natgillin/translations-raw huggingface dataset:
The treatment effect of ibrutinib in Study PCYC-1115-CA was consistent across high-risk patients with del17p/TP53 mutation, del11q, and/or unmutated IGHV.
Učinek zdravljenja z ibrutinibom je bil v študiji PCYC-1115-CA enoten pri vseh bolnikih s povečanim tveganjem z delecijo 17p/mutacijo TP53, delecijo 11q in/ali z nemutiranim genom za IGHV.
• fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath - these could be signs of an infection (viral, bacterial or fungal).
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - zvišana telesna temperatura, mrazenje, bolečine po telesu, občutek utrujenosti, simptomi prehlada ali gripe, zadihanost - to so lahko znaki okužbe (virusne, bakterijske ali glivične).
At baseline, 45% had advanced clinical stage (Rai Stage III or IV), 35% of patients had at least one tumor ≥5 cm, 39% with baseline anemia, 23% with baseline thrombocytopenia, 65% had elevated β2 microglobulin >3500 mcg/L, 47% had a CrCL <60 mL/min, 20% of patients presented with del11q, 6% of patients presented with del17p/tumor protein 53 (TP53) mutation, and 44% of patients presented with unmutated immunoglobulin heavy chain variable region (IGHV).
Ob izhodišču je imelo 45% bolnikov napredovali klinični stadij (stadij II ali IV po Rai-u), 35% bolnikov je imelo vsaj en tumor ≥ 5 cm, 39% bolnikov anemijo, 23% bolnikov trombocitopenijo, 65% bolnikov zvišan β2 mikroglobulin > 3500 mcg/l, 47% bolnikov CrCL < 60 ml/min, 20% bolnikov delecijo 11q, 6% bolnikov je imelo delecijo 17p oziroma mutacijo gena za tumorski protein 53 (TP53) in 44% bolnikov je imelo nemutiran gen za variabilni del težke verige imunoglobulina (IGHV - immunoglobulin heavy chain variable region).
Non-melanoma skin cancer Basal cell carcinoma Squamous cell carcinoma
pogosti nemelanomski kožni raki* bazalnocelični karcinom skvamozni karcinom
The dihydrodiol metabolite is at most a weak inducer of CYP450 isoenzymes in vitro.
Dihidrodiolni presnovek ibrutiniba je in vitro zelo šibek induktor izoencimov CYP450.
Each carton contains (28 film-coated tablets) 2 wallets.
Ena škatla vsebuje 2 zgibanki (28 filmsko obloženih tablet).
At baseline, 52% had advanced clinical stage (Rai Stage III or IV), 32% of patients had bulky disease (≥5 cm), 44% with baseline anemia, 22% with baseline thrombocytopenia, 28% had a CrCL <60 mL/min, and the median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 4 (range, 0 to 12).
Ob izhodišču jih je imelo 52% napredovali klinični stadij (stadij Rai III ali IV), 32% bolnikov je imelo bolezen z veliko tumorsko maso (bulky disease) (≥5 cm), 44% jih je imelo izhodiščno anemijo, 22% izhodiščno trombocitopenijo, 28% jih je imelo očistek kreatinina <60 ml/min, mediana kumulativna ocena bolezni za geriatrične bolnike (CIRS-G-Median Cumulative Illness Rating Score for Geriatrics) pa je bila 4 (od 0 do 12).
• Take the capsules orally (by mouth) with a glass of water.
Jemanje tega zdravila - Kapsule zaužijte peroralno s kozarcem vode.
The median investigator-assessed PFS was not reached in the IMBRUVICA arm and was 15 months [95% CI (10.22, 19.35)] in the chlorambucil arm; (HR=0.14 [95% CI (0.09, 0.21)]).
V skupini z zdravilom IMBRUVICA mediana vrednost PFS po oceni raziskovalca ni bila dosežena, v skupini s klorambucilom pa je bila 15 mesecev [95-odstotni IZ (10,22; 19,35)]; (razmerje ogroženosti (HR) = 0,14 [95-odstotni IZ (0,09; 0,21)]).
Therefore, concomitant use of IMBRUVICA with strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers should be avoided whenever possible and co-administration should only be considered when the potential benefits clearly outweigh the potential risks.
Zato se je treba sočasni uporabi zdravila IMBRUVICA z močnimi zaviralci CYP3A4 in močnimi ali zmernimi induktorji CYP3A4 izogibati kadar koli je to mogoče.
Discontinuation and dose reduction due to adverse reactions Of the 1200 patients treated with IMBRUVICA for B-cell malignancies, 5% discontinued treatment primarily due to adverse reactions.
Prekinitev zdravljenja in zmanjšanje odmerka zaradi neželenih učinkov zdravila Med 1.200 bolniki, pri katerih so malignome celic B zdravili z zdravilom IMBRUVICA, jih je 5% prekinilo zdravljenje zaradi neželenih učinkov (vključno s pljučnico, atrijsko fibrilacijo, krvavitvijo in trombocitopenijo).
IMBRUVICA was administered orally at 420 mg once daily until disease progression or unacceptable toxicity.
Bolniki so prejemali 420 mg zdravila IMBRUVICA peroralno enkrat na dan do napredovanja bolezni ali do nesprejemljive toksičnosti.
Women should avoid becoming pregnant while taking IMBRUVICA and for up to 3 months after ending treatment.
Ženske morajo v času jemanja zdravila IMBRUVICA in še 3 mesece po zaključku zdravljenja paziti, da ne zanosijo.
The recommended dose for the treatment of MCL is 560 mg once daily.
MCL Priporočeni odmerek za zdravljenje MCL je 560 mg enkrat na dan.
Patients (n=269) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or chlorambucil at a starting dose of 0.5 mg/kg on days 1 and 15 of each 28-day cycle for a maximum of 12 cycles, with an allowance for intrapatient dose increases up to 0.8 mg/kg based on tolerability.
Bolniki (n = 269) so bili randomizirani 1:1 na zdravilo IMBRUVICA v odmerku 420 mg/dan do napredovanja bolezni ali do nesprejemljivega toksičnega delovanja zdravila, ali na klorambucil v začetnem odmerku 0,5 mg/kg, na 1. in 15. dan vsakega 28-dnevnega kroga zdravljenja, za največ 12 krogov, z možnostjo povečanja odmerka na 0,8 mg/kg, odvisno od bolnikovega prenašanja zdravila.
The updated Kaplan-Meier curve for PFS is shown in Figure 7.
Dopolnjena Kaplan-Meierjeva krivulja PFS je prikazana na Sliki 7.
The median investigator-assessed PFS2 (time from randomisation until PFS event after first subsequent anti-neoplastic therapy) according to IWCLL criteria was 65.4 months [95% CI (51.61, not estimable)] in the IMBRUVICA arm and 38.5 months [95% CI (19.98, 47.24)] in the ofatumumab arm, respectively; HR=0.54 [95% CI (0.41, 0.71)].
Mediana PFS2 po oceni raziskovalca (čas od randomizacije do dogodka PFS po prvem nadaljnem anti-neoplastičnem zdravljenju) po kriterijih IWCLL je bila 65,4 meseca [95-odstotni IZ (51,61; ocena ni mogoča)] v skupini z zdravilom IMBRUVICA in 38,5 meseca [95-odstotni IZ (19,98; 47,24)] v skupini z ofatumumabom; razmerje ogroženosti (HR) = 0,54 [95-odstotni IZ (0,41; 0,71)].
Each carton contains (30 film-coated tablets) 3 wallets.
Ena škatla vsebuje 3 zgibanke (30 filmsko obloženih tablet).
There have been reports of bleeding events in patients treated with IMBRUVICA, both with and without thrombocytopenia.
Pri bolnikih, ki so jemali zdravilo IMBRUVICA, so poročali o krvavitvah s trombocitopenijo ali brez nje.
Table 7: Efficacy results in patients with CLL (Study PCYC-1112-CA) Endpoint
Preglednica 7: Rezultati učinkovitosti pri bolnikih s KLL (študija PCYC-1112-CA) Cilj opazovanja
IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Zdravilo IMBRUVICA je kot samostojno zdravilo indicirano za zdravljenje odraslih bolnikov s ponovitvijo limfoma plaščnih celic (MCL - mantle cell lymphoma) ali z na zdravljenje neodzivno obliko te bolezni.
The median time since diagnosis was 91 months and the median number of prior treatments was 2 (range: 1 to 13 treatments).
Mediana časa od postavitve diagnoze je bila 91 mesecev, mediano število predhodnih terapij je bilo 2 (od 1 do 13 terapij).
Not known Not known
,a neznana pogostnost
The median time since diagnosis was 74 months, and the median number of prior treatments was 2 (range: 1 to 11 treatments).
Mediana časa od postavitve diagnoze je bila 74 mesecev, mediano število predhodnih terapij pa je bilo 2 (od 1 do 11 terapij).
There was a statistically significant sustained platelet or haemoglobin improvement in the ITT population in favor of ibrutinib versus chlorambucil.
Pri ITT populaciji bolnikov je v prid ibrutinibu v primerjavi s klorambicilom prišlo do statistično značilnega dolgotrajnega izboljšanja v številu trombocitov ali koncentraciji hemoglobina.
At baseline, 53% of patients had bulky disease (≥5 cm), 21% had high-risk score by Simplified MIPI, 60% had extranodal disease and 54% had bone marrow involvement at screening.
Ob izhodišču na izbirnem (angl. screening) obisku je imelo 53% bolnikov bolezen z veliko tumorsko maso (≥ 5 cm), 21% jih je imelo ocenjeno visoko tveganje s poenostavljenim mednarodnim prognostičnim indeksom MIPI, pri 60% bolnikov se je bolezen razširila izven bezgavk in 54% bolnikov je zajela kostni mozeg.
Purple oblong tablets (15 mm in length and 7 mm in width), debossed with “ibr” on one side and “280” on the other side.
Vijolične, podolgovate tablete (15 mm dolge in 7 mm široke) z vtisnjeno oznako “ibr” na eni in "280" na drugi strani.
p<0.005 for OS
ofatumumab p<0,0001
Women of child-bearing potential/Contraception in females Based on findings in animals, IMBRUVICA may cause foetal harm when administered to pregnant women.
Glede na ugotovitve pri živalih bi zdravilo IMBRUVICA pri uporabi med nosečnostjo lahko imelo škodljiv učinek na plod.
Patients (n=229) were randomized 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity or chlorambucil at a dose of 0.5 mg/kg on Days 1 and 15 of each 28-day cycle for 6 cycles.
Bolniki (n=229) so bili v razmerju 1:1 randomizirani na prejemanje bodisi zdravila IMBRUVICA 420 mg na dan do napredovanja bolezni ali do nesprejemljive toksičnosti ali na prejemanje klorambucila v odmerku 0,5 mg/kg na 1. in 15. dan 28-dnevnega kroga zdravljenja, 6 krogov zdravljenja.
In patients who develop signs and/or symptoms of ventricular tachyarrhythmia, IMBRUVICA should be temporarily discontinued and a thorough clinical benefit/risk assessment should be performed before possibly restarting therapy.
Pri bolnikih, pri katerih so se pojavili simptomi in/ali znaki ventrikularne tahiaritmije je treba zdravljenje z zdravilom IMBRUVICA začasno prekiniti.
In both arms, patients received 1000 mg of obinutuzumab on Days 1, 8 and 15 of the first cycle, followed by treatment on the first day of 5 subsequent cycles (total of 6 cycles, 28 days each).
V obeh skupinah so bolniki prejeli 1000 mg obinutuzumaba na 1., 8. in 15. dan prvega kroga zdravljenja in nato prvi dan v
HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response
HR (hazard ratio) = razmerje ogroženosti, IZ = interval zaupanja, ORR (Overall Response Rate) = celokupni delež odgovora, OS (overall survival) = celokupno preživetje, PFS (Progression Free Survival) = preživetje brez napredovanja bolezni, PR (partial response) = delni odgovor
IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets
IMBRUVICA 140 mg filmsko obložene tablete IMBRUVICA 280 mg filmsko obložene tablete IMBRUVICA 420 mg filmsko obložene tablete IMBRUVICA 560 mg filmsko obložene tablete
The updated Kaplan-Meier curve for PFS is shown in Figure 4.
Dopolnjena Kaplan-Meierjeva krivulja PFS je prikazana na Sliki 4.
Number of deaths (%) HR (95% CI)
HR (95% IZ) ORR (CR +PR) vrednost-p OS število smrti (%) HR (95% IZ)
Patients (n=578) were randomised 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with BR until disease progression, or unacceptable toxicity.
Bolnike (n = 578) so randomizirali 1:1 na prejemanje 420 mg zdravila IMBRUVICA na dan ali placeba v kombinaciji z BR do napredovanja bolezni ali do nesprejemljivega toksičnega delovanja zdravila.
Consider alternative agents with less CYP3A4 induction.
Razmisliti velja o uporabi drugih učinkovin, ki v manjši meri inducirajo CYP3A4.
Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone
Jedro tablete brezvodni koloidni silicijev dioksid premrežen natrijev karmelozat laktoza monohidrat magnezijev stearat mikrokristalna celuloza povidon natrijev lavrilsulfat (E487)
Patients (n=391) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or ofatumumab for up to 12 doses (300/2,000 mg).
Bolnike (n = 391) so randomizirali v razmerju 1:1 tako, da so prejemali bodisi 420 mg zdravila IMBRUVICA dnevno do napredovanja bolezni ali nesprejemljivega toksičnega delovanja zdravila, ali ofatumumab do največ 12 odmerkov (300/2000 mg).
Co-administration of grapefruit juice, containing CYP3A4 inhibitors, in eight healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by approximately 4- and 2-fold, respectively.
Pri osmih zdravih prostovoljcih je sočasno uživanje soka grenivke, ki vsebuje zaviralce CYP3A4, povečalo izpostavljenost (Cmax in AUC) ibrutinibu za približno 4-krat oziroma 2-krat.
- Keep this leaflet.
Razprite zgibanko.
Figure 4: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1115-CA with 48 Months Follow-up
Slika 4: Kaplan-Meierjeva krivulja PFS (ITT populacija) v študiji PCYC-1115-CA z 48-mesečnim spremljanjem
If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg (one capsule) for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Če mora bolnik jemati katerega od močnih zaviralcev CYP3A4, in koristi sočasne uporabe presegajo tveganja, je treba odmerek zdravila IMBRUVICA med sočasno uporabo zaviralcev zmanjšati na 140 mg (na eno kapsulo) ali pa začasno (za 7 dni ali manj) prekiniti zdravljenje z zdravilom IMBRUVICA.
The median age was 71 years (range, 40 to 87 years), 64% were male, and 96% were Caucasian.
Mediana starost bolnikov je bila 71 let (od 40 do 87 let), 64% jih je bilo moškega spola in 96% je bilo belcev.
The median age was 73 years (range, 65 to 90 years), 63% were male, and 91% were Caucasian.
Mediana starost bolnikov je bila 73 let (od 65 do 90 let), 63% jih je bilo moškega spola, 91% je bilo belcev.
The overall response rate per IRC observed in the monotherapy arm was 87% (0% CR, 29% VGPR, 42% PR, 16% MR).
Celokupni delež odgovora po oceni komisije IRC je bil v skupini z monoterapijo 87% (0% s popolnim odgovorom, 29% z zelo dobrim delnim odgovorom, 42% z delnim odgovorom in 16% z minimalnim odgovorom).
Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), debossed with “ibr” on one side and “420” on the other side.
Rumeno-zelene do zelene, podolgovate tablete (17,5 mm dolge in 7,4 mm široke) z vtisnjeno oznako “ibr” na eni in "420" na drugi strani.
IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets ibrutinib
IMBRUVICA 140 mg filmsko obložene tablete IMBRUVICA 280 mg filmsko obložene tablete IMBRUVICA 420 mg filmsko obložene tablete IMBRUVICA 560 mg filmsko obložene tablete ibrutinib
The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian.
Mediana starost bolnikov je bila 68 let (razpon, 34; 88 let), 74% jih je bilo moškega spola in 87% je bilo belcev.
Administer supportive care including hydration and/or cytoreduction as indicated.
Bolnike je treba skrbno spremljati in po potrebi uvesti podporne ukrepe vključno s hidracijo in/ali citoredukcijo.
Ninety patients randomised to placebo+BR crossed over to receive IMBRUVICA following IRC confirmed progression.
Ko je IRC potrdila napredovanje bolezni, je 90 bolnikov, ki so bili randomizirani na placebo + BR prešlo na zdravljenje z zdravilom IMBRUVICA.
Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), debossed with “ibr” on one side and “560” on the other side.
Rumene do oranžne, podolgovate tablete (19 mm dolge in 8,1 mm široke) z vtisnjeno oznako “ibr” na eni in "560" na drugi strani.
Lymphocytosis was not observed in patients with WM treated with IMBRUVICA.
Pri bolnikih z WM, zdravljenih z zdravilom IMBRUVICA, limfocitoze niso opazili.
Ibrutinib was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse at oral doses up to 2000 mg/kg/day with an exposure margin of approximately 23 (males) to 37 (females) times the human AUC of ibrutinib at a dose of 560 mg daily.
V 6-tedenski študiji pri transgenih miših (Tg.rasH2), ki so peroralno prejemale ibrutinib v odmerku do 2000 mg/kg/dan in meji izpostavljenosti, ki je bila 23-kratnik (samci) do 27-kratnik (samice) vrednosti AUC ibrutiniba pri ljudeh, ki so prejemali dnevni odmerek 560 mg, ibrutinib ni bil karcinogen.
If the toxicity reoccurs, the once daily dose should be reduced by 140 mg. A second reduction of dose by 140 mg may be considered as needed.
Če se znaki toksičnega učinkovanja ponovijo, je treba dnevni odmerek zmanjšati za 140 mg.
The safety and efficacy of IMBRUVICA in patients previously treated for CLL were further evaluated in a randomised, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with BR versus placebo+BR (Study CLL3001).
Varnost in učinkovitost zdravila IMBRUVICA pri bolnikih, predhodno zdravljenih za KLL so ocenjevali tudi v randomizirani, multicentrični, dvojno slepi študiji faze 3, kjer so primerjali zdravilo IMBRUVICA v kombinaciji z BR in kombinacijo placebo + BR (študija CLL3001).
In vitro platelet aggregation
Agregacija trombocitov in vitro
HDPE bottles with a child-resistant polypropylene closure.
Plastenka iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko.
Ninety-three percent of patients had a baseline ECOG performance status of 0 or 1, and 7% of patients had a baseline ECOG performance status of 2.
Triindevetdeset odstotkov bolnikov je imelo izhodiščno oceno splošne zmogljivosti po lestvici ECOG 0 ali 1, 7% bolnikov pa je imelo izhodiščno oceno po lestvici ECOG 2.
The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian.
Njihova mediana starost je bila 68 let (od 40 do 84 let), 77% jih je bilo moškega spola in 92% je bilo belcev.
Number of events (%) Median (95% CI), months
PFS število dogodkov (%) mediana (95% IZ), meseci ni dosežena
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
Pri bolnikih z blago okvaro jeter (razreda A po Child-Pughu) je priporočeni odmerek 280 mg na dan.
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules).
Pri bolnikih z blago okvaro jeter (razreda A po Child-Pughu) je priporočeni odmerek 280 mg (dve kapsuli) na dan.
Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Preglednica 11: Rezultati učinkovitosti v študiji PCYC-1127-CA
At baseline, the median serum IgM value was 3.2 g/dL (range, 0.6 to 8.3 g/dL), 63% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L) and MYD88 L265P mutations were present in 77% of patients, absent in 13% of patients, and 9% of patients were not evaluable for mutation status.
(hemoglobin ≤11 g/dl ali 6,8 mmol/l), mutacije MYD88 L265P pa so bile prisotne pri 77% bolnikov in odsotne pri 13% bolnikov, medtem ko pri 9% bolnikih mutacijskega statusa ni bila mogoče oceniti.
IMBRUVICA contains sodium
Zdravilo IMBRUVICA vsebuje natrij
CI=confidence interval; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response; NR=not reached
IZ = interval zaupanja, CR (complete response) = popolni odgovor, DOR (duration of response) = trajanje odgovora, ND = ni dosežen
Not reached HR=0.203 [95% CI: 0.150, 0.276]
PFS mediana (95% IZ), meseci ni dosežena HR = 0,203 [95% IZ: 0,150; 0,276]
If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Če mora bolnik jemati katerega od močnih zaviralcev CYP3A4, in koristi sočasne uporabe presegajo tveganja, je treba odmerek zdravila IMBRUVICA med sočasno uporabo zaviralcev zmanjšati na 140 mg ali pa začasno (za 7 dni ali manj) prekiniti zdravljenje z zdravilom IMBRUVICA.
• Do not breast-feed while you are taking this medicine.
- V času jemanja tega zdravila ne smete dojiti.
Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001
Slika 1: Kaplan-Meierjeva krivulja PFS (populacija z namenom zdravljenja; (ITT-Intention To Treat Population) v študiji MCL3001
IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
IMBRUVICA 140 mg filmsko obložene tablete: Ena tableta vsebuje 140 mg ibrutiniba.
• If you miss a dose, it can be taken as soon as possible on the same day with a return to the normal schedule the following day.
Če ste pozabili vzeti zdravilo IMBRUVICA - Če ste pozabili vzeti odmerek, ga lahko vzamete čimprej istega dne, naslednjega dne pa spet začnete z odmerjanjem po običajnem razporedu.
Patients (n=150) were randomized 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with rituximab until disease progression or unacceptable toxicity.
Bolniki (n=150) so bili v razmerju 1:1 randomizirani na prejemanje bodisi zdravila IMBRUVICA 420 mg na dan ali placeba v kombinaciji z rituksimabom do napredovanja bolezni ali do nesprejemljivega toksičnega delovanja zdravil.
VGPR (%)
PFS (%)
• Tell your doctor immediately if you become pregnant.
- Če zanosite, takoj obvestite zdravnika.
The response rate per IRC observed in the monotherapy arm was 71% (0% CR, 29% VGPR, 42% PR).
Po oceni komisije IRC je bil delež odgovora v skupini z monoterapijo 71% (0% s popolnim odgovorom, 29% z zelo dobrim delnim odgovorom in 42% z delnim odgovorom).
The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian.
Mediana starost bolnikov je bila 64 let (od 31 do 86 let), 66% jih je bilo moškega spola in 91% je bilo belcev.
The median time since diagnosis was 6 years and the median number of prior treatments was 2 (range, 1 to 11 treatments).
Mediana časa od postavitve diagnoze je bila 6 let, mediano število predhodnih terapij je bilo 2 (od 1 do 11 terapij).
Patients with mild or moderate renal impairment were treated in IMBRUVICA clinical studies.
Pri bolnikih z okvaro ledvic niso izvajali posebnih študij, so pa bolnike z blago oziroma zmerno okvaro ledvic zdravili v okviru kliničnih študij zdravila IMBRUVICA.
• Take the tablets orally (by mouth) with a glass of water.
Jemanje tega zdravila - Tablete zaužijte peroralno s kozarcem vode.
HOW TO TAKE IMBRUVICA
Kako jemati zdravilo IMBRUVICA
How to take IMBRUVICA
KAKO JEMATI ZDRAVILO IMBRUVICA
All subjects
vsi preiskovanci
Do not open, break or chew them.
Kapsul se ne sme odpirati, drobiti ali žvečiti.
The safety and efficacy of IMBRUVICA in patients with treatment naïve CLL/SLL were further evaluated in a randomized, multi-center, open-label, Phase 3 study (PCYC-1130-CA) of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab.
Varnost in učinkovitost zdravila IMBRUVICA pri bolnikih s KLL/SLL brez predhodnega zdravljenja so ocenjevali tudi v randomizirani, multicentrični, odprti študiji faze 3 (študiji PCYC-1130-CA) z zdravilom IMBRUVICA v kombinaciji z obinutuzumabom v primerjavi s klorambucilom v kombinaciji z obinutuzumabom.
IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib.
IMBRUVICA 560 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 560 mg ibrutiniba.
Ibrutinib did not show meaningful inhibition of platelet aggregation using other agonists of platelet aggregation.
Pri sočasni uporabi ibrutiniba z drugimi agonisti agregacije trombocitov ibrutinib ni pomembno zaviral agregacije trombocitov.
Eighty-one percent of patients had a baseline ECOG performance status of 0 or 1, and 19% had a baseline ECOG performance status of 2.
Enainosemdeset odstotkov bolnikov je imelo izhodiščno oceno splošne zmogljivosti po lestvici ECOG 0 ali 1, 19% bolnikov pa je imelo izhodiščno oceno po lestvici ECOG 2.
Your doctor will check your blood counts before or during the treatment and in rare cases they may need to give you another medicine.
Zdravnik bo pregledoval vašo krvno sliko pred zdravljenjem ali med njim.
Strong CYP3A4 inhibitors
Močni zaviralci CYP3A4