FrancophonIA/ELRC3.0 huggingface dataset:
English: In acute coronary syndrome, Zyllt is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Danish: Ved akut koronarsyndrom anvendes Zyllt sammen med aspirin, og behandlingen indledes almindeligvis med en initialdosis på fire 75 mg-tabletter.
English: The standard dose of Zyllt is one 75 mg tablet once a day, taken with or without food.
Danish: Standarddosis af Zyllt er en 75 mg-tablet en gang dagligt med eller uden et måltid.
English: This means that Zyllt is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Zyllt er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union (EU), kaldet Plavix.
English: What are the benefit and risk of Zyllt?
Danish: Hvilken fordel og risiko er der forbundet med Zyllt?
English: Zyllt can be started between a few days and 35 days after the attack;
Danish: Behandling med Zyllt kan påbegyndes få dage efter anfaldet og indtil 35 dage efter
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zyllt has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Zyllt er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: Zyllt is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Zyllt anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: Zyllt is a medicine that contains the active substance clopidogrel.
Danish: Zyllt er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: Zyllt can be started between seven days and six months after the stroke;
Danish: Behandling med Zyllt kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter
English: Zyllt can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Danish: Zyllt kan anvendes til patienter, som har myokardieinfarkt med ”forhøjelse af ST-segmentet” (ST-segmentelevation), dvs. en unormal visning på elektrokardiogrammet eller EKG'et, når lægen vurderer, at patienterne kan have gavn af denne behandling.
English: Because Zyllt is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Zyllt er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Why has Zyllt been approved?
Danish: Hvorfor blev Zyllt godkendt?
English: Because Zyllt is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Zyllt er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: The active substance in Zyllt, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Zyllt, clopidogrel, er en trombocytfunktionshæmmer.
English: What is Zyllt?
Danish: Hvad er Zyllt?
English: What is Zyllt used for?
Danish: Hvad anvendes Zyllt til?
English: How has Zyllt been studied?
Danish: Hvordan blev Zyllt undersøgt?
English: How is Zyllt used?
Danish: Hvordan anvendes Zyllt?
English: How does Zyllt work?
Danish: Hvordan virker Zyllt?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Actelsar HCT on 13 March 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Actelsar HCT den 13. marts 2013.
English: The full EPAR for Actelsar HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Actelsar HCT findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: telmisartan / hydrochlorothiazide
Danish: Telmisartan/hydrochlorothiazid
English: This is a summary of the European public assessment report (EPAR) for Actelsar HCT.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Actelsar HCT.
English: The Committee recommended that Actelsar HCT be approved for use in the EU.
Danish: Udvalget anbefalede, at Actelsar HCT godkendes til anvendelse i EU.
English: This means that Actelsar HCT is similar to a ‘reference medicine' already authorised in the European Union (EU) called MicardisPlus.
Danish: Det betyder, at Actelsar HCT er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder MicardisPlus.
English: It is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Danish: Tolucombi anvendes til patienter med essentiel hypertension (højt blodtryk), som ikke kan kontrolleres tilfredsstillende ved hjælp af telmisartan alene.
English: Actelsar HCT is a ‘generic medicine'.
Danish: Actelsar HCT er et ‘generisk lægemiddel'.
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Actelsar HCT.
Danish: Tabletterne med 80/25 mg anvendes til patienter, hvis blodtryk ikke kan kontrolleres med 80/12,5 mg-tabletterne, eller som er blevet stabiliseret ved hjælp af de to aktive stoffer indtaget separat, inden de skiftede til Actelsar HCT.
English: Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Telmisartan er en ”angiotensin II-receptorantagonist”, som betyder, at den blokerer virkningen af et hormon i kroppen kaldet angiotensin II.
English: The dose of Actelsar HCT to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Danish: Den dosis af Actelsar HCT, som skal anvendes, afhænger af den dosis af telmisartan, som patienten tog tidligere: Patienter, som fik 40 mg telmisartan, skal tage 40/12,5 mg-tabletterne, og patienter, der fik 80 mg telmisartan, skal tage 80/12,5 mg-tabletterne.
English: Other information about Actelsar HCT
Danish: Andre oplysninger om Actelsar HCT
English: What measures are being taken to ensure the safe and effective use of Actelsar HCT?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Actelsar HCT?
English: What is Actelsar HCT and what is it used for?
Danish: Hvad er Actelsar HCT, og hvad anvendes det til?
English: What are the benefits and risks of Actelsar HCT?
Danish: Hvilke fordele og risici er der forbundet med Actelsar HCT?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Actelsar HCT has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Actelsar HCT er af sammenlignelig kvalitet og er bioækvivalent med MicardisPlus.
English: For more information about treatment with Actelsar HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Actelsar HCT, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Actelsar HCT is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid.
Danish: Actelsar HCT fås som tabletter (40 mg eller 80 mg telmisartan og 12,5 mg hydrochlorothiazid, 80 mg telmisartan og 25 mg hydrochlorothiazid), som indtages gennem munden en gang dagligt med væske.
English: It is not intended to provide practical advice on how to use Actelsar HCT.
Danish: Det er ikke en praktisk vejledning i, hvordan Actelsar HCT bør anvendes.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Actelsar HCT, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Actelsar HCT, herunder passende forholdsregler, som patienter og sundhedspersonale bør træffe.
English: Therefore, the CHMP's view was that, as for MicardisPlus, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for MicardisPlus.
English: Because Actelsar HCT is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus.
Danish: Da Actelsar HCT er et generisk lægemiddel, har patientundersøgelserne været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet MicardisPlus.
English: Because Actelsar HCT is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Actelsar HCT er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Actelsar HCT is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Danish: Actelsar HCT er et lægemiddel, som indeholder de to aktive stoffer telmisartan og hydrochlorothiazid.
English: Actelsar HCT contains two active substances, telmisartan and hydrochlorothiazide.
Danish: Actelsar HCT indeholder to aktive stoffer telmisartan og hydrochlorothiazid.
English: Why is Actelsar HCT approved?
Danish: Hvorfor blev Actelsar HCT godkendt?
English: For practical information about using Actelsar HCT, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Actelsar HCT, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How has Actelsar HCT been studied?
Danish: Hvordan blev Actelsar HCT undersøgt?
English: How is Actelsar HCT used?
Danish: Hvordan anvendes Actelsar HCT?
English: How does Actelsar HCT work?
Danish: Hvordan virker Actelsar HCT?
English: Below is a brief description of the studies and their results:
Danish: Nedenfor gives en beskrivelse af undersøgelserne og resultaterne heraf:
English: Humira received a marketing authorisation valid throughout the EU on 8 September 2003.
Danish: Humira fik en markedsføringstilladelse med gyldighed i hele EU den 8. september 2003.
English: Some rare but serious side effects have been reported, including serious infections.
Danish: Der er indberettet sjældne men alvorlige bivirkninger, herunder alvorlige infektioner.
English: Other information about Humira
Danish: Andre oplysninger om Humira
English: Humira is given as an injection under the skin, usually every 2 weeks.
Danish: Humira gives som en injektion under huden, normalt hver anden uge.
English: What measures are being taken to ensure the safe and effective use of Humira?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Humira?
English: However, these are considered to be manageable and specific recommendations are given to help doctors manage these risks.
Danish: Disse anses dog for at kunne håndteres, og der gives specifikke anbefalinger, som kan hjælpe læger med at reducere disse risici.
English: Further information on Humira can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/humira.
Danish: Yderligere information om Humira findes på agenturets websted under: https://www.ema.europa.eu/en/medicines/human/EPAR/humira.
English: As for all medicines, data on the use of Humira are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Humira løbende overvåget.
English: An overview of Humira and why it is authorised in the EU
Danish: En oversigt over Humira, og hvorfor det er godkendt i EU
English: The European Medicines Agency decided that Humira'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 Humira opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: The proportions of patients taking placebo who achieved this goal were 28% in the first study and 26% in the second.
Danish: Andelen af patienter, der fik placebo og nåede dette mål, var på henholdsvis 28 % i den første undersøgelse og 26 % i den anden.
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is calculated according to the child's weight.
Danish: Dosen og injektionshyppigheden afhænger af den sygdom, der skal behandles, og dosen til et barn skal beregnes ud fra barnets vægt.
English: What is Humira and what is it used for?
Danish: Hvad er Humira, og hvad anvendes det til?
English: • In non-infectious uveitis, Humira was found effective in 3 studies.
Danish: • Ved non-infektiøs uveitis var Humira effektivt i 3 undersøgelser.
English: The first study involved adults whose disease was not controlled with high doses of corticosteroids.
Danish: Den første undersøgelse omfattede voksne, hvis sygdom ikke var under kontrol med høje doser af kortikosteroider.
English: Humira must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Danish: Humira må ikke anvendes til patienter med aktiv tuberkulose eller andre svære infektioner eller til patienter med moderat til svær hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen).
English: Humira is a medicine that acts on the immune system and is used to treat the following conditions:
Danish: Humira er et lægemiddel, der virker på immunsystemet, og som anvendes til følgende sygdomme:
English: The study in younger children (aged 2 to 4 years) showed that the majority of children responded well to Humira treatment and this response was maintained after 24 weeks.
Danish: Undersøgelsen hos små børn (2-4 år) viste, at størstedelen af børnene reagerede godt på behandling med Humira, og virkningen holdt sig efter 24 uger.
English: Humira is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Danish: Humira bruges oftest til voksne, når deres tilstand er svær eller forværres, eller når patienter ikke kan få andre behandlinger.
English: In patients who had not taken methotrexate in the past, the combination of Humira and methotrexate was also more effective than methotrexate alone.
Danish: Hos de patienter, der ikke tidligere havde fået methotrexat, var kombinationen af Humira og methotrexat også mere effektiv end methotrexat alene.
English: Side effects reported with Humira are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Humira vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Patients or their carers can inject Humira once they have been trained.
Danish: Patienten eller dennes omsorgsperson kan injicere Humira efter at have fået passende oplæring.
English: What are the risks associated with Humira?
Danish: Hvilke risici er der forbundet med Humira?
English: The active substance in Humira, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Danish: Det aktive stof i Humira, adalimumab, er et monoklonalt antistof (en type protein), der er opbygget, så det genkender og binder sig til et kemisk stof i kroppen, der kaldes tumornekrosefaktor (TNF).
English: Humira can only be obtained with a prescription.
Danish: Humira udleveres kun efter recept.
English: Doctors treating uveitis should also take advice from doctors who have experience of using Humira.
Danish: Læger der behandler uveitis bør også rådføre sig med læger, der har erfaring i brug af Humira.
English: The second study involved adults whose uveitis was under control with a corticosteroid but the corticosteroid dose was then reduced or stopped and Humira or placebo introduced.
Danish: Den anden undersøgelse omfattede voksne, hos hvem uveitis var under kontrol med et kortikosteroid, men hvor dosen af kortikosteroid blev reduceret eller stoppet og Humira eller placebo introduceret.
English: For more information about using Humira, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Humira, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Humira, when used as directed, has been shown in clinical trials to be effective at reducing important symptoms of each of the conditions for which it is approved.
Danish: Når Humira blev anvendt som foreskrevet, viste det sig i de kliniske undersøgelser at være effektivt til at mindske vigtige symptomer på hver af de sygdomme, som det er godkendt til.
English: Humira has been studied extensively and has been shown to be effective at reducing symptoms in patients with inflammatory conditions.
Danish: Humira er blevet grundigt undersøgt og har vist sig at være effektivt til at mindske symptomer hos patienter med betændelsestilstande.
English: Treatment with Humira must be started and supervised by a doctor who has experience in the treatment of the diseases that Humira is used for.
Danish: Behandling med Humira skal indledes og overvåges af en læge med erfaring i behandling af de sygdomme, Humira anvendes til.
English: The studies included adult patients for the most part, but included children in studies for Crohn's disease, plaque psoriasis, polyarticular juvenile idiopathic arthritis, non-infectious anterior uveitis and enthesitis-related arthritis.
Danish: Undersøgelserne omfattede hovedsageligt voksne patienter, men omfattede også børn i forbindelse med undersøgelser af Crohns sygdom, plaquepsoriasis, polyartikulær juvenil idiopatisk artritis, non-infektiøs anterior uveitis og enthesitis-relateret artritis.
English: More than twenty main studies involving over 9,500 patients have looked at the effects of Humira in reducing symptoms of inflammatory conditions.
Danish: I 20 hovedundersøgelser hos over 9 500 patienter så man nærmere på Humiras evne til mindske symptomerne på betændelsestilstande.
English: • In hidradenitis suppurativa, 59% of patients receiving Humira in one main study and 42% of patients in another achieved at least a 50% reduction in abscesses and nodules after 12 weeks, without any increase in abscess count or fistulas.
Danish: • Ved hidradenitis suppurativa oplevede 59 % af de patienter, der fik Humira i en hovedundersøgelse, og 42 % af patienterne i en anden undersøgelse mindst en mindskelse på 50% af bylder og knuder efter 12 uger, og uden nogen stigning i antallet af bylder eller fistler.
English: The most common side effects with Humira (which may affect more than 1 in 10 people) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Danish: De hyppigste bivirkninger ved Humira (som kan forekomme hos mere end 1 ud af 10 personer) er infektioner (herunder i næse, hals og sinuitis), reaktioner på injektionsstedet (rødme, kløe, blødning, smerte eller hævelse), hovedpine og knogle- og muskelsmerter.
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Danish: • non-infektiøs uveitis (betændelse af hinden under det hvide af øjeæblet).
English: Patients treated with Humira must be given a reminder card with information on the safety of the medicine.
Danish: Patienter, der behandles med Humira, skal have udleveret et særligt patientinformationskort, som indeholder sikkerhedsoplysninger om lægemidlet.
English: • Humira also produced a greater improvement in symptoms than placebo in studies of psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis without evidence in the X-ray of ankylosing spondylitis but with clear signs of inflammation, and induction and maintenance phases of treatment for Crohn's disease, psoriasis and ulcerative colitis.
Danish: • Humira gav også en større forbedring af symptomerne end placebo i undersøgelserne af arthritis psoriatica, ankyloserende spondylitis og axial spondyloarthritis uden belæg for ankyloserende spondylitis ved røntgen, men med tydelige tegn på betændelse, samt i induktions- og vedligeholdelsesfaserne i forbindelse med behandling af Crohns sygdom, psoriasis og colitis ulcerosa.
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Humira is used to treat.
Danish: Dette stof er en medvirkende årsag til betændelsestilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Humira.
English: For detailed information on the use of Humira in all conditions, including when it can be used in children, see package leaflet or contact your doctor or pharmacist.
Danish: Fore mere information om brugen af Humira til alle tilstande, herunder hvornår det kan anvendes til børn, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: In the third study in children aged 2 to 18 years with non-infectious anterior uveitis, in whom methotrexate alone did not work, treatment failed in about 60% of patients receiving placebo with methotrexate compared with about 27% of patients given Humira with methotrexate.
Danish: I den 3. undersøgelse af børn i alderen 2-18 år med non-infektiøs anterior uveitis, hos hvem methotrexat alene ikke virkede, var behandlingen virkningsløs hos ca. 60 % af de patienter, der fik placebo med methotrexat, sammenlignet med ca. 27 % af de patienter, der fik Humira med methotrexat.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Danish: Andre sjældne alvorlige bivirkninger (som kan forekomme hos 1 ud af 1000 personer) omfatter knoglemarvens svigtende produktion af blodceller, nervelidelser, lupus og lupuslignende sygdomme (hvor immunsystemet angriber patientens eget væv og forårsager betændelse og organskader) og Stevens-Johnsons syndrom (livstruende reaktion med influenzalignende symptomer og smertefuldt hududslæt, herunder ved munden, øjnene og kønsorganerne).
English: For enthesitis-related arthritis, treatment with Humira resulted in fewer swollen and tender joints compared with placebo.
Danish: Ved enthesitis-relateret artritis medførte behandling med Humira færre hævede og smertende led end med placebo.
English: • In studies in adults and children with plaque psoriasis, including psoriasis of the nail, a higher proportion of patients receiving Humira had improvements in symptoms compared with patients receiving methotrexate or placebo (a dummy treatment).
Danish: • I undersøgelsen af voksne og børn med plaquepsoriasis, herunder neglepsoriasis, opnåede en større andel af de patienter, der fik Humira, en forbedring af symptomerne sammenlignet med dem, der fik methotrexat eller placebo (en virkningsløs behandling).