FrancophonIA/ELRC3.0 huggingface dataset:
English: Across the RMS and PPMS trials, symptoms associated with IRRs included, but are not limited to: pruritus, rash, urticaria, erythema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, nausea, tachycardia.
Croatian: U ispitivanjima primjene kod RMS-a i PPMS-a, simptomi povezani s reakcijama na infuziju uključivali su, između ostalih: pruritus, osip, urtikariju, eritem, navale crvenila, hipotenziju, pireksiju, umor, glavobolju, omaglicu, nadraženost grla, orofaringealnu bol, dispneju, edem ždrijela ili grkljana, mučninu, tahikardiju.
English: Out of 1311 patients treated with Ocrevus, 12 (~1%) tested positive for treatment-emergent ADAs, of which 2 patients tested positive for neutralising antibodies.
Croatian: 12 (~1%) bilo je pozitivno na protutijela na lijek koja su se razvila tijekom liječenja, a 2 od tih 12 bolesnika bila su pozitivna na neutralizirajuća protutijela.
English: An increased rate of serious infections was observed during episodes of confirmed total lymphocytes counts decrease in ocrelizumab treated patients.
Croatian: Među bolesnicima liječenima okrelizumabom opažena je povećana stopa ozbiljnih infekcija tijekom epizoda potvrđenog pada ukupnog broja limfocita.
English: An increased number of malignancies (including breast cancers) have been observed in clinical trials in patients treated with ocrelizumab, compared to control groups.
Croatian: U kliničkim je ispitivanjima u bolesnika liječenih okrelizumabom opažen povećan broj slučajeva zloćudnih bolesti (uključujući rak dojke) u odnosu na kontrolne skupine.
English: Within each System Organ Class, the adverse reactions are presented in order of decreasing frequency.
Croatian: Unutar svakog organskog sustava nuspojave su prikazane u padajućem nizu prema učestalosti.
English: In PPMS, a decrease in lymphocytes <LLN was observed in 26.3% of Ocrevus treated patients vs 11.7% of placebo-treated patients.
Croatian: Kod PPMS-a je pad broja limfocita < DGN-a primijećen u 26,3% bolesnika liječenih lijekom Ocrevus naspram 11,7% onih koji su primali placebo.
English: The following two premedications must be administered prior to each Ocrevus infusion to reduce the frequency and severity of IRRs (see Infusion-related reactions in section 4.4 for additional steps to reduce IRRs): · 100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each Ocrevus infusion; · antihistamine approximately 30-60 minutes prior to each Ocrevus infusion; In addition, premedication with an antipyretic (e.g paracetamol) may also be considered approximately 30-60 minutes prior to each Ocrevus infusion.
Croatian: Prije svake infuzije lijeka Ocrevus mora se primijeniti premedikacija sa sljedeća dva lijeka kako bi se smanjile učestalost i težina reakcija na infuziju (za dodatne korake za smanjivanje reakcija na infuziju vidjeti odlomak Reakcije na infuziju u dijelu 4.4): · 100 mg metilprednizolona (ili ekvivalenta) primijenjenog intravenski približno 30 minuta prije svake infuzije lijeka Ocrevus · antihistaminik približno 30 - 60 minuta prije svake infuzije lijeka Ocrevus
English: Common: may affect up to 1 in 10 people · cough · a build-up of thick mucus in the nose, throat or chest.
Croatian: Česte: mogu se javiti u do 1 na 10 osoba · kašalj · nakupljanje guste sluzi u nosu, grlu ili prsnom košu · niske vrijednosti jedne vrste bijelih krvnih stanica (neutropenija)
English: Ocrevus must be diluted before it is given to you.
Croatian: Ocrevus se mora razrijediti prije primjene.
English: When the reaction has stopped, the infusion may be continued.
Croatian: Infuzija se može nastaviti nakon što se reakcija povuče.
English: The safety and efficacy of Ocrevus in patients with hepatic impairment has not been formally studied.
Croatian: Sigurnost i djelotvornost lijeka Ocrevus u bolesnika s oštećenjem bubrežne funkcije nisu se formalno ispitivale.
English: There were no life-threatening IRRs.
Croatian: Nije bilo reakcija na infuziju opasnih po život.
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).
Croatian: 12 mjeseci nakon posljednje infuzije lijeka Ocrevus (vidjeti u nastavku i dijelove 5.1 i 5.2).
English: In patients treated with ocrelizumab a booster vaccine (13-PCV) given 4 weeks after 23-PPV did not markedly enhance the response to 12 serotypes
Croatian: (13-valentnim pneumokoknim konjugiranim cjepivom, 13-PCV) primijenjena 4 tjedna nakon cjepiva 23-PPV nije značajno pojačala odgovor na 12 serotipova sadržanih u oba ta cjepiva.
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.
Croatian: (smrtonosnih) bila je niska u svim liječenim skupinama, ali je kod PPMS-a među bolesnicima liječenima lijekom Ocrevus naspram onih koji su primali placebo zabilježena viša stopa po život opasnih (1,6% naspram 0,4%) i smrtonosnih infekcija (0,6% naspram 0%).
English: Non-confirmatory p-value; hierarchical testing procedure terminated before reaching endpoint.
Croatian: Eksploracijski rezultat utemeljen na cjelokupnoj populaciji predviđenoj za liječenje (engl. intent-to-treat, ITT). p-vrijednost nije potvrdna; postupak hijerarhijskog testiranja završen je prije dostizanja mjere ishoda.
English: All life-threatening infections resolved without discontinuing ocrelizumab.
Croatian: Sve po život opasne infekcije povukle su se bez prekida liječenja okrelizumabom.
English: If a patient experiences a severe IRR (such as dyspnea) or a complex of flushing, fever, and throat pain symptoms, the infusion should be interrupted immediately and the patient should receive symptomatic treatment.
Croatian: Ako se u bolesnika pojavi teška reakcija na infuziju (kao što je dispneja) ili kombinacija navale crvenila, vrućice i grlobolje, treba odmah privremeno prekinuti infuziju i primijeniti simptomatsko liječenje.
English: 40% reduction in risk of CDP HR (95% CI): 0.60 (0.45, 0.81) (p =0.0006)
Croatian: Smanjenje rizika od potvrđene progresije onesposobljenosti za 40% HR (95% CI): 0,60 (0,45; 0,81) (p=0,0006)
English: Patients with known IgE mediated hypersensitivity to ocrelizumab must not be treated (see section 4.3).
Croatian: Bolesnike s poznatom aktivnom zloćudnom bolešću ne smije se liječiti lijekom Ocrevus (vidjeti dio 4.3).
English: · The rate can be increased in 40 mL/hour increments every 30 minutes to a maximum of 200 mL/hour
Croatian: · Brzina se može povećavati u koracima od 40 ml/h svakih 30 minuta do najviše 200 ml/h
English: In RMS, a decrease in lymphocyte < LLN was observed in 20.7% of Ocrevus patients compared with 32.6% of patients treated with interferon beta-1a.
Croatian: Kod RMS-a je primijećen pad broja limfocita < DGN-a u 20,7% bolesnika liječenih lijekom Ocrevus u odnosu na 32,6% onih koji su primali interferon beta-1a.
English: In the placebo-controlled (PPMS) clinical trial, a higher proportion of patients with oral herpes (2.7% vs 0.8%) were observed in the Ocrevus treatment arm.
Croatian: U placebom kontroliranom kliničkom ispitivanju (PPMS) veći udio bolesnika s oralnim herpesom zabilježen je u skupini koja je primala Ocrevus (2,7% naspram 0,8%).
English: In the active-controlled (RMS) treatment period, a decrease in neutrophils < LNN was observed in 14.7% of Ocrevus patients compared with 40.9% of patients treated with interferon beta-1a.
Croatian: Tijekom razdoblja liječenja kontroliranog aktivnim lijekom (RMS) primijećen je pad broja neutrofila < DGN-a u 14,7% bolesnika liječenih lijekom Ocrevus i 40,9% onih koji su primali interferon beta-1a.
English: · Tell your doctor before being given Ocrevus if you are pregnant, think that you might be pregnant or are planning to have a baby.
Croatian: · Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obavijestite svog liječnika o tome prije nego primite Ocrevus.
English: Do not shake the vial.
Croatian: Bočica se ne smije tresti.
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°C and subsequently for 8 hours at room temperature, unless dilution is undertaken in controlled and validated aseptic conditions.
Croatian: Pripremljeni lijek ne bi se smio čuvati dulje od 24 sata na temperaturi od 2°C do 8°C, a nakon toga dulje od 8 sati na sobnoj temperaturi, osim ako razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičnim uvjetima.
English: See sections 4.4 and 4.5.
Croatian: Vidjeti dijelove 4.4 i 4.5.
English: If a patient experiences a mild to moderate IRR (e.g., headache), the infusion rate should be reduced to half the rate at the onset of the event.
Croatian: Ako bolesnik doživi blagu do umjerenu reakciju na infuziju (npr. glavobolju), brzinu kojom se infuzija primjenjivala u trenutku nastupa reakcije treba prepoloviti.
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).
Croatian: Preporučuje se prije primjene utvrditi imunološki status bolesnika jer se teško imunokompromitirane bolesnike (npr. one s limfopenijom, neutropenijom ili hipogamaglobulinemijom) ne smije liječiti
English: · While you are being treated with Ocrevus, you should not be given live or live attenuated vaccines (for example BCG for tuberculosis or vaccines against yellow fever).
Croatian: · Tijekom liječenja lijekom Ocrevus ne smijete primiti živa ni živa atenuirana cjepiva (primjerice,
English: 10 mL concentrate in a glass vial.
Croatian: 6.5 Vrsta i sadržaj spremnika 10 ml koncentrata u staklenoj bočici.
English: Ocrevus is used to treat adults with: · Relapsing forms of multiple sclerosis (RMS) · Early primary progressive multiple sclerosis (PPMS)
Croatian: · relapsirajuće oblike multiple skleroze (RMS) · ranu primarno progresivnu multiplu sklerozu (PPMS)
English: Common: may affect up to 1 in 10 people sinus infection bronchitis (bronchial tube inflammation) herpes infection (cold sore or shingles).
Croatian: Česte: mogu se javiti u do 1 na 10 osoba - infekcija sinusa - bronhitis (upala dišnih putova) - herpesna infekcija (herpes simpleks ili herpes zoster) - infekcija želuca i crijeva (gastroenteritis) - infekcija dišnih putova - virusna infekcija - kožna infekcija (celulitis)
English: Infusion Adjustments in case of IRRs
Croatian: · Prilagodbe infuzije u slučaju reakcija na infuziju
English: · If you get any side effects, talk to your doctor or nurse.
Croatian: · Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: Concentrate for solution for infusion 300 mg/10 ml
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 300 mg/10 ml
English: · Tell your doctor or nurse straight away if you think your MS is getting worse or if you notice any new symptoms.
Croatian: · Odmah obavijestite svog liječnika ili medicinsku sestru ako mislite da Vam se MS
English: Event-driven (Minimum 120 weeks and 253 confirmed disability progression events) (Median follow-up time: Ocrevus 3.0 years, Placebo 2.8 years
Croatian: (Medijan praćenja: Ocrevus 3,0 godine; placebo 2,8 godina
English: · Ocrevus infusions should not be administered as an intravenous push or bolus.
Croatian: · Infuzije lijeka Ocrevus ne smiju se primijeniti brzom ili bolusnom intravenskom injekcijom.
English: In the placebo-controlled (PPMS) clinical trial, the proportion of Ocrevus patients presenting decreased neutrophils was higher (12.9 %) than placebo patients (10.0 %); among these a higher percentage of patients (4.3%) in the Ocrevus group had Grade 2 or above neutropenia vs 1.3% in the placebo group; approximately 1% of the patients in the Ocrevus group had Grade 4 neutropenia vs 0% in the placebo group.
Croatian: U placebom kontroliranom kliničkom ispitivanju (PPMS) udio bolesnika koji su imali snižen broj neutrofila bio je veći među bolesnicima liječenima lijekom Ocrevus (12,9%) nego među onima koji su primali placebo (10,0%); među njima se neutropenija 2. ili višeg stupnja javila u više bolesnika u skupini liječenoj lijekom Ocrevus (4,3%) nego onih koji su primali placebo (1,3%).
English: Solutions of Ocrevus for intravenous administration are prepared by dilution of the drug product into an infusion bag containing isotonic 0.9% sodium chloride (300 mg / 250 mL or 600 mg / 500 mL), to a final drug concentration of approximately 1.2 mg/mL.
Croatian: Otopine lijeka Ocrevus za intravensku primjenu pripremaju se tako da se lijek razrijedi u infuzijskoj vrećici koja sadrži izotoničnu otopinu natrijeva klorida od 9 mg/ml (0,9%) (300 mg/250 ml ili 600 mg/500 ml) do konačne koncentracije lijeka od približno 1,2 mg/ml.
English: · The first 600 mg dose of Ocrevus will be given as 2 separate infusions (300 mg each), given
Croatian: · Prva doza lijeka Ocrevus od 600 mg primijenit će se u 2 zasebne infuzije (svaka od 300 mg) u razmaku od 2 tjedna.
English: This is because of a very rare and life-threatening brain infection, called ‘progressive multifocal leukoencephalopathy' (PML), which can cause symptoms similar to those of MS. PML can occur in patients taking medicines like Ocrevus, and other medicines used for treating MS. Tell your partner or carer about your Ocrevus treatment.
Croatian: Naime, može se javiti vrlo rijetka i po život opasna infekcija mozga, koja se zove ‘progresivna multifokalna leukoencefalopatija' (PML) i koja može uzrokovati simptome slične simptomima MS-a.
English: Reproductive toxicity was observed in pre and post natal development studies (see section 5.3).
Croatian: U ispitivanjima prenatalnog i postnatalnog razvoja utvrđena je reproduktivna toksičnost (vidjeti dio 5.3).
English: Cranial MRI showed imaging features characteristic of inflammatory activity either by T1 Gd enhancing lesions or T2 lesions.
Croatian: U nalazima MR oslikavanja glave bile su vidljive značajke karakteristične za upalnu aktivnost, odnosno T1 lezije naglašene gadolinijem ili T2 lezije.
English: 9.8% Ocrevus vs 15.2% IFN 40% (p=0.0006)7
Croatian: 9,8% uz Ocrevus naspram 15,2% uz IFN 40% (p=0,0006) 43% (p=0,0139)7
English: Proportion of patients with Gd enhancing T1 lesions Mean EDSS*
Croatian: Udio bolesnika s T1 lezijama naglašenima gadolinijem (Gd)
English: During the infusion: · The following measures need to be taken for patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation: their infusion must be interrupted immediately and permanently symptomatic treatment must be administered the patient must be monitored until the pulmonary symptoms have resolved because initial improvement of clinical symptoms could be followed by deterioration · Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms.
Croatian: primjena infuzije mora se odmah i trajno obustaviti mora se primijeniti simptomatsko liječenje bolesnika se mora nadzirati sve dok se plućni simptomi ne povuku, jer nakon početnog poboljšanja kliničkih simptoma može uslijediti njihovo pogoršanje
English: Blood immunoglobulin G decreased
Croatian: M u krvi snižena vrijednost imunoglobulina G u krvi
English: Defined as decrease of ≥ 1.0 point from the baseline EDSS score for patients with baseline EDSS score ≥ 2 and ≤ 5.5, or ≥0.5 when the baseline score is > 5.5.
Croatian: Definirao se kao smanjenje početnog EDSS rezultata za ≥ 1,0 bod u bolesnika čiji je početni EDSS rezultat iznosio ≥ 2 i ≤ 5,5 odnosno za ≥ 0,5 u bolesnika čiji je početni rezultat iznosio > 5,5.
English: The safety and efficacy of Ocrevus in patients with renal impairment has not been formally studied.
Croatian: Sigurnost i djelotvornost lijeka Ocrevus u bolesnika s oštećenjem jetrene funkcije nisu se formalno ispitivale.
English: Relative Increase2
Croatian: Relativno povećanje2
English: · Hypotension, as a symptom of IRR, may occur during Ocrevus infusions.
Croatian: · Tijekom infuzija lijeka Ocrevus može se pojaviti hipotenzija kao simptom reakcije na infuziju.
English: The safety of immunisation with live or live-attenuated vaccines, following Ocrevus therapy has not been studied.
Croatian: Nije se ispitivala sigurnost cijepljenja živim ili živim atenuiranim cjepivima nakon liječenja lijekom
English: Due to the potential depletion of B cells in infants of mothers who have been exposed to Ocrevus during pregnancy, it is recommended that vaccination with live or live-attenuated vaccines should be delayed until B-cell levels have recovered; therefore, measuring CD19-positive B-cell levels, in neonates and infants, prior to vaccination is recommended It is recommended that all vaccinations other than live or live-attenuated should follow the local immunisation schedule and measurement of vaccine-induced response titers should be considered to check whether individuals have mounted a protective immune response because the efficacy of the vaccination may be decreased.
Croatian: Zbog moguće deplecije B-stanica u novorođenčadi/dojenčadi majki izloženih lijeku Ocrevus tijekom trudnoće, preporučuje se odgoditi cijepljenje novorođenčadi/dojenčadi živim ili živim atenuiranim cjepivima dok im se broj B-stanica ne vrati u normalu; stoga se preporučuje prije cijepljenja odrediti broj CD19-pozitivnih B-stanica u novorođenčadi i dojenčadi.
English: If you miss an infusion of Ocrevus
Croatian: Ako ste propustili primiti dozu lijeka Ocrevus
English: Disposal of unused/expired medicines
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
English: Premedication for infusion-related reactions
Croatian: · Premedikacija za reakcije na infuziju
English: These reactions may present as pruritus, rash, urticaria, erythema, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea and tachycardia (see section 4.8).
Croatian: Mogu se manifestirati kao pruritus, osip, urtikarija, eritem, nadraženost grla, orofaringealna bol, dispneja, edem ždrijela ili grkljana, navale crvenila, hipotenzija, pireksija, umor, glavobolja, omaglica, mučnina i tahikardija
English: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has been reported in patients treated with anti-CD20 antibodies.
Croatian: Reaktivacija virusa hepatitisa B U bolesnika liječenih anti-CD20 protutijelima prijavljena je reaktivacija virusa hepatitisa B (HBV),
English: Proportion of patients with 12 week Confirmed Disability Progression Risk Reduction (Pooled Analysis Risk Reduction (Individual Studies
Croatian: Udio bolesnika s 12-tjednom potvrđenom progresijom onesposobljenosti Smanjenje rizika (analiza objedinjenih podataka
English: The majority of IRRs in both treatment groups were mild to moderate.
Croatian: U obje je skupine većina reakcija na infuziju bila blage do umjerene težine.
English: One patient with grade 3 (between 500 and 1000 cells/mm3) and one patient with grade 4 (< 500 cells/mm3) neutropenia required specific treatment with granulocyte-colony stimulating factor, and remained on ocrelizumab after the episode.
Croatian: 4. stupnja (< 500 stanica/mm3) bilo je potrebno specifično liječenje faktorom stimulacije kolonije granulocita, nakon čega su ti bolesnici nastavili liječenje okrelizumabom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1231/001 1-vial pack EU/1/17/1231/002 2-vials pack
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1231/001 pakiranje od 1 bočice
English: The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion.
Croatian: Početna doza od 600 mg primjenjuje se u dvije zasebne intravenske infuzije - najprije se primjenjuje jedna infuzija od 300 mg, a 2 tjedna kasnije druga infuzija od 300 mg
English: Amount of Ocrevus to be administered
Croatian: Ocrevus koju treba primijeniti
English: The impact of treatment-emergent ADAs on safety and efficacy cannot be assessed given the low incidence of ADA associated with Ocrevus.
Croatian: Zbog niske incidencije protutijela na lijek povezanih s lijekom Ocrevus, ne može se ocijeniti utjecaj koji protutijela nastala tijekom liječenja imaju na sigurnost i djelotvornost terapije.
English: CD20 is a cell surface antigen found on pre-B cells, mature and memory B cells but not expressed on lymphoid stem cells and plasma cells.
Croatian: CD20 je površinski stanični antigen koji se nalazi na pre-B-stanicama te zrelim i memorijskim
English: The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion (Table 1).
Croatian: Početna doza od 600 mg primjenjuje se u dvije zasebne intravenske infuzije - najprije se primjenjuje jedna infuzija od 300 mg, a 2 tjedna kasnije druga infuzija od 300 mg (Tablica 1).
English: Study duration
Croatian: Trajanje ispitivanja
English: Name and address of the manufacturer responsible for batch release
Croatian: Sjedinjene Američke Države Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Evaluation including Magnetic Resonance Imaging (MRI) scan preferably with contrast (compared with pre-treatment MRI), confirmatory cerebro-spinal fluid (CSF) testing for John Cunningham (JC) Viral Deoxyribonucleic acid (DNA) and repeat neurological assessments, should be considered.
Croatian: Treba razmotriti obradu koja uključuje oslikavanje magnetskom rezonancijom (MR), po mogućnosti kontrastnim sredstvom (snimku treba usporediti s nalazima MR oslikavanja provedenog prije početka liječenja), testiranje cerebrospinalne tekućine radi potvrde prisutnosti deoksiribonukleinske kiseline (DNK) John
English: Do not use the solution if discoloured or if the solution contains foreign particulate matter.
Croatian: Otopina se ne smije primijeniti ako je promijenila boju ili ako sadrži strane čestice.
English: Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30mg/mL.
Croatian: Jedna bočica sadrži 300 mg okrelizumaba u 10 ml, što daje koncentraciju od 30 mg/ml.
English: Single infusion 600 mg in 500 mL · Initiate the infusion at a rate of 40 mL/hour for 30 minutes
Croatian: Jedna infuzija 600 mg u 500 ml · Infuziju treba započeti brzinom od 40 ml/h tijekom 30 minuta
English: The majority of the neutrophil decreases were transient (only observed once for a given patient treated with Ocrevus) and were Grade 1 (<1500 cells/mm3) and 2 (between 1000 and 1500 cells/mm3) in severity.
Croatian: Ocrevus kod kojeg je došlo do takvog pada, on je zabilježen samo jednom) te je bio 1. stupnja (< 1500 stanica/mm3) i 2. stupnja (između 1000 i 1500 stanica/mm3) težine.
English: Individual benefit risk should be considered in patients with known risk factors for malignancies and in patients who are being actively monitored for recurrence of malignancy.
Croatian: U bolesnika s poznatim faktorima rizika za zloćudne bolesti i onih koje se aktivno nadzire zbog mogućeg povrata zloćudne bolesti treba razmotriti individualni omjer koristi i rizika.
English: Patients should be monitored during the infusion and for at least one hour after the completion of the infusion.
Croatian: Zbrinjavanje reakcija na infuziju tijekom i nakon infuzije Bolesnike treba nadzirati tijekom infuzije i još najmanje jedan sat nakon njezina završetka.
English: Positive response to ³5 serotypes in 23-PPV at 4 weeks after vaccination was 71.6% in the ocrelizumab group and 100% in the control group.
Croatian: Pozitivan odgovor na ≥ 5 serotipova sadržanih u 23-valentnom pneumokoknom polisaharidnom cjepivu (23-PPV) 4 tjedna nakon cijepljenja zabilježen je u 71,6% bolesnika liječenih okrelizumabom i
English: IFN 44 mcg (n=418)
Croatian: IFN 44 µg (n=418)
English: After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line.
Croatian: Način primjene Ocrevus se nakon razrjeđivanja primjenjuje intravenskom infuzijom kroz zasebnu liniju.