FrancophonIA/ELRC3.0 huggingface dataset:
English: On 31 May 2016, BioMarin International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kyndrisa, for the treatment of Duchenne muscular dystrophy.
Danish: Den 31. maj 2016 meddelte BioMarin International Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Kyndrisa til behandling af Duchennes muskeldystrofi tilbage.
English: Duchenne muscular dystrophy is a serious genetic disease, which mainly affects boys and is usually diagnosed before the age of 6.
Danish: Duchennes muskeldystrofi er en alvorlig genetisk sygdom, der primært rammer drenge, og som normalt diagnosticeres før seksårs alderen.
English: Kyndrisa was expected to be used for the treatment of Duchenne muscular dystrophy in patients aged 5 years and older who are able to walk and whose disease is due to certain genetic mutations (defects) that can be treated with ‘exon 51 skipping technology'.
Danish: Kyndrisa skulle anvendes til behandling af Duchennes muskeldystrofi hos patienter i alderen fem år og derover, som er i stand til at gå, og hvis sygdom skyldes visse genetiske forandringer (defekter), der kan behandles med "exon 51 skipping"-teknologi.
English: The studies compared the effects of Kyndrisa with placebo (a dummy treatment) and the main measure of effectiveness was the change in the distance the patient could walk in six minutes after 24 or 48 weeks of treatment.
Danish: I undersøgelserne blev virkningen af Kyndrisa sammenlignet med placebo (en uvirksom behandling), og det primære mål for virkningen var ændringen i den afstand, patienten kunne gå i løbet af seks minutter efter 24 eller 48 ugers behandling.
English: This technology enables the protein-making apparatus in cells to skip some areas of the dystrophin gene and allow the production of a shortened but partially working dystrophin protein.
Danish: Denne teknologi sætter den proteindannende mekanisme i cellerne i stand til at udelade visse dele af dystrofingenet og muliggør dannelsen af et forkortet, men delvist fungerende dystrofinprotein.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Kyndrisa could not have been approved for the treatment of Duchenne muscular dystrophy.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Kyndrisa ikke ville kunne være blevet godkendt til behandling af Duchennes muskeldystrofi.
English: It was to be available as a solution for injection under the skin.
Danish: Det var hensigten, at det skulle markedsføres som injektionsvæske, opløsning, til indsprøjtning under huden.
English: Duchenne muscular dystrophy is caused by mutations in the gene for the protein dystrophin, which lead to the production of a non-functional dystrophin.
Danish: Duchennes muskeldystrofi skyldes mutationer i genet for proteinet dystrofin, hvilket medfører dannelse af ikke-funktionel dystrofin.
English: It causes progressive weakness and loss of muscle function, and usually leads to death in adolescence or early adulthood.
Danish: Sygdommen forårsager fremadskridende svækkelse og tab af muskelfunktion, og patienterne dør typisk i teenagealderen eller i starten af deres voksenliv.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Kyndrisa eller i programmer for anvendelse af Kyndrisa med særlig udleveringstilladelse?
English: Kyndrisa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 February 2009 for Duchenne muscular dystrophy.
Danish: Kyndrisa blev udpeget som "lægemiddel til sjældne sygdomme" den 27. februar 2009 til behandling af Duchennes muskeldystrofi.
English: Page 2/2
Danish: juni 2016
English: 22014 Incheon Republic of Korea
Danish: 22014 Incheon Republikken Korea
English: Two dosing options are available:
Danish: Der foreligger to doseringsmuligheder:
English: OPEN HERE LIFT HERE
Danish: ÅBN HER LØFT HER
English: Date of first authorisation: 28 March 2019
Danish: Dato for første markedsføringstilladelse: 28. marts 2019
English: Important information:
Danish: Vigtige oplysninger:
English: Your doctor will discuss and decide with you the most appropriate dosing schedule.
Danish: Din læge vil drøfte og beslutte den mest hensigtsmæssige doseringsplan sammen med dig.
English: How much and when to inject
Danish: Hvornår og hvor meget skal du injicere
English: Intrinsic and extrinsic factors
Danish: Intrinsiske og ekstrinsiske faktorer
English: Evaluation of the need to continue treatment is recommended regularly thereafter.
Danish: Evaluering af behovet for at fortsætte behandlingen anbefales regelmæssigt derefter.
English: Any further decision to continue treatment should be taken on an individual patient basis.
Danish: Alle yderligere beslutninger om at fortsætte behandlingen skal tages på en individuel patientbasis.
English: More than 1,400 patients were treated for at least 12 months.
Danish: Mere end 1.400 patienter blev behandlet i mindst 12 måneder.
English: No safety signal was observed during the 15-month combined treatment period.
Danish: Der blev ikke observeret noget sikkerhedssignal i løbet af den 15 måneder lange kombinerede behandlingsperiode.
English: You wait another 10 seconds (to make sure all of the medicine is injected).
Danish: Du venter yderligere 10 sekunder (for at sikre, at al medicinen er injiceret).
English: Long-term study (Study 3)
Danish: Længerevarende studie (studie 3)
English: d) Wash your hands with soap and water and dry well with a clean towel.
Danish: d) Vask hænderne med vand og sæbe, og tør dem grundigt med et rent håndklæde.
English: Do not remove pressure until the 3 steps below are complete.
Danish: Du må ikke holde op med at presse nedad, før de 3 nedenstående trin er gennemført.
English: The treatment benefit should be assessed within 3 months after initiation of treatment.
Danish: Fordelene ved behandlingen bør vurderes inden for 3 måneder efter behandlingen initieres.
English: No safety data are available in these patients.
Danish: Ingen sikkerhedsdata er tilgængelige for disse patienter.
English: One of these 6 patients developed neutralising antibodies.
Danish: En af disse 6 patienter udviklede neutraliserende antistoffer.
English: ATC code: Not yet assigned.
Danish: ATC-kode: endnu ikke tildelt.
English: Overall, 19% of the patients had previously used topiramate.
Danish: I alt havde 19 % af patienterne tidligere brugt topiramat.
English: AJOVY is not recommended for children and adolescents below the age of 18 years because it has not been studied in this age group.
Danish: AJOVY anbefales ikke til børn og unge under 18 år, fordi det ikke er undersøgt i denne aldersgruppe.
English: Make sure the name AJOVY appears on the label.
Danish: Kontroller, at navnet AJOVY står på etiketten.
English: This reduction in CGRP's activity reduces migraine attacks.
Danish: Dette fald i aktiviteten af CGRP mindsker migræneanfaldene.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment if necessary.
Danish: I tilfælde af overdosering anbefales det at patienten monitoreres for tegn eller symptomer på bivirkninger og gives passende symptomatisk behandling, hvis det er nødvendigt.
English: It is unknown whether fremanezumab is excreted in human milk.
Danish: Det er ukendt, om fremanezumab udskilles i human mælk.
English: The expiration date has passed.
Danish: Udløbsdatoen er overskredet.
English: 61% of patients completing Study 3 achieved a 50% response in the last month of the study.
Danish: 61 % af de patienter der gennemførte studie 3 opnåede et 50 % respons i løbet af den sidste måned i studiet.
English: The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine.
Danish: Behandlingen bør initieres af en læge med erfaring i diagnosticering og behandling af migræne.
English: No formal clinical drug interaction studies have been performed with AJOVY.
Danish: Der er ikke udført formelle kliniske interaktionsstudier med AJOVY.
English: Slowly push the plunger in.
Danish: Tryk langsomt stemplet ind.
English: A population pharmacokinetic analysis looking at age, race, gender, and weight was conducted on data from 2,546 subjects.
Danish: En populationsfarmakokinetisk analyse der så på alder, race, køn og vægt, blev udført på data fra 2.546 forsøgspersoner.
English: AJOVY reduces the frequency of migraine attacks and days with headache.
Danish: AJOVY sænker hyppigheden af migræneanfald og dage med hovedpine.
English: The safety and efficacy of AJOVY in children and adolescents below the age of 18 years have not yet been established.
Danish: AJOVYs sikkerhed og virkning hos børn og unge i alderen under 18 år er endnu ikke klarlagt.
English: (Note: When the blue plunger has filled the viewing window you will still be able to see the grey stopper.)
Danish: (Bemærk: Når det blå stempel fylder hele vinduet, kan man stadig se den grå stopper.)
English: You hear the first “click” (this signals the start of the injection and the blue plunger starts to move).
Danish: Du hører det første “klik” (dette er et signal om, at injektionen starter, og det blå stempel begynder nu at bevæge sig).
English: Doses up to 2,000 mg have been administered intravenously in clinical trials without dose-limiting toxicity.
Danish: Doser på op til 2.000 mg er blevet administreret intravenøst i kliniske studier uden dosisbegrænsende toksicitet.
English: The most frequently observed local reactions at the injection site were pain, induration and erythema.
Danish: De hyppigst observerede lokale reaktioner på injektionsstedet var smerter, induration og erytem.
English: Fremanezumab has an estimated half-life of 30 days.
Danish: Fremanezumab har en estimeret halveringstid på 30 dage.
English: All injection site reactions resolved, mostly within a few hours or days.
Danish: Alle reaktioner på injektionsstedet forsvandt for det meste inden for nogle få timer eller dage.
English: − If multiple injections are required, they may be given in the same or different area (abdomen, thigh, upper arm), but you should avoid injecting in exactly the same place.
Danish: − Hvis flere injektioner er påkrævet, kan de gives på samme eller forskellige områder (mave, lår og overarm), men du bør undgå at injicere på nøjagtigt samme sted.
English: Major cardiovascular diseases
Danish: Alvorlige kardiovaskulære sygdomme
English: A total of over 2,500 patients (more than 1,900 patient years) have been treated with AJOVY in registration studies.
Danish: Over 2.500 patienter i alt (mere end 1.900 patientår) er blevet behandlet med AJOVY i registreringsstudier.
English: Frequency categories are 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: Hyppighedskategorier er estimeret i henhold til 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: Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with fremanezumab.
Danish: Behandlingen er beregnet til patienter, der har mindst 4 migrænedage om måneden når behandlingen med fremanezumab initieres.
English: No data on exposure-efficacy relationship in subjects with body weight >132 kg is available.
Danish: Der foreligger ingen data om forholdet mellem eksponering og virkning hos personer med en kropsvægt >132 kg.
English: • Carefully read the AJOVY package leaflet to learn more about your medicine.
Danish: • Læs omhyggeligt indlægssedlen til AJOVY for at få mere at vide om din medicin.
English: Pharmacotherapeutic group: Not yet assigned.
Danish: Farmakoterapeutisk klassifikation: endnu ikke tildelt.
English: Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) have not been studied.
Danish: Patienter med svært nedsat nyrefunktion (eGFR <30 ml/min/1,73 m2) er ikke blevet undersøgt.
English: This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks.
Danish: Denne medicin mindsker også de invaliderende symptomer, som forekommer i forbindelse med migræne, og den mindsker behovet for lægemidler til behandling af migræneanfald.
English: Tell your doctor if you have or have had cardiovascular disease (problems affecting the heart and blood vessels) before using this medicine, because AJOVY has not been studied in patients with certain cardiovascular diseases.
Danish: Fortæl det til din læge, hvis du har eller har haft hjerte-karsygdomme (problemer, der påvirker hjertet og blodkarrene), før du tager denne medicin, da AJOVY ikke er undersøgt hos patienter med bestemte hjerte-karsygdomme.
English: Your doctor or nurse will explain to you or your caregiver how to give the injection.
Danish: Lægen eller sygeplejersken eller din omsorgsperson vil forklare dig, hvordan du skal tage injektionen.
English: Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Danish: Reaktioner på injektionsstedet nødvendiggjorde generelt ikke seponering af lægemidlet.
English: This medicine is not expected to have any effect on your ability to drive or use machines.
Danish: Dette lægemiddel forventes ikke at påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Gently pinch up at least 2.5 cm of the skin that you have cleaned.
Danish: Tag fat om en hudfold på mindst 2,5 cm af den hud, som du har renset forinden.
English: The marketing authorisation holder shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Pain, induration and erythema were typically observed immediately after injection while pruritus and rash appeared within a median of 24 and 48 hours, respectively.
Danish: Smerter, induration og erytem blev typisk observeret straks efter injektionen, mens den mediane forekomst af pruritus og udslæt var hhv. 24 og 48 timer derefter.
English: There is a limited amount of data from the use of AJOVY in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af AJOVY til gravide kvinder.
English: It is preferable to avoid the use of AJOVY during pregnancy as the effects of this medicine in pregnant women are not known.
Danish: Det anbefales at undgå at bruge AJOVY under graviditeten, da virkningen af denne medicin er ukendt hos gravide.
English: The following ADRs have been identified in the AJOVY clinical development programme (Table 1).
Danish: Følgende bivirkninger er blevet identificeret i forbindelse med AJOVYs kliniske udviklingsprogram (tabel 1).
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: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet.
English: Commonly reported adverse drug reactions (ADRs) were local reactions at the injection site (pain [24%], induration [17%], erythema [16%] and pruritus [2%]).
Danish: Almindeligt rapporterede bivirkninger (ADR) var lokale reaktioner på injektionsstedet (smerter [24 %],induration [17 %], erytem [16 %] og kløe [2 %]).
English: AJOVY should not be used if the solution has been frozen.
Danish: AJOVY må ikke bruges, hvis opløsningen har været frosset.
English: The patients enrolled had at least a 12-month history of migraine (with and without aura) according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria.
Danish: De inkluderede patienter havde mindst 12 måneders anamnese med migræne (med eller uden aura) i overensstemmelse med diagnosekriterierne fra International Classification of Headache Disorders (ICHD-III).
English: − Choose an injection area from the following areas: Your stomach area (abdomen), avoid about 5 cm around the belly button The front of your thighs, about 5 cm above the knee and 5 cm below the groin The back of your upper arms, in the fleshy areas of the upper back portion
Danish: − Vælg et injektionssted fra følgende områder: Din mave, undgå ca. 5 cm omkring navlen Forsiden af dine lår, ca. 5 cm over knæet, og 5 cm under lysken Bagsiden af dine overarme, i fyldige områder bag på overarmen
English: If a fremanezumab injection is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen.
Danish: Hvis en fremanezumab-injektion glemmes på den planlagte dato, skal behandlingen genoptages snarest muligt med den angivne dosis og behandlingsregime.
English: c) Remove the needle from your skin.
Danish: c) Kanylen fjernes fra huden.
English: − Press down on the pre-filled pen and keep pressed down against the skin for about 30 seconds.
Danish: − Pres den fyldte pen nedad, og hold den presset nedad mod huden i omkring 30 sekunder.
English: − Place the pre-filled pen at a 90° angle against your skin at the injection site.
Danish: − Placer den fyldte pen i en 90° vinkel mod din hud på injektionsstedet.
English: Elderly patients (>70 years), patients using opioids or barbiturates on more than 4 days per month, and patients with pre-existing myocardial infarction, cerebrovascular accident, and thromboembolic events were excluded.
Danish: Ældre patienter (over 70 år), patienter, der brugte opioider eller barbiturater i mere end 4 dage om måneden, og patienter med præeksisterende myokardieinfarkt, cerebrovaskulære hændelser og tromboemboliske hændelser blev ekskluderet.
English: The antibody responses were of low titer.
Danish: Antistofresponserne havde lave titer.
English: However, body weight did not have an observed effect on the clinical efficacy based on the exposure-response analyses in episodic and chronic migraine patients.
Danish: Men kropsvægten havde ingen observeret indflydelse på den kliniske virkning baseret på analysen af eksponeringsresponset i patienter med episodisk og kronisk migræne.
English: − Wait 10 seconds to allow the skin to dry before injecting.
Danish: − Vent 10 sekunder, så huden er tør, før du giver injektionen.
English: Afterwards, use of fremanezumab could be considered during breast-feeding only if clinically needed.
Danish: Herefter kan brugen af fremanezumab overvejes under amning, dog kun hvis det er klinisk nødvendigt.
English: Do not use this medicine if you are allergic to fremanezumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke dette lægemiddel, hvis du er allergisk over for fremanezumab eller et af de øvrige indholdsstoffer i AJOVY (angivet i punkt 6).
English: Hypersensitivity reactions were reported with fremanezumab in less than 1% of patients in clinical trials.
Danish: Der blev rapporteret om overfølsomhedsreaktioner over for fremanezumab hos mindre end 1 % af patienterne i kliniske studier.
English: Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1).
Danish: Patienter med bestemte alvorlige kardiovaskulære sygdomme blev udelukket fra at deltage i kliniske studier (se pkt.
English: AJOVY has no or negligible influence on the ability to drive and use machines.
Danish: AJOVY påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: It should not be administered by the intravenous or intramuscular route.
Danish: Det må ikke administreres intravenøst eller intramuskulært.
English: Adults with a history of episodic migraine (less than 15 headache days per month) were included in the study.
Danish: Voksne med en episodisk-migræne-anamnese (mindre end 15 hovedpinedage om måneden) blev inkluderet i studiet.
English: Push the plunger all the way down as far as it will go to inject all of the medicine.
Danish: Tryk stemplet helt i bund, så langt som det kan komme, for at injicere al medicinen.
English: Approximately 52% of the patients in the study had acute headache medication overuse.
Danish: Omtrent 52 % af patienterne i studiet havde et medicinsk overforbrug af akut hovedpinemedicin.
English: 79% of patients completed the 12-month treatment period of Study 3.
Danish: 79 % af patienterne gennemførte den 12 måneder lange behandlingsperiode i studie 3.
English: Median accumulation ratio, based on once monthly and once quarterly dosing regimens, is approximately 2.4 and 1.2, respectively.
Danish: Det mediane akkumulationsforhold baseret på doseringsregimer én gang månedligt og én gang i kvartalet, var hhv. ca. 2,4 og 1,2.
English: CGRP levels have been shown to increase significantly during migraine and return to normal with headache relief.
Danish: CGRP-niveauerne har vist sig at stige signifikant under migræneanfald og vende tilbage til det normale niveau ved hovedpinelindring.
English: Overall, 30% of the patients had previously used topiramate and 15% onabotulinumtoxin A. A total of 1,034 patients completed the 12-week double-blind treatment period.
Danish: I alt havde 30 % af patienterne tidligere brugt topimarat og 15 % onabotulinumtoxin A. I alt gennemførte 1.034 patienter den dobbeltblindede behandlingsperiode af 12 ugers varighed.
English: Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one.
Danish: Brug en påmindelsesmetode, fx ved at notere det i din kalender eller dagbog, så du ikke glemmer en dosis eller får en dosis for hurtigt efter den sidste dosis.
English: All local injection site reactions were transient and predominantly mild to moderate in severity.
Danish: Alle lokale reaktioner på injektionsstedet var forbigående og overvejende af let til moderat sværhedsgrad.
English: b) Inject by following the 4 steps below.
Danish: b) Injicer ved at følge de 4 nedenstående trin.
English: Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period.
Danish: Det er kendt, at humant IgG bliver udskilt i brystmælken i de første dage efter fødslen, hvilket snart efter falder til lave koncentrationer.
English: While the precise mechanism of action by which fremanezumab prevents migraine attacks is unknown, it is believed that prevention of migraine is obtained by its effect modulating the trigeminal system.
Danish: Selvom den præcise virkningsmekanisme hvorved fremanezumab forhindrer migræneanfald ikke er kendt, antages det at den forebygger migræne ved hjælp af dens modulerende virkning på trigeminussystemet.
English: The blue plunger fills the window when the injection is complete.
Danish: Det blå stempel fylder hele vinduet, når injektionen er gennemført.
English: You and your doctor should decide if you will use AJOVY while breast-feeding.
Danish: Du og din læge skal beslutte, om du kan bruge AJOVY, så længe du ammer.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., is essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.