FrancophonIA/ELRC3.0 huggingface dataset:
English: The studies BO21223/GALLIUM and GAO4753g/GADOLIN enrolled patients with iNHL including FL.
Slovenian: V študijah BO21223/GALLIUM in GAO4753g/GADOLIN so bili vključeni bolniki z iNHL,
English: Based on the FACT-Lym questionnaire collected during treatment and follow-up phases, patients in both treatment arms experienced clinically meaningful improvements in lymphoma-related symptoms as defined by a ³ 3 point increase from baseline in the Lymphoma subscale, a ³ 6 point increase from baseline in the FACT Lym TOI and a ³ 7 point increase from baseline in the FACT Lym Total score.
Slovenian: Izidi po navedbi bolnika Na podlagi vprašalnika FACT-Lym, uporabljenega med zdravljenjem in obdobjem spremljanja, so se pri bolnikih iz obeh zdravljenih skupin simptomi, povezani z limfomom, klinično pomembno izboljšali, kot določa zvečanje za ≥ 3 točke od izhodišča na podlestvici za limfome, zvečanje za ≥ 6 točk od izhodiščne ocene FACT-Lym TOI in zvečanje za ≥ 7 točk od izhodiščne skupne ocene FACT-Lym.
English: The incidences presented in the following sections if referring to iNHL are the highest incidence of that ADR reported from either pivotal study (BO21223/GALLIUM, GAO4753g/GADOLIN).
Slovenian: V spodnjih poglavjih navedene incidence, ki se nanašajo na iNHL, so najvišje incidence neželenih učinkov, ki so jih poročali ali iz ene ali iz druge ključne študije (BO21223/GALLIUM, GAO4753g/GADOLIN).
English: In addition, there were no apparent effects of bendamustine, FC, chlorambucil or CHOP on the pharmacokinetics of Gazyvaro.
Slovenian: Dodatno ni bilo vidnih učinkov bendamustina, FC, klorambucila ali CHOP na farmakokinetiko zdravila Gazyvaro.
English: A type of liver disease called “hepatitis B” has also been reported to reoccur in patients who have had hepatitis B in the past.
Slovenian: Pri bolnikih, ki so imeli v preteklosti vrsto jetrne bolezni, imenovane hepatitis B, je bila opisana ponovitev hepatitisa B.
English: 1100 mg prednisone/prednisolone or 20 mg dexamethasone or 80 mg methylprednisolone.
Slovenian: 1 100 mg prednizona/prednizolona ali 20 mg deksametazona ali 80 mg metilprednizolona.
English: Efficacy results for patients with previously untreated CLL are summarised in Table 7.
Slovenian: Rezultati učinkovitosti za bolnike s še nezdravljeno KLL so povzeti v preglednici 7.
English: EQ-5D utility scores were similar at baseline, during treatment and follow-up.
Slovenian: Rezultati uporabnosti, merjeni z vprašalnikom za merjenje uporabnosti EQ-5D, so bili podobni v izhodišču, med zdravljenjem in obdobjem spremljanja.
English: In total, six cycles of Gazyvaro (every 28 days) were given in combination with six cycles of bendamustine, and a total of eight cycles of Gazyvaro (every 21 days) were given in combination with six cycles of CHOP or eight cycles of CVP.
Slovenian: Skupno so dali šest ciklov zdravila Gazyvaro (vsakih 28 dni) v kombinaciji s šestimi cikli bendamustina ali osem ciklov zdravila Gazyvaro (vsakih 21 dni) v kombinaciji s šestimi cikli CHOP ali osmimi cikli CVP.
English: For subgroups, reduction of the risk of disease progression or death ranged from 92% to 58% for GClb versus Clb and 72% to 29% for GClb versus RClb.
Slovenian: Po podskupinah je zmanjšanje tveganja za napredovanje bolezni ali za smrt segalo od 92 % do 58 % v skupini, ki je prejemala zdravilo Gazyvaro in klorambucil v primerjavi s klorambucilom samim in od 72 % do 29 % v skupini, ki je prejemala zdravilo Gazyvaro in klorambucil v primerjavi s skupino, ki je prejemala rituksimab in klorambucil.
English: The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered on Day 1 of each cycle.
Slovenian: Priporočeni odmerek zdravila Gazyvaro v kombinaciji s klorambucilom je 1000 mg, uporabljen 1. dan vsakega cikla.
English: Chlorambucil N=118
Slovenian: 2. faza klorambucil n = 118
English: Motor symptoms with corticospinal tract findings (e.g. muscular weakness, paralysis and sensory disturbances), sensory abnormalities, cerebellar symptoms, and visual field defects are common.
Slovenian: Pogosti so motorični simptomi s prizadetostjo kortikospinalnega trakta (npr. mišična šibkost, paraliza in senzorične motnje), senzorične nepravilnosti, cerebelarni simptomi in izpadi vidnega polja.
English: The most frequently reported coexisting medical conditions (using a cut off of 30% or higher), in the MedDRA body systems are: Vascular disorders (73%), Cardiac disorders (46%), Gastrointestinal disorders (38%), Metabolism and nutrition disorders (40%), Renal and urinary disorders (38%), Musculoskeletal and connective tissue disorders (33%).
Slovenian: Najpogosteje zabeležena sočasna bolezenska stanja (z uporabo meje 30 % ali več) po organskih sistemih MedDRA so bila: žilne bolezni (73 %), srčne bolezni (46 %), bolezni prebavil (38 %), presnovne in prehranske motnje (40 %), bolezni sečil (38 %), bolezni mišično-skeletnega sistema in vezivnega tkiva (33 %).
English: Median was not reached at time of analysis # not adjusted for multiplicity **Assessed as per modified Cheson 2007 criteria ‡ End of Induction = end of induction phase, does not include monotherapy maintenance
Slovenian: Neprilagojeno glede multiplicitete **Ocenjeno po modificiranem kriteriju Cheson 2007
English: In a 26-week cynomolgus monkey study, hypersensitivity reactions were noted and attributed to the foreign recognition of the humanised antibody in cynomolgus monkeys (0.7-6 times the clinical exposure based on Cmax and AUC at steady state after weekly administration of 5, 25, and 50 mg/kg).
Slovenian: V 26-tedenski študiji na opicah cynomolgus so zabeležili preobčutljivost, ki so jo pripisali prepoznavi humaniziranega protitelesa pri opicah cynomolgus kot tujka (0,7- do 6-kratna klinična izpostavljenost na podlagi Cmax in AUC v stanju dinamičnega ravnovesja po vsakotedenski uporabi 5, 25 in
English: Grade 3-4 IRRs occurred in 12% of patients.
Slovenian: Reakcije, povezane z infuzijo, 3. do 4. stopnje so se pojavile pri 12 % bolnikov.
English: · When Gazyvaro is given to patients with CLL or FL together with other medicines for cancer - this slows down the time it takes for their disease to get worse.
Slovenian: • Ko zdravilo Gazyvaro uporabljajo bolniki s kronično limfocitno levkemijo in folikularnim limfomom skupaj z drugimi zdravili za zdravljenje raka, to podaljša obdobje do poslabšanja bolezni.
English: What Gazyvaro looks like and contents of the pack
Slovenian: Izgled zdravila Gazyvaro in vsebina pakiranja
English: Management of IRRs (all indications)
Slovenian: Obvladovanje reakcij, povezanih z infuzijo (vse indikacije)
English: Data during follow up, especially for the chlorambucil alone arm, is limited.
Slovenian: Podatkov iz obdobja spremljanja je malo, še zlasti za skupino, ki je dobivala samo klorambucil.
English: Hypersensitivity may be difficult to clinically distinguish from IRRs.
Slovenian: Preobčutljivost je včasih težko klinično ločiti od reakcij, povezanih z infuzijo.
English: The rates of Grade 3-4 IRRs (which occurred in relatively few patients) were similar before and after mitigation measures were implemented.
Slovenian: Pogostnost reakcij, povezanih z infuzijo, 3. do 4. stopnje (ki se je pojavila pri relativno majhnem številu bolnikov) je bila podobna pred in po uvedbi ukrepov za blažitev.
English: In the pivotal BO21004/CLL11 study, 46% (156 out of 336) of patients with CLL treated with Gazyvaro plus chlorambucil were 75 years or older (median age was 74 years).
Slovenian: V ključni študiji BO21004/CLL11 je bilo 46 % (156 od 336) bolnikov s KLL, zdravljenih s kombinacijo zdravila Gazyvaro in klorambucila, starih 75 let ali več (mediana starosti je bila 74 let).
English: Cycle 1
Slovenian: 1. cikel
English: For CLL patients receiving the Day 1 (Cycle 1) dose split over two days, the Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour, but not increased further.
Slovenian: Za bolnike s KLL lahko odmerek 1. dne (1. cikla) razdelite na dva dni, hitrost infundiranja je mogoče 1. dan (1. cikla) po 1 uri spet povečati na 25 mg/uro, ne sme pa se je povečati bolj.
English: HBVscreening should be performed in all patients before initiation of treatment with Gazyvaro.
Slovenian: Pred začetkom zdravljenja z zdravilom Gazyvaro je treba pri vseh bolnikih opraviti presejalno testiranje za HBV.
English: Table 8 Summary of efficacy in patients with previously untreated FL from BO21223/ GALLIUM study
Slovenian: Povzetek o učinkovitosti pri bolnikih s predhodno nezdravljenim FL iz študije BO21223/študija GALLIUM
English: Patients with previously untreated follicular lymphoma
Slovenian: Bolniki s predhodno nezdravljenim folikularnim limfomom
English: Cycle 1: Day 1 for CLL and FL
Slovenian: 1. dan pri KLL in FL
English: The most common Grade 3-5 adverse reactions were neutropenia (10%), and anaemia, febrile neutropenia, thrombocytopenia, sepsis, upper respiratory tract infection, and urinary tract infection (all at 1%).
Slovenian: Najbolj pogosti neželeni učinki stopnje 3-5 so bili nevtropenija (10 %) in anemija, febrilna nevtropenija, trombocitopenija, sepsa, okužba zgornjih dihal in okužbe sečil (vsi 1 %).
English: In the pivotal studies (BO21223/GALLIUM, GAO4753g/GADOLIN) in iNHL, 5% (35 out of 698) and 8% (15 out of 194) of patients treated with Gazyvaro, respectively, had moderate renal impairment (CrCL < 50 mL/min).
Slovenian: V ključnih študijah (BO21223/GALLIUM, GAO4753g/GADOLIN) pri iNHL je imelo 5 % bolnikov (35 od 698) in 8 % bolnikov (15 od 194), zdravljenih z zdravilom Gazyvaro, zmerno ledvično okvaro (očistek kreatinina < 50 ml/min).
English: Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of Gazyvaro as outlined below.
Slovenian: Obvladovanje reakcij, povezanih z infuzijo, lahko zahteva začasno prekinitev infundiranja, zmanjšanje hitrosti infundiranja ali prenehanje zdravljenja z zdravilom Gazyvaro, kot je prikazano spodaj.
English: Glycoengineering of the Fc part of obinutuzumab results in higher affinity for FcɣRIII receptors on immune effector cells such as natural killer (NK) cells, macrophages and monocytes as compared to non-glycoengineered antibodies.
Slovenian: Glikoinženirska obdelava dela Fc obinutuzumabu v primerjavi s protitelesi, ki niso glikoinženirsko obdelana, poveča afiniteto za receptorje FcɣRIII na imunskih efektorskih celicah, kakršne so naravne celice ubijalke (natural killer cells - NK), makrofagi in monociti.
English: Day of treatment cycle
Slovenian: Dan cikla zdravljenja
English: Patients with a Grade 3 IRR with the previous infusion OR Patients with lymphocyte counts >25 x 109/L prior to next treatment
Slovenian: Bolniki, ki so imeli med prejšnjim infundiranjem reakcijo, povezano z infuzijo, 3. stopnje, ALI bolniki s številom limfocitov > 25 x 109/l pred naslednjim zdravljenjem
English: These trials investigated Gazyvaro in combination with chlorambucil for CLL and with bendamustine, CHOP or CVP followed by Gazyvaro maintenance therapy for iNHL.
Slovenian: V teh preskušanjih so proučevali zdravilo Gazyvaro v kombinacijah s klorambucilom pri KLL in bendamustinom, CHOP ali CVP, čemur je sledilo vzdrževalno zdravljenje z zdravilom Gazyvaro, pri iNHL.
English: The rates of Grade 3-4 IRRs (which were based on a relatively small number of patients) were similar before and after mitigation measures were implemented.
Slovenian: Deleži z infuzijo povezanih reakcij 3. do 4. stopnje (ki temeljijo na razmeroma majhnem številu bolnikov) so bili pred uvedbo ukrepov za ublažitev in po tem podobni.
English: These patients experienced more serious adverse events, adverse events leading to death and adverse events leading to treatment withdrawal than patients with a CrCl ≥ 50 mL/min (see section 4.2 and 5.2).
Slovenian: Ti bolniki so imeli več resnih neželenih dogodkov, neželenih dogodkov, ki so povzročili smrt, in neželenih dogodkov, ki so povzročili ukinitev zdravljenja, kot bolniki z očistkom kreatinina ≥ 50 ml/min (glejte poglavji 4.2 in 5.2).
English: Table 6 Summary of ADRs reported with a higher incidence (difference of ≥2% versus the comparator arm) in patients# receiving Gazyvaro + chemotherapy* System organ class
Slovenian: Povzetek neželenih učinkov, zabeleženih z večjo incidenco (razlika ≥ 2 % glede na primerjalno skupino)# med prejemniki zdravila Gazyvaro + kemoterapije*
English: Tell your doctor or nurse straight away if you get any signs of infection during and after your Gazyvaro treatment.
Slovenian: Zdravniku ali medicinski sestri morate takoj povedati, če med zdravljenjem z zdravilom Gazyvaro ali po njem dobite simptome okužbe.
English: The population pharmacokinetic analysis of obinutuzumab showed that age did not affect the pharmacokinetics of obinutuzumab.
Slovenian: Populacijska farmakokinetična analiza obinutuzumaba je pokazala, da starost ne vpliva na farmakokinetiko obinutuzumaba.
English: Gazyvaro should not be administered in the presence of an active infection and caution should be exercised when considering the use of Gazyvaro in patients with a history of recurring or chronic infections.
Slovenian: Zdravila Gazyvaro se ne sme uporabiti pri bolnikih z aktivno okužbo, pri bolnikih z anamnezo ponavljajočih se ali kroničnih okužb pa je pri razmisleku o uporabi zdravila Gazyvaro potrebna previdnost.
English: The majority of patients had follicular lymphoma (81%).
Slovenian: Večina bolnikov (81 %) je imela folikularni limfom.
English: For management of IRRs see section 4.2 Posology and method of administration.
Slovenian: Za obvladovanje reakcij, povezanih z infuzijo, glejte poglavje 4.2 Odmerjanje in način uporabe.
English: For instructions on dilution of Gazyvaro before administration, see section 6.6.
Slovenian: Za navodila glede redčenja zdravila Gazyvaro pred uporabo glejte poglavje 6.6.
English: Patients with a CrCl < 30 mL/min were excluded from the study (see section 5.1).
Slovenian: Bolniki z očistkom kreatinina < 30 ml/min so bili iz študije izključeni (glejte poglavje 5.1).
English: Gazyvaro + Bendamustine followed by Gazyvaro maintenance N=155
Slovenian: Zdravilo Gazyvaro + bendamustin, nato vzdrževalno zdravljenje z zdravilom Gazyvaro n = 155
English: All Grades Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL)
Slovenian: Vse stopnje zdravilo Gazyvaro + kemoterapija* (KLL, iNHL), sledi Gazyvaro za vzdrževalno zdravljenje (iNHL)
English: If you are not sure talk to your doctor or nurse before being given Gazyvaro.
Slovenian: Če ste negotovi, se pred prejemanjem zdravila Gazyvaro posvetujte z zdravnikom ali medicinsko sestro.
English: Patients with a CrCl < 40 mL/min were excluded from the studies (see section 5.1).
Slovenian: Bolniki z očistkom kreatinina < 40 ml/min so bili iz študij izključeni (glejte poglavje 5.1).
English: Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype.
Slovenian: Obinutuzumab je rekombinantno, humanizirano in glikoinženirsko obdelano monoklonsko protitelo proti CD20 tipa II izotipa IgG1.
English: In patients treated with Gazyvaro 8 out of 140 patients in the randomised phase and 2 out of 6 in the run in phase tested positive for ATA at 12 months of follow up.
Slovenian: zdravljenimi z zdravilom Gazyvaro, je bilo po 12 mesecih spremljanja na protiterapevtska protitelesa pozitivnih 8 od 140 bolnikov v randomizirani fazi in 2 od 6 v uvajalni fazi.
English: Patients in the G+B arm who did not have disease progression (i.e. patients with a complete response (CR), partial response (PR) or stable disease (SD)) at the end of induction continued receiving Gazyvaro maintenance once every two months for two years or until disease progression (whichever occurred first).
Slovenian: Bolniki v skupini G + B, ki jim bolezen na koncu indukcije ni napredovala (tj. bolniki s popolnim odgovorom (CR), delnim odgovorom (PR) ali stabilno boleznijo (SD)), so še naprej prejemali vzdrževalno zdravljenje z zdravilom Gazyvaro enkrat na dva meseca v obdobju dveh let ali do napredovanja bolezni (kar od tega se je zgodilo prej).
English: If the first bag is completed without modifications of the infusion rate or interruptions, the second bag may be administered on the same day (no dose delay necessary, no repetition of premedication), provided that appropriate time, conditions and medical supervision are available throughout the infusion.
Slovenian: Če med dajanjem prve vrečke ni bilo treba prilagoditi hitrosti infundiranja ali infundiranja prekiniti, je mogoče drugo vrečko uporabiti isti dan (odlog odmerka ni potreben, prav tako ni potrebna ponovitev premedikacije).
English: Offspring exposure on day 28 post-partum suggests that obinutuzumab can cross the blood-placenta barrier.
Slovenian: Izpostavljenost mladičev 28. dan po porodu kaže, da obinutuzumab prehaja skozi krvno-placentno pregrado.
English: Gazyvaro is a concentrate for solution for infusion and is a colourless to slightly brown liquid.
Slovenian: Zdravilo Gazyvaro je koncentrat za raztopino za infundiranje in je brezbarvna do rjavkasta tekočina.
English: Kaplan-Meier curves for progression-free survival (PFS) and Overall Survival (OS) are shown in Figures 1-4.
Slovenian: Kaplan-Meierjeve krivulje preživetja brez napredovanja bolezni in celokupnega preživetja prikazujejo slike od 1 do 4.
English: Primary Endpoint in FL population IRC-assessed PFS (PFS-IRC) Number (%) of patients with event Median time to event (months, 95% CI)
Slovenian: Primarni opazovani dogodek v populaciji s FL PFS po oceni IRC (PFS-IRC) Število (%) bolnikov z dogodkom Mediani čas do dogodka (meseci, 95-% IZ)
English: MRD positivef (%)
Slovenian: MRD-negativnie (%) MRD-pozitivni f
English: Chronic lymphocytic leukaemia (CLL, in combination with chlorambucil1)
Slovenian: Kronična limfocitna levkemija (KLL, v kombinaciji s klorambucilom1)
English: In case of exposure during pregnancy, depletion of B-cells may be expected in infants due to the pharmacological properties of the product.
Slovenian: Zaradi farmakoloških lastnosti zdravila je mogoče v primeru izpostavljenosti med nosečnostjo pričakovati zmanjšanje števila celic B pri dojenčkih.
English: Gazyvaro is used together with another medicine for cancer called chlorambucil.
Slovenian: Zdravilo Gazyvaro uporabljamo v kombinaciji z drugim zdravilom proti raku, imenovanim klorambucil.
English: Mitigation measures to reduce IRRs should be followed (see section 4.2).
Slovenian: Za zmanjšanje reakcij, povezanih z infuzijo, je treba upoštevati ukrepe za ublažitev (glejte poglavje 4.2).
English: For instructions on dilution of Gazyvaro before administration, see below.
Slovenian: Za navodila glede redčenja zdravila Gazyvaro pred uporabo glejte spodnjo preglednico.
English: These patients experienced more serious adverse events and adverse events leading to death than patients with a CrCl ≥ 50 mL/min (see section 4.2, 4.4 and 5.2).
Slovenian: Ti bolniki so imeli več resnih neželenih učinkov in neželenih učinkov, ki so povzročili smrt, kot bolniki z očistkom kreatinina ≥ 50 ml/min (glejte poglavja 4.2, 4.4 in 5.2).
English: Most frequently reported (≥ 5%) symptoms associated with an IRR were nausea, vomiting, diarrhoea, headache, dizziness, fatigue, chills, pyrexia, hypotension, flushing, hypertension, tachycardia, dyspnoea, and chest discomfort.
Slovenian: Simptomi, povezani z infuzijsko reakcijo, o katerih so poročali najpogosteje (≥ 5 %), so bili navzea, bruhanje, diareja, glavobol, omotica, utrujenost, mrzlica, zvišana telesna temperatura, hipotenzija, zardevanje, hipertenzija, tahikardija, dispneja in nelagodnje v prsnem košu.
English: Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen (study GAO4753g/GADOLIN).
Slovenian: Bolniki s folikularnim limfomom, ki se niso odzvali na zdravljenje, ali jim je bolezen napredovala med ali v 6 mesecih po zdravljenju z rituksimabom ali shemami z rituksimabom (študija GAO4753g/GADOLIN)
English: Follicular lymphoma (FL)
Slovenian: • Folikularnega limfoma (FL)
English: In a phase III, open label, multicentre, randomised clinical study (GAO4753g/GADOLIN), 396 patients with iNHL who had no response during treatment or who progressed within 6 months following the last dose of rituximab or a rituximab-containing regimen (including rituximab monotherapy as part of induction or maintenance treatment) were evaluated.
Slovenian: V odprti, multicentrični, randomizirani klinični študiji faze III (GAO4753g/GADOLIN) so ocenili 396 bolnikov z iNHL, ki se niso odzvali na zdravljenje ali jim je bolezen napredovala v 6 mesecih po zadnjem odmerku rituksimaba oz. sheme z rituksimabom (vključno z monoterapijo z rituksimabom v okviru indukcijskega ali vzdrževalnega zdravljenja).
English: The primary analysis based on independent Review Committee (IRC) assessment demonstrated a statistically significant - 45% reduction in the risk of disease progression or death, in patients with iNHL receiving G+B followed by Gazyvaro maintenance, compared with patients receiving bendamustine alone.
Slovenian: Pokazala je statistično značilno 45-odstotno zmanjšanje tveganja za napredovanje bolezni ali smrt pri bolnikih z iNHL, ki so prejemali G + B in nato vzdrževalno zdravljenje z zdravilom Gazyvaro, v primerjavi z bolniki, ki so prejemali samo bendamustin.
English: Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRs in patients with CLL and FL (see section 4.4)
Slovenian: Premedikacija, ki jo je treba dati pred infundiranjem zdravila Gazyvaro za zmanjšanje tveganja reakcij, povezanih z infuzijo, pri bolnikih s KLL in FL (glejte poglavje 4.4)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use after dilution Do not shake the vial
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo Za intravensko uporabo po razredčenju
English: Co-administration with Gazyvaro had no effect on the pharmacokinetics of bendamustine, FC, chlorambucil or the individual components of CHOP.
Slovenian: Sočasno dajanje zdravila Gazyvaro ni imelo vpliva na farmakokinetiko bendamustina, FC, klorambucila ali posameznih učinkovin v CHOP.
English: Chronic lymphocytic leukaemia (in combination with chlorambucil1)
Slovenian: Kronična limfocitna levkemija (v kombinaciji s klorambucilom1)
English: Table 2 Dose of Gazyvaro to be administered during 6 treatment cycles each of 28 days duration for patients with CLL
Slovenian: Odmerek zdravila Gazyvaro, ki ga je treba dati v 6 ciklih zdravljenja, od katerih vsak traja 28 dni, pri bolnikih s KLL
English: It is given into a vein as a drip (intravenous infusion) over several hours.
Slovenian: Zdravilo boste dobili v veno z intravensko infuzijo, ki traja več ur.
English: Postponing vaccination with live vaccines should be considered for infants born to mothers who have been exposed to Gazyvaro during pregnancy until the infant's B-cell levels are within normal ranges (see section 4.4).
Slovenian: Pri dojenčkih mater, ki so bile med nosečnostjo izpostavljene zdravilu Gazyvaro, je treba razmisliti o odložitvi cepljenja z živimi virusnimi cepivi, dokler se število celic B pri dojenčku ne vrne na normalne vrednosti (glejte poglavje 4.4).
English: Obinutuzumab, as a glycoengineered antibody, is characterised by enhanced ADCC and ADCP compared to non-glycoengineered antibodies at an equivalent dose.
Slovenian: Za obinituzumab, ki je glikoinženirsko protitelo, je pri ekvivaletnem odmerku značilna močnejša ADCC in ADCP kot pri protitelesih, ki niso glikoinženirsko obdelana.
English: The incidence of thrombocytopenia was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm (16% vs. 7%) especially during the first cycle.
Slovenian: Incidenca trombocitopenije je bila s kombinacijo zdravila Gazyvaro in klorambucila večja kot s kombinacijo rituksimaba in klorambucila (16 % v primerjavi s 7 %), še zlasti v prvem ciklu.