FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from a cross-study comparison indicated that irinotecan-containing regimens (IFL or FOLFIRI) have no effect on the pharmacokinetics of panitumumab.
Danish: Resultaterne fra en sammenligning på tværs af studie viste, at regimer, der indeholder irinotecan (IFL eller FOLFIRI), ikke har nogen indvirkning på panitumumabs farmakokinetik.
English: It is important to tell your doctor if you plan to breast-feed.
Danish: Det er vigtigt, at De fortæller det til Deres læge, hvis De planlægger at amme.
English: Some rashes have been associated with redness, itching and flaking of the skin which can become severe.
Danish: Nogle tilfælde af udslæt har været forbundet med rødmen, kløe og skældannelse i huden, som kan blive alvorlig.
English: These findings were observed at doses approximately equivalent to the recommended human dose and were reversible upon termination of administration of panitumumab.
Danish: Dette observeredes ved doser omtrent svarende til den anbefalede humane dosis og var reversible ved seponering af panitumumab.
English: The efficacy results from an analysis adjusting for potential bias from unscheduled assessments are shown in the table below.
Danish: Effekt-resultaterne fra en analyse, hvor der justeredes for ikke-planlagte vurderinger, vises i nedenstående tabel.
English: Studies to evaluate the mutagenic and carcinogenic potential of panitumumab have not been performed.
Danish: Der er ikke udført studier til evaluering af panitumumabs mutagene og karcinogene potentiale.
English: Do not use Vectibix:
Danish: Brug ikke Vectibix:
English: This medicine contains 3.45 mg sodium (main component of cooking/table salt) in each mL unit.
Danish: Dette lægemiddel indeholder 3,45 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. ml.
English: Patients who experience severe diarrhoea should be instructed to consult a healthcare professional urgently.
Danish: Patienter, der får svær diarré, skal opfordres til straks at søge læge.
English: BRAF mutations were not predictive of the outcome for panitumumab treatment in combination with FOLFOX or FOLFIRI.
Danish: BRAF-mutationer var ikke prædiktive for resultatet af behandling med panitumumab i kombination med FOLFOX eller FOLFIRI.
English: The solution should be colourless and may contain visible translucent-to-white, amorphous, proteinaceous particulates (which will be removed by in-line filtration).
Danish: Opløsningen skal være farveløs og kan indeholde synlige halvgennemsigtige til hvide, amorfe, proteinlignende partikler (som fjernes ved integreret filtrering).
English: If a patient develops dermatologic reactions that are grade 3 (CTCAE v 4.0) or higher, or that are considered intolerable, see the recommendation for dose modification in section 4.2.
Danish: Hvis en patient udvikler dermatologiske reaktioner af grad 3 (CTCAE v. 4.0) eller højere, eller som betragtes som uacceptable, henvises der til den anbefalede dosisændring i punkt 4.2.
English: If you experience a severe skin reaction, your doctor may recommend an adjustment of the dose of Vectibix.
Danish: Hvis De får en alvorlig hudreaktion, vil Deres læge muligvis anbefale, at dosis af Vectibix justeres.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på etiketten og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Panitumumab binds onto the EGFR and prevents the cancer cell from receiving the messages it needs for growth and division.
Danish: Panitumumab binder sig til EGFR og forhindrer cancercellen i at modtage de meddelelser, den skal bruge for at vokse og dele sig.
English: Acute renal failure has been observed in patients who develop severe diarrhoea and dehydration.
Danish: Akut nyresvigt er blevet observeret hos patienter, som udvikler svær diaré og dehydrering.
English: A multinational, randomised, controlled trial was conducted in 463 patients with EGFR-expressing metastatic carcinoma of the colon or rectum after confirmed failure of oxaliplatin and irinotecancontaining regimens.
Danish: Et multinationalt, randomiseret, kontrolleret studie blev udført med 463 patienter med EGFR-udtrykkende metastatisk carcinom i colon eller rectum efter bekræftet manglende effekt af regimer, der indeholdt oxaliplatin og irinotecan.
English: Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4) mutations.
Danish: Mutationsstatus skal bestemmes af et erfarent laboratorium med en valideret testmetode til påvisning af mutationer af KRAS (exon 2, 3 og 4) og NRAS (exon 2, 3 og 4).
English: Adverse events observed included skin toxicity, diarrhoea, dehydration and fatigue and were consistent with the safety profile at the recommended dose.
Danish: De observerede bivirkninger omfattede hudtoksicitet, diaré, dehydering og træthed og stemte overens med sikkerhedsprofilen ved den anbefalede dosis.
English: Fertility studies conducted in female cynomolgus monkeys showed that panitumumab may produce prolonged menstrual cycle and/or amenorrhea and reduced pregnancy rate which occurred at all doses evaluated.
Danish: Fertilitetsstudier udført med cynomolgusaber af hunkøn viste, at panitumumab måske kan resultere i forlænget menstruationscyklus og/eller amenorré og reduceret graviditetsrate, hvilket forekom ved alle evaluerede doser.
English: Doses higher than 1,000 mg should be infused over approximately 90 minutes.
Danish: Doser, der er højere end 1.000 mg, bør infunderes over ca. 90 minutter.
English: In the event of acute onset or worsening pulmonary symptoms, Vectibix treatment should be interrupted and a prompt investigation of these symptoms should occur.
Danish: I tilfælde af akut fremkomst eller forværring af pulmonære symptomer bør behandlingen med Vectibix afbrydes, og der bør foretages en omgående undersøgelse af disse symptomer.
English: Response rate (investigator assessed)a (95% CI) Stable Disease PFS
Danish: ORR n (%) Responsrate (vurderet af investigator)a (95 % CI) Stabil sygdom PFS
English: Very commonly reported adverse reactions occurring in ≥ 20% of patients were gastrointestinal disorders [diarrhoea (46%), nausea (39%), vomiting (26%), constipation (23%) and abdominal pain (23%)]; general disorders [fatigue (35%), pyrexia (21%)]; metabolism and nutrition disorders [decreased appetite (30%)]; infections and infestations [paronychia (20%)]; and skin and subcutaneous disorders [rash (47%), dermatitis acneiform (39%), pruritus (36%), erythema (33%) and dry skin
Danish: Meget almindeligt rapporterede bivirkninger, der opstod hos ≥ 20 % af patienterne, var gastrointestinale gener [diaré (46 %), kvalme (39 %), opkastning (26 %), obstipation (23 %) og abdominalsmerter (23 %)]; almene symptomer [træthed (35 %), pyreksi (21 %)]; gener vedrørende metabolisme og ernæring [nedsat appetit (30 %)]; infektioner og parasitære sygdomme [paronykia (20 %)] samt sygdomme i hud og subkutane væv [udslæt (47 %), dermatitis acneiform (39 %), pruritus (36 %), erytem (33 %) og tør hud (21 %)].
English: In an exploratory analysis of banked tumour specimens from this study, 11 of 72 patients (15%) with wild-type RAS tumours receiving panitumumab had an objective response compared to only 1 of 95 patients (1%) with mutant RAS tumour status.
Danish: I en eksplorativ analyse af tumorpræparater i en biobank fra denne studie havde 11 ud af 72 patienter (15 %) med vildtype-RAS-tumorer, der fik panitumumab, en objektiv respons sammenlignet med kun 1 ud af 95 patienter (1 %) med muteret RAS-tumorstatus.
English: The mean (± SD) AUC0-tau and CL were 1,306 ± 374 mcg•day/mL and 4.9 ± 1.4 mL/kg/day, respectively.
Danish: Middel- (± SD) -AUC0-tau og -CL var henholdsvis 1.306 ± 374 µg•dag/ml og 4,9 ± 1,4 ml/kg/dag.
English: Formal male fertility studies have not been conducted; however, microscopic evaluation of male reproductive organs from repeat-dose toxicity studies in cynomolgus monkeys at doses up to approximately 5-fold the human dose on a mg/kg basis, revealed no differences compared to control male monkeys.
Danish: Der er ikke udført formelle fertilitetsstudier med mænd; mikroskopisk undersøgelse af reproduktive organer hos cynomolgusaber af hankøn i studier af toksicitet ved gentagen dosis med doser på op til 5 gange den humane dosis på mg/kg-basis afslørede imidlertid ingen forskel sammenlignet med kontrolgruppen af hanaber.
English: Panitumumab + FOLFIRI Wild-type RAS (n = 69)
Danish: Panitumumab + FOLFIRI Vildtype-RAS (n = 69)
English: (mucosal inflammation);
Danish: (slimhindeinflammation)
English: Therefore administration of Vectibix in combination with IFL should be avoided (see section 4.5).
Danish: Administration af Vectibix sammen med IFL bør derfor undgås (se pkt.
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with Vectibix should be interrupted or discontinued.
Danish: Hvis diagnosen ulcerativ keratitis kan bekræftes, skal behandlingen med Vectibix afbrydes eller seponeres.
English: In vitro assays and in vivo animal studies have shown that panitumumab inhibits the growth and survival of tumour cells expressing EGFR.
Danish: In vitro analyser og in vivo dyrestudier har vist, at panitumumab hæmmer væksten og overlevelsen af tumorceller, der udtrykker EGFR.
English: The addition of panitumumab to radiation, chemotherapy or other targeted therapeutic agents, in animal studies resulted in an increase in antitumour effects compared to radiation, chemotherapy or targeted therapeutic agents alone.
Danish: Tilføjelsen af panitumumab til stråling, kemoterapi eller andre målrettede terapeutiske midler resulterede i dyrestudier i en stigning i anti-tumor-virkninger sammenlignet med stråling, kemoterapi eller målrettede terapeutiske midler alene.
English: Progressively decreasing serum magnesium levels leading to severe (grade 4) hypomagnesaemia have been observed in some patients.
Danish: Der er observeret tiltagende fald i serum-magnesiumniveauerne, hvilket har ført til svær (grad 4) hypomagnesiæmi hos nogle patienter.
English: Patients may be advised to apply moisturiser and sunscreen to face, hands, feet, neck, back and chest every morning during treatment, and to apply the topical steroid to face, hands, feet, neck, back and chest every night during treatment.
Danish: Patienterne kan tilrådes at applicere fugtighedscreme og solbeskyttelsescreme på ansigt, hænder, fødder, hals, ryg og bryst hver morgen under behandlingen og steroidcreme hver aften.
English: Toxic epidermal necrolysis4
Danish: Toksisk epidermal nekrolyse4
English: Data on the development of anti-panitumumab antibodies has been evaluated using two different screening immunoassays for the detection of binding anti-panitumumab antibodies (an ELISA which detects high-affinity antibodies, and a Biosensor Immunoassay which detects both high and low-affinity antibodies).
Danish: Data vedrørende udviklingen af anti-panitumumab-antistoffer er blevet evalueret vha. to forskellige screenings-immunanalyser til påvisning af bindende anti-panitumumab-antistoffer (en ELISA, som påviser højaffinitetsantistoffer, og en biosensor-immunanalyse, som påviser både høj- og lavaffinitetsantistoffer).
English: Panitumumab has been shown to cause foetal abortions and/or foetal deaths in cynomolgus monkeys when administered during the period of organogenesis at doses approximately equivalent to the recommended human dose.
Danish: Det er blevet påvist, at panitumumab forårsager abort og/eller fosterdød hos cynomolgusaber, når det indgives i løbet af organdannelsesperioden i doser omtrent svarende til den anbefalede humane dosis.
English: Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).
Danish: Vectibix indgives intravenøst (i en vene) med en infusionspumpe (et apparat, der giver en langsom injektion).
English: A total of 1,010 patients refractory to chemotherapy were randomised 1:1 to receive Vectibix or cetuximab to test whether Vectibix is non-inferior to cetuximab.
Danish: I alt 1.010 patienter, der var refraktære over for kemoterapi, blev randomiseret i forholdet 1:1 til at få Vectibix eller cetuximab for at afprøve, om Vectibix er noninferiør til cetuximab.
English: If you experience severe diarrhoea please tell your doctor or nurse since you may lose a lot of water from your body (become dehydrated) and this could damage your kidneys.
Danish: Fortæl det til lægen eller sygeplejersken, hvis De får kraftig diarré, da De derved kan miste en masse væske fra kroppen (blive dehydreret), hvilket kan skade Deres nyrer.
English: Mutant RAS (n = 74)
Danish: Muteret RAS (n = 74)
English: Following a single-dose administration of panitumumab as a 1-hour infusion, the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner and clearance (CL) of panitumumab decreased from 30.6 to 4.6 mL/day/kg as the dose increased from 0.75 to 9 mg/kg.
Danish: Efter administration af en enkelt dosis panitumumab som 1 times infusion øgedes area under the concentration-curve (AUC) mere end på en dosisproportionel måde, og clearancen (CL) af panitumumab faldt fra 30,6 til 4,6 ml/dag/kg, da dosis steg fra 0,75 til 9 mg/kg.
English: Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR.
Danish: Panitumumab er et rekombinant, fuldt humant IgG2 monoklonalt antistof, der binder med høj affinitet og specificitet til det humane EGFR.
English: Patients were randomised 1:1 to receive Vectibix at a dose of 6 mg/kg given once every two weeks plus best supportive care (not including chemotherapy) (BSC) or BSC alone.
Danish: Patienterne blev randomiseret i forholdet 1:1 til at få Vectibix ved en dosis på 6 mg/kg indgivet én gang hver anden uge plus bedste understøttende behandling (ingen kemoterapi) (BSC) eller BSC alene.
English: The efficacy results for the study are presented in the table below.
Danish: Effektresultaterne fra studiet vises i nedenstående tabel.
English: Data from an interaction study involving Vectibix and irinotecan in patients with mCRC indicated that the pharmacokinetics of irinotecan and its active metabolite, SN-38, are not altered when the medicinal products are co-administered.
Danish: Data fra et interaktionsstudie med Vectibix og irinotecan hos patienter med mCRC viste, at farmakokinetikken for irinotecan og dets aktive metabolit SN-38 ikke ændres, når lægemidlerne indgives sammen.
English: What you need to know before you use Vectibix
Danish: Det skal De vide, før De begynder at bruge Vectibix
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: kan ramme flere end 1 ud af 10 personer
English: Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in monkeys (see section 5.3).
Danish: Dyrestudier har vist reversible virkninger på menstruationscyklus og reduceret fertilitet hos hunaber (se pkt.
English: Patient tumour samples with wild-type KRAS exon 2 (codons 12/13) status were tested for additional RAS mutations in KRAS exon 3 (codons 61) and exon 4 (codons 117/146) and NRAS exon 2 (codons 12/13), exon 3 (codon 61), and exon 4 (codons 117/146) and BRAF exon 15 (codon 600).
Danish: Tumorprøver fra patienter med vildtype-KRAS exon 2 (codon 12/13) blev testet for yderligere RAS-mutationer i KRAS-exon 3 (codon 61) og exon 4 (codon 117/146) og NRAS-exon 2 (codon 12/13), exon 3 (codon 61), exon 4 (codon 117/146) og BRAF-exon 15 (codon 600).
English: It is recommended that you limit sun exposure whilst receiving Vectibix and if you are experiencing skin reactions as sunlight can worsen these.
Danish: Det anbefales, at De begrænser den tid, De opholder Dem i solen, mens De får Vectibix, og hvis De får hudreaktioner, da sollys kan forværre disse reaktioner.
English: Seek medical attention immediately if you experience symptoms of an allergic reaction to Vectibix, including but not limited to difficulty breathing, chest tightness, a sensation of choking, dizziness, or fainting.
Danish: Søg omgående lægehjælp, hvis De får symptomer på en overfølsomhedsreaktion over for Vectibix, herunder, men ikke begrænset til, vejrtrækningsbesvær, trykken for brystet, kvælningsfornemmelse, svimmelhed eller besvimelse.
English: Patients who have severe dermatologic reactions or soft tissue toxicity or who develop worsening reactions whilst receiving Vectibix should be monitored for the development of inflammatory or infectious sequelae (including cellulitis and necrotising fasciitis), and appropriate treatment promptly initiated.
Danish: Patienter, der får alvorlige dermatologiske reaktioner eller bløddelstoksicitet, eller som udvikler reaktioner, der forværres, mens de får Vectibix, bør monitoreres for udvikling af inflammatoriske eller infektiøse følgevirkninger (herunder cellulitis og nekrotiserende fasciitis), og en behørig behandling bør straks påbegyndes.
English: A trend towards worse survival was also observed with panitumumab in the irinotecan cohort regardless of KRAS mutational status.
Danish: Der observeredes også en tendens mod ringere overlevelse med panitumumab i irinotecan-kohorten uanset KRAS-mutationsstatus.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Median overall survival was 19.4 (95% CI: 18.4, 20.8) and 24.5 (95% CI: 20.4, 24.5) in the panitumumab arm and the non-panitumumab arm.
Danish: Median for generel overlevelse var 19,4 (95 % CI: 18,4; 20,8) og 24,5 (95 % CI: 20,4; 24,5) i henholdsvis panitumumab-armen og ikke-panitumumab-armen.
English: Symptoms may include headache, rashes, itching or hives, flushing, swelling (face, lips, mouth, around the eyes, and throat area), rapid and irregular heartbeat, fast pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a decrease in blood pressure that may be severe or life-threatening and, very rarely, may lead to death.
Danish: Symptomerne kan være hovedpine, udslæt, kløe eller nældefeber, rødmen, hævelse (ansigt, læber, mund, omkring øjnene og hals), hurtige og uregelmæssige hjerteslag, hurtig puls, øget svedtendens, kvalme, opkastning, svimmelhed, åndedrætsbesvær eller synkebesvær eller et fald i blodtrykket, som kan være alvorligt eller livstruende og i meget sjældne tilfælde dødeligt.
English: First-line combination with FOLFOX
Danish: Første-linje-kombination med FOLFOX
English: In patients with a history of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with panitumumab versus the risk of pulmonary complications must be carefully considered.
Danish: Hos patienter med interstitiel pneumonitis eller lungefibrose i anamnesen skal fordelene ved behandling med panitumumab kontra risikoen for pulmonale komplikationer overvejes nøje.
English: An additional analysis of efficacy data by KRAS (exon 2) status did not identify a subset of patients who benefited from panitumumab in combination with oxaliplatin- or irinotecan based chemotherapy and bevacizumab.
Danish: En supplerende analyse af effektdata ud fra KRAS-status (exon 2) kunne ikke identificere en undergruppe af patienter, som havde gavn af panitumumab i kombination med oxaliplatin- eller irinotecan-baseret kemoterapi og bevacizumab.
English: Results suggest that age (21-88), gender, race, hepatic function, renal function, chemotherapeutic agents, and EGFR membrane staining intensity (1+, 2+, 3+) in tumour cells had no apparent impact on the pharmacokinetics of panitumumab.
Danish: Resultaterne tyder på, at alder (21-88), køn, race, lever- og nyrefunktion, kemoterapeutiske midler og farveintensiteten af EGFR-membraner (1+, 2+, 3+) i tumorceller ikke har nogen åbenbar indvirkning på panitumumabs farmakokinetik.
English: Vectibix does not contain any antimicrobial preservative or bacteriostatic agent.
Danish: Vectibix indeholder ikke noget antimikrobielt konserveringsmiddel eller bakteriehæmmende stof.
English: The observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medicinal products and underlying disease, therefore, comparison of the incidence of antibodies to other products may be misleading.
Danish: Den observerede forekomst af antistofpositivitet i en analyse kan være påvirket af adskillige faktorer, herunder analysemetodik, prøvehåndtering, prøveindsamlingstidspunkter, samtidige lægemidler og underliggende sygdom; sammenligning af forekomsten af antistoffer med andre produkter kan derfor være misvisende.
English: In rare cases patients may experience blistering of the skin, mouth, eyes and genitals, which may indicate a severe skin reaction called “Stevens-Johnson syndrome” or blistering of the skin, which may indicate a severe skin reaction called “toxic epidermal necrolysis”.
Danish: Nogle patienter kan i sjældne tilfælde udvikle blærer på huden, i munden og øjnene samt på kønsorganerne, hvilket kan være tegn på en alvorlig hudreaktion, der kaldes for “Stevens-Johnsons syndrom”, eller blærer på huden, hvilket kan være tegn på en alvorlig hudreaktion, der kaldes for “toksisk epidermal nekrolyse”.
English: Following the recommended dose regimen (6 mg/kg given once every 2 weeks as a 1-hour infusion), panitumumab concentrations reached steady-state levels by the third infusion with mean (± Standard Deviation [SD]) peak and trough concentrations of 213 ± 59 and 39 ± 14 mcg/mL, respectively.
Danish: Efter det anbefalede dosisregimen (6 mg/kg indgivet én gang hver 2. uge som 1 times infusion) nåede koncentrationerne af panitumumab steady-state-niveauerne ved den tredje infusion med middel(± Standard deviation [SD]) maksimum- og minimumskoncentrationer på henholdsvis 213 ± 59 og 39 ± 14 µg/ml.
English: Patients with a history of, or evidence of, interstitial pneumonitis or pulmonary fibrosis were excluded from clinical studies.
Danish: Patienter med tidligere eller tegn på interstitiel pneumonitis eller lungefibrose blev ekskluderet fra kliniske studier.
English: In combination with irinotecan- or oxaliplatin-based chemotherapy:
Danish: I kombination med irinotecan- eller oxaliplatin-baseret kemoterapi:
English: Patients with additional RAS mutations beyond KRAS exon 2 were unlikely to benefit from the addition of panitumumab to FOLFIRI and a detrimental effect was seen with the addition of panitumumab to FOLFOX in these patients.
Danish: Det var ikke sandsynligt, at patienter med RAS-mutationer udover KRAS exon 2 kunne opnå en fordel ved tilføjelse af panitumumab til FOLFIRI, og der blev observeret en skadelig virkning ved tilføjelse af panitumumab til FOLFOX hos disse patienter.
English: Wild-type RAS population PFS
Danish: Population med vildtype-RAS PFS
English: These toxicities infrequently led to discontinuation of Vectibix or of chemotherapy.
Danish: Disse bivirkninger førte kun sjældent til seponering af Vectibix eller kemoterapien.
English: Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 94%) treated with Vectibix.
Danish: Dermatologisk relaterede reaktioner, en farmakologisk effekt, der observeres med epidermal vækstfaktorreceptor (EGFR)-hæmmere, opleves af næsten alle patienter (ca. 94 %), der bliver behandlet med Vectibix.
English: • if you have previously had or have evidence of interstitial pneumonitis (swelling of the lungs causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Danish: • hvis De tidligere har haft eller har tegn på interstitiel lungebetændelse (hævelse i lungerne, der medfører hoste og åndedrætsbesvær) eller lungefibrose (ardannelse og fortykkelse i lungerne ledsaget af stakåndethed).