FrancophonIA/ELRC3.0 huggingface dataset:
English: Response was maintained for an average of 14.9 months in the first study, and 15.2 months in the second study.
Danish: Responsen varede i gennemsnit 14,9 måneder i det første studie og 15,2 måneder i det andet studie.
English: The medicine is available as capsules (150 mg).
Danish: Lægemidlet fås som kapsler (150 mg).
English: As for all medicines, data on the use of Alecensa are continuously monitored.
Danish: Som for alle lægemidler bliver oplysningerne vedrørende brugen af Alecensa løbende overvåget.
English: The European Medicines Agency decided that Alecensa's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Alecensa opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Other information about Alecensa
Danish: Andre oplysninger om Alecensa
English: The most common side effects with Alecensa (which may affect more than 2 in 10 people) are constipation, muscle pain and oedema (swelling) including of the ankles and feet, the face, the eyelids and the area around the eyes.
Danish: De hyppigste bivirkninger ved Alecensa (som optræder hos mere end 2 ud af 10 patienter) er forstoppelse, muskelsmerter og ødem (hævelse), herunder i anklerne og fødderne, ansigtet, øjenlågene og omkring øjnene.
English: What measures are being taken to ensure the safe and effective use of Alecensa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Alecensa?
English: Alecensa can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.
Danish: Alecensa udleveres kun på recept, og behandlingen skal påbegyndes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: In the second study, the complete or partial response rate at the time of analysis was 51% (62 out of 122 patients).
Danish: I det andet studie var der på analysetidspunktet komplet eller delvis respons hos 51 % (62 ud af 122 patienter).
English: Two main studies involved a total of 225 patients in whom the disease progressed despite previous treatment with Xalkori (crizotinib).
Danish: Der er gennemført to hovedstudier med i alt 225 patienter, hos hvem sygdommen udviklede sig på trods af tidligere behandling med Xalkori (crizotinib).
English: For more information about using Alecensa, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Alecensa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Side effects reported with Alecensa are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Alecensa vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The recommended usual dose is 4 capsules taken twice a day with food (1,200 mg in total).
Danish: Den anbefalede dosis er normalt 4 kapsler, der tages to gange om dagen i forbindelse med et måltid (1 200 mg i alt).
English: An overview of Alecensa and why it is authorised in the EU
Danish: Oversigt over Alecensa, og hvorfor det er godkendt i EU
English: Alecensa contains the active substance alectinib.
Danish: Alecensa indeholder det aktive stof alectinib.
English: The safety profile of Alecensa was considered acceptable and in line with that of other ALK inhibitors.
Danish: Alecensas sikkerhedsprofil blev anset for acceptabel og for at svare til andre ALK-hæmmeres sikkerhedsprofil.
English: Why is Alecensa authorised in the EU?
Danish: Hvorfor er Alecensa godkendt i EU?
English: After 1 year of treatment, 68% of patients receiving Alecensa lived without their disease getting worse compared with 49% of patients receiving Xalkori.
Danish: Efter et års behandling havde 68 % af de patienter, der fik Alecensa, ikke oplevet sygdomsforværring sammenlignet med 49 % blandt de patienter, der fik Xalkori.
English: What is Alecensa and what is it used for?
Danish: Hvad er Alecensa, og hvad anvendes det til?
English: Alecensa was compared with Xalkori and the main measure of effectiveness was how long patients lived without their disease getting worse.
Danish: Alecensa blev sammenlignet med Xalkori, og virkningen blev hovedsagelig målt på, hvor længe patienterne levede, uden at sygdommen forværredes.
English: For patients with severe liver impairment the recommended dose is 3 capsules taken twice a day with food (900 mg in total).
Danish: Til patienter med svært nedsat leverfunktion er den anbefalede dosis 3 kapsler, der tages to gange om dagen i forbindelse med et måltid (900 mg i alt).
English: ALK belongs to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Danish: ALK tilhører en familie af proteiner, der kaldes receptor-tyrosinkinaser, (RTK), som medvirker ved cellers vækst og ved udviklingen af nye blodkar, der forsyner dem.
English: What are the risks associated with Alecensa?
Danish: Hvilke risici er der forbundet med Alecensa?
English: The third study involved 303 patients whose ALK-positive NSCLC had not been treated before.
Danish: Det tredje studie omfattede 303 patienter med ALK-positiv NSCLC, der ikke tidligere var blevet behandlet.
English: The doctor may reduce the dose or stop treatment temporarily if side effects occur.
Danish: Hvis der opstår bivirkninger, kan lægen nedsætte dosis eller midlertidigt standse behandlingen.
English: Alecensa is a cancer medicine used to treat adults with a lung cancer called non-small-cell lung cancer (NSCLC), when the disease is advanced and has not been treated before or has been treated before with a cancer medicine called Xalkori (crizotinib).
Danish: Alecensa er et kræftmiddel, der anvendes til behandling af voksne med ikkesmåcellet lungekræft (NSCLC), når sygdommen er fremskreden og ikke har været behandlet tidligere eller har været behandlet med et kræftmiddel, der hedder Xalkori (crizotinib).
English: Alecensa was also better than Xalkori at treating previously untreated patients with ALK-positive NSCLC.
Danish: Alecensa var også bedre end Xalkori til behandling af tidligere ubehandlede patienter med ALK-positiv NSCLC.
English: Patients whose disease progresses during or shortly after treatment with Xalkori currently have very limited treatment options and Alecensa can be of benefit in these patients.
Danish: Der er på nuværende tidspunkt meget få behandlingsmuligheder for patienter, hos hvem sygdommen udvikler sig under behandling med Xalkori eller kort tid derefter, og Alecensa kan være gavnlig hos disse patienter.
English: In both studies Alecensa was not compared with any other treatment or placebo (a dummy treatment).
Danish: Alecensa blev ikke sammenlignet med anden behandling eller placebo (et uvirksomt stof) i nogen af de to studier.
English: In patients with ALKpositive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion.
Danish: Hos patienter med ALK-positiv NSCLC dannes en unormal form af ALK, der stimulerer kræftcellerne til at dele sig og vokse ukontrolleret.
English: Alecensa is used on its own and only if the NSCLC is ‘ALK-positive', which means that the cancer cells have certain defects affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).
Danish: Alecensa anvendes alene og kun ved NSCLC, der er "ALK-positiv", dvs. at kræftcellerne har visse defekter i det gen, der producerer proteinet ALK (anaplastisk lymfom kinase).
English: For the full list of side effects and restrictions with Alecensa, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Alecensa fremgår af indlægssedlen.
English: The active substance in Alecensa, alectinib, is an ALK inhibitor and works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.
Danish: Det aktive stof i Alecensa, alectinib, virker ved at blokere aktiviteten af ALK, hvorved kræftens vækst og udbredelse nedsættes.
English: Alecensa has been shown to be effective in treating ALK-positive NSCLC in three studies.
Danish: Det er i tre studier blevet påvist, at Alecensa er effektivt til at behandle ALK-positiv NSCLC.
English: How is Alecensa used?
Danish: Hvordan anvendes Alecensa?
English: What benefits of Alecensa have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Alecensa?
English: In the first study around 52% of patients given Alecensa (35 out of 67) were considered by the treating doctors to have shown a complete or partial response to the medicine at the time of analysis.
Danish: I det første studie var der ifølge de behandlende læger på analysetidspunktet fuldstændig eller delvis respons på lægemidlet hos ca. 52 % af de patienter, der fik Alecensa (35 ud af 67).
English: Genetic defects affecting ALK (‘ALK-positive' status) should be confirmed in advance by appropriate methods.
Danish: Det bør på forhånd være fastslået ved hjælp af passende metoder, at patienten har gendefekten for ALK (er "ALK-positiv").
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alecensa have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Alecensa.
English: Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Danish: Virkningen af behandlingen (responsen) blev vurderet ved kropsskanning og standardiserede kriterier for organtumorer.
English: How does Alecensa work?
Danish: Hvordan virker Alecensa?
English: Date of first authorisation: 28th August 2015
Danish: Dato for første markedsføringstilladelse: 28 August 2015
English: Talc(E553b)
Danish: Talkum (E553b)
English: • Inappropriate behaviour.
Danish: • Upassende opførsel.
English: • Difficulty with writing properly.
Danish: • Problemer med at skrive korrekt.
English: It is advised not to drink alcohol while taking this medicine.
Danish: Det tilrådes ikke at drikke alkohol, når du tager dette lægemiddel.
English: • Your doctor will tell you to take this medicine either twice or three times a day.
Danish: • Din læge vil fortælle, at du enten skal tage dette lægemiddel 2 gange eller 3 gange dagligt.
English: • Slow or reduced movement of the body.
Danish: • Langsom eller nedsat kropsbevægelse.
English: Package Leaflet: Information For The User
Danish: Indlægsseddel: Information til brugeren
English: These symptoms may occur more commonly or severely if you have been taking this medicine for a longer period of time.
Danish: Disse symptomer kan forekomme oftere eller i en alvorligere grad, hvis du har taget dette lægemiddel i længere tid.
English: If you are an elderly patient (over 65 years of age), you should take this medicine normally except if you have problems with your kidneys.
Danish: Hvis du er ældre (over 65 år), skal du tage dette lægemiddel som normalt, medmindre du har nyreproblemer.
English: Pregabalin Accord with food, drink and alcohol
Danish: Brug af Pregabalin Accord sammen med mad, drikke og alkohol
English: Pregabalin Accord should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Danish: Pregabalin Accord bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (hvis fordelene for moderen klart opvejer den mulige risiko for fosteret/det nyfødte barn).
English: • Increased appetite.
Danish: • Øget appetit.
English: This should be considered when prescribing pregabalin in this condition.
Danish: Der bør tages hensyn til dette, når pregabalin ordineres til denne tilstand.
English: Pregabalin Accord and certain other medicines may influence each other (interaction).
Danish: Pregabalin Accord og anden medicin kan påvirke hinanden (interaktion).
English: Pregabalin Accord is for oral use only.
Danish: Pregabalin Accord er kun til oral anvendelse.
English: Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands
Danish: Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Holland
English: Pregabalin Accord is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Danish: Pregabalin Accord er ikke beregnet til at blive brugt alene, men skal altid anvendes i kombination med anden behandling mod epilepsi.
English: Continue taking this medicine until your doctor tells you to stop.
Danish: Fortsæt med at tage dette lægemiddel, indtil din læge beder dig om at stoppe.
English: Angioedema, allergic reaction
Danish: Angioødem, allergiske reaktioner.
English: These platelet changes were not present in rats or in humans based on short-term and limited long-term clinical data.
Danish: Disse trombocytændringer er ikke til stede hos rotter eller hos mennesker baseret på kliniske korttids- eller begrænsede langtidsdata.
English: It is important to take your medicine regularly at the same time each day.
Danish: Det er vigtigt, at du tager dette lægemiddel regelmæssigt og på samme tid hver dag.
English: If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Danish: Hvis Du glemmer at tage en dosis, skal du tage den straks, du kommer i tanke herom, medmindre det er ved at være tid for din næste dosis.
English: Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Danish: Variabiliteten i farmakokinetikken for pregabalin hos forskellige forsøgspersoner er lav (< 20%).
English: This medicine is used to treat long lasting pain caused by damage to the nerves.
Danish: Dette lægemiddel anvendes til behandling af langvarige smerter, som skyldes beskadigede nervebaner.
English: This medicine is for oral use only.
Danish: Dette lægemiddel er kun til oral anvendelse.
English: 08039 Barcelona, Spain
Danish: 08039 Barcelona, Spanien
English: Oxycodone - (used as a pain-killer) Lorazepam - (used for treating anxiety) Alcohol
Danish: Oxycodon - (er et smertestillende middel) Lorazepam - (anvendes til behandling af angst) Alkohol
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V .
English: This medicine may be taken with or without food.
Danish: Dette lægemiddel kan tages både sammen med og uden mad.
English: Warnings and Precautions
Danish: Advarsler og forsigtighedsregler
English: • Coldness of hands and feet.
Danish: • Kolde hænder og fødder.
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5-methylhexanoic acid].
Danish: Det aktive indholdsstof, pregabalin, er en gamma-aminosmørsyre-analog [(S)-3-(aminomethyl)-5methylhexansyre].
English: UNIQUE IDENTIFIER-HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: • Painful menstrual periods.
Danish: • Smertefuld menstruation.
English: In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 L/kg.
Danish: Hos mennesker er pregabalins tilsyneladende fordelingsvolumen efter oral indgift ca. 0,56 l/kg.
English: This medicine is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Danish: Dette lægemiddel anvendes til behandling af visse former for epilepsi (partielle anfald med eller uden sekundær generalisering) hos voksne.
English: This medicine may produce dizziness, sleepiness and decreased concentration.
Danish: Dette lægemiddel kan give svimmelhed, søvnighed og nedsat koncentrationsevne.
English: If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du har indtryk af, at virkningen af dette lægemiddel er for stærk eller alt for svag, skal du tale med din læge eller apotekspersonalet.
English: Your doctor will prescribe PregabalinAccord for you to help treat your epilepsy when your current treatment is not controlling your condition.
Danish: Din læge vil udskrive Pregabalin Accord til behandling af din epilepsi, hvis din nuværende behandling ikke kan kontrollere din tilstand.
English: Pregabalin Accord may be taken with or without food.
Danish: Pregabalin Accord kan tages med eller uden mad.
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Danish: Farmakoterapeutisk klassifikation: Antiepileptika, andre antiepileptika, ATC-kode: N03AX16
English: Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom
Danish: Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, Storbritannien
English: You should take Pregabalin Accord in addition to your current treatment.
Danish: Du skal tage Pregabalin Accord sammen med din nuværende behandling.
English: For three times a day take this medicine once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Danish: For 3 gange dagligt skal dette lægemiddel tages én gang om morgenen, én gang om eftermiddagen og én gang om aftenen, og omtrent samme tid hver dag.
English: Efficacy has not been studied in other models of neuropathic pain.
Danish: Effekten i andre modeller af neuropatiske smerter er ikke undersøgt.
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Accord is taken together with medicines containing:
Danish: Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Pregabalin Accord tages sammen med lægemidler, der indeholder:
English: • A small number of people being treated with anti-epileptics such as Pregabalin Accord have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel Pregabalin Accord har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: A meta-analysis of randomised placebo controlled studies of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Danish: En metaanalyse af randomiserede, placebokontrollerede studier med antiepileptika har også vist en let forøget risiko for selvmordstanker og -adfærd.
English: • Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence.
Danish: • Inden du tager denne medicin, skal du fortælle lægen, hvis du har eller tidligere har haft et misbrug af alkohol, stoffer eller medicin eller har været afhængig.
English: UNIQUE IDENTIFIER-2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: This medicine should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Danish: Dette lægemiddel bør ikke tages under graviditet, eller mens du ammer, medmindre din læge har givet dig en anden besked.
English: In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by Week 1 and was maintained throughout the treatment period.
Danish: I kliniske studier op til 12 uger af både perifere og centrale neuropatiske smerter ses en reduktion af smerter efter 1 uge, og denne reduktion opretholdes gennem hele behandlingsperioden.
English: • Loss of appetite, weight loss, low blood sugar, high blood sugar.
Danish: • Manglende appetit, vægttab, lavt blodsukker, højt blodsukker.
English: Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.
Danish: Pregabalin bindes til en hjælpeundergruppe (2- protein) i de spændingsafhængige calciumkanaler i centralnervesystemet.
English: Pregabalin was excreted into breast milk with average steady-state concentrations approximately 76% of those in maternal plasma.
Danish: Pregabalin blev udskilt i modermælken med gennemsnitlige koncentrationer ved steady state på ca. 76% af de koncentrationer, der sås i moderens plasma.
English: A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles.
Danish: Flere forskellige sygdomme kan være årsag til disse perifere neuropatiske smerter, f.eks. diabetes eller helvedesild.
English: Adverse reactions on male reproductive organs and sperm parameters were reversible and occurred only at exposures sufficiently in excess of therapeutic exposure or were associated with spontaneous degenerative processes in male reproductive organs in the rat.
Danish: Bivirkninger på de mandlige forplantningsorganer og spermparametre var reversible og opstod kun ved eksponeringer, der i væsentlig grad oversteg den terapeutiske eksponering, eller som var forbundet med spontane, degenerative processer i de mandlige forplantningsorganer hos rotten.
English: • Difficulty with or painful urination, incontinence.
Danish: • Vanskelighed ved eller smertefuld vandladning, inkontinens.
English: Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life.
Danish: Perifere og centrale neuropatiske smerter kan også være forbundet med humørsvingninger, søvnforstyrrelser, træthed (udmattelse) og kan have indflydelse på det fysiske og sociale velvære, og den samlede livskvalitet.
English: You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Danish: Du bør ikke køre bil, betjene indviklede maskiner eller udsætte dig for andre aktiviteter, der kan være farlige, før du ved, om denne medicin påvirker din evne til at udføre disse aktiviteter.
English: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for pregabalin, eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: BID = Two divided doses * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose + Supplementary dose is a single additional dose
Danish: Engangsdosis * Total døgndosis (mg/døgn) skal fordeles som anført under dosisinterval for at give mg/dosis Supplerende dosis er en enkelt tillægsdosis.
English: • Some patients taking this medicine have reported symptoms suggesting an allergic reaction.
Danish: • Hos nogle patienter, der tager dette lægemiddel, er der rapporteret om symptomer, der tyder på en overfølsomhedsreaktion.
English: For twice a day take this medicine once in the morning and once in the evening, at about the same time each day.
Danish: For 2 gange dagligt skal dette lægemiddel tages én gang om morgenen og én gang om aftenen, og omtrent samme tid hver dag.
English: If at any time you have these thoughts, immediately contact your doctor.
Danish: Hvis du på noget tidspunkt får sådanne tanker, bør du straks kontakte din læge.
English: Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Danish: Pregabalin Accord er indiceret som supplerende behandling til voksne med refraktære partielle anfald med eller uden sekundær generalisering.
English: Pregabalin Accord may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Danish: Pregabalin Accord kan forårsage svimmelhed og søvnighed, og derfor kan det påvirke evnen til at køre bil eller betjene maskiner.