FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with bevacizumab have an increased risk of haemorrhage, especially tumour-associated haemorrhage.
Danish: Patienter, som behandles med bevacizumab, har en øget risiko for at udvikle blødning, særligt tumorassocieret blødning.
English: The overall incidence of NCI-CTC Grade 3 and 4 hypertension in patients receiving bevacizumab ranged from 0.4% to 17.9%.
Danish: Den totale hyppighed af NCI-CTC grad 3 og 4 hypertension blev set hos mellem 0,4 % og 17,9 % af patienterne, som fik bevacizumab.
English: • Pregnancy (see section 4.6).
Danish: Graviditet (se pkt.
English: • Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
Danish: Overfølsomhed over for præparater fremstillet i ovarieceller (CHO) fra kinesisk hamster eller andre rekombinante eller humaniserede antistoffer.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside (EMA): http://www.ema.europa.eu
English: 85 mg/m2 intravenous 2 h
Danish: 85 mg/m 2 intravenøs 2
English: 6.6 Special precautions for disposal and other handling Zirabev should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
Danish: Zirabev bør fremstilles af en sundhedsfaglig person under anvendelse af aseptisk teknik for at sikre steriliteten af den fremstillede opløsning.
English: Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1250 mg/m2 intravenous infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with bevacizumab at a dose of 7.5 or 15 mg/kg intravenous infusion day 1 of every 3-week cycle.
Danish: Patienterne blev randomiseret til platinbaseret kemoterapi, cisplatin 80 mg/m 2 som intravenøs infusion på dag 1 og gemcitabin 1.250 mg/m2 som intravenøs infusion på dag 1 og 8 i hver 3-ugers serie i op til 6 serier (CG) med placebo eller til CG i kombination med bevacizumab i en dosis på 7,5 eller 15 mg/kg som intravenøs infusion på dag 1 i hver 3-ugers serie.
English: Deep vein thrombosis
Danish: , Dyb venetrombose
English: Cases of non-mandibular osteonecrosis have been observed in bevacizumab treated paediatric patients (see section 4.8, Paediatric population).
Danish: Tilfælde af ikke-mandibulær osteonekrose er blevet observeret hos pædiatriske patienter behandlet med bevacizumab (se pkt.
English: Zirabev may impair female fertility.
Danish: Zirabev kan nedsætte kvinders frugtbarhed.
English: These clinically significant adverse reactions were reported in clinical trials but the grade 3-5 reactions did not meet the threshold of at least a 2% difference compared to the control arm. Table 2 also includes clinically significant adverse reactions that were observed only in the postmarketing setting,
Danish: Disse klinisk signifikante bivirkninger blev rapporteret i kliniske studier, men grad 3-5 bivirkningerne opfyldte ikke grænsen på mindst 2 % forskel i forhold til kontrolarmen.
English: • inflammation of the moist lining of mouth and gut, lungs and air passages, reproductive,
Danish: • inflammation (betændelseslignende reaktion) i slimhinder i mund og tarme, lunger og luftveje, kønsdele og urinveje,
English: FOLFOX-4 or FOLFOX-4 + bevacizumab
Danish: FOLFOX-4 + bevacizumab
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), GI perforations (all grade) were reported in 3.2% of patients, all of whom had a history of prior pelvic radiation.
Danish: Fra et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (studie GOG-0240), blev gastrointestinale perforationer (alle grader) rapporteret hos 3,2% af patienterne og alle havde tidligere fået stråling af bækkenet.
English: Hypersensitivity, Infusion reactions a,b,d
Danish: Overfølsomhed, Infusionsreaktione a,b,d
English: Proteinuria a,b
Danish: Proteinuri a,b
English: • E3200: Bevacizumab 10 mg/kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4) in bevacizumab-naïve patients.
Danish: • E3200: Bevacizumab 10 mg/kg legemsvægt hver 2. uge i kombination med leucovorin og 5-fluoruracil bolus, efterfulgt af 5-fluoruracil infusion og intravenøs oxaliplatin (FOLFOX-4) til bevacizumab-naive patienter.
English: a 10 mg/kg every 2 weeks b Relative to control arm
Danish: 10 mg/kg hver 2. uge I forhold til kontrolarmen
English: Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
Danish: Zirabev er, i kombination med paclitaxel, indiceret til 1.-linjebehandling af voksne patienter med metastatisk brystkræft.
English: Infection, Urinary tract infection
Danish: Infektion, Urinvejsinfektio n
English: There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder.
Danish: Der har været sjældne rapporter om symptomer, der stemmer overens med PRES, en sjælden neurologisk forstyrrelse, hos bevacizumabbehandlede patienter.
English: ● a hole in your gut wall,
Danish: ● hul i tarmvæggen,
English: Zirabev is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Danish: Zirabev bruges også hos voksne til behandling af fremskreden ikke-småcellet lungekræft.
English: Congestive heart failure a,b
Danish: Kongestivt hjertesvigt a,b
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-240), 1.8% of bevacizumab-treated patients and 1.4% of control patients were reported to have had nongastrointestinal vaginal, vesical, or female genital tract fistulae.
Danish: I et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (GOG-0240) blev det rapporteret, at 1,8 % af de bevacizumabbehandlede patienter og 1,4 % af patienterne i kontrolgruppen havde haft ikke-gastrointestinale -vaginale, -vesikale eller gynækologiske fistler.
English: In clinical trials, the overall incidence of arterial thromboembolic reactions ranged up to 3.8% in the bevacizumab containing arms compared with up to 2.1% in the chemotherapy control arms.
Danish: I kliniske studier var den samlede forekomst af arterielle tromboemboliske bivirkninger op til 3,8 % i bevacizumab-armen sammenlignet med op til 2,1 % i kontrolgruppen, som fik kemoterapi alene.
English: Severe side effects, which may be common (may affect up to 1 in 10 people), include:
Danish: Alvorlige bivirkninger, som kan være almindelige (kan forekomme hos op til 1 ud af 10 patienter), omfatter:
English: In patients with NSCLC excluding predominant squamous histology, all Grade reactions were seen with a frequency of up to 9.3% when treated with bevacizumab plus chemotherapy compared with up to 5% in the patients treated with chemotherapy alone.
Danish: Hos de patienter med NSCLC, der ikke har dominerende planocellulær histologi, der blev behandlet med bevacizumab og kemoterapi, blev der set bivirkninger af alle grader med frekvenser på op til 9,3 % sammenlignet med op til 5 % hos de patienter, der kun blev behandlet med kemoterapi.
English: • ML18147: Bevacizumab 5.0 mg/kg of body weight every 2 weeks or bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin in patients with disease progression following first-line treatment with bevacizumab.
Danish: • ML18147: Bevacizumab 5,0 mg/kg legemsvægt hver 2. uge eller bevacizumab 7,5 mg/kg legemsvægt hver 3. uge i kombination med fluoropyrimidin/irinotecan eller fluoropyrimidin/oxaliplatin til patienter med sygdomsprogression efter 1.linje-behandling med bevacizumab.
English: First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy Zirabev is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Zirabev as a single agent until disease progression.
Danish: Zirabev administreres sammen med platinbaseret kemoterapi i op til 6 behandlingsserier, efterfulgt af behandling med Zirabev som monoterapi indtil sygdomsprogression.
English: Very common (may affect more than 1 in 10 people) side effects, which were not severe, include:
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter), som ikke var alvorlige, omfatter:
English: Each ml of concentrate contains 25 mg of bevacizumab*.
Danish: Hver ml koncentrat indeholder 25 mg bevacizumab*.
English: Each ml of concentrate contains 25 mg of bevacizumab.
Danish: Hver ml koncentrat indeholder 25 mg bevacizumab.
English: Asthenia, Fatigue, Pyrexia, Pain, Mucosal inflammation
Danish: Asteni, Træthed, Pyreksi, Smerte, Slimhindeinflamm ation
English: Fistula b,d
Danish: Fistler b,d
English: • Haemorrhage, including pulmonary haemorrhage/haemoptysis, which is more common in non- small cell lung cancer patients (see section 4.4).
Danish: Blødninger, inklusive pulmonal blødning/hæmoptyse, som er mere almindelig hos patienter med ikke-småcellet lungekræft (se pkt.
English: In clinical trials across all indications the overall incidence of NCI-CTCAE v.3 Grade 3-5 bleeding reactions ranged from 0.4% to 6.9% in bevacizumab treated patients, compared with up to 4.5% of patients in the chemotherapy control group.
Danish: I kliniske studier inden for alle indikationer spændte hyppigheden af NCI-CTCAE v.3 grad 3-5 blødning fra 0,4 % til 6,9 % hos bevacizumabbehandlede patienter versus 4,5 % hos de patienter, der fik kemoterapi alene.
English: Bvb + IFNa
Danish: Bv b + IFN
English: (12.0 vs 15.0 months; p = 0.6267)
Danish: (12,0 vs. 15,0 måneder; p = 0,6267)
English: (16.2 vs. 12.0 months; p = 0.1342)
Danish: (16,2 vs. 12,0 måneder; p = 0,1342)
English: Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg q 3 weeks
Danish: Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg hver 3. uge
English: Myocardial infarction was reported in up to 1.4% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.7% of patients treated with chemotherapy alone.
Danish: Myokardieinfarkt blev rapporteret hos op til 1,4 % af patienterne, som fik bevacizumab i kombination med kemoterapi, sammenlignet med op til 0,7 % af patienterne, som fik kemoterapi alene.
English: Ovarian failure b,c,d
Danish: Ovariesvigt b,c,d
English: Hypersensitivity, Infusion reactions a,b,c
Danish: Overfølsomhed, Infusionsreaktio ner a,b,c
English: The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, longer progression-free survival, and a trend in longer survival, compared with 5-FU/FA chemotherapy alone (see Table 5).
Danish: Sammenlignet med 5-FU/FA-kemoterapi alene medførte tillæg af bevacizumab 5 mg/kg hver 2. uge til 5-FU/FA højere, objektive responsrater, længere progressionsfri overlevelse og en tendens til længere overlevelse (se tabel 5).
English: Severe side effects, which may be very common (may affect more than 1 in 10 people), include:
Danish: Alvorlige bivirkninger, som kan være meget almindelige (kan forekomme hos flere end 1 patient ud af 10), omfatter:
English: One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression.
Danish: Der blev randomiseret 105 patienter til 5-FU/FA + placebo-armen og 104 patienter til 5-FU/FA + bevacizumab-armen (5 mg/kg hver 2. uge).
English: This was a Phase III randomised, controlled, open-label trial investigating bevacizumab 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy versus fluoropyrimidine-based chemotherapy alone in patients with mCRC who have progressed on a first- line bevacizumab-containing regimen.
Danish: Studiet var et fase III randomiseret, kontrolleret, åbent studie, som undersøgte bevacizumab 5,0 mg/kg hver 2. uge eller 7,5 mg/kg hver 3. uge i kombination med fluoropyrimidin-baseret kemoterapi versus fluoropyrimidin-baseret kemoterapi alene, til patienter med metastatisk kolorektalkræft, som progredierede på et 1.linje bevacizumab-indeholdende regime.
English: If you stop treatment with Zirabev
Danish: Hvis du holder op med at bruge Zirabev
English: (14.9 vs. 11.9 months; p = 0.1061)
Danish: (14,9 vs. 11,9 måneder; p = 0,1061)
English: Diarrhoea, Nausea, Vomiting, Abdominal pain
Danish: Diarré, Kvalme, Opkastning, Abdominalsmer ter
English: Febrile neutropenia, Leucopenia, Neutropenia b, Thrombo-cytopenia
Danish: Febril neutropeni, Leukopeni, Neutropeni a, Trombocytopen
English: (11.9 vs.14.3 months; p = 0.4825)
Danish: (11,9 vs. 14,3 måneder; p = 0,4825)
English: Paclitaxel 135 mg/m2 intravenous over 24 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m intravenous over 3 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 1 plus bevacizumab 15 mg/kg intravenous on Day 1 (q3w)
Danish: Paclitaxel 135 mg/m 2 intravenøst over 24 timer på dag 1 og cisplatin 50 mg/m 2 intravenøst på dag 2 plus bevacizumab 15 mg/kg intravenøst på dag 2, hver 3. uge; eller Paclitaxel 175 mg/m 2 intravenøst over 3 timer på dag 1 og cisplatin 50 mg/m 2 intravenøst på dag 2 plus bevacizumab 15 mg/kg intravenøst på dag 2, hver 3. uge; eller Paclitaxel 175 mg/m 2 intravenøst over 3 timer på dag 1 og cisplatin 50 mg/m 2 intravenøst på dag 1 plus bevacizumab 15 mg/kg intravenøst på dag 1, hver 3. uge
English: Zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
Danish: Zirabev er, i kombination med platinbaseret kemoterapi, indiceret til 1.-linjebehandling af voksne patienter med ikke-operabel fremskreden, metastatisk eller recidiverende, ikke-småcellet lungekræft.
English: Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by intravenous infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or
Danish: Patienter blev randomiseret til platinbaseret kemoterapi (paclitaxel 200 mg/m2 og carboplatin AUC = 6,0, begge som intravenøs infusion) (PC) på dag 1 af hver 3-ugers serie i op til 6 serier eller PC i kombination med bevacizumab med en dosis på 15 mg/kg intravenøs infusion på dag 1 af hver 3ugers serie.
English: Posterior reversible encephalopathy syndrome a,b,c
Danish: Posteriort reversibelt encefalopatisyn drom a,b,c
English: Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with bevacizumab (analyses shown in Table 7), consistent with the statistically significant benefit observed in the pooled analysis.
Danish: Sekundære analyser af progressionsfri overlevelse, baseret på responsvurderinger fra ”ontreatment”-populationen, bekræftede den signifikante, superiore, kliniske effekt for patienter, behandlet med bevacizumab (analyser vist i tabel 7).
English: The median age was 46.0 years (range: 20-83) in the Chemo alone group and 48.0 years (range: 22-85) in the Chemo+bevacizumab group; with 9.3% of patients in the Chemo alone group and 7.5% of patients in the Chemo+bevacizumab group over the age of 65 years.
Danish: Gennemsnitsalderen var 46,0 år (interval: 20-83) i kemoterapigruppen og 48,0 år (interval: 22-85) i kemoterapi+bevacizumabgruppen.
English: Zirabev is also used for the treatment of adult patients with metastatic breast cancer.
Danish: Zirabev anvendes også hos voksne til behandling af metastatisk brystkræft.
English: Placebo + IFNa
Danish: Placebo + IFN
English: Severe adverse reactions by frequency
Danish: Tabel 2 Alvorlige bivirkninger inddelt efter frekvens
English: Median PFS (months) Hazard ratio [95% CI]
Danish: Median PFS (måneder) Hazard ratio [95% konfidensinterval]
English: Overall survival - primary analysis Hazard ratio (95% CI)
Danish: Samlet overlevelse - Primær analyse Hazard Ratio (95% konfidensinterval)
English: Grange Castle Business Park
Danish: Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin
English: Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under bevacizumab treatment.
Danish: Patienter i bevacizumabbehandling kan have risiko for at udvikle venøse tromboemboliske bivirkninger, herunder lungeemboli.
English: Concentrate for solution for infusion 1 vial of 4 ml
Danish: Koncentrat til infusionsvæske, opløsning 1 hætteglas á 16 ml
English: Pulmonary haemorrhage/ Haemoptysis b,d
Danish: Pulmonal blødning/Hæmopt yse b,d
English: Gastrointestinal disorder, Proctalgia
Danish: Gastrointestinale forstyrrelser, Proktalgi
English: The recommended dose of Zirabev, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
Danish: Den anbefalede dosis af Zirabev administreres som intravenøs infusion og administreres enten som 5 mg/kg eller 10 mg/kg legemsvægt en gang hver 2. uge eller som 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge.
English: Best overall response ratea
Danish: Bedste objektive responsrate
English: • NO16966: Bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or bevacizumab 5 mg/kg every 2 weeks in combination with leucovorin plus 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
Danish: • NO16966: Bevacizumab 7,5 mg/kg legemsvægt hver 3. uge i kombination med oral capecitabin og intravenøs oxaliplatin (XELOX) eller bevacizumab 5 mg/kg hver 2. uge i kombination med leucovorin plus 5-fluoruracil bolus efterfulgt af 5-fluoruracil infusion og intravenøs oxaliplatin (FOLFOX-4).
English: 130 mg/m2 intravenous 2 h
Danish: 130 mg/m 2 intravenøs 2
English: The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, significantly longer progression-free survival, and a trend in longer survival as compared to 5-FU/FA chemotherapy alone.
Danish: Sammenlignet med 5-FU/FA-kemoterapi alene medførte tillæg af bevacizumab 5 mg/kg hver 2. uge til 5-FU/FV højere, objektive responsrater, signifikant længere progressionsfri overlevelse og en tendens til længere overlevelse.
English: In locally recurrent and metastatic breast cancer trials, Grade 3-5 wound healing complications were observed in up to 1.1% of patients receiving bevacizumab compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
Danish: I kliniske studier omhandlende lokalt recidiverende eller metastatisk brystkræft blev der observeret sårhelingskomplikationer af grad 3-5 hos op til 1,1 % af patienterne, som fik bevacizumab, og hos op til 0,9 % af patienterne i kontrolarmene (NCI-CTCAE v. 3).
English: (17.5 vs.15.0 months; p = 0.0584)
Danish: (17,5 vs. 15,0 måneder; p = 0,0584)
English: (14.9 vs. 17.5 months; p = 0.4146)
Danish: (14,9 vs. 17,5 måneder; p = 0,4146)
English: This was a phase III randomised, active-controlled, open-label trial investigating bevacizumab 10 mg/kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second line) with advanced colorectal cancer.
Danish: Dette var et fase III, randomiseret, aktivt kontrolleret, ublindet studie, som undersøgte bevacizumab 10 mg/kg i kombination med leucovorin og 5-fluoruracil bolus efterfulgt af 5fluoruracil infusion med intravenøs oxaliplatin (FOLFOX-4), administreret hver 2. uge til tidligere behandlede (2. linje) patienter med fremskreden kolorektalkræft.
English: Cisplatin/Gemcitabine + bevacizumab 7.5 mg/kg q 3 weeks
Danish: Cisplatin/Gemcitabin + bevacizumab 7,5 mg/kg hver 3. uge
English: Dyspnoea, Rhinitis, Epis taxis , Cough
Danish: Dyspnø, Rinitis, Epistaxis, Hoste
English: (16.2 vs 17.5 months; p = 0.3769)
Danish: (16,2 vs. 17,5 måneder; p = 0,3769)
English: • comparative incidences noted between clinical trial treatment arms (with at least a 10% difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2% difference compared to the control arm for NCI-CTCAE Grade 3-5 reactions,
Danish: Tabel 1 viser frekvensen af alle bivirkninger, hvor der er fastslået årsagssammenhæng med bevacizumab gennem: komparativ incidens, som er konstateret mellem behandlingsarme i kliniske studier (med mindst 10 % forskel i forhold til kontrolarmen for NCI-CTCAE grad 1-5 bivirkninger eller med mindst 2 % forskel i forhold til kontrolarmen for NCI-CTCAE grad 3-5 bivirkninger),
English: Zirabev is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Danish: Zirabev er medicin som anvendes hos voksne til behandling af fremskreden kræft i tyktarmen eller endetarmen.
English: In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026.
Danish: I FOLFOX undergruppen var den mediane PFS 8,6 måneder i placebogruppen vs. 9,4 måneder for bevacizumab-behandlede patienter, HR = 0,89, 97,5 % konfidensinterval = [0,73-1,08]; p-værdi = 0,1871.
English: Overall response rate Rate (percent) 95% CI
Danish: Samlet responsrate Rate (procent) 95 % konfidensinterval p-værdi
English: Posterior reversible encephalopathy syndrome (see section 4.4)
Danish: Posteriort reversibelt encefalopati-syndrom (PRES) (se pkt.
English: Zirabev 25 mg/ml concentrate for solution for infusion bevacizumab
Danish: Zirabev 25 mg/ml koncentrat til infusionsvæske, opløsning bevacizumab
English: Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Danish: Lungeemboli, Hypoksi, Dysfonia
English: 200 mg/m2 intravenous 2 h
Danish: 200 mg/m2 intravenøs 2
English: No Bevacizumab
Danish: Ingen Bevacizumab
English: Peripheral sensory neuropathy a
Danish: Nervesystemet Perifer sensorisk neuropati
English: • Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival and overall survival in the eligible per-protocol population.
Danish: XELOX-armene, var non-inferiore med hensyn til progressionsfri overlevelse og samlet overlevelse i den egnede ”per protocol” patientpopulation i forhold til FOLFOX-4-armene.
English: B-cell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
Danish: I et klinisk studie er der blevet set en øget hyppighed af CHF hos patienter med diffust storcellet Bcelle lymfom, der fik bevacizumab sammen med en kumulativ doxorubicindosis, som var større end 300 mg/m2.
English: Osteonecrosis of the jaw b,c
Danish: Osteonekrose af kæben b,c
English: (17.5 vs.14.3 months; p = 0.0609)
Danish: (17,5 vs. 14,3 måneder; p = 0,0609)
English: There have also been less common reactions of minor mucocutaneous haemorrhage in other locations, such as gingival bleeding or vaginal bleeding.
Danish: Mindre slimhindeblødninger lokaliseret andre steder, som fx gingival eller vaginal blødning har også været rapporteret som mindre almindelige bivirkninger.
English: How to use Zirabev
Danish: Sådan skal du bruge Zirabev
English: b Relative to control arm.
Danish: I forhold til kontrolarmen.