FrancophonIA/ELRC3.0 huggingface dataset:
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: 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: Progression of Kaposi's sarcoma has been observed in rituximab-exposed patients with preexisting Kaposi's sarcoma.
Slovenian: Pri bolnikih s Kaposijevim sarkomom, ki so se zdravili z rituksimabom, so opazili napredovanje Kaposijevega sarkoma.
English: Alopecia Pruritus Urticaria Skin disorder
Slovenian: Bolezni kože in podkožja alopecija pruritus urtikarija bolezni kože
English: There are no data on the safety of rituximab in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
Slovenian: Podatkov o varnosti zdravila rituksimab pri bolnikih z zmernim srčnim popuščanjem (III. razred NYHA)
English: Maintenance and relapse
Slovenian: žrela in spolovil.
English: In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of rituximab.
Slovenian: Tudi fludarabin in ciklofosfamid nista imela opaznega učinka na farmakokinetiko rituksimaba.
English: Clinical experience in granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
Slovenian: Klinične izkušnje pri granulomatozi s poliangiitisom (Wegenerjevi granulomatozi) in mikroskopskem poliangiitisu
English: Ritemvia monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
Slovenian: Zdravilo Ritemvia je indicirano za samostojno zdravljenje 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.
English: The recommended dose of Ritemvia used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 infusions in total).
Slovenian: Priporočeni odmerek zdravila Ritemvia za vzdrževalno zdravljenje bolnikov s predhodno nezdravljenimi folikularnimi limfomi, ki so se odzvali na indukcijsko zdravljenje, je: 375 mg/m2 telesne površine enkrat na 2 meseca (z začetkom 2 meseca po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 12 infuzij).
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1 (ITT population)
Slovenian: Klinični odzivi ob času primarnega cilja preskušanja 1 (populacija, ki so jo nameravali zdraviti).
English: Ritemvia
Slovenian: Rituksimab
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če je ne uporabimo takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; čas običajno ne sme presegati
English: All patients Newly diagnosed n=99 n=48 n=51
Slovenian: Vsi bolniki n = 99
English: In the maintenance therapy clinical trial, 7/57 (12%) patients in the rituximab arm experienced at least one infusion-related reaction.
Slovenian: V kliničnem preskušanju vzdrževalnega zdravljenja se je vsaj ena z infuzijo povezana reakcija pojavila pri 7 od 57 (12%) bolnikov v skupini z rituksimab.
English: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 μg/mL for 2 × 500 mg dose and ranged from 298 to 341 μg/mL for 2 × 1000 mg dose.
Slovenian: Povprečna serumska Cmax rituksimaba po prvi infuziji je bila 157 do 171 μg/ml za 2 x 500 mg odmerek ter 298 do 341 μg/ml za 2 x 1.000 mg odmerek.
English: The ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Slovenian: Celokupen odgovor je znašal 57% (95-% interval zaupanja 41%-73%; popoln odgovor 14%, delni odgovor 43%), mediana časa do napredovanja bolezni je bila pri odzivnih bolnikih 19,4 meseca (razpon 5,3 do 38,9 meseca).
English: IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with those seen for rheumatoid arthritis patients in clinical trials (see section 4.8).
Slovenian: V kliničnih preskušanjih so bile z infuzijo povezane reakcije pri bolnikih z granulomatozo s poliangiitisom, mikroskopskim poliangiitisom in navadnim pemfigusom podobne istim pri bolnikih z revmatoidnim artritisom (glejte poglavje 4.8).
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: Pri KLL je bila celokupna incidenca srčnih bolezni stopnje 3 ali 4 nizka, 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: All patients treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris must be given the patient alert card with each infusion.
Slovenian: Vsem bolnikom, ki se z zdravilom rituksimab zdravijo za revmatoidni artritis, granulomatozo s poliangiitisom, mikroskopski poliangiitis ali navadnega pemfigusa, je treba ob vsaki infuziji dati opozorilno kartico za bolnike (glejte Dodatek IIIA - Označevanje).
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with rituximab.
Slovenian: Pred začetkom zdravljenja z zdravilom rituksimab je priporočljivo določiti koncentracije imunoglobulinov.
English: If you have heart disease or angina, these reactions might get worse.
Slovenian: Obstoječa bolezen srca in angina pektoris se lahko poslabšata.
English: Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171 - 1177 µg/mL) after the eighth infusion.
Slovenian: Pri 37 bolnikih z ne-Hodgkinovim limfomom, ki so prejeli 375 mg/m2 rituksimaba z intravensko infuzijo v osmih odmerkih enkrat na teden, se je povprečna Cmax povečala z vsako naslednjo infuzijo, tako da se je iz povprečne vrednosti 243 µg/ml (od 16 do 582 µg/ml) po prvi infuziji povečala na 550 µg/ml (171 do 1.177 µg/ml) po osmi infuziji.
English: However, a large component of inter-individual variability remained for CL2 after correction for CD19-positive cell counts and tumour lesion size.
Slovenian: Bolniki z večjim številom CD19 pozitivnih celic ali večjimi tumorskimi lezijami so imeli večji Cl2, vseeno pa je precejšnja variabilnost Cl2 med posamezniki ostala tudi po prilagoditvi števila CD19 pozitivnih celic in velikosti tumorskih lezij.
English: albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Slovenian: V vseh podskupinah bolnikov (spol, starost, starosti prilagojen mednarodni prognostični indeks, stadij po klasifikaciji Ann Arbor, ECOG (Eastern Cooperative Oncology Group), koncentracija mikroglobulina ß2, koncentracija LDH, koncentracija albumina, B simptomi, obsežna bolezen, ekstranodalne lokalizacije, infiltracija kostnega mozga) je bilo razmerje tveganj za preživetje brez dogodkov za R-CHOP v primerjavi s CHOP manjše kot 0,83, za skupno preživetje pa manjše kot 0,95.
English: In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
Slovenian: Pri KLL je bila celokupna incidenca bolezni živčevja stopnje 3 ali 4 nizka, tako v študiji v prvi liniji zdravljenja (4% R-FC, 4% FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (3% R-FC, 3% FC).
English: Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the rituximab infusion.
Slovenian: Ker se med infuzijo rituksimaba lahko pojavi hipotenzija, je treba premisliti o tem, da bi 12 ur pred infuzijo zdravila rituksimab bolnik prenehal jemati zdravila proti visokemu krvnemu tlaku.
English: • high or low blood pressure (low blood pressure especially when standing upright)
Slovenian: težave s srcem - na primer srčni infarkt, neredno ali hitro bitje srca, visok ali nizek krvni tlak (nizek krvni tlak zlasti po hitrem vstajanju),
English: • If you are having Ritemvia alone
Slovenian: Če prejemate samo zdravilo Ritemvia,
English: Rituximab was administered as two IV infusions separated by an interval of 15 days.
Slovenian: Rituksimab so bolniki prejeli v dveh intravenskih infuzijah v razmiku 15 dni.
English: Following second infusion, mean Cmax ranged from 183 to 198 μg/mL for the 2 × 500 mg dose and ranged from 355 to 404 μg/mL for the 2 × 1000 mg dose.
Slovenian: Po drugi infuziji je bila povprečna Cmax 183 do 198 μg/ml za 2 x 500 mg odmerek ter 355 do 404 μg/ml za 2 x 1.000 mg odmerek.
English: Physician information
Slovenian: KLINIČNI PODATKI
English: Rituximab N=505
Slovenian: n = 505
English: You might get infections more easily during your treatment with Ritemvia.
Slovenian: Med zdravljenjem z zdravilom Ritemvia ste lahko bolj nagnjeni k okužbam.
English: Mean change in HAQ‐DI
Slovenian: Povprečna sprememba HAQ-DI
English: Previously untreated follicular lymphoma
Slovenian: Predhodno nezdravljeni folikularni limfomi
English: Rituximab (n = 99)
Slovenian: Rituksimab (n = 99)
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Ritemvia Vsebina pakiranja in dodatne informacije
English: Median EFS: 36 Not reached p < 0.0001
Slovenian: mediana EFS: ni doseženo p < 0,0001
English: Co-administration with methotrexate had no effect on the pharmacokinetics of rituximab in rheumatoid arthritis patients.
Slovenian: Sočasna uporaba metotreksata pri bolnikih z revmatoidnim artritisom ni vplivala na farmakokinetiko rituksimaba.
English: Rituximab (N=167)
Slovenian: Rituksimab (n = 167)
English: Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences.
Slovenian: Je glikoziliran imunoglobulin s humanim IgG1 konstantnim delom in mišjo lahko in težko verigo v variabilnem delu.
English: Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of rituximab for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis.
Slovenian: Pri uporabi rituksimaba za zdravljenje avtoimunskih bolezni so poročali o smrtnih primerih progresivne multifokalne levkoencefalopatije, in sicer pri revmatoidnem artritisu in avtoimunskih boleznih, za katere zdravilo ni odobreno, vključno s sistemskim eritematoznim lupusom (SLE) in vaskulitisom.
English: 9.25 years log-rank p value hazard ratio (95% CI) risk reduction TNLT (median)
Slovenian: 9,25 let vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja TNLT (mediana)
English: • loss of hair
Slovenian: • izguba telesne mase,
English: There was no apparent negative impact of the presence of ADA on safety or efficacy in the maintenance therapy clinical trial.
Slovenian: V kliničnem preskušanju vzdrževalnega zdravljenja prisotnost ADA ni imela opaznega negativnega vpliva na varnost ali učinkovitost.
English: Ear and labyrinth disorders tinnitus, ear pain hearing loss5
Slovenian: vključno z motnjami labirinta tinitus, bolečine v ušesu izguba sluha5
English: Uncommon side effects (may affect up to 1 in 100 people):
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 bolnikov):
English: • low number of white blood cells, with or without fever or blood cells called “platelets”
Slovenian: bakterijske ali virusne okužbe, bronhitis, majhno število belih krvnih celic (z zvišano telesno temperaturo ali zmanjšanje brez nje) ali krvnih celic, ki jih imenujemo trombociti (krvne ploščice),
English: R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI.
Slovenian: Zdravljenje z R-CHOP je bilo glede na starost prilagojen mednarodni prognostični indeks ugodno za bolnike z majhnim in velikim tveganjem.
English: Very rare myocardial infarction
Slovenian: miokardni infarkt atrijska undulacija
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximab-treated patients vs. 5% for azathioprine treated patients.
Slovenian: V kliničnem preskušanju vzdrževalnega zdravljenja je bila pojavnost nevtropenije vseh stopenj v skupini z zdravilom rituksimab 0% in v skupini z azatioprinom 5%.
English: Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with rituximab.
Slovenian: Zato morajo ženske v rodni dobi med zdravljenjem z zdravilom rituksimab in še 12 mesecev po njem uporabljati učinkovita kontracepcijska sredstva.
English: b) Granulomatosis with polyangiitis or microscopic polyangiitis
Slovenian: b) granulomatoze s poliangiitisom ali mikroskopskega poliangiitisa
English: Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001 MCID HAQ-DI ≥0.22, MCID SF-36 PHS >5.42, MCID SF-36 MHS >6.33
Slovenian: Značilna razlika v primerjavi s placebom ob času primarnega cilja študije: * p < 0,05; **p < 0,001; ***p ≤ 0,0001 MCID HAQ
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: Rituksimab v kombinaciji z metotreksatom je značilno povečal delež bolnikov, ki so dosegli najmanj 20
English: • memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare,
Slovenian: • poslabšanje spomina, motnje mišljenja, težave s hojo ali izguba vida - lahko so posledica zelo redke, resne okužbe možganov, ki je včasih smrtna (imenujemo jo progresivna multifokalna levkoencefalopatija ali PML).
English: Table 9 Maintenance phase: overview of efficacy results rituximab vs. observation (28 months median observation time)
Slovenian: Vzdrževalno zdravljenje: pregled učinkovitosti zdravljenja z rituksimabom v primerjavi z opazovanjem (mediana časa opazovanja 28 mesecev)
English: The two treatment groups were well balanced in baseline disease characteristics and disease status.
Slovenian: Terapevtski skupini sta imeli ob začetku zdravljenja dobro uravnotežene značilnosti in stanje bolezni.
English: Table 17 Complete remission at 6-months by disease status Rituximab
Slovenian: Popolna remisija po 6 mesecih glede na stanje bolezni.
English: Very rare side effects (may affect up to 1 in 10,000 people):
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri 1 od 10.000 bolnikov):
English: In a multicentre, 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 rituximab, were re-treated with 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Slovenian: 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 rituksimabom, ponovno prejelo 4 odmerke po 375 mg/m2 rituksimaba v obliki intravenske infuzije enkrat na teden.
English: Rituximab, administered as an intravenous infusion at a dose of 375 mg/m2 at weekly intervals for 4 doses to 203 patients with NHL naive to rituximab, yielded a mean Cmax following the fourth infusion of 486 µg/mL (range, 77.5 to 996.6 µg/mL).
Slovenian: Povprečna Cmax po četrti infuziji pri 203 bolnikih z ne-Hodgkinovim limfomom, ki se z rituksimabom prej še niso zdravili in so prejeli po 375 mg/m2 rituksimaba z intravensko infuzijo v štirih odmerkih enkrat na teden, je bila 486 µg/ml (od 77,5 do 996,6 µg/ml).
English: No difference between the R-CHOP and CHOP group was observed in the incidence of other grade 3 and 4 cardiac events including heart failure, myocardial disease and manifestations of coronary artery disease.
Slovenian: Incidenca preostalih srčnih dogodkov 3. in 4. stopnje (vključno s srčnim popuščanjem, miokardno boleznijo in manifestacijami koronarne bolezni) se med skupinama R-CHOP in CHOP ni razlikovala.
English: • Feeling generally unwell or listless.
Slovenian: • bolečina, ne da bi se poškodovali, • splošno slabo počutje ali brezvoljnost.
English: Duration of response * Disease free survival (DFS)**
Slovenian: Preživetje brez boleznia (DFS)
English: In the maintenance therapy clinical trial, 30/57 (53%) patients in the rituximab arm experienced infections.
Slovenian: V kliničnem preskušanju vzdrževalnega zdravljenja so se okužbe v skupini z zdravilom rituksimab pojavile pri 30 od 57 (53%) bolnikov.
English: Ritemvia is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Slovenian: Rituksimab je bistra brezbarvna tekočina v sterilnih vialah za enkratno uporabo, apirogena in brez konzervansov.
English: Cmax following second infusion, was 207 μg/mL for the 2 × 500 mg dose and ranged from 377 to 386 μg/mL for the 2 × 1000 mg dose.
Slovenian: Po drugi infuziji je bila Cmax 207 μg/ml za 2 x 500 mg odmerek ter 377 do 386 μg/ml za 2 x 1000 mg odmerek.
English: Nervous system disorders headache paraesthesia, migraine, dizziness, sciatica
Slovenian: Bolezni živčevja glavobol parestezija, migrena, omotica, išias
English: The analysis of all secondary parameters (response rates, progression-free survival, disease-free survival, duration of response) verified the treatment effect of R-CHOP compared to CHOP.
Slovenian: preživetja brez bolezni, trajanja odgovora) so preverjali učinke zdravljenja z R-CHOP v primerjavi z zdravljenjem s shemo CHOP.
English: The recommended dose of Ritemvia in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Slovenian: Priporočeni odmerek zdravila Ritemvia 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: 375 mg/m2 telesne površine na cikel do 8 ciklov.
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: 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 - ADCC), ki jo posreduje eden ali več receptorjev Fcγ na površini granulocitov, makrofagov ali naravnih celic ubijalk.
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 × 1000 mg, IV, 2 weeks apart), were similar with a mean maximum serum concentration of 369 μg/mL and a mean terminal half-life of 19.2 days.
Slovenian: po enakem odmerjanju (2 x 1.000 mg, intravensko, v razmiku 2 tednov) so bili podobni s povprečno maksimalno koncentracijo v serumu 369 µg/ml in povprečnim končnim razpolovnim časom 19,2 dneva.
English: • feeling tired or dizzy
Slovenian: občutek utrujenosti ali omotičnosti,
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with autoimmune arthritis.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z rituksimabom za vse podskupine pediatrične populacije z avtoimunskim artritisom(za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Skin and Subcutaneous tissue disorders pruritus, rash, +alopecia urticaria, sweating, night sweats, +skin disorder severe bullous skin reactions, StevensJohnson syndrome toxic epidermal necrolysis (Lyell's syndrome)7
Slovenian: znojenje, nočno znojenje, +bolezen kože hude bulozne kožne reakcije, StevensJohnsonov sindrom, toksična epidermalna nekroliza (Lyellov sindrom)7
English: Neurologic disorders
Slovenian: Nevrološke bolezni
English: • Signs of PML include: - Confusion, memory loss or problems thinking - Loss of balance or a change in the way you walk or talk - Decreased strength or weakness on one side of your body - Blurred vision or loss of vision.
Slovenian: - zmanjšano moč ali šibkost na eni strani telesa, - zamegljen vid ali izgubo vida.
English: There were no CTC Grade 4 IRRs and no deaths due to IRRs in the clinical trials.
Slovenian: Common Toxicity Criteria) in smrti zaradi reakcij v kliničnih preskušanjih ni bilo.
English: Corticosteroids will usually be given by injection before the start of Ritemvia treatment.
Slovenian: Pred začetkom zdravljenja z zdravilom Ritemvia boste ponavadi dobili kortikosteriod v injekciji.
English: In patients with non-Hodgkin's lymphoma, premedication with glucocorticoids should be considered if Ritemvia is not given in combination with glucocorticoid-containing chemotherapy.
Slovenian: Če zdravilo Ritemvia za zdravljenje ne-Hodgkinovega limfoma ni uporabljeno v kombinaciji s kemoterapijo, ki vključuje glukokortikoid, je treba razmisliti o premedikaciji z glukokortikoidi.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom, mikroskopskim poliangiitisom ali navadnim pemfigusom je med zdravljenjem z zdravilom Ritemvia in po njem priporočljiva profilaksa proti pljučnici, ki jo povzroča Pneumocystis jirovecii, kot je ustrezno glede na lokalne smernice klinične prakse.
English: Gastrointestinal disorders dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Slovenian: Bolezni prebavil dispepsija, diareja, gastroezofagealni refluks, razjede v ustih, bolečina v zgornjem delu trebuha
English: log-rank p value hazard ratio (95% CI) risk reduction Overall response rate* chi-squared test p value odds ratio (95% CI)
Slovenian: vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja Delež celokupnega odgovora* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ) Delež popolnega odgovora (CR/CRu)* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ)
English: Decreased haemoglobin
Slovenian: Preiskave znižan hemoglobin
English: Clinical experience in non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Slovenian: Klinične izkušnje pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji