FrancophonIA/ELRC3.0 huggingface dataset:
English: During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with rituximab and observation.
Slovenian: Med vzdrževalnim zdravljenjem je bila incidenca srčnih bolezni 3. ali 4. stopnje med bolniki, zdravljenimi z rituksimabom, in opazovano skupino primerljiva.
English: In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Slovenian: V kliničnem preskušanju indukcije remisije je bil delež pojavljanja srčnih dogodkov na primarni končni točki po 6 mesecih približno 273 na 100 bolnik-let (95-% interval zaupanja, 149-470).
English: If you have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
Slovenian: Če imate granulomatozo s poliangiitisom, mikroskopski poliangiitis ali navadni pemfigus, zdravniku povejte tudi:
English: Body system Adverse Event
Slovenian: Telesni sistem Neželeni učinek
English: Hazard ratio (95% CI)
Slovenian: Razmerje ogroženosti (95% CI)
English: • reduced platelets number just after the infusion - this can be reversed, but can be fatal in rare cases
Slovenian: zmanjšanje števila belih krvnih celic, ki se ne pojavi takoj, zmanjšanje števila trombocitov tik po infundiranju zdravila - to je mogoče odpraviti, a v redkih primerih je lahko smrtno,
English: serious viral infection2 pneumocystis jirovecii
Slovenian: resna virusna okužba2, pnevmocisto za (Pneumocys tis jirovecii)
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) PFS: preživetje brez napredovanja bolezni (Progression-Free Survival) TTF: čas do neuspeha zdravljenja (Time to Treatment Failure) Deleži OS (celokupnega preživetja - Overall survival): deleži preživetja ob času analiz ORR: celokupni odgovor (Overall Response Rate)
English: The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p=0.0001).
Slovenian: Končna analiza je potrdila, da je bilo zdravljenje z R-CHOP povezano s klinično pomembnim in statistično značilnim podaljšanjem trajanja preživetja brez dogodkov (primarni parameter učinkovitosti; dogodki so bili smrt, ponovitev bolezni ali napredovanje limfoma, ali uvedba novega protilimfomskega zdravljenja) (p=0,0001).
English: • low number of red blood cells (anaemia), low number of all blood cells
Slovenian: majhno število rdečih krvnih celic (anemija), majhno število vseh krvnih celic, alergijske reakcije (preobčutljivost),
English: Aseptically withdraw the necessary amount of Ritemvia, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Slovenian: Aseptično odvzamemo potrebno količino rituksimaba in jo razredčimo, da dobimo izračunano koncentracijo od 1 do 4 mg/ml rituksimaba v infuzijski vrečki, ki vsebuje sterilno apirogeno 0,9-%
English: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).
Slovenian: Med zdravljenjem z zdravilom rituksimab se lahko pojavijo resne okužbe, vključno s smrtnimi (glejte poglavje 4.8).
English: The recommended dosage is 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP.
Slovenian: Priporočeni odmerek 375 mg/m2 telesne površine damo prvi dan vsakega cikla kemoterapije po intravenski infuziji glukokortikoidne sestavine CHOP.
English: Exacerbations of pre-existing cardiac conditions such as angina pectoris or congestive heart failure or severe cardiac disorders (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
Slovenian: Poslabšanje obstoječih bolezenskih stanj srca, kot je angina pektoris ali kongestivno srčno popuščanje, ali hude srčne bolezni (srčno popuščanje, miokardni infarkt, atrijska fibrilacija), pljučni edem, odpoved več organov, sindrom razpada tumorja, sindrom sproščanja citokinov, ledvična odpoved in odpoved dihal, so se pri bolnikih pojavili z nižjo ali neznano pogostnostjo.
English: In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p < 0.0001, log-rank test).
Slovenian: V študiji pri bolnikih v prvi liniji zdravljenja po mediani opazovanja 48,1 meseca je bila mediana preživetja brez napredovanja bolezni 55 mesecev v skupini R-FC in 33 mesecev v skupini FC (p < 0,0001, test log rank).
English: Rituximab was administered on the first day of the treatment cycle.
Slovenian: Zdravilo rituksimab so prejeli prvi dan cikla zdravljenja.
English: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to rituximab therapy.
Slovenian: Zdravniki morajo pred zdravljenjem z zdravilom rituksimab pregledati status cepljenja bolnikov in upoštevati veljavne smernice za cepljenje.
English: Non-Hodgkin's lymphoma (NHL)
Slovenian: Ne-Hodgkinov limfom (NHL)
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time)
Slovenian: Indukcijsko zdravljenje: pregled rezultatov učinkovitosti CHOP v primerjavi z R-CHOP (mediana časa opazovanja 31 mesecev)
English: Ritemvia is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Slovenian: Zdravilo Ritemvia je indicirano za zdravljenje predhodno nezdravljenih bolnikov s III. in IV. stadijem folikularnih limfomov v kombinaciji s kemoterapijo.
English: Table 1 ADRs reported in clinical trials or during post-marketing surveillance in patients with NHL and CLL disease treated with rituximab monotherapy/maintenance or in combination with chemotherapy
Slovenian: Neželeni učinki, opaženi med kliničnimi preskušanji ali med nadzorom v obdobju trženja pri bolnikih z NHL in KLL, ki so se zdravili z rituksimabom kot samostojnim/vzdrževalnim zdravljenjem ali v kombinaciji s kemoterapijo
English: The majority of these subjects were also exposed to cytotoxic chemotherapy.
Slovenian: Večina teh bolnikov je hkrati prejemala tudi citotoksično kemoterapijo.
English: Infusion-related adverse reactions of all kinds have been observed in 77% of patients treated with rituximab (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10% of patients) see section 4.8.
Slovenian: Z infuzijo povezane neželene reakcije vseh vrst so opazili pri 77% bolnikov, ki so se zdravili z rituksimabom (vključno s sindromom sproščanja citokinov, ki sta ga spremljala hipotenzija in bronhospazem pri 10% bolnikov), glejte poglavje 4.8.
English: Rituximab maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p< 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Slovenian: Vzdrževalno zdravljenje z rituksimabom je pomembno podaljšalo mediano PFS pri bolnikih, odzivnih na indukcijsko zdravljenje s CHOP (mediana PFS 37,5 meseca v primerjavi z 11,6 meseca, p < 0,0001), kot tudi pri bolnikih, odzivnih na indukcijsko zdravljenje z R-CHOP (mediana PFS 51,9 meseca v primerjavi z 22,1 meseca, p=0,0071).
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group．
Slovenian: Razlika med terapevtskima skupinama glede celokupnega preživetja je pokazala značilno klinično razliko (p = 0,029, log-rang test s stratifikacijo po centru): po 53 mesecih je bil delež preživetja v skupini z R-CVP 80,9 % in v skupini s CVP 71,1 %.
English: Hazard Ratio (95% CI)
Slovenian: Razmerje ogroženosti (95-% CI)
English: Induction of remission
Slovenian: Indukcija remisije
English: Should non-live vaccinations be required whilst receiving rituximab therapy, these should be completed at least 4 weeks prior to commencing the next course of rituximab.
Slovenian: Če je potrebno cepljenje z mrtvimi cepivi med zdravljenjem z zdravilom rituksimab, mora biti zaključeno najmanj 4 tedne pred začetkom naslednjega cikla zdravila rituksimab.
English: Overall, 4% of patients in the rituximab arm experienced adverse events leading to discontinuation.
Slovenian: V celoti so 4% bolnikov v skupini z zdravilom rituksimab imeli takšne neželene učinke, ki so povzročili prenehanje uporabe zdravila.
English: The cumulative incidence rate curves showed that time to first major relapse was longer in patients with rituximab starting from month 2 and was maintained up to month 28 (Figure 3).
Slovenian: Krivulje kumulativnih stopenj incidence so pokazale, da je bil čas do prvega hujšega recidiva pri bolnikih, ki so prejemali zdravilo rituksimab, daljši, in sicer od 2. meseca naprej; to se je ohranilo do
English: Vascular disorders hypertension, orthostatic hypotension, hypotension vasculitis (predominate ly cutaneous), leukocytoclas tic vasculitis
Slovenian: Žilne bolezni hipertenzija, ortostatska hipotenzija, hipotenzija vaskulitis (pretežno kožni), levkocitoklastični vaskulitis
English: Although rituximab is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
Slovenian: Čeprav zdravilo rituksimab pri samostojnem zdravljenju ne deluje mielosupresivno, je potrebna previdnost pri bolnikih, ki imajo število nevtrofilcev < 1,5 x 109/l in/ali trombocitov < 75 x 109/l.
English: Patients were excluded from the study in relapsed/refractory CLL if they had previously been treated with monoclonal antibodies or if they were refractory (defined as failure to achieve a partial remission for at least 6 months) to fludarabine or any nucleoside analogue.
Slovenian: Iz študije pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, so bili izključeni tisti, ki so bili predhodno zdravljeni z monoklonskimi protitelesi ali ki se niso odzvali na zdravljenje (ki niso dosegli delne remisije za vsaj 6 mesecev) s fludarabinom ali katerim drugim nukleozidnim analogom.
English: Excipients: This medicinal product contains 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Slovenian: Pomožne snovi: To zdravilo vsebuje 11,5 mmol (ali 263,2 mg) natrija na 50-ml vialo.
English: In the majority of these cases, rituximab was administered with chemotherapy.
Slovenian: V večini teh primerov so rituksimab uporabili skupaj s kemoterapijo.
English: Late neutropenia
Slovenian: Pozna nevtropenija
English: The prepared Ritemvia solution should be administered as an intravenous infusion through a dedicated line.
Slovenian: Pripravljeno raztopino zdravila Ritemvia dajemo kot intravensko infuzijo skozi poseben kanal.
English: 3 see also section haematologic adverse reactions below
Slovenian: 3 Glejte tudi poglavje hematološki neželeni učinki spodaj.
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: Incidenca neželenih dogodkov krvi in limfatičnega sistema 3. ali 4. stopnje je bila pri bolnikih s KLL, 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: Maintenance infusions of rituximab 500 mg were administered at months 12 and 18.
Slovenian: Vzdrževalni infuziji 500 mg zdravila rituksimab sta bili uporabljeni 12. in 18. mesec.
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is < 1% of patients by the eighth cycle of rituximab-containing treatment.
Slovenian: Incidenca simptomov in znakov, povezanih z infuzijo, se je z nadaljnjimi infuzijami precej zmanjšala in je bila do osmega cikla zdravljenja z rituksimabom < 1%.
English: Following two intravenous infusions of rituximab at a dose of 1000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 L (range, 1.7 to 7.51 L).
Slovenian: Po dveh intravenskih infuzijah rituksimaba v odmerku 1.000 mg v razmiku dveh tednov je bil povprečni končni razpolovni čas 20,8 dni (razpon 8,58 do 35,9 dni), povprečni sistemski očistek je bil 0,23 l/dan (razpon 0,091 do 0,67 l/dan), povprečen volumen distribucije v stanju dinamičnega ravnovesja pa 4,6 l (razpon 1,7 do 7,51 l).
English: The PK parameters of rituximab in these patients appear similar to what has been observed in rheumatoid arthritis patients.
Slovenian: Farmakokinetični parametri rituksimaba so bili pri teh bolnikih podobni kot pri bolnikih z revmatoidnim artritisom.
English: In case of such an event with a suspected relationship to rituximab, treatment should be permanently discontinued.
Slovenian: Če se pojavi tak neželen učinek z možno povezavo z zdravilom rituksimab, je treba zdravljenje trajno ukiniti.
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs. 0% FC.
Slovenian: Pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, je bila incidenca okužbe s hepatitisom B stopnje 3 ali 4 (reaktivacija in primarna okužba) 2% pri R-FC v primerjavi z 0% pri FC (fludarabin in ciklofosfamid).
English: • high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “lactate dehydrogenase (LDH)” in the blood, low calcium levels in the blood
Slovenian: velika koncentracija krvnega sladkorja, hujšanje, oteklost obraza in telesa, visoka raven encima LDH v krvi, majhna koncentracija kalcija v krvi,
English: Patients received 2 × 1000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Slovenian: Bolniki so prejeli 2 x 1000 mg rituksimaba v razmiku 2 tednov in metotreksat (10 do 25 mg/teden).
English: The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/ m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
Slovenian: Povprečna Cmax (n=15) je bila 408 µg/ml (od 97 do 764 µg/ml) po peti infuziji 500 mg/m2, povprečni končni razpolovni čas pa je bil 32 dni (od 14 do 62 dni).
English: Bulky disease
Slovenian: Obsežna bolezen
English: Figure 4: Number of patients who were off or minimal corticosteroid (≤ 10mg/day) therapy over time
Slovenian: Slika 4: Število bolnikov brez kortikosteroidnega zdravljenja ali z minimalnim kortikosteroidnim zdravljenjem (≤ 10mg/dan) glede na čas zdravljenja
English: Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle and any subsequent cycles if the lymphocyte count is still > 25 x 109/L.
Slovenian: Že za prvo infuzijo pri teh bolnikih razmislimo o zmanjšanju pretoka ali delitvi odmerka na dva dneva v prvem ciklu in, če je število limfocitov še vedno večje od 25 x 109/l, tudi v vseh nadaljnjih ciklih.
English: The incidence of IRR decreased with subsequent courses (see section 4.8).
Slovenian: Incidenca reakcij, povezanih z infuzijo, se je z nadaljnjimi cikli zdravljenja zmanjšala (glejte poglavje 4.8).
English: Severe skin reactions such as Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported (see section 4.8).
Slovenian: Poročali so o hudih kožnih reakcijah, kot sta toksična epidermalna nekroliza (Lyellov sindrom) in Stevens-Johnsonov sindrom; nekatere so se končale s smrtnim izidom (glejte poglavje 4.8).
English: Patients with a high tumour burden or with a high number (≥25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution.
Slovenian: Bolnike z veliko tumorsko maso ali velikim številom (≥ 25 x 109/l) krožečih malignih celic, kot so bolniki s KLL, pri katerih obstaja večje tveganje izjemno hudega sindroma sproščanja citokinov, zdravimo le izjemno pazljivo.
English: Patients with a high tumour burden or with a high number (≥ 25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution.
Slovenian: Bolnike z veliko tumorsko maso ali velikim številom (≥ 25 x 109/l) krožečih malignih celic, kot so bolniki s KLL, pri katerih obstaja večje tveganje izjemno hudega sindroma sproščanja citokinov, zdravimo izjemno pazljivo.
English: Figure 1: Change from baseline of DAS28-ESR by baseline autoantibody status
Slovenian: Sprememba v DAS28-ESR od izhodišča glede na izhodiščno stanje protiteles.
English: Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Slovenian: Prozorne viale iz stekla tipa I z gumijastim zamaškom, ki vsebujejo 500 mg rituksimaba v 50 ml.
English: Table 18 Percentage of PV patients who achieved complete remission off corticosteroid therapy for two months or more at month 24 (Intent-to-Treat Population - PV)
Slovenian: Odstotek bolnikov z navadnim pemfigusom, ki so po 24 mesecih dosegli popolno remisijo brez kortikosteroidnega zdravljenja v obdobju dveh mesecev ali več (populacija z-namenom-zdravljenja - navadni pemfigus)
English: Seropositive (n=506)
Slovenian: Seropozitivni (n = 506)
English: This is equivalent to 13.2% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: 13,2% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Figure 4: Number of patients who were off or on minimal corticosteroid (≤10 mg/day) therapy over time
Slovenian: Slika 4: Število bolnikov brez kortikosteroidnega zdravljenja ali z minimalnim kortikosteroidnim zdravljenjem (≤ 10 mg/dan) glede na čas zdravljenja
English: Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied rituximab doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Slovenian: Iz populacijske farmakokinetične analize pri 298 bolnikih z ne-Hodgkinovim limfomom, ki so prejeli enkratno ali večkratno infuzijo rituksimaba (odmerki od 100 do 500 mg/m2) samostojno ali v kombinaciji s CHOP, lahko ocenimo nespecifični očistek tipične populacije bolnikov (Cl1): 0,14 l/dan, specifični očistek (Cl2), h kateremu je verjetno pripomoglo breme celic B ali tumorsko breme:
English: The safety profile of rituximab in patients with moderate to severe rheumatoid arthritis (RA) is summarised in the sections below.
Slovenian: Varnostni profil rituksimaba pri bolnikih z zelo aktivnim revmatoidnim artritisom je povzet v spodnjem besedilu.
English: Radiographic analysis at 2 years in Trial 1 demonstrated significantly reduced progression of structural joint damage in patients receiving rituximab in combination with methotrexate compared to methotrexate alone as well as a significantly higher proportion of patients with no progression of joint damage over the 2 year period.
Slovenian: 1 je po 2 letih pokazala značilno manjše napredovanje strukturnih okvar sklepov pri bolnikih, ki so prejemali rituksimab v kombinaciji z metotreksatom, kot pri tistih, ki so prejemali samo metotreksat; prav tako je pokazala značilno večji delež bolnikov brez napredovanja okvar sklepov v 2-letnem obdobju.
English: This medicinal product contains 263.2 mg sodium per 50 mL vial, equivalent to 13.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.For the full list of excipients, see section 6.1.
Slovenian: To zdravilo vsebuje 263,2 mg natrija na 50 mL viale, kar je enako 13,2% največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: 42-months p = 0.029
Slovenian: 42 mesecev p = 0,029
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and very rare (< 1/10,000).
Slovenian: Pogostnost je opredeljena kot zelo pogosta (≥ 1/10), pogosta (≥ 1/100 do < 1/10), občasna (> 1/1000 do ≤ 1/100) in zelo redka (≤ 1/10000).
English: The majority of patients had received rituximab in combination with chemotherapy or as part of a haematopoietic stem cell transplant.
Slovenian: Večina bolnikov je prejemala rituksimab v kombinaciji s kemoterapijo ali v okviru presaditve krvotvornih matičnih celic.
English: The incidence, types and severity of IRRs were consistent with that observed historically.
Slovenian: Incidenca, vrsta in resnost neželenih reakcij, povezanih z infuzijo, je bila podobna, kot opažena v preteklosti.
English: Cardiovascular adverse reactions
Slovenian: Kardiovaskularni neželeni učinki
English: Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Slovenian: Prozorne viale iz stekla tipa I z gumijastim zamaškom, ki vsebujejo 100 mg rituksimaba v 10 ml.
English: R‐CHOP
Slovenian: R-CHOP NR
English: And
Slovenian: O
English: You may be asked not to take these other medicines 12 hours before you are given Ritemvia.
Slovenian: Morda vam bo naročil, da ne jemljite teh drugih zdravil 12
English: 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 (see section 4.8).
Slovenian: Pri odločanju za uporabo zdravila rituksimab morajo biti zdravniki previdni pri bolnikih z anamnezo ponavljajočih se ali kroničnih okužb ali s sočasnimi boleznimi, zaradi katerih so lahko bolniki dodatno nagnjeni k resnim okužbam (glejte poglavje 4.8).
English: In a prospective, open label, international, multicentre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or rituximab plus CHOP (R-CHOP, n=234).
Slovenian: V prospektivnem, odprtem, mednarodnem, multicentričnem preskušanju faze III je bilo 465 bolnikov, pri katerih so se folikularni limfomi ponovili ali se niso odzvali na zdravljenje, randomiziranih v prvi del indukcijskega zdravljenja s CHOP (ciklofosfamid, doksorubicin, vinkristin, prednizolon, n=231) ali zdravljenje z rituksimabom in CHOP (R-CHOP, n=234).
English: Subsequent infusions may be administered no sooner than 16 weeks following the previous infusion.
Slovenian: Nadaljnje infuzije se lahko dajo po preteku najmanj 16 tednov po prejšnji infuziji.
English: The Patient information about Ritemvia should contain the following key elements:
Slovenian: Gradivo za bolnika o zdravilu Ritemvia mora vsebovati naslednje ključne vsebine: