FrancophonIA/ELRC3.0 huggingface dataset:
English: During post-marketing use case reports of MAS in Kineret treated patients with Still's disease have been received.
Danish: Der er modtaget indberetninger af tilfælde med MAS ved anvendelse efter markedsføringen hos patienter i behandling med Kineret for Stills sygdom.
English: Clinical efficacy and safety in Still's disease
Danish: Klinisk virkning og sikkerhed ved Stills sygdom
English: The pre-filled syringe has an outer rigid plastic needle shield attached to an inner needle cover.
Danish: Den fyldte injektionssprøjte har en udvendig kanylebeskyttelse af hård plast, som er fæstnet til den indvendige kanylehætte.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Hyperlink reference not valid.http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Kineret findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Hepatic Events
Danish: Leverrelaterede hændelser
English: Still's disease: Children weighing less than 50 kg are dosed by body weight with a starting dose of 1-2 mg/kg/day, patients weighing 50 kg or more are dosed with 100 mg/day.
Danish: Stills sygdom: Børn, der vejer under 50 kg, doseres pr. kropsvægt, med en startdosis på 1-2 mg/kg/dag.
English: In RA patients the most common and consistently reported treatment-related adverse reactions associated with Kineret were ISRs.
Danish: Den hyppigste og mest konsekvent rapporterede behandlingsrelaterede bivirkning hos RA-patienter i forbindelse med Kineret var reaktioner på injektionsstedet.
English: Uncommon (≥ 1/1,000 to < 1/100) Allergic reactions including anaphylactic reactions, angioedema, urticaria and pruritus
Danish: Allergiske reaktioner, herunder anafylaktiske reaktioner, angioødem, urticaria og pruritus
English: Injecting Kineret yourself
Danish: Injicering af Kineret
English: MedDRA Organ System Frequency
Danish: Medra-organsystem
English: • Never put the pre-filled syringes that you have used into your normal household rubbish bin.
Danish: • Brugte, fyldte injektionssprøjter må ikke bortskaffes med det almindelige husholdningsaffald.
English: Inject the liquid slowly and evenly, always keeping the skin pinched as in Figure E.
Danish: Stik kanylen helt ind i huden, som Deres læge eller sygeplejerske har vist det. Sprøjt væsken ind i langsomt og jævnt tempo, hele tiden med huden imellem de to fingre som vist i figur E.
English: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
Danish: Kineret 100 mg/0,67 ml injektionsvæske, opløsning i fyldt injektionssprøjte.
English: No dose adjustment is needed for patients with mild renal impairment (CLcr 60 to 89 ml/min).
Danish: Dosisjustering er ikke nødvendig for patienter med let nedsat nyrefunktion (kreatininclearance (CLcr) 60 til 89 ml/minut).
English: • Patient and caregiver information pack
Danish: • Informationspakke til patienter og plejepersonale
English: If you use more Kineret than you should
Danish: Hvis De har brugt for meget Kineret
English: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe Anakinra
Danish: Kineret 100 mg/0,67 ml injektionsvæske, opløsning i fyldt injektionssprøjte Anakinra
English: - Serious infections such as pneumonia (a chest infection) or infections of the skin can occur during Kineret treatment.
Danish: Hvis en af følgende bivirkninger opstår, skal De kontakte Deres læge omgående: - Alvorlige infektioner såsom lungebetændelse eller infektioner i huden kan opstå under behandling med Kineret.
English: One out of the 15 patients discontinued due to ISRs.
Danish: En ud af de 15 patienter seponerede behandlingen på grund af reaktioner på injektionsstedet.
English: • Keep used syringes out of reach and sight of children.
Danish: • Brugte sprøjter skal opbevares utilgængeligt for børn.
English: Posology
Danish: Bag
English: Kineret.
Danish: Udslæt
English: - The other ingredients are anhydrous citric acid, sodium chloride, disodium edetate dihydrate, polysorbate 80 and sodium hydroxide and water for injections.
Danish: - Øvrige indholdsstoffer: vandfri citronsyre, natriumchlorid, dinatriumedetatdihydrat,
English: “Where should you give your injection?” section and the “How do you give your injection?” section.
Danish: og afsnittet "Sådan giver De injektionen".
English: • a pre-filled syringe of Kineret
Danish: • en fyldt injektionssprøjte med Kineret
English: Undesirable Effect
Danish: Bivirkning
English: What Kineret is and what it is used for What you need to know before you use Kineret How to use Kineret
Danish: Det skal De vide, før De begynder at bruge Kineret Sådan skal De bruge Kineret Bivirkninger
English: What Kineret looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: EU/1/06/339/003 Preotact
Danish: EU/1/06/339/003
English: Subcutaneous powder: dual-chamber cartridge (glass) in pre-filled pen; solvent: dual-chamber cartridge (glass) in pre-filled pen
Danish: Subkutan anvendelse pulver: tokammercylinderampul (glas) i fyldt pen; solvens: tokammercylinderampul (glas) i fyldt pen
English: This authorisation was based on the authorisation granted to Avamys in January 2008 (‘informed consent').
Danish: Denne tilladelse var baseret på den tilladelse, der blev udstedt til Avamys i januar 2008 ('informeret samtykke').
English: The name of the medicine was changed to Alisade on 25 March 2009.
Danish: Navnet på lægemidlet blev ændret til Alisade den 25. marts 2009.
English: Other information about Alisade:
Danish: Andre oplysninger om Alisade:
English: It usually starts to work from eight hours after the first spray, but it may take several days to get the maximum benefit.
Danish: Den begynder normalt at virke fra otte timer efter første pust, dog kan det vare adskillige dage, før man oplever det fulde udbytte.
English: This is generally mild or moderate and tends to affect adults who have used Alisade for more than six weeks.
Danish: Den vil generelt være mild eller moderat og har en tendens til at påvirke voksne, der bruger Alisade i mere end seks uger.
English: The effects of Alisade were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Alisade blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: However, it was not possible to determine if Alisade worked in children below the age of six years, because there were too few children below this age included the studies.
Danish: Det var dog ikke muligt at afgøre, om Alisade virkede hos børn under seks år, fordi der deltog for få børn i den aldersgruppe i undersøgelsen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fluticasone Furoate GSK to Glaxo Group Ltd on 6 October 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Alisade til Glaxo Group Limited den 6. oktober 2008.
English: The Committee recommended that Alisade be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Alisade.
English: fluticasone furoate EPAR summary for the public
Danish: fluticasonfuroat EPAR - sammendrag for offentligheden
English: The most common side effect with Alisade (seen in more than 1 patient in 10) is epistaxis (nosebleeds).
Danish: Den hyppigste bivirkning ved Alisade (som ses hos mere end 1 ud af hver 10 patienter) er epistaksis (næseblod).
English: The full EPAR for Alisade can be found here.
Danish: Den fuldstændige EPAR om Alisade findes her.
English: Alisade should only be used for as long as the patient is exposed to the allergen, such as pollen, house dust mites or other animals.
Danish: Alisade må kun bruges så længe, patienten er udsat for allergener såsom pollen, husstøvmider eller andre dyr.
English: Previously known as Fluticasone Furoate GSK.
Danish: Tidligere kendt under navnet fluticasonfuroat GSK.
English: The active substance in Alisade, fluticasone furoate, is a corticosteroid.
Danish: Det aktive stof i Alisade, fluticasonfuroat, er et kortikosteroid.
English: In all of the studies, the main measure of effectiveness was the change in four symptoms of allergy affecting the nose.
Danish: I alle undersøgelser blev behandlingens virkning hovedsagelig bedømt ved at se på ændringen i fire allergisymptomer, som påvirkede næsen.
English: Alisade was compared with placebo (a dummy treatment) in six main studies involving almost 2,500 patients.
Danish: Virkningen af Alisade blev først sammenlignet med placebo (et virkningsløst præparat) i 6 hovedundersøgelser, som omfattede næsten 2 500 patienter.
English: Alisade is used to treat the symptoms of allergic rhinitis.
Danish: Alisade anvendes til at behandle symptomer på allergisk rhinitis.
English: Alisade is for use in patients aged six years and over.
Danish: Alisade kan anvendes af patienter fra seks år og derover.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Alisade's benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Alisade er større end risiciene ved behandling af symptomer på allergisk rhinitis hos patienter fra seks år og derover.
English: In the study of perennial allergic rhinitis, Alisade had reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.
Danish: I undersøgelsen med tilbagevendende allergisk rhinitis reducerede Alisade scoren med 3,6 point efter fire uger sammenlignet med en reduktion på 2,8 point med placebo.
English: Why has Alisade been approved?
Danish: Hvorfor blev Alisade godkendt?
English: What is the risk associated with Alisade?
Danish: Hvilken risiko er der forbundet med Alisade?
English: In the studies of seasonal allergic rhinitis in patients aged 12 years or over, Alisade reduced symptom scores from around 9 points at the start of the study by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo.
Danish: I undersøgelserne af sæsonbestemt allergisk rhinitis hos patienter fra 12 år reducerede Alisade symptomscoren på omkring 9 point ved behandlingens begyndelse med mellem 3,6 og 5,4 point i løbet af to uger sammenlignet med en reduktion på 2,3 til 3,7 ved brug af placebo.
English: Alisade was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over.
Danish: Alisade var mere effektivt end placebo med hensyn til at reducere symptomer ved allergisk rhinitis hos patienter fra seks år og derover.
English: This is inflammation of the nasal passages caused by an allergy, resulting in runny nose, blocked nose, itching and sneezing.
Danish: Det er en betændelse i næsepassagerne, som forårsages af allergi, hvilket giver løbende næse, stoppet næse, kløe og nysen.
English: Alisade is a nasal spray that contains the active substance fluticasone furoate.
Danish: Alisade er en næsespray, der indeholder det aktive stof fluticasonfuroat
English: The recommended dose of Alisade for patients aged 12 years and over is two sprays in each nostril once a day.
Danish: Den anbefalede dosis Alisade for patienter fra 12 år og derover er to pust i hvert næsebor en gang om dagen.
English: The first four studies looked at Alisade used in patients aged 12 years or over: three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis (hay fever), while the fourth lasted four weeks and involved 302 patients with perennial (nonseasonal) allergies, such as allergies to animals.
Danish: Tre af disse var kortvarige undersøgelser, der varede to uger og omfattede i alt 886 patienter med sæsonbestemt allergisk rhinitis (høfeber), mens den fjerde varede fire uger og omfattede 302 patienter med tilbagevendende (ikke-sæsonbestemte) allergier, f.eks. allergier over for dyreskæl (hud og hår).
English: The other two studies were carried out in children aged between two and 11 years: the first involved 558 children with perennial allergic rhinitis and the second involved 554 children with seasonal allergic rhinitis.
Danish: Den første omfattede 558 børn med tilbagevendende allergisk rhinitis, og den anden omfattede 554 børn med sæsonbestemt allergisk rhinitis.
English: For the full list of all side effects reported with Alisade, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Alisade fremgår af indlægssedlen.
English: Alisade should not be used in people who are allergic to fluticasone furoate or any of the other ingredients.
Danish: Alisade må ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for fluticasonfuroat eller nogen af indholdsstofferne.
English: How has Alisade been studied?
Danish: Hvordan blev Alisade undersøgt?
English: What benefit has Alisade shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Alisade?
English: What is Alisade used for?
Danish: Hvad anvendes Alisade til?
English: What is Alisade?
Danish: Hvad er Alisade?
English: How is Alisade used?
Danish: Hvordan anvendes Alisade?
English: The company informed the CHMP that this withdrawal has no consequences for patients.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ikke har nogen konsekvenser for patienter.
English: Two medicines are bioequivalent when they produce the same levels of the active substances in the body.
Danish: To lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the time required to generate the supporting data makes this product unviable.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den tid, der er nødvendig for at generere understøttende data, gør, at produktet ikke er rentabelt.
English: The CHMP was concerned that there was uncertainty about how the bioequivalence study was conducted.
Danish: CHMP var betænkelig ved, at der var usikkerhed om, hvordan bioækvivalensundersøgelsen var blevet gennemført.
English: It was expected to reduce the risk of fractures (broken bones) in the spine and the hip.
Danish: Det forventedes at mindske risikoen for knoglebrud i rygsøjlen og hoften.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the medicine could not have been approved based on the data presented by the company.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at lægemidlet ikke kunne være blevet godkendt på grundlag af de oplysninger, der var forelagt af virksomheden.
English: Alendronic acid reduces the loss of bone tissue and colecalciferol, also known as vitamin D3, increases the absorption of calcium and formation of bone.
Danish: Alendronsyre reducerer tabet af knoglevæv, og colecalciferol, der også kaldes D3-vitamin, øger absorptionen af kalcium og knogledannelsen.
English: On 27 May 2016, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Alendronic Acid/Colecalciferol Mylan, for the treatment of postmenopausal osteoporosis in women at risk of vitamin D deficiency.
Danish: Den 27. maj 2016 meddelte Mylan SAS officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Alendronic Acid/Colecalciferol Mylan til behandling af knogleskørhed (osteoporose) hos kvinder efter overgangsalderen med risiko for D-vitaminmangel.
English: The CHMP also considered that data from the study do not convincingly establish that Alendronic Acid/Colecalciferol Mylan is sufficiently similar to the reference medicine, Fosavance.
Danish: CHMP vurderede også, at data fra undersøgelsen ikke i overbevisende grad fastslog, at Alendronic Acid/Colecalciferol Mylan svarer tilstrækkeligt til referencelægemidlet Fosavance.
English: Alendronic Acid/Colecalciferol Mylan is a medicine that contains two active substances: alendronic acid and colecalciferol.
Danish: Alendronic Acid/Colecalciferol Mylan er et lægemiddel, der indeholder to aktive stoffer: alendronsyre og colecalciferol.
English: This means that Alendronic Acid/Colecalciferol Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Fosavance.
Danish: Det betyder, at det var hensigten, at Alendronic Acid/Colecalciferol Mylan skulle være identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Fosavance.
English: Because Alendronic Acid/Colecalciferol Mylan is a generic medicine, the company had presented results of a study to determine that Alendronic Acid/Colecalciferol Mylan is bioequivalent to the reference medicine, Fosavance.
Danish: Da Alendronic Acid/Colecalciferol Mylan er et generisk lægemiddel, har virksomheden fremlagt undersøgelser, der skulle vise, at Alendronic Acid/Colecalciferol Mylan er bioækvivalent med referencelægemidlet Fosavance.
English: Alendronic Acid/Colecalciferol Mylan was developed as a ‘generic medicine'.
Danish: Alendronic Acid/Colecalciferol Mylan er udviklet som et "generisk lægemiddel".
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Alendronic Acid/Colecalciferol Mylan could not have been approved for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Danish: Efter gennemgang af de oplysninger, der forelå på tilbagetrækningstidspunktet, havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Alendronic Acid/Colecalciferol Mylan ikke kunne godkendes til behandling af knogleskørhed hos kvinder efter overgangsalderen med risiko for Dvitaminmangel.
English: Alendronic Acid/Colecalciferol Mylan is expected to work in the same way as the reference medicine, Fosavance.
Danish: Alendronic Acid/Colecalciferol Mylan forventes at virke på samme måde som referencelægemidlet Fosavance.
English: What is Alendronic Acid/Colecalciferol Mylan?
Danish: Hvad er Alendronic Acid/Colecalciferol Mylan?
English: Alendronic Acid/Colecalciferol Mylan was to be used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of insufficient vitamin-D levels.
Danish: Alendronic Acid/Colecalciferol Mylan skulle anvendes til behandling af knogleskørhed (osteoporose) hos kvinder efter overgangsalderen, som har risiko for D-vitaminmangel.
English: What was Alendronic Acid/Colecalciferol Mylan expected to be used for?
Danish: Hvad forventedes Alendronic Acid/Colecalciferol Mylan anvendt til?
English: How is Alendronic Acid/Colecalciferol Mylan expected to work?
Danish: Hvordan forventes Alendronic Acid/Colecalciferol Mylan at virke?
English: EMA/354096/2016
Danish: juni 2016
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 Alendronic Acid/Colecalciferol Mylan eller i programmer for anvendelse af Alendronic Acid/Colecalciferol Mylan med særlig udleveringstilladelse?
English: What is Adlumiz?
Danish: Hvad er Adlumiz?
English: It was to be available as 100 mg tablets to be taken by mouth.
Danish: Det skulle leveres som 100 mg-tabletter, der tages gennem munden.
English: What was Adlumiz expected to be used for?
Danish: Hvad forventedes Adlumiz anvendt til?
English: This meant that a thorough evaluation of potential risks with Adlumiz was not possible.
Danish: Det betyder, at det ikke har været muligt at foretage en grundig vurdering af de potentielle risici ved Adlumiz.
English: The company that applied for authorisation is Helsinn Birex Pharmaceuticals Ltd.
Danish: Den virksomhed, der har indgivet ansøgningen, er Helsinn Birex Pharmaceuticals Ltd.
English: The company requested a re-examination of the initial opinion.
Danish: Virksomheden har anmodet om revurdering af udtalelsen.
English: Activation of the receptor causes release of substances in the body which are expected to act in the brain to increase appetite and prevent weight loss.
Danish: Aktivering af receptoren medfører frigivelse af stoffer i kroppen, der forventes at påvirke hjernen på en sådan måde, at appetitten øges, så vægttab kan forebygges.
English: Therefore the CHMP was of the opinion that the benefits of Adlumiz did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CHMP var derfor af den opfattelse, at fordelene ved Adlumiz ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: Adlumiz is a medicine that contains the active substance anamorelin hydrochloride.
Danish: Adlumiz er et lægemiddel, der indeholder det aktive stof anamorelinhydrochlorid.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Danish: CHMP gennemgik begrundelsen for anmodningen og revurderede udtalelsen, men bekræftede den 14. september 2017 afslaget på ansøgningen om markedsføringstilladelse.
English: In addition, following an inspection at clinical study sites, CHMP considered that the safety data on the medicine had not been recorded adequately.
Danish: Efter inspektion på forsøgscentrene mener CHMP desuden, at der ikke er registreret tilstrækkelige data om lægemidlets sikkerhed.
English: Adlumiz attaches to and activates a target on cells called a ghrelin receptor.
Danish: Adlumiz binder til og aktiverer en struktur i cellerne, der kaldes en ghrelin-receptor.
English: The company presented results of two main studies involving a total of around 1,000 non-small cell lung cancer patients with cachexia.
Danish: Virksomheden fremlagde resultater fra to hovedundersøgelser, der omfattede i alt ca. 1.000 patienter med ikke-småcellet lungekræft og kakeksi (muskelsvækkelse og ekstrem afmagring).
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Adlumiz, intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer.
Danish: Den 18. maj 2017 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse og anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Adlumiz, der er beregnet til behandling af anoreksi (appetitløshed), kakeksi (muskelsvækkelse og ekstrem afmagring) eller uønsket vægttab hos patienter med ikke-småcellet lungekræft.
English: Patients were given either Adlumiz or placebo (a dummy treatment) and the main measures of effectiveness were changes in lean body mass (body weight excluding fat) and hand grip strength.
Danish: Patienterne fik enten Adlumiz eller placebo (et ikke-aktivt stof), og de primære mål for virkning var ændringer i Lean Body Mass (legemsvægt uden kropsfedt) og gribestyrke i hænderne.
English: The CHMP concluded that the studies show a marginal effect of Adlumiz on lean body mass and no proven effect on hand grip strength or patients' quality of life.
Danish: Ifølge CHMP fremgår det af undersøgelserne, at Adlumiz kun har marginal effekt på Lean Body Mass (legemsvægten uden kropsfedt) og ingen dokumenteret effekt på gribestyrken i hænderne eller patienternes livskvalitet.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with Adlumiz.
Danish: Virksomheden har til CHMP oplyst, at der for øjeblikket ikke gennemføres kliniske undersøgelser eller programmer for anvendelse af Adlumiz med særlig udleveringstilladelse i Europa.
English: How does Adlumiz work?
Danish: Hvordan virker Adlumiz?