natgillin/translations-raw huggingface dataset:
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.
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.
No patients in the MabThera arm had fatal adverse events.
Noben bolnik v skupini z zdravilom MabThera ni imel neželenih učinkov s smrtnim izidom.
• you have a severe active infection at the moment • you have a weak immune system.
(navedeno v poglavju 6); · imate trenutno hudo, aktivno okužbo; · imate oslabel imunski sistem;
Peripheral B cell counts declined below normal following completion of the first dose of MabThera.
Število perifernih celic B se je po dokončanju prvega odmerka zdravila MabThera zmanjšalo pod normalno vrednost.
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.
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).
The emergence of ADAwas not associated with clinical deterioration or with an increased risk of reactions to subsequent infusions in the majority of patients.
Pojav ADA pri večini bolnikov ni bil povezan s kliničnim poslabšanjem ali povečanim tveganjem za reakcije pri nadaljnjih infuzijah.
• low number of red blood cells (anaemia)
· nizko število rdečih krvnih celic (anemija),
Reactions where the medicine is injected
Reakcije na mestu, kjer je bilo dano zdravilo
MabThera induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
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.
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.
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.
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.
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
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.
Med programom razvoja je bil varnostni profil podkožne oblike zdravila MabThera podoben kot pri intravenski obliki; izjema so bile lokalne kožne reakcije.
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).
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).
late neutropenia2 Serum sickness-like reaction
nevtropenija2 reakcija, podobna serumski bolezni
MabThera was administered on the first day of each treatment cycle.
MabThera je bilo uporabljeno prvi dan vsakega cikla zdravljenja.
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.
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.
Cyclophosphamide Difference (CI 95%)
Ciklofosfamid Razlika (95-% IZ)
Kaplan--Meier Estimate of Median Time to Event (Months)
Kaplan-Meierjeva ocena medianega časa do dogodka (meseci)
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.
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.
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.
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.
Animal studies did not reveal deleterious effects of rituximab or recombinant human hyaluronidase (rHuPH20) on reproductive organs.
Študije na živalih niso pokazale škodljivih učinkov rituksimaba ali rekombinantne humane hialuronidaze (rHuPH20) na reproduktivne organe.
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.
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).
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.
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.
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.
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.
Therefore vaccination with live virus vaccines is not recommended whilst on MabThera or whilst peripherally B cell depleted.
Cepljenje z živimi virusnimi cepivi zato ni priporočljivo med zdravljenjem z zdravilom MabThera ali medtem, ko je število perifernih celic B zmanjšano.
38 months
30 mesecev
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).
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).
body surface area.
telesne površine.
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).
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).
This is because MabThera can cross the placenta and may affect your baby.
Zdravilo MabThera namreč prehaja skozi posteljico (placento) in lahko škoduje otroku.
In the MabThera group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
V skupini, ki je prejemala zdravilo MabThera, je 48 % bolnikov doseglo popolno remisijo po 12 mesecih in 39 % bolnikov po 18 mesecih.
MabThera 500 mg concentrate for solution for infusion EU/1/98/067/002
MabThera 500 mg koncentrat za raztopino za infundiranje EU/1/98/067/002
Overall, 4% of patients in the MabThera arm experienced adverse events leading to discontinuation.
V celoti so 4 % bolnikov v skupini z zdravilom MabThera imeli takšne neželene učinke, ki so povzročili prenehanje uporabe zdravila.
Mean Change in SF-36 PHS
Povprečna sprememba SF-36 PHS
In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following MabThera.
Pri bolnikih z revmatodnim artritisom jih je 283 po zdravljenju z zdravilom MabThera prejelo nadaljnje zdravljenje z biološkim DMARD.
Common side effects (may affect up to 1 in 10 people): • Infections such as bronchial tube inflammation (bronchitis)
Pogosti neželeni učinki (pojavijo se lahko pri do 1 od 10 bolnikov): · okužbe, kot je vnetje bronhijev (bronhitis),
The overall safety profile was consistent with the well-established safety profile for MabThera in approved autoimmune indications, including GPA/MPA.
Na splošno so se varnostne značilnosti ujemale z dobro znanimi varnostnimi značilnostmi zdravila MabThera pri odobrenih avtoimunskih indikacijah, vključno z GPA/MPA.
When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied (see section 4.8).
Če zdravilo MabThera uporabimo v kombinaciji s kemoterapijo, je treba uporabiti standardno zmanjšanje odmerkov citostatikov (glejte poglavje 4.8).
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.
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.
Erosion score
Ocena erozij
Three of the patients had received two courses of MabThera before enrolment and thus were given a third course in the study.
Trije od teh bolnikov so bili dvakrat zdravljeni z zdravilom MabThera pred vključitvijo, tako so v študiji prejeli tretje zdravljenje z zdravilom MabThera.
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.
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.
• Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue,
· alergijske reakcije, vključno s piskanjem ali kratko sapo, otekanjem obraza in jezika ter kolapsom.
If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.
Če zdravilo MabThera prejemate skupaj z drugimi zdravili, so nekateri neželeni učinki, ki se vam pojavijo, lahko posledica drugih zdravil.
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.
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.
If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.
Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo MabThera.
• damage to the intestinal wall (perforation)
· odpoved dihanja · okvara črevesne stene (predrtje)
Patients with active hepatitis B disease should not be treated with MabThera.
Bolniki z aktivno boleznijo, ki jo povzroči virus hepatitisa B, se ne smejo zdraviti z zdravilom MabThera.
• nerve damage in arms and legs, paralysed face
· okvara živcev v rokah in nogah, paraliza obraza
The majority of local cutaneous reactions seen following administration of MabThera subcutaneous formulation was mild or moderate and resolved without any specific treatment.
Večina lokalnih kožnih reakcij po uporabi podkožne oblike zdravila MabThera je bila blagih ali zmernih in so minile brez posebnega zdravljenja.
The overall response rate (ORR) in the intent-to-treat (ITT) population was 48 % (CI95% 41% - 56%) with a 6% complete response (CR) and a 42 % partial response (PR) rate.
Celokupen odgovor (ORR, overall response rate) v populaciji z namenom zdraviti (ITT, the intent-totreat) je bil 48 % (95-% interval zaupanja 41−56 %), od tega popoln odgovor (CR, complete response) pri 6 %, delni odgovor (PR, partial response) pa pri 42 %.
Premedication with glucocorticoids should also be considered.
V poštev pride tudi premedikacija z glukokortikoidi.
Cases of fatal PML that occurred after disease progression and retreatment have also been reported in clinical trials.
do katerih je prišlo po napredovanju bolezni in ponovnem zdravljenju, so poročali tudi v kliničnih preskušanjih.
The comparison of predicted median Cmax data for MabThera subcutaneous formulation and intravenous formulation are summarized in Table 7.
Primerjava podatkov za predvideno mediano največje koncentracije (Cmax) za podkožno in intravensko obliko zdravila MabThera je povzeta v preglednici 7.
Patients with human anti-mouse antibody (HAMA) or anti-drug antibody (ADA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Bolniki s prisotnimi humanimi protimišjimi protitelesi (human anti-mouse antibody - HAMA) ali protitelesi proti zdravilu (human anti-drug antibody - ADA) imajo lahko alergijske ali preobčutljivostne reakcije, če jih zdravimo z drugimi diagnostičnimi ali terapevtskimi monoklonskimi protitelesi.
• Periodic Safety Update Reports
· Redno posodobljena poročila o varnosti zdravila (PSUR)
A higher proportion of patients receiving the original MabThera/MTX treatment also had no erosive progression over 56 weeks (Table 13).
Prav tako pri večjem deležu bolnikov, ki so prvotno prejemali zdravilo MabThera in metotreksat, ni prišlo do napredovanja erozij v 56 tednih (preglednica 13).
The trial demonstrated non-inferiority of MabThera to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Preskušanje je dokazalo neinferiornost zdravila MabThera v primerjavi s ciklofosfamidom glede popolne remisije po 6 mesecih (preglednica 16).
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Posodobljen RMP je treba predložiti: · na zahtevo Evropske agencije za zdravila; · ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
2 vials of 10 mL
2 viali po 10 ml
• asthma, too little oxygen reaching the body organs
· astma, telesne organe doseže premalo kisika · oteklost trebuha
Following induction of remission with other standard of care immunosuppressants, MabThera maintenance treatment should be initiated during the 4 week period that follows disease remission.
Po indukciji remisije z drugimi imunosupresivi, ki spadajo v okvir običajnega zdravljenja, je treba vzdrževalno zdravljenje z zdravilom MabThera začeti v 4-tedenskem obdobju po remisiji bolezni.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 500 mg / 50 mL
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 500 mg/50 ml
Relapsing n=51
Ponovitev n = 51
MabThera maintenance treatment reduced the risk of death by 56 % (95 % CI; 22 %-75 %).
Vzdrževalno zdravljenje z zdravilom MabThera je zmanjšalo tveganje za smrt za 56 % (95-% interval zaupanja: 22-75 %).
Conditional simulations that summarized the impact of all body size dependencies on rituximab exposure demonstrated that, while fixed subcutaneous dosing leads to larger differences in exposure (Ctrough and AUCτ) between subjects with low and high body sizes compared to body-weight-adjusted intravenous dosing, it allows to maintain Ctrough and AUCτ values for all body-size groups at the levels not lower than levels attained by intravenous dosing, thus achieving at least the same target saturation as for intravenousdosing.
Pogojne simulacije, v katerih so povzeli vplive vseh telesnih mer na izpostavljenost rituksimabu, so pokazale, da fiksno podkožno odmerjanje v primerjavi z intravenskim, ki je prilagojeno na telesno maso, po eni strani povzroča večje razlike v izpostavljenosti zdravilu (Ctrough in AUCτ) med bolniki z majhnimi in velikimi telesnimi merami, po drugi strani pa omogoča ohranjanje vrednosti Ctrough in AUCτ za vse bolnike ne glede na telesne mere na ravneh, ki niso nižje od tistih, ki jih dosežemo z intravenskim odmerjanjem.
The cumulative incidence rate curves showed that time to first major relapse was longer in patients with MabThera starting from month 2 and was maintained up to month 28 (Figure 3).
Krivulje kumulativnih stopenj incidence so pokazale, da je bil čas do prvega hujšega recidiva pri bolnikih, ki so prejemali zdravilo MabThera, daljši, in sicer od 2. meseca naprej; to se je ohranilo do 28. meseca (slika 3).
Anti-rituximab antibodies were detected in only 13 patients and did not result in any clinically relevant increase in steady-state clearance.
Protitelesa proti rituksimabu so ugotovili le pri 13 bolnikih in niso klinično pomembno podaljšala očistka v stanju dinamičnega ravnovesja.
For CLL patients similar results are assumable considering similarities between both diseases, but this has not been investigated in clinical trials.
Zaradi podobnosti med boleznima sklepamo, da bi bili rezultati za bolnike s KLL podobni, a tega niso preučili v kliničnem preskušanju.
This set of reactions which includes syndrome of cytokine release, tumor lysis syndrome and anaphylactic and hypersensitivity reactions are described below.
Ta skupina reakcij, ki vključuje sindrom sproščanja citokinov, sindrom razpada tumorja in anafilaktične ter preobčutljivostne reakcije, je opisana spodaj.
Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.
Na voljo so le omejeni podatki glede učinkovitosti in varnosti pri bolnikih, ki so se predhodno zdravili z monoklonskimi protitelesi, vključno z zdravilom MabThera, ali pri bolnikih, ki se na prejšnje zdravljenje z zdravilom MabThera in kemoterapijo niso odzvali.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 100 mg / 10 mL
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 100 mg/10 ml
1 vial of 50 mL
1 viala po 50 ml
MabThera infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.
Infuzija zdravila MabThera je sledila intravenski infuziji 100 mg metiprednizolona; bolniki so 15 dni tudi peroralno jemali prednizon.
If patients did not experience a serious infusion-related reaction with their first or subsequent infusions of a dose of 1000 mg MabThera administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/mL in a 250 mL volume).
Če bolniki niso imeli resne reakcije, povezane z infuzijo, pri prvem ali nadaljnjem infundiranju odmerka 1000 mg zdravila Mabthera, ki je potekalo v skladu z originalno shemo dajanja, lahko drugo in nadaljnje infuzije prejmejo hitreje z enako koncentracijo kot v prejšnjih infuzijah (4 mg/ml v 250ml volumnu).
The best responses to MabThera are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti-Cyclic Citrullinated Peptide (anti-CCP).
Na zdravljenje z zdravilom MabThera se najbolje odzovejo tisti bolniki, pri katerih je krvni test za revmatoidni faktor (RF) in/ali anti-ciklični citrulinirani peptid (anti-CCP) pozitiven.
A total of 64 patients with CLL were enrolled at any point prior to cycle 5 during their treatment with MabThera intravenous formulation in combination with chemotherapy.
Skupno so vključili 64 bolnikov s KLL na kateri koli točki pred 5. ciklom med zdravljenjem z intravensko obliko zdravila MabThera v kombinaciji s kemoterapijo.
Age, gender and WHO performance status had no effect on the pharmacokinetics of MabThera.
Starost, spol in stanje zmogljivosti po SZO niso vplivali na farmakokinetiko zdravila MabThera.
Overall the results confirm that MabThera subcutaneous formulation 1600 mg has a comparable benefit/risk profile to that of MabThera intravenous formulation 500 mg/m2.
Skupno rezultati potrjujejo, da ima podkožna oblika zdravila MabThera v odmerku 1600 mg primerljivo razmerje med koristmi in tveganji kot intravenska oblika zdravila MabThera v odmerku 500 mg/m2.
Among the 3189 patients treated with MabThera, 1135 (36%) experienced at least one IRR with 733/3189 (23%) of patients experiencing an IRR following first infusion of the first exposure to MabThera.
Med 3.189 bolniki, ki so prejeli zdravilo MabThera, se je vsaj ena z infuzijo povezana reakcija pojavila pri 1.135 bolnikih (36 %), od tega pa se je pri 733 od 3.189 bolnikov (23 %) reakcija pojavila po prejemu prve infuzije zdravila MabThera.
Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
Med zdravljenjem z zdravilom MabThera se lahko pojavijo resne okužbe, vključno s smrtnimi (glejte poglavje 4.8).
For subjects weighing > 90 kg, Ctrough values were the same for the intravenous and subcutaneous regimens.
Pri bolnikih s telesno maso > 90 kg so pri intravenskem in podkožnem režimu odmerjanja zabeležili enake Ctrough.
All healthcare professionals administering MabThera subcutaneous formulation will be provided with an Educational Material (« step by step guide » and « comparison card ») to minimise the risk of off label use and administration route error.
Vsi zdravstveni delavci, ki dajejo zdravilo MabThera v podkožni obliki, bodo z namenom zmanjševanja tveganja neodobrene uporabe zdravila in napak zaradi nepravilne poti dajanja zdravila prejeli izobraževalno gradivo (vodnik po korakih in kartico za primerjavo).