FrancophonIA/ELRC3.0 huggingface dataset:
English: Orion Pharma Puh/Tel: + 358 10 4261
Slovenian: Suomi/Finland Orion Pharma Puh/Tel: + 358 10 4261
English: Blitzima is a biosimilar medicinal product.
Slovenian: Zdravilo Blitzima je podobno biološko zdravilo.
English: When Blitzima is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Slovenian: Če zdravilo Blitzima uporabimo v kombinaciji s kemoterapijo, je treba uporabiti standardno zmanjšanje odmerkov citostatikov.
English: NAPP Pharmaceuticals Ltd. Tel: +44 1223 424444
Slovenian: United Kingdom NAPP Pharmaceuticals Ltd. Tel: +44 1223 424444
English: There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6% vs. 15.4%).
Slovenian: Bolniki z obsežno boleznijo so imeli višjo incidenco neželenih učinkov 3. ali 4. stopnje kot bolniki brez obsežne bolezni (25,6 % v primerjavi s 15,4 %).
English: This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphataemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
Slovenian: Ta sindrom ima lahko nekatere značilnosti sindroma razpada tumorja, npr. hiperurikemijo, hiperkaliemijo, hipokalciemijo, hiperfosfatemijo, akutno ledvično odpoved, zvišano laktat-dehidrogenazo (LDH), ter ga lahko spremlja akutna odpoved dihal in smrt.
English: In these patients the rate of clinically relevant infection while on rituximab was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
Slovenian: Delež klinično pomembnih okužb pri teh bolnikih je bil 6,01 na 100 bolnik-let, ko so se zdravili z rituksimabom, v primerjavi s 4,97 na 100 bolnik-let po tem, ko so prejeli nadaljnje zdravljenje z biološkim DMARD.
English: The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
Slovenian: Farmakokinetični profil rituksimaba, dajanega v 6 infuzijah po 375 mg/m v kombinaciji s šestimi cikli kemoterapije CHOP, je bil podoben kot pri dajanju samega rituksimaba.
English: In patients where the treatment is working, Blitzima may be continued for 2 years after completing the initial treatment.
Slovenian: Pri bolnikih, pri katerih takšno zdravljenje deluje, je mogoče z uporabo zdravila Blitzima nadaljevati še dve leti po dokončanju začetnega zdravljenja.
English: Following induction of remission with Blitzima, maintenance treatment should be initiated no sooner than 16 weeks after the last Blitzima infusion.
Slovenian: Po indukciji remisije z zdravilom Blitzima se vzdrževalnega zdravljenja ne sme začeti prej kot 16 tednov po zadnji infuziji zdravila Blitzima.
English: Safety and efficacy of Blitzima have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Slovenian: Varnosti in učinkovitosti zdravila Blitzima v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
English: If you are having Blitzima with other medicines, some of the side effects you may get may be due to the other medicines.
Slovenian: Če prejemate zdravilo Blitzima skupaj z drugimi zdravili, se nekateri neželeni učinki lahko pojavijo zaradi drugih zdravil.
English: Date of most recent infusion:
Slovenian: Datum zadnjega podaljšanja:
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, hipertenzijo, imunosupresivnim zdravljenjem in/ali kemoterapijo.
English: Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Slovenian: Zdravila rituksimab se ne sme dajati bolnikom z aktivno, hudo okužbo (npr. tuberkulozo, sepso ali oportunističnimi okužbami, glejte poglavje 4.3).
English: Further, significantly higher proportion of patients achieved MCIDs for these scores (Table 14).
Slovenian: Poleg tega je značilno večji delež bolnikov dosegel MCID za ti oceni (preglednica 14).
English: 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).
Slovenian: Rezultati iz drugih podpornih študij z uporabo rituksimaba v kombinaciji z drugimi kemoterapijami (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).
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Blitzima (the last dose of methylprednisolone may be given on the same day as the first infusion of Blitzima).
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom (Wegenerjevo granulomatozo) ali mikroskopskim poliangiitisom je pred prvo infuzijo zdravila Blitzima priporočljiva intravenska uporaba metilprednizolona, ki se ga daje od 1 do 3 dni v odmerku 1000 mg na dan (zadnji odmerek metilprednizolona je lahko uporabljen na dan prve infuzije zdravila Blitzima).
English: What Blitzima is and what it is used for What you need to know before you use Blitzima How to use Blitzima
Slovenian: Kaj je zdravilo Blitzima in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Blitzima Kako uporabljati zdravilo Blitzima Možni neželeni učinki
English: ACR70 EULAR Response (Good/Moderate)
Slovenian: ACR20 ACR50 ACR70 Odziv po EULAR (dober/zmeren) Povprečna sprememba v DAS
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov 97 bolnikov z granulomatozo s poliangiitisom in z mikroskopskim poliangiitisom, ki so štiri tedne prejemali 375 mg/m rituksimaba enkrat na teden, je ocenjeni mediani končni razpolovni čas izločanja 23 dni (razpon: od 9 do 49 dni).
English: What Blitzima looks like and contents of the pack
Slovenian: Izgled zdravila Blitzima in vsebina pakiranja
English: Contraindications for use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Slovenian: Kontraindikacije za uporabo pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji Preobčutljivost na učinkovino ali mišje beljakovine ali na katero koli drugo pomožno snov, navedeno v poglavju 6.1.
English: • Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any
Slovenian: • informacije o znakih in simptomih okužb, še posebno PML, in informacije o nujnosti, da nemudoma obvestijo svojega zdravnika, če izkusijo katerega od znakov ali simptomov,
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of rituximab treated patients and 0.27% (2/731) of placebo-treated patients developed severe neutropenia.
Slovenian: V kliničnih preskušanjih, nadzorovanih s placebom, je pri 0,94% (13/1382) bolnikov, zdravljenih z rituksimabom in pri 0,27% (2/731) bolnikov, ki so prejemali placebo, prišlo do razvoja hude nevtropenije.
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 povečalo delež bolnikov, ki so dosegli najmanj 20% izboljšanje glede na ACR oceno v primerjavi z bolniki, ki so se zdravili samo z metotreksatom (preglednica 12).
English: Rituximab is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Slovenian: Zdravilo rituksimab lahko spremljajo reakcije, povezane z infuzijo, ki morda nastanejo zaradi sprostitve citokinov in/ali drugih kemičnih mediatorjev.
English: 40% of patients with bone marrow involvement responded compared to 59% of patients with no bone marrow involvement (p=0.0186).
Slovenian: Na zdravljenje se je odzvalo 40% bolnikov z infiltracijo kostnega mozga v primerjavi z 59% bolnikov brez infiltracije kostnega mozga (p=0,0186).
English: • The need to check, prior to Blitzima treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Slovenian: • informacije o nujnosti, da pred dajanjem zdravila Blitzima preverijo, ali je bolnik morda okužen, imunsko oslabljen, ali jemlje zdravila, ki vplivajo na imunski sistem, ali jih je jemal v preteklosti, ali se je nedavno cepili oziroma to namerava,
English: Following induction of remission with other standard of care immunosuppressants, Blitzima maintenance treatment should be initiated during the 4 week period that follows disease remission.
Slovenian: Po indukciji remisije z drugimi imunosupresivi, ki spadajo v okvir običajnega zdravljenja, je treba vzdrževalno zdravljenje z zdravilom Blitzima začeti v 4-tedenskem obdobju po remisiji bolezni.
English: Blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Slovenian: Vzdrževalno zdravljenje z zdravilom Blitzima je indicirano za zdravljenje bolnikov s folikularnimi limfomi, ki se odzovejo na indukcijsko zdravljenje.
English: In the clinical trial on induction of remission, which included 99 rituximab-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197-285) at the 6month primary endpoint.
Slovenian: V kliničnem preskušanju indukcije remisije, v katerega so prejeli vključili 99 bolnikov, zdravljenih rituksimab, je bil celotni delež okužb na primarni končni točki po 6 mesecih približno 237 na 100 bolniklet (95-% interval zaupanja, 197-285).
English: • The need to monitor patients for infections, especially PML, during and after Blitzima treatment
Slovenian: • informacije o nujnosti, da bolnike spremljajo zaradi nastanka mogočih okužb, posebno progresivne multifokalne levkoencefalopatije (PML), med zdravljenjem z zdravilom Blitzima in po njem,
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 follicular lymphoma and chronic lymphocytic leukaemia.
Slovenian: 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
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 28. meseca (slika 3).
English: Subsequent doses of Blitzima can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Slovenian: Nadaljnje odmerke zdravila Blitzima lahko dajemo z začetno hitrostjo 100 mg/h, ki jo lahko vsakih 30 minut povečujemo po 100 mg/h, dokler ne dosežemo največje hitrosti infundiranja 400 mg/h.
English: % SF‐36 PHS MCID Mean change in SF‐36 MHS
Slovenian: Povprečna sprememba SF-36 PHS % bolnikov z MCID v SF-36 PHS Povprečna sprememba SF-36 MHS % bolnikov z MCID v SF-36 MHS
English: This is equivalent to 13.2% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 13,2% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Blitzima is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Slovenian: Zdravilo Blitzima je indicirano za zdravljenje bolnikov s CD20-pozitivnim difuznim velikoceličnim B ne-Hodgkinovim limfomom v kombinaciji s kemoterapijo CHOP (ciklofosfamid, doksirubicin, vinkristin, prednizolon).
English: Similarly, in all studies a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12).
Slovenian: Podobno je v vseh študijah dober do zmeren odziv po klasifikaciji Evropske lige za boj proti revmatizmu (EULAR, European League Against Rheumatism) doseglo pomembno več bolnikov, ki so se zdravili z rituksimabom in metotreksatom, kakor bolnikov, ki so se zdravili samo z metotreksatom (preglednica 12).
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Blitzima infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom (Wegenerjevo granulomatozo), mikroskopskim poliangiitisom v remisiji ali navadnim pemfigusom je treba 30 minut pred pričetkom infundiranja zdravila Blitzima zaključiti z intravenskim dajanjem 100 mg metilprednizolona za zmanjšanje incidence in resnosti reakcij, povezanih z infuzijo.
English: Infusion-related reactions2 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility.
Slovenian: Dogodke so kot neželene učinke ocenili šele po natančni oceni in v primerih, v katerih je bila vzročna povezanost med zdravilom in neželenim učinkom vsaj smiselna možnost.
English: 99 patients were treated for induction of remission of GPA and MPA in a clinical trial with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Slovenian: Devetindevetdeset bolnikov so za indukcijo remisije GPA in MPA zdravili z rituksimabom (375 mg/m enkrat na teden 4 tedne) in z glukokortikoidi (glejte poglavje 5.1).
English: • Feeling generally unwell or listless.
Slovenian: • splošno slabo počutje ali brezvoljnost.
English: Blitzima should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Slovenian: Zdravilo Blitzima je treba dajati prvi dan vsakega cikla kemoterapije po uporabi glukokortikoidne sestavine kemoterapije, če jo shema vsebuje.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
Slovenian: Sprejeta je utemeljitev, da Braillova pisava ni potrebna
English: • If you are having Blitzima with chemotherapy Blitzima will be given to you on the same day as your chemotherapy.
Slovenian: Če prejemate zdravilo Blitzima skupaj s kemoterapijo, ga boste dobili isti dan kot kemoterapijo.
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: hematotoksičnost, nevtropenična okužba, okužba sečil, senzorična motnja, pireksija.
English: Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL
Slovenian: Okužbe (predvsem bakterijske in virusne) so v kliničnih preskušanjih opazili pri 30-55% bolnikov z neHodgkinovim limfomom in pri 30-50% bolnikov s KLL.
English: Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Slovenian: Rituksimab je pri 70 do 80% bolnikov povzročil zmanjšanje števila celic B, z zmanjšanjem koncentracije imunoglobulinov v serumu pa je bilo povezano le malo primerov.
English: In the rituximab group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
Slovenian: V skupini, ki je prejemala rituksimab, je 48% bolnikov doseglo popolno remisijo po 12 mesecih in 39% bolnikov po 18 mesecih.
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Slovenian: Po 8 ciklih zdravljenja je bil popolni odgovor v skupini R-CHOP 76,2%, v skupini CHOP pa 62,4% (p=0,0028).
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult
Slovenian: To je enako 2,6% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
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: Number of responders (response rate [%]) a p-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Slovenian: Število odzivnih (delež odziva [%]) Vrednost p je vrednost iz Fisherjevega eksaktnega testa s sredinskim popravkom p.
English: Elderly No dose adjustment is required in elderly patients (aged > 65 years).
Slovenian: Starejši Starejšim bolnikom (> 65 let) odmerka ni treba prilagoditi.
English: Mundipharma CVA Tél/Tel: + 32 15 45 1180
Slovenian: Luxembourg/Luxemburg Mundipharma CVA Tél/Tel: + 32 15 45 1180
English: The proportion of CTC Grade 3 events, and of IRRs leading to withdrawal decreased by course and were rare from course 3 onwards.
Slovenian: Delež reakcij stopnje 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.
English: Blitzima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Slovenian: Zdravilo Blitzima je indicirano za zdravljenje predhodno nezdravljenih bolnikov s III. in IV. stadijem folikularnih limfomov v kombinaciji s kemoterapijo.
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: Cardiac disorders angina pectoris, atrial fibrillation, heart failure, myocardial infarction atrial flutter
Slovenian: Srčne bolezni angina pektoris, atrijska fibrilacija, srčno popuščanje, miokardni infarkt atrijska undulacija
English: Patients treated with Blitzima must be given the patient alert card with each infusion.
Slovenian: Bolniki, ki prejemajo zdravilo Blitzima, morajo ob vsaki infuziji dobiti opozorilno kartico.
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/m telesne površine damo prvi dan vsakega cikla kemoterapije po intravenski infuziji glukokortikoidne sestavine CHOP.
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to < 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/m rituksimaba (po enem na teden) in je na tej ravni ostalo do 6 mesecev.
English: A total of 321 patients (162 R-CVP, 159 CVP) received therapy and were analysed for efficacy.
Slovenian: Skupno so zdravili in glede učinkovitosti analizirali 321 bolnikov (162 RCVP, 159 CVP).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA NA VIALI
English: +left ventricular failure, +supraventricular tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia severe cardiac disorders4 and 6
Slovenian: +popuščanje levega prekata, +supraventriku larna tahikardija, +ventrikularna tahikardija, +angina pektoris, +ishemija miokarda, bradikardija hude srčne bolezni4 in 6
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 10
English: The Patient information about Blitzima should contain the following key elements:
Slovenian: Gradivo za bolnika o zdravilu Blitzima mora vsebovati naslednje ključne vsebine:
English: Experience from non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Summary of safety profile
Slovenian: Izkušnje pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji Povzetek varnostnega profila
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/m 2, povprečni končni razpolovni čas pa je bil 32 dni (od 14 do 62 dni).
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po redčenju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: Talk to your doctor, pharmacist or nurse before you are given Blitzima if:
Slovenian: Opozorila in previdnostni ukrepi Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Blitzima: