FrancophonIA/ELRC3.0 huggingface dataset:
English: Postponing vaccination with live vaccines should be considered for infants born to mothers who have been exposed to Gazyvaro during pregnancy until the infant's B-cell levels are within normal ranges (see section 4.4).
Croatian: Potrebno je razmotriti odgodu cijepljenja u dojenčadi čije su majke bile izložene lijeku Gazyvaro tijekom trudnoće dok se broj B stanica u dojenčeta ne vrati unutar raspona normalnih vrijednosti (vidjeti dio 4.4).
English: The most common Grade 3-5 adverse reactions were neutropenia (10%), and anaemia, febrile neutropenia, thrombocytopenia, sepsis, upper respiratory tract infection, and urinary tract infection (all at 1%).
Croatian: Najčešće nuspojave 3. - 5. stupnja bile su neutropenija (10%) i anemija, febrilna neutropenija, trombocitopenija, sepsa, infekcija gornjih dišnih putova i infekcija mokraćnog sustava (svaka po 1%).
English: Gazyvaro + Bendamustine followed by Gazyvaro maintenance N=155
Croatian: Gazyvaro + bendamustin nakon čega slijedi terapija održavanja lijekom Gazyvaro N= 155
English: Upon resolution of symptoms, the infusion can be restarted at no more than half the previous rate (the rate being used at the time that the IRR occurred) and, if the patient does not experience any IRR symptoms, the infusion rate escalation can resume at the increments and intervals as appropriate for the treatment dose (see Tables 4 and 5).
Croatian: Nakon povlačenja simptoma, infuziju je moguće ponovno započeti brzinom koja ne smije biti veća od polovice prethodne brzine (brzine primjene u trenutku razvoja reakcije na infuziju), a ako se u bolesnika ne pojave simptomi reakcije na infuziju, njezinu brzinu je moguće nastaviti postupno povećavati u intervalima koji odgovaraju dozi (vidjeti Tablice 4 i 5).
English: · Keep the container in the outer carton in order to protect from light.
Croatian: · Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Follicular versus non-follicular was also a stratification factor for the study but is not applicable in the subgroup analysis of patients with FL. § Best response within 12 months of start of treatment
Croatian: Folikularni versus nefolikularni limfom također je bio stratifikacijski čimbenik u ispitivanju, ali taj čimbenik nije primjenjiv na analizu podskupine bolesnika s FL-om.
English: In patients receiving Gazyvaro plus chemotherapy, the incidence of IRRs was highest on Day 1 and gradually decreased with subsequent infusions.
Croatian: Incidencija reakcija na infuziju u bolesnika koji su primali Gazyvaro plus kemoterapiju bila je najveća 1. dan te se postupno smanjivala sa sljedećim infuzijama.
English: However, once the majority of CD20 cells are bound with obinutuzumab, the impact of TMDD on PK is minimised.
Croatian: Međutim, nakon što se većina CD20 stanica veže za obinutuzumab,
English: The rates of Grade 3-4 IRRs (which were based on a relatively small number of patients) were similar before and after mitigation measures were implemented.
Croatian: Stope reakcija na infuziju 3. i 4. stupnja (procijenjene na relativno malom broju bolesnika) bile su slične prije i nakon uvođenja mjera za njihovo ublažavanje.
English: Grade 3-4 IRRs occurred in 12% of patients.
Croatian: Reakcije na infuziju 3. - 4. stupnja nastupile su u 12% bolesnika.
English: If you had recurring or chronic infections before the start of Gazyvaro treatment, tell your doctor about it.
Croatian: Ako ste prije početka liječenja lijekom Gazyvaro imali dugotrajne infekcije ili infekcije koje su se neprestano vraćale, obavijestite o tome svog liječnika.
English: For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.
Croatian: Za liječenje sindroma lize tumora potrebno je, sukladno kliničkoj indikaciji, korigirati poremećene vrijednosti elektrolita, nadzirati bubrežnu funkciju i ravnotežu tekućina te uvesti potporno liječenje, uključujući dijalizu.
English: In total, six cycles of Gazyvaro (every 28 days) were given in combination with six cycles of bendamustine, and a total of eight cycles of Gazyvaro (every 21 days) were given in combination with six cycles of CHOP or eight cycles of CVP.
Croatian: Ukupno je primijenjeno šest ciklusa lijeka Gazyvaro (svakih 28 dana) u kombinaciji sa šest ciklusa bendamustina, odnosno ukupno osam ciklusa lijeka Gazyvaro (svakih 21 dan) u kombinaciji sa šest ciklusa protokola CHOP ili osam ciklusa protokola CVP.
English: Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).
Croatian: Kronična limfocitna leukemija (KLL) Gazyvaro je u kombinaciji s klorambucilom indiciran za liječenje odraslih bolesnika s prethodno neliječenim KLL-om i komorbiditetima, zbog kojih u njih nije prikladna terapija temeljena na punoj dozi fludarabina (vidjeti dio 5.1).
English: · Six 21-day cycles in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP), followed by 2 additional cycles of Gazyvaro alone or · Eight 21-day cycles in combination with cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone (CVP).
Croatian: · šest 21-dnevnih ciklusa u kombinaciji s ciklofosfamidom, doksorubicinom, vinkristinom i prednizolonom (protokol CHOP), nakon čega slijede 2 dodatna ciklusa monoterapije lijekom Gazyvaro ili · osam 21-dnevnih ciklusa u kombinaciji s ciklofosfamidom, vinkristinom i prednizonom/prednizolonom/metilprednizolonom (protokol CVP)
English: Respiratory symptoms such as bronchospasm, larynx and throat irritation, wheezing, laryngeal oedema and cardiac symptoms such as atrial fibrillation have also been reported (see section 4.4).
Croatian: Također su prijavljeni respiratorni simptomi, poput bronhospazma, nadraženosti grkljana i grla, piskanja pri disanju, edema grkljana, te srčani simptomi, poput fibrilacije atrija (vidjeti dio 4.4).
English: The median comorbidity score was 8 and 76% of the patients enrolled had a comorbidity score above 6.
Croatian: Medijan rezultata bodovanja komorbiditeta iznosio je 8, a 76% bolesnika uključenih u ispitivanje imalo je rezultat bodovanja komorbiditeta veći od 6. Medijan procijenjenog CrCl iznosio je 62 ml/min,
English: · PML is a very rare and life-threatening brain infection that has been reported in very few patients having treatment with Gazyvaro.
Croatian: · PML je vrlo rijetka i po život opasna infekcija mozga prijavljena kod primjene lijeka Gazyvaro.
English: Chronic lymphocytic leukaemia (CLL, in combination with chlorambucil1)
Croatian: Kronična limfocitna leukemija (KLL, u kombinaciji s klorambucilom1)
English: The rates of Grade 3-4 IRRs (which occurred in relatively few patients) were similar before and after mitigation measures were implemented.
Croatian: Stope reakcija na infuziju 3. - 4. stupnja (koje su nastupile u razmjerno malog broja bolesnika) bile su slične i prije i nakon provedbe profilaktičkih mjera.
English: Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRs in patients with CLL and FL (see section 4.4)
Croatian: Tablica 1 Premedikacija koju je potrebno primijeniti prije infuzije lijeka Gazyvaro radi smanjenja rizika od reakcija na infuziju u bolesnika s KLL-om i FL-om (vidjeti dio 4.4)
English: The population pharmacokinetic analysis of obinutuzumab showed that creatinine clearance does not affect pharmacokinetics of obinutuzumab.
Croatian: Oštećenje funkcije bubrega Populacijska farmakokinetička analiza obinutuzumaba pokazala je da klirens kreatinina ne utječe na farmakokinetiku obinutuzumaba.
English: Chlorambucil was given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles (1 to 6).
Croatian: Klorambucil je primjenjivan peroralno u dozi od 0,5 mg/kg tjelesne težine 1. dan i 15. dan u svakom ciklusu liječenja (1.-6. ciklusa).
English: Injury, poisoning and procedural complications Very common
Croatian: Ozljede, trovanja i proceduralne komplikacije vrlo često reakcije na infuziju reakcije na infuziju
English: No incompatibilities have been observed between Gazyvaro, in concentration ranges from 0.4 mg/mL to 20.0 mg/mL after dilution of Gazyvaro with sodium chloride 9 mg/mL (0.9%) solution for injection, and: · PVC, polyethylene (PE), polypropylene or polyolefin bags · PVC, polyurethane (PUR) or PE infusion sets · optional inline filters with product contact surfaces of polyethersulfone (PES), a 3-way stopcock infusion aid made from polycarbonate (PC), and catheters made from polyetherurethane (PEU).
Croatian: Nisu primijećene inkompatibilnosti između lijeka Gazyvaro u koncentracijama u rasponu od 0,4 mg/ml do 20,0 mg/ml nakon razrjeđivanja otopinom za injekciju 9 mg/ml (0,9%) natrijevog klorida i: · vrećica načinjenih od PVC-a, polietilena (PE), polipropilena ili poliolefina · infuzijskih setova načinjenih od PVC-a, poliuretana (PUR) ili polietilena (PE)
English: No Grade 5 events of thrombocytopenia were reported.
Croatian: Nisu zabilježeni slučajevi trombocitopenije 5. stupnja.
English: · infection of upper airways (infection of nose, pharynx, larynx and sinuses), cough
Croatian: · infekcija gornjih dišnih putova (infekcija nosa, ždrijela, grkljana i sinusa), kašalj
English: Atrial fibrillation, cardiac failure Atrial fibrillation, cardiac failure,
Croatian: Srčani poremećaji često fibrilacija atrija, zatajenje srca fibrilacija atrija, zatajenje srca
English: Gazyvaro + chlorambucil N= 238
Croatian: Gazyvaro + klorambucil N=238
English: The incidence of neutropenia was higher in the Gazyvaro plus chlorambucil arm (41%) compared to the rituximab plus chlorambucil arm with the neutropenia resolving spontaneously or with use of granulocyte-colony stimulating factors.
Croatian: Incidencija neutropenije bila je veća u skupini liječenoj lijekom Gazyvaro i klorambucilom (41%) nego u skupini liječenoj rituksimabom i klorambucilom, a povukla se spontano ili uz primjenu čimbenika poticanja rasta kolonija granulocita.
English: Gazyvaro was given by intravenous infusion as a dose of 1,000 mg on Days 1, 8 and 15 of Cycle 1, on Day 1 of subsequent cycles.
Croatian: Gazyvaro se primjenjivao intravenskom infuzijom u dozi od 1000 mg 1., 8. i 15. dan 1. ciklusa te 1. dan ostalih ciklusa.
English: Tell your doctor or nurse if you notice any of the side effects listed above.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od navedenih nuspojava.
English: No studies have been conducted to investigate the pharmacokinetics of obinutuzumab in paediatric patients.
Croatian: Nisu provedena ispitivanja kojima bi se ocijenila farmakokinetika obinutuzumaba u pedijatrijskih bolesnika.
English: Serum concentrations of obinutuzumab in offspring were similar to those in the mothers on day 28 post-partum, whereas concentrations in milk on the same day were very low, suggesting that obinutuzumab crosses the placenta (see section 5.3).
Croatian: 28 dana nakon okota, dok su koncentracije u mlijeku istoga dana bile vrlo niske, što pokazuje da obinutuzumab prolazi kroz posteljicu (vidjeti dio 5.3).
English: Chronic Lymphocytic Leukaemia
Croatian: Kronična limfocitna leukemija
English: Intravenous corticosteroid1,4 (mandatory for CLL, recommended for FL)
Croatian: Intravenski kortikosteroid1,4 (obavezno kod KLL-a,
English: Only the highest frequency observed in the trials is reported (based on studies BO21004/previously untreated CLL, BO21223/previously untreated advanced iNHL and GAO4753g/rituximab refractory iNHL)
Croatian: Prijavljena je samo najveća učestalost primijećena u ispitivanjima (na temelju ispitivanja BO21004/prethodno neliječen KLL, BO21223/prethodno neliječen uznapredovao iNHL
English: 2 e.g. 1,000 mg acetaminophen/paracetamol
Croatian: 2 npr. 1000 mg acetaminofena/paracetamola npr. 50 mg difenhidramina
English: Median observation time 34 months
Croatian: Medijan vremena promatranja: 34 mjeseca
English: Chronic lymphocytic leukaemia (in combination with chlorambucil1)
Croatian: Kronična limfocitna leukemija (u kombinaciji s klorambucilom1)
English: Thirty-four percent of patients were enrolled on comorbidity score alone, and 23% of patients were enrolled with only impaired renal function.
Croatian: Trideset i četiri posto bolesnika uključeno je u ispitivanje samo na temelju rezultata bodovanja za komorbiditeta, a 23%
English: Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Gazyvaro infusion and for the first hour after administration (see section 4.4).
Croatian: Stoga, potrebno je razmotriti suzdržavanje od antihipertenzivnog liječenja 12 sati prije i tijekom svake infuzije lijeka Gazyvaro te još sat vremena nakon primjene lijeka (vidjeti dio 4.4).
English: 22.8 months median observation time g
Croatian: medijan vremena promatranja: 22,8 mjeseci g medijan vremena promatranja: 18,7 mjeseci g
English: 2 Bendamustine is given intravenously on Days 1 and 2 of all treatment cycles (Cycles 1-6) at 90 mg/m2/day; CHOP and CVP according to standard regimens
Croatian: 1000 mg Bendamustin se primjenjuje intravenski 1. i 2. dan u svim ciklusima liječenja (1. - 6. ciklus) u dozi od 90 mg/m2/dan; protokoli CHOP i CVP primjenjuju se prema standardnom režimu.
English: The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered over Day 1 and Day 2 (or Day 1 continued), and on Day 8 and Day 15 of the first 28 day treatment cycle.
Croatian: Preporučena doza lijeka Gazyvaro u kombinaciji s klorambucilom je 1000 mg, a primjenjuje se tijekom 1. i 2. dana (ili u nastavku 1. dana) te 8. dan i 15. dan prvog ciklusa liječenja u trajanju od 28 dana.
English: For management of IRRs see section 4.2 Posology and method of administration.
Croatian: Za zbrinjavanje reakcija na infuziju vidjeti dio 4.2 'Doziranje i način primjene'.
English: Patients with a CrCl < 40 mL/min were excluded from the studies (see section 5.1).
Croatian: Bolesnici koji su imali CrCl < 40 ml/min nisu bili uključeni u ispitivanja (vidjeti dio 5.1).
English: Cases of hepatitis B reactivation have been reported in patients treated with Gazyvaro (see section 4.4).
Croatian: U bolesnika liječenih lijekom Gazyvaro prijavljeni su slučajevi reaktivacije hepatitisa B (vidjeti dio 4.4).
English: White blood cell count decreased, neutrophil count decreased, weight increased
Croatian: smanjen broj neutrofila, povećanje tjelesne težine smanjen broj bijelih krvnih stanica, smanjen broj neutrofila
English: Rituximab + Chemotherapy followed by rituximab maintenance N=601
Croatian: Rituksimab + kemoterapija, nakon čega slijedi terapija održavanja rituksimabom N=601
English: These reactions led to unscheduled termination of 6/36 animals treated with obinutuzumab during dosing and recovery phases; these changes were partially reversible.
Croatian: Te su reakcije tijekom razdoblja doziranja i oporavka dovele do neplaniranog usmrćivanja 6/36 životinja kojima je primjenjivan obinutuzumab;
English: Median observation time 35 months
Croatian: Medijan vremena promatranja: 35 mjeseci
English: Tell your doctor or nurse straight away if you get any signs of infection during and after your Gazyvaro treatment.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako tijekom ili nakon liječenja lijekom Gazyvaro dobijete bilo koji simptom infekcije.
English: Patients with a CrCl < 30 mL/min were excluded from the study (see section 5.1).
Croatian: Bolesnici koji su imali CrCl < 30 ml/min nisu bili uključeni u ispitivanje (vidjeti dio 5.1).
English: Induction treatment of approximately six months (six treatment cycles of Gazyvaro, each of 28 day duration when combined with bendamustine, or eight treatment cycles of Gazyvaro, each of 21 day duration when combined with CHOP or CVP) followed by maintenance once every 2 months for 2 years or until disease progression (whichever occurs first).
Croatian: Uvodno liječenje u trajanju od približno šest mjeseci (šest ciklusa liječenja lijekom Gazyvaro, od kojih svaki traje 28 dana, kada se primjenjuje u kombinaciji s bendamustinom, ili osam ciklusa liječenja lijekom Gazyvaro, od kojih svaki traje 21 dan, kada se primjenjuje u kombinaciji s protokolom CHOP ili CVP), nakon čega slijedi terapija održavanja jedanput svaka 2 mjeseca tijekom 2 godine ili do progresije bolesti (što god nastupi ranije).
English: Gazyvaro + chlorambucil N= 333
Croatian: Gazyvaro + klorambucil N=333
English: Cycles 2-6 or 2-8
Croatian: 2. - 6. ciklus ili 2. - 8. ciklus
English: In the pivotal BO21004/CLL11 study, 27% (90 out of 336) of patients treated with Gazyvaro plus chlorambucil had moderate renal impairment (CrCl < 50 mL/min).
Croatian: U ključnom ispitivanju BO21004/CLL11, 27% (90 od 336) bolesnika liječenih lijekom Gazyvaro i klorambucilom imalo je umjereno oštećenje funkcije bubrega (CrCl < 50 ml/min).
English: 1 Chlorambucil is given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles
Croatian: 1000 mg 1Klorambucil se primjenjuje peroralno u dozi od 0,5 mg/kg tjelesne težine 1. dan i 15. dan u svim ciklusima liječenja
English: Beyond Cycle 1 the incidence of IRRs in subsequent infusions was comparable between the Gazyvaro and the relevant comparator arms.
Croatian: incidencija reakcija na infuziju kod sljedećih infuzija bila je usporediva između skupine koja je primala Gazyvaro i relevantne usporedne skupine.
English: Day 1 (100 mg)
Croatian: 1. dan (100 mg)
English: Rituximab + chlorambucil N= 330
Croatian: rituksimab + klorambucil N=330
English: What Gazyvaro is used for
Croatian: Za što se Gazyvaro koristi
English: No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
Croatian: U ispitivanjima toksičnosti ponovljenih doza na makaki majmunima nisu primijećeni štetni učinci na reproduktivne organe mužjaka ni ženki (vidjeti dio 5.3).
English: IRRs may be clinically indistinguishable from immunoglobulin E (IgE) mediated allergic reactions (e.g. anaphylaxis).
Croatian: Reakcije na infuziju klinički mogu biti istovjetne alergijskim reakcijama posredovanim imunoglobulinom E (IgE) (npr. anafilaksiji).
English: Transient elevation in liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase) has been observed shortly after the first infusion of Gazyvaro.
Croatian: Ubrzo nakon prve infuzije lijeka Gazyvaro primijećeno je prolazno povišenje vrijednosti jetrenih enzima (aspartat aminotransferaze [AST], alanin aminotransferaze [ALT] i alkalne fosfataze).
English: Recovery of B-cells was observed within 12-18 months of follow up in 35% (14 out of 40) of patients without progressive disease and 13% (5 out of 40) with progressive disease.
Croatian: (14 od 40) bolesnika čija bolest nije bila progresivna te u 13% (5 od 40) bolesnika s progresivnom bolešću.
English: Overall, 7% of patients experienced an IRR leading to discontinuation of Gazyvaro.
Croatian: Ukupno je 7% bolesnika imalo reakciju na infuziju koja je dovela do trajnog prekida liječenja lijekom Gazyvaro.
English: Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen (study GAO4753g/GADOLIN).
Croatian: Bolesnici s folikularnim limfomom koji nisu odgovorili na liječenje rituksimabom ili protokolom koji sadrži rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja (ispitivanje GAO4753g/GADOLIN).
English: Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Gazyvaro infusion and for the first hour after administration.
Croatian: Stoga, potrebno je razmotriti suzdržavanje od antihipertenzivnog liječenja 12 sati prije i tijekom svake infuzije lijeka Gazyvaro te još sat vremena nakon primjene lijeka.
English: respectively at Cycle 6 and AUC and Cmax in iNHL of 13172 µg•d/mL and 635.7 µg/mL in females and 9769 µg•d/mL and 481.3 µg/mL in males, respectively), indicating that there is no need to dose adjust based on gender.
Croatian: 6. ciklusu liječenja bolesnika s KLL-om iznosio je 11 282 µg•d/ml odnosno 578,9 µg/ml u žena te 8451 µg•d/ml odnosno 432,5 µg/ml u muškaraca, dok su AUC odnosno Cmax u bolesnika s iNHL-om iznosili 13 172 µg•d/ml odnosno 635,7 µg/ml u žena te 9769 µg•d/ml odnosno 481,3 µg/ml u muškaraca), što znači da nema potrebe za prilagođavanjem doze na temelju spola.
English: Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype.
Croatian: Obinutuzumab je humanizirano i glikoinženjeringom modificirano rekombinantno monoklonsko anti-CD20 protutijelo tipa II, koje pripada podskupini IgG1.
English: A population pharmacokinetic (PK) model was developed to analyse the PK data in 469 iNHL, 342 CLL and 130 diffuse large B-cell lymphoma (DLBCL) patients from Phase I, Phase II and Phase III studies who received obinutuzumab alone or in combination with chemotherapy.
Croatian: 469 bolesnika s iNHL-om, 342 bolesnika s KLL-om i 130 bolesnika s difuznim B-velikostaničnim limfomom (engl. diffuse large B-cell lymphoma, DLBCL) koji su u ispitivanjima faze I, faze II i faze III primali obinutuzumab samostalno ili u kombinaciji s kemoterapijom.
English: Patients with a high tumour burden and/or high circulating lymphocyte count in CLL [> 25 x 109/L] may be at increased risk of severe IRRs.
Croatian: Bolesnici s KLL-om koji imaju veliko tumorsko opterećenje i/ili velik broj limfocita u cirkulaciji (> 25 x 109/l) mogu imati povećan rizik od teških reakcija na infuziju.
English: No Grade 3-5 IRRs were reported beyond the first 1,000 mg infusions of Cycle 1.
Croatian: Nakon infuzije prvih 1000 mg u 1. ciklusu nije prijavljena više niti jedna reakcija na infuziju 3.-5. stupnja.
English: · Use an effective method of contraception while being treated with Gazyvaro.
Croatian: Zaštita od trudnoće · Koristite učinkovitu metodu sprječavanja trudnoće dok se liječite lijekom Gazyvaro.
English: The incidence of IRRs with subsequent infusions was 3% with the second 1,000 mg dose and 1% thereafter.
Croatian: tijekom druge doze od 1000 mg te 1% nakon toga.
English: Difference in MRD rates, (95% CI) Event free survival
Croatian: Razlika u stopama MRD-a (95% CI)
English: Gazyvaro infusions should not be administered as an intravenous push or bolus.
Croatian: Gazyvaro se ne smije primijeniti brzom niti bolusnom intravenskom injekcijom.
English: Patients who experience neutropenia should be closely monitored with regular laboratory tests until resolution.
Croatian: Bolesnike u kojih se pojavi neutropenija potrebno je pažljivo pratiti redovitim laboratorijskim pretragama sve do normalizacije krvne slike.
English: An enhanced pre and postnatal development (ePPND) toxicity study in pregnant cynomolgus monkeys showed no evidence of teratogenic effects.
Croatian: Prošireno istraživanje toksičnih učinaka na prenatalni i postnatalni razvoj u skotnih ženki makaki majmuna nije ukazalo na teratogene učinke.
English: HBVscreening should be performed in all patients before initiation of treatment with Gazyvaro.
Croatian: Prije početka liječenja lijekom Gazyvaro u svih bolesnika je potrebno napraviti probir na HBV.
English: Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRsin CLL and FL patients
Croatian: Tablica 1 Premedikacija koju je potrebno primijeniti prije infuzije lijeka Gazyvaro radi smanjenja rizika od reakcija na infuziju u bolesnika s KLL-om i FL-om
English: Gazyvaro +Chemotherapy followed by Gazyvaro maintenance N=601
Croatian: Gazyvaro + kemoterapija, nakon čega slijedi terapija održavanja lijekom Gazyvaro N=601
English: Table 7 Summary of efficacy from BO21004/CLL11 study Stage 1a
Croatian: Tablica 7 Sažetak rezultata za djelotvornost iz ispitivanja BO21004/CLL11
English: Efficacy results for patients with previously untreated CLL are summarised in Table 7.
Croatian: Rezultati za djelotvornost u bolesnika s prethodno neliječenom kroničnom limfocitnom leukemijom sažeto su prikazani u Tablici 7.