FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of infections that were serious or required IV antibiotics, was approximately 4 per 100 patient years.
Slovenian: Incidenca okužb, ki so bile resne ali so zahtevale uporabo intravenskega antibiotika, je bila približno 4 na 100 bolnik-let.
English: Rarely Ritemvia can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Slovenian: Redko lahko zdravilo Ritemvia povzroči resno možgansko okužbo, imenovano progresivna multifokalna levkoencefalopatija ali PML.
English: Mild or moderate infusion-related reactions (IRRs) (section 4.8) usually respond to a reduction in the rate of infusion.
Slovenian: Blage ali zmerne reakcije, povezane z infuzijo (poglavje 4.8), lahko običajno zmanjšamo z manjšim infuzijskim pretokom.
English: • What the signs of an infection are
Slovenian: • Kateri so znaki okužbe
English: Ritemvia should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Slovenian: Zdravilo Ritemvia je treba dajati pod nadzorom izkušenega zdravnika in v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo (glejte poglavje 4.4).
English: Median TTF/PFS/ EFS mo
Slovenian: Mediane TTF/PFS/EFS (meseci)
English: Other medicines and Ritemvia
Slovenian: Druga zdravila in zdravilo Ritemvia
English: On the basis of limited experience with rituximab in rheumatoid arthritis patients (see section 4.8) the present data do not seem to suggest any increased risk of malignancy.
Slovenian: Na osnovi omejenih izkušenj z rituksimabom pri zdravljenju revmatoidnega artritisa (glejte poglavje 4.8) sedanji podatki ne kažejo kakršnegakoli povečanega tveganja za razvoj malignih bolezni.
English: The rate of serious infections was approximately 25 per 100 patient years.
Slovenian: Delež resnih okužb je bil približno 25 na 100 bolnik-let.
English: Only the highest frequency observed in the trials is reported
Slovenian: Navedena je samo največja pogostnost, ugotovljena v preskušanjih.
English: Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of patients in clinical trials, and were predominantly seen during the first infusion, usually in the first one to two hours.
Slovenian: O znakih in simptomih, ki bi lahko nakazovali reakcije, povezane z infuzijo, so poročali pri več kot 50% bolnikov v kliničnih preskušanjih; večinoma so jih opazili med prvo infuzijo, po navadi v prvih dveh urah.
English: At week 48 seropositive patients were 2-3 times more likely to achieve ACR responses compared to seronegative patients.
Slovenian: 48. teden je bila pri seropozitivnih bolnikih 2- do 3-krat večja verjetnost, da dosežejo odzive ACR, kot pri seronegativnih bolnikih.
English: Patients reporting signs and symptoms of infection following rituximab therapy should be promptly evaluated and treated appropriately.
Slovenian: Bolnike, pri katerih se pojavijo znaki in simptomi okužbe po zdravljenju z zdravilom rituksimab, je treba nemudoma pregledati in primerno zdraviti.
English: Rituximab is not indicated for these patients, since the safety data about long-term rituximab treatment are insufficient, in particular concerning the risk of development of malignancies and PML.
Slovenian: Rituksimab ni indicirano za uporabo pri teh bolnikih zaradi nezadostnih podatkov o varnosti dolgoročnega zdravljenja z rituksimabom, še posebej v zvezi s tveganjem za razvoj malignih bolezni ter PML.
English: The incidence of all grade infections was similar between the arms.
Slovenian: Pojavnost okužb vseh stopenj je bila med skupinama podobna.
English: No dose reductions of Ritemvia are recommended.
Slovenian: Odmerka zdravila Ritemvia ni priporočljivo zmanjšati.
English: Contents of the pack and other information What Ritemvia contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ritemvia
English: Body system
Slovenian: Organski sistem
English: It is not known whether Ritemvia has an effect on you being able to drive or use any tools or machines.
Slovenian: Ni znano, ali zdravilo Ritemvia vpliva na vašo sposobnost za upravljanje vozil ali strojev.
English: 6.11 years
Slovenian: 6,11 let
English: The rate of all ADRs following first rituximab exposure was highest during the first 6 months and declined thereafter.
Slovenian: Delež vseh neželenih učinkov, ki so se pojavili po prvi izpostavitvi rituksimabu, je bil najvišji v prvih 6 mesecih in se je potem zmanjševal.
English: Neurologic events
Slovenian: Nevrološki dogodki
English: Patients who develop severe cytokine release syndrome should have their infusion interrupted immediately (see section 4.2) and should receive aggressive symptomatic treatment.
Slovenian: Bolnikom, pri katerih se pojavi hud sindrom sproščanja citokinov, je treba infundiranje nemudoma prekiniti (glejte poglavje 4.2) in dobiti morajo agresivno simptomatsko zdravljenje.
English: Worst case imputation is applied for patients with missing data
Slovenian: Za bolnike z manjkajočimi podatki so uporabili imputacijo za najslabši primer.
English: What you need to know before you use Ritemvia Do not take Ritemvia if:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ritemvia Ne uporabljajte zdravila Ritemvia, če:
English: Mean Cmax was 16 to 19% higher following second infusion compared to the first infusion for both doses.
Slovenian: Povprečna Cmax je bila za 16 do 19 % večja po drugi infuziji v primerjavi s prvo infuzijo pri obeh odmerkih.
English: In patients where the treatment is working, Ritemvia may be continued for 2 years after completing the initial treatment.
Slovenian: Pri bolnikih, pri katerih takšno zdravljenje deluje, je mogoče zdravila Ritemvia nadaljevati še dve leti po dokončanju začetnega zdravljenja.
English: Included patients were 21 to 75 years of age and had newly diagnosed or relapsing disease in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide.
Slovenian: Vključeni bolniki so bili stari od 21 do 75 let in so imeli novodiagnosticirano bolezen ali recidiv bolezni v popolni remisiji po kombiniranem zdravljenju z glukokortikoidi in pulznim ciklofosfamidom.
English: In a long-term observational safety study, 97 GPA/MPA patients received treatment with rituximab (mean of 8 infusions [range 1-28]) for up to 4 years, according to their physician's standard practice and discretion.
Slovenian: V dolgoročni opazovalni študiji varnosti je 97 bolnikov z GPA/MPA prejemalo zdravljenje z rituksimab (v povprečju 8 infuzij [razpon od 1 do 28]) do 4 leta, v skladu s standardno prakso in presojo njihovega zdravnika.
English: The consequences of long term B cell depletion in paediatric patients are unknown.
Slovenian: Posledice dolgotrajnega zmanjšanja števila celic B pri pediatričnih bolnikih niso znane.
English: On the basis of standardised incidence ratios, the incidence of malignancies appears to be similar to that previously reported in patients with ANCA-associated vasculitis.
Slovenian: Na podlagi standardiziranih incidenčnih razmerij je incidenca malignih bolezni podobna, kot je bila pred tem opisana pri bolnikih z vaskulitisom, povezanim z ANCA.
English: Skin papilloma * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
Slovenian: kožni papilomi * Z infundiranjem povezane reakcije so vključevale simptome, zbrane ob naslednjem načrtovanem obisku po vsaki infuziji, in neželene dogodke, ki so se pojavili na dan infuzije ali en dan po njej.
English: Primary analysis (median FU: 25 months)
Slovenian: Primarna analiza (mediana spremljanja: 25 mesecev)
English: Cumulative incidence over time of first major relapse
Slovenian: Kumulativna incidenca glede na čas prvega hujšega recidiva
English: What are the signs of getting an infection?
Slovenian: Kateri so znaki okužbe?
English: 3 Reactions occurring during or within 24 hours of infusion.
Slovenian: 3Reakcije, ki so se pojavile med infuzijo ali v prvih 24 urah po njej.
English: • If you respond well to treatment, you may be given Ritemvia every 2 or 3 months for two years.
Slovenian: Če se boste dobro odzvali na zdravljenje, boste lahko zdravilo Ritemvia dobivali na dva meseca ali tri, in sicer dve leti.
English: Very common side effects (may affect more than 1 in 10 people): allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion long lasting depression loss of hair
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): alergijske reakcije, ki se najverjetneje pojavijo med infuzijo, a se lahko pojavijo tudi do 24 ur po infuziji, dolgotrajna depresija, izpadanje las.
English: • tremors (shakiness, often in the hands)
Slovenian: tremor (tresenje, pogosto tresenje rok),
English: Patients could receive 1000 mg IV at the time of relapse (see section 5.1).
Slovenian: Bolniki so lahko dobili 1.000 mg intravensko ob času recidiva (glejte poglavje 5.1).
English: Read the leaflet for further information.
Slovenian: Za dodatne informacije preberite navodilo za uporabo.
English: These studies support the use of rituximab with any chemotherapy.
Slovenian: Te študije podpirajo uporabo rituksimaba s katerokoli kemoterapijo.
English: These are listed below under “Other side effects”.
Slovenian: Naštete so spodaj pod naslovom Drugi neželeni učinki.
English: Infections Tell your doctor immediately if you get signs of an infection including:
Slovenian: Zdravniku nemudoma povejte, če se vam pojavijo znaki okužbe, na primer:
English: Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately.
Slovenian: Pri bolnikih, pri katerih se pojavijo hude reakcije, zlasti huda dispneja, bronhospazem ali hipoksija, moramo infuzijo takoj prekiniti.
English: PML, reactivation of hepatitis B
Slovenian: PML, reaktivacija hepatitisa B
English: Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Slovenian: Podskupine bolnikov - kombinirano zdravljenje z rituksimabom Starejši bolniki (≥ 65 let)
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC02.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC02.
English: This antigen does not internalize upon antibody binding and is not shed from the cell surface.
Slovenian: Po vezavi s protitelesom ne vstopa v notranjost celice, niti se ne odcepi s celične površine.
English: This compares favourably with the TTP achieved after the prior course of rituximab (12.4 months).
Slovenian: To je lepo primerljivo s časom do napredovanja bolezni, ki je bil dosežen po predhodnem zdravljenju z rituksimabom (12,4 meseca).
English: Seropositive patients also had a significantly greater decrease in DAS28-ESR compared to seronegative patients (Figure 1).
Slovenian: Seropozitivni bolniki so imeli tudi značilno večje zmanjšanje v DAS28-ESR kot seronegativni bolniki (slika 1).
English: Therefore patients with a history of cardiac disease should be monitored closely (see Infusion-related reactions, above).
Slovenian: Bolnike z anamnezo bolezni srca je zato treba natančno opazovati (glejte Reakcije, povezane z infuzijo, zgoraj).
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake Uporabno do/EXP.
English: Pneumocystis jirovecii pneumonia prophylaxis was required for all patients with CD4+ T-lymphocyte counts less than 250 per cubic millimeter.
Slovenian: Profilaksa proti pljučnici zaradi Pneumocystis jirovecii je bila zahtevana za vse bolnike, ki so imeli število limfocitov T CD4+ manj kot 250 na kubični milimeter.
English: For mixing the solution, gently invert the bag in order to avoid foaming.
Slovenian: Za mešanje raztopine vrečko rahlo obrnemo, tako da preprečimo penjenje.
English: Patients with a history of pulmonary insufficiency or those with pulmonary tumour infiltration may be at greater risk of poor outcome and should be treated with increased caution.
Slovenian: Bolniki z anamnezo pljučne insuficience ali tisti s pljučno tumorsko infiltracijo imajo lahko večje tveganje za slab izid in jih je treba zdraviti posebno pazljivo.
English: This is because Ritemvia may pass into breast milk.
Slovenian: Zdravilo Ritemvia namreč lahko prehaja v materino mleko.
English: Prednisone N=36
Slovenian: prednizon n = 36
English: Treatment start date and contact details
Slovenian: Začetek zdravljenja in podatki za stik
English: Ritemvia may be used for the treatment of several different conditions in adults.
Slovenian: Zdravilo Ritemvia se uporablja za zdravljenje več različnih bolezni pri odraslih.
English: • taste problems - such as changes in the way things taste
Slovenian: motnje okušanja - na primer spremenjen okus stvari,
English: The majority of patients were ANCApositive at diagnosis or during the course of their disease; had histologically confirmed necrotizing small-vessel vasculitis with a clinical phenotype of GPA/MPA, or renal limited ANCA-associated vasculitis; or both.
Slovenian: Večina bolnikov je bila ob postavitvi diagnoze ali med potekom bolezni ANCA-pozitivnih; imeli so histološko potrjen nekrotizirajoč vaskulitis malih žil s kliničnim fenotipom GPA/MPA, ledvično omejen z ANCA povezan vaskulitis ali oboje.
English: No pharmacokinetic data are available in patients with hepatic or renal impairment.
Slovenian: Farmakokinetičnih podatkov pri bolnikih z jetrno in ledvično okvaro ni na voljo.
English: Peripheral blood B cell counts begin to increase from week 24 and evidence for repopulation is observed in the majority of patients by week 40, whether rituximab was administered as monotherapy or in combination with methotrexate.
Slovenian: Število perifernih celic B se je začelo povečevati od 24. tedna in znake ponovne populacije so opazili pri večini bolnikov do 40. tedna ne glede na to, ali so rituksimab prejemali kot samostojno zdravljenje ali v kombinaciji z metotreksatom.
English: Of the patients originally receiving methotrexate alone, 81% received rituximab either as rescue between weeks 16-24 or in the extension trial, before week 56.
Slovenian: Od bolnikov, ki so prvotno dobivali samo metotreksat, jih je 81% dobilo rituksimab kot rešilno zdravilo (rescue) med 16. in 24. tednom ali v okviru nadaljevalne študije pred 56. tednom.
English: Neutropenic events, including severe late onset and persistent neutropenia, have been rarely reported in the post-marketing setting, some of which were associated with fatal infections.
Slovenian: O dogodkih nevtropenije, vključno s hudo obliko pozne in dolgotrajne nevtropenije, so po prihodu zdravila na trg poročali redko, nekateri dogodki pa so bili povezani z usodnimi okužbami.
English: 2Details on infusion related reactions are provided in the description of selected adverse drug reactions section.
Slovenian: Podrobnosti o reakcijah, povezanih z infundiranjem, so navedene v opisu v poglavju o izbranih neželenih učinkih zdravila.
English: Patients in a severely immunocompromised state.
Slovenian: Bolniki, ki so hudo imunsko oslabeli.
English: Efficacy outcomes in rituximab treated patients were analysed based on autoantibody status prior to commencing treatment.
Slovenian: Izide učinkovitosti so pri bolnikih, zdravljenih z rituksimabom, analizirali na podlagi stanja protiteles pred začetkom zdravljenja.
English: During or within the first 24 hours of the infusion you may develop fever, chills and shivering.
Slovenian: Med infuzijo ali v prvih 24 urah po njej se lahko pojavijo zvišana telesna temperatura, mrazenje in drgetanje.
English: IRRs may occur as a result of hypersensitivity and/or to the mechanism of action.
Slovenian: Reakcije, povezane z infuzijo, se lahko pojavijo kot rezultat preobčutljivosti in/ali mehanizma delovanja.
English: Measure blood neutrophils prior to each course of rituximab, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Slovenian: Število nevtrofilcev v krvi je treba določiti pred vsakim ciklom zdravila rituksimab in redno do 6 mesecev po končanem zdravljenju ter pri znakih ali simptomih okužbe (glejte poglavje 4.8).
English: For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+" where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
Slovenian: Pri vsakem izrazu so pri določitvi pogostnosti upoštevali neželene učinke vseh stopenj (od blage do hude), razen za izraze, označene s "+", kjer so pri določitvi pogostnosti upoštevali le hude neželene učinke (≥ 3. stopnja po lestvici skupnih meril toksičnosti Nacionalnega inštituta za raka (NCI common toxicity criteria)).
English: Mean change in DAS † Outcome at 24 weeks
Slovenian: † Izid po 24 tednih
English: Severe infusion-related reactions (such as bronchospasm, hypotension) occurred in up to 12% of the cases.
Slovenian: Hude reakcije, povezane z infuzijo (npr. bronhospazem, hipotenzija), so se pojavile pri do 12% bolnikov.
English: Specific studies to determine the effects of rituximab on fertility have not been performed.
Slovenian: Specifičnih študij za ugotavljanje učinkov rituksimaba na plodnost niso izvedli.
English: Prednisone tapering was to be completed by 6 months from the start of study treatment.
Slovenian: Postopno zmanjševanje prednizona so morali končati do 6 mesecev po začetku raziskovanega zdravljenja.
English: From month 12 to month 18, 8 relapses were observed in the rituximab group compared with four in the cyclophosphamide group.
Slovenian: Od 12. do 18. meseca so v skupini z rituksimabom zabeležili 8 ponovitev in v skupini s ciklofosfamidom 4.
English: Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections.
Slovenian: Zdravniku povejte tudi, če imate pogoste ali hude okužbe;
English: Population pharmacokinetic analysis of the same data gave similar mean values for systemic clearance and half-life, 0.26 L/day and 20.4 days, respectively.
Slovenian: Populacijska farmakokinetična analiza istih podatkov je dala podobne povprečne vrednosti za sistemski očistek in razpolovni čas, 0,26 L/dan in 20,4 dni.
English: Cytokine release syndrome may be clinically indistinguishable from acute hypersensitivity reactions.
Slovenian: Sindrom sproščanja citokinov je lahko klinično nerazločljiv od akutnih preobčutljivostnih reakcij.
English: A diagnosis of PRES/RPLS requires confirmation by brain imaging.
Slovenian: Diagnozo PRES/RPLS je treba potrditi s slikanjem možganov.
English: Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of IRRs (see sections 4.2 and 4.4).
Slovenian: Premedikacija z intravenskimi glukokortikoidi je pomembno znižala incidenco in resnost z infuzijo povezanih reakcij (glejte poglavji 4.2 in 4.4).
English: • an increase in the amount of potassium in the blood
Slovenian: povečanje količine kalija v krvi,
English: The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Slovenian: Protitelo je pridobljeno iz suspenzije kulture celic sesalcev (ovarij kitajskega hrčka) in očiščeno z afinitetno kromatografijo ter ionsko izmenjavo, vključno s specifičnimi postopki inaktivacije in odstranjevanja virusov.
English: The proportions of patients experiencing cardiac reactions (all or serious) did not increase over multiple courses.
Slovenian: Delež bolnikov, pri katerih so se pojavili neželeni učinki, povezani s srcem (vsi ali resni), se z nadaljnjimi cikli zdravljenja ni povečeval.
English: These patients were treated either with rituximab monotherapy (as induction treatment or maintenance treatment following induction treatment) or in combination with chemotherapy.
Slovenian: Ti bolniki so prejemali rituksimab kot samostojno zdravljenje (kot indukcijsko zdravljenje ali vzdrževalno zdravljenje po indukcijskem zdravljenju) ali v kombinaciji s kemoterapijo.
English: Number of responders (response rate [%]) a p-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Slovenian: Število odzivnih (delež odziva [%]) aVrednost p je vrednost iz Fisherjevega eksaktnega testa s sredinskim popravkom p. b 95-% interval zaupanja je korigiran Newcombov interval.
English: Of the 99 patients treated with rituximab, 12 (12%) experienced at least one IRR.
Slovenian: Od 99 bolnikov, zdravljenih z rituksimab, se je pri 12 (12%) pojavila vsaj ena IRR.
English: Respiratory system Cases of interstitial lung disease, some with fatal outcome, have been reported.
Slovenian: Poročali so o primerih intersticijske bolezni pljuč, nekateri so bili smrtni.
English: This is because there is not much information about the use of Ritemvia in children and young people.
Slovenian: O uporabi zdravila Ritemvia pri otrocih in mladostnikih namreč ni veliko informacij.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna
English: However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with rituximab and for 12 months following rituximab treatment.
Slovenian: A zaradi dejstva, da se materini IgG izločajo v materino mleko, in da so rituksimab našli v mleku doječih opic, ženske med zdravljenjem z zdravilom rituksimab in 12 mesecev po njem ne smejo dojiti.
English: in the blood which help protect against infection
Slovenian: (IgG), v krvi; ta protitelesa pomagajo pri zaščiti proti okužbam.
English: In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
Slovenian: V primerjavi s sindromom sproščanja citokinov se prave preobčutljivostne reakcije praviloma pojavijo že v nekaj minutah po začetku infundiranja.
English: The incidence of thrombocytopenia was low (<1%, grade 3/4) and was not different between treatment arms.
Slovenian: Incidenca trombocitopenije je bila nizka (< 1% 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
English: PK parameters for rituximab were comparable over the two treatment courses.
Slovenian: Farmakokinetični parametri za rituksimab so bili med dvema cikloma zdravljenja primerljivi.
English: For CLL patients similar results are assumable considering similarities between both diseases but that has not been investigated in clinical trials.
Slovenian: Zaradi podobnosti med boleznima sklepamo, da bi bili rezultati za bolnike s KLL podobni, a tega niso preučili v kliničnem preskušanju.
English: Corticosteroids given by mouth may be started at any time by your doctor to treat your condition.
Slovenian: Kortikosteroide, ki jih boste uživali, pa vam zdravnik lahko za zdravljenje vaše bolezni uvede kadar koli.
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of Ritemvia maintenance therapy, up to 5 years.
Slovenian: Pri bolnikih z večjim tveganjem za recidiv je treba razmisliti o dolgotrajnejšem vzdrževalnem zdravljenju z zdravilom Ritemvia, do 5 let.
English: The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with rituximab, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following rituximab therapy.
Slovenian: Podatki, ki so na voljo, nakazujejo, da je pojavnost klinično pomembnih okužb nespremenjena, ko ta zdravila uporabimo pri bolnikih, ki so jih prej zdravili z rituksimabom, vendar jih moramo skrbno opazovati glede znakov okužbe, če po zdravljenju z zdravilom rituksimab prejmejo biološka zdravila in/ali DMARD.