natgillin/translations-raw huggingface dataset:
Analysis of patient populations with differing baseline levels of disease activity, including active and highly active disease, showed that the efficacy of Ocrevus on ARR and 12 week CDP was consistent with the overall population.
Analiza populacij bolnikov z različnimi izhodiščnimi ravnmi aktivnosti bolezni, vključno z aktivno in zelo aktivno boleznijo, je pokazala, da je bila učinkovitost zdravila Ocrevus, kar zadeva preračunani delež recidivov na leto in 12-tedensko potrjeno napredovanje prizadetosti, skladna s celotno populacijo.
Constant clearance was estimated at 0.17 L/day, and initial time-dependent clearance at 0.0489 L/day which declined with a half-life of 33 weeks.
Ocenjeni stalni očistek je 0,17 l/dan in ocenjeni uvodni od časa odvisni očistek 0,0489 l/dan, ki se je zmanjševal z razpolovnim časom 33 tednov.
Infections were predominantly mild to moderate in severity and patients recovered with treatment by standard therapies.
Okužbe so bile pretežno blage do zmerne in bolniki so okrevali po uporabi običajnih načinov zdravljenja.
· Tell your doctor or nurse straight away if you think your MS is getting worse or if you notice any new symptoms.
• Zdravniku ali medicinski sestri morate takoj povedati, če se vam zdi, da se vam multipla skleroza slabša, ali če opazite kakršen koli nov simptom.
· Before you start treatment with Ocrevus and before subsequent infusions, your doctor may ask you to have a blood test to verify your immune system because infections may occur more frequently in case of severe problems with your immune system.
• Pred začetkom zdravljenja z zdravilom Ocrevus in pred nadaljnjimi infundiranji lahko zdravnik naroči preiskavo krvi, s katero preveri imunski sistem, kajti okužbe so lahko v primeru hudih težav z imunskim sistemom pogostejše.
The above examples of dose interruption and slowing (for mild/moderate and severe IRRs) will result in a change in the infusion rate and increase the total duration of the infusion, but not the total dose.
Zgornji primeri prekinitve odmerka in upočasnitve (za blage/zmerne in hude z infuzijo povezane reakcije) spremenijo hitrost infundiranja in podaljšajo njegovo trajanje, ne spremenijo pa celotnega odmerka.
This is because the immune cells that Ocrevus targets also help to fight infection.
Imunske celice, ki so cilj zdravila Ocrevus, namreč pomagajo tudi pri premagovanju okužb.
There is limited clinical trial experience with doses higher than the approved intravenous dose of Ocrevus.
Iz kliničnih preskušanj je malo izkušenj z odmerki, večjimi od odobrenega intravenskega odmerka zdravila Ocrevus.
Relative Increase (Pooled Analysis1) Relative Increase (Individual Studies
Relativno povečanje (kumulativna analiza Relativno povečanje (posamezna študija
The impact of treatment-emergent ADAs on safety and efficacy cannot be assessed given the low incidence of ADA associated with Ocrevus.
Vpliva ADA, ki nastanejo med zdravljenjem, na varnost in učinkovitost ni mogoče oceniti glede na majhno pojavnost ADA, povezanih z zdravilom Ocrevus.
1 Symptoms reported as IRRs within 24 hours of the infusion are described below in ‘Infusion-related reactions'.
Simptomi, zabeleženi kot z infuzijo povezane reakcije v 24 urah po infundiranju, so opisani v spodnjem odstavku "Z infuzijo povezane reakcije".
20.7% Ocrevus vs 15.6% IFN
20,7 % zdravilo Ocrevus v primerjavi s 15,6 % IFN
Knowledge is limited as to whether concomitant steroid use for symptomatic treatment of relapses is associated with an increased risk of infections in clinical practice.
Malo je znanega o tem, ali je sočasna uporaba steroidov za simptomatsko zdravljenje recidivov v klinični praksi povezana z večjim tveganjem za okužbe.
Patients with active HBV (i.e. an active infection confirmed by positive results for HBsAg and anti HB testing) should not be treated with Ocrevus.
Bolnikov z aktivnim HBV (tj. z aktivno okužbo, potrjeno s pozitivnim rezultatom HBsAg in testiranjem anti-HB) se ne sme zdraviti z zdravilom Ocrevus.
Available pharmacodynamic/toxicological data in animals have shown excretion of ocrelizumab in milk (for details see section 5.3).
Farmakodinamični/toksikološki podatki, ki so na voljo za živali, so pokazali, da se okrelizumab izloča v materino mleko (za podrobnosti glejte poglavje 5.3).
Percentage change in brain volume from Week 24 to week 96 Relative reduction in brain volume loss
Odstotek spremembe volumna možganov od 24. do 96. tedna Relativno zmanjšanje izgube možganskega volumna
An exploratory analysis identified the following factors associated with risk of serious infections: higher doses of Ocrevus than recommended in MS, other comorbidities, and chronic use of immunosuppressants/corticosteroids.
V eksploratorni analizi so zaznali naslednje dejavnike, povezane s tveganjem za resne okužbe: odmerki zdravila Ocrevus, večji od priporočenih pri multipli sklerozi, druge sočasne bolezni in kronična uporaba imunosupresivov/kortikosteroidov.
· Before you start any other medicines, tell your doctor when you had your last Ocrevus infusion.
• Preden začnete uporabljati katero koli novo zdravilo, morate zdravniku povedati, kdaj ste prejeli zadnjo infuzijo zdravila Ocrevus.
It is recommended that the product is used immediately after dilution.
Zdravilo je priporočljivo uporabiti takoj po razredčenju.
· 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).
• Med zdravljenjem z zdravilom Ocrevus ne smete dobiti živih ali živih oslabljenih cepiv (na primer BCG proti tuberkulozi ali cepiv proti rumeni mrzlici).
The safety of immunisation with live or live-attenuated vaccines, following Ocrevus therapy has not been studied and vaccination with live-attenuated or live vaccines is not recommended during treatment and not until B-cell repletion (in clinical trials, the median time for B-cell repletion was 72 weeks).
Varnost imunizacije z živimi ali živimi oslabljenimi cepivi po zdravljenju z zdravilom Ocrevus ni raziskana in cepljenje z živimi ali živimi oslabljenimi virusnimi cepivi med zdravljenjem in do ponovnega porasta števila celic B ni priporočljivo (v kliničnih preskušanjih je bil mediani čas do ponovnega porasta celic B 72 tednov).
· Infusion-related reactions are the most common side effect of Ocrevus treatment (very common: may affect more than 1 in 10 people).
• Z infuzijo povezane reakcije so najpogostejši neželeni učinek zdravljenja z zdravilom Ocrevus (so zelo pogoste: pojavijo se lahko pri več kot 1 od 10 bolnikov).
· If you are treated with Ocrevus for primary progressive multiple sclerosis, and you have swallowing difficulties, Ocrevus may increase the risk of severe pneumonia.
• Če prejemate zdravilo Ocrevus za zdravljenje primarno progresivne multiple skleroze in imate težave s požiranjem, lahko zdravilo Ocrevus poveča tveganje za hudo pljučnico.
Ocrevus has no or negligible influence on the ability to drive and use machines.
Zdravilo Ocrevus nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Subsequent Doses (600 mg) once every 6 months
(600 mg) enkrat na 6 mesecev
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.
CD20 je antigen na celični površini, ki je prisoten na celicah pred-B in spominskih celicah B, ni pa izražen na limfatičnih matičnih celicah ali na plazmatkah.
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.
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.