natgillin/translations-raw huggingface dataset:
In the majority of patients, irrespective of indication, IRRs were mild to moderate and could be managed by the slowing or temporary halting of the first infusion, but severe and life-threatening IRRs requiring symptomatic treatment have also been reported.
Pri večini bolnikov ne glede na indikacijo so bile reakcije, povezane z infuzijo, blage do zmerne in jih je bilo mogoče obvladati z upočasnitvijo ali začasno prekinitvijo prvega infundiranja.
Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro or 120 mg/m2/day when given alone.
Bendamustin so dajali intravensko 1. in 2. dan vseh ciklov zdravljenja (od 1. do 6. cikla) v odmerku 90 mg/m2/dan, če je bil uporabljen v kombinaciji z zdravilom Gazyvaro, ali 120 mg/m2/dan, če je bil uporabljen sam.
539.3 μg/mL and AUC(τ) value was 10956 μg•day/mL.
10956 µg•dan/ml.
Uncommon (may affect up to 1 in 100 people)
znižanje kalija Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
Overall, 7% of patients experienced an IRR leading to discontinuation of Gazyvaro.
V celoti so se pri 7 % bolnikov pojavile reakcije, povezane z infuzijo, ki so povzročile prenehanje uporabe zdravila Gazyvaro.
HR (95% CI) p-value (Log-Rank test, stratified*)
HR (95-% IZ) Vrednost p (stratificirani log-rang test*)
The incidence of neutropenia was higher in the Gazyvaro plus chlorambucil arm (41%) compared to the rituximab plus chlorambucil arm with the neutropenia resolving spontaneously or with use of granulocyte-colony stimulating factors.
Incidenca nevtropenije je bila s kombinacijo zdravila Gazyvaro in klorambucila večja (41 %) kot s kombinacijo rituksimaba in klorambucila; nevtropenija je minila sama od sebe ali po uporabi granulocitne kolonije stimulirajočih faktorjev.
· fluids · medicines to reduce a fever · medicines to reduce pain (analgesics) · medicines to reduce inflammation (corticosteroids) · medicines to reduce an allergic reaction (anti-histamines)
• zdravila za zmanjšanje alergijske reakcije (antihistaminiki)
Intravenous corticosteroid1 (mandatory)
Intravenski kortikosteroid1
No studies have been conducted to investigate the pharmacokinetics of obinutuzumab in paediatric patients.
Študij za preučitev farmakokinetike obinutuzumaba pri pediatričnih bolnikih niso izvedli.
The incidence of infection was 81% in the Gazyvaro plus chemotherapy arm (with Grade 3-5 events reported in 22% of patients and fatal events reported in 3% of patients).
Incidenca okužb je bila v skupini, zdravljeni z zdravilom Gazyvaro in kemoterapijo, 81 % (neželene učinke 3. do 5. stopnje so zabeležili pri 22 % bolnikov, o učinku s smrtnim izidom pa so poročali pri 3 % bolnikov).
The metabolism of obinutuzumab has not been directly studied.
Presnova obinutuzumaba ni neposredno raziskana.
Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Obvestite zdravnika ali medicinsko sestro, če opazite katerega koli od naslednjih neželenih učinkov:
Indolent Non-Hodgkin Lymphoma including Follicular Lymphoma
Indolentni ne-Hodgkinov limfom, vključno s folikularnim limfomom
Grades 3-5† Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL)
3. do 5. stopnja zdravilo Gazyvaro + kemoterapija* (KLL, iNHL), sledi Gazyvaro za vzdrževalno zdravljenje (iNHL)
No experience with overdose is available from human clinical studies.
Iz kliničnih študij pri človeku ni izkušenj s prevelikim odmerjanjem.
Transient elevation in liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase) has been observed shortly after the first infusion of Gazyvaro.
Kmalu po prvi infuziji zdravila Gazyvaro so opažali prehodno zvišanje jetrnih encimov (aspartataminotransferaze [AST], alanin-aminotransferaze [ALT], alkalne fosfataze).
Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).
Zdravilo Gazyvaro je v kombinaciji s klorambucilom indicirano za zdravljenje odraslih bolnikov s predhodno nezdravljeno kronično limfocitno levkemijo (KLL), pri katerih zdravljenje s polnim odmerkom fludarabina zaradi pridruženih bolezni ni primerno (glejte poglavje 5.1).
Table 3 Follicular lymphoma: Dose of Gazyvaro to be administered during induction treatment, followed by maintenance treatment
Folikularni limfom: odmerek zdravila Gazyvaro, ki ga je treba dati med indukcijskim zdravljenjem, čemur sledi vzdrževalno zdravljenje
Atrial fibrillation, cardiac failure Atrial fibrillation, cardiac failure,
Srčne bolezni pogosti atrijska fibrilacija, srčno popuščanje atrijska fibrilacija, srčno popuščanje
1 Chlorambucil is given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles
1000 mg Klorambucil dajemo peroralno v odmerku 0,5 mg/kg telesne mase na 1. dan in 15. dan vseh ciklusov zdravljenja.
The risk of disease progression or death was reduced in the GClb arm compared to the RClb arm and Clb arm in all subgroups except in the subgroup of patients with deletion 17p.
Tveganje za napredovanje bolezni ali za smrt je bilo v skupini, ki je prejemala zdravilo Gazyvaro in klorambucil, v vseh podskupinah manjše kot v skupinah, ki so prejemale ali rituksimab in klorambucil ali samo klorambucil, razen v podskupini bolnikov z delecijo 17p.
Rituximab + chlorambucil N= 330
rituksimab + klorambucil n = 330
However, results from the population analysis have shown that the differences in exposure are not significant (with an estimated median AUC and Cmax in CLL patients of 11282 µg•d/mL and 578.9 µg/mL in females and 8451 µg•d/mL and 432.5 µg/mL in males,
Vendar pa so rezultati populacijske analize pokazali, da so razlike v izpostavljenosti nepomembne (v 6. ciklu sta bili pri bolnikih s KLL ocenjeni mediani vrednosti AUC in Cmax 11282 µg•dan/ml in 578,9 µg/ml pri ženskah ter 8451 µg•dan/ml in 432,5 µg/ml pri moških ter pri bolnikih z iNHL AUC in Cmax 13172 µg•dan/ml in 635,7 µg/ml pri ženskah ter 9769 µg•dan/ml in 481,3 µg/ml pri moških); to kaže, da odmerka ni treba prilagoditi glede na spol.
Day 2 (or Day 1 continued) (900 mg)
2. dan (ali 1. dannadaljevanje) (900 mg)
Respiratory symptoms such as bronchospasm, larynx and throat irritation, wheezing, laryngeal oedema and cardiac symptoms such as atrial fibrillation have also been reported (see section 4.4).
Poročali so tudi o respiratornih simptomih, kot so bronhospazem, vnetje grla in žrela, sopenje in edem grla, ter o srčnih težavah, kot je atrijska fibrilacija (glejte poglavje 4.4).
Patients who experience overdose should have immediate interruption or reduction of their infusion and be closely supervised.
V primeru prevelikega odmerjanja je treba infundiranje nemudoma prekiniti ali ga upočasniti, bolnika pa natančno nadzorovati.
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of Gazyvaro as outlined below (see also section 4.4).
Obvladovanje reakcij, povezanih z infuzijo (vse indikacije) Obvladovanje reakcij, povezanih z infuzijo, lahko zahteva začasno prekinitev infundiranja, zmanjšanje hitrosti infundiranja ali prenehanje zdravljenja z zdravilom Gazyvaro, kot je prikazano spodaj (glejte tudi poglavje 4.4).
Patient Reported Outcomes
Izidi po navedbi bolnika
IRRs may be clinically indistinguishable from immunoglobulin E (IgE) mediated allergic reactions (e.g. anaphylaxis).
Reakcije, povezane z infuzijo, so lahko klinično nerazločljive od alergijskih reakcij, posredovanih z imunoglobulini E (IgE) (npr. anafilaktična reakcija).
Dysuria, urinary incontinence
Bolezni sečil pogosti dizurija, urinarna inkontinenca občasni dizurija, urinarna inkontinenca
Withdraw 40 mL of concentrate from the vial and dilute in polyvinyl chloride (PVC) or non-PVC polyolefin infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Iz viale potegnite 40 ml koncentrata in ga razredčite v polivinilkloridnih (PVC) ali ne-PVC infuzijskih vrečkah, ki vsebujejo 0,9-% (9 mg/ml) raztopino natrijevega klorida za injekcije.
Rituximab + Chemotherapy followed by rituximab maintenance N=601
Rituksimab + kemoterapija, nato vzdrževalno zdravljenje z rituksimabom n = 601
Haemorrhagic events and Grade 3-5 haemorrhagic events occurred in 12% and 5% of patients, respectively.
Hemoragični dogodki so se pojavili pri 12 % bolnikov, hemoragični dogodki 3. do 5. stopnje pa pri 5 % bolnikov.
For patients with CLL the recommended dose of Gazyvaro in combination with chlorambucil is shown in Table 2.
Za bolnike s KLL priporočeni odmerek zdravila Gazyvaro v kombinaciji s klorambucilom prikazuje preglednica 2.
If you miss a Gazyvaro treatment
Če ste izpustili zdravljenje z zdravilom Gazyvaro
Cases of prolonged neutropenia (2% in the Gazyvaro plus chlorambucil arm and 4% in the rituximab plus chlorambucil arm) and late onset neutropenia (16% in the Gazyvaro plus chlorambucil arm and 12% in the rituximab plus chlorambucil arm) were also reported (see section 4.4).
Poročali so tudi o primerih dolgotrajne nevtropenije (2 % s kombinacijo zdravila Gazyvaro in klorambucila, 4 % s kombinacijo rituksimaba in klorambucila) in primerih pozno nastale nevtropenije (16 % s kombinacijo zdravila Gazyvaro in klorambucila in 12 % s kombinacijo rituksimaba in klorambucila) (glejte poglavje 4.4).
Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRsin CLL and FL patients
Premedikacija, ki jo je treba dati pred infundiranjem zdravila Gazyvaro za zmanjšanje tveganja reakcij, povezanih z infuzijo, pri bolnikih s KLL in FL
Therapy with Gazyvaro should be withheld during the investigation of potential PML and permanently discontinued in case of confirmed PML.
Med preiskovanjem suma na PML je treba zdravljenje z zdravilom Gazyvaro prekiniti, če je PML potrjena, pa ga je treba trajno končati.
No meaningful differences were seen between the arms in HRQOL or health status measures.
Med zdravljenima skupinama niso opazili pomembnih razlik v zdravstveni kakovosti življenja ali merilih zdravstvenega statusa.
One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL.
Ena viala s 40 ml koncentrata vsebuje 1000 mg obinutuzumaba; to ustreza koncentraciji pred razredčenjem 25 mg/ml.
Table 9 Summary of efficacy in patients with FL# from GAO4753g/GADOLIN study
Povzetek o učinkovitosti pri bolnikih s FL# iz študije GAO4753g/GADOLIN
Tell your doctor or nurse straight away if you get any of the following symptoms during your infusion or up to 24 hours after having your infusion:
Zdravniku ali medicinski sestri morate takoj povedati, če se vam med infundiranjem ali v 24 urah po njem pojavi kar koli od spodaj navedenega:
Induction (in combination with chemotherapy2) Gazyvaro should be administered with chemotherapy as follows:
Indukcija (v kombinaciji s kemoterapijo2) Zdravilo Gazyvaro apliciramo v kombinaciji s kemoterapijo, kot je opisano spodaj:
Patients with no IRR during the previous infusion
Bolniki, ki med prejšnjim infundiranjem niso imeli reakcije, povezane z infuzijo
Injury, poisoning and procedural complications Very common
Poškodbe, zastrupitve in zapleti postopkov zelo pogosti reakcije, povezane z infuzijo reakcije, povezane z infuzijo
Cycles 2-6 or 2-8
2. do 6. cikel ali 2. do 8. cikel
Patients who are considered to be at risk of TLS (e.g. patients with a high tumour burden and/or a high circulating lymphocyte count [> 25 x 109/L] and/or renal impairment [CrCl < 70 mL/min]) should receive prophylaxis.
Bolniki z velikim tveganjem za sindrom razpada tumorja (npr. bolniki z velikim tumorskim bremenom in/ali velikim številom limfocitov v periferni krvi [> 25 x 109/l]) in/ali ledvično okvaro (očistek kreatinina < 70 ml/min) morajo prejeti profilakso.
Poloxamer 188
poloksamer 188 in voda za injekcije.
IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Interval * Stratification factors were chemotherapy regimen, FLIPI risk group for follicular lymphoma, geographic region Significance level at this efficacy interim analysis: 0.012 ¶ Data Not Yet Mature.
* Stratifikaciski dejavniki so bili: režim kemoterapije, rizična skupina FLIPI za folikularni limfom, geografska regija § Stopnja značilnosti pri tej vmesni analizi učinkovitosti: 0,012
Figure 5 Kaplan-Meier curve of INV-assessed progression-free survival in patients with previously untreated FL (Study BO21223/GALLIUM)
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po raziskovalčevi oceni pri bolnikih s predhodno nezdravljenim FL (študija BO21223/GALLIUM)
METHOD OF ADMINISTRATION For intravenous use after dilution
POSTOPEK UPORABE Za intravensko uporabo po razredčenju
Keep the vial in the outer carton in order to protect from light
Ne zamrzujte Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
Infusion can be continued upon resolution of symptoms and, if the patient does not experience any IRR symptoms, the infusion rate escalation can resume at the increments and intervals as appropriate for the treatment dose (see Tables 4 and 5).
Po izginotju simptomov je infundiranje mogoče nadaljevati in če se bolniku ne pojavi noben simptom reakcije, povezane z infuzijo, je mogoče hitrost infundiranja povečevati v korakih in presledkih, ki ustrezajo uporabljenemu odmerku (glejte preglednici 4 in 5).
STATEMENT OF ACTIVE SUBSTANCE(S)
Popolni odgovor (CR) Delni odgovor (PR)
Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with Gazyvaro (see section 4.8).
Pri bolnikih, zdravljenih z zdravilom Gazyvaro, je bila opisana progresivna multifokalna levkoencefalopatija (PML) (glejte poglavje 4.8).
Vaccination with live virus vaccines is not recommended during treatment and until B-cell recovery because of the immunosuppressive effect of obinutuzumab (see section 4.4).
Zaradi imunosupresivnega učinka obinutuzumaba cepljenje z živimi virusnimi cepivi ni priporočljivo med zdravljenjem in do okrevanja celic B (glejte poglavje 4.4).
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime in številko serije uporabljenega zdravila jasno zabeležiti (ali navesti) v bolnikovi dokumentaciji.
No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance [CrCl] 30-89 mL/min) (see section 5.2).
Bolnikom z blago do zmerno ledvično okvaro (očistek kreatinina 30-89 ml/min) odmerka ni treba prilagoditi (glejte poglavje 5.2).
Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Zdravilo Gazyvaro je v kombinaciji z bendamustinom ter s poznejšo vzdrževalno uporabo zdravila Gazyvaro indicirano za zdravljenje bolnikov s folikularnim limfomom (FL), ki se na zdravljenje z rituksimabom ali shemo, ki je vključevala rituksimab, niso odzvali ali jim je bolezen med ali v 6 mesecih po takšnem zdravljenju napredovala.
Gazyvaro + chlorambucil N= 238
zdravilo Gazyvaro + klorambucil n = 238
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,000 mg/40 mL
koncentrat za raztopino za infundiranje 1000 mg/40 ml
Patients (CLL) with both CIRS > 6 and CrCl < 70 mL/min are more at risk of infections, including severe infections (see section 4.8).
Bolniki (KLL), ki imajo hkrati CIRS > 6 in očistek kreatinina < 70 ml/min, imajo večje tveganje za okužbe, vključno s hudimi okužbami (glejte poglavje 4.8).
In order to reduce the rate of infusion related reactions in patients, an amendment was implemented and 140 patients received the first Gazyvaro dose administered over 2 days (Day 1 [100 mg] and Day 2 [900 mg]) (see section 4.2 and 4.4).
Za zmanjšanje deleža reakcij, povezanih z infuzijo, je bila sprejeta sprememba in 140 bolnikov je dobilo prvi odmerek zdravila Gazyvaro v 2 dneh (1. dan
Patients were stratified according to region, iNHL subtype (follicular versus non-follicular), rituximab-refractory type (whether refractory to prior rituximab monotherapy or rituximab in combination with chemotherapy)
Bolnike so stratificirali glede na regijo, podvrsto iNHL (folikularni ali nefolikularni), vrsto refraktarnosti na rituksimab (refraktaren na predhodno monoterapijo z rituksimabom ali na rituksimab v kombinaciji s kemoterapijo) in število predhodnih zdravljenj (≤ 2 ali > 2).
Chronic Lymphocytic Leukaemia
Kronična limfocitna levkemija
In the majority of patients, Gazyvaro was given intravenously as a 1,000 mg initial dose administered on Day 1, Day 8 and Day 15 of the first treatment cycle.
Večina bolnikov je zdravilo Gazyvaro dobila intravensko kot začetni odmerek 1000 mg, uporabljen 1., 8. in 15. dan prvega cikla zdravljenja.
The incidence of IRRs was 66% with the infusion of the first 1,000 mg of Gazyvaro (20% of patients experiencing a Grade 3-4 IRR).
med infundiranjem prvih 1000 mg zdravila Gazyvaro (20 % bolnikov je imelo reakcijo, povezano z infuzijo od 3. do 4. stopnje).
No post-baseline HAHA (Human Anti-Human Antibody) were observed in patients with iNHL treated in study GAO4753g/GADOLIN.
Pri nobenem bolniku z iNHL se po začetku zdravljenja v študiji GAO4753g/GADOLIN niso razvila protitelesa HAHA (Human Anti-Human Antibody).
For patients with FL, the recommended dose of Gazyvaro in combination with chemotherapy is shown in Table 3.
Za bolnike s FL je priporočeni odmerek zdravila Gazyvaro v kombinaciji s kemoterapijo prikazan v preglednici 3.
Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Gazyvaro infusion and for the first hour after administration.
Zato je treba začasno prekiniti uporabo antihipertenzivnih zdravil v obdobju 12 ur pred infundiranjem zdravila Gazyvaro, med celotnim infundiranjem in še prvo uro po koncu dajanja zdravila.
From the population PK model, after the Cycle 6 Day 1 infusion in CLL patients, the estimated median Cmax value was 465.7 μg/mL and AUC(τ) value was 8961 μg•d/mL and in iNHL patients the estimated median Cmax value was
Na podlagi populacijskega farmakokinetičnega modela je bila pri bolnikih s KLL po infuziji 1. dan 6. cikla ocenjena mediana Cmax 465,7 µg/ml in AUC(τ)
In the non-FL population the HR for IRC-assessed PFS was 0.94 [95% CI: 0.49, 1.90].
V populaciji, ki ni imela FL, je bilo razmerje ogroženosti po oceni IRC 0,94 [95-% interval zaupanja:
In patients with underlying cardiac disease, arrhythmias (such as atrial fibrillation and tachyarrhythmia), angina pectoris, acute coronary syndrome, myocardial infarction and heart failure have occurred when treated with Gazyvaro (see section 4.8).
Pri bolnikih z obstoječo srčno boleznijo so se med zdravljenjem z zdravilom Gazyvaro pojavile motnje srčnega ritma (npr. atrijska fibrilacija in tahiaritmija), angina pektoris, akutni koronarni sindrom, akutni miokardni infarkt in srčno popuščanje (glejte poglavje 4.8).
What Gazyvaro is and what it is used for
Kaj je zdravilo Gazyvaro in za kaj ga uporabljamo Kaj je zdravilo Gazyvaro
Gazyvaro +Chemotherapy followed by Gazyvaro maintenance N=601
Zdravilo Gazyvaro + kemoterapija, nato vzdrževalno zdravljenje z zdravilom Gazyvaro n = 601
Cycles 2 - 6
2. do 6. cikel
Gazyvaro + chlorambucil N= 333
zdravilo Gazyvaro + klorambucil n = 333
If no IRR occurred during the previous infusion, administer at 50 mg/hr.
Če med predhodnim infundiranjem ni bilo reakcij, povezanih z infuzijo, začnite s hitrostjo 50 mg/uro.
No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
V študijah toksičnosti ponavljajočih se odmerkov, ki so jih opravili na opicah cynomolgus, niso ugotovili neželenih učinkov na reproduktivne organe samcev in samic (glejte poglavje 5.3).
Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with anti-CD20 antibodies including Gazyvaro (see section 4.8).
Bolnikom, zdravljenim s protitelesi proti CD20 (vključno z zdravilom Gazyvaro), se lahko pojavi reaktivacija virusa hepatitisa B (HBV), v nekaterih primerih s posledičnim fulminantnim hepatitisom, jetrno odpovedjo in smrtjo (glejte poglavje 4.8).
No formal drug-drug interaction studies have been performed, although limited drug-drug interaction sub-studies have been undertaken for Gazyvaro with bendamustine, CHOP, fludarabine and cyclophosphamide (FC), and chlorambucil.
Izvedli pa so nekaj podštudij medsebojnega delovanja med zdravili za zdravilo Gazyvaro z bendamustinom, CHOP, fludarabinom in ciklofosfamidom (FC) in klorambucilom.
To ensure differentiation of the two infusion bags for the initial 1,000 mg dose, it is recommended to utilise bags of different sizes to distinguish between the 100 mg dose for Cycle 1 Day 1 and the 900 mg dose for Cycle 1 Day 1 (continued) or Day 2.
Za zagotovitev razlikovanja obeh infuzijskih vrečk za začetni odmerek 1000 mg je priporočljivo uporabiti različno veliki vrečki, da lahko razlikujete med 100-mg odmerkom za 1. dan 1. cikla in 900mg odmerkom za 1. dan 1. cikla (nadaljevanje) ali 2. dan. Za pripravo 2 infuzijskih vrečk potegnite iz viale 40 ml koncentrata in 4 ml razredčite v 100-ml PVC ali ne-PVC poliolefinski infuzijski vrečki,
Stage 1a compared Gazyvaro plus chlorambucil to chlorambucil alone in 356 patients and Stage 2 compared Gazyvaro plus chlorambucil to rituximab plus chlorambucil in 663 patients.
Faza 1a je primerjala kombinacijo zdravila Gazyvaro in klorambucila s samim klorambucilom pri 356
The overall incidence of haemorrhagic events was similar in the Gazyvaro treated arm and in the rituximab treated arm.
Celotna incidenca krvavitev je bila v skupini z zdravilom Gazyvaro podobna kot v skupini z rituksimabom.
Follicular versus non-follicular was also a stratification factor for the study but is not applicable in the subgroup analysis of patients with FL. § Best response within 12 months of start of treatment
Stratifikacijski dejavnik v študiji je bila tudi folikularna bolezen v primerjavi z nefolikularno, vendar ta dejavnik ne pride v poštev za analizo podskupin bolnikov s folikularnim limfomom.
Thrombocytopenia occurred more frequently in Cycle 1 in the Gazyvaro plus chemotherapy arm. Thrombocytopenia occurring during or 24 hours from end of infusion (acute thrombocytopenia) was more frequently observed in patients in the Gazyvaro plus chemotherapy arm than in the comparator arm.
Trombocitopenijo, ki se je pojavila med ali v 24-ih urah po končanem infundiranju (akutno trombocitopenijo), so bolj pogosto opazili v skupini bolnikov, zdravljeni z zdravilom Gazyvaro in kemoterapijo, kot v primerjalni skupini.
PML is a very rare and life-threatening brain infection that has been reported with Gazyvaro.
Progresivna multifokalna levkoencefalopatija (PML) PML je zelo redka in smrtno nevarna okužba možganov, opisana med uporabo zdravila Gazyvaro.
Gazyvaro is given under the supervision of a doctor experienced in such treatment.
Zdravilo Gazyvaro boste prejeli pod nadzorom zdravnika z izkušnjami za zdravljenje raka.
Respiratory, thoracic and mediastinal disorders Very common
Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti kašelj§
Chronic lymphocytic leukaemia · You will be given 6 treatment cycles of Gazyvaro in combination with another medicine for cancer called chlorambucil.
• Dobili boste 6 ciklov zdravljenja z zdravilom Gazyvaro v kombinaciji z drugim zdravilom za zdravljenje raka, imenovanim klorambucil.
Dyspepsia, colitis, haemorrhoids Diarrhoea, colitis
pogosti dispepsija, kolitis, hemoroidi diareja, kolitis občasni zaprtost, hemoroidi