FrancophonIA/ELRC3.0 huggingface dataset:
English: The reactions reported were usually reversible with a reduction in rate, or interruption, of MabThera infusion and administration of an anti-pyretic, an antihistamine, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Slovenian: Reakcije, o katerih so poročali, so bile običajno reverzibilne z zmanjšanjem hitrosti ali prekinitvijo infuzije zdravila MabThera in dajanjem antipiretika, antihistaminika in občasno kisika, fiziološke raztopine intravensko ali bronhodilatatorja, in glukokortikoidov, če je bilo to potrebno.
English: Product information Physician information Patient information Patient Alert card
Slovenian: izobraževalno gradivo za zdravnika, izobraževalno gradivo za bolnika, opozorilno kartico za bolnika.
English: Fourteen patients (37%) in the MabThera group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
Slovenian: Z zdravljenjem povezane okužbe so se pojavile pri 14 bolnikih (37 %) v skupini z zdravilom MabThera in pri 15 bolnikih (42 %) v skupini s standardnim odmerkom prednizona.
English: The recommended dosage of MabThera for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Slovenian: Priporočeno odmerjanje zdravila MabThera za indukcijo remisije pri zdravljenju granulomatoze s poliangiitisom in mikroskopskega poliangiitisa je 375 mg/m2 telesne površine v intravenski infuziji 1krat na teden 4 tedne (skupaj štiri infuzije).
English: See also infusion-related reactions below.
Slovenian: Glejte tudi poglavje reakcije, povezane z infuzijo, spodaj.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,600 mg/13.4 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1600 mg/13,4 ml
English: For subjects in the middle and low BSA tritiles, average Ctrough values following intravenous dosing were approximately 12% and 26% lower compared to the subcutaneous regimen.
Slovenian: Pri bolnikih s telesno površino v srednji in spodnji tretjini so pri intravenskem odmerjanju v primerjavi s podkožnim odmerjanjem zabeležili približno 12 % oz. 26 % manjše povprečne Ctrough.
English: MabThera can be given alone or with other medicines called “chemotherapy”.
Slovenian: Zdravilo MabThera lahko uporabljamo samostojno ali skupaj z drugimi zdravili, ki jih imenujemo kemoterapija.
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 2a).
Slovenian: Analiza celokupnega preživetja je pokazala signifikantno korist zdravljenja R-FC glede na samo kemoterapijo FC (p = 0,0319, test log-rang) (preglednica 3a).
English: Significant reductions in disability index (HAQ-DI) and fatigue (FACIT-Fatigue) scores were observed in patients treated with MabThera compared to patients treated with methotrexate alone.
Slovenian: (HAQ-DI, Health Assessment Questionnaire Disability Index) in utrujenosti (FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy) v primerjavi z bolniki, ki so se zdravili le z metotreksatom.
English: • reduced platelets number just after the infusion - this can be reversed, but can be fatal in rare cases
Slovenian: · zmanjšanje števila belih krvnih celic, ki se ne pojavi takoj, · zmanjšanje števila trombocitov tik po infundiranju zdravila - to je mogoče odpraviti, a v redkih primerih je lahko smrtno,
English: 48-months p = 0.0096
Slovenian: mesecev p = 0,0096
English: A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 2a and Table 2b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 3) were analysed for efficacy.
Slovenian: 810 bolnikov (403 R-FC, 407 FC) iz študije pri bolnikih v prvi liniji zdravljenja (preglednici 3a ter 3b) ter 552 bolnikov (276 R-FC, 276 FC) iz študije pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (preglednica 4).
English: Table 16 Percentage of patients who achieved complete remission at 6 months (Intent-to-treat population*)
Slovenian: Odstotek bolnikov, ki so po 6 mesecih dosegli popolno remisijo (populacija, ki so jo nameravali zdraviti*) MabThera (n = 99)
English: The ORR was 36 % (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Slovenian: Celokupen odgovor je znašal 36 % (95-% interval zaupanja 21-51 %; popoln odgovor 3 %, delni odgovor 33 %); mediana časa do napredovanja bolezni je za odzivne bolnike znašala 9,6 meseca (razpon 4,5 do 26,8 meseca).
English: In stage 2, MabThera subcutaneous formulation at a fixed dose of 1400 mg was administered as subcutaneous injection during maintenance treatment, after at least one cycle of MabThera intravenous formulation to FL patients who had previously responded to MabThera intravenous formulation in induction.
Slovenian: V 2. stopnji so podkožno obliko zdravila MabThera dajali v fiksnem odmerku v podkožni injekciji med vzdrževalnim zdravljenjem po vsaj enem ciklu intravenske oblike zdravila MabThera; to zdravljenje so prejemali bolniki s FL, ki so se pred tem odzvali na intravensko obliko zdravila MabThera med indukcijskim zdravljenjem.
English: MabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Slovenian: Granulomatoza s poliangiitisom in mikroskopski poliangiitis Zdravilo MabThera je v kombinaciji z glukokortikoidi indicirano za zdravljenje odraslih bolnikov s hudo, aktivno granulomatozo s poliangiitisom (GPA, Wegenerjevo granulomatozo) in z mikroskopskim poliangiitisom (MPA).
English: 42-months p = 0.029
Slovenian: mesecev p = 0,029
English: The safety profile of MabThera in combination with short-term, low-dose glucocorticoids in the treatment of patients with pemphigus vulgaris was studied in a Phase 3, randomised, controlled, multicenter, open-label study in pemphigus patients that included 38 pemphigus vulgaris (PV) patients randomised to the MabThera group.
Slovenian: Povzetek varnostnih značilnosti Varnostne značilnosti zdravila MabThera v kombinaciji s kratkotrajno uporabo majhnih odmerkov glukokortikoida za zdravljenje bolnikov z navadnim pemfigusom so raziskali v randomizirani, kontrolirani, multicentrični odprti študiji faze III, v kateri so 38 bolnikov randomizirali v skupino, ki je prejemala zdravilo MabThera.
English: Patients randomised to the MabThera group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15.
Slovenian: Ti bolniki so prejeli začetni odmerek 1000 mg intravensko 1. dan študije in drugi odmerek 1000 mg intravensko 15. dan študije.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution Read the package leaflet before use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za subkutano uporabo Pred uporabo preberite priloženo navodilo
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Vial of 50 mL (10 mg/mL)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 50 ml viala (10 mg/ml)
English: MabThera subcutaneous formulation MabThera intravenous formulation
Slovenian: MabThera podkožna oblika MabThera intravenska oblika
English: Placebo+MTX MabThera+MTX (2 x 1000 mg)
Slovenian: Zdravilo MabThera + metotreksat (2 x 1000 mg)
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče zadnji dan navedenega meseca.
English: The incidence of infusion-related symptoms decreases substantially with subsequent infusions and is less than 1 % after eight doses of MabThera.
Slovenian: Incidenca simptomov, povezanih z infuzijo, se z nadaljnjimi infuzijami bistveno zmanjšuje in je po osmih odmerkih zdravila MabThera manjša kot 1 %.
English: CLL affects a type of white blood cell called B-lymphocytes, which originates from the bone marrow and develops in the lymph nodes.
Slovenian: Posebno prizadene vrsto belih krvnih celic, imenovano limfociti B, ki nastajajo v kostnem mozgu in se razvijajo v limfnih vozličih.
English: The safety profile of MabThera in patients with PV was consistent with that observed in RA and GPA/MPA patients.
Slovenian: Varnostne značilnosti zdravila MabThera pri bolnikih z navadnim pemfigusom so se skladale z varnostnimi značilnostmi, opaženimi pri bolnikih z revmatoidnim artritisom in GPA/MPA.
English: The prepared MabThera solution should be administered as an intravenous infusion through a dedicated line.
Slovenian: Pripravljeno raztopino zdravila MabThera dajemo kot intravensko infuzijo skozi poseben kanal.
English: Events seen following subcutaneous administration were mild or moderate, apart from one patient who reported a local cutaneous reaction of Grade 3 intensity (injection site rash) following the first MabThera subcutaneous administration (Cycle 2).
Slovenian: Neželeni dogodki, ki so se pojavili po podkožni uporabi, so bili blagi ali zmerni, razen pri enem bolniku, pri katerem so po prvi podkožni uporabi zdravila MabThera (2. cikel) poročali o lokalni kožni reakciji 3. stopnje intenzivnosti (izpuščaj na mestu injiciranja).
English: Similar events were observed in the CLL SAWYER trial (BO25341) and were reported in up to 42% of patients in the MabThera subcutaneous arm.
Slovenian: Podobne dogodke so opazili v preskušanju SAWYER (BO25341) pri bolnikih s KLL; o njih so poročali pri do 42 %
English: Rituximab intravenous formulation (n = 205)
Slovenian: rituksimab: intravenska oblika (n = 205)
English: The most common IRRs included cytokine release syndrome, flushing, throat irritation, and tremor.
Slovenian: Med najpogostejšimi IRR so bili sindrom sproščanja citokinov, napadi rdečice, draženje žrela in tremor.
English: The frequencies of ADRs reported with MabThera alone or in combination with chemotherapy are summarised in Table 1.
Slovenian: Pogostnosti neželenih učinkov, zabeleženih med samostojnim zdravljenjem z zdravilom MabThera ali v kombinaciji s kemoterapijo, so povzete v preglednici 1.
English: In the clinical trial on induction of remission, the incidence of malignancy in MabThera treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period).
Slovenian: Incidenca malignih bolezni med bolniki, ki so v klinični študiji pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom prejemali zdravilo MabThera, je bila v kliničnem preskušanju indukcije remisije ob končnem zaključnem datumu študije (tj. ko je zadnji bolnik dokončal obdobje spremljanja) 2,00 na 100 bolnik-let.
English: These events were Grade 3 injection site rash and dry mouth.
Slovenian: To sta bila neželena dogodka 3. stopnje: izpuščaj na mestu injiciranja in suhost ust.
English: Symptoms included pain, swelling, induration, haemorrhage, erythema, pruritus and rash (see section 4.8).
Slovenian: Med simptomi in znaki so bili bolečine, oteklost, zatrdelost, krvavitev, eritem, srbenje in izpuščaj (glejte poglavje 4.8).
English: • you are allergic to hyaluronidase (an enzyme that helps to increase the absorption of injected active substance)
Slovenian: · če ste alergični na hialuronidazo (encim, ki pomaga povečati absorpcijo injicirane zdravilne učinkovine), · če imate trenutno hudo, aktivno okužbo, · če imate oslabel imunski sistem.
English: MabThera should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Slovenian: Zdravilo MabThera je treba dati v dveh 500-mg intravenskih infuzijah, med katerima mora biti 2-tedenski presledek; temu sledijo 500-mg intravenske infuzije na 6 mesecev.
English: Table 2 Summary of adverse drug reactions reported in clinical trials or during postmarketing surveillance occurring in patients with rheumatoid arthritis receiving MabThera
Slovenian: Povzetek neželeni učinkov, o katerih so poročali med kliničnimi študijami ali po prihodu zdravila na trg pri bolnikih z revmatoidnim artritisom, ki so prejemali zdravilo MabThera
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Vial of 10 mL (10 mg/mL)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 10 ml viala (10 mg/ml)
English: In case of such an event with a suspected relationship to MabThera, treatment should be permanently discontinued.
Slovenian: Če se pojavi tak neželen učinek z možno povezavo z zdravilom MabThera, je treba zdravljenje trajno ukiniti.
English: • severe blistering skin conditions that can be life-threatening.
Slovenian: · huda stanja z mehurji na koži, ki so lahko življenjsko ogrožujoča.
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving MabThera for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Slovenian: Neželeni učinki, ki so se pojavili pri ≥ 5 % bolnikov, ki so prejeli zdravilo MabThera za vzdrževalno zdravljenje GPA in MPA in pogosteje kot v primerjalni skupini
English: Psychiatric disorders Insomnia
Slovenian: Psihiatrične motnje nespečnost
English: Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium.
Slovenian: Ena 50-ml viala vsebuje 11,5 mmol (263,2 mg) natrija.
English: CHVP-IFN, R-CHVP-IFN,
Slovenian: CHVP-IFN: R-CHVPIFN: 175
English: Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 7).
Slovenian: Pomembna korist vzdrževalnega zdravljenja z zdravilom MabThera se je pokazala tudi pri sekundarnih opazovanih dogodkih - preživetju brez dogodkov (event-free survival - EFS), času do naslednjega zdravljenja limfoma (time to next anti-lymphoma treatment - TNLT), času do naslednje kemoterapije (time to next chemotherapy - TNCT) in celokupnem odgovoru (overall response rateORR) v primarni analizi (preglednica 7).
English: The estimated median terminal elimination half-life of MabThera subcutaneous formulation was 29.7 days (range, 9.9 to 91.2 days).The analysis data set contained 6003 quantifiable samples from 403 patients administered SC and/or IV rituximab in trials BP22333 (3736 samples from 277 patients) and BO22334 (2267 samples from126 patients).
Slovenian: Nabor podatkov za analizo je obsegal 6003 za kvantifikacijo primerne vzorce 403 bolnikov, ki so rituksimab dobili podkožno in/ali intravensko v preskušanjih BP22333 (3736 vzorcev 277 bolnikov) in BO22334 (2267 vzorcev 126 bolnikov).
English: Similarly, for subjects in the high BSA tritile, Ctrough values were the same for the intravenous and subcutaneous regimens.
Slovenian: Podobno so pri bolnikih s telesno površino v zgornji tretjini zabeležili enake Ctrough pri intravenskem in podkožnem režimu.
English: % SF-36 PHS MCID Mean change in SF-36 MHS % SF-36 MHS MCID
Slovenian: % bolnikov z MCID v SF-36 MHS
English: Clinical experience of MabThera subcutaneous formulation in chronic lymphocytic leukaemia
Slovenian: Klinične izkušnje s podkožno obliko zdravila MabThera pri kronični limfocitni levkemiji
English: Predicted median Cmax (q2m) µg/mL Predicted median Cmax (q3m) µg/mL
Slovenian: Predvidena mediana Cmax (na 3 mesece) µg/ml
English: Upon administration of MabThera at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171 - 1177 µg/mL) after the eighth infusion.
Slovenian: Pri 37 bolnikih z ne-Hodgkinovim limfomom, ki so prejeli 375 mg/m2 zdravila MabThera z intravensko infuzijo v osmih odmerkih enkrat na teden, se je povprečna Cmax povečala z vsako naslednjo infuzijo, tako da se je iz povprečne vrednosti 243 µg/ml (od 16 do 582 µg/ml) po prvi infuziji povečala na 550 µg/ml (171 do 1177 µg/ml) po osmi infuziji.
English: Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Slovenian: Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (PRES, posterior reversible encephalopathy syndrome) oziroma sindroma reverzibilne posteriorne levkoencefalopatije (RPLS, reversible posterior leukoencephalopathy syndrome).
English: • The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.
Slovenian: · Pomožne snovi so natrijev citrat, polisorbat 80, natrijev klorid, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
English: Table 1 ADRs reported in clinical trials or during postmarketing surveillance in patients with NHL and CLL disease treated with MabThera monotherapy/maintenance or in combination with chemotherapy
Slovenian: Neželeni učinki, opaženi med kliničnimi preskušanji ali med nadzorom v obdobju trženja pri bolnikih z NHL in KLL, ki so se zdravili z zdravilom MabThera kot samostojnim/vzdrževalnim zdravljenjem ali v kombinaciji s kemoterapijo
English: Similarly, the geometric mean AUC (CV%) values at Cycle 6 were higher among the subcutaneous group than the intravenous group; 4088 µg•day/mL (34.2) versus 3630 µg•day/mL (32.8) respectively) with a resulting adjusted geometric mean ratio [90% CI] of 1.10 [0.98-1.24].
Slovenian: Podobno so bile geometrične sredine AUC (KV %) v 6. ciklu višje pri skupini, ki je zdravilo prejemala podkožno, kot pri skupini, ki ga je prejemala intravensko; geometrična sredina AUC (KV %) je bila s podkožno obliko 4088 µg·dan/ml (34,2) in z intravensko obliko 3630 µg·dan/ml (32,8); prilagojeno razmerje geometričnih sredin [90-% IZ] je bilo 1,10 [0,98-1,24].
English: Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41 %.
Slovenian: Kaplan-Meierjeva ocena mediane trajanja preživetja brez dogodkov po Kaplan-Meierju je bila 35 mesecev v skupini R-CHOP v primerjavi s 13 meseci v skupini CHOP; to pomeni zmanjšanje tveganja za dogodke za 41 %.
English: Local cutaneous reactions, including injection site reactions were very common in patients receiving MabThera subcutaneous formulation.
Slovenian: Lokalne kožne reakcije, vključno z reakcijami na mestu injiciranja, so bile pri bolnikih, ki so prejemali podkožno obliko zdravila MabThera, zelo pogoste.
English: Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 4).
Slovenian: Pomembna korist vzdrževalnega zdravljenja z zdravilom MabThera se je pokazala tudi pri sekundarnih opazovanih dogodkih - preživetju brez dogodkov (event-free survival - EFS), času do naslednjega zdravljenja limfoma (time to next anti-lymphoma treatment - TNLT), času do naslednje kemoterapije (time to next chemotherapy - TNCT) in celokupnem odgovoru (overall response rateORR) v primarni analizi (preglednica 4).
English: Toxicity studies in cynomolgus monkeys have shown no other effect than the expected pharmacological depletion of B cells in peripheral blood and in lymphoid tissue.
Slovenian: Rituksimab se je izkazal kot visokospecifičen za antigen CD20 na celicah B. Študije toksičnosti pri opicah Cynomologus niso pokazale drugih učinkov od pričakovanega farmakološkega upada števila celic B v periferni krvi in limfatičnem tkivu.
English: Other side effects include:
Slovenian: · Znaki PML vključujejo:
English: Limited experience with doses higher than the approved dose of intravenous MabThera formulation is available from clinical trials in humans.
Slovenian: Iz kliničnih preskušanj pri človeku je le malo izkušenj z odmerki, večjimi od odobrenega odmerka intravenske oblike zdravila MabThera.
English: MabThera maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, >= 60 years), FLIPI score (<=1, 2 or >= 3), induction therapy (R-CHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR,CRu or PR).
Slovenian: Vzdrževalno zdravljenje z zdravilom MabThera je pokazalo konsistentno korist pri vseh preiskovanih, vnaprej opredeljenih podskupinah glede na spol (moški, ženski), starost (< 60 let, ≥ 60 let), oceno po indeksu FLIPI (Follicular Lymphoma International Prognostic Index) (≤ 1, 2 ali ≥ 3), indukcijsko zdravljenje (R-CHOP, R-CVP ali R-FCM) in ne glede na odgovor na indukcijsko zdravljenje (CR/CRu ali PR).
English: This is a type of protein called a “monoclonal antibody”.
Slovenian: imenujemo jo monoklonsko protitelo.
English: What MabThera contains
Slovenian: Kaj vsebuje zdravilo MabThera
English: In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or MabThera in combination with FC (R-FC).
Slovenian: V dveh odprtih, randomiziranih preskušanjih so skupno 817 bolnikov s KLL, ki prej niso bili zdravljeni, ter 552 bolnikov, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, randomizirali v skupino, ki je prejemala kemoterapijo FC (fludarabin 25 mg/m2, ciklofosfamid 250 mg/m2, 1. do 3. dan) vsake 4 tedne, 6 ciklov, ali zdravilo MabThera v kombinaciji s kemoterapijo FC (R-FC).
English: Rituximab intravenous formulation (n = 88)
Slovenian: rituksimab: intravenska oblika (n = 88)
English: The benefit in terms of PFS was consistently observed in most patient subgroups analysed according to disease risk at baseline (i.e. Binet stages A-C) (Table 2b).
Slovenian: Korist v smislu preživetja brez napredovanja bolezni so konsistentno opažali pri večini podskupin, ki so jih analizirali glede na tveganje bolezni pred vključitvijo (npr. stopnjo po Binetu A-C) (preglednica 3b).
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with MabThera to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Slovenian: Bolnikom s KLL, katerih število limfocitov je > 25 x 109/l, je za zmanjšanje pogostnosti in resnosti akutnih reakcij, povezanih z infuzijo, in/ali sindroma sproščanja citokinov priporočljivo intravensko dati 100 mg prednizona/prednizolona malo pred infuzijo zdravila MabThera.
English: Sodium MabThera 1600 mg contains less than 1 mmol sodium per dose, i.e. it is essentially sodium-free.
Slovenian: Natrij Zdravilo MabThera 1600 mg vsebuje manj kot 1 mmol natrija na odmerek, kar pomeni, da je praktično brez natrija.
English: MabThera is administered on day 1 of each chemotherapy cycle after intravenous infusion of the glucocorticoid component of CHOP.
Slovenian: Zdravilo MabThera je treba uporabiti prvi dan vsakega cikla kemoterapije po intravenski infuziji glukokortikoidne sestavine CHOP.
English: This will be administered as 2 separate infusions which are given 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years.
Slovenian: Tega boste dobili v 2 ločenih infuzijah v presledku 2 tednov, nadaljevalo pa se bo z
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving MabThera for induction of remission of GPA and MPA, and at a higher frequency than the comparator group.
Slovenian: Neželeni učinki, ki so se v 6 mesecih pojavili pri ≥ 5 % bolnikov, ki so prejeli zdravilo MabThera za indukcijo remisije GPA in MPA in pogosteje kot v primerjalni skupini