natgillin/translations-raw huggingface dataset:
Syvoghalvfems (97) patienter i IFN alfa-2a-armen og 131 patienter i Avastin-armen reducerede dosis af IFN alfa-2a fra 9 MIE tre gange ugentligt til enten 6 eller 3 MIE tre gange ugentligt som præspecificeret i protokollen.
Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the Avastin arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
Det er vist, at bevacizumab er embryotoksisk og teratogent, når det gives til kaniner.
Bevacizumab has been shown to be embryotoxic and teratogenic when administered to rabbits.
Frontlinjebehandling af ovariecancer
Front-line treatment of ovarian cancer
Der foreligger information om race for 29,3 % af patienterne, og næsten alle var kaukasiere.
CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Avastin i kombination med interferon alfa-2a til 1.-linjebehandling af patienter med fremskreden og/eller metastatisk renalcellekarcinom (BO17705)
Avastin in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
De 649 randomiserede patienter (641 behandlede) havde Karnofsky performancestatus (KPS) på ≥ 70 %, ingen CNS-metastaser og tilstrækkelig organfunktion.
The 649 randomised patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%,
Recidiv af kræft indenfor strålefeltet af den tidligere strålebehandling er yderligere en risikofaktor for udvikling af gastrointestinale-vaginale fistler.
Recurrence of cancer within the field of prior radiation is an additional important risk factor for the development of GI-vaginal fistulae.
De fleste patienter, som udviklede CHF under studier af metastatisk brystkræft, udviste symptombedring og/eller forbedring af venstre ventrikels funktion efter passende medicinsk behandling.
Most patients who developed CHF during mBC trials showed improved symptoms and/or left ventricular function following appropriate medical therapy.
Der findes ingen informationer om sikkerhedsprofilen af Avastin hos patienter med kongenit hæmoragisk diatese, erhvervet koagulationsdefekt eller hos patienter, som får fuld dosis af antikoagulantia for behandling af tromboemboli, før behandlingen med Avastin påbegyndes, da sådanne patienter ikke indgik i de kliniske studier.
There is no information on the safety profile of Avastin in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting Avastin treatment, as such patients were excluded from clinical trials.
Avastin er et koncentrat til opløsning til infusion.
Avastin is a concentrate for solution for infusion.
Samlet responsrate Rate (procent)
Overall response rate Rate (%)
Avastin er blevet udviklet og fremstillet til behandling af kræft efter injektion i blodbanen.
Avastin has been developed and made to treat cancer by injecting it into the bloodstream.
Responsrate (for patienter med målbar sygdom)b
Response rate (for patients with measurable disease)b
Studiet bestod af to dele: en initial, ublindet 2-armet del (del 1) hvor patienterne blev randomiseret til to forskellige behandlingsarme (XELOX og FOLFOX-4) og en efterfølgende 2 x 2 faktor 4-armet del (del 2), hvor patienterne blev randomiseret til fire behandlingsarme(XELOX + placebo, FOLFOX-4 + placebo, XELOX + Avastin, FOLFOX-4 + Avastin).
The trial contained two parts: an initial unblinded 2-arm part (Part I) in which patients were randomised to two different treatment groups (XELOX and FOLFOX-4) and a subsequent 2 x 2 factorial 4-arm part (Part II) in which patients were randomised to four treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + Avastin, FOLFOX-4 + Avastin).
Du kan finde yderligere oplysninger om Avastin på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Behandlingen skal seponeres permanent hos patienter, som udvikler gastrointestinal perforation.
Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
Tabel 1 viser frekvensen af alle bivirkninger, hvor der er fastslået årsagssammenhæng med Avastin gennem
Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with Avastin through:
• hvis du er allergisk over for celleprodukter fra kinesisk hamsterovarie (CHO) eller overfor andre rekombinante humane eller humaniserede antistoffer.
● you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
• hvis du har eller har haft smerter i munden, tænderne og/eller kæben, hævelse eller sår inde i munden, følelsesløshed eller en følelse af tyngde i kæben, eller får en løs tand, skal du straks fortælle det til din læge og tandlæge.
● if you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth tell your doctor and dentist immediately.
FOLFOX-4 eller XELOX + placebo (n=701)
FOLFOX-4 or XELOX + placebo (n=701)
I kliniske studier for metastatisk kolorektalkræft var der ingen forøget risiko for postoperativ blødning eller sårhelingskomplikationer hos patienter, der fik foretaget større kirurgiske indgreb mellem 28 og 60 dage før påbegyndelsen af behandlingen med Avastin.
In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of postoperative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting Avastin.
Kliniske studier har vist, at Avastinbehandlingen er forbundet med midlertidige stigninger i serumkreatinin (i intervallet 1,5-1,9 gange baseline-niveau), både med og uden proteinuri.
Clinical trials have shown that transient increases in serum creatinine (ranging between 1.5-1.9 times baseline level), both with and without proteinuria, are associated with the use of Avastin.
Fortæl din læge, hvis du får en platin- eller taxan-baseret behandling til lungekræft eller til brystkræft, som har spredt sig.
Tell your doctor if you are using platinum- or taxane-based therapies for lung or metastatic breast cancer.
5,8 % af den samlede randomiserede patientpopulation havde stadium III B sygdom.
3 5.8% of the overall randomised patient population had Stage IIIB disease.
Vurdering af bevacizumabs metabolisme hos kaniner efter en intravenøs enkeltdosis af 125I-bevacizumab tyder på, at dets metaboliske profil svarer til, hvad der kan forventes af et nativt IgG-molekyle, som ikke binder VEGF.
Biotransformation 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.
Studieresultaterne viser, at 94 % (277/296) af de kvalificerede patienter kom i enkeltstofbehandling med bevacizumab ved serie 7.
Trial results show that 94% (277 / 296) of eligible patients went on to receive single agent bevacizumab at cycle 7.
Patienter kan have en øget risiko for udvikling af fistler, når de behandles med Avastin.
Patients may be at increased risk for the development of fistulae when treated with Avastin.
Avastin administreres i kombination med et af følgende kemoterapiregimer: paclitaxel og cisplatin eller paclitaxel og topotecan.
Avastin is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Objektiv responsrate 1
Objective Response Rate 1
Derfor er risikoen for CNS-blødning hos disse patienter ikke blevet undersøgt prospektivt i randomiserede kliniske studier (se pkt.
Therefore, the risk of CNS haemorrhage in such patients has not been prospectively evaluated in randomised clinical trials (see section 4.8).
Hvis du får hovedpine, synsforstyrrelser, bliver omtåget eller får kramper med eller uden forhøjet blodtryk, skal du kontakte lægen.
If you have headache, vision changes, confusion or seizure with or without high blood pressure, please contact your doctor.
MAHA er en hæmolytisk lidelse, som kan optræde med fragmentering af røde blodlegemer, anæmi og thrombocytopeni.
MAHA is a haemolytic disorder which can present with red cell fragmentation, anaemia, and thrombocytopenia.
Den primære effektparameter for studiet var varigheden af progressionsfri overlevelse.
The primary efficacy parameter of the trial was the duration of progression-free survival.
Neutropeni og infektioner (se pkt.
Neutropenia and infections (see section 4.8)
• rødme, afskalning, ømhed, smerter eller blisterdannelse på fingre eller fødder,
• redness, peeling, tenderness, pain, or blistering on the fingers or feet,
Kliniske sikkerhedsdata tyder på, at hyppigheden af hypertension sandsynligvis er dosisafhængig.
Clinical safety data suggest that the incidence of hypertension is likely to be dose-dependent.
Dette kliniske fase III-studie sammenlignede rituximab/cyclophosphamid/doxorubicin/vincristin/prednison (R-CHOP) plus bevacizumab med RCHOP uden bevacizumab.
This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) plus bevacizumab to RCHOP without bevacizumab.
• en udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner),
• an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections),
• protein i urinen, efterfulgt af hævelser på kroppen,
● presence of protein in your urine accompanied by swelling of your body,
Gastrointestinale-vaginale fistler i studie GOG-0240
GI-vaginal Fistulae in study GOG-0240
• fistel: abnorm, rørformet forbindelse mellem indre organer og hud eller andre væv, som normalt ikke er forbundet, inklusive forbindelse mellem skeden og tarmen hos patienter med livmoderhalskræft.
• fistula: abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected, including connections between vagina and the gut in patients with cervical cancer.
Ovariefunktionen blev genoprettet hos 86,2 % af disse evaluerbare kvinder efter seponering af bevacizumab.
After discontinuation of bevacizumab treatment, ovarian function recovered in 86.2% of these evaluable women.
Hætteglas (uåbnet)
Vial (unopened)
I situationer, hvor tidlig afbrydelse af kemoterapi var påkrævet, fortsatte behandlingen med Avastin som enkeltstof indtil sygdomsprogression.
In situations where early discontinuation of chemotherapy was required, treatment with Avastin as a single agent continued until disease progression.
Smerter i munden, tænderne og/eller kæben, hævelse eller sår inde i munden, følelsesløshed eller en følelse af tyngde i kæben eller løsnen af en tand.
Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
fluoropyrimidin/irinotecaneller fluoropyrimidin/oxaliplatinbaseret kemoterapi fluoropyrimidin/irinotecaneller fluoropyrimidin/oxaliplatinbaseret kemoterapi + Avastina
fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy + Avastina
• reduktion i antallet af hvide blodceller i blodet og i antallet af celler, der hjælper blodet med at størkne,
• reduction in the number of white cells in the blood, and cells that help the blood clot,
• Avastin kan også øge risikoen for at udvikle blodpropper i venerne (en type blodkar),
● Avastin can also increase the risk of developing blood clots in your veins (a type of blood vessel).
bolus/infusion på dag 1 og 2
5-fluorouracil IV bolus/infusion, each on days 1 and 2
For patienter, der udvikler PRES, anbefales tidlig opdagelse af symptomerne sammen med hurtig behandling af specifikke symptomer, herunder kontrol af hypertension (hvis der er tilknyttet en alvorlig ukontrolleret hypertension) samtidig med, at bevacizumabbehandlingen afbrydes.
In patients developing PRES, early recognition of symptoms with prompt treatment of specific symptoms including control of hypertension (if associated with severe uncontrolled hypertension) is recommended in addition to discontinuation of bevacizumab therapy.
Tabel 24: Eksploratoriske PFS- og OS-analyser af kemoterapi-kohorten Kemoterapi
Table 24: Exploratory PFS and OS analyses by chemotherapy cohort CT
Metabolismen og eliminationen af bevacizumab er lignende den for endogent IgG, dvs. primært via proteolytisk katabolisme i hele kroppen inklusive endotelceller.
The metabolism and elimination of bevacizumab is similar to endogenous IgG i.e. primarily via proteolytic catabolism throughout the body, including endothelial cells, and does not rely primarily on elimination through the kidneys and liver.
De hyppigst observerede bivirkninger i alle kliniske studier hos patienter, som fik Avastin, var hypertension, træthed eller asteni, diarré og abdominalsmerter.
The most frequently observed adverse reactions across clinical trials in patients receiving Avastin were hypertension, fatigue or asthenia, diarrhoea and abdominal pain.
Resultater for effekt i studierne AVF0780g og AVF2192g AVF0780g
Table 5 Efficacy results for trials AVF0780g and AVF2192g AVF0780g
PRES-diagnosen kræver bekræftelse ved en hjernescanning, fortrinsvist magnetisk resonans- (MR) skanning.
A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
• hul i maven eller tarmen
• a hole in the stomach or intestines,
19 % af patienterne havde tidligere fået kemoterapi og 14 % havde tidligere fået strålebehandling.
19% of the patients had received prior chemotherapy and 14% prior radiotherapy.
I nogle kliniske studier med Avastin er forekomsten af disse reaktioner almindelig (op til 5 % af bevacizumabbehandlede patienter).
The incidence of these reactions in some clinical trials of Avastin is common (up to 5% in bevacizumabtreated patients).
Nekrotiserende fasciitis, som regel sekundært til sårhelingskomplikationer, gastrointestinal perforation eller fisteldannelse (sjælden) (se også pkt.
Necrotising fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation (rare) (see also section 4.4)
Der blev set en koncentrationsafhængig nedbrydningsprofil for bevacizumab efter fortynding med glucoseopløsninger (5 %).
A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
PFS undergruppeanalyser, som er afhængige af tiden til recidiv siden den sidste platinbehandling, er opsummeret i tabel 21.
PFS subgroup analyses depending on recurrence since last platinum therapy are summarised in Table 21.
Hyppigheden af CHF var højere end det, som tidligere er observeret for doxorubicinbehandling, i begge arme, og hyppigheden var højst i R-CHOP plus bevacizumab-armen.
While the incidence of CHF was, in both arms, above that previously observed for doxorubicin therapy, the rate was higher in the R-CHOP plus bevacizumab arm.
Alligevel er søvnighed og synkope blevet rapporteret ved anvendelse af Avastin (se tabel 1, pkt.
However, somnolence and syncope have been reported with Avastin use (see table 1 in section 4.8).
Hos kaniner er det vist, at bevacizumab hæmmer sårheling i doser under den foreslåede kliniske dosis.
In rabbits, bevacizumab was shown to inhibit wound healing at doses below the proposed clinical dose.
Hvis bivirkningerne i kliniske studier er registreret som både bivirkning af alle grader og bivirkning af grad 3-5, er den højeste frekvens, som er observeret hos patienter, rapporteret.
When events were noted as both all grade and grade 3-5 adverse drug reactions in clinical trials, the highest frequency observed in patients has been reported.
Disse resultater antyder, at tæt observation med passende kardielle vurderinger bør overvejes ved bevacizumab-behandling hos patienter, som har fået kumulative doxorubicindoser større end 300 mg/m2.
These results suggest that close clinical observation with appropriate cardiac assessments should be considered for patients exposed to cumulative doxorubicin doses greater than 300 mg/m2 when combined with bevacizumab.
I publicerede rapporter har tilfælde af ikke-mandibulær osteonekrose været observeret hos patienter under 18 år behandlet med Avastin.
In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years treated with Avastin.
Kombination af Avastin med en anden medicin, sunitinibmalat (ordineret for kræft i nyrerne eller mave- tarmkanalen) kan forårsage alvorlige bivirkninger.
Combinations of Avastin with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Sikkerhedsprofilen for Avastin er baseret på data fra kliniske studier med over 5.700 patienter med forskellige maligne sygdomme, som primært blev behandlet med Avastin i kombination med kemoterapi.
The overall safety profile of Avastin is based on data from over 5,700 patients with various malignancies, predominantly treated with Avastin in combination with chemotherapy in clinical trials.
Investigatorvurderet PFS-analyse med data cut-off den 30. november 2010.
Investigator assessed PFS analysis with data cut-off date of 30 November 2010.
95 % konfidensinterval
95% CI
En eksplorativ, multivariant, baglæns trinvis (backward stepwise) Cox-regressionsanalyse indikerede, at følgende prognostiske faktorer ved baseline var stærkt relateret til overlevelse uafhængigt af behandling: Køn, antal hvide blodlegemer, antal blodplader, vægttab i de 6 måneder inden indtræden i studiet, antal metastaser, summen af den længste diameter af targetlæsioner, Motzer-score.
An exploratory multivariate Cox regression model using backward selection indicated that the following baseline prognostic factors were strongly associated with survival independent of treatment: gender, white blood cell count, platelets, body weight loss in the 6 months prior to trial entry, number of metastatic sites, sum of longest diameter of target lesions, Motzer score.
Der har været rapporteret alvorlige sårhelingskomplikationer, herunder anastomotiske komplikationer, hvoraf nogle havde dødelig udgang.
Serious wound healing complications, including anastomotic complications, have been reported, some of which had a fatal outcome.
Opbevar hætteglasset i den ydre karton
Keep the vial in the outer carton
De fleste patienter, som fik CHF, havde metastatisk brystkræft og var tidligere behandlet med antracykliner, havde fået strålebehandling af venstre brystvæg eller havde andre risikofaktorer for CHF.
Most of the patients who experienced CHF had metastatic breast cancer and had received previous treatment with anthracyclines, prior radiotherapy to the left chest wall or other risk factors for CHF were present.
Det primære effektmål var samlet overlevelse, defineret som tiden fra randomisering indtil død, uanset årsag
The primary outcome measure was overall survival defined as the time from randomisation until death from any cause.
Behandling af platinresistent recidiverende sygdom: Avastin administreres i kombination med et af følgende stoffer - paclitaxel, topotecan (givet ugentligt) eller pegyleret liposomal doxorubicin.
Treatment of platinum-resistant recurrent disease: Avastin is administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin.
Progressionsfri overlevelse*
Progression-Free Survival*
Alvorlige bivirkninger defineres som bivirkninger med mindst 2 % forskel i forhold til kontrolarmen i kliniske studier for NCI-CTCAE grad 3-5 bivirkninger.
Severe reactions are defined as adverse events with at least a 2% difference compared to the control arm in clinical studies for NCI-CTCAE Grade 3-5 reactions.
Forekomsten af CNS-blødning hos patienter med ubehandlede CNS-metastaser, som fik bevacizumab, er ikke blevet prospektivt undersøgt i randomiserede kliniske studier.
The incidence of CNS bleeding in patients with untreated CNS metastases receiving bevacizumab has not been prospectively evaluated in randomised clinical trials.
• forhøjet tryk i øjet,
• Increased eye pressure,
Tillæg af erlotinib til bevacizumab resulterede ikke i forbedring af den samlede overlevelse (HR = 1,764; p = 0,1789), varighed af objektiv respons (6,7 vs 9,1 måneder) eller tid til progession af symptomer (HR = 1,172; p = 0,5076).
The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p=0.1789), duration of objective response (6.7 vs 9.1 months) or time to symptom progression (HR = 1.172; p=0.5076).
Tabel 22 Effektresultater1,2 fra studie GOG-0213 Primært endepunkt
Table 22 Efficacy results1,2 from study GOG-0213 Primary Endpoint
• Aktivt stof; bevacizumab.
• The active substance is bevacizumab.
Bevacizumabs farmakokinetik er vel karakteriseret med den pædiatriske populationsfarmakokinetiske model med data fra 70 patienter i studie BO20294 (1,4-17,6 år; 11,6-77,5 kg) og 59 patienter i studie BO25041(1-17 år; 11,2-82,3 kg).
The pharmacokinetics of bevacizumab was well characterized by the paediatric population PK model for 70 patients in Study BO20924 ((1.4 to 17.6 years; 11.6 to 77.5 kg) and 59 patients in Study BO25041 (1 to 17 years; 11.2 to 82.3 kg).
Størstedelen af patienterne havde epitelialt ovariekarcinom (87,7 %), efterfulgt af primært peritonealt karcinom (6,9 %) og tubakarcinom (3,7 %) eller en blanding af de tre oprindelser (1,7 %).
The majority of patients had EOC (87.7%) followed by PPC (6.9%) and FTC (3.7%) or a mixture of the three origins (1.7%).
Den typiske værdi for det perifere volumen (Vp) var 1,69 l og 2,35 l for henholdsvis kvindelige og mandlige patienter, når bevacizumab administreres sammen med antineoplastiske lægemidler.
The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
I sjældne tilfælde blev der også set tumorassocieret blødning ved andre tumortyper og lokalitet, inklusive tilfælde af blødning i centralnervesystemet (CNS) hos patienter med CNS-metastaser (se pkt.
Tumour-associated haemorrhage was also seen rarely in other tumour types and locations, including cases of central nervous system (CNS) bleeding in patients with CNS metastases (see section 4.4).
Der har været rapporteret alvorlige sårhelingskomplikationer, herunder anastomotiske komplikationer, med dødelig udgang.
Serious wound healing complications, including anastomotic complications, with a fatal outcome have been reported.
Det skal du vide, før du begynder at bruge Avastin
What you need to know before you use Avastin
Systemiske bivirkninger, herunder ikke-okulære blødninger og arterielle tromboemboliske bivirkninger, er blevet rapporteret efter intravitreal injektion af VEGFhæmmere.
Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.
Der var en lille forskel, med ubetydelige signifikans, mellem tid til progression af sygdom i gruppen behandlet med 3 mg/kg i forhold til placebogruppen (hazard ratio, 1,26; p = 0,053).
There was a small difference, of borderline significance, between the time to progression of disease in the 3 mg/kg group and that in the placebo group (hazard ratio, 1.26; p=0.053).
Det er ikke relevant at anvende bevacizumab i den pædiatriske population for indikationerne behandling af cancer i kolon, rektum, bryst, lunge, ovarie, æggeleder, peritoneum, cervix og nyre.
There is no relevant use of bevacizumab in the paediatric population in the indications for treatment of cancers of the colon, rectum, breast, lung, ovarian, fallopian tube, peritoneum, cervix and kidney.