FrancophonIA/ELRC3.0 huggingface dataset:
English: Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain magnetic resonance imaging (MRI), and lumbar puncture (cerebrospinal fluid testing for John Cunningham viral DNA).
Slovenian: Ovrednotenje PML vključuje (a ni omejeno na) posvet z nevrologom, magnetnoresonančno slikanje možganov in lumbalno punkcijo (testiranje cerebrospinalnega likvorja na DNK virusa John Cunningham).
English: These patients experienced more serious adverse events and adverse events leading to death than those patients < 75 years of age.
Slovenian: Ti bolniki so imeli več resnih neželenih učinkov in neželenih učinkov, ki so povzročili smrt, kot bolniki, mlajši od 75 let.
English: Cycle 1:
Slovenian: 1. cikel:
English: In the pivotal studies in iNHL up to 1% of patients experienced gastrointestinal perforation.
Slovenian: V ključnih študijah pri iNHL je imelo gastro-intestinalne perforacije do 1 % bolnikov.
English: If you had recurring or chronic infections before the start of Gazyvaro treatment, tell your doctor about it.
Slovenian: Če ste pred začetkom zdravljenja z zdravilom Gazyvaro imeli ponavljajoče se ali kronične okužbe, o tem obvestite zdravnika.
English: Tumour lysis syndrome is a potentially life-threatening complication, caused by chemical changes in the blood due to the breakdown of dying cancer cells (see section 3).
Slovenian: Sindrom razpada tumorja je lahko življenje ogrožajoč zaplet, ki ga povzročijo kemijske spremembe v krvi zaradi razgradnje odmirajočih rakavih celic (glejte poglavje 3).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Gazyvaro in all subsets of the paediatric population in CLLand FL (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Gazyvaro za vse podskupine pediatrične populacije pri kronični limfocitni levkemiji in folikularnem limfomu (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The combination of obinutuzumab with chlorambucil, bendamustine, CHOP or CVP may increase the risk of neutropenia (see section 4.4).
Slovenian: Kombinacija obinutuzumaba s klorambucilom, bendamustinom, CHOP ali CVP lahko poveča tveganje za nevtropenijo (glejte poglavje 4.4).
English: The planned treatment interval for Gazyvaro should be maintained between doses.
Slovenian: Med odmerki je treba ohranjati načrtovani terapevtski interval za zdravilo Gazyvaro.
English: Do not use other diluents such as glucose (5%) solution (see section 6.2).
Slovenian: Ne uporabljajte drugih raztopin za redčenje, npr. 5-% raztopine glukoze (glejte poglavje 6.2).
English: NR (25.4,-)
Slovenian: ND (25,4; -)
English: Patients who have pre-existing cardiac or pulmonary conditions should be monitored carefully throughout the infusion and the post-infusion period.
Slovenian: Bolnike z obstoječo boleznijo srca ali pljuč je treba skrbno nadzorovati ves čas infundiranja in v obdobju po njem.
English: What Gazyvaro is and what it is used for What you need to know before you are given Gazyvaro How Gazyvaro is given
Slovenian: Kaj je zdravilo Gazyvaro in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Gazyvaro Kako se daje zdravilo Gazyvaro
English: During maintenance, maintain the original dosing schedule for subsequent doses.
Slovenian: Med vzdrževanjem za nadaljnje odmerke ohranite originalni razpored odmerjanja.
English: Patients in the CLL pivotal study BO21004/CLL11 were tested at multiple time-points for anti-therapeutic antibodies (ATA) to Gazyvaro.
Slovenian: Bolnike s KLL v ključni študiji BO21004/CLL11 so na več časovnih točkah testirali glede protiterapevtskih protiteles (anti-therapeutic antibodies - ATA) proti zdravilu Gazyvaro.
English: · Tell your doctor or nurse straight away if you have memory loss, trouble speaking, difficulty walking or problems with your eyesight.
Slovenian: • Zdravniku ali medicinski sestri morate takoj povedati, če se vam poslabša spomin, pojavijo težave z govorom, težave s hojo ali težave z vidom.
English: Difference in MRD rates, (95% CI) Event free survival
Slovenian: Razlika v deležih MRD (95-% IZ) Preživetje brez dogodka
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000) in zelo redki (< 1/10.000).
English: Instructions on the rate of infusion are shown in Tables 4-5.
Slovenian: Navodila glede hitrosti infundiranja so prikazana v preglednicah 4-5.
English: Premedication for subsequent infusions and other premedication should be administered as described below.
Slovenian: Premedikacijo med nadaljnjimi infundiranji in drugo premedikacijo je treba uporabiti, kot je opisano spodaj.
English: · Tell your doctor or nurse straight away if you get any of the infusion related reactions listed at the start of section 4.
Slovenian: • Zdravniku ali medicinski sestri morate takoj povedati, če se vam pojavi kakšna reakcija, povezana z infuzijo, navedena na začetku 4. poglavja.
English: Elderly No dose adjustment is required in elderly patients (see section 5.2).
Slovenian: Starejši Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: The safety and efficacy of Gazyvaro in patients with impaired hepatic function has not been established.
Slovenian: Varnost in učinkovitost zdravila Gazyvaro pri bolnikih z okvarjenim delovanjem jeter nista ugotovljeni.
English: Patients should be closely monitored for thrombocytopenia, especially during the first cycle; regular laboratory tests should be performed until the event resolves, and dose delays should be considered in case of severe or life-threatening thrombocytopenia.
Slovenian: Bolnike je treba natančno spremljati glede trombocitopenije, zlasti v prvem ciklu; izvajati je treba redne laboratorijske preiskave krvne slike, dokler dogodek ne mine, pri hudi ali življenje ogrožajoči trombocitopeniji pa je treba razmisliti o preložitvi odmerka na kasnejši čas.
English: Patients with one or more individual organ/system impairment score of 4 as assessed by the CIRS definition, excluding eyes, ears, nose, throat and larynx organ system, were excluded.
Slovenian: Prav tako so bili izključeni bolniki, ki so imeli oceno okvare enega ali več posameznih organov/organskih sistemov stopnje 4 po definiciji CIRS (izključujoč organske sisteme oči, ušesa, nos, žrelo in grlo).
English: In the QLQC30 and QLQ-CLL-16 questionnaires conducted during the treatment period, no substantial difference in any of the subscales was observed.
Slovenian: Ocena z vprašalnikoma QLQC30 in QLQ-CLL-16, opravljena med zdravljenjem, ni na nobeni podlestvici pokazala bistvenih razlik.
English: Obinutuzumab is not a substrate, inhibitor, or inducer of cytochrome P450 (CYP450), uridine diphosphate glucuronyltransferase (UGT) enzymes and transporters such as P-glycoprotein.
Slovenian: Obinutuzumab ni substrat, zaviralec ali induktor citokroma P450 (CYP450), encimov uridindifosfatglukuroniltransferaze (UGT) ali prenašalcev, kakršen je P-glikoprotein.
English: In addition, in vivo, obinutuzumab mediates a low degree of complement dependent cytotoxicity (CDC).
Slovenian: Poleg tega obinutuzumab in vivo posreduje nizko stopnjo od komplementa odvisne citotoksičnosti (complement dependent cytotoxicity - CDC).
English: Consideration should be given to the need for regular monitoring of blood cell count and for increased risk of infections while patients are B-cell depleted.
Slovenian: Razmisliti je treba o rednih kontrolah števila krvnih celic in tveganja za okužbe med obdobjem, ko je število celic B zmanjšano.
English: These events may occur as part of an IRR and can be fatal.
Slovenian: Ti dogodki se lahko pojavijo kot del reakcij, povezanih z infuzijo, in so lahko smrtni.
English: For these reasons, comparison of incidence of antibodies to Gazyvaro with the incidence of antibodies to other products may be misleading.
Slovenian: Zato je lahko primerjava incidence protiteles proti zdravilu Gazyvaro z incidenco protiteles proti drugim zdravilom zavajajoča.
English: Required amount of Gazyvaro concentrate
Slovenian: Potrebna količina koncentrata zdravila Gazyvaro
English: Gazyvaro is for intravenous use.
Slovenian: Zdravilo Gazyvaro je namenjeno za intravensko uporabo.
English: The median estimated CrCl was 62 mL/min and 66% of all patients had a CrCl < 70 mL/min.
Slovenian: Mediana ocenjenega očistka kreatinina je bila 62 ml/min in 66 % vseh bolnikov je imelo očistek kreatinina < 70 ml/min.
English: · Six 28-day cycles in combination with bendamustine2 or
Slovenian: • šest 28-dnevnih ciklov v kombinaciji z bendamustinom2 ali
English: Administer at 25 mg/hr over 4 hours.
Slovenian: Začnite s hitrostjo 25 mg/uro v 4 urah.
English: If there are any modifications of the infusion rate or interruptions during the first 100 mg the second bag must be administered the following day.
Slovenian: Če je med dajanjem prvih 100 mg treba spremeniti hitrost infundiranja ali infundiranje prekiniti, je treba drugo vrečko dati naslednji dan.
English: The PFS results in the post hoc analysis are consistent with the primary analysis and its significance is unchanged and the safety profile is consistent with the primary analysis.
Slovenian: Rezultati preživetja brez napredovanja bolezni v analizi post hoc so skladni s primarno analizo; pomen preživetja brez napredovanja bolezni je nespremenjen in varnostni profil skladen s primarno analizo.
English: · Tell your doctor or nurse straight away if you get any signs of infection after your Gazyvaro treatment (see "Infections" in section 4).
Slovenian: • Zdravniku ali medicinski sestri takoj povejte, če se po zdravljenju z zdravilom Gazyvaro pri vas pojavijo kakršni koli znaki okužbe (glejte poglavje 4 “Okužbe”).
English: · This induction phase will be followed by a “maintenance phase” - during this time you will be given Gazyvaro every 2 months for up to 2 years as long as your disease does not progress.
Slovenian: • Temu indukcijskemu zdravljenju bo sledilo vzdrževalno zdravljenje - med tem časom boste v naslednjih dveh letih dobili zdravilo Gazyvaro vsaka 2 meseca, dokler vaša bolezen ne bo napredovala.
English: Some signs/symptoms regarded as “cortical” (e.g. aphasia or visual-spatial disorientation) may occur.
Slovenian: Pojavijo se lahko nekateri znaki ali simptomi, ki veljajo za "kortikalne" (npr. afazija ali vizualno-prostorska dezorientiranost).
English: The incidence of prolonged neutropenia and late onset neutropenia was 3% and 7%, respectively.
Slovenian: Incidenca podaljšane nevtropenije je bila 3 % in zakasnjene nevtropenije 7 %.
English: Day 2 (or Day 1 continued)
Slovenian: 2. dan (ali 1. dan - nadaljevanje)
English: There have been no studies performed with other routes of administration.
Slovenian: Raziskav o drugih načinih uporabe niso izvedli.
English: With a median observation time of 24.1 months for FL patients, 48 patients (28.1%) in the B arm and 30 patients (18.3%) in the G+B arm had died.
Slovenian: Mediani čas opazovanja za bolnike s folikularnim limfomom je bil 24,1 meseca; 48 bolnikov (28,1 %) iz skupine, ki je prejemala bendamustin, in 30 bolnikov (18,3 %) iz skupine, ki je prejemala G + B, je umrlo.
English: Obinutuzumab is a Type II humanised anti-CD20 monoclonal antibody of the IgG1 subclass derived by humanisation of the parental B-Ly1 mouse antibody and produced in the Chinese Hamster Ovary cell line by recombinant DNA technology.
Slovenian: Obinutuzumab je humanizirano anti-CD20 monoklonsko protitelo tipa II podrazreda IgG1, pridobljeno s humanizacijo parentalnega mišjega protitelesa B-Ly1 in proizvedeno v celični liniji jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
English: Patients who received G-CSF prophylaxis had a lower rate of Grade 3-5 infections (see section 4.4).
Slovenian: Bolniki, ki so prejeli profilakso G-CSF, so imeli manjši delež okužb 3. do 5. stopnje (glejte poglavje 4.4).
English: If a planned dose of Gazyvaro is missed, it should be administered as soon as possible; do not omit it or wait until the next planned dose.
Slovenian: V primeru izpustitve načrtovanega odmerka zdravila Gazyvaro je treba odmerek uporabiti čim prej; ne izpustite ga in ne čakajte do naslednjega načrtovanega odmerka.
English: The safety of immunisation with live or attenuated viral vaccines following Gazyvaro therapy has not been studied and vaccination with live virus vaccines is not recommended during treatment and until B-cell recovery.
Slovenian: Varnost imunizacije z živimi ali oslabljenimi virusnimi cepivi po zdravljenju z zdravilom Gazyvaro ni raziskana in cepljenje z živimi virusnimi cepivi med zdravljenjem in do okrevanja celic B ni priporočljivo.
English: Compared to Type I antibodies, obinutuzumab, a Type II antibody, is characterised by an enhanced direct cell death induction with a concomitant reduction in CDC at an equivalent dose.
Slovenian: V primerjavi s protitelesi tipa I je za obinutuzumab, ki je protitelo tipa II, značilna močnejša neposredna indukcija celične smrti s sočasnim zmanjšanjem CDC pri ekvivalentnem odmerku.
English: In patients receiving Gazyvaro plus chemotherapy, the incidence of IRRs was highest on Day 1 and gradually decreased with subsequent infusions.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Gazyvaro in kemoterapijo, je bila incidenca reakcij, povezanih z infuzijo, največja 1. dan in se je z nadaljnjimi infundiranji postopoma zmanjševala.
English: The incidence of IRRs with subsequent infusions was 3% with the second 1,000 mg dose and 1% thereafter.
Slovenian: Incidenca reakcij, povezanih z infuzijo, je bila med nadaljnjimi infundiranji z drugim 1000-mg odmerkom 3-%, pozneje pa 1-%.
English: An updated RMP should be submitted: · At the request of the European Medicines Agency; · Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: · Before each infusion of Gazyvaro, you will be given medicines which help to reduce possible infusion related reactions or “tumour lysis syndrome”.
Slovenian: • Pred vsakim infundiranjem zdravila Gazyvaro boste dobili zdravila, ki pomagajo zmanjšati možne reakcije, povezane z infuzijo, ali “sindrom razpada tumorja”.
English: · If you do have an infusion related reaction following the small part of your first dose, you will be given the rest of your first dose on Day 2.
Slovenian: • Če se vam po infundiranju majhne količine prvega odmerka pojavi reakcija, povezana z infuzijo, boste preostanek prvega odmerka dobili 2. dan.
English: 11.6% of the patients had marginal zone lymphoma (MZL) and 7.1% had small lymphocytic lymphoma (SLL).
Slovenian: (marginal zone lymphoma - MZL) in 7,1 % jih je imelo limfom malih limfocitov (small lymphocytic lymphoma - SLL).
English: The following side effects have been reported with this medicine:
Slovenian: S tem zdravilom so bili opisani naslednji neželeni učinki:
English: Oral analgesic/anti-pyretic2
Slovenian: Peroralni analgetik/antipiretik2
English: Table 7 Summary of efficacy from BO21004/CLL11 study Stage 1a
Slovenian: Povzetek o učinkovitosti iz študije BO21004/CLL11 Faza 1a
English: · Use an effective method of contraception while being treated with Gazyvaro.
Slovenian: • Med zdravljenjem z zdravilom Gazyvaro uporabljajte učinkovit način kontracepcije.
English: · Grade 3 (severe): Infusion must be temporarily stopped and symptoms treated.
Slovenian: • 3. stopnja (hude): Infundiranje je treba začasno ustaviti in zdraviti simptome.
English: · changes in blood tests: anaemia (low levels of red blood cells) low levels of all types of white blood cell (combined) low levels of neutrophils (a type of white blood cell) low level of platelets (a type of blood cell that helps your blood to clot)
Slovenian: anemija (majhno število rdečih krvnih celic) majhno število vseh vrst belih krvnih celic (skupaj) majhno število nevtrofilcev (vrste belih krvnih celic) majhno število trombocitov (vrste krvnih celic, ki pomagajo pri strjevanju krvi)
English: The subgroups evaluated included IPI, FLIPI, Bulky Disease, B Symptoms at baseline, Ann Arbor Stage and ECOG at baseline.
Slovenian: Ocenjene podskupine so vključevale IPI, FLIPI, obsežno bolezen, izhodiščne B simptome, stadij Ann Arbor in izhodiščni status zmogljivosti po ECOG.
English: · Grade 4 (life threatening): Infusion must be stopped and therapy must be permanently discontinued.
Slovenian: • 4. stopnja (življenje ogrožajoče): Infundiranje je treba ustaviti in zdravljenje trajno končati.
English: Animal studies have shown secretion of obinutuzumab in breast milk (see section 5.3).
Slovenian: Študije na živalih so pokazale, da se obinutuzumab izloča v materino mleko (glejte poglavje 5.3).
English: An enhanced pre and postnatal development (ePPND) toxicity study in pregnant cynomolgus monkeys showed no evidence of teratogenic effects.
Slovenian: Razširjena študija toksičnosti za pred- in poporodni razvoj (enhanced pre and postnatal developmentePPND) pri brejih opicah cynomolgus ni pokazala teratogenih učinkov.
English: Duration of treatment Six treatment cycles, each of 28 day duration.
Slovenian: Trajanje zdravljenja Šest ciklov zdravljenja, od katerih vsak traja 28 dni.
English: Gazyvaro was administered prior to chemotherapy.
Slovenian: Zdravilo Gazyvaro so aplicirali pred kemoterapijo.
English: R-Chemo: Rituximab plus chemotherapy, G-Chemo: Gazyvaro plus chemotherapy, HR: hazard ratio, CI: confidence interval
Slovenian: r-kemo: rituksimab plus kemoterapija, G-kemo: Gazyvaro plus kemoterapija, RO: razmerje ogroženosti, IZ: interval zaupanja
English: The most frequently observed adverse drug reactions (ADRs) in patients receiving Gazyvaro were IRRs, which occurred predominantly during infusion of the first 1,000 mg. IRRs may be related to cytokine release syndrome which has also been reported in Gazyvaro treated patients.
Slovenian: Najpogosteje opaženi neželeni učinki pri bolnikih, ki so prejemali zdravilo Gazyvaro, so bile reakcije, povezane z infuzijo, ki so se pretežno pojavile med infundiranjem prvih 1000 mg. Reakcije, povezane z infuzijo, so lahko povezane s sindromom sproščanja citokinov, o katerem so prav tako poročali pri bolnikih, zdravljenih z zdravilom Gazyvaro.
English: 22.8 months median observation time g
Slovenian: 22,8 meseca g
English: In study GAO4753g/GADOLIN, patients in the bendamustine arm received 6 months of induction treatment only, whereas after the induction period, patients in the Gazyvaro plus bendamustine arm continued with Gazyvaro maintenance treatment.
Slovenian: V študiji GAO4753g/GADOLIN so bolniki v skupini z bendamustinom prejeli samo 6-mesečno indukcijsko zdravljenje, medtem ko so po indukcijskem obdobju bolniki v skupini, zdravljeni z zdravilom Gazyvaro in bendamustinom, nadaljevali z zdravljenjem z zdravilom Gazyvaro.
English: It should be given as an intravenous infusion through a dedicated line after dilution.
Slovenian: Po razredčenju ga je treba dati kot intravensko infuzijo po namenski liniji.
English: Gazyvaro can be used in adults to treat two different types of cancer
Slovenian: Zdravilo Gazyvaro uporabljamo za zdravljenje dveh vrst raka pri odraslih:
English: Efficacy results for patients with previously untreated FL are summarised in Table 8.
Slovenian: Rezultati učinkovitosti pri bolnikih s predhodno nezdravljenim FL so povzeti v preglednici 8.
English: For CLL cycles 2 - 6 and all FL cycles
Slovenian: Za 2. do 6. cikel KLL in vse cikle FL
English: In clinical studies with Gazyvaro, doses ranging from 50 mg up to and including 2,000 mg per infusion have been administered.
Slovenian: V kliničnih študijah zdravila Gazyvaro so uporabili odmerke od 50 mg do (in vključno) 2000 mg na infuzijo.
English: In patients who received the recommended measures for prevention of IRRs as described in section 4.2, a decreased incidence of IRRs of all Grades was observed.
Slovenian: Pri bolnikih, ki so prejeli priporočene ukrepe za preprečitev reakcij, povezanih z infuzijo, kot je opisano v poglavju 4.2, je to zmanjšalo incidenco reakcij, povezanih z infuzijo, vseh stopenj.
English: Gazyvaro contains the active substance obinutuzumab, which belongs to a group of medicines called “monoclonal antibodies”.
Slovenian: Zdravilo Gazyvaro vsebuje učinkovino obinutuzumab, ki spada v skupino zdravil, imenovanih “monoklonska protitelesa”.
English: Induction (in combination with bendamustine2) Gazyvaro should be administered in six 28-day cycles in combination with bendamustine2.
Slovenian: Indukcija (v kombinaciji z bendamustinom2) Zdravilo Gazyvaro se mora aplicirati v šestih 28-dnevnih ciklih v kombinaciji z bendamustinom2.
English: Prior to enrolment, patients had to have documented CD20+ CLL, and one or both of the following measures of coexisting medical conditions: comorbidity score (CIRS) of greater than 6 or reduced renal function as measured by CrCl < 70 mL/min.
Slovenian: Pred vključitvijo so morali imeti bolniki potrjeno KLL CD20+ in zadostiti enemu ali obema meriloma za sočasne bolezni: oceno komorbidnosti (CIRS) več kot 6 ali zmanjšano delovanje ledvic z očistkom kreatinina < 70 ml/min.
English: In nonclinical studies, obinutuzumab induces direct cell death and mediates antibody dependent cellular cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP) through recruitment of FcɣRIII positive immune effector cells.
Slovenian: V predkliničnih študijah je obinutuzumab induciral neposredno celično smrt in je posredoval od protiteles odvisno celično citotoksičnost (antibody dependent cellular cytotoxicity - ADCC) in od protiteles odvisno celično fagocitozo (antibody dependent cellular phagocytosis - ADCP) s privabljanjem FcɣRIII-pozitivnih imunskih efektorskih celic.
English: · medicine to prevent tumour lysis syndrome (such as allopurinol).
Slovenian: • zdravila za preprečevanje sindroma razpada tumorja (kot je alopurinol)
English: Pharmacokinetic data in patients with severe renal impairment (CrCl 15-29 mL/min) is limited (n=8), therefore no dose recommendations can be made.
Slovenian: Farmakokinetičnih podatkov za bolnike s hudo ledvično okvaro (očistek kreatinina 15-29 ml/min) je malo (n = 8), zato priporočil za odmerjanje ni mogoče dati.
English: 4.If a corticosteroid-containing chemotherapy regimen is administered on the same day as Gazyvaro, the corticosteroid can be administered as an oral medicinal product if given at least 60 minutes prior to Gazyvaro, in which case additional IV corticosteroid as premedication is not required.
Slovenian: Če se kemoterapija, ki vključuje kortikosteroid, daje na isti dan kot zdravilo Gazyvaro, se lahko uporabi peroralna oblika k ortikosteroida, če se ga da vsaj 60 minut pred uporabo zdravila Gazyvaro; v tem primeru dodaten kortikosteroid v intravenski obliki kot premedikacija ni potreben.
English: In CLL patients who received the combined measures for prevention of IRRs (adequate corticosteroid, oral analgesic/anti-histamine, omission of antihypertensive medicine in the morning of the first infusion, and the Cycle 1 Day 1 dose administered over 2 days) as described in section 4.2, a decreased incidence of IRRs of all Grades was observed.
Slovenian: Pri bolnikih s KLL, ki so bili deležni kombiniranih ukrepov za preprečitev reakcij, povezanih z infuzijo (ustreznih kortikosteroidov, peroralnih analgetikov/antihistaminikov, neuporabe antihipertenzivov na jutro prvega infundiranja ter uporabe odmerka za 1. dan 1. cikla v 2 dneh), kot so opisani v poglavju 4.2, je bila incidenca z infuzijo povezanih reakcij vseh stopenj manjša.