natgillin/translations-raw huggingface dataset:
In CLL patients, co-administration with rituximab did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide. 
Pri bolnikih s KLL sočasna uporaba rituksimaba ni vplivala na farmakokinetiko fludarabina ali ciklofosfamida.
• short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells 
kratkotrajno povečanje količine nekaterih vrst protiteles v krvi (imenujemo jih imunoglobulini - IgM), snovi v krvi, ki nastajajo zaradi razgradnje odmirajočih rakavih celic, okvara živcev v rokah in nogah, paraliza obraza,
14 patients (37%) in the rituximab group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group. 
Z zdravljenjem povezane okužbe so se pojavile pri 14 bolnikih (37%) v skupini z zdravilom rituksimab in pri 15 bolnikih (42%) v skupini s standardnim odmerkom prednizona.
Cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome. 
Pri bolnikih, ki so prejemali rituksimab, so poročali o reaktivaciji virusa hepatitisa B, vključno s fulminantnim hepatitisom s smrtnim izidom.
• unusual feelings of the skin - such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch 
neobičajni občutki na koži - na primer omrtvičenost, mravljinčenje, zbadanje, pekoč občutek, občutek gomazenja na koži, slabše zaznavanje dotika,
Patients with non-Hodgkin's lymphoma should then be evaluated for evidence of tumour lysis syndrome including appropriate laboratory tests and, for pulmonary infiltration, with a chest X-ray. 
Pri bolnikih z ne-Hodgkinovim limfomom v takem primeru preverimo - vključno z laboratorijskimi testi - možnost pojava sindroma razpada tumorja in pljučno infiltracijo z rentgenskim pregledom prsnega koša.
The Physician information about Ritemvia should contain the following key elements: 
Gradivo za zdravnika o zdravilu Ritemvia mora vsebovati naslednje ključne vsebine:
It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. 
Veže se na površino vrste belih krvnih celic, limfocitov B. Ko se veže na površino teh celic,
Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma 
Koliko zdravila boste dobili in kako pogosto a) Če se zdravite zaradi ne-Hodgkinovega limfoma
The most frequent adverse reactions considered due to receipt of rituximab were IRRs. 
Najpogostejši neželeni učinki, za katere so menili, da so nastali zaradi prejetja rituksimaba, so bile reakcije, povezane z infuzijo.
Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab-arms compared to control arms. 
V kliničnih preskušanjih so o okužbah spodnjih dihal (vključno s pljučnico) v skupini z rituksimabom poročali s podobno incidenco kot v kontrolnih skupinah.
If the same severe adverse reactions occur for a second time, the decision to stop the treatment should be seriously considered on a case by case basis. 
Če ponovno pride do enakih neželenih reakcij, razmislimo o ukinitvi zdravljenja.
Maintenance and relapse infusions were administered no sooner than 16 weeks following the previous infusion. 
Vzdrževalne infuzije in infuzije zaradi recidiva so bile uporabljene nič prej kot 16 tednov po prejšnji infuziji.
Excipients: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections. 
Pomožne snovi: natrijev klorid, trinatrijev citrat dihidrat, polisorbat 80, voda za injekcije.
Patients randomised to the rituximab group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15. 
Ti bolniki so prejeli začetni odmerek 1.000 mg intravensko 1. dan študije in drugi odmerek 1.000 mg intravensko 15. dan študije.
FU: follow-up; NR: not reached at time of clinical cut off, TNCT: time to next chemotherapy treatment; TNLT: time to next anti lymphoma treatment. 
NR: ni doseženo ob času kliničnega zaključka zbiranja podatkov (not reached), TNCT: čas do naslednje kemoterapije; TNLT: čas do naslednjega zdravljenja limfoma; CR: popolni odgovor; CRu: nepotrjeni popolni odgovor.
Rituximab binding to CD20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis. 
Vezava rituksimaba na antigen CD20 na limfocitih B povzroči celično smrt v procesu apoptoze.
Overall survival (median) 
Celokupno preživetje (OS)
What Ritemvia is used for 
Za kaj uporabljamo zdravilo Ritemvia
R-CVP led to a significant benefit over CVP for the primary endpoint, time to treatment failure (27 months vs. 6.6 months, p < 0.0001, log-rank test). 
Skupina R-CVP je imela glede primarnega opazovanega dogodka (časa do neuspeha zdravljenja) značilno prednost pred skupino CVP (27 mesecev v primerjavi s 6,6 meseca, p < 0,0001, log-rang test).
• severe blistering skin conditions that can be life-threatening. 
huda stanja z mehurji na koži, ki so lahko življenjsko ogrožujoča.
Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumour lysis syndrome. 
Med drugimi simptomi so bili pordevanje, angioedem, bronhospazem, bruhanje, navzea, urtikarija/izpuščaj, utrujenost, glavobol, draženje žrela, rinitis, srbenje, bolečina, tahikardija, hipertenzija, hipotenzija, dispneja, dispepsija, astenija in značilnosti sindroma razpada tumorja.
This medicine contains 52.6 mg sodium (main component of cooking/table salt) in each 10 mL vial. 
To zdravilo vsebuje 52,6 mg natrija (glavne sestavine kuhinjske soli) na 10 mL viale.
Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present. 
Rdečina, pogosto povezana z mehurji, se lahko pojavi na koži ali na sluznici, kot je notranjost ustne votline, področje genitalij ali vek, prisotna je lahko tudi zvišana telesna temperatura,
Infections and infestations upper respiratory tract infection, urinary tract infections bronchitis, sinusitis, gastroenteritis, tinea pedis 
Infekcijske in parazitske bolezni okužba zgornjih dihal, okužbe sečil bronhitis, sinuzitis, gastroenteritis, tinea pedis
• fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell 
• zvišana telesna temperatura, kašelj, vneto grlo, pekoča bolečina pri uriniranju, občutek šibkosti ali splošno slabo počutje;
fungal infections, infections of unknown origin, sinus inflammation, hepatitis B 
okužbe neznanega vzroka, vnetje obnosnih votlin, hepatitis B,
Limited experience with doses higher than the approved dose of intravenous rituximab formulation is available from clinical trials in humans. 
Iz kliničnih preskušanj pri človeku je le malo izkušenj z odmerki, večjimi od odobrenega odmerka intravenske oblike rituksimaba.
Median TTF: years Not reached p < 0.001 
mediana TTF: 2,6 leta ni doseženo p < 0,001
Patients randomised to the rituximab group received an initial intravenous infusion of 1000 mg rituximab on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15. 
Bolniki, randomizirani v skupino z zdravilom rituksimab, so prejeli uvodno intravensko infuzijo 1.000 mg zdravila rituksimab 1. dan študije v kombinaciji z 0,5 mg/kg/dan peroralnega prednizona (z zmanjševanjem odmerka v obdobju 3 mesecev), če so imeli zmerno bolezen , ali v kombinaciji z 1 mg/kg/dan peroralnega prednizona (z zmanjševanjem odmerka v obdobju 6 mesecev), če so imeli hudo bolezen, ter drugo intravensko infuzijo 1.000 mg 15. dan študije.
Immune system disorders infusion related reactions4, angioedema hypersensitivit y anaphylaxi s tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-related acute reversible thrombocytope nia4 
Bolezni imunskega sistema z infuzijo povezane reakcije4, angioedem preobčutljivost anafilaksija sindrom lize tumorja, sindrom sproščanja citokinov4, serumska bolezen z infuzijo povezana akutna reverzibilna trombocitopenija4
cell return, with counts > 10 cells/μL by month 12, increasing to 87% of patients by month 18. 
Pri večini bolnikov (81 %) se je število celic B ponovno povečalo na > 10 celic/µl do 12. meseca, do 18. meseca pa še pri večjem, 87-% deležu bolnikov.
There were no differences reported for the incidence of anaemia. 
Incidenca anemije se ni razlikovala.
Experience from rheumatoid arthritis 
Izkušnje pri revmatoidnem artritisu
Physicians should exercise caution when considering the use of rituximab in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection, e.g. hypogammaglobulinaemia (see section 4.8). 
Pri odločanju za uporabo zdravila rituksimab je potrebna previdnost pri bolnikih z anamnezo ponavljajočih se ali kroničnih okužb ali s sočasnimi boleznimi, zaradi katerih so lahko bolniki dodatno nagnjeni k pojavu resnih okužb, npr. s hipogamaglobulinemijo (glejte poglavje 4.8).
Response rate and CR rates analysed using Chi-squared Test. NR: not reached; N/A: not applicable *: only applicable to patients achieving a CR, nPR, PR; **: only applicable to patients achieving a CR; 
NR: nedoseženo; n.a. neaplikabilno *: aplikabilno samo za bolnike, ki so dosegli CR, nPR (nodularni delni odgovor), PR; **: aplikabilno samo za bolnike, ki so dosegli CR
Very rare cases of fatal PML have been reported following the use of rituximab. 
Pri uporabi rituksimaba so poročali o zelo redkih smrtnih primerih PML.
• severe skin problems causing blisters that can be life-threatening. 
hude težave s kožo, ki povzročijo mehurje in so lahko smrtno nevarne.
In most cases, the infusion can be resumed at a 50% reduction in rate (e.g. from 100 mg/h to 50 mg/h) when symptoms have completely resolved. 
Ko se simptomi popolnoma izboljšajo, lahko pri večini primerov infuzijo nadaljujemo s polovično hitrostjo infundiranja (npr. s 100 mg/h na 50 mg/h).
The most common infections in the rituximab group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis. 
Najpogostejše okužbe v skupini z zdravilom rituksimab so bile okužbe z virusoma herpes simpleks in herpes zoster, bronhitis, okužbe sečil, glivične okužbe in konjunktivitis.
The recommended dosage of Ritemvia for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total). 
Priporočeno odmerjanje zdravila Ritemvia za indukcijo remisije pri zdravljenju granulomatoze s poliangiitisom in mikroskopskega poliangiitisa je 375 mg/m2 telesne površine v intravenski infuziji 1-krat na teden 4 tedne (skupaj štiri infuzije).
Biotec Services International Ltd. Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, UK And 
Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, Velika Britanija in
Elderly No dose adjustment is required in elderly patients (aged >65 years). 
Starejši Starejšim bolnikom (> 65 let) odmerka ni treba prilagoditi.
Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely. 
Zelo redko sta bila opisana toksična epidermalna nekroliza (Lyellov sindrom) ali Stevens-Johnsonov sindrom, v nekaterih primerih s smrtnim izidom.
Pemphigus vulgaris is an autoimmune condition that causes painful blisters on the skin and lining of the mouth, nose, throat and genitals. 
Navadni pemfigus je avtoimunska bolezen, ki povzroča boleče mehurje na koži ter sluznici ust, nosu, žrela in spolovil.
Also do not breast-feed for 12 months after your last treatment with Ritemvia. 
Prav tako ne smete dojiti še 12 mesecev po zadnjem odmerku zdravila Ritemvia.
 Infections, see section 4.4. 
• okužbe, glejte poglavje 4.4;
The pre-specified primary analysis was conducted at a median observation time of 25 months from randomisation, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progressionfree survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7). 
Ob mediani časa opazovanja 25 mesecev od randomizacije so izvedli vnaprej določeno primarno analizo; vzdrževalno zdravljenje z rituksimabom pri bolnikih s predhodno nezdravljenimi folikularnimi limfomi klinično pomembno in statistično značilno izboljšalo primarni opazovani dogodek - preživetje brez napredovanja bolezni (progression free survival - PFS), kot ga je določil raziskovalec - v primerjavi z opazovano skupino (preglednica 7).
A total of 321 patients (162 R-CVP, 159 CVP) received therapy and were analysed for efficacy. 
Skupno so zdravili in glede učinkovitosti analizirali 321 bolnikov (162 R-CVP,
38 months 
32.teden
• low mood and loss of interest or enjoyment in doing things, feeling nervous 
slabo razpoloženje in izguba zanimanja ali veselja za početje stvari, živčnost, motnje okušanja - na primer spremenjen okus stvari,
Rituximab is associated with infusion related reactions (IRRs), which may be related to release of cytokines and/or other chemical mediators. 
Reakcije, povezane z infuzijo Zdravilo rituksimab lahko spremljajo reakcije, povezane z infuzijo, ki morda nastanejo zaradi sprostitve citokinov in/ali drugih kemičnih mediatorjev.
Among the 3189 patients treated with rituximab, 1,135 (36%) experienced at least one IRR with 733/3,189 (23%) of patients experiencing an IRR following first infusion of the first exposure to rituximab. 
Med 3.189 bolniki, ki so prejeli rituksimab, 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 rituksimaba.
Re-treatment, weekly for 4 doses 
Ponovno zdravljenje, 4 odmerki, enkrat na teden
Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation. 
Bolniki s pozitivno serologijo na hepatitis B (HBsAg ali HBcAb) se morajo pred začetkom zdravljenja posvetovati s specialistom za jetrna obolenja.
Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1x109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1x109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with rituximab plus FC. 
V študijah pri bolnikih s KLL, ki še niso bili zdravljeni in pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, so ocenili, da je bila pri do 25% bolnikov zdravljenih z R-FC nevtropenija podaljšana (opredeljena kot število nevtrofilcev, ki med dnevoma 24 in 42 po zadnjem prejetem odmerku ostane pod 1x109/l) ali pa se je po zdravljenju z rituksimabom in FC pojavila kasneje (opredeljena kot število nevtrofilcev pod 1x109/l po 42. dnevu od zadnjega prejetega odmerka pri bolnikih, ki niso imeli podaljšane nevtropenije ali pa so si opomogli pred dnevom 42).
Most adverse events in the rituximab arm were mild or moderate in intensity. 
Večina neželenih učinkov v skupini z rituksimab je bila blagih ali zmernih.
An analysis of overall survival confirmed the significant benefit of rituximab maintenance over observation (p=0.0039 log-rank test). 
Analiza celokupnega preživetja je potrdila pomembno korist vzdrževalnega zdravljenja z rituksimabom v primerjavi z opazovano skupino (p = 0,0039, test log-rang).
If you are being treated for non-Hodgkin's Lymphoma 
a) Če se zdravite zaradi ne-Hodgkinovega limfoma
In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or rituximab in combination with FC (R-FC). 
V dveh odprtih, randomiziranih preskušanjih so skupno 817 bolnikov s KLL, ki prej niso bili zdravljeni, ter 552 bolnikov, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, randomizirali v skupino, ki je prejemala kemoterapijo FC (fludarabin 25 mg/m2, ciklofosfamid 250 mg/m2, 1. do 3. dan) vsake 4 tedne, 6 ciklov, ali rituksimab v kombinaciji s kemoterapijo FC (R-FC).
Urinary tract infection Bronchitis 
Infekcijske in parazitske bolezni bronhitis rinitis
Results from other supportive studies using rituximab in combination with other chemotherapy regimens (including CHOP, FCM, PC, PCM, bendamustine and cladribine) for the treatment of previously untreated and/or relapsed/refractory CLL patients have also demonstrated high overall response rates with benefit in terms of PFS rates, albeit with modestly higher toxicity (especially myelotoxicity). 
(vključno s CHOP, FCM, PC, PCM, bendamustinom in kladribinom) za zdravljenje bolnikov s KLL, ki predhodno še niso bili zdravljeni in/ali pri katerih se je bolezen ponovila oziroma se na prejšnje zdravljenje niso odzvali, so prav tako pokazali visok delež celokupnih odgovorov s koristjo v smislu preživetja brez napredovanja bolezni, vendar z rahlo večjo toksičnostjo (predvsem mielotoksičnostjo).
The safety profile of rituximab in patients with PV was consistent with that observed in RA and GPA/MPA patients. 
Varnostne značilnosti zdravila rituksimab pri bolnikih z navadnim pemfigusom so se skladale z varnostnimi značilnostmi, opaženimi pri bolnikih z revmatoidnim artritisom in GPA/MPA.
Package leaflet: Information for the patient Ritemvia 100 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring. 
Navodilo za uporabo Ritemvia 100 mg koncentrat za raztopino za infundiranje rituksimab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Initial treatment, weekly for 4 doses 
Začetno zdravljenje, 4 odmerki, enkrat na teden
In the induction of remission clinical trial, at 6 months, in the rituximab 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 rituksimaba zabeležili nizke IgA, IgG in IgM pri 27%, 58% in 51% (v tem zaporedju), med prejemniki ciklofosfamida pa pri 25%, 50% in 46%.
• infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, 
okužba krvi (sepsa), pljučnica, pasovec, prehlad, okužbe sapnic (bronhov), glivične okužbe,
Mean terminal elimination half-life ranged from 15 to 16 days for the 2 × 500 mg dose group and 17 to 21 days for the 2 × 1000 mg dose group. 
Povprečni končni razpolovni čas izločanja je bil 15 do 16 dni za 2 x 500 mg odmerek ter 17 do 21 dni za 2 x 1.000 mg odmerek.
Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24 System Organ Class 
Neželeni učinki iz klinične študije pri bolnikih z navadnim pemfigusom, zdravljenih z zdravilom Rituksimab do 24. meseca Organski sistem
This variability in V1 (27.1% and 19.0%) contributed by the range in BSA (1.53 to 2.32 m2) and concurrent CHOP therapy, respectively, were relatively small. 
Razlike v V1 glede na telesno površino (1,53 do 2,32 m2) so bile 27,1 %, glede na zdravljenje s CHOP pa 19,0 %, kar je relativno malo.
In the PV population, 5 (13%) patients in the rituximab group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the rituximab group and 33 (92%) of patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria. 
Glede na izrazitost bolezni, določeno po Harmanovih merilih, je imelo v populaciji z navadnim pemfigusom zmerno bolezen 5 (13%) bolnikov v skupini z zdravilom rituksimab in 3 (8%) bolnikov v skupini s standardnim prednizonom, hudo bolezen pa 33 (87%) bolnikov v skupini z zdravilom rituksimab in 33 (92%) bolnikov v skupini s standardnim prednizonom.
Package leaflet: Information for the patient Ritemvia 500 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring. 
Navodilo za uporabo Ritemvia 500 mg koncentrat za raztopino za infundiranje rituksimab Za to zdravilo se izvaja dodatno spremljanje varnosti.
The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with follicular lymphoma and chronic lymphocytic leukaemia. 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z rituksimabom za vse podskupine pediatrične populacije s folikularnim limfomom in kronično limfocitno levkemijo (podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The proportion of CTC Grade 3 events, and of IRRs leading to withdrawal decreased by course and were rare from course 3 onwards. 
3 po CTC ter reakcij, ki so vodile do prekinitve zdravljenja, se je zmanjševal z nadaljnjimi cikli; te reakcije so bile od 3. cikla naprej redke.
Ritemvia should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter. 
Zdravilo Ritemvia je treba dati v dveh 500-mg intravenskih infuzijah, med katerima mora biti 2tedenski presledek; temu sledijo 500-mg intravenske infuzije na 6 mesecev.
You will always be given Ritemvia as a drip (intravenous infusion). 
Zdravilo Ritemvia boste dobili v intravenski infuziji.
Response rate and CR rates analysed using Chi-squared Test. NR: not reached; N/A: not applicable *: only applicable to patients achieving a CR, nPR, PR **: only applicable to patients achieving a CR 
NR: nedoseženo; n.a. neaplikabilno * aplikabilno samo za bolnike, ki so dosegli CR, nPR (nodularni delni odgovor), PR ** aplikabilno samo za bolnike, ki so dosegli CR
The percentage of patients reporting ADRs upon re-treatment with further courses of rituximab was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs). 
Odstotek bolnikov, pri katerih so se po ponovnem zdravljenju z rituksimabom pojavili neželeni učinki, je bil podoben kakor po prvem zdravljenju (za neželene učinke katere koli stopnje in 3. ali 4. stopnje).
UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.> 
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
The Patient Alert Card for Ritemvia in non-oncology indications should contain the following key elements: 
Opozorilna kartica za bolnika z neonkološko indikacijo mora vsebovati naslednje ključne vsebine:
• Previously untreated follicular lymphoma 
• Predhodno nezdravljeni folikularni limfomi
The pharmacokinetics of rituximab were assessed following two IV doses of 500 mg and 1000 mg upon re-treatment in the second course. 
Farmakokinetiko rituksimaba so ocenili po dveh 500 mg in 1000 mg intravenskih odmerkih pri ponovnem zdravljenju v drugem ciklu.
The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy. 
Pri primerih PRES/RPLS, o katerih so poročali, so bili prisotni znani dejavniki tveganja za PRES/RPLS, vključno z bolnikovo osnovno boleznijo, hipertenzijo,