FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: What Gazyvaro is and what it is used for
Slovenian: Kaj je zdravilo Gazyvaro in za kaj ga uporabljamo Kaj je zdravilo Gazyvaro
English: Gazyvaro +Chemotherapy followed by Gazyvaro maintenance N=601
Slovenian: Zdravilo Gazyvaro + kemoterapija, nato vzdrževalno zdravljenje z zdravilom Gazyvaro n = 601
English: Cycles 2 - 6
Slovenian: 2. do 6. cikel
English: Gazyvaro + chlorambucil N= 333
Slovenian: zdravilo Gazyvaro + klorambucil n = 333
English: If no IRR occurred during the previous infusion, administer at 50 mg/hr.
Slovenian: Če med predhodnim infundiranjem ni bilo reakcij, povezanih z infuzijo, začnite s hitrostjo 50 mg/uro.
English: No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Izvedli pa so nekaj podštudij medsebojnega delovanja med zdravili za zdravilo Gazyvaro z bendamustinom, CHOP, fludarabinom in ciklofosfamidom (FC) in klorambucilom.
English: 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.
Slovenian: 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,
English: 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.
Slovenian: Faza 1a je primerjala kombinacijo zdravila Gazyvaro in klorambucila s samim klorambucilom pri 356
English: The overall incidence of haemorrhagic events was similar in the Gazyvaro treated arm and in the rituximab treated arm.
Slovenian: Celotna incidenca krvavitev je bila v skupini z zdravilom Gazyvaro podobna kot v skupini z rituksimabom.
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: PML is a very rare and life-threatening brain infection that has been reported with Gazyvaro.
Slovenian: Progresivna multifokalna levkoencefalopatija (PML) PML je zelo redka in smrtno nevarna okužba možganov, opisana med uporabo zdravila Gazyvaro.
English: Gazyvaro is given under the supervision of a doctor experienced in such treatment.
Slovenian: Zdravilo Gazyvaro boste prejeli pod nadzorom zdravnika z izkušnjami za zdravljenje raka.
English: Respiratory, thoracic and mediastinal disorders Very common
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti kašelj§
English: Chronic lymphocytic leukaemia · You will be given 6 treatment cycles of Gazyvaro in combination with another medicine for cancer called chlorambucil.
Slovenian: • Dobili boste 6 ciklov zdravljenja z zdravilom Gazyvaro v kombinaciji z drugim zdravilom za zdravljenje raka, imenovanim klorambucil.
English: Dyspepsia, colitis, haemorrhoids Diarrhoea, colitis
Slovenian: pogosti dispepsija, kolitis, hemoroidi diareja, kolitis občasni zaprtost, hemoroidi
English: In the small subgroup of patients with deletion 17p, only a positive trend was observed compared to Clb (HR=0.42, p=0.0892); no benefit was observed compared to RClb.
Slovenian: (razmerje ogroženosti = 0,42, p = 0,0892); v primerjavi s R-Clb pa koristi niso opazili.
English: Day 8 (1,000 mg)
Slovenian: 8. dan (1000 mg)
English: · If you get any side effects, talk to your doctor or nurse.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
English: · Chronic lymphocytic leukaemia (also called “CLL”) Gazyvaro is used in patients who have not had any treatment for CLL before and who have other illnesses which make it unlikely that they would be able to tolerate a full dose of a different medicine used to treat CLL called fludarabine.
Slovenian: Zdravilo Gazyvaro uporabljamo pri bolnikih, ki pred tem še niso prejemali nobenega zdravljenja za kronično limfocitno levkemijo in imajo pridružene bolezni, zaradi katerih je verjetno, da ne bi prenesli polnega odmerka drugega zdravila za zdravljenje kronične limfocitne levkemije, imenovanega fludarabin.
English: Stage 2
Slovenian: Slika 2.
English: Chronic lymphocytic leukaemia (CLL)
Slovenian: • Kronične limfocitne levkemije (KLL)
English: A population pharmacokinetic (PK) model was developed to analyse the PK data in 469 iNHL, 342 CLL and 130 diffuse large B-cell lymphoma (DLBCL) patients from Phase I, Phase II and Phase III studies who received obinutuzumab alone or in combination with chemotherapy.
Slovenian: Za analizo farmakokinetičnih podatkov pri 469 bolnikih z indolentnim ne-Hodgkinovim limfomom (iNHL), 342 bolnikih s KLL in 130 bolnikih z difuznim velikoceličnim limfomom B (DLBCL) v študijah I., II.
English: In Cycle 1, the overall incidence of IRRs was higher in patients receiving Gazyvaro plus chemotherapy compared to patients in the comparator arm.
Slovenian: Skupna incidenca reakcij, povezanih z infuzijo, je bila v 1. ciklu večja v skupini, ki je prejemala kombinacijo zdravila Gazyvaro in kemoterapije, kot v primerjalni skupini.
English: What you need to know before you are given Gazyvaro
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Gazyvaro Zdravila Gazyvaro ne smete dobiti:
English: 3 e.g. 50 mg diphenhydramine
Slovenian: Npr. 1000 mg paracetamola Npr. 50 mg difenhidramina
English: Maintenance phase
Slovenian: Začetna faza
English: No Grade 3-5 IRRs were reported beyond the first 1,000 mg infusions of Cycle 1.
Slovenian: Po infundiranju prvih 1000 mg v 1. ciklu ni bilo več opisanih reakcij, povezanih z infuzijo od 3. do 5. stopnje.
English: The incidence of IRRs was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm.
Slovenian: Incidenca reakcij, povezanih z infuzijo, je bila večja s kombinacijo zdravila Gazyvaro in klorambucila kot s kombinacijo rituksimaba in klorambucila.
English: Patients with renal impairment (CrCl < 50 mL/min) and patients with both Cumulative Illness Rating Scale (CIRS) > 6 and CrCl < 70 mL/min are more at risk of IRRs, including severe IRRs (see section 4.8).
Slovenian: Bolniki z ledvično okvaro (očistek kreatinina < 50 ml/min) in bolniki, ki imajo hkrati kumulativno oceno bolezni po lestvici CIRS (Cumulative Illness Rating Scale) > 6 in očistek kreatinina < 70 ml/min, imajo večje tveganje za reakcije, povezane z infuzijo, vključno s hudimi reakcijami, povezanimi z infuzijo (glejte poglavje 4.8).
English: Hypotension may occur during Gazyvaro intravenous infusions.
Slovenian: Med intravenskim infundiranjem zdravila Gazyvaro se lahko pojavi hipotenzija.
English: · Six 21-day cycles in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP), followed by 2 additional cycles of Gazyvaro alone or · Eight 21-day cycles in combination with cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone (CVP).
Slovenian: • osem 21-dnevnih ciklov v kombinaciji s ciklofosfamidom, vinkristinom in prednizonom/prednizolonom/metilprednizolonom (CVP).
English: HR (95% CI) p-value (Log-Rank test, stratified*) Secondary Endpoints Investigator-assessed PFS (PFS-INV) Number (%) of patients with event Median time to event (months, 95% CI) HR (95% CI) p-value (Log-Rank test, stratified*)
Slovenian: Vrednost p (stratificirani log-rang test*) Sekundarni opazovani dogodki PFS po raziskovalčevi oceni (PFS-INV) Število (%) bolnikov z dogodkom Mediani čas do dogodka (meseci, 95-% IZ) HR (95-% IZ)
English: Dose of Gazyvaro
Slovenian: Odmerek zdravila Gazyvaro
English: Cycle 1 - this will include three doses of Gazyvaro in the 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro: · Day 1 - full dose (1,000 mg) · Day 8 - full dose (1,000 mg) · Day 15 - full dose (1,000 mg).
Slovenian: 1. cikel - vključuje tri odmerke zdravila Gazyvaro v 28 ali 21 dneh, odvisno od tega, katera druga zdravila za zdravljenje raka boste prejeli skupaj z zdravilom Gazyvaro: • 1. dan - celoten odmerek (1000 mg)
English: CLL only - Cycle 1
Slovenian: Samo za 1. cikel KLL
English: Based on a subgroup analysis in previously untreated follicular lymphoma, the efficacy in FLIPI low risk (0-1) patients is currently inconclusive (see section 5.1).
Slovenian: O učinkovitosti pri bolnikih z nizkim tveganjem po točkovalniku FLIPI (0-1) na podlagi analize podskupin bolnikov s predhodno nezdravljenim folikularnim limfomom se trenutno ne more sklepati
English: Day 2 for CLL only
Slovenian: 1. cikel: 2. dan samo pri KLL
English: (INV-assessed, CT) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (Cochran-Mantel-Haenszel test) Complete Response (CR) Partial Response (PR)
Slovenian: (raziskovalčeva ocena, CT) Odzivni bolniki (%) (CR, PR) Razlika v deležu odgovora (%) [95-%
English: Severe and life-threatening neutropenia including febrile neutropenia has been reported during treatment with Gazyvaro.
Slovenian: Med zdravljenjem z zdravilom Gazyvaro so poročali o hudi in življenje ogrožajoči nevtropeniji, vključno s febrilno nevtropenijo.
English: Results of subgroup analyses (not adjusted for multiplicity) were, in general, consistent with the results seen in the FL population, supporting the robustness of the overall result.
Slovenian: Rezultati analiz podskupin Rezultati analiz podskupin (neprilagojeni glede multiplicitete) so se na splošno skladali z rezultati,
English: In the pivotal clinical study BO21004/CLL11, 91% (40 out of 44) of evaluable patients treated with Gazyvaro were B-cell depleted (defined as CD19+ B-cell counts < 0.07 x 109/L) at the end of treatment period and remained depleted during the first 6 months of follow up.
Slovenian: V ključni klinični študiji BO21004/CLL11 je imelo 91 % (40 od 44) ocenljivih bolnikov, zdravljenih z zdravilom Gazyvaro, na koncu obdobja zdravljenja odsotnost celic B (opredeljeno kot število celic B
English: Patients who achieved a complete or partial response to induction treatment (i.e. the initial 6 treatment cycles) with Gazyvaro in combination with bendamustine or have stable disease should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Slovenian: Bolniki, ki dosežejo popolni ali delni odgovor na indukcijsko zdravljenje (tj. na prvih 6 ciklov zdravljenja) z zdravilom Gazyvaro v kombinaciji z bendamustinom ali imajo stabilno bolezen, morajo še naprej prejemati monoterapijo z zdravilom Gazyvaro 1.000 mg kot vzdrževalno zdravljenje enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
English: Patients with an IRR (Grade 1 or 2) with the previous infusion
Slovenian: Bolniki, ki so imeli med prejšnjim infundiranjem reakcijo, povezano z infuzijo, 1. ali 2. stopnje
English: · Continue to use effective contraception for 18 months after stopping treatment with Gazyvaro.
Slovenian: • Z uporabo učinkovitega načina kontracepcije nadaljujte še 18 mesecev po prejemu zadnjega odmerka zdravila.
English: Content of the pack and other information
Slovenian: Shranjevanje zdravila Gazyvaro Vsebina pakiranja in dodatne informacije
English: Patients with renal impairment (CrCl < 50 mL/min) are more at risk of neutropenia (see section 4.8).
Slovenian: Bolniki z ledvično okvaro (očistek kreatinina < 50 ml/min) imajo večje tveganje za nevtropenijo (glejte poglavje 4.8).
English: Due to the potential depletion of B-cells in infants of mothers who have been exposed to Gazyvaro during pregnancy, infants should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant's B-cell count has recovered.
Slovenian: Zaradi možnega zmanjšanega števila celic B pri dojenčkih mater, ki so bile med nosečnostjo izpostavljene zdravilu Gazyvaro, je treba pri dojenčkih kontrolirati njihovo število.
English: HistidineHistidine hydrochloride monohydrate Trehalose dihydrate
Slovenian: histidin histidinijev klorid monohidrat trehaloza dihidrat poloksamer 188 voda za injekcije
English: Since human immunoglobulin G (IgG) is secreted in human milk and the potential for absorption and harm to the infant is unknown, women should be advised to discontinue breast-feeding during Gazyvaro therapy and for 18 months after the last dose of Gazyvaro.
Slovenian: Človeški imunoglobulin podvrste G (IgG) se izloča v materino mleko; možnost za absorpcijo in škodljivi vpliv pri dojenčku ni znan.
English: Gazyvaro was given by intravenous infusion as a dose of 1,000 mg on Days 1, 8 and 15 of Cycle 1, on Day 1 of subsequent cycles.
Slovenian: Zdravilo Gazyvaro so dajali v intravenski infuziji v odmerku 1000 mg 1., 8. in 15. dan cikla, 1. dan od
English: A clear relationship between thrombocytopenia and haemorrhagic events has not been established.
Slovenian: Jasne povezanosti med trombocitopenijo in krvavitvami niso ugotovili.
English: Severe and life-threatening thrombocytopenia including acute thrombocytopenia (occurring within 24 hours after the infusion) has been observed during treatment with Gazyvaro.
Slovenian: Med zdravljenjem z zdravilom Gazyvaro so opažali hudo in življenje ogrožajočo trombocitopenijo, vključno z akutno trombocitopenijo (ki se je pojavila znotraj 24 ur po infuziji).
English: Day 15 (1,000 mg)
Slovenian: 15. dan (1000 mg)
English: What Gazyvaro is used for
Slovenian: Za kaj uporabljamo zdravilo Gazyvaro
English: The incidence of infection was 38% in the Gazyvaro plus chlorambucil arm and 37% in the rituximab plus chlorambucil arm (with Grade 3-5 events reported in 12% and 14%, respectively and fatal events reported in < 1% in both treatment arms).
Slovenian: Gazyvaro in klorambucila 38-% in s kombinacijo rituksimaba in klorambucila 37-% (neželene učinke od 3. do 5. stopnje so zabeležili pri 12 % bolnikov v prvi skupini in 14 % v drugi skupini, učinkov s smrtnim izidom pa je bilo v obeh skupinah < 1 %).
English: · Follicular lymphoma (also called “FL”) Gazyvaro is used in patients who have not had any treatment for FL Gazyvaro is used in patients who have had at least one treatment with a medicine called rituximab before and whose FL has come back or got worse during or after this treatment.
Slovenian: Zdravilo Gazyvaro uporabljamo pri bolnikih, ki so pred tem prejemali vsaj eno zdravljenje z zdravilom, imenovanim rituksimab, a se je folikularni limfom med tem zdravljenjem ali po njem pri njih ponovil ali poslabšal.
English: Upper respiratory tract infection, sinusitis§, , urinary tract infection, pneumonia§ ,herpes zoster§
Slovenian: Infekcijske in parazitske bolezni zelo pogosti okužba zgornjih dihal, sinuzitis§, okužba sečil, pljučnica§, herpes zoster§
English: IRRs are very common during the first infusion of Gazyvaro, and patients experiencing infusion related symptoms should be advised not to drive or use machines until symptoms abate.
Slovenian: Bolnikom, pri katerih se pojavijo z infuzijo povezani simptomi, je treba naročiti, naj ne upravljajo vozil ali strojev, dokler simptomi ne minejo.
English: Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative such as a urate oxidase (e.g. rasburicase) starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice.
Slovenian: To naj sestaljata ustrezna hidracija in dajanje urikostatika (npr. alopurinola) ali primernega alternativnega zdravljenja, kot je uratna oksidaza (npr. rasburikaza), ki se začne 12 do
English: Kaplan-Meier curves for progression-free survival (PFS) are shown in Figure 5.
Slovenian: Meierjevi krivulji preživetja brez napredovanja bolezni sta prikazani na sliki 5.
English: Cases of 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 4.4).
Slovenian: Med zdravljenjem z zdravilom Gazyvaro so se pojavili primeri motenj srčnega ritma (npr. atrijska fibrilacija in tahiaritmije), angine pektoris, akutnega koronarnega sindroma, akutnega miokardnega infarkta in srčnega popuščanja (glejte poglavje 4.4).
English: They will help you weigh up the benefit of continuing Gazyvaro against the risk to your baby.
Slovenian: Gazyvaro v primerjavi s tveganjem za otroka.
English: Cough, oropharyngeal pain
Slovenian: • herpetični mehurčki
English: Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Slovenian: Bolniki, ki dosežejo popolni ali delni odgovor na indukcijsko zdravljenje z zdravilom Gazyvaro v kombinaciji s kemoterapijo, morajo še naprej prejemati monoterapijo z zdravilom Gazyvaro 1000 mg kot vzdrževalno zdravljenje enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
English: 1See section 5.1 for information on chlorambucil dose
Slovenian: 1 Za podatke o odmerku klorambucila glejte poglavje 5.1.
English: Median observation time 35 months
Slovenian: Mediani čas opazovanja
English: Four percent of patients treated with Gazyvaro plus chlorambucil experienced acute thrombocytopenia (occurring within 24 hours after the Gazyvaro infusion) (see section 4.4).
Slovenian: Akutna trombocitopenija (nastala v 24 urah po infundiranju zdravila Gazyvaro) se je pojavila pri 4 % bolnikov, zdravljenih s kombinacijo zdravila Gazyvaro in klorambucila (glejte poglavje 4.4).
English: No renal toxicity with a causal relationship to obinutuzumab has been observed in humans.
Slovenian: Pri človeku niso opazili toksičnosti za ledvice, ki bi bila vzročno povezana z obinutuzumabom.
English: White blood cell count decreased, neutrophil count decreased, weight increased
Slovenian: Preiskave pogosti zmanjšanje števila belih krvnih celic, zmanjšanje števila nevtrofilcev, povečanje telesne mase zmanjšanje števila belih krvnih celic, zmanjšanje števila nevtrofilcev
English: The bag should be gently inverted to mix the solution in order to avoid excessive foaming.
Slovenian: Da bi preprečili pretirano penjenje raztopine, je treba vrečko za premešanje raztopine previdno obračati.
English: · The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, poloxamer 188 and water for injections.
Slovenian: • Druge sestavine zdravila so histidin, histidinijev klorid monohidrat, trehaloza dihidrat,
English: Fatal haemorrhagic events have also been reported in Cycle 1 in patients treated with Gazyvaro.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Gazyvaro, so bili v 1. ciklu opisane tudi krvavitve s smrtnim izidom.
English: For each subsequent treatment cycle (Cycles 2 to 6), patients received Gazyvaro 1,000 mg on Day 1 only.
Slovenian: V vseh nadaljnjih ciklih zdravljenja (2. do 6. cikel) so bolniki dobili 1000 mg zdravila Gazyvaro samo 1. dan. Klorambucil so dobivali peroralno v odmerku 0,5 mg/kg telesne mase 1. in 15. dan v vseh ciklih zdravljenja (od 1. do 6.
English: · infection of upper airways (infection of nose, pharynx, larynx and sinuses), cough
Slovenian: • okužba zgornjih dihalnih poti (okužba nosu, žrela, grla in sinusov), kašelj Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: No. (%) of patients with event Median time to event (months)
Slovenian: Število (%) bolnikov z dogodkom 65 (55,1 %) Mediani čas do dogodka (meseci)
English: Administer at 50 mg/hr.
Slovenian: začnite s hitrostjo 50 mg/uro.
English: Patients with renal impairment (CrCl < 50 mL/min) are more at risk of thrombocytopenia (see section 4.8).
Slovenian: Bolniki z ledvično okvaro (očistek kreatinina < 50 ml/min) imajo večje tveganje za trombocitopenijo (glejte poglavje 4.8).
English: Hypotension, as a symptom of IRRs, may occur during Gazyvaro intravenous infusions.
Slovenian: Med intravenskim infundiranjem zdravila Gazyvaro se lahko kot simptom reakcij, povezanih z infuzijo, pojavi hipotenzija.
English: In the pivotal BO21004/CLL11 study, 27% (90 out of 336) of patients treated with Gazyvaro plus chlorambucil had moderate renal impairment (CrCl < 50 mL/min).
Slovenian: V ključni študiji BO21004/CLL11 je imelo zmerno ledvično okvaro (očistek kreatinina < 50 ml/min) 27 % (90 od 336) bolnikov, zdravljenih s kombinacijo zdravila Gazyvaro in klorambucila.
English: Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy (CHOP or CVP or bendamustine) should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Slovenian: Bolniki, ki dosežejo popolni ali delni odgovor na indukcijsko zdravljenje z zdravilom Gazyvaro v kombinaciji s kemoterapijo (CHOP, CVP ali bendamustin) nadaljujejo z monoterapijo z zdravilom Gazyvaro 1000 mg kot vzdrževalnim zdravljenjem enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
English: Median observation time: 20 months
Slovenian: Mediani čas opazovanja:
English: How to store Gazyvaro
Slovenian: Kako uporabljati zdravilo Gazyvaro Prejemanje zdravila Gazyvaro
English: Cycles 2-6 or 2-8 - this will be just one dose of Gazyvaro in the 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro: · Day 1 - full dose (1,000 mg).
Slovenian: 2. do 6. ali 2. do 8. cikel - vključujejo le en odmerek zdravila Gazyvaro v 28 ali 21 dneh, odvisno od tega, katera druga zdravila za zdravljenje raka boste prejeli skupaj z zdravilom Gazyvaro: