FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of previous hypersensitivity or infusion-related reaction, recommendations for management of hypersensitivity/infusion-related reactions should be followed, as for Table 1.
Danish: I tilfælde af en tidligere overfølsomhedsreaktion eller infusionsrelateret reaktion skal anbefalingerne til håndtering af overfølsomhedsreaktioner/infusionsrelaterede reaktioner følges, se tabel 1.
English: - Blood levels of magnesium, calcium, potassium and phosphate During treatment, your doctor will check your blood periodically for levels of several substances such as magnesium, calcium, potassium and phosphate.
Danish: - Koncentrationen af magnesium, calcium, kalium og fosfat i blodet Under behandlingen vil lægen løbende kontrollere koncentrationen af forskellige stoffer i blodet, f.eks. magnesium, calcium, kalium og fosfat.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC, or up to 4 hours at 9 ºC to 25 ºC.
Danish: Anvendelse af andre opbevaringstider og -betingelser er på brugerens eget ansvar og må normalt ikke overstige 24 timer ved 2 °C til 8 °C eller 4 timer ved 9 °C til 25 °C.
English: a Grade per NCI-CTCAE, Version 3.0 b Once the infusion rate has been reduced for a Grade 1 or 2 hypersensitivity/infusion-related reaction, it is recommended that the lower infusion rate be utilized for all subsequent infusions.
Danish: aGrad i henhold til NCI-CTCAE, version 3.0. bNår infusionshastigheden er blevet nedsat på grund af en overfølsomhedsreaktion/infusionsrelateret reaktion af grad 1 eller 2, anbefales det at benytte den lavere infusionshastighed ved alle efterfølgende infusioner.
English: If patients experience treatment-related symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Danish: Hvis patienter oplever behandlingsrelaterede 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.
English: Permanently discontinue if symptoms do not resolve to Grade ≤ 2 after holding for 2 consecutive cycles (6 weeks)
Danish: Seponer permanent behandlingen, hvis symptomerne ikke er reduceret til grad ≤ 2 efter en pause på 2 serier i træk (6 uger).
English: • Stop the infusion; when the reaction has resolved to Grade ≤ 1, resume infusion at a 50 % decreased infusion rate.b
Danish: • Stop infusionen; når reaktionen er reduceret til grad ≤ 1, genoptages infusionen med en infusionshastighed, der er nedsat med 50 %.b
English: Clear to slightly opalescent and colourless to slightly yellow liquid, with pH 6.0.
Danish: Klar til let opaliserende og farveløs til let gul væske med pH 6,0.
English: Overall survival Number of events (n) Median - months (95 % CIa) Hazard ratio (95 % CI)b, c Two-sided log-rank p-valuec 1-year Overall survival rate (%)
Danish: Samlet overlevelse Antal hændelser (n) Median - måneder (95 % CIa) Hazard ratio (95 % CI)b, c To-sidet log-rank p-værdic 1-års overlevelsesrate (%)
English: Cardiovascular comorbidities, performance status and the likely tolerability to chemotherapy with add-on necitumumab should therefore be thoroughly evaluated prior to the initiation of treatment in patients above 70 years of age.
Danish: Derfor bør kardiovaskulære komorbiditeter, performancestatus og forventet tolerabilitet over for kemoterapi med necitumumab som tillæg, omhyggeligt evalueres, før der indledes behandling hos patienter over 70 år.
English: • Temporarily withhold, for a maximum of 6 weeks following Day 1 of the most recent treatment cycle, until symptoms resolve to Grade ≤ 2.
Danish: • Afbryd midlertidigt behandlingen, i maksimalt 6 uger efter dag 1 i den seneste behandlingsserie, indtil symptomerne er reduceret til grad ≤ 2.
English: Special attention should be given to patients with clinical evidence of concomitant infectious conditions including early signs of active infections.
Danish: Patienter med kliniske tegn på ledsagende infektiøse tilstande, herunder tidlige tegn på aktive infektioner, skal have særlig bevågenhed.
English: Monitor patients during and following the infusion for signs of hypersensitivity and infusion-related reactions with resuscitation equipment and appropriate medical resources readily available.
Danish: Under og efter infusionen skal patienterne monitoreres for tegn på overfølsomhedsreaktioner og infusionsrelaterede reaktioner, og der skal være let adgang til genoplivningsudstyr og relevante medicinske ressourcer.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC22
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, monoklonale antistoffer, ATCkode: L01XC22.
English: Necitumumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Danish: Necitumumab er et humant monoklonalt antistof af typen IgG1, der produceres i murine (NS0) celler ved rekombinant DNA-teknologi.
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept og naturpræparater.
English: Specific animal studies to test necitumumab for carcinogenic potential or potential to impair fertility have not been performed.
Danish: Der er ikke udført specifikke dyrestudier med henblik på at undersøge necitumumab for karcinogent potentiale eller potentiale til at nedsætte fertilitet.
English: Patients should be monitored during infusion for signs of infusion-related reactions (see section 4.4).
Danish: Under infusionen skal patienterne monitoreres for tegn på infusionsrelaterede reaktioner (se pkt.
English: Necitumumab is a recombinant human IgG1 monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 1 (EGFR) and blocks the ligand binding site, blocking activation by all known ligands and inhibiting relevant biological consequences in vitro.
Danish: Necitumumab er et rekombinant humant monoklonalt antistof af typen IgG1, der med høj affinitet og specificitet binder sig til den humane epidermale vækstfaktorreceptor 1 (EGFR) og blokerer ligandbindingsstedet, hvilket forhindrer EGFR i at blive aktiveret af alle kendte ligander og modvirker relevante biologiske konsekvenser in vitro.
English: There is no relevant use of necitumumab in the paediatric population in the non-small cell lung cancer indication.
Danish: Det er ikke relevant at anvende necitumumab hos den pædiatriske population til indikationen ikkesmåcellet lungecancer.
English: Patients received a maximum of six cycles of chemotherapy in each arm; patients in the Portrazza+GC arm who had no progression continued to receive single-agent Portrazza until disease progression, unacceptable toxicity, or withdrawal of consent.
Danish: Patienterne fik maksimalt 6 serier kemoterapi i hver arm; i Portrazza + GC-armen fortsatte patienter, der ikke progredierede, med at få Portrazza som enkeltstof indtil sygdomsprogression, uacceptabel toksicitet eller tilbagetrækning af samtykke.
English: SQUIRE, a global, multicenter, two-arm, randomized study of Portrazza, was conducted in 1,093 patients with stage IV (American Joint Committee on Cancer Version 7) squamous NSCLC, including patients with ECOG PS2, who had received no prior anticancer therapy for metastatic disease.
Danish: SQUIRE var et globalt, randomiseret to-armet multicenterstudie med Portrazza, som blev udført med 1.093 patienter med stadie IV (American Joint Committee on Cancer, 7. udgave) planocellulær NSCLC, herunder patienter med en ECOG PS 2, der ikke tidligere havde fået anticancer-behandling for metastatisk sygdom.
English: Table 2 - Management recommendations for skin reactions Toxicity gradea
Danish: Tabel 2 - Anbefalinger til håndtering af hudreaktioner Toksicitetsgrada
English: There are no data on the effect of necitumumab on human fertility.
Danish: Der er ingen data om virkningen af necitumumab på fertiliteten hos mennesker.
English: The recommended dose of Portrazza is 800 mg (flat dose) administered as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle.
Danish: Den anbefalede dosis af Portrazza er 800 mg (fast dosis) administreret som en intravenøs infusion over 60 minutter på dag 1 og dag 8 i hver 3-ugers-serie.
English: A pre-planned exploratory analysis performed after the primary analysis, determined clinical efficacy outcome according to the level of tumour EGFR protein expression.
Danish: En præspecificeret eksplorativ analyse udført efter den primære analyse, fastslog den kliniske effekt i forhold til graden af EGFR-proteinekspression i tumoren.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Portrazza in all subsets of the paediatric population in non-small cell lung cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Portrazza i alle undergrupper af den pædiatriske population med ikke-småcellet lungecancer (se pkt.
English: In vivo studies in cell line-derived xenograft models of human cancer, including non-small cell lung carcinoma, demonstrate that necitumumab has antitumor activity both in monotherapy and in combination with gemcitabine and cisplatin.
Danish: In vivo studier med cellelinje-afledte xenograftmodeller af human cancer, herunder ikke-småcellet lungekarcinom, viser, at necitumumab har antitumoraktivitet både som monoterapi og i kombination med gemcitabin og cisplatin.
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 får symptomer, der påvirker din evne til at koncentrere dig og reagere, må du ikke føre motorkøretøj eller betjene maskiner, før virkningen er forsvundet.
English: The most common adverse reactions were skin reactions, venous thromboembolic events and laboratory abnormalities (hypomagnesaemia and albumin-corrected hypocalcaemia).
Danish: De mest almindelige bivirkninger var hudreaktioner, venøse tromboemboliske hændelser og anormale laboratorieresultater (hypomagnesiæmi og albuminkorrigeret hypocalcæmi).
English: Other body proteins (called growth factors) can attach to the EGFR and stimulate the cancer cell to grow and divide.
Danish: Nogle af kroppens andre proteiner (kaldet vækstfaktorer) kan binde sig til EGFR og dermed stimulere kræftcellen til at vokse og formere sig.
English: Based on population pharmacokinetic approach (PopPK), the mean volume of distribution at steady state (Vss) for necitumumab was 6.97 L (CV
Danish: På basis af populationsfarmakokinetik (PopPK) var det gennemsnitlige fordelingsvolumen ved steady state (Vss) for necitumumab 6,97 l (CV 31 %).
English: Dose dependent reversible skin toxicity was observed in the 26-week monkey study.
Danish: Der blev observeret dosisafhængig, reversibel hudtoksicitet i 26-ugers-studiet med aber.
English: Patients may be advised to apply moisturiser, sunscreen and topical steroid cream to face, hands, feet, neck, back and chest.
Danish: Patienterne skal eventuelt rådes til at påføre fugtighedscreme, solcreme og steroidcreme (lokalt) på ansigt, hænder, fødder, hals, ryg og brystkasse.
English: No animal studies have been specifically conducted to evaluate the effect of necitumumab on reproduction and foetal development; however, based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies.
Danish: Der er ikke specifikt udført dyrestudier med henblik på at vurdere effekten af necitumumab på reproduktion og føtal udvikling; baseret på necitumumabs virkningsmekanisme og på dyremodeller, hvor EGFR-ekspression er afbrudt, kan necitumumab imidlertid forårsage fosterskader eller udviklingsanomalier.
English: Severe skin rections were reported in approximately 6 % of patients while 1.7 % of patients discontinued due to skin reactions.
Danish: Der blev rapporteret om svære hudreaktioner hos ca. 6 % af patienterne, og 1,7 % af patienterne fik seponeret behandlingen på grund af hudreaktioner.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Der skal udvises forsigtighed ved administration hos patienter på natriumkontrolleret diæt.
English: Symptoms of severe skin reactions may include acne-like skin conditions and skin rash.
Danish: Symptomer på alvorlige hudreaktioner kan omfatte akne-lignende hudtilstande og hududslæt.
English: The important side effects of Portrazza are skin reactions and blood clots in the veins.
Danish: Vigtige bivirkninger ved Portrazza er hudreaktioner og blodpropper i venerne.
English: The incidence of fatal ATEs was 0.6% in the experimental arm versus 0.2% in the control arm (see also section 4.4).
Danish: Forekomsten af dødelige ATE'er var 0,6 % i forsøgsarmen versus 0,2 % i kontrolarmen (se også pkt.
English: Cardiorespiratory arrest or sudden death was reported in 2.8% (15/538) of patients treated with necitumumab in combination with gemcitabine and cisplatin compared to 0.6% (3/541) of patients treated with chemotherapy alone.
Danish: Kardiorespiratorisk stop eller pludselig død blev rapporteret hos 2,8 % (15/538) af de patienter, der blev behandlet med necitumumab i kombination med gemcitabin og cisplatin, sammenlignet med 0,6 % (3/541) af de patienter, der blev behandlet med kemoterapi alene.
English: Portrazza has no known influence on the ability to drive and use machines.
Danish: Portrazza påvirker så vidt vides ikke evnen til at føre motorkøretøj og betjene maskiner.
English: Skin reactions were reported in approximately 78 % of patients and mainly presented as acneiform rash, dermatitis acneiform, dry skin, pruritus, skin fissures, paronychia and palmar-plantar erythrodysaesthesia syndrome.
Danish: Hudreaktioner blev rapporteret hos ca. 78 % af patienterne og var overvejende akneiformt udslæt, akneiform dermatitis, tør hud, pruritus, revner i huden, paronychion og palmoplantar erytrodysæstesisyndrom.
English: Although modeling results suggest that the disposition of necitumumab was statistically dependent on body weight, simulations indicated that weight-based dosing would not significantly decrease PK variability.
Danish: Selvom resultater fra opstillede modeller tyder på, at absorptionen, fordelingen, metaboliseringen og udskillelsen af necitumumab var statistisk afhængig af kropsvægt, indikerede simuleringer, at vægtbaseret dosering ikke ville mindske variabiliteten af PK signifikant.
English: Efficacy results are shown in Table 4.
Danish: Effektdata er vist i tabel 4.
English: Prior to each necitumumab infusion, premedication for possible skin reactions must be considered (see section 4.4).
Danish: Før hver infusion med necitumumab skal præmedicinering mod mulige hudreaktioner overvejes (se pkt.
English: Infusion-related reactions were reported in 1.5 % of patients and mainly present as chills, fever or dyspnoea.
Danish: Infusionsrelaterede reaktioner blev rapporteret hos 1,5 % af patienterne og var overvejende kulderystelser, feber og dyspnø.
English: The concentrate for solution for infusion must be clear to slightly opalescent and colourless to slightly yellow prior to dilution.
Danish: Koncentratet til infusionsvæske, opløsning skal være klart til let opaliserende og farveløst til let gult inden fortynding.
English: Pre-emptive skin treatment including skin moisturiser, sun screen, topical steroid cream (1 % hydrocortisone) and an oral antibiotic (e.g. doxycycline) may be useful in the management of dermatologic reactions as clinically appropriate.
Danish: Alt efter klinisk behov kan forebyggende hudbehandling, der omfatter fugtighedscreme, solcreme, lokalt påført steroidcreme (1 % hydrocortison) og et oralt antibiotikum (f.eks. doxycyclin), være gavnlig i håndteringen af dermatologiske reaktioner.
English: However, no adverse effects on male or female reproductive organs were observed in monkeys treated for 26 weeks with necitumumab.
Danish: Der blev imidlertid ikke set nogen bivirkninger på forplantningsorganerne hos han- og hunaber, som blev behandlet med necitumumab i 26 uger.
English: Patients were randomised to receive first-line Portrazza at 800 mg plus chemotherapy consisting of gemcitabine at 1,250 mg/m2 and cisplatin at 75 mg/m2 (Portrazza+GC Arm), or gemcitabine-cisplatin chemotherapy alone (GC Arm).
Danish: Patienterne blev randomiseret til at få førstelinjebehandling med 800 mg Portrazza plus kemoterapi bestående af 1.250 mg/m2 gemcitabin og 75 mg/m2 cisplatin (Portrazza + GC-arm) eller gemcitabin/cisplatin-kemoterapi alene (GC-arm).
English: The most common serious adverse reactions (Grade ≥3) observed in necitumumab-treated patients are skin reactions (6.3 %) and venous thromboembolic events (4.3 %).
Danish: De mest almindelige alvorlige bivirkninger (grad ≥ 3), der blev observeret hos patienter behandlet med necitumumab, var hudreaktioner (6,3 %) og venøse tromboemboliske hændelser (4,3 %).
English: Patients should be carefully monitored for serum electrolytes, including serum magnesium, potassium, and calcium, prior to each necitumumab administration and after completion of necitumumab treatment, until within normal limits.
Danish: Patienternes koncentration af serumelektrolytter, herunder serummagnesium, -kalium og -calcium, bør monitoreres nøje forud for hver administration af necitumumab og efter endt behandling med necitumumab, indtil værdierne ligger i normalområdet.
English: There has been limited experience with necitumumab overdose in human clinical trials.
Danish: Der er begrænset erfaring med overdosering af necitumumab fra kliniske studier med mennesker.
English: Adverse drug reactions (ADRs) which were reported in patients with squamous non-small cell lung cancer are listed below in MedDRA body system organ class, frequency and grade of severity.
Danish: Bivirkninger, der blev rapporteret hos patienter med planocellulær ikke-småcellet lungecancer, er anført nedenfor i henhold til MedDRA-systemorganklasse, hyppighed og sværhedsgrad.
English: If you have a severe infusion-related reaction, your doctor may recommend adjusting the dose of Portrazza, or stop your treatment with Portrazza.
Danish: Hvis du får en alvorlig infusionsrelateret reaktion, kan lægen anbefale en justering af dosen af Portrazza eller stoppe din behandling med Portrazza.
English: Animal reproduction studies have not been conducted with necitumumab.
Danish: Der er ikke udført dyrereproduktionsstudier med necitumumab.
English: Administration of necitumumab should be carefully considered in those patients with a history of thromboembolic events (such as pulmonary embolism, deep vein thrombosis, myocardial infarction, stroke) or preexisting risk factors for thromboembolic events (such as advanced age, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with acquired or inherited thrombophilic disorders).
Danish: Administration af necitumumab bør overvejes nøje til patienter med tidligere tromboemboliske hændelser (f.eks. lungeemboli, dyb venetrombose, myokardieinfarkt, slagtilfælde) eller med kendte risikofaktorer for tromboemboliske hændelser (f.eks. fremskreden alder, langvarigt immobiliserede patienter, svært hypovolæmiske patienter, patienter med erhvervede eller arvelige trombofililidelser).
English: Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.
Danish: Anvend aseptisk teknik ved klargøring af opløsningen til infusion for at sikre sterilitet af den klargjorte opløsning.
English: If you have a severe skin reaction, your doctor may recommend adjusting the dose of Portrazza, or stop your treatment with Portrazza.
Danish: Hvis du får en alvorlig hudreaktion, kan lægen anbefale en justering af dosen af Portrazza eller stoppe din behandling med Portrazza.
English: Clinically relevant toxicities with respect to the elderly and those patients with Eastern Cooperative Oncology Group (ECOG) performance status score 2 (ECOG PS2) were similar to the overall population in patients receiving necitumumab plus chemotherapy consisting of gemcitabine and cisplatin.
Danish: Den klinisk relevante toksicitet hos ældre og patienter med en performancestatus-score på 2 i henhold til Eastern Cooperative Oncology Group (ECOG) (ECOG PS 2) var den samme som hos den samlede population af patienter, der fik necitumumab plus kemoterapi bestående af gemcitabin og cisplatin.
English: The pharmacokinetics of gemcitabine/cisplatin were not affected when co-administered with necitumumab and the pharmacokinetics of necitumumab were not affected when co-administered with gemcitabine/cisplatin.
Danish: Farmakokinetikken af gemcitabin/cisplatin blev ikke påvirket ved samtidig administration af necitumumab, og farmakokinetikken af necitumumab blev ikke påvirket ved samtidig administration af gemcitabin/cisplatin.
English: No dose adjustments are required in patients with mild or moderate renal impairment (see section 5.2).
Danish: Der kræves ingen dosisjusteringer hos patienter med let eller moderat nedsat nyrefunktion (se pkt.
English: Portrazza is administered in addition to gemcitabine and cisplatin-based chemotherapy for up to 6 cycles of treatment followed by Portrazza as a single agent in patients whose disease has not progressed, until disease progression or unacceptable toxicity.
Danish: Portrazza administreres i tillæg til gemcitabin- og cisplatinbaseret kemoterapi i op til 6 behandlingsserier efterfulgt af Portrazza som enkeltstof hos patienter, hvis sygdom ikke er progredieret, indtil der observeres sygdomsprogression eller uacceptabel toksicitet.
English: No other formal interaction studies with necitumumab have been performed in humans.
Danish: Der er ikke udført andre formelle interaktionsstudier med necitumumab hos mennesker.
English: Excipients: sodium citrate dihydrate, citric acid anhydrous, sodium chloride, glycine, mannitol, polysorbate 80 and water for injections.
Danish: Hjælpestoffer: natriumcitratdihydrat, citronsyre, vandfri, natriumchlorid, glycin, mannitol, polysorbat 80 og vand til injektionsvæsker.
English: Following the dose regimen of 800 mg necitumumab on day 1 and day 8 of a 21 day schedule, the geometric mean of necitumumab Cmin was 98.5 μg/mL (Coefficient of Variation 80 %) in serum from patients with squamous NSCLC after five cycles of treatment in combination with gemcitabine and cisplatin.
Danish: Efter et doseringsregime på 800 mg necitumumab på dag 1 og dag 8 i et 21-dages-forløb var den geometriske middelværdi af Cmin af necitumumab 98,5 μg/ml (variationskoefficient 80 %) i serum hos patienter med planocellulær NSCLC efter 5 behandlingsserier i kombination med gemcitabin og cisplatin.
English: These include low blood levels of magnesium, calcium, potassium or phosphate.
Danish: Ændringerne omfatter et fald i koncentrationen af magnesium, calcium, kalium eller fosfat i blodet.
English: Necitumumab should not be administered to patients with multiple risk factors for thromboembolic events unless the benefits outweigh the risks to the patient.
Danish: Necitumumab bør ikke administreres til patienter med multiple risikofaktorer for tromboemboliske hændelser, med mindre fordelene for patienten opvejer risici.
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Danish: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland Fremstiller
English: 50 mL solution in a vial (Type I glass) with a chlorobutyl elastomer stopper, an aluminium seal and a polypropylene cap.
Danish: 50 ml opløsning i et hætteglas (type I-glas) med en chlorbutylelastomerprop, en aluminiumsforsegling og en polypropylenhætte.