na avatrombopag ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Animal Toxicology and/or Pharmacology
Croatian: Toksikologija i/ili farmakologija u životinja
English: No metabolites of avatrombopag were detected in plasma.
Croatian: Nisu pronađeni metaboliti avatrombopaga u plazmi.
English: There are no data on the presence of avatrombopag in human milk, the effects on the breastfed child, or the effects on milk production.
Croatian: Nema podataka o prisutnosti avatrombopaga u majčinu mlijeku, učincima na dojeno dijete ni učincima na stvaranje mlijeka.
English: Avatrombopag was present in the milk of lactating rats, see section 5.3.
Croatian: Avatrombopag je bio prisutan u mlijeku štakora, vidjeti dio 5.3.
English: Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics, ATC code: B02BX08
Croatian: Farmakoterapijska skupina: Antihemoragici, ostali sistemski hemostatici, ATK oznaka: B02BX08 Mehanizam djelovanja
English: The safety and efficacy of avatrombopag in children aged less than 18 years have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost avatrombopaga u djece mlađe od 18 godina nisu još ustanovljene.
English: The patient should undergo their procedure 5 to 8 days after the last dose of avatrombopag.
Croatian: Bolesnik se treba podvrgnuti postupku 5. do 8. dan nakon zadnje doze avatrombopaga.
English: It belongs to a group of medicines called thrombopoietin receptor agonists.
Croatian: On pripada skupini lijekova koji se nazivaju agonisti receptora trombopoetina.
English: Hypergastrinemia-related gastric carcinoids in rodents are generally considered to be of low risk or relevance to humans.
Croatian: Želučani karcinoidi u glodavaca povezani s hipergastrinemijom se općenito smatraju niskog rizika ili važnosti za ljude.
English: Due to the limited information available, avatrombopag should only be used in Child-Pugh class C patients when the expected benefit outweighs the expected risks.
Croatian: Zbog ograničenih dostupnih informacija, avatrombopag se smije koristiti samo u bolesnika s Child Pugh stupnjem C kada je očekivana korist veća od očekivanih rizika.
English: Elderly No dose adjustment is required for patients aged 65 years and older (see section 5.2).
Croatian: Nisu potrebne prilagodbe doze u bolesnika u dobi od 65 godina i starijih (vidjeti dio5.2).
English: Poly(vinyl alcohol) (E1203) Talc (E553b)
Croatian: Poli(vinilni alkohol) (E1203) Talk (E553b)
English: • Doptelet is available in 20 mg tablets.
Croatian: • Doptelet je dostupan u tabletama od 20 mg.
English: What you need to know before you take Doptelet 3.
Croatian: Što morate znati prije nego počnete uzimati Doptelet
English: If you stop taking Doptelet
Croatian: Ako prestanete uzimati Doptelet
English: Blister (polyamide and polyvinyl chloride-laminated aluminium film with push-through aluminium and polyethylene terephthalate foil) containing either 10 or 15 film-coated tablets.
Croatian: Blister (poliamidni i polivinilkloridni laminarni aluminijski film s folijom za protiskivanje od aluminija i polietilentereftalata) koji sadrži 10 ili 15 filmom obloženih tableta.
English: Doptelet has no or negligible influence on the ability to drive and use machines.
Croatian: Doptelet ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: There is no specific antidote for overdose with avatrombopag.
Croatian: Nema specifičnog antidota za predoziranje avatrombopagom.
English: Patient populations were similar between the low and high baseline platelet count cohorts, and consisted of 66% male and 35% female; median age 58 years and 61% White, 34% Asian, and 3% Black.
Croatian: Populacija bolesnika je bila slična među skupinama s niskom i visokom početnom vrijednošću broja trombocita, a sastojala se od 66% muškaraca i 35% žena, s medijanom dobi 58 godina, te 61% bijelaca, 34% azijata i 3% crnaca.
English: No dosage adjustment is expected for these patients.
Croatian: Kod ovih se bolesnika ne očekuju prilagodbe doze.
English: The efficacy of avatrombopag was similar across various subgroups for the pooled Phase 3 study population (Study 1 and Study 2).
Croatian: Djelotvornost avatrombopaga je bila slična u raznim podskupinama za objedinjenu populaciju ispitivanja faze 3 (Ispitivanje 1 i Ispitivanje 2).
English: Effect of avatrombopag
Croatian: Učinak avatrombopaga