natgillin/translations-raw huggingface dataset:
The symptoms disappear or improve between relapses but damage may build up and lead to permanent disability. 
Med enim in drugim recidivom simptomi izginejo ali se izboljšajo, toda okvara se lahko kopiči in povzroči trajno prizadetost.
Event-driven (Minimum 120 weeks and 253 confirmed disability progression events) (Median follow-up time: Ocrevus 3.0 years, Placebo 2.8 years 
Z dogodki vodeno (najmanj 120 tednov in 253 dogodkov potrjenega napredovanja prizadetosti) (Mediani čas spremljanja: zdravilo Ocrevus 3,0 leta, placebo 2,8 leta)
Physicians should review the immunisation status of patients being considered for treatment with Ocrevus. 
Zdravniki morajo preveriti imunizacijsko stanje bolnikov, pri katerih razmišljajo o zdravljenju z zdravilom Ocrevus.
Medicines you will have before you are given Ocrevus Before you are given Ocrevus, you will receive other medicines to prevent or reduce possible side effects such as infusion-related reactions (see sections 2 and 4 for information about infusion-related reactions). 
Zdravila, ki jih boste dobili, preden boste dobili zdravilo Ocrevus Preden boste dobili zdravilo Ocrevus, vam bodo dali druga zdravila, da bi z njimi preprečili ali zmanjšali možne neželene učinke, na primer z infuzijo povezane reakcije (za informacije o z infuzijo povezanih reakcijah glejte poglavji 2 in 4).
Physicians should take prompt action for patients presenting with pneumonia. 
Zdravniki morajo pri bolnikih s pljučnico nemudoma ukrepati.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1231/001 1-vial pack EU/1/17/1231/002 2-vials pack 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1231/001 Pakiranje z 1 vialo EU/1/17/1231/002 Pakiranje z 2 vialama
* Expanded Disability Status Scale ** Patients who had not been treated with any MS medication in the 2 years prior to randomization. 
*Razširjena lestvica stopnje prizadetosti (EDSS - Expanded Disability Status Scale) ** Bolniki, ki niso v 2 letih pred randomizacijo prejemali nobenega zdravila za zdravljenje multiple skleroze.
Group A: Ocrevus 600 mg Group B: interferon beta-1a 44 mcg S.C. (IFN) 
Skupina A: zdravilo Ocrevus 600 mg Skupina B: interferon beta-1a 44 µg s.c. (IFN)
Symptoms of IRRs may occur during any infusion, but have been more frequently reported during the first infusion. 
Simptomi z infuzijo povezanih reakcij se lahko pojavijo med katerim koli infundiranjem, vendar so o njih pogosteje poročali med prvim infundiranjem.
· In primary progressive MS. the symptoms generally continue to worsen from the start of the disease. 
• Pri primarno progresivni multipli sklerozi se simptomi praviloma že vse od začetka bolezni stalno slabšajo.
· Infusion-related reactions are the most common side effect of Ocrevus treatment. 
• Z infuzijo povezane reakcije so najpogostejši neželeni učinek zdravljenja z zdravilom Ocrevus.
· Do not use Ocrevus if you are pregnant unless you have discussed this with your doctor. 
• Če ste noseči, ne uporabljajte zdravila Ocrevus, dokler se o tem ne posvetujete z zdravnikom.
They might notice symptoms of PML that you do not, such as memory lapses, trouble thinking, difficulty walking, sight loss, changes in the way you talk, which your doctor may need to investigate. 
Mogoče je, da bodo oni opazili simptome PML, ki jih vi ne - na primer motnje v spominu, težave pri razmišljanju, težave s hojo, slabšanje vida, spremembe v načinu govorjenja
Treatment with Ocrevus resulted in a decrease in total immunoglobulins over the controlled period of the studies, mainly driven by reduction in IgM. 
Zdravljenje z zdravilom Ocrevus je v kontroliranem obdobju študij povzročilo znižanje celotnih imunoglobulinov; to znižanje je bilo predvsem posledica znižanja IgM.
Do not use diluents other than the one detailed in section 6.6 to dilute Ocrevus since its use has not been tested. 
Za redčenje zdravila Ocrevus ne uporabljajte drugih redčil kot tistih, ki so navedena v poglavju 6.6, ker njihova uporaba ni testirana.
It is not recommended to use other immunosuppressives concomitantly with Ocrevus except corticosteroids for symptomatic treatment of relapses. 
Sočasno z zdravilom Ocrevus ni priporočljivo uporabljati drugih imunosupresivov razen kortikosteroidov za simptomatsko zdravljenje recidivov.
See section 4.4 and section 4.8 (subsection ‘Description of selected adverse reactions') for further details. 
Za dodatne podrobnosti glejte poglavji 4.4 in 4.8 (podpoglavje "Opis izbranih neželenih učinkov").
The longest follow up time after the last Ocrevus infusion (Phase II study WA21493, N=51) indicates that the median time to B-cell repletion (return to baseline/LLN whichever occurred first) was 72 weeks (range 27 - 175 weeks). 
Najdaljši čas spremljanja po zadnji infuziji zdravila Ocrevus (študija faze II WA21493, n = 51) kaže, da je mediani čas do ponovnega porasta celic B (vrnitve na izhodiščno raven ali spodnjo normalno mejo, kar od tega se zgodi prej) 72 tednov (razpon: od 27 do 175 tednov).
The population pharmacokinetics estimate of the central volume of distribution was 2.78 L. Peripheral volume and inter-compartment clearance were estimated at 2.68 L and 0.294 L/day. 
Populacijska farmakokinetična ocena centralnega volumna porazdelitve je 2,78 l. Ocenjeni periferni volumen je 2,68 l in ocenjeni medrazdelčni očistek 0,294 l/dan.
· To reduce the risk of infusion-related reaction, your doctor will give you other medicines before each infusion of Ocrevus (see section 3) and you will be closely monitored during the infusion and for at least one hour after the infusion has been given. 
• Za zmanjšanje tveganja reakcij, povezanih z infuzijo, vam bo zdravnik pred vsakim infundiranjem zdravila Ocrevus dal še druga zdravila (glejte poglavje 3); poleg tega vas bodo med infundiranjem zdravila in vsaj še eno uro po koncu infundiranja skrbno nadzirali.
The infusion should be restarted only after all symptoms have resolved. 
Infundiranje se lahko znova začne, šele ko minejo vsi simptomi.
· If you miss an infusion of Ocrevus, talk to your doctor to arrange to have it as soon as possible. 
• Če ste izpustili infuzijo zdravila Ocrevus, se posvetujte z zdravnikom, da jo boste dobili čim prej.
After treatment with Ocrevus over 2 years, the proportion of patients with positive antibody titers against S. pneumoniae, mumps, rubella and varicella were generally similar to the proportions at baseline. 
Po zdravljenju z zdravilom Ocrevus v obdobju 2 let je bil delež bolnikov s pozitivnimi titri protiteles proti S. pneumoniae, mumpsu, rdečkam in noricam na splošno podoben izhodiščnemu deležu.
Proportion of patients Relapse free at 96 weeks 
Delež bolnikov brez recidiva po 96 tednih2
Out of 1311 patients treated with Ocrevus, 12 (~1%) tested positive for treatment-emergent ADAs, of which 2 patients tested positive for neutralising antibodies. 
Od 1311 bolnikov, zdravljenih z zdravilom Ocrevus, je bilo 12 (~1 %) pozitivnih glede ADA, nastalih med zdravljenjem; 2 od teh bolnikov sta imela pozitiven test za nevtralizacijska protitelesa.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
Patients with a history of congestive heart failure (New York Heart Association III & IV) were not studied. 
Pri bolnikih z anamnezo kongestivnega srčnega popuščanja (razredov III in IV po New York Heart Association) ni bilo raziskav.
· Patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation, must have their infusion interrupted immediately and permanently. 
• Bolnikom, ki se jim pojavijo hudi pljučni simptomi, na primer bronhospazem ali poslabšanje astme, je treba infundiranje nemudoma in trajno prekiniti.
After administering symptomatic treatment, monitor the patient until the pulmonary symptoms have resolved because initial improvement of clinical symptoms could be followed by deterioration. 
Po uporabi simptomatskega zdravljenja je treba bolnika nadzirati, dokler pljučni simptomi ne minejo, saj lahko uvodnemu izboljšanju kliničnih simptomov sledi poslabšanje.
In addition, innate immunity and total T-cell numbers are not affected. 
Poleg tega zdravilo ne vpliva na vrojeno imunost in celotno število celic T.
Group A: Ocrevus 600 mg Group B: Placebo, in 2:1 randomisation 
Skupina A: zdravilo Ocrevus 600 mg Skupina B: placebo, randomizacija v razmerju 2:1
1000 New Horizons Way Vacaville 
Genentech Inc. 1000 New Horizons Way
Within each System Organ Class, the adverse reactions are presented in order of decreasing frequency. 
Znotraj posameznega organskega sistema so neželeni učinki navedeni po padajoči pogostnosti.
· In the event an intravenous infusion cannot be completed the same day, the remaining solution should be discarded. 
• Če intravenskega infundiranja ni mogoče dokončati isti dan, je treba preostalo raztopino zavreči.
Study duration 
Trajanje študije
The safety and efficacy of Ocrevus in children and adolescents aged 0 to 18 years has not yet been established. 
Varnost in učinkovitost zdravila Ocrevus nista ugotovljeni pri otrocih in mladostnikih, starih od 0 do 18 let.
Study population 
Populacija v študiji
Treatment of severely immunocompromised patients 
Zdravljenje imunsko zelo oslabelih bolnikov
The incidence remains within the background rate expected for an MS population. 
Pojavnost ostaja v okviru deleža, pričakovanega za populacijo z multiplo sklerozo.
Exploratory result based on complete ITT population. 
Eksploratoren rezultat na podlagi celotne populacije z namenom zdravljenja.
Any vaccinations should be given at least 6 weeks before you start treatment with Ocrevus. 
Vsa cepljenja morate opraviti vsaj 6 tednov pred začetkom zdravljenja z zdravilom Ocrevus.
Your doctor may decide to delay your treatment with Ocrevus or may ask you to stop such medicines before starting treatment with Ocrevus. 
Zdravnik se lahko odloči za odlog zdravljenja z zdravilom Ocrevus ali vam naroči, da takšna zdravila prenehate jemati, preden začnete zdravljenje z zdravilom Ocrevus.
A risk of PML cannot be ruled-out since John Cunningham (JC) virus infection resulting in PML has been observed in patients treated with anti-CD20 antibodies and other MS therapies, and associated with risk factors (e.g. patient population, polytherapy with immunosuppressants). 
Tveganja za PML ni mogoče izključiti, ker so okužbo z virusom John Cunningham s posledično PML opažali pri bolnikih, zdravljenih s protitelesi proti CD20 in drugimi zdravili proti multipli sklerozi ter v povezavi z dejavniki tveganja (npr. populacija bolnikov, politerapija z imunosupresivi).
All life-threatening infections resolved without discontinuing ocrelizumab. 
Vse življenjsko ogrožajoče okužbe so minile brez prenehanja uporabe okrelizumaba.
There were two cases of moribundityone attributed to weakness due to premature birth accompanied by opportunistic infection and the other to an infective meningoencephalitis involving the cerebellum of the neonate from a maternal dam with an active infection (mastitis). 
Opisana sta bila dva smrtna primera: eden zaradi šibkosti po prezgodnji skotitvi ob hkratni oportunistični okužbi in drugi zaradi infekcijskega meningoencefalitisa, ki je zajel male možgane novoskotenega mladiča zaradi aktivne okužbe (mastitisa) pri samici materi.
Patients in Group B were administered Interferon beta-1a (Rebif) 44 mcg via subcutaneous injection 3 times per week. 
Bolniki v skupini B so prejemali 44 µg interferona beta-1a (zdravilo Rebif) v subkutani intravenski injekciji 3-krat na teden.
· Known active malignancies (see section 4.4) 
• Znane aktivne maligne bolezni (glejte poglavje 4.4)
A greater proportion of patients in each group experienced IRRs with the first infusion of each dose compared with the second infusion of that dose. 
V vsaki skupini je bil delež bolnikov, ki so se jim pojavile z infuzijo povezane reakcije, večji ob prvem infundiranju vsakega odmerka kot pri drugem infundiranju takšnega odmerka.
For the B cell counts, CD19 is used, as the presence of Ocrevus interferes with the recognition of CD20 by the assay. 
Za ocenjevanje števila celic B se uporablja CD19, ker prisotnost zdravila Ocrevus moti prepoznavo CD20 v testu.
Relative reduction 
Relativno zmanjšanje
Patients should be monitored during the infusion and for at least one hour after the completion of the infusion (see section 4.4). 
Bolnike je treba nadzirati med infundiranjem in vsaj še eno uro po koncu infundiranja (glejte poglavje 4.4).
· Premedication: Patients must receive premedication to reduce the frequency and severity of IRRs (see section 4.2. 
• Premedikacija: bolniki morajo dobiti premedikacijo za zmanjšanje pogostnosti in izrazitosti z infuzijo povezanih reakcij (glejte poglavje 4.2).
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). 
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).
· The product is intended for single use only. 
• Zdravilo je namenjeno le za enkratno uporabo.
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). 
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).
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. 
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).
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. 
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.
· Physicians should alert patients that an IRR can occur within 24 hours of infusion. 
• Zdravniki morajo bolnike opozoriti, da se lahko z infuzijo povezana reakcija pojavi v 24 urah po infundiranju.
Do not use the solution if discoloured or if the solution contains foreign particulate matter (see section 3 for a description of the solution). 
Raztopine ne uporabite, če je spremenjene barve ali vsebuje tuje delce (za opis raztopine glejte poglavje 3).
· 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. 
• Pri recidivnih oblikah multiple skleroze (RMS) zdravilo Ocrevus bistveno zmanjša število napadov (recidivov) in bistveno upočasni napredovanje bolezni.
· 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. 
• Pred začetkom intravenskega infundiranja mora biti vsebina vreče na sobni temperaturi, da bi preprečili infuzijsko reakcijo kot posledico dajanja raztopine pri nizki temperaturi.
· The rate can be increased in 30 mL/hour increments every 30 minutes to a maximum of 180 mL/hour. 
• Hitrost je mogoče na 30 minut povečevati po 30 ml/uro do največ 180 ml/uro.
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). 
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.
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). 
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).
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. 
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.
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. 
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.
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). 
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).
No incompatibilities between Ocrevus and polyvinyl chloride (PVC) or polyolefin (PO) bags and intravenous administration sets have been observed. 
6.2 Inkompatibilnosti Opazili niso nobenih inkompatibilnosti med zdravilom Ocrevus in polivinilkloridnimi (PVC) ali poliolefinskimi (PO) vrečami in kompleti za intravensko dajanje.
Neither carcinogenicity nor mutagenicity studies have been conducted with ocrelizumab. 
Z okrelizumabom niso izvedli ne študij kancerogenosti ne mutagenosti.
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. 
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.
Your doctor will consider the benefit of you taking Ocrevus against the risk to your baby. 
Zdravnik bo pretehtal koristi uporabe zdravila Ocrevus v primerjavi s tveganjem za otroka.
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). 
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.
There is a limited amount of data from the use of Ocrevus in pregnant women. 
O uporabi zdravila Ocrevus pri nosečnicah je podatkov malo.
90% of all patients had their B-cells repleted to LLN or baseline by approximately two and a half years after the last infusion. 
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.
It will be given as an infusion into a vein (intravenous infusion or IV infusion). 
Dobili ga boste kot infuzijo v veno (intravenska infuzija ali i.v.
The initial infusion rate at restart should be half of the infusion rate at the time of onset of the reaction. 
Začetna hitrost infundiranja ob ponovnem začetku mora biti polovica tiste hitrosti, pri kateri je prišlo do reakcije.
Your doctor will tell you whether your MS may affect your ability to drive or use tools and machines safely. 
Zdravnik vam bo povedal, ali lahko multipla skleroza vpliva na vašo sposobnost za varno upravljanje upravljanja vozil in strojev.
· Initial Dose 
• Začetni odmerek
Sinusitis, bronchitis, oral herpes, gastroenteritis, respiratory tract infection, viral infection, herpes zoster, conjunctivitis, cellulitis 
nazofaringitis, gripa sinuzitis, bronhitis, oralni herpes, gastroenteritis, okužba dihal, virusna okužba, herpes zoster, konjunktivitis, celulitis
Your doctor will wait until the infection is resolved before giving you Ocrevus. 
Zdravnik bo počakal, dokler okužba ne mine, preden vam bo dal zdravilo Ocrevus.
HBV screening should be performed in all patients before initiation of treatment with Ocrevus as per local guidelines. 
Pred začetkom zdravljenja z zdravilom Ocrevus je treba pri vseh bolnikih opraviti presejalne preiskave za HBV v skladu z lokalnimi smernicami.
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). 
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).
The 600 mg infusions in RMS and the 2 x 300 mg infusions in PPMS demonstrated consistent PK/PD profiles. 
Infundiranja 600 mg pri RMS in 2 x 300 mg pri PPMS so pokazala skladne farmakokinetične/farmakodinamične značilnosti.
Additional information on IRRs can be found in section 4.4. 
Dodatne informacije o z infuzijo povezanih reakcijah so navedene v poglavju 4.4.
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. 
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.
If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently (see ‘Hypersensitivity Reactions' below). 
V primeru suma na preobčutljivostno reakcijo med infundiranjem je treba infundiranje nemudoma in trajno končati (glejte "Preobčutljivostne reakcije", spodaj).
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). 
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).
Table 3 Study Design, Demographic and Baseline Characteristics Study 1 
Načrt študije, demografske in izhodiščne značilnosti Študija 1
Each infusion will last about 3 hours 30 minutes. 
Vsako infundiranje bo trajalo približno 3 ure in 30 minut.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 
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).