FrancophonIA/ELRC3.0 huggingface dataset:
English: Brodalumab is a monoclonal antibody, a specialised type of protein that recognises and attaches to certain proteins in the body.
Danish: Brodalumab er et monoklonalt antistof, en specialiseret type protein, der genkender og binder sig specifikt til bestemte proteiner i kroppen.
English: No dose adjustment is recommended.
Danish: Dosisjustering anbefales ikke.
English: • if you have an infection or have any signs of infection listed in Section 4 “Possible Side Effects”
Danish: • hvis du har en infektion eller nogen af de tegn på infektion, der er nævnt i punkt 4 om bivirkninger
English: • your stomach area (abdomen), except for a 5-centimetre area right around your belly button
Danish: • dit lår • dit maveområde (abdomen), undtagen de 5 cm lige rundt om navlen.
English: The most commonly reported adverse reactions in all Kyntheum-treated patients were arthralgia (4.6%), headache (4.3%), fatigue (2.6%), diarrhoea (2.2%), and oropharyngeal pain (2.1%).
Danish: De mest almindeligt rapporterede bivirkninger hos alle patienter behandlet med Kyntheum var artralgi (4,6 %), hovedpine (4,3 %), træthed (2,6 %), diarré (2,2 %) og orofaryngeale smerter (2,1 %).
English: The majority of infections consisted of nasopharyngitis, upper respiratory tract infection, pharyngitis, urinary tract infections, bronchitis, and influenza, which did not necessitate treatment discontinuation.
Danish: Størstedelen af infektionerne omfattede nasofaryngitis, infektion i de øvre luftveje, faryngitis, urinvejsinfektioner, bronchitis og influenza, som ikke krævede seponering af behandlingen.
English: Do not try to inject yourself until your healthcare provider has shown you the right way to give the injections.
Danish: Forsøg ikke at injicere selv, før din læge har vist dig, hvordan injektionerne skal gives.
English: Kyntheum is a medicine that contains the active substance brodalumab.
Danish: Kyntheum er et lægemiddel, der indeholder det aktive stof brodalumab.
English: Patients with a history of Crohn's disease should be followed for signs and symptoms of active Crohn's disease.
Danish: Patienter med Crohns sygdom i anamnesen skal følges for tegn og symptomer på aktiv Crohns sygdom.
English: For safety reasons:
Danish: Sikkerhedsforanstaltninger:
English: Population pharmacokinetic modelling indicated that exposure decreased as body weight increased.
Danish: Populationsfarmakokinetiske modeller viste, at eksponeringen falder, når vægten øges.
English: Based on the magnitude of change in exposure of midazolam, no dose adjustment of CYP3A4/3A5 substrates is necessary when administered concomitantly with Kyntheum.
Danish: Baseret på størrelsen af ændringen i eksponeringen for midazolam er ingen dosisjustering af CYP3A4/3A5-substrater nødvendig, når de samtidig administreres med Kyntheum.
English: Concomitant immunosuppressive therapy
Danish: Samtidig immunosuppressiv behandling
English: Upper arm Stomach area (abdomen)
Danish: Overarm Maveområde (abdomen)
English: If a patient suffers from new or worsening symptoms of depression and/or suicidal ideation or behaviour is identified, it is recommended to discontinue treatment with Kyntheum.
Danish: Hvis en patient lider af nye eller forværrede symptomer på depression, og/eller der ses selvmordstanker eller -adfærd, anbefales det at seponere behandlingen med Kyntheum.
English: Based on an exploratory descriptive analysis, no relationship was observed between exposure and incidence of serious infections and infestations, candida infections, viral infections, and suicidal ideation and behaviour events.
Danish: På baggrund af en eksploratorisk deskriptiv analyse blev der ikke observeret nogen forbindelse mellem eksponering og incidens af alvorlige infektioner og parasitære sygdomme, candida-infektioner, virusinfektioner samt selvmordstanker og -adfærd.
English: • if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.
Danish: • hvis du får anden behandling mod psoriasis, f.eks. et andet lægemiddel, der undertrykker dit immunsystem, eller lysbehandling med ultraviolet (UV) lys.
English: As the metabolism of brodalumab is unknown in infants, benefit risk for exposure of the infant to live vaccines following third trimester exposure to Kyntheum should be discussed with a physician.
Danish: Da brodalumabs metabolisme er ukendt hos spædbørn, bør fordele og risici ved spædbarnets eksponering for levende vacciner efter eksponering for Kyntheum i tredje trimester drøftes med en læge.
English: In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Danish: I tilfælde af overdosering anbefales det, at patienten monitoreres for tegn eller symptomer på bivirkninger, og at relevant symptomatisk behandling indledes omgående.
English: • if you feel depressed, anxious, or have thoughts of suicide, or have unusual mood changes
Danish: • hvis du føler dig deprimeret, har angst eller selvmordstanker, eller hvis der sker usædvanlige ændringer i dit humør
English: Patients enrolled were candidates for systemic therapy, including phototherapy, biologic and nonbiologic systemic therapies.
Danish: De indrullerede patienter var kandidater til systemisk behandling, herunder lysbehandling samt biologisk og ikke-biologisk systemisk behandling.
English: The subcutaneous bioavailability of brodalumab estimated by population pharmacokinetic modelling was 54.7% (relative standard error [RSE] = 4.25%).
Danish: Den subkutane biotilgængelighed af brodalumab estimeret efter populationsfarmakokinetiske modeller var 54,7 % (relativ standardfejl [RSE] = 4,25 %).
English: The mutagenic potential of brodalumab was not evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes.
Danish: Brodalumabs mutagene potentiale er ikke blevet undersøgt, men monoklonale antistoffer forventes ikke at ændre DNA eller kromosomer.
English: It is normal to see a drop of liquid at the end of the needle.
Danish: Det er normalt at se en dråbe væske på nålespidsen.
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and should use adequate contraception while using Kyntheum and for at least 12 weeks after the last dose of Kyntheum.
Danish: Hvis du er en kvinde, i den fødedygtige alder, bør du undgå at blive gravid, og du skal bruge sikker prævention, mens du er i behandling med Kyntheum og i mindst 12 uger efter den sidste dosis Kyntheum.
English: LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
Danish: LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Danmark
English: At Week 12, patients originally randomised to Kyntheum who achieved sPGA success (0 or 1) were re-randomised to receive either placebo or continued Kyntheum at their induction dose.
Danish: Ved uge 12 blev de patienter, der oprindeligt var randomiseret til Kyntheum, og som opnåede en sPGA-succes (0 eller 1), genrandomiseret til enten at få placebo eller fortsætte med deres induktionsdosis af Kyntheum.
English: No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Danish: Der foreligger ingen farmakokinetiske data for patienter med nedsat nyre- eller leverfunktion.
English: Anti-tuberculosis therapy should be considered prior to initiation of Kyntheum in patients with latent tuberculosis.
Danish: Behandling mod tuberkulose skal overvejes, inden Kyntheum initieres hos patienter med latent tuberkulose.
English: • Do not leave the syringe in direct sunlight.
Danish: • Lad ikke injektionssprøjten ligge i direkte sollys.
English: No data are available on the effect of brodalumab on human fertility.
Danish: Der foreligger ingen data om brodalumabs indvirkning på fertiliteten hos mennesker.
English: Uncommon Candida infections (including oral, genital, and oesophageal infections)
Danish: Candida-infektioner (herunder orale, genitale og øsofageale infektioner)
English: Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal ideation, anxiety, or other mood changes, and they should contact their healthcare provider if such events occur.
Danish: Patienter, omsorgspersoner og pårørende skal informeres om, at de skal være opmærksomme på opståen eller forværring af depression, selvmordstanker, angst eller andre humørændringer, og at de skal kontakte lægen, hvis sådanne hændelser finder sted.
English: Leave the syringe at room temperature for at least 30 minutes before injecting.
Danish: Lad injektionssprøjten ligge i stuetemperatur i mindst 30 minutter, før du injicerer.
English: Together you will consider the benefit of breast-feeding to the baby and the benefit of Kyntheum to you.
Danish: I skal sammen overveje de fordele, som amning giver barnet, og de fordele, som Kyntheum giver dig.
English: Women of childbearing potential should use an effective method of contraception during treatment and for at least 12 weeks after treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i mindst 12 uger efter behandlingen.
English: Step 2: Getting ready to inject E. When you are ready to inject, pull the grey needle cap straight out and away from your body
Danish: Trin 2: Forberedelse af injektionen E. Når du er klar til at injicere, trækker du den grå nålehætte af (lige op og væk fra kroppen)
English: • Do not remove the grey needle cap until you are ready to inject.
Danish: • Fjern ikke den grå nålehætte, før du er klar til at injicere.
English: Important: Keep the skin pinched until after you have injected.
Danish: Vigtigt: Bliv ved med at knibe huden sammen, indtil du er færdig med injektionen.
English: Retreatment was available at or after Week 16 for patients with return of disease and rescue treatment was available after 12 weeks of retreatment.
Danish: Genbehandling var tilgængelig ved eller efter uge 16 for patienter med tilbagevendende sygdom, og nødbehandling var tilgængelig efter 12 ugers genbehandling.
English: Reduced absolute neutrophil count
Danish: Nedsat absolut neutrofiltal
English: Once Kyntheum has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 14 days or discarded.
Danish: Når Kyntheum er taget ud af køleskabet og har fået stuetemperatur (højst 25 °C), skal det enten anvendes inden for 14 dage eller bortskaffes.
English: AMAGINE-2 and AMAGINE-3 were identical placebo- and ustekinumab-controlled trials conducted in 1831 and 1881 patients, respectively.
Danish: AMAGINE-2 og AMAGINE-3 var identiske placebo- og ustekinumab-kontrollerede forsøg gennemført med henholdsvis 1.831 og 1.881 patienter.
English: Vaccination of infants with live vaccines following third trimester exposure to Kyntheum should be discussed with a physician (see also section 4.6).
Danish: Vaccination af spædbørn med levende vacciner efter eksponering for Kyntheum i tredje trimester bør drøftes med en læge (se også pkt.
English: • Avoid injecting into areas with scars or stretch marks.
Danish: • Undgå at injicere i områder med ar eller strækmærker.
English: • if you have recently had or you or your baby are going to have a vaccination, see "Warnings and precautions" in section "2.
Danish: • hvis du for nylig har fået en vaccination, eller du eller dit barn skal have en vaccination, skal du se ”Advarsler og forsigtighedsregler” i afsnit 2 ”Det skal du vide, før du begynder at bruge
English: Quality of life/patient reported outcomes
Danish: Livskvalitet/patientrapporterede resultater
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet (se pkt.
English: Active Crohn's disease.
Danish: Aktiv Crohns sygdom.
English: Label and expiration date
Danish: Etiket og udløbsdato
English: Although a role for interleukin (IL)-17A and IL-17RA in the regulation of CYP450 enzymes has not been reported, the effect of brodalumab on CYP3A4/3A5 activity was evaluated in a disease-drug-drug interaction study.
Danish: Selv om det ikke er rapporteret, at interleukin (IL)-17A og IL-17RA spiller en rolle i reguleringen af CYP450-enzymer, blev brodalumabs virkning på CYP3A4/3A5-aktiviteten evalueret i et sygdom-lægemiddel-lægemiddel-interaktionsstudie.
English: Impact of weight on pharmacokinetics
Danish: Vægtens indflydelse på farmakokinetikken
English: None of the Grade 3 or 4 ANC decreases in the psoriasis patients were associated with a serious infection (see also section
Danish: Ingen af tilfældene med fald i ANC af grad 3 eller 4 hos psoriasispatienterne var forbundet med en alvorlig infektion (se også pkt.
English: The proportion of patients who achieved a Psoriasis Symptom Inventory (PSI) score of 0 (not at all) or 1 (mild) on every item (itch, burning, stinging, pain, redness, scaling, cracking and flaking) at Week 12 are shown in Table 2.
Danish: Andelen af patienter, som fik en PSI-score (Psoriasis Symptom Inventory) på 0 (slet ingen) eller 1 (let) for hvert punkt (kløe, brænden, svie, smerter, rødme, afskalning, revnedannelse og flagedannelse) i uge 12, er vist i tabel 2.
English: Brodalumab clearance decreases with increasing dose and exposure increases in a greater than doseproportional manner.
Danish: Brodalumabs clearance falder med en stigende dosis, og eksponeringen øges i et forhold, der er større end dosen.
English: PASI 75 response at 2 weeks ranged between 20% and 25% in the Phase 3 trials compared to placebo (0% to 0.6%) and ustekinumab (3% to 3.5%).
Danish: PASI 75-responsen ved 2 uger lå mellem 20 % og 25 % i fase 3-forsøgene sammenlignet med placebo (0 % og 0,6 %) og ustekinumab (3 % og 3,5 %).
English: Patients were predominantly men (69%) and white (91%), with a mean age of 45 years (18 to 86 years), of these 6.1% were >65 years of age and 0.3% were >75 years of age.
Danish: Patienterne var hovedsagelig mænd (69 %) og kaukasiere (91 %) med en gennemsnitsalder på 45 år (18-86 år), hvoraf 6,1 % var >65 år, og 0,3 % var >75 år.
English: sPGA (%)
Danish: 87* Ikke relevant sPGA (%)
English: • warm, red and painful skin, or a painful skin rash with blisters.
Danish: • varm, rød og smertefuld hud eller et smertefuldt hududslæt med blærer.
English: It is therefore preferable to avoid the use of Kyntheum during pregnancy.
Danish: Du bør derfor undgå brugen af Kyntheum under graviditeten.
English: Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Danish: Klinisk vigtige aktive infektioner (f.eks. aktiv tuberkulose, se pkt.
English: The risk and benefit of treatment with Kyntheum should be carefully weighed for patients with a history of depression and/or suicidal ideation or behaviour, or for patients who develop such symptoms.
Danish: Risici og fordele ved behandling med Kyntheum skal vurderes nøje for patienter med depression og/eller selvmordstanker eller -adfærd i anamnesen samt for patienter, som udvikler sådanne symptomer.
English: The pharmacokinetics of brodalumab was similar between Japanese and non-Japanese patients with psoriasis.
Danish: Andre populationer Brodalumabs farmakokinetik var den samme for japanske og ikke-japanske psoriasispatienter.
English: A caregiver may also give you an injection in your upper, outer arm.
Danish: Din omsorgsperson kan også give dig en injektion bag på overarmen.
English: • Do not use a Kyntheum pre-filled syringe if it has been dropped on a hard surface.
Danish: • Brug ikke en fyldt injektionssprøjte med Kyntheum, hvis den har været tabt på en hård overflade.
English: Kyntheum is given as an injection under the skin (known as a subcutaneous injection).
Danish: Kyntheum gives som en injektion under huden (også kaldet subkutan injektion).
English: Brodalumab belongs to a group of medicines called interleukin (IL) inhibitors.
Danish: Brodalumab tilhører en gruppe af lægemidler, der kaldes interleukin-hæmmere (IL-hæmmere).
English: Brodalumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
Danish: Brodalumab er et rekombinant humant monoklonalt antistof fremstillet i CHO-celler (ovarieceller fra kinesisk hamster).
English: Population pharmacokinetic analysis indicated that gender did not have an effect on brodalumab pharmacokinetics.
Danish: Populationsfarmakokinetiske analyser viste, at kønnet ikke havde nogen indvirkning på brodalumabs farmakokinetik.
English: The percentage of patients that at Week 12 achieved a DLQI (Dermatology Life Quality Index) score of 0 or 1 was 56%, 61%, 59% in the Kyntheum 210 mg group and 5%, 5%, 7% in the placebo group in AMAGINE-1, -2 and -3, respectively (adjusted p-value <0.001) and 44% in the ustekinumab groups (AMAGINE-2 and -3).
Danish: Procentdelen af patienter, der i uge 12 opnåede en DLQI-score (Dermatology Life Quality Index) på 0 eller 1, var 56 %, 61 %, 59 % i Kyntheum 210 mg-gruppen og 5 %, 5 %, 7 % i placebogruppen i henholdsvis AMAGINE-1, -2 og -3 (justeret p-værdi <0,001) og 44 % i ustekinumab-grupperne (AMAGINE-2 og -3).
English: In all three clinical trials, examination of age, gender, race, use of prior systemic or photo therapy, use of prior biologics, and biologic failures did not identify differences in response in all key endpoints [PASI 75, PASI 100, sPGA success (0 or 1), and sPGA clear (0)] to Kyntheum among these subgroups.
Danish: I alle tre kliniske forsøg identificeredes der ved undersøgelsen af alder, køn, race, tidligere systemisk behandling eller lysbehandling, tidligere biologisk behandling og manglende respons på biologisk behandling ikke nogen forskelle i responsen på Kyntheum blandt disse undergrupper for alle hovedendepunkters vedkommende [PASI 75, PASI 100, sPGA-succes (0 eller 1) og sPGA "clear" (0)].
English: What you need to know before you use Kyntheum Do not use Kyntheum:
Danish: Det skal du vide, før du begynder at bruge Kyntheum Brug ikke Kyntheum:
English: Comprehensive instructions for administration are given in the package leaflet.
Danish: Der findes udførlige instruktioner om administration i indlægssedlen.
English: Adverse reactions from clinical trials (Table 1) are listed by MedDRA system organ class (SOC).
Danish: Bivirkninger fra kliniske forsøg (tabel 1) er anført efter MedDRA-systemorganklasse.
English: Along with primary efficacy endpoints, clinically important improvements were observed in Psoriasis Scalp Severity Index (PSSI) at Week 12 (AMAGINE-1) and in Nail Psoriasis Severity Index (NAPSI) at Week 12 and 52 (AMAGINE-1,-2, and -3).
Danish: Foruden de primære effektendepunkter blev der observeret klinisk signifikante forbedringer i PSSI (Psoriasis Scalp Severity Index) ved uge 12 (AMAGINE-1) og i NAPSI (Nail Psoriasis Severity Index) ved uge 12 og 52 (AMAGINE-1, -2 og -3).
English: - The active substance is brodalumab.
Danish: - Aktivt stof: brodalumab.
English: • Do not put the syringe back in the refrigerator once it has reached room temperature.
Danish: • Læg ikke injektionssprøjten tilbage i køleskabet, når den først har fået stuetemperatur.
English: Brodalumab is expected to be mainly eliminated via catabolism and hepatic impairment is not expected to influence clearance.
Danish: Det forventes, at brodalumab hovedsagelig elimineres via katabolisme, og nedsat leverfunktion forventes ikke at påvirke clearance.
English: Following subcutaneous administrations of 210 mg, brodalumab exhibits non-linear pharmacokinetics typical for a monoclonal antibody that undergoes target-mediated drug disposition.
Danish: Efter subkutan administration af 210 mg udviser brodalumab en ikke-lineær farmakokinetik, der er typisk for et monoklonalt antistof, som er genstand for en mål-medieret lægemiddelfordeling.
English: Renal and hepatic impairment Kyntheum has not been studied in these patient populations.
Danish: Kyntheum er ikke blevet undersøgt hos disse patientpopulationer.
English: Throw away Kyntheum if it is not used within 14 days of storage at room temperature.
Danish: Kyntheum skal bortskaffes, hvis det ikke er anvendt efter 14 dages opbevaring ved stuetemperatur.
English: The majority of patients with suicidal behaviour had a history of depression and/or suicidal ideation or behaviour.
Danish: Størstedelen af de patienter, der udviste selvmordsadfærd, havde depression og/eller selvmordstanker eller -adfærd i anamnesen.
English: The median time to maximum concentration (Tmax) was 3.0 days (range: 2.0 to 4.0 days) and the mean area under the concentration time curve to the last measurable concentration (AUClast) was 111 mcg*day/ml (SD = 64.4 mcg*day/ml).
Danish: Den gennemsnitlige tid til maksimal koncentration (Tmax) var 3,0 dage (område: 2,0 til 4,0 dage), og det gennemsnitlige areal under kurven til den sidst målbare koncentration (AUClast) var 111 µg*dag/ml (SD = 64,4 µg*dag/ml).
English: • Keep in the refrigerator (2°C to 8°C).
Danish: • Opbevares i køleskab (2 °C - 8 °C).
English: • Do not remove the finger grips.
Danish: • Fjern ikke fingergrebene.
English: Tinea infections (including tinea pedis, tinea versicolor, tinea cruris)
Danish: Almindelig Influenza Tinea-infektioner (herunder tinea pedis, tinea versicolor og tinea cruris)
English: Using Kyntheum will benefit you by leading to improvements of skin clearance and reducing psoriasis signs and symptoms, such as itch, redness, scaling, burning, stinging, cracking, flaking and pain.
Danish: Brug af Kyntheum vil gavne dig ved at forbedre hudens tilstand og mindske tegn og symptomer på psoriasis, såsom kløe, rødme, afskalning, brændende og stikkende fornemmelse, revnedannelse, flagedannelse og smerter.
English: Figure 1: PASI 100 during induction and maintenance phase for Kyntheum and ustekinumab (AMAGINE-2 and AMAGINE-3, pooled)
Danish: Figur 1: PASI 100 under induktions- og vedligeholdelsesfasen for Kyntheum og ustekinumab (AMAGINE-2 og AMAGINE-3, puljet)
English: Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet efter hyppighed med de hyppigste bivirkninger anført først.
English: Kyntheum has no or negligible influence on the ability to drive and use machines.
Danish: Kyntheum påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Blocking IL-17RA inhibits IL-17 cytokine-induced responses resulting in normalization of inflammation in the skin.
Danish: Ved at blokere IL-17RA hæmmes de IL-17-cytokininducerede responser, hvilket resulterer i en normalisering af inflammation i huden.
English: The efficacy and safety of Kyntheum was assessed in 4373 adult plaque psoriasis patients across three multinational, randomised, double-blind, phase 3, placebo-controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3).
Danish: Kyntheums virkning og sikkerhed blev vurderet hos 4.373 voksne patienter med plaque-psoriasis i tre multinationale, randomiserede, dobbeltblinde, placebokontrollerede kliniske fase 3-forsøg (AMAGINE-1, AMAGINE-2 og AMAGINE-3).
English: Tell your doctor or pharmacist:
Danish: Fortæl det altid til lægen eller apotekspersonalet:
English: Within each frequency grouping adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter faldende alvorlighedsgrad.
English: Place finger or thumb on edge of tray to secure it while you remove syringe.
Danish: Placer en finger eller din tommelfinger på bakkens hjørne for at holde den fast, mens du tager injektionssprøjten ud.
English: One serious case of cryptococcal meningitis and one serious case of coccidioidies infection were observed in clinical trials (see section 4.4).
Danish: Der blev observeret ét alvorligt tilfælde af kryptokokmeningitis og ét alvorligt tilfælde af coccidioidies-infektion i de kliniske forsøg (se pkt.
English: Caution should be exercised when considering the use of Kyntheum in patients with a chronic infection or a history of recurrent infection.
Danish: Der bør udvises forsigtighed, når det overvejes at anvende Kyntheum til patienter med en kronisk infektion eller tilbagevendende infektion i anamnesen.