FrancophonIA/ELRC3.0 huggingface dataset:
English: Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Danish: Gennembrudssmerter vil sige, at patienten pludselig får flere smerter trods løbende behandling med smertestillende midler.
English: The Committee noted that several cases of misuse or abuse of the medicine had been reported in the studies, and was concerned about the risk of addiction in non-cancer patients when using Effentora in the long term.
Danish: Udvalget konstaterede, at der var beskrevet adskillige tilfælde af forkert brug eller misbrug af lægemidlet i undersøgelserne og var betænkelig ved risikoen for afhængighed ved længerevarende anvendelse hos andre patienter end kræftpatienter.
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 concerns and was of the provisional opinion that Effentora could not have been approved for the treatment of breakthrough pain in adults with long-term pain other than cancer pain.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Effentora ikke kunne godkendes til behandling af gennembrudssmerter hos voksne med længerevarende smerter af anden årsag end kræft.
English: In adults with long-term pain due to causes other than cancer, Effentora was expected to work in the same way as it does in adults with cancer pain.
Danish: Hos voksne med længerevarende smerter af anden årsag end kræft forventedes Effentora at virke på samme måde som hos voksne med smerter forårsaget af kræft.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Effentora in patients with non-cancer-related long-term pain did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Effentora til patienter med længerevarende smerter af anden årsag end kræft ikke opvejede risiciene.
English: In Effentora, it is given as a buccal tablet, so that fentanyl is absorbed through the lining of the mouth.
Danish: I Effentora gives det som en bukkaltablet, der bevirker, at fentanyl optages gennem mundslimhinden.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Effentora?
English: Effentora was also expected to be used to treat breakthrough pain in adults with long-term persistent pain from causes other than cancer, who were already receiving regular treatment with opioids to control their persistent pain.
Danish: Effentora forventedes også anvendt til behandling af gennembrudssmerter hos voksne, som har vedvarende smerter af anden årsag end kræft og i forvejen får regelmæssig behandling med opioider til kontrol af smerterne.
English: The CHMP considered that, although the use of Effentora is accepted in cancer patients who have limited survival, further data were needed to support its safe use in adults with non-cancer-related pain, who have normal life expectancy and may need long-term treatment.
Danish: Anvendelse af Effentora accepteres hos kræftpatienter med begrænset overlevelse, men CHMP fandt, at der må kræves flere data til at underbygge dets sikkerhed hos voksne, der har smerter af anden årsag end kræft, og som har en normal forventet levetid og kan behøve længerevarende behandling.
English: On 11 July 2013, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Effentora, to extend the treatment for breakthrough pain to adult patients with chronic (long-term) persistent pain from causes other than cancer.
Danish: officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om en ny indikation for Effentora, der ville betyde, at behandling af gennembrudssmerter blev udvidet til at omfatte voksne patienter med kroniske (længerevarende) smerter af anden årsag end kræft.
English: Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemidde lform
English: The main studies lasted for two to four weeks.
Danish: Hovedundersøgelserne varede to til fire uger.
English: The marketing authorisation was renewed on 12 March 2004 and on 12 March 2009.
Danish: Markedsføringstilladelsen blev fornyet den 12. marts 2004 og den 12. marts 2009.
English: Sonata has been studied in a total of 14 studies, involving nearly 3,500 adults and elderly patients.
Danish: Sonata var genstand for i alt 14 undersøgelser med deltagelse af næsten 3 500 voksne og ældre patienter.
English: Other information about Sonata:
Danish: Andre oplysninger om Sonata:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sonata on 12 March 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sonata den 12. marts 1999.
English: It is available as capsules (white and brown: 5 mg; white: 10 mg).
Danish: Det leveres som kapsler (hvide og lysebrune: 5 mg, og hvide: 10 mg).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SONATA EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) SONATA EPAR - sammendrag for offentligheden
English: Zaleplon is chemically different from the benzodiazepines, but it acts on the same receptors in the brain.
Danish: Zaleplon er kemisk forskelligt fra benzodiazepinerne, men virker på de samme receptorer i hjernen.
English: The full EPAR for Sonata is available here.
Danish: Den fuldstændige EPAR for Sonata findes her.
English: Treatment with Sonata should be as short as possible and should last for no more than two weeks.
Danish: Sonata bør anvendes så kortvarigt som muligt og højst i to uger.
English: The Committee recommended that Sonata be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Sonata.
English: Sonata is taken immediately before going to bed, or after the patient has gone to bed and is having difficulty falling asleep.
Danish: Sonata tages umiddelbart før sengetid, eller når patienten er gået i seng og har svært ved at falde i søvn.
English: It is used only when the insomnia is severe, disabling or causing extreme distress.
Danish: Det anvendes kun, når søvnløsheden er alvorlig, invaliderende eller udsætter personen for ekstrem lidelse.
English: Some studies also looked at the time spent asleep and sleeping patterns.
Danish: Nogle undersøgelser så også nærmere på søvnlængde og søvnmønster.
English: Sonata is a medicine that contains the active substance zaleplon.
Danish: Sonata er et lægemiddel, der indeholder det aktive stof zaleplon.
English: The active substance in Sonata, zaleplon, belongs to a group of medicines that are related to the benzodiazepines.
Danish: Det aktive stof i Sonata, zaleplon, tilhører en gruppe lægemidler, der er beslægtet med benzodiazepiner.
English: The powder in Sonata capsules is coloured with an intense dark blue dye, to prevent it being given to someone without their knowledge.
Danish: Pulveret i Sonata-kapslerne er farvet kraftigt blåt for at undgå, at det kan gives til en person, uden at vedkommende opdager det.
English: Sonata 10 mg was more effective than placebo in decreasing the time taken to fall asleep and increasing time spent asleep during the first half of the night.
Danish: Sonata 10 mg var mere effektivt end placebo til at gøre indsovningstiden kortere og øge søvnlængden i første halvdel af natten.
English: It must not be used in patients with severe liver or kidney problems, sleep apnoea syndrome (frequent interruption of breathing during sleep), myasthenia gravis (a disease causing muscle weakness) or severe respiratory insufficiency (breathing disorders), or in patients under 18 years of age.
Danish: Det må ikke anvendes til patienter med svær lever- eller nyresygdom, søvnapnøsyndrom (hyppige åndedrætsophold under søvn), myasthenia gravis (en nervesygdom, der giver muskelsvækkelse) eller svært nedsat vejrtrækning, og må desuden ikke anvendes til patienter under 18 år.
English: The most common side effects with Sonata (seen in between 1 and 10 patients in 100) are amnesia (memory problems), paraesthesia (unusual sensations like pins and needles), somnolence (sleepiness) and dysmenorrhoea (painful menstruation).
Danish: De mest almindelige bivirkninger ved Sonata (som ses hos mellem 1 og 10 patienter ud af 100) er hukommelsesproblemer (amnesi), usædvanlige følefornemmelser som f.eks. prikken og stikken (paræstesi), søvnighed (somnolens), og stærke, smertefulde kramper under menstruation (dysmenoré).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Sonata's benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Sonata opvejer risiciene ved behandling af patienter, der lider af søvnløshed og har besvær med at falde i søvn, hvis lidelsen er alvorlig, invaliderende eller udsætter personen for ekstrem lidelse.
English: What is the risk associated with Sonata?
Danish: Hvilken risiko er der forbundet med Sonata?
English: The time taken to fall asleep was reduced in adults taking Sonata 10 mg, and the effects were maintained for up to four weeks.
Danish: Indsovningstiden blev kortere for de voksne patienter, som fik Sonata 10 mg, og virkningen holdt sig i indtil fire uger.
English: Five of these studies were comparative: Sonata was compared with placebo (a dummy treatment) or with zolpidem or triazolam (other medicines used in insomnia).
Danish: Fem af undersøgelserne var sammenlignende, hvor Sonata blev sammenlignet med placebo (uvirksom behandling) og med zolpidem eller triazolam (andre sovemidler).
English: Sonata should not be used in people who may be hypersensitive (allergic) to zaleplon or any of the other ingredients.
Danish: Sonata bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for zaleplon eller andre af indholdsstofferne.
English: Sonata also preserved sleep patterns in the studies that measured the time spent in different stages of sleep.
Danish: Det blev desuden påvist, at Sonata bevarede søvnmønsteret i de undersøgelser, hvor varigheden af de forskellige søvnstadier måltes.
English: For the full list of all side effects reported with Sonata, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Sonata fremgår af indlægssedlen.
English: Why has Sonata been approved?
Danish: Hvorfor blev Sonata godkendt?
English: Sonata must not be taken by children or by patients who have severe liver or kidney problems.
Danish: Sonata må ikke gives til børn eller patienter med svære lever- eller nyreproblemer.
English: The recommended dose is 10 mg, except for the elderly or patients with mild or moderate liver disease, who should take 5 mg.
Danish: Den anbefalede dosis er 10 mg, dog kun 5 mg til ældre og patienter med moderat leversygdom.
English: Sonata is used for the treatment of adults with insomnia who have difficulty falling asleep.
Danish: Sonata anvendes til behandling af voksne patienter, der lider af søvnløshed og som har besvær med at falde i søvn.
English: The main measure of effectiveness was the time taken to fall asleep.
Danish: Behandlingens virkning blev hovedsagelig bedømt på den tid, det tog at falde i søvn (indsovningstiden).
English: What is Sonata?
Danish: Hvad er Sonata?
English: By activating its receptors, zaleplon increases GABA's effects, which encourages sleep.
Danish: Ved at aktivere receptorerne øger zaleplon gammaaminosmørsyres søvnfremmende virkning.
English: In elderly patients, the time taken to fall asleep was often decreased with Sonata 5 mg and was always decreased with Sonata 10 mg, when they were compared with placebo in the two-week studies.
Danish: I to-ugersundersøgelserne hos ældre patienter afkortede Sonata 5 mg ofte indsovningstiden i forhold til placebo, mens Sonata 10 mg altid gav kortere indsovningstid end placebo.
English: For more information, see the Package Leaflet.
Danish: Yderligere oplysninger fremgår af indlægssedlen.
English: It is a gamma-amino butyric acid (GABA) receptor agonist, which means that it attaches to the receptors for the neurotransmitter GABA and activates them.
Danish: Det er en gammaaminosmørsyre (GABA) receptoragonist, dvs. det bindes til receptorerne for gammaaminosmørsyre-neurotransmitteren og aktiverer dem. Neurotransmittere som gammaaminosmørsyre er kemiske stoffer, som muliggør kommunikation mellem nervecellerne.
English: How has Sonata been studied?
Danish: Hvordan blev Sonata undersøgt?
English: What is Sonata used for?
Danish: Hvad anvendes Sonata til?
English: No food should be eaten with or shortly before taking Sonata, because it can reduce the medicine's effects.
Danish: Den maksimale daglige dosis af Sonata er 10 mg. Der må ikke tages to doser i løbet af én nat. Der bør ikke indtages mad sammen med eller umiddelbart inden indtagelsen af Sonata, da det kan svække lægemidlets virkning.
English: What benefit has Sonata shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Sonata?
English: How is Sonata used?
Danish: Hvordan anvendes Sonata?
English: In the brain, GABA is involved in bringing about sleep.
Danish: I hjernen medvirker gammaaminosmørsyre til at skabe søvnvirkningen.
English: How does Sonata work?
Danish: Hvordan virker Sonata?
English: Adopted at the 5-8 October 2015 PRAC
Danish: Vedtaget den 5.-8. oktober 2015, PRAC
English: Anakinra - Thrombocytopenia (EPITT no 18337)
Danish: Anakinra - Trombocytopeni (EPITT nr. 18337)
English: In clinical studies in RA and CAPS patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
Danish: I kliniske studier hos patienter med reumatoid artrit og kryopyrin-associerede periodiske syndromer (CAPS) blev trombocytopeni indberettet hos 1,9 % af patienterne i anakinragruppen sammenlignet med 0,3 % i placebogruppen.
English: Summary of Product Characteristics: Section 4.8 - Undesirable effects:
Danish: Punkt 4.8 - Bivirkninger:
English: Blood and lymphatic system disorders Frequency ‘common': thrombocytopenia
Danish: Blod og lymfesystem "Almindelig": Trombocytopeni
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/661880/2015
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger om signaler EMA/PRAC/680931/2015
English: Common side effects (may affect up to 1 in 10 people): - Thrombocytopenia (low level of blood platelets).
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): - Trombocytopeni (lavt antal blodplader)
English: Package Leaflet:
Danish: Produktresumé:
English: The thrombocytopenias have been mild, i.e. platelet counts have been >75 x109/l.
Danish: Tilfældene af trombocytopeni var lette, dvs. trombocyttal >75 x109/l.
English: During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l).
Danish: Efter markedsføring af Kineret er der indberettet trombocytopeni, herunder enkelte tilfælde af svær trombocytopeni (dvs. trombocyttal <10 x109/l).
English: Intravenous use Ethylen-vinyl-acetate cryo bag (EVA)
Danish: Intravenøs brug Ethylen-vinyl-acetat frysepose (EVA)
English: 1 bag
Danish: 1 pose
English: MA (EU) number
Danish: MA (EU)-nummer Særnavn Styrke
English: EU/1/16/1121/001 Zalmoxis
Danish: EU/1/16/1121/001 Zalmoxis 5-20 x 106 celler/mL Dispersion til infusion
English: Immediate Packaging Content Pack size
Danish: Indhold Pakningsstørrelse
English: 5-20 x 106 cells/mL
Danish: 10-100 ml
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, administrationsvej og indehavere af markedsføringstilladelser i medlemsstaterne
English: AstraZeneca S.p.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (Milano) Italy
Danish: Palazzo Volta Via F. Sforza 20080 - Basiglio (Milano) Italy
English: United Kingdom AstraZeneca UK Limited 600 Capability Green
Danish: Storbritannien AstraZeneca UK Limited 600 Capability Green
English: AstraZeneca S.A.
Danish: AstraZeneca S.p.A.
English: SEROQUEL XR 200 mg 200mg
Danish: SEROQUEL XR 200 mg
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110
Danish: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel, Belgium
English: SEROQUEL XR 150 mg 150mg
Danish: SEROQUEL XR 150 mg
English: SEROQUEL XR 400 mg 400mg
Danish: SEROQUEL XR 400 mg
English: SEROQUEL XR 300 mg 300mg
Danish: SEROQUEL XR 300 mg
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens, Greece
Danish: Grækenland AstraZeneca S.A. 4 Theotokopoulou & Astronafton str
English: EU/1/18/1349/001 DECTOVA
Danish: EU/1/18/1349/001
English: Intravenous use vial (glass)
Danish: Hætteglas (glas)
English: Solution for infusion
Danish: Infusionsvæske, opløsning
English: In both studies,
Danish: I begge
English: The recommended dose is one capsule once a day at the same time each day.
Danish: Den anbefalede dosis er en kapsel en gang dagligt på samme tidspunkt hver dag.
English: Patients should not use more than one capsule in a day.
Danish: Patienten bør ikke anvende mere end en kapsel dagligt.
English: The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment.
Danish: Agenturet bemærkede endvidere, at det, at lægemidlet tages én gang dagligt, kan gøre det lettere for patienterne at overholde behandlingen.
English: Further information on Seebri Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Seebri Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Danish: studier blev virkningen hovedsagelig målt på patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde, en person kan udånde på et sekund).
English: After 12 weeks of treatment, Seebri Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Danish: Efter 12 ugers behandling øgede Seebri Breezhaler FEV1 med 97 ml mere end med placebo i det første studie og 108 ml mere end i det andet studie.
English: This helps to keep the airways open and allows the patient to breathe more easily.
Danish: Dette hjælper med at holde luftvejene åbne, så patienten bedre kan trække vejret.
English: To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.
Danish: For at tage en dosis anbringer patienten en kapsel i inhalatoren og indånder pulveret fra kapslen gennem munden.
English: The most common side effects with Seebri Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Danish: De hyppigste bivirkninger ved Seebri Breezhaler (som optræder hos mere end 1 ud af 100 patienter) er tør mund, nasopharyngitis (betændelse i næse og svælg), søvnløshed, knogle- og muskelsmerter samt gastroenteritis (diarré og opkastning).
English: Seebri Breezhaler (glycopyrronium bromide) EMA/326863/2018
Danish: Seebri Breezhaler (glycopyrroniumbromid) EMA/326863/2018
English: As for all medicines, data on the use of Seebri Breezhaler are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Seebri Breezhaler løbende overvåget.
English: Seebri Breezhaler received a marketing authorisation valid throughout the EU for Seebri Breezhaler on 28 September 2012.
Danish: Seebri Breezhaler fik en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 28. september 2012.
English: Side effects reported with Seebri Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Seebri Breezhaler vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Danish: KOL er en langvarig sygdom, hvor luftveje og lungeblæresække bliver beskadiget eller blokeret, så det er vanskeligt at trække vejret.
English: The European Medicines Agency noted that Seebri Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at Seebri Breezhaler havde en beskeden, men relevant gavnlig virkning for patienter, idet det forbedrede lungefunktionen og symptomerne på KOL.
English: Therefore, the Agency decided that Seebri Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Seebri Breezhaler opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Seebri Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Danish: Seebri Breezhaler var mere effektivt end placebo (en virkningsløs behandling) til at lindre symptomerne ved KOL i to hovedstudier, hvori der indgik i alt 1 888 patienter med KOL.
English: Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways.
Danish: De muskarine receptorer styrer muskelsammentrækningen, og når glycopyrroniumbromid inhaleres, får det musklerne i luftvejene til at slappe af.
English: Seebri Breezhaler is used for maintenance (regular) treatment.
Danish: Seebri Breezhaler anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: For more information about using Seebri Breezhaler, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Seebri Breezhaler, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Seebri Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Seebri Breezhaler er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: An overview of Seebri Breezhaler and why it is authorised in the EU
Danish: En oversigt over Seebri Breezhaler og hvorfor det er godkendt i EU
English: Why is Seebri Breezhaler authorised in the EU?
Danish: Hvorfor blev Seebri Breezhaler godkendt i EU?
English: This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs.
Danish: Det betyder, at den udvider luftvejene ved at blokere visse receptorer i muskelcellerne i lungerne.
English: For more information about treatment with Seebri Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Seebri Breezhaler, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Seebri Breezhaler and what is it used for?
Danish: Hvad er Seebri Breezhaler, og hvad anvendes det til?
English: For the full list of all side effects and restrictions with Seebri Breezhaler, see the package leaflet.
Danish: Den fuldstændige liste over alle bivirkninger og begrænsninger ved Seebri Breezhaler fremgår af indlægssedlen.