natgillin/translations-raw huggingface dataset:
Den kliniske effekt af bevacizumab, målt som PFS, blev observeret hos alle testede præspecificerede undergrupper (herunder sygdomsfrit interval, antal metastatiske foci, tidligere adjuverende kemoterapi og østrogenreceptorstatus (ER)).
The clinical benefit of bevacizumab as measured by PFS was seen in all pre-specified subgroups tested (including disease-free interval, number of metastatic sites, prior receipt of adjuvant chemotherapy and oestrogen receptor (ER) status).
Progressionsfri overlevelse1
Progression-free survival1
En tredje gruppe på 110 patienter fik en bolus af 5-FU/FA + bevacizumab (arm 3).
A third group of 110 patients received bolus 5-FU/FA + bevacizumab (Arm 3).
Der blev ikke set øget hyppighed af andre bivirkninger, inklusive gastrointestinal perforation, sårhelingskomplikationer, kongestiv hjerteinsufficiens og blødninger hos ældre patienter (> 65 år), som fik bevacizumab, sammenlignet med patienter under 65 år, som fik bevacizumab.
No increase in the incidence of other reactions, including gastrointestinal perforation, wound healing complications, congestive heart failure, and haemorrhage was observed in elderly patients (> 65 years) receiving bevacizumab as compared to those aged ≤ 65 years treated with bevacizumab.
• AVF2107g: Et ugentligt regime med irinotecan/bolus af 5-fluoruracil/folininsyre (IFL-regime) i 4 uger i hver 6 ugers cyklus (Saltz-regimet).
• AVF2107g: A weekly schedule of irinotecan/bolus 5-fluorouracil/folinic acid (IFL) for a total of 4 weeks of each 6 week-cycle (Saltz regimen).
MVASI er, i kombination med kemoterapi baseret på fluoropyrimidin, indiceret til behandling af voksne patienter med metastatisk karcinom i colon eller rectum.
MVASI in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Yderligere tre studier med bevacizumab er blevet udført hos patienter med metastatisk kolorektalkræft: 1.linje-behandling (NO16966), 2. linje-behandling uden tidligere bevacizumab- behandling (E3200) samt 2. linje-behandling efter sygdomsprogression efter i 1.-linje-behandling med bevacizumab (ML18147).
Three additional studies with bevacizumab have been conducted in mCRC patients: first-line (NO16966), second-line with no previous bevacizumab treatment (E3200), and second-line with previous bevacizumab treatment following disease progression in first-line (ML18147).
Behandlingen med MVASI skal stoppes permanent, hvis du får
The administration of MVASI should be permanently discontinued if you develop
• MVASI kan øge risikoen for blødning eller problemer med sårhelingen efter operation.
• MVASI can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
MVASI er beregnet til intravenøs anvendelse.
MVASI is for intravenous use.
Mulige risikofaktorer inkluderer planocellulær histologi, behandling med antireumatiske/antiinflammatoriske lægemidler, behandling med antikoagulantia, tidligere strålebehandling, behandling med bevacizumab, aterosklerose i anamnesen, central placering af tumor og kavernedannelse i tumorer før eller under behandling.
Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, bevacizumab therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy.
Studiet evaluerede effekten af at tilføje bevacizumab til carboplatin+paclitaxel og fortsætte med bevacizumab som monoterapi til sygdomsprogession eller uacceptabel toksicitet, sammenlignet med carboplatin+paclitaxel alene.
The study evaluated the effect of adding bevacizumab to carboplatin+paclitaxel and continuing bevacizumab as a single agent until disease progression or unacceptable toxicity compared to carboplatin+paclitaxel alone.
Administration af bevacizumab eller dets parenterale, murine antistof til nøgne mus i xenotransplantationsmodeller af kræft medførte omfattende anti-tumor aktivitet ved humane kræftformer,
Administration of bevacizumab or its parental murine antibody to xenotransplant models of cancer in nude mice resulted in extensive anti-tumour activity in human cancers, including colon, breast, pancreas and prostate.
For patienter, der udvikler PRES, anbefales behandling af symptomerne samt kontrol af hypertensionen samtidig med, at MVASIbehandlingen afbrydes.
In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of MVASI.
Alle symptomerne var reversible efter afbrydelse af behandling med bevacizumab og sunitinibmaleat (se Hypertension, Proteinuri, PRES i pkt.
All of these findings were reversible upon discontinuation of bevacizumab and sunitinib malate (see Hypertension, Proteinuria, PRES in section 4.4).
• Overfølsomhed over for præparater fremstillet i ovarieceller (CHO) fra kinesisk hamster eller andre rekombinante eller humaniserede antistoffer.
• Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
Overfølsomhed Infusionsreaktionera,b,d
Hypersensitivity, Infusion reactionsa,b,d
Hos de patienter, der blev behandlet med bevacizumab, er der fra kliniske studier set en stigning på mindst 2 % i hyppigheden af følgende grad 3 og 4 (NCI-CTCAE v. 3) laboratorieanormaliteter sammenlignet med kontrolgrupperne: Hyperglykæmi, nedsat hæmoglobin, hypokaliæmi, hyponatriæmi, nedsat antal hvide blodceller, stigning i international normaliseret ratio (INR).
Across clinical trials, the following grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patients treated with bevacizumab with at least a 2% difference compared to the corresponding control groups: hyperglycaemia, decreased haemoglobin, hypokalaemia, hyponatraemia, decreased white blood cell count, increased international normalised ratio (INR).
Sammenlagt blev 1.873 patienter randomiseret til tre lige store arme:
A total of 1,873 patients were randomised in equal proportions to the following three arms:
Hos patienter i studie AVF3694g, som fik antracykliner samtidig med bevacizumab, svarede hyppigheden af CHF af grad 3 eller højere i de respektive bevacizumab- og kontrolarme til de hyppigheder, som er set i andre studier af metastatisk brystkræft: 2,9 % i antracyklin + bevacizumab-armen og 0 % i antracyklin + placebo-armen.
For patients in study AVF3694g who received anthracyclines concomitantly with bevacizumab, the incidences of grade 3 or higher CHF for the respective bevacizumab and control arms were similar to those in the other studies in metastatic breast cancer: 2.9% in the anthracycline + bevacizumab arm and 0% in the anthracycline + placebo arm.
Hazard ratio (95 % konfidensinterval) > 12 måneder (n = 282) Median
Hazard ratio (95% CI) > 12 months (n = 282) Median
** Randomiserede patienter med målbar sygdom ved baseline.
** Randomised patients with measurable disease at baseline.
• Blødninger, inklusive pulmonal blødning/hæmoptyse, som er mere almindelig hos patienter med ikke-småcellet lungekræft (se pkt.
• Haemorrhage, including pulmonary haemorrhage/haemoptysis, which is more common in non small cell lung cancer patients (see section 4.4).
Overfølsomhedsreaktioner og infusionsreaktioner (ikke kendt) med følgende mulige co-manifestationer: dyspnø/vejrtrækningsbesvær, blussen/rødme/udslæt, hypotension eller hypertension, nedsat iltmætning, brystsmerter, rigor og kvalme/opkastning (se også pkt.
Immune system disorders Hypersensitivity reactions and infusion reactions (not known); with the following possible co-manifestations: dyspnoea/difficulty breathing, flushing/redness/rash, hypotension or hypertension, oxygen desaturation, chest pain, rigors and nausea/vomiting (see also section 4.4 and Hypersensitivity reactions/infusion reactions above)
• AVF0780g: I kombination med en bolus af 5-fluoruracil/folininsyre (5-FU/FA) i 6 uger i hver 8 ugers cyklus (Roswell Park regimet).
• AVF0780g: In combination with bolus 5-fluorouracil/folinic acid (5-FU/FA) for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen).
I et enkelt-arms-studie (PBTC-022) blev18 børn med recidiverende eller progredierende højgrads-gliom, som ikke involverede hjernebroen (herunder 8 med glioblastom [WHO grad IV], 9 med anaplastisk astrocytom [grad III] og 1 med anaplastisk oligodendrogliom [grad III]), behandlet med bevacizumab (10 mg/kg) med 2 ugers mellemrum og derefter med bevacizumab i kombination med CPT-11 (125-350 mg/m²) hver anden uge indtil progression.
In a single-arm study (PBTC-022), 18 children with recurrent or progressive non-pontine high-grade glioma (including 8 with glioblastoma [WHO grade IV], 9 with anaplastic astrocytoma [grade III] and 1 with anaplastic oligodendroglioma [grade III]) were treated with bevacizumab (10 mg/kg) two weeks apart and then with bevacizumab in combination with CPT-11 (125-350 mg/m2) once every two weeks until progression.
Resultater for samlet overlevelse fra studie GOG-0240 med forsøgsbehandling Behandlingssammenligning
Overall survival results from study GOG-0240 by trial treatment Treatment comparison Other factor
Frontlinjebehandling: MVASI administreres sammen med carboplatin og paclitaxel i op til 6 behandlingsserier, efterfulgt af fortsat behandling med MVASI som monoterapi indtil sygdomsprogression eller i op til 15 måneder eller indtil uacceptabel toksicitet, alt efter hvad der forekommer først.
Front-line treatment: MVASI is administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of MVASI as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier.
Der er observeret en øget hyppighed af alvorlig neutropeni, febril neutropeni eller infektion med eller uden alvorlig neutropeni (herunder nogle dødsfald) hos patienter, som blev behandlet med visse myelotoksiske kemoterapiregimer plus bevacizumab i forhold til kemoterapi alene.
Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed in patients treated with some myelotoxic chemotherapy regimens plus bevacizumab in comparison to chemotherapy alone.
Effekt af antineoplastiske lægemidler på bevacizumabs farmakokinetik
Effect of antineoplastic agents on bevacizumab pharmacokinetics
Af de 452 patienter randomiseret ved baseline var størstedelen kaukasiere (80,0 % i kemoterapigruppen og 75,3 % i kemoterapi + bevacizumab-gruppen), havde planocellulært karcinom (67,1 % i kemoterapigruppen og 69,6 % i kemoterapi + bevacizumab-gruppen), havde vedvarende/recidiverende sygdom (83,6 % i kemoterapigruppen og 82,8 % i kemoterapi + bevacizumab-gruppen), havde 1-2 metastatiske områder (72,0 % i kemoterapigruppen og 76,2 % i kemoterapi + bevacizumab-gruppen), havde lymfeknude-involvering (50,2 % i kemoterapigruppen og 56,4 % i kemoterapi + bevacizumabgruppen) og havde en platin-fri periode på ≥ 6 måneder (72,5 % i kemoterapigruppen og 64,4 % i kemoterapi + bevacizumab-gruppen).
Of the 452 patients randomised at baseline, the majority of patients were white (80.0% in the chemo alone group and 75.3% in the chemo + bevacizumab group), had squamous cell carcinoma (67.1% in the chemo alone group and 69.6% in the chemo + bevacizumab group), had persistent/recurrent disease (83.6% in the chemo alone group and 82.8% in the chemo + bevacizumab group), had 1-2 metastatic sites (72.0% in the chemo alone group and 76.2% in the chemo + bevacizumab group), had lymph node involvement (50.2% in the chemo alone group and 56.4% in the chemo + bevacizumab group), and had a platinum free interval ≥ 6 months (72.5% in the chemo alone group and 64.4% in the chemo + bevacizumab group).
Der blev ikke vist en signifikant forbedring af hændelsesfri overlevelse (EFS) (vurderet af en central Radiology Review Committee), når bevacizumab var føjet til RT/T-behandlingsarmen, sammenlignet med RT/T-behandlingsarmen alene (Hazard Ratio = 1,44; 95 % konfidensinterval: 0,90; 2,30).
The study did not meet its primary endpoint of demonstrating a significant improvement of event free survival (EFS) (Central Radiology Review Committee (CRRC)-assessed) when bevacizumab was added to the RT/T arm compared with RT/T alone (HR = 1.44; 95% CI: 0.90, 2.30).
Nekrotiserende fasciitis, som regel sekundært til sårhelingskomplikationer, gastrointestinal perforation eller fisteldannelse (sjælden) (se også pkt.
Infections and infestations Necrotising fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation (rare) (see also section 4.4)
For yderligere information henvises til Tabel 3 ”Bivirkninger rapporteret post-marketing”.
For further information please refer to table 3 “Adverse reactions reported in post-marketing setting”.
Der er ikke observeret klinisk relevante interaktioner af bevacizumab på farmakokinetikken af samtidig administreret interferon alfa 2a, erlotinib (og den aktive metabolit OSI-420) eller af følgende kemoterapeutika: irinotecan (og den aktive metabolit SN38), capecitabin, oxaliplatin (bestemt ved måling af frit og totalt platin) og cisplatin.
No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of co-administered interferon alfa 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 100 mg/4 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/4 mL
Hazard ratio blev estimeret ud fra Cox proportionelle hazard modeller stratificeret efter varighed af platinfri periode før inklusion i studiet per eCRF (electronic case report form) og sekundær kirurgisk tumorreduktionsstatus Ja/Nej.
Hazard ratio was estimated from Cox proportional hazards models stratified by the duration of platinum free-interval prior to enrolling onto this study per eCRF (electronic case report form) and secondary surgical debulking status Yes/No (Yes = randomised to undergo cytoreduction or randomised to not undergo cytoreduction; No = not a candidate or did not consent to cytoreduction).
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 400 mg/16 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 400 mg/16 mL
Det primære endepunkt var progressionsfri overlevelse og de sekundære endepunkter for studiet inkluderede længden af den samlede overlevelse.
The primary endpoint was progression-free survival, secondary endpoints for the trial included the duration of overall survival.
• Gastrointestinale perforationer (se pkt.
• Gastrointestinal perforations (see section 4.4).
Der blev randomiseret 813 patienter til behandling med IFL + placebo (arm 1) eller IFL + bevacizumab (5 mg/kg hver 2. uge, arm 2).
Eight hundred and thirteen patients were randomised to receive IFL + placebo (Arm 1) or IFL + bevacizumab (5 mg/kg every 2 weeks, Arm 2).
Tidligere strålebehandling er en væsentlig risikofaktor for udvikling af gastrointestinalevaginale fistler, og alle patienter, som fik gastrointestinale-vaginale fistler, havde tidligere fået strålebehandling.
Prior radiation is a major risk factor for the development of GI-vaginal fistulae and all patients with GI-vaginal fistulae had a history of prior radiation.
Sårhelingskomplikationera,b Palmoplantar erytrodysæstesi syndrom
Wound healing complicationsa,b, Palmar-plantar erythrodysaesthesia syndrome
Hypertensionb,d Tromboemboli (venøs)b,d
Hypertensionb,d, Thromboemboli sm (venous)b,d
Resultaterne for behandling med bevacizumab og førsøgsbehandling fra den primære analyse og followup-analysen er præsenteret i tabel 24 og 25.
Results from the primary analysis and the follow-up analysis are presented by bevacizumab treatment and by trial treatment in table 24 and 25, respectively.
Effekten og sikkerheden af bevacizumab i kombination med kemoterapi (paclitaxel og cisplatin eller paclitaxel og topotecan) i behandlingen af patienter med persisterende, recidiverende eller metastatisk cervixkarcinom blev evalueret i studiet GOG-0240, et randomiseret, 4-armet, åbent fase III multicenterstudie.
The efficacy and safety of bevacizumab in combination with chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in the treatment for patients with persistent, recurrent or metastatic carcinoma of the cervix was evaluated in study GOG-0240, a randomised, four-arm, open label, multicentre phase III trial.
Resultaterne er præsenteret i tabel 11.
Results are presented in table 11.
MVASI vil blive givet i kombination med kemoterapibehandling, der indeholder fluoropyrimidin.
MVASI will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Hypertension blev generelt adækvat behandlet med orale antihypertensiva som f.eks. ACE-hæmmere, diuretika og calciumantagonister.
Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensinconverting enzyme inhibitors, diuretics and calcium-channel blockers.
I et retrospektivt studie på en enkelt institution blev 12 konsekutive børn (2005-2008) med recidiverende eller progredierende høj-grads-gliom (3 med WHO grad IV, 9 med grad III) behandlet med bevacizumab (10 mg/kg) og irinotecan (125 mg/m²) hver anden uge.
In a retrospective single institution series, 12 consecutive (2005 to 2008) children with relapsed or progressive high-grade glioma (3 with WHO grade IV, 9 with grade III) were treated with bevacizumab (10 mg/kg) and irinotecan (125 mg/m2) every 2 weeks.
Effektresultater fra studie BO17705
Efficacy results for trial BO17705
Studie E2100 var et åbent, randomiseret, aktivt kontrolleret, multicenter klinisk studie til evaluering af bevacizumab i kombination med paclitaxel til lokalt recidiverende eller metastatisk brystkræft hos patienter, som ikke tidligere havde fået kemoterapi for lokalt recidiverende og metastatisk sygdom.
Trial E2100 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating bevacizumab in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) MVASI 25 mg/ml koncentrat, sterilt bevacizumab i.v.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MVASI 25 mg/mL sterile concentrate bevacizumab
Patienter med histologisk bekræftet metastatisk kolorektalkræft og sygdomsprogression blev randomiseret 1:1 indenfor 3 måneder efter seponering af 1.linje bevacizumab-behandling og fik fluoropyrimidin/oxaliplatin- eller fluoropyrimidin/irinotecan-baseret kemoterapi (kemoterapi ændret afhængigt af 1.linje-kemoterapi) med eller uden bevacizumab.
Patients with histologically confirmed mCRC and disease progression were randomised 1:1 within 3 months after discontinuation of bevacizumab first-line therapy to receive fluoropyrimidine/oxaliplatin- or fluoropyrimidine/irinotecan-based chemotherapy (chemotherapy switched depending on first-line chemotherapy) with or without bevacizumab.
Sådan skal du bruge MVASI
How to use MVASI
• en blodprop i arterierne,
• a blood clot in your arteries,
10 mg/kg hver 2. uge.
10 mg/kg every 2 weeks.
CHF-bivirkninger af grad 3 eller højere var lidt hyppigere hos patienter i behandling med bevacizumab i kombination med kemoterapi end hos patienter, som blev behandlet med kemoterapi alene.
CHF grade 3 or higher reactions were somewhat more frequent among patients receiving bevacizumab in combination with chemotherapy than in patients receiving chemotherapy alone.
Patienter, som tidligere var behandlet med bevacizumab eller tidligere havde fået systemisk anticancerbehandling for ovariecancer (f.eks. kemoterapi, behandling med monoklonale antistoffer, behandling med tyrosinkinasehæmmer eller hormonbehandling), eller som tidligere havde fået strålebehandling af abdomen eller bækken, blev ekskluderet fra studiet.
Patients who had received prior therapy with bevacizumab or prior systemic anti-cancer therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, or hormonal therapy) or previous radiotherapy to the abdomen or pelvis were excluded from the study.
FOLFOX-4 eller XELOX + bevacizumab (n = 699)
FOLFOX-4 or XELOX + bevacizumab (n = 699)
MVASI skal seponeres hos patienter med livstruende (grad 4) tromboemboliske bivirkninger, herunder lungeemboli (NCI-CTCAE v. 3).
MVASI should be discontinued in patients with life-threatening (grade 4) thromboembolic reactions, including pulmonary embolism (NCI-CTCAE v.3).
Patienter, som tidligere har oplevet en venøs tromboembolisk bivirkning, kan have en højere risiko for fornyet hændelse, hvis de får bevacizumab i kombination med kemoterapi, end hvis de får kemoterapi alene.
Patients who have experienced a venous thromboembolic reaction may be at higher risk for a recurrence if they receive bevacizumab in combination with chemotherapy versus chemotherapy alone.
Brugen af bevacizumab er blevet forbundet med alvorlige tilfælde af fistler, herunder også letale tilfælde.
Bevacizumab use has been associated with serious cases of fistulae including reactions resulting in death.
• åbent sår eller hul i slimhinderne i maven eller tyndtarmen (symptomer kan være mavesmerter, oppustethed, sort tjæreagtig afføring eller blod i afføringen eller blod i opkast),
• an open sore or hole in the lining of the stomach or small intestine (the signs may include abdominal pain, feeling bloated, black tarry stools or blood in your stools (faeces) or blood in your vomit),
Overfølsømhed Infusionsreaktionera,b,c
Infusion reactionsa,b,c
Tilføjelse af bevacizumab til RT/T viste ikke kliniske fordele i studie BO25041 hos 60 evaluerbare børn med nyligt diagnosticeret supratentorielt eller infratentorielt cerebellært eller pedunkulært høj-grads-gliom (se pkt.
Addition of bevacizumab to RT/T did not demonstrate clinical benefit in study BO25041 in 60 evaluable children patients with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG) (see section 4.2 for information on paediatric use).
Grad 4 proteinuri (nefrotisk syndrom) blev set hos op til 1,4 % af de patienter, som blev behandlet med bevacizumab.
Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of patients treated with bevacizumab.
Tilfælde af osteonekrose af kæben (ONJ) er blevet rapporteret hos patienter behandlet med bevacizumab, hvoraf de fleste tilfælde forekom hos patienter, der havde kendte risikofaktorer for ONJ, navnlig eksponering for intravenøse bisfosfonater og/eller en anamnese med tandsygdomme, som krævede invasive tandprocedurer (se også pkt.
Cases of osteonecrosis of the jaw (ONJ) have been reported in patients treated with bevacizumab, most of which occurred in patients who had identified risk factors for ONJ, in particular exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4) Cases of non-mandibular osteonecrosis have been observed in bevacizumab-treated paediatric patients (see section 4.8, Paediatric population)
Der bør udvises forsigtighed, når patienter med klinisk signifikant hjertesygdom, såsom hjertekarsygdom eller kongestiv hjerteinsufficiens, behandles med bevacizumab.
Caution should be exercised when treating patients with clinically significant cardiovascular disease such as pre-existing coronary artery disease, or congestive heart failure with bevacizumab.
Ingen bevacizumab
No bevacizumab
Patienter med tromboemboliske bivirkninger ≤ grad 3 (NCI-CTCAE v. 3) skal monitoreres nøje.
Patients with thromboembolic reactions ≤ grade 3 need to be closely monitored (NCI-CTCAE v.3).
Placebo eller bevacizumab
Placebo or bevacizumab
Når MVASI administreres i kombination med topotecan (givet på dag 1-5 hver 3. uge), er den anbefalede MVASI-dosis 15 mg/kg kropsvægt en gang hver 3. uge som intravenøs infusion.
When MVASI is administered in combination with topotecan (given on days 1-5, every 3 weeks), the recommended dose of MVASI is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.