FrancophonIA/ELRC3.0 huggingface dataset:
English: Once the review is concluded, EMA will communicate further and provide guidance to patients and healthcare professionals.
Croatian: Nakon što dovrši ocjenjivanje lijeka, EMA će dostaviti dodatne obavijesti te bolesnicima i zdravstvenim djelatnicima pružiti smjernice.
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Croatian: Ocjenjivanje je prvotno proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za procjenu sigurnosnih pitanja u području lijekova za humanu uporabu.
English: Doctors should reevaluate each patient taking Zydelig first-line for CLL, and only continue treatment if the benefits outweigh the risks.
Croatian: Liječnici moraju napraviti ponovnu procjenu za svakog bolesnika koji uzima lijek Zydelig za CLL kao terapiju prve linije i nastaviti liječenje samo ako koristi nadmašuju rizike.
English: • Patients should be informed about the risk of serious infections with Zydelig.
Croatian: • Bolesnici moraju biti obaviješteni o riziku od teških infekcija pri primjeni lijeka Zydelig.
English: Measures include close monitoring and use of antibiotics to prevent pneumonia
Croatian: Mjere obuhvaćaju pomno praćenje i uporabu antibiotika za prevenciju upale pluća.
English: More information on the approved uses of Zydelig can be found here.
Croatian: Više informacija o odobrenim primjenama lijeka Zydelig dostupno je ovdje.
English: • Further details on these provisional measures will be provided in writing to healthcare professionals and the product information will be updated accordingly.
Croatian: • Zdravstvenim djelatnicima pisanim su putem pružene dodatne pojedinosti o ovim privremenim mjerama, a informacije o proizvodu ažurirane su u skladu s time.
English: • Your doctor will order regular blood tests to minimise the risk of infections or neutropenia (low white blood cell count which may make you more likely to develop an infection).
Croatian: • Liječnik će propisati da morate obavljati redovite krvne pretrage kako bi se rizik od infekcija ili neutropenije (niska razina bijelih krvnih stanica koja povećava rizik od razvoja infekcije) smanjio na najmanju moguću mjeru.
English: Most deaths related to infections such as Pneumocystis jirovecii pneumonia and cytomegalovirus infections.
Croatian: Većina smrtnih slučajeva povezana je s infekcijama kao što su upala pluća uzrokovana gljivicom Pneumocystis jirovecii i citomegalovirusne infekcije.
English: The PRAC recommends that all patients treated with Zydelig should receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia).
Croatian: PRAC je preporučio da bi svi bolesnici koji se liječe lijekom Zydelig trebali primati antibiotike radi prevencije određene vrste upale pluća (upala pluća uzrokovana gljivicom Pneumocystis jiroveci).
English: Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called nonHodgkin lymphoma).
Croatian: Lijek Zydelig trenutačno je odobren u EU-u za liječenje dviju vrsta raka krvi, kronične limfocitne leukemije (CLL) i folikularnog limfoma (skupina raka koji se naziva ne-Hodgkinovim limfomom).
English: The clinical trials, which have now been stopped, involved patients with CLL and indolent non-Hodgkin lymphoma.
Croatian: Ta su klinička ispitivanja, koja su sad već prekinuta, uključivala bolesnike s CLL-om i indolentnim ne-Hodgkinovim limfomom.
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended.
Croatian: Preporučuje se također redovito kliničko i laboratorijsko praćenje radi utvrđivanja mogućih citomegalovirusnih infekcija.
English: • All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and should be monitored for respiratory signs and symptoms.
Croatian: • Svi bolesnici moraju primiti preventivnu terapiju za upalu pluća uzrokovanu gljivicom P. jirovecii tijekom liječenja lijekom Zydelig i potrebno ih je nadzirati radi praćenja respiratornih znakova i simptoma.
English: Patients should also be monitored for infection and have regular blood tests for white cell counts because low counts can increase their risk of infection.
Croatian: Bolesnici također trebaju biti pod stalnim nadzorom radi utvrđivanja moguće infekcije te obavljati redovite pretrage krvi radi provjere razine bijelih krvnih stanica jer niske razine mogu povećati rizik od pojave infekcije.
English: • No new patients with chronic lymphocytic leukaemia (CLL) will be started on Zydelig if they have not received previous treatment for their cancer.
Croatian: • U novih bolesnika s kroničnom limfocitnom leukemijom (CLL) više se neće započeti liječenje lijekom Zydelig ako bolesnici prethodno nisu primali terapiju za rak.
English: • If you are taking Zydelig, you will receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia) and be monitored for signs of infections.
Croatian: • Ako uzimate lijek Zydelig, primat ćete antibiotike radi prevencije određene vrste upale pluća (upala pluća uzrokovana gljivicom Pneumocystis jiroveci) i biti pod nadzorom radi utvrđivanja mogućih znakova infekcije.
English: • a type of non-Hodgkin lymphoma called follicular lymphoma where it is used on its own.
Croatian: • vrste ne-Hodgkinovog limfoma koji se naziva folikularni limfom, pri čemu se primjenjuje kao monoterapija.
English: Zydelig should not be started in patients with a generalised infection.
Croatian: Liječenje lijekom Zydelig ne smije se započeti u bolesnika s generaliziranom infekcijom.
English: These will now be forwarded to the European Commission (EC), which will issue a provisional legally binding decision applicable in all EU Members States.
Croatian: Te su preporuke proslijeđene Europskoj komisiji (EK), koja je objavila privremenu zakonski obvezujuću odluku primjenjivu u svim državama članicama EU-a od 23. ožujka 2016.
English: • Zydelig can continue to be used in combination, only with rituximab, in CLL patients who have received at least one prior therapy, and as monotherapy in patients with follicular lymphoma that is refractory to two lines of treatment.
Croatian: • Lijek Zydelig može se i dalje upotrebljavati u kombinaciji, samo s rituksimabom, u bolesnika s CLLom koji su prethodno primili barem jednu terapiju te kao monoterapija u bolesnika s folikularnim limfomom koji se pokazao otpornim na dvije prethodne linije terapije.
English: In case the patient has moderate or severe neutropenia treatment with Zydelig may have to be interrupted, in line with the updated summary of product characteristics (SmPC).
Croatian: Ako bolesnik ima neutropeniju umjerenog ili teškog stupnja, liječenje lijekom Zydelig možda će biti potrebno prekinuti u skladu s ažuriranim sažetkom opisa svojstava lijeka.
English: • Further information on Zydelig will be provided as necessary.
Croatian: • Po potrebi će se pružiti dodatne informacije o lijeku Zydelig.
English: • Patients should also have regular checks of their blood counts to detect neutropenia.
Croatian: • Bolesnici također trebaju redovito provjeravati razine krvnih stanica radi utvrđivanja moguće neutropenije.
English: • As a precaution and while a thorough review is ongoing, Zydelig should not be started as first-line treatment in patients with CLL who have the 17p deletion or TP53 mutation.
Croatian: • Kao mjera opreza i sve dok je u tijeku temeljito ocjenjivanje lijeka, liječenje lijekom Zydelig ne smije se početi kao terapija prve linije u bolesnika s CLL-om koji imaju deleciju 17p ili mutaciju TP53.
English: It should also not be started in previously untreated patients with CLL whose cancer cells have certain genetic mutations (17p deletion or TP53 mutation).
Croatian: Također se ne smije započeti u bolesnika s CLL-om koji prethodno nisu liječeni, a čije stanice raka imaju određene genske mutacije (delecija 17p ili mutacija TP53).
English: The review started after a higher rate of serious adverse events was seen in three clinical trials among patients receiving Zydelig compared with placebo (a dummy treatment).1 The adverse events included deaths related to infections such as pneumonia.
Croatian: Ocjenjivanje je počelo nakon što je u trima kliničkim ispitivanjima na bolesnicima koji primaju lijek Zydelig uočena veća stopa ozbiljnih štetnih događaja u usporedbi s bolesnicima koji su primali placebo (slijepo liječenje).1
English: • chronic lymphocytic leukaemia in patients who have received previous treatment as well as in previously untreated patients who have certain genetic mutations (17p deletion or TP53 mutation) in their cancer cells.
Croatian: • kronične limfocitne leukemije u bolesnika koji su prethodno liječeni te u bolesnika koji prethodno nisu bili liječeni, a koji imaju određene genske mutacije (delecija 17p ili mutacija TP53) u svojim stanicama raka.
English: Patients who are already on treatment will have their treatment reviewed by their doctor.
Croatian: U slučaju bolesnika koji već primaju terapiju tim lijekom liječnik će ocijeniti treba li nastaviti s terapijom.
English: Zydelig must not be started in patients with any evidence of ongoing systemic infection.
Croatian: Liječenje lijekom Zydelig ne smije se početi u bolesnika s postojećom sistemskom infekcijom.
English: There have been reports of serious side effects in clinical studies with the cancer medicine Zydelig.
Croatian: U kliničkim ispitivanjima utvrđene su teške nuspojave lijeka za liječenje raka Zydelig.
English: You should contact your doctor straight away if you develop fever, cough or difficulty breathing.
Croatian: Ako uočite da imate vrućicu, kašalj ili teškoće pri disanju, smjesta se obratite svom liječniku.
English: • Increased rates of serious adverse effects including deaths were seen in 3 clinical trials in the treatment arm evaluating the addition of Zydelig to standard therapy in first-line CLL and relapsed indolent non-Hodgkin lymphoma.
Croatian: • U trima kliničkim ispitivanjima procjene učinka dodavanja lijeka Zydelig standardnoj terapiji prve linije u liječenju bolesnika s CLL-om i bolesnika u kojih se ponovno pojavio indolentni neHodgkinov limfom uočene su veće stope teških nuspojava, što uključuje smrtne slučajeve.
English: The clinical trial in CLL involved patients who had not received previous treatment, some of whom had the 17p deletion or TP53 mutation; however, it also investigated a combination of medicines which is currently not approved.
Croatian: Kliničko ispitivanje na bolesnicima s CLL-om uključivalo je bolesnike koji prethodno nisu bili liječeni, od kojih su neki imali deleciju 17p ili mutaciju TP53.
English: • Further information on the review of Zydelig will be provided as necessary and once the review is concluded.
Croatian: • Nakon dovršetka ocjenjivanja bit će pružene dodatne informacije o ocjeni lijeka Zydelig.
English: 2 - What you need to know before you take {product name}
Croatian: 2 - Što morate znati prije nego počnete uzimati [naziv lijeka]
English: It is important to tell your doctor if you are taking:
Croatian: Liječnika morate obavijestiti ako uzimate:
English: N.B: For Evotaz, Section 4.4 warning should be maintained.
Croatian: Napomena: Za Evotaz, potrebno je zadržati upozorenja iz dijela 4.4.
English: Moreover, the tables with information on interactions should be modified according to the following instructions:
Croatian: Osim toga, tablice s informacijama o interakcijama potrebno je izmijeniti u skladu s uputama u nastavku:
English: Adopted at the 30 August-2 September 2016 PRAC
Croatian: Usvojeno na sjednici PRAC-a 30. kolovoza - 2. rujna 2016.
English: Interaction not studied with any of the components of <product name>.
Croatian: Nije ispitana interakcija niti s jednom komponentom <naziv lijeka>.
English: Cases of Cushing's syndrome and adrenal suppression have been reported.
Croatian: Zabilježeni su slučajevi Cushingova sindroma i adrenalne supresije.
English: Agomelatine - Urinary retention (EPITT no 18637)
Croatian: Agomelatin - Urinarna retencija (EPITT br. 18637)
English: Note: it is acknowledged that the package leaflet for some products may need to be slightly modified in order to incorporate the above message.
Croatian: Napomena: za neke lijekove možda je potrebno malo izmijeniti uputu o lijeku kako bi se dodala prethodno navedena poruka.
English: Iomeprol - Haemolysis (EPITT no 18625)
Croatian: Iomeprol - Hemoliza (EPITT br. 18625)
English: Frequency “rare”: Inability to completely empty the bladder
Croatian: Učestalost „rijetko”: Nemogućnost potpunog pražnjenja mjehura
English: Plasma concentrations of these medicinal products may be increased when coadministered with <product name>, resulting in reduced serum cortisol concentrations.
Croatian: Mogu biti povećane koncentracije tih lijekova u plazmi kada se primjenjuju istodobno s <naziv lijeka>, što dovodi do smanjenih koncentracija kortizola u serumu.
English: 2 - What you need to know before you <take> <use> {product name} Other medicines and {product name} <Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.> Warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Croatian: 2 - Što morate znati prije nego počnete <uzimati> <primjenjivati> {naziv lijeka} Drugi lijekovi i {naziv lijeka} <Obavijestite svog <liječnika> <ili> <ljekarnika> ako <uzimate> <primjenjujete>, nedavno ste <uzeli> <primijenili> ili biste mogli <uzeti> <primijeniti> bilo koje druge lijekove.>
English: Summary of product characteristics of corticosteroids (excluding topical formulations)
Croatian: Sažetak opisa svojstava lijeka za kortikosteroide (isključujući topikalne formulacije)
English: Haemolytic anaemia (abnormal breakdown of red blood cells, which may cause fatigue, rapid heart rate and shortness of breath)
Croatian: Hemolitička anemija (neuobičajeno raspadanje crvenih krvnih stanica koje može uzrokovati umor, ubrzane srčane otkucaje i nedostatak zraka)
English: Interaction with other medicinal products and other forms of interaction Patients treated with vitamin K antagonists:
Croatian: 4.5. Interakcije s drugim lijekovima i drugi oblici interakcija Bolesnici liječeni antagonistima vitamina K:
English: Blood and lymphatic system disorders (frequency not known): Haemolytic anaemia
Croatian: Poremećaji krvi i limfnog sustava (učestalost nepoznata): Hemolitička anemija
English: For Victrelis, Sovaldi, Harvoni, Daklinza, Zepatier and Epclusa (products for which pharmacokinetic studies with warfarin have not been performed)
Croatian: Za lijekove Victrelis, Sovaldi, Harvoni, Daklinza, Zepatier i Epclusa (lijekovi za koje nisu provedena farmakokinetička ispitivanja s varfarinom)
English: For Olysio, Viekirax and Exviera (products for which pharmacokinetic studies with warfarin have been performed)
Croatian: Za lijekove Olysio, Viekirax i Exviera (lijekovi za koje su provedena farmakokinetička ispitivanja s varfarinom)
English: Results of interaction studies with warfarin should be included here as applicable
Croatian: Ovdje je potrebno navesti rezultate ispitivanja interakcija s varfarinom, ako je primjenjivo
English: Undesirable effects Renal and urinary disorders Frequency “rare”: Urinary retention
Croatian: Poremećaji bubrega i mokraćnog sustava Učestalost „rijetko”: Urinarna retencija
English: As liver function may change during treatment with {product name}, a close monitoring of International Normalised Ratio (INR) values is recommended.
Croatian: Budući da tijekom liječenja {naziv lijeka} može doći do promjene u funkciji jetre, preporučuje se pomno praćenje vrijednosti međunarodnog normaliziranog omjera (INR).
English: Interaction with other medicinal products and other forms of interaction
Croatian: 4.5. Interakcije s drugim lijekovima i drugi oblici interakcija
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.
Croatian: Kombinaciju treba izbjegavati, osim kada korist nadmašuje povećani rizik od sistemskih nuspojava kortikosteroida, a u tom slučaju bolesnike je potrebno pratiti radi eventualnih sistemskih učinaka kortikosteroida.
English: Warfarin and other vitamin K antagonists
Croatian: Varfarin i drugi antagonisti vitamina
English: Concomitant use of <product name> and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression
Croatian: Istodobnom primjenom <naziv lijeka> i kortikosteroida koji se metaboliziraju putem CYP3A (npr flutikazonpropionata ili drugih inhalacijskih ili nazalnih kortikosteroida) može se povećati rizik od razvoja sistemskih učinaka kortikosteroida, uključujući Cushingov sindrom i adrenalnu supresiju
English: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Croatian: Kortikosteroide koji uključuju betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon.
English: If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Croatian: Ako se ne mogu primjenjivati alternativni lijekovi, potrebno je započeti s primjenom tih lijekova tek nakon medicinske procjene i pod pomnim praćenjem liječnika radi eventualnih nuspojava kortikosteroida.
English: Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Croatian: Kortikosteroidi koji se prvenstveno metaboliziraju putem CYP3A (uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon).
English: Cobicistat containing products: cobicistat; cobicistat, atazanavir sulfate; cobicistat, darunavir; cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide; cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarateDrug interaction with corticosteroids leading to adrenal suppression (EPITT no 18647)
Croatian: Lijekovi koji sadržavaju kobicistat: kobicistat; kobicistat, atazanavirsulfat; kobicistat, darunavir; kobicistat, elvitegravir, emtricitabin, tenofoviralafenamid; kobicistat, elvitegravir, emtricitabin, tenofovirdizoproksilfumaratInterakcija lijekova s kortikosteroidima koja dovodi do adrenalne supresije (EPITT br. 18647)
English: Boceprevir ; daclatasvir; dasabuvir; elbasvir, grazoprevir; ledipasvir, sofosbuvir; ombitasvir, paritaprevir, ritonavir; simeprevir; sofosbuvir; sofosbuvir, velpatasvir - Drug interaction between direct-acting antivirals (DAAV) and vitamin K antagonists leading to a reduced international normalised ratio (INR) (EPITT no 18654)
Croatian: Boceprevir; daklatasvir; dasabuvir; elbasvir, grazoprevir; ledipasvir, sofosbuvir; ombitasvir, paritaprevir, ritonavir; simeprevir; sofosbuvir; sofosbuvir, velpatasvir - Interakcija između protuvirusnih lijekova s izravnim djelovanjem i antagonista vitamina
English: While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Croatian: Iako se ne očekuje promjena farmakokinetike varfarina, preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) sa svim antagonistima vitamina K zbog promjena u funkciji jetre tijekom liječenja {naziv lijeka}.
English: Special warnings and precautions for use or 4.5.
Croatian: Posebna upozorenja i mjere opreza pri uporabi ili 4.5. Interakcije s drugim lijekovima i drugi oblici interakcija, ako je primjereno
English: Summary of product characteristics of cobicistat containing products
Croatian: Sažetak opisa svojstava lijeka za lijekove koji sadržavaju kobicistat
English: beclomethasone for intranasal or inhalational use should be considered, particularly for long term use.
Croatian: Potrebno je uzeti u obzir alternativne kortikosteroide koji manje ovise o metabolizmu putem CYP3A, npr. beklometazon za intranazalnu ili inhalacijsku primjenu, osobito za dugoročnu primjenu.
English: Interaction not studied Close monitoring of INR is recommended with all vitamin K antagonists.
Croatian: Interakcija nije ispitana Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja {naziv lijeka}.
English: Package leaflet of cobicistat containing products
Croatian: Uputa o lijeku za lijekove koji sadržavaju kobicistat
English: Do not refrigerate or freeze.
Croatian: Ne hladiti ili zamrzavati.
English: Keep the bottle tightly closed.
Croatian: Držati bočicu čvrsto zatvorenu.
English: ATCvet code: QJ02AC02.
Croatian: ATCvet kod: QJ02AC02.
English: Vet-Animal ul.
Croatian: Vet-životinja ul.
English: France/ Luxembourg/ Portugal/ Italy/ Sweden/ Finland/ Czech Republic/ Slovakia/ Hongary/ Bulgaria/ Romania/ Croatia/ Slovenia/ Republic of Cyprus/ Denmark/ Estonia/ Latvia/ Lithuania/ Malta:
Croatian: Francuska / Luksemburg / Portugal / Italija / Švedska / Finska / Češka / Slovačka / Hongarija / Bugarska / Rumunjska / Hrvatska / Slovenija / Republika Cipar / Danska / Estonija / Latvija / Litva / Malta:
English: Do not store above 25 °C.
Croatian: Nemojte čuvati pri temperaturi iznad 25 C.
English: EXP {month/year} Once opened, use within 28 days.
Croatian: EXP {mjesec/godina} Jednom otvoren upotrijebiti u roku od 28 dana.
English: Where there is more than one bird in the home/cage, all infected and treated birds should be separated from other birds.
Croatian: U slučaju kada je više od jedne ptice u domu/kavezu, sve inficirane i tretirane ptice trebaju se odvojiti od ostalih ptica.
English: United Kingdom Petlife International Ltd.
Croatian: Ujedinjeno Kraljevstvo Petlife International Ltd.
English: Data were limited on the minimum inhibitory concentrations for different Candida isolates.
Croatian: Podaci su bili ograničeni na minimalne inhibitorne koncentracije za različite izolate Candida.
English: Ornamental birds, particularly:
Croatian: Ukrasne ptice, posebice:
English: Keep the bottle in the outer carton in order to protect from light.
Croatian: Držati bočicu u vanjskom kartonu radi zaštite od svjetla.
English: A graduated polypropylene oral syringe is also included.
Croatian: Uključena je i graduirana peroralna polipropilenska štrcaljka.
English: Dechra Veterinary Products GmbH-Austria Hintere Achmühlerstraße 1A 6850 Dornbirn
Croatian: Dechra Veterinary Products GmbH-Austrija Hintere Achmühlerstraße 1A 6850 Dornbirn
English: Dechra Veterinary Products/Albrecht GmbH Veterinär-medizinische Erzeugnisse Hauptstr.
Croatian: Veterinarski proizvodi Dechra / Albrecht GmbH Veterinär-medizinische Erzeugnisse Hauptstr.
English: Dose and treatment schedule:
Croatian: Doza i raspored terapije:
English: In case of accidental contact with the eyes, rinse thoroughly with water.
Croatian: U slučaju da nehotice dođe do kontakta s očima, temeljito isperite vodom.
English: The different target species consume different types of food and exhibit differing metabolism.
Croatian: Različite ciljne vrste ptica konzumiraju različite tipove hrane i imaju različite metabolizme.
English: The minimum inhibitory concentrations of itraconazole for different Aspergillus isolates in birds in Europe varies between 0.25 and >16 g/ml.
Croatian: Minimalne inhibitorne koncentracije itrakonazola za različite izolate Aspergillus u ptica u Europi variraju između 0,25 i >16 g/ml.
English: Frequent and repeated use of antifungals from the same class may increase the risk of development of resistance to that class of antifungals.
Croatian: Česta i ponovljena primjena antimikotika iz iste klase može povećati rizik od razvijanja rezistentnosti na tu klasu antimikotika.
English: Do not use in birds intended for human consumption.
Croatian: Ne koristiti na pticama namijenjenima za prehranu ljudi.
English: After dosing, the syringe should be washed with hot water and dried.
Croatian: Nakon doziranja, potrebno je oprati štrcaljku u vrućoj vodi i osušiti je.