FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the CHMP considered that methysergide seems to benefit a small patient population of migraine and cluster headache patients.
Danish: Samlet fandt CHMP, at methysergid synes at være til fordel for en lille patientpopulation med migræne og klyngehovedpine.
English: • The Committee considered that there is some evidence for clinically significant efficacy of methysergide in the prophylactic treatment of severe, debilitating migraine and cluster headache for which therapeutic alternatives are limited.
Danish: • udvalget fandt, at der er nogen evidens for, at methysergid har en klinisk betydningsfuld virkning til profylaktisk behandling af svær invaliderende migræne og klyngehovedpine, for hvilke der kun findes begrænsede behandlingsalternativer.
English: Considering the overall data available, the CHMP is of the opinion that there is some evidence of clinically significant efficacy of methysergide in the prophylactic treatment of severe and debilitating migraine.
Danish: Efter gennemgang af samtlige foreliggende data finder CHMP, at der er nogen evidens for klinisk betydningsfuld virkning af methysergid til profylaktisk behandling af svær og invaliderende migræne.
English: − Is favourable for the prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Danish: − er gunstigt til profylaktisk behandling af svær intraktabel migræne (med eller uden forvarsel) med funktionel invaliditet hos voksne.
English: • the prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Danish: • profylaktisk behandling af svær intraktabel migræne (med eller uden forvarsel) med funktionel invaliditet hos voksne.
English: − Is favourable for the prophylactic treatment of episodic and chronic cluster headache in adults.
Danish: − er gunstigt til profylaktisk behandling af episodisk og kronisk klyngehovedpine hos voksne.
English: 2 Pedersen E, Møller CE. Methysergide in migraine prophylaxis.
Danish: Pedersen E, Møller CE. methysergid in migraine prophylaxis.
English: • the prophylactic treatment of episodic and chronic cluster headache in adults.
Danish: • profylaktisk behandling af episodisk og kronisk klyngehovedpine hos voksne.
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends the variation to the terms of the marketing authorisation for methysergide containing medicinal products referred to in Annex I.
Danish: − ikke er gunstigt til behandling af diarré af forårsaget af karcinoid sygdom anbefaler CHMP i medfør af artikel 116 i direktiv 2001/83/EF ændring af betingelserne for markedsføringstilladelserne for de i bilag I omhandlede lægemidler, der indeholder methysergid.
English: In addition, further trials comparing methysergide with placebo or comparators were also presented, some of which also showed efficacy of methysergide compared to placebo in this indication5,6,7.
Danish: Nogle af dem viste virkning af methysergid sammenlignet med placebo til denne indikation5,6,7.
English: Methysergide is not effective for treating a migraine attack that is already present.
Danish: Methysergid er ikke effektivt til behandling af et manifest migræneanfald.
English: Clin Pharmacol Ther 19645:201-204
Danish: Clin Pharmacol Ther 19645:201-204 5 Curran DA, Lance JW.
English: Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type, Cluster and Medication-Overuse Headache.
Danish: Migraine, Tension-Type, Cluster and Medication-Overuse Headache.
English: With regard to the indication “cluster headache”, the applicant referred to a review11 which suggested the prophylactic efficacy of methysergide, particularly for the episodic form of cluster headache and to a study12 where 69% of cluster headache patients reported to have good to excellent results.
Danish: For indikationen “klyngehovedpine” henviste ansøgeren til en oversigtsartikel11, der pegede på profylaktisk virkning af methysergid, navnlig ved den episodiske form af klyngehovedpine, og til en
English: The results of these studies are suggestive of the efficacy of methysergide compared to placebo in the prophylaxis of migraine.
Danish: Disse undersøgelser tyder på, at methysergid i sammenligning med placebo har profylaktisk virkning mod migræne.
English: Lance JW et al. An evaluation of methysergide in the prevention of migraine and other vascular headaches.
Danish: An evaluation of methysergid in the prevention of migraine and other vascular headaches.
English: The minimal duration of treatment before concluding failure is 2 months.
Danish: Behandlingen skal have haft en varighed af mindst to måneder, før det kan konkluderes, om der er behandlingssvigt.
English: Curran DA, Lance JW.
Danish: Lance JW et al.
English: There are a number of pharmacological pathways by which methysergide may be effective in preventing migraine, for instance some data support the role of antagonism of the 5-HT2B receptor in the prophylaxis of migraine.
Danish: Således underbygger nogle data, at dets antagonistiske virkning på 5-HT2B-receptoren spiller en rolle i profylakse af migræne.
English: 18 Bendtsen L, Birk S, Kasch H et al. Reference programme: Diagnosis and treatment of headache disorders and facial pain.
Danish: Bendtsen L, Birk S, Kasch H et al.
English: The overall reduction was 54%.
Danish: Den samlede reduktion var 54 %.
English: Date of first authorisation: 16 August 2016.
Danish: Dato for første markedsføringstilladelse: 16. august 2016.
English: ● Risk management plan (RMP)
Danish: ● Risikostyringsplan (RMP)
English: An updated RMP should be submitted: ● At the request of the European Medicines Agency;
Danish: En opdateret RMP skal fremsendes: ● på anmodning fra Det Europæiske Lægemiddelagentur
English: In this short period, a risk to the suckling child cannot be excluded.
Danish: I denne korte periode kan en risiko for det ammede barn ikke udelukkes.
English: Over 52 weeks
Danish: Over 52 uger
English: Your doctor will work out the right dose for you.
Danish: Lægen vil beregne den rette dosis for dig.
English: % reduction
Danish: % reduktion
English: Over 16 weeks
Danish: Over 16 uger
English: This is not unusual for proteinaceous solutions.
Danish: Dette er ikke usædvanligt for proteinholdige opløsninger.
English: Infusion time may vary depending on the total volume to be infused.
Danish: Infusionstiden kan variere, afhængigt af det totale volumen, der skal gives.
English: Maintenance OCS was not allowed.
Danish: Vedligeholdelsesbehandling med OCS var ikke tilladt.
English: This is particularly important: - if you are receiving other medicines which affect your immune system; - if you have recently received a vaccination or if you are likely to need a vaccination.
Danish: Dette er især vigtigt: - hvis du får andre lægemidler, som påvirker dit immunsystem - hvis du er blevet vaccineret for nylig, eller hvis det er sandsynligt, at du har behov for at blive vaccineret.
English: These cases resulted in the discontinuation of treatment.
Danish: Disse tilfælde medførte seponering af behandlingen.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of reslizumab in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (færre end 300 graviditetsudfald) fra anvendelse af reslizumab til gravide kvinder.
English: Results were supported by the secondary efficacy endpoints and were in line with the overall population.
Danish: Resultaterne blev støttet af de sekundære virkningsendepunkter og stemte overens med resultaterne for den samlede population.
English: Inter-individual variability in peak and overall exposure is approximately 20-30%
Danish: Inter-individuel variabilitet i maksimal og samlet eksponering er ca. 20-30 %.
English: No data are available for children aged up to 11 years.
Danish: Der foreligger ingen data for børn i alderen op til 11 år.
English: Do NOT stop treatment with CINQAERO unless your doctor tells you to, even if you feel better.
Danish: Du må IKKE stoppe behandlingen med CINQAERO, medmindre lægen fortæller dig det, heller ikke selv om du får det bedre.
English: The recommended dose is based on patient body weight and should only be adjusted for significant changes in body weight.
Danish: Den anbefalede dosis er baseret på patientens legemsvægt, og må kun justeres for signifikante ændringer i legemsvægten.
English: • Serious allergic reactions
Danish: • Alvorlige allergiske reaktioner:
English: It may take more than one dose before your asthma symptoms improve.
Danish: Mere end én dosis kan være nødvendig, før dine astmasymptomer bliver bedre.
English: LT-08409 Vilnius Lithuania
Danish: LT-08409 Vilnius Litauen
English: As a precautionary measure, it is preferable to avoid the use of CINQAERO during pregnancy.
Danish: Som en sikkerhedsforanstaltning foretrækkes det, at CINQAERO undgås under graviditet.
English: Treatment duration CINQAERO is intended for long-term treatment.
Danish: Behandlingsvarighed CINQAERO er beregnet til langtidsbehandling.
English: There are limited data available on the use of reslizumab in patients older than 75 years of age.
Danish: Der er begrænsede data for anvendelse af reslizumab hos patienter over 75 år.
English: The dose depends on your body weight.
Danish: Dosis afhænger af din legemsvægt.
English: CINQAERO will be given every 4 weeks.
Danish: Du vil få CINQAERO hver 4. uge.
English: Elimination Reslizumab clearance is approximately 7 mL/hour.
Danish: Elimination Reslizumabs clearance er ca. 7 ml/time.
English: The infusion will take about 20 to 50 minutes.
Danish: Infusionen tager omkring 20 til 50 minutter.
English: The active substance in this medicine may pass into breast milk but only during the first few days after birth.
Danish: Det aktive stof i dette lægemiddel kan udskilles i mælken, men kun de første par dage efter fødslen.
English: *See subsection “Description of selected adverse reactions” below
Danish: *Se afsnittet “Beskrivelse af udvalgte bivirkninger” nedenunder
English: *** Patients weighing more than 188 kg were not studied.
Danish: *** Patienter, der vejer over 188 kg, blev ikke undersøgt.
English: This medicine is NOT intended for use in children and adolescents below the age of 18 years.
Danish: Dette lægemiddel er IKKE beregnet til børn og unge under 18 år.
English: Study III was a 16-week, randomised, placebo-controlled study.
Danish: Studie III var et 16-ugers randomiseret, placebokontrolleret studie.
English: Subgroup GINA 4 and 5
Danish: Undergruppe GINA 4 og 5
English: They were fully resolved with standard treatment with no residual effect.
Danish: Reaktionerne forsvandt helt med standardbehandling uden residuale effekter.
English: Patients should be instructed on how to recognise symptoms of serious allergic reactions.
Danish: Patienterne skal instrueres i at genkende symptomer på alvorlige allergiske reaktioner.
English: It is unknown whether reslizumab is excreted in human milk.
Danish: Det er ukendt, om reslizumab udskilles i human mælk.
English: There are limited safety data in non-white ethnic populations.
Danish: Der er begrænsede sikkerhedsdata hos ikke-kaukasiske etniske populationer.
English: Maintenance OCS (up to 10 mg per day prednisone equivalent) were allowed.
Danish: Vedligeholdelsesbehandling med OCS (ækvivalent med op til 10 mg prednison dagligt) var tilladt.
English: Interrupting or stopping treatment with this medicine may cause your asthma symptoms to come back.
Danish: Hvis du afbryder eller stopper behandlingen med dette lægemiddel, kan det evt. medføre, at dine astmasymptomer vender tilbage.
English: The medicinal product should be inspected visually before use.
Danish: Lægemidlet skal inspiceres visuelt inden brug.
English: d The percentage of patients with refractory asthma (based on the American Thoracic Society
Danish: d Procentdelen af patienter med refraktær astma (baseret på definitionen fra American Thoracic
English: Available non-clinical data do not suggest an effect on fertility.
Danish: De tilgængelige non-kliniske data tyder ikke på påvirkning af fertiliteten.
English: b CI = Confidence interval.
Danish: b CI = Konfidensinterval.
English: NAb a FEV1=forced expiratory volume in 1 second b NA=not available c The GINA classification is based on the Global Initiative for Asthma (GINA) definition:
Danish: NAb a FEV1 = forceret eksspiratorisk volumen i det første sekund b NA = ikke tilgængeligt c GINA-klassifikationen er baseret på Global Initiative for Asthma (GINA)-definitionen:
English: Mean number of exacerbations in previous year
Danish: Gennemsnitligt antal eksacerbationer det seneste år
English: The most frequently reported adverse reaction during treatment was increased blood creatine phosphokinase, which occurred in approximately 2% of patients.
Danish: Den hyppigst rapporterede bivirkning under behandlingen var forhøjet kreatinkinase i blodet, hvilket opstod hos ca. 2 % af patienterne.
English: Any concentrate remaining in the vial must be discarded.
Danish: Al koncentrat, der er tilbage i hætteglasset, skal bortskaffes.
English: As reslizumab binds to a soluble target, linear non-target-mediated clearance is expected.
Danish: Da reslizumab binder til et target i opløsning, forventes en lineær ikke-target-medieret clearance.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du får dette lægemiddel.
English: The safety and efficacy of CINQAERO in children and adolescents aged up to 17 years have not been established for the indication of CINQAERO.
Danish: CINQAEROs sikkerhed og virkning hos børn og unge i alderen op til 17 år er ikke klarlagt ved indikationen for CINQAERO.
English: Table 2: Adverse reactions System organ class
Danish: Tabel 2: Bivirkninger Systemorganklasse
English: The concentrate must not be used if coloured (except slightly yellow) or if foreign particles are present.
Danish: Koncentratet må ikke anvendes, hvis det er farvet (undtagen hvis det er let gulligt), eller hvis der er fremmedlegemer til stede.
English: There was no prior asthma exacerbation requirement for this study.
Danish: Der var ikke et krav til tidligere astmaeksacerbationer i dette studie.
English: Remove CINQAERO from the refrigerator.
Danish: CINQAERO fjernes fra køleskabet.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and 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, genotoksicitet, karcinogent potentiale samt reproduktions- og udviklingstoksicitet.
English: A double dose must not be administered to make up for a missed dose.
Danish: Der må ikke administreres en dobbeltdosis som erstatning for den glemte dosis.
English: Talk to your doctor or nurse before you are given CINQAERO: - if you have a parasitic infection or if you live in an area where parasitic infections are common or if you are travelling to such a region, as this medicine may weaken your body's ability to fight certain types of parasitic infections.
Danish: Kontakt lægen eller sygeplejersken, før du får CINQAERO: - hvis du har en parasitinfektion (indvoldsorm), hvis du bor i områder, hvor parasitinfektioner er almindelige, eller hvis du rejser til sådanne steder, da dette lægemiddel kan svække kroppens evne til at bekæmpe infektion med visse parasitter.
English: No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving reslizumab or the response to new immunisations in patients receiving reslizumab.
Danish: Der foreligger ingen data for sekundær transmission af infektion fra personer, der får levende vacciner, til patienter, der får reslizumab, eller for responset på nye immuniseringer hos patienter, der får reslizumab.
English: Asthma-related symptoms or exacerbations may occur during treatment.
Danish: Astmarelaterede symptomer eller eksacerbationer kan forekomme under behandlingen.
English: Always follow the instructions exactly as your doctor has told you.
Danish: Følg altid lægens anvisning nøjagtigt.
English: The solution for infusion is intended only for intravenous use after dilution and should be prepared using aseptic technique as follows:
Danish: Infusionsvæsken er kun beregnet til intravenøs anvendelse efter fortynding og skal fremstilles med aseptisk teknik på følgende måde:
English: Given the small sample size and baseline imbalances resulting from subgroup analysis, no conclusion can be drawn regarding asthma efficacy in the paediatric population.
Danish: Grundet det lille antal patienter og ubalancer ved baseline, der stammer fra undergruppeanalysen, kan der ikke drages nogen konklusioner om virkningen på astma hos den pædiatriske population.
English: In vitro data indicate that IL-5 and reslizumab are unlikely to affect CYP1A2, 3A4 or 2B6 activity.
Danish: In vitro-data indikerer, at det ikke er sandsynligt, at IL-5 og reslizumab påvirker aktiviteten af CYP1A2, 3A4 og 2B6.
English: Proportions of patients in GINA steps 4 and 5c
Danish: Andel af patienter i GINA trin 4 og 5c
English: Reslizumab should not be used to treat acute asthma exacerbations.
Danish: Reslizumab bør ikke anvendes til behandling af akutte eksacerbationer af astma.
English: If you miss a scheduled dose of CINQAERO, ask your doctor when to schedule your next treatment.
Danish: Hvis du glemmer at få en planlagt dosis CINQAERO, skal du spørge lægen om, hvornår du skal have din næste behandling.
English: - The active substance is reslizumab.
Danish: - Aktivt stof: reslizumab.
English: Peak serum concentrations of approximately 80 µg/mL are typically observed at the end of the infusion.
Danish: Maksimale serumkoncentrationer på ca. 80 µg/ml bliver typisk observeret ved infusionens afslutning.
English: It is recommended that the solution for infusion be administered immediately after preparation.
Danish: Det anbefales, at infusionsvæsken administreres umiddelbart efter fremstilling.
English: [ATS]/European Respiratory Society [ERS] 2000 workshop definition for refractory asthma) from Studies I and II was analysed post hoc.
Danish: Society [ATS] / European Respiratory Society [ERS] 2000 workshop om refraktær astma) fra studie I og II blev analyseret post hoc.
English: This should be taken into consideration.
Danish: 5.2), hvilket der skal tages hensyn til.
English: Reslizumab is an antibody with a molecular mass of 147 kDaltons and is therefore not expected to be excreted in urine.
Danish: Reslizumab er et antistof med en molekylmasse på 147 kDaltons, og det forventes derfor ikke, at det udskilles i urinen.
English: ** The nominal volume of the vials (10 mL or 2.5 mL for each vial) has to be used.
Danish: ** Det nominelle volumen af hætteglassene (10 ml eller 2,5 ml for hvert hætteglas) skal anvendes.
English: 95% CI a Rate adjusted for stratification factors (baseline usage of OCS and geographical region).
Danish: 95 % CI a Raten er justeret for stratifikationsfaktorer (anvendelse af OCS ved baseline og geografisk region).
English: In a population pharmacokinetic analysis, patients were classified by baseline liver function levels.
Danish: I en populationsfarmakokinetisk analyse blev patienterne klassificeret efter leverfunktionsniveau ved baseline.
English: IL-5 is a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils.
Danish: IL-5 er et vigtigt cytokin, der er ansvarligt for differentiering, modning, rekruttering og aktivering af humane eosinofile celler.
English: The antibodies had no impact on clinical pharmacodynamics, efficacy or safety.
Danish: Antistofferne påvirkede ikke den kliniske farmakodynamik, virkningen eller sikkerheden.
English: Patients below 35 kg or above 199 kg
Danish: Patienter under 35 kg eller over 199 kg
English: The concentrate does not contain any preservatives.
Danish: Koncentratet indeholder ingen konserveringsmidler.
English: If a reslizumab infusion is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen.
Danish: Hvis en infusion med reslizumab glemmes på den planlagte dato, skal doseringen genoptages snarest muligt med den angivne dosis og behandlingsprogram.
English: Results for FEV1, ACQ and AQLQ are shown in Table 5 below for the overall population, and subgroup GINA 4 and 5.
Danish: Resultater for FEV1, ACQ og AQLQ er vist i tabel 5 nedenfor for den samlede population og for undergruppe GINA 4 og 5.
English: Sputum eosinophils were measured in a subset of 38 adult patients at the end of therapy.
Danish: Eosinofile celler i sputum blev målt i en subgruppe med 38 voksne patienter ved behandlingens afslutning.
English: The highest single dose administered intravenously was reported at 12.1 mg/kg and had no clinical consequences for the patient.
Danish: Den højeste rapporterede intravenøse enkeltdosis er 12,1 mg/kg, som ikke havde kliniske følger for patienten.
English: * This dosing scheme is based on a maximum dose of 3 mg/kg.
Danish: * Dette doseringsskema er baseret på en maksimal dosis på 3 mg/kg.
English: Serious allergic reactions can happen uncommonly (may affect up to 1 in 100 people) while receiving CINQAERO or afterwards.
Danish: Alvorlige allergiske reaktioner kan forekomme med hyppigheden "ikke almindelig" (kan forekomme hos op til 1 ud af 100 personer), mens du får CINQAERO eller bagefter.
English: The primary endpoint was the change from baseline over 16 weeks in FEV1.
Danish: Det primære endepunkt var ændringen i FEV1 over 16 uger i forhold til baseline.
English: What you need to know before you are given CINQAERO You must not receive CINQAERO:
Danish: Det skal du vide, før du begynder at få CINQAERO Du må ikke få CINQAERO:
English: No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of reslizumab with other medicinal products.
Danish: Der er ikke udført fysiske eller biokemiske kompatibilitetsstudier for at evaluere administration af reslizumab sammen med andre lægemidler.
English: CINQAERO is for intravenous infusion only.
Danish: CINQAERO er kun til intravenøs infusion.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases; ATC code: R03DX08
Danish: Farmakoterapeutisk klassifikation: Midler mod obstruktiv lungesygdom, andre systemiske midler mod obstruktiv lungesygdom, ATC-kode: R03DX08
English: Intravenous use, after dilution only.
Danish: Intravenøs anvendelse, kun efter fortynding.
English: Fertility There are no fertility data in humans.
Danish: Der foreligger ingen fertilitetsdata for mennesker.
English: What are the benefits of using CINQAERO
Danish: Hvad er fordelen ved at anvende CINQAERO
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.
Danish: I tilfælde af en overdosis anbefales det at overvåge patienten for symptomer på bivirkninger og give relevant symptomatisk behandling.
English: Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Danish: Patienterne skal informeres om at kontakte lægen, hvis deres astma stadig er ukontrolleret eller bliver værre, efter behandlingen er påbegyndt.
English: Based on the characteristics of reslizumab, drug-drug interactions are not expected.
Danish: Baseret på reslizumabs karakteristika forventes der ikke lægemiddelinteraktioner.
English: Your doctor or nurse will watch you closely for signs of a reaction.
Danish: Lægen eller sundhedspersonerne vil observere dig nøje for tegn på en reaktion.
English: Common (may affect up to 1 in 10 people) • Increase of an enzyme in your blood (blood creatine phosphokinase).
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer) • Forhøjet niveau af et enzym i blodet (kreatinkinase).