natgillin/translations-raw huggingface dataset:
Det primære endepunkt var OS, og de sekundære endepunkter inkluderede PFS, objektiv responsrate (ORR) og livskvalitet (Quality of life (QoL)) bedømt ved the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. 
The primary endpoint was OS and the secondary endpoints included PFS, objective response rate (ORR) and quality of life (QoL) using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.
Dosis af de individuelle komponenter i FOLFIRI kan reduceres ved specifikke toksiciteter. 
Dose reductions for individual components of FOLFIRI may be made for specific toxicities.
Cyramza anbefales ikke under graviditet og til reproduktionsdygtige kvinder, som ikke bruger kontraception. 
Cyramza is not recommended during pregnancy and in women of childbearing potential not using contraception.
Patienterne skal overvåges for kliniske tegn og symptomer på hepatisk encefalopati. 
Patients should be monitored for clinical signs and symptoms of hepatic encephalopathy.
Tabel 5 angiver detaljer for dosisudsættelse eller dosisreduktion af FOLFIRI-komponenterne ved den næste serie baseret på maksimal grad af specifikke bivirkninger. 
Table 5 provides details of dose delays or dose reductions of components of FOLFIRI at the next cycle based on maximum grade of specific adverse drug reactions.
Det primære endepunkt var samlet overlevelse (OS), og de sekundære endepunkter omfattede progressionsfri overlevelse (PFS) og total responsrate (ORR). 
The primary endpoint was overall survival (OS) and the secondary endpoints included progression free survival (PFS) and overall response rate (ORR).
Der var ingen klar afvigelse fra dosisproportionaliteten i farmakokinetikken for ramucirumab fra 6 mg/kg til 20 mg/kg. 
There was no clear deviation from dose proportionality in pharmacokinetics of ramucirumab from 6 mg/kg to 20 mg/kg.
- skal gennemgå en planlagt operation, hvis du for nyligt har gennemgået en operation, eller hvis du har ringe sårheling efter operation. 
- are going to have planned surgery, if you had recent surgery or if you have poor wound healing after surgery.
Hvis patienterne oplever symptomer, som påvirker deres evne til at koncentrere sig og reagere, anbefales det, at de ikke fører motorkøretøj eller betjener maskiner, før virkningen har fortaget sig. 
If patients experience symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Præmedicinering anbefales med en histamin H1-antagonist (f.eks. diphenhydramin) inden infusion af ramucirumab. 
Premedication is recommended with a histamine H1 antagonist (for example diphenhydramine) prior to infusion of ramucirumab.
I REACH-2 var patienternes demografi og sygdomskarakteristika ved baseline generelt balanceret mellem armene, bortset fra AFP, som var lavere i placeboarmen. 
In REACH-2, baseline patient demographics and disease characteristics were generally balanced between arms, except for AFP, which was lower in the placebo arm.
d Dette omfatter: blodtryksstigning og hypertension. 
d Includes: blood pressure increased and hypertension.
Hvis du får Cyramza i kombination med enten paclitaxel eller docetaxel på den samme dag, vil du få Cyramza først. 
If you are receiving Cyramza in combination with either paclitaxel or docetaxel on the same day, Cyramza will be given first.
Hvis det ikke bruges straks, er brugeren ansvarlig for opbevaringstiden i brug og betingelserne inden brug, som normalt ikke vil være mere end 24 timer ved 2 ºC til 8 ºC, medmindre der er foretaget fortynding under kontrollerede og validerede aseptiske forhold. 
If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ºC to 8 ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Der er ikke udført dyreforsøg for at teste ramucirumab for potentiale for karcinogenicitet eller genotoksicitet. 
No animal studies have been performed to test ramucirumab for potential of carcinogenicity or genotoxicity.
Patienterne kan have en øget risiko for udvikling af fistler i forbindelse med behandling med Cyramza. 
Patients may be at increased risk for the development of fistula when treated with Cyramza.
Baseret på PopPK har følgende kovarianter ingen indvirkning på ramucirumabs fordeling: alder, køn, race, albuminniveau. 
Based on PopPK, the following covariates were found to have no impact on ramucirumab disposition: age, sex, race, albumin levels.
Hvis du oplever en infusionsrelateret reaktion under behandlingen, øges den tid, det tager at indgive infusionen, under resten af den pågældende infusion og ved alle efterfølgende infusioner. 
If you experience an infusion-related reaction during treatment, the time taken to give your infusion will be increased for the rest of that infusion and for all future infusions.
Din læge kan udskrive medicin, som kan afhjælpe symptomerne. 
Your doctor may prescribe treatment to help with the symptoms.
En forbedring i PFS var også forbundet med øget ramucirumab-eksponering ved fremskreden gastrisk cancer, NSCLC og mCRC. 
An improvement in PFS was also associated with increasing ramucirumab exposure for advanced gastric cancer, NSCLC, and mCRC.
Lægemidlet gives som en infusion via et drop over et tidsrum på ca. 60 minutter. 
This medicine is given by infusion via a drip over a period of approximately 60 minutes.
Hvis det ikke anvendes straks, er brugeren ansvarlig for opbevaringstiden i brug og betingelserne inden brug, som normalt ikke vil være mere end 24 timer ved 2 ºC til 8 ºC. 
If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C.
Denne receptor bruges, når der dannes nye blodårer. 
This receptor is needed in the development of new blood vessels.
Randomiseringen blev stratificeret i henhold til vægttab i løbet af de sidste 3 måneder (≥ 10 % versus < 10 %), geografisk region og placeringen af den primære tumor (mavesæk versus den gastroøsofagale overgang). 
Randomisation was stratified by weight loss over the prior 3 months (≥ 10% versus < 10%), geographic region, and location of the primary tumour (gastric versus GEJ).
f Dette omfatter et tilfælde af nefrotisk syndrom. 
f Includes one case of nephrotic syndrome
Dyreforsøg har været utilstrækkelige med hensyn til reproduktionstoksicitet (se pkt. 
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Beholderen skal forsigtigt vendes op og ned for at sikre, at væsken blandes tilstrækkeligt. 
The container should be gently inverted to ensure adequate mixing.
Dette omfatter hepatisk encefalopati og hepatisk koma. 
Includes hepatic encephalopathy and hepatic coma.
Der foreligger ingen data om brug af ramucirumab til gravide kvinder. 
There are no data from the use of ramucirumab in pregnant women.
Beslutningen om at genoptage behandlingen med ramucirumab efter et kirurgisk indgreb skal baseres på et klinisk skøn med hensyn til tilstrækkelig sårheling. 
The decision to resume ramucirumab following surgical intervention should be based on clinical judgment of adequate wound healing.
Papendorpseweg 83 3528 BJ Utrecht Holland 
Papendorpseweg 83 3528 BJ Utrecht
Hvis patienten bliver gravid under behandlingen med ramucirumab, skal hun informeres om den potentielle risiko ved opretholdelse af graviditeten og risikoen for fostret. 
If the patient becomes pregnant while being treated with ramucirumab, she should be informed of the potential risk to the maintenance of pregnancy and the risk to the foetus.
Bivirkninger fra andre kilder 
Adverse reactions from other sources
Cyramza er til intravenøs brug. 
Cyramza is for intravenous use.
Den relative behandlingseffekt (vurderet ved HR) af Cyramza sammenlignet med placebo var generelt konsistent på tværs af subgrupper, herunder alder, race, sygdomsætiologi og årsag til seponering af sorafenib (progressiv sygdom vs. intolerance). 
The relative treatment effect (assessed by HR) of Cyramza compared to placebo was generally consistent across subgroups, including age, race, aetiology of disease and reason for discontinuation of sorafenib (progressive disease vs. intolerance).
Objektiv responsrate (CR + PR) 
Objective response rate (CR +PR)
Da angiogenese er afgørende for opretholdelse af en graviditet og for fosterudviklingen, kan hæmningen af angiogenese efter administration af ramucirumab medføre uønskede effekter på graviditeten, herunder fostret. 
As angiogenesis is critical to maintenance of pregnancy and to foetal development, the inhibition of angiogenesis following ramucirumab administration may result in adverse effects on pregnancy, including the foetus.
- Unormale urinprøver (‘proteinuri'): Cyramza kan øge risikoen for udvikling eller forværring af unormale niveauer af protein i urinen. 
- Abnormal urine test (‘proteinuria'): Cyramza may increase the risk of developing or worsening of abnormal levels of protein in the urine.
Dette omfatter: træthed og asteni. 
Includes: fatigue and asthenia.
Lægen vil sørge for, at hvis du allerede har forhøjet blodtryk, vil det blive bragt under kontrol inden påbegyndelse af behandlingen med Cyramza. 
Your doctor will make sure that if you already have high blood pressure, it is brought under control before starting Cyramza.
- har alvorlig leversygdom ("cirrose") og relaterede lidelser som f.eks. uforholdsmæssig stor væskeophobning i maveregionen ("ascites"). 
- have severe liver disease (‘cirrhosis') and associated conditions, such as excessive accumulation of fluid in your abdomen (‘ascites').
Dosering og hyppighed af indgivelse 
Dosage and frequency of administration
Demografiske og baseline-karakteristika for ITT-populationen var sammenlignelige mellem de 2 behandlingsarme. 
Demographic and baseline characteristics for the ITT population were similar between treatment arms.
Acetylsalicylsyredoser op til 325 mg/dag var tilladt (se pkt 5.1). 
Aspirin use at doses up to 325 mg/day was permitted (see section 5.1).
Cyramza i kombination med paclitaxel 
Cyramza in combination with paclitaxel
Hvis du oplever symptomer, der påvirker din evne til at koncentrere dig eller reagere, må du ikke føre motorkøretøj eller betjene maskiner, før virkningen er forsvundet. 
If you experience any symptoms affecting your ability to concentrate and react, do not drive or use machines until the effect goes away.
Koncentratet er en klar til let opaliserende og farveløs til let gul opløsning, pH 6,0. 
The concentrate is a clear to slightly opalescent and colourless to slightly yellow solution, pH 6.0.
Ramucirumab må kun bruges til disse patienter, hvis de potentielle fordele ved behandlingen skønnes at opveje den potentielle risiko for progressivt leversvigt. 
Ramucirumab should only be used in these patients if the potential benefits of treatment are judged to outweigh the potential risk of progressive hepatic failure.
Randomiseringen var stratificeret efter geografisk region, tumor KRAS-status (mutant eller wild-type) og tid til sygdomsprogression (TTP) efter påbegyndelse af førstelinjebehandling (< 6 måneder versus ≥ 6 måneder). 
Randomisation was stratified by geographic region, tumour KRAS status (mutant or wild-type), and time to disease progression (TTP) after commencing first-line treatment (<6 months versus ≥6 months).
Ramucirumab er et humant, receptor-målrettet antistof, som specifikt binder sig til VEGF-receptor 2 og blokerer binding af VEGF-A, VEGF-C og VEGF-D. Som følge heraf hæmmer ramucirumab ligand-stimuleret aktivering af VEGF-receptor 2 og dens downstream signalkomponenter, herunder p44/p42 mitogen-aktiverede proteinkinaser, neutraliserende liglandinduceret proliferation og migration af humane endotelceller. 
Ramucirumab is a human receptor-targeted antibody that specifically binds VEGF Receptor 2 and blocks binding of VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand stimulated activation of VEGF Receptor 2 and its downstream signalling components, including p44/p42 mitogen-activated protein kinases, neutralising ligand-induced proliferation and migration of human endothelial cells.
Da ramucirumab imidlertid er en antiangiogen behandling og kan have potentiale til at påvirke sårhelingen negativt, skal behandling med ramucirumab seponeres i mindst 4 uger inden en planlagt operation. 
However, since ramucirumab is an antiangiogenic therapy and may have the potential to adversely affect wound healing, ramucirumab treatment should be withheld for at least 4 weeks prior to scheduled surgery.
Symptomerne kan omfatte svedtendens eller andre tegn på infektion, såsom hovedpine, smerter i lemmerne eller nedsat appetit. 
Symptoms may include sweating or other signs of infection, such as headache, pain in the limbs or decreased appetite.
Blodtællinger og koagulationsparametre skal monitoreres hos patienter med lidelser, som disponerer for blødning, og hos patienter, som behandles med antikoagulantia eller andre samtidige lægemidler, som øger risikoen for blødning. 
Blood counts and coagulation parameters should be monitored in patients with conditions predisposing to bleeding, and in those treated with anticoagulants or other concomitant medicinal products that increase the risk of bleeding.
*Perioden på 28 dage begynder på dag 1 i serien efter den serie, hvor bivirkningen opstod 
*The 28 day time period begins on day 1 of the cycle subsequent to the ADR.
- Unormale rørlignende forbindelser eller passager inde i kroppen ("fistler"): Cyramza kan øge risikoen for unormale rørlignende forbindelser eller passager inde i kroppen mellem indre organer og huden eller andet væv. 
- Abnormal tube-like connections or passageways inside the body (‘fistula'): Cyramza may increase the risk of abnormal tube-like connections or passageways inside the body between internal organs and skin or other tissues.
- hvis røntgen viser, at der er et hulrum eller et hul i lungekræften, eller hvis lungekræften er tæt på en større blodåre. 
- if there is X-ray evidence that the lung cancer has a cavity or hole in it or if the lung cancer is close to major blood vessels.
Dosisjusteringer for ramucirumab 
Posology adjustments for ramucirumab
Patienterne skal monitoreres under infusionen for tegn på overfølsomhed. 
Patients should be monitored during the infusion for signs of hypersensitivity.
Baseret på PopPK var middel-clearance (CV %) for ramucirumab 0,015 l/time (30 %) og middelhalveringstiden var 14 dage (20 %). 
Based on PopPK, the mean (CV%) clearance of ramucirumab was 0.015 L/hour (30%) and the mean half-life was 14 days (20%).
Infusionsrelaterede reaktioner blev rapporteret i kliniske studier med ramucirumab. 
Infusion-related reactions were reported in clinical studies with ramucirumab.
Ved hæmatologisk toksicitet af NCI CTCAE-grad 4 eller paclitaxel-relateret ikke-hæmatologisk toksicitet af grad 3 anbefales det at reducere dosis af paclitaxel med 10 mg/m2 for alle efterfølgende serier. 
For NCI CTCAE Grade 4 haematological toxicity or Grade 3 paclitaxel-related non-haematological toxicity, it is recommended to reduce the paclitaxel dose by 10 mg/m2 for all following cycles.
Den mediane OS for patienter med enhver grad af neutropeni var længere i ramucirumabarmen (16,1 måneder) end i placebo-armen (12,6 måneder). 
The median OS in patients with any grade neutropenia was greater in the ramucirumab arm (16.1 months) than in the placebo arm (12.6 months).
Tabel 2: Kriterier, der skal opfyldes inden administration af FOLFIRI Kriterier 
Table 2: Criteria to be met prior to FOLFIRI administration Criteria
Der er derfor begrænset erfaring med kombinationen af ramucirumab og docetaxel hos disse patienter med fremskreden NSCLC såvel som hos patienter med nedsat nyrefunktion, kardiovaskulær sygdom og svær overvægt. 
Therefore there is limited experience with the combination of ramucirumab and docetaxel in these patients with advanced NSCLC as well as in patients with renal impairment, cardiovascular disease and obesity.
Der er utilstrækkelige data til at vurdere effekterne af ADA'erne på effekten af eller sikkerheden ved ramucirumab. 
There is insufficient data to evaluate the effects of ADAs on the efficacy or safety of ramucirumab.
Hvis en patient oplever en infusionsrelateret reaktion af grad 1 eller 2, skal der gives præmedicinering ved alle efterfølgende infusioner. 
If a patient experiences a Grade 1 or 2 infusion-related reaction premedication must be given for all subsequent infusions.
Stratificeret log-rank p-værdi 
Stratified log-rank p-value
Alvorlige og undertiden dødelige arterielle tromboemboliske hændelser (ATE'er), herunder myokardieinfarkt, hjertestop, hjerneblødning og cerebral iskæmi, er rapporteret i kliniske studier. 
Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia have been reported in clinical studies.
I svære tilfælde omfattede symptomerne bronkospasmer, supraventrikulær takykardi og hypotension. 
In severe cases symptoms included bronchospasm, supraventricular tachycardia, and hypotension.
Indgives via infusionspumpe. 
Administer via infusion pump.
- har en lidelse, som øger risikoen for blødning. 
- have any condition which increases the risk of bleeding.
Reproduktionsdygtige kvinder/Kontraception hos kvinder Reproduktionsdygtige kvinder skal rådes til at undgå graviditet under behandlingen med Cyramza og skal informeres om den potentielle risiko for graviditeten og fostret. 
Women of childbearing potential/Contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on Cyramza and should be informed of the potential hazard to the pregnancy and foetus.
En akkumuleringsratio på 1,5 blev observeret for ramucirumab ved dosering hver anden uge. 
An accumulation ratio of 1.5 was observed for ramucirumab when dosed every 2 weeks.
Brug ikke lægemidlet efter den udløbsdato, der står på den ydre pakning og etiketten på hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP.
Det primære effektmål i REACH-2 blev understøttet af en statistisk signifikant forbedring i progressionsfri overlevelse hos patienter behandlet med Cyramza sammenlignet med placebobehandlede patienter. 
The major efficacy outcome in REACH-2 was supported by a statistically significant improvement in progression free survival in Cyramza treated patients compared to placebo treated patients.
Virkningen af ramucirumab er ikke blevet undersøgt hos patienter med alvorlige sår eller sår, som ikke heler. 
The impact of ramucirumab has not been evaluated in patients with serious or non-healing wounds.
1.200 mg/m2 over 46-48 timer a 5-FU = fluoruracil. 
1,200 mg/m2 over 46-48 hours a 5-FU = 5-fluorouracil.
Hvis der observeres partikler, skal infusionsopløsningen bortskaffes. 
If particulate matter is identified, discard the infusion solution.
11 (2,2 %) af de patienter, som fik ramucirumab, og 2 (0,5 %) kontrolpatienter udviklede ADA'er. 
Eleven (2.2%) of ramucirumab treated patients and two (0.5%) of control treated patients developed ADAs.
Størstedelen (75 %) af de patienter, der blev randomiseret i studiet, havde tidligere fået platin- og fluorpyrimidin-kombinationsbehandling uden antracylin. 
A majority (75%) of patients randomised in the study received prior platinum and fluoropyrimidine combination therapy without anthracycline.
Patienter med ukontrolleret hypertension blev eksluderet fra studierne, og behandling med ramucirumab må ikke påbegyndes hos disse patienter indtil og med mindre at den præeksisterende hypertension er bragt under kontrol. 
Patients with uncontrolled hypertension were excluded from the trials: ramucirumab treatment should not be initiated in such patients until and unless their pre-existing hypertension is controlled.
Patienter behandlet med Cyramza oplevede en statistisk signifikant forbedring i samlet overlevelse sammenlignet med placebo (tabel 12). 
Patients treated with Cyramza experienced a statistically significant improvement in OS, compared to placebo (Table 12).
De mest alvorlige bivirkninger forbundet med behandling med ramucirumab (som monoterapi eller i kombination med cytotoksisk kemoterapi) var følgende: 
The most serious adverse reactions associated with ramucirumab treatment (as a single agent or in combination with cytotoxic chemotherapy) were:
For de patienter, som fik Cyramza plus paclitaxel, var den mediane behandlingsvarighed 19 uger, og for patienter, som fik placebo plus paclitaxel, var den mediane behandlingsvarighed 12 uger. 
For patients treated with Cyramza plus paclitaxel the median duration of therapy was 19 weeks, and for patients treated with placebo plus paclitaxel the median duration of therapy was 12 weeks.
Cyramza kan øge forekomsten af forhøjet blodtryk. 
Cyramza can increase the incidence of high blood pressure.
Randomiseringen blev stratificeret i henhold til geografisk region, tid til progression fra påbegyndelse af førstelinjebehandling (<6 måneder versus ≥6 måneder) og målbarhed af sygdommen. 
Randomisation was stratified by geographic region, time to progression from the start of first-line therapy (<6 months versus ≥6 months) and disease measurability.
Komorbiditeter relateret til fremskreden alder, performancestatus og mulig tolerabilitet overfor kemoterapi skal derfor evalueres grundigt, før behandling påbegyndes hos ældre (se pkt. 
Comorbidities associated with advanced age, performance status and the likely tolerability to chemotherapy should therefore be thoroughly evaluated prior to the initiation of treatment in the elderly (see sections 4.2 and 5.1).
Proteinuria,h 
Proteinuriaa,f
Baseret på en populationsfarmakokinetisk (PopPK) model var det gennemsnitlige distributionsvolumen (variationskoefficient [CV%]) ved steady state for ramucirumab 5,4 l (15 %). 
Based on population pharmacokinetic approach (PopPK), the mean (% coefficient of variation [CV%]) volume of distribution at steady state for ramucirumab was 5.4L (15%).
ORR var sammenlignelig for de 2 behandlingsarme (13,4 % versus 12,5 % for henholdsvis ramucirumab plus FOLFIRI versus placebo plus FOLFIRI). 
The ORR was similar for both treatment arms (13.4% versus 12.5%, ramucirumab plus FOLFIRI versus placebo plus FOLFIRI, respectively).
Hvis urinprotein er ≥ 2+ ved en urinstix-analyse, skal der udføres 24-timers urinopsamling. 
If the urine protein is ≥2+ on a dipstick, a 24 hour urine collection should be performed.
Der var ikke inkluderet patienter i REGARD med Child-Pugh B eller C levercirrose. 
There were no patients with Child-Pugh B or C liver cirrhosis enrolled in REGARD.
Patienter, der indgik i dette studie, havde sygdomsprogression under eller efter tidligere sorafenibbehandling eller var intolerante overfor sorafenib. 
Patients enrolled into the study had disease progression on or after prior sorafenib therapy or were intolerant to sorafenib.
På listen over bivirkninger herover, udgør disse: Lavt antal hvide blodlegemer, lavt antal blodplader i blodet, lavt indhold i blodet af albumin, kalium eller natrium, tilstedeværelse af protein i urinen. 
From the side effects listed above, these are: low white blood cell counts; low platelet count in the blood; low blood levels of albumin, potassium or sodium; presence of protein in the urine.
Når proteinindholdet i urinen er faldet til et bestemt niveau, kan behandlingen genoptages ved en lavere dosis. 
Once the urine protein level has decreased to a certain level, treatment may be restarted with a lower dose.
Patienternes blodtryk skal monitoreres inden hver indgift af ramucirumab og skal behandles på klinisk indikation. 
The blood pressure of patients should be monitored prior to each ramucirumab administration and treated as clinically indicated.
Der foreligger ingen anbefalinger for dosisreduktion. 
No dose reductions are recommended.
Elektiv kirurgi eller nedsat sårhelingsevne 
Elective surgery or impaired wound healing