FrancophonIA/ELRC3.0 huggingface dataset:
English: Ulcerative keratitis1,4 Keratitis1
Danish: Ulcerativ keratitis1,4 Keratitis1
English: Patients were treated until disease progression or unacceptable toxicity occurred.
Danish: Patienterne blev behandlet, indtil sygdomsprogression eller uacceptabel toksicitet forekom.
English: Contact lens use is also a risk factor for keratitis and ulceration.
Danish: Anvendelse af kontaktlinser er også en risikofaktor for keratitis og ulceration.
English: If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 60 minutes.
Danish: Hvis den første infusion tåles, kan de efterfølgende infusioner indgives over 30 til 60 minutter.
English: It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant.
Danish: Det er vigtigt at fortælle det til Deres læge, hvis De er gravid, tror De kan være gravid eller planlægger at blive gravid.
English: Date of latest renewal: 15 January 2015
Danish: Dato for første markedsføringstilladelse: 3. december 2007 Dato for seneste fornyelse: 15. januar 2015
English: No new toxicities or worsening of previously recognised toxicities beyond the expected additive effects were observed.
Danish: Der blev ikke observeret nogen ny toksicitet eller forværring af tidligere identificeret toksicitet udover de forventede additive effekter.
English: Monitoring as above and repletion as appropriate of these electrolytes is also recommended.
Danish: Monitorering som beskrevet ovenfor samt retablering efter behov af disse elektrolytter anbefales også.
English: Adverse reactions seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Danish: De bivirkninger, der er set hos dyr ved eksponeringsniveauer svarende til kliniske eksponeringsniveauer og med mulig relevans for klinisk anvendelse, var som følger:
English: Other electrolyte disturbances, including hypokalaemia, have also been observed.
Danish: Andre elektrolytforstyrrelser, herunder hypokaliæmi er også observeret.
English: The primary endpoint was PFS.
Danish: Det primære endepunkt var PFS.
English: The final concentration should not exceed 10 mg/mL.
Danish: Den endelige koncentration bør ikke overskride 10 mg/ml.
English: You should speak with your doctor before driving or using machines, as some side effects may impair your ability to do so safely.
Danish: De bør tale med Deres læge, før De kører bil eller bruger maskiner, da visse bivirkninger kan forringe Deres evne til at gøre dette sikkert.
English: The recommended infusion time is approximately 60 minutes.
Danish: Den anbefalede infusionstid er ca. 60 minutter.
English: Cases of interstitial lung disease (ILD), both fatal and non-fatal, have been reported, mainly from the Japanese population.
Danish: Tilfælde af interstitiel lungesygdom (ILD), både letale og ikke-letale, er blevet rapporteret, fortrinsvis fra den japanske population.
English: Other key endpoints included the PFS, time to response, TTP, and duration of response.
Danish: Andre vigtige endepunkter omfattede PFS, tid til respons, TTP og responsvarighed.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should be no longer than 24 hours at 2°C - 8°C.
Danish: Hvis opløsningen ikke anvendes straks, er opbevaringstid og -forhold før anvendelse brugerens ansvar, og opbevaringstiden må ikke overstige 24 timer ved 2 °C-8 °C.
English: If these levels are too low, your doctor may prescribe you appropriate supplements.
Danish: Hvis niveauerne er for lave, kan lægen ordinere passende tilskud.
English: Prolonged exposure to the sun can make the rash worse.
Danish: Længerevarende ophold i solen kan forværre udslættet.
English: Doses up to 9 mg/kg have been tested in clinical trials.
Danish: Doser på op til 9 mg/kg er blevet undersøgt i kliniske studier.
English: Non-serious cases of keratitis have been observed in 0.3% of clinical trial patients.
Danish: Der er observeret ikke-alvorlige tilfælde af keratitis hos 0,3 % af patienter i kliniske studier.
English: There have been reports of overdose at doses up to approximately twice the recommended therapeutic dose (12 mg/kg).
Danish: Der har været indberetninger om overdosis ved doser på op til omtrent det dobbelte af den anbefalede terapeutiske dosis (12 mg/kg).
English: This is equivalent to 0.017% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 0,017 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: The maximum frequency estimated from the upper limit of 95% confidence interval for the point estimate, i.e., 3/2,224 (or 0.13%).
Danish: Den maksimale hyppighed blev estimeret fra den øvre grænse af 95 % konfidensinterval for punktestimatet, dvs. 3/2.224 (eller 0,13 %).
English: The elimination half-life was approximately 7.5 days (range: 3.6 to 10.9 days).
Danish: Elimineringstiden var cirka 7,5 dage (interval: 3,6 til 10,9 dage).
English: The most serious side effects and main side effects for Vectibix are listed below:
Danish: De mest alvorlige bivirkninger og de væsentligste bivirkninger af Vectibix er angivet nedenfor:
English: Patients should be informed of the possibility of a late onset reaction and instructed to contact their physician if symptoms of a hypersensitivity reaction occur.
Danish: Patienterne skal informeres om risikoen for en forsinket reaktion og instrueres i at kontakte deres læge, hvis der opstår symptomer på en overfølsomhedsreaktion.
English: However, at doses above 2 mg/kg, the AUC of panitumumab increases in an approximately dose-proportional manner.
Danish: Ved doser over 2 mg/kg stiger AUC for panitumumab dog på en omtrent dosisproportionel måde.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/423/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/423/001
English: KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) and NRAS (Neuroblastoma RAS viral oncogene homologue) are highly related members of the RAS oncogene family.
Danish: KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) og NRAS (Neuroblastoma RAS viral oncogene homologue) er kraftigt forbundne medlemmer af familien af RAS-onkogener.
English: Vectibix should be inspected visually prior to administration.
Danish: Vectibix skal kontrolleres visuelt inden administration.
English: Secondary endpoints included PFS and objective response rate (ORR).
Danish: De sekundære endepunkter omfattede PFS og objektiv responsrate (ORR).
English: Monoclonal antibodies are proteins, which specifically recognise and attach (bind) to other unique proteins in the body.
Danish: Monoklonale antistoffer er proteiner, som specifikt genkender og fastgør sig (binder sig) til andre unikke proteiner i kroppen.
English: The median time to first symptom of dermatologic reaction was 10 days, and the median time to resolution after the last dose of Vectibix was 31 days.
Danish: Mediantiden indtil det første symptom på dermatologisk reaktion var 10 dage, og mediantiden indtil afhjælpning efter den sidste dosis af Vectibix var 31 dage.
English: • Compared with patients who did not develop antibodies, no relationship between the presence of anti-panitumumab antibodies and pharmacokinetics, efficacy and safety has been observed.
Danish: • Sammenlignet med patienter, der ikke udviklede antistoffer, blev der ikke observeret nogen sammenhæng mellem forekomst af anti-panitumumab-antistoffer og farmakokinetik, effekt og sikkerhed.
English: Do not administer Vectibix if its appearance is not as described above.
Danish: Vectibix må ikke administreres, hvis det ikke ser ud som beskrevet ovenfor.
English: Conjunctivitis Paronychia1
Danish: Conjunctivitis Paronykia1
English: The detection of antibody formation is dependent on the sensitivity and specificity of the assay.
Danish: Påvisningen af antistofdannelse afhænger af analysens følsomhed og specificitet.
English: Please consult your doctor if you are unsure of your RAS tumour status.
Danish: Spørg Deres læge, hvis De er i tvivl om Deres RAS-tumorstatus.
English: There is no clinical data to support dose adjustments in the elderly.
Danish: Der findes ingen kliniske data, som understøtter dosisjustering til ældre.
English: EGFR has been implicated in the control of prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo.
Danish: EGFR har imidlertid været impliceret i kontrollen af prænatal udvikling og kan være væsentlig for normal organdannelse, proliferation og differentiering i udviklingen af embryoet.
English: EGFR is a transmembrane glycoprotein that is a member of a subfamily of type I receptor tyrosine kinases including EGFR (HER1/c-ErbB-1), HER2, HER3, and HER4.
Danish: EGFR er et transmembrant glycoprotein, der er medlem af en underfamilie af type I-receptor tyrosinkinaser, herunder EGFR (HER1/c-ErbB-1), HER2, HER3 og HER4.
English: There are no adequate data from the use of Vectibix in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af Vectibix hos gravide kvinder.
English: Activating mutations in the RAS genes occur frequently in a variety of human tumours and have been implicated in both oncogenesis and tumour progression.
Danish: Aktiverende mutationer i RAS-generne opstår hyppigt i flere forskellige humane tumorer og har været impliceret i både onkogenese og tumorprogression.
English: • If you have any further questions, ask your doctor.
Danish: • Spørg lægen, hvis der er mere, De vil vide.
English: The major study objective was comparison of PFS in the oxaliplatin cohort.
Danish: Det vigtigste studieformål var sammenligning af PFS i oxaliplatin-kohorten.
English: Vectibix could affect your unborn baby or ability to stay pregnant.
Danish: Vectibix kan påvirke Deres ufødte barn eller evne til at forblive gravid.
English: When growth factors (other body proteins) attach to the EGFR, the cancer cell is stimulated to grow and divide.
Danish: Når vækstfaktorer (andre kropsproteiner) fastgør sig til EGFR, stimuleres cancercellen til at vokse og dele sig.
English: Vectibix has not been tested in pregnant women.
Danish: Vectibix er ikke blevet afprøvet på gravide kvinder.
English: • No evidence of an altered safety profile was found in patients who tested positive for antibodies to Vectibix.
Danish: • Der blev ikke fundet nogen tegn på ændret sikkerhedsprofil hos patienter, der blev testet positive for antistoffer mod Vectibix.
English: Panitumumab treatment was discontinued due to a statistically significant reduction in PFS in patients receiving panitumumab observed in an interim analysis.
Danish: Panitumumab-behandlingen blev indstillet på grund af en statistisk signifikant reduktion i PFS hos patienter, som fik panitumumab, observeret ved en interimanalyse.
English: It is unknown whether panitumumab is excreted in human breast milk.
Danish: Det er ukendt, om panitumumab udskilles i human mælk.
English: For these ADRs the maximum frequency category was estimated from the upper limit of 95% confidence interval for the point estimate based on regulatory guidelines for estimation of the frequency of adverse reactions from spontaneous reporting.
Danish: For disse lægemiddelbivirkninger blev gruppen med maksimal hyppighed estimeret fra den øvre grænse af 95 % konfidensinterval for punktestimatet, baseret på myndighedernes retningslinjer for estimering af hyppigheden af bivirkninger fra spontane indberetninger.
English: The RAS/BRAF ascertainment was 85% (1,014 of 1,186 randomised patients).
Danish: Fastlæggelse af RAS/BRAF var 85 % (1.014 ud af 1.186 randomiserede patienter).
English: BRAF mutations in exon 15 were found to be prognostic of worse outcome.
Danish: Det blev konstateret, at BRAF-mutationer i exon 15 var prognostiske for et dårligere udfald.
English: At the fourth occurrence
Danish: Fjerde gang
English: These can be mild or moderate (likely to occur in approximately 5 out of 100 people who take Vectibix), or severe (likely to occur in 1 out of 100 people who take Vectibix).
Danish: Sådanne reaktioner kan være milde eller moderate (opstår sandsynligvis hos cirka 5 ud af 100 personer, der får Vectibix) eller alvorlige (opstår sandsynligvis hos 1 ud af 100 personer, der får Vectibix).
English: See section 2 “Vectibix contains sodium”.
Danish: Se punkt 2, “Vectibix indeholder natrium”.
English: Tumour samples obtained from the primary resection of colorectal cancer were analysed for the presence of the seven most common activating mutations in the codon 12 and 13 of the KRAS gene.
Danish: Tumorprøver, der var indsamlet fra den primære resektion af kolorektal cancer, blev analyseret for forekomst af syv af de mest almindelige aktiverende mutationer i kodon 12 og 13 i KRAS-genet.
English: Vectibix may have a minor influence on the ability to drive and use machines.
Danish: Vectibix kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: A variety of stimuli, including that from the EGFR activate KRAS and NRAS which in turn stimulate other intracellular proteins to promote cell proliferation, cell survival and angiogenesis.
Danish: En lang række stimuli, herunder det fra EGFR, aktiverer KRAS og NRAS, som til gengæld stimulerer andre intracellulære proteiner til at fremme celleproliferationen, celleoverlevelsen og angiogenesen.
English: An exploratory analysis showed similar results to those in the previous table.
Danish: En eksplorativ analyse viste resultater, der svarede til resultaterne i foregående tabel.
English: If Vectibix is used during pregnancy or if the patient becomes pregnant while receiving this medicinal product, she should be advised of the potential risk for loss of the pregnancy or potential hazard to the foetus.
Danish: Hvis Vectibix anvendes under graviditet, eller hvis patienten bliver gravid, mens hun får dette lægemiddel, skal hun underrettes om den mulige risiko for afbrydelse af graviditeten og om potential fare for fosteret.
English: If patients experience treatment-related symptoms affecting their vision and/or ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Danish: Hvis patienterne oplever behandlingsrelaterede symptomer, der påvirker deres syn og/eller evne til at koncentrere sig eller reagere, frarådes det, at de fører motorkøretøj eller anvender maskiner, før virkningen har fortaget sig.
English: KRAS and NRAS genes encode small, GTP-binding proteins involved in signal transduction.
Danish: KRAS- og NRAS-generne koder for små GTP-bindende proteiner, der er involveret i signaltransduktionen.
English: Evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with Vectibix.
Danish: Dokumentation for vildtype-RAS-status (KRAS og NRAS) er påkrævet, inden behandling med Vectibix iværksættes.
English: Human IgG is known to cross the placental barrier, and panitumumab may therefore be transmitted from the mother to the developing foetus.
Danish: Humant IgG er kendt for at krydse placentabarrieren, og panitumumab kan derfor overføres fra moderen til det udviklende foster.
English: The potential for absorption and harm to the infant after ingestion is unknown.
Danish: Muligheden for absorption og skade på den nyfødte efter indtagelse er ukendt.
English: Your doctor will also check your blood levels of magnesium and calcium periodically during your treatment, and for up to 8 weeks after you have finished your treatment.
Danish: Lægen vil kontrollere indholdet af magnesium og kalcium i blodet regelmæssigt under behandlingen og op til 8 uger efter, at De er færdig med behandlingen.
English: Stevens-Johnson syndrome4
Danish: Stevens-Johnsons syndrom4
English: Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological reactions as follows:
Danish: Der kan være behov for dosisjustering af Vectibix i tilfælde af følgende alvorlige (≥ grad 3) dermatologiske reaktioner:
English: Vectibix will be stored in the healthcare facility where it is used.
Danish: Vectibix vil blive opbevaret på hospitalet, hvor det anvendes.
English: Vectibix is used alone or in combination with other anti-cancer medicines.
Danish: Vectibix anvendes alene eller i kombination med anden medicin mod kræft.
English: If Vectibix is to be used in combination with FOLFOX then it is recommended that mutational status be determined by a laboratory that participates in a RAS External Quality Assurance programme or wild-type status be confirmed in a duplicate test.
Danish: Hvis Vectibix skal anvendes i kombination med FOLFOX, anbefales det, at mutationsstatus fastlægges af et laboratorium, som deltager i et eksternt RAS-kvalitetssikringsprogram, eller at vildtypestatus bekræftes i en ekstra test.
English: Additional mutations in KRAS and NRAS at exon 3 (codon 59) were subsequently identified (n = 7).
Danish: Der blev efterfølgende identificeret yderligere mutationer i KRAS og NRAS ved exon 3 (codon 59) (n = 7).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/5 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL ENHEDER 100 mg/5 ml
English: This medicinal product contains 3.45 mg sodium per mL, equivalent to 0.017% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 3,45 mg natrium pr. ml, svarende til 0,017 % af den WHO anbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: A positive benefitrisk balance has not been documented in patients with ECOG 2 performance status.
Danish: Der er ikke dokumenteret en positiv fordel/risikobalance hos patienter med ECOG-performance-status 2.
English: Vectibix is intended for single use only.
Danish: Vectibix er kun beregnet til engangsbrug.
English: Administration of Vectibix
Danish: Administration af Vectibix
English: CI = confidence interval a In patients that crossed over to panitumumab after progression on BSC alone (95% CI)
Danish: CI = konfidensinterval a Hos patienter, der skiftede til panitumumab efter progression på BSC alene (95 % CI)
English: If ILD is diagnosed, Vectibix should be permanently discontinued and the patient should be treated appropriately.
Danish: Hvis ILD diagnosticeres, bør Vectibix seponeres permanent, og patienten bør behandles behørigt.
English: EGFR promotes cell growth in normal epithelial tissues, including the skin and hair follicle, and is expressed on a variety of tumour cells.
Danish: EGFR fremmer cellevækst i normale epitheliale væv, herunder hud- og hårfollikler, og udtrykkes på en række tumorceller.
English: A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates on panitumumab pharmacokinetics.
Danish: Der blev udført en populationsfarmakokinetisk analyse for at udforske de mulige indvirkninger af udvalgte kovariater på panitumumabs farmakokinetik.
English: Dilute in a total volume of 100 mL.
Danish: Fortynd i en samlet mængde på 100 ml.
English: Animal studies are insufficient with respect to embryo-foetal development since foetal panitumumab exposure levels were not examined.
Danish: Dyrestudier er utilstrækkelige hvad angår embryoets/fosterets udvikling, eftersom eksponeringsniveauerne af panitumumab for fosteret ikke er undersøgt.
English: Panitumumab recognises and binds specifically to a protein known as epidermal growth factor receptor (EGFR), which is found on the surface of some cancer cells.
Danish: Panitumumab genkender og binder sig specifikt til et protein, der kaldes for epidermal vækstfaktorreceptor (EGFR), som findes på overfladen af visse cancerceller.
English: In some cases, it may cause infected sores requiring medical and/or surgical treatment, or cause severe skin infections that in rare cases could be fatal.
Danish: Det kan i nogle tilfælde medføre inficerede sår, der kræver medicinsk og/eller kirurgisk behandling, eller alvorlige hudinfektioner, som i sjældne tilfælde kan være letale.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC08
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC08
English: Binding of panitumumab to EGFR results in internalisation of the receptor, inhibition of cell growth, induction of apoptosis, and decreased interleukin 8 and vascular endothelial growth factor production.
Danish: Binding af panitumumab til EGFR resulterer i internalisering af receptoren, hæmning af cellevækst, induktion af apoptose og nedsat produktion af interleukin 8 og vaskulær endotel vækstfaktor.
English: • if you are allergic to panitumumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for panitumumab eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: • local or widespread rash which may be bumpy (with or without spots), itchy, red or flaky;
Danish: • lokalt eller udbredt udslæt, som kan være knoldet (med eller uden pletter), kløende, rødt eller skællende
English: Wear sunscreen and a hat if you are going to be exposed to sunlight.
Danish: Brug solbeskyttelsescreme og en hat, hvis De skal opholde Dem i solen.
English: Paronychial inflammation was associated with swelling of the lateral nail folds of the toes and fingers.
Danish: Inflammation af paronykium blev forbundet med hævelse af tæernes og fingrenes laterale neglefold.
English: Overall, the safety profile of panitumumab was similar to that of cetuximab, in particular regarding skin toxicity.
Danish: Overordnet lignede panitumumabs sikkerhedsprofil cetuximabs profil, især for så vidt angår hudtoksicitet.
English: Combination with FOLFIRI
Danish: Kombination med FOLFIRI
English: • eye inflammation (conjunctivitis);
Danish: • øjenbetændelse (conjunctivitis)
English: Skin-related reactions are likely to occur in approximately 94 out of 100 people who take Vectibix and are usually mild to moderate.
Danish: Hudrelaterede reaktioner opstår med sandsynlighed hos cirka 94 ud af 100 personer, der får Vectibix, og er normalt milde til moderate.
English: Pulmonary complications
Danish: Pulmonale komplikationer
English: No overall differences in safety or efficacy were observed in elderly patients (≥ 65 years of age) treated with Vectibix monotherapy.
Danish: Der blev ikke observeret nogen overordnede forskelle i sikkerhed eller effekt hos ældre patienter (≥ 65 år), der blev behandlet med Vectibix som monoterapi.
English: There is no relevant use of Vectibix in the paediatric population in the indication treatment of colorectal cancer.
Danish: Det er ikke relevant at anvende Vectibix hos den pædiatriske population til behandling af kolorektal cancer.
English: As monotherapy:
Danish: Som monoterapi:
English: RAS mutational status should be determined using a validated test method by an experienced laboratory (see section 4.2).
Danish: RAS-mutationsstatus skal bestemmes ved en valideret testmetode af et erfarent laboratorium (se pkt.
English: These events consisted predominantly of rash and dermatitis acneiform and were mostly mild to moderate in severity.
Danish: Disse hændelser bestod fortrinsvis af udslæt og dermatitis acneiform og var for det meste lette til moderate i styrke.
English: Because human IgG is secreted into human milk, panitumumab might also be secreted.
Danish: Da humant IgG udskilles i human mælk, er der også mulighed for, at panitumumab bliver udskilt.
English: Diarrhoea when reported was mainly mild or moderate in severity.
Danish: De indberettede tilfælde af diaré var hovedsagelig milde eller moderate i styrke.
English: Chapped lips Dry lips
Danish: Sprukne læber Tørre læber
English: However, infusion reactions were more frequent with cetuximab (13% versus 3%) but electrolyte disturbances were more frequent with panitumumab, especially hypomagnesaemia (29% versus 19%).
Danish: Infusionsrelaterede reaktioner forekom dog hyppigere med cetuximab (13 % vs. 3 %), mens elektrolytforstyrrelser var hyppigere med panitumumab, herunder især hypomagnesæmi (29 % vs. 19 %).
English: Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies.
Danish: Vectibix indeholder det aktive stof panitumumab, som hører til en gruppe medicin, der kaldes for monoklonale antistoffer.