FrancophonIA/ELRC3.0 huggingface dataset:
English: An open-label, two arm, randomised study (OMB114242) was conducted in patients with bulky fludarabine refractory CLL who had failed at least 2 prior therapies (n=122) comparing Arzerra monotherapy (n=79) to physicians' choice (PC) of therapy (n=43).
Croatian: Otvoreno, randomizirano ispitivanje dviju skupina (OMB114242) bilo je provedeno na bolesnicima s izraženijim KLL-om refraktornim na fludarabin, u kojih su barem dvije prethodne terapije bile neuspješne (n=122), a u kojem se uspoređivala Arzerra u monoterapiji (n=79) s terapijom prema izboru liječnika (n=43).
English: Population (treatment) Dosing regimen
Croatian: Populacija (liječenje)
English: Infusion rate (ml/hour)
Croatian: Brzina infuzije (ml/sat)
English: When ofatumumab was administered as single agent in patients with refractory CLL, the median decrease in B-cell counts was 22% after the first infusion and 92% at the eighth weekly infusion.
Croatian: Kada se ofatumumab primjenjivao samostalno u bolesnika s refraktornim KLL-om, medijan smanjenja broja B-stanica je bio 22% nakon prve infuzije i 92% nakon osme tjedne infuzije.
English: Immunisations
Croatian: Imunizacija
English: Discontinuation of HBV antiviral therapy should be discussed with physicians with expertise in managing hepatitis B.
Croatian: O prekidu antivirusne terapije za HBV treba razgovarati s liječnicima koji imaju iskustva u liječenju hepatitisa B.
English: When ofatumumab was administered in combination with chlorambucil in patients with previously untreated CLL, the median decreases in B-cell counts after the first cycle and prior to the sixth monthly cycle were 94% and >99%.
Croatian: Kada se ofatumumab primjenjivao u kombinaciji s klorambucilom u bolesnika s prethodno neliječenim KLL-om, medijan smanjenja broja B-stanica nakon prvog ciklusa odnosno prije šestog mjesečnog ciklusa iznosio je 94% i >99%.
English: Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of adult patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Croatian: Arzerra je u kombinaciji s klorambucilom ili bendamustinom indicirana za liječenje odraslih bolesnika s KLL-om koji prethodno nisu bili liječeni i koji nisu podobni za terapiju utemeljenu na fludarabinu.
English: Nine patients (4%) treated with ofatumumab and chlorambucil, and three patients treated with chlorambucil alone had late-onset neutropenia (defined as Grade 3 or 4 neutropenia starting at least 42 days after the last treatment).
Croatian: U devet bolesnika (4%) liječenih ofatumumabom i klorambucilom i tri bolesnika liječena samo klorambucilom primijećena je odgođena neutropenija (koja se definira kao neutropenija 3. ili 4. stupnja koja nastupa najmanje 42 dana nakon posljednje doze).
English: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR United Kingdom
Croatian: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR Ujedinjeno Kraljevstvo
English: Arzerra must not be administered as an intravenous push or bolus.
Croatian: Arzerra se ne smije primijeniti kao intravenska injekcija ili bolus.
English: Previously untreated chronic lymphocytic leukaemia (CLL)
Croatian: Prethodno neliječena kronična limfocitna leukemija (KLL)
English: • shingles, cold sores (possible symptoms of herpes viral infection that can potentially be severe).
Croatian: • herpes zoster, herpes simpleks (mogući simptomi infekcije virusom herpesa koji mogu biti teški).
English: Study OMB110913 (randomised, open-label, parallel-arm, multicentre trial) evaluated the efficacy of ofatumumab in combination with fludarabine and cyclophosphamide compared with fludarabine and cyclophosphamide in 365 patients with relapsed CLL (defined as a patient who has received at least one prior CLL therapy and previously achieved a complete or partial remission/response, but after a period of six or more months demonstrated evidence of disease progression).
Croatian: U ispitivanju OMB110913 (randomizirano, otvoreno, multicentrično ispitivanje s paralelnim skupinama) ocijenjena je djelotvornost ofatumumaba u kombinaciji s fludarabinom i ciklofosfamidom u usporedbi s fludarabinom i ciklofosfamidom u 365 bolesnika s relapsnim KLL-om (koji se definira kao bolesnik koji je primio namjenje jedno prethodno liječenje za KLL i prethodno je postigao potpunu ili djelomičnu remisiju/odgovor, ali je pokazao progresiju bolesti nakon razdoblja od šest ili više mjeseci).
English: • fever, coughing, difficulty breathing, wheezing, possible symptoms of infections of the lungs or airways (respiratory tract) including pneumonia
Croatian: • vrućica, kašalj, otežano disanje, piskanje, mogući simptomi infekcije pluća ili dišnih puteva (dišnog sustava), uključujući upalu pluća
English: Nervous system disorders Metabolism and nutrition disorders
Croatian: Poremećaji živčanog sustava Poremećaji metabolizma i prehrane sindrom lize tumora
English: Arzerra in combination with chlorambucil showed a statistically significant (71%) improvement in median PFS compared with chlorambucil alone (HR: 0.57; 95% CI: 0.45, 0.72) (see Table 1 and Figure 1).
Croatian: Arzerra u kombinaciji s klorambucilom dovela je do statistički značajnog poboljšanja medijana PFS-a (71%) u usporedbi s monoterapijom klorambucilom (HR: 0,57; 95% CI: 0,45; 0,72) (vidjeti Tablicu 1 i Sliku 1).
English: • difficulty and pain when passing urine, exaggerated sense of needing to urinate, urinary tract infections
Croatian: • poteškoće i bol prilikom mokrenja, pretjerana potreba za mokrenjem, infekcije mokraćnih puteva
English: Bowel obstruction has been reported in patients receiving anti-CD20 monoclonal antibody therapy, including ofatumumab.
Croatian: Opstrukcija crijeva je prijavljena u bolesnika koji su primali terapiju anti-CD20 monoklonskim antitijelima, uključujući ofatumumab.
English: • Cycle 1: 300 mg on day 1 followed 1 week later by 1000 mg on day 8
Croatian: • 1. ciklus: 300 mg 1. dana, a zatim 1000 mg tjedan dana kasnije, tj. 8. dana
English: No data comparing Arzerra in combination with bendamustine or with chlorambucil versus a rituximab based regimen such as rituximab with chlorambucil is available.
Croatian: Nema podataka kojima bi se usporedila Arzerra u kombinaciji s bendamustinom ili klorambucilom u odnosu na liječenje utemeljeno na rituksimabu, primjerice rituksimab s klorambucilom.
English: No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min) (see section 5.2).
Croatian: Ne preporučuje se prilagođavanje doze kod bolesnika s blagim do umjerenim oštećenjem bubrega (klirens kreatinina >30 ml/min) (vidjeti dio 5.2).
English: First infusion
Croatian: Prva infuzija
English: The diluted solution for infusion must be used within 24 hours of preparation.
Croatian: Razrijeđena infuzijska otopina mora se iskoristiti unutar 24 sata od pripreme.
English: The PFS in the monotherapy Arzerra arm was comparable to the results seen with Arzerra monotherapy in study Hx-CD20-406.
Croatian: PFS u skupini koja je primila lijek Arzerra u monoterapiji bio je usporediv s rezultatima primjene lijeka Arzerra u monoterapiji opaženim u ispitivanju Hx-CD20-406.
English: Table 4 Summary of clinical improvement with a minimum duration of 2 months in refractory patients with abnormalities at baseline
Croatian: Tablica 4 Sažetak kliničkih poboljšanja koja su trajala barem 2 mjeseca u bolesnika s refraktornom bolešću koji su imali abnormalnosti u početnim vrijednostima
English: • if you are allergic (hypersensitive) to ofatumumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični (preosjetljivi) na ofatumumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) Ako smatrate da bi se to moglo odnositi na Vas, provjerite to sa svojim liječnikom.
English: 3 vials
Croatian: 3 bočice
English: In the event of a severe infusion-related reaction, the infusion of Arzerra must be interrupted immediately and symptomatic treatment instituted (see section 4.2).
Croatian: U slučaju teške reakcije povezane s infuzijom odmah se mora prekinuti s davanjem infuzije lijeka Arzerra i započeti sa simptomatskom terapijom (vidjeti dio 4.2).
English: Previously untreated CLL
Croatian: Prethodno neliječen KLL
English: Hazard Ratio=0.67 95% CI (0.51,0.88) p-value=0.0032
Croatian: Omjer hazarda=0,67 95% CI (0,51,0,88) p-vrijednost=0,0032
English: Arzerra is used to treat chronic lymphocytic leukaemia (CLL).
Croatian: Arzerra se koristi u terapiji kronične limfocitne leukemije (KLL).
English: Reactivation has also occurred in patients who appear to have resolved hepatitis B infection (i.e. HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [antiHBs] positive).
Croatian: Reaktivacija je zabilježena i u bolesnika koji su naizgled izliječili infekciju hepatitisom B (tj. bolesnika negativnih na HBsAg, pozitivnih na anti-HBc i pozitivnih na protutijela na površinski antigen hepatitisa B [anti-HBs]).
English: The safety of, and ability to generate a primary or anamnestic response to, immunisation with live attenuated or inactivated vaccines during treatment with ofatumumab has not been studied.
Croatian: Sigurnost imunizacije živim atenuiranim ili inaktiviranim cjepivima, kao i sposobnost stvaranja primarnog ili memorijskog odgovora na cijepljenje, nije ispitivana tijekom terapije ofatumumabom.
English: There was no statistically significant difference in the primary endpoint of IRC assessed PFS (5.4 vs. 3.6 months, HR=0.79, p=0.27).
Croatian: Nije bilo statistički značajne razlike u primarnom ishodu preživljenja bez progresije bolesti (PFS) prema ocjeni neovisnog ocjenjivačkog povjerenstva (5,4 naspram 3,6 mjeseci, HR=0,79, p=0,27).
English: Also contains: arginine, sodium acetate (E262), sodium chloride, polysorbate 80 (E433), edetate disodium (E386), hydrochloric acid (E507), water for injections.
Croatian: Također sadrži: arginin, natrijev acetat (E262), natrijev klorid, polisorbat 80 (E433), dinatrijev edetat (E386), kloridnu kiselinu (E507), vodu za injekcije.
English: This should be taken into consideration by patients on a controlled sodium diet.
Croatian: Bolesnici na dijeti s kontroliranim unosom natrija ovo trebaju uzeti u obzir.
English: Hazard Ratio=0.57 95% CI (0.45, 0.72) p-value<0.001
Croatian: Omjer hazarda=0,57 95% CI (0,45, 0,72) p-vrijednost<0,001
English: Clear to opalescent, colourless to pale yellow liquid.
Croatian: Bistra do opalescentna, bezbojna do blijedožuta tekućina.
English: In the pivotal study (OMB110913, ofatumumab plus fludarabine and cyclophosphamide 181 patients; fludarabine and cyclophosphamide 178 patients) in relapsed CLL patients, prolonged neutropenia was reported in 38 (11%) patients (18 patients [10%] treated with ofatumumab in combination with fludarabine and cyclophosphamide compared to 20 patients [11%] in the fludarabine and cyclophosphamide arm).
Croatian: U ključnom ispitivanju (OMB110913; 181 bolesnik je primao ofatumumab plus fludarabin i ciklofosfamid, 178 bolesnika je primalo fludarabin i ciklofosfamid) u bolesnika s relapsnim KLL-om, dugotrajna neutropenija prijavljena je u 38 (11%) bolesnika (18 bolesnika [10%] liječenih ofatumumabom u kombinaciji s fludarabinom i ciklofosfamidom u usporedbi s 20 bolesnika [11%] u skupini koja je liječena fludarabinom i ciklofosfamidom).
English: Uncommon side effects that may show up in your blood tests:
Croatian: Manje česte nuspojave koje se mogu pokazati u krvnim pretragama:
English: In the pivotal study for untreated CLL (OMB110911; ofatumumab plus chlorambucil 217 patients, chlorambucil alone 227 patients), prolonged neutropenia (defined as Grade 3 or 4 neutropenia not resolved between 24 and 42 days after last dose of study treatment) was reported in 41 patients (9%) (23 patients [11%] treated with ofatumumab and chlorambucil, 18 patients [8%] treated with chlorambucil alone).
Croatian: U ključnom ispitivanju u bolesnika s neliječenim KLL-om (OMB110911; 217 bolesnika je primalo ofatumumab plus klorambucil, 277 bolesnika je primalo samo klorambucil), dugotrajna neutropenija (definirana kao neutropenija 3. ili 4. stupnja koja se nije povukla između 24. i 42. dana nakon primljene posljednje doze u ispitivanju) prijavljena je u 41 bolesnika (9%) (23 bolesnika [11%] liječena ofatumumabom i klorambucilom te 18 bolesnika [8%] liječenih samo klorambucilom).
English: Previously untreated patients (ofatumumab + chlorambucil)
Croatian: Prethodno neliječeni bolesnici (ofatumumab + klorambucil)
English: Arzerra contains sodium
Croatian: Arzerra sadrži natrij
English: These patients also experienced comparable clinical improvement, in terms of the efficacy endpoints and haematological parameters detailed above, to patients refractory to both fludarabine and alemtuzumab.
Croatian: Među tim bolesnicima bilo je onih u kojih je došlo do mjerljivog kliničkog poboljšanja prema ranije navedenim mjerama ishoda djelotvornosti i hematološkim parametrima, kao i onih koji nisu reagirali niti na fludarabin niti na alemtuzumab.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
English: No detrimental effects on such activities are predicted from the pharmacology of ofatumumab.
Croatian: Iz farmakologije ofatumumaba se ne mogu predvidjeti štetni učinci na takve aktivnosti.
English: 2) How to dilute the solution for infusion
Croatian: 2) Kako razrijediti otopinu za infuziju
English: *If the second infusion is completed without severe infusion-related ADRs.
Croatian: *Ako primjena druge infuzije završi bez teških nuspojava povezanih s infuzijom.
English: • blue discolouration of the lips and extremities (possible symptoms of hypoxia)
Croatian: • plava boja usana i udova (mogući simptomi smanjene opskrbe tkiva kisikom)
English: Patient median age was 61 years (range: 32 to 90 years, 7% were 75 years of age or older), 60% were male and 16%, 55% and 28% of patients were Binet stage A, B and C, respectively.
Croatian: Medijan dobi bolesnika iznosio je 61 godinu (raspon: 32 do 90 godina, 7% bolesnika bilo je u dobi od 75 godina ili starijih), 60% bolesnika bili su muškarci, i 16% bolesnika bilo je Binet stupnja A, 55% je bilo Binet stupnja B i 28% je bilo Binet stupnja C.
English: Contact your doctor immediately if you experience constipation, a swollen abdomen or abdominal pain.
Croatian: Odmah se obratite svom liječniku ukoliko imate zatvor, natečen trbuh ili bol u trbuhu.
English: Hepatitis B infection and reactivation, progressive multifocal leukoencephalopathy
Croatian: Infekcije i infestacije infekcija donjih sepsa (uključujući infekcija hepatitisom B i reaktivacija hepatitisa B, progresivna multifokalna leukoencefalopatija
English: ----OFA + FC (N=183) Median 28.94 months 95% CI (22.80, 35.88) ____FC (N=182) Median 18.83 months 95% CI (14.42,25.82)
Croatian: ____FC (N=182) Medijan 18,83 mjeseci 95% CI (14,42,25,82)
English: Glaxo Operations UK Ltd. Harmire Road Barnard Castle Durham, DL12 8DT United Kingdom
Croatian: Harmire Road Barnard Castle Durham, DL12 8DT Ujedinjeno Kraljevstvo
English: 1) Before diluting Arzerra
Croatian: 1) Prije razrjeđivanja lijeka Arzerra
English: The CD20 molecule is not shed from the cell surface and is not internalised following antibody binding.
Croatian: Molekula CD20 se nakon vezanja protutijela ne odvaja od stanične površine i ne ulazi u stanicu.
English: At the end of organogenesis (day 48 of gestation), the ofatumumab exposure (AUCinf) corresponded to 0.46 to 3.6 times the human exposure after the eighth infusion of the maximum recommended human dose (MRHD) of 2000 mg. At day 100 of gestation, depletion of B-cells relating to the pharmacological activity of ofatumumab were observed in foetal cord blood and foetal splenic tissues.
Croatian: Na kraju organogeneze (48. dana gestacije), izloženost ofatumumabu (AUCinf) odgovarala je 0,46 do 3,6 puta izloženosti u ljudi nakon osme infuzije maksimalne preporučene ljudske doze (engl.
English: • skin rash
Croatian: • kožni osip
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE
English: Study OMB110911 (randomised, open-label, parallel-arm, multicentre) evaluated the efficacy of Arzerra in combination with chlorambucil compared with chlorambucil alone in 447 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment (e.g. due to advanced age or presence of co-morbidities), with active disease and indicated for treatment.
Croatian: U ispitivanju OMB110911 (randomizirano, otvoreno, multicentrično ispitivanje s paralelnim skupinama) ocijenjena je djelotvornost lijeka Arzerra u kombinaciji s klorambucilom u usporedbi s monoterapijom klorambucilom u 447 bolesnika s prethodno neliječenim KLL-om za koje se smatralo da nisu podobni za liječenje utemeljeno na fludarabinu (npr. zbog starije dobi ili popratnih bolesti), a koji su imali aktivnu bolest i indikaciju za liječenje.
English: In patients who develop reactivation of HBV while receiving Arzerra, Arzerra and any concomitant chemotherapy should be interrupted immediately, and appropriate treatment instituted.
Croatian: U bolesnika u kojih tijekom liječenja lijekom Arzerra dođe do reaktivacije HBV-a treba odmah prekinuti primjenu lijeka Arzerra i svih istodobno primjenjivanih kemoterapija te uvesti odgovarajuću terapiju.
English: Complete blood counts, including neutrophil and platelet counts, should be obtained at regular intervals during Arzerra therapy and more frequently in patients who develop cytopenias.
Croatian: Tijekom terapije Arzerrom u redovitim se razmacima treba pratiti kompletna krvna slika, uključujući neutrofile, te broj trombocita, i to češće u bolesnika koji razviju citopenije.
English: Patient median age was 64 years (range: 41 to 87 years), and the majority were male (73%) and white (96%).
Croatian: Medijan dobi bolesnika bio je 64 godine (raspon: 41 do 87 godina), većina su bili muškarci (73%) i bijelci (96%).
English: • frequent infections, fever, chills, sore throat or mouth ulcers due to infections
Croatian: • česte infekcije, vrućica, zimica, grlobolja ili vrijedovi u ustima zbog infekcija
English: One ml contains 20 mg ofatumumab.
Croatian: Jedan ml sadrži 20 mg ofatumumaba.
English: Overall response rate Responders, n (%) 95.3% CI (%) Response rate in patients with prior rituximab therapy Responders, n (%) 95% CI (%) Response rate in patients with chromosomal abnormality 17p deletion Responders, n (%) 95% CI (%) 11q deletion Responders, n (%) 95% CI (%) Median overall survival Months 95% CI Progression-free survival Months 95% CI Median duration of response Months 95% CI Median time to next CLL therapy Months 95% CI The overall response was assessed by an Independent Response Committee using the 1996 NCI-WG guidelines for CLL.
Croatian: Stopa ukupnog odgovora Bolesnici s odgovorom, n (%) 95,3% CI (%) Stopa odgovora u bolesnika s ranijom terapijom rituksimabom Bolesnici s odgovorom, n (%) 95% CI (%) Stopa odgovora u bolesnika s kromosomskim abnormalnostima delecija 17p Bolesnici s odgovorom, n (%) 95% CI (%) delecija 11q Bolesnici s odgovorom, n (%) 95% CI (%) Medijan ukupnog preživljenja Mjeseci 95% CI
English: Urticaria*, pruritus*,
Croatian: urtikarija *, pruritus*, navale crvenila*
English: The initial rate of the first and second infusion of Arzerra should be 12 ml/hour.
Croatian: Početna brzina prve infuzije Arzerre treba biti 12 ml/sat.
English: The remaining infusions will then be given once a month for up to 11 months.
Croatian: Preostale infuzije primjenjivat će se jedanput mjesečno tijekom najviše 11 mjeseci.
English: Table 1 Summary of PFS with Arzerra in combination with chlorambucil compared with chlorambucil in previously untreated CLL
Croatian: Tablica 1 Sažetak za PFS kod primjene lijeka Arzerra u kombinaciji s klorambucilom u usporedbi s monoterapijom klorambucilom u bolesnika s prethodno neliječenim KLL-om
English: Arzerra is indicated for the treatment of CLL in adult patients who are refractory to fludarabine and alemtuzumab.
Croatian: Arzerra je indicirana za liječenje KLL-a u odraslih bolesnika koji ne reagiraju na fludarabin i alemtuzumab.
English: For patients who show evidence of prior (HBsAg negative, anti-HBc positive) hepatitis B infection, physicians with expertise in managing hepatitis B should be consulted regarding monitoring and initiation of HBV antiviral therapy.
Croatian: Kod bolesnika u kojih postoje znakovi prethodne infekcije hepatitisom B (bolesnici negativni na HBsAg i pozitivni na anti-HBc) potrebno je zatražiti savjet liječnika s iskustvom u liječenju hepatitisa B u vezi praćenja i uvođenja antivirusne terapije protiv HBV-a.
English: B-cells after the first ofatumumab infusion, leaving a reduced number of CD20
Croatian: Nakon prve infuzije ofatumumabom došlo je do brzog smanjenja broja CD20
English: If the preceding infusion(s) has (have) been completed without severe infusion-related ADRs, the subsequent infusions can start at a rate of 25 ml/hour and should be increased every 30 minutes up to a maximum of 400 ml/hour (see section 6.6).
Croatian: Ako primjena prethodne(ih) infuzije(a) završi bez teških nuspojava povezanih s infuzijom, sljedeće infuzije mogu započeti brzinom od 25 ml/sat, koju treba povećavati svakih 30 minuta do najviše 400 ml/sat (vidjeti dio 6.6).
English: During infusion, the rate should be increased every 30 minutes to a maximum of 400 ml/h (see section 6.6).
Croatian: Tijekom infuzije brzinu treba povećavati svakih 30 minuta do najviše 400 ml/sat (vidjeti dio 6.6).
English: How to administer the diluted solution
Croatian: Kako primijeniti razrijeđenu otopinu
English: Agranulocytosis, coagulopathy, red cell aplasia, lymphopenia
Croatian: Poremećaji krvi i limfnog sustava agranulocitoza, koagulopatija, aplazija crvenih krvnih stanica, limfopenija
English: The remaining infusions will then be given once a month for four months.
Croatian: Preostale infuzije se daju jednom mjesečno tijekom četiri mjeseca.
English: Vaccination and Arzerra
Croatian: Cijepljenje i Arzerra
English: Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in those who are hepatitis B core antibody (anti-HBc) positive but HBsAg negative.
Croatian: Slučajevi su prijavljeni u bolesnika pozitivnih na površinski antigen hepatitisa B (HBsAg) te u bolesnika pozitivnih na protutijelo na jezgreni antigen hepatitisa B (anti-HBc), ali negativnih na HBsAg.
English: *If the previous infusion was completed without severe infusion-related ADRs.
Croatian: *Ako primjena prethodne infuzije završi bez teških nuspojava povezanih s infuzijom.
English: • rapid heart beat
Croatian: • ubrzani otkucaji srca
English: Even with premedication, severe reactions, including cytokine release syndrome, have been reported following use of ofatumumab.
Croatian: Čak i s primjenom premedikacije, nakon primjene ofatumumaba zabilježene su teške reakcije, uključujući sindrom oslobađanja citokina.
English: Infusion schedule
Croatian: Raspored infuzija
English: If any adverse reactions are observed, infusion rates should be reduced (see section 4.2).
Croatian: U slučaju bilo koje nuspojave, brzinu infuzije treba smanjiti (vidjeti dio 4.2).
English: Figure 1 Kaplan-Meier estimates of IRC-assessed PFS in previously untreated CLL
Croatian: Slika 1 Kaplan-Meierova krivulja procijenjenog PFS-a kod prethodno neliječenog KLL-a prema ocjeni neovisnog ocjenjivačkog povjerenstva
English: The remaining infusions will then be given once a month for up to 6 months.
Croatian: Preostale infuzije primjenjivat će se jedanput mjesečno tijekom najviše 6 mjeseci.
English: Arzerra is for intravenous infusion and must be diluted prior to administration.
Croatian: Arzerra je lijek za intravensku infuziju i prije primjene mora se razrijediti.
English: Infusion number
Croatian: Broj infuzije
English: How to dilute the solution for infusion
Croatian: Kako razrijediti otopinu za infuziju
English: During infusion, the rate should be increased every 30 minutes to a maximum of 200 ml/hour (see section 6.6).
Croatian: Tijekom trajanja infuzije, svakih 30 minuta brzinu treba povećavati do najviše 200 ml/sat (vidjeti dio 6.6).