natgillin/translations-raw huggingface dataset:
Patienter blev randomiseret til platinbaseret kemoterapi (paclitaxel 200 mg/m2 og carboplatin AUC = 6,0, begge som i.v.-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 i.v.-infusion på dag 1 af hver 3-ugers serie.
Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by IV infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or PC in combination with bevacizumab at a dose of 15 mg/kg IV infusion day 1 of every 3-week cycle.
Grad 4 hypertension (hypertensiv krise) forekom hos op til 1,0 % af patienterne, som fik bevacizumab og kemoterapi, i forhold til op til 0,2 % af patienterne, som fik kemoterapi alene.
Grade 4 hypertension (hypertensive crisis) occurred in up to 1.0% of patients treated with bevacizumab and chemotherapy compared to up to 0.2% of patients treated with the same chemotherapy alone.
PFS-undergruppeanalyse af sygdomsstadie og tumoreduktionsstatus er sammenfattet i tabel 18.
PFS subgroup analyses by disease stage and debulking status are summarised in table 18.
PFS-undergruppeanalyse af sygdomsstadie og tumorreduktionsstatus er sammenfattet i tabel 16.
PFS subgroup analyses by disease stage and debulking status are summarised in table 16.
konfidensinterval Hazard ratioc p-værdi
Hazard ratioc p-value
Patienter, som tidligere har haft hypertension, kan have øget risiko for at udvikle proteinuri, når de behandles med bevacizumab.
Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with bevacizumab.
• CP-arm: Carboplatin (AUC 6) og paclitaxel (175 mg/m2) i 6 serier af 3 ugers varighed.
• CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration.
Resultaterne fra dette studie er sammenfattet i tabel 15.
The results of this study are summarised in table 15.
Sjælden Meget sjælden
Very common Common Uncommon Rare
INFORMATION I BRAILLESKRIFT Fritaget for krav om blindskrift.
INFORMATION IN BRAILLE Justification for not including Braille accepted.
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.
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), GI perforations (all grade) were reported in 3.2% of patients, all of whom had a history of prior pelvic radiation.
Effektresultater fra studie BO17707 (ICON7)
Efficacy results from study BO17707 (ICON7) Progression-free survival
• E3200: bevacizumab 10 mg/kg legemsvægt hver 2. uge i kombination med leucovorin og 5fluoruracil bolus, efterfulgt af 5-fluoruracil infusion og intravenøs oxaliplatin (FOLFOX-4) til bevacizumab-naive patienter.
• 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.
Patienterne blev randomiseret til platinbaseret kemoterapi, cisplatin 80 mg/m 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.
Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1,250 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 IV infusion day 1 of every 3-week cycle.
• hjertesvigt,
• heart failure,
I nogle kliniske studier har anafylaktiske og anafylaktoide reaktioner været rapporteret oftere hos patienter, som blev behandlet med bevacizumab i kombination med kemoterapi end med kemoterapi alene.
In some clinical trials anaphylactic and anaphylactoid-type reactions were reported more frequently in patients receiving bevacizumab in combination with chemotherapy than with chemotherapy alone.
I et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (GOG-0240) blev det rapporteret, at 1,8 % af de bevacizumab-behandlede patienter og 1,4 % af patienterne i kontrolgruppen havde haft ikke-gastrointestinale -vaginale, -vesikale eller gynækologiske fistler.
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-0240), 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.
MVASI er, i kombination med carboplatin og gemcitabin eller i kombination med carboplatin og paclitaxel, indiceret til behandling af voksne patienter med første recidiv af platinsensitiv epitelial ovariecancer, tubacancer eller primær peritonealcancer, som ikke tidligere har fået behandling med bevacizumab eller andre VEGF-hæmmere eller VEGF-receptor-målrettede lægemidler.
MVASI, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Patienter, som behandles med bevacizumab, har en øget risiko for at udvikle blødning, særligt tumorassocieret blødning.
Patients treated with bevacizumab have an increased risk of haemorrhage, especially tumourassociated haemorrhage.
Behandlingsskema
Treatment
Tromboemboli (arteriel)b,d Blødningb,d Dyb venetrombose
Thromboembolis m (arterial)b,d, Haemorrhageb,d, Deep vein thrombosis
(p-værdi Sekundære endepunkter Progressionsfri overlevelse (primær analyse)6 Median PFS (måneder)1 Hazard ratio (95 % konfidensinterval)
Secondary endpoints Progression-free survival - Primary analysis6 Median PFS (months)1 Hazard ratio [95% CI]
I-bevacizumab tyder på, at dets metaboliske profil svarer til, hvad der kan forventes af et nativt IgG-molekyle, som ikke binder VEGF.
Assessment of bevacizumab metabolism in rabbits following a single IV dose of 125I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
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 et1.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.
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.
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.
Hvert hætteglas indeholder 100 mg bevacizumab i 4 ml opløsning eller 400 mg bevacizumab i 16 ml opløsning.
Each vial contains 100 mg bevacizumab in 4 mL of solution or 400 mg bevacizumab in 16 mL of solution.
• 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.
• 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.
Oxaliplatin Leucovorin 5-Fluoruracil
5-Fluorouracil
Kombination af bevacizumab og sunitinibmaleat
Combination of bevacizumab and sunitinib malate
Du kan finde yderligere oplysninger på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
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 bevacizumab-behandlede patienter versus 4,5 % hos de patienter, der fik kemoterapi alene.
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.
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.
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.
Studiet inkluderede patienter med persisterende, recidiverende eller metastatisk planocellulært karcinom, adenoskvamøst karcinom eller adenokarcinom i cervix, som ikke kunne kureres med operation og/eller strålebehandling, og som ikke tidligere havde fået behandling med bevacizumab, andre VEGF-hæmmere eller VEGF-receptor-målrettede lægemidler.
Eligible patients had persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which was not amenable to curative treatment with surgery and/or radiation therapy and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Studie E4599 var et åbent, randomiseret, aktivt kontrolleret, multicenter klinisk studie til evaluering af bevacizumab som 1.-linjebehandling af patienter med lokal fremskreden (stadie IIIb med malignt pleural effusion), metastatisk eller recidiverende NSCLC, der ikke har dominerende planocellulær histologi.
E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating bevacizumab as first-line treatment of patients with locally advanced (stage IIIB with malignant pleural effusion), metastatic or recurrent NSCLC other than predominantly squamous cell histology.
16 ml opløsning i et hætteglas (type I glas) med butylgummiprop indeholdende 400 mg bevacizumab.
16 mL solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.
4 ml opløsning i et hætteglas (type I glas) med butylgummiprop indeholdende 100 mg bevacizumab.
4 mL solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
Recidiverende ovariecancer
Recurrent ovarian cancer
• Pegyleret liposomal doxorubicin 40 mg/m2 som 1 mg/min i.v.-infusion, kun på dag 1 hver 4. uge.
• PLD 40 mg/m2 as a 1 mg/min IV infusion on day 1 only every 4 weeks.
Anden faktor Samlet overlevelse - Primær analyse1 Hazard ratio (95 % konfidensinterval)
Overall survival - Primary analysis1 Hazard ratio (95% CI)
• hul i tarmvæggen,
• a hole in your gut wall,
I to tidligere studier med i alt 30 børn over 3 år med recidiverende eller progredierende høj-grads-gliom blev der ikke observeret antitumor-aktivitet ved behandling med bevacizumab og irinotecan (CPT-11).
Anti-tumour activity was not observed in two earlier studies among a total of 30 children aged > 3 years old with relapsed or progressive high-grade glioma when treated with bevacizumab and irinotecan (CPT 11).
Effektresultater fra studie AVF4095g Progressionsfri overlevelse
Efficacy results from study AVF4095g
Anoreksi Hypomagnesiæmi Hyponatriæmi
Anorexia Hypomagnesae mia
Resultater vises i tabel 22.
Results are presented in table 22.
MVASI er, i kombination med paclitaxel, topotecan eller pegyleret liposomal doxorubicin, indiceret til behandling af voksne patienter med platin-resistent recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer, som ikke har gennemgået mere end to kemoterapiregimer, og som ikke tidligere har fået behandling med bevacizumab, andre VEGF-hæmmere eller med VEGF-receptor-målrettede lægemidler (se pkt.
MVASI in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents (see section 5.1).
Der blev randomiseret 105 patienter til 5-FU/FA + placebo-armen og 104 patienter til 5FU/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.
Kun patienter, som havde histologisk dokumenteret ovariecancer, primært peritonealcancer eller tubacancer, som havde recidiv ˃ 6 måneder efter platinbaseret kemoterapi, som ikke havde fået kemoterapi for recidiverende sygdom, og som ikke tidligere havde fået bevacizumab eller behandling med andre VEGF-hæmmere eller VEGF-receptor-målrettede lægemidler, blev inkluderet i studiet.
Only patients with histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that had recurred > 6 months after platinum-based chemotherapy and who had not received chemotherapy in the recurrent setting and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents were included in the study.
Et stort fase III-studie blev designet for at undersøge behandlingseffekten af bevacizumab i kombination med paclitaxel, målt ved det primære endepunkt progressionsfri overlevelse (PFS).
A large phase III trial was designed to investigate the treatment effect of bevacizumab in combination with paclitaxel, as measured by the primary endpoint of PFS. A clinically meaningful and statistically significant improvement in PFS was observed.
2 timer 1.000 mg/m2 oral to gange daglig
1,000 mg/m2 oral bid
Strålebehandling
Radiotherapy
Proteinuri er blevet rapporteret hos mellem 0,7 % og 54,7 % af patienterne, som fik bevacizumab i kliniske studier.
In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving bevacizumab.
• CPB7,5+-arm: Carboplatin (AUC 6) og paclitaxel (175 mg/m bevacizumab (7,5 mg/kg hver 3. uge) i op til 12 måneder (bevacizumab blev startet i anden kemoterapiserie, hvis behandling blev initieret inden for 4 uger efter operation, og i første serie, hvis behandling blev initieret mere end 4 uger efter operation).
• CPB7.5+ arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks plus bevacizumab (7.5 mg/kg q3w) for up to 12 months (bevacizumab was started at cycle 2 of chemotherapy if treatment was initiated within 4 weeks of surgery or at cycle 1 if treatment was initiated more than 4 weeks after surgery).
Intestinal obstruktion Rektovaginale fistlerc,d Gastrointestinale forstyrrelser Stomatitis
Intestinal obstruction, Recto-vaginal fistulaec,d, Gastrointestinal disorder, Stomatitis, Proctalgia
Samlet overlevelse (OS)
Primary endpoint Overall survival (OS)
• 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).
I kliniske studier af ovariecancer blev der observeret sårhelingskomplikationer af grad 3-5 hos op til 1,8 % af patienterne i bevacizumab-armen i forhold til 0,1 % i kontrolarmen (NCI-CTCAE v. 3).
In clinical trials of ovarian cancer, grade 3-5 wound healing complications were observed in up to 1.8% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3).
Hazard ratio (95 % konfidensinterval) (registrerings-form)b p-værdi
Hazard ratio (95% CI) (registration form)b
Pulmonal hypertensionc Næseseptum perforationc
Pulmonary hypertensionc, Nasal septum perforationc
Information om føtale misdannelser observeret efter markedsføring er angivet i pkt.
Information on foetal malformations observed in the post-marketing setting are provided in sections 4.6 and 4.8.
Febril neutropeni Leukopeni Neutropenib Trombocytopeni
Febrile neutropenia, Leucopenia, Neutropeniab Thrombocytope nia
MVASI vil blive givet sammen med kemoterapibehandling, der indeholder platin.
MVASI will be administered together with a chemotherapy regimen containing platinum.
Der har været sjældne rapporter om symptomer, der stemmer overens med PRES, en sjælden neurologisk forstyrrelse, hos bevacizumab-behandlede patienter.
There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder.
Ovariesvigtb,c,d
Ovarian failureb,c,d
Cisplatin/Gemcitabin + bevacizumab 15 mg/kg hver 3. uge
Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 weeks
Posteriort reversibelt encefalopati-syndrom (PRES) (se pkt.
Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4.8)
Det primære endepunkt var progressionsfri overlevelse; de sekundære endepunkter omfattede objektiv responsrate og samlet overlevelse.
The primary endpoint was progression-free survival, with secondary endpoints including objective response rate and overall survival.
• Kemoterapi + bevacizumab-armen:
• CT + BV arm (chemotherapy plus bevacizumab):
Topotecan + paclitaxel vs cisplatino + paclitaxel
Topotecan + Paclitaxel vs. Cisplatin + Paclitaxel
Mindre slimhindeblødninger lokaliseret andre steder, som f.eks. 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.
Den primære analyse af investigatorvurderet PFS med cut-off den 28. februar 2010 viser en ustratificeret hazard ratio på 0,79 (95 % konfidensinterval: 0,68-0,91, tosidig log-rank p-værdi 0,0010) med en median PFS på 16,0 måneder i CP-armen og 18,3 måneder i CPB7,5+-armen.
The primary analysis of investigator assessed PFS with a data cut-off date of 28 February 2010 shows an unstratified hazard ratio of 0.79 (95% CI: 0.68-0.91, 2-sided log-rank p-value 0.0010) with a median PFS of 16.0 months in the CP arm and 18.3 months in the CPB7.5+ arm.
• Hvert 4 ml hætteglas indeholder 100 mg bevacizumab svarende til 1,4 mg/ml efter foreskreven fortynding.
• Each 4 mL vial contains 100 mg of bevacizumab, corresponding to 1.4 mg/mL when diluted as recommended.
Studiet var et åbent, randomiseret, aktivt kontrolleret, klinisk fase II-studie, som undersøgte bevacizumab i kombination med 5-FU/FA som 1.-linjebehandling af metastatisk kolorektalkræft.
This was a phase II randomised, active-controlled, open-labelled clinical trial investigating bevacizumab in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer.
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).
* Eksploratorisk analyse, opdateret analyse af samlet overlevelse på klinisk cut-off 28. oktober 2015, hvor ca.
Exploratory analysis; OS updated analysis at clinical cut-off on 28 October 2015, approx. 45% patient had died and OS is therefore considered immature.
Gastrointestinal perforationa,b
Gallbladder perforationa,b
(16,2 vs 12,0 måneder: p =
(16.2 vs. 12.0 months; p = 0.1342)
(12,0 vs 15,0 måneder; p =
(12.0 vs. 15.0 months;
Der blev randomiseret 71 patienter til bolus 5-FU/FA eller 5-FU/FA + bevacizumab (5 mg/kg hver 2. uge).
Seventy-one patients were randomised to receive bolus 5-FU/FA or 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks).
Procentdelen af patienter med ECOG-performancestatus 1 eller ≥ 2 var henholdsvis 38,7 % og 5,0 % i kemoterapi-armen og 29,8 % og 9,0 % i kemoterapi + bevacizumabarmen.
The percentage of patients with an ECOG PS of 1 or ≥ 2 was 38.7% and 5.0% in the CT arm, and 29.8% and 9.0% in the CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Medianalder var 46,0 år (spændvidde: 20-83) i kemoterapigruppen og 48,0 år (spændvidde: 22-85) i kemoterapi + bevacizumab-gruppen.
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.
Effektresultaterne er præsenteret i tabel 12.
The efficacy results are presented in table 12.
I et klinisk studie BO20924 gav tilføjelse af bevacizumab til standardbehandlingen ingen kliniske fordele hos 71 evaluérbare børn (fra 6 måneder til under 18 år) med metastatisk rabdomyosarkom og ikkerabdomyosarkom bløddelssarkom.
Addition of bevacizumab to standard of care did not demonstrate clinical benefit in clinical trial BO20924, in 71 evaluable children (from age 6 months to less than 18 years old) patients with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma (see section 4.2 for information on paediatric use).
Patienter i behandling med bevacizumab 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.
Hvert hætteglas med 16 ml koncentrat indeholder 400 mg bevacizumab.
Each vial of 16 mL of concentrate contains 400 mg of bevacizumab.
Når lægemidlet anvendes til voksne patienter med fremskreden kræft i æggestokkene, kræft i æggelederne eller primær bughindekræft, hvor sygdommen er kommet igen mere end 6 måneder efter sidste kemoterapi, som indeholdt platin, vil MVASI blive givet sammen med carboplatin og gemcitabin eller sammen med carboplatin og paclitaxel.
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back at least 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, MVASI will be administered in combination with carboplatin and gemcitabine or with carboplatin and paclitaxel.
• Carboplatin (AUC 4, dag 1) og gemcitabin (1.000 mg/m2 på dag 1 og 8) samtidig med bevacizumab (15 mg/kg, dag 1) hver 3. uge i 6 og op til 10 behandlingsserier, efterfulgt af bevacizumab (15 mg/kg hver 3. uge) som monoterapi indtil sygdomsprogresssion eller uacceptabel toksicitet.
• Carboplatin (AUC 4, day 1) and gemcitabine (1,000 mg/m2 on days 1 and 8) and concurrent bevacizumab (15 mg/kg day 1) every 3 weeks for 6 and up to 10 cycles followed by bevacizumab (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity.