natgillin/translations-raw huggingface dataset:
Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with MabThera.
Pri bolnikih z revmatoidnim artritisom, ki so jih zdravili z zdravilom MabThera, so opazili hipogamaglobulinemijo (IgG ali IgM pod spodnjo mejo normale).
respiratory failure4,
+odpoved več organov4
• muscle problems - such as tight muscles, joint or muscle pain, back and neck pain
· koprivnica, močnejše znojenje, nočno znojenje · težave z mišicami - na primer napete mišice, bolečine v sklepih ali mišicah, bolečine v hrbtu in vratu
Table 13 Radiographic outcomes at 1 year (mITT population) Placebo+MTX MabThera+MTX 2 × 1000 mg
Radiološki izidi po 1 letu v študiji 1 (populacija, ki so jo nameravali zdraviti) Placebo + metotreksat
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 10 mg/mL rituximab.
1 viala vsebuje 10 mg/ml rituksimaba.
The overall rate of infection was approximately 94 per 100 patient years in MabThera treated patients.
Okužbe Pri bolnikih, ki so se zdravili z zdravilom MabThera, je bil celokupni delež okužb približno 94 na
There are no data on the safety of MabThera in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
Podatkov o varnosti zdravila MabThera pri bolnikih z zmernim srčnim popuščanjem (III. razred
You must also do this for 12 months after your last treatment with MabThera.
Učinkovito kontracepcijsko zaščito morate nadaljevati še 12 mesecev po zadnjem odmerku zdravila MabThera.
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.
Hodgkinovim limfomom (NHL) in KLL niso proučevali in cepljenje z živimi virusnimi cepivi ni priporočljivo.
MabThera subcutaneous formulation should be injected subcutaneously into the abdominal wall and never into areas where the skin is red, bruised, tender, hard or areas where there are moles or scars.
Zdravila se nikdar ne sme injicirati v predele kože, ki je pordela, podpluta, občutljiva, zatrdela; prav tako se ga ne sme injicirati v predele, kjer so na koži znamenja ali brazgotine.
MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion rituximab
Navodilo za uporabo MabThera 100 mg koncentrat za raztopino za infundiranje MabThera 500 mg koncentrat za raztopino za infundiranje rituksimab
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.
Kronična limfocitna levkemija Priporočeni odmerek zdravila MabThera v kombinaciji s kemoterapijo pri bolnikih, ki predhodno še niso bili zdravljeni oziroma se na prejšnje zdravljenje niso odzvali ali pa se je bolezen pri njih ponovila, je 375 mg/m2 telesne površine, ki ga damo na dan 0 prvega cikla zdravljenja, v naslednjih ciklih zdravljenja pa dajemo 1. dan 500 mg/m2 telesne površine, skupaj 6 ciklov.
Localised candida infections as well as Herpes zoster were reported at a higher incidence in the MabThera-containing arm of randomised studies.
V randomiziranih študijah so pri bolnikih, ki so prejemali zdravilo MabThera, opažali večjo incidenco lokaliziranih okužb s kandido in herpesom zostrom.
After a median observation time of 31 months for patients randomised to the induction phase, R-CHOP significantly improved the outcome of patients with relapsed/refractory follicular lymphoma when compared to CHOP (see Table 8).
mesečnega opazovanja izid zdravljenja pomembno izboljšal v primerjavi s skupino CHOP (glejte preglednico 8).
• swelling of the hands or ankles
· otekanje rok ali gležnjev.
B lymphocytes are involved in the cause of these conditions.
V nastanek teh bolezni so vpleteni limfociti B. e)
Baseline tumour load was available only in trial BO22334.
Manjkajočih vrednosti sospremenljivk ni bilo; izjema je izhodiščno število celic B. Izhodiščno tumorsko breme je bilo na voljo le v preskušanju BO22334.
Nervous system disorders paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety
Bolezni živčevja parestezije, hipestezija, agitiranost,
The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis.
Domena rituksimaba Fab se veže na antigen CD20 na B-limfocitih in prek domene Fc sproži imunska dogajanja, ki privedejo do razgradnje celic B. Mogoča mehanizma celične razgradnje sta od komplementa odvisna citotoksičnost (complement-dependent cytotoxicity - CDC), ki je posledica vezave C1q, in od protiteles odvisna celična citotoksičnost (antibody-dependent cellular cytotoxicity
MabThera, administered as an intravenous infusion at a dose of 375 mg/m2 at weekly intervals for 4
MabThera, ponovno prejelo 4 odmerke po 375 mg/m2 zdravila MabThera v obliki intravenske infuzije enkrat na teden.
Mean Cmax for serum rituximab following first infusion was 170 to 175 µg/mL for 2 x 500 mg dose and 317 to 370 µg/mL for 2 x 1000 mg dose.
170 do 175 mg/ml za 2 x 500 mg odmerek ter 317 do 370 mg/ml za 2 x 1000 mg odmerek.
• Weight loss
· siljenje na bruhanje
Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
bolečina v prsnem košu, dispneja, izrazitejši kašelj, rinitis astma, bronchiolitis obliterans,
For retreatment with MabThera monotherapy for patients who have responded to previous treatment with MabThera monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks
Priporočeni odmerek zdravila MabThera za ponovno samostojno zdravljenje bolnikov s folikularnim limfomom, ki so se odzvali na prejšnje samostojno zdravljenje z zdravilom MabThera po tem, ko se na predhodno zdravljenje niso odzvali ali se je pri njih bolezen ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne (glejte poglavje 5.1).
6 Contents of the pack and other information
5 Shranjevanje zdravila MabThera Vsebina pakiranja in dodatne informacije
• producing more tears, tear duct problems, inflamed eye (conjunctivitis)
· omotica ali občutek tesnobe · močnejše solzenje, težave s solznimi izvodili, vnetje očesa (konjunktivitis) · zvonjenje v ušesih, bolečine v ušesu
Closely monitor patients with pre-existing cardiac conditions and those who experienced prior cardiopulmonary adverse reactions.
Opaženi v glavnem pri bolnikih z obstoječimi boleznimi srca in/ali kardiotoksično kemoterapijo ter pretežno v zvezi z reakcijami, povezanimi z infuzijo.
The recommended dose of MabThera monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne.
In the induction of remission clinical trial, at 6 months, in the MabThera group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline had low IgA, IgG and IgM levels, respectively, compared to 25%, 50% and 46% in the cyclophosphamide group.
V kliničnem preskušanju indukcije remisije so po 6 mesecih pri bolnikih, ki so imeli izhodiščno normalne ravni imunoglobulinov, med prejemniki zdravila MabThera zabeležili nizke IgA, IgG in
• If you get any side effects talk to your doctor, pharmacist or nurse.
· Če opazite kateri koli neželeni učinek se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 1400 mg once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 administrations in total).
· Ponovitev folikularnih limfomov ali neodzivna bolezen Priporočeni odmerek zdravila MabThera za vzdrževalno zdravljenje bolnikov s ponovitvijo folikularnih limfomov ali neodzivno boleznijo, ki so se odzvali na indukcijsko zdravljenje, je: 375 mg/m2 telesne površine enkrat na 3 mesece (z začetkom 3 mesece po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 8 infuzij).
Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia lung disease7 respiratory failure4,
bolečina v prsnem košu, dispneja, izrazitejši kašelj, rinitis astma, bronhiolitis obliterans,
You should also tell them about your MabThera treatment.
Povejte, da se zdravite z zdravilom MabThera.
Mean terminal elimination half-life ranged from 15 to 16 days for the 2 x 500 mg dose group and 17 to 21 days for the 2 × 1000 mg dose group.
x 500 mg odmerek ter 17 do 21 dni za 2 x 1000 mg odmerek.
MabThera is used for the treatment of patients with moderate to severe pemphigus vulgaris.
navadnega pemfigusa Zdravilo MabThera se uporablja za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
The recommended dose of MabThera in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: first cycle with MabThera intravenous formulation 375 mg/m2
Priporočeni odmerek zdravila MabThera v kombinaciji s kemoterapijo za indukcijsko zdravljenje bolnikov s folikularnimi limfomi, ki se predhodno še niso zdravili ali se na prejšnje zdravljenje niso odzvali ali se jim je bolezen ponovila, je: prvi cikel z intravensko obliko zdravila MabThera 375 mg/m2 telesne površine, nato nadaljnji cikli s podkožno obliko zdravila MabThera, injiciranega v fiksnem odmerku 1400 mg na cikel do 8 ciklov.
The highest risk of experiencing an administration related reaction is generally observed at cycle one.
V prvem ciklusu zdravljenja je na splošno največje tveganje za pojav reakcij, povezanih z dajanjem zdravila.
In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log--rank test).
FC in 20,6 meseca v skupini FC (p = 0,0002, test log-rang).
Neutropenia can occur several months after the administration of MabThera (see section 4.4).
MabThera (glejte poglavje 4.4).
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.
Uporaba zdravila MabThera pri bolnikih, ki še niso prejemali metotreksata, ni priporočljiva, ker ni bilo dokazano ugodno razmerje med koristjo in tveganji.
• flushing or redness of the skin
· trzanje ali tresenje mišic,
EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
ORR: celokupni odgovor (Overall Response Rate) CRR: popolni odgovor (Complete Response Rate) PFS: preživetje brez napredovanja bolezni (Progression-Free Survival) (delež z dogodkom, napredovanjem/ponovitvijo bolezni ali smrtjo iz katerega koli vzroka)
Initial treatment, bulky disease, weekly for 4 doses In pooled data from three trials, 39 patients with relapsed or chemoresistant, bulky disease (single lesion ≥ 10 cm in diameter), low grade or follicular B cell NHL received 375 mg/m2 of MabThera as intravenous infusion weekly for four doses.
Združeni podatki treh preskušanj navajajo, da je 39 bolnikov, pri katerih se je nizko maligni ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo in so imeli obsežno bolezen (ena lezija ³ 10 cm v premeru), prejelo 4 odmerke po 375 mg/m2 zdravila
• indigestion
· nespečnost,
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.
NHL niso proučevali in cepljenje z živimi virusnimi cepivi ni priporočljivo.
After a median observation time of 31 months for patients randomised to the induction phase, R-CHOP significantly improved the outcome of patients with relapsed/refractory follicular lymphoma when compared to CHOP (see Table 5).
mesečnega opazovanja izid zdravljenja pomembno izboljšal v primerjavi s skupino CHOP (glejte preglednico 5).
Clinical experience of MabThera concentrate for solution for infusion in CLL
Klinične izkušnje s koncentratom za raztopino za infundiranje zdravila MabThera pri kronični limfocitni anemiji
Severe infections were reported in about 4% of patients treated with MabThera monotherapy.
Pri 4 % bolnikov, ki so prejemali zdravilo MabThera kot samostojno zdravljenje, so opazili hude okužbe.
Do not breast-feed while you are being treated with MabThera.
Med zdravljenjem z zdravilom MabThera ne smete dojiti.
When rituximab sticks to the surface of this cell, the cell dies.
Veže se na površino vrste belih krvnih celic, limfocitov B. Ko se rituksimab veže na površino teh celic, povzroči njihovo smrt.
See Section 4.2 for information on paediatric use.
MabThera za vse podskupine pediatrične populacije z avtoimunskim artritisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Musculoskelet al, connective tissue and bone disorders hypertonia, myalgia, arthralgia, back pain, neck pain, pain
Bolezni mišično skeletnega sistema in vezivnega tkiva hipertonija, mialgija, artralgija,
There are no adequate and well-controlled data from studies in pregnant women, however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to MabThera during pregnancy.
Pri nekaterih dojenčkih, katerih matere so med nosečnostjo prejemale zdravilo MabThera, pa so poročali o prehodnem zmanjšanju števila celic B in limfocitopeniji.
• Infections such as pneumonia (bacterial)
resna virusna okužba2, pnevmocisto za (Pneumocys tis jirovecii)
In the majority of these cases, MabThera was administered with chemotherapy.
MabThera uporabili skupaj s kemoterapijo.
Hypogammaglobulinaemia (IgA, IgG or IgM below the lower limit of normal) has been observed in granulomatosis with polyangiitis and microscopic polyangiitis patients treated with MabThera.
Pri bolnikih z granulomatozo s poliangiitisom ali mikroskopskim poliangiitisom, ki so prejemali zdravilo MabThera, so opažali hipogamaglobulinemijo (IgA, IgG ali IgM pod spodnjo mejo normale).
• coughing or shortness of breath
· odpoved dihanja,
MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/002
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/98/067/002
This medicine may make you more likely to get infections.
Ker prejemate zdravilo MabThera, je večja verjetnost, da dobite okužbo.
Nervous system disorders Dizziness
Bolezni živčevja glavobol omotica
You will always be given MabThera as a drip (intra-venous infusion).
Zdravilo MabThera boste dobili v intravenski infuziji.
In a multi-centre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of MabThera, were re-treated with 375 mg/m2 of MabThera as intravenous infusion weekly for four doses.
Ponovno zdravljenje, 4 odmerki, enkrat na teden V multicentričnem preskušanju brez primerjalne skupine je 58 bolnikov, pri katerih se je nizko maligni ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo ter so dosegli objektivni klinični odgovor na predhodno zdravljenje z zdravilom
MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/004
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/98/067/004
2 What you need to know before you are given MabThera
Na tej kartici je opisano: · Kaj morate vedeti, preden prejmete zdravilo MabThera
The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Pri 24 mesecih je bila ocena celokupnega preživetja v skupini R-CHOP 68,2 %, v skupini CHOP pa 57,4 %.
A two-stage phase Ib trial to investigate the pharmacokinetics, safety and tolerability of MabThera subcutaneous formulation in patients with follicular lymphoma (FL) as part of maintenance treatment.
Preskušanje BP22333 (SparkThera) Pri bolnikih s folikularnimi limfomi so kot del vzdrževalnega zdravljenja izvedli dvostopenjsko preskušanje faze Ib za proučitev farmakokinetike, varnosti in prenašanja podkožne oblike zdravila
Subcutaneous injections:
glivične okužbe,
Following induction of remission with MabThera, maintenance treatment should be initiated no sooner than 16 weeks after the last MabThera infusion.
Po indukciji remisije z zdravilom MabThera se vzdrževalnega zdravljenja ne sme začeti prej kot
CHOP (R-CHOP).
zdravila MabThera in sheme CHOP (R-CHOP).
The incidence of IRR decreased with subsequent courses (see section 4.8).
in prehodne (glejte poglavje 4.8).
MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/98/067/001
Dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Bolezni prebavil dispepsija, diareja, gastroezofagealni refluks, razjede v ustih,
heart failure4
odpoved dihal4
Number of Subjects with Major Relapse
ODGOVOREN ZA SPROŠČANJE SERIJ
MabThera is a clear, colourless solution, supplied as a concentrate for solution for infusion.
Zdravilo MabThera je bistra, brezbarvna raztopina.
CRR - Complete Response Rate
CRRa ocena
• severe skin problems causing blisters that can be life-threatening.
· okvara črevesne stene (predrtje), · hude težave s kožo, ki povzročijo mehurje in so lahko smrtno nevarne.
patients.
stopnje).
infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
Povprečni končni razpolovni čas izločanja je bil 15 do 16 dni za 2
and 6
Pri 24
MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Zdravilo MabThera je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
Premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy.
Če zdravilo MabThera ni uporabljeno v kombinaciji s kemoterapijo, ki vključuje glukokortikoid, je treba razmisliti o premedikaciji z glukokortikoidi.
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
Nadaljnja analiza trajanja celokupnega preživetja, ki so jo izvedli po mediani časa sledenja 60 mesecev, je potrdila prednost zdravljenja z R-CHOP pred CHOP
• eating disorders, not eating enough, leading to weight loss
zaprtost, težave z želodcem · motnje hranjenja, nezadostno uživanje hrane, kar povzroči hujšanje
Baseline CD19-positive cell counts and size of measurable tumour lesions contributed to some of the variability in CL2 of MabThera in data from 161 patients given 375 mg/m2 as an intravenous infusion for 4
K variabilnosti Cl2 zdravila MabThera pri 161 bolnikih, ki so v štirih tednih enkrat na teden dobili 375 mg/m2 zdravila
**: only applicable to patients achieving a CR;
NR: ni doseženo; a: velja le za bolnike, ki so dosegli CR (popolni odgovor).
Premedication consisting of an analgesic/antipyretic and an antihistamine should always be administered before each dose of MabThera subcutaneous formulation.
Pred vsakim odmerkom podkožne oblike zdravila MabThera mora bolnik vedno dobiti premedikacijo, ki obsega analgetik/antipiretik in antihistaminik.
MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/003
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/98/067/003
Severe IRRs with fatal outcome have been reported in rheumatoid arthritis patients in the post-marketing setting.
V obdobju trženja so pri bolnikih z revmatoidnim artritisom poročali o resnih, z infuzijo povezanih reakcijah, ki so se končale s smrtjo.
• heart beating faster than normal
· bolečina v trebuhu, · bolečina v mišicah, · hitrejše bitje srca kot običajno.
cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month timepoint.
Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom se je število perifernih celic B zmanjšalo na < 10 celic/µl po dveh infundiranjih 375 mg/m2 rituksimaba (po enem na teden) in je na tej ravni ostalo do 6 mesecev.
MabThera subcutaneous formulation at a fixed dose of 1400 mg was administered for 6 cycles subcutaneously during induction at 3-weekly intervals, following the first cycle of MabThera intravenous formulation, in previously untreated FL patients in combination with chemotherapy.
Predhodno še nezdravljenim bolnikom s folikularnimi limfomi so (v kombinaciji s kemoterapijo) po opravljenem prvem ciklu zdravljenja z intravensko obliko zdravila MabThera dajali podkožno obliko zdravila v fiksnem odmerku 1400 mg, in sicer 6 ciklov podkožno med indukcijskim zdravljenjem v 3tedenskih presledkih.
• Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica,
· neobičajni občutki na koži - na primer omrtvičenost, mravljinčenje, zbadanje, pekoč občutek, občutek gomazenja na koži, slabše zaznavanje dotika,
Pneumocystis jirovecii
Geometrična sredina AUCτ
A total of 6/34 (18%) of MabThera treated patients from the maintenance therapy clinical trial developed ADA.
V kliničnem preskušanju vzdrževalnega zdravljenja so se ADA pojavila pri skupno 6 od 34 (18 %) bolnikov, zdravljenih z zdravilom MabThera.
MabThera at a fixed dose of 1600 mg was administered for 5 cycles subcutaneously at 4-weekly intervals, following the first cycle of MabThera intravenous formulation, in previously untreated CLL patients in combination with chemotherapy (fludarabine and cyclophosphamide (FC).
Bolnikom s KLL, ki še niso bili zdravljeni, so v kombinaciji s kemoterapijo (fludarabinom in ciklofosfamidom (FC)) po opravljenem prvem ciklu zdravljenja z intravensko obliko zdravila MabThera dajali podkožno obliko zdravila v fiksnem odmerku 1600 mg, in sicer 5 ciklov podkožno v 4-tedenskih presledkih.
OS rates,
neješčnost,
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use only
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Very rare cases of PML have been reported during post-marketing use of the MabThera intravenous formulation in NHL (see section 4.8).
opisani zelo redki primeri PML (glejte poglavje 4.8).
They were characterized by pulmonary events and in some cases included rapid tumour lysis and features of tumour lysis syndrome in addition to fever, chills, rigors, hypotension, urticaria, angioedema and other symptoms (see section 4.8).
Značilni zanje so bili pljučni dogodki in v nekaterih primerih hiter razpad tumorja z značilnostmi sindroma razpada tumorja, poleg zvišane telesne temperature, mrzlice,
Log-Rank p value
Vrednost p v testu log rang
This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and vasculitis.
Pri uporabi zdravila MabThera za zdravljenje revmatoidnega artritisa in avtoimunskih bolezni, ki vključujejo sistemski eritematozni lupus (SLE) in vaskulitis, so poročali o zelo redkih primerih smrtne progresivne multifokalne levkoencefalopatije (PML).
Diluted medicinal product
UPORABO ZDRAVILA
MabThera maintenance treatment consisted of a single infusion of MabThera at 375 mg/m2 body surface area given every 2 months until disease progression or for a maximum period of two years.
V okviru vzdrževalnega zdravljenja so bolniki prejeli eno infuzijo zdravila MabThera v odmerku 375 mg/m2 telesne površine vsaka 2