FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Nordimet are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Nordimet vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Nordimet and why it is authorised in the EU
Danish: En oversigt over Nordimet, og hvorfor det er godkendt i EU
English: The reference medicine for Nordimet is Lantarel FS.
Danish: Referencelægemidlet for Nordimet er Lantarel FS.
English: The European Medicines Agency concluded that Nordimet was comparable to its reference medicine.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Nordimet kunne sammenlignes med referencelægemidlet.
English: The Agency therefore decided that Nordimet's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Nordimet opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: This means that it is similar to a ‘reference medicines' containing the same active substance, but Nordimet is available in more strengths.
Danish: Det betyder, at det er identisk med et "referencelægemiddel", som indeholder samme aktive stof, men Nordimet findes i forskellige styrker.
English: Nordimet contains the active substance methotrexate.
Danish: Nordimet indeholder det aktive stof methotrexat.
English: For more information about using Nordimet, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Nordimet, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: No additional studies were needed as Nordimet is a hybrid medicine that is given by injection and contains the same active substance as the reference medicine, Lantarel FS.
Danish: Der krævedes ingen supplerende studier, eftersom Nordimet er et hybridlægemiddel, der indgives ved injektion og indeholder det samme aktive stof som referencelægemidlet, Lantarel FS.
English: Why is Nordimet authorised in the EU?
Danish: Hvorfor er Nordimet godkendt i EU?
English: What is Nordimet and what is it used for?
Danish: Hvad er Nordimet, og hvad anvendes det til?
English: The way methotrexate, the active substance in Nordimet, works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.
Danish: Hvorfor methotrexat, det aktive stof i Nordimet, virker hos patienter med artritis og psoriasis, vides ikke helt, men methotrexats fordele menes at stamme fra stoffets evne til at reducere betændelse og undertrykke et overaktivt immunforsvar.
English: What are the risks associated with Nordimet?
Danish: Hvilke risici er der forbundet med Nordimet?
English: Nordimet is a medicine used to treat the following inflammatory conditions:
Danish: Nordimet er et lægemiddel, der anvendes til at behandle følgende betændelsestilstande:
English: For the full list of side effects and restrictions of Nordimet, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Nordimet fremgår af indlægssedlen.
English: Nordimet is available as various strengths of injection and it can only be obtained with a prescription.
Danish: Nordimet findes som injektionsvæske i forskellige styrker og fås kun på recept.
English: The most common side effects with Nordimet (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver.
Danish: De hyppigste bivirkninger ved Nordimet (som kan forekomme hos mere end 1 ud af 10 personer) er virkninger i fordøjelsessystemet (f.eks. betændelse i munden, fordøjelse, mavesmerter, kvalme og appetitløshed) og blodprøver, der viser leverændringer.
English: Because Nordimet has the same composition as the reference medicine its benefits are taken as being the same as those of Lantarel FS.
Danish: Da Nordimet har samme sammensætning som referencelægemidlet, anses fordelene for at være de samme som for Lantarel FS.
English: Nordimet must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system.
Danish: Nordimet må ikke anvendes til patienter med alkoholmisbrug, leverproblemer, svære nyreproblemer, blodsygdomme, svækket immunsystem (kroppens forsvar), alvorlige eller langvarige infektioner såsom tuberkulose og hivinfektion, sår i munden, betændelse i munden og sår i fordøjelsessystemet.
English: • active rheumatoid arthritis, a disease causing inflammation in joints;
Danish: • aktiv rheumatoid artrit, der er en sygdom, som forårsager betændelse i leddene
English: • severe disabling psoriasis, a disease causing red, scaly patches on the skin, when other treatments have not worked well enough;
Danish: • alvorlig invaliderende psoriasis, der er en sygdom, som medfører områder med rød og afskallende hud (anvendes, når andre behandlinger ikke har virket godt nok)
English: NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;
Danish: NSAID'er ikke har virket godt nok)
English: • severe psoriatic arthritis, inflammation of the joints that occurs in patients with psoriasis.
Danish: • alvorlig psoriatisk artrit, der er betændelse i leddene, som optræder hos patienter med psoriasis.
English: The company provided data from the published literature on methotrexate.
Danish: Virksomheden fremlagde data fra faglitteraturen om methotrexat.
English: What benefits of Nordimet have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Nordimet?
English: • severe juvenile idiopathic arthritis (JIA), a joint disease in children, when medicines known as
Danish: • alvorlig juvenil idiopatisk artrit, der er en ledsygdom hos børn (anvendes, når lægemidler kaldet
English: How does Nordimet work?
Danish: Hvordan virker Nordimet?
English: How is Nordimet used?
Danish: Hvordan anvendes Nordimet?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nordimet have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nordimet.
English: 20 mg/mL Concentrate for solution for infusion
Danish: 20 mg/ml
English: The study continued for over three years.
Danish: Undersøgelsen varede i mere end 3 år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mimpara on 22 October 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Mimpara den 22. oktober 2004.
English: The full EPAR for Mimpara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Mimpara findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Mimpara is a medicine used to treat:
Danish: Mimpara er et lægemiddel til behandling af:
English: This is a summary of the European public assessment report (EPAR) for Mimpara.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Mimpara.
English: Other information about Mimpara
Danish: Andre oplysninger om Mimpara
English: ‘Secondary' means that it is caused by another condition (serious kidney disease) while ‘primary' means there is no other cause.
Danish: 'Sekundær' betyder, at sygdommen er forårsaget af en anden tilstand (alvorlig nyresygdom), mens 'primær' betyder, at der ikke er nogen anden årsag.
English: What measures are being taken to ensure the safe and effective use of Mimpara?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mimpara?
English: Why is Mimpara approved?
Danish: Hvorfor blev Mimpara godkendt?
English: What is Mimpara and what is it used for?
Danish: Hvad er Mimpara, og hvad anvendes det til?
English: The European Medicines Agency therefore concluded that Mimpara's benefits outweigh the risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Mimpara opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Mimpara.
English: It is not intended to provide practical advice on how to use Mimpara.
Danish: Det er ikke en praktisk vejledning i, hvordan Mimpara bør anvendes.
English: The dose is adjusted, according to the patient's PTH and calcium levels.
Danish: Dosen justeres i henhold til patientens PTH- og kalciumniveau.
English: The capsules should not be swallowed whole but should be opened and the granules sprinkled in food or liquid.
Danish: Kapslerne skal ikke synkes hele, men åbnes, så granulatet kan drysses i mad eller væske.
English: Mimpara is available as tablets and as granules in capsules, to be taken with food or shortly after a meal.
Danish: Mimpara fås som tabletter og som granulat i kapsler, og det skal tages sammen med mad eller kort tid efter et måltid.
English: What are the risks associated with Mimpara?
Danish: Hvilke risici er der forbundet med Mimpara?
English: Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Mimpara over a total of almost six years.
Danish: Blandt disse fortsatte 45 patienter i en fjerde, langvarig undersøgelse, der så nærmere på virkningen af Mimpara over i alt næsten seks år.
English: With regard to the medicine's safety, side effects seen in patients are considered manageable.
Danish: For så vidt angår sikkerheden ved lægemidlet, anses bivirkningerne hos patienterne for at kunne behandles.
English: The dose of Mimpara should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Danish: Dosen af Mimpara øges efter behov hver anden til fjerde uge op til 90 mg tre-fire gange dagligt, indtil den er tilstrækkelig til at nedsætte kalciumkoncentrationen i blodet til det normale.
English: Mimpara must not be used in patients with hypocalcaemia (low blood calcium levels).
Danish: Mimpara må ikke gives til patienter med hypocalcæmi (lavt kalciumniveau i blodet).
English: For more information about treatment with Mimpara, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mimpara, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Mimpara contains the active substance cinacalcet.
Danish: Mimpara indeholder det aktive stof cinacalcet.
English: The main measure of effectiveness was the number of patients whose blood calcium levels fell by more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study).
Danish: Virkningen blev hovedsagelig målt på antallet af patienter, hvis kalciumniveau i blodet faldt med mere end 1 mg pr. deciliter på det tidspunkt, hvor en vedligeholdelsesdosis var fundet (mellem 2 og 16 uger efter undersøgelsens start).
English: The main measure of effectiveness was the reduction of PTH levels by 30%.
Danish: Virkningen blev hovedsagelig målt på et fald i PTH-niveauet på 30 %.
English: In patients with secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day, while in children the daily starting dose depends on the child's weight.
Danish: Hos patienter med sekundær hyperparatyroidisme er den anbefalede startdosis 30 mg én gang om dagen, mens den daglige startdosis hos børn afhænger af barnets vægt.
English: For the full list of side effects and restrictions of Mimpara, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Mimpara fremgår af indlægssedlen.
English: Mimpara produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism (15 out of 17).
Danish: Mimpara medførte et fald i kalciumniveauet i blodet på mere end 1 mg/dl hos 62 % af kræftpatienterne (18 ud af 29) og hos 88 % af patienterne med primær hyperparatyroidisme (15 ud af 17).
English: This means that it mimics the action of calcium in the body.
Danish: Det betyder, at stoffet efterligner kalciums virkning i kroppen.
English: The active substance in Mimpara, cinacalcet, is a calcimimetic agent.
Danish: Det aktive stof i Mimpara, cinacalcet, er et kalcimimetisk stof.
English: • secondary hyperparathyroidism (overactive parathyroid glands) in adults and children aged 3 years and older with serious kidney disease who need dialysis (to clear their blood of waste products).
Danish: • sekundær hyperparatyroidisme (overaktive biskjoldbruskkirtler) hos voksne og børn fra 3 år og opefter med alvorlig nyresygdom, som har behov for dialyse (for at få renset deres blod for affaldsstoffer).
English: In children, Mimpara was compared with placebo in a study involving 43 children aged 6 to 18 years with serious kidney disease.
Danish: For så vidt angår børn, blev Mimpara sammenholdt med placebo i en undersøgelse med 43 børn i alderen 6-18 år, som havde en alvorlig nyresygdom.
English: In this study, 55% (12 out of 22) children given Mimpara achieved a 30% reduction of PTH levels, compared with 19% (4 out of 21) children given placebo.
Danish: I denne undersøgelse opnåede 55 % (12 ud af 22) af de børn, der fik Mimpara, et fald i PTH-niveauet på 30 % sammenholdt med 19 % (4 ud af 21) af de børn, der fik placebo.
English: In hyperparathyroidism, the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of blood calcium, bone and joint pain and deformities of the arms and legs.
Danish: Hyperparatyroidisme er en sygdom, hvor biskjoldbruskkirtlerne i halsen danner for meget paratyroideahormon (PTH), hvilket kan medføre højt kalciumindhold i blodet, smerter i knoglerne og leddene og deforme arme og ben.
English: For practical information about using Mimpara, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Mimpara, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In patients with hypercalcaemia who also have parathyroid gland cancer or primary hyperparathyroidism, the recommended starting dose of Mimpara for adults is 30 mg twice a day.
Danish: Hos patienter med hyperkalcæmi, der også har kræft i biskjoldbruskkirtlerne eller primær hyperparatyroidisme, er den anbefalede startdosis af Mimpara til voksne 30 mg to gange dagligt.
English: Mimpara brought about a 42% reduction in average PTH levels compared with an increase of 8% in patients taking placebo.
Danish: Mimpara medførte et fald på 42 % i det gennemsnitlige PTH-niveau sammenholdt med en stigning på 8 % hos de patienter, der fik placebo.
English: A further three studies compared Mimpara with placebo in a total of 136 patients with primary hyperparathyroidism over up to a year.
Danish: Mimpara blev i yderligere tre undersøgelser sammenholdt med placebo hos i alt 136 patienter med primær hyperparatyroidisme i op til et år.
English: The most common side effects with Mimpara (in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Danish: De hyppigste bivirkninger (som optræder hos mere end 1 ud af 10 patienter) er kvalme og opkastning.
English: The reduction in PTH levels also leads to a decrease in blood calcium levels.
Danish: Mindskelsen af PTH-indholdet medfører også et lavere kalciumindhold i blodet.
English: The main measure of effectiveness was the number of patients who had a parathyroid hormone level below 250 micrograms per litre after 6 months.
Danish: Virkningen blev hovedsagelig målt på antallet af patienter, som havde et PTH-niveau under 250 mikrogram pr. liter efter 6 måneder.
English: In these studies, about 40% of the patients taking Mimpara had parathyroid hormone levels below 250 micrograms per litre, compared with about 6% of those taking placebo.
Danish: I disse undersøgelser havde ca. 40 % af de patienter, der fik Mimpara, et PTH-niveau under 250 mikrogram pr. liter sammenholdt med ca. 6 % af dem, der fik placebo.
English: Mimpara has been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid cancer, and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective.
Danish: Mimpara er vurderet i en undersøgelse med 46 patienter med hyperkalcæmi, herunder 29 med kræft i biskjoldbruskkirtlerne, og 17 med primær hyperparatyroidisme, som ikke kunne få biskjoldbruskkirtlerne fjernet, eller hvor kirurgisk fjernelse af biskjoldbruskkirtlerne ikke var effektivt.
English: The results supported the use of Mimpara for hypercalcaemia in patients with primary hyperparathyroidism.
Danish: Resultaterne støttede brugen af Mimpara mod hyperkalcæmi hos patienter med primær hyperparatyroidisme.
English: • hypercalcaemia (high blood calcium levels) in adults with cancer of the parathyroid glands or with primary hyperparathyroidism when the parathyroid glands cannot be removed.
Danish: • hyperkalcæmi (højt niveau af kalcium i blodet) hos voksne med kræft i biskjoldbruskkirtlerne eller med primær hyperparatyroidisme, hvor det ikke er muligt at fjerne biskjoldbruskkirtlerne.
English: How is Mimpara used?
Danish: Hvordan anvendes Mimpara?
English: Mimpara has been compared with placebo (a dummy treatment) in three main studies involving 1,136 adults with secondary hyperparathyroidism who were on dialysis because they had a serious kidney disease.
Danish: Mimpara er blevet sammenholdt med placebo (uvirksom behandling) i tre hovedundersøgelser med 1 136 voksne patienter med sekundær hyperparatyroidisme, som var i dialyse på grund af en alvorlig nyresygdom.
English: Studies showed that Mimpara was effective in both adults and children at reducing levels of parathyroid hormone in patients with secondary hyperparathyroidism who were undergoing dialysis for kidney disease.
Danish: Undersøgelser har vist, at Mimpara var effektivt hos både børn og voksne til at reducere niveauet af paratyroideahormon (PTH) hos patienter med sekundær hyperparatyroidisme, som var i dialyse på grund af nyresygdom.
English: In addition, Mimpara reduced high calcium levels in the majority of patients with parathyroid gland cancer or primary hyperparathyroidism.
Danish: Derudover medførte Mimpara et fald i de forhøjede kalciumniveauer hos flertallet af patienter med kræft i biskjoldbruskkirtlerne eller primær hyperparatyroidisme.
English: Parathyroid gland cancer or primary hyperparathyroidism
Danish: Kræft i biskjoldbruskkirtlerne eller primær hyperparatyroidisme
English: What benefits of Mimpara have been shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Mimpara?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mimpara 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 Mimpara.
English: How does Mimpara work?
Danish: Hvordan virker Mimpara?
English: By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands.
Danish: Cinacalcet virker ved at øge følsomheden af biskjoldbruskkirtlernes kalciumreceptorer, der regulerer udskillelsen af PTH. Ved at øge følsomheden af disse receptorer mindsker cinacalcet produktionen af PTH i biskjoldbruskkirtlerne.
English: Date of latest renewal: 15 March 2015
Danish: Dato for første godkendelse: 15. marts 2010 Dato for seneste fornyelse: 15. marts 2015
English: • opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids treatment.
Danish: • opioider: mens du er i behandling med clopidogrel, bør du fortælle det til lægen, før du får ordineret enhver form for behandling med opioider.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Patients should also be told that it might take longer than usual to stop bleeding when they take Clopidogrel/Acetylsalicylic acid Zentiva, and that they should report any unusual bleeding (site or duration) to their physician.
Danish: Patienter bør også informeres om, at det kan tage længere tid end normalt at standse blødninger, når de tager Clopidogrel/Acetylsalicylsyre Zentiva, samt at de bør kontakte deres læge ved enhver usædvanlig blødning (sted eller varighed).
English: If you forget to take Clopidogrel/Acetylsalicylic acid Zentiva If you forget to take a dose of Clopidogrel/Acetylsalicylic acid Zentiva, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Danish: Hvis du har glemt at tage Clopidogrel/Acetylsalicylsyre Zentiva Hvis du glemmer at tage en dosis Clopidogrel/Acetylsalicylsyre Zentiva til sædvanlig tid, men kommer i tanke om det i løbet af 12 timer, skal du omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: Clopidogrel/Acetylsalicylic acid Zentiva should not be used during the first two trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel/ASA.
Danish: Clopidogrel/Acetylsalicylsyre Zentiva bør ikke anvendes i graviditetens første to trimestre, medmindre den kliniske situation for kvinden kræver behandling med clopidogrel/ASA.
English: Due to the presence of both components of the medicinal product, Clopidogrel/Acetylsalicylic acid Zentiva is contraindicated in case of:
Danish: På grund af tilstedeværelsen af begge komponenter i lægemidlet er Clopidogrel/Acetylsalicylsyre Zentiva kontraindiceret i tilfælde af:
English: If you experience prolonged bleeding when taking Clopidogrel/Acetylsalicylic acid Zentiva If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: Hvis du får langvarige blødninger, mens du tager Clopidogrel/Acetylsalicylsyre Zentiva Hvis du skærer dig eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: Following therapeutic doses, approximately 10% is found excreted in the urine as salicylic acid, 75% as salicyluric acid, 10% phenolic- and 5% acyl-glucuronides of salicylic acid.
Danish: Efter terapeutiske doser findes ca. 10 % af det udskilte i urinen som salicylsyre, 75 % som salicylurinsyre, 10 % som phenol- og 5 % som acylglukuronid af salicylsyre.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Clopidogrel/Acetylsalicylic acid Zentiva in all subsets of the paediatric population in the treatment of coronary atherosclerosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Clopidogrel/Acetylsalicylsyre Zentiva i alle undergrupper af den pædiatriske population ved behandling af koronar aterosklerose (se pkt.