FrancophonIA/ELRC3.0 huggingface dataset:
English: Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.
Danish: Portrazza i kombination med gemcitabin og cisplatin er indiceret til behandling af voksne patienter med lokalt avanceret eller metastatisk ikke-småcellet lungecancer med epidermal vækstfaktorreceptor (EGFR)-udtrykkende planocellulær histologi og som ikke tidligere har fået kemoterapi mod denne tilstand.
English: Progression free survival Number of events (n) Median - months (95 % CI) Hazard ratio (95 % CI) b, c Two-sided log-rank p-value c a Abbreviations: CI = confidence interval b Hazard ratio is expressed as treatment/control and estimated from Cox model c Stratified by the randomization strata (ECOG PS [0-1 vs. 2], and geographic region [North
Danish: Progressionsfri overlevelse Antal hændelser (n) Median - måneder (95 % CI) Hazard ratio (95 % CI) b, c To-sidet log-rank p-værdi c a Forkortelser: CI = konfidensinterval b Hazard ratio er udtrykt som behandling/kontrol og estimeret ved brug af Cox's model c Stratificeret efter randomiseringsstratae (ECOG PS [0-1 vs. 2] og geografisk område
English: Necitumumab hinders other proteins from binding to the EGFR and thus prevents the cancer cell from growth and division.
Danish: Necitumumab forhindrer andre proteiner i at binde sig til EGFR og forhindrer på denne måde, at kræftcellen vokser og formerer sig.
English: Blood clots in the veins
Danish: Blodpropper i venerne
English: If not used immediately, the prepared necitumumab dosing solution must be stored at 2°C to 8°C for a duration not to exceed 24 hours, or may be held at 9°C to 25°C for up to 4 hours.
Danish: Anvendes den klargjorte necitumumabopløsning til dosering ikke med det samme, må opbevaringstiden ikke overstige 24 timer ved 2 °C til 8 °C eller 4 timer ved 9 °C til 25 °C.
English: Based on the results of the population pharmacokinetic analysis, hepatic status (as assessed by alanine aminotransferase, aspartate transaminase and total bilirubin) had no significant effect on the pharmacokinetics of necitumumab.
Danish: På basis af resultaterne af den populationsfarmakokinetiske analyse havde leverstatus (bestemt ud fra niveauet af alaninaminotransferase, aspartattransaminase og total-bilirubin) ingen signifikant effekt på farmakokinetikken af necitumumab.
English: Detailed instructions for your doctor or your nurse on how to prepare Portrazza infusion are included at the end of this package leaflet (see ‘Handling instructions').
Danish: I slutningen af denne indlægsseddel er der detaljerede instruktioner i, hvordan læger og sundhedspersonale skal klargøre Portrazza til infusion (se 'Instruktioner i håndtering').
English: Hypersensitivity/infusion-related reactions (IRRs) were reported with necitumumab.
Danish: Overfølsomhedsreaktioner/infusionsrelaterede reaktioner Der blev rapporteret om overfølsomhedsreaktioner/infusionsrelaterede reaktioner (IRR'er) med necitumumab.
English: Common (may affect up to 1 in 10 people) - headache - coughing up blood (haemoptysis) - nosebleed (epistaxis) - strange tastes; metallic taste (dysgeusia) - eye inflammation (conjunctivitis) - blood clots in the arteries - urinary tract infection (bladder and/or kidneys) - pain when passing urine (dysuria) - difficulty in swallowing (dysphagia) - muscle spasms - inflammation of veins in the legs (phlebitis) - allergic reactions - pain in your mouth and throat (oropharyngeal pain)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter): - hovedpine - ophostning af blod (hæmoptyse) - næseblod (epistaxis) - smagsforstyrrelser (dysgeusi), herunder underlig smag og metallisk smag - øjenbetændelse (konjunktivitis) - blodpropper i arterierne - urinvejsinfektion (blære og/eller nyrer) - smerter ved vandladning (dysuri) - synkebesvær (dysfagi) - muskeltrækninger - årebetændelse i benene (flebitis) - allergiske reaktioner - smerter i munden og halsen (orofaryngeale smerter).
English: What Portrazza looks like and contents of the pack Portrazza 800 mg concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow liquid in a glass vial with a rubber stopper.
Danish: Portrazza 800 mg koncentrat til infusionsvæske, opløsning (sterilt koncentrat) er en klar til let opaliserende og farveløs til let gul væske i et hætteglas af glas med gummiprop.
English: Avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Portrazza as this medicine may potentially cause harm to your unborn child. Talk to your doctor about the best contraception for you.
Danish: Undgå at blive gravid, mens du er i behandling med dette lægemiddel og i mindst 3 måneder efter den sidste dosis af Portrazza, da dette lægemiddel muligvis kan skade det ufødte barn.
English: The large majority of patients (95.2% of evaluable patients; n = 935) had tumor samples expressing EGFR protein; 4.8% (n = 47) were not detectable for EGFR protein expression.
Danish: Langt hovedparten af patienterne (95,2 % af de evaluerede patienter; n = 935) havde EGFR-proteinudtrykkende tumorprøver.
English: The following table provides the frequency and severity of ADRs based on results from SQUIRE, a global, multicenter, two-arm, randomized Phase 3 study in adult patients with squamous NSCLC randomised to treatment with necitumumab in combination with gemcitabine/cisplatin or gemcitabine/cisplatin.
Danish: Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger baseret på resultater fra SQUIRE, et globalt, randomiseret fase 3-multicenterstudie med to arme, der omfattede voksne patienter med planocellulær NSCLC, som var randomiseret til behandling med necitumumab i kombination med gemcitabin/cisplatin eller gemcitabin/cisplatin alene.
English: Discard any unused portion of necitumumab left in a vial, as the product contains no antimicrobial preservatives.
Danish: Kasser eventuelle rester af ikke anvendt necitumumab, der er tilovers i et hætteglas, da produktet ikke indeholder antimikrobielle konserveringsmidler.
English: See section 4 for more details about skin reactions.
Danish: Se afsnit 4 for at få yderligere oplysninger om hudreaktioner.
English: Elderly No dose reductions other than those recommended for all patients are necessary (see sections 4.4 and
Danish: Der kræves ingen særlige dosisreduktioner ud over de dosisreduktioner, der anbefales til alle patienter (se pkt.
English: In approximately 5 out of 100 patients these skin reactions are likely to be severe.
Danish: Hos ca. 5 ud af 100 patienter kan disse hudreaktioner være alvorlige.
English: Cases of cardiorespiratory disorders and unexplained death were observed in patients treated with Portrazza in combination with gemcitabine and cisplatin and in patients treated with gemcitabine and cisplatin alone.
Danish: Der er set tilfælde af kardiorespiratoriske sygdomme og uforklarlige dødsfald hos patienter, der blev behandlet med Portrazza kombineret med gemcitabin og cicplatin, og hos patienter, der alene blev behandlet med gemcitabin og cicplatin.
English: Administer via an infusion pump.
Danish: Administrer infusionsopløsningen via en infusionspumpe.
English: Discontinuation of necitumumab in patients who experience a VTE or ATE should be considered after a thorough benefit risk assessment for the individual patient.
Danish: Det bør overvejes at seponere necitumumab hos patienter, der oplever en VTE eller ATE, efter en omhyggelig vurdering af fordele i forhold til risici hos den enkelte patient.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Danish: Patienterne skal instrueres i at søge lægehjælp, hvis de udvikler symptomer som åndenød, smerter i brystkassen eller hævelse i en arm eller et ben.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of 50 mL contains 800 mg necitumumab (16 mg/mL).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Ét hætteglas med 50 ml indeholder 800 mg necitumumab (16 mg/ml).
English: Severe VTEs were reported in approximately 4 % of patients.
Danish: Der blev rapporteret om alvorlige VTE'er hos ca. 4 % af patienterne.
English: Do not administer the solution if you notice any particulate matter or discoloration.
Danish: Opløsningen må ikke bruges, hvis der bemærkes partikler eller misfarvning.
English: Common Arterial thromboembolic events
Danish: Almindelig Arterielle tromboemboliske hændelser
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 800 mg/50 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 800 mg/50 ml
English: What Portrazza contains - The active substance is necitumumab.
Danish: Portrazza indeholder: - Aktivt stof: necitumumab.
English: There are no data regarding necitumumab administration in patients with moderate or severe hepatic impairment (see section 5.2).
Danish: Der foreligger ingen data om administration af necitumumab til patienter med moderat eller svært nedsat leverfunktion (se pkt.
English: Following improvement to Grade ≤ 2, resume at reduced dose of 400 mg.
Danish: genoptages behandlingen med en reduceret dosis på 400 mg.
English: After dilution When prepared as directed, infusion solutions of Portrazza contain no antimicrobial preservatives.
Danish: Ved klargøring som angivet indeholder infusionsopløsninger med Portrazza ingen antimikrobielle konserveringsmidler.
English: Contraceptive measures or abstinence are recommended (see section 4.6).
Danish: Det anbefales at anvende prævention eller afholde sig fra seksuelt samkvem (se pkt.
English: It is available in packs of: - 1 vial of 50 mL
Danish: Det fås i pakninger med: - 1 hætteglas med 50 ml.
English: Appropriate medical resources for the treatment of severe infusion reactions should be available during necitumumab infusions.
Danish: Under infusioner med necitumumab skal de relevante medicinske ressourcer til behandling af alvorlige infusionsreaktioner være til rådighed.
English: Very common (may affect more than 1 in 10 people): - itching; dry skin; scaling; nail disorders (skin reactions) - vomiting - fever or high temperature (pyrexia) - decreased weight - mouth ulcers and cold sores (stomatitis)
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter): - kløe, tør hud, hudafskalning, negleproblemer (hudreaktioner) - opkastning - feber eller høj temperatur (pyreksi) - vægttab - sår i munden og forkølelsessår (stomatitis).
English: Women of childbearing potential should be advised to avoid becoming pregnant while on necitumumab.
Danish: Fertile kvinder skal rådes til at undgå graviditet, mens de er i behandling med necitumumab.
English: A similar observation was made in a clinical trial investigating necitumumab in combination with pemetrexed and cisplatin versus pemetrexed and cisplatin alone as the first-line therapy in patients with advanced non-squamous NSCLC.
Danish: En lignende observation blev gjort i et klinisk forsøg, der undersøgte necitumumab i kombination med pemetrexed og cisplatin versus pemetrexed og cisplatin alene som førstelinjebehandling til patienter med avanceret ikke-planocellulær NSCLC.
English: Hypokalaemiac
Danish: Hypokaliæmic
English: Women of childbearing potential have to use effective contraception during necitumumab treatment and up to 3 months after last administration of necitumumab treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med necitumumab og i op til 3 måneder efter den sidste administration af necitumumabbehandlingen.
English: - Cardiorespiratory disorders
Danish: - Kardiorespiratoriske sygdomme
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 800 mg/ 50 mL
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 800 mg/50 ml
English: An improvement was observed in subgroups for OS and PFS including the pre-specified stratification factors [ECOG PS score (0-1 vs. 2) and geographic region (North America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia)]; in patients age 70 and over, the hazard ratio for overall survival was 1.03 (0.75, 1.42) (see Figure 2).
Danish: Der blev set en forbedring af OS og PFS i subgrupper, herunder de præspecificerede stratificeringsfaktorer [ECOG PS-score (0-1 vs. 2) og geografisk region (Nordamerika, Europa og Australien vs. Sydamerika, Sydafrika og Indien vs. Østasien).
English: Table 1 - Management recommendations for hypersensitivity/infusion-related reactions
Danish: Tabel 1 - Anbefalinger til håndtering af overfølsomhedsreaktioner/infusionsrelaterede reaktioner
English: Vials contain 800 mg as a 16 mg/mL solution of necitumumab; one 50 mL vial contains the complete dose.
Danish: Hætteglassene indeholder 800 mg som en necitumumab-opløsning på 16 mg/ml; ét 50 ml hætteglas indeholder den fulde dosis.
English: There are no data regarding necitumumab administration in patients with severe renal impairment.
Danish: Der foreligger ingen data om administration af necitumumab til patienter med svært nedsat nyrefunktion.
English: The recommended dose of Portrazza is 800 mg on days 1 and 8 of each 3-week cycle.
Danish: Den anbefalede dosis af Portrazza er 800 mg på dag 1 og dag 8 i hver behandlingsserie, som varer 3 uger.
English: Women of childbearing potential/contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on necitumumab and should be informed of the potential hazard to the pregnancy and foetus.
Danish: Fertile kvinder skal rådes til at undgå graviditet under behandlingen med necitumumab og skal informeres om den mulige risiko ved graviditet og skade på fosteret.
English: Common Urinary tract infection
Danish: Almindelig Urinvejsinfektion
English: There is no known antidote for necitumumab overdose.
Danish: Der findes ingen kendt modgift i tilfælde af overdosering med necitumumab.
English: In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, an increased rate of infections was observed early after start of treatment, which led to subsequent infectious complications such as pneumonia and/or sepsis.
Danish: I et klinisk fase 2-forsøg, der undersøgte necitumumab i kombination med paclitaxel og carboplatin versus paclitaxel og carboplatin alene som førstelinjebehandling til patienter med stadie IVmetastatisk planocellulær NSCLC, blev en øget forekomst af infektioner observeret tidligt efter behandlingsstart, hvilket efterfølgende ledte til infektiøse komplikationer, såsom pneumoni og/eller sepsis.
English: ADRs reported in ≥ 1 % of necitumumab treated patients in SQUIRE
Danish: Tabel 3 - Bivirkninger rapporteret hos ≥ 1 % af de patienter, der blev behandlet med necitumumab i SQUIRE
English: Based on the results of the population pharamacokinetic analysis, there was no impact of age on necitumumab exposure.
Danish: På basis af resultaterne af den populationsfarmakokinetiske analyse blev eksponeringen for necitumumab ikke påvirket af alder.
English: In patients with no detectable EGFR protein expression, no improvement in overall survival (hazard ratio [HR] = 1.52 [0.74, 3.12]) or progression free survival (hazard ratio [HR] = 1.33 [0.65, 2.70] was observed.
Danish: Der blev ikke observeret en forbedring i samlet overlevelse (hazard ratio [HR] = 1,52 [0,74, 3,12]) eller progressionsfri overlevelse (hazard ratio [HR] = 1,33 [0,65, 2,70] hos patienter, hvor EGFRproteinekspression ikke blev påvist.
English: If particulate matter or discolouration is identified, discard the vial.
Danish: Hvis der observeres partikler eller misfarvning, skal hætteglasset kasseres.
English: In patients with detectable EGFR protein expression (indicated patient population), overall survival was statistically significantly improved in the Portrazza+GC Arm as compared to the GC Arm with an estimated reduction in risk of death of 21% (hazard ratio [HR] = 0.79 [0.69, 0.92]; p = 0.002) and a median OS of 11.7 months in the Portrazza+GC Arm and 10.0 months in the GC Arm. A statistically significant improvement in progression-free survival was also observed (HR = 0.84 [0.72, 0.97]; p = 0.018), with a median PFS of 5.7 months in the Portrazza+GC Arm and 5.5 months in the GC Arm.
Danish: Hos patienter med EGFR-proteinekspression (den indicerede patientpopulation) var den samlede overlevelse statistisk signifikant forbedret i Portazza+GC-armen i forhold til GC-armen, med en estimeret reduktion i risikoen for død på 21 % (hazard ratio [HR] = 0,79 [0,69, 0,92]; p = 0,002) og en median OS på 11,7 måneder i Portrazza+GC-armen og 10,0 måneder i GC-armen.
English: Cardiorespiratory disorders
Danish: Kardiorespiratoriske forstyrrelser
English: The incremental risk of cardiopulmonary arrest or sudden death in patients with a history of coronary artery disease, congestive heart failure, or arrhythmias as compared to those without these comorbid conditions is not known.
Danish: Den øgede risiko for kardiopulmonalt stop eller pludselig død hos patienter med koronararteriesygdom, hjerteinsufficiens eller arytmi i anamnesen sammenlignet med patienter uden disse komorbiditeter kendes ikke.
English: Common Haemoptysis Common Epistaxis Common Oropharyngeal pain 1.1
Danish: Almindelig Hæmoptyse Almindelig Epistaxis Almindelig Orofaryngeale smerter
English: Symptoms may include swelling, pain and tenderness of the limb, difficulty breathing, chest pain, or an abnormal heartbeat and discomfort.
Danish: Symptomerne kan omfatte hævelse af samt smerter og ømhed i lemmerne, vejrtrækningsbesvær, smerter i brystkassen eller en unormal puls og ubehag.
English: Eyelash trichomegaly Isolated cases of Grade 1 trichomegaly have been reported in patients treated with necitumumab.
Danish: Der er rapporteret om enkeltstående tilfælde af grad 1 trikomegali hos patienter behandlet med necitumumab.
English: Effective contraception has to be used during necitumumab treatment and up to 3 months after last administration of necitumumab treatment.
Danish: De skal benytte sikre svangerskabsforebyggende metoder under behandlingen med necitumumab og i op til 3 måneder efter den sidste administration af necitumumabbehandlingen.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Portrazza 800 mg sterile concentrate necitumumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Portrazza 800 mg sterilt koncentrat necitumumab
English: Portrazza may increase this risk.
Danish: Portrazza kan øge denne risiko, hvilket din læge vil drøfte med dig.
English: In patients who have experienced a previous Grade 1 or 2 hypersensitivity or infusion related reaction to Portrazza, premedication with a corticosteroid and an antipyretic in addition to an antihistamine is recommended.
Danish: Det anbefales at præmedicinere patienter, der tidligere har haft en overfølsomhedsreaktion eller infusionsrelateret reaktion af grad 1 eller 2 på Portrazza, med et kortikosteroid og et antipyretikum i tillæg til et antihistamin.
English: In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone (106 versus 55 patients, 2:1 randomisation) as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, a higher rate of death, including death due to infection, was observed for the necitumumab plus paclitaxel/carboplatin arm during the first 4 months (see also section 4.4), with a later trend towards improved survival after 4 months.
Danish: I et klinisk fase 2-forsøg, der undersøgte necitumumab i kombination med paclitaxel og carboplatin versus paclitaxel og carboplatin alene (henholdsvis 106 og 55 patienter, 2:1 randomisering) som førstelinjebehandling til patienter med stadie IV-metastatisk planocellulær NSCLC, blev en øget forekomst af dødsfald observeret, herunder død som følge af infektion, i necitumumab plus paclitaxel/carboplatin-armen indenfor de første 4 måneder (se også pkt.
English: There were no relevant differences in the distribution of demographics, disease characteristics, or the use of post-study systemic therapy between the subset of patients with detectable EGFR protein expression and the ITT population.
Danish: Der var ingen relevante forskelle i fordelingen mellem den EGFR-proteinudtrykkende subgruppe af patienter og ITT populationen mht. demografi, sygdomskarakteristika og brug af systemisk behandling efter studiedeltagelse.
English: Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients and mainly present as stroke and myocardial infarction.
Danish: Arterielle tromboemboliske hændelser (ATE'er) blev rapporteret hos ca. 4 % af patienterne og var overvejende slagtilfælde og myokardieinfarkt.
English: In patients who have experienced a previous Grade 1-2 hypersensitivity or infusion-related reaction to Portrazza, premedication with a corticosteroid and an antipyretic in addition to an antihistamine is recommended.
Danish: Det anbefales at præmedicinere patienter, der tidligere har haft en overfølsomhedsreaktion eller en infusionsrelateret reaktion af grad 1-2 på Portrazza, med et kortikosteroid og et antipyretikum i tillæg til et antihistamin.
English: Common Conjunctivitis
Danish: Almindelig Konjunktivitis
English: Blood clots can also lead to a blockage in the blood vessels of the lung.
Danish: Blodpropper kan også føre til blokering af blodkar i lungerne.
English: Necitumumab exhibits concentration-dependent clearance.
Danish: Clearancen af necitumumab er koncentrationsafhængig.
English: Symptoms may include difficulty breathing, chest pain, or an abnormal heartbeat and discomfort.
Danish: Symptomerne kan omfatte vejrtrækningsbesvær, smerter i brystkassen eller en unormal puls og ubehag.
English: Manufacturer Lilly S.A., Avda de la Industria, 30, Alcobendas, Madrid, 28108, Spain
Danish: Lilly S.A., Avda de la Industria, 30, Alcobendas, Madrid, 28108, Spanien Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Symptoms may include swelling, pain and tenderness of the limb.
Danish: Symptomerne kan omfatte hævelse, smerte og ømhed i benet.
English: Each 50 mL vial contains 800 mg of necitumumab.
Danish: Hvert 50 ml hætteglas indeholder 800 mg necitumumab.
English: Toxicity gradea
Danish: Toksicitetsgrada
English: Venous thromboembolic events (VTEs) were reported in approximately 8 % of patients and mainly present as pulmonary embolism and deep vein thrombosis.
Danish: Venøse tromboemboliske hændelser (VTE'er) blev rapporteret hos ca. 8 % af patienterne og var overvejende lungeemboli og dyb venetrombose.
English: Women of childbearing potential/contraception in females Based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies.
Danish: På baggrund af virkningsmekanismen og dyremodeller, hvor EGFR-ekspression var afbrudt, kan necitumumab forårsage fosterskader eller udviklingsanomalier.
English: Skin reactions were reported with necitumumab (see section 4.8).
Danish: Der blev rapporteret om hudreaktioner med necitumumab (se pkt.
English: A separate infusion line must be used and the line must be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection at the end of the infusion.
Danish: Der skal anvendes en særskilt infusionsslange, og slangen skal skylles med 0,9 % (9 mg/ml) natriumchloridopløsning til injektion ved afslutningen af infusionen.
English: • For subsequent infusions, please see premedication section.
Danish: • Se afsnittet om præmedicinering i forbindelse med håndtering af efterfølgende infusioner.