natgillin/translations-raw huggingface dataset:
*Bevacizumab er et rekombinant humaniseret monoklonalt antistof, som fremstilles ved DNA teknologi i ovarieceller fra kinesiske hamstere.
*Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Det vides, at IgG passerer placentabarrieren, og bevacizumab forventes at hæmme angiogenesen hos fostret og er dermed under mistanke for at kunne forårsage alvorlige medfødte misdannelser ved indgivelse under graviditet.
IgGs are known to cross the placenta, and bevacizumab is anticipated to inhibit angiogenesis in the foetus, and thus is suspected to cause serious birth defects when administered during pregnancy.
En GOG PS på 2 ved baseline var rapporteret hos 0,9 % af patienterne i CP-armen og 1,2 % af patienterne i CPB-armen.
A GOG PS of 2 at baseline was reported in 0.9% of patients in the CP arm and in 1.2% of patients in the CPB arm.
Sikkerheden og effekten af bevacizumab hos børn under 18 år er ikke klarlagt.
The safety and efficacy of bevacizumab in children less than 18 years old have not been established.
Det frarådes at anvende MVASI til børn og unge under 18 år, da sikkerheden og fordelene ved MVASI ikke er fastlagt hos denne patientgruppe.
MVASI use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Progressionsfri overlevelse efter tid fra sidste platinbehandling indtil recidiv
Progression-free survival by time from last platinum therapy to recurrence
ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
MVASI er kontraindiceret under graviditet (se pkt.
MVASI is contraindicated in pregnancy (see section 4.3).
Der er evidens for, at alle grader af proteinuri (US National Cancer Institute Common Terminology Criteria for Adverse Event [NCI-CTCAE v. 3]) kan være relateret til dosis.
There is evidence suggesting that all grade (US National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Yderligere blev en præspecificeret analyse med datacensurering for CA-125-progressioner udført såvel som en uafhængig vurdering af PFS fastlagt ved radiologiske scanninger.
In addition, a pre-specified analysis of the data censoring for CA-125 progression events was conducted, as well as an independent review of PFS as determined by radiological scans.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger MVASI
Talk to your doctor, pharmacist or nurse before using MVASI
Der blev rapporteret dødelig udgang i ca. en tredjedel af de alvorlige tilfælde af gastrointestinal perforation, hvilket svarer til 0,2-1 % af alle bevacizumab-behandlede patienter.
Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab-treated patients.
MVASI skal seponeres permanent, hvis en klinisk signifikant hypertension ikke kan kontrolleres tilstrækkeligt med standard antihypertensionsbehandling, eller hvis patienten udvikler hypertensiv krise eller hypertensiv encefalopati.
MVASI should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Kvinder, som ikke er kommet i overgangsalderen (kvinder, som har en menstruationscyklus), kan opleve, at deres menstruation bliver uregelmæssig eller udebliver, og at deres frugtbarhed bliver nedsat.
Pre-menopausal women (women who have a menstrual cycle) may notice that their periods become irregular or are missed and may experience impaired fertility.
Statistisk signifikante forbedringer i den progressionsfrie overlevelse og objektive responsrate sås også (se tabel 8).
Statistically significant improvements in progression-free survival and objective response rate were also observed (see table 8).
Hos patienter, som udvikler problemer med sårheling under behandlingen, bør behandlingen seponeres, indtil såret er fuldstændig helet.
In patients who experienced wound healing complications during therapy, treatment should be withheld until the wound is fully healed.
• Det er muligt, at MVASI kan forårsage blødning i og omkring hjernen.
• It is possible that MVASI may cause bleeding in and around your brain.
Bevacizumab blev kombineret med to kemoterapiregimer:
Bevacizumab was combined with two chemotherapy regimens:
Det er ikke påvist, at MVASI nedsætter din evne til at køre bil eller betjene maskiner.
MVASI has not been shown to reduce your ability to drive or to use any tools or machines.
• hvis du behøver invasiv tandbehandling (f.eks. tandudtrækning) eller en tandoperation, skal du fortælle din tandlæge, at du er i behandling med MVASI (bevacizumab), især hvis du også bliver eller er blevet behandlet med bisfosfonater, som injektion i blodet.
• if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with MVASI (bevacizumab), in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
Proteinurib,d
Proteinuriab,d
Patienter og procentdel af patienter med det bedste objektive respons bekræftet komplet respons eller partielt respons; procent beregnet på grundlag af patienter med målbar sygdom ved baseline.
Patients and percentage of patients with best overall response of confirmed CR or PR; percentage calculated on patients with measurable disease at baseline.
Med hensyn til sikkerheden var der overordnet en højere forekomst af grad 3-5 bivirkninger i E3200-studiet sammenlignet med ML18147-studiet.
In terms of safety, there was a higher overall incidence of grade 3-5 AEs in study E3200 relative to study ML18147.
Patienter med metastaser til centralnervesystemet, herunder tidligere behandlede eller resekterede hjernelæsioner, blev ekskluderet.
Patients with central nervous system metastases, including previously-treated or resected brain lesions, were excluded.
• MVASI kan forårsage infektioner og nedsætte antallet af neutrofiler (en type blodceller, som er vigtige for at beskytte dig mod bakterier).
• MVASI may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
Du må ikke amme under behandling med MVASI og i mindst 6 måneder efter sidste MVASI-dosis, da MVASI kan påvirke væksten og udviklingen af dit barn.
You must not breast-feed your baby during treatment with MVASI and for at least 6 months after the last dose of MVASI, as this medicine may interfere with the growth and development of your baby.
Alle analyser i tabellen er stratificerede.
All analyses presented in this table are stratified analyses.
En stor del af patienterne (omkring 62 %) fik derefter forskellige anticancerbehandlinger uden for protokollen, hvilket kan have haft indflydelse på den samlede overlevelse.
A high proportion of patients (approximately 62%) went on to receive a variety of non-protocol specified anti-cancer therapies, which may have impacted the analysis of overall survival.
Sikkerhedsforanstaltninger som skal tages før håndtering og administration af lægemidlet For instruktion i fortynding af lægemidlet før administration, se pkt.
Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, see section 6.6.
Sikkerheden ved at genoptage behandlingen med bevacizumab hos patienter, der tidligere har udviklet PRES, er ikke kendt.
The safety of reinitiating bevacizumab therapy in patients previously experiencing PRES is not known.
MVASI bør klargøres af en sundhedsfaglig person under anvendelse af aseptisk teknik for at sikre steriliteten af den klargjorte opløsning.
MVASI should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
Endepunkt (måneder)
Endpoint (months)
Langtidsvirkningerne af bevacizumabbehandling på fertiliteten er ukendt.
Long term effects of the treatment with bevacizumab on fertility are unknown.
De fleste patienter var FIGO stadie III (68 % i begge), efterfulgt af FIGO stadie IV (13 % og 14 %), FIGO stadie II (10 % og 11 %) og FIGO stadie I (9 % og 7 %).
Most patients were FIGO stage III (both 68%) followed by FIGO stage IV (13% and 14%), FIGO stage II (10% and 11%) and FIGO stage I (9% and 7%).
Da bevacizumab kan påvirke sårheling negativt, blev patienter som havde fået foretaget større operationer indenfor de sidste 28 dage, ekskluderet fra deltagelse i kliniske studier i fase III.
As bevacizumab may adversely impact wound healing, patients who had major surgery within the last 28 days were excluded from participation in phase III clinical trials.
Kombination af MVASI og disse behandlinger kan øge risikoen for alvorlige bivirkninger.
These therapies in combination with MVASI may increase the risk of severe side effects.
Stratificeret efter varighed af behandlingsfri periode før inklusion i studiet per registreringsform og sekundær kirurgisk tumorreduktionsstatus Ja/Nej.
b stratified by the duration of treatment free-interval prior to enrolling onto this study per the registration form, and secondary surgical debulking status Yes/No.
Tabel 1 og 2 opsummerer de bivirkninger, som er associeret til brugen af bevacizumab i kombination med forskellige kemoterapiregimer til flere forskellige indikationer.
Tables 1 and 2 list adverse reactions associated with the use of bevacizumab in combination with different chemotherapy regimens in multiple indications.
Farmakodynamisk virkninger
Pharmacodynamic effects
I begge studier var der en tendens til, at eksponeringen var lavere ved lavere legemsvægt.
In both studies, bevacizumab exposure trended lower as body weight decreased.
Bevacizumab er blevet forbundet med alvorlige tilfælde af gastrointestinal perforation.
Bevacizumab has been associated with serious cases of gastrointestinal perforation.
• MVASI kan øge risikoen for, at der dannes abnorme forbindelser eller passager mellem to organer eller blodårer.
• MVASI may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Patienter skal overvåges for tegn og symptomer på CNS-blødning, og behandling med MVASI skal seponeres i tilfælde af intrakranial blødning.
Patients should be monitored for signs and symptoms of CNS bleeding, and MVASI treatment discontinued in cases of intracranial bleeding.
829 patienter blev randomiseret (292 FOLFOX-4, 293 bevacizumab + FOLFOX-4 og 244 bevacizumab monoterapi).
Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 bevacizumab + FOLFOX-4 and 244 bevacizumab monotherapy).
5.1 for yderligere oplysninger om human epidermal vækstfaktor receptor 2(HER2) status.
For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.
• svær blødning.
• any severe bleeding.
Dosisreduktion af IFN alfa-2a syntes ikke at påvirke effekten af kombinationen af bevacizumab og IFN alfa-2a, baseret på antal hændelser i tidsrummet for progressionsfri overlevelse, som er vist ved en undergruppeanalyse.
Dose reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of bevacizumab and IFN alfa-2a based on PFS event free rates over time, as shown by a subgroup analysis.
Der er ikke foretaget studier for at evaluere bevacizumabs carcinogene og mutagene potentiale.
Studies to evaluate the mutagenic and carcinogenic potential of bevacizumab have not been performed.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter fortynding.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution.
Patienternes medianalder var 61,0 år (spændevidde 25-84).
The median age of patients was 61.0 (range: 25-84) years.
Den højeste dosis, som blev afprøvet på mennesker (20 mg/kg legemsvægt, intravenøst hver 2. uge), var forbundet med svær migræne hos flere patienter.
The highest dose tested in humans (20 mg/kg of body weight, intravenous every 2 weeks) was associated with severe migraine in several patients.
Sikkerheden og effekten af samtidigt administreret strålebehandling og bevacizumab er ikke fastlagt.
The safety and efficacy of concomitant administration of radiotherapy and bevacizumab has not been established.
• hul i maven eller tarmen,
• a hole in the stomach or intestines,
Bevacizumab binder til vaskulær endotelial vækst faktor (VEGF), som er den primære faktor i vaskulogenesen og angiogenesen, og hæmmer derved bindingen af VEGF til dets receptorer, Flt-1 (VEGFR-1) og KDR (VEGFR-2), på overfladen af endotelceller.
Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells.
Behandlingen med MVASI skal midlertidigt afbrydes
The administration of MVASI should be temporarily discontinued
Koncentrationen af den endelige bevacizumab-opløsning skal ligge inden for følgende grænser: 1,4 mg/ml-16,5 mg/ml.
The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/mL to 16.5 mg/mL.
Brug ikke MVASI, hvis du opdager partikler eller misfarvning før indgift.
Do not use MVASI if you notice any particulate matter or discolouration prior to administration.
Resultaterne for effekt af bevacizumab i kombination med IFL-kemoterapi fremgår af tabel 4.
The efficacy results of bevacizumab in combination with IFL-chemotherapy are displayed in table 4.
Tumorvurdering og responsevaluering var bestemt af investigatorerne udfra GOG RECIST kriterier (revideret RECIST guideline (version 1.1) Eur J Cancer.
Tumour assessments and response evaluations were determined by the investigators using the GOG RECIST criteria (Revised RECIST guideline (version 1.1).
Perifer sensorisk neuropatia
Peripheral sensory neuropathya
Followup-analyse blev udført ved data cut-off 7. marts 2014; p-værdier er kun vist for oplysende formål.
Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only.
Den observerede stigning i serum-kreatinin var ikke forbundet med højere forekomst af kliniske manifestationer af nedsat nyrefunktion hos patienter, som var behandlet med bevacizumab.
The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with bevacizumab.
Progressionsfri overlevelse og objektiv responsrate var inferior i bevacizumab monoterapi-armen i forhold til FOLFOX4armen.
Progression-free survival and objective response rate were inferior in the bevacizumab monotherapy arm compared to the FOLFOX-4 arm.
Der foreligger ingen information om effekten af bevacizumab hos patienter, der har ukontrolleret hypertension ved behandlingens påbegyndelse.
There is no information on the effect of bevacizumab in patients with uncontrolled hypertension at the time of initiating therapy.
• Hvis du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, antineoplastiske midler, andre antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC07.
Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC07.
I de fleste af de kliniske studier med bevacizumab blev patienter med præ-eksisterende CHF af NYHA (New York Heart Association) klasse II-IV ekskluderet, og derfor findes der ingen data for risikoen for
In most clinical trials of bevacizumab, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
Hver pakning med MVASI indeholder et hætteglas.
Each pack of MVASI contains one vial.
• hvis du har problemer med sårheling efter en operation,
• if you have problems with wound healing following surgery,
Tillæg af bevacizumab til IFL resulterede i en statistisk signifikant stigning i den samlede overlevelse (overall survival) (OS), progressionsfri overlevelse (progression free survival) (PFS) og samlet responsrate (se tabel 4).
The addition of bevacizumab to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see table 4).
Hypertension resulterede sjældent i afbrydelse af behandlingen med bevacizumab eller hospitalsindlæggelse.
It rarely resulted in discontinuation of bevacizumab treatment or hospitalisation.
• hvis du er allergisk over for bevacizumab eller et af de øvrige indholdsstoffer i MVASI (angivet i punkt 6).
• you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
Det drejede sig for det meste om NCI-CTCAE v. 3 grad 1 næseblod, som varede mindre end 5 minutter og ophørte uden behandling, og som ikke krævede ændringer i behandlingen med bevacizumab.
These were most commonly NCI-CTCAE v.3 grade 1 epistaxis that lasted less than 5 minutes, resolved without medical intervention and did not require any changes in the bevacizumab treatment regimen.
Med makroskopisk residualsygdom.
With gross residual disease.
• Alternativt kan en dosis på 1,25 mg/m2 administreres over 30 minutter på dag 1-5 hver 3. uge.
Alternatively, a 1.25 mg/m2 dose could be administered over 30 minutes on days 1-5 every 3 weeks.
Investigatorvurderet GOG-protokolspecificeret PFS-analyse (hverken censureret for CA-125-progressioner eller censureret for NPT før sygdomsprogression) med data-cut-off den 25. februar 2010.
Investigator assessed GOG protocol-specified PFS analysis (neither censored for CA-125 progressions nor censored for NPT prior to disease progression) with data cut-off date of 25 February, 2010.
I fleste tilfælde kan den nødvendige mængde MVASI blive fortyndet med 0,9 % natriumchlorid opløsning til injektion op til 100 ml (total volumen).
In the majority of the occasions the necessary amount of MVASI can be diluted with 0.9% sodium chloride solution for injection to a total volume of 100 mL.
Der skal udføres EGFR-mutationstest før igangsættelse af kombinationsbehandling med MVASI og erlotinib.
EGFR mutation testing should be performed prior to initiation of treatment with the combination of MVASI and erlotinib.
Individuelle tilfælde og samling af tilfælde med alvorlige okulære bivirkninger er blevet rapporteret efter ikke-godkendt intravitreal anvendelse af bevacizumab i hætteglas godkendt til intravenøs administration til kræftpatienter.
Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of bevacizumab compounded from vials approved for intravenous administration in cancer patients.
Samlet set var ca. 34 % af patienterne FIGO stadie III optimalt tumorreducerede med makroskopisk residualsygdom, 40 % stadie III sub-optimalt tumorreducerede, og 26 % var stadie IVpatienter.
Overall approximately 34% of patients were FIGO stage III optimally debulked with gross residual disease, 40% stage III suboptimally debulked, and 26% were stage IV patients.
Koncentratet er en klar til let opaliserende, farveløs til let gul væske i et hætteglas af glas med gummilukke.
The concentrate is a clear to slightly opalescent, colourless to slightly yellow liquid in a glass vial with a rubber stopper.
A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Der er observeret øget forekomst af hypertension hos bevacizumab-behandlede patienter.
An increased incidence of hypertension was observed in bevacizumab-treated patients.
Hvis patienter oplever symptomer, som påvirker deres syn eller koncentration eller deres reaktionsevne, bør de frarådes at køre bil eller betjene maskiner, indtil symptomerne aftager.
If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive and use machines until symptoms abate.
Kombination af MVASI med en anden medicin, sunitinibmalat (ordineret for kræft i nyrerne eller mavetarmkanalen) kan forårsage alvorlige bivirkninger.
Combinations of MVASI with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Der er dokumenteret kemisk og fysisk holdbarhed før anvendelsen i 48 timer ved 2 °C til 30 °C i natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion.
Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/mL (0.9%) solution for injection.
De eneste faktorer, som viste statistisk signifikant sammenhæng med blødning, var behandling med bevacizumab og planocellulær histologi.
The only variables that showed statistically significant correlations with bleeding were bevacizumab therapy and squamous cell histology.
Tandundersøgelse og passende forebyggende tandbehandling bør overvejes før behandling med MVASI.
A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with MVASI.
For yderligere information henvises til nedenstående afsnit ”Beskrivelse af udvalgte alvorlige bivirkninger”.
For additional information refer below within section “Description of selected serious adverse reactions”.
Dette kliniske fase III-studie sammenlignede rituximab/cyclophosphamid/doxorubicin/vincristin/prednison (R-CHOP) plus bevacizumab med R-CHOP uden bevacizumab.
This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/ vincristine/prednisone (R-CHOP) plus bevacizumab to R-CHOP without bevacizumab.
Der var to primære formål med studiet: At vise, at XELOX var non-inferior i forhold til FOLFOX-4, og at vise, at bevacizumab i kombination med FOLFOX-4 eller XELOX kemoterapi var bedre i forhold til kemoterapi alene.
In this trial, there were two primary objectives: to show that XELOX was non-inferior to FOLFOX-4 and to show that bevacizumab in combination with FOLFOX-4 or XELOX chemotherapy was superior to chemotherapy alone.
I situationer, hvor tidlig afbrydelse af kemoterapi var påkrævet, fortsatte behandlingen med bevacizumab som enkeltstof indtil sygdomsprogression.
In situations where early discontinuation of chemotherapy was required, treatment with bevacizumab as a single agent continued until disease progression.
5,8 % af den samlede randomiserede patientpopulation havde stadium III B sygdom.
5.8% of the overall randomised patient population had stage IIIB disease.
Den tilsvarende forekomst hos kontrolgruppen, som blev behandlet med kemoterapi alene, var henholdsvis 1,1 % og 0,8 %.
The corresponding frequencies in the control group receiving chemotherapy alone were 1.1% vs. 0.8%, respectively.
Endelig analyse.
Final analysis
• MVASI kan øge risikoen for at få protein i urinen, især hvis du har forhøjet blodtryk.
• MVASI increases the risk of having protein in your urine especially if you already have high blood pressure.
Der blev ikke observeret nogen signifikant forskel i varighed af overlevelse hos patienter, der modtog bevacizumab monoterapi i forhold til patienter, som blev behandlet med FOLFOX-4.
No significant difference was observed in the duration of overall survival between patients who received bevacizumab monotherapy compared to patients treated with FOLFOX-4.
Almindelige bivirkninger (kan påvirke op til 1 patient ud af 10), som ikke er alvorlige, omfatter: • ændringer i stemmen og hæshed.
Common (may affect up to 1 in 10 people) side effects, which were not severe, include: • voice changes and hoarseness.
Bevacizumab vs ingen bevacizumab
Bevacizumab vs. No bevacizumab