FrancophonIA/ELRC3.0 huggingface dataset:
English: No substantial differences related to age were seen in safety and efficacy (see section 5.1).
Croatian: Nisu utvrđene značajne razlike u sigurnosti primjene ili djelotvornosti povezane s dobi (vidjeti dio 5.1).
English: No teratogenicity or maternal toxicity were observed in an animal reproduction study with administration of ofatumumab to pregnant monkeys (see section 5.3).
Croatian: Nije uočena teratogenost ili toksičnost za majku u reprodukcijskom ispitivanju na životinjama kada se ofatumumab primjenjivao u gravidnih ženki majmuna (vidjeti dio 5.3).
English: Your doctor may test the amount of electrolytes, such as magnesium and potassium, in your blood before and during your treatment with Arzerra.
Croatian: Vaš će liječnik možda provesti pretrage kako bi utvrdio količinu elektrolita u krvi, poput magnezija i kalija, prije i tijekom liječenja lijekom Arzerra.
English: 28 days.
Croatian: 1. dana svakih 28 dana.
English: The median progression-free survival was 5.5 months (95% CI: 4.6, 6.4) and the median overall survival was 17.4 months (95% CI: 15.0, 24.0).
Croatian: Medijan preživljenja bez progresije bio je 5,5 mjeseci (95% CI: 4,6; 6,4), a medijan ukupnog preživljenja bio je 17,4 mjeseca (95% CI: 15,0; 24,0).
English: Peripheral B-cell counts remained low throughout the remainder of therapy in most patients and remained below baseline up to 15 months after the last dose in patients who responded.
Croatian: Broj perifernih Bstanica je u većine bolesnika ostao nizak tijekom ostatka terapije, a u bolesnika koji su odgovorili na liječenje zadržao se ispod početnih vrijednosti do 15 mjeseci nakon posljednje doze.
English: Treatment with Arzerra (when given as 4 once-weekly infusions), led to a 50% objective response rate in the highest dose group (1st dose: 500 mg; 2nd, 3rd and 4th dose: 2,000 mg) and included 12 partial remissions and one nodular partial remission.
Croatian: Terapija lijekom Arzerra (davana kao 4 infuzije jednom tjedno) dovela je do stope objektivnog odgovora od 50% u skupini s najvišom dozom (1. doza: 500 mg; 2., 3. i 4. doza: 2000 mg) i uključivala je 12 djelomičnih remisija i jednu nodularnu djelomičnu remisiju.
English: Overall, the pharmacokinetics of ofatumumab were consistent across the indications, whether given as a single agent or in combination with fludarabine and cyclophosphamide or chlorambucil.
Croatian: Sveukupno, farmakokinetika ofatumumaba bila je konzistentna u svim indikacijama, bilo da se davao u monoterapiji ili u kombinaciji s fludarabinom i ciklofosfamidom ili klorambucilom.
English: Arzerra was also given to a group of patients (n=112) with bulky lymphadenopathy (defined as at least one lymph node >5 cm) who were also refractory to fludarabine.
Croatian: Arzerra je bila primijenjena i skupini bolesnika (n=112) s izraženijom limfadenopatijom (definiranom kao barem jedan limfni čvor > 5cm), a koji također nisu reagirali na fludarabin.
English: ------Chlorambucil (N=226) Median 13.1 months____Ofatumumab + Chlorambucil (N=221)
Croatian: ------Klorambucil (N=226) Medijan 13,1 mjeseci ____ Ofatumumab + klorambucil (N=221) Medijan 22,4 mjeseci
English: Due to the risk of infection, administration of live attenuated vaccines should be avoided during and after treatment with ofatumumab, until B-cell counts are normalised.
Croatian: Zbog rizika od infekcije, tijekom i nakon terapije ofatumumabom treba izbjegavati primjenu živih atenuiranih cjepiva, sve do normalizacije broja B-stanica.
English: From a microbiological point of view, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stajališta, pripremljenu otopinu treba primijeniti odmah.
English: Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule.
Croatian: Ofatumumab je ljudsko monoklonsko protutijelo (IgG1) koje se specifično veže za određeni epitop, obuhvaćajući i male i velike izvanstanične petlje molekule CD20.
English: The antibody in Arzerra recognises a substance on the surface of lymphocytes and causes the lymphocyte to die.
Croatian: Antitijela u lijeku Arzerra prepoznaju tvar na površini limfocita i uzrokuju njihovu smrt.
English: Cycle 1 61.4
Croatian: 1. ciklus 61,4
English: Administration of live vaccines to neonates and infants exposed to ofatumumab in utero should be avoided until B-cell recovery occurs (see sections 4.4 and 4.5).
Croatian: Potrebno je izbjegavati primjenu živih cjepiva u novorođenčadi i dojenčadi koja su bila izložena ofatumumabu in utero dok se broj B-stanica ne oporavi (vidjeti dijelove 4.4 i 4.5).
English: No clinically relevant pharmacokinetic interactions were observed between ofatumumab and fludarabine, cyclophosphamide,bendamustine, chlorambucil, or its active metabolite, phenylacetic acid mustard.
Croatian: Nisu uočene klinički značajne farmakokinetičke interakcije između ofatumumaba i fludarabina, ciklofosfamida, bendamustina, klorambucila niti njegova aktivna metabolita, {4-[bis(2-kloroetil)amino]fenil}acetatne kiseline.
English: This includes 643 patients treated with ofatumumab as monotherapy (in patients with relapsed or refractory CLL) and 525 patients treated with ofatumumab in combination with chemotherapy (chlorambucil or bendamustine or fludarabine and cyclophosphamide).
Croatian: To uključuje 643 bolesnika liječena ofatumumabom u monoterapiji (bolesnici s relapsnim ili refraktornim KLL-om) i 525 bolesnika liječenih ofatumumabom u kombinaciji s kemoterapijom (klorambucil ili bendamustin ili fludarabin i ciklofosfamid).
English: • blockage in the gut (intestine), which may feel like stomach pain.
Croatian: • zastoj u crijevima koji se može osjetiti kao bol u trbuhu.
English: Patients should be closely monitored during administration of ofatumumab for the onset of infusionrelated reactions, including cytokine release syndrome, particularly during the first infusion.
Croatian: Potrebno je pomno nadzirati bolesnike tijekom primjene ofatumumaba zbog mogućeg nastupa reakcija povezanih s infuzijom, uključujući sindrom otpuštanja citokina, osobito tijekom prve infuzije.
English: The ORR was higher for OFA+FC versus FC (84% versus 68%, p=0.0003).
Croatian: ORR je bio viši za OFA+FC nego za FC (84% naspram 68%, p=0.0003).
English: • Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.
Croatian: • Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
English: Very common side effects that may show up in your blood tests:
Croatian: Vrlo česte nuspojave koje se mogu pokazati u krvnim pretragama:
English: Infusions 3* to 12 Infusion rate (ml/hour)
Croatian: 3.*-12. infuzija Brzina infuzije (ml/sat)
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije reakcije povezane s infuzijom
English: • yellow skin and eyes, nausea, loss of appetite, dark urine (possible symptoms of an infection or reactivation of hepatitis B virus)
Croatian: • žuta koža i oči, mučnina, gubitak teka, tamna mokraća (mogući simptomi infekcije virusom hepatitisa B ili reaktivacije virusa hepatitisa B)
English: The main pharmacokinetic parameters of ofatumumab as a single agent or in combination are summarised in Table 5.
Croatian: Glavni farmakokinetički parametri ofatumumaba u monoterapiji ili u kombinaciji sažeti su u Tablici 5.
English: Thirteen (7%) patients treated with ofatumumab in combination with fludarabine and cyclophosphamide, and 5 (3%) patients treated with fludarabine and cyclophosphamide had late-onset neutropenia.
Croatian: Trinaest (7%) bolesnika liječenih ofatumumabom u kombinaciji s fludarabinom i ciklofosfamidom, i 5 (3%) bolesnika liječenih fludarabinom i ciklofosfamidom imalo je odgođenu neutropeniju.
English: No formal studies were conducted to examine the effect of hepatic impairment.
Croatian: Nisu provedena formalna ispitivanja kojima bi se ocijenio učinak oštećenja jetre.
English: Median creatinine clearance (CrCl), assessed with the use of the Cockroft-Gault formula, was 70 ml/min and 48% of patients had a CrCl of <70 ml/min.
Croatian: Medijan klirensa kreatinina (CrCl), ocijenjen primjenom Cockroft-Gaultove formule, iznosio je 70 ml/min, a u 48% bolesnika
English: This dose will be increased, usually to 1000 mg or 2000 mg, for the remaining infusions.
Croatian: Za ostale infuzije, ova će se doza povećati obično do 1000 mg ili 2000 mg.
English: Refractory CLL:
Croatian: Refraktorni KLL:
English: It is unknown whether Arzerra is excreted in human milk, however human IgG is secreted in human milk.
Croatian: Nije utvrđeno izlučuje li se Arzerra u majčino mlijeko u ljudi, no ljudski IgG se izlučuje u majčino mlijeko.
English: • throat pain or irritation
Croatian: • bol ili iritacija grla
English: Table 3 Summary of response to Arzerra in patients with refractory CLL
Croatian: Tablica 3 Sažetak odgovora na lijek Arzerra u bolesnika s refraktornim KLL-om
English: If you are having any vaccinations tell your doctor, or the person giving you the vaccine, that you are being treated with Arzerra.
Croatian: Ako ćete primiti bilo koje cjepivo, molimo da kažete svom liječniku ili osobi koja Vam daje cjepivo da se liječite lijekom Arzerra.
English: Breast-feeding should be discontinued during treatment with Arzerra and for 12 months following treatment.
Croatian: Dojenje treba prekinuti tijekom terapije Arzerrom i 12 mjeseci nakon terapije.
English: Patients with a history of cardiac disease should be monitored closely.
Croatian: Bolesnike koji u anamnezi imaju bolest srca treba pozorno pratiti.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip*
English: • Subsequent cycles (up to a maximum of 6 cycles in total): 1000 mg on day 1 every 28 days.
Croatian: • Sljedeći ciklusi (tijekom najviše 6 ciklusa ukupno): 1000 mg 1. dana svakih 28 dana.
English: Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Croatian: Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
English: ORR (%) 95% CI P value p<0.001
Croatian: ORR (%) 95% CI p-vrijednost p< 0,001
English: Study OMB115991 evaluated the efficacy of Arzerra in combination with bendamustine in 44 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment.
Croatian: U ispitivanju OMB115991 ocjenjivala se djelotvornost lijeka Arzerra u kombinaciji s bendamustinom u 44 bolesnika s prethodno neliječenim KLL-om za koje se smatralo da nisu podobni za liječenje utemeljeno na fludarabinu.
English: These may affect up to 1 in 10 people:
Croatian: Ove se mogu javiti u do 1 na 10 osoba:
English: The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complementdependent cytotoxicity and resultant lysis of tumour cells.
Croatian: Vezivanje ofatumumaba na proksimalni membranski epitop CD20 molekule uzrokuje regrutaciju i aktivaciju puta komplementa na staničnoj površini što dovodi do citotoksičnosti ovisne o komplementu i rezultirajućoj lizi tumorskih stanica.
English: Arzerra should be permanently discontinued in patients who develop an anaphylactic reaction to the medicinal product.
Croatian: Arzerru treba trajno obustaviti u bolesnika koji razviju anafilaktičku reakciju na lijek.
English: • Use a reliable method of contraception to avoid becoming pregnant while you are being treated with Arzerra, and for 12 months after your last dose of Arzerra.
Croatian: • Koristite pouzdane metode kontracepcije kako biste spriječili trudnoću za vrijeme liječenja lijekom Arzerra te tijekom najmanje 12 mjeseci nakon zadnje doze lijeka Arzerra.
English: Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL.
Croatian: Arzerra je indicirana u kombinaciji s fludarabinom i ciklofosfamidom za liječenje odraslih bolesnika s relapsnim KLL-om.
English: Arzerra should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available.
Croatian: Lijek Arzerra smije se primjenjivati samo pod nadzorom liječnika koji ima iskustva u primjeni antitumorske terapije te u okruženju u kojem je odmah dostupna sva oprema za oživljavanje.
English: 8 weekly infusions followed by 4 monthly infusions th dose 827
Croatian: 8 tjednih infuzija nakon kojih slijede 4 mjesečne infuzije
English: • difficulty in breathing, shortness of breath, chest tightness, cough
Croatian: • teškoće s disanjem, nedostatak zraka, stezanje u prsnom košu, kašalj
English: Figure 2 Kaplan-Meier estimates of PFS in relapsed CLL
Croatian: Slika 2 Kaplan-Meierova krivulja procijenjenog PFS-a kod relapsnog KLL-a
English: • fluid in the lungs (pulmonary oedema) causing breathlessness
Croatian: • tekućina u plućima (plućni edem), koja uzrokuje nedostatak zraka
English: Patients with benefit/patients with abnormality at baseline (%) Patients refractory to fludarabine and alemtuzumab
Croatian: Bolesnici s koristi/bolesnici s abnormalnim početnim vrijednostima (%) Bolesnici koji ne reagiraju na fludarabin i alemtuzumab
English: For the highest dose group, the median time to progression was 15.6 weeks (95% CI: 15,22.6) in the full analysis population, and 23 weeks (CI: 20,31) in responders.
Croatian: Za skupinu koja je primala najvišu dozu medijan vremena do progresije bio je 15,6 tjedana (95% CI: 15, 22,6) u cijeloj analiziranoj populaciji, i 23 tjedna (CI: 20; 31) u bolesnika koji su odgovorili na terapiju.
English: In addition, the binding of ofatumumab allows the recruitment of natural killer cells allowing the induction of cell death through antibody-dependent cell-mediated cytotoxicity.
Croatian: Dodatno, vezanje ofatumumaba omogućuje regrutiranje NK(od eng. natural killer) stanica što dovodi do poticanja smrti stanica putem citotoksičnosti ovisne o protutijelima posredovane stanicama.
English: Arzerra 1000 mg is available in a pack containing 1 vial.
Croatian: Arzerra 1000 mg dostupna je u pakiranju koje sadrži 1 bočicu.
English: Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of complement defence molecules.
Croatian: Za ofatumumab je pokazano da inducira značajnu lizu stanica koje imaju visoku razinu ekspresije molekula za obranu od komplementa.
English: Of the 1,168 patients receiving ofatumumab in clinical trials for CLL, 682 patients (58%) experienced an infection.
Croatian: Od 1168 bolesnika liječenih ofatumumabom u kliničkim ispitivanjima KLL-a, njih 682 (58%) imalo je infekciju.
English: Intravenous and subcutaneous administration to monkeys resulted in the expected depletion of peripheral and lymphoid tissue B-cell counts with no associated toxicological findings.
Croatian: Intravenska i supkutana primjena u majmuna je izazvala očekivano smanjenje broja B-stanica na periferiji i u limfnom tkivu, bez sa tim povezanim toksikološkim nalazima.
English: • fever or, alternatively, a very low body temperature, chest pain, shortness of breath or rapid breathing, shaking, chills, confusion, dizziness, decreased urination and rapid pulse, (possible symptoms of blood infection)
Croatian: • vrućica ili, u drugom slučaju, vrlo niska tjelesna temperatura, bol u prsnom košu, nedostatak zraka ili ubrzano disanje, tresavica, zimica, smetenost, omaglica, smanjeno mokrenje i ubrzani puls, (mogući simptomi infekcije krvi)
English: Paediatric population No pharmacokinetic data are available in paediatric patients.
Croatian: Ne postoje farmakokinetički podaci za pedijatrijsku populaciju.
English: Any unused infusion solution should be discarded 24 hours after preparation.
Croatian: Sva infuzijska otopina koja nije iskorištena mora se baciti 24 sata nakon pripreme.
English: *Up to 13 infusions in previously untreated CLL; up to 7 infusions in relapsed CLL **Corticosteroid may be either reduced or omitted for subsequent infusions at the discretion of the physician, if a severe infusion-related adverse drug reaction (ADR) did not occur with the preceding infusion(s).
Croatian: *Do 13 infuzija kod prethodno neliječenog KLL-a; do 7 infuzija kod relapsnog KLL-a **Ako bolesnik nakon prethodnih infuzija ne razvije tešku nuspojavu na lijek povezanu s infuzijom, kortikosteroid se u sljedećim infuzijama može ili primijeniti u smanjenoj dozi ili izostaviti, sukladno liječničkoj procjeni.
English: If an infusion-related ADR is observed during infusion, see below section “Dose modification and reinitiation of therapy after infusion-related ADRs”.
Croatian: Ako se tijekom infuzije uoči nuspojava povezana s infuzijom, vidjeti dio ispod „Prilagodba doze i ponovno započinjanje terapije nakon nuspojava povezanih s infuzijom“.
English: If an anaphylactic reaction occurs, Arzerra should be immediately and permanently discontinued and appropriate medical treatment should be initiated.
Croatian: Ako dođe do anafilaktičke reakcije, odmah treba trajno prekinuti primjenu Arzerre i započeti s odgovarajućim liječenjem.
English: The median CIRS score was 7 (range: 4 to 17), 36% of patients had CrCL <70 ml/min, 93% of patients had ECOG 0 or 1.
Croatian: Medijan rezultata na ljestvici za ocjenu kumulativne bolesti (engl. cumulative illness rating score, CIRS) iznosio je 7 (raspon: 4 do 17), 36% bolesnika imalo je CrCl <70 ml/min, 93% bolesnika imalo je ECOG status 0 ili 1.
English: Driving and using machines Arzerra is unlikely to affect your ability to drive or use machines.
Croatian: Malo je vjerojatno da će Arzerra utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: The response to vaccination could be impaired when B-cells are depleted.
Croatian: Odgovor na cijepljenje može biti oslabljen pri smanjenom broju B-stanica.
English: If a diagnosis of PML is suspected Arzerra should be discontinued and referral to a neurologist should be considered.
Croatian: Ako se sumnja na dijagnozu PML, treba prekinuti s davanjem lijeka Arzerra i uputiti bolesnika neurologu.
English: Arzerra contains 34.8 mg sodium in each 300 mg dose, 116 mg sodium in each 1000 mg dose and 232 mg sodium in each 2000 mg dose.
Croatian: Arzerra sadrži 34,8 mg natrija u svakoj dozi od 300 mg, 116 mg natrija u svakoj dozi od 1000 mg i 232 mg natrija u svakoj dozi od 2000 mg.
English: Previously untreated CLL and relapsed CLL:
Croatian: Prethodno neliječen KLL i relapsni KLL:
English: There is a potential for immunogenicity with therapeutic proteins such as ofatumumab.
Croatian: Kod terapijskih proteina poput ofatumumaba postoji potencijal za imunogenost.
English: Of the 1,168 patients receiving ofatumumab in clinical trials, 420 patients (36%) experienced an adverse event associated with a decreased neutrophil count; 129 (11%) experienced a serious adverse event associated with a decreased neutrophil count.
Croatian: Od 1168 bolesnika liječenih ofatumumabom u kliničkim ispitivanjima, u njih 420 (36%) pojavila se nuspojava povezana sa smanjenim brojem neutrofila; 129 (11%) bolesnika imalo je ozbiljnu nuspojavu povezanu sa smanjenim brojem neutrofila.
English: If the infusion rate had not been increased from the starting rate of 12 ml/hour prior to interrupting due to an ADR, the infusion should be restarted at 12 ml/hour, the standard starting infusion rate.
Croatian: Ako se prije prekida infuzije zbog nuspojava brzina davanja nije povisila s početnih 12 ml/sat, brzina pri ponovnom započinjanju infuzije treba biti 12 ml/sat, što je standardna početna brzina infuzije.
English: Arzerra is therefore not recommended for use in this patient population.
Croatian: Stoga se primjena Arzerre u toj skupini bolesnika ne preporučuje.
English: It is recommended that patients have electrolytes such as potassium and magnesium measured prior to and during the administration of ofatumumab.
Croatian: U bolesnika se preporučuje izmjeriti vrijednosti elektrolita poput kalija i magnezija prije i tijekom primjene ofatumumaba.
English: Of the 1,168 patients receiving ofatumumab in clinical trials for CLL, the most frequently observed ADRs were infusion-related reactions which occurred in 711 patients (61%) at any time during treatment.
Croatian: Od 1168 bolesnika liječenih ofatumumabom u kliničkim ispitivanjima KLL-a, najčešće primijećene nuspojave na lijek bile su reakcije povezane s infuzijom, koje su se javile u 711 bolesnika (61%) u nekom trenutku tijekom liječenja.
English: 3) How to administer the diluted solution
Croatian: 3) Kako primijeniti razrijeđenu otopinu
English: Progressive multifocal leukoencephalopathy (PML) Progressive multifocal leukoencephalopathy (PML), a serious and life-threatening brain condition, has been reported with medicines like Arzerra.
Croatian: Progresivna multifokalna leukoencefalopatija (PML) Kod lijekova kao što je Arzerra zabilježena je progresivna multifokalna leukoencefalopatija (PML), koja je ozbiljno i životno ugrožavajuće stanje koje pogađa mozak.
English: This medicinal product contains 34.8 mg sodium per 300 mg dose, 116 mg sodium per 1000 mg dose and 232 mg sodium per 2000 mg dose.
Croatian: Ovaj lijek sadrži 34,8 mg natrija u dozi od 300 mg, 116 mg natrija u dozi od 1000 mg i 232 mg natrija u dozi od 2000 mg.
English: Breast-feeding is not recommended during treatment with Arzerra and for 12 months after the last dose.
Croatian: Dojenje se ne preporučuje tijekom terapije lijekom Arzerra te tijekom 12 mjeseci nakon zadnje doze.
English: Infusion-related reactions may include, but are not limited to, anaphylactoid events, bronchospasm, cardiac events (e.g. myocardial ischaemia/infarction, bradycardia), chills/rigors, cough, cytokine release syndrome, diarrhoea, dyspnoea, fatigue, flushing, hypertension, hypotension, nausea, pain, pulmonary oedema, pruritus, pyrexia, rash, and urticaria.
Croatian: Reakcije na infuziju mogu uključivati, između ostaloga, anafilaktoidne događaje, bronhospazam, srčane tegobe (npr. ishemiju/infarkt miokarda, bradikardiju), zimice/tresavice, kašalj, sindrom oslobađanja citokina, proljev, dispneju, umor, navale crvenila, hipertenziju, hipotenziju, mučninu, bolove, plućni edem, pruritus, pireksiju, osip i urtikariju.
English: Subsequent infusions*
Croatian: Sljedeće infuzije*
English: • allergic reactions, sometimes severe where symptoms include raised and itchy rash (hives),
Croatian: • alergijske reakcije, ponekad teške kod kojih simptomi uključuju ispupčen osip koji svrbi
English: Increases above 5 msec were observed in the median/mean QT/QTc intervals in the pooled analysis.
Croatian: U objedinjenoj su analizi primijećena produljenja medijana/srednje vrijednosti QT/QTc intervala veća od 5 ms.
English: When ofatumumab was administered in combination with fludarabine and cyclophosphamide in patients with relapsed CLL, the median decrease from baseline was 60% after the first infusion and complete depletion (100%) was reached after 4 cycles.
Croatian: Kada se ofatumumab primjenjivao u kombinaciji s fludarabinom i ciklofosfamidom u bolesnika s relapsnim KLL-om, medijan smanjenja od početne vrijednosti bio je 60% nakon prve infuzije, a potpuno smanjenje (100%) je postignuto nakon 4 ciklusa.
English: Previously untreated CLL and relapsed CLL
Croatian: Prethodno neliječen KLL i relapsni KLL
English: It is not known whether the ingredients in Arzerra pass into human milk.
Croatian: Nije poznato prelaze li sastojci lijeka Arzerra u majčino mlijeko.
English: Arzerra 100 mg is available in a pack containing 3 vials.
Croatian: Arzerra 100 mg dostupna je u pakiranju koje sadrži 3 bočice.
English: If the coadministration is judged unavoidable, the risks and benefits of vaccinating patients during therapy with ofatumumab should be considered (see section 4.4).
Croatian: Ako se procijeni da je istovremena primjena neizbježna, treba razmotriti rizike i koristi cijepljenja za bolesnika tijekom primanja terapije ofatumumabom (vidjeti dio 4.4.).