FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Trombocytopeni, der opstod under eller 24 timer efter endt infusion (akut trombocytopeni) blev observeret hyppigere hos patienter i Gazyvaro plus kemoterapi-armen end i komparator-armen.
English: ● a hole in the stomach or intestines (gastrointestinal perforation, especially in cases where the cancer affects the gastrointestinal tubes)
Danish: • hul i mavesækken eller tarmene (gastrointestinal perforation.
English: Gazyvaro +Chemotherapy followed by Gazyvaro maintenance N=601
Danish: Gazyvaro + Kemoterapi efterfulgt af Gazyvaro vedligeholdelsesbehandling N=601
English: The incidence of IRRs was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm.
Danish: Incidensen af infusionsrelaterede reaktioner var højere i Gazyvaro plus chlorambucil-armen end i rituximab plus chlorambucil-armen.
English: Very common (may affect more than 1 in 10 people) · fever · lung infection · headache · joint pain, back pain · feeling weak · diarrhoea, constipation · sleeplessness · hair loss, itchiness · urinary tract infection, nose and throat inflammation, shingles
Danish: Meget almindelige (kan påvirke mere end 1 ud af 10 patienter) feber lungeinfektion hovedpine ledsmerter, smerter i ryg svaghedsfølelse diarré, forstoppelse
English: Hypersensitivity reactions with immediate (e.g. anaphylaxis) and delayed onset (e.g. serum sickness) have been reported in patients treated with Gazyvaro.
Danish: Overfølsomhedsreaktioner med hurtig (fx anafylaksi) og sen (fx serum-syge) indtræden er rapporteret hos patienter behandlet med Gazyvaro.
English: Cases of hepatitis B reactivation have been reported in patients treated with Gazyvaro (see section 4.4).
Danish: Reaktivering af hepatitis B Der er indberettet tilfælde af reaktivering af hepatitis B hos patienter behandlet med Gazyvaro (se pkt.
English: Induction treatment of approximately six months (six treatment cycles of Gazyvaro, each of 28 day duration when combined with bendamustine, or eight treatment cycles of Gazyvaro, each of 21 day duration when combined with CHOP or CVP) followed by maintenance once every 2 months for 2 years or until disease progression (whichever occurs first).
Danish: Induktionsbehandling på omkring seks måneder (seks behandlingsserier med Gazyvaro, hver af 28 dages varighed i kombination med bendamustin, eller otte behandlingsserier med Gazyvaro, hver af 21 dages varighed i kombination med CHOP eller CVP) efterfulgt af vedligeholdelsesbehandling én gang hver 2. måned i 2 år eller indtil sygdomsprogression (hvad end, der opstår først).
English: 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)
Danish: Patienterne var stratificeret udfra region, subgruppe af indolent non-Hodgkin lymfom (follikulært versus ikke-follikulært), rituximab-refraktær type (hvorvidt patienten var refraktær over for tidligere rituximab monoterapi eller rituximab i kombination med kemoterapi) samt antallet af tidligere behandlinger (≤ 2 versus > 2).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Dette bør ikke være mere end 24 timer ved 2-8°C, med mindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Your healthcare professional will throw away any medicines that are no longer being used.
Danish: Lægen eller sundhedspersonalet smider eventuelle medicinrester ud.
English: TLS has been reported with Gazyvaro.
Danish: Der er rapporteret tumorlysesyndrom med Gazyvaro.
English: · fluids · medicines to reduce a fever · medicines to reduce pain (analgesics) · medicines to reduce inflammation (corticosteroids) · medicines to reduce an allergic reaction (anti-histamines)
Danish: væske medicin mod feber medicin mod smerter medicin mod betændelseslignende reaktioner (inflammation) (kortikosteroid) medicin mod allergi (antihistamin) medicin til at forhindre tumorlysesyndrom (såsom allopurinol)
English: Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRsin CLL and FL patients
Danish: Tabel 1 Præmedicinering, der skal gives inden infusion af Gazyvaro med henblik på at reducere risiko for infusionsrelaterede reaktioner hos patienter med kronisk lymfatisk leukæmi og follikulært lymfom
English: · On Day 1 of your first cycle, you will be given part of your first Gazyvaro dose of 100 milligrams (mg) very slowly.
Danish: • På 1. dag i den første behandlingsserie, starter du med at få en mindre del af din første Gazyvaro-dosis.
English: If you get any of the above, tell your doctor or nurse straight away.
Danish: Hvis du oplever et eller flere af ovenstående punkter, skal du straks kontakte lægen eller sundhedspersonalet.
English: The overall incidence of haemorrhagic events was similar in the Gazyvaro treated arm and in the rituximab treated arm.
Danish: Den totale incidens af hæmorrhagiske bivirkninger i Gazyvaro-armen svarede til den i rituximab-armen.
English: Most frequently reported: · nausea · fatigue · dizziness · headache · diarrhoea · fever, flushing or chills · vomiting · shortness of breath · low or high blood pressure · heart beating very fast · chest discomfort
Danish: Oftest indberettet: kvalme træthed svimmelhed hovedpine diarré feber, ansigtsrødme eller kulderystelser opkastning åndenød lavt eller højt blodtryk hurtig hjerterytme (puls)
English: 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).
Danish: Der er også rapporteret respirations symptomer som bronkospasme, irritation i svælg og hals, stridor, larynxsødem og kardielle symptomer som atrieflimren (se pkt.
English: In patients with FLIPI score 0-1 (low risk), no difference between Gazyvaro plus chemotherapy and rituximab plus chemotherapy was observed (INV-assessed PFS HR 1.17 (95%CI 0.63;2.19, 40 PFS events).
Danish: Der blev ikke observeret nogen forskel mellem Gazyvaro plus kemoterapi og rituximab plus kemoterapi hos patienter med FLIPI score 0-1 (lav risiko) (investigator-vurderet progressionsfri overlevelse hazard ratio 1,17 (95 % konfidensinterval 0,63; 2,19; 40 tilfælde af progressionfri overlevelse).
English: NR (25.4,-)
Danish: 4.2 og 4.4).
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).
Danish: Disse patienter oplevede flere alvorlige bivirkninger og bivirkninger medførende død end patienter med CrCl ≥50 ml/min (se pkt.
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.
Danish: Spædbørn, hvis mødre er behandlet med obinutuzumab under graviditeten, bør på grund af risiko for B-celledepletering monitoreres for dette, og vaccinationer med levende virusvacciner bør udsættes til spædbarnets B-celletal er inden for normalområdet.
English: One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL.
Danish: Et hætteglas med 40 ml koncentrat indeholder 1000 mg obinutuzumab svarende til en koncentration før fortynding på 25 mg/ml.
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.
Danish: Der bør jævnligt tages blodprøver, indtil bivirkningen forsvinder, og dosisforsinkelse bør overvejes ved svær eller livstruende trombocytopeni.
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.
Danish: Incidensen af trombocytopeni var højere i Gazyvaro plus chlorambucil-armen sammenlignet med rituximab plus chlorambucil-armen (16 % versus7 %), særligt i den første behandlingsserie.
English: Hypersensitivity may be difficult to clinically distinguish from IRRs.
Danish: Det kan klinisk være svært at skelne mellem overfølsomhed og infusionsrelaterede reaktioner.
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.
Danish: Hos patienter med kronisk lymfatisk leukæmi, derprofylaktisk fik kombineret behandling mod infusionsrelaterede reaktioner (tilstrækkeligt kortikosteroid, oralt analgetikum/antihistamin, udeladelse af antihypertensiv medicin om morgenen ved første infusion samt første dosis i 1. behandlingsserie, fordelt over 2 dage), som beskrevet i pkt.
English: Hyperuricaemia
Danish: Hyperuricæmi
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.
Danish: Udelukkende 1. behandlingsserie ved kronisk lymfatisk leukæmi For at være sikker på at kunne kende forskel på de to infusionsposer til den initiale dosis på 1000 mg, anbefales det at bruge poser af forskellig størrelse til 100 mg-dosen, der skal gives på 1. dag 1 i 1. behandlingsserie, og 900 mg-dosen, der skal gives på 1. dag (fortsat) eller 2. dag.
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).
Danish: Der er set tilfælde af arytmi (fx atrieflimren og takyarytmi), angina pectoris, akut koronarsyndrom, myokardieinfarkt og hjertesvigt ved behandling med Gazyvaro (se pkt.
English: Difference in MRD rates, (95% CI) Event free survival
Danish: Forskel i MRD-forekomst, (95% KI)
English: It should be given as an intravenous infusion through a dedicated line after dilution (see section 6.6).
Danish: Det skal gives som intravenøs infusion i separat infusionsslange efter fortynding (se pkt.
English: In the Gazyvaro plus chemotherapy arm, the incidence of Grade 1-4 neutropenia (50%) was higher relative to the comparator arm with an increased risk during the induction period.
Danish: Indolent non-Hodgkin lymfom inklusive follikulært lymfom I Gazyvaro plus kemoterapi-armen var incidensen af grad 1-4 neutropeni (50 %) højere i forhold til komparator-armen, med en øget risiko under induktionsperioden.
English: · Do not breast-feed during treatment with Gazyvaro or for 18 months after stopping treatment with Gazyvaro.
Danish: • Du må ikke amme mens du er i behandling med Gazyvaro og i 18 måneder efter, du har stoppet behandlingen med Gazyvaro, da små mængder af medicinen kan udskilles i mælken.
English: Gazyvaro is used together with another medicine for cancer called chlorambucil.
Danish: - Gazyvaro bruges sammen med chlorambucil, et andet lægemiddel mod kræft
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).
Danish: Patienterne i Gazyvaro plus bendamustin-armen, som ikke havde sygdomsprogression (dvs. patienter med komplet respons, partielt respons eller stabil sygdom) ved slutningen af induktionsperioden, fortsatte med at få Gazyvarovedligeholdelsesbehandling én gang hver 2. måned i 2 år eller indtil sygdomsprogression (afhængigt af hvad der opstod først).
English: HistidineHistidine hydrochloride monohydrate Trehalose dihydrate
Danish: Histidinhydrochloridmonohydrat Trehalosedihydrat Poloxamerer 188
English: No formal pharmacokinetic study has been conducted in patients with hepatic impairment.
Danish: Nedsat leverfunktion Der er ikke gennemført formelle farmakokinetiske studier med patienter med nedsat leverfunktion.
English: Administer at 50 mg/hr.
Danish: Giv 50 mg/time.
English: Cycle 1:
Danish: 1. serie:
English: In repeat-dose toxicity studies in cynomolgus monkeys obinutuzumab had no adverse effects on male and female reproductive organs.
Danish: I toksicitetsstudier med gentagne doser til cynomolgusaber, påvirkede obinutuzumab ikke forplantningsorganerne, hverken hos hanner eller hunner.
English: Progressive multifocal leukoencephalopathy PML has been reported in patients treated with Gazyvaro (see section 4.4).
Danish: Der er indberettet progressiv multifokal leukoencefalopati hos patienter behandlet med Gazyvaro (se pkt.
English: 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.
Danish: De fleste patienter fik Gazyvaro intravenøst med en initial dosis på 1000 mg, administreret på 1. dag, 8. dag og 15. dag i den første behandlingsserie.
English: Clearly label each infusion bag.
Danish: Begge infusionsposer mærkes tydeligt.
English: Patients with renal impairment (CrCl < 50 mL/min) are more at risk of neutropenia (see section 4.8).
Danish: Patienter med nedsat nyrefunktion (CrCl <50 ml/min) har højere risiko for neutropeni (se pkt.
English: · Tell your doctor or nurse straight away if you get any signs of infection after your Gazyvaro treatment (see "Infections" in section 4).
Danish: • Hvis du oplever tegn på infektion efter behandling med Gazyvaro skal du straks kontakte lægen eller sundhedspersonalet (se under afsnit 4, ”Infektioner”).
English: No definitive conclusions could be drawn on efficacy in the MZL and SLL sub-populations.
Danish: Der kan ikke drages definitive konklusioner på effekten hos de 2 sub-populationer, marginal zone lymfom og småcellet lymfocytært lymfom.
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).
Danish: Der er hos patienter med underliggende hjertesygdom set arytmier (fx atrieflimren og takyarytmier), angina pectoris, akut koronarsyndrom, myokardieinfarkt og hjertesvigt under behandling med Gazyvaro (se pkt.
English: · Keep the container in the outer carton in order to protect from light.
Danish: • Hætteglasset skal opbevares i æsken for at beskytte mod lys.
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.
Danish: Gazyvaro blev administreret ved intravenøs infusion som en dosis på 1000 mg på dag 1, 8 og 15 i 1. behandlingsserie, og på dag 1 i efterfølgende behandlingsserier.
English: Patients with inadequate liver function (National Cancer Institute - Common Terminology Criteria for Adverse Events Grade 3 liver function tests (AST, ALT > 5 x ULN for > 2 weeks; bilirubin > 3 x ULN) and renal function (CrCl < 30 mL/min) were excluded.
Danish: Patienter med nedsat leverfunktion (grad 3 ved NCI's definition (ASAT/ALAT >5 x øvre grænseværdi i >2 uger; bilirubin >3 x øvre grænseværdi) og nedsat nyrefunktion (CrCl <30 ml/min) kunne ikke deltage i studiet.
English: Day 15 (1,000 mg)
Danish: 15. dag (1000 mg)
English: 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,
Danish: Populationsanalyse af data ved 6. cyklus har dog vist, at forskellene i eksponeringen ikke er signifikante (med en estimeret median-AUC og -Cmax hos kronisk lymfatisk leukæmi-patienter på henholdvis 11282 µg•døgn/ml og 578,9 µg/ml for kvinder og 8451 µg•døgn/ml og 432,5 µg/ml for mænd i 6. behandlingsserie og med et estimeret median-AUC og -Cmax hos patienter med indolent non-Hodgkin lymfom på hhv. 13172 µg•døgn/ml og 635,7 µg/ml for kvinder og 9769 µg•døgn/ml og 481,3 µg/ml for mænd), og der dermed ikke er grund til at justere dosis på baggrund af køn.
English: Health-related quality of life assessments, specific to fatigue through treatment period, show no statistically significant difference suggesting that the addition of Gazyvaro to a chlorambucil regimen does not increase the experience of fatigue for patients.
Danish: Vurderinger af helbredsrelateret livskvalitet, særligt af træthed i behandlingsperioden, har ikke vist statistisk signifikante forskelle.
English: 1100 mg prednisone/prednisolone or 20 mg dexamethasone or 80 mg methylprednisolone.
Danish: 100 mg prednison/prednisolon, 20 mg dexamethason eller 80 mg methylprednisolon Hydrocortison må ikke anvendes, da det er vist at være ineffektivt til at reducere hyppigheden af infusionsrelaterede reaktioner.
English: Table 9 Summary of efficacy in patients with FL# from GAO4753g/GADOLIN study
Danish: Tabel 9 Resumé af effektresultater hos patienter med follikulært lymfom (FL)# i GAO4753g /GADOLIN-studiet
English: Figure 5 Kaplan-Meier curve of INV-assessed progression-free survival in patients with previously untreated FL (Study BO21223/GALLIUM)
Danish: Kaplan-Meier-kurve over progressionsfri overlevelse, vurderet af en investigator, hos patienter med tidligere ubehandlet follikulært lymfom (studie BO21223/GALLIUM)
English: Cycles 2 - 6
Danish: Behandlingsserie 2 - 6
English: 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.
Danish: Risiko for sygdomsprogression eller død var (alle subgrupper) reduceret i gruppen, der fik Gazyvaro plus chlorambucil (GClb) sammenlignet med gruppen, der fik rituximab plus chlorambucil (RClb) og gruppen, der kun fik chlorambucil (Clb) undtagen i den subgruppe af patienter med deletion 17p.
English: The planned treatment interval for Gazyvaro should be maintained between doses.
Danish: Det er vigtigt at overholde de planlagte dosisintervaller for Gazyvaro.
English: To prepare the 2 infusion bags, withdraw 40 mL of concentrate from the vial and dilute 4 mL into a 100 mL PVC or non-PVC polyolefin infusion bag and the remaining 36 mL in a 250 mL PVC or non-PVC polyolefin infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: For at tilberede de to infusionsposer trækkes 40 ml koncentrat op af hætteglasset - de 4 ml tilsættes en 100 ml PVCeller non-PVC polyolefininfusionspose, de resterende 36 ml tilsættes en 250 ml-infusionspose; begge af PVC eller non-PVC polyolefin indeholdende natriumchlorid 9 mg/ml (0,9%) injektionsvæske.
English: Constipation, haemorrhoids
Danish: Forstoppelse, hæmorider
English: 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.
Danish: * Stratificeringsfaktorer var kemoterapi, FLIPI risikogruppe for follikulært lymfom og geografiske områder § Signifikansniveau ved denne interim effekt analyse: 0,012 ¶ Data er endnu ikke fuldstændige.
English: HR (95% CI) p-value (Log-Rank test, stratified*)
Danish: p-værdi (stratificeret log-rank test,*)
English: Chronic Lymphocytic Leukaemia
Danish: Kronisk lymfatisk leukæmi
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.
Danish: • Du vil herefter få Gazyvaro hver anden måned i op til 2 år, så længe din sygdom ikke bliver værre.
English: The safety and efficacy of Gazyvaro has not been established in patients with severe renal impairment (CrCl < 30 mL/min) (see sections 4.8 and 5.2).
Danish: Sikkerhed og virkning af Gazyvaro hos patienter med alvorlig nedsat nyrefunktion (CrCl <30 ml/min) er ikke klarlagt (se pkt.
English: After dilution, chemical and physical stability have been demonstrated in sodium chloride 9 mg/mL (0.9%) solution for injection at concentrations of 0.4 mg/mL to 20 mg/mL for 24 hours at 2°C to 8°C
Danish: Produktet er efter fortynding med natriumchlorid 9 mg/ml (0,9%) opløsning til injektion i koncentrationer på 0,4-20 mg/ml vist at være kemisk og fysisk holdbart i 24 timer ved 2-8°C efterfulgt af 48 timer (inklusive infusionstid) ved ≤30°C.
English: 22.8 months median observation time g
Danish: 22,8 måneders medianobservationstidg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ(E) Gazyvaro 1000 mg, koncentrat til infusionsvæske, opløsning obinutuzumab
English: · Tell your doctor or nurse straight away if you have memory loss, trouble speaking, difficulty walking or problems with your eyesight.
Danish: • Hvis du oplever dårlig hukommelse, problemer med at tale, besvær med at gå eller problemer med synet, skal du straks kontakte lægen eller sundhedspersonalet.
English: However, weekly obinutuzumab dosing from post-coitum day 20 to delivery resulted in complete depletion of B-cells in infant monkeys at weekly intravenous obinutuzumab doses of 25 and 50 mg/kg (2-5 times the clinical exposure based on Cmax and AUC).
Danish: Ugentlig intravenøs dosering af obinutuzumab, i doser af 25 og 50 mg/kg (2-5 gange den kliniske eksponering baseret på Cmax og AUC), fra 20 dage post-coitus til fødsel medførte dog fuldstændig depletering af B-celler hos det nyfødte afkom.
English: 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.
Danish: Patienter der vurderes at være i risiko for tumorlysesyndrom (fx patienter med høj tumorbyrde og/eller højt antal cirkulerende lymfocytter [>25 x 109/l]) og/eller nedsat nyrefunktion (CrCl <70 ml/min) bør have profylakse.
English: Keep the vial in the outer carton in order to protect from light
Danish: Opbevares i den ydre æske for at beskytte mod lys
English: Day 8 (1,000 mg)
Danish: 8. dag (1000 mg)
English: What Gazyvaro is and what it is used for What you need to know before you are given Gazyvaro How Gazyvaro is given
Danish: Det skal du vide, før du begynder at få Gazyvaro Sådan får du Gazyvaro
English: Patients with renal impairment (CrCl < 50 mL/min) are more at risk of thrombocytopenia (see section 4.8).
Danish: Patienter med nedsat nyrefunktion (CrCl <50 ml/min) har højere risiko for trombocytopeni (se pkt.
English: Median observation time: 20 months
Danish: 20 måneders median observationstid
English: Pyrexia, Asthenia
Danish: Pyreksi, asteni
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.
Danish: • Gazyvaro gives sammen med anden medicin mod kræft til patienter med kronisk lymfatisk leukæmi og follikulært lymfom for at forsinke en forværring af sygdommen.