FrancophonIA/ELRC3.0 huggingface dataset:
English: Choose a different site each time you give yourself an injection.
Danish: Vælg et nyt sted, hver gang du giver dig selv en indsprøjtning.
English: Both -2.5
Danish: Begge -2,5
English: Your symptoms may return if you stop the treatment.
Danish: Dine symptomer kan komme igen, hvis du stopper med behandlingen.
English: Press the start button.
Danish: Tryk på startknappen.
English: The injections can also be given by another individual who has been appropriately instructed.
Danish: Injektionerne kan også gives af en anden person, der har fået den nødvendige instruktion.
English: Most of the reactions were mild or moderate in severity.
Danish: De fleste af reaktionerne var lette eller moderate i sværhedsgrad.
English: If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.
Danish: Hvis du er nødt til at bruge det samme indsprøjtningsområde, så sørg for, at det ikke er på samme sted, som du brugte sidst.
English: Note: When the injection is completed, the window will turn yellow and you may hear a second click.
Danish: Bemærk: Når indsprøjtningen er færdig, vil vinduet blive gult, og du kan måske høre endnu et klik.
English: Efficacy outcomes MMD
Danish: Effektresultater MMD
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler, bør navnet og batchnummeret på det administrerede lægemiddel tydeligt registreres.
English: Two elimination phases were observed for erenumab.
Danish: Der blev observeret to eliminationsfaser for erenumab.
English: Differences from placebo were observed from Month 1 onwards.
Danish: Forskellen fra placebo blev observeret fra måned 1 og frem.
English: Stomach area (abdomen)
Danish: Maveområde (abdomen)
English: 59% of patients completing the study achieved a 50% response in the last month of the study.
Danish: 59 % af patienterne der fuldførte studiet opnåede et respons på 50 % i den sidste måned af studiet.
English: Patients with poorly controlled hypertension or BMI >40 were excluded from Study 1.
Danish: Patienter med dårlig kontrolleret hypertension eller BMI > 40 blev ekskluderet fra studie 1.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 3 months of treatment.
Danish: Det bør overvejes at seponere behandlingen hos patienter, som ikke har vist respons efter 3 måneders behandling.
English: 114 cases were received from postmarketing sources and 3 from clinical trials.
Danish: 114 tilfælde er modtaget efter markedsføring og 3 tilfælde er fra kliniske studier.
English: The safety and efficacy of Aimovig in children below the age of 18 years have not yet been established.
Danish: Aimovigs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Talk to your doctor or pharmacist about proper disposal.
Danish: Tal med lægen eller apotekspersonalet om korrekt bortskaffelse.
English: In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required.
Danish: I tilfælde af en overdosering bør patienten behandles symptomatisk, og understøttende tiltag indledes efter behov.
English: Approximately 41% of patients in the study had medication overuse.
Danish: Cirka 41 % af patienterne i studiet havde et overforbrug af medicin.
English: Do not reuse the pen.
Danish: Genbrug ikke pennen.
English: The most frequent injection site reactions were localised pain, erythema and pruritus.
Danish: De hyppigste reaktioner på injektionsstedet var lokaliseret smerte, erytem og pruritus.
English: Do not stop using Aimovig without talking to your doctor first.
Danish: Du må ikke holde op med at bruge Aimovig uden først at have talt med lægen.
English: Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine.
Danish: Behandlingen bør initieres af læger med erfaring indenfor diagnose og behandling af migræne.
English: Do not give this medicine to children or adolescents (under 18 years old) because the use of Aimovig has not been studied in this age group.
Danish: Aimovig må ikke anvendes til børn eller unge (under 18 år), da brugen af Aimovig ikke er blevet undersøgt hos denne aldersgruppe.
English: It has biological activity in cynomolgus monkeys, but this species is not an appropriate model for evaluation of tumorigenic risk.
Danish: Det har biologisk aktivitet hos cynomolgusaber, men denne art er ikke en hensigtsmæssig model til vurdering af risiko for karcinogenicitet.
English: Apply an adhesive plaster if needed.
Danish: Sæt et hæfteplaster på, hvis det er nødvendigt.
English: Note: Needle is inside.
Danish: Bemærk: Kanyle er indeni.
English: Aimovig is given as an injection under your skin (known as a subcutaneous injection).
Danish: Aimovig gives som en indsprøjtning under huden (kendt som en subkutan indsprøjtning).
English: No cases of overdose have been reported in clinical studies.
Danish: Der er ikke rapporteret nogen tilfælde af overdosering i kliniske studier.
English: Use Aimovig exactly as prescribed by your doctor.
Danish: Anvend Aimovig nøjagtigt som foreskrevet af din læge.
English: Both <0.001a,d
Danish: Begge <0,001a,d
English: Pharmacotherapeutic group: Analgetics, antimigraine preparations, ATC code: N02CX07
Danish: Farmakoterapeutisk klassifikation: Analgetika, antimigræne præparater, ATC-kode: N02CX07
English: 79.8% completed the entire study out to 52 weeks.
Danish: 79,8 % gennemførte hele studiet indtil uge 52.
English: It belongs to a group of medicines called monoclonal antibodies.
Danish: Det tilhører en gruppe af lægemidler, der kaldes monoklonale antistoffer.
English: On a clean, well-lit work surface, place the:
Danish: På en ren, godt oplyst overflade anbringer du nu:
English: Pruritus includes preferred terms of generalised pruritus, pruritus and pruritic rash.
Danish: Pruritus omfatter de foretrukne termer for generaliseret pruritus, pruritus og kløende udslæt.
English: Make sure that you inject the entire contents of both pens.
Danish: Sørg for, at du får indsprøjtet hele indholdet af begge penne.
English: A total of over 2,500 patients (more than 2,600 patient years) have been treated with Aimovig in registration studies.
Danish: Flere end 2.500 patienter (mere end 2.600 patientbehandlings år) er blevet behandlet med Aimovig i de kliniske registreringsstudier.
English: The injection must be administered within 5 minutes.
Danish: Indsprøjtningen skal gives inden for 5 minutter.
English: The outer area of your upper arm can also be used as an injection site, but only if someone else is giving you the injection.
Danish: Det ydre område af din overarm kan også anvendes som indsprøjtningssted, men kun hvis en anden giver dig indsprøjtningen.
English: There are a limited amount of data from the use of erenumab in pregnant women.
Danish: Der er utilstrækkelige data i anvendelse af erenumab til gravide kvinder.
English: After you have cleaned the area, do not touch it again before injecting.
Danish: Efter at du har rengjort området, må du ikke røre ved det igen, før du foretager indsprøjtningen.
English: Do not try to inject Aimovig until this training has been given.
Danish: Forsøg ikke at indsprøjte Aimovig, før denne oplæring er gennemført.
English: Aimovig showed similar exercise duration compared to placebo and did not aggravate myocardial ischaemia in these patients.
Danish: Aimovig viste lignende træningsvarighed sammenlignet med placebo og forværrede ikke myokardieiskæmi hos disse patienter.
English: Pregnancy Your doctor will decide whether you should stop using Aimovig during pregnancy.
Danish: Graviditet Din læge vil beslutte, om du skal stoppe med at bruge Aimovig under graviditet.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on 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); very rare (<1/10,000).
Danish: Derudover er den tilsvarende hyppighedskategori for hver bivirkning baseret på følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000).
English: There were also no adverse effects on surrogate markers of fertility (anatomical pathology or histopathology changes in reproductive organs) in these studies.
Danish: Der var heller ingen bivirkninger på surrogatmarkører for fertilitet (anatomiske patologiske eller histopatologiske forandringer i reproduktionsorganer) i disse studier.
English: See section “Injection site reactions” below.
Danish: Se afsnit “Reaktioner på injektionsstedet” nedenfor.
English: Doses up to 280 mg have been administered subcutaneously in clinical studies with no evidence of dose-limiting toxicity.
Danish: Doser på op til 280 mg er blevet administreret subkutant i kliniske studier uden tegn på dosisbegrænsende toksicitet.
English: Clinical studies have demonstrated that the majority of patients responding to therapy showed clinical benefit within 3 months.
Danish: Det er i kliniske studier påvist, at størstedelen af patienterne der responderede på behandlingen opnåede en klinisk effekt inden for 3 måneder.
English: In both studies, the patients enrolled had at least a 12-month history of migraine (with or without aura) according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria.
Danish: I begge studier havde de inkluderede patienter en anamnese med migræne i mindst 12 måneder (med eller uden aura) i henhold til de diagnostiske kriterier International Classification of Headache Disorders (ICHD-III).
English: Injection site pain typically subsided within 1 hour after administration.
Danish: Smerterne på injektionsstedet fortog sig typisk inden for 1 time efter administration.
English: Note: Do not touch the start button yet.
Danish: Bemærk: Du må endnu ikke røre ved startknappen.
English: Patient-reported outcome measures HIT-6
Danish: Mål på patientrapporterede udfald HIT-6
English: Your doctor or nurse will give you or your caregiver training in the right way to prepare and inject Aimovig.
Danish: Lægen eller sygeplejersken vil oplære dig eller sundhedspersonalet i den rigtige måde at klargøre og indsprøjte Aimovig på.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for erenumab, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for erenumab er CHMP nået frem til følgende videnskabelige konklusioner:
English: Aimovig has not been studied in elderly patients.
Danish: Aimovig er ikke undersøgt hos ældre patienter.
English: Pooled across the two doses, a reduction of -9.3 MMD was observed after 52 weeks relative to core study baseline.
Danish: Fra begge doser blev observeret en reduktion på -9,3 MMD efter 52 uger i forhold til core study baseline.
English: If you have received more Aimovig than you should or if the dose has been given earlier than it should have been, tell your doctor.
Danish: Hvis du har fået for meget Aimovig, eller hvis dosis er blevet givet tidligere, end den skulle, skal du fortælle det til lægen.
English: Do not leave the cap off for more than 5 minutes.
Danish: Lad ikke hætten være taget af i mere end 5 minutter.
English: Less than 2% of patients in these studies discontinued due to adverse events.
Danish: Mindre end 2 % af forsøgspersonerne udgik af studierne på grund af bivirkninger.
English: The mutagenic potential of erenumab has not been evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes.
Danish: Erenumabs mutagene potentiale er ikke blevet vurderet; monoklonale antistoffer forventes dog ikke at ændre DNA eller kromosomer.
English: 74.1% of patients completed the 52-week extension.
Danish: 74,1 % af patienterne gennemførte de 52 ugers forlængelse af studiet.
English: CI = confidence interval; MMD = monthly migraine days; HIT-6 = Headache Impact Test; MIDAS = Migraine Disability Assessment a
Danish: CI = konfidensinterval, MMD = månedlige migrænedage, HIT-6 = Headache Impact Test, MIDAS = Migraine Disability Assessment.
English: After you remove the pen from the skin, the needle will automatically be covered by the safety guard.
Danish: Når du tager pennen væk fra huden, vil kanylen automatisk blive dækket af beskyttelseskransen.
English: Throughout the dosing period erenumab is predominantly eliminated via a non-specific proteolytic pathway with the effective half-life of 28 days.
Danish: Under hele doseringsperioden elimineres erenumab primært via en uspecifik proteolytisk vej med en effektiv halveringstid på 28 dage.
English: Patients with renal impairment Patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) have not been studied.
Danish: Patienter med nedsat nyrefunktion Patienter med svært nedsat nyrefunktion (eGFR <30 ml/min/1,73 m2) er ikke blevet undersøgt.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet.
English: Do not use Aimovig: - if you are allergic to erenumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Aimovig: - hvis du er allergisk over for erenumab eller et af de øvrige indholdsstoffer i Aimovig (angivet i punkt 6).
English: For secondary endpoints, all p-values are reported as unadjusted p-values and are statistically significant after adjustment for multiple comparisons.
Danish: For sekundære endepunkter er alle p-værdier rapporteret som ikke justerede p-værdier og er statistisk signifikante efter justering for flere sammenligninger.
English: Inspect the pen(s).
Danish: Undersøg pennen(e).
English: Both
Danish: Begge
English: Do not use any pen that has been dropped.
Danish: Brug ikke en pen, som har været tabt.
English: Yellow window (injection complete)
Danish: Gult vindue (injektion færdig)
English: It is unknown whether erenumab is excreted in human milk.
Danish: Det vides ikke, om erenumab udskilles i human modermælk.
English: In contrast with other neuropeptides, CGRP levels have been shown to increase significantly during migraine and return to normal with headache relief.
Danish: I modsætning til andre neuropeptider har CGRPniveauerne vist sig at stige signifikant under migræne og blive normaliseret igen, når migrænen har fortaget sig.
English: At low concentrations, the elimination is predominately through saturable binding to target (CGRP-R), while at higher concentrations the elimination of erenumab is largely through a non-specific proteolytic pathway.
Danish: Ved lave koncentrationer sker elimineringen primært gennem mættet binding til receptoren (CGRP-R), mens elimineringen af erenumab ved højere koncentrationer i høj grad sker via en uspecifik proteolytisk vej.
English: Note: Needle is inside the pen.
Danish: Bemærk: Kanyle er inden i pennen.
English: For data collection a recall period of 3 months has been used.
Danish: Der er anvendt en recall periode på tre måneder for data indsamling.
English: Clean the injection site with an alcohol wipe and let the skin dry.
Danish: Rens indsprøjtningsstedet med en desinfektionsserviet, og lad huden tørre.
English: Patients were allowed to use acute headache treatments during the study.
Danish: Det var tilladt for patienterne at benytte akutte hovedpinebehandlinger under studiet.
English: Following a single 140 mg intravenous dose, the mean (SD) volume of distribution during the terminal phase (Vz) was estimated to be 3.86 (0.77) l.
Danish: Efter en enkelt intravenøs 140 mg dosis blev middelværdien (SD) af fordelingsvolumenet under den terminale fase (Vz) estimeret til at være 3,86 (0,77) l.
English: Patients had a median age of 43 years, 83% were female and 94% were white.
Danish: Patienterne havde en medianalder på 43 år, 83 % var kvinder, og 94 % var hvide.
English: If you stop using Aimovig
Danish: Hvis du holder op med at bruge Aimovig
English: Some patients may benefit from a dose of 140 mg every 4 weeks (see section 5.1).
Danish: Nogle patienter kan få gavn af en dosis på 140 mg hver 4. uge (se pkt.
English: Carcinogenicity studies have not been conducted with erenumab.
Danish: Der er ikke udført karcinogenicitetsstudier med erenumab.
English: Do not leave the grey needle cap off for more than 5 minutes.
Danish: Lad ikke den grå kanylehætte være taget af i mere end 5 minutter.
English: Overall, 68% had failed one or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability, and 49% had failed two or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability.
Danish: Samlet set havde 68 % oplevet svigt af en eller flere tidligere profylaktiske behandlinger med farmakoterapi på grund af manglende virkning eller dårlig tolerabilitet, og 49 % havde oplevet svigt af to eller flere tidligere profylaktiske behandlinger med farmakoterapi på grund af manglende virkning eller dårlig tolerabilitet.
English: Intravenous infusion of CGRP induces migraine-like headache in patients.
Danish: Intravenøs infusion af CGRP inducerer migrænelignende hovedpine hos patienter.
English: Elderly patients (>65 years), patients with opioid overuse in study in chronic migraine, patients with medication overuse in study in episodic migraine, and also patients with pre-existing myocardial infarction, stroke, transient ischaemic attacks, unstable angina, coronary artery bypass surgery or other re-vascularisation procedures within 12 months prior to screening were excluded.
Danish: Ældre patienter (>65 år), patienter med opioid-overforbrug i studier med kronisk migræne, patienter med medicinsk-overforbrug i studier med episodisk migræne, og også patienter med eksisterende myokardieinfarkt, slagtilfælde, forbigående iskæmiske anfald, ustabil angina pectoris, koronararterie-bypassoperation eller andre revaskulariseringsprocedurer inden for 12 måneder før screening var udelukket fra studiet.
English: Remove your thumb from the button, but keep pushing down on the skin.
Danish: Flyt tommelfingeren fra knappen, men bliv ved med at presse pennen ned mod huden.
English: Step 2: Get ready
Danish: Trin 2: Gør dig klar
English: For exploratory endpoints, no p-value is presented.
Danish: For eksplorative endepunkter er der ingen p-værdi angivet.
English: Avoid injecting into areas with scars or stretch marks.
Danish: Undgå at indsprøjte i områder med ar eller strækmærker.
English: No interaction with oral contraceptives (ethinyl estradiol/norgestimate) or sumatriptan was observed in studies with healthy volunteers.
Danish: Der er ikke set nogen interaktioner med oral kontraceptiva (ethinyl estradiol/norgestimat) eller sumatriptan i studier med raske frivillige forsøgspersoner.
English: Aimovig has not been studied in patients with certain cardiovascular diseases.
Danish: Aimovig er ikke blevet undersøgt hos patienter med visse hjerte-kar-sygdomme.
English: Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1).
Danish: Patienter med visse kardiovaskulære sygdomme blev ekskluderet fra de kliniske studier (se pkt.
English: Note: You must push all the way down but do not touch the start button until you are ready to inject.
Danish: Bemærk: Du skal presse hele vejen ned, men rør ikke ved startknappen, før du er klar til at foretage indsprøjtningen.
English: Talk to your doctor before using Aimovig: - if you have ever had an allergic reaction to rubber latex.
Danish: Kontakt lægen, før du bruger Aimovig: - hvis du nogensinde har fået en allergisk reaktion mod naturgummi/latex.
English: There was no impact of anti-erenumab antibody development on efficacy or safety.
Danish: Udvikling af anti-erenumab-antistoffer havde ingen indvirkning på hverken virkning eller sikkerhed.
English: Monoclonal antibodies like Aimovig are known to pass into breast milk during the first few days after birth, but after this first period Aimovig can be used.
Danish: Monoklonale antistoffer, såsom Aimovig, udskilles i modermælken de første få dage efter fødslen, men efter denne periode kan Aimovig bruges.
English: The injection can be administered into the abdomen, thigh or into the outer area of the upper arm (the arm should be used only if the injection is being given by a person other than the patient; see section 5.2).
Danish: Injektionen kan administreres i abdomen, i låret eller i det ydre område af overarmen (armen må kun anvendes, hvis injektionen gives af en anden person end patienten; se pkt.
English: Both <0.001a
Danish: Begge <0,001a
English: Common: may affect up to 1 in 10 people - allergic reactions such as rash, swelling or hives - constipation - itching - muscle spasms - injection site reactions, such as pain, redness and swelling where the injection is given.
Danish: Almindelige: kan forekomme hos op til 1 ud af 10 personer - allergiske reaktioner, som fx udslæt, hævelse og nældefeber - forstoppelse - kløe - muskelkramper - reaktioner på indsprøjtningsstedet, fx smerter, rødme og hævelse, der hvor indsprøjtningen er givet.
English: Gather all materials needed for the injections:
Danish: Find alle de materialer frem, der skal bruges til indsprøjtningerne:
English: For HIT-6: Change and reduction from baseline were evaluated in the last 4 weeks of the 12-week double-blind treatment phase.
Danish: For HIT-6: Ændring og reduktion i forhold til baseline blev vurderet i de sidste 4 uger af den dobbeltblindede behandlingsfase på 12 uger.
English: If there is any blood on the skin, press a cotton ball or gauze pad onto the injection site.
Danish: Hvis der er blod på huden, så pres et stykke vat eller gaze mod indsprøjtningsstedet.
English: For data collection a recall period of 1 month has been used.
Danish: Der er anvendt en recall periode på en måned for data indsamling.
English: Label and expiry date
Danish: Etiket og udløbsdato
English: It is normal to see a drop of liquid at the end of the needle.
Danish: Det er helt normalt at se en dråbe væske for enden af kanylen.
English: Injection site reactions b
Danish: Reaktioner på injektionsstedet b
English: The removable cap of the Aimovig pre-filled syringe/pen contains dry natural rubber latex, which may cause allergic reactions in individuals sensitive to latex.
Danish: Den aftagelige hætte på den fyldte injektionssprøjte/pen med Aimovig indeholder tørt naturgummi/latex, som kan forårsage allergiske reaktioner hos personer, der er overfølsomme over for latex.
English: Measurable erenumab serum concentrations were observed in the infant monkeys at birth, confirming that erenumab, like other IgG antibodies, crosses the placental barrier.
Danish: Der blev observeret målbare serumkoncentrationer af erenumab hos de nyfødte abeunger ved fødslen, hvilket bekræfter, at erenumab, som andre IgG-antistoffer, passerer placentabarrieren.
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne ordnet efter hyppighed med den hyppigste bivirkning først.
English: Inhibition of the effects of CGRP could theoretically attenuate compensatory vasodilation in ischaemic-related conditions.
Danish: Blokering af effekten af CGRP kan teoretisk dæmpe kompenserende vasodilation i iskæmiskrelaterede sygdomme.
English: You may need to use either one or two pens based on your prescribed dose.
Danish: Du skal bruge enten en eller to penne alt afhængig af din ordinerede dosis.
English: ≥50% MMD responders Percentage [%]
Danish: ≥50% MMD responsrate Procentdel [%]
English: A study evaluated the effect of a single intravenous dose of 140 mg Aimovig in subjects with stable angina under controlled exercise conditions.
Danish: Et studie undersøgte effekten af en enkelt intravenøs dosis på 140 mg Aimovig hos forsøgspersoner med stabil angina pectoris under kontrollerede træningsforhold.