FrancophonIA/ELRC3.0 huggingface dataset:
English: For information related to the autoimmune indications, please refer to the SmPC of MabThera intravenous formulation.
Estonian: Autoimmuunhaigustega seotud teave vt MabThera intravenoosse ravimvormi ravimi omaduste kokkuvõte.
English: MabThera contains the active substance “rituximab”.
Estonian: MabThera sisaldab toimeainena rituksimabi.
English: The safety of immunisation with live viral vaccines, following MabThera therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Estonian: Mitte-Hodgkini lümfoomi ja kroonilise lümfoidse leukeemiaga patsientidel ei ole uuritud MabThera-ravi järgse elusviirust sisaldavate vaktsiinidega immuniseerimise ohutust ning vaktsineerimine elusviirust sisaldavate vaktsiinidega ei ole soovitatav.
English: Do not have MabThera if:
Estonian: Teile ei tohi MabThera't manustada:
English: What MabThera 1600 mg solution for subcutaneous injection contains
Estonian: Mida MabThera 1600 mg subkutaanne süstelahus sisaldab
English: Maintenance treatment with MabThera led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p< 0.0001 log-rank test).The median PFS was 42.2 months in the MabThera maintenance arm compared to 14.3 months in the observation arm.
Estonian: Säilitusravi MabThera'ga viis esmase tulemusnäitaja (PFS: aeg säilitusfaasi randomiseerimisest kuni retsidiivi, haiguse progresseerumise või surmani) kliiniliselt ja statistiliselt olulise paranemiseni võrreldes ainult vaatlusega (p< 0,0001 logaritmiline astaktest).
English: During MabThera maintenance treatment for up to 2 years, leucopoenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Estonian: Kuni 2 aastat kestnud MabThera säilitusravi jooksul kirjeldati leukopeeniat (5 % vs 2 %, 3./4.
English: inflammation, irritation in the lungs, throat or sinuses, being short of breath, runny nose
Estonian: ärritus kopsudes, kurgus või ninakõrvalkoobastes, hingeldus, nohu
English: MabThera 500 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
Estonian: MabThera 500 mg infusioonilahuse kontsentraat Iga ml sisaldab 10 mg rituksimabi.
English: During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopoenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), grade 3/4 neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), grade 3/4 pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Estonian: raskusastme leukopeenia (R-CHOP 88 % vs. CHOP 79 %, R-FC 23 % vs. FC 12 %), 3. või 4. raskusastme neutropeenia (R-CVP 24 % vs. CVP 14 %; R-CHOP 97 % vs. CHOP 88 %, R-FC 30 % vs. FC 19 % eelnevalt ravimata KLL puhul), 3. või 4. raskusastme pantsütopeenia (R-FC 3 % vs. FC 1 % eelnevalt ravimata KLL puhul) esinemissagedus tavaliselt suurem kui ainult kemoteraapia puhul.
English: In patients treated with MabThera, the occurrence of pre-existing ischemic cardiac conditions becoming symptomatic, such as angina pectoris, has been observed, as well as atrial fibrillation and flutter.
Estonian: MabThera'ga ravitud mitte-Hodgkini lümfoomiga patsientidel on täheldatud olemasolevate isheemiliste südamehaiguste muutumist sümptomaatiliseks (stenokardia ja müokardiinfarkt), samuti kodade virvendust ja laperdust.
English: MabThera 1600 mg Rituximab
Estonian: MabThera 1400 mg Rituksimab
English: arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Estonian: +kodade virvendus, tahhükardia, +südame häire
English: Since hypotension may occur during MabThera administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to giving MabThera.
Estonian: Kuna MabThera manustamise ajal võib tekkida hüpotensioon, tuleb kaaluda antihüpertensiivse ravi katkestamist 12 tundi enne MabThera manustamist.
English: FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy.
Estonian: Efektiivsust analüüsiti kokku 810 patsiendil (403 R-FC, 407 FC) esmavaliku ravi uuringus (tabel 10a ja tabel 10b) ja 552 patsiendil (276 R-FC, 276 FC) retsidiveerunud/refraktaarse KLL uuringus (tabel 11).
English: During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Estonian: raskusastme leukopeenia (R-CHOP 88 % vs CHOP 79 %, R-FC 23 % vs FC 12 %), neutropeenia (R-CVP 24 % vs CVP 14 %; R-CHOP 97 % vs CHOP 88 %, R-FC 30 % vs FC 19 % eelnevalt ravimata KLL puhul) ja pantsütopeenia (R-FC 3 % vs FC 1 % eelnevalt ravimata KLL puhul) esinemissagedus tavaliselt suurem kui ainult kemoteraapia puhul.
English: The objective of the Part 1 was to select a MabThera subcutaneous formulation dose that resulted in comparable MabThera serum Ctrough levels compared with MabThera intravenous formulation.
Estonian: Esimese perioodi eesmärk oli valida MabThera subkutaanse ravimvormi annus, mis viis MabThera intravenoosse ravimvormiga võrreldava minimaalse kontsentratsiooni saavutamiseni seerumis (Cmin).
English: The chemotherapy should be given after MabThera infusion.
Estonian: Kemoteraapia järgneb MabThera infusioonile.
English: +left ventricular failure, +supraventricu lar tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia severe cardiac disorders 4 and 6
Estonian: +vasaku vatsakese puudulikkus, +supraventrikulaarne tahhükardia, +ventrikulaarne tahhükardia, +stenokardia, +müokardi isheemia, bradükardia rasked kardiaalsed häired 4 ja 6
English: A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
Estonian: Aktiivse võrdlusravimiga randomiseeritud topeltpimedas platseebokontrollitud mitmekeskuselises samaväärsuse uuringus osales ja sai ravi kokku 197 raske ägeda granulomatoosse polüangiidi (75 %) ja mikroskoopilise polüangiidiga (24 %) patsienti alates 15 aasta vanusest.
English: (q3m) µg/mL
Estonian: Geomeetriline keskmine Cmin (q3m) µg/ml
English: In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1 -5) every 3 weeks for 8 cycles or MabThera 375 mg/m2 in combination with CVP (R-CVP).
Estonian: Avatud randomiseeritud uuringus osales kokku 322 varem ravi mittesaanud follikulaarse lümfoomiga patsienti, kes randomiseeriti saama CVP-kemoteraapiat (tsüklofosfamiid 750 mg/m2, vinkristiin 1,4 mg/m2 kuni maksimaalselt 2 mg 1. päeval ja prednisoloon 40 mg/m2 ööpäevas 1. kuni 5. päeval), 8 tsüklit iga 3 nädala järel või MabThera't 375 mg/m2 kombinatsioonis CVPga (R-CVP).
English: Each vial contains 1400 mg/11.7 mL of rituximab.
Estonian: Iga viaal sisaldab 1400 mg/11,7 ml rituksimabi.
English: During MabThera maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Estonian: Kuni 2 aastat kestnud MabThera säilitusravi jooksul kirjeldati leukopeeniat (5 % vs. 2 %, 3./4.
English: No dose adjustment is required in elderly patients (aged >65 years).
Estonian: Eakad Eakatel (vanuses > 65 aasta) ei ole vaja annust korrigeerida.
English: Also do not breast-feed for 12 months after your last treatment with MabThera.
Estonian: Samuti ei tohi last rinnaga toita 12 kuud pärast viimast MabThera-ravi, sest MabThera võib erituda rinnapiima.
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
Estonian: Tabel 1 Kõrvaltoimed, mida on kirjeldatud kliinilistes uuringutes või turuletulekujärgsel perioodil mitte-Hodgkini lümfoomi ja kroonilise lümfoidse leukeemiaga patsientidel, kes said MabThera monoteraapiat/säilitusravi või kombineeritud ravi kemoteraapiaga
English: Patients should be observed for at least 15 minutes following MabThera subcutaneous administration.
Estonian: Pärast MabThera subkutaanset manustamist tuleb patsiente jälgida vähemalt 15 minuti jooksul.
English: Clinical experience of MabThera subcutaneous formulation in chronic lymphocytic leukaemia
Estonian: MabThera subkutaanse ravimvormi kasutamise kliiniline kogemus kroonilise lümfoidse leukeemia korral
English: Cases of progressive multifocal leukoencephalopathy with fatal outcome have been reported following use of MabThera for the treatment of autoimmune diseases.
Estonian: MabThera kasutamisel autoimmuunhaiguste raviks on kirjeldatud surmaga lõppenud progresseeruva multifokaalse leukoentsefalopaatia juhtusid.
English: • severe skin problems causing blisters that can be life-threatening
Estonian: • ville põhjustavad raskekujulised nahaprobleemid, mis võivad olla eluohtlikud
English: The safety of immunisation with live viral vaccines, following MabThera therapy has not been studied for NHL patients and vaccination with live virus vaccines is not recommended.
Estonian: Mitte-Hodgkini lümfoomiga patsientidel ei ole uuritud MabThera-ravi järgse elusviirust sisaldavate vaktsiinidega immuniseerimise ohutust ning vaktsineerimine elusviirust sisaldavate vaktsiinidega ei ole soovitatav.
English: This set of reactions which includes syndrome of cytokine release, tumor lysis syndrome and anaphylactic and hypersensitivity reactions are described below.
Estonian: Järgnevalt on kirjeldatud manustamisega seotud reaktsioone, mis hõlmavad tsütokiini vabanemise sündroomi, tuumori lüüsi sündroomi ning anafüktilisi ja ülitundlikkusreaktsioone.
English: Response rate and CR rates analysed using Chi-squared Test. NR: not reached; n.a.: not applicable *: only applicable to patients achieving a CR, nPR, PR **: only applicable to patients achieving a CR
Estonian: *: kehtib ainult CR, nPR, PR saavutanud patsientide kohta; NR: saavutamata; n.a. ei ole kohaldatav **: kehtib ainult CR saavutanud patsientide kohta
English: MabThera is indicated in adults in combination with chemotherapy for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL).
Estonian: MabThera kombinatsioonis kemoteraapiaga on näidustatud eelnevalt ravimata või retsidiveerunud/refraktaarse kroonilise lümfoidse leukeemiaga (KLL) täiskasvanute raviks.
English: For information related to the other indications, please refer to the SmPC of MabThera intravenous formulation.
Estonian: Teiste näidustuste kohta teabe saamiseks vt MabThera intravenoosse ravimvormi ravimi omaduste kokkuvõtet.
English: Pneumocystis jirovecii
Estonian: raske viirusinfektsioon2 Pneumocysti s jirovecii
English: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 µg/mL for 2 x 500 mg dose and ranged from 298 to 341 µg/mL for 2 x 1000 mg dose.
Estonian: Rituksimabi keskmine Cmax pärast esimest infusiooni jäi vahemikku 157...171 µg/ml 2 x 500 mg annuse puhul ja vahemikku 298...341 µg/ml 2 x 1000 mg annuse puhul.
English: OS rates,
Estonian: OS määrad,
English: Table 11 Treatment of relapsed/refractory chronic lymphocytic leukaemia - overview of efficacy results for MabThera plus FC vs. FC alone (25.3 months median observation time) Efficacy Parameter
Estonian: Tabel 11 Retsidiveerunud/refraktaarse kroonilise lümfoidse leukeemia ravi - ülevaade efektiivsuse tulemustest MabThera pluss FC vs ainult FC kasutamisel (keskmine vaatlusaeg 25,3 kuud) Efektiivsuse näitaja Kaplan-Meieri järgi hinnatud keskmine aeg juhu tekkeni (kuud)
English: You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.
Estonian: Ravi alguses manustatakse MabThera't alati veeni (veenisisene infusioon).
English: Angina pectoris, atrial fibrillation, heart failure, myocardial infarction
Estonian: Stenokardia, kodade virvendusarütmia, südamepuudulikkus, müokardiinfarkt
English: See Section 4.2 for information on paediatric use.
Estonian: Teave lastel kasutamise kohta: vt lõik 4.2.
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs 0% in FC.
Estonian: astme B-hepatiidi (reaktivatsioon ja esmane infektsioon) esinemissagedus 2 % R-FC vs 0 % FC puhul.
English: collapse
Estonian: Seljavalu
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.
Estonian: 6. kuul kirjeldatud kõrvaltoimed, mille esinemissagedus MabThera't GPA ja MPA remissiooni induktsiooniks saanud patsientide seas oli ≥ 5 % ja suurem kui võrdlusravimi grupis
English: with counts >10 cells/μL by month 12, increasing to 87% of patients by month 18.
Estonian: Enamikel patsientidel (81 %) ilmnesid 12. kuuks B-rakkude arvu taastumise nähud (B-rakkude arv > 10 rakku/mikrol), 18. kuul täheldati seda 87 %-l patsientidest.
English: MabThera should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Estonian: MabThera't manustatakse iga kemoteraapia tsükli esimesel päeval pärast kemoteraapia glükokortikoidkomponendi veenisisest manustamist vajadusel.
English: Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of MabThera is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Estonian: Varem metotreksaati mittesaanud reumatoidartriidiga patsiendid MabThera't ei ole soovitatav kasutada varem metotreksaati mittesaanud patsientidel, sest soodsat riski ja kasu suhet ei ole kindlaks tehtud.
English: Very rare cases of PML have been reported during post-marketing use of the MabThera intravenous formulation in NHL (see section 4.8).
Estonian: MabThera intravenoosse ravimvormi turuletulekujärgsel kasutamisel mitte-Hodgkini lümfoomi (NHL) raviks on väga harva kirjeldatud PML'i juhtusid (vt lõik 4.8).
English: MabThera subcutaneous formulation MabThera intravenous formulation
Estonian: MabThera subkutaanne ravimvorm MabThera intravenoosne ravimvorm
English: • high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme
Estonian: • kõrge veresuhkru tase, kehakaalu langus, näo ja keha turse, laktaatdehüdrogenaasiks (LDH)
English: The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 1400 mg once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 administrations in total).
Estonian: MabThera subkutaanse ravimvormi soovitatav säilitusravi annus eelnevalt ravimata follikulaarse lümfoomiga patsientidele, kes on reageerinud induktsioonravile, on 1400 mg üks kord iga 2 kuu järel (alustades 2 kuud pärast induktsioonravi viimast annust) kuni haiguse progresseerumiseni või maksimaalselt kahe aasta jooksu (kokku 12 infusiooni)l.
English: MabThera is administered on day 1 of each chemotherapy cycle after intravenous infusion of the glucocorticoid component of CHOP.
Estonian: MabThera't manustatakse iga kemoteraapia tsükli esimesel päeval pärast CHOP-kemoteraapia glükokortikoidkomponendi veeniinfusiooni.
English: Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocyt openia anaemia, +pancytopenia, +granulocytopeni a coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Estonian: Vere ja lümfisüsteemi häired neutropeenia, leukopeenia, +febriilne neutropeenia, +trombotsütop eenia aneemia, +pantsütopeenia, +granulotsütopeeni a hüübimishäired, aplastiline aneemia, hemolüütiline aneemia, lümfadenopaatia
English: Erosion score
Estonian: Erosiivsuse aste
English: InSparkThera, no severe administration-related reactions were reported.
Estonian: Tõsiseid infusiooniga seotud reaktsioone ei täheldatud.
English: How MabThera is given
Estonian: Kuidas MabThera't manustatakse
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with MabThera resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Estonian: MabThera säilitusravi tulemusena saavutati esmase tulemusnäitaja - uurija poolt hinnatud progressioonivaba elulemuse (PFS) - kliiniliselt ja statistiliselt oluline paranemine võrreldes eelnevalt ravimata follikulaarse lümfoomiga patsientide vaatlusgrupiga (tabel 7).
English: Regular full blood counts, including neutrophil and platelet counts, should be performed during MabThera therapy.
Estonian: MabThera-ravi ajal tuleb regulaarselt kontrollida täisvere pilti, sealhulgas neutrofiilide ja trombotsüütide arvu.
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with MabThera resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 4).
Estonian: MabThera säilitusravi tulemusena saavutati esmase tulemusnäitaja - uurija poolt hinnatud progressioonivaba elulemuse (PFS) - kliiniliselt ja statistiliselt oluline paranemine võrreldes eelnevalt ravimata follikulaarse lümfoomiga patsientide vaatlusgrupiga (tabel 4).
English: The recommended dose of MabThera in combination with chemotherapy for induction treatment of previously untreated or relapsed/refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Estonian: MabThera soovitatav annus kombinatsioonis kemoteraapiaga eelnevalt ravimata või retsidiveerunud/refraktaarse follikulaarse lümfoomi induktsioonraviks on 375 mg/m2 kehapinna kohta ühes tsüklis, kokku 8 tsükli jooksul.
English: MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion
Estonian: MabThera 100 mg infusioonilahuse kontsentraat MabThera 500 mg infusioonilahuse kontsentraat
English: Body system Adverse event
Estonian: Organsüsteem Kõrvaltoime
English: Gastrointestin al disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
Estonian: Seedetrakti häired iiveldus oksendamine, kõhulahtisus, kõhuvalu, düsfaagia, stomatiit, kõhukinnisus, düspepsia, isutus, kurguärritus kõhu suurenemine seedetrakti perforatsioon7
English: The serum rituximab Cmax at cycle 7 was similar between the two treatment arms, with geometric mean (CV%) values of 250.63 (19.01) μg/mL and 236.82 (29.41) μg/mL for the intravenous and the subcutaneous formulations respectively, with the resulting geometric mean ratio (Cmax, SC/Cmax, IV) of 0.941 (90% CI: 0.872, 1.015).
Estonian: Rituksimabi Cmax 7. tsükli ajal oli sarnane kahes ravirühmas; geomeetrilised keskmised (CV %) väärtused olid 250,63 (19,01) μg/ml ja 236,82 (29,41) μg/ml vastavalt intravenoosse ja subkutaanse ravimvormi puhul.
English: In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or MabThera 375 mg/m2 plus
Estonian: Randomiseeritud avatud uuringus said 399 eelneva ravita eakat patsienti (vanus 60...80 eluaastat), kellel esines difuusne suurerakuline B-lümfoom, kaheksa tsüklit CHOP-kemoteraapiat (tsüklofosfamiid 750 mg/m2, doksorubitsiin 50 mg/m2, vinkristiin 1,4 mg/m2 kuni maksimaalselt 2 mg 1. päeval ja prednisoloon 40 mg/m2/päevas 1. kuni 5. päeval) iga 3 nädala järel või raviskeemi MabThera annuses 375 mg/m2 pluss CHOP (R-CHOP).
English: MabThera 100 mg concentrate for solution for infusion Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Estonian: MabThera 100 mg infusioonilahuse kontsentraatÜhekordseks kasutamiseks mõeldud säilitusainevaba, läbipaistev klaasviaal butüülkummist korgiga, mis sisaldab 100 mg/10 ml rituksimabi.
English: In SAWYER (BO25341), severe administration-related reactions (Grade ≥3) were reported in four patients (5%) following MabThera subcutaneous administration.
Estonian: Uuringus SAWYER (BO25341) kirjeldati MabThera subkutaanse ravimvormi manustamise järgselt raskeid (≥3.
English: MabThera subcutaneous
Estonian: MabThera subkutaanne ravimvorm
English: Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired bronhospasm4, respiratoorne haigus, rindkerevalu, hingeldus, köha suurenemine, nohu astma, oblitereeruv bronhioliit, kopsukahjustus, hüpoksia interstitsiaal ne kopsuhaigus hingamispuudulikkus4
English: The recommended dose of MabThera used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 infusions in total).
Estonian: MabThera soovitatav säilitusravi annus eelnevalt ravimata follikulaarse lümfoomiga patsientidele, kes on reageerinud induktsioonravile, on 375 mg/m2 kehapinna kohta üks kord iga 2 kuu järel (alustades 2 kuud pärast induktsioonravi viimast annust) kuni haiguse progresseerumiseni või maksimaalselt kahe aasta jooksul (kokku 12 infusiooni).
English: Clinical experience of MabThera subcutaneous formulation in Non-Hodgkin's lymphoma
Estonian: MabThera subkutaanse ravimvormi kasutamise kliiniline kogemus mitte-Hodgkini lümfoomi korral
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.
Estonian: Keskmine Cmax suurenes iga järgneva infusiooni puhul, ulatudes väärtusest 243 µg/ml (vahemik 16...582 µg/ml) pärast esimest infusiooni kuni väärtuseni 550 µg/ml (vahemik 171...1177 µg/ml) pärast kaheksandat infusiooni.
English: The recommended dosage of MabThera in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Estonian: MabThera soovitatav annus kombinatsioonis kemoteraapiaga eelnevalt ravimata ja retsidiveerunud/refraktaarse haigusega patsientidele on 375 mg/m2 kehapinna kohta esimese ravitsükli 0-päeval ning seejärel 500 mg/m2 kehapinna kohta iga järgneva tsükli esimesel päeval, kokku 6 tsüklit.