FrancophonIA/ELRC3.0 huggingface dataset:
English: This is because it has not been studied in these age groups.
Croatian: To je zbog toga jer nije ispitan u ovim dobnim skupinama.
English: Recommended dose modifications are described below:
Croatian: Preporučene prilagodbe doza opisane su niže:
English: The following adverse effects were seen in studies of 13-weeks duration in rats and dogs.
Croatian: Sljedeći štetni učinci uočeni su u ispitivanjima u trajanju od 13 tjedana u štakora i pasa.
English: The half-life of ibrutinib is 4 to 13 hours.
Croatian: Poluvijek ibrutiniba je 4 do 13 sati.
English: Includes events with fatal outcome.
Croatian: Uključujući događaje sa smrtnim ishodom.
English: • if you have high blood pressure
Croatian: • ako imate visok krvni tlak
English: Date of latest renewal: 25 June 2019
Croatian: Datum posljednje obnove odobrenja: 25. lipnja 2019.
English: Tell a doctor straight away if you notice any of the following side effects:
Croatian: Odmah recite liječniku ako primijetite bilo koju od sljedećih nuspojava:
English: This is because it can increase the amount of IMBRUVICA in your blood.
Croatian: To je zato što mogu povećati količinu lijeka IMBRUVICA u Vašoj krvi.
English: Do not get pregnant while you are taking this medicine.
Croatian: Nemojte zatrudnjeti dok uzimate ovaj lijek.
English: Hydration should be maintained and serum creatinine levels monitored periodically.
Croatian: Mora se održavati hidratacija i periodično pratiti razina kreatinina u serumu.
English: Your doctor will check your blood counts before or during the treatment and in rare cases they may need to give you another medicine.
Croatian: Liječnik će Vam provjeriti krvnu sliku prije ili tijekom liječenja, a u rijetkim slučajevima možda će Vam morati dati drugi lijek.
English: Not known Not known
Croatian: Nepoznato Nepoznato
English: By blocking this protein, IMBRUVICA helps kill and reduce the number of cancer cells.
Croatian: Blokirajući ovaj protein, IMBRUVICA pomaže ubiti i smanjiti broj stanica raka.
English: The mechanism for the bleeding-related events is not fully understood.
Croatian: Mehanizam nastanka događaja povezanih s krvarenjem nije u potpunosti jasan.
English: Total (N=63)
Croatian: Ukupno (N = 63)
English: All patients received BR for a maximum of six 28-day cycles.
Croatian: Svi bolesnici su primili BR od najviše šest 28-dnevnih ciklusa.
English: atazanavir, or fosamprenavir
Croatian: atazanavir ili fosamprenavir
English: Push tablet through from other side.
Croatian: Pritisnite tabletu kroz blister na drugu stranu.
English: Pancreatic findings partially recovered during comparable reversal periods.
Croatian: Nalazi gušterače su se djelomično oporavili tijekom usporedivih razdoblja promjene.
English: Median time to response was 1.9 months.
Croatian: Medijan vremena do odgovora bio je 1,9 mjeseci.
English: Grade ≥3
Croatian: Stupanj ≥3
English: • inflammation within the lungs that may lead to permanent damage
Croatian: • upala u plućima koja može dovesti do trajnog oštećenja
English: After a single oral administration of radiolabeled [
Croatian: Nakon jednokratne peroralne primjene radioaktivno označenog [
English: CLL and WM
Croatian: KLL i WM
English: All gastrointestinal, lymphoid and bone findings recovered following recovery periods of 6-13 weeks.
Croatian: Svi gastrointestinalni, limfoidni i koštani nalazi oporavili su se nakon razdoblja oporavka od 6-13 tjedana.
English: No clinical data are available on this interaction.
Croatian: Nisu dostupni klinički podaci vezani uz ovu interakciju.
English: Most patients with fatal infections also had neutropenia.
Croatian: Većina bolesnika s fatalnim infekcijama imala je i neutropeniju.
English: This does not necessarily mean that your blood cancer is getting worse.
Croatian: To ne mora nužno ukazivati na pogoršanje raka krvi.
English: It is currently unknown whether ibrutinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method.
Croatian: Trenutno nije poznato može li ibrutinib smanjiti učinkovitost hormonskih kontraceptiva, stoga žene koje uzimaju hormonske kontraceptive moraju dodati barijernu metodu.
English: If these toxicities persist or recur following two dose reductions, discontinue the medicinal product.
Croatian: Ako ove toksičnosti potraju ili se ponove nakon dva smanjenja doze, prekinite primjenu lijeka.
English: • diarrhoea, your doctor may need to give you a fluid and salt replacement or another medicine
Croatian: • proljev, liječnik će Vam možda trebati dati nadomjestak tekućine i soli ili drugi lijek
English: When you take a tablet, fill in the day of the week or the date in the space provided.
Croatian: Kad uzmete tabletu, ispišite dan u tjednu ili datum na predviđenom mjestu na pakiranju.
English: Also tell your doctor if you take any of the following medicines - The effects of IMBRUVICA or other medicines may be influenced if you take IMBRUVICA together with any of the following medicines:
Croatian: Također recite liječniku ako uzimate bilo koji od sljedećih lijekova - Na učinke lijeka IMBRUVICA ili drugih lijekova može se utjecati ako uzimate lijek IMBRUVICA zajedno s nekim od sljedećih lijekova:
English: • if you are allergic to ibrutinib or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na ibrutinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: No specific dose adjustment is required for elderly patients (aged ≥65 years).
Croatian: Nije potrebna specifična prilagodba doze za starije bolesnike (dobi ≥ 65 godina).
English: • if you are planning to have any surgery- your doctor may ask you to stop taking IMBRUVICA for a short time (3 to 7 days) before and after your surgery.
Croatian: • ako planirate ići na bilo kakvu operaciju - liječnik od Vas može zatražiti da prestanete uzimati lijek IMBRUVICA na kratko vrijeme (3 do 7 dana) prije i nakon operacije.
English: Use as directed by your physician.
Croatian: Uzmite prema uputama svoga liječnika.
English: The apparent volume of distribution at steady state (Vd, ss/F) was approximately 10,000 L.
Croatian: Prividni volumen distribucije u stanju dinamičke ravnoteže (Vd, ss/F) bio je otprilike 10 000 l.
English: No dose adjustment is required in combination with mild inhibitors.
Croatian: Nije potrebna prilagodba doze u kombinaciji sa slabim inhibitorima.
English: Carcinogenicity/genotoxicity
Croatian: Kancerogenost/genotoksičnost
English: Patients who ingested more than the recommended dose should be closely monitored and given appropriate supportive treatment.
Croatian: Bolesnici koji su unijeli više od preporučene doze moraju se pažljivo pratiti, te im se mora pružiti odgovarajuće potporno liječenje.
English: • if you have ever had unusual bruising or bleeding or are on any medicines or supplements that increase your risk of bleeding (see section “Other medicines and IMBRUVICA”)
Croatian: • ako ste ikada imali neuobičajene modrice ili krvarenje ili uzimate bilo koji lijek ili dodatak prehrani koji Vam povećava rizik krvarenja (vidjeti dio „Drugi lijekovi i IMBRUVICA”)
English: (Stevens-Johnson syndrome).
Croatian: (Stevens-Johnsonov sindrom).
English: Table 10: ORR and DOR in patients with WM
Croatian: Tablica 10: ORR i DOR u bolesnika s WM-om
English: • if you have recently had any surgery, especially if this might affect how you absorb food or medicines from your stomach or gut
Croatian: • ako ste nedavno bili na operaciji, posebno ako bi to moglo utjecati na apsorpciju hrane ili lijekova iz želuca ili crijeva
English: This includes medicines obtained without a prescription, herbal medicines and supplements.
Croatian: Ovo uključuje lijekove koje ste nabavili bez recepta, biljne lijekove i dodatke prehrani.
English: Patients previously untreated for CLL
Croatian: Bolesnici koji prethodno nisu bili liječeni za KLL
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), not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Unmutated IGHV
Croatian: Nemutiran IGHV
English: Do not take IMBRUVICA with grapefruit or Seville oranges (bitter oranges) - this includes eating them, drinking the juice or taking a supplement that might contain them.
Croatian: Nemojte uzimati lijek IMBRUVICA s grejpfrutom ili seviljskom narančom (gorkom narančom) - ovo uključuje njihovo uzimanje kao hrane, pijenje soka ili uzimanje dodataka prehrani koji bi ih mogli sadržavati.
English: Adverse reactions leading to dose reduction occurred in approximately 7% of patients.
Croatian: Nuspojave koje su dovele do smanjenja doze pojavile su se kod oko 7% bolesnika.
English: Take the capsules and this leaflet with you.
Croatian: Uzmite kapsule i ovu uputu sa sobom.
English: Take the tablets and this leaflet with you.
Croatian: Uzmite tablete i ovu uputu sa sobom.
English: This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.
Croatian: Ova zabilježena limfocitoza je farmakodinamički učinak i ne smije se smatrati progresijom bolesti u odsutnosti drugih kliničkih nalaza.
English: A second reduction of dose by 140 mg may be considered as needed.
Croatian: Drugo smanjenje doze za 140 mg može se razmotriti prema potrebi.
English: Best Overall Response (%) CR
Croatian: Najbolji ukupni odgovor (%) CR
English: It belongs to a class of medicines called protein kinase inhibitors.
Croatian: On pripada skupini lijekova koji se zovu inhibitori protein kinaze.
English: • The active substance is ibrutinib.
Croatian: • Djelatna tvar je ibrutinib.
English: Ibrutinib exposure increases with doses up to 840 mg.
Croatian: Izloženost ibrutinibu raste s dozama do 840 mg.
English: Other medicines and IMBRUVICA
Croatian: Drugi lijekovi i IMBRUVICA
English: There is no specific antidote for IMBRUVICA.
Croatian: Ne postoji specifični antidot za lijek IMBRUVICA.
English: If you miss a dose of IMBRUVICA, take it as soon as you remember on the same day.
Croatian: Ako propustite dozu lijeka IMBRUVICA, uzmite ju, čim se sjetite, istoga dana.
English: Involvement of CYP2D6 in the metabolism of ibrutinib appears to be minimal.
Croatian: Čini se da je sudjelovanje CYP2D6 u metabolizmu ibrutiniba minimalno.
English: • nose bleeds, small red or purple spots caused by bleeding under the skin
Croatian: • krvarenje iz nosa, male crvene ili ljubičaste točkice uzrokovane krvarenjem ispod kože
English: Spontaneous reports from post-marketing experience.
Croatian: Spontane prijave iz iskustva nakon stavljanja lijeka u promet.
English: IMBRUVICA contains lactose (a type of sugar).
Croatian: IMBRUVICA sadrži laktozu (vrstu šećera).
English: Loc. Borgo S. Michele, 04100 Latina,
Croatian: Borgo S. Michele, 04100 Latina,
English: Not reached
Croatian: Nije dostignut
English: Del11q
Croatian: Delecija 11q
English: Ibrutinib is rapidly absorbed after oral administration with a median Tmax of 1 to 2 hours.
Croatian: Ibrutinib se brzo apsorbira nakon peroralne primjene uz medijan Tmax od 1 do 2 sata.
English: If you take more IMBRUVICA than you should If you take more IMBRUVICA than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više lijeka IMBRUVICA nego što ste trebali, odmah se obratite liječniku ili idite u bolnicu.
English: ORR (%) p-value p<0.0001
Croatian: ORR (%) p-vrijednost p < 0,0001
English: Reported cases of invasive fungal infections have been associated with fatal outcomes.
Croatian: Prijavljeni slučajevi invazivnih gljivičnih infekcija povezani su sa smrtnim ishodima.
English: a (CR+PR) P-value
Croatian: a (CR +PR) P-vrijednost OS
English: What IMBRUVICA is and what it is used for
Croatian: Što je IMBRUVICA i za što se koristi
English: With a median follow-up time on study of 34 months (range, 8.6+ to 37.7 months), the median duration of response has not been reached.
Croatian: Uz medijan od 34 mjeseca praćenja u sklopu ispitivanja (raspon: 8,6+ do 37,7 mjeseci) medijan trajanja odgovora nije dostignut.
English: The capsules should be swallowed whole with water and should not be opened, broken, or chewed.
Croatian: Kapsule se moraju progutati cijele s vodom i ne smiju se otvarati, lomiti ili žvakati.
English: Of the 1200 patients treated with IMBRUVICA, 64% were 65 years of age or older.
Croatian: Od 1200 bolesnika liječenih lijekom IMBRUVICA, 64% je imalo 65 ili više godina.
English: The dihydrodiol metabolite and other metabolites are P-gp substrates.
Croatian: Dihidrodiolni metabolit i drugi metaboliti su supstrati P-gp-a.
English: This effect has also been observed in about one third of patients with relapsed or refractory MCL treated with IMBRUVICA.
Croatian: Ovaj učinak je također bio uočen kod otprilike jedne trećine bolesnika s relapsnim ili refraktornim MCL-om koji su liječeni lijekom IMBRUVICA.
English: Monitor patients closely and take appropriate precautions.
Croatian: Pažljivo pratite bolesnike i primjenjujte prikladne mjere opreza.
English: • supplements that may increase your risk of bleeding such as fish oil, vitamin E or flaxseed.
Croatian: • dodatke prehrani koji mogu povećati rizik od krvarenja, poput ribljeg ulja, vitamina E ili sjemenki lana.
English: 17.5 (15.8, NR)
Croatian: 17,5 (15,8; ND)
English: Apparent clearance (CL/F) is approximately 1,000 L/h.
Croatian: Prividni klirens (CL/F) je otprilike 1000 l/h.
English: Median follow-up time on study=26.5 months.
Croatian: Medijan trajanja praćenja u sklopu ispitivanja = 26,5 mjeseci.
English: • low white blood cell counts with fever (febrile neutropenia)
Croatian: • nizak broj bijelih krvnih stanica s vrućicom (febrilna neutropenija)
English: Rate of Sustained Haemoglobin Improvement b, c
Croatian: Stopa održanog poboljšanja vrijednosti hemoglobina b, c
English: Overall Response Rate (CR, VGPR, PR, MR)
Croatian: Ukupna stopa odgovora (CR, VGPR, PR, MR)
English: IMBRUVICA should be administered orally once daily with a glass of water approximately at the same time each day.
Croatian: IMBRUVICA se mora primijeniti peroralno jedanput na dan s čašom vode, otprilike u isto vrijeme svaki dan.
English: NR (0.03+, 18.8+)
Croatian: ND (0,03+, 18,8+)
English: As no clinical data are available on this interaction, it cannot be excluded that ibrutinib could inhibit intestinal P-gp and BCRP after a therapeutic dose.
Croatian: Budući da nema dostupnih kliničkih podataka o ovoj interakciji, ne može se isključiti mogućnost da ibrutinib inhibira crijevni P-gp i BCRP nakon terapijske doze.
English: Take IMBRUVICA tablet by mouth, at about the same time each day, with a glass of water.
Croatian: Uzmite tabletu lijeka IMBRUVICA kroz usta, i otprilike u isto vrijeme svaki dan, s čašom vode.
English: Rare (may affect up to 1 in 1,000 people) • severely increased white blood cell count that may cause cells to clump together.
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba) • izrazito povećan broj bijelih krvnih stanica, što može uzrokovati sljepljivanje stanica
English: • severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals
Croatian: • težak osip s mjehurima i ljuštenjem kože, naročito oko usta, nosa, očiju i spolnih organa
English: This is because IMBRUVICA may affect the way some other medicines work.
Croatian: To je zbog toga jer IMBRUVICA može utjecati na djelovanje nekih drugih lijekova.
English: If a dose is not taken at the scheduled time, it can be taken as soon as possible on the same day with a return to the normal schedule the following day.
Croatian: Ako doza nije uzeta u predviđeno vrijeme, može se uzeti što je prije moguće istog dana, uz povratak na normalni raspored uzimanja sljedeći dan.
English: The efficacy was similar across all of the subgroups examined, including in patients with and without deletion 17p, a pre-specified stratification factor (Table 8).
Croatian: Djelotvornost je bila slična za sve ispitivane podskupine, uključujući bolesnike sa ili bez delecije 17p, unaprijed određenog čimbenika stratifikacije (Tablica 8).
English: If using hormonal contraceptives such as birth control pills or devices, a barrier method of contraception (e.g. condoms) must also be used.
Croatian: Ako uzimate hormonske kontraceptive poput kontracepcijskih tableta ili kontracepcijskih naprava, također se mora koristiti i barijerna metoda kontracepcije (npr. prezervativ).
English: You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability to drive or use any tools or machines.
Croatian: Možete osjećati umor ili omaglicu nakon uzimanja lijeka IMBRUVICA, što može imati utjecaja na Vašu sposobnost upravljanja vozilima ili upotrebu bilo kakvih alata ili strojeva.
English: • high level of “uric acid” in the blood (shown in blood tests), which may cause gout
Croatian: • visoka razina „mokraćne kiseline” u krvi (vidljivo iz krvnih nalaza), što može uzrokovati giht
English: Therefore, no precautions are necessary in patients with different CYP2D6 genotypes.
Croatian: Stoga, nisu nužne mjere opreza u bolesnika s različitim genotipom CYP2D6.
English: Lymphocytosis: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment.
Croatian: Limfocitoza: laboratorijske pretrage mogu pokazati povišenje bijelih krvnih stanica (zvanih „limfociti”) u krvi u prvim tjednima liječenja.
English: Absolute bioavailability in fasted condition (n=8) was 2.9% (90% CI=2.1 - 3.9) and doubled when combined with a meal.
Croatian: Apsolutna bioraspoloživost natašte (n = 8) bila je 2,9% (90% CI = 2,1 - 3,9), a udvostručila se kada je kombiniran s obrokom.
English: • swollen hands, ankles or feet
Croatian: • otečene šake, gležnjevi ili stopala
English: IMBRUVICA should be held at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
Croatian: Liječenje lijekom IMBRUVICA mora se prekinuti barem 3 do 7 dana prije i poslije operacije, ovisno o vrsti operacije i riziku od krvarenja.
English: Frequency (All grades)
Croatian: Učestalost (Svi stupnjevi)
English: After confirmed disease progression, patients on chlorambucil were able to crossover to ibrutinib.
Croatian: Nakon potvrđene progresije bolesti, bolesnici na klorambucilu mogli su prijeći na ibrutinib.
English: Administration of ibrutinib in fasted condition resulted in approximately 60% of exposure (AUClast) as compared to either 30 minutes before, 30 minutes after (fed condition) or 2 hours after a high fat breakfast.
Croatian: Primjena ibrutiniba natašte rezultirala je s oko 60% izloženosti (AUClast) u usporedbi s bilo 30 minuta prije, 30 minuta nakon (stanje sitosti), ili 2 sata nakon unosa doručka s visokim udjelom masti.
English: • Take the capsules about the same time each day.
Croatian: • Uzmite kapsule svaki dan, otprilike u isto vrijeme.
English: There is no evidence that the lower Cmax would have clinical significance, and medicinal products that increase stomach pH (e.g., proton pump inhibitors) have been used without restrictions in the pivotal clinical studies.
Croatian: Nema dokaza da bi niži Cmax imao klinički značaj, te su lijekovi koji povisuju želučanu pH vrijednost (npr. inhibitori protonske pumpe) bili korišteni bez ograničenja u pivotalnim kliničkim ispitivanjima.
English: What IMBRUVICA is and what it is used for What you need to know before you take IMBRUVICA How to take IMBRUVICA
Croatian: Što je IMBRUVICA i za što se koristi Što morate znati prije nego počnete uzimati lijek IMBRUVICA
English: • high blood pressure.
Croatian: • visok krvni tlak.
English: Each bottle contains either 90 or 120 capsules.
Croatian: Jedna boca sadrži 90 ili 120 kapsula.
English: The median time to response was 1.0 month (range: 0.7-13.4 months).
Croatian: Medijan vremena do odgovora iznosio je 1,0 mjesec (raspon: 0,7-13,4 mjeseci).
English: Reversible binding of ibrutinib to human plasma protein in vitro was 97.3% with no concentration dependence in the range of 50 to 1,000 ng/mL.
Croatian: Reverzibilno vezanje ibrutiniba na proteine plazme u ljudi in vitro je bilo 97,3%, bez ovisnosti o koncentraciji u rasponu od 50 do 1000 ng/ml.
English: Rai stage 0/I/II
Croatian: 0/I/II
English: The DOR ranged from 3.9 to 24.2+ months.
Croatian: Trajanje odgovora bilo je u rasponu od 3,9 do 24,2 i više mjeseci.
English: p<0.005 for OS
Croatian: p < 0,005 za OS
English: Race There are insufficient data to evaluate the potential effect of race on ibrutinib pharmacokinetics.
Croatian: Rasa Nema dovoljno podataka koji bi procijenili potencijalni učinak rase na farmakokinetiku ibrutiniba.
English: Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioral signs or symptoms.
Croatian: Liječnici moraju uzeti u obzir pojavu PML-a u diferencijalnoj dijagnozi u bolesnika s novim ili pogoršanim neurološkim, kognitivnim ili bihevioralnim znakovima ili simptomima.
English: • temporary episode of neurologic dysfunction caused by loss of blood flow, stroke.
Croatian: • privremena epizoda poremećaja neurološke funkcije uzrokovana gubitkom protoka krvi,
English: When taking IMBRUVICA, 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: Tijekom uzimanja lijeka IMBRUVICA, odmah obavijestite svog liječnika ako Vi ili netko kod Vas primijeti: gubitak pamćenja, poteškoće s razmišljanjem, poteškoće s hodanjem ili gubitak vida - to može biti zbog vrlo rijetke, ali ozbiljne infekcije mozga koja može imati smrtni ishod (progresivna multifokalna leukoencefalopatija ili PML).
English: The tablets should be swallowed whole with water and should not be broken or chewed.
Croatian: Tablete se moraju progutati cijele s vodom i ne smiju se lomiti ili žvakati.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE27.
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE27.
English: Flip open the pack.
Croatian: Otvorite pakiranje.
English: IMBRUVICA has minor influence on the ability to drive and use machines.
Croatian: IMBRUVICA malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • low number of cells that help blood clot (platelets), very low number of white blood cells shown in blood tests
Croatian: • nizak broj stanica koje pomažu pri zgrušavanju krvi (krvne pločice), vrlo nizak broj bijelih krvnih stanica - vidi se iz krvnih pretraga
English: Monitor complete blood counts monthly.
Croatian: Potrebno je jednom mjesečno kontrolirati kompletnu krvnu sliku.
English: Median follow-up time on study=9 months
Croatian: Medijan trajanja praćenja u sklopu ispitivanja = 9 mjeseci
English: Ibrutinib is metabolised in the liver.
Croatian: Ibrutinib se metabolizira u jetri.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 October 2014
Croatian: Datum prvog odobrenja: 21. listopada 2014.
English: Frequency calculated from monotherapy clinical studies.
Croatian: Učestalost izračunata iz kliničkih ispitivanja monoterapije.
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Croatian: Za bolesnike koji imaju pozitivan test na infekciju HBV-om, preporučuje se savjetovanje s liječnikom iskusnim u liječenju hepatitisa B.
English: Ibrutinib has minimal renal clearance; urinary excretion of metabolites is <10% of the dose.
Croatian: Ibrutinib ima minimalni bubrežni klirens; izlučivanje metabolita mokraćom je < 10% doze.
English: 18.1 (11.1, NE)
Croatian: 18,1 (11,1; NP)