FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tell your doctor immediately if you become pregnant.
Croatian: • Odmah obavijestite svog liječnika ako zatrudnite.
English: What Zydelig is and what it is used for
Croatian: Što je Zydelig i za što se koristi
English: If you take more Zydelig than you should
Croatian: Ako uzmete više Zydeliga nego što ste trebali
English: Age ≥ 65 years
Croatian: Dob ≥ 65 godina
English: The median number of prior therapies was 3.0.
Croatian: Medijan broja prethodnih terapija bio je 3,0.
English: Your doctor will monitor you for evidence of infection.
Croatian: Liječnik će Vas nadzirati zbog znakova infekcije.
English: Infections (see section 4.4)
Croatian: Infekcije (vidjeti dio 4.4)
English: STOP taking Zydelig and seek medical help immediately if you experience any of the following:
Croatian: PRESTANITE uzimati Zydelig i odmah potražite liječničku pomoć ako osjetite nešto od sljedećeg:
English: The median duration of response (DOR) has not been reached.
Croatian: Medijan trajanja odgovora (DOR, duration of response) nije dosegnut.
English: • Zydelig should not be used during pregnancy.
Croatian: • Zydelig se ne smije uzimati u trudnoći.
English: → Talk to your doctor if this applies to you.
Croatian: → Obratite se svom liječniku ako se to odnosi na Vas.
English: Zydelig can be taken with or without food.
Croatian: Zydelig se može uzimati s hranom ili bez hrane.
English: The median time since diagnosis was 7.7 years.
Croatian: Medijan vremena od postavljanja dijagnoze iznosio je 7,7 godina.
English: Most frequently observed were infections in the respiratory system and septic events.
Croatian: Najčešće su bile uočene infekcije dišnog sustava i septički događaji.
English: Contents of the pack and other information What Zydelig contains
Croatian: Sadržaj pakiranja i druge informacije Što Zydelig sadrži
English: • changes in the number of white blood cells
Croatian: • promjene broja bijelih krvnih stanica
English: Other medicines and Zydelig
Croatian: Drugi lijekovi i Zydelig
English: Talk to your doctor before taking Zydelig.
Croatian: Obratite se svom liječniku prije nego uzmete Zydelig.
English: Patients should be advised to report new respiratory symptoms promptly.
Croatian: Bolesnike treba upozoriti da odmah prijave nove respiratorne simptome.
English: The film-coated tablet can be taken with or without food (see section 5.2).
Croatian: Filmom obložena tableta može se uzeti s hranom ili bez nje (vidjeti dio 5.2).
English: • who have received at least one prior therapy (see section 4.4), or
Croatian: • koji su prethodno primili najmanje jednu terapiju (vidjeti dio 4.4) ili
English: There is no information about the safety of this medicine in pregnant women.
Croatian: Nema podataka o sigurnosti uzimanja ovog lijeka u trudnica.
English: Any grade
Croatian: Bilo koji stupanj
English: Ask your doctor if you have any questions about any of your medicines.
Croatian: Obratite se svom liječniku ako imate bilo kakvih pitanja o bilo kojem od svojih lijekova.
English: (may affect more than 1 in 10 people)
Croatian: (mogu se pojaviti u više od 1 na 10 osoba)
English: In vitro interaction data
Croatian: Podaci o interakcijama in vitro
English: If you are currently breast-feeding, talk to your doctor before starting treatment.
Croatian: Ako trenutno dojite, razgovarajte sa svojim liječnikom prije početka liječenja.
English: Special populations Elderly
Croatian: Posebne populacije Stariji
English: Response category*† CR
Croatian: Kategorija odgovora*† CR
English: • if you are allergic to idelalisib or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na idelalisib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare but serious brain infection which can be fatal (progressive multifocal leukoencephalopathy or PML).
Croatian: Odmah obavijestite svog liječnika ako primijetite ili netko drugi na Vama primijeti: gubitak pamćenja, poteškoće u razmišljanju, poteškoće s hodanjem ili gubitak vida - ovi simptomi mogu nastati uslijed vrlo rijetke, ali ozbiljne infekcije mozga koja može biti smrtonosna (progresivna multifokalna leukoencefalopatija ili PML).
English: Date of first authorisation: 18 September 2014 Date of latest renewal: 30 April 2019
Croatian: Datum posljednje obnove odobrenja: 30. travnja 2019.
English: Progression free survival (%)
Croatian: Preživljenje bez progresije bolesti (%)
English: What Zydelig is and what it is used for What you need to know before you take Zydelig How to take Zydelig
Croatian: Što je Zydelig i za što se koristi Što morate znati prije nego počnete uzimati Zydelig Kako uzimati Zydelig
English: Your doctor will check your blood counts before or during treatment with Zydelig and in rare cases they may need to give you another medicine.
Croatian: Liječnik će Vam provjeriti krvnu sliku prije ili tijekom liječenja Zydeligom, a u rijetkim slučajevima možda će Vam trebati dati drugi lijek.
English: Zydelig may be used for the treatment of two different cancers in adults:
Croatian: Zydelig se može koristiti za liječenje dvije različite vrste raka u odraslih osoba:
English: Peeling away of the skin may lead to serious infection.
Croatian: Ljuštenje kože može dovesti do ozbiljne infekcije.
English: Zydelig should not be used with any other medicines unless your doctor has told you it is safe to do so.
Croatian: Zydelig se ne bi trebao primjenjivati s niti jednim drugim lijekom ukoliko Vam Vaš liječnik nije rekao da je to sigurno.
English: CYP3A/P-gp inhibitors
Croatian: CYP3A/P-gp inhibitori
English: For pulmonary arterial hypertension:
Croatian: Za plućnu arterijsku hipertenziju:
English: What Zydelig looks like and contents of the pack
Croatian: Kako Zydelig izgleda i sadržaj pakiranja
English: Your doctor may also decide to permanently stop treatment with Zydelig.
Croatian: Vaš liječnik također može odlučiti da se liječenje Zydeligom trajno prekine.
English: For patients with CrCl < 60 mL/min, alternative antibacterials should be considered.
Croatian: U bolesnika s CrCl < 60 ml/min treba razmotriti alternativne antibakterijske lijekove.
English: One hundred and twelve (89.6%) subjects were refractory to their last regimen prior to study entry.
Croatian: Stotinu i dvanaest (89,6%) ispitanika bilo je refrakterno na posljednji tretman prije ulaska u ispitivanje.
English: The analysis of PFS was based on evaluation by an IRC.
Croatian: Analiza PFS-a temeljena je na procjeni IRC-a.
English: Alternative medicinal products, such as olanzapine, may be considered.
Croatian: Može se razmotriti primjena drugih lijekova, kao što je olanzapin.
English: The apparent volume of distribution for idelalisib (mean) was approximately 96 L.
Croatian: Prividni volumen distribucije idelalisiba (srednja vrijednost) bio je približno 96 l.
English: In this disease, the lymphocytes multiply too quickly and live for too long, so that there are too many of them circulating in the blood.
Croatian: U toj bolesti, limfociti se prebrzo umnožavaju i predugo žive, tako da ih previše cirkulira u krvi.
English: Assessment of adverse reactions is based on two Phase 3 studies (study 312-0116 and study 312-0119) and six Phase 1 and 2 studies.
Croatian: Procjena nuspojava temelji se na dva ispitivanja faze 3 (ispitivanju 312-0116 i ispitivanju 312-0119) i šest ispitivanja faze 1 i 2.
English: Treatment of overdose with Zydelig consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Croatian: Liječenje predoziranja Zydeligom obuhvaća opće suportivne mjere uključujući nadzor vitalnih znakova, kao i promatranje kliničkog statusa bolesnika.
English: If necessary, your doctor may decide to stop treatment for a while, before starting treatment again at the same or a lower dose.
Croatian: Ako bude potrebno, Vaš liječnik može odlučiti privremeno prekinuti liječenje, a zatim ponovo nastaviti liječenje istom ili nižom dozom.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nakon navedenog, nositelj odobrenja će periodička izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Idelalisib induced inflammatory changes in both rats and dogs.
Croatian: Idelalisib je izazvao upalne promjene i u štakora i u pasa.
English: Lymphocytosis**
Croatian: Limfocitoza**
English: Patients should be monitored for respiratory signs and symptoms throughout treatment.
Croatian: Bolesnike treba nadzirati zbog respiratornih znakova i simptoma tijekom cijelog trajanja liječenja.
English: • if you have shortness of breath or difficulty breathing
Croatian: • ako osjećate nedostatak zraka ili otežano dišete
English: Effects on embryo-foetal development were not investigated in a second species.
Croatian: Učinci na embriofetalni razvoj nisu ispitivani na drugoj vrsti.
English: Treatment should be continued until disease progression or unacceptable toxicity.
Croatian: Liječenje treba nastaviti do progresije bolesti ili neprihvatljive toksičnosti.
English: Do not stop taking this medicine unless your doctor tells you to.
Croatian: Nemojte prestati uzimati ovaj lijek osim ako Vam to ne kaže Vaš liječnik.
English: It is very important that you read the package leaflets that are provided with these medicines too.
Croatian: Vrlo je važno da pročitate i upute o lijeku koje dobijete uz te lijekove.
English: 17p deletion/TP53 mutation
Croatian: Delecija 17p/mutacija TP53
English: The median time from diagnosis of CLL to randomisation was 8.5 years.
Croatian: Medijan vremena od postavljanja dijagnoze KLL-a do randomizacije iznosio je 8,5 godina.
English: Idelalisib is 93% to 94% bound to human plasma proteins at concentrations observed clinically.
Croatian: Od 93% do 94% idelalisiba veže se na proteine plazme pri koncentracijama opaženim u kliničkim uvjetima.
English: BCRP, OATP1B1, OATP1B3 and P-gp substrates
Croatian: BCRP, OATP1B1, OATP1B3 i P-gp supstrati
English: (may affect up to 1 in 10 people)
Croatian: (mogu se pojaviti u najviše 1 na 10 osoba)
English: However, your doctor may reduce this dose to 100 mg twice a day if you experience particular side effects.
Croatian: Međutim, Vaš liječnik može smanjiti ovu dozu na 100 mg dva puta na dan ako Vam se jave određene nuspojave.
English: Taking Zydelig with certain medicines may stop them working properly, or may make side effects worse.
Croatian: Uzimanje Zydeliga s nekim lijekovima može spriječiti njihovo pravilno djelovanje ili pogoršati nuspojave.
English: Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
Croatian: Liječnici trebaju uzeti u obzir PML u diferencijalnoj dijagnozi u bolesnika s novim ili pogoršanim neurološkim, kognitivnim ili bihevioralnim znakovima ili simptomima.
English: Response category*†
Croatian: Kategorija odgovora*†
English: What you need to know before you take Zydelig Do not take Zydelig
Croatian: Što morate znati prije nego počnete uzimati Zydelig Nemojte uzimati Zydelig
English: Alternatively, switching to pravastatin, rosuvastatin, or pitavastatin may be considered.
Croatian: Alternativno, može se razmotriti prebacivanje na pravastatin, rosuvastatin ili pitavastatin.
English: DOR was a secondary endpoint and was defined as the time from the first documented response (CR, PR, or MR) to the first documentation of disease progression or death from any cause.
Croatian: Sekundarna mjera ishoda bio je DOR definiran kao vrijeme proteklo od prvog zabilježenog odgovora (CR, PR, ili MR) do prve zabilježene progresije bolesti ili smrti bilo kojeg uzroka.
English: Do not stop taking Zydelig
Croatian: Nemojte prestati uzimati Zydelig
English: Frequencies are defined as follows: 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), and not known (cannot be estimated from available data).
Croatian: Učestalosti su definirane 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Tell your doctor right away:
Croatian: Odmah obavijestite svog liječnika:
English: Further investigation of this topic in current B-cell malignancy studies is not planned.
Croatian: Daljnja ispitivanja ove teme u trenutačnim ispitivanjima zloćudne bolesti B-stanica nisu planirana.
English: • as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4).
Croatian: • kao prva linija liječenja u prisutnosti delecije 17p ili mutacije TP53 u bolesnika koji nisu pogodni za druge terapije (vidjeti dio 4.4).
English: Nearly all (95.9%) subjects had received prior anti-CD20 monoclonal antibodies.
Croatian: Skoro svi (95,9%) ispitanici već su primali anti-CD20 monoklonska protutijela.
English: In many instances the pathogen was not identified; however, both conventional and opportunistic pathogens, including PJP and CMV, were among those identified.
Croatian: U mnogim slučajevima patogen nije bio identificiran; međutim, među onima koji su identificirani bili su i konvencionalni i oportunistički patogeni, uključujući PJP i CMV.
English: • The active substance is idelalisib.
Croatian: • Djelatna tvar je idelalisib.
English: The following pack size is available: outer carton containing 1 plastic bottle of 60 film-coated tablets.
Croatian: Dostupna je sljedeća veličina pakiranja: kutija koja sadrži 1 plastičnu bocu sa 60 filmom obloženih tableta.
English: • if you have liver problems
Croatian: • ako imate problema s jetrom
English: Based on findings in animals, idelalisib may cause foetal harm.
Croatian: Na temelju nalaza u životinja, idelalisib može uzrokovati oštećenje fetusa.
English: SJS or TEN occurred within one month of the medicinal combination and fatal outcomes have resulted.
Croatian: SJS ili TEN javili su se unutar jednog mjeseca primjene kombinacije tih lijekova i rezultirali smrtnim ishodom.
English: Concentration monitoring of sedatives/hypnotics is recommended and dose reduction may be considered.
Croatian: Preporučuje se praćenje koncentracija sedativa/hipnotika i može se razmotriti sniženje doze.
English: Overall iNHL cohort (N=125) n (%)
Croatian: Ukupna kohorta s iNHL-om (N = 125) n (%)
English: Nearly all PJP infections, including fatal cases, occurred in the absence of PJP prophylaxis.
Croatian: Gotovo sve infekcije PJP-om, uključujući slučajeve sa smrtnim ishodom, pojavile su se u odsutnosti profilakse PJP-a.
English: • midazolam, triazolam, when taken by mouth to help you sleep and/or relieve anxiety
Croatian: • midazolam, triazolam, kad se uzimaju kroz usta za ublažavanje tjeskobe i/ili Vam pomažu zaspati
English: Zydelig is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Zydelig tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Take care to not miss a dose of Zydelig.
Croatian: Pazite da ne propustite uzeti dozu Zydeliga.
English: The median OS, including long-term follow-up for all 125 subjects, was 48.6 months.
Croatian: Medijan OS-a, uključujući dugotrajno praćenje svih 125 ispitanika, iznosio je 48,6 mjeseci.
English: It works by blocking the effects of an enzyme involved in multiplication and survival of certain white blood cells called lymphocytes.
Croatian: Djeluje tako da blokira učinke enzima uključenog u umnožavanje i preživljavanje određenih bijelih krvnih stanica koje se zovu limfociti.
English: Malformations were observed at exposures from 12 times the human exposure based on AUC.
Croatian: Malformacije su zabilježene pri 12 puta većoj izloženosti temeljenoj na AUC od izloženosti ljudi.
English: In general, B-lymphocyte dependent areas were more affected than T-lymphocyte dependent areas.
Croatian: Općenito, područja ovisna o B limfocitima bila su jače zahvaćena nego područja ovisna o T limfocitima.
English: Clinical monitoring is recommended for increased signs/symptoms of corticosteroid effects.
Croatian: Preporučuje se kliničko praćenje zbog znakova/simptoma pojačanih učinaka kortikosteroida.
English: Because this enzyme is overactivated in certain cancerous white blood cells, by blocking it, Zydelig will kill and reduce the number of cancer cells.
Croatian: Budući da je taj enzim pretjerano aktivan u određenim tumorskim bijelim krvnim stanicama, njegovim blokiranjem Zydelig ubija tumorske stanice i smanjuje njihov broj.
English: ALPHA-1 ADRENORECEPTOR ANTAGONISTS
Croatian: ANTAGONISTI ALFA 1-ADRENORECEPTORA Alfuzosin
English: In FL Zydelig is used on its own in patients whose cancer has not responded to treatment with two previous cancer treatments.
Croatian: U FL-u, Zydelig se koristi sam u bolesnika čiji rak nije odgovorio na dva prethodna liječenja protiv raka.
English: There have been cases of PJP after stopping idelalisib treatment.
Croatian: Bilo je slučajeva PJP-a nakon prekida liječenja idelalisibom.
English: All subjects were refractory to rituximab and 124 of 125 subjects were refractory to at least one alkylating agent.
Croatian: Svi ispitanici bili su refrakterni na rituksimab i 124 od 125 ispitanika bilo je refrakterno na najmanje jedan alkilirajući lijek.
English: In particular, tell your doctor if you are taking any of the following:
Croatian: Osobito je važno obavijestiti Vašeg liječnika ako uzimate sljedeće:
English: Clinical monitoring is recommended and a lower starting dose of atorvastatin may be considered.
Croatian: Preporučuje se kliničko praćenje i može se razmotriti niža početna doza atorvastatina.
English: • Zydelig may make the contraceptive “pill” and implanted hormonal contraceptives work less well.
Croatian: • Zydelig može smanjiti djelovanje kontracepcijske „pilule“ i kontracepcijskog implantata.
English: CI: confidence interval; n: number of responding subjects NR: not reached * Response as determined by an independent review committee (IRC) where ORR = complete response (CR) + partial response (PR) + minor response (MR) in subjects with WM. † In the overall iNHL cohort, 1 subject (0.6%) with WM had the best overall response of MR
Croatian: CI: interval pouzdanosti; n: broj ispitanika s odgovorom NR: nije dostignuto * Odgovor je odredilo neovisno stručno povjerenstvo (IRC), vrijedi ORR = potpuni odgovor (CR) + parcijalni odgovor (PR) + slab odgovor (MR, minor response) u ispitanika s WM-om. † U ukupnoj kohorti s iNHL-om, 1 ispitanik (0,6%) s WM-om imao je slab odgovor (MR) kao najbolji ukupan odgovor.
English: Idelalisib is not considered to have broad immunosuppressive activity.
Croatian: Smatra se da idelalisib nema široko imunosupresivno djelovanje.
English: This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.
Croatian: Ova opažena limfocitoza farmakodinamički je učinak i ne smije se smatrati progresivnom bolešću ako nema drugih kliničkih nalaza.
English: At a dose 2.7 times the maximum recommended dose, idelalisib did not prolong the QT/QTc interval (i.e.,< 10 ms).
Croatian: Pri dozi 2,7 puta većoj od najveće preporučene doze idelalisib nije produljio QT/QTc interval (tj., < 10 ms).
English: The mean blood-to-plasma concentration ratio was approximately 0.5.
Croatian: Srednja vrijednost omjera koncentracija u krvi i plazmi iznosila je približno 0,5.
English: It is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method as a second form of contraception.
Croatian: Trenutno nije poznato može li idelalisib smanjiti učinkovitost hormonske kontracepcije pa stoga žene koje uzimaju hormonsku kontracepciju trebaju dodatno koristiti i barijernu metodu kao drugi oblik kontracepcije.
English: Then take your next dose as usual.
Croatian: Nakon toga nastavite s uobičajenim uzimanjem doza.
English: ** LNR defined as the proportion of subjects who achieved a ≥ 50% decrease in the sum of products of the greatest perpendicular diameters of index lesions.
Croatian: ** LNR je definiran kao udio ispitanika koji su postigli smanjenje zbroja umnožaka najvećih okomitih promjera praćenih lezija ≥ 50%.
English: Pneumonitis and organising pneumonia
Croatian: Pneumonitis i organizirajuća pneumonija
English: Efficacy results are summarised in Tables 3 and 4.
Croatian: Rezultati djelotvornosti sažeti su u tablicama 3 i 4.
English: Swallow the tablet whole.
Croatian: Progutajte cijelu tabletu.
English: CYP2C8 substrates
Croatian: CYP2C8 supstrati
English: In CLL Zydelig treatment is used in combination with another medicine (rituximab) in patients who have certain high-risk factors or in patients whose cancer has come back after at least one previous treatment.
Croatian: U KLL-u se liječenje Zydeligom primjenjuje u kombinaciji s drugim lijekom (rituksimabom) u bolesnika koji imaju određene visokorizične čimbenike ili u bolesnika čiji se rak vratio nakon najmanje jednog prethodnog liječenja.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX47
Croatian: Farmakoterapijska skupina: antineoplastici, drugi antineoplastici, ATK oznaka: L01XX47
English: Electrocardiographic
Croatian: Elektrokardiografija
English: Unchanged idelalisib accounted for 23% of total radioactivity recovered in urine over 48 hours and 12% of total radioactivity recovered in faeces over 144 hours.
Croatian: Nepromijenjeni idelalisib činio je 23% ukupne radioaktivnosti prisutne u mokraći tijekom 48 sati i 12% ukupne radioaktivnosti u stolici tijekom 144 sata.
English: Prophylaxis for PJP should therefore be administered to all patients throughout idelalisib treatment, and for a period of 2 to 6 months after discontinuation.
Croatian: Profilaksu PJP-a stoga treba primjenjivati u svih bolesnika tijekom cijelog trajanja liječenja idelalisibom i tijekom razdoblja od 2 do 6 mjeseci nakon prekida liječenja.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 8 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvi PSUR za ovaj lijek dostaviti unutar 8 mjeseci nakon dobivanja odobrenja.
English: Cases of progressive multifocal leukoencephalopathy (PML) have been reported following the use of idelalisib within the context of prior or concomitant immunosuppressive therapies that have been associated with PML.
Croatian: Slučajevi progresivne multifokalne leukoencefalopatije (PML) prijavljeni su nakon primjene idelalisiba u kontekstu prethodnih ili istodobnih terapija imunosupresivima koje su bile povezane s PML-om.
English: Treatment with Zydelig must be permanently discontinued in the event of moderate or severe symptomatic pneumonitis or organising pneumonia (see sections 4.4 and 4.8).
Croatian: Liječenje Zydeligom mora se trajno prekinuti u slučaju umjerenog ili teškog simptomatskog pneumonitisa ili organizirajuće pneumonije (vidjeti dijelove 4.4 i 4.8).
English: Treatment with Zydelig should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal, or viral infection.
Croatian: Liječenje Zydeligom ne smije se započeti u bolesnika u kojih postoji bilo kakav dokaz prisutnosti sustavne bakterijske, gljivične ili virusne infekcije.
English: Zydelig has no or negligible influence on the ability to drive and use machines.
Croatian: Zydelig ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.