FrancophonIA/ELRC3.0 huggingface dataset:
English: Avoid use in severely dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity.
Croatian: Zbog povećanog rizika od toksičnog oštećenja bubrega, korištenje proizvoda treba izbjegavati, kod jako dehidriranih i hipovolemičnih životinja te životinja s hipotenzijom.
English: The product is slightly irritant to the eye. Rinse any splashes from eyes immediately with plenty of water.
Croatian: U slučaju da veterinarsko-medicinski proizvod nehotice dospije u oči, temeljito ih isperite vodom.
English: EXP Once broached, use within 28 days, by __/__/__.
Croatian: EXP Rok valjanosti poslije prvog otvaranja bočice je 28 dana __/__/__.
English: EXP Once broached, use within 28 days.
Croatian: EXP Rok valjanosti poslije prvog otvaranja bočice je 28 dana.
English: This overview was last updated in 01-2019.
Croatian: Ovaj sažetak posljednji je put ažuriran u 01. 2019.
English: Further information on Adcetris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Adcetris.
Croatian: Više informacija o lijeku Adcetris možete naći na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Adcetris.
English: The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment.
Croatian: Glavna mjera djelotvornosti bio je postotak bolesnika koji su potpuno ili djelomično odgovorili na liječenje.
English: Every year, the Agency will review any new information that may become available and this overview will be updated as necessary.
Croatian: Svake godine Agencija procjenjuje sve nove informacije koje postanu dostupne te se ovaj sažetak po potrebi ažurira.
English: This means that there is more evidence to come, especially about the medicine's long-term effects, which are needed to confirm the positive benefit-risk balance.
Croatian: To znači da se očekuju dodatni podatci, osobito o dugoročnim učincima ovog lijeka, koji su potrebni da bi se potvrdio pozitivan omjer koristi i rizika.
English: The main measure of effectiveness was how long patients lived without their disease getting worse.
Croatian: Glavna mjera djelotvornosti bilo je razdoblje preživljenja bez pogoršanja bolesti.
English: The doctor may interrupt or stop treatment, or reduce the dose, if the patient develops certain serious side effects.
Croatian: Liječnik može privremeno prekinuti ili okončati terapiju ili smanjiti dozu ako bolesnik razvije određene ozbiljne nuspojave.
English: The medicine is given by a 30 minute infusion (drip) into a vein every 2 or 3 weeks.
Croatian: Lijek se daje intravenskom infuzijom (nakapavanje) u trajanju od 30 minuta svaka dva ili tri tjedna.
English: The most common side effects of Adcetris given alone (which may affect more than 1 in 10 people) are infections (including infections of the nose and throat), peripheral sensory or motor neuropathy (nerve damage that affects feeling or muscle control and co-ordination), tiredness, nausea (feeling sick), diarrhoea, fever, neutropenia, rash, cough, vomiting, joint pain, infusion-related reactions, itching, constipation, dyspnoea (difficulty breathing), weight loss, muscle pain and abdominal (belly) pain.
Croatian: Najčešće nuspojave lijeka Adcetris kao monoterapije (koje se mogu javiti u više od 1 na 10 osoba) su infekcije (uključujući infekcije nosa i grla), periferna senzorna ili motorna neuropatija (oštećenje živaca koje utječe na osjet ili kontrolu mišića i koordinaciju), umor, mučnina (slabost), proljev, groznica, neutropenija, osip, kašalj, povraćanje, bol u zglobovima, reakcije povezane s infuzijom, svrbež, zatvor, dispneja (otežano disanje), gubitak težine, bol u mišićima i abdomenu (trbuhu).
English: What measures are being taken to ensure the safe and effective use of Adcetris?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Adcetris?
English: Adcetris has been given ‘conditional approval'.
Croatian: Za lijek Adcetris izdano je „uvjetno odobrenje”.
English: Adcetris (brentuximab vedotin)
Croatian: Adcetris (brentuksimab vedotin)
English: A complete response was observed in 33% of patients (34 out of 102).
Croatian: Potpuni odgovor uočen je u 33 % bolesnika (34 od 102).
English: Further information on the orphan designations can be found on the European Medicines Agency's website (Hodgkin's lymphoma: 15 January 2009; Anaplastic large cell lymphoma: 15 January 2009; Cutaneous T-cell lymphoma: 11 January 2012).
Croatian: Više informacija o statusu lijeka za rijetke bolesti možete naći na internetskim stranicama Europske agencije za lijekove (Hodgkinov limfom: 15. siječnja 2009.; anaplastični velikostanični limfom: 15. siječnja 2009.; limfom kožnih T-stanica: 11. siječnja 2012.).
English: Other information about Adcetris
Croatian: Ostale informacije o lijeku Adcetris
English: The benefit was sustained during 3 years of follow-up.
Croatian: Tijekom tri godine praćenja zabilježeno je održavanje korisnih učinaka.
English: The Agency further noted that the overall safety profile of Adcetris was acceptable given the serious conditions for which it is used.
Croatian: Nadalje, Agencija je napomenula da je ukupni sigurnosni profil lijeka Adcetris prihvatljiv uzimajući u obzir ozbiljna stanja za čije se liječenje primjenjuje.
English: After 2 years, 82% of patients given Adcetris survived without their disease getting worse, compared with 77% of patients given bleomycin.
Croatian: Nakon dvije godine 82 % bolesnika koji su primali lijek Adcetris preživjelo je bez pogoršanja bolesti, u usporedbi sa 77 % bolesnika koji su primali bleomicin.
English: Adcetris received a conditional marketing authorisation valid throughout the EU on 25 October 2012.
Croatian: Lijek Adcetris dobio je uvjetno odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 25. listopada 2012.
English: In these patients, who generally have poor outcomes and lack suitable treatments, Adcetris could lead to a cure or could enable them to undergo potentially curative treatments.
Croatian: U tih bolesnika, koji općenito imaju loše ishode i za koje nema odgovarajućeg liječenja, lijek Adcetris mogao bi dovesti do izlječenja ili im omogućiti da se podvrgnu potencijalno kurativnom liječenju.
English: The data on these patients showed that 55% of patients (22 out of 40) responded to treatment.
Croatian: Podatci o tim bolesnicima pokazali su da je 55 % bolesnika (22 od 40) odgovorilo na liječenje.
English: For 23% of these patients (9 out of 40) a complete response was observed.
Croatian: U 23 % tih bolesnika (9 od 40) zabilježen je potpuni odgovor.
English: Adcetris must not be used together with bleomycin (another cancer medicine) as this combination is damaging to the lungs.
Croatian: Adcetris se ne smije primjenjivati zajedno s bleomicinom (drugi lijek protiv raka) jer ta kombinacija oštećuje pluća.
English: Patients should be monitored during and after the infusion for certain side effects and they should have full blood counts (tests of the number of blood cells) before every dose of Adcetris.
Croatian: Potreban je nadzor bolesnika tijekom i nakon infuzije zbog mogućnosti pojave određenih nuspojava, kao i pregled kompletne krvne slike (kontrole broja krvnih stanica) prije primjene svake doze lijeka Adcetris.
English: Adcetris is also used to treat adults with two other lymphomas:
Croatian: Adcetris se primjenjuje i u liječenju odraslih osoba s drugim dvjema vrstama limfoma:
English: For more information about using Adcetris, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Adcetris, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: An overview of Adcetris and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Adcetris i zašto je odobren u EU-u
English: These diseases are rare, and Adcetris was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates.
Croatian: Te su bolesti rijetke, a Adcetris je dobio status „lijeka za liječenje rijetkih bolesti” na različite datume.
English: Therefore, the Agency decided that the benefits of Adcetris are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi lijeka Adcetris nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: What is Adcetris and what is it used for?
Croatian: Što je Adcetris i za što se primjenjuje?
English: In this study, the average time patients lived before their disease got worse was around 43 months in those given Adcetris, compared with around 24 months in those given placebo.
Croatian: U tom ispitivanju prosječno vrijeme koje su bolesnici živjeli bez pogoršanja bolesti bilo je otprilike 43 mjeseca u onih koji su primali lijek Adcetris, u usporedbi s otprilike 24 mjeseca u onih koji su primali placebo.
English: When given with other cancer medicines, patients may also be given a medicine to help prevent neutropenia (low white blood cell count).
Croatian: Kada se primjenjuje zajedno s drugim lijekovima protiv raka, bolesnici mogu dobiti i lijek koji pomaže u sprječavanju neutropenije (niska razina bijelih krvnih stanica).
English: As for all medicines, data on the use of Adcetris are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Adcetris kontinuirano se prate.
English: Response to treatment was assessed using body scans and patients' clinical data.
Croatian: Procjena odgovora na liječenje provodila se snimanjem tijela i na osnovi kliničkih podataka bolesnika.
English: The company that markets the medicine will carry out a study on the benefits of the medicine in sALCL patients and a safety study in a larger population of HL and sALCL patients.
Croatian: Tvrtka koje stavlja u promet ovaj lijek provest će ispitivanje o koristima od ovog lijeka u bolesnika sa sALCL-om i ispitivanje sigurne primjene u većoj populaciji bolesnika s HL-om i sALCL-om.
English: Side effects reported with Adcetris are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Adcetris pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The recommended dose depends on body weight and whether Adcetris is given with other cancer medicines.
Croatian: Preporučena doza ovisi o tjelesnoj težini i o tome primjenjuje li se Adcetris zajedno s drugim lijekovima protiv raka.
English: Why is Adcetris authorised in the EU?
Croatian: Zašto je lijek Adcetris odobren u EU-u?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adcetris 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 Adcetris nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The European Medicines Agency noted that, despite limited data and studies that did not compare Adcetris with a control treatment, Adcetris was considered beneficial for patients with HL and sALCL whose cancer had come back or had not responded to therapy.
Croatian: Europska agencija za lijekove zaključila je da se, unatoč ograničenim podatcima i ispitivanjima u kojima lijek Adcetris nije uspoređen s kontrolnim liječenjem, smatra da je Adcetris koristan za bolesnike s HL-om i sALCL-om čiji se rak ponovo javio ili koji nisu odgovorili na liječenje.
English: Treatment should continue for up to 6 months when used with other cancer medicines or up to 1 year when used alone.
Croatian: Liječenje treba nastaviti najviše šest mjeseci ako se lijek primjenjuje zajedno s drugim lijekovima protiv raka ili najviše jednu godinu ako se primjenjuje kao monoterapija.
English: Adcetris is used when the tumour cells are CD30-positive (when they have a protein called CD30 on their surface) and is given:
Croatian: Adcetris se primjenjuje kada su stanice tumora pozitivne na CD30 (kada na površini imaju protein naziva CD30), a daje se:
English: In this study, 75% of patients (76 out of 102) responded partially or completely to treatment.
Croatian: U tom ispitivanju 75 % bolesnika (76 od 102) u potpunosti je ili djelomično odgovorilo na liječenje.
English: In this study, 86% of patients (50 out of 58) responded partially or completely to treatment and this response was complete for 59% (34 out of 58).
Croatian: U tom ispitivanju 86 % bolesnika (50 od 58) odgovorilo je na liječenje djelomično ili potpuno, a u 59 % bolesnika (34 od 58) odgovor je bio potpun.
English: Adcetris is a cancer medicine used to treat adults with Hodgkin's lymphoma (HL, a type of cancer that originates from blood cells in the lymphatic system, a part of the immune system).
Croatian: Adcetris je lijek protiv raka koji se primjenjuje za liječenje odraslih osoba s Hodgkinovim limfomom (HL, vrsta raka koja nastaje u krvnim stanicama u limfnom sustavu, dijelu imunosnog sustava).
English: In addition, giving Adcetris to patients who have had a stem cell transplant and are considered at risk of the cancer progressing or coming back, resulted in a clear clinical benefit.
Croatian: Osim toga, davanje lijeka Adcetris bolesnicima koji su bili podvrgnuti transplantaciji matičnih stanica i za koje se smatra da su izloženi riziku od napredovanja ili ponovne pojave raka imalo je jasne kliničke koristi.
English: What are the risks associated with Adcetris?
Croatian: Koji su rizici povezani s lijekom Adcetris?
English: Adcetris can only be obtained with a prescription, and it should be given under the supervision of a doctor who has experience in the use of cancer treatments.
Croatian: Adcetris se izdaje samo na liječnički recept i smije se davati samo pod nadzorom liječnika s iskustvom u primjeni lijekova za liječenje raka.
English: • together with doxorubicin, vinblastine and dacarbazine (other cancer medicines) in HL patients who have stage IV disease (advanced cancer that has spread to other parts of the body) that has not been treated before;
Croatian: • u kombinaciji s doksorubicinom, vinblastinom i dakarbazinom (drugi lijekovi protiv raka) u bolesnika s HL-om čija je bolest u stadiju IV (uznapredovali rak koji se proširio na druge dijelove tijela) koji nije prethodno liječen;
English: • when patients have had an autologous stem cell transplant but are considered to be at increased risk of the cancer coming back or not responding;
Croatian: • u bolesnika koji su bili podvrgnuti transplantaciji autolognih matičnih stanica, ali se smatra da su izloženi povećanom riziku od ponovnog pojavljivanja raka ili izostanka odgovora;
English: • when the cancer has come back or has not responded to an autologous stem cell transplant (a transplant of the patient's own blood-producing cells);
Croatian: • kada se rak ponovno javio ili kada bolesnik nije odgovorio na transplantaciju autolognih matičnih stanica (transplantacija vlastitih stanica bolesnika koje proizvode krv);
English: In patients with CTCL, a clinically significant benefit was seen over treatment with bexarotene or methotrexate.
Croatian: U bolesnika s CTCL-om zapažena je klinički značajna korist u odnosu na liječenje beksarotenom ili metotreksatom.
English: What information is still awaited for Adcetris?
Croatian: Koje se još informacije očekuju o lijeku Adcetris?
English: Adcetris was studied in 58 sALCL patients whose cancer had come back or had not responded to treatment.
Croatian: Adcetris je ispitivan u 58 bolesnika sa sALCL-om čiji se rak ponovo javio ili koji nisu odgovorili na liječenje.
English: For the full list of all side effects with Adcetris, including side effects when used with doxorubicin, vinblastine and dacarbazine, see the package leaflet.
Croatian: Potpuni popis svih nuspojava pri primjeni lijeka Adcetris, uključujući nuspojave pri primjeni u kombinaciji s doksorubicinom, vinblastinom i dakarbazinom, potražite u uputi o lijeku.
English: The proportion of patients whose disease responded to treatment for at least 4 months was 56% of those given Adcetris (36 of 64 patients) and 13% of those given alternative treatments (8 of 64 patients).
Croatian: Među bolesnicima koji su primali lijek Adcetris, u 56 % bolesnika (36 od 64) zabilježen je odgovor na terapiju tijekom barem četiri mjeseca, u usporedbi s 13 % bolesnika (8 od 64) koji su primali alternativne terapije.
English: In a main study of 1334 patients with CD30-positive HL who had not received previous treatment, Adcetris was compared with bleomycin (another HL medicine) when each was given with other cancer medicines (doxorubicin, vinblastine and dacarbazine).
Croatian: U glavnom ispitivanju koje je obuhvatilo 1 334 bolesnika s HL-om pozitivnim na CD30 koji nisu primili prethodno liječenje Adcetris je uspoređen s bleomicinom (drugi lijek za liječenje HL-a), a oba lijeka primijenjena su u kombinaciji s drugim lijekovima protiv raka (doksorubicin, vinblastin i dakarbazin).
English: The active substance in Adcetris, brentuximab vedotin, is made up of a CD30 monoclonal antibody (a type of protein that attaches to CD30).
Croatian: Djelatna tvar u lijeku Adcetris, brentuksimab vedotin, sastoji se od monoklonskog protutijela CD30 (vrsta proteina koja se vezuje na CD30).
English: Previously untreated patients with advanced HL also benefited from Adcetris used in combination with other cancer medicines.
Croatian: Bolesnici s uznapredovalim HL-om koji nisu prethodno liječeni također su imali koristi od primjene lijeka Adcetris u kombinaciji drugim lijekovima protiv raka.
English: • when the cancer has come back or has not responded to at least two other therapies and when autologous stem cell transplant or multi-agent chemotherapy (a combination of cancer medicines) cannot be used.
Croatian: • kada se rak ponovno javio ili kada bolesnik nije odgovorio na najmanje dvije prethodne terapije i kada nije primjenjiva transplantacija autolognih matičnih stanica ili kombinirana kemoterapija (kombinacija lijekova za liječenje raka).
English: • systemic anaplastic large cell lymphoma (sALCL, a CD30-positive cancer of white blood cells called T lymphocytes), when the cancer has come back or has not responded to other treatments;
Croatian: • sistemskog anaplastičnog velikostaničnog limfoma (sALCL, rak pozitivan na CD30 koji zahvaća bijele krvne stanice naziva T limfociti) kada se rak ponovno javio ili kada bolesnik nije odgovorio na druge terapije;
English: How does Adcetris work?
Croatian: Kako djeluje Adcetris?
English: In addition, the company provided data on 40 patients with CD30-positive HL, whose cancer had come back or had not responded to at least 2 prior therapies and who were not eligible for autologous stem cell transplant or multi-agent chemotherapy.
Croatian: Osim toga, tvrtka je dostavila podatke o 40 bolesnika s HL-om pozitivnim na CD30 čiji se rak ponovo javio ili koji nisu odgovorili na najmanje dvije prethodne terapije i za koje nije bila prikladna autologna transplantacija matičnih stanica ili kombinirana kemoterapija.
English: The study compared treatment with Adcetris and treatment with another appropriate medicine (methotrexate or bexarotene).
Croatian: U tom ispitivanju terapija lijekom Adcetris uspoređena je s terapijom drugim odgovarajućim lijekom (metotreksatom ili beksarotenom).
English: • CD30-positive cutaneous T-cell lymphoma (CTCL), a lymphoma of T lymphocytes that initially affects the skin, in patients who have received at least one previous treatment.
Croatian: • limfoma kožnih T-stanica (CTCL) pozitivnih na CD30, limfoma T limfocita koji na početku zahvaća kožu, u bolesnika koji su prethodno primili barem jednu terapiju.
English: The monoclonal antibody is attached to monomethyl auristatin E, a cytotoxic (cell-killing) molecule.
Croatian: Monoklonsko protutijelo veže se na monometil auristatin E, citotoksičnu molekulu (koja ubija stanice).
English: What benefits of Adcetris have been shown in studies?
Croatian: Koje su koristi od lijeka Adcetris utvrđene u ispitivanjima?
English: Adcetris contains the active substance brentuximab vedotin.
Croatian: Adcetris sadrži djelatnu tvar brentuksimab vedotin.
English: In another main study, Adcetris was compared with placebo (a dummy treatment) in 329 patients with CD30-positive HL who had received an autologous stem cell transplant and who were at increased risk of their cancer progressing or coming back.
Croatian: U drugom glavnom ispitivanju Adcetris je uspoređen s placebom (prividno liječenje) u 329 bolesnika s HL-om pozitivnim na CD30 koji su primili autolognu transplantaciju matičnih stanica i u kojih je postojao povećan rizik od napredovanja ili ponovne pojave raka.
English: How is Adcetris used?
Croatian: Kako se Adcetris primjenjuje?
English: Adcetris has been shown to be of benefit in CD30-positive cutaneous T-cell lymphoma in a main study in 128 patients with CD30-positive CTCL who had had at least one previous treatment.
Croatian: Lijek Adcetris pokazao se korisnim u liječenju limfoma kožnih T-stanica pozitivnih na CD30 u glavnom ispitivanju kojim je bilo obuhvaćeno 128 bolesnika s CTCL-om pozitivnim na CD30 koji su prethodno bili liječeni barem jedanput.
English: In another main study, Adcetris was used in 102 patients with CD30-positive HL, who had previously received an autologous stem cell transplant and whose cancer had come back or had not responded to previous treatment.
Croatian: U drugom glavnom ispitivanju Adcetris je primijenjen na 102 bolesnika s HL-om pozitivnim na CD30 koji su prethodno primili autolognu transplantaciju matičnih stanica i čiji se rak vratio ili u kojih nije bilo odgovora na prethodno liječenje.
English: For the full list of all restrictions with Adcetris, see the package leaflet.
Croatian: Potpuni popis svih ograničenja pri primjeni lijeka Adcetris potražite u uputi o lijeku.
English: The monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells, and once inside the cancer cells, it stops them from dividing, and the cancer cells eventually die.
Croatian: E u stanice raka pozitivne na CD30 i, kada se nađe unutar njih, zaustavlja njihovu diobu pa stanice raka naposljetku odumru.
English: A complete response is when a patient has no signs of cancer.
Croatian: Kada u bolesnika nema znakova raka, smatra se da je postignut potpun odgovor.
English: Cutaneous T-cell lymphoma
Croatian: Limfom kožnih T-stanica
English: Side effects are similar in children.
Croatian: Nuspojave su slične kod djece.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 12 August 2010.
Croatian: Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” prestale su 12. kolovoza 2010.
English: A second dose may be given after an interval of at least three weeks.
Croatian: Druga doza može se primijeniti nakon intervala od najmanje tri tjedna.
English: The virus has first been inactivated (killed) so that it does not cause any disease.
Croatian: Virus je prvo inaktiviran (ubijen) kako ne bi uzrokovao bolesti.
English: Pandemrix was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Croatian: Pandemrix je prvobitno odobren u „iznimnim okolnostima” zbog toga što su, iz znanstvenih razloga, u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
English: This summary was last updated in 05-2016.
Croatian: Sažetak je posljednji put ažuriran u 05.2016.
English: This will help to protect against the disease caused by the virus.
Croatian: Ovo pomaže pri zaštiti od bolesti koju uzrokuje virus.
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Croatian: Imunosni sustav potom će moći proizvoditi protutijela brže kada bude ponovno izložen virusu.
English: It contains parts of influenza (flu) viruses that have been inactivated.
Croatian: Sadrži određene dijelove virusa influence (gripe) koji su inaktivirani.