natgillin/translations-raw huggingface dataset:
Som forud planlagt blev inklusionen i arm 3 standset, så snart sikkerheden af bevacizumab med IFL-regimet var dokumenteret og blev anset for acceptabel. 
Enrolment in Arm 3 was discontinued, as pre-specified, once safety of bevacizumab with the IFL regimen was established and considered acceptable.
● Denne medicin kan forårsage infektioner og nedsætte antallet af neutrofiler (en type blodceller, som er vigtige for at beskytte dig mod bakterier). 
● This medicine may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
● En sjælden neurologisk bivirkning kaldet posteriort reversibelt encefalopati- syndrom (PRES) har været knyttet til bevacizumabbehandling. 
● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with bevacizumab treatment.
● Risikoen for at udvikle blodpropper i arterierne (en type blodkar) kan øges, hvis du er over 65 år, hvis du har sukkersyge, eller hvis du tidligere har haft blodpropper i arterierne. 
● The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
Zirabev er udelukkende til engangsbrug, da produktet ikke indeholder konserveringsmidler. 
Zirabev is for single-use only, as the product contains no preservatives.
I alle kliniske studier blev bevacizumab administreret som en intravenøs infusion. 
In all clinical trials, bevacizumab was administered as an intravenous infusion.
Fortæl straks din læge, hvis du er gravid, bliver gravid under behandling med denne medicin eller har planer om at blive gravid. 
Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.
Du bør tale med din læge om det. 
You should discuss this with your doctor.
Før du får Zirabev, eller imens du bliver behandlet med Zirabev: 
Before you are given Zirabev or while you are being treated with Zirabev:
Bedste samlede respons - primær analyse 
Best overall response - Primary analysis
Der skal iagttages forsigtighed, når disse patienter behandles med Zirabev. 
Caution should be taken when treating these patients with Zirabev.
● Din læge beslutter, hvornår du skal have den næste dosis Zirabev. 
● your doctor will decide when you should be given your next dose of Zirabev.
Patienter med nylig pulmonal blødning/hæmoptyse (> 2,5 ml rødt blod) bør ikke behandles med Zirabev. 
Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 ml of red blood) should not be treated with Zirabev.
Fremstiller Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland 
Manufacturer Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
Blandt de 110 patienter randomiseret til arm 3 (5-FU/FA + bevacizumab) inden lukning af denne arm, var den mediane samlede overlevelse 18,3 måneder og den mediane progressionsfri overlevelse var 8,8 måneder. 
Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression free survival was 8.8 months.
Nasal septumperforation (ikke kendt) Pulmonal hypertension (ikke kendt) Dysfoni (almindelig) 
Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Der bør udvises forsigtighed, når Zirabev og intravenøse bisfosfonater administreres samtidigt eller sekventielt. 
Caution should be exercised when Zirabev and intravenous bisphosphonates are administered simultaneously or sequentially.
Stop ikke behandlingen med Zirabev før, du har diskuteret det med din læge. 
Do not stop treatment with Zirabev unless you have discussed this with your doctor.
Vurdering af bevacizumabs metabolisme hos kaniner efter en intravenøs enkeltdosis af 
Assessment of bevacizumab metabolism in rabbits following a single intravenous dose of
Dosis af Zirabev afhænger af din legemsvægt og af den type kræft, der skal behandles. 
The dose of Zirabev needed depends on your body weight and the kind of cancer to be treated.
● svært forhøjet blodtryk, som ikke kan kontrolleres med blodtrykssænkende medicin, eller hvis blodtrykket pludseligt stiger alvorligt, 
● severe high blood pressure which cannot be controlled by blood pressure medicines; or a sudden severe rise in blood pressure,
● Denne medicin kan øge risikoen for at få protein i urinen, især hvis du har forhøjet blodtryk. 
● This medicine increases the risk of having protein in your urine especially if you already have high blood pressure.
Inden indledning af behandling med Zirabev bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme. 
Before initiating Zirabev, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Zirabev indeholder det aktive stof bevacizumab, som er et humaniseret monoklonalt antistof (et slags protein, som normalt laves af immunsystemet, og som hjælper med at beskytte kroppen mod infektioner og kræft). 
Zirabev contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
● hvis du behøver invasiv tandbehandling (fx tandudtrækning) eller en tandoperation, skal du fortælle din tandlæge, at du er i behandling med Zirabev, 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 Zirabev, in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
EU/1/18/1344/001 100 mg/4 ml vial EU/1/18/1344/002 400 mg/16 ml vial 
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1344/001 100 mg/4 ml vial EU/1/18/1344/002 400 mg/16 ml vial
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; alle p-værdier er kun vist for oplysende formål 
Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only
*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.
Din læge vil ordinere den dosis Zirabev, som passer til dig. 
Your doctor will prescribe a dose of Zirabev that is right for you.
● Denne medicin kan forårsage blødning, især tumor-relateret blødning. 
● This medicine may cause bleeding, especially tumour-related bleeding.
Infusionsvæsker med Zirabev bør ikke administreres eller blandes med glucoseopløsninger. 
Zirabev infusions should not be administered or mixed with glucose solutions.
Det frarådes at anvende Zirabev til børn og unge under 18 år, da sikkerheden og fordelene ved Zirabev ikke er fastlagt hos denne patientgruppe. 
Zirabev 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.
Der blev rapporteret dødelig udgang i ca. en tredjedel af de alvorlige tilfælde af gastrointestinal perforation, hvilket svarer til 0,2-1 % af alle bevacizumabbehandlede 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.
Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Zirabev: 
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Zirabev:
Bevacizumab blev kombineret med to kemoterapiregimer: 
bevacizumab was combined with two chemotherapy regimens:
Natriumhydroxid (til justering af pH-værdien) Vand til injektionsvæsker 
Sodium hydroxide (for pH adjustment) Water for injections
Patienterne blev behandlet indtil sygdomsprogression. 
Patients were treated until disease progression.
Forskel i responsrater 
Difference in response rates
Fistler er også rapporteret efter markedsføring. 
Fistulae have also been reported in post-marketing experience.
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 CHF i denne population. 
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.
Der er ikke observeret uforligeligheder mellem Zirabev og polyvinylchlorid- eller polyolefinposer. 
No incompatibilities between Zirabev and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
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.
Zirabev skal seponeres permanent, hvis en klinisk signifikant hypertension ikke kan kontrolleres tilstrækkeligt med standard antihypertensionsbehandling, eller hvis patienten udvikler hypertensiv krise eller hypertensiv encefalopati. 
Zirabev 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.
Resultaterne for den primære analyse og followup-analysen er præsenteret for bevacizumabbehandling og forsøgsbehandling i henholdsvis tabel 14 og 15. 
Results from the primary analysis and the follow-up analysis are presented by bevacizumab Treatment and by Trial Treatment in Table 14 and Table 15, respectively.
● Zirabev kan øge risikoen for at udvikle et svagt hjerte. 
● Zirabev can increase the risk of developing a weak heart.
● svær blødning. 
● any severe bleeding.
Virkningsresultaterne 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.
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 sub-group analysis.
I bevacizumab-armen kunne patienter få bevacizumab som enkeltstofbehandling hver 3. uge indtil sygdomsprogression eller indtil uacceptabel toksicitet. 
In the bevacizumab-containing arms, patients could receive bevacizumab as a single-agent every 3 weeks until disease progression or unacceptable toxicity.
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 nonprotocol specified anti- cancer therapies, which may have impacted the analysis of overall survival.
Afhængig af den dosis, som er foreskrevet til dig, vil en del af indholdet i hætteglasset med Zirabev eller hele indholdet blive fortyndet med natriumchloridopløsning (saltvandsopløsning) før anvendelsen. 
Depending on the dose prescribed for you, some or all of the contents of the Zirabev vial will be diluted with sodium chloride solution before use.
Din læge bør vejlede dig om anvendelsen af prævention under behandlingen med Zirabev og i mindst 6 måneder efter sidste dosis Zirabev. 
Your doctor should advise you about using contraception during treatment with Zirabev and for at least 6 months after the last dose of Zirabev.
● Det er muligt, at Zirabev kan forårsage blødning i og omkring hjernen. 
● It is possible that Zirabev may cause bleeding in and around your brain.
● hvis du er allergisk over for bevacizumab eller et af de øvrige indholdsstoffer (angivet i afsnit 6). 
● if you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
Zirabev skal administreres under supervision af en læge med erfaring i anvendelse af antineoplastiske lægemidler. 
Zirabev must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Tabel 7 Nøgletal for virkningsresultater af superioritets-analysen (ITT Population, studie NO16966) 
Table 7 Key efficacy results for the superiority analysis (ITT population, trial NO16966) Endpoint (months)
Zirabev er et biosimilært lægemiddel. 
Zirabev is a biosimilar medicinal product.
5.1 for yderligere oplysninger om human epidermal vækstfaktorreceptor 2 (HER2)-status. 
For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.
Zirabev bør seponeres hos patienter, der udvikler nekrotiserende fasciitis og relevant behandling straks påbegyndes. 
Zirabev therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
● 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.
Der blev givet bevacizumab 10 mg/kg hver 2. uge indtil sygdomsprogression. 
Bevacizumab 10 mg/kg was given every 2 weeks until disease progression.
Bevacizumab er ikke godkendt til anvendelse hos patienter under 18 år. 
Bevacizumab is not approved for use in patients under the age of 18 years.
Ibevacizumab tyder på, at dets metaboliske profil svarer til, hvad der kan forventes af et nativt IgGmolekyle, som ikke binder VEGF. 
I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, antineoplastiske midler, andre antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01X C07 
Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01X C07
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 bevacizumabbehandlingen. 
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.
Tillæg af bevacizumab til IFL resulterede i en statistisk signifikant stigning i den samlede overlevelse (overall survival) (OS), progressionsfri overlevelse (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).
Bevacizumab som tillæg til kombinationsstandardbehandlingen blev tolereret hos denne pædiatriske population. 
Bevacizumab addition to multimodal standard of care treatment seemed to be tolerated in this paediatric population.
Patienter skal overvåges for tegn og symptomer på CNS-blødning, og behandling med Zirabev skal seponeres i tilfælde af intrakranial blødning. 
Patients should be monitored for signs and symptoms of CNS bleeding, and Zirabev treatment discontinued in cases of intracranial bleeding.
Alligevel er der rapporteret søvnighed og besvimelse ved anvendelse af bevacizumab. 
However, sleepiness and fainting have been reported with bevacizumab use.
● Denne medicin kan øge risikoen for blødning eller problemer med sårhelingen efter operation. 
● This medicine can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Efter korrektion for legemsvægt havde mandlige patienter en højere bevacizumab-clearance (+ 17 %) i forhold til kvindelige patienter. 
After correcting for body weight, male patients had a higher bevacizumab clearance (+ 17%) than females.
Zirabev er ikke formuleret til intravitreal anvendelse. 
Intravitreal use Zirabev is not formulated for intravitreal use.
Vaskulære sygdomme Renal trombotisk mikroangiopati, som kan manifestere sig som proteinuri (ikke kendt) med eller uden samtidig anvendelse af sunitinib. 
Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Oxaliplatin Capecitabin 
Oxaliplatin Capecitabine
Hypertension resulterede sjældent i afbrydelse af bevacizumabbehandlingen eller hospitalsindlæggelse. 
It rarely resulted in discontinuation of bevacizumab treatment or hospitalisation.
● Zirabev kan øge risikoen for, at der dannes abnorme forbindelser eller passager mellem to organer eller blodårer. 
● Zirabev may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Nekrotiserende fasciitis c 
Necrotising fasciitis c
Gastrointestinale-vaginale fistler i studie GOG-0240 
GI-vaginal fistulae in study GOG-0240
XELOX eller XELOX + bevacizumab 
XELOX or XELOX + bevacizumab
● hvis du er allergisk (overfølsom) over for produkter fremstillet i ovarieceller (CHO) fra kinesisk hamster eller andre rekombinante humane eller humaniserede antistoffer. 
● if you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Tabel 11 Virkningsresultater i studie E4599 
Table 11 Efficacy results for trial E4599
• nedsat antal af celler i blodet, inklusive hvide blodlegemer som hjælper med at bekæmpe infektioner i kroppen (kan være ledsaget af feber) og celler, der hjælper blodet med at størkne, 
• decreased number of cells in the blood, including white cells that help to fight against infections (this may be accompanied by fever), and cells that help the blood to clot,
Effektdata fra studierne AVF0780g og AVF2192g, som undersøgte bevacizumab i kombination med 5-FU/FA-kemoterapi, er sammenfattet i tabel 5. 
The efficacy data from trials AVF0780g and AVF2192g investigating bevacizumab in combination with 5-FU/FA-chemotherapy are summarised in Table 5.
Progressionsfri overlevelse og objektiv responsrate var inferior i bevacizumab monoterapi-armen i forhold til FOLFOX-4-armen. 
Progression-free survival and objective response rate were inferior in the bevacizumab monotherapy arm compared to the FOLFOX-4 arm.
Tabel 8 Resultater for virkning i studie E3200 
Table 8 Efficacy results for trial E3200
Asteni, Træthed, 
Asthenia, Fatigue,
Zirabev administreres i kombination med et af følgende kemoterapiregimer: paclitaxel og cisplatin eller paclitaxel og topotecan. 
Zirabev is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
De eneste faktorer, som viste statistisk signifikant sammenhæng med blødning, var bevacizumabbehandling og planocellulær histologi. 
The only variables that showed statistically significant correlations with bleeding were bevacizumab therapy and squamous cell histology.
Tilfælde af osteonekrose af kæben (ONJ) er blevet rapporteret hos patienter behandlet med bevacizumab, hvoraf de fleste tilfælde forekom hos patienter, der havde kendte risikofaktorer for ONJ, navnlig eksponering for intravenøse bisfosfonater og/eller en anamnese med tandsygdomme, som krævede invasive tandprocedurer (se også pkt. 
Cases of Osteonecrosis of the Jaw (ONJ) have been reported in patients treated with bevacizumab, most of which occurred in patients who had identified risk factors for ONJ, in particular exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4)
Analysen af primært endepunkt viste ingen forskel mellem bevacizumab + placeboarmen og bevacizumab + erlotinib-armen (median progressionsfri overlevelse 8,5 vs. 9,9 måneder). 
The analysis of the primary endpoint showed no difference between the bevacizumab + Placebo arm and the bevacizumab + Erlotinib arm (median PFS 8.5 versus 9.9 months).
< Der er anført en 2D-stregkode, som indeholder en entydig identifikator.> 
2D barcode carrying the unique identifier included.
I fleste tilfælde kan den nødvendige mængde Zirabev blive fortyndet med 0,9 % natriumchlorid opløsning til injektion op til 100 ml (totalvolumen). 
In the majority of the occasions the necessary amount of Zirabev can be diluted with 0.9% sodium chloride solution for injection to a total volume of 100 mL.
Brug ikke Zirabev, hvis du opdager partikler eller misfarvning før indgift. 
Do not use Zirabev if you notice any particulate matter or discolouration prior to administration.
Inden for hver frekvensgruppe er bivirkningerne anført efter aftagende alvorlighed. 
Within each frequency category, adverse reactions are presented in the order of decreasing seriousness.
● hvis du har problemer med sårheling efter en operation, 
● if you have problems with wound healing following surgery,
Dette har som regel været sekundært til sårhelingskomplikationer, gastrointestinal perforation eller fisteldannelse. 
This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation.
Du må ikke amme under behandling med Zirabev og i mindst 6 måneder efter sidste dosis Zirabev, da Zirabev kan påvirke væksten og udviklingen af dit barn. 
You must not breast-feed your baby during treatment with Zirabev and for at least 6 months after the last dose of Zirabev, as this medicine may interfere with the growth and development of your baby.
Det kliniske billede af PRES er ofte uspecifikt, og diagnosticeringen kræver derfor en bekræftelse ved en hjernescanning, helst magnetisk resonans (MR) scanning. 
The clinical presentation of PRES is often nonspecific, and therefore the diagnosis of PRES requires confirmation by brain imaging, preferably MRI.
Dette var et randomiseret fase II-studie, der blev udført for at sammenligne effekt og sikkerhed af bevacizumab vs. placebo. 
This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
Der er påvist nedsat koncentration af cirkulerende vaskulær endotelial vækstfaktor (VEGF) efter intravitreal anti-VEGF-behandling. 
A reduction of circulating VEGF concentration has been demonstrated following intravitreal anti-VEGF therapy.
En interimanalyse viste, at der var signifikant forlængelse af tid til progression af sygdom for 10 mg/kg gruppen i forhold til placebogruppen (hazard ratio, 2,55; p < 0,001). 
An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
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.
● Zirabev kan øge hyppigheden af forhøjet blodtryk. 
● Zirabev can increase the incidence of high blood pressure.
Pulmonal hypertension a, 
Pulmonary hypertension a,