FrancophonIA/ELRC3.0 huggingface dataset:
English: Rixathon is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Rixathon je dobavljeno v sterilnih, apirogenih vialah brez konzervansov za enkratno uporabo.
English: For retreatment with Rixathon monotherapy for patients who have responded to previous treatment with rituximab 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 (see section 5.1).
Slovenian: Priporočeni odmerek zdravila Rixathon za ponovno samostojno zdravljenje bolnikov s folikularnim limfomom, ki so se odzvali na prejšnje samostojno zdravljenje z rituksimabom 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).
English: Hypertension, orthostatic hypotension, hypotension
Slovenian: Bolezni živčevja parestezije, hipestezija, agitiranost,
English: • bald spots on the scalp, chills, headache
Slovenian: • plešasti predeli na lasišču, mrzlica, glavobol,
English: The Patient Alert Card for Rixathon contains the following key elements: - The need to carry the card at all times and to show the card to all treating health care professionals - Warning on the risk of infections and PML, including the symptoms - The need for patients to contact their health care professional if symptoms occur
Slovenian: - informacije o nujnosti svetovanja bolnikom glede tveganja za okužbe in PML, vključno s simptomi, na katere naj bodo pozorni, in informacije o nujnosti, da nemudoma obvestijo svojega zdravnika, če izkusijo katerega od simptomov, - informacije o nujnosti, da opozorilno kartico izročijo bolniku ob vsakem infundiranju.
English: This medicinal product contains 11.5 mmol (263.2 mg) sodium per 50 mL vial.
Slovenian: To zdravilo vsebuje 11,5 mmol (263,2 mg) natrija na 50-ml vialo.
English: +pancytopenia, +granulocytopenia disorders, aplastic anaemia, haemolytic anaemia, lymphadeno pathy increase in serum IgM levels3
Slovenian: hemolitična anemija, limfadenopatija prehodno zvečanje koncentrac ije IgM v serumu3
English: Follicular non-Hodgkin's lymphoma
Slovenian: Ne-Hodgkinov limfom Folikularni ne-Hodgkinov limfom
English: The efficacy and safety of rituximab in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study.
Slovenian: Klinične izkušnje pri navadnem pemfigusu V randomizirani, odprti, kontrolirani multicentrični študiji so učinkovitost in varnost rituksimaba v kombinaciji s kratkotrajnim zdravljenjem z majhnim odmerkom glukokortikoida (prednizon) ocenili pri novodiagnosticiranih bolnikih z zmernim do hudim pemfigusom (74 z navadnim pemfigusom
English: All indications
Slovenian: DRUGI PODATKI
English: • flushing or redness of the skin
Slovenian: • omotica ali občutek tesnobe,
English: Limited information from one study in relapsed/refractory CLL patients suggests that rituximab 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 rituksimabom poslabša tudi izid primarnih okužb z virusom hepatitisa B. Pri vseh bolnikih je treba pred začetkom zdravljenja z zdravilom Rixathon 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: • hives, increased sweating, night sweats
Slovenian: +alopecija urtikarija, znojenje,
English: Rituximab 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: 20-% izboljšanje glede na ACR oceno v primerjavi z bolniki, ki so se zdravili samo z metotreksatom (preglednica 12).
English: neutropenia3
Slovenian: pozna nevtropenija3
English: Dizziness Tremor
Slovenian: Razredčena raztopina
English: 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
Slovenian: TTP: čas do napredovanja bolezni ali smrti (Time to progression or death)
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje hiperholesterolemija
English: Packs of 2 or 3 vials.
Slovenian: V škatli sta 2 viali ali 3 viale.
English: , leucopenia, +febrile neutropenia, +thrombocyt openia
Slovenian: +febrilna okužba, +herpes zoster, +okužbe dihal,
English: Table 13 Radiographic outcomes at 1 year (mITT population)
Slovenian: Radiološki izidi po 1 letu v študiji 1 (populacija, ki so jo nameravali zdraviti) Placebo + metotreksat
English: Patients treated with rituximab in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
Slovenian: Značilna razlika v primerjavi s kombinacijo placebo + metotreksat ob času primarnega cilja preskušanja: ***p ≤ 0,0001 V vseh študijah je bilo pri bolnikih, ki so se zdravili z rituksimabom in metotreksatom, zmanjšanje aktivnosti bolezni (DAS28, Disease Activity Score) pomembno večje kot pri bolnikih, ki so se zdravili samo z metotreksatom (preglednica 12).
English: Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev citrat polisorbat 80 natrijev klorid natrijev hidroksid klorovodikova kislina voda za injekcije
English: Patients were stratified by baseline disease severity (moderate or severe) and randomised 1:1 to receive either rituximab 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
English: OTHER
Slovenian: Vse
English: • skin rashes, including acne or spots
Slovenian: • kožni izpuščaji, vključno z aknami ali lisami, • pordevanje ali rdečina kože,
English: 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 1,000 mg dose.
Slovenian: 170 do 175 μg/ml za 2 x 500 mg odmerek ter 317 do 370 μg/ml za 2 x 1.000 mg odmerek.
English: TNLT (median) log-rank p value hazard ratio (95% CI) risk reduction
Slovenian: TNLT (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
English: Severe infections were reported in about 4% of patients treated with rituximab monotherapy.
Slovenian: Pri 4 % bolnikov, ki so prejemali rituksimab kot samostojno zdravljenje, so opazili hude okužbe.
English: In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC).
Slovenian: tako v študiji v prvi liniji zdravljenja (4 % R-FC, 3 % FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (4 % R- FC, 4 % FC).
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
Slovenian: Nadaljnja analiza trajanja celokupnega preživetja, ki so jo izvedli po mediani časa sledenja 60 mesecev, je potrdila prednost zdravljenja z R-CHOP pred CHOP (p = 0,0071), kar pomeni zmanjšanje tveganja za dogodke za 32 %.
English: ORR2)
Slovenian: Primarna učinkovitost ORR2)
English: Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in autoimmune conditions.
Slovenian: Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (PRES, posterior reversible encephalopathy syndrome) oziroma sindroma reverzibilne posteriorne levkoencefalopatije (RPLS, reversible posterior leukoencephalopathy syndrome).
English: Asthma, bronchiolitis obliterans, lung disorder,
Slovenian: bolečina v prsnem košu, dispneja, izrazitejši kašelj, rinitis astma, bronhiolitis obliterans,
English: 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.
Slovenian: 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
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg/10 ml
English: You might get infections more easily during your treatment with Rixathon.
Slovenian: Med zdravljenjem z zdravilom Rixathon ste lahko bolj nagnjeni k okužbam.
English: The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients (< 65 years), with previously untreated or relapsed/refractory CLL.
Slovenian: ki predhodno še niso bili zdravljeni ali pri katerih se je bolezen ponovila oziroma se na predhodno zdravljenje niso odzvali, višja pri starejših bolnikih v primerjavi z mlajšimi bolniki (< 65 let).
English: The recommended dose of Rixathon 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.
Slovenian: • Bolniki, ki se na prejšnje zdravljenje niso odzvali ali se je pri njih bolezen ponovila Priporočeni odmerek zdravila Rixathon za samostojno indukcijsko zdravljenje odraslih bolnikov s III. 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.
English: Rixathon is a clear, colourless to slightly yellowish solution, supplied as a concentrate for solution for infusion.
Slovenian: Zdravilo Rixathon je bistra, brezbarvna do rumenkasta raztopina.
English: 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).
Slovenian: FC in 20,6 meseca v skupini FC (p = 0,0002, test log rank).
English: Maintenance treatment with rituximab 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 rituximab maintenance arm compared to 14.3 months in the observation arm.
Slovenian: Vzdrževalno zdravljenje z rituksimabom 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-rank).
English: In the induction of remission clinical trial, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Slovenian: pojavila pri 24 % prejemnikov rituksimaba (en cikel) in pri 23 % prejemnikov ciklofosfamida.
English: Rixathon is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Slovenian: e) navadnega pemfigusa Zdravilo Rixathon se uporablja za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
English: TNCT (median) log-rank p value hazard ratio (95% CI) risk reduction
Slovenian: TNCT (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
English: The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Slovenian: Pri primerih PRES/RPLS, o katerih so poročali, so bili prisotni znani dejavniki tveganja za PRES/RPLS, vključno z bolnikovo osnovno boleznijo,
English: • Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica,
Slovenian: • zvečana koncentracija holesterola v krvi, • nenormalni občutki v koži, kot je otrplost, mravljinčenje, zbadanje ali žarjenje, išias, migrena,
English: They were characterised 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).
Slovenian: drgetanja, hipotenzije, urtikarije, angioedema in drugih simptomov (glejte poglavje 4.8).
English: Secondary efficacy Overall survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Slovenian: Celokupno preživetje (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
English: Duration of response * Disease free survival (DFS)** Time to new CLL treatment
Slovenian: TTF: čas do neuspeha zdravljenja (Time to Treatment Failure)
English: Packs of 1 or 2 vials.
Slovenian: V škatli sta 1 viala ali 2 viali.
English: Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Slovenian: Uporaba rituksimaba pri bolnikih, ki še niso prejemali metotreksata, ni priporočljiva, ker ni bilo dokazano ugodno razmerje med koristjo in tveganji.
English: Event-free survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Slovenian: Preživetje brez dogodka (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
English: Table 17 Complete remission at 6-months by disease status Rituximab Cyclophosphamide Difference (CI 95%)
Slovenian: Popolna remisija po 6 mesecih glede na stanje bolezni Rituksimab
English: • Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth
Slovenian: • slaba prebava, driska, zgaga, vnetje in/ali razjede v žrelu in ustih,
English: Renal failure4
Slovenian: odpoved dihal4
English: Blood and Neutropenia Anaemia,
Slovenian: aplastična anemija,
English: Measure blood neutrophils prior to each course of Rixathon, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Slovenian: 6 mesecev po končanem zdravljenju ter pri znakih ali simptomih okužbe (glejte poglavje 4.8).
English: Patients who have clinically significant cardiovascular disease, including arrhythmias, or previous serious infusion reactions to any prior biologic therapy or to rituximab, should not be administered the more rapid infusion.
Slovenian: povezano z infuzijo na katero koli biološko zdravilo ali na rituksimab, ne smejo prejeti hitrejše infuzije.
English: Infusion site pain
Slovenian: bolečina na mestu infundiranja
English: Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Slovenian: Zdravilo Rixathon je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
English: OS rates,
Slovenian: • izpadanje las,
English: Late
Slovenian: Občasni
English: Nervous System Disorders
Slovenian: Bolezni živčevja glavobol omotica
English: Malignancies
Slovenian: ZDRAVILOM
English: Number of Subjects with Major Relapse
Slovenian: (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: • short term increase in the amount of some types of anti-bodies in the blood (called
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri 1 od 10.000 bolnikov): • kratkotrajno povečanje količine nekaterih vrst protiteles v krvi (imenujemo jih imunoglobulini
English: Severe cardiac disorders 4 and
Slovenian: Bolezni sečil ledvična odpoved4
English: All physicians who are expected to prescribe Rixathon for NHL/CLL are provided with the following to reduce the risk of administration route errors: - Product information - HCP Alert card addressing the correct use of Rixathon
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Za indikacije ne-Hodgkinovega limfoma (NHL) in kronične levkocitne levkemije (KLL): Vsi zdravniki, ki lahko predpišejo zdravilo Rixathon za NHL in KLL, za zmanjševanje tveganja za napake v dajanju, prejmejo:
English: Closely monitor patients with pre-existing cardiac conditions and those who experienced prior cardiopulmonary adverse reactions.
Slovenian: Bolnike, ki imajo težave s srcem, in tiste, pri katerih so v preteklosti opazili kardio- pulmonalne neželene učinke, je treba pozorno spremljati.
English: A small number of cases of hepatitis-B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the postmarketing setting.
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom, ki so rituksimab prejemali v obdobju trženja, so poročali o majhnem številu primerov reaktivacije hepatitisa B; nekateri od teh primerov so se končali s smrtjo.
English: 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 rituximab during pregnancy.
Slovenian: Pri nekaterih dojenčkih, katerih matere so med nosečnostjo prejemale rituksimab, pa so poročali o prehodnem zmanjšanju števila celic B in limfocitopeniji.
English: You will always be given Rixathon as a drip (intra-venous infusion).
Slovenian: Zdravilo Rixathon boste dobili v intravenski infuziji.
English: Psychiatric Disorders
Slovenian: KLINIČNI PODATKI
English: Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells.
Slovenian: ADCC), ki jo posreduje eden ali več receptorjev Fcγ na površini granulocitov, makrofagov ali naravnih celic ubijalk.
English: 1) Estimates were calculated by hazard ratios
Slovenian: Ocena po prirejeni Sharpovi lestvici Ocena erozij
English: Severe bullous skin reactions, StevensJohnson Syndrome toxic epidermal necrolysis (Lyell's Syndrome)
Slovenian: nočno znojenje, +bolezen kože hude bulozne kožne reakcije, StevensJohnsonov sindrom,
English: • IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Slovenian: Najpogosteje zabeleženi ali opaženi resni neželeni učinki so bili: • z infuzijo povezane reakcije (vključno s sindromom sproščanja citokinov, sindromom razpada tumorja), glejte poglavje 4.4;
English: This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and vasculitis.
Slovenian: Pri uporabi rituksimaba 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).
English: • eating disorders, not eating enough, leading to weight loss
Slovenian: zaprtost, težave z želodcem, • motnje hranjenja, nezadostno uživanje hrane, kar povzroči hujšanje,
English: Primary efficacy Progression-free survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Slovenian: Preživetje brez napredovanja bolezni (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
English: All physicians who are expected to prescribe Rixathon for non-oncology indications are provided with the following: - Product information - HCP educational leaflet - Patient educational leaflet
Slovenian: Za neonkološke indikacije: Vsi zdravniki, ki lahko predpišejo zdravilo Rixathon za neonkološke indikacije, prejmejo:
English: vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 15) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
Slovenian: V odprtem randomiziranem preskušanju so skupaj 332 predhodno še nezdravljenih bolnikov s folikularnimi limfomi randomizirali na prejemanje kemoterapije CVP (750 mg/m2 ciklofosfamida, 1,4 mg/m2 vinkristina do največ 2 mg 1. dan in 40 mg/m2/dan prednizolona od 1. do 5. dneva) na 3 tedne 8 ciklov, ali na 375 mg/m2 rituksimaba v kombinaciji s CVP (R-CVP).
English: • Additional risk minimisation measures For the indications non-Hodgkin´s lymphoma (NHL) and Chronic lymphocytic leukaemia
Slovenian: Kontraindikacije za uporabo pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji
English: ACR20 ACR50 ACR70 EULAR response (good/moderate) Mean change in DAS
Slovenian: Odziv po EULAR (dober/zmeren)
English: migraine, dizziness
Slovenian: zardevanje, splošno slabo počutje,
English: Severe vision loss5
Slovenian: bolečine v ušesu izguba sluha5
English: Disease-free survivala Subgroup analysis PFS
Slovenian: Analiza podskupin Preživetje brez napredovanja bolezni (PFS)
English: The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
Slovenian: Naslednji izrazi so bili med kliničnimi preskušanji zabeleženi kot neželeni učinki, a so imeli v skupinah, ki so prejemale rituksimab, podobno ali nižjo incidenco kot v kontrolnih skupinah:
English: Study Treatment, N
Slovenian: čas do novega zdravljenja KLL
English: A total of 6/34 (18%) of rituximab treated patients from the maintenance therapy clinical trial developed ADA.
Slovenian: V kliničnem preskušanju vzdrževalnega zdravljenja so se ADA pojavila pri skupno 6 od 34 (18 %) bolnikov, zdravljenih z rituksimabom.
English: • muscle problems - such as tight muscles, joint or muscle pain, back and neck pain
Slovenian: • koprivnica, močnejše znojenje, nočno znojenje, • težave z mišicami - na primer napete mišice, bolečine v sklepih ali mišicah, bolečine v hrbtu in vratu, • splošno nelagodje, neprijetno počutje ali utrujenost, tresenje, znaki gripe,
English: Rate
Slovenian: Delež
English: < 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Slovenian: 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.
English: Immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
Slovenian: IgM), snovi v krvi, ki nastajajo zaradi razgradnje odmirajočih rakavih celic, • okvara živcev v rokah in nogah, paraliza obraza,
English: (CLL):
Slovenian: ml volumnu).
English: • respiratory failure
Slovenian: • odpoved dihanja,
English: Pneumocystis jirovecii
Slovenian: Navadni pemfigus
English: 30 ml (10 mg/ml) 1 vial
Slovenian: 300 mg koncentrat za pripravo raztopine za infundiranje intravenska uporaba viala (steklena) 30 ml (10 mg/ml) 1 viala
English: MA (EU)-number (Invented) Name Strength Pharmaceutical Form
Slovenian: (Izmišljeno) ime Jakost
English: (Invented) name
Slovenian: Zaščiteno ime Jakost
English: London, 23 October 2008 Doc.
Slovenian: London, 23. oktobra 2008 Sklic dok.
English: Ref. EMEA/544525/2008
Slovenian: EMEA/180879/2009