FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions from other sources
Danish: Bivirkninger fra andre kilder
English: Cyramza is for intravenous use.
Danish: Cyramza er til intravenøs brug.
English: 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).
Danish: 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).
English: Objective response rate (CR +PR)
Danish: Objektiv responsrate (CR + PR)
English: 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.
Danish: 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.
English: - Abnormal urine test (‘proteinuria'): Cyramza may increase the risk of developing or worsening of abnormal levels of protein in the urine.
Danish: - Unormale urinprøver (‘proteinuri'): Cyramza kan øge risikoen for udvikling eller forværring af unormale niveauer af protein i urinen.
English: Includes: fatigue and asthenia.
Danish: Dette omfatter: træthed og asteni.
English: Your doctor will make sure that if you already have high blood pressure, it is brought under control before starting Cyramza.
Danish: Lægen vil sørge for, at hvis du allerede har forhøjet blodtryk, vil det blive bragt under kontrol inden påbegyndelse af behandlingen med Cyramza.
English: - have severe liver disease (‘cirrhosis') and associated conditions, such as excessive accumulation of fluid in your abdomen (‘ascites').
Danish: - har alvorlig leversygdom ("cirrose") og relaterede lidelser som f.eks. uforholdsmæssig stor væskeophobning i maveregionen ("ascites").
English: Dosage and frequency of administration
Danish: Dosering og hyppighed af indgivelse
English: Demographic and baseline characteristics for the ITT population were similar between treatment arms.
Danish: Demografiske og baseline-karakteristika for ITT-populationen var sammenlignelige mellem de 2 behandlingsarme.
English: Aspirin use at doses up to 325 mg/day was permitted (see section 5.1).
Danish: Acetylsalicylsyredoser op til 325 mg/dag var tilladt (se pkt 5.1).
English: Cyramza in combination with paclitaxel
Danish: Cyramza i kombination med paclitaxel
English: If you experience any symptoms affecting your ability to concentrate and react, do not drive or use machines until the effect goes away.
Danish: 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.
English: The concentrate is a clear to slightly opalescent and colourless to slightly yellow solution, pH 6.0.
Danish: Koncentratet er en klar til let opaliserende og farveløs til let gul opløsning, pH 6,0.
English: 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.
Danish: Ramucirumab må kun bruges til disse patienter, hvis de potentielle fordele ved behandlingen skønnes at opveje den potentielle risiko for progressivt leversvigt.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Symptoms may include sweating or other signs of infection, such as headache, pain in the limbs or decreased appetite.
Danish: Symptomerne kan omfatte svedtendens eller andre tegn på infektion, såsom hovedpine, smerter i lemmerne eller nedsat appetit.
English: 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.
Danish: 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.
English: *The 28 day time period begins on day 1 of the cycle subsequent to the ADR.
Danish: *Perioden på 28 dage begynder på dag 1 i serien efter den serie, hvor bivirkningen opstod
English: - 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.
Danish: - 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.
English: - 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.
Danish: - hvis røntgen viser, at der er et hulrum eller et hul i lungekræften, eller hvis lungekræften er tæt på en større blodåre.
English: Posology adjustments for ramucirumab
Danish: Dosisjusteringer for ramucirumab
English: Patients should be monitored during the infusion for signs of hypersensitivity.
Danish: Patienterne skal monitoreres under infusionen for tegn på overfølsomhed.
English: Based on PopPK, the mean (CV%) clearance of ramucirumab was 0.015 L/hour (30%) and the mean half-life was 14 days (20%).
Danish: Baseret på PopPK var middel-clearance (CV %) for ramucirumab 0,015 l/time (30 %) og middelhalveringstiden var 14 dage (20 %).
English: Infusion-related reactions were reported in clinical studies with ramucirumab.
Danish: Infusionsrelaterede reaktioner blev rapporteret i kliniske studier med ramucirumab.
English: 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.
Danish: 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.
English: 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).
Danish: Den mediane OS for patienter med enhver grad af neutropeni var længere i ramucirumabarmen (16,1 måneder) end i placebo-armen (12,6 måneder).
English: Table 2: Criteria to be met prior to FOLFIRI administration Criteria
Danish: Tabel 2: Kriterier, der skal opfyldes inden administration af FOLFIRI Kriterier
English: 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.
Danish: 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.
English: There is insufficient data to evaluate the effects of ADAs on the efficacy or safety of ramucirumab.
Danish: Der er utilstrækkelige data til at vurdere effekterne af ADA'erne på effekten af eller sikkerheden ved ramucirumab.
English: If a patient experiences a Grade 1 or 2 infusion-related reaction premedication must be given for all subsequent infusions.
Danish: Hvis en patient oplever en infusionsrelateret reaktion af grad 1 eller 2, skal der gives præmedicinering ved alle efterfølgende infusioner.
English: Stratified log-rank p-value
Danish: Stratificeret log-rank p-værdi
English: Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia have been reported in clinical studies.
Danish: Alvorlige og undertiden dødelige arterielle tromboemboliske hændelser (ATE'er), herunder myokardieinfarkt, hjertestop, hjerneblødning og cerebral iskæmi, er rapporteret i kliniske studier.
English: In severe cases symptoms included bronchospasm, supraventricular tachycardia, and hypotension.
Danish: I svære tilfælde omfattede symptomerne bronkospasmer, supraventrikulær takykardi og hypotension.
English: Administer via infusion pump.
Danish: Indgives via infusionspumpe.
English: - have any condition which increases the risk of bleeding.
Danish: - har en lidelse, som øger risikoen for blødning.
English: 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.
Danish: 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.
English: An accumulation ratio of 1.5 was observed for ramucirumab when dosed every 2 weeks.
Danish: En akkumuleringsratio på 1,5 blev observeret for ramucirumab ved dosering hver anden uge.
English: Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP.
Danish: 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.
English: 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.
Danish: 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.
English: The impact of ramucirumab has not been evaluated in patients with serious or non-healing wounds.
Danish: Virkningen af ramucirumab er ikke blevet undersøgt hos patienter med alvorlige sår eller sår, som ikke heler.
English: 1,200 mg/m2 over 46-48 hours a 5-FU = 5-fluorouracil.
Danish: 1.200 mg/m2 over 46-48 timer a 5-FU = fluoruracil.
English: If particulate matter is identified, discard the infusion solution.
Danish: Hvis der observeres partikler, skal infusionsopløsningen bortskaffes.
English: Eleven (2.2%) of ramucirumab treated patients and two (0.5%) of control treated patients developed ADAs.
Danish: 11 (2,2 %) af de patienter, som fik ramucirumab, og 2 (0,5 %) kontrolpatienter udviklede ADA'er.
English: A majority (75%) of patients randomised in the study received prior platinum and fluoropyrimidine combination therapy without anthracycline.
Danish: Størstedelen (75 %) af de patienter, der blev randomiseret i studiet, havde tidligere fået platin- og fluorpyrimidin-kombinationsbehandling uden antracylin.
English: 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.
Danish: 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.
English: Patients treated with Cyramza experienced a statistically significant improvement in OS, compared to placebo (Table 12).
Danish: Patienter behandlet med Cyramza oplevede en statistisk signifikant forbedring i samlet overlevelse sammenlignet med placebo (tabel 12).
English: The most serious adverse reactions associated with ramucirumab treatment (as a single agent or in combination with cytotoxic chemotherapy) were:
Danish: De mest alvorlige bivirkninger forbundet med behandling med ramucirumab (som monoterapi eller i kombination med cytotoksisk kemoterapi) var følgende:
English: 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.
Danish: 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.
English: Cyramza can increase the incidence of high blood pressure.
Danish: Cyramza kan øge forekomsten af forhøjet blodtryk.
English: Randomisation was stratified by geographic region, time to progression from the start of first-line therapy (<6 months versus ≥6 months) and disease measurability.
Danish: Randomiseringen blev stratificeret i henhold til geografisk region, tid til progression fra påbegyndelse af førstelinjebehandling (<6 måneder versus ≥6 måneder) og målbarhed af sygdommen.
English: 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).
Danish: Komorbiditeter relateret til fremskreden alder, performancestatus og mulig tolerabilitet overfor kemoterapi skal derfor evalueres grundigt, før behandling påbegyndes hos ældre (se pkt.
English: Proteinuriaa,f
Danish: Proteinuria,h
English: Based on population pharmacokinetic approach (PopPK), the mean (% coefficient of variation [CV%]) volume of distribution at steady state for ramucirumab was 5.4L (15%).
Danish: Baseret på en populationsfarmakokinetisk (PopPK) model var det gennemsnitlige distributionsvolumen (variationskoefficient [CV%]) ved steady state for ramucirumab 5,4 l (15 %).
English: The ORR was similar for both treatment arms (13.4% versus 12.5%, ramucirumab plus FOLFIRI versus placebo plus FOLFIRI, respectively).
Danish: ORR var sammenlignelig for de 2 behandlingsarme (13,4 % versus 12,5 % for henholdsvis ramucirumab plus FOLFIRI versus placebo plus FOLFIRI).
English: If the urine protein is ≥2+ on a dipstick, a 24 hour urine collection should be performed.
Danish: Hvis urinprotein er ≥ 2+ ved en urinstix-analyse, skal der udføres 24-timers urinopsamling.
English: There were no patients with Child-Pugh B or C liver cirrhosis enrolled in REGARD.
Danish: Der var ikke inkluderet patienter i REGARD med Child-Pugh B eller C levercirrose.
English: Patients enrolled into the study had disease progression on or after prior sorafenib therapy or were intolerant to sorafenib.
Danish: Patienter, der indgik i dette studie, havde sygdomsprogression under eller efter tidligere sorafenibbehandling eller var intolerante overfor sorafenib.
English: 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.
Danish: 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.
English: Once the urine protein level has decreased to a certain level, treatment may be restarted with a lower dose.
Danish: Når proteinindholdet i urinen er faldet til et bestemt niveau, kan behandlingen genoptages ved en lavere dosis.
English: The blood pressure of patients should be monitored prior to each ramucirumab administration and treated as clinically indicated.
Danish: Patienternes blodtryk skal monitoreres inden hver indgift af ramucirumab og skal behandles på klinisk indikation.
English: No dose reductions are recommended.
Danish: Der foreligger ingen anbefalinger for dosisreduktion.
English: Elective surgery or impaired wound healing
Danish: Elektiv kirurgi eller nedsat sårhelingsevne
English: Based on limited data from REGARD patients with HER2-positive gastric or GEJ adenocarcinoma and patients previously treated with trastuzumab (in RAINBOW), it is considered unlikely that Cyramza has a detrimental effect or that it has no effect in patients with HER2-positive gastric cancer.
Danish: Baseret på begrænsede data vedrørende REGARD-patienter med HER2-positiv gastrisk cancer eller GEJ adenokarcinom samt patienter tidligere behandlet med trastuzumab (i RAINBOW), vurderes det som usandsynligt, at Cyramza har en skadelig virkning eller ingen virkning hos patienter med HER2positiv gastrisk cancer.
English: If you have a wound that heals poorly during treatment, dosing of Cyramza will be stopped until the wound is fully healed.
Danish: Hvis du under behandlingen får et sår, som har svært ved at hele, vil behandlingen med Cyramza blive stoppet, indtil såret er komplet helet.
English: Treatment with Cyramza may need to be stopped temporarily until high blood pressure is controlled with medicines, or stopped permanently if it cannot be adequately controlled.
Danish: Det kan være nødvendigt at stoppe behandlingen med Cyramza midlertidigt, indtil det forhøjede blodtryk er bragt under kontrol med medicin, eller stoppe behandlingen permanent, hvis det ikke er muligt at opnå tilstrækkelig kontrol med blodtrykket.
English: Stratified CMH p-value
Danish: Stratificeret CMH p-værdi
English: Histidine monohydrochloride Sodium chloride Glycine (E640) Polysorbate 80 (E433) Water for injections
Danish: Histidinhydrochlorid Natriumchlorid Glycin (E640) Polysorbat 80 (E433) Vand til injektionsvæsker
English: The target organs identified in repeated dose cynomolgus monkey toxicity studies were kidney (glomerulonephritis), bone (thickening and abnormal endochondral ossification of the epiphyseal growth plate) and female reproductive organs (decreased weight of ovaries and uterus).
Danish: De målorganer, som blev identificeret i toksicitetsforsøg med gentagne doser hos cynomolgusaber, var nyrer (glomerulonephritis), knogle (fortykkelse og unormal endokondral ossifikation af epifysens vækstskive) og de kvindelige reproduktionsorganer (nedsat vægt af ovarier og uterus).
English: Read the paclitaxel or docetaxel package leaflet for further information.
Danish: Læs indlægssedlen for paclitaxel eller docetaxel for yderligere information.
English: Infection (sepsis) may be severe and could lead to death.
Danish: Infektion kan blive alvorlig (blodforgiftning) og være dødelig.
English: Symptoms of a stroke may include sudden numbness or weakness of the arm, leg and face, feeling confused, difficulty speaking or understanding others, sudden difficulty in walking or loss of balance or coordination or sudden dizziness.
Danish: Symptomer på slagtilfælde kan omfatte pludselig følelsesløshed eller svaghed i armen, benet og ansigtet, følelse af forvirring, talebesvær eller problemer med at forstå andre, pludselige problemer med at gå eller tab af balance eller koordination eller pludselig svimmelhed.
English: Hypokalaemiaa,b Hyponatraemiaa Hypoalbuminaemiaa
Danish: Hypokaliæmia,b Hyponatriæmia Hypoalbuminæmia
English: It is recommended to reduce the docetaxel dose by 10 mg/m2 for all following cycles.
Danish: Det anbefales, at reducere docetaxeldosis med 10 mg/m2 i alle efterfølgende serier.
English: Prior to each paclitaxel infusion, patients should have a complete blood count and blood chemistry performed to evaluate hepatic function.
Danish: Inden hver infusion af paclitaxel skal patienterne have foretaget en komplet blodtælling og analyse af blodets sammensætning for at vurdere leverfunktionen.
English: Permanent discontinuation
Danish: Permanent seponering
English: The median relative dose intensity of Cyramza was 98.6% and of placebo was 99.6%.
Danish: Den mediane relative dosisintensitet af Cyramza var 98,6 % og 99,6 % for placebo.
English: Cyramza is available in packs of: - 1 vial of 10 ml - 2 vials of 10 ml - 1 vial of 50 ml
Danish: Cyramza fås i pakninger med: - 1 hætteglas med 10 ml - 2 hætteglas med 10 ml - 1 hætteglas med 50 ml
English: Pre-specified subgroup analyses for both PFS and OS according to age (<65 and ≥65 years), gender, race, ECOG PS (0 or ≥1), number of organs involved, liver metastases only, site of primary tumour (colon or rectum), carcinoembryonic antigen levels (<200 μg/L, ≥200 μg/L), all showed a treatment effect favouring Cyramza plus
Danish: Præspecificerede subgruppeanalyser af både PFS og OS i forhold til alder (<65 og ≥65 år), køn, race, ECOG-PS (0 eller ≥ 1), antal involverede organer, kun levermetastaser, lokalisation af primær tumor (kolon eller rektum), karcinoembryonalt antigen-niveau (< 200 μg/ml, ≥ 200μg/ml) viste alle en behandlingseffekt til fordel for Cyramza plus FOLFIRI over for placebo plus FOLFIRI.
English: Peripheral oedema Infusion-related reactionsa a Terms represent a group of events that describe a medical concept rather than a single event or preferred term.
Danish: Perifært ødem Infusionsrelaterede reaktionera a Termen repræsenterer en gruppe bivirkninger, som beskriver et medicinsk begreb frem for en enkelt bivirkning eller en foretrukken term.
English: Body weight is considered a significant co-variate of ramucirumab pharmacokinetics supporting the dosing based on body weight.
Danish: Legemsvægt betragtes som en signifikant kovariant for ramucirumabs farmakokinetik og støtter derved doseringen baseret på legemsvægt.
English: Arterial blood clots can lead to serious conditions, including heart attack or stroke.
Danish: Arterielle blodpropper kan føre til alvorlige lidelser, herunder hjerteanfald eller slagtilfælde.
English: Each 50 ml vial contains approximately 85 mg sodium (main component of cooking/table salt).
Danish: Hvert 50 ml hætteglas indeholder ca. 85 mg natrium (hovedkomponent af madlavnings-/bordsalt).
English: A relevant exposure-efficacy association was observed for ramucirumab in REACH-2 (see section 5.2).
Danish: En relevant sammenhæng mellem eksponering og effekt blev observeret for ramucirumab i REACH-2 (se pkt.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på de fremstillere, der er ansvarlig for batchfrigivelse
English: Randomisation was stratified by geographic region, gender, prior maintenance, and ECOG PS. Cyramza at 10 mg/kg or placebo and docetaxel at 75 mg/m2 were each administered by intravenous infusion on day 1 of a 21-day cycle.
Danish: Randomiseringen var stratificeret efter geografisk region, køn, tidligere vedligeholdelsesbehandling og ECOG-PS. Cyramza 10 mg/kg eller placebo og docetaxel 75 mg/m2 blev hver især administreret ved intravenøs infusion på dag 1 i en serie på 21 dage.