FrancophonIA/ELRC3.0 huggingface dataset:
English: MabThera 1600 mg is used to treat chronic lymphocytic leukaemia -in adults.
Slovenian: Za kaj uporabljamo zdravilo MabThera Zdravilo MabThera 1600 mg se uporablja za zdravljenje kronične limfocitne levkemije pri odraslih.
English: Further, a significantly higher proportion of patients achieved MCIDs for these scores (Table 14).
Slovenian: Poleg tega je značilno večji delež bolnikov dosegel MCID za ti oceni
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).
Slovenian: Geometrična sredina (KV %) je bila z intravensko obliko 250,63 (19,01) µg/ml in s podkožno 236,82 (29,41) µg/ml; razmerje geometričnih sredin (Cmax s.c./Cmax i.v.)
English: Pack of 1 vial.
Slovenian: V škatli je 1 viala.
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving MabThera.
Slovenian: Reaktivacija hepatitisa B Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom, ki so zdravilo
English: MabThera 100 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
Slovenian: MabThera 100 mg koncentrat za raztopino za infundiranje En ml vsebuje 10 mg rituksimaba.
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.
Slovenian: Incidenca levkopenije in nevtropenije 3. ali 4. stopnje sta bili v skupini, ki je prejemala vzdrževalno zdravljenje z zdravilom MabThera do 2 leti, višja (levkopenija: 5 %, nevtropenija: 10 %) kot v opazovani skupini (levkopenija: 2 %, nevtropenija: 4 %).
English: IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with those seen for rheumatoid arthritis patients in clinical trials (see section
Slovenian: V kliničnih preskušanjih so bile z infuzijo povezane reakcije pri bolnikih z granulomatozo s poliangiitisom, mikroskopskim poliangiitisom in navadnim pemfigusom podobne tistim pri bolnikih z revmatoidnim artritisom (glejte poglavje 4.8).
English: Your doctor or nurse will place the sticker on the syringe before injection.
Slovenian: Na stekleni viali je nalepka s podatki o zdravilu, ki jo bo zdravnik ali medicinska sestra pred injiciranjem zdravila nalepila na brizgo.
English: Progression--free survival (PFS) Overall survival
Slovenian: log-rang p vrednost preživetje brez napredovanja bolezni (PFS) celokupno preživetje
English: b) Chronic lymphocytic leukaemia
Slovenian: b) kronične limfocitne levkemije
English: Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.
Slovenian: Med drugimi resnimi neželenimi učinki so poročali tudi o reaktivaciji virusa hepatitisa B in o PML
English: CHOP R-CHOP
Slovenian: Celokupno preživetje (OS) CHOP R-CHOP
English: In a population pharmacokinetic analysis in 403 follicular lymphoma patients who received subcutaneous and/or intravenous MabThera, single or multiple infusions of MabThera as a single agent or in combination with chemotherapy, the population estimates of nonspecific clearance (CL1), initial specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.194 L/day, 0.535 L/day, and 4.37 L/day, respectively.
Slovenian: Populacijska ocena nespecifičnega očistka (CL1) je bila 0,194 l/dan, začetnega specifičnega očistka (CL2), h kateremu verjetno pripomorejo celice B ali tumorsko breme, 0,535 l/dan in volumna porazdelitve centralnega razdelka (V1) 4,37 l/dan.
English: Nervous system disorders paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety dysgeusia peripheral neuropathy, facial nerve palsy5
Slovenian: vazodilatacija, omotica, anksioznost dizgevzija periferna nevropatija, paraliza obraznega živca5
English: When injected under your skin, it is given in the stomach area, not in other sites of the body, and not into areas of the stomach where the skin is red, bruised, tender, hard or where there are moles or scars.
Slovenian: Prav tako se ga ne sme injicirati v predele trebuha, kjer je koža pordela, podpluta, občutljiva, trda ali ima znamenja ali brazgotine.
English: Previously untreated follicular lymphoma
Slovenian: Vzdrževalno zdravljenje Predhodno nezdravljeni folikularni limfomi
English: Experience from granulomatosis with polyangiitis and microscopic polyangiitis
Slovenian: Izkušnje pri granulomatozi s poliangiitisom in mikroskopskem poliangiitisu Indukcija remisije
English: At 24 months, estimates for overall survival were 68.2 % in the R-CHOP arm compared to 57.4 % in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32 %.
Slovenian: Nadaljnja analiza trajanja celokupnega preživetja, ki so jo izvedli po medianem sledenju 60 mesecev, je potrdila prednost zdravljenja z R-CHOP pred CHOP (p = 0,0071), kar pomeni zmanjšanje tveganja za dogodke za 32 %.
English: Complete response (CR/CRu) rate* 48% 67% 53% 67% chi-squared test p value odds ratio (95% CI)
Slovenian: vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja Delež celokupnega odgovora* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ) Delež popolnega odgovora (CR/CRu)* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ)
English: In a multi-centre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of MabThera as intravenous infusion weekly for eight doses.
Slovenian: V multicentričnem preskušanju brez primerjalne skupine je 37 bolnikov, pri katerih se je nizko maligni ne-Hodgkinov limfom ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo, prejemalo osem odmerkov po 375 mg/m2 zdravila MabThera v obliki intravenske infuzije enkrat na teden.
English: 3Infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythema)
Slovenian: pruritus, urtikarija, draženje žrela, vročinski oblivi, hipotenzija, rinitis, okorelost, tahikardija, utrujenost, orofaringealna bolečina, periferni edem, eritem)
English: Progression-‑ -free survival (PFS)
Slovenian: Preživetje brez napredovanja bolezni (PFS)
English: The dose of 1600 mg of MabThera subcutaneous formulation was selected for the Part 2 of the study.
Slovenian: Za 2. del preskušanja so izbrali 1600-mg odmerek podkožne oblike zdravila Mabthera.
English: The incidence of treatment-induced/enhanced anti-rHuPH20 antibodies was 8% in the intravenous group compared with 15% in the subcutaneous group, and none of the patients who tested positive for anti-rHuPH20 antibodies tested positive for neutralizing antibodies.
Slovenian: Incidenca z zdravljenjem povzročenega/okrepljenega nastajanja protiteles proti rHuPH20 (rekombinantni humani hialuronidazi) je bila 8 % v skupini z intravensko obliko zdravila in 15 % v skupini s podkožno obliko zdravila.
English: • heart problems - such as heart attack, uneven or fast heart rate
Slovenian: · težave s srcem - na primer srčni infarkt, neredno ali hitro bitje srca · visok ali nizek krvni tlak (nizek krvni tlak zlasti po hitrem vstajanju)
English: Subsequent doses of MabThera can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Slovenian: Nadaljnje odmerke zdravila MabThera lahko dajemo z začetno hitrostjo 100 mg/h, ki jo lahko vsakih
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Slovenian: Vzdrževalno zdravljenje: pregled učinkovitosti zdravljenja z zdravilom
English: The incidence of infusion-related symptoms decreased substantially with subsequent intravenous infusions and is <1% of patients by the eighth cycle of MabThera (containing) treatment.
Slovenian: Incidenca simptomov in znakov, povezanih z infuzijo, se je z nadaljnjimi intravenskimi infuzijami precej zmanjšala in je bila do osmega cikla zdravljenja z zdravilom MabThera < 1 %.
English: Rituximab exposure increased dose proportional over the 375 mg/m2 to 800 mg/m2 subcutaneous dose range.
Slovenian: 375 mg/m2 do 800 mg/m2 s.c. povečevala sorazmerno odmerku.
English: PFS - Progression-Free Survival (proportion with event, disease progression/relapse or death from any cause) a - at 3 month follow-up visit (Part 2) b - at time of final analysis (median follow-up 53 months)
Slovenian: a v času obiska po 3-mesečnem spremjanju (2. del) b v času končne analize (mediana spremljanja 53 mesecev)
English: • memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare,
Slovenian: · poslabšanje spomina, motnje mišljenja, težave s hojo ali izguba vida - lahko so posledica zelo redke, resne okužbe možganov, ki je bila smrtna (imenujemo jo progresivna multifokalna levkoencefalopatija ali PML).
English: Each vial contains 1600 mg/ 13.4 mL rituximab.
Slovenian: 1 viala vsebuje 1600 mg/13,4 ml rituksimaba.
English: Vascular disorders Hypertension
Slovenian: Žilne bolezni hipertenzija napadi rdečice
English: doses to 203 patients with NHL naive to MabThera, yielded a mean Cmax following the fourth infusion of 486 µg/mL (range, 77.5 to 996.6 µg/mL).
Slovenian: MabThera prej še niso zdravili in so prejeli po 375 mg/m2 zdravila MabThera z intravensko infuzijo v štirih odmerkih enkrat na teden, je bila 486 µg/ml (od 77,5 do 996,6 µg/ml).
English: weekly doses.
Slovenian: 100 bolnik-let.
English: The chemotherapy should be given after MabThera infusion.
Slovenian: Kemoterapijo dajemo po infuziji zdravila MabThera.
English: Since hypotension may occur during MabThera administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the MabThera infusion.
Slovenian: Ker se med aplikacijo zdravila MabThera lahko pojavi hipotenzija, je treba premisliti o tem, da bi 12 ur pred infuzijo zdravila MabThera bolnik prenehal jemati zdravila proti visokemu krvnemu tlaku.
English: A total of 1078 patients responded to induction therapy, of which 1018 were randomised to MabThera maintenance therapy (n=505) or observation (n=513).
Slovenian: Na indukcijsko zdravljenje se je odzvalo 1.078 bolnikov, od teh jih je bilo 1.018 randomiziranih v vzdrževalno zdravljenje z zdravilom
English: • skin rashes, including acne or spots
Slovenian: · kožni izpuščaji, vključno z aknami ali lisami, · pordevanje ali rdečina kože,
English: NAME OF THE MEDICINAL PRODUCT MabThera 1600 mg solution for subcutaneous injection
Slovenian: IME ZDRAVILA MabThera 1600 mg raztopina za podkožno injiciranje
English: Do not take MabThera if:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo MabThera Ne uporabljajte zdravila MabThera, če:
English: NAME OF THE MEDICINAL PRODUCT MabThera 1400 mg solution for subcutaneous injection
Slovenian: IME ZDRAVILA MabThera 1400 mg raztopina za podkožno injiciranje
English: InSABRINA, severe administration-related reactions (grade≥3) were reported in two patients (2%) following administration of MabThera subcutaneous formulation.
Slovenian: V preskušanju SABRINA so pri dveh bolnikih (2 %) po uporabi podkožne oblike zdravila MabThera zabeležili hude reakcije (≥ 3. stopnje), povezane z dajanjem zdravila.
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is <1% of patients by the eighth cycle of MabThera (containing) treatment.
Slovenian: Incidenca simptomov in znakov, povezanih z infuzijo, se je z nadaljnjimi infuzijami precej zmanjšala in je bila do osmega cikla zdravljenja z zdravilom MabThera < 1 %.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 500 mg concentrate for solution for infusion Rituximab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MabThera 500 mg koncentrat za raztopino za infundiranje rituksimab i.v.
English: None of the 99 MabThera-treated patients were ADA positive at screening.
Slovenian: Ob presejanju ni imel pozitivnega izvida ADA nobeden od 99 bolnikov, zdravljenih z zdravilom MabThera.
English: Limited information from one study in relapsed/refractory CLL patients suggests that MabThera treatment may also worsen the outcome of primary hepatitis B infections.
Slovenian: Omejeni podatki iz ene študije pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, kažejo, da lahko zdravljenje z zdravilom MabThera poslabša tudi izid primarnih okužb z virusom hepatitisa B. Pri vseh bolnikih je treba pred začetkom zdravljenja z zdravilom MabThera narediti presejalni test na virus hepatitisa B. To vključuje najmanj določanje statusa HBsAg in HBcAb, ki ju lahko dopolnimo z ostalimi primernimi označevalci v skladu z lokalnimi smernicami.
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of MabThera.
Slovenian: Pred uporabo zdravila MabThera mora bolnik vedno dobiti premedikacijo, ki obsega antipiretik in antihistaminik, npr. paracetamol in difenhidramin.
English: Each vial contains 1400 mg/11.7 mL rituximab.
Slovenian: 1 viala vsebuje 1400 mg/11,7 ml rituksimaba.
English: InSparkThera, no severe administration-related reactions were reported.
Slovenian: Resnih neželenih reakcij, povezanih z infuzijo, niso opazili.
English: Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential must employ effective contraceptive methods during and for 12 months after treatment with MabThera.
Slovenian: Zato morajo ženske v rodni dobi med zdravljenjem z zdravilom MabThera in še 12 mesecev po njem uporabljati učinkovita kontracepcijska sredstva.
English: MabThera should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Slovenian: Zdravila MabThera se ne sme dajati bolnikom z aktivno, hudo okužbo (npr. tuberkulozo,
English: The recommended dosage of MabThera for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Slovenian: Priporočeni odmerek zdravila MabThera za zdravljenje navadnega pemfigusa je 1000 mg v intravenski infuziji, ki ji čez dva tedna sledi druga intravenska infuzija 1000 mg; uporablja se v kombinaciji z glukokortikoidi, katerih odmerke postopoma zmanjšujemo.
English: Table 9 Maintenance phase: overview of efficacy results MabThera vs. observation (28 months median observation time) Efficacy Parameter
Slovenian: MabThera v primerjavi z opazovanjem (mediana časa opazovanja 28 mesecev)
English: Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more MabThera treated patients treated with MabThera and methotrexate compared to patients treated with methotrexate alone (Table 12).
Slovenian: Rheumatism) doseglo pomembno več bolnikov, ki so se zdravili z zdravilom MabThera in metotreksatom, kakor bolnikov, ki so se zdravili samo z metotreksatom (preglednica 12).
English: Table 3 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
Slovenian: Zdravljenje kronične limfocitne levkemije pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje - pregled rezultatov o učinkovitosti za zdravilo MabThera v kombinaciji s kemoterapijo FC v primerjavi s samo kemoterapijo FC (mediana opazovanja 25,3 meseca)
English: Co-administration with methotrexate had no effect on the pharmacokinetics of MabThera in rheumatoid arthritis patients.
Slovenian: Sočasna uporaba metotreksata pri bolnikih z revmatoidnim artritisom ni vplivala na farmakokinetiko zdravila MabThera.
English: At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, patients were randomly assigned to receive either MabThera (two 500 mg IV infusions separated by two weeks (on Day 1 and Day 15) followed by 500 mg IV every 6 months for
Slovenian: Takrat in znotraj največ 1 meseca po zadnjem pulzu ciklofosfamida so bolnike randomizirali ali na prejemanje zdravila MabThera (dve 500-mg intravenski infuziji v presledku dveh tednov (1. in 15. dan) in nato 500 mg intravensko vsakih 6 mesecev v obdobju 18 mesecev) ali na prejemanje azatioprina (peroralno v odmerku 2 mg/kg/dan 12 mesecev, nato 1,5 mg/kg/dan 6 mesecev in nazadnje 1 mg/kg/dan 4 mesece (prenehanje zdravljenja po teh 22 mesecih)).
English: MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.
Slovenian: Zdravilo MabThera je v kombinaciji s kemoterapijo indicirano za zdravljenje bolnikov s kronično limfocitno levkemijo, ki predhodno še niso bili zdravljeni oziroma se na prejšnje zdravljenje niso odzvali ali pa se je bolezen pri njih ponovila.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 1600 mg solution for subcutaneous injection Rituximab subcutaneous
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MabThera 1600 mg raztopina za podkožno injiciranje rituksimab subkutano
English: • respiratory failure
Slovenian: · odpoved dihanja
English: Table 2a First--line treatment of chronic lymphocytic leukaemia Overview of efficacy results for MabThera plus FC vs. FC alone - 48.1 months median observation time Efficacy Parameter
Slovenian: Pregled rezultatov o učinkovitosti za zdravilo MabThera v kombinaciji s kemoterapijo FC v primerjavi s samo kemoterapijo FC - mediana opazovanja 48,1 meseca
English: MabThera 1600 mg solution for subcutaneous injection rituximab
Slovenian: MabThera 1600 mg raztopina za podkožno injiciranje rituksimab
English: Patients in both arms received 1000mg of pulse intravenous (IV) methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Slovenian: Bolniki v obeh terapevtskih skupinah so prejemali 1000 mg metilprednizolona (ali drugega glukokortikoida v enakovrednem odmerku) na dan pulzno intravensko (i.v.)
English: This card tells you:
Slovenian: Priporočeni odmerek je:
English: What MabThera 1600 mg solution for subcutaneous injection looks like and contents of the pack
Slovenian: Izgled zdravila MabThera 1600 mg raztopina za podkožno injiciranje in vsebina pakiranja
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.
Slovenian: Vzdrževalno zdravljenje z zdravilom MabThera je klinično pomembno in statistično značilno izboljšalo primarni cilj - preživetje brez napredovanja bolezni (progression free survival - PFS) (čas od randomizacije v vzdrževalno zdravljenje do ponovitve bolezni, napredovanja bolezni ali smrti) v primerjavi z opazovano skupino (p < 0,0001, test log-rang).
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).
Slovenian: Zdravilo MabThera je v kombinaciji s kemoterapijo indicirano za zdravljenje odraslih bolnikov s kronično limfocitno levkemijo (KLL), ki predhodno še niso bili zdravljeni oziroma se na prejšnje zdravljenje niso odzvali ali pa se je bolezen pri njih ponovila.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 1400 mg solution for subcutaneous injection Rituximab subcutaneous
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MabThera 1400 mg raztopina za podkožno injiciranje rituksimab subkutano
English: Table 2 Efficacy results for SABRINA (BO22334) (Intent to Treat Population) Pooled Stages 1 & 2 N = 410
Slovenian: Rezultati učinkovitosti za preskušanje SABRINA (BO22334) (populacija, ki so jo nameravali zdraviti)
English: Since hypotension may occur during MabThera administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to giving MabThera.
Slovenian: Ker se med aplikacijo zdravila MabThera lahko pojavi hipotenzija, je treba premisliti o tem, da bi 12 ur pred dajanjem zdravila MabThera bolnik prenehal jemati zdravila proti visokemu krvnemu tlaku.
English: For the 60 re-treatments on study, the ORR was 38% (CI95% 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
Slovenian: Za 60 ponovnih zdravljenj je bil celokupen odgovor na zdravljenje 38 % (95-% interval zaupanja 26-51 %; 10 % popoln odgovor, 28 % delni odgovor).
English: MabThera 1400 mg solution for subcutaneous injection rituximab
Slovenian: MabThera 1400 mg raztopina za podkožno injiciranje rituksimab
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with CLL.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev izsledkov študij z rituksimabom za vse podskupine pediatrične populacije s folikularnimi limfomi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Outcome†
Slovenian: PRILOGA I
English: A small number of spontaneous and literature cases of hypogammaglobulinaemia have been observed in paediatric patients treated with MabThera, in some cases severe and requiring long-term immunoglobulin substitution therapy.
Slovenian: Ta je bila v nekaj primerih huda in je zahtevala dolgotrajno nadomestno zdravljenje z imunoglobulini.
English: The serum MabThera Cmax at Cycle 6 was lower in the subcutaneous arm than the intravenous, with geometric mean (CV%) values of 202 (36.1) μg/mL and 280 (24.6) μg/mL with the resulting geometric mean ratio (Cmax, SC/Cmax, IV) of 0.719 (90% CI: 0.653, 0.792).
Slovenian: Geometrična sredina (KV %) je bila s podkožno obliko 202 (36,1) µg/ml in z intravensko 280 (24,6) µg/ml; razmerje geometričnih sredin (Cmax s.c./Cmax i.v.)
English: Regular full blood counts, including neutrophil and platelet counts, should be performed during MabThera therapy.
Slovenian: Med zdravljenjem z zdravilom MabThera je treba redno kontrolirati celotno krvno sliko, vključno s številom nevtrofilcev in trombocitov.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 100 mg concentrate for solution for infusion Rituximab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MabThera 100 mg koncentrat za raztopino za infundiranje rituksimab i.v.
English: lung infiltration,
Slovenian: infiltracija pljuč
English: MabThera subcutaneous formulation contains recombinant human hyaluronidase (rHuPH20), an enzyme used to increase the dispersion and absorption of co-administered substances when administered subcutaneously.
Slovenian: Podkožna oblika zdravila MabThera vsebuje rekombinantno humano hialuronidazo (rHuPH20).
English: 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)).