FrancophonIA/ELRC3.0 huggingface dataset:
English: mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse effects.
Danish: Enkeltdoser op til 1200 mg og gentagne doser op til 1200 mg to gange daglig er blevet givet til raske personer i 9 dage uden klinisk betydende bivirkninger.
English: Rare: duodenal, gastricoesophageal, intestinal and colonic ulceration, dysphagia, intestinal perforation, oesophagitis, melaena
Danish: Sjælden: sår i spiserør, mavesæk, tolvfingertarmen, tyndtarmen og colon, synkebesvær, intestinal perforation, esophagitis, melæna
English: A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in longterm clinical trials (see 5.1).
Danish: Signifikant forskel i den gastrointestinale sikkerhed mellem selektive COX-2 hæmmere + acetylsalicylsyre vs.
English: For excipients, see 6.1.
Danish: Øvrige indholdsstoffer, se pkt.
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (4.3, 4.4, 4.8 and 5.1).
Danish: Patientens behov for symptomlindring samt behandlingsrespons bør genovervejes med jævne mellemrum, især hos patienter med osteoarthrosis (se pkt.
English: Member State
Danish: Medlems- land
English: Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
Danish: I et peri/post-natalt forsøg med rotter, som inkluderede behandling i den organdannende periode, blev diafragmabrok også set.
English: Breast feeding (See 4.6 and 5.3).
Danish: 4.6 og 5.3).
English: Patients known to be CYP2C9 poor metabolisers should be treated with caution.
Danish: Forsigtighed bør udvises i behandling af patienter med kendt nedsat CYP2C9 metabolisering.
English: Marketing Authorisation Holder
Danish: Indehaver af markedføringstilladelsen
English: In preliminary data from two studies in patients with colorectal polyps treated with celecoxib 400 mg daily (see Section 5.1) the excess rate over placebo of myocardial infarction over 3 years was 7 events per 1000 patients (Uncommon).
Danish: Foreløbige data fra 2 studier på patienter med kolorektale polypper behandlet med celecoxib 400 mg daglig (se pkt.
English: Musculoskeletal and connective tissue disorders Uncommon: leg cramps
Danish: Muskuloskeletale-, bindevævs- og knoglelidelser Ikke almindelig: lægkramper Meget sjælden: myositis
English: The plasma concentrations of drugs that are substrates of this enzyme may be increased when celecoxib is used concomitantly.
Danish: Under behandling med celecoxib kan plasmakoncentrationerne af lægemidler, der nedbrydes af dette enzym, stige.
English: Vascular disorders Uncommon: hypertension, hypertension aggravated
Danish: Ikke almindelig: hypertension, forværring af allerede erkendt hypertension Sjælden: iskæmisk slagtilfælde
English: Hepatic impairment: Treatment should be initiated at half the recommended dose in patients with established moderate liver impairment with a serum albumin of 25-35 g/l.
Danish: Hos patienter med moderat nedsat leverfunktion (serumalbumin 25-35 g/l) bør behandlingen indledes med halvdelen af den anbefalede dosis.
English: Cardiac disorders Uncommon: myocardial infarction*, heart failure, palpitations
Danish: Lidelser i myo-, endo-, perikardium og klapper Ikke almindelig: myokardieinfarkt
English: 6 PHARMACEUTICAL PARTICULARS
Danish: FARMAKOLOGISKE OPLYSNINGER
English: Capsule shells contain gelatin, titanium dioxide E171; ink contains indigotine E132
Danish: Kapsler 100 mg: Mærkningsblækket indeholder farvestoffet indigotin I (E 132).
English: Renal impairment: Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution.
Danish: Erfaring med celecoxib hos patienter med let til moderat nedsat nyrefunktion er begrænset, hvorfor sådanne patienter bør behandles med forsigtighed (se afsnit 4.3, 4.4 og 5.2).
English: Skin and subcutaneous tissue disorders
Danish: Vaskulære (ekstrakardielle) lidelser
English: The European Commission granted a marketing authorisation valid throughout the European Union for Copalia HCT on 4 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Copalia HCT den 4. november 2009.
English: The full EPAR for Copalia 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 Copalia HCT 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 Copalia HCT.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Copalia HCT.
English: Copalia HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Danish: Copalia HCT indtages gennem munden, og dosis er en tablet dagligt på samme tidspunkt hver dag og helst om morgenen.
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 Copalia HCT.
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 Copalia HCT.
English: For more information about treatment with Copalia 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 Copalia HCT, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients received either Copalia HCT or one of the three combinations containing only two of the active substances for eight weeks.
Danish: Patienterne fik enten Copalia HCT eller en af de tre kombinationer, som kun indeholdt to af de aktive stoffer, i otte uger.
English: The main study showed the benefit of the highest strength of Copalia HCT in lowering the blood pressure.
Danish: Hovedundersøgelsen påviste den gavnlige virkning af den højeste styrke af Copalia HCT til nedsættelse af blodtrykket.
English: The three active substances in Copalia HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Danish: De tre aktive stoffer i Copalia HCT er lægemidler mod forhøjet blodtryk, som allerede anvendes i Den Europæiske Union (EU).
English: The dose of Copalia HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Danish: Den dosis af Copalia HCT, som skal anvendes, er den samme som doserne af tre individuelt aktive stoffer, som patienten fik tidligere.
English: The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Copalia HCT which combines the three substances in a single tablet.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) bemærkede, at der var større sandsynlighed for, at patienter, der allerede fik de tre aktive stoffer, ville overholde behandlingen, hvis de fik ordineret Copalia HCT, hvor de tre stoffer er kombineret i en enkelt tablet.
English: Treatment with the highest strength of Copalia HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Danish: Behandling med den højeste styrke af Copalia HCT var mere effektiv til at behandle hypertension end tokombinationsbehandlinger, der hver indeholdt to aktive stoffer.
English: Copalia HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Danish: Copalia HCT anvendes til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne, hvis blodtryk allerede er tilstrækkeligt kontrolleret med en kombination af amlopidin, valsartan og hydrochlorthiazid.
English: Copalia HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Danish: Copalia HCT er et lægemiddel, der indeholder de tre aktive stoffer amlodipin, valsartan og hydrochlorthiazid.
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Copalia HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Danish: Den gennemsnitlige reduktion af blodtrykket var ca. 39,7/24,7 mmHg hos patienter, der fik Copalia HCT, sammenlignet med 32/19,7 mmHg, 33,5/21,5 mmHg og 31,5/19,5 mmHg hos patienter, der henholdsvis fik kombinationerne valsartan/hydrochlorthiazid, valsartan/amlodipin og hydrochlorthiazid/amlodipin.
English: Other information about Copalia HCT
Danish: Andre oplysninger om Copalia HCT
English: The CHMP therefore decided that Copalia HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Copalia opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Copalia HCT.
English: Copalia HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Copalia HCT.
Danish: Copalia HCT må ikke anvendes af personer, der er overfølsomme (allergiske) over for de aktive stoffer, andre sulfonamider, dihydropyridinderivater eller andre af indholdsstofferne i Copalia HCT.
English: For the full list of all side effects reported with Copalia HCT, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Copalia HCT fremgår af indlægssedlen.
English: For all doses, Copalia HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Danish: Copalia HCT opfyldte endvidere i samtlige doser kravet om at dokumentere, at lægemidlet var sammenligneligt med kombinationerne af de individuelt aktive stoffer indtaget separat.
English: The most common side effects with Copalia HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Danish: De hyppigste bivirkninger ved Copalia HCT (som optræder hos mellem 1 og 10 patienter ud af 100) er hypokaliæmi (lavt kaliumindhold i blodet)), svimmelhed, hovedpine, hypotension (for lavt blodtryk), dyspepsi (halsbrand), pollakisuri (usædvanlig hyppig vandladning), træthed og ødem (væskeansamling).
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Copalia HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Danish: Derudover blev der gennemført en hovedundersøgelse af 2 271 patienter med moderat til svær hypertension, som blev behandlet med den højeste styrke af Copalia HCT (320 mg valsartan, 10 mg amlodipin og 25 mg hydrochlorthiazid).
English: The daily dose of Copalia HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Danish: Den daglige dosis af Copalia HCT må ikke overskride 10 mg amlodipin, 320 mg valsartan og 25 mg hydrochlorthiazid.
English: Finally, Copalia HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Danish: Endelig må Copalia HCT ikke anvendes hos patienter med hypokaliæmi (lavt kaliumindhold i blodet), hyponatriæmi (lavt saltindhold i blodet) og hypercalcæmi (forhøjet calciumniveau i blodet), som ikke reagerer på behandling, og hos patienter med hyperurikæmi (forhøjet urinsyre i blodet), der udløser symptomer.
English: What is the risk associated with Copalia HCT?
Danish: Hvilken risiko er der forbundet med Copalia HCT?
English: It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique).
Danish: Det må ikke anvendes til gravide, som er længere end tre måneder henne i graviditeten, Det må heller ikke anvendes hos patienter, som har leverproblemer eller galdeproblemer (f.eks. gulsot), alvorlige nyreproblemer, anuri (en sygdom, hvor patienten har manglende urinproduktion eller evne til at tømme blæren), eller hos patienter i dialyse (en blodrensningsteknik).
English: Copalia HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Danish: Copalia HCT i kombination med lægemidler, der indeholder aliskiren (som anvendes til behandling af essentiel hypertension), må ikke anvendes til patienter med diabetes eller moderat eller alvorlig nyresygdom.
English: Why has Copalia HCT been approved?
Danish: Hvorfor blev Copalia HCT godkendt?
English: What is Copalia HCT?
Danish: Hvad er Copalia HCT?
English: How has Copalia HCT been studied?
Danish: Hvordan blev Copalia HCT undersøgt?
English: What is Copalia HCT used for?
Danish: Hvad anvendes Copalia HCT til?
English: What benefit has Copalia HCT shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Copalia HCT?
English: How is Copalia HCT used?
Danish: Hvordan anvendes Copalia HCT?
English: How does Copalia HCT work?
Danish: Hvordan virker Copalia HCT?
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: De gældende tekster til produktresume, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i Koordinationsgruppen.
English: b L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology c adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al)
Danish: Human papillomavirusa type 18 L1 proteinb,c a Human papillomavirus = HPV b L1 protein i form af viruslignende partikler produceret i gærceller (Saccharomyces cerevisiae CANADE 3C-5 (stamme 1895)) ved hjælp af rekombinant DNA
English: Human Papillomavirusa Type 6 L1 proteinb,c
Danish: Human papillomavirus a type 11 L1 protein b,c a type 16 L1 proteinb,c Human papillomavirus
English: Route of Administration
Danish: teknologi.
English: Lartruvo has been given ‘conditional approval'.
Danish: Lartruvo har fået en "betinget godkendelse".
English: These three-week cycles should be repeated until the disease gets worse or side effects become unacceptable.
Danish: Denne tre-ugers serie gentages, indtil sygdommen forværres, eller bivirkningerne bliver uacceptable.
English: This is a summary of the European public assessment report (EPAR) for Lartruvo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lartruvo.
English: This protein is often found on the surface of cells where it plays a role in regulating cell multiplication.
Danish: Dette protein findes ofte på overfladen af celler, hvor det spiller en rolle i reguleringen af cellernes deling.
English: Other information about Lartruvo
Danish: Andre oplysninger om Lartruvo
English: The recommended dose of Lartruvo is 15 mg per kilogram body weight, given twice over a period of three weeks, on days 1 and 8.
Danish: Den anbefalede dosis Lartruvo er 15 mg pr. kg legemsvægt, som gives to gange over en periode på tre uger, på dag 1 og dag 8.
English: However, because of the small number of patients included in the main study, further data will be needed from the company that markets the medicine.
Danish: Eftersom der kun indgik et lille antal patienter i hovedundersøgelsen, er det dog nødvendigt med yderligere data fra den virksomhed, der markedsfører lægemidlet.
English: What measures are being taken to ensure the safe and effective use of Lartruvo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lartruvo?
English: Doxorubicin is given on day 1 of each cycle, after the Lartruvo infusion.
Danish: Doxorubicin gives på dag 1 i hver serie efter infusionen af Lartruvo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Lartruvo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Lartruvo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Since Lartruvo has been granted a conditional approval, the company that markets Lartruvo will provide additional data from an ongoing study in order to further confirm the efficacy and safety of the medicine.
Danish: Da Lartruvo har fået en betinget godkendelse, skal virksomheden, der markedsfører Lartruvo, fremlægge yderligere data fra en igangværende undersøgelse med henblik på yderligere bekræftelse af virkningen af og sikkerheden ved lægemidlet.
English: Because the number of patients with soft tissue sarcoma is low, the disease is considered ‘rare', and Lartruvo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 12 February 2015.
Danish: Da antallet af patienter med bløddelskarcinom er lavt, betragtes sygdommen som "sjælden", og Lartruvo blev udpeget som "lægemiddel til sjældne sygdomme" den 12. februar 2015.
English: During the infusion, patients should be monitored for signs and symptoms of infusion-related reactions and trained staff and equipment for emergency resuscitation should be available.
Danish: Under infusionen skal patienterne overvåges for tegn og symptomer på infusionsrelaterede reaktioner, og der skal være uddannet personale og udstyr til nødbehandling i umiddelbar nærhed.
English: What is Lartruvo and what is it used for?
Danish: Hvad er Lartruvo, og hvad anvendes det til?
English: The full EPAR for Lartruvo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lartruvo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most serious side effects were neutropenia and musculoskeletal pain.
Danish: De alvorligste bivirkninger var neutropeni og smerter i bevægeapparatet.
English: Why is Lartruvo approved?
Danish: Hvorfor blev Lartruvo godkendt?
English: Lartruvo can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the treatment of cancer.
Danish: Lartruvo udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges af en læge med erfaring i kræftbehandling.
English: It is not intended to provide practical advice on how to use Lartruvo.
Danish: Det er ikke en praktisk vejledning i, hvordan Lartruvo bør anvendes.
English: The most frequent side effects which lead to treatment termination were infusion-related reactions (allergic reactions which can be serious, with symptoms such as chills, fever and difficulty breathing) and mucositis.
Danish: De hyppigste bivirkninger, der medførte ophør af behandlingen, var infusionsrelaterede reaktioner (allergiske reaktioner, der kan være alvorlige, med symptomer som f.eks. kulderystelser, feber og vejrtrækningsbesvær) og mucositis.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Lartruvo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Lartruvo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In cancers such as soft tissue sarcoma, this protein is present in high levels or is overactive, causing cells to become cancerous.
Danish: Ved kræft som f.eks. bløddelskarcinom findes proteinet i store mængder eller er overaktivt, hvilket får cellerne til at blive cancerøse.
English: For more information about treatment with Lartruvo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lartruvo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Lartruvo?
Danish: Hvilke risici er der forbundet med Lartruvo?
English: What information is still awaited for Lartruvo?
Danish: Hvilke oplysninger afventes der stadig for Lartruvo?
English: By attaching to PDGFRα on sarcoma cells, Lartruvo is expected to block its activity, thereby slowing down the growth of the cancer.
Danish: Ved at binde til PDGFRα på karcinomceller forventes Lartruvo at blokere dette proteins aktivitet og dermed få kræften til at vokse langsommere.
English: Lartruvo is given in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo alone in patients whose disease has not got worse.
Danish: Lartruvo gives i kombination med doxorubicin i op til 8 behandlingscyklusser, hvorefter det gives alene hos patienter, hvis sygdom ikke er blevet forværret.
English: The study showed that Lartruvo plus doxorubicin was more effective than doxorubicin alone at prolonging the time patients live without their disease getting worse (progression-free survival).
Danish: Undersøgelsen viste, at Lartruvo + doxorubicin havde større virkning end doxorubicin alene i forhold til at forlænge den tid, som patienterne levede i, uden at deres sygdom blev værre (progressionsfri overlevelse).
English: Lartruvo is available as a solution for infusion (drip) into a vein.
Danish: Lartruvo fås som en væske til infusion (drop) i en vene.
English: Patients treated with Lartruvo plus doxorubicin lived for an average of 6.6 months without their disease getting worse, compared with 4.1 months for patients treated with doxorubicin alone.
Danish: De patienter, som fik Lartruvo + doxorubicin, levede gennemsnitligt i 6,6 måneder uden sygdomsforværring sammenlignet med 4,1 måneder for dem, der kun fik doxorubicin.
English: The most common side effects with Lartruvo (which may affect more than 1 in 10 people) include nausea (feeling sick), musculoskeletal pain (bone and muscle pain), neutropenia (low levels of neutrophils, a type of white blood cells that fights infection) and mucositis (inflammation of the body's moist surfaces, most commonly affecting the mouth and throat).
Danish: De hyppigste bivirkninger ved Lartruvo (som kan forekomme hos flere end 1 ud af 10 personer) omfatter kvalme, smerter i bevægeapparatet (knogle- og muskelsmerter), neutropeni (lavt antal neutrofiler, der er en type hvide blodlegemer, der bekæmper infektioner) og betændelse i kroppens slimhinder, især i munden og svælget (mucositis).
English: In addition, patients treated with the combination Lartruvo plus doxorubicin lived overall almost twice as long as patients treated with doxorubicin (26.5 versus 14.7 months, respectively).
Danish: Derudover levede de patienter, der blev behandlet med Lartruvo + doxorubicin, overordnet set næsten dobbelt så længe som de patienter, der blev behandlet med doxorubicin alene (hhv. 26,5 og 14,7 måneder).