FrancophonIA/ELRC3.0 huggingface dataset:
English: • After aseptic dilution in D-glucose solution
Slovenian: · Po aseptični razredčitvi z raztopino D-glukoze
English: Some cases of late neutropenia occurring more than four weeks after the last infusion of MabThera were reported.
Slovenian: Poročali so o posameznih primerih pozne nevtropenije, ki se je pojavila več kot 4 tedne po zadnji infuziji zdravila MabThera.
English: Currently, there are limited data on possible drug interactions with MabThera.
Slovenian: Trenutno je le malo podatkov o mogočih medsebojnih učinkih zdravil pri uporabi zdravila MabThera.
English: Patients in the MabThera group who relapsed could receive an additional infusion of MabThera 1000 mg in combination with reintroduced or escalated prednisone dose.
Slovenian: Bolniki v skupini z zdravilom MabThera, ki se jim je pojavil recidiv, so lahko prejeli dodatno infuzijo 1000 mg zdravila MabThera v kombinaciji s ponovno uvedenim prednizonom ali povečanjem odmerka prednizona.
English: Beginning the therapy with MabThera intravenous infusion would allow a better handling of the administration reactions by slowing or stopping the intravenous infusion.
Slovenian: Začetek zdravljenja z intravensko infuzijo zdravila MabThera omogoča boljše obvladanje takšnih reakcij, ker je intravensko infuzijo mogoče upočasniti ali končati.
English: As with the intravenous formulation, MabThera subcutaneous formulation should be administered in an environment where full resuscitation facilities are immediately available and under the close supervision of an experienced healthcare professional.
Slovenian: Tako kot intravensko obliko je treba tudi podkožno obliko zdravila MabThera dajati v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo, ter pod natančnim nadzorom izkušenega zdravnika.
English: These studies support the use of MabThera with any chemotherapy.
Slovenian: Te študije podpirajo uporabo zdravila MabThera s katero koli kemoterapijo.
English: • pain in the muscles or in the hands or feet
Slovenian: · bolečina v mišicah ali dlaneh ali stopalih,
English: Names and addresses of the manufacturers of the biological active substance
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine
English: • you have ever had or might now have a hepatitis infection.
Slovenian: · če ste kdaj imeli okužbo z virusom hepatitisa, ali če menite, da jo imate zdaj.
English: MabThera subcutaneous formulation is not intended for intravenous administration and should be given via subcutaneous injection only.
Slovenian: Podkožna oblika zdravila MabThera ni namenjena intravenski uporabi in se lahko daje le s podkožno injekcijo.
English: Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the MabThera group (12%) and eight patients in the azathioprine group (14%).
Slovenian: Blažji recidivi (takšni, ki niso bili življenjsko ogrožajoči in niso vključevali okvare pomembnega organa) so se pojavili pri sedmih bolnikih v skupini z zdravilom MabThera (12 %) in pri osmih bolnikih v skupini z azatioprinom (14 %).
English: There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following MabThera (see section 4.5).
Slovenian: Iz kliničnih preskušanj ni zadostnih podatkov za popolno oceno varnosti uporabe drugih DMARD (vključno z zaviralci TNF in drugimi biološkimi zdravili), ki sledijo zdravljenju z zdravilom MabThera (glejte poglavje 4.5).
English: L-histidine hydrochloride monohydrate α,α-trehalose dihydrate L-methionine
Slovenian: L-histidin-klorid monohidrat a,a-trehaloza-dihidrat
English: This is because there is not much information about the use of MabThera in children and young people.
Slovenian: O uporabi zdravila MabThera pri otrocih in mladostnikih namreč ni veliko informacij.
English: These patients were treated either with MabThera monotherapy (as induction treatment or maintenance treatment following induction treatment) or in combination with chemotherapy.
Slovenian: Ti bolniki so prejemali zdravilo MabThera kot samostojno zdravljenje (kot indukcijsko zdravljenje ali vzdrževalno zdravljenje po indukcijskem zdravljenju) ali v kombinaciji s kemoterapijo.
English: Unopened vial 36 months
Slovenian: 6.3 Rok uporabnosti Neodprta viala 36 mesecev
English: MabThera is usually taken together with another medicine called methotrexate.
Slovenian: Zdravilo MabThera se običajno jemlje skupaj z zdravilom, imenovanim metotreksat.
English: They are not specifically related to the route of administration of MabThera and can be observed with both formulations.
Slovenian: Reakcije niso specifično povezane s potjo uporabe zdravila MabThera in se lahko pojavijo pri obeh oblikah zdravila.
English: MabThera may be used for the treatment of several different conditions in adults.
Slovenian: Zdravilo MabThera se uporablja za zdravljenje več različnih bolezni pri odraslih.
English: Neutropenia was not associated with an observed increase in serious infection in MabThera-treated patients.
Slovenian: Nevtropenija ni bila povezana z opaznim povečanjem resnih okužb med bolniki, ki so prejemali zdravilo MabThera.
English: However, the higher incidence of neutropenia in patients treated with MabThera and chemotherapy was not associated with a higher incidence of infections and infestations compared to patients treated with chemotherapy alone.
Slovenian: Toda višje incidence nevtropenije pri bolnikih, ki so prejemali zdravilo MabThera v kombinaciji s kemoterapijo, ni spremljala višja incidenca infekcijskih in parazitskih bolezni kot pri bolnikih, zdravljenih samo s kemoterapijo.
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: (see section 5.1).
Slovenian: (glejte poglavje 4.4).
English: Reactivation of hepatitis B infection has also been very rarely reported in RA patients receiving MabThera (see Section 4.4).
Slovenian: O reaktivaciji okužbe z virusom hepatitisa B so zelo redko poročali tudi pri bolnikih z revmatoidnim artritisom, ki so prejemali zdravilo MabThera (glejte poglavje 4.4).
English: The proportion of patients with IgG levels below the LLN was about 60% in the MabThera group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Slovenian: Delež bolnikov s koncentracijo IgG pod spodnjo mejo normalne vrednosti je bil med 2-letnim zdravljenjem približno 60 % v skupini, ki je prejemala zdravilo MabThera, v opazovani skupini pa se je zmanjšal (36 % po dveh letih).
English: Of 356 patients evaluated for anti-drug antibody (ADA), 1.1 % (4 patients) were positive.
Slovenian: Od 356 bolnikov, pri katerih so ocenjevali prisotnost protiteles proti zdravilu (anti-drug antibody -ADA), so bili pozitivni 4 bolniki (1,1 %).
English: All patients were followed until month 28 (10 or 6 months, respectively, after the last MabThera infusion or azathioprine dose).
Slovenian: Vse bolnike so spremljali do 28. meseca (10 mesecev po zadnji infuziji zdravila MabThera ali 6 mesecev po zadnjem odmerku azatioprina).
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of MabThera maintenance therapy, up to 5 years.
Slovenian: Pri bolnikih z večjim tveganjem za recidiv je treba razmisliti o dolgotrajnejšem vzdrževalnem zdravljenju z zdravilom MabThera, do 5 let.
English: Use of MabThera may be associated with an increased risk of progressive multifocal leukoencephalopathy (PML).
Slovenian: Uporaba zdravila MabThera je lahko povezana z večjim tveganjem za progresivno multifokalno levkoencefalopatijo (PML).
English: Table 2 Efficacy results for SAWYER (BO25341) (Intent to Treat Population)
Slovenian: Rezultati učinkovitosti za preskušanje SAWYER (BO25341) (populacija, ki so jo nameravali zdraviti)
English: • Severe vision loss (sign of brain nerves damage).
Slovenian: · ledvična odpoved · hudo poslabšanje vida (znak poškodbe možganskih živcev)
English: • you have ever had heart problems (such as angina, palpitations or heart failure) or breathing problems.
Slovenian: · če ste kdaj imeli težave s srcem (npr. angino pektoris, razbijanje srca ali srčno popuščanje) ali težave z dihanjem.
English: Some local cutaneous reactions occurred more than 24 hours after the MabThera subcutaneous administration.
Slovenian: Nekatere lokalne kožne reakcije so se pojavile več kot 24 ur po podkožni uporabi zdravila MabThera.
English: Trials of MabThera in patients with early arthritis (patients without prior methotrexate treatment and patients with an inadequate response to methotrexate, but not yet treated with TNF-alpha inhibitors) have met their primary endpoints.
Slovenian: V preskušanjih z zdravilom MabThera pri bolnikih z zgodnjim artritisom (bolniki, ki se še niso zdravili z metotreksatom in bolniki z nezadostnim odzivom na metotreksat, ki se še niso zdravili z zaviralci TNF-alfa) so bili primarni cilji doseženi.
English: It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) is being given to the patient, as prescribed.
Slovenian: Pomembno je preveriti nalepke na zdravilu in tako zagotoviti, da bolnik dobi ustrezno obliko (intravensko ali podkožno), ki mu je bila predpisana.
English: This is because in a few cases, MabThera could cause hepatitis B to become active again, which can be fatal in very rare cases.
Slovenian: V maloštevilnih primerih namreč lahko bolezen zaradi zdravila MabThera ponovno izbruhne; to je lahko v zelo redkih primerih smrtno.
English: MabThera should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Slovenian: Zdravila MabThera se ne sme dajati bolnikom z aktivno, hudo okužbo (npr. tuberkulozo, sepso ali oportunističnimi okužbami, glejte poglavje 4.3) ali hudo imunokompromitiranim bolnikom (npr. pri zelo nizkih vrednostih CD4 ali CD8).
English: Radiographic analysis at 2 years in Trial 1 demonstrated significantly reduced progression of structural joint damage in patients receiving MabThera in combination with methotrexate compared to methotrexate alone as well as a significantly higher proportion of patients with no progression of joint damage over the 2 year period.
Slovenian: Radiološka analiza v preskušanju 1 je po 2 letih pokazala značilno manjše napredovanje strukturnih okvar sklepov pri bolnikih, ki so prejemali zdravilo MabThera v kombinaciji z metotreksatom, kot pri tistih, ki so prejemali samo metotreksat; prav tako je pokazala značilno večji delež bolnikov brez napredovanja okvar sklepov v 2-letnem obdobju.
English: No patients in the MabThera arm had fatal adverse events.
Slovenian: Noben bolnik v skupini z zdravilom MabThera ni imel neželenih učinkov s smrtnim izidom.
English: • you have a severe active infection at the moment • you have a weak immune system.
Slovenian: (navedeno v poglavju 6); · imate trenutno hudo, aktivno okužbo; · imate oslabel imunski sistem;
English: Peripheral B cell counts declined below normal following completion of the first dose of MabThera.
Slovenian: Število perifernih celic B se je po dokončanju prvega odmerka zdravila MabThera zmanjšalo pod normalno vrednost.
English: In addition to dependence on body size, time-dependent clearance was higher in subjects with higher baseline tumour size, which is consistent with target-mediated elimination.
Slovenian: Poleg odvisnosti od telesne velikosti je bil od-časa-odvisen-očistek večji pri bolnikih z večjim tumorjem v izhodišču, kar je skladno s tarčno posredovanim izločanjem (target-mediated elemination).
English: The emergence of ADAwas not associated with clinical deterioration or with an increased risk of reactions to subsequent infusions in the majority of patients.
Slovenian: Pojav ADA pri večini bolnikov ni bil povezan s kliničnim poslabšanjem ali povečanim tveganjem za reakcije pri nadaljnjih infuzijah.
English: • low number of red blood cells (anaemia)
Slovenian: · nizko število rdečih krvnih celic (anemija),
English: Reactions where the medicine is injected
Slovenian: Reakcije na mestu, kjer je bilo dano zdravilo
English: MabThera induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Slovenian: Zdravilo MabThera je pri 70 do 80 % bolnikov povzročilo zmanjšanje števila celic B, z zmanjšanjem koncentracije imunoglobulinov v serumu pa je bilo povezano le malo primerov.
English: The overall safety profile was consistent with the well-established safety profile of MabThera in RA and GPA/MPA and no new adverse drug reactions were reported.
Slovenian: Na splošno so se varnostne značilnosti ujemale z dobro znanimi varnostnimi značilnostmi zdravila MabThera pri RA in GPA/MPA; poročali niso o nobenih novih neželenih učinkih zdravila.
English: Of the patients originally receiving methotrexate alone, 81 % received MabThera 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 zdravilo MabThera kot rešilno zdravilo (rescue) med 16. in 24. tednom ali v okviru nadaljevalne študije pred
English: During the development programme, the safety profile of MabThera subcutaneous formulation was comparable to that of the intravenous formulation with the exception of local cutaneous reactions.
Slovenian: Med programom razvoja je bil varnostni profil podkožne oblike zdravila MabThera podoben kot pri intravenski obliki; izjema so bile lokalne kožne reakcije.
English: MabThera 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 MabThera je treba dajati pod natančnim nadzorom izkušenega zdravnika in v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo (glejte poglavje 4.4).
English: late neutropenia2 Serum sickness-like reaction
Slovenian: nevtropenija2 reakcija, podobna serumski bolezni
English: MabThera was administered on the first day of each treatment cycle.
Slovenian: MabThera je bilo uporabljeno prvi dan vsakega cikla zdravljenja.
English: The recommended initial rate for infusion is 50 mg/h; after the first 30 minutes, it can be escalated in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h.
Slovenian: Prva infuzija Priporočena začetna hitrost infundiranja je 50 mg/h; po prvih 30 minutah jo lahko vsakih 30 minut povečujemo po 50 mg/h, dokler ne dosežemo največje hitrosti infundiranja 400 mg/h.
English: Cyclophosphamide Difference (CI 95%)
Slovenian: Ciklofosfamid Razlika (95-% IZ)
English: Kaplan--Meier Estimate of Median Time to Event (Months)
Slovenian: Kaplan-Meierjeva ocena medianega časa do dogodka (meseci)
English: In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg MabThera separated by a 14 day interval.
Slovenian: Pri bolnikih z revmatoidnim artritisom so takojšen upad števila celic B v periferni krvi opazili po dveh infuzijah 1000 mg zdravila MabThera v presledku 14 dni.
English: Patients were stratified by baseline disease severity (moderate or severe) and randomised 1:1 to receive either MabThera and low-dose prednisone or standard-dose prednisone.
Slovenian: Bolnike so stratificirali glede na izhodiščno izrazitost bolezni (zmerno ali hudo) in jih v razmerju 1:1 randomizirali ali na prejemanje zdravila MabThera in majhnega odmerka prednizona ali na prejemanje standardnega odmerka prednizona.
English: Animal studies did not reveal deleterious effects of rituximab or recombinant human hyaluronidase (rHuPH20) on reproductive organs.
Slovenian: Študije na živalih niso pokazale škodljivih učinkov rituksimaba ali rekombinantne humane hialuronidaze (rHuPH20) na reproduktivne organe.
English: MabThera is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Slovenian: Zdravilo MabThera je indicirano za zdravljenje bolnikov s CD20-pozitivnim difuznim velikoceličnim B ne-Hodgkinovim limfomom v kombinaciji s kemoterapijo CHOP (ciklofosfamid, doksirubicin, vinkristin, prednizolon).
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti- Cyclic Citrullinated Peptide (anti-CCP) who were treated with MabThera in combination with methotrexate showed an enhanced response compared to patients negative to both.
Slovenian: Učinkovitost pri serološko pozitivnih (RF in/ali anti-CCP) bolnikih Bolniki, serološko pozitivni za revmatoidni faktor (RF) in/ali anti-ciklični citrulinirani peptid (antiCCP), ki so prejemali zdravilo MabThera v kombinaciji z metotreksatom, so imeli izrazitejši odziv kot bolniki, negativni za oba.
English: In studies of MabThera in patients with Waldenstrom's macroglobulinaemia, transient increases in serum IgM levels have been observed following treatment initiation, which may be associated with hyperviscosity and related symptoms.
Slovenian: Pri bolnikih z Waldenstromovo makroglobulinemijo so v študijah z zdravilom MabThera po začetku zdravljenja opazili prehodna zvišanja koncentracij IgM v serumu, kar pa je lahko povezano s hiperviskoznostjo in sorodnimi simptomi.
English: Therefore vaccination with live virus vaccines is not recommended whilst on MabThera or whilst peripherally B cell depleted.
Slovenian: Cepljenje z živimi virusnimi cepivi zato ni priporočljivo med zdravljenjem z zdravilom MabThera ali medtem, ko je število perifernih celic B zmanjšano.
English: 38 months
Slovenian: 30 mesecev
English: MabThera in combination with methotrexate significantly increased the proportion of patients achieving at least a 20 % improvement in ACR score compared with patients treated with methotrexate alone (Table 12).
Slovenian: Zdravilo MabThera v kombinaciji z metotreksatom je značilno povečalo delež bolnikov, ki so dosegli najmanj 20-% izboljšanje glede na ACR oceno v primerjavi z bolniki, ki so se zdravili samo z metotreksatom (preglednica 12).
English: body surface area.
Slovenian: telesne površine.
English: Post-authorisation efficacy study (PAES): In order to further investigate the efficacy of Mabthera in the subgroup of patients with established PV as well as to further characterise its long term efficacy and safety on disease progression, the MAH should submit the preliminary study and the final study report of the ongoing randomised phase 3 study (PEMPHIX WA29330).
Slovenian: Mabthera v podskupini bolnikov s potrjenim navadnim pemfigusom in za nadaljnjo opredelitev njegove dolgoročne učinkovitosti in varnosti na napredovanje bolezni mora imetnik dovoljenja za promet z zdravilom predložiti preliminarno in končno študijsko poročilo randomizirane študije faze 3 (PEMPHIX WA29330).
English: This is because MabThera can cross the placenta and may affect your baby.
Slovenian: Zdravilo MabThera namreč prehaja skozi posteljico (placento) in lahko škoduje otroku.
English: In the MabThera group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
Slovenian: V skupini, ki je prejemala zdravilo MabThera, je 48 % bolnikov doseglo popolno remisijo po 12 mesecih in 39 % bolnikov po 18 mesecih.
English: MabThera 500 mg concentrate for solution for infusion EU/1/98/067/002
Slovenian: MabThera 500 mg koncentrat za raztopino za infundiranje EU/1/98/067/002
English: Overall, 4% of patients in the MabThera arm experienced adverse events leading to discontinuation.
Slovenian: V celoti so 4 % bolnikov v skupini z zdravilom MabThera imeli takšne neželene učinke, ki so povzročili prenehanje uporabe zdravila.
English: Mean Change in SF-36 PHS
Slovenian: Povprečna sprememba SF-36 PHS
English: In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following MabThera.
Slovenian: Pri bolnikih z revmatodnim artritisom jih je 283 po zdravljenju z zdravilom MabThera prejelo nadaljnje zdravljenje z biološkim DMARD.
English: Common side effects (may affect up to 1 in 10 people): • Infections such as bronchial tube inflammation (bronchitis)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri do 1 od 10 bolnikov): · okužbe, kot je vnetje bronhijev (bronhitis),
English: The overall safety profile was consistent with the well-established safety profile for MabThera in approved autoimmune indications, including GPA/MPA.
Slovenian: Na splošno so se varnostne značilnosti ujemale z dobro znanimi varnostnimi značilnostmi zdravila MabThera pri odobrenih avtoimunskih indikacijah, vključno z GPA/MPA.
English: When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied (see section 4.8).
Slovenian: Če zdravilo MabThera uporabimo v kombinaciji s kemoterapijo, je treba uporabiti standardno zmanjšanje odmerkov citostatikov (glejte poglavje 4.8).
English: Serious cardiac reactions were reported at a rate of 1.3 per 100 patient years in the MabThera treated patients compared to 1.3 per 100 patient years in placebo treated patients.
Slovenian: Delež resnih neželenih učinkov, povezanih s srcem, je bil 1,3 na 100 bolnik-let pri bolnikih, ki so se zdravili z zdravilom MabThera, v primerjavi z 1,3 na 100 bolnik-let pri bolnikih, ki so prejemali placebo.
English: Erosion score
Slovenian: Ocena erozij
English: Three of the patients had received two courses of MabThera before enrolment and thus were given a third course in the study.
Slovenian: Trije od teh bolnikov so bili dvakrat zdravljeni z zdravilom MabThera pred vključitvijo, tako so v študiji prejeli tretje zdravljenje z zdravilom MabThera.
English: The objective of stage 2 was to provide additional efficacy and safety data for subcutaneous rituximab compared with rituximab intravenous using the 1400 mg subcutaneous dose established in stage 1.
Slovenian: Cilj 2. stopnje je bil pridobiti dodatne podatke o učinkovitosti in varnosti podkožno danega rituksimaba ob uporabi 1400-mg podkožnega odmerka, določenega v 1. stopnji, v primerjavi z intravensko danim rituksimabom.
English: • Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue,
Slovenian: · alergijske reakcije, vključno s piskanjem ali kratko sapo, otekanjem obraza in jezika ter kolapsom.
English: If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.
Slovenian: Če zdravilo MabThera prejemate skupaj z drugimi zdravili, so nekateri neželeni učinki, ki se vam pojavijo, lahko posledica drugih zdravil.
English: MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
Slovenian: Zdravilo MabThera je v kombinaciji z metotreksatom indicirano za zdravljenje odraslih bolnikov z zelo aktivnim revmatoidnim artritisom, ki niso zadostno odgovorili na druga imunomodulirajoča zdravila (DMARD, disease-modifying anti-rheumatic drugs), vključno z enim ali več zaviralci tumorje nekrotizirajočega faktorja (TNF), ali jih niso prenašali.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo MabThera.
English: • damage to the intestinal wall (perforation)
Slovenian: · odpoved dihanja · okvara črevesne stene (predrtje)
English: Patients with active hepatitis B disease should not be treated with MabThera.
Slovenian: Bolniki z aktivno boleznijo, ki jo povzroči virus hepatitisa B, se ne smejo zdraviti z zdravilom MabThera.