FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended to verify the patient's immune status before dosing since severely immunocompromised patients (e.g. with lymphopenia, neutropenia, hypogammaglobulinemia) should not be treated (see sections 4.3 and 4.8).
Slovenian: Pred uporabo zdravila je priporočljivo preveriti bolnikovo imunsko stanje, saj se imunsko zelo oslabelih bolnikov (npr. z limfopenijo, nevtropenijo, hipogamaglobulinemijo) ne sme zdraviti (glejte poglavji 4.3 in 4.8).
English: · The product is intended for single use only.
Slovenian: • Zdravilo je namenjeno le za enkratno uporabo.
English: Women of child bearing potential should use contraception while receiving Ocrevus and for 12 months after the last infusion of Ocrevus (see below and section 5.1 and 5.2).
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Ocrevus in še 12 mesecev po zadnjem odmerku zdravila Ocrevus uporabljati kontracepcijo (glejte spodaj in poglavji 5.1 in 5.2).
English: In the Phase III studies, between each dose of Ocrevus, up to 5% of patients showed B-cell repletion (> lower limit of normal (LLN) or baseline) at least at one time point.
Slovenian: V študijah faze III so med posameznimi odmerki zdravila Ocrevus pri do 5 % bolnikov na vsaj eni časovni točki ugotovili ponovni porast celic B (> spodnja normalna meja ali izhodiščna vrednost).
English: In other auto-immune conditions, use of Ocrevus concomitantly with immunosuppressive medications (e.g. chronic corticosteroids, non-biologic and biologic disease-modifying antirheumatic drugs [DMARDS], mycophenolate mofetil, cyclophosphamide, azathioprine) resulted in an increase of serious infections, including opportunistic infections.
Slovenian: Pri drugih avtoimunskih boleznih je uporaba zdravila Ocrevus sočasno z imunosupresivnimi zdravili (npr. kronično uporabljanimi kortikosteroidi, nebiološkimi in biološkimi imunomodulirajočimi antirevmatičnimi zdravili (DMARD - disease-modifying antirheumatic drugs), mofetilmikofenolatom, ciklofosfamidom, azatioprinom) povzročila porast resnih okužb, vključno z oportunističnimi okužbami.
English: · Physicians should alert patients that an IRR can occur within 24 hours of infusion.
Slovenian: • Zdravniki morajo bolnike opozoriti, da se lahko z infuzijo povezana reakcija pojavi v 24 urah po infundiranju.
English: Do not use the solution if discoloured or if the solution contains foreign particulate matter (see section 3 for a description of the solution).
Slovenian: Raztopine ne uporabite, če je spremenjene barve ali vsebuje tuje delce (za opis raztopine glejte poglavje 3).
English: · In Relapsing forms of MS (RMS),Ocrevus helps to significantly reduce the number of attacks (relapses) and significantly slow down the progression of the disease.
Slovenian: • Pri recidivnih oblikah multiple skleroze (RMS) zdravilo Ocrevus bistveno zmanjša število napadov (recidivov) in bistveno upočasni napredovanje bolezni.
English: · Prior to the start of the intravenous infusion, the content of the infusion bag should be at room temperature to avoid an infusion reaction due to the administration of the solution at low temperatures.
Slovenian: • Pred začetkom intravenskega infundiranja mora biti vsebina vreče na sobni temperaturi, da bi preprečili infuzijsko reakcijo kot posledico dajanja raztopine pri nizki temperaturi.
English: · The rate can be increased in 30 mL/hour increments every 30 minutes to a maximum of 180 mL/hour.
Slovenian: • Hitrost je mogoče na 30 minut povečevati po 30 ml/uro do največ 180 ml/uro.
English: Ocrevus treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to manage severe reactions such as serious infusion-related reactions (IRRs).
Slovenian: Zdravljenje z zdravilom Ocrevus morajo začeti in nadzorovati usposobljeni zdravniki z izkušnjami pri odkrivanju in zdravljenju nevroloških stanj, ki imajo dostop do ustrezne medicinske podpore, potrebne za obvladanje hudih reakcij, kot so na primer resne z infuzijo povezane reakcije.
English: Patients in MS trials (WA21092, WA21093 and WA25046) were tested at multiple time points (baseline and every 6 months post treatment for the duration of the trial) for anti-drug antibodies (ADAs).
Slovenian: Bolnike v preskušanjih za multiplo sklerozo (WA21092, WA21093 in WA25046) so na več časovnih točkah (izhodiščno in vsakih 6 mesecev po zdravljenju med trajanjem preskušanja) testirali glede protiteles proti zdravilu (ADA - anti-drug antibodies).
English: The table 2 summarises the ADRs that have been reported in association with the use of Ocrevus in 1311 patients (3054 patient years) during the controlled treatment periods of MS clinical trials.
Slovenian: Preglednica 2 povzema neželene učinke, o katerih so poročali v zvezi z uporabo zdravila Ocrevus pri 1311 bolnikih (3054 bolnik-let) med obdobji kontroliranega zdravljenja v kliničnih preskušanjih pri multipli sklerozi.
English: The overall exposure (AUC over the 24 weeks dosing interval) was identical in the 2 x 300 mg in PPMS and 1 x 600 mg in RMS studies, as expected given an identical dose was administered.
Slovenian: Celotna izpostavljenost (AUC v 24-tedenskem intervalu odmerjanja) je bila v študijah z 2 x 300 mg pri PPMS in z 1 x 600 mg pri RMS enaka, kot je pričakovati glede na to, da je bil uporabljen enak odmerek.
English: When initiating Ocrevus after an immunosuppressive therapy or initiating an immunosuppressive therapy after Ocrevus, the potential for overlapping pharmacodynamic effects should be taken into consideration (see section 5.1 Pharmacodynamic effects).
Slovenian: V primeru uvedbe zdravila Ocrevus po imunosupresivnih zdravilih ali v primeru uvedbe imunosupresivnih zdravil po zdravilu Ocrevus je treba upoštevati možnost za prekrivanje farmakodinamičnih učinkov (glejte poglavje 5.1, Farmakodinamični učinki).
English: No incompatibilities between Ocrevus and polyvinyl chloride (PVC) or polyolefin (PO) bags and intravenous administration sets have been observed.
Slovenian: 6.2 Inkompatibilnosti Opazili niso nobenih inkompatibilnosti med zdravilom Ocrevus in polivinilkloridnimi (PVC) ali poliolefinskimi (PO) vrečami in kompleti za intravensko dajanje.
English: Neither carcinogenicity nor mutagenicity studies have been conducted with ocrelizumab.
Slovenian: Z okrelizumabom niso izvedli ne študij kancerogenosti ne mutagenosti.
English: The percentage of patients with seroprotective titers against five influenza strains ranged from 20.0-60.0% and 16.7-43.8% pre-vaccination and at 4 weeks post vaccination from 55.6-80.0% in patients treated with ocrelizumab and 75.0-97.0% in the control group , respectively.
Slovenian: Delež bolnikov s serološkimi zaščitnimi titri proti petim sevom gripe je bil pred cepljenjem 20,0-60,0 % pri bolnikih, zdravljenih z okrelizumabom, in 16,7-43,8 % v kontrolni skupini, 4 tedne po cepljenju pa 55,6-80,0 % pri bolnikih, zdravljenih z okrelizumabom, in 75,0-97,0 % v kontrolni skupini.
English: Your doctor will consider the benefit of you taking Ocrevus against the risk to your baby.
Slovenian: Zdravnik bo pretehtal koristi uporabe zdravila Ocrevus v primerjavi s tveganjem za otroka.
English: Therefore, after Dose 1 it is recommended to administer Ocrevus in a 600 mg single infusion (see section 4.2) to reduce the total number of infusions (with concurrent exposure to prophylactic methylprednisolone and an antihistamine) and the related infusion reactions).
Slovenian: Zato je zdravilo Ocrevus po 1. odmerku priporočljivo dajati v eni 600-mg infuziji (glejte poglavje 4.2), da bi zmanjšali celotno število infundiranj (s sočasno izpostavljenostjo profilaktičnemu metilprednizolonu in antihistaminiku) in z njimi povezanih reakcij.
English: There is a limited amount of data from the use of Ocrevus in pregnant women.
Slovenian: O uporabi zdravila Ocrevus pri nosečnicah je podatkov malo.
English: 90% of all patients had their B-cells repleted to LLN or baseline by approximately two and a half years after the last infusion.
Slovenian: Pri 90 % bolnikov se je število celic B vrnilo na spodnjo normalno mejo ali izhodiščno raven v približno dveh letih in pol po zadnji infuziji zdravila.
English: It will be given as an infusion into a vein (intravenous infusion or IV infusion).
Slovenian: Dobili ga boste kot infuzijo v veno (intravenska infuzija ali i.v.
English: The initial infusion rate at restart should be half of the infusion rate at the time of onset of the reaction.
Slovenian: Začetna hitrost infundiranja ob ponovnem začetku mora biti polovica tiste hitrosti, pri kateri je prišlo do reakcije.
English: Your doctor will tell you whether your MS may affect your ability to drive or use tools and machines safely.
Slovenian: Zdravnik vam bo povedal, ali lahko multipla skleroza vpliva na vašo sposobnost za varno upravljanje upravljanja vozil in strojev.
English: · Initial Dose
Slovenian: • Začetni odmerek
English: Sinusitis, bronchitis, oral herpes, gastroenteritis, respiratory tract infection, viral infection, herpes zoster, conjunctivitis, cellulitis
Slovenian: nazofaringitis, gripa sinuzitis, bronhitis, oralni herpes, gastroenteritis, okužba dihal, virusna okužba, herpes zoster, konjunktivitis, celulitis
English: Your doctor will wait until the infection is resolved before giving you Ocrevus.
Slovenian: Zdravnik bo počakal, dokler okužba ne mine, preden vam bo dal zdravilo Ocrevus.
English: HBV screening should be performed in all patients before initiation of treatment with Ocrevus as per local guidelines.
Slovenian: Pred začetkom zdravljenja z zdravilom Ocrevus je treba pri vseh bolnikih opraviti presejalne preiskave za HBV v skladu z lokalnimi smernicami.
English: The infusion may be slowed, temporarily stopped or permanently stopped if you have an infusion-related reaction, depending on how serious it is (see sections 2 and 4 for information about infusion-related reactions).
Slovenian: V primeru z infuzijo povezane reakcije vam lahko infundiranje upočasnijo, začasno prekinejo ali trajno prenehajo, odvisno od tega, kako resna je reakcija (za informacije o reakcijah, povezanih z infuzijo, glejte poglavji 2 in 4).
English: The 600 mg infusions in RMS and the 2 x 300 mg infusions in PPMS demonstrated consistent PK/PD profiles.
Slovenian: Infundiranja 600 mg pri RMS in 2 x 300 mg pri PPMS so pokazala skladne farmakokinetične/farmakodinamične značilnosti.
English: Additional information on IRRs can be found in section 4.4.
Slovenian: Dodatne informacije o z infuzijo povezanih reakcijah so navedene v poglavju 4.4.
English: The pharmacokinetics of ocrelizumab in the MS studies were described by a two compartment model with time-dependent clearance, and with PK parameters typical for an IgG1 monoclonal antibody.
Slovenian: Farmakokinetiko okrelizumaba v študijah za multiplo sklerozo so opisali z dvorazdelčnim modelom, v katerem je očistek odvisen od časa, in s farmakokinetičnimi parametri, značilnimi za monoklonsko protitelo IgG1.
English: If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently (see ‘Hypersensitivity Reactions' below).
Slovenian: V primeru suma na preobčutljivostno reakcijo med infundiranjem je treba infundiranje nemudoma in trajno končati (glejte "Preobčutljivostne reakcije", spodaj).
English: There is no specific antidote in the event of an overdose; interrupt the infusion immediately and observe the patient for IRRs (see section 4.4).
Slovenian: Specifičnega antidota v primeru prevelikega odmerjanja ni; infundiranje je treba nemudoma prekiniti in bolnika opazovati glede pojava z infuzijo povezanih reakcij (glejte poglavje 4.4).
English: Table 3 Study Design, Demographic and Baseline Characteristics Study 1
Slovenian: Načrt študije, demografske in izhodiščne značilnosti Študija 1
English: Each infusion will last about 3 hours 30 minutes.
Slovenian: Vsako infundiranje bo trajalo približno 3 ure in 30 minut.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: · Medicines that affect your immune system : if you have ever taken, are taking or are planning to take medicines that affect the immune system - such as chemotherapy, immunosuppressants or other medicines used to treat MS.
Slovenian: • Zdravila, ki vplivajo na imunski sistem: če ste kdaj jemali, trenutno jemljete ali nameravate začeti jemati zdravila, ki vplivajo na imunski sistem, na primer kemoterapijo, imunosupresivna zdravila ali druga zdravila, ki se uporabljajo za zdravljenje multiple skleroze.
English: Sodium Acetate Trihydrate Glacial Acetic Acid Trehalose Dihydrate Polysorbate 20
Slovenian: natrijev acetat trihidrat koncentrirana ocetna kislina trehaloza dihidrat polisorbat 20
English: Exposure in utero to ocrelizumab and vaccination of neonates and infants with live or live attenuated vaccines
Slovenian: Izpostavljenost okrelizumabu in utero in cepljenje novorojenčkov in dojenčkov z živimi ali živimi oslabljenimi cepivi
English: The maternal doses administered in this study resulted in maximum mean serum concentrations (Cmax) that were 4.5- and 21-fold above those anticipated in the clinical setting.
Slovenian: Pri materah uporabljeni odmerki so v tej študiji povzročili največjo povprečno koncentracijo v serumu (Cmax), ki je bila od 4,5- do 21-krat nad koncentracijo, predvideno pri klinični uporabi.
English: Percentage change in brain volume from Week 24 to Week 120
Slovenian: Odstotek spremembe volumna možganov od 24. do 120. tedna
English: What you need to know before you are given Ocrevus
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Ocrevus
English: · Periodic safety update reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: Relative reduction in rate of brain volume loss
Slovenian: Relativno zmanjšanje hitrosti izgubljanja volumna možganov
English: The product is intended for single use only.
Slovenian: Zdravilo je namenjeno le za enkratno uporabo.
English: Type 1 acute hypersensitivity reactions (IgE-mediated) may be clinically indistinguishable from IRR symptoms.
Slovenian: Akutne preobčutljivostne reakcije tipa 1 (posredovane z IgE) se lahko klinično ne razlikujejo od simptomov z infuzijo povezanih reakcij.
English: · Ocrevus may contain fine translucent and/or reflective particles associated with enhanced opalescence.
Slovenian: • Zdravilo Ocrevus lahko vsebuje drobne prosojne in/ali svetlobo odbijajoče delce, ki povečujejo njegovo opalescentnost.
English: In a randomized open-label study, RMS patients were able to mount humoral responses, although decreased, to tetanus toxoid, 23-valent pneumococcal polysaccharide with or without a booster vaccine, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines.
Slovenian: V randomizirani odprti študiji so bili bolniki z RMS sposobni doseči humoralne odzive, čeprav zmanjšane, na tetanusni toksoid, 23-valentni pnevmokokni polisaharid z obnovitvenim cepljenjem ali brez njega, neoantigen hemocianina iz školjke (keyhole limpet hemocyanin) in sezonska cepiva proti gripi.
English: In a randomized open-label study in RMS patients (N=102), the percentage of patients with a positive response to tetanus vaccine at 8 weeks after vaccination was 23.9% in the ocrelizumab group compared to 54.5% in the control group (no disease-modifying therapy except interferon-beta).
Slovenian: V randomizirani odprti študiji pri bolnikih z RMS (n = 102) je bil delež bolnikov s pozitivnim odzivom na tetanusno cepivo 8 tednov po cepljenju 23,9 % v skupini z okrelizumabom v primerjavi s 54,5 % v kontrolni skupini (brez zdravil, razen interferona-beta).
English: It is unknown whether ocrelizumab/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se okrelizumab ali njegovi presnovki pri človeku izločajo v materino mleko.
English: In a pre- and post-natal development study in cynomolgus monkeys, administration of ocrelizumab from gestation day 20 to approximately 5 weeks postpartum was associated with glomerulopathy, lymphoid follicle formation in bone marrow, lymphoplasmacytic renal inflammation, and decreased testicular weight in offspring.
Slovenian: V študiji pre- in postnatalnega razvoja pri opicah cynomolgus je bila uporaba okrelizumaba od 20. dne gestacije do približno 5. tedna po porodu povezana z glomerulopatijo, tvorbo limfatičnih foliklov v kostnem mozgu, limfoplazmocitnim vnetjem ledvic in zmanjšano maso mod pri potomstvu.
English: Women should be advised to discontinue breast-feeding during Ocrevus therapy.
Slovenian: Ženskam je treba svetovati, naj med zdravljenjem z zdravilom Ocrevus prenehajo dojiti.
English: The proportion of respiratory tract infections was higher in Ocrevus treated patients compared to interferon beta-1-a and placebo.
Slovenian: Delež okužb dihal je bil med prejemniki zdravila Ocrevus večji kot med prejemniki interferona beta-1a in placeba.
English: For subsequent infusions, more severe symptoms than previously experienced, or new severe symptoms, should prompt consideration of a potential hypersensitivity reaction.
Slovenian: Če se pri poznejših infundiranjih pojavijo hujši simptomi, kot jih je bolnik imel prej, ali se pojavijo novi hudi simptomi, je treba pomisliti na možnost, da gre za preobčutljivostno reakcijo.
English: Keep the vial in the outer carton in order to protect from light Keep the vials in the outer carton in order to protect from light
Slovenian: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo Viali shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
English: In the event an intravenous infusion cannot be completed the same day, the remaining solution should be discarded.
Slovenian: Če intravenskega infundiranja ni mogoče dokončati isti dan, je treba preostalo raztopino zavreči.
English: There are no dedicated PK studies of ocrelizumab in patients ≥55 years due to limited clinical experience (see section 4.2).
Slovenian: Posebnih farmakokinetičnih študij okrelizumaba pri bolnikih, starih ≥ 55 let, zaradi premalo kliničnih izkušenj ni (glejte poglavje 4.2).
English: The frequency of grade 4 (life-threatening) and grade 5 (fatal) infections was low in all treatment groups, but in PPMS it was higher with Ocrevus compared with placebo for life-threatening (1.6% vs 0.4%) and fatal (0.6% vs 0%) infections.
Slovenian: Pogostnost okužb 4. stopnje (življenjsko ogrožajočih) in 5. stopnje (s smrtnim izidom) je bila v vseh terapevtskih skupinah majhna, a je bila pri PPMS z zdravilom Ocrevus večja kot s placebom tako za življenjsko ogrožajoče okužbe (1,6 % v primerjavi z 0,4 %) kot za tiste s smrtnim izidom (0,6 % v primerjavi z 0 %).
English: Following cell surface binding, ocrelizumab selectively depletes CD20-expressing B cells through antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptosis.
Slovenian: Po vezavi na površino celic okrelizumab selektivno zmanjša število celic B, ki imajo izražen CD20, in sicer s celično fagocitozo, odvisno od protiteles (ADCP - antibodydependent cellular phagocytosis), celično citotoksičnostjo, odvisno od protiteles (ADCC - antibodydependent cellular cytotoxicity), citotoksičnostjo, odvisno od komplementa (CDC - complementdependent cytotoxicity), in z apoptozo.
English: 6.6 Special precautions for disposal and other handling Instructions for dilution
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za razredčenje
English: One patient, who received 2000 mg of Ocrevus, died of systemic inflammatory response syndrome (SIRS) of unknown etiology, following a magnetic resonance imaging (MRI) examination 12 weeks after the last infusion; an anaphylactoid reaction to the MRI gadolinium-contrast agent could have contributed to the SIRS.
Slovenian: En bolnik, ki je prejel 2000 mg zdravila Ocrevus, je umrl zaradi sindroma sistemskega vnetnega odziva neznane etiologije po magnetnoresonančnih posnetkih 12 tednov po zadnji infuziji; morda je k sindromu pripomogla anafilaktoidna reakcija na magnetnoresonančno kontrastno sredstvo z gadolinijem.
English: Each infusion will last about 2 hours 30 minutes.
Slovenian: Vsako infundiranje bo trajalo približno 2 uri in 30 minut.
English: You must not be given Ocrevus:
Slovenian: Zdravila Ocrevus ne smete dobiti:
English: · Diseases that affect your immune system: if you have another disease which affects the immune system.
Slovenian: • Bolezni, ki prizadenejo imunski sistem: Če imate kakšno drugo bolezen, ki prizadene imunski sistem, morda ne boste mogli dobiti zdravila Ocrevus.
English: · The next 600 mg doses of Ocrevus will be given as a single infusion.
Slovenian: • Naslednje 600-mg odmerke zdravila Ocrevus boste dobili v enkratni infuziji.
English: This reduces inflammation and attacks on the myelin sheath, reduces the chance of having a relapse and slows the progression of your disease.
Slovenian: To zmanjša vnetje in napade imunskega sistema na mielinske ovojnice, zmanjša možnost za recidive in upočasni napredovanje bolezni.
English: These included both active treatment naive and previously treated inadequate responders, as defined by clinical or imaging features.
Slovenian: Vključile so bolnike, ki še niso prejemali aktivnega zdravljenja, in bolnike, ki se niso odzvali na predhodno zdravljenje, kar je bilo opredeljeno klinično ali s slikovno diagnostiko.
English: In the ocrelizumab MS pivotal studies the administration of corticosteroids for the treatment of relapse was not associated with an increased risk of serious infection.
Slovenian: V ključnih študijah okrelizumaba pri multipli sklerozi uporaba kortikosteroidov za zdravljenje recidiva ni bila povezana z večjim tveganjem za resne okužbe.
English: No B cell count data have been collected in neonates and infants exposed to ocrelizumab and the potential duration of B-cell depletion in neonates and infants is unknown (see section 4.4).
Slovenian: Pri novorojenčkih in dojenčkih, ki so bili izpostavljeni okrelizumabu, podatki o številu celic B niso bili zbrani in možno trajanje zmanjšanega števila celic B pri njih ni znano (glejte poglavje 4.4).
English: Data prospectively pooled from Study 1 and 2 2 Non-confirmatory p-value analysis; not part of the pre-specified testing hierarchy
Slovenian: Nekonfirmativna analiza vrednosti p; ni del vnaprej določene hierarhije testiranj.
English: Infusion-related reactions can happen during the infusion or up to 24 hours after the infusion.
Slovenian: Z infuzijo povezane reakcije se lahko pojavijo med infundiranjem ali do 24 ur po njem.
English: The first subsequent dose of 600 mg should be administered six months after the first infusion of the initial dose.
Slovenian: Prvi nadaljnji 600-mg odmerek zdravila je treba dati šest mesecev po prvi infuziji začetnega odmerka.
English: Geometric mean anti-tetanus toxoid specific antibody titers at 8 weeks were 3.74 and 9.81 IU/ml, respectively.
Slovenian: Geometrična povprečna titra specifičnih protiteles proti tetanusnemu toksoidu sta bila po 8 tednih 3,74 i.e./ml v skupini z okrelizumabom in 9,81 i.e./ml v kontrolni skupini.
English: If tolerated, the infusion rate may then be increased according to the patient's initial infusion rate.
Slovenian: Če bolnik to prenaša, je nato mogoče hitrost infundiranja povečati v skladu z bolnikovo začetno hitrostjo infundiranja.
English: It is a type of protein called a ‘monoclonal antibody'.
Slovenian: Ta učinkovina spada v skupino beljakovin, imenovanih monoklonska protitelesa.
English: The majority of IRRs in both treatment groups were mild to moderate.
Slovenian: Večina z infuzijo povezanih reakcij v obeh terapevtskih skupinah je bila blagih do zmernih.
English: · Tell your doctor or nurse straight away if you have any infusion-related reaction (see section 4 for a list of infusion-related reactions).
Slovenian: • Zdravniku ali medicinski sestri morate takoj povedati, če imate kakšne z infuzijo povezane reakcije (seznam z infuzijo povezanih reakcij najdete v poglavju 4).