natgillin/translations-raw huggingface dataset:
Stop taking IMBRUVICA and tell a doctor straight away if you notice any of the following side effects: itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat - you may be having an allergic reaction to the medicine.
Če opazite katerega od naslednjih neželenih učinkov, prenehajte jemati zdravilo IMBRUVICA in takoj obvestite zdravnika: srbeč izpuščaj z bulicami na koži, oteženo dihanje, otekanje v obraz, ustnice ali grlo oziroma žrelomorda imate alergijsko reakcijo na zdravilo.
(Stevens-Johnson syndrome).
Johnsonov sindrom)
The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg once daily (for details of the combination regimen, see section 5.1).
Priporočeni odmerek za zdravljenje KLL, samostojno ali v kombinaciji, je 420 mg enkrat na dan (za podrobne informacije o odmerjanju v kombinaciji glejte poglavje 5.1).
Lowest Observed Effect Level (LOEL) (60 mg/kg/day) margins in the dog are 3.6-fold (males) and 2.3-fold (females).
Pri psih je najnižja koncentracija z opaznim učinkom (LOEL - Lowest Observed Effect Level) (60 mg/kg/dan) 3,6-kratna (pri samcih) in 2,3-kratna (pri samicah).
Grade 3 or higher or serious infusion-related reactions were observed in 3% of patients treated with IMBRUVICA+obinutuzumab and 9% of patients treated with chlorambucil+obinutuzumab.
Infuzijske reakcije stopnje 3 ali več oziroma resne infuzijske reakcije so opazili pri 3% bolnikov, ki so prejemali zdravilo IMBRUVICA in obinutuzumab, ter pri 9% bolnikov, ki so prejemali klorambucil in obinutuzumab.
At baseline, 58% of patients had at least one tumour ≥5 cm. Thirty-two percent of patients had deletion 17p (with 50% of patients having deletion 17p/TP53 mutation), 24% had 11q deletion, and 47% of patients had unmutated IGHV.
Ob izhodišču je imelo 58% bolnikov najmanj en tumor velikosti ≥5 cm. Dvaintrideset odstotkov bolnikov je imelo prisotno delecijo 17p (pri čemer je imelo 50% bolnikov delecijo 17p/mutacijo TP53), 24% jih je imelo delecijo 11q in 47% bolnikov je imelo nemutiran gen za IGHV.
In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the strong CYP3A4 inhibitor voriconazole increased Cmax by 6.7-fold and AUC by 5.7-fold.
Pri bolnikih z malignomi celic B, ki jemljejo zdravilo IMBRUVICA s hrano, je sočasno jemanje vorikonazola, močnega zaviralca CYP3A4, povečalo Cmax za 6,7-krat in AUC za 5,7-krat.
Adverse reactions in patients treated with ibrutinib for B-cell malignancies and post-marketing adverse reactions are listed below by system organ class and frequency grouping.
Neželeni učinki pri bolnikih z malignomi celic B in neželeni učinki, poročani po začetku trženja zdravila, so navedeni po organskih sistemih in kategorijah pogostnosti.
A randomised, multicenter, open-label phase 3 study (PCYC-1115-CA) of IMBRUVICA versus chlorambucil was conducted in patients with treatment-naïve CLL who were 65 years of age or older.
Randomizirano, multicentrično, odprto študijo faze 3 zdravila IMBRUVICA v primerjavi s klorambucilom (študija PCYC-1115-CA) so izvedli pri bolnikih s še nezdravljeno KLL, starih 65 let ali več.
The effect of impaired liver function varied substantially between individuals, but on average a 2.7-, 8.2-, and 9.8-fold increase in ibrutinib exposure (AUClast) was observed in subjects with mild (n=6, Child-Pugh class A), moderate (n=10, Child-Pugh class B) and severe (n=8, Child-Pugh class C) hepatic impairment, respectively.
Vpliv okvarjenega delovanja jeter se je med posamezniki sicer precej razlikoval, v povprečju pa so pri bolnikih z blago (n = 6; razred A po Child-Pughu), zmerno (n = 10; razred B po Child-Pughu ) oziroma hudo okvaro jeter (n = 8; razred C po Child-Pughu) opazili 2,7-kratno, 8,2-kratno oziroma 9,8-kratno povečanje izpostavljenosti ibrutinibu (AUCzadnja).
Strong inhibitors of CYP3A4 (e.g., ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazodon, cobicistat, voriconazole and posaconazole) should be avoided.
Močnim zaviralcem CYP3A4 (na primer ketokonazolu, indinavirju, nelfinavirju, ritonavirju, sakvinavirju, klaritromicinu, telitromicinu, itrakonazolu, nefazodonu, kobicistatu, vorikonazolu in posakonazolu) se je treba izogibati.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Če karkoli od zgoraj navedenega velja za vas (ali če o tem niste prepričani), se pred začetkom jemanja tega zdravila posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
In an in vitro study, ibrutinib demonstrated inhibition of collagen-induced platelet aggregation.
V in vitro študiji je ibrutinib zaviral s kolagenom povzročeno agregacijo trombocitov.
Consequently the foetal NOAEL was 5 mg/kg/day (approximately 0.7 times the AUC of ibrutinib at a dose of 560 mg daily) (see section 4.6).
Koncentracija NOAEL pri plodu je bila posledično 5 mg/kg/dan, kar pomeni približno 0,7-kratnik AUC ibrutiniba pri odmerjanju 560 mg/dan (glejte poglavje 4.6).
Cases of cerebrovascular accident, transient ischaemic attack and ischaemic stroke including fatalities have been reported with the use of ibrutinib, with and without concomitant atrial fibrillation and/or hypertension.
Ob uporabi ibrutiniba so poročali o primerih cerebrovaskularnega insulta, prehodnega ishemičnega napada in ishemične možganske kapi s sočasno atrijsko fibrilacijo in/ali hipertenzijo ali brez njiju.
120 capsules
90 kapsul 120 kapsul
The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg (three capsules) once daily (for details of the combination regimen, see section 5.1).
Priporočeni odmerek za zdravljenje KLL, samostojno ali v kombinaciji, je 420 mg (tri kapsule) enkrat na dan (za podrobne informacije o odmerjanju v kombinaciji glejte poglavje 5.1).
All patients had a baseline ECOG performance status of 0 or 1.
Vsi bolniki so imeli oceno splošne zmogljivosti po lestvici ECOG 0 ali 1.
The ORR including PR with lymphocytosis was 70.6%.
Pri limfocitozi je bil ORR (vključno z delnim odgovorom) 70,6%.
The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.
Priporočeni odmerek zdravila IMBRUVICA je štiri kapsule (560 mg) enkrat na dan.
What IMBRUVICA looks like and contents of the pack IMBRUVICA 140 mg film-coated tablets
Izgled zdravila IMBRUVICA in vsebina pakiranja IMBRUVICA 140 mg filmsko obložene tablete
There are no data from the use of IMBRUVICA in pregnant women.
Podatkov o uporabi zdravila IMBRUVICA pri nosečnicah ni.
IMBRUVICA Film-Coated Tablets Janssen-Cilag SpA Via C. Janssen,
IMBRUVICA filmsko obložene tablete Janssen-Cilag SpA
Not known Stevens-Johnson syndrome
Stevens-Johnsonov sindrom neznana pogostnost neznana pogostnost
Bendamustine was dosed at 70 mg/m2 infused IV over 30 minutes on Cycle 1, Days 2 and 3, and on Cycles 2-6, Days 1 and 2 for up to 6 cycles.
Bolniki so 1. krog zdravljenja prejeli 70 mg/m bendamustina v obliki 30 minutne IV infuzije na dan 2 in 3, in 2.-6. krog zdravljenja na dan 1 in 2 do največ 6 krogov zdravljenja.
The safety and efficacy of IMBRUVICA in patients with relapsed or refractory MCL were evaluated in a single open-label, multi-center phase 2 study (PCYC-1104-CA) of 111 patients.
Varnost in učinkovitost zdravila IMBRUVICA pri bolnikih s ponovitvijo oziroma z neodzivno obliko MCL so ocenjevali v eni sami odprti multicentrični študiji faze 2 (PCYC-1104-CA), ki je vključevala 111 bolnikov.
Progression Free Survival Number of events (%) Median (95% CI), months
Preživetje brez napredovanja bolezni število dogodkov (%) mediana (95% IZ), meseci ni dosežena
Patients treated for MCL in clinical studies received IMBRUVICA at 560 mg once daily and patients treated for CLL or WM in clinical studies received IMBRUVICA at 420 mg once daily.
V kliničnih študijah so bolniki z MCL prejemali 560 mg zdravila IMBRUVICA enkrat na dan, bolniki s KLL ali WM pa 420 mg zdravila IMBRUVICA enkrat na dan.
Neoplasms benign and malignant (incl cysts and polyps)
Benigne in maligne novotvorbe (vključno s cistami in polipi)
The recommended dose for the treatment of WM is 420 mg (three capsules) once daily.
Priporočeni odmerek za zdravljenje WM je 420 mg (tri kapsule) enkrat na dan.
If you are not sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.
Če o tem niste povsem prepričani, se pred začetkom uporabe tega zdravila posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The median duration of treatment for MCL was 11 months (range, 0 to 87 months) with 31% and 17% of patients receiving treatment for more than 2 years and 4 years, respectively.
Mediano trajanje zdravljenja pri MCL je bilo 11 mesecev (od 0 do 87 mesecev), pri tem je 31% bolnikov prejemalo zdravljenje več kot 2 leti, 17% pa več kot 4 leta.
• The other ingredients are: capsule content: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sodium lauril sulfate (E487) capsule shell: gelatin and titanium dioxide (E171) printing ink: shellac, black iron oxide (E172), and propylene glycol (E1520).
- Druge sestavine zdravila so: vsebina kapsule: premrežen natrijev karmelozat, magnezijev stearat, mikrokristalna celuloza in natrijev lavrilsulfat (E487) ovojnica kapsule: želatina in titanov dioksid (E171) črnilo za tisk: šelak, črni železov oksid (E172) in propilenglikol (E1520)
At baseline, 39% of patients had bulky disease (≥5 cm), 49% had high-risk score by Simplified MCL International Prognostic Index (MIPI), and 72% had advanced disease (extranodal and/or bone marrow involvement) at screening.
Ob izhodišču na izbirnem (angl. screening) obisku je imelo 39% bolnikov bolezen z veliko tumorsko maso (≥ 5 cm), 49% jih je imelo ocenjeno visoko tveganje s poenostavljenim mednarodnim prognostičnim indeksom limfoma plaščnih celic (angl. Simplified MCL International Prognostic Index, MIPI) in 72% bolnikov je imelo napredovali stadij bolezni (razširitev bolezni izven bezgavk in/ali zajetost kostnega mozga).
A randomised, multi-center, open-label phase 3 study of IMBRUVICA versus ofatumumab (PCYC-1112-CA) was conducted in patients with relapsed or refractory CLL.
Randomizirano multicentrično odprto študijo faze 3 zdravila IMBRUVICA v primerjavi z ofatumumabom (študija PCYC-1112-CA) so izvajali pri bolnikih s ponovitvijo oziroma z neodzivno obliko KLL.
Black iron oxide (E172) Propylene glycol (E1520)
Črnilo za tisk šelak črni železov oksid (E172) propilenglikol (E1520)
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.
Če karkoli od zgoraj navedenega velja za vas (ali če o tem niste prepričani), se pred začetkom uporabe zdravila IMBRUVICA posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The median number of prior treatments was 4 (range, 1 to 7 treatments).
Mediano število predhodnih terapij je bilo 4 (od 1 do 7 terapij).
No effects on fertility or reproductive capacities were observed in male or female rats up to the maximum dose tested, 100 mg/kg/day (HED 16 mg/kg/day).
Niso opazili učinkov na plodnost ali sposobnost razmnoževanja pri podganjih samcih ali samicah, ki so prejemali odmerke do največ 100 mg/kg/dan (odmerek, ekvivalenten odmerku 16 mg/kg/dan pri ljudeh).
Co-administration of rifampicin, a strong CYP3A4 inducer, in 18 fasted healthy subjects, decreased exposure (Cmax and AUC) of ibrutinib by 92 and 90%, respectively.
Sočasna uporaba rifampicina, močnega induktorja CYP3A4, pri 18 zdravih teščih osebah je zmanjšala izpostavljenost ibrutinibu (Cmax za 92% in AUC za 90%).
Median duration of overall response, months (range)
mediana trajanja odgovora, meseci (razpon)
Therefore, women of child-bearing potential must use highly effective contraceptive measures while taking IMBRUVICA and for three months after stopping treatment.
Zato morajo ženske v rodni dobi med zdravljenjem z zdravilom IMBRUVICA in še tri mesece po zaključku zdravljenja uporabljati zelo učinkovito metodo kontracepcije.
Yellow-green to green round (9 mm) tablets, written with “ibr” on one side and “140” on the other side.
Rumeno-zelene do zelene, okrogle tablete (9 mm) z vtisnjeno oznako “ibr” na eni in "140" na drugi strani.
Simulations using fasted conditions suggested that the strong CYP3A4 inhibitor clarithromycin may increase the AUC of ibrutinib by a factor of 14.
Simulacije v teščem stanju kažejo, da močni zaviralec CYP3A4 klaritromicin lahko 14-krat poveča AUC ibrutiniba.
No maximum tolerated dose was reached in the phase 1 study in which patients received up to 12.5 mg/kg/day (1,400 mg/day).
V študiji faze 1, v kateri so bolniki prejemali do 12,5 mg/kg/dan (1.400 mg/dan), niso dosegli največjega odmerka, ki ga bolniki še prenašajo.
The median time since diagnosis was 43 months, and median number of prior treatments was 2 (range: 1 to 9 treatments), including 51% with prior high-dose chemotherapy, 18% with prior bortezomib, 5% with prior lenalidomide, and 24% with prior stem cell transplant.
Mediana časa od postavitve diagnoze je bila 43 mesecev, mediano število predhodnih terapij pa 2 (od 1 do 9 terapij), kar vključuje 51% bolnikov s predhodno visokoodmerno kemoterapijo, 18% s predhodno uporabo bortezomiba, 5% s predhodno uporabo lenalidomida in 24% s predhodno presaditvijo matičnih celic.
Co-administration of strong or moderate CYP3A4 inhibitors with IMBRUVICA may lead to increased ibrutinib exposure and consequently a higher risk for toxicity.
Pri sočasni uporabi zmernih do močnih zaviralcev CYP3A4 in zdravila IMBRUVICA lahko pride do povečane izpostavljenosti ibrutinibu in posledično do večjega tveganja za pojav toksičnosti.
Refractory disease to purine analog Yes
Bolezen, neodzivna na analoge purinskih baz da ne
Del17p/TP53
Delecija 17p/mutacija TP53 da ne
Table 3: Efficacy Results in patients with relapsed or refractory MCL (Study MCL3001) Endpoint
Preglednica 3: Rezultati učinkovitosti pri bolnikih s ponovitvijo oziroma neodzivno obliko MCL (študija MCL3001)
The 2-year PFS rate estimates for the high-risk CLL/SLL population were 78.8% [95% CI (67.3, 86.7)] and 15.5% [95% CI (8.1, 25.2)] in the IMBRUVICA+obinutuzumab and chlorambucil+obinutuzumab arms, respectively.
Ocenjena stopnja 2-letnega preživetja pri bolnikih s KLL/SLL s povečanim tveganjem je bila 78,8% [95-odstotni IZ (67,3; 86,7)] v skupini z zdravilom IMBRUVICA in obinutuzumabom ter 15,5% [95-odstotni IZ (8,1; 25,2)] v skupini s klorambucilom in obinutuzumabom.
The median time since diagnosis was 42 months, and median number of prior treatments was 3 (range: 1 to 5 treatments), including 35% with prior high-dose chemotherapy, 43% with prior bortezomib, 24% with prior lenalidomide, and 11% with prior autologous or allogeneic stem cell transplant.
Mediana časa od postavitve diagnoze je bila 42 mesecev, mediano število predhodnih terapij pa 3 (od 1 do 5 terapij), kar vključuje 35% bolnikov s predhodno visokoodmerno kemoterapijo, 43% s predhodno uporabo bortezomiba, 24% s predhodno uporabo lenalidomida in 11% s predhodno avtologno ali alogeno presaditvijo matičnih celic.
In patients with baseline cytopenias, sustained hematologic improvement was: platelets 77.1% versus 42.9%; haemoglobin 84.3% versus 45.5% for ibrutinib and chlorambucil respectively.
Pri bolnikih z izhodiščnimi citopenijami je pri zdravljenju z ibrutinibom v primerjavi s klorambucilom prišlo do dolgotrajnega hematološkega izboljšanja : trombociti 77,1% proti 42,9%; hemoglobin 84,3% proti
Caution should be exercised if co-administering ibrutinib with CYP3A4 substrates administered orally with narrow therapeutic range (such as dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus and tacrolimus).
Pri sočasnem peroralnem dajanju ibrutiniba s substrati CYP3A4 z ozkim terapevtskim oknom (kot so dihidroergotamin, ergotamin, fentanil, ciklosporin, sirolimus in takrolimus), je potrebna previdnost.
Infections (including sepsis, neutropenic sepsis, bacterial, viral, or fungal infections) were observed in patients treated with IMBRUVICA.
Pri bolnikih, ki so jemali zdravilo IMBRUVICA, so opažali okužbe (vključno s sepso, nevtropenično sepso in bakterijskimi, virusnimi ali glivičnimi okužbami).
At baseline, 65% of patients presented with CLL/SLL with high risk factors (del17p/TP53 mutation [18%], del11q [15%], or unmutated IGHV [54%]).
Ob izhodišču je imelo 65% bolnikov KLL/SLL prisotne dejavnike povečanega tveganja (delecijo 17p/mutacijo TP53 [18%], delecijo 11q [15%] ali nemutiran gen za IGHV [54%]).
sinus or throat (upper respiratory tract infection), or lung, or skin.
Lahko gre za okužbo nosu, sinusov ali grla oziroma žrela (okužba zgornjih dihal) ter okužbo pljuč ali kože.
There are no data in patients with severe renal impairment or patients on dialysis (see section 5.2).
O uporabi pri bolnikih s hudo okvaro ledvic oziroma pri bolnikih na dializnem zdravljenju ni podatkov (glejte poglavje 5.2).
The treatment effect of ibrutinib in Study PCYC-1112-CA was consistent across high-risk patients with deletion 17p/TP53 mutation, deletion 11q, and/or unmutated IGHV.
Učinek zdravljenja z ibrutinibom je bil v študiji PCYC-1112-CA enoten pri vseh bolnikih s povečanim tveganjem z delecijo 17p/mutacijo TP53, delecijo 11q in/ali z nemutiranim genom za IGHV.
Non-melanoma skin cancers were reported more frequently in patients treated with IMBRUVICA than in patients treated with comparators in pooled comparative randomised phase 3 studies.
V združenih primerjalnih randomiziranih študijah faze 3 so pri bolnikih, zdravljenih z zdravilom IMBRUVICA o nemelanomskih kožnih rakih poročali pogosteje kot pri bolnikih, ki so se zdravili s primerjanimi zdravili.
IMBRUVICA was administered orally at 560 mg once daily until disease progression or unacceptable toxicity.
Bolniki so prejemali zdravilo IMBRUVICA peroralno v odmerku 560 mg enkrat na dan do napredovanja bolezni oziroma do nesprejemljivega toksičnega delovanja zdravila.
Co-administration of ketoconazole, a very strong CYP3A4 inhibitor, in 18 fasted healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by 29- and 24-fold, respectively.
Sočasna uporaba ketokonazola, zelo močnega zaviralca CYP3A4, pri 18 zdravih teščih osebah je povečala izpostavljenost ibrutinibu (Cmax 29-krat in AUC 24-krat).
Cerebrovascular accident a, #
ishemična možganska kap a, #
HR (95% CI) Overall Response Rate CR
HR (95% IZ) Celokupni delež odgovora
Leukostasis
Levkostaza
The corresponding increase in unbound ibrutinib exposure (AUCunbound, last) is estimated to be 4.1-, 9.8-, and 13-fold in subjects with mild, moderate, and severe hepatic impairment, respectively (see section 4.2).
Ocenjujejo, da pri bolnikih z blago, zmerno oziroma hudo okvaro jeter pride do 4,1-kratnega, 9,8-kratnega oziroma 13-kratnega povečanja izpostavljenosti nevezanemu ibrutinibu (AUCnevezana, zadnja) (glejte poglavje 4.2).
Tell a doctor straight away if you notice any of the following side effects:
Če opazite katerega od naslednjih neželenih učinkov, takoj obvestite zdravnika:
Cardiac arrhythmia
Srčne aritmije
There are no data in patients with severe renal impairment or patients on dialysis (see section 4.2).
O uporabi pri bolnikih s hudo okvaro ledvic oziroma pri bolnikih na dializnem zdravljenju ni podatkov (glejte poglavje 4.2).
Consequently the foetal NOAEL was 10 mg/kg/day (approximately 1.3 times the AUC of ibrutinib at a dose of 560 mg daily) (see section 4.6).
Koncentracija brez opaznega škodljivega učinka (NOAEL) pri plodu je bila torej 10 mg/kg/dan, kar pomeni približno 1,3-kratnik AUC ibrutiniba pri odmerjanju 560 mg dnevno (glejte poglavje 4.6).
In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the CYP3A4 inhibitor erythromycin increased Cmax by 3.4-fold and AUC by 3.0-fold.
Pri bolnikih z malignomi celic B, ki jemljejo zdravilo IMBRUVICA s hrano, je sočasno jemanje eritromicina, zaviralca CYP3A4, povečalo Cmax za 3,4-krat in AUC za 3,0-krat.
Urticaria Erythema Onychoclasis
Okvara ledvic
Patients should be closely monitored for signs of IMBRUVICA toxicity if a CYP3A4 inhibitor must be used (see sections 4.2 and 4.5).
Bolnike, ki morajo jemati zaviralce CYP3A4, je treba skrbno spremljati glede znakov toksičnega delovanja zdravila IMBRUVICA (glejte poglavji 4.2 in 4.5).
Consider temporarily withholding IMBRUVICA.
V takem primeru je treba razmisliti o začasni prekinitvi jemanja zdravila IMBRUVICA.
30 film-coated tablets
10 filmsko obloženih tablet
The recommended dose of IMBRUVICA is 560 mg once a day.
Priporočeni odmerek zdravila IMBRUVICA je 560 mg enkrat na dan.
Upon initiation of treatment, a reversible increase in lymphocyte counts (i.e., ≥50% increase from baseline and an absolute count >5,000/mcL), often associated with reduction of lymphadenopathy, has been observed in about three fourths of patients with CLL treated with IMBRUVICA.
Pri približno treh četrtinah bolnikov s kronično limfocitno levkemijo, ki so prejemali zdravilo IMBRUVICA, so po uvedbi zdravljenja opazili reverzibilno povečanje števila limfocitov (in sicer ≥ 50-odstotno povečanje glede na izhodiščno vrednost in absolutno število limfocitov 5.000/mikroliter), kar je bilo pogosto povezano z zmanjšanjem limfadenopatije.
PR=PR+nPR.
PR=delni odgovor (PR) + nodularni delni odgovor (nPR)
Cerebrovascular accidents
Cerebrovaskularni insulti
The median OS was 67.7 months [95% CI (61.0, not estimable)] in the IMBRUVICA arm.
Mediano OS v skupini z zdravilom IMBRUVICA je bilo 67,7 mesecev [95-odstotni IZ (61,0; ocena ni mogoča)].
Among previously treated patients, the median number of prior treatments was 2 (range, 1 to 6 treatments).
Pri predhodno zdravljenih bolnikih je bilo mediano število predhodnih terapij 2 (od 1 do 6 terapij).
How IMBRUVICA works
Kako zdravilo IMBRUVICA deluje
• Swallow the capsules whole.
Kapsule je treba pogoltniti cele z vodo.
The tablets should be swallowed whole with water and should not be broken or chewed.
Tableto pogoltnite celo, ne smete je drobiti ali žvečiti.
Each hard capsule contains 140 mg of ibrutinib.
Ena trda kapsula vsebuje 140 mg ibrutiniba.
If a moderate CYP3A4 inhibitor (e.g., fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone and dronedarone) is indicated, reduce IMBRUVICA dose to 280 mg for the duration of the inhibitor use.
Če mora bolnik uporabljati katerega od zmernih zaviralcev CYP3A4 (na primer flukonazol, eritromicin, amprenavir, aprepitant, atazanavir, ciprofloksacin, krizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amjodaron in dronedaron), je med uporabo zaviralca indicirano odmerek zdravila IMBRUVICA zmanjšati na 280 mg (dve kapsuli).
The median investigator-assessed PFS according to IWCLL criteria was 44.1 months [95% CI (38.47, 56.18)] in the IMBRUVICA arm and 8.1 months [95% CI (7.79, 8.25)] in the ofatumumab arm, respectively; HR=0.15 [95% CI (0.11, 0.20)].
Mediana vrednost PFS po oceni raziskovalca po kriterijih IWCLL je bila 44,1 meseca [95-odstotni IZ (38,47; 56,18)] v skupini z zdravilom IMBRUVICA in 8,1 meseca [95-odstotni IZ (7,79; 8,25)] v skupini z ofatumumabom; razmerje ogroženosti (HR) = 0,15 [95-odstotni IZ (0,11; 0,20)].
Table 5: Efficacy results in Study PCYC-1130-CA
Preglednica 5: Rezultati učinkovitosti v študiji PCYC-1130-CA
Urinary tract infection Sinusitis
pogosti sepsa* okužba sečil sinusitis*
Dizziness Uncommon Cerebrovascular accident a, #
, a omotičnost občasni cerebrovaskularni insult a, #
The safety and efficacy of IMBRUVICA in WM (IgM-excreting lymphoplasmacytic lymphoma) were evaluated in an open-label, multi-center, single-arm trial of 63 previously treated patients.
Varnost in učinkovitost zdravila IMBRUVICA pri WM (IgM-ekskretorni limfoplazmocitoidni limfom) so ocenili pri 63 že zdravljenih bolnikih v odprti, multicentrični študiji z enim krakom.
Hepatitis B virus (HBV) status should be established before initiating treatment with IMBRUVICA.
Pri bolnikih, zdravljenih z zdravilom IMBRUVICA so poročali o primerih reaktivacije virusa hepatitisa B. Pred uvedbo zdravljenja z zdravilom IMBRUVICA je treba preveriti prisotnost virusa hepatitisa B (HBV).