FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with tumours can have high levels of calcium in their blood, released from the bones.
Danish: Patienter med tumorer kan have øget calciumindhold i blodet, der er afgivet fra knoglerne.
English: Zoledronic acid Teva is a ‘generic medicine'.
Danish: Zoledronsyre Teva er et »generisk lægemiddel«.
English: Other information about Zoledronic acid Teva
Danish: Andre oplysninger om Zoledronsyre Teva
English: Zoledronic acid Teva is a medicine that contains the active substance zoledronic acid.
Danish: Zoledronsyre Teva er et lægemiddel, der indeholder det aktive stof zoledronsyre.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Danish: Reduktionen af knogletabet bidrager til at mindske sandsynligheden for knoglebrud, og dette hjælper med at forebygge knoglebrud hos kræftpatienter med knoglemetastaser.
English: Zoledronic acid Teva zoledronic acid
Danish: Zoledronsyre Teva zoledronsyre
English: The Committee recommended that Zoledronic acid Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Zoledronsyre Teva.
English: Why has Zoledronic acid Teva been approved?
Danish: Hvorfor blev Zoledronsyre Teva godkendt?
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Danish: Når lægemidlet anvendes til forebyggelse af knoglekomplikationer, kan infusionen gentages hver tredje til fjerde uge, og patienterne bør desuden tage calcium- og D-vitamintilskud.
English: What is Zoledronic acid Teva?
Danish: Hvad er Zoledronsyre Teva?
English: How has Zoledronic acid Teva been studied?
Danish: Hvordan blev Zoledronsyre Teva undersøgt?
English: How does Zoledronic acid Teva work?
Danish: Hvordan virker Zoledronsyre Teva?
English: What is Zoledronic acid Teva used for?
Danish: Hvad anvendes Zoledronsyre Teva til?
English: How is Zoledronic acid Teva used?
Danish: Hvordan anvendes Zoledronsyre Teva?
English: Package size
Danish: Påfyldningsvolumen Pakningsstørrelse
English: EU Number
Danish: EU-nummer Særnavn Styrke
English: Packaging
Danish: Indgivelsesvej Emballage
English: Content
Danish: Lægemiddelform
English: The majority of these reactions were mild or moderate and of short duration.
Danish: Størstedelen af disse reaktioner sted var lette eller moderate og af kort varighed.
English: It is available as tablets (18 mg).
Danish: Det leveres som tabletter (18 mg).
English: With regard to safety, the side effects reported in the studies did not raise any major concerns.
Danish: Vedrørende sikkerheden gav de beskrevne virkninger i undersøgelserne ikke anledning til større betænkeligheder.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Selincro on 25 February 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Selincro den 25. februar 2013.
English: The full EPAR for Selincro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Selincro findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Selincro.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Selincro.
English: The effects of Selincro were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Selincro blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Thereafter, the patient will be asked to record his or her alcohol consumption for approximately two weeks.
Danish: Derefter bliver patienten bedt om at registrere sit alkoholforbrug gennem ca. 2 uger.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Selincro.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Selincro.
English: At the patient's initial visit to their doctor, the patient's overall health, alcohol dependence, and level of alcohol consumption (based on patient reporting) will be evaluated.
Danish: Ved patientens første besøg hos lægen vurderes patientens almene helbredstilstand, alkoholafhængighed og alkoholforbrug (på grundlag af patientens egne oplysninger).
English: If the patient has started drinking without Selincro, a tablet should be taken as soon as possible.
Danish: Hvis patienten er begyndt at drikke uden Selincro, skal patienten tage én tablet snarest muligt.
English: The patient should take one Selincro tablet by mouth ‘as needed', which means when there is a risk that they would start drinking.
Danish: Patienten skal tage en Selincro tablet “efter behov”, dvs. når der er risiko for, at patienten vil begynde at drikke.
English: As a guide: a bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g alcohol.
Danish: Som vejledning tjener følgende: En flaske vin (750 ml, 12 % v/v alkohol) indeholder ca. 70 g alkohol, og en flaske øl (330 ml, 5 % v/v alkohol) indeholder ca. 13 g alkohol.
English: For more information about treatment with Selincro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Selincro, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It should only be used together with psychosocial support (counselling) and only in people who do not have physical withdrawal symptoms and who do not require immediate detoxification.
Danish: Det bør kun anvendes sammen med psykosocial støtte (rådgivning), og kun hos personer, som ikke har fysiske abstinenssymptomer eller kræver øjeblikkelig afgiftning.
English: The most common side effects (seen in more than 1 patient in 10) were nausea (feeling sick), dizziness, insomnia (difficulty sleeping) and headache.
Danish: De almindeligste bivirkninger (som ses hos flere end 1 ud af 10 behandlede) er kvalme, svimmelhed, søvnløshed og hovedpine.
English: Selincro was compared with placebo (a dummy treatment) in two main studies involving 1,322 men and women with alcohol dependence.
Danish: Selincro blev sammenlignet med placebo (virkningsløs behandling) i to hovedundersøgelser, hvori der deltog 1 322 mænd og kvinder med alkoholafhængighed.
English: The active substance in Selincro, nalmefene, attaches to certain opioid receptors in the brain.
Danish: Det aktive stof i Selincro, nalmefen, bindes til visse opioidreceptorer i hjernen.
English: Daily alcohol consumption with Selincro fell from 102 g to 44 g in the first study and from 113 g to 43 g in the second.
Danish: Med Selincro faldt det daglige alkoholforbrug fra 102 g til 44 g i den første undersøgelse og fra 113 g til 43 g i den anden.
English: Before starting treatment with Selincro, the patient is asked to record their level of alcohol consumption over a two week period.
Danish: Før påbegyndelse af behandlingen med Selincro bliver patienten bedt om at registrere sit alkoholforbrug i en 2-ugers periode.
English: Opioid receptors play a role in addiction and, by attaching to them and modifying their activity, nalmefene helps reduce the urge to drink in people accustomed to large amounts of alcohol.
Danish: Opioidreceptorer spiller en rolle ved afhængighed, og når nalmefen bindes til receptorerne og ændrer deres aktivitet, nedsætter det drikketrangen hos personer, der har vænnet sig til store mængder alkohol.
English: Selincro must not be used in people who are hypersensitive (allergic) to nalmefene or any of its other ingredients.
Danish: Selincro må ikke anvendes hos personer, der er overfølsomme (allergiske) over for nalmefen eller andre af indholdsstofferne.
English: Selincro nalmefene
Danish: Selincro nalmefen
English: Data on the use of Selincro from standard clinical studies are available for a period of six months to one year.
Danish: Der findes oplysninger om brug af Selincro i sædvanlige kliniske undersøgelser med en varighed fra seks måneder til et år.
English: The main measures of effectiveness were the reduction in the number of heavy drinking days and the average daily alcohol consumption after six months of treatment.
Danish: Virkningen blev hovedsagelig bedømt på reduktionen i antallet af dage med stort alkoholforbrug og i det gennemsnitlige daglige alkoholforbrug efter seks måneders behandling.
English: All patients also received counselling to help them reduce their drinking and keep to their treatment.
Danish: Alle patienterne modtog desuden rådgivning med henblik på at hjælpe dem til at nedsætte deres alkoholforbrug og fortsætte med behandlingen.
English: Selincro does not prevent the intoxicating effects of alcohol.
Danish: Selincro forhindrer ikke de berusende virkninger af alkohol.
English: The CHMP decided that Selincro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP afgjorde, at fordelene ved Selincro overstiger risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Selincro.
English: Caution is advised if Selincro is prescribed for more than one year.
Danish: Der tilrådes forsigtighed, hvis Selincro ordineres i længere tid end et år.
English: Only one tablet can be taken on any given day and it should preferably be taken one to two hours before they are likely to start drinking.
Danish: På en enkelt dag må patienten kun tage én tablet, fortrinsvis 1-2 timer før patienten forventer at ville begynde at drikke.
English: Selincro is medicine that contains the active substance nalmefene.
Danish: Selincro er et lægemiddel, der indeholder det aktive stof nalmefen.
English: Selincro was shown to be more effective than placebo in reducing the number of heavy drinking days and daily alcohol consumption.
Danish: Selincro blev påvist at være mere effektivt end placebo til at mindske antallet af dage med stort alkoholforbrug og det daglige alkoholforbrug.
English: These improvements were better than those seen with placebo by about 2.7 to 3.7 heavy drinking days a month and about 10 to 18 g of alcohol a day.
Danish: I forhold til placebo var forbedringen ca. 2,7-3,7 dage med stort alkoholforbrug pr. måned og ca. 10-18 g alkohol dagligt.
English: Other information about Selincro
Danish: Andre oplysninger om Selincro
English: Treatment must also include counselling to help the patient reduce their drinking and keep to their treatment.
Danish: Behandlingen kan desuden omfatte rådgivning med henblik på at hjælpe patienten til at nedsætte sit forbrug og fortsætte med behandlingen.
English: Selincro can only be obtained by prescription.
Danish: Selincro udleveres kun efter recept.
English: It must also not be used in patients with severe liver or kidney impairment or a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures (fits) and tremors).
Danish: Det må heller ikke anvendes hos patienter, som har svært nedsat lever- eller nyrefunktion eller for nylig har haft akutte alkoholabstinenser (med hallucinationer, krampeanfald og rysten).
English: At the next visit (after the two weeks), Selincro may be started if the patient continues to have a high level of alcohol consumption (above 60 g per day for men and 40 g per day for women).
Danish: Ved næste besøg (efter de to uger) kan behandlingen med Selincro påbegyndes, hvis patienten fortsat har et stort alkoholforbrug (over 60 g dagligt for mænd og 40 g dagligt for kvinder).
English: The CHMP noted that Selincro was shown to be effective in reducing alcohol consumption in men drinking more than 60 g and women drinking more than 40 g a day.
Danish: CHMP bemærkede, at Selincro var påvist at være effektivt til at nedsætte alkoholforbrug hos mænd, der drikker mere end 60 g, og kvinder, der drikker mere end 40 g dagligt.
English: What is the risk associated with Selincro?
Danish: Hvilken risiko er der forbundet med Selincro?
English: Selincro is used to help reduce alcohol consumption in adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women).
Danish: Selincro anvendes til at nedsætte alkoholforbruget hos alkoholafhængige voksne med et forbrug på mere end 60 g alkohol dagligt (for mænd) eller over 40 g dagligt (for kvinder).
English: Why has Selincro been approved?
Danish: Hvorfor blev Selincro godkendt?
English: It must not be used in patients taking opioid medicines, in patients who have a current or recent addiction to opioids, patients with acute opioid withdrawal symptoms, or in patients suspected to have used opioids recently.
Danish: der er eller for nylig har været afhængige af opioider, patienter med akutte abstinenser efter opioider eller patienter, der formodes at have anvendt opioider for nylig.
English: What is Selincro?
Danish: Hvad er Selincro?
English: How has Selincro been studied?
Danish: Hvordan blev Selincro undersøgt?
English: What is Selincro used for?
Danish: Hvad anvendes Selincro til?
English: In these patients, after six months, the number of heavy drinking days a month with Selincro fell from 23 to 10 in the first study and from 23 to 11 in the second.
Danish: Hos de patienter, der i forvejen havde et forbrug på mere end 60 g alkohol dagligt (for mænd) eller over 40 g dagligt (for kvinder), var der væsentlig bedring, sædvanligvis inden for de første fire ugers behandling Efter seks måneders behandling med Selincro faldt antallet af dage med stor alkoholindtagelse hos disse patienter fra 23 til 10 i den første undersøgelse og fra 23 til 11 i den anden.
English: What benefit has Selincro shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Selincro?
English: How is Selincro used?
Danish: Hvordan anvendes Selincro?
English: How does Selincro work?
Danish: Hvordan virker Selincro?
English: NA: Not Achieved
Danish: NA: Ikke opnået
English: Symptoms you should be aware of
Danish: Symptomer, som du skal være opmærksom på
English: You may need medical help.
Danish: Det kan være nødvendigt med lægehjælp.
English: Take care in direct sunlight
Danish: Vær forsigtig ved direkte sollys
English: Each carton contains one bottle.
Danish: Hver karton indeholder én flaske.
English: Patients, n
Danish: Patienter, n
English: Complete response % Partial response %
Danish: Fuldstændig respons % Delvis respons %
English: This is because it may harm your unborn baby.
Danish: Det skyldes, at det muligvis kan skade dit ufødte barn.
English: • It is important to keep taking Rubraca every day - as long as your doctor prescribes it for you.
Danish: - Det er vigtigt at fortsætte med at tage Rubraca hver dag - så længe din læge ordinerer det til dig.
English: Date of first authorisation: 24 May 2018 Date of latest renewal: 13 March 2019
Danish: Dato for første markedsføringstilladelse: 24. maj 2018 Dato for seneste fornyelse: 13. marts 2019
English: A potential risk cannot be ruled out based on the safety margin observed.
Danish: En mulig risiko kan ikke udelukkes baseret på den observerede sikkerhedsmargen.
English: Treatment was continued until disease progression or unacceptable toxicity.
Danish: Behandlingen blev fortsat indtil sygdomsprogression eller uacceptabel toksicitet.
English: Therefore, use in this patient population is not recommended.
Danish: Anvendelse til denne patientpopulation anbefales derfor ikke.
English: Steady state was achieved after 1 week of dosing.
Danish: Steady state blev opnået efter 1 uges dosering.
English: At the time of the analysis of PFS, OS data were not mature (with 22% of events).
Danish: På tidspunktet for analysen af PFS var OS data ikke modne (med 22 % af hændelserne).
English: Median overall survival was not achieved in this population.
Danish: Der blev ikke opnået nogen gennemsnitlig overlevelse i denne population.
English: The doses should be taken approximately 12 hours apart.
Danish: Doserne skal tages med cirka 12 timers mellemrum.
English: Efficacy results are summarised in Table 4 and Figure 1.
Danish: Effektivitetsresultater er opsummeret i tabel 4 og figur 1.
English: The results should be interpreted with caution due to the limited representation of some subgroup phenotypes.
Danish: Resultaterne bør fortolkes med forsigtighed på grund af den begrænsede repræsentation af visse undergruppe-fænotyper.
English: • Do not stop taking this medicine without talking to your doctor first.
Danish: - Hold ikke op med at tage dette lægemiddel uden først at tale med lægen.
English: Censoring N (%)
Danish: Censurering N (%)
English: Take care if you feel tired or feel sick (nauseous).
Danish: Pas på, hvis du føler dig træt eller har kvalme.
English: Primary Efficacy N=106
Danish: Primær effekt N=106
English: There are limited clinical data in patients aged 75 or over.
Danish: Der er begrænsede kliniske data for patienter i alderen 75 eller derover.
English: Your doctor may also do weekly tests, if you have low blood cell counts for a long time.
Danish: Din læge kan også udføre ugentlige tests, hvis du har et lavt antal af blodceller i længere tid.
English: • Take the tablets once in the morning and once in the evening, approximately 12 hours apart.
Danish: - Tag tabletterne én gang om morgenen og én gang om aftenen med cirka 12 timers mellemrum.
English: ARIEL3 Efficacy Results Parameter
Danish: ARIEL3 effektmål Parameter
English: For the platinum-refractory population (N=7), there were no responders.
Danish: For den platinrefraktære population (N = 7) var der ingen responser.
English: The absolute oral bioavailability at 600 mg has not been determined.
Danish: Den absolutte orale biotilgængelighed på 600 mg er ikke fastlagt.
English: Efficacy results from all patients treated are summarized in Table 5.
Danish: Resultater for effekt fra alle behandlede patienter er sammenfattet i tabel 5.
English: This means you take a total of 1,200 mg each day.
Danish: Det betyder, at du tager i alt 1.200 mg hver dag.
English: An analysis of progression-free survival (PFS) was also performed.
Danish: En analyse af progressionsfri overlevelse (PFS, progressionfree survival) blev også udført.
English: Age, race, and body weight
Danish: Alder, race og kropsvægt
English: Investigator Assessment
Danish: Investigator-vurdering
English: If you have certain side effects your doctor may recommend a lower dose, or temporarily stop your treatment.
Danish: Hvis du har visse bivirkninger, vil din læge muligvis anbefale en lavere dosis eller midlertidigt stoppe din behandling.
English: Grade 4 reactions require treatment modification (see Table 2).
Danish: Klasse 4 reaktioner kræver behandlingsændring (se tabel 2).
English: The food effect on PK was not considered clinically significant.
Danish: Virkningen af mad på PK blev ikke betragtet som klinisk signifikant.
English: Due date: Q2
Danish: Tidsfrist: Q2
English: In the event of suspected overdose, physicians should follow general supportive measures and should treat symptomatically.
Danish: I tilfælde af formodet overdosis bør læger følge generelle understøttende foranstaltninger, og der bør gives symptomatisk behandling.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Danish: Fortæl det straks til din læge, hvis du oplever nogen af de følgende bivirkninger - du kan få brug for omgående lægebehandling:
English: PFS assessed by blinded independent radiology review (BIR) was a key secondary efficacy outcome.
Danish: PFS vurderet ved blindet uafhængig radiologisk gennemgang - BIR (Blinded Independent Radiology Review) var et vigtigt sekundært effektmål.
English: HR (95% CI) p-valueb a. All randomised patients.
Danish: HR (95 % CI) p-værdib a. Alle randomiserede patienter.
English: These may be signs and symptoms that Rubraca is affecting your stomach.
Danish: Dette kan være tegn og symptomer på, at Rubraca påvirker maven.
English: Platinum Sensitive N=79
Danish: Platinfølsom N=79
English: Objective response rate (ORR) N
Danish: Objektiv responsrate (ORR) n
English: These reactions are manageable with routine medical treatment and/or dose adjustment for more severe cases.
Danish: Disse reaktioner kan håndteres med rutinemæssig medicinsk behandling og/eller dosisjustering i mere alvorlige tilfælde.
English: Rubraca is supplied in plastic bottles.
Danish: Rubraca leveres i plastflasker.
English: Then take your next dose at the usual time.
Danish: Tag din næste dosis på det sædvanlige tidspunkt.
English: A total of 32% of patients were in complete response (CR) to their most recent therapy.
Danish: I alt 32 % af patienterne var i komplet respons (CR) på deres seneste behandling.
English: See section 4 for more information.
Danish: 4 for flere oplysninger.
English: What Rubraca is used for
Danish: Hvad Rubraca bruges til
English: Kaplan-Meier Curves of Progression-Free Survival in ARIEL3 as Assessed by Investigator: ITT population
Danish: Kaplan-Meier-kurver for progressionsfri overlevelse i ARIEL3 vurderet af investigator: ITT-population
English: • You can take the tablets with or without food.
Danish: - Du kan tage tabletten med eller uden mad.
English: The safety and efficacy of Rubraca in children or adolescents aged less than 18 years have not been established.
Danish: Rubraca sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Detection of BRCA mutation
Danish: Påvisning af BRCA-mutation
English: These increases in serum creatinine were clinically asymptomatic.
Danish: Disse øgninger af serumkreatinin var klinisk asymptomatiske.
English: Mechanism of action and pharmacodynamics effects
Danish: Virkningsmekanisme og farmakodynamiske virkninger
English: There is no specific treatment in the event of Rubraca overdose, and symptoms of overdose are not established.
Danish: Der findes ingen specifik behandling i tilfælde af overdosis af Rubraca, og symptomer på overdosering er ikke klarlagt.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særligt som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Patients with changes (mutations) in genes called BRCA are at risk of developing a number of types of cancer.
Danish: Patienter med ændringer (mutationer) i generne, der kaldes BRCA har en risiko for at udvikle en række forskellige typer kræft.
English: Pregnant women should be informed of the potential risk to a foetus.
Danish: Gravide kvinder skal informeres om den potentielle risiko for fosteret.
English: Your doctor may test your bone marrow to check for any problems.
Danish: Din læge kan undersøge din knoglemarv for at undersøge, om der er nogen problemer.
English: Although no cases were reported during therapy in patients who received placebo, one case has been reported in a placebo - treated patient during the long term safety follow up.
Danish: Selvom der ikke er indberettet tilfælde under behandling hos patienter, der fik placebo, er der indberettet et enkelt tilfælde hos en placebobehandlet patient under den langsigtede sikkerhedsopfølgning.