natgillin/translations-raw huggingface dataset:
Sekundære endepunkter Progressionsfri overlevelse (primær analyse)6 Median PFS (måneder)1
Progression-free survival - Primary analysis6 Median PFS (months)1
bolusinjektion umiddelbart efter leucovorin
5-Fluorouracil: IV bolus injection immediately after leucovorin
Cisplatin/Gemcitabin + Avastin
Cisplatin/Gemcitabine + Avastin
Patienter, som behandles med Avastin, har en øget risiko for at udvikle blødning, særligt tumorassocieret blødning.
Patients treated with Avastin have an increased risk of haemorrhage, especially tumour-associated haemorrhage.
● 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).
Behandlingen blev givet indtil sygdomsprogression eller indtil uacceptabel toksicitet.
Treatment was given until progressive disease or unacceptable toxicity.
Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
● Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2 ºC - 8 ºC) Må ikke nedfryses
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Progressionsfri overlevelse efter tid fra sidste platinbehandling indtil recidiv.
Table 21 Progression-free survival by time from last platinum therapy to recurrence Investigator Assessment
● 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).
Behandlingen skal seponeres permanent hos patienter, som udvikler arterielle tromboemboliske bivirkninger.
Therapy should be permanently discontinued in patients who develop arterial thromboembolic reactions.
I E3200-studiet blev der anvendt en bevacizumabdosis svarende til 5 mg/kg/uge til bevacizumab-naive patienter, mens der i ML18147-studiet blev anvendt en bevacizumabdosis svarende til 2,5 mg/kg/uge til patienter, som tidligere var behandlet med bevacizumab.
Study E3200 used a 5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-naïve patients, while study ML18147 used a 2.5 mg/kg/week equivalent dose of bevacizumab in bevacizumabpretreated patients.
● 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.
Efterfølgende infusioner vil måske kun vare 30 minutter.
Later infusions may be given to you over 30 minutes.
Patienter, behandlet med Avastin for persisterende, recidiverende eller metastatisk cervixcancer, har en øget risiko for dannelse af fistler mellem vagina og alle dele af mave-tarmkanalen (gastrointestinale-vaginale fistler).
Patients treated for persistent, recurrent, or metastatic cervical cancer with Avastin are at increased risk of fistulae between the vagina and any part of the GI tract (Gastrointestinal-vaginal fistulae).
For patienter, der udvikler PRES, anbefales behandling af symptomerne samt kontrol af hypertensionen samtidig med, at Avastinbehandlingen afbrydes.
In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Avastin.
Meget almindelig Almindelig
Very Common
De blødninger, som blev observeret i de kliniske studier, var fortrinsvis tumorassocierede blødninger (se nedenfor) og mindre slimhindeblødninger (f.eks. epistaxis).
The haemorrhagic reactions that have been observed in clinical trials were predominantly tumourassociated haemorrhage (see below) and minor mucocutaneous haemorrhage (e.g. epistaxis).
Randomiserede patienter med stadie III optimalt tumoreduceret sygdom 2,3
Randomised patients stage III optimally debulked disease 2,3
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.
Hvis du holder op med at få Avastin
If you stop treatment with Avastin
Den første infusion vil vare 90 minutter.
The first infusion will be given to you over 90 minutes.
Investigators vurdering*
Investigator assessment*
0,65 (p < 0,0001) 95 % konfidensinterval (0,56-0,76)
0.65 (p < 0.0001) 95% CI (0.56; 0.76)
Frontlinjebehandling: Avastin administreres sammen med carboplatin og paclitaxel i op til 6 behandlingsserier, efterfulgt af fortsat behandling med Avastin som monoterapi indtil sygdomsprogression eller i op til 15 måneder eller indtil uacceptabel toksicitet, alt efter hvad der forekommer først.
Front-line treatment: Avastin is administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of Avastin as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 400 mg/16 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 400 mg/16 ml
• alvorlige infektioner i huden eller underliggende lag, især hvis du har haft huller i tarmvæggen eller problemer med sårheling
• serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing,
Progressionfri overlevelse Median (måneder)
Progression-Free Survival Median (months)
Abscesa,b,d
Sepsis, Abscessb,d,
I studie BO20924 hvor Avastin var givet sammen med standardbehandlingen af metastatisk rabdomyosarkom og ikke-rabdomyosarkom bløddelssarkom var sikkerhedsprofilen hos de Avastinbehandlede børn sammenlignelig med den som var observeret hos Avastinbehandlede voksne.
In study BO20924 of Avastin with current standard of care in rhabdomyosarcoma and nonrhabdomyosarcoma soft tissue sarcoma, the safety profile of Avastin treated children was comparable with that observed in adults treated with Avastin.
Avastin administreres sammen med platinbaseret kemoterapi i op til 6 behandlingsserier, efterfulgt af behandling med Avastin som monoterapi indtil sygdomsprogression.
Avastin is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Avastin as a single agent until disease progression.
Størstedelen af patienter i begge arme have ECOG-performancestatus på 0 (kemoterapi: 56,4 % versus kemoterapi + bevacizumab: 61,2 %).
The majority of patients in both arms had an ECOG Performance Status (PS) of 0 (CT: 56.4% vs. CT + BV: 61.2%).
● Overfølsomhed over for det aktive stof eller et eller flere af indholdsstofferne anført i pkt.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Arm 2 Carboplatin/ Paclitaxel + Avastin 15 mg/kg hver 3. uge
Carboplatin/ Paclitaxel + Avastin 15 mg/kg q 3 weeks
Sådan skal du bruge Avastin
How to use Avastin
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 100 mg/4 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/4 ml
Tabel 23 Effektresultater fra Studie MO22224 Primært endepunkt
Table 23 Efficacy Results from Study MO22224
Bevacizumab er, i kombination med capecitabin, indiceret til 1.-linjebehandling af voksne patienter med metastatisk brystkræft, for hvem anden kemoterapi inklusive taxaner eller antracykliner ikke betragtes som værende hensigtsmæssig.
Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate.
4.4 og 4.8) Øget hyppighed af alvorlig neutropeni, febril neutropeni eller infektion med eller uden alvorlig neutropeni (herunder nogle dødsfald) er hovedsagelig blevet observeret hos patienter behandlet med platin- eller taxanbaserede terapier i behandlingen af NSCLC og mBC.
Combination with platinum- or taxane-based therapies (see sections 4.4 and 4.8) Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed mainly in patients treated with platinumor taxane-based therapies in the treatment of NSCLC and mBC.
Grad 4 proteinuri (nefrotisk syndrom) blev set hos op til 1,4% af de patienter, som blev behandlet med Avastin.
Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of patients treated with Avastin.
• muskel- og ledsmerter, muskelsvaghed,
• muscle and joint pain, muscular weakness,
Tidligere strålebehandling er en væsentlig risikofaktor for udvikling af gastrointestinale-vaginale 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 GIvaginal fistulae had a history of prior radiation.
• infektion i huden eller i de dybereliggende lag under huden,
• infections of the skin or deeper layers under the skin,
Bevacizumab er, i kombination med kemoterapi baseret på fluoropyrimidin, indiceret til behandling af voksne patienter med metastatisk karcinom i colon eller rectum.
Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Af de 452 patienter randomiseret ved baseline var størstedelen kaukasiere (80,0 % i kemoterapigruppen og 75,3 % i kemoterapi+Avastingruppen), havde planocellulært karcinom (67,1 % i kemoterapigruppen og 69,6 % i kemoterapi+Avastingruppen), havde vedvarende/recidiverende sygdom (83,6 % i kemoterapigruppen og 82,8 % i kemoterapi+Avastingruppen), havde 1-2 metastatiske områder (72,0 % i kemoterapigruppen og 76,2 % i kemoterapi+Avastingruppen), havde lymfeknude-involvering (50,2 % i kemoterapigruppen og 56,4 % i kemoterapi+Avastingruppen) og havde en platin-fri periode på ≥ 6 måneder (72,5 % i kemoterapigruppen og 64,4 % i kemoterapi+Avastingruppen).
Of the 452 patients randomized at baseline, the majority of patients were white (80.0% in the Chemo alone group and 75.3% in the Chemo+Avastin group), had squamous cell carcinoma (67.1% in the Chemo alone group and 69.6% in the Chemo+Avastin group), had persistent/recurrent disease (83.6% in the Chemo alone group and 82.8% in the Chemo+Avastin group), had 1-2 metastatic sites (72.0% in the Chemo alone group and 76.2% in the Chemo+Avastin group), had lymph node involvement (50.2% in the Chemo alone group and 56.4% in the Chemo+Avastin group), and had a platinum free interval ≥ 6 months (72.5% in the Chemo alone group and 64.4% in the Chemo+Avastin group).
Eksfoliativ dermatitis Tør hud Misfarvet hud
Exfoliative dermatitis, Dry skin, Skin discoloration
Avastins sikkerhed og virkning ved behandling af recidiverende epitelial ovariecancer, tubacancer og primær peritonealcancer blev undersøgt i tre fase III-studier (AVF4095g, MO22224 og GOG-0213) hos forskellige patientpopulationer og med forskellige kemoterapiregimer.
The safety and efficacy of Avastin in the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer was studied in three phase III trials (AVF4095g , MO22224 and GOG-0213) with different patient populations and chemotherapy regimens.
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/oxaliplatinor fluoropyrimidine/irinotecan-based chemotherapy (chemotherapy switched depending on first-line chemotherapy) with or without bevacizumab.
● Gastrointestinale perforationer (se pkt.
• Gastrointestinal perforations (see section 4.4).
Hvis det sker, skal du straks tale med din læge, apotekspersonale eller sundhedspersonale herom.
If this happens you should talk to your doctor, pharmacist or nurse immediately.
Grad 4 proteinuri (nefrotisk syndrom) blev set hos op til 1,4 % af de behandlede patienter.
Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of treated patients.
Tilfælde af ikke-mandibulær osteonekrose er blevet observeret hos pædiatriske patienter behandlet med Avastin (se afsnittet ”pædiatrisk population” ovenfor i dette pkt.
Cases of non-mandibular osteonecrosis have been observed in Avastin treated paediatric patients (see section 4.8, Paediatric population).
INFORMATION I BRAILLESKRIFT Fritaget for krav om blindeskrift
INFORMATION IN BRAILLE Justification for not including Braille accepted
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 anticancer 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.
Perifer sensorisk neuropatia
Peripheral sensory neuropathy a
Patienter, som tidligere har oplevet en venøs tromboembolisk bivirkninger, kan have en højere risiko for fornyet hændelse, hvis de får Avastin 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 Avastin in combination with chemotherapy versus chemotherapy alone.
Se produktresuméet for erlotinib for information vedrørende dosering og administration af erlotinib.
For the posology and method of administration of erlotinib, please refer to the full erlotinib prescribing information.
• Det er muligt, at Avastin kan forårsage allergiske og/eller infusionsrelaterede reaktioner.
● It is possible that Avastin can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
• blødning fra den nedre del af tyktarmen
• bleeding from the lower part of the large bowel,
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 angiotensin-converting enzyme inhibitors, diuretics and calcium-channel blockers.
• feber,
• fever,
Den totale hyppighed af NCI-CTC grad 3 og 4 hypertension blev set hos mellem 0,4 % og 17,9 % af patienterne, som fik Avastin.
The overall incidence of NCI-CTC Grade 3 and 4 hypertension in patients receiving Avastin ranged from 0.4% to 17.9%.
Når Avastin administreres i kombination med topotecan (givet på dag 1-5 hver 3. uge), er den anbefalede Avastindosis 15 mg/kg kropsvægt en gang hver 3. uge som intravenøs infusion.
When Avastin is administered in combination with topotecan (given on days 1-5, every 3 weeks), the recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
• hul i galdeblæren (symptomer kan være mavesmerter, feber og kvalme/opkastning),
• hole in the gall bladder (symptoms and signs may include abdominal pain, fever, and nausea/vomiting).
Effektresultater fra studie BO17707 (ICON7)
Table 18 Efficacy results from study BO17707 (ICON7)
Sekundære PFS analyser, baseret på responsvurderinger fra ”on-treatment”populationen, bekræftede den signifikante, superiore, kliniske effekt for patienter, behandlet med Avastin (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 Avastin (analyses shown in Table 7), consistent with the statistically significant benefit observed in the pooled analysis.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas á 16 ml
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 16 ml
5.1 for yderligere oplysninger HER2-status.
For further information as to HER2 status, please refer to section 5.1.
Der blev ikke set øget hyppighed af andre bivirkninger, inklusive gastrointestinal perforation, sårhelingskomplikationer, kongestiv hjerteinsufficiens og blødninger hos ældre patienter (> 65 år), som fik Avastin, sammenlignet med patienter under 65 år, som fik Avastin.
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)
Resultater fra de randomiserede fase III-studier, PACCE og CAIRO-2, hos patienter med metastisk karcinom i colon eller rectum tyder på, at anvendelse af anti-EGFR monoklonale antistoffer, henholdsvis panitumumab og cetuximab, i kombination med bevaxizumab og kemoterapi, er forbundet med nedsat progressionsfri overlevelse (PFS) og/eller samlet overlevelse (OS) samt øget toksicitet sammenlignet med bevacizumab og kemoterapi alene.
Results from the randomised phase III studies, PACCE and CAIRO-2, in patients with mCRC suggest that the use of anti-EGFR monoclonal antibodies panitumumab and cetuximab, respectively, in combination with bevacizumab plus chemotherapy, is associated with decreased PFS and/or OS, and with increased toxicity compared with bevacizumab plus chemotherapy alone.
• en blodprop i arterierne,
● a blood clot in your arteries,
Der bør udvises forsigtighed, når patienter med klinisk signifikant hjertesygdom, såsom hjertekarsygdom eller kongestiv hjerteinsufficiens, behandles med Avastin.
Caution should be exercised when treating patients with clinically significant cardiovascular disease such as pre-existing coronary artery disease, or congestive heart failure with Avastin.
Tabel 26: Resultater for samlet overlevelse fra studie GOG-0240 med forsøgsbehandling
Table 26 Overall survival results from study GOG-0240 by Trial Treatment Treatment
NR=ikke nået.
Relative to control arm. NR = not reached.
Tilføjelse af Avastin til RT/T vidste ikke kliniske fordele i studie BO25041 hos 60 evaluerbare børn med nyligt diagnosticeret supratentorielt eller infratentorielt cerebellært eller pedunkulært høj-gradsgliom (se pkt.
Addition of Avastin 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 highgrade glioma (HGG) (See section 4.2 for information on paediatric use).
• Kemoterapi+bevacizumab-armen:
• CT+BV Arm (chemotherapy plus bevacizumab):
• Median PFS-øgning på 5,6 måneder, hazard ratio 0,421 (p < 0,0001, 95 % konfidensinterval 0,343-0,516)
• Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516)
Det primære endepunkt for studiet var objektiv responsrate og progressionsfri overlevelse.
The primary endpoints of the trial were objective response rate and progression-free survival.
● 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).
PFS-undergruppeanalyse af sygdomsstadie og tumorreduktionsstatus er sammenfattet i tabel 17.
PFS subgroup analyses by disease stage and debulking status are summarised in Table 17.
Progressionsfri overlevelseb Investigators vurdering
Progression-free survivalb Investigator Assessment
En tredje gruppe på 33 patienter fik bolus 5-FU/FA + Avastin (10 mg/kg hver 2. uge).
A third group of 33 patients received bolus 5-FU/FA + Avastin (10 mg/kg every 2 weeks).
Avastin vil blive givet i kombination med kemoterapibehandling, der indeholder fluoropyrimidin.
Avastin will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Primær-analyse blev udført ved data cut-off 12. december 2012 og betragtes som den endelige analyse Followup-analyse blev udført ved data cut-off 7. marts 2014
Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis
Venøse tromboemboliske bivirkninger af grad 3-5 (NCI-CTCAE v. 3) sås hos op mod 7,8 % af patienter, behandlet med kemoterapi plus bevacizumab i forhold til op mod 4,9 % af patienter, som fik kemoterapi alene (på tværs af indikationer eksklusive persisterende, recidiverende eller metastatisk cervixcancer).
Grade 3-5 (NCI-CTCAE v.3) venous thromboembolic reactions have been reported in up to 7.8% of patients treated with chemotherapy plus bevacizumab compared with up to 4.9% in patients treated with chemotherapy alone (across indications, excluding persistent, recurrent, or metastatic cervical cancer).
AVF3694g var et fase III, multicenter, randomiseret, placebokontrolleret studie designet til at evaluere effekten og sikkerheden af Avastin i kombination med kemoterapi sammenlignet med kemoterapi plus placebo som 1.-linjebehandling til patienter med HER-2 negativ metastatisk eller lokalt recidiverende brystkræft.
Study AVF3694g was a Phase III, multicentre, randomised, placebo-controlled trial designed to evaluate the efficacy and safety of Avastin in combination with chemotherapy compared to chemotherapy plus placebo as first-line treatment for patients with HER2-negative metastatic or locally recurrent breast cancer.
Avastins sikkerhed og virkning ved behandling af platinfølsom, recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer hos patienter, som ikke tidligere havde fået kemoterapi for recidiverende sygdom eller bevacizumab-behandling, blev undersøgt i et fase III, randomiseret, dobbeltblindet, placebokontrolleret studie (AVF4095g).
The safety and efficacy of Avastin in the treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who have not received prior chemotherapy in the recurrent setting or prior bevacizumab treatment, was studied in a phase III randomised, double-blind, placebo-controlled trial (AVF4095g).
Behandlingen bør midlertidigt stoppes før elektiv kirurgi.
Therapy should be withheld for elective surgery.
Investigator vurdering
Investigator assessment
Randomiserede, kliniske studier viste at alder > 65 år var associeret med øget risiko for udvikling af arterielle tromboemboliske bivirkninger, inklusive cerebrovaskulære tilfælde, transitorisk cerebral iskæmi og myokardieinfarkt.
In randomised clinical trials, age > 65 years was associated with an increased risk of developing arterial thromboembolic reactions, including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs).
Roche Pharma AG Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen Tyskland
Roche Pharma AG Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen Germany
Høj-grads-gliomI 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).
Kongestivt hjertesvigta,b Supraventrikulær takykardi
Congestive heart failureb,d, Supraventricular tachycardia