natgillin/translations-raw huggingface dataset:
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.
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.
Ovariesvigt b,c,d
Ovarian failure b,c,d
Overfølsomhed, Infusionsreaktio ner a,b,c
Hypersensitivity, Infusion reactions a,b,c
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).
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).
Alvorlige bivirkninger, som kan være meget almindelige (kan forekomme hos flere end 1 patient ud af 10), omfatter:
Severe side effects, which may be very common (may affect more than 1 in 10 people), include:
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).
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.
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.
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.
Hvis du holder op med at bruge Zirabev
If you stop treatment with Zirabev
(14,9 vs. 11,9 måneder; p = 0,1061)
(14.9 vs. 11.9 months; p = 0.1061)
Diarré, Kvalme, Opkastning, Abdominalsmer ter
Diarrhoea, Nausea, Vomiting, Abdominal pain
Febril neutropeni, Leukopeni, Neutropeni a, Trombocytopen
Febrile neutropenia, Leucopenia, Neutropenia b, Thrombo-cytopenia
(11,9 vs. 14,3 måneder; p = 0,4825)
(11.9 vs.14.3 months; p = 0.4825)
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
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)
Zirabev er, i kombination med platinbaseret kemoterapi, indiceret til 1.-linjebehandling af voksne patienter med ikke-operabel fremskreden, metastatisk eller recidiverende, ikke-småcellet lungekræft.
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.
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.
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
Posteriort reversibelt encefalopatisyn drom a,b,c
Posterior reversible encephalopathy syndrome a,b,c
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).
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.
Gennemsnitsalderen var 46,0 år (interval: 20-83) i kemoterapigruppen og 48,0 år (interval: 22-85) i kemoterapi+bevacizumabgruppen.
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.
Zirabev anvendes også hos voksne til behandling af metastatisk brystkræft.
Zirabev is also used for the treatment of adult patients with metastatic breast cancer.
Tabel 2 Alvorlige bivirkninger inddelt efter frekvens
Severe adverse reactions by frequency
Median PFS (måneder) Hazard ratio [95% konfidensinterval]
Median PFS (months) Hazard ratio [95% CI]
Samlet overlevelse - Primær analyse Hazard Ratio (95% konfidensinterval)
Overall survival - primary analysis Hazard ratio (95% CI)
Patienter i bevacizumabbehandling kan have risiko for at udvikle venøse tromboemboliske bivirkninger, herunder lungeemboli.
Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under bevacizumab treatment.
Koncentrat til infusionsvæske, opløsning 1 hætteglas á 16 ml
Concentrate for solution for infusion 1 vial of 4 ml
Pulmonal blødning/Hæmopt yse b,d
Pulmonary haemorrhage/ Haemoptysis b,d
Gastrointestinale forstyrrelser, Proktalgi
Gastrointestinal disorder, Proctalgia
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.
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.
Bedste objektive responsrate
Best overall response ratea
• 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).
• 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).
130 mg/m 2 intravenøs 2
130 mg/m2 intravenous 2 h
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.
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.
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).
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).
(17,5 vs. 15,0 måneder; p = 0,0584)
(17.5 vs.15.0 months; p = 0.0584)
(14,9 vs. 17,5 måneder; p = 0,4146)
(14.9 vs. 17.5 months; p = 0.4146)
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.
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.
Cisplatin/Gemcitabin + bevacizumab 7,5 mg/kg hver 3. uge
Cisplatin/Gemcitabine + bevacizumab 7.5 mg/kg q 3 weeks
Dyspnø, Rinitis, Epistaxis, Hoste
Dyspnoea, Rhinitis, Epis taxis , Cough
(16,2 vs. 17,5 måneder; p = 0,3769)
(16.2 vs 17.5 months; p = 0.3769)
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),
• 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,
Zirabev er medicin som anvendes hos voksne til behandling af fremskreden kræft i tyktarmen eller endetarmen.
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.
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.
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.
Samlet responsrate Rate (procent) 95 % konfidensinterval p-værdi
Overall response rate Rate (percent) 95% CI
Posteriort reversibelt encefalopati-syndrom (PRES) (se pkt.
Posterior reversible encephalopathy syndrome (see section 4.4)
Zirabev 25 mg/ml koncentrat til infusionsvæske, opløsning bevacizumab
Zirabev 25 mg/ml concentrate for solution for infusion bevacizumab
Lungeemboli, Hypoksi, Dysfonia
Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
200 mg/m2 intravenøs 2
200 mg/m2 intravenous 2 h
Ingen Bevacizumab
No Bevacizumab
Nervesystemet Perifer sensorisk neuropati
Peripheral sensory neuropathy a
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.
• 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.
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.
B-cell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
Osteonekrose af kæben b,c
Osteonecrosis of the jaw b,c
(17,5 vs. 14,3 måneder; p = 0,0609)
(17.5 vs.14.3 months; p = 0.0609)
Mindre slimhindeblødninger lokaliseret andre steder, som fx gingival eller vaginal blødning har også været rapporteret som mindre almindelige bivirkninger.
There have also been less common reactions of minor mucocutaneous haemorrhage in other locations, such as gingival bleeding or vaginal bleeding.
Sådan skal du bruge Zirabev
How to use Zirabev
I forhold til kontrolarmen.
b Relative to control arm.
Den mediane, samlede overlevelse var 20,3 måneder for placebogruppen vs. 21,2 måneder for bevacizumab-behandlede patienter i FOLFOX undergruppen, HR = 0,94, 97,5 % konfidensinterval = [0,75-1,16]; p-værdi = 0,4937.
The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab treated patients in the FOLFOX treatment subgroup, HR=0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Aneurismer og arterielle dissektioner, renal trombotisk mikroangiopati
Aneurysms and artery dissections, Renal thrombotic microangiopathy b,c
Palmoplantar erytrodysæstesisy ndrom
Palmar-plantar erythrodysaesth esia syndrome
400 mg/m2 intravenøs bolus, 600 mg/m2 intravenøs
400 mg/m2 intravenous bolus,
Venøs tromboemboli: Hyppigheden af venøse tromboemboliske bivirkninger i kliniske studier var den samme for patienter, som fik bevacizumab i kombination med kemoterapi, sammenlignet med dem, som fik kemoterapi alene.
The incidence of venous thromboembolic reactions in clinical trials was similar in patients receiving bevacizumab in combination with chemotherapy compared to those receiving the control chemotherapy alone.
Dette var et fase III, randomiseret, dobbeltblindet (med hensyn til bevacizumab), klinisk studie, hvori bevacizumab 7,5 mg/kg i kombination med oral capecitabin og intravenøs oxaliplatin (XELOX) administreret hver 3. uge blev undersøgt i forhold til bevacizumab 5 mg/kg i kombination med leucovorin med 5-fluoruracil bolus efterfulgt af 5-fluoruracil infusion og intravenøs oxaliplatin (FOLFOX-4), administreret hver 2. uge.
This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating bevacizumab 7.5 mg/kg in combination with oral capecitabine and intravenous oxaliplatin (XELOX), administered on a 3- weekly schedule; or bevacizumab 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Zirabev blive givet sammen med kemoterapibehandling, der indeholder platin.
Zirabev will be administered together with a chemotherapy regimen containing platinum.
Galdeblæreperf oration b,c
Gallbladder perforation b,c
Paclitaxel 175 mg/m2 intravenøst over 3 timer på dag 1 og topotecan 0,75 mg/m intravenøst over 30 minutter på dag 1-3, hver 3. uge
Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and topotecan 0.75 mg/m2
Andre bivirkninger ved behandling med bevacizumab, der blev set med en højere frekvens hos patienter over 65 år versus patienter ≤ 65 år, var grad 3-4 leukopeni og trombocytopeni (NCI-CTCAE v. 3) samt neutropeni (alle grader), diarré, kvalme, hovedpine og træthed (se pkt.
Other reactions with a higher frequency seen in patients over 65 were Grade 3-4 leucopenia and thrombocytopenia (NCI-CTCAE v.3); and all Grade neutropenia, diarrhoea, nausea, headache and fatigue as compared to those aged ≤ 65 years when treated with bevacizumab (see sections 4.4 and 4.8 under Thromboembolism).
I studie BO25041 blev bevacizumab føjet til post-operativ strålebehandling med samtidig adjuverende temozolomidbehandling hos pædiatriske patienter med nyligt diagnosticeret supratentorielt, infratentorielt, cerebellært eller pedunkulært høj-grads-gliom.
In study BO25041 of bevacizumab added to postoperative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with bevacizumab.
KARTON
Schedule
Posteriort reversibelt encefalopatis yndrom a,b,d
Posterior reversible encephalopathy syndrome a,b,d
4.4 og Overfølsomhedsreaktioner/infusionsreaktioner ovenfor)
Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Tabel 10 Virkningsresultater i studie E2100
Table 10 Trial E2100 efficacy results Progression-free survival
Antal patienter Samlet overlevelse Median tid (måneder) 95 % konfidensinterval
Number of patients Overall survival Median time (months) 95% CI
Samlet overlevelse Median (måneder)
Overall survival Median (months)
• diarré, kvalme, opkastning, mavesmerter,
• diarrhoea, nausea, vomiting and abdominal pain.
Intestinal perforation, Ileus, Intestinal obstruktion, Rektovaginale fistler d,e
Intestinal perforation, Ileus, Intestinal obstruction,
Fistler a,b,
Fistula a,b
• næseblod.
nose bleeds.
(p-værdi Sekundære endepunkter
Secondary endpoints
Myalgi, Artralgi, Muskelsvaghed , Rygsmerter
Myalgia, Arthralgia, Muscular weaknes s, Back pain
Ældre patienter
Other special populations Elderly patients
• Paclitaxel 135 mg/m 2 intravenøst over 24 timer på dag 1 og cisplatin 50 mg/m 2 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, 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, hver 3. uge
Paclitaxel 135 mg/m intravenous over 24 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 2, every 3 weeks (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 (q3w); or
Effekt af antineoplastiske lægemidler på bevacizumabs farmakokinetik
4.5 Interaction with other medicinal products and other forms of interaction Effect of antineoplastic agents on bevacizumab pharmacokinetics
efter fortynding
Disodium edetate
I et studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer var forekomsten af gastrointestinale-vaginale fistler 8,3 % hos bevacizumabbehandlede patienter og 0,9 % i kontrolgruppen.
In a trial of patients with persistent, recurrent or metastatic cervical cancer, the incidence of GI-vaginal fistulae was 8.3% in bevacizumab-treated patients and 0.9% in control patients, all of whom had a history of prior pelvic radiation.
Lever og galdeveje Galdeblæreperforation (ikke kendt)
Gall bladder perforation (not known)
Hypertensiv encephalopati
Hypertensive encephalopathy c
Gastrointestinale perforationer og fistler (se pkt.
Gastrointestinal (GI) perforations and fistulae (see section 4.4)
5.3), skal kvinden stoppe med at amme under behandlingen og i mindst 6 måneder efter sidste bevacizumabdosis.
As maternal IgG is excreted in milk and bevacizumab could harm infant growth and development (see section 5.3), women must discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose of bevacizumab.
Gastrointestinale perforationer (se pkt.
• Gastrointestinal perforations (see section 4.4).
Baseret på et substudie fra NSABP C-08 med 295 patienter For yderligere information henvises til nedenstående afsnit "Yderligere information om visse alvorlige bivirkninger".
c Based on a substudy from NSABP C-08 with 295 patients d
Samlet overlevelse - followup-analyse
Overall survival - Follow-up analysis Median (months)
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
Name and address of the manufacturer responsible for batch release Pfizer Ireland Pharmaceuticals
Ved forskellige indikationer er der set fistler, der involverer andre dele af kroppen end mavetarmkanalen (fx bronkopleurale og biliære fistler).
Uncommon (≥ 0.1% to < 1%) reports of fistulae that involve areas of the body other than the gastrointestinal tract (e.g. bronchopleural and biliary fistulae) were observed across various indications.
Hvert hætteglas indeholder 400 mg bevacizumab.
Each vial contains 400 mg bevacizumab.
I et randomiseret fase II-studie (BO25041) blev 121 patienter ≥ 3 år til < 18 år med nyligt diagnosticeret supratentorielt eller infratentorielt cerebellært eller pedunkulært høj-grads-gliom behandlet med post-operativ strålebehandling (RT) og adjuverende temozolomid (T) med og uden bevacizumab: 10 mg/kg intravenøst hver 2. uge.
In a randomized phase II study (BO25041) a total of 121 patients aged ≥ 3 years to <18 years with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG)
Den anbefalede dosis af Zirabev er 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
The recommended dose of Zirabev is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Blæreperforation a,b
Gallbladder perforation a,b
Hos patienter, behandlet med bevacizumab for persisterende, recidiverende eller metastatisk cervixcancer, er tidligere strålebehandling en risikofaktor for gastrointestinal perforation og alle patienter, som fik gastrointestinal perforation, havde tidligere fået strålebehandling.
Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with bevacizumab and all patients with GI perforation had a history of prior radiation.
Gastrointestinal t ulcus c,
Gastrointestinal ulcer c, Rectal haemorrhage
● en blodprop i lungerne,
● a blood clot in the blood vessels of your lungs,
Den anbefalede dosis af Zirabev er 10 mg/kg legemsvægt en gang hver 2. uge eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Den anbefalede dosis af Zirabev er 15 mg/kg kropsvægt en gang hver 3. uge som intravenøs infusion.
The recommended dose of Zirabev is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Gastrointestinalt ulcus
Gastrointestinal ulcer a
Kemoterapi + bevacizumab (n=227)
Chemotherapy + bevacizumab (n=227)
Zirabev 25 mg/ml koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT Zirabev 25 mg/ml concentrate for solution for infusion.
Den anbefalede dosis af Zirabev er 10 mg/kg legemsvægt en gang hver 2. uge administreret som intravenøs infusion.
The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Læs indlægssedlen inden brug
For intravenous use after dilution Read the package leaflet before use
4.6 Fertilitet, graviditet og amning og i pkt.
4.6 Fertility, pregnancy and lactation Women of childbearing potential
Samlet overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval)
Overall survival Median (months) Hazard ratio 95% CI
Tal med din læge, hvis du har tilstande, som forårsager betændelse i maveregionen (fx diverticulitis, mavesår, tyktarmsbetændelse forbundet med kemoterapi).
If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
Det skal du vide, før du begynder at bruge Zirabev Sådan skal du bruge Zirabev Bivirkninger
What Zirabev is and what it is used for What you need to know before you use Zirabev How to use Zirabev
Zirabev bruges også hos voksne til behandling af fremskreden nyrekræft.
Zirabev is also used for treatment of adult patients with advanced kidney cancer.
Median PFS**
assessment)**
Føtale anormaliteter a,c
Foetal abnormalities a,c
Artralgi Myalgi
Arthralgia, Myalgia