natgillin/translations-raw huggingface dataset:
Use of preparations containing St. John's Wort is contraindicated in patients treated with IMBRUVICA.
Uzimanje pripravaka koji sadrže gospinu travu je kontraindicirano u bolesnika koji uzimaju lijek IMBRUVICA.
• acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or naproxen
• acetilsalicilatnu kiselinu i nesteroidne protuupalne lijekove poput ibuprofena ili naproksena
Strong inhibitors of CYP3A4 (e.g., ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazodon, cobicistat, voriconazole and posaconazole) should be avoided.
Snažni inhibitori CYP3A4 (npr. ketokonazol, indinavir, nelfinavir, ritonavir, sakvinavir, klaritromicin, telitromicin, itrakonazol, nefazodon, kobicistat, vorikonazol i posakonazol) moraju se izbjegavati.
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.
Otkriveno je da ibrutinib inducira gastrointestinalne učinke (mekana stolica/proljev i/ili upala) i limfoidnu depleciju u štakora i u pasa, s razinom bez opaženih štetnih učinaka (engl.
In patients who develop atrial fibrillation on therapy with IMBRUVICA a thorough assessment of the risk for thromboembolic disease should be undertaken.
Kod bolesnika koji tijekom uzimanja lijeka IMBRUVICA razviju fibrilaciju atrija, potrebno je detaljno procijeniti rizik od tromboembolijske bolesti.
Progression free survival (PFS) was assessed by IRC according to IWCLL criteria.
Preživljenje bez progresije (PFS) procijenjeno je prema IRC-u prema IWCLL kriterijima.
IMBRUVICA+Obinutuzumab N=113
+ obinutuzumab N=113
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.
Sigurnost i djelotvornost lijeka IMBRUVICA u WM-u (limfoplazmocitoidni limfom s IgM ekskrecijom ) su procijenjene u otvorenom, multicentričnom ispitivanju s jednom skupinom od 63 prethodno liječenih bolesnika.
Consider alternative agents with less CYP3A4 induction.
Razmotrite alternativne lijekove koji su slabiji CYP3A4 induktori.
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.
Na početku, 53% bolesnika imalo je veliku tumorsku masu (≥ 5 cm), 21% imalo je skor visokog rizika prema Pojednostavljenom MIPI indeksu, 60% imalo je ekstranodalnu bolest i 54% imalo je zahvaćenost koštane srži pri probiru.
• weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral neuropathy).
• slabost, utrnulost, trnci ili bol u Vašim šakama ili stopalima ili drugim dijelovima tijela
HDPE bottles with a child-resistant polypropylene closure.
HDPE boce sa sigurnosnim čepom za djecu od polipropilena.
IMBRUVICA was administered orally at 560 mg once daily until disease progression or unacceptable toxicity.
IMBRUVICA je bila primijenjena peroralno, u dozi od 560 mg jedanput dnevno do progresije bolesti ili neprihvatljive toksičnosti.
Each carton contains (28 film-coated tablets) 2 wallets.
Svaka kutija sadrži (28 filmom obloženih tableta) 2 omota.
• medicines called calcium channel blockers for high blood pressure or chest pain - diltiazem or verapamil
• lijekove za visoki krvni tlak ili bol u prsnom košu, koji se zovu blokatori kalcijevih kanala diltiazem ili verapamil
If you are not sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.
Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek.
Hypertension has occurred in patients treated with IMBRUVICA (see section 4.8).
U bolesnika liječenih lijekom IMBRUVICA zabilježena je hipertenzija (vidjeti dio 4.8).
In pregnant rabbits, ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal malformations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased post-implantation loss.
Ibrutinib u dozi od 15 mg/kg/dan ili višoj bio je povezan s koštanim malformacijama (fuzija sternebri), a ibrutinib u dozi od 45 mg/kg/dan bio je povezan s povećanim postimplantacijskim gubitkom u skotnih kunića.
Patients were randomised 1:1 to receive either IMBRUVICA orally at 560 mg once daily for 21 days or temsirolimus intravenously at 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21-day cycle.
Bolesnici su bili randomizirani 1:1 kako bi primili ili 560 mg lijeka IMBRUVICA peroralno jedanput dnevno tijekom perioda od 21 dana ili 175 mg temsirolimusa intravenski 1., 8., 15. dan u prvom ciklusu nakon čega je slijedilo 75 mg 1., 8., 15. dan svakog sljedećeg 21-dnevnog ciklusa.
• 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).
• Drugi sastojci su: sadržaj kapsule: umrežena karmelozanatrij, magnezijev stearat, mikrokristalična celuloza i natrijev laurilsulfat (E487) ovojnica kapsule: želatina i titanijev dioksid (E171) tinta za označavanje: šelak, crni željezov oksid (E172) i propilenglikol (E1520).
How IMBRUVICA works
Kako IMBRUVICA djeluje
Not reached (1.9+, 36.4+)
Nije dostignut (1,9+; 36,4+) 24,8 (1,9; 30,3+)
Monitor patient closely for toxicity and follow dose modification guidance as needed (see sections 4.2 and 4.4).
Pažljivo pratite bolesnika na toksičnost i prema potrebi slijedite smjernice za prilagodbu doze (vidjeti dijelove 4.2 i 4.4).
HR (95% CI) Overall Response Rate CR
HR (95% CI) Ukupna stopa odgovora
Monitor patient closely for toxicity and follow dose modification guidance as needed.
Pratite bolesnika pažljivo na toksičnost i prema potrebi slijedite smjernice za prilagodbu doze.
Progression Free Survival Number of events (%) Median (95% CI), months
Preživljenje bez progresije bolesti Broj događaja (%) Medijan (95% CI), mjeseci
First restart at 560 mg daily restart at 420 mg daily
Prva započnite ponovno s 560 mg na dan započnite ponovno s 420 mg na dan
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).
Zbog toga je fetalni NOAEL bio 5 mg/kg/dan (otprilike 0,7 puta AUC ibrutiniba u dozi od 560 mg na dan) (vidjeti dio 4.6).
Cases of invasive fungal infections, including cases of Aspergillosis, Cryptococcosis and Pneumocystis jiroveci infections have been reported following the use of ibrutinib.
Nakon primjene ibrutiniba prijavljeni su slučajevi invazivnih gljivičnih infekcija, uključujući slučajeve aspergiloze, kriptokokoze i infekcija gljivicom Pneumocystis jiroveci.
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.
Omjeri hazarda za PFS u prethodno neliječenih i prethodno liječenih bolesnika te u bolesnika s mutacijama L265P u genu MYD88 i bolesnika bez navedenih mutacija odgovarali su omjeru hazarda za PFS u ITT populaciji.
Not reached HR=0.203 [95% CI: 0.150, 0.276]
Nije dostignuto HR = 0,203 [95% CI: 0,150; 0,276]
Women of child-bearing potential/Contraception in females Based on findings in animals, IMBRUVICA may cause foetal harm when administered to pregnant women.
Na temelju nalaza u životinja, IMBRUVICA može izazvati oštećenja fetusa ako se primjenjuje trudnicama.
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)].
Medijan PFS2 prema ocjeni ispitivača (vrijeme od randomizacije do PFS događaja nakon prve sljedeće terapije antineoplasticima) na temelju kriterija IWCLL-a iznosio je 65,4 mjeseca [95% CI (51,61; nije procjenjivo)] u skupini liječenoj lijekom IMBRUVICA i 38,5 mjeseci [95% CI (19,98; 47,24)] u onoj liječenoj ofatumumabom; HR=0,54 [95% CI (0,41; 0,71)].
What IMBRUVICA is
Što je IMBRUVICA
Table 3: Efficacy Results in patients with relapsed or refractory MCL (Study MCL3001) Endpoint
Tablica 3: Rezultati djelotvornosti u bolesnika s relapsnim ili refraktornim MCL-om (Ispitivanje MCL3001)
Any grade infusion-related reactions were observed in 25% of patients treated with IMBRUVICA+obinutuzumab and 58% of patients treated with chlorambucil+obinutuzumab.
Reakcije na infuziju bilo kojeg stupnja težine opažene su u 25% bolesnika liječenih lijekom IMBRUVICA u kombinaciji s obinutuzumabom te u 58% onih koji su primali klorambucil plus obinutuzumab.
IMBRUVICA Film-Coated Tablets Janssen-Cilag SpA Via C. Janssen,
IMBRUVICA filmom obložene tablete Janssen-Cilag SpA
If symptoms develop, interrupt IMBRUVICA and manage ILD appropriately.
Ukoliko se razviju simptomi, privremeno ukinite lijek IMBRUVICA iz terapije i prikladno liječite intersticijsku bolest pluća.
Progression-free survival (PFS) was assessed by IRC according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.
Preživljenje bez progresije (engl. progression free survival, PFS) bilo je procijenjeno od strane IRC-a prema revidiranim kriterijima Međunarodne radne skupine za non-Hodgkinov limfom (NHL).
There are no data from the use of IMBRUVICA in pregnant women.
Nema podataka o primjeni lijeka IMBRUVICA u trudnica.
CI=confidence interval; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response; NR=not reached
CI = interval pouzdanosti; CR = kompletni odgovor; DOR = trajanje odgovora; ORR = ukupna stopa odgovora; PR = djelomični odgovor; ND = nije dostignuto
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.
U bolesnika s malignim bolestima B-stanica koji uzimaju lijek IMBRUVICA s hranom, istodobna primjena snažnog CYP3A4 inhibitora vorikonazola povisila je Cmax za 6,7 puta i AUC za 5,7 puta.
The Kaplan-Meier landmark estimate for OS at 48-months was 85.5% in the IMBRUVICA arm.
U skupini koja je primala lijek IMBRUVICA procijenjeni OS prema Kaplan-Meieru u 48. mjesecu kao ključnoj vremenskoj točki iznosio je 85,5%.
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, otvoreno ispitivanje faze 3 (PCYC-1115-CA) s lijekom IMBRUVICA naspram klorambucila provedeno je u bolesnika u dobi od 65 godina ili starijih koji prehodno nisu bili liječeni za KLL.
The ORR and DOR were assessed using criteria adopted from the Third International Workshop of WM.
ORR i DOR (engl. duration of response, trajanje odgovora) bili su procijenjeni uz korištenje kriterija usvojenih na trećoj internacionalnoj radionici o WM (engl. the Third International Workshop of Waldenström's macroglobulinaemia).
Grade 3 or 4 infusion-related reactions were observed in 1% of patients treated with IMBRUVICA+rituximab and 16% of patients treated with placebo+rituximab.
Reakcije na infuziju 3. ili 4. stupnja težine opažene su u 1% bolesnika koji su primali lijek IMBRUVICA plus rituksimab te u 16% onih koji su primali placebo plus rituksimab.
• medicines called kinase inhibitors for treatment of other cancers - crizotinib or imatinib
• lijekove za liječenje drugih vrsta raka, koji se zovu inhibitori kinaza - krizotinib, imatinib
Tests and check-ups before and during treatment Tumour lysis syndrome (TLS): Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment.
Sindrom lize tumora: tijekom liječenja raka, a ponekad čak i bez liječenja pojavile su se neuobičajene razine kemijskih tvari u krvi uzrokovane brzim raspadom stanica raka.
Capsule content Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Sodium lauril sulfate (E487)
Sadržaj kapsule karmelozanatrij, umrežena magnezijev stearat celuloza, mikrokristalična natrijev laurilsulfat (E487)
Treatment-emergent grade 3 or 4 cytopenias (neutropenia, thrombocytopenia and anaemia) were reported in patients treated with IMBRUVICA.
Citopenije stupnja 3 ili 4 nastale tijekom liječenja (neutropenija, trombocitopenija i anemija) bile su prijavljene u bolesnika liječenih lijekom IMBRUVICA.
Number of events (%) Median (95% CI), months
Broj događaja (%) Medijan (95% CI), mjeseci
90% of radioactivity was excreted within 168 hours, with the majority (80%) excreted in the faeces and <10% accounted for in urine.
C]-ibrutiniba u zdravih ispitanika, otprilike 90% radioaktivnosti izlučilo se unutar 168 sati, većim dijelom (80%) izlučilo se fecesom, a < 10% mokraćom.
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).
Preporučena doza za liječenje kronične limfocitne leukemije, bilo u monoterapiji ili u kombinaciji, je 420 mg jedanput na dan (za detalje kombiniranog režima liječenja, vidjeti dio 5.1).
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).
Preporučena doza za liječenje kronične limfocitne leukemije, bilo u monoterapiji ili u kombinaciji, je 420 mg (tri kapsule) jedanput na dan (za detalje kombiniranog režima liječenja, vidjeti dio 5.1).
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).
Nisu zabilježeni učinci na plodnost ili reproduktivne kapacitete u mužjaka ili ženki štakora do maksimalne ispitane doze, 100 mg/kg/dan (HED 16 mg/kg/dan).
Non-melanoma skin cancer Basal cell carcinoma Squamous cell carcinoma
Nemelanomski rak kože* Karcinom bazalnih stanica Karcinom skvamoznih stanica
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.
Reakcije na infuziju 3. i višeg stupnja težine ili ozbiljne reakcije na infuziju opažene su u 3% bolesnika liječenih lijekom IMBRUVICA u kombinaciji s obinutuzumabom te u 9% onih koji su primali klorambucil plus obinutuzumab.
Atrial fibrillation Uncommon Ventricular tachyarrhythmia
Atrijska fibrilacija Manje često Ventrikularna tahiaritmija*
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.
Medijan vremena od dijagnoze bio je 42 mjeseca, a medijan broja prethodnih liječenja bio je 3 (raspon: 1 do 5 liječenja), uključujući 35% s prethodnim liječenjem kemoterapijom visoke doze, 43% s prethodnim bortezomibom, 24% s prethodnim lenalidomidom, i 11% s prethodnom autolognom ili alogenom transplantacijom matičnih stanica.
At baseline, 65% of patients presented with CLL/SLL with high risk factors (del17p/TP53 mutation [18%], del11q [15%], or unmutated IGHV [54%]).
Na početku ispitivanja 65% bolesnika imalo je KLL/LMS s faktorima visokog rizika (delecijom 17p/mutacijom TP53 [18%], delecijom 11q [15%] ili nemutiranim IGHV-om [54%]).
Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.
U bolesnika koji imaju povećani rizik za oportunističke infekcije u obzir uzmite profilaksu sukladno standardnoj skrbi.
Second restart at 420 mg daily restart at 280 mg daily
Druga započnite ponovno s 420 mg na dan započnite ponovno s 280 mg na dan
PFS Median (95% CI), months
PFS Medijan (95% CI), mjeseci
120 hard capsules
90 tvrdih kapsula 120 tvrdih kapsula
Simulations using fasted conditions suggested that the strong CYP3A4 inhibitor clarithromycin may increase the AUC of ibrutinib by a factor of 14.
Simulacije u stanju natašte pokazale su da snažni CYP3A4 inhibitor klaritromicin može povećati AUC ibrutiniba 14 puta.
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.
Po uvođenju liječenja kod otprilike tri četvrtine bolesnika s KLL-om liječenih lijekom IMBRUVICA bio je uočen reverzibilan porast broja limfocita (tj. ≥ 50% porast u odnosu na početnu vrijednost i apsolutni broj > 5000/μl), često udružen sa smanjenjem limfadenopatije.
Black iron oxide (E172) Propylene glycol (E1520)
Tinta za označavanje šelak željezov oksid, crni (E172) propilenglikol (E1520)
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).
Posljedično NOAEL za fetus bio je 10 mg/kg/dan (otprilike 1,3 puta AUC ibrutiniba pri dozi od 560 mg na dan) (vidjeti dio 4.6).
ORR OS
OOR OS
A large increase in the number of circulating lymphocytes (e.g., >400,000/mcL) has been observed in some patients.
U nekih bolesnika je uočen veliki porast broja limfocita u cirkulaciji (tj. > 400 000/μl).
Leukostasis
Leukostaza
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.
Istodobna primjena rifampicina, snažnog induktora CYP3A4, u 18 zdravih ispitanika natašte, smanjila je izloženost ibrutinibu (Cmax za 92% i AUC za 90%).
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).
U ispitivanju faze 1 u kojem su bolesnici primili do 12,5 mg/kg/dan (1400 mg/dan) nije postignuta maksimalna podnošljiva doza.
CI=confidence interval; HR=hazard ratio; CR=complete response; PR=partial response.
CI = interval pouzdanosti; HR = omjer hazarda; CR = potpuni odgovor; PR = djelomični odgovor.
CI=confidence interval; HR=hazard ratio; CR=complete response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response IRC evaluated, median follow-up 18.4 months.
CI = interval pouzdanosti; HR = omjer hazarda; CR = potpuni odgovor; ORR = ukupna stopa odgovora; OS = ukupno preživljenje; PFS = preživljenje bez progresije; PR = djelomični odgovor procijenjeno prema IRC-u, medijan praćenja 18,4 mjeseci.
IMBRUVICA was administered orally at 420 mg once daily until disease progression or unacceptable toxicity.
Lijek IMBRUVICA je bio primjenjivan peroralno u dozi od 420 mg jedanput dnevno do progresije bolesti ili neprihvatljive toksičnosti.
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).
Ako korist nadvladava rizik, a snažni CYP3A4 inhibitor se mora uzimati, smanjite dozu lijeka IMBRUVICA na 140 mg (jedna kapsula) dok traje primjena inhibitora ili privremeno prekinite lijek IMBRUVICA (na 7 dana ili manje).
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.
Medijan vremena od dijagnoze bio je 43 mjeseca i medijan broja prethodnih liječenja bio je 2 (raspon: 1 do 9 liječenja), uključujući 51% s prethodnom kemoterapijom u visokoj dozi, 18% s prethodnim liječenjem bortezomibom, 5% s prethodnim liječenjem lenalidomidom i 24% s prethodnom transplantacijom matičnih stanica.
The recommended dose of IMBRUVICA is 560 mg once a day.
Preporučena doza lijeka IMBRUVICA je 560 mg jedanput na dan.
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).
Ako korist nadvladava rizik, a snažni CYP3A4 inhibitor se mora uzimati, smanjite dozu lijeka IMBRUVICA na 140 mg dok traje primjena inhibitora ili privremeno prekinite lijek IMBRUVICA (na 7 dana ili manje).
HR (95% CI) ORR
HR (95% CI) OOR
The investigator-assessed ORR was 91.2% in the IMBRUVICA arm versus 36.8% in the chlorambucil arm.
Ukupna stopa odgovora prema ocjeni ispitivača iznosila je 91,2% u skupini koja je primala lijek IMBRUVICA te 36,8% u onoj liječenoj klorambucilom.
The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.
Preporučena doza lijeka IMBRUVICA je četiri kapsule (560 mg) jedanput na dan.
Among previously treated patients, the median number of prior treatments was 2 (range, 1 to 6 treatments).
Među prethodno liječenim bolesnicima medijan broja prethodnih terapija iznosio je 2 (raspon: 1 do 6 terapija).
Tumor flare in the form of IgM increase occurred in 8.0% of subjects in the IMBRUVICA+rituximab arm and 46.7% of subjects in the placebo+rituximab arm.
IgM javilo se u 8,0% ispitanika koji su primali lijek IMBRUVICA plus rituksimab te u 46,7% onih koji su primali placebo plus rituksimab.
IMBRUVICA should not be used in children and adolescents.
Djeca i adolescenti ne smiju uzimati lijek IMBRUVICA.
Ibrutinib has a pH dependent solubility, with lower solubility at higher pH. A lower Cmax was observed in fasted healthy subjects administered a single 560 mg dose of ibrutinib after taking omeprazole at 40 mg once daily for 5 days (see section 5.2).
Niži Cmax bio je zabilježen u zdravih ispitanika kojima je primijenjena jedna doza ibrutiniba od 560 mg natašte nakon uzimanja 40 mg omeprazola jedanput na dan tijekom 5 dana (vidjeti dio 5.2).
Toxicity occurrence
Pojava toksičnosti
These may be signs and symptoms of stroke.
To mogu biti znaci i simptomi moždanog udara.
• Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called lymphocytes that also involves the lymph nodes.
• kronična lifmocitna leukemija, vrsta raka koja zahvaća bijele krvne stanice koje se zovu limfociti, a zahvaća i limfne čvorove.
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.
Ako je indiciran umjereni CYP3A4 inhibitor (npr. flukonazol, eritromicin, amprenavir, aprepitant, atazanavir, ciprofloksacin, krizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodaron i dronedaron), smanjite dozu lijeka IMBRUVICA na 280 mg dok traje primjena inhibitora.
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.
U bolesnika s malignim bolestima B-stanica koji uzimaju lijek IMBRUVICA s hranom, istodobna primjena CYP3A4 inhibitora eritromicina povisila je Cmax za 3,4 puta i AUC za 3,0 puta.
Very common Pneumonia Upper respiratory tract infection
Vrlo često Pneumonija* Infekcija gornjeg dišnog sustava
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.
Istodobna primjena soka od grejpfruta, koji sadrži CYP3A4 inhibitore, u osam zdravih ispitanika povisila je izloženost ibrutinibu (Cmax za oko 4 i AUC za oko 2 puta).
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Ako se bilo što od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek.