natgillin/translations-raw huggingface dataset:
It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy.
Zdravilo je namenjeno bolnikom s še ne zdravljeno WM ali bolnikom, pri katerih se je bolezen ponovila ali niso odgovorili na zdravljenje oziroma bolnikom, ki niso primerni za kemoterapijo v kombinaciji s protitelesi.
By blocking this protein, IMBRUVICA helps kill and reduce the number of cancer cells.
Z zaviranjem te beljakovine pomaga zdravilo IMBRUVICA uničevati rakaste celice in zmanjševati njihovo število, hkrati pa tudi upočasni poslabšanje rakave bolezni.
Each bottle contains either 90 or 120 capsules.
Ena plastenka vsebuje bodisi 90 ali 120 kapsul.
Chlorambucil+Obinutuzumab N=116
klorambucil+obinutuzumab N=116
The study enrolled patients who were 65 years of age or older or <65 years of age with coexisting medical conditions, reduced renal function as measured by creatinine clearance <70 mL/min, or presence of del17p/TP53 mutation.
V študijo so bili vključeni bolniki, ki so bili stari 65 let ali več ali bolniki, mlajši od 65 let s sočasnimi boleznimi, zmanjšano ledvično funkcijo, opredeljeno z očistkom kreatinina <70 ml/min, ali prisotno delecijo 17p oziroma mutacijo TP53.
PFS hazard ratios for treatment-naïve patients, previously treated patients, and patients with or without MYD88 L265P mutations were consistent with the PFS hazard ratio for the ITT population.
Razmerja ogroženosti za PFS pri bolnikih brez predhodnega zdravljenja, pri bolnikih s predhodnim zdravljenjem in pri bolnikih z mutacijo MYD88 L265P oziroma brez nje so se ujemala z razmerjem ogroženosti za PFS pri populaciji ITT.
The open-label, multi-center study (PCYC-1102-CA) included 51 patients with relapsed or refractory CLL, who received 420 mg once daily.
Odprta multicentrična študija (PCYC-1102-CA) je vključevala 51 bolnikov s ponovitvijo ali z neodzivno obliko KLL, ki so prejemali odmerek 420 mg enkrat na dan.
Use of either anticoagulants or medicinal products that inhibit platelet function (antiplatelet agents) concomitantly with IMBRUVICA increases the risk of major bleeding.
Sočasna uporaba zdravila IMBRUVICA z antikoagulanti ali z zdravili, ki zavirajo delovanje trombocitov (protitrombocitna zdravila) poveča tveganje za večjo krvavitev.
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.
In vitro je reverzibilna vezava ibrutiniba na humane plazemske beljakovine znašala 97,3% in v območju od 50 do 1.000 ng/ml ni bila odvisna od koncentracije.
The median age was 67 years (range, 47 to 90 years).
Mediana starost bolnikov je bila 67 let (od 47 do 90 let).
Bulky disease <5 cm ≥5 cm
Velika tumorska masa <5 cm ≥5 cm
Lymphocytosis: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment.
Limfocitoza: V prvih nekaj tednih zdravljenja lahko izvidi laboratorijskih preiskav pokažejo zvečano število belih krvnih celic (imenovanih "limfociti") v vaši krvi.
Grade 3 or higher pneumonia occurred more frequently among elderly patients treated with IMBRUVICA (12% of patients age ≥65 versus 7% of patients <65 years of age).
Pri starejših bolnikih, ki so prejemali zdravilo IMBRUVICA, se je pogosteje pojavila pljučnica stopnje 3 ali več (12% bolnikov, starih ≥ 65 v primerjavi s 7% bolnikov < 65 let).
The first dose of obinutuzumab was divided between day 1 (100 mg) and day 2 (900 mg).
Prvi odmerek obinutuzumaba so prejeli deljeno: 100 mg 1. dan in 900 mg 2. dan.
Each carton contains one bottle of either 90 or 120 hard capsules.
Ena škatla vsebuje eno plastenko z 90 ali 120 trdimi kapsulami.
Treatment should continue until disease progression or no longer tolerated by the patient.
Z zdravljenjem je treba nadaljevati do napredovanja bolezni oziroma dokler bolnik prenaša zdravilo.
Responses to IMBRUVICA are shown in Table 10.
Odgovori na zdravilo IMBRUVICA so prikazani v Preglednici 10.
No human data on the effects of ibrutinib on fertility are available.
Podatkov o vplivu ibrutiniba na plodnost pri ljudeh ni na voljo.
Sensitivity analysis in which crossover patients from the ofatumumab arm were not censored at the date of first dose of IMBRUVICA.
Analiza občutljivosti, za katero pri bolnikih iz skupine z ofatumumabom, ki so zamenjali zdravilo, podatki niso bili cenzurirani z dnem prvega odmerka zdravila IMBRUVICA.
If symptoms develop, interrupt IMBRUVICA and manage ILD appropriately.
Če se simptomi pojavijo, je treba zdravljenje z zdravilom IMBRUVICA prekiniti in ILD ustrezno zdraviti.
IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
Zdravilo IMBRUVICA je kot samostojno zdravilo indicirano za zdravljenje odraslih bolnikov z Waldenstromovo makroglobulinemijo (WM - Waldenström's macroglobulinaemia), ki so predhodno prejeli vsaj eno vrsto zdravljenja oziroma v prvi liniji pri bolnikih, ki niso primerni za kemoimunoterapijo.
Unmutated IGHV Yes
Nemutiran gen za IGHV da ne
In patients at high risk and where alternatives to IMBRUVICA are non-suitable, tightly controlled treatment with anticoagulants should be considered.
Pri bolnikih z velikim tveganjem in kadar druge možnosti zdravljenja niso primerne, je treba razmisliti o zdravljenju z antikoagulanti, ki pa mora biti skrbno nadzorovano.
Progression free survival (PFS) was assessed by IRC according to IWCLL criteria.
Podatke o preživetju brez napredovanja bolezni (PFS) je ocenjevala IRC po kriterijih IWCL.
Monitor patient closely for toxicity and follow dose modification guidance as needed (see sections 4.2 and 4.4).
Bolnike je treba skrbno spremljati glede toksičnega delovanja zdravila in po potrebi upoštevati smernice za prilagajanje odmerka (glejte poglavji 4.2 in 4.4).
If the toxicity reoccurs, the once daily dose should be reduced by one capsule (140 mg).
Če se znaki toksičnega učinkovanja ponovijo, je treba dnevni odmerek zmanjšati za eno kapsulo (za 140 mg).
Mild inducers may be used concomitantly with IMBRUVICA, however, patients should be monitored for potential lack of efficacy.
Zdravilo IMBRUVICA se sočasno lahko uporablja z blagimi induktorji, vendar je treba bolnike skrbno spremljati glede znakov pomanjkanja učinkovitosti.
• Take the tablets about the same time each day.
- Tablete vzemite vsak dan ob približno istem času.
Grapefruit and Seville oranges should be avoided during IMBRUVICA treatment, as these contain moderate inhibitors of CYP3A4 (see section 4.2).
Med zdravljenjem z zdravilom IMBRUVICA se je treba izogibati uživanju grenivk in seviljskih pomaranč, ker vsebujejo zmerne zaviralce CYP3A4 (glejte poglavje 4.2).
Median time to initial response, months (range) Median time to CR, months (range)
mediana časa do začetnega odgovora, meseci (razpon) mediana časa do popolnega odgovora, meseci (razpon)
The dihydrodiol metabolite and other metabolites are P-gp substrates.
Dihidrodiolni presnovek in drugi presnovki so substrati P-glikoproteina.
Ibrutinib may also inhibit BCRP in the liver and increase the exposure of medicinal products that undergo BCRP-mediated hepatic efflux, such as rosuvastatin.
Ibrutinib lahko zavira tudi BCRP v jetrih in zveča izpostavljenost zdravilom, katerih izločanje skozi jetra je povezano z BCRP, kot je rosuvastatin.
The dihydrodiol metabolite of ibrutinib is a weak inhibitor toward CYP2B6, CYP2C8, CYP2C9, and CYP2D6.
Dihidrodiolni presnovek ibrutiniba je šibek zaviralec encimov CYP2B6, CYP2C8, CYP2C9 in CYP2D6.
To minimise the potential for an interaction in the GI tract, oral narrow therapeutic range, P-gp or BCRP substrates such as digoxin or methotrexate should be taken at least 6 hours before or after IMBRUVICA.
Da bi zmanjšali možnost medsebojnega delovanja v prebavilih, je treba substrate P-glikoproteina ali BCRP, ki imajo ozko peroralno terapevtsko okno, kot sta digoksin ali metotreksat, jemati najmanj 6 ur pred odmerjanjem zdravila IMBRUVICA oziroma najmanj 6 ur po njem.
Film-coat
Filmska obloga
Patients with congenital bleeding diathesis have not been studied.
Bolnikov s prirojeno hemoragično diatezo niso preučevali.
What IMBRUVICA looks like and contents of the pack IMBRUVICA are white opaque, hard capsules marked with “ibr 140 mg” in black ink on one side.
Izgled zdravila IMBRUVICA in vsebina pakiranja Zdravilo IMBRUVICA so bele, neprozorne trde kapsule s črno oznako "ibr 140 mg" na eni strani.
IMBRUVICA therapy should be withheld for any new onset or worsening grade ≥3 non-haematological toxicity, grade 3 or greater neutropenia with infection or fever, or grade 4 haematological toxicities.
Zdravljenje z zdravilom IMBRUVICA je treba prekiniti pri pojavu nehematološke toksičnosti stopnje 3 ali več ali pri poslabšanju že prej prisotnih znakov hematološke toksičnosti na stopnjo 3 ali več, pri nevtropeniji stopnje 3 s pridruženo okužbo ali zvišanjem telesne temperature ali pri znakih hematološke toksičnosti stopnje 4.
PFS Median PFS (95% CI), (months)
PFS mediana PFS (95% IZ), (meseci)
Ibrutinib forms a covalent bond with a cysteine residue (Cys-481) in the BTK active site, leading to sustained inhibition of BTK enzymatic activity.
Ibrutinib tvori kovalentno vez s cisteinskim ostankom (Cys-481) na aktivnem mestu BTK, kar povzroči dolgotrajno zaviranje aktivnosti tega encima.
In both disease types, lymphocytosis typically occurs during the first month of IMBRUVICA therapy and typically resolves within a median of 8.0 weeks in patients with MCL and 14 weeks in patients with CLL.
Pri obeh vrstah bolezni se limfocitoza običajno pojavi v prvem mesecu zdravljenja z zdravilom IMBRUVICA in praviloma izzveni v mediano 8,0 tedna pri bolnikih z limfomom plaščnih celic in v 14 tednih pri bolnikih s kronično limfocitno levkemijo.
IMBRUVICA should not be used during pregnancy.
Zdravila IMBRUVICA se ne sme jemati med nosečnostjo.
Ibrutinib is primarily metabolised by cytochrome P450 enzyme 3A4 (CYP3A4).
Ibrutinib primarno presnavlja encim 3A4 (CYP3A4) citokromoma P450.
ORR including PR with lymphocytosis d (%)
ORR, ki vključuje delni odgovor z limfocitozo d (%)
Ibrutinib has a pH dependent solubility, with lower solubility at higher pH.
Topnost ibrutiniba je odvisna od pH in je pri višjem pH manjša.
IMBRUVICA with food
Zdravilo IMBRUVICA skupaj s hrano
Cases of atrial fibrillation and atrial flutter have been reported particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation.
O primerih atrijske fibrilacije in atrijske undulacije so poročali zlasti pri bolnikih z dejavniki tveganja za bolezni srca, hipertenzijo, z akutnimi okužbami in z atrijsko fibrilacijo v anamnezi.
In vitro studies indicated that ibrutinib is a weak reversible inhibitor toward CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and intestinal (but not hepatic) CYP3A4 and does not display clinically relevant time-dependent inhibition of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP2D6.
Rezultati študij in vitro kažejo, da je ibrutinib šibek reverzibilni zaviralec encimov CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4 v črevesju (v jetrih pa ne) ter ne kaže klinično pomembnega, od časa odvisnega zaviranja CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in CYP2D6.
Once the symptoms of the toxicity have resolved to grade 1 or baseline (recovery), IMBRUVICA therapy may be reinitiated at the starting dose.
Ko se simptomi toksičnega delovanja zmanjšajo na stopnjo 1 ali povsem izzvenijo (ko bolnik okreva), se lahko zdravilo IMBRUVICA ponovno uvede (v začetnem odmerku).
14.6 (10.4, NE) HR=0.43 [95% CI: 0.32, 0.58]
14,6 (10,4; NE) HR = 0,43 [95% IZ: 0,32; 0,58]
Table 9: Efficacy Results in patients with CLL (Study CLL3001)
Preglednica 9: Rezultati učinkovitosti pri bolnikih s KLL (študija CLL3001)
Ibrutinib is rapidly absorbed after oral administration with a median Tmax of 1 to 2 hours.
Ibrutinib se po peroralnem odmerjanju hitro absorbira, pri čemer je mediana časa do najvišje koncentracije (Tmax) 1 do 2 uri.
The investigator-assessed ORR was 91.2% in the IMBRUVICA arm versus 36.8% in the chlorambucil arm.
ORR po oceni raziskovalca je bil v skupini z zdravilom IMBRUVICA 91,2% v primerjavi s 36,8% v skupini s klorambucilom.
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.
Kliničnih podatkov o tem medsebojnem delovanju ni, zato ni mogoče izključiti možnosti, da bi ibrutinib pri terapevtskih odmerkih zaviral P-glikoprotein in BCRP v črevesju.
All patients in clinical studies received IMBRUVICA until disease progression or no longer tolerated.
Vsi bolniki so v kliničnih študijah prejemali zdravilo IMBRUVICA, dokler so ga dobro prenašali ali do napredovanja bolezni.
Population pharmacokinetics indicated that age does not significantly influence ibrutinib clearance from the circulation.
Populacijska farmakokinetika kaže, da starost ne vpliva bistveno na izločanje ibrutiniba iz krvnega obtoka.
If any doubt exists, referral to a neurologist and appropriate diagnostic measures for PML including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments should be considered.
V primeru dvoma je treba bolnika napotiti k nevrologu in razmisliti o nadaljnih ustreznih diagnostičnih metodah za ugotavljanje PML, vključno s slikanjem z magnetno resonanco (MRI), po možnosti s kontrastom, določanjem prisotnosti DNK virusa JC v cerebrospinalni tekočini in ponovno nevrološko oceno.
Ibrutinib is a potent, small-molecule inhibitor of Bruton's tyrosine kinase (BTK).
Ibrutinib je majhna molekula z močnim zaviralnim delovanjem na Brutonovo tirozinsko kinazo (BTK).
At baseline, the median serum IgM value was 3.5 g/dL, and 60% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L).
Na začetku zdravljenja so bile mediane serumske koncentracije IgM 3,5 g/dl, 60% bolnikov je bilo anemičnih (hemoglobin ≤ 11 g/dl ali 6,8 mmol/l).
These include minor bleeding events such as contusion, epistaxis, and petechiae; and major bleeding events, some fatal, including gastrointestinal bleeding, intracranial haemorrhage, and haematuria.
To vključuje manjše hemoragične dogodke, kot so podplutbe, krvavitev iz nosu in petehije, ter večje krvavitve (nekatere so bile smrtne), vključno z gastrointestinalno in intrakranialno krvavitvijo ter hematurijo.
Paediatric population No pharmacokinetic studies were performed with IMBRUVICA in patients under 18 years of age.
Pri bolnikih, ki so stari manj kot 18 let, niso izvedli nobene farmakokinetične študije z zdravilom IMBRUVICA.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake "Uporabno do" oziroma "EXP".
Cryptococcal infections Pneumocystis infections Aspergillus infections Hepatitis B reactivation
občasni kriptokokna okužba* pnevmocistična okužba* okužba z aspergilusom* reaktivacija hepatitisa B
In a hepatic impairment study, data showed an increase in ibrutinib exposure (see section 5.2).
Podatki iz študij uporabe zdravila pri bolnikih z okvaro jeter kažejo povečano izpostavljenost ibrutinibu (glejte poglavje 5.2).
No specific dose adjustment is required for elderly patients (aged ≥65 years).
Starejši Pri starejših bolnikih (starih 65 let ali več) posebno prilagajanje odmerjanja ni potrebno.
In fasted healthy subjects administered a single 560 mg dose of ibrutinib after taking omeprazole at 40 mg once daily for 5 days, compared to ibrutinib alone, geometric mean ratios (90% CI) were 83% (68-102%), 92% (78-110%), and 38% (26-53%) for AUC0-24, AUClast, and Cmax, respectively.
Pri zdravih teščih osebah, ki so prejele enkratni 560 mg odmerek ibrutiniba po jemanju 40 mg omeprazola enkrat na dan, 5 dni, v primerjavi s tistimi, ki so prejeli samo ibrutinib, je bilo razmerje geometrijskih sredin (90% IZ) 83% (68-102%), 92% (78-110%), in 38% (26-53%) za AUC0-24, AUCzadnja, oziroma Cmax.
Intolerance to excipients
Intoleranca na pomožne snovi
Ibrutinib was found to induce gastrointestinal effects (soft faeces/diarrhoea and/or inflammation) and lymphoid depletion in rats and dogs with a No Observed Adverse Effect Level (NOAEL) of 30 mg/kg/day in both species.
Ugotovili so, da ibrutinib pri podganah in psih povzroča gastrointestinalne učinke (mehko blato/drisko in/ali vnetje) in pomanjkanje limfocitov (limfocitno deplecijo); koncentracija brez opaznega škodljivega učinka (NOAEL - No Observed Adverse Effect Level) je bila 30 mg/kg/dan pri obeh vrstah živali.
• Waldenström's macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes.
- Waldenstromova makroglobulinemija (WM), to je vrsta raka, ki prizadene bele krvne celice (limfocite).
IMBRUVICA may make you bleed more easily.
Zdravilo IMBRUVICA lahko poveča možnost krvavitve.
Rituximab was administered weekly at a dose of 375 mg/m2 for 4 consecutive weeks (weeks 1-4) followed by a second course of weekly rituximab for 4 consecutive weeks (weeks 17-20).
Rituksimab so jim odmerjali enkrat na teden v odmerku 375 mg/m2 4 zaporedne tedne (v tednih 1 do 4) in nato v drugem krogu odmerjanja rituksimaba enkrat na teden 4 zaporedne tedne (v tednih 17 do 20).
Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each.
Ena škatla z 28-dnevnim pakiranjem vsebuje 28 filmsko obloženih tablet v 2 kartonskih zgibankah, v katerih je v vsaki po 14 filmsko obloženih tablet.
The patient should not take extra tablets to make up the missed dose.
Bolnik naj ne jemlje dodatnih tablet, da bi nadomestil pozabljeni odmerek.
Based on mean exposure (AUC) at the 560 mg/day clinical dose, AUC ratios were 2.6 and 21 at the NOAEL in male and female rats, and 0.4 and 1.8 at the NOAEL in male and female dogs, respectively.
Glede na povprečno izpostavljenost (AUC) pri kliničnem odmerku 560 mg/dan je bilo razmerje AUC pri NOAEL 2,6 oziroma 21 pri podganjih samcih oziroma samicah in 0,4 oziroma 1,8 pri pasjih samcih oziroma samicah.
Patients should be monitored for fever, neutropenia and infections and appropriate anti-infective therapy should be instituted as indicated.
Bolnike je treba spremljati glede morebitnega pojava zvišane telesne temperature, nevtropenije in okužbe ter po potrebi uvesti ustrezno antimikrobno zdravljenje.
IMBRUVICA is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to treatment.
Zdravilo IMBRUVICA je namenjeno bolnikom s še nezdravljeno KLL oziroma bolnikom, pri katerih se je bolezen ponovila ali niso odgovorili na zdravljenje.
Do not get pregnant while you are taking this medicine.
Nosečnost in dojenje Pazite, da ne boste zanosili v času jemanja tega zdravila.
Avoid concomitant use of strong or moderate CYP3A4 inducers (e.g., carbamazepine, rifampicin, phenytoin).
Izogibati se je treba sočasni uporabi močnih ali zmernih induktorjev CYP3A (na primer karbamazepina, rifampicina, fenitoina).
High risk (del17p/TP53/del11q/unmutated IGHV) Yes
Povečano tveganje (delecija 17p/mutacija TP53/delecija 11q/nemutiran gen za IGHV) Da ne
The patient should not take extra capsules to make up the missed dose.
Bolnik naj ne jemlje dodatnih kapsul, da bi nadomestil pozabljeni odmerek.
Chlorambucil N=133
klorambucil N = 133
If a CYP3A4 inducer must be used, closely monitor patients for signs of IMBRUVICA lack of efficacy.
Če je potrebna sočasna uporaba z induktorji CYP3A4, je treba bolnike skrbno spremljati glede znakov pomanjkanja učinkovitosti.
Fatigue, dizziness and asthenia have been reported in some patients taking IMBRUVICA and should be considered when assessing a patient's ability to drive or operate machines.
Pri nekaterih bolnikih, ki so jemali zdravilo IMBRUVICA, so poročali o utrujenosti, omotičnosti in asteniji, kar je treba upoštevati pri presoji bolnikove sposobnosti za vožnjo in upravljanje strojev.
HR (95% CI)
HR (95% IZ)
Tumour response was assessed according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.
Tumorski odgovor so ocenjevali po popravljenih kriterijih mednarodne delovne skupine (IWG - International Working Group) za ne-Hodgkinove limfome.
Based on in vitro data, ibrutinib is a weak reversible inhibitor towards CYP3A4 at the intestinal level and may therefore increase the exposure to CYP3A4 substrates sensitive to gut CYP3A metabolism.
Na osnovi podatkov in vitro je ibrutinib šibek reverzibilni zaviralec CYP3A4 v prebavilih in lahko zveča izpostavljenost substratom CYP3A4, občutljivim na metabolizem CYP3A v črevesju.
Race There are insufficient data to evaluate the potential effect of race on ibrutinib pharmacokinetics.
Rasa Za oceno morebitnega vpliva rase na farmakokinetiko ibrutiniba ni dovolj podatkov.
The capsules should be swallowed whole with water and should not be opened, broken, or chewed.
- Kapsule pogoltnite cele, ne smete jih odpirati, drobiti ali žvečiti.
Patients with CLL who received at least one prior therapy Single agent
Bolniki s KLL, ki so prej prejeli vsaj eno vrsto zdravljenja Samostojno zdravilo
Median follow-up time on study=9 months
Mediano trajanje spremljanja bolnikov v študiji je bilo 9 mesecev.
At baseline, 39.2% of patients had Rai Stage IV, 45.1% had bulky disease (≥5 cm), 35.3% had deletion 17p and 31.4% had deletion 11q.
Ob izhodišču je imelo 39,2% bolnikov stadij IV po Rai-u, 45,1% jih je imelo bolezen z veliko tumorsko maso (≥ 5 cm), 35,3% jih je imelo delecijo 17p in 31,4% jih je imelo delecijo 11q.
White opaque, hard capsule of 22 mm in length, marked with “ibr 140 mg” in black ink.
Bela neprosojna 22 mm dolga trda kapsula s črno oznako "ibr 140 mg".
Ibrutinib has minimal renal clearance; urinary excretion of metabolites is <10% of the dose.
Ibrutinib se le v majhni meri izloča skozi ledvice; izločanje presnovkov z urinom predstavlja manj kot 10% danega odmerka.
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.
Če bolnik izpusti odmerek, ga lahko vzame čimprej istega dne, naslednjega dne pa spet začne z odmerjanjem po običajnem razporedu.
The efficacy data was further evaluated by an Independent Review Committee (IRC) demonstrating an ORR of 69%, with a 21% complete response (CR) rate and a 48% partial response (PR) rate.
Podatke o učinkovitosti je dodatno ovrednotila neodvisna komisija za pregled podatkov (IRCIndependent Review Committee) in ugotovila, da je ORR znašal 69%, pri čemer je bilo bolnikov s popolnim odgovorom 21%, bolnikov z delnim odgovorom pa 48%.
A second reduction of dose by 140 mg may be considered as needed.
Po potrebi se lahko odmerek ponovno zmanjša za 140 mg.
IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Zdravilo IMBRUVICA je kot samostojno zdravilo ali v kombinaciji z bendamustinom in rituksimabom (BR) indicirano za zdravljenje odraslih bolnikov s KLL, ki so predhodno prejeli vsaj eno vrsto zdravljenja.
At baseline, 56% of patients had at least one tumour ≥5 cm, 26% had del11q.
Ob izhodišču je imelo 56% bolnikov najmanj en tumor velikosti ≥ 5 cm, 26% bolnikov je imelo prisotno delecijo 11q.
With a median follow-up time on study of 65 months in Study PCYC-1112-CA, an 85% reduction in the risk of death or progression by investigator assessment was observed for patients in the IMBRUVICA arm.
Z medianim trajanjem spremljanja bolnikov v študiji 65 mesecev so v študiji PCYC-1112-CA ugotavljali 85-odstotno zmanjšanje tveganja za smrt ali napredovanje bolezni po oceni raziskovalca pri bolnikih v skupini z zdravilom IMBRUVICA.
Severe cardiac disease Patients with severe cardiovascular disease were excluded from IMBRUVICA clinical studies.
Bolniki s hudimi kardiovaskularnimi boleznimi niso bili vključeni v klinične študije zdravila IMBRUVICA.