FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was median progression-free survival (PFS) as assessed by a blinded Independent Review Committee (IRC) using the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
Croatian: Primarna mjera ishoda bio je medijan preživljenja bez progresije bolesti (engl. progression-free survival, PFS) prema ocjeni zaslijepljenog neovisnog ocjenjivačkog povjerenstva utemeljenoj na smjernicama radne skupine sponzorirane od strane Nacionalnog instituta za rak (engl.
English: Medicines of this type (monoclonal antibodies) can cause infusion reactions when they are injected into the body.
Croatian: Kada se ubrizgavaju u tijelo, lijekovi ove vrste (monoklonska protutijela) mogu uzrokovati reakcije na infuziju.
English: One ml of concentrate contains 20 mg of ofatumumab.
Croatian: Jedan ml koncentrata sadrži 20 mg ofatumumaba.
English: Patients received ofatumumab as intravenous infusions (cycle 1: 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days).
Croatian: Bolesnici su primali ofatumumab u obliku intravenskih infuzija (1. ciklus: 300 mg 1. dana i 1000 mg 8. dana; sljedeći ciklusi: 1000 mg 1. dana svakih 28 dana).
English: IGHV unmutated & ZAP-70 positive (n=122)
Croatian: ZAP-70 (n=35) nemutiran IGHV i negativna ekspresija ZAP-70 (n=27) nemutiran IGHV i pozitivna ekspresija ZAP-70 (n=122)
English: The overall survival results showed a HR=0.78 (56.4 months versus 45.8 months for the OFA+FC arm versus FC arm; 95% CI: 0.56-1.09; p=0.1410).
Croatian: Rezultati ukupnog preživljenja su pokazali HR=0,78 (56,4 mjeseca za skupinu OFA+FC naspram 45,8 mjeseci za skupinu FC; 95% CI: 0,56-1,09; p=0,1410).
English: • slow heart beat
Croatian: • usporeni otkucaji srca
English: Arzerra should be discontinued in patients who experience serious or life-threatening cardiac arrhythmias.
Croatian: Terapiju lijekom Arzerra treba prekinuti u bolesnika kod kojih se javi ozbiljna srčana aritmija ili ona koja ugrožava život.
English: Before diluting Arzerra
Croatian: Prije razrjeđivanja lijeka Arzerra
English: PFS based on local (investigator) assessment was consistent with the primary endpoint and resulted in a ~11-month improvement in median PFS (OFA+FC 27.2 months versus 16.8 months for FC; HR=0.66 (95% CI: 0.51, 0.85, p=0.0009).
Croatian: PFS temeljen na lokalnoj procjeni (ispitivača) je bio u skladu s primarnom mjerom ishoda i rezultirao je poboljšanjem medijana PFS-a od otprilike 11 mjeseci (OFA+FC 27,2 mjeseca naspram 16,8 mjeseci za FC; HR=0,66; 95% CI: 0,51; 0,85; p=0,0009).
English: Arzerra is available in packs of 3 vials.
Croatian: Arzerra je dostupna u pakiranju s 3 bočice.
English: Ofatumumab should be a colourless to pale yellow solution.
Croatian: Otopina ofatumumaba bi trebala biti bezbojna do blijedožuta.
English: Very common symptoms of an infusion-related reaction (may affect more than 1 in 10 people):
Croatian: Vrlo česti simptomi reakcije povezane s infuzijom (mogu se javiti u više od 1 na 10 osoba):
English: The primary endpoint of progression-free survival (PFS), as assessed by a blinded independent review committee (IRC) using the updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008), was prolonged in the ofatumumab plus fludarabine-cyclophosphamide (OFA+FC) arm compared to the fludarabine-cyclophosphamide (FC) arm (28.9 months versus 18.8 months; HR: 0.67; 95% CI: 0.51-0.88, p=0.0032) resulting in a 10-month improvement in median PFS (see Figure 2).
Croatian: National Cancer Institute-sponsored Working Group, NCI-WG) (2008.), koje je produženo u skupini koja je primala ofatumumab i fludarabin-ciklofosfamid (OFA+FC) u usporedbi sa skupinom koja je primala fludarabin-ciklofosfamid (FC) (28,9 mjeseci naspram 18,8 mjeseci; HR: 0,67; 95% CI: 0,51-0,88, p=0,0032) rezultirajući poboljšanjem medijana PFS-a od 10 mjeseci (vidjeti Sliku 2).
English: Patient median age was 61 years (range: 27 to 82 years), the majority were male (58%), and all were white.
Croatian: Medijan dobi bolesnika bio je 61 godina (raspon: 27 do 82 godine), većina su bili muškarci (58%) i svi su bili bijelci.
English: Abbreviations: β2M = beta-2-microglobulin, CI = confidence interval; CIRS-G = Cumulative Illness Rating Scale for Geriatrics, CLL = chronic lymphocytic leukaemia, CrCl = creatinine clearance, ECOG = Eastern Cooperative Oncology Group, IGHV = Immunoglobulin Heavy Chain Variable Region, IRC = Independent Review Committee, N = number, NR = not reached, PFS = progression-free survival, ZAP-70 = zeta-chain-associated protein kinase 70.
Croatian: Kratice: β2M = beta-2-mikroglobulin, CI = interval pouzdanosti, CIRS-G = ljestvica za ocjenu kumulativne bolesti u starijih bolesnika, KLL = kronična limfocitna leukemija, CrCl = klirens kreatinina, ECOG = istočna kooperativna onkološka skupina, IGHV (engl.
English: For patients with missing baseline data, latest screening/unscheduled data was carried forward to baseline.
Croatian: Za bolesnike u kojih su nedostajale početne vrijednosti, kao početne vrijednosti uzeli su se podaci od posljednjeg probira/neplanirane posjete.
English: The median age was 69 years (range: 35 to 92 years), 27% patients were ≥75 years of age, 63% were male and 89% were white.
Croatian: Medijan dobi iznosio je 69 godina (raspon: 35 do 92 godine), 27% bolesnika bilo je u dobi od ≥75 godina, 63% bolesnika bili su muškarci, a njih 89% bili su bijelci.
English: Resumption of Arzerra in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing hepatitis B.
Croatian: O nastavku liječenja lijekom Arzerra u bolesnika u kojih se reaktivacija povuče treba razgovarati s liječnikom koji ima iskustva u liječenju hepatitisa B.
English: • shaking or shivering
Croatian: • tresavica ili drhtanje
English: Dose modification and reinitiation of therapy after infusion-related ADRs In the event of a mild or moderate ADR, the infusion should be interrupted and restarted at half of the infusion rate at the time of interruption once the patient's condition is stable.
Croatian: Prilagodba doze i ponovno započinjanje terapije nakon nuspojava povezanih s infuzijom U slučaju blage ili umjerene nuspojave, infuziju treba prekinuti te kada bolesnikovo stanje bude stabilno, ponovno ju započeti brzinom dvostruko manjom od one koja je bila u vrijeme prekida.
English: Musculoskeletal and connective tissue disorders General disorders and administration site conditions syndrome*, chills (including rigors)*, hyperhidrosis*
Croatian: Opće tegobe i smetnje na mjestu primjene pireksija*, umor* sindrom oslobađanja citokina*, zimica (uključujući tresavicu)*, hiperhidr oza *
English: The clinical status of the patient and the ADR profile of ofatumumab should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8).
Croatian: Pri razmatranju bolesnikove sposobnosti provođenja aktivnosti koje zahtijevaju mogućnost rasuđivanja te motoričke i kognitivne vještine, treba imati na umu klinički status bolesnika i profil nuspojava ofatumumaba (vidjeti dio 4.8).
English: How to store Arzerra
Croatian: Kako čuvati lijek Arzerra
English: Do not shake the ofatumumab vial for this inspection.
Croatian: Za ovu provjeru, ne tresite bočicu ofatumumaba.
English: The safe use of ofatumumab in humans during lactation has not been established.
Croatian: U ljudi nije utvrđena sigurnost primjene ofatumumaba tijekom dojenja.
English: Anaphylactic reactions (including anaphylactic shock)*
Croatian: Poremećaji imunološkog sustava preosjetljivost* anafilaktičke reakcije (uključujući anafilaktički šok)*
English: Discard any unused solution after this time.
Croatian: Nakon tog vremena treba baciti svu neiskorištenu otopinu.
English: In patients with CLL, tumour lysis syndrome (TLS) may occur with use of Arzerra.
Croatian: Uz primjenu Arzerre u bolesnika s KLL-om može doći do sindroma lize tumora (TLS; eng. tumour lysis syndrome).
English: Additionally a group of patients (n=16) who were intolerant/ineligible for fludarabine treatment and/or intolerant to alemtuzumab treatment were treated with Arzerra.
Croatian: Lijekom Arzerra je liječena i skupina bolesnika (n=16) koji nisu podnosili/bili podobni za primanje terapije fludarabinom i/ili nisu podnosili terapiju alemtuzumabom.
English: • If you do become pregnant during treatment with Arzerra, tell your doctor.
Croatian: • Recite svom liječniku ako zatrudnite tijekom terapije lijekom Arzerra.
English: Abbreviations: CI = confidence interval, CLL = chronic lymphocytic leukaemia, CR = complete response, IRC = Independent Review Committee, MRD = minimal residue disease, N = number, ORR = overall response rate
Croatian: Kratice: CI = interval pouzdanosti, KLL = kronična limfocitna leukemija, CR = potpuni odgovor, MRD (engl.
English: Complete resolution of constitutional symptoms b
Croatian: 9/l) Potpuni oporavak od osnovnih simptoma b
English: Ofatumumab has also been shown to induce cell lysis in both high and low CD20 expressing cells and in rituximabresistant cells.
Croatian: Za ofatumumab je pokazano i da inducira lizu stanica i u stanica s visokom i u stanica s niskom ekspresijom CD20, kao i u stanica otpornih na rituksimab.
English: Arzerra is available in packs of 1 vial.
Croatian: Arzerra je dostupna u pakiranju s 1 bočicom.
English: Median time to next therapy was longer for the OFA+FC arm versus FC (48.1 months versus 40.1 months; HR: 0.73; 95% CI: 0.51-1.05).
Croatian: Medijan vremena do sljedeće terapije je bio duži za skupinu OFA+FC nego za FC (48,1 mjesec naspram 40,1 mjesec; HR: 0,73; 95% CI: 0,51-1,05).
English: The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed doubling the rate every 30 minutes).
Croatian: Brzinu infuzije i dalje se može povećavati sukladno standardnom postupku, mišljenju liječnika i bolesnikovoj podnošljivosti (brzina se ne smije udvostručavati u intervalima manjim od 30 minuta).
English: 300 mg dose - Use three 100 mg/5 ml vials (15 ml total, 5 ml per vial):
Croatian: Doza od 300 mg - koristite tri bočice od 100 mg/5 ml (15 ml ukupno, 5 ml po bočici):
English: You will be given medicines such as anti-histamines, steroids or pain relievers to help reduce any reaction.
Croatian: Kako bi se smanjila bilo koja reakcija, dobit ćete lijekove poput antihistaminika, steroida ili lijekova protiv bolova.
English: Each glass vial is closed with a rubber stopper and aluminium over-seal, and contains 50 ml of concentrate (1000 mg of ofatumumab).
Croatian: Jedna staklena bočica je zatvorena gumenim čepom te aluminijskim pokrovnim čepom, a sadrži 50 ml koncentrata (1000 mg ofatumumaba).
English: Median time to progression was longer for the OFA+FC arm versus FC (42.1 months versus 26.8 months; HR: 0.63; 95% CI: 0.45-0.87).
Croatian: Medijan vremena do progresije je bio duži za skupinu OFA+FC nego za FC (42,1 mjesec naspram 26,8 mjeseci; HR: 0,63; 95% CI: 0,45-0,87.)
English: No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min).
Croatian: Ne preporučuje se prilagođavanje doze kod bolesnika s blagim do umjerenim oštećenjem bubrega (klirens kreatinina >30 ml/min).
English: Common symptoms of an infusion-related reaction (may affect up to 1 in 10 people):
Croatian: Česti simptomi reakcije povezane s infuzijom (mogu se javiti u do 1 na 10 osoba):
English: Subsequent infusions
Croatian: Sljedeće infuzije
English: The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed increasing the rate every 30 minutes).
Croatian: Brzinu infuzije i dalje se može povećavati sukladno standardnom postupku, mišljenju liječnika i bolesnikovoj podnošljivosti (brzina se ne smije povećavati u intervalima manjima od 30 minuta).
English: Lymphadenopathy 50% improvement Complete resolution Splenomegaly 50% improvement Complete resolution Hepatomegaly 50% improvement Complete resolution Haemoglobin <11 g/dl at baseline to >11 g/dl post baseline Platelet counts ≤100x10 increase or >100x10 Neutrophils <1x10
Croatian: Potpuni oporavak Hemoglobin <11 g/dl za početne vrijednosti do >11 g/dl nakon početka Broj trombocita ≤100x10 vrijednosti do >50% povećanje ili >100x10 nakon početka Neutrofili <1x10
English: No formal studies of Arzerra in patients with hepatic impairment have been performed.
Croatian: Nisu provedena ispitivanja lijeka Arzerra u bolesnika s oštećenjima jetre.
English: Each glass vial is closed with a rubber stopper and aluminium over-seal, and contains 5 ml of concentrate (100 mg of ofatumumab).
Croatian: Jedna staklena bočica je zatvorena gumenim čepom te aluminijskim pokrovnim čepom, a sadrži 5 ml koncentrata (100 mg ofatumumaba).
English: Uncommon symptoms of an infusion-related reaction (may affect up to 1 in 100 people):
Croatian: Manje česti simptomi reakcije povezane s infuzijom (mogu se javiti u do 1 na 100 osoba):
English: None of the patients had an increase of QTc to >500 msec. A concentration-dependent increase in QTc was not detected.
Croatian: Niti u jednog se bolesnika QTc interval nije produljio na > 500 ms.
English: • Withdraw 50 ml of ofatumumab from each of the two 1000 mg vials and inject into the 1000 ml bag;
Croatian: • Izvucite po 50 ml ofatumumaba iz svake od dvije bočice od 1000 mg te ih ubrizgajte u vrećicu od 1000 ml;
English: Any unused solution remaining after this time should be discarded.
Croatian: Nakon tog vremena, svu neiskorištenu otopinu treba baciti.
English: Cycle 1 51.8 2620
Croatian: 1. ciklus 51,8
English: How Arzerra is given
Croatian: Kako se daje lijek Arzerra
English: Risk factors for TLS include a high tumour burden, high concentrations of circulating cells (≥25,000/mm hypovolaemia, renal insufficiency, elevated pre-treatment uric acid levels and elevated lactate dehydrogenase levels.
Croatian: Čimbenici rizika za TLS uključuju veliko opterećenje tumorskom masom, visoke koncentracije cirkulirajućih stanica (≥ 25 000/mm
English: Patients received Arzerra as monthly intravenous infusions (cycle 1 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days) in combination with intravenous bendamustine 90 mg/m on days 1 and 2 every 28 days.
Croatian: Bolesnici su primali lijek Arzerra u obliku mjesečnih intravenskih infuzija (1. ciklus: 300 mg 1. dana i 1000 mg 8. dana; sljedeći ciklusi: 1000 mg 1. dana svakih 28 dana) u kombinaciji s intravenskim bendamustinom u dozi od 90 mg/m
English: Patients received either Arzerra as monthly intravenous infusions (cycle 1: 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days) in combination with chlorambucil (10 mg/m2 orally on days 1-7 every 28 days) or chlorambucil alone (10 mg/m orally on days 1-7 every
Croatian: Bolesnici su primali ili lijek Arzerra u obliku mjesečnih intravenskih infuzija (1. ciklus: 300 mg 1. dana i 1000 mg 8. dana; sljedeći ciklusi: 1000 mg 1. dana svakih 28 dana) u kombinaciji s klorambucilom (10 mg/m peroralno od 1. do 7. dana svakih
English: 1000 mg dose - Use one 1000 mg/50 ml vial (50 ml total, 50 ml per vial):
Croatian: Doza od 1000 mg - koristite jednu bočicu od 1000 mg/50 ml (50 ml ukupno, 50 ml po bočici):
English: All patients should be screened for HBV infection by measuring HBsAg and anti-HBc before initiation of Arzerra treatment.
Croatian: Prije uvođenja lijeka Arzerra potrebno je u svih bolesnika napraviti probir na infekciju HBV-om mjerenjem razine HBsAg i anti-HBc.
English: 1000 mg
Croatian: 1000 ml;
English: Live attenuated or inactivated vaccine efficacy may be impaired with ofatumumab.
Croatian: Ofatumumab može smanjiti djelotvornost živog atenuiranog ili inaktiviranog cjepiva.
English: If any infusion-related adverse reactions are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2 for further information).
Croatian: Ako se primijeti bilo koja nuspojava povezana s infuzijom, treba prekinuti davanje infuzije i ponovno započeti kada je bolesnikovo stanje stabilno (za dodatne informacije vidjeti dio 4.2).
English: 2000 mg dose - Use two 1000 mg/50 ml vials (100 ml total, 50 ml per vial):
Croatian: Doza od 2000 mg - koristite dvije bočice od 1000 mg/50 ml (100 ml ukupno, 50 ml po bočici):
English: • anaphylactic reaction including anaphylactic shock, where symptoms include breathlessness or difficulty breathing, wheezing or coughing, light-headedness, dizziness, changes in levels of consciousness, hypotension, with or without mild generalised itching, skin reddening, swelling of the face and/or throat, blue discolouration of the lips, tongue or skin
Croatian: • anafilaktička reakcija koja uključuje anafilaktički šok, kod kojeg simptomi uključuju nedostatak zraka ili otežano disanje, piskanje ili kašalj, ošamućenost, omaglicu, promjene razine svijesti,
English: Concentrate for solution for infusion.
Croatian: koncentrat za otopinu za infuziju
English: Arzerra 1000 mg sterile concentrate ofatumumab
Croatian: Arzerra 1000 mg sterilni koncentrat ofatumumab i.v.
English: Arzerra 100 mg sterile concentrate ofatumumab
Croatian: Arzerra 100 mg sterilni koncentrat ofatumumab i.v.
English: If you get any side effects, talk to your doctor or nurse.
Croatian: Ako dobijete bilo koji od ovih simptoma, odmah obavijestite svog liječnika ili medicinsku sestru.
English: No formal studies of Arzerra in patients with renal impairment have been performed.
Croatian: Nisu provedena ispitivanja lijeka Arzerra u bolesnika s oštećenjem bubrega.
English: IRC-assessed primary and subgroup analyses of PFS, months
Croatian: Primarna analiza PFS-a i analiza PFS-a po podskupinama prema ocjeni neovisnog ocjenjivačkog povjerenstva, mjeseci klorambucil (N=226)
English: In the event of a severe ADR, the infusion should be interrupted and restarted at 12 ml/hour, once the patient's condition is stable.
Croatian: U slučaju teške nuspojave, infuziju treba prekinuti te kada bolesnikovo stanje bude stabilno, ponovno ju započeti brzinom od 12 ml/sat.
English: Peripheral B-cell counts decreased after the first ofatumumab infusion in patients with haematological malignancies.
Croatian: U bolesnika s hematološkim zloćudnim bolestima broj perifernih B-stanica se nakon prve infuzije ofatumumaba smanjio.
English: Cardiac disorders
Croatian: Kardiovaskularne tegobe
English: Hepatitis B virus (HBV) infection and reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has occurred in patients treated with medicinal products classified as CD20directed cytolytic antibodies, including Arzerra.
Croatian: U bolesnika liječenih lijekovima koji su svrstani u skupinu citolitičkih protutijela s ciljanim djelovanjem na CD20, uključujući lijek Arzerra, došlo je do infekcije virusom hepatitisa B (HBV) i njegove reaktivacije, koja je u nekim slučajevima uzrokovala fulminantni hepatitis, zatajenje jetre i smrt.
English: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 50 ml of concentrate for solution for infusion.
Croatian: Prozirna staklena bočica (tip I) s čepom od bromobutilne gume te aluminijskim prstenom, koja sadrži 50 ml koncentrata za otopinu za infuziju.
English: Flush line before and after ofatumumab administration with sodium chloride 9 mg/ml (0.9%) solution for injection to avoid this.
Croatian: Kako bi to izbjegli, isperite cijev prije i poslije primjene ofatumumaba otopinom natrijevog klorida za injekcije od 9 mg/ml (0,9%).
English: Check with your doctor if you think any of these may apply to you.
Croatian: Ako smatrate da bi se bilo što od ovog moglo odnositi na Vas, provjerite to sa svojim liječnikom.
English: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 5 ml of concentrate for solution for infusion.
Croatian: Prozirna staklena bočica (tip I) s čepom od bromobutilne gume te aluminijskim prstenom, koja sadrži 5 ml koncentrata za otopinu za infuziju.
English: Vascular disorders
Croatian: Opstrukcija crijeva
English: Edetate disodium (E386) Hydrochloric acid (E507) (for pH-adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari arginin natrijev acetat (E262) natrijev klorid polisorbat 80 (E433) dinatrijev edetat (E386) kloridna kiselina (E507) (za podešavanje pH) voda za injekcije
English: Respiratory, thoracic and mediastinal disorders oropharyngeal pain*, nasal congestion*
Croatian: Krvožilni poremećaji Poremećaji dišnog sustava, prsišta i sredoprsja dispneja*, kašalj* bronhospazam*,
English: • Withdraw 50 ml of ofatumumab from the 1000 mg vial and inject into the 1000 ml bag
Croatian: • Izvucite 50 ml ofatumumaba iz bočice od 1000 mg te ih ubrizgajte u vrećicu od 1000 ml;
English: Table 2 Summary of secondary outcomes of Arzerra in combination with chlorambucil compared with chlorambucil in previously untreated CLL
Croatian: Vrijeme preživljenja bez progresije (mjeseci) Tablica 2 Sažetak sekundarnih mjera ishoda za lijek Arzerra u kombinaciji s klorambucilom u usporedbi s monoterapijom klorambucilom u bolesnika s prethodno neliječenim
English: Cases of progressive multifocal leukoencephalopathy (PML) resulting in death have been reported in CLL patients receiving cytotoxic pharmacotherapy, including ofatumumab.
Croatian: U bolesnika s KLL-om koji su primali farmakoterapiju citotoksičnim lijekovima, uključujući ofatumumab, zabilježeni su slučajevi progresivne multifokalne leukoencefalopatije (PML) koja je rezultirala smrću.
English: Infusion 1
Croatian: 1. infuzija
English: You should be tested for hepatitis B (a liver disease) before starting Arzerra treatment.
Croatian: Prije početka liječenja lijekom Arzerra morate se testirati na hepatitis B (jetrenu bolest).
English: ***Corticosteroid may be reduced for subsequent infusions at the discretion of the physician, if a severe infusion-related ADR did not occur with the preceding infusion(s).
Croatian: ***Ako bolesnik nakon prethodnih infuzija ne razvije tešku nuspojavu na lijek povezanu s infuzijom, kortikosteroid se u sljedećim infuzijama može primijeniti u smanjenoj dozi, sukladno liječničkoj procjeni.
English: Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion
Croatian: Arzerra 100 mg koncentrat za otopinu za infuziju Arzerra 1000 mg koncentrat za otopinu za infuziju
English: Each vial contains 100 mg of ofatumumab in 5 ml.
Croatian: Jedna bočica sadrži 100 mg ofatumumaba u 5 ml.
English: Chlorambuci + Chl
Croatian: Klorambucil Ofatumumab plus klorambucil
English: • breathlessness, cough
Croatian: • nedostatak zraka, kašalj
English: • Withdraw 5 ml of ofatumumab from each of the three 100 mg vials and inject into the 1000 ml bag;
Croatian: • Izvucite po 5 ml ofatumumaba iz svake od tri bočice od 100 mg te ih ubrizgajte u vrećicu od
English: • Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Croatian: • Izvucite i uklonite 100 ml otopine natrijevog klorida za injekcije od 9 mg/ml (0,9%) iz vrećice od 1000 ml;
English: If any infusion-related adverse reactions are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2 of the SmPC).
Croatian: Ako se primijeti bilo koja nuspojava povezana s infuzijom, treba prekinuti davanje infuzije i ponovno započeti kada je bolesnikovo stanje stabilno (vidjeti dio 4.2 Sažetka opisa svojstava lijeka).
English: Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion ofatumumab
Croatian: Arzerra 100 mg koncentrat za otopinu za infuziju Arzerra 1000 mg koncentrat za otopinu za infuziju ofatumumab
English: The Arzerra concentrate must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration, using aseptic technique.
Croatian: Koristeći aseptičku tehniku, Arzerra koncentrat prije davanja mora se razrijediti u otopini natrijevog klorida za injekcije od 9 mg/ml (0,9%).
English: • flushing
Croatian: • mučnina