FrancophonIA/ELRC3.0 huggingface dataset:
English: Dacomitinib should not be used during pregnancy.
Danish: Dacomitinib bør ikke anvendes under graviditeten.
English: These effects were reversible with the exception of hair follicles and kidney changes.
Danish: Disse effekter var reversible bortset fra hårfollikler og forandringer i nyrerne.
English: • Loss of appetite
Danish: • Tab af appetit
English: Encourage adequate oral fluid intake during diarrhoea.
Danish: Tilskynd til tilstrækkelig oral væskeindtagelse ved diarré.
English: Local antacids and H2 receptor antagonists may be used if needed.
Danish: Der kan anvendes antacida og H2-receptorantagonister, hvis det er nødvendigt.
English: • if you are allergic to dacomitinib or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for dacomitinib eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Advise patients to use protective clothing and sunscreen before exposure to the sun.
Danish: Patienterne skal rådes til at bære beskyttende tøj og solcreme, inden de eksponeres for solen.
English: Vizimpro has minor influence on the ability to drive and use machines.
Danish: Vizimpro påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Treatment with Vizimpro should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandlingen med Vizimpro skal påbegyndes og overvåges af en læge med erfaring i administration af lægemidler mod cancer.
English: If the patient vomits or misses a dose, an additional dose should not be taken and the next prescribed dose should be taken at the usual time the next day.
Danish: Hvis patienten kaster op eller glemmer en dosis, må der ikke tages en ekstra dosis, og den næste dosis skal tages på det sædvanlige tidspunkt den følgende dag.
English: You should have an anti-diarrhoeal medicine available before you start taking Vizimpro.
Danish: Du skal have et lægemiddel mod diarré tilgængeligt, inden du begynder at tage Vizimpro.
English: EGFR mutation status was determined by a standardised and commercially available test kit.
Danish: Status af EGFR-mutationer blev bekræftet ved hjælp af standardiserede og kommercielt tilgængelige testkits.
English: • The recommended dose is 45 mg taken by mouth each day.
Danish: • Den anbefalede dosis er 45 mg dagligt som tages gennem munden.
English: Other forms of interactions
Danish: Andre typer interaktioner
English: Tell your doctor immediately while taking this medicine:
Danish: Fortæl det straks til lægen, når du tager dette lægemiddel:
English: If you feel tired or your eyes are irritated, you should use caution when driving or using machines.
Danish: Hvis du føler dig træt, eller hvis dine øjne er irriterede, skal du udvise forsigtighed, Når du fører motorkøretøj eller anvender maskiner.
English: • Pimozide and thioridazine, used to treat schizophrenia and psychosis
Danish: • Pimozid og thioridazin, som anvendes til behandling af skizofreni og psykose
English: If you miss a dose or vomit, take your next dose as scheduled.
Danish: Hvis du glemmer en dosis eller kaster op, skal du tage din næste dosis som planlagt.
English: The recommended dose of Vizimpro is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs.
Danish: Den anbefalede dosis af Vizimpro er 45 mg oralt en gang dagligt indtil sygdomsprogression eller uacceptabel toksicitet forekommer.
English: The median duration of treatment with Vizimpro across the pooled data set was 66.7 weeks.
Danish: Den mediane behandlingsvarighed med Vizimpro i alle puljede datasæt var 66,7 uger.
English: • Inflammation of the mouth and lips
Danish: • Betændelse i munden og læberne
English: Key secondary endpoints included objective response rate (ORR), duration of response (DoR), and overall survival (OS).
Danish: De vigtigste sekundære endepunkter inkluderede objektiv responsrate (ORR), responsvarighed (DoR) og samlet overlevelse (OS).
English: The following medicines may reduce how well Vizimpro works:
Danish: De følgende lægemidler kan nedsætte virkningen af Vizimpro:
English: If dose reduction is necessary, then the dose of Vizimpro should be reduced as described in Table 1.
Danish: Hvis dosisreduktion er nødvendig, skal dosis af Vizimpro nedsættes, som det er beskrevet i tabel 1.
English: The tablets should be swallowed with water and can be taken with or without meals.
Danish: Tabletterne skal synkes med vand og kan tages i forbindelse med eller udenfor måltider.
English: Treatment was administered orally on a continuous daily basis until disease progression, institution of new anticancer therapy, intolerable toxicity, withdrawal of consent, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Danish: Behandlingen blev administreret oralt på kontinuerlig daglig basis indtil sygdomsprogression, introduktion af ny anticancerbehandling, uacceptabel toksicitet, tilbagetrækning af samtykke, død eller investigators beslutning i overensstemmelse med protokollen uanset, hvad der indtraf først.
English: Race was 23% White, 77% Asian, and < 1% Black.
Danish: Race: 23% af patienterne var hvide, 77% var asiater og <1% var sorte.
English: Co-administration of dacomitinib and CYP2D6 substrates
Danish: Co-administration af dacomitinib og CYP2D6-substrater
English: • Dry, red, or itchy eyes
Danish: • Tørre, røde eller kløende øjne
English: Consider adding broad spectrum oral or intravenous antibiotics if any of these conditions worsen to greater than or equal to Grade 2 severity.
Danish: Det skal overvejes at tilføje bredspektret oral eller intravenøs antibiotika, hvis nogle af disse tilstande forværres til en sværhedsgrad på 2 eller derover.
English: Diarrhoea may result in dehydration with or without renal impairment, which could be fatal if not adequately treated.
Danish: Diarré kan forårsage dehydrering med eller uden nedsat nyrefunktion, hvilket kan være letalt, hvis det ikke behandles tilstrækkeligt.
English: All effects occurred at systemic exposure below that in humans at the recommended dose of 45 mg once daily.
Danish: Alle virkninger forekom ved en systemisk eksponering, der ligger under den humane eksponering, ved den anbefalede dosis på 45 mg en gang dagligt.
English: Vizimpro can be used as your first treatment once your lung cancer has spread to your other lung or other organs.
Danish: Vizimpro kan bruges som din første behandling, når lungekræften har spredt sig til den anden lunge eller andre organer.
English: Some lung problems may get worse during treatment with Vizimpro, as Vizimpro may cause inflammation of the lungs during treatment.
Danish: Visse lungeproblemer kan blive værre under behandling med Vizimpro, eftersom Vizimpro kan forårsage betændelse i lungerne under behandlingen.
English: The primary endpoint of the study was progression-free survival (PFS) as determined by blinded Independent Radiology Central (IRC) review.
Danish: Studiets primære endepunkt var progressionsfri overlevelse (PFS), som blev vurderet ved en blindet gennemgang af en uafhængig radiologisk komité (Independent Radiologic Central (IRC)).
English: The safety and efficacy of Vizimpro in the paediatric population (< 18 years of age) have not been established.
Danish: Vizimpros sikkerhed og virkning i den pædiatriske population (alder <18 år) er ikke klarlagt.
English: • Skin rash (very common)
Danish: • Hududslæt (meget almindeligt)
English: Following dacomitinib 45 mg daily dosing, steady-state was reached within 14 days.
Danish: Efter en daglig dosis dacomitinib på 45 mg blev steady state nået indenfor 14 dage.
English: ARCHER 1050 - Kaplan-Meier curve for PFS per IRC review - ITT population
Danish: ARCHER 1050 - Kaplan-Meier-kurve for PFS ifølge IRC-gennemgangen - ITTpopulation
English: Median DoR in months (95% CI) HR (95% CI)
Danish: Median DoR i måneder (95% CI) HR(95% CI)
English: Dacomitinib should be administered 2 hours before or at least 10 hours after taking H2 receptor antagonists.
Danish: Dacomitinib bør gives 2 timer før eller senest 10 timer efter indtagelse af H2-receptorantagonister.
English: There are no data on the use of dacomitinib in pregnant women.
Danish: Der er ingen data fra anvendelse af dacomitinib til gravide kvinder.
English: If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR' (epidermal growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with Vizimpro.
Danish: Hvis en test har vist, at du har kræft med ændringer (mutationer) i et gen kaldet EGFR (human epidermal vækstfaktorreceptor) og kræften har spredt sig til den anden lunge eller andre organer, vil kræften sandsynligvis reagere på behandling med Vizimpro.
English: If treatment for rash is not working or the rash is getting worse (for example, you have peeling or cracking of the skin) you should tell your doctor immediately, since your doctor may decide to stop your treatment with Vizimpro.
Danish: Hvis behandlingen for udslæt ikke virker, eller udslættet bliver værre (fx hvis huden skaller af eller der opstår revner i huden), skal du straks fortælle det til din læge, da din læge kan beslutte at stoppe behandlingen med Vizimpro.
English: The demographic characteristics of the overall study population were 60% female; median age at enrolment was 62 years with 10.8% being ≥ 75 years old.
Danish: Demografien for den samlede forsøgspopulation var 60% kvinder; gennemsnitsalderen ved inkludering var 62 år; 10,8% var ≥75 år.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Vizimpro:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Vizimpro:
English: If there is any possibility that you may become pregnant you must use effective contraception during treatment, and for at least 17 days afterwards.
Danish: Hvis der er mulighed for, at du kan blive gravid, skal du anvende sikker prævention under behandlingen, og i mindst 17 dage efter behandlingens ophør.
English: Based on its mechanism of action, dacomitinib may cause foetal harm when administered to a pregnant woman.
Danish: Baseret på dets virkningsmekanisme kan dacomitinib forårsage føtal skade, når det administreres til gravide kvinder.
English: Immediate treatment of diarrhoea is important.
Danish: Det er vigtigt, at diarré behandles med det samme.
English: Based on data from observations in 8 patients in Study A7471001, there was no apparent effect of local antacid administration on Cmax and AUCinf of dacomitinib.
Danish: Baseret på data fra observationer af 8 patienter i A7471001-studiet, var der ingen tilsyneladende effekt af administration af antacida på dacomitinibs Cmax og AUCinf.
English: Medicinal products metabolised by cytochrome P450 (CYP)2D6
Danish: Lægemidler som metaboliseres via cytochrom P450 (CYP)2D6
English: • If you are being treated with any of the medicines listed in section Other medicines and Vizimpro.
Danish: • Hvis du bliver behandlet med et af de lægemidler, der er anført i afsnittet Brug af anden medicin sammen med Vizimpro.
English: At first signs of increased frequency of bowel movements, contact your doctor immediately, drink plenty of fluids, and start antidiarrhoea treatment as soon as possible.
Danish: Ved de første tegn på øget hyppighed af afføring, skal du straks kontakte din læge, du skal drikke masser af væske og starte behandling mod diarré så hurtigt som muligt.
English: Rash, erythematous and exfoliative skin conditions may occur or worsen in areas exposed to the sun.
Danish: Udslæt, erytematøse og eksfoliative hudsygdomme kan forekomme eller forværres på områder, der eksponeres for solen.
English: Very common adverse reactions in patients occurring in at least 10% of patients in Study ARCHER 1050 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 4.
Danish: Meget almindelige bivirkninger, der forekom hos mindst 10% af patienterne i studiet ARCHER 1050, er opsummeret ifølge National Cancer Institute-Common Toxicity Criteria -grad i tabel 4.
English: The treatment of dacomitinib overdose should consist of symptomatic treatment and general supportive measures.
Danish: I tilfælde af overdosering af dacomitinib bør der gives symptombehandling og generel understøttende behandling.
English: Effect of dacomitinib on drug transporters
Danish: Effekt af dacomitinib på lægemiddeltransportører
English: Aluminium/aluminium blister containing 10 film-coated tablets.
Danish: Aluminium/aluminium blisterpakning indeholdende 10 filmovertrukne tabletter.
English: Among NSCLC patients treated with dacomitinib 45 mg daily, there have been isolated reports of hepatotoxicity in 4 (1.6%) patients.
Danish: Blandt patienter med NSCLC, der blev behandlet med dacomitinib 45 mg en gang dagligt, har der været isolerede rapporter om hepatotoksicitet hos 4 (1,6%) patienter.
English: This may mean that you have an inflammation of the lungs called interstitial lung disease and can be fatal.
Danish: Det betyder, at du måske har en betændelse i lungerne, der kaldes interstitiel lungesygdom, som kan være dødelig.
English: In particular, the effects of some medicines may increase when taken with Vizimpro.
Danish: Virkningen af visse andre lægemidler kan muligvis forstærkes, når de tages sammen med Vizimpro.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving Vizimpro.
Danish: Fertile kvinder skal rådes til at undgå at blive gravide, mens de får Vizimpro.
English: 1 fatal event was reported in the dacomitinib arm.
Danish: 1 letalt tilfælde blev rapporteret i dacomitinib-armen
English: Therefore, periodic liver function testing is recommended.
Danish: Derfor anbefales det, at udføre periodiske levertest.
English: Female patients taking dacomitinib during pregnancy or who become pregnant while taking dacomitinib should be apprised of the potential hazard to the foetus.
Danish: Kvindelige patienter, der får dacomitinib under graviditeten eller som bliver gravide, mens de får dacomitinib, skal informeres om den mulige risiko for fosteret.
English: Tiredness and eye irritation can occur in patients taking Vizimpro.
Danish: Træthed og øjenirritation kan forekomme hos patienter, som tager Vizimpro.
English: You should not become pregnant during treatment with Vizimpro because this medicine could harm the baby.
Danish: Du må ikke blive gravid under behandling med Vizimpro, da dette lægemiddel kan skade barnet.
English: A phototoxicity study with dacomitinib in pigmented rats showed no phototoxicity potential.
Danish: Et forsøg der undersøgte dacomitinibs fototoksicitet i pigmenterede rotter viste ikke et fototoksisk potentiale.
English: The plasma half-life of dacomitinib ranges from 54 to 80 hours.
Danish: Halveringstiden for dacomitinib i plasma ligger i området fra 54-80 timer.
English: Vizimpro contains the active substance dacomitinib, which belongs to a group of medicines called protein tyrosine kinase inhibitors which are used to treat cancer.
Danish: Vizimpro indeholder det aktive stof dacomitinib, som tilhører en gruppe af lægemidler kaldet proteintyrosinkinasehæmmere, som bruges til at behandle kræft.
English: If concomitant use of such medicinal products is considered necessary, they should follow their respective labels for dose recommendation regarding co-administration with strong CYP2D6 inhibitors.
Danish: Hvis samtidig brug af disse anses for nødvendigt, skal de respektive dosisanbefalinger i produktinformationen vedrørende co-administration med stærke CYP2D6-hæmmere følges.
English: Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000).
Danish: Inden for hver systemorganklasse er bivirkningerne listet efter hyppighed med de hyppigste bivirkninger angivet først, og i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 to <1/100); sjælden (≥1/10.000 til <1/1.000).
English: O-desmethyl dacomitinib accounted for 16% of human plasma radioactivity and is formed mainly by CYP2D6 and to a lesser extent CYP2C9.
Danish: O-desmethyl dacomitinib udgjorde 16% af radioaktiviteten i human plasma, og det dannes primært af CYP2D6 og i mindre grad af CYP2C9.
English: Because many medicinal products are excreted in human milk, and because of the potential for serious adverse reactions in breast-fed infants from exposure to dacomitinib, mothers should be advised against breast-feeding while receiving this medicinal product.
Danish: Eftersom mange lægemidler udskilles i human mælk, og på grund af muligheden for alvorlige bivirkninger hos spædbørn, der ammes og eksponeres for dacomitinib, bør ammende mødre tilrådes at ophøre med amning, mens de får dette lægemiddel.
English: If you take H2 blocker medicine take your dose of Vizimpro at least 2 hours before or 10 hours after taking the H2 blocker medicine.
Danish: Hvis du tager en ”H2-blokker”, skal du tage din Vizimpro-dosis mindst 2 timer før eller 10 timer efter, at du har taget lægemidlet, der blokerer H2.
English: Skin-related adverse reactions were Grades 1 to 3.
Danish: Hudrelaterede bivirkninger var grad 1 til 3.
English: Thus, dacomitinib is not expected to be genotoxic at clinically relevant exposure concentrations.
Danish: Derfor forventes det ikke, at dacomitinib er genotoksisk ved klinisk relevante koncentrationer.
English: Vizimpro contains lactose and sodium
Danish: Vizimpro indeholder lactose og natrium
English: Dacomitinib showed a clearance of 20.0 L/hr with an inter-individual variability of 32% (CV%).
Danish: Dacomitinib havde en clearance på 20,0 l/time med en interindividuel variation på 32% (CV%).
English: You should not take these medicines during your treatment with Vizimpro.
Danish: Du må ikke tage disse lægemidler, mens du behandles med Vizimpro.
English: Dacomitinib binds selectively and irreversibly to its HER family targets thereby providing prolonged inhibition.
Danish: Dacomitinib bindes selektivt og irreversibelt til receptorer i HERfamilien, og medfører herved langvarig hæmning.
English: Table 3 presents adverse reactions for Vizimpro.
Danish: Tabel 3 viser bivirkninger i forbindelse med Vizimpro.
English: Co-administration of dacomitinib with agents that increase gastric pH
Danish: Co-administration af dacomitinib med midler, der øger gastrisk pH
English: Exposure response relationships
Danish: Relationer mellem respons og eksponering
English: Decreased appetite Hypokalaemiaa
Danish: Nedsat appetit Hypokaliæmi
English: • if you develop diarrhoea.
Danish: • Hvis du får diarré.
English: Tell your doctor as soon as possible if you notice any of the other following side effects:
Danish: Kontakt din læge hurtigst muligt, hvis du opdager en eller flere af de følgende bivirkninger:
English: Rash, erythematous and exfoliative skin condition adverse reactions were reported in 79.2% and 5.5%, respectively, of patients receiving Vizimpro.
Danish: Bivirkningerne udslæt, erytematøse og eksfoliative hudsygdomme blev rapporteret hos henholdsvis 79,2% og 5,5% af patienterne, der fik Vizimpro.
English: Environmental risk assessment studies have shown that dacomitinib has the potential to be very persistent, bioaccumulative and toxic to the environment (see section 6.6).
Danish: Miljørisikovurderingsstudier har vist, at dacomitinib har potentiale til at være meget persistent, bioakkumulerende og toksisk for miljøet (se pkt.
English: Proactive management of diarrhoea should start at the first sign of diarrhoea especially within the first 2 weeks of starting dacomitinib, including adequate hydration combined with anti-diarrhoeal medicinal products and continued until loose bowel movements cease for 12 hours.
Danish: Proaktiv behandling af diarré skal påbegyndes ved de første tegn på diarré, særligt i de første 2 uger efter start af dacomitinib, herunder med tilstrækkelig hydrering kombineret med anti-diarré lægemidler og dette fortsættes, indtil diarréen har været ophørt i 12 timer.
English: • Inflammation of the lungs (common, may affect up to 1 in 10 people) Difficulty in breathing, shortness of breath, possibly with a cough or fever.
Danish: • Lungebetændelse (almindelig, kan forekomme hos op til 1 ud af 10 personer): Åndedrætsbesvær, åndenød, muligvis med hoste eller feber.
English: Anti-diarrhoeal medicinal products (e.g., loperamide) should be used and, if necessary, escalated to the highest recommended approved dose.
Danish: Anti-diarré lægemidler (fx loperamid) bør anvendes og dosis sættes op til den højeste, anbefalede og godkendte dosis, hvis det er nødvendigt.
English: Significant exposure-safety relationship was defined for Grade ≥ 3 rash/dermatitis acneiform, other skin toxicities, diarrhoea and Grade ≥ 1 stomatitis.
Danish: Der sås en signifikant relation mellem eksponering og sikkerhed i forbindelse med grad ≥3 udslæt/acneiform dermatitis, andre hudtoksiciteter, diarré og stomatitis af grad ≥1.
English: Maternal body weight gain and food intake were lower in pregnant rats and rabbits.
Danish: Maternel vægtøgning og fødeindtagelse var lavere hos drægtige rotter og kaniner.
English: The European Medicines Agency has waived the obligation to submit the results of studies with dacomitinib in all subsets of the paediatric population in NSCLC indication (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med dacomitinib i alle undergrupper af den pædiatriske population i behandlingen af NSCLC (se pkt.
English: A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomised to dacomitinib compared with those randomised to gefitinib, see Table 5 and Figure 1.
Danish: Ifølge IRC's bedømmelse var der en statistisk signifikant forbedring af PFS for patienter, som var randomiseret til dacomitinib, sammenlignet med patienter, som var randomiseret til gefitinib, se tabel 5 og figur 1.
English: Tell your doctor right away if you have any new or worsening symptoms including difficulty in breathing, shortness of breath, or cough with or without phlegm (mucous), or fever.
Danish: Fortæl det straks til lægen, hvis du får nye eller forværrede symptomer, herunder åndedrætsbesvær, åndenød eller hoste med eller uden slim eller feber.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne angivet efter faldende sværhedsgrad.
English: • For Grade ≥ 3 toxicity, withhold dacomitinib until symptoms resolve to Grade ≤ 2.
Danish: • I forbindelse med toksicitet af grad ≥ 3 skal dacomitinib-behandling stilles i bero, indtil symptomerne bedres til grad ≤ 2.
English: Contact your doctor immediately if you notice any of the following side effects - you may need urgent medical treament:
Danish: Kontakt straks din læge, hvis du får en eller flere af følgende bivirkninger, da du kan have behov for akut lægehjælp.
English: The inhibition of CYP2D6 translated into approximately a 90% reduction in metabolite exposure and an approximate 37% increase in dacomitinib exposure.
Danish: Hæmningen af CYP2D6 medfører en reduktion i eksponering for metabolitter på ca. 90% og en forøgelse i eksponering for dacomitinib på ca. 37%.
English: • Diarrhoea (very common, may affect more than 1 in 10 people) Diarrhoea may lead to fluid loss (common), low blood potassium (very common), and worsening kidney function and can be fatal.
Danish: • Diarré (meget almindelig, kan forekomme hos flere end 1 ud af 10 personer): Diarré kan føre til væsketab (almindeligt), lavt kaliumindhold i blodet (meget almindeligt) og forværret nyrefunktion, og kan være dødelig.
English: • if you ever had any other lung problems.
Danish: • Hvis du har andre lungeproblemer.
English: Very common adverse reactions in Phase 3 Study ARCHER 1050 (N=451) Dacomitinib (N=227)
Danish: Meget almindelige bivirkninger i fase 3-studiet ARCHER 1050 (N=451)
English: First dose reduction
Danish: Første dosisreduktion