FrancophonIA/ELRC3.0 huggingface dataset:
English: Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Croatian: Svaka infuzija traje dva sata i daje se bolesniku svakih šest sati tijekom četiri uzastopna dana prije liječenja ciklofosfamidom ili melfalanom i presađivanja.
English: This is a summary of the European public assessment report (EPAR) for Busilvex.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Busilvex.
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 Busilvex.
Croatian: Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Busilvex.
English: This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (or ‘stem') cells (cells that make other types of cell).
Croatian: To znači da ubijaju stanice, posebice stanice koje se brzo razvijaju, poput tumorskih ili progenitorskih (ili „matičnih”) stanica (stanica koje tvore druge tipove stanica).
English: It contains the active substance busulfan.
Croatian: Sadrži djelatnu tvar busulfan.
English: This helps the transplanted cells to ‘engraft' (when they start to grow and produce normal blood cells).
Croatian: To pomaže da se presađene stanice „prime” (kada počnu rasti i proizvoditi normalne stanice krvi).
English: For more information about treatment with Busilvex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Busilvex pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Before receiving Busilvex, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Croatian: Prije primanja lijeka Busilvex, bolesnici moraju primiti premedikaciju antikonvulzivnim lijekovima (da bi se spriječili napadaji) i antiemeticima (da bi se spriječilo povraćanje).
English: Cyclophosphamide, melphalan or fludarabine are used to suppress the immune system, so that the body's natural defences are decreased.
Croatian: Ciklofosfamid, melfalan ili fludarabin se zatim koriste za potiskivanje imunološkog sustava, tako da se oslabi prirodna obrana tijela.
English: Since Busilvex in combination with fludarabine has been used in clinical practice for many years, data from 7 studies (involving 731 patients) which looked at the effectiveness of Busilvex and fludarabine as ‘reduced-intensity' conditioning treatment were presented.
Croatian: Budući da se Busilvex u kombinaciji s fludarabinom koristio u kliničkoj praksi tijekom dugog niza godina, dostavljeni su podaci iz 7 ispitivanja (sa 731 bolesnika) u kojima se istražila učinkovitost lijeka Busilvex i fludarabina pri kondicioniranju smanjenog intenziteta.
English: The main measures of effectiveness were the number of patients with myeloablation and ‘engraftment' (the time for the transplanted stem cells to begin growing and for white blood cells to return to higher levels).
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika s mijeloablacijom i „primanje presatka” (vrijeme potrebno da transplantirane matične stranice počnu rasti, a bijele krvne stanice vrate u više razine).
English: The data from the published studies showed that Busilvex in combination with fludarabine was effective as a ‘reduced-intensity' conditioning treatment, with complete engraftment achieved in 80 to 100% of patients.
Croatian: Podaci iz objavljenih ispitivanja pokazali su da je lijek Busilvex u kombinaciji s fludarabinom učinkovit kao terapija kondicioniranja smanjenog intenziteta, s potpunim primanjem presatka postignutim u 80 do 100 % bolesnika.
English: Busilvex must not be used in women who are pregnant.
Croatian: Lijek Busilvex ne smije se koristiti u trudnica.
English: Engraftment was obtained in 13 days in adults and 21 days in children with ‘allotransplantation' (when the patient receives cells from a donor).
Croatian: Primanje presatka postignuto je 13 dana u odraslih osoba i 21 dan u djece nakon „alogenog presađivanja” (kada bolesnik zaprimi stanice od donatora).
English: When used in combination with fludarabine, the recommended dose of Busilvex is 3.2 mg per kilogram given once a day as a three-hour infusion immediately after fludarabine, for 2 or 3 consecutive days.
Croatian: Kad se uzima u kombinaciji s fludarabinom, preporučena doza lijeka Busilvex iznosi 3,2 mg po kilogramu tjelesne težine, jedanput dnevno trosatnom infuzijom odmah nakon uzimanja fludarabina, 2 ili 3 uzastopna dana.
English: Busulfan is used before transplantation to destroy abnormal cells and the patient's existing haematopoietic progenitor cells.
Croatian: Busulfan se koristi prije presađivanja za uništavanje abnormalnih stanica i postojećih hematopoetskih progenitorskih stanica bolesnika.
English: Apart from the decrease in blood cell counts, which is the intended effect of the medicine, the most serious side effects of Busilvex are infection, liver disorders including blocking of a liver vein, graft versus host disease (when the transplanted cells attack the body) and respiratory (lung) disorders.
Croatian: Izuzev smanjivanja broja krvnih stanica, što je i predviđeno djelovanje lijeka, najozbiljnije nuspojave lijeka Busilvex su upale, poremećaji funkcije jetre, uključujući i blokiranje jetrene vene, reakcija presatka na domaćina (kada presađene stanice napadaju tijelo), te respiratorni poremećaji (poremećaji funkcije pluća).
English: The active substance in Busilvex, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Croatian: Djelatna tvar u lijeku Busilvex, busulfan, ubraja se u grupu lijekova poznatih pod nazivom „alkilirajuće tvari”.
English: Busilvex should be used by a doctor who has experience in treatments given before transplantation.
Croatian: Primjenu lijeka Busilvex mora nadzirati liječnik iskusan u terapijama koje prethode presađivanju.
English: On average, engraftment was reached in 10 days in adults and 11 days in children with ‘autotransplantation' (when the patient receives their own cells, harvested and stored before the transplant).
Croatian: Primanje presatka postignuto je u prosjeku 10 dana u odraslih osoba i 11 dana u djece nakon „autolognog presađivanja” (nakon što su bolesnici zaprimili svoje vlastite stanice, uzete i pohranjene prije presađivanja).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom of Busilvex varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Busilvex is given as a central intravenous infusion (drip into a central vein in the chest).
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom primjenjuje kao središnja intravenozna infuzija (drip u središnju venu u prsima).
English: The Committee decided that Busilvex's benefits are greater than its risks in these settings and recommended that Busilvex be given marketing authorisation.
Croatian: Odbor je odlučio da koristi od lijeka Busilvex u ovim postavkama nadmašuju s njim povezane rizike, te je preporučio izdavanje odobrenja za stavljanje lijeka Busilvex u promet.
English: Other information about Busilvex
Croatian: Ostale informacije o lijeku Busilvex
English: When used in combination with cyclophosphamide or melphalan the recommended dose of Busilvex in adults is 0.8 mg per kilogram body weight.
Croatian: Ako se uzima u kombinaciji s kiklofosfamidom ili melpfalanom, preporučena doza lijeka Busilvex u odraslih osoba iznosi 0,8 mg po kilogramu tjelesne težine.
English: Busilvex is a concentrate to be made up into a solution for infusion (drip into a vein).
Croatian: Busilvex je koncentrat za otopinu za infuziju (drip u venu).
English: The CHMP concluded that the effectiveness of Busilvex in combination with cyclophosphamide and melphalan for conventional conditioning, and with fludarabine for reduced-intensity conditioning had been shown; Busilvex also provides an alternative to busulfan tablets, which have disadvantages such as the large number of tablets that need to be taken.
Croatian: CHMP je zaključio da je djelotvornost lijeka Busilvex u kombinaciji s kiklofosfamidom ili melpfalanom za konvencionalno kondicioniranje dokazano, tj. u kombinaciji s fludarabinom za kondicioniranje smanjenog intenziteta; Busilvex pruža alternativu liječenju tabletama busulfana, čiji je nedostatak velika količina tableta koja se mora popiti.
English: Breast-feeding should be stopped when treatment with Busilvex is started.
Croatian: Dojenje se mora prekinuti prilikom počinjanja liječenja lijekom Busilvex.
English: Busilvex is used in adults and children as part of a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Croatian: Busilvex je indiciran u odraslih i djece kao dio terapije kondicioniranja (pripreme) prije presađivanja hematopoetskih progenitorskih stanica (krvotvornih stanica).
English: Why has Busilvex been approved?
Croatian: Zašto je Busilvex odobren?
English: Busilvex in combination with cyclophosphamide or melphalan has been studied in patients, mainly with blood cancer, who needed transplantation of haematopoietic progenitor cells.
Croatian: Busilvex u kombinaciji s kiklofosfamidom ili melpfalanom ispitan je u bolesnika, uglavnom s rakom krvi, kojima je bilo potrebno presađivanje hematopoetskih progenitorskih stanica.
English: What is the risk associated with Busilvex?
Croatian: Koji su rizici povezani s lijekom Busilvex?
English: In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busilvex is given right after treatment with another medicine, fludarabine.
Croatian: U odraslih bolesnika podobnih za režim kondicioniranja smanjenog intenziteta, Busilvex se daje odmah nakon liječenja fludarabinom.
English: When Busilvex was given in combination with cyclophosphamide or melphalan, all adults and children achieved myeloablation.
Croatian: Kod uzimanja lijeka Busilvex u kombinaciji s kiklofosfamidom ili melpfalanom, sve odrasle osobe i djeca postigla su mijeloablaciju.
English: What is Busilvex?
Croatian: Što je Busilvex?
English: For a conventional conditioning treatment, Busilvex is given before treatment with a second medicine, cyclophosphamide, in adults, and either cyclophosphamide or an alternative medicine, melphalan, in children.
Croatian: Kod konvencionalne terapije kondicioniranja, Busilvex se u odraslih daje prije liječenja drugim lijekom, kiklofosfamidom, tj. u slučaju djece prije liječenja kiklofosfamidom ili alternativnim lijekom, melpfalanom.
English: For the full list of all side effects and restrictions with Busilvex, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Busilvex potražite u uputi o lijeku.
English: What benefit has Busilvex shown during the studies?
Croatian: Koje su koristi lijeka Busilvex utvrđene u ispitivanjima?
English: What is Busilvex used for?
Croatian: Za što se Busilvex koristi?
English: How is Busilvex used?
Croatian: Kako se Busilvex koristi?
English: How has Busilvex been studied?
Croatian: Kako je Busilvex ispitan?
English: How does Busilvex work?
Croatian: Kako djeluje Busilvex?
English: Pifeltro (doravirine)
Croatian: Pifeltro (doravirin)
English: Further information on Pifeltro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pifeltro.
Croatian: Više informacija o lijeku Pifeltro nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/pifeltro.
English: What measures are being taken to ensure the safe and effective use of Pifeltro?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pifeltro?
English: Pifeltro (doravirine) EMA/821744/2018
Croatian: Pifeltro (doravirin) EMA/661893/2018
English: Other information about Pifeltro
Croatian: Ostale informacije o lijeku Pifeltro
English: Pifeltro must not be used with certain medicines that may reduce its effectiveness.
Croatian: Lijek Pifeltro ne smije se primjenjivati u kombinaciji s određenim lijekovima koji mogu smanjiti njegovu učinkovitost.
English: Pifeltro is available as tablets (100 mg) and can only be obtained with a prescription.
Croatian: Lijek Pifeltro dostupan je u obliku tableta (100 mg) i izdaje se samo na liječnički recept.
English: Side effects reported with Pifeltro are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Pifeltro pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Pifeltro helps keep the amount of HIV in the blood at a low level.
Croatian: Lijek Pifeltro održava količinu HIV-a u krvi na niskoj razini.
English: Pifeltro is an antiviral medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Pifeltro je protuvirusni lijek koji se primjenjuje za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: What is Pifeltro and what is it used for?
Croatian: Što je Pifeltro i za što se primjenjuje?
English: It does not cure HIV infection or AIDS but, when used in combination with other antivirals, it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Ne liječi infekciju HIV-om ni AIDS, ali kada se primjenjuje u kombinaciji s drugim protuvirusnim lijekovima, može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
English: Doravirine blocks the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Croatian: Doravirin blokira djelovanje reverzne transkriptaze, enzima koji HIV-u omogućuje reprodukciju u zaraženim stanicama.
English: What are the risks associated with Pifeltro?
Croatian: Koji su rizici povezani lijekom Pifeltro?
English: The most common side effects with Pifeltro (which may affect up to 1 in 10 people) are nausea (feeling sick) and headache.
Croatian: Najčešće nuspojave lijeka Pifeltro (koje se mogu javiti u do 1 na 10 osoba) jesu mučnina (slabost) i glavobolja.
English: In addition, Pifeltro's side effects are mostly mild.
Croatian: Osim toga, nuspojave lijeka Pifeltro uglavnom su blage.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pifeltro 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 Pifeltro nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Pifeltro are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Pifeltro kontinuirano se prate.
English: An overview of Pifeltro and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Pifeltro i zašto je odobren u EU-u
English: The European Medicines Agency therefore decided that Pifeltro's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Pifeltro nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: For more information about using Pifeltro, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Pifeltro pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Why is Pifeltro authorised in the EU?
Croatian: Zašto je lijek Pifeltro odobren u EU-u?
English: In a second study with 728 patients, 84% of patients treated with Pifeltro in combination with tenofovir disoproxil and lamivudine had undetectable HIV levels by 48 weeks compared with 80% of patients given a combination of efavirenz, tenofovir disoproxil and emtricitabine.
Croatian: U drugom ispitivanju kojim je bilo obuhvaćeno 728 bolesnika, 84 % bolesnika liječenih lijekom Pifeltro u kombinaciji s tenofovirdizoproksilom i lamivudinom imalo je nemjerljive razine HIV-a u krvi nakon 48 tjedana, u usporedbi s 80 % bolesnika koji su primali kombinaciju efavirenza, tenofovirdizoproksila i emtricitabina.
English: How is Pifeltro used?
Croatian: Kako se Pifeltro koristi?
English: The active substance in Pifeltro, doravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Croatian: Djelatna tvar lijeka Pifeltro, doravirin, jest nenukleozidni inhibitor reverzne transkriptaze (NNRTI).
English: The medicine is not suitable for patients who are infected with HIV that is resistant to medicines in the same class as Pifeltro (non-nucleoside reverse transcriptase inhibitors or NNRTIs).
Croatian: Lijek nije prikladan za bolesnike zaražene virusom HIV-a rezistentnim na lijekove iz iste skupine kao i lijek Pifeltro (nenukleozidne inhibitore reverzne transkriptaze ili NNRTI-je).
English: In a study of 766 patients, 83% of patients taking Pifeltro (together with either emtricitabine and tenofovir disoproxil or abacavir and lamivudine) had undetectable levels of HIV in their blood (fewer than 40 copies/ml) after 48 weeks of treatment.
Croatian: U ispitivanju kojim je bilo obuhvaćeno 766 bolesnika, 83 % bolesnika koji su primali lijek Pifeltro (zajedno s emtricitabinom i tenofovirdizoproksilom ili abakavirom i lamivudinom) imalo je nemjerljive razine HIV-a u krvi (manje od 40 kopija/ml) nakon 48 tjedana terapije.
English: This compares with 79% of patients taking standard combination of darunavir plus ritonavir (together with either emtricitabine and tenofovir disoproxil or abacavir and lamivudine).
Croatian: To je usporedivo sa 79 % bolesnika koju su primali standardnu kombinaciju darunavira i ritonavira (zajedno s emtricitabinom i tenofovirdizoproksilom ili abakavirom i lamivudinom).
English: Pifeltro is used together with other antiviral medicines.
Croatian: Pifeltro je lijek koji se primjenjuje u kombinaciji s drugim protuvirusnim lijekovima.
English: How does Pifeltro work?
Croatian: Kako djeluje Pifeltro?
English: What benefits of Pifeltro have been shown in studies?
Croatian: Koje su koristi od lijeka Pifeltro utvrđene u ispitivanjima?
English: Pifeltro used in combination with other antivirals is as effective as standard HIV combination treatments at keeping HIV infection under control.
Croatian: Lijek Pifeltro u kombinaciji s drugim protuvirusnim lijekovima jednako je učinkovit kao i standardna liječenja HIV-a u kontroliranju infekcije HIV-om.
English: Studies showed that Pifeltro taken with other antivirals was as effective at keeping HIV infection under control as standard HIV combination treatments.
Croatian: U ispitivanjima je utvrđeno da je lijek Pifeltro kada se uzimao s drugim protuvirusnim lijekovima bio jednako učinkovit u kontroliranju infekcije HIV-om kao i standardna kombinirana liječenja HIV-a.
English: Pifeltro contains the active substance doravirine.
Croatian: Pifeltro sadržava djelatnu tvar doravirin.
English: For the full list of side effects and restrictions with Pifeltro, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Pifeltro potražite u uputi o lijeku.
English: 1ml (200 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Croatian: 1 ml (200mg/ml) 12 (3 x 4) napunjenih brizgalica (višestruko pakiranje)
English: 1ml (200 mg/ml) 1 pre-filled pen
Croatian: 1 ml (200mg/ml) 1 napunjena brizgalica
English: 1ml (200 mg/ml) 4 pre-filled pens
Croatian: 1 ml (200mg/ml) 4 napunjenih brizgalica
English: 1ml (200 mg/ml) 1 pre-filled syringe
Croatian: 1 ml (200mg/ml) 1 napunjena štrcaljka
English: The full EPAR for Avastin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Avastin nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated.
Croatian: Doza iznosi između 5 i 15 mg po kilogramu tjelesne težine svaka dva ili tri tjedna, ovisno o tipu raka koji se liječi.
English: In all of the studies, the main measure of effectiveness was either overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
Croatian: U svim tim ispitivanjima, glavna mjera djelotvornosti bila je ukupna stopa preživljenja (koliko su dugo bolesnici živjeli) ili preživljenje bez progresije (koliko su dugo bolesnici živjeli bez pogoršanja bolesti).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Avastin on 12 January 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Avastin u promet koje vrijedi na prostoru Europske unije od 12. siječnja 2005.
English: As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, helping to slow down the growth of tumours.
Croatian: Kao rezultat toga, tumorske stanice ne mogu razviti vlastitu opskrbu krvlju te su im uskraćeni kisik i hranjive tvari, što pomaže pri usporavanju rasta tumora.
English: The first infusion of Avastin should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well.
Croatian: Prva infuzija lijeka Avastin treba trajati najmanje 90 minuta, no naknadne infuzije mogu se primijeniti tijekom kraćeg razdoblja ako je bolesnik dobro podnio prvu infuziju.
English: This is a summary of the European public assessment report (EPAR) for Avastin.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Avastin.
English: The third study involved 829 patients who had failed previous treatment including a fluoropyrimidine and irinotecan.
Croatian: Treće je ispitivanje obuhvatilo 829 bolesnika kod kojih prethodno liječenje, koje je uključivalo fluoropirimidin i irinotekan, nije bilo uspješno.
English: By attaching to VEGF, Avastin stops it having an effect.
Croatian: Vezivanjem na VEGF Avastin zaustavlja njegovo djelovanje.
English: What measures are being taken to ensure the safe and effective use of Avastin?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Avastin?
English: Other information about Avastin
Croatian: Ostale informacije o lijeku Avastin
English: Several studies have shown that Avastin is effective at treating the types of cancers for which it is approved.
Croatian: Nekoliko je ispitivanja pokazalo da je lijek Avastin djelotvoran u liječenju vrsta raka za koje je odobren.
English: What is Avastin and what is it used for?
Croatian: Što je Avastin i za što se koristi?
English: The CHMP decided that Avastin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je zaključio da koristi lijeka Avastin nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Avastin 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 Avastin nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: • advanced or metastatic kidney cancer, in combination with interferon alfa-2a;
Croatian: • uznapredovalim ili metastatskim rakom bubrega, u kombinaciji s interferonom alfa-2a;