FrancophonIA/ELRC3.0 huggingface dataset:
English: • sore throat, feeling of pressure or pain in the cheeks and forehead, infections of the ear, nose or throat.
Croatian: • grlobolja, osjećaj pritiska ili boli u obrazima i čelu, infekcije uha, nosa ili grla.
English: Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Croatian: Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Njemačka
English: Ofatumumab may cause foetal B-cell depletion based on findings from animal studies and on its mechanism of action (see section 5.1).
Croatian: Ofatumumab može uzrokovati smanjenje broja fetalnih B-stanica temeljem otkrića iz ispitivanja na životinjama i svog mehanizma djelovanja (vidjeti dio 5.1).
English: Chlorambucil
Croatian: Klorambucil
English: Pre-medication attenuates infusion-related reactions but these may still occur, predominantly during the first infusion.
Croatian: Premedikacija ublažava reakcije povezane s infuzijom, ali se one i dalje mogu dogoditi, osobito tijekom prve infuzije.
English: Arzerra is administered by intravenous infusion; therefore, absorption is not applicable.
Croatian: Arzerra se primjenjuje putem intravenske infuzije; stoga, apsorpcija nije primjenjiva.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8 ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja su odgovornost osobe koja primjenjuje lijek, a ne bi trebali biti dulji od 24 h na 2°C-8°C, osim ako je priprema/razrjeđivanje provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: Limited data are available in the heterogeneous non-white population and in patients with an ECOG performance status of 2.
Croatian: Dostupni su ograničeni podaci o heterogenoj populaciji koja nije bijele rase i o bolesnicima s funkcionalnim ECOG statusom 2.
English: If you think you have had such a reaction before, tell your doctor before you are given Arzerra.
Croatian: Ako mislite da ste ranije imali takvu reakciju, recite to svom liječniku prije nego što primite lijek Arzerra.
English: Cmax = maximum ofatumumab concentration at the end of infusion, AUC = exposure to ofatumumab over a dosing period, CL = ofatumumab clearance after multiple doses, T½ = terminal half-life Numbers rounded to three significant digits
Croatian: Cmax = najviša koncentracija ofatumumaba na kraju infuzije, AUC = izloženost ofatumumabu tijekom perioda doziranja, CL = klirens ofatumumaba nakon višestrukih doza, T½ = terminalni poluvijek Brojevi su zaokruženi do tri značajne znamenke
English: *These events are likely attributable to ofatumumab in the setting of an infusion-related reaction and typically occur after the start of infusion and within 24 hours after the completion of the infusion (see section 4.4).
Croatian: *Ti se događaji vjerojatno mogu pripisati ofatumumabu kao reakcije povezane s infuzijom, a obično se javljaju nakon početka infuzije te unutar 24 sata po njezinu završetku (vidjeti dio 4.4).
English: The usual dose of Arzerra for the first infusion is 300 mg.
Croatian: Uobičajena doza za prvu infuziju lijeka Arzerra je 300 mg.
English: Pharmacotherapeutic group: antineoplasic agents, monoclonal antibodies, ATC code: L01XC10
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: antineoplastici, monoklonska antitijela, ATK oznaka: L01XC10
English: Number at risks at
Croatian: Broj bolesnika pod rizikom
English: Ofatumumab has a small volume of distribution, with mean Vss values ranging from 1.7 to 8.1 l across studies, dose levels, and infusion number.
Croatian: Ofatumumab ima malen volumen distribucije, sa srednjim vrijednostima Vss u rasponu od 1,7 do 8,1 l ovisno o ispitivanju, visini doze i broju infuzija.
English: The ORR in this group was 43% (95.3% CI: 33, 53).
Croatian: ORR je u ovoj skupini iznosio 43% (95,3% CI: 33, 53).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive.
Croatian: Reaktivacija HBV-a definira se kao iznenadan porast replikacije HBV-a, koji se manifestira kao brzo povećanje razina HBV DNK u serumu, ili pronalazak HBsAg u osobe koja je prethodno bila negativna na HBsAg i pozitivna na anti-HBc.
English: Approximately 60% of patients received 3-6 cycles of Arzerra and 32% received 7-12 cycles.
Croatian: Približno 60% bolesnika primilo je 3-6 ciklusa lijeka Arzerra, dok je njih 32% primilo 7-12 ciklusa.
English: Since ofatumumab may cause foetal B-cell depletion, effective contraception (methods that result in less than 1% pregnancy rates) has to be used during Arzerra therapy and for 12 months after the last Arzerra dose.
Croatian: S obzirom da ofatumumab može uzrokovati smanjenje broja fetalnih B-stanica, mora se koristiti učinkovita metoda kontracepcije (metode koje rezultiraju trudnoćom u manje od 1% slučajeva) tijekom terapije Arzerrom i najmanje 12 mjeseci nakon zadnje primljene doze Arzerre.
English: Ofatumumab is a human monoclonal antibody produced in a recombinant murine cell line (NS0).
Croatian: Ofatumumab je ljudsko monoklonsko protutijelo koje je proizvedeno u rekombinantnoj mišjoj staničnoj liniji (NS0).
English: • increase in potassium, phosphate and uric acid in the blood that can cause kidney problems (tumour lysis syndrome) The symptoms of this condition include:
Croatian: • povećanje kalija, fosfata i mokraćne (uratne) kiseline u krvi, što može uzrokovati probleme s bubrezima (sindrom lize tumora) Simptomi ovog stanja uključuju:
English: Adverse reactions reported in patients treated with ofatumumab as monotherapy and with ofatumumab in combination with chemotherapy, are listed below by MedDRA body system organ class and by frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Croatian: Nuspojave prijavljene u bolesnika liječenih ofatumumabom u monoterapiji ili ofatumumabom u kombinaciji s kemoterapijom, navode se u nastavku i to prema MedDRA klasifikaciji organskih sustava i učestalosti, koristeći sljedeće kategorije: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne mogu se procijeniti iz raspoloživih podataka).
English: • 2000 mg weekly for 7 doses (infusions 2 to 8) followed 4-5 weeks later by
Croatian: • 2000 mg jednom tjedno sljedećih 7 doza (2. do 8. infuzija), a zatim nakon 4-5 tjedana slijedi
English: PFS benefit with the addition of Arzerra was observed in all patients, including those with poor-risk biological features (such as 17p or 11q deletion, unmutated IGHV, β2M >3500 μg/l, and ZAP-70 expression).
Croatian: Poboljšanje PFS-a nakon dodavanja lijeka Arzerra primijećeno je u svih bolesnika, uključujući i one s niskorizičnim biološkim značajkama (poput delecije 17p ili 11q, nemutiranog IGHV, β2M > 3500 μg/l i ekspresije ZAP-70).
English: However, patients with hepatic impairment are unlikely to require dose modification (see section 5.2).
Croatian: Međutim, bolesnici s oštećenjem jetre vjerojatno neće trebati prilagodbu doze (vidjeti dio 5.2).
English: Your doctor will weigh up the benefit to you against the risk to your baby of taking Arzerra while you're pregnant.
Croatian: Vaš će liječnik procijeniti Vašu korist od uzimanja lijeka Arzerra u trudnoći u usporedbi s rizikom za Vaše dijete.
English: As ofatumumab is a monoclonal antibody, genotoxicity and carcinogenicity studies have not been conducted with ofatumumab.
Croatian: Obzirom da je ofatumumab monoklonsko antitijelo, ispitivanja genotoksičnosti i kancerogenosti s ofatumumabom nisu provedena.
English: CR (%) CR with MRD negativity (% of CR) Median duration of response, all patients, months 95% CI P value p<0.001
Croatian: CR (%) CR s negativnim nalazom na MRD (% CR-a) Medijan trajanja odgovora, svi bolesnici, mjeseci 95% CI p-vrijednost p< 0,001
English: The risks and benefits of vaccinating patients during Arzerra therapy should be considered.
Croatian: Treba razmotriti rizike i koristi cijepljenja bolesnika tijekom terapije Arzerrom.
English: Store the diluted infusion solution between 2C and 8 C and use within 24 hours.
Croatian: Razrijeđenu infuziju čuvajte između 2ºC i 8ºC te iskoristite unutar 24 sata.
English: Arzerra contains ofatumumab, which belongs to a group of medicines called monoclonal antibodies.
Croatian: Arzerra sadrži ofatumumab koji pripada grupi lijekova koji se nazivaju monoklonska protutijela.
English: Intravenous ofatumumab has been associated with infusion-related reactions.
Croatian: Ofatumumab za intravensku primjenu povezuje se s reakcijama povezanim s infuzijom.
English: If you have or have had hepatitis B, tell your doctor before you are given Arzerra.
Croatian: Ako imate ili ste ikada imali hepatitis B, obavijestite liječnika o tome prije nego primite lijek Arzerra.
English: Ofatumumab had non-linear pharmacokinetics related to its decreasing clearance over time.
Croatian: Ofatumumab je imao nelinearnu farmakokinetiku povezanu sa svojim klirensom koji se smanjuje s vremenom.
English: Patients refractory to fludarabine and alemtuzumab n=95
Croatian: Bolesnici koji ne reagiraju na terapiju fludarabinom i alemtuzumabom n=95
English: Intravenous administration of ofatumumab to pregnant cynomolgus monkeys at 100 mg/kg once weekly from days 20 to 50 of gestation did not elicit maternal or foetal toxicity or teratogenicity.
Croatian: Intravenska primjena doze ofatumumaba od 100 mg/kg jednom tjedno u gravidnih ženki cynomolgus majmuna, od 20. do 50. dana gestacije nije izazvala toksičnost za majku ili fetus kao ni teratogene učinke.
English: Refractory CLL (ofatumumab)
Croatian: Refraktorni KLL (ofatumumab)
English: Patients who present with abdominal pain, especially early in the course of ofatumumab therapy, should be evaluated and appropriate treatment instituted.
Croatian: Bolesnike koji osjete bolove u trbuhu, osobito rano u početku terapije ofatumumabom, treba pregledati i započeti s odgovarajućom terapijom.
English: Age ≥75 years (n=119) Co-morbidity 0 or 1 (n=126) Co-morbidity 2 or more (n=321) ECOG 0, 1 (n=411) ECOG 2 (n=35)
Croatian: dob ≥75 godina (n=119) popratne bolesti: 0 ili 1 (n=126) popratne bolesti: 2 ili više (n=321) ECOG 0, 1 (n=411) ECOG 2 (n=35)
English: Arzerra concentrate for solution for infusion does not contain a preservative; therefore dilution should be carried out under aseptic conditions.
Croatian: Arzerra koncentrat za otopinu za infuziju ne sadrži konzervanse, prema tome, razrjeđivanje treba provoditi u aseptičkim uvjetima.
English: Baseline disease characteristics and prognostic markers were balanced between treatment arms and representative of a relapsed CLL population.
Croatian: Početne karakteristike bolesti i prognostički markeri bili su ujednačeni među liječenim skupinama i reprezentativni za populaciju s relapsnim KLL-om.
English: Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, United Kingdom Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Croatian: Glaxo Operations UK Limited (posluje kao Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, Ujedinjeno Kraljevstvo Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ujedinjeno Kraljevstvo
English: CIRS-G ≤10 (n=310) CIRS-G >10 (n=137) CrCl <70 ml/min (n=214) CrCl ≥70 ml/min (n=227) 17p or 11q deletion (n=90) IGHV mutated (≤98%) (n=177) IGHV unmutated (>98%) (n=227) β2M ≤3500 μg/l (n=109) β2M >3500 μg/l (n=322) ZAP-70 positive (n=161) ZAP-70 intermediate (n=160) ZAP-70 negative (n=100) IGHV mutated & ZAP-70 negative (n=60)
Croatian: CIRS-G ≤10 (n=310) CIRS-G >10 (n=137) CrCl <70 ml/min (n=214) CrCl ≥70 ml/min (n=227) delecija 17p ili 11q (n=90) mutiran IGHV (≤98%) (n=177) nemutiran IGHV (>98%) (n=227) β2M ≤3500 μg/l (n=109) β2M >3500 μg/l (n=322) pozitivna ekspresija ZAP-70 (n=161) umjerena ekspresija ZAP-70 (n=160) negativna ekspresija ZAP-70 (n=100) mutiran IGHV i negativna ekspresija ZAP-70 (n=60)
English: You may need extra check-ups while you are being treated with Arzerra.
Croatian: Možda će Vam biti potrebni dodatni pregledi tijekom terapije lijekom Arzerra.
English: The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumours.
Croatian: Molekula CD20 je transmembranski fosfoprotein izražen na B limfocitima od pre-B do zrele B limfocitne faze i na B-staničnim tumorima.
English: Baseline calculated creatinine clearance was not found to be a significant factor on ofatumumab pharmacokinetics in a cross-study population analysis in patients with calculated creatinine clearance values ranging from 26 to 287 ml/min.
Croatian: Osnovna izračunata vrijednost klirensa kreatinina nije se pokazala značajnim čimbenikom za farmakokinetiku ofatumumaba u analizi više ispitivanja u populaciji bolesnika s izračunatim vrijednostima klirensa kreatinina u rasponu od 26 do 287 ml/min.
English: Arzerra was administered as monotherapy to 223 patients with refractory CLL (study Hx-CD20-406).
Croatian: Arzerra se davala kao monoterapija u 223 bolesnika s refraktornim KLL-om (ispitivanje Hx-CD20-406).
English: If you have any questions on the use of Arzerra, ask the doctor or nurse who is giving you the infusion.
Croatian: Ukoliko imate bilo kakva pitanja o primjeni lijeka Arzerra, upitajte liječnika ili medicinsku sestru koji Vam daju infuziju.
English: If you have been previously treated for CLL you will usually have a course of 12 infusions.
Croatian: Ako ste prethodno primili liječenje za KLL, obično ćete primiti niz od 12 infuzija.
English: Insufficient data exist regarding the safety of resuming Arzerra in patients who develop HBV reactivation.
Croatian: Nema dovoljno podataka o sigurnosti ponovne primjene lijeka Arzerra u bolesnika u kojih nastupi reaktivacija HBV-a.
English: 268 (23%) of the 1,168 patients experienced ≥Grade 3 infections.
Croatian: 268 (23%) od 1168 bolesnika imalo je infekcije ≥ 3. stupnja.
English: The overall safety profile of ofatumumab is based on data from 1,168 patients in clinical trials in CLL (see section 5.1).
Croatian: Ukupan sigurnosni profil ofatumumaba u bolesnika temelji se na podacima prikupljenima u 1168 bolesnika u kliničkim ispitivanjima KLL-a (vidjeti dio 5.1).
English: Hypersensitivity to ofatumumab or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na ofatumumab ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Reactivation of HBV replication is often followed by hepatitis, i.e. increase in transaminase levels and, in severe cases, increase in bilirubin levels, liver failure, and death.
Croatian: Reaktivaciju replikacije HBV-a često prati hepatitis, tj. povećanje razine transaminaza te, u teškim slučajevima, povećanje razine bilirubina, zatajenje jetre i smrt.
English: These included improvements associated with constitutional symptoms, lymphadenopathy, organomegaly, or cytopenias (see Table 4).
Croatian: Uključivala su poboljšanja vezana uz osnovne simptome, limfadenopatiju, organomegaliju ili citopeniju (vidjeti Tablicu 4.)
English: In all patients with CLL, ofatumumab induces rapid and profound B-cell depletion, whether given as a single agent or in combination.
Croatian: U svih bolesnika s KLL-om, ofatumumab izaziva brzo i opsežno smanjenje broja B-stanica, bilo kada se daje samostalno ili u kombinaciji.
English: The infusion must be completed within 24 hours after preparation.
Croatian: Infuzija se mora završiti unutar 24 sata od pripreme.
English: The primary endpoint was ORR assessed by the investigator according to the 2008 IWCLL guidelines.
Croatian: Primarna mjera ishoda bio je ORR prema ocjeni ispitivača sukladno IWCLL smjernicama iz 2008.
English: Therefore Arzerra is not recommended for use in children and adolescents.
Croatian: Stoga se primjena lijeka Arzerra ne preporučuje u djece i adolescenata.
English: The response rate in patients with prior rituximab therapy was 38% (95% CI: 23, 61).
Croatian: Stopa odgovora u bolesnika s ranijom terapijom rituksimabom bila je 38% (95% CI: 23; 61).
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA
English: The overall response rate in this group was 63% (95.3% CI: 35, 85).
Croatian: Stopa odgovora u ovoj skupini bila je 63% (95,3% CI: 35, 85).
English: Arzerra must not be mixed with, or administered as an infusion with other medicinal products or intravenous solutions.
Croatian: Arzerra se ne smije miješati ili davati kao infuzija s drugim lijekovima ili intravenskim otopinama.
English: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 were enrolled into the study and 91% had an ECOG performance status of 0 or 1.
Croatian: Eastern Cooperative Oncology Group, ECOG) od 0 do 2, a njih 91% imalo je funkcionalni ECOG status od 0 ili 1.
English: Patients with evidence of prior HBV infection should be monitored for clinical and laboratory signs of hepatitis or HBV reactivation during treatment with and for 6-12 months following the last infusion of Arzerra.
Croatian: U bolesnika u kojih postoje znakovi prethodne infekcije HBV-om treba pažljivo pratiti kliničke i laboratorijske znakove hepatitisa ili reaktivacije HBV-a tijekom liječenja te još 6-12 mjeseci nakon posljednje infuzije lijeka Arzerra.
English: Complete resolution of constitutional symptoms (fever, night sweats, fatigue, weight loss) defined as the presence of any symptoms at baseline, followed by no symptoms present.
Croatian: Potpuni oporavak od općih simptoma (vrućice, noćnog znojenja, umora, gubitka težine) definiran kao prisustvo bilo kojih simptoma na početku, koji su kasnije nestali.
English: If you have not been previously treated for CLL you will have a maximum of 13 infusions.
Croatian: Ako prethodno niste primili liječenje za KLL, primit ćete najviše 13 infuzija.
English: Pulmonary oedema*, hypoxia*
Croatian: plućni edem*, hipoksija *
English: What Arzerra looks like and contents of the pack Arzerra is a colourless to pale yellow concentrate for solution for infusion.
Croatian: Kako Arzerra izgleda i sadržaj pakiranja Arzerra je bezbojni do blijedožuti koncentrat za otopinu za infuziju.
English: Gender had a modest effect (12%) on ofatumumab central volume of distribution in a cross-study population analysis, with higher Cmax and AUC values observed in female patients (48% of the patients in this analysis were male and 52% were female); these effects are not considered clinically relevant, and no dose adjustment is recommended.
Croatian: U analizi populacije iz više ispitivanja, spol je imao umjeren utjecaj (12%) na centralni volumen distribucije ofatumumaba, s višim zabilježenim vrijednostima Cmax i AUC u žena bolesnica (48% bolesnika u toj analizi bili su muškarci, a 52% su bile žene); ti utjecaji ne smatraju se klinički značajnima i ne preporučuje se prilagođavanje doze.
English: 0 to 100 mg**
Croatian: 0 do 100 mg**
English: No large changes in the mean QTc interval (i.e. >20 milliseconds) were detected.
Croatian: Nisu primijećene značajnije promjene srednje vrijednosti QTc intervala (tj. > 20 milisekundi).
English: 36 patients had a normal karyotype and chromosomal aberrations were detected in 174 patients; there were 47 patients with 17p deletion, 73 patients with 11q deletion, 23 patients with trisomy 12q, and 31 patients with 13q deletion as the sole aberration.
Croatian: 36 bolesnika imalo je normalan kariotip, dok su kromosomske aberacije otkrivene u 174 bolesnika; 47 bolesnika imalo je deleciju 17p, 73 bolesnika imalo je deleciju 11q, 23 bolesnika imalo je trisomiju 12q, a 31 bolesnik imao je deleciju 13q kao jedinu aberaciju.
English: Ofatumumab is eliminated in two ways: a target-independent route like other IgG molecules and a target-mediated route which is related to binding to B-cells.
Croatian: Ofatumumab se eliminira na dva načina: putem nepovezanim s metom poput drugih IgG molekula i, putem povezanim s metom koji se odnosi na vezanje za B-stanice.
English: Seven percent of patients had ≥Grade 3 infusion-related reactions at any time during treatment.
Croatian: Sedam posto bolesnika imalo je reakcije povezane s infuzijom ≥ 3. stupnja u nekom trenutku tijekom liječenja.
English: Of these 223 patients, 95 patients were refractory to fludarabine and alemtuzumab therapy (defined as failure to achieve at least a partial response with fludarabine or alemtuzumab treatment or disease progression within 6 months of the last dose of fludarabine or alemtuzumab).
Croatian: Od tih 223 bolesnika, 95 bolesnika nije reagiralo na terapiju fludarabinom i alemtuzumabom (definirano kao nemogućnost dobivanja barem djelomičnog odgovora na terapiju fludarabinom ili alemtuzumabom ili progresija bolesti unutar 6 mjeseci od zadnje doze fludarabina ili alemtuzumaba).
English: Therefore, the concomitant use of these agents with ofatumumab should be avoided.
Croatian: Stoga treba izbjegavati njihovu istovremenu primjenu s ofatumumabom.
English: No studies on the effects of Arzerra on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja o učincima lijeka Arzerra na sposobnost upravljanja vozilima i rada sa strojevima.
English: For previously untreated CLL, the recommended dosage and schedule is:
Croatian: Za prethodno neliječen KLL, preporučena doza i raspored su:
English: The effect of multiple doses of Arzerra on the QTc interval was evaluated in a pooled analysis of three open-label studies in patients with CLL (N=85).
Croatian: Učinak višekratnih doza lijeka Arzerra na QTc interval ocijenjen je u objedinjenoj analizi triju otvorenih ispitivanja u bolesnika s KLL-om (N=85).
English: • Subsequent cycles (until best response or a maximum of 12 cycles): 1000 mg on day 1 every
Croatian: • Sljedeći ciklusi (do postizanja najboljeg odgovora ili tijekom najviše 12 ciklusa): 1000 mg
English: Management of TLS includes correction of electrolyte abnormalities, monitoring of renal function, maintenance of fluid balance and supportive care.
Croatian: Terapija TLS-a uključuje ispravljanje poremećenih vrijednosti elektrolita, praćenje bubrežne funkcije, održavanje ravnoteže tekućine i prateću njegu.
English: Arzerra treatment should not be initiated in patients with evidence of current hepatitis B infection (HBsAg positive) until the infection has been adequately treated.
Croatian: Liječenje lijekom Arzerra ne smije se započeti u bolesnika u kojih postoje znakovi trenutne infekcije hepatitisom B (bolesnici pozitivni na HBsAg) sve dok se ne primijeni odgovarajuća terapija za infekciju.
English: Do not use this medicine after the expiry date shown on the carton and vial label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na bočici.
English: There are limited pharmacokinetic data in patients with severe renal impairment (creatinine clearance <30 ml/min).
Croatian: Postoje ograničeni farmakokinetički podaci za bolesnike s teškim oštećenjem bubrega (klirens kreatinina <30 ml/min).
English: Patients with a history of decreased pulmonary function may be at a greater risk for pulmonary complications from severe reactions and should be monitored closely during infusion of Arzerra.
Croatian: Bolesnici u čijoj povijesti bolesti postoji smanjena funkcija pluća mogu imati veći rizik za razvijanje plućnih komplikacija od ostalih teških nuspojava te ih stoga tijekom infuzije Arzerre treba pažljivo pratiti.