FrancophonIA/ELRC3.0 huggingface dataset:
English: Leukoencephalopathy
Danish: Leukoencefalopati
English: - retinoids (for the treatment of psoriasis and other skin diseases) - antiepileptic medicines (prevention of seizures) - barbiturates (sleeping medicines) - sedatives - oral contraceptives - probenecid (for gout) - antibiotics - pyrimethamine (for the prevention and treatment of malaria) - vitamin preparations containing folic acid - proton pump inhibitors (for the treatment of heartburn, ulcers and some other stomach complaints) - theophylline (for breathing problems) - mercaptopurine (for the treatment of certain types of leukaemia).
Danish: vitaminpræparater med folsyre protonpumpehæmmere (til behandling af halsbrand, mavesår og visse andre mavesymptomer) theophyllin (mod vejrtrækningsproblemer) mercaptopurin (til behandling af visse typer leukæmi (blodkræft)) kræftmedicin (såsom doxorubicin og procarbazin ved behandling med høje doser methotrexat)
English: If you take more Jylamvo than you should
Danish: Hvis du har taget for meget Jylamvo
English: Package leaflet: Information for the user Jylamvo 2 mg/ml oral solution methotrexate
Danish: LÆGEMIDLETS NAVN Jylamvo, oral opløsning, 2 mg/ml methotrexat
English: Vaginal
Danish: Faryngitis
English: Do not store above 25ºC.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25 ºC.
English: Pancreatitis, Enteritis, Malabsorption, Melaena, Gingivitis
Danish: Pankreatitis Enteritis Malabsorption Melæna Gingivitis
English: Doses exceeding 20 mg (10 ml)/week can be associated with a substantial increase in toxicity,
Danish: Doser på over 20 mg (10 ml) om ugen kan være forbundet med betydeligt øget toksicitet, navnlig knoglemarvsdepression.
English: If you suffer from diarrhoea please speak to your doctor.
Danish: Du skal tale med lægen, hvis du får diarré.
English: Orange flavour
Danish: Hemiparese Parese
English: Hepatic impairment
Danish: Neutropeni Lymfadenopati
English: For arthritis and psoriasis take only once a week on ………….
Danish: Ved gigt og psoriasis tages dette lægemiddel kun én gang om ugen hver ______________(skriv tydeligt hvilken ugedag lægemidlet skal tages).
English: Encephalopathy/
Danish: Encefalopati
English: Cytotoxic
Danish: Eosinofili
English: Pain,
Danish: Se pkt.
English: One ml of solution contains 2 mg of methotrexate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml opløsning indeholder 2 mg methotrexat.
English: DO NOT measure to the narrow tip of the plunger.
Danish: Der må IKKE måles efter stemplets smalle spids.
English: Therakind (Europe) Limited
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Therakind (Europe) Limited
English: Eosinophilia, Neutropenia, Lymphadenopathy
Danish: Muskler, knogler og bindevæv
English: Treatment of rheumatoid arthritis, severe juvenile idiopathic arthritis, severe psoriasis and severe psoriatic arthritis with Jylamvo is a long-term treatment.
Danish: Behandlingen er langvarig, når Jylamvo anvendes mod gigt, svær gigt af ukendt oprindelse hos unge (svær juvenil idiopatisk artritis), svær psoriasis og svær psoriasisgigt.
English: System organ class
Danish: Systemorgankla sse
English: Excipient warnings
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk
English: − liver failure
Danish: Nedsat nyrefunktion
English: painful urination
Danish: Inadækvat sårheling Urticaria
English: Musculoskeletal and connective tissue disorders
Danish: Osteoporose Artralgi Myalgi
English: The medicine is available as tablets (15, 30 and 45 mg) and the recommended starting dose is 15 or 30 mg once a day.
Danish: Lægemidlet fås som tabletter (15, 30 og 45 mg), og den anbefalede startdosis er 15 eller 30 mg en gang dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Accord on 21 March 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pioglitazone Accord den 21. marts 2012.
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Danish: Denne dosis skal muligvis øges efter en til to uger til en dosis på op til 45 mg en gang dagligt, hvis der er behov for en bedre kontrol af blodsukkerkoncentrationen i blodet.
English: The full EPAR for Pioglitazone Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Pioglitazone Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Danish: Derved reduceres mængden af blodsukker, og dette medvirker til at regulere type 2-diabetes.
English: Pioglitazone Accord is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Danish: Pioglitazone Accord anvendes til behandling af type 2-diabetes hos voksne (på 18 år og derover), især overvægtige.
English: Treatment with Pioglitazone Accord should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Danish: Behandlingen med Pioglitazone Accord skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke får tilstrækkelig gavn af behandlingen.
English: The active substance in Pioglitazone Accord, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Pioglitazone Accord, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv producerer.
English: This means that Pioglitazone Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Pioglitazone Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Actos.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pioglitazone Accord.
English: The Committee recommended that Pioglitazone Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at Pioglitazone Accordgodkendes til anvendelse i EU.
English: Pioglitazone Accord is a ‘generic medicine'.
Danish: Pioglitazone Accord er et "generisk lægemiddel".
English: Pioglitazone Accord contains the active substance pioglitazone.
Danish: Pioglitazone Accord indeholder det aktive stof pioglitazon.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pioglitazone Accord has been shown to have comparable quality and to be bioequivalent to Actos.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pioglitazone Accord er af sammenlignelig kvalitet og er bioækvivalent med Actos.
English: Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Actos.
English: • together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: • sammen med insulin hos patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
English: Other information about Pioglitazone Accord
Danish: Andre oplysninger om Pioglitazone Accord
English: What measures are being taken to ensure the safe and effective use of Pioglitazone Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pioglitazone Accord?
English: For more information about treatment with Pioglitazone Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pioglitazone Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Because Pioglitazone Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Danish: Da Pioglitazone Accord er et generisk lægemiddel, har patientundersøgelserne været begrænset til tests for at påvise, at det er bioækvivalent med referencelægemidlet Actos.
English: • on its own in patients for whom metformin (another diabetes medicine) is not suitable.
Danish: • som enebehandling til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet
English: The company that markets Pioglitazone Accord will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Danish: Materialet skal redegøre for den mulige risiko for hjertesvigt og blærekræft ved lægemidler, der indeholder pioglitazon, kriterier for udvælgelse af patienterne og behovet for regelmæssig gennemgang og indstilling af behandlingen, hvis patienten ikke længere har gavn af den.
English: Because Pioglitazone Accord 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 Pioglitazone Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What are the benefits and risks of Pioglitazone Accord?
Danish: Hvilken fordel og risiko er der forbundet med Pioglitazone Accord?
English: • in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
Danish: • i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene, eller sammen med et sulfonylurinstof (en anden type lægemiddel mod diabetes), når metformin ikke er egnet til patienter, som ikke er tilfredsstillende reguleret med et sulfonylurinstof alene
English: It is not intended to provide practical advice on how to use Pioglitazone Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Pioglitazone Accord bør anvendes.
English: What is Pioglitazone Accord and what is it used for?
Danish: Hvad er Pioglitazone Accord, og hvad anvendes det til?
English: Pioglitazone Accord can only be obtained with a prescription.
Danish: Pioglitazone Accord udleveres kun efter recept.
English: For practical information about using Pioglitazone Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pioglitazone Accordd, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pioglitazone Accord 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 Pioglitazone Accord.
English: Why is Pioglitazone Accord approved?
Danish: Hvorfor blev Pioglitazone Accord godkendt?
English: EPAR summary for the public
Danish: EPAR - sammendrag for offentligheden pioglitazon
English: How has Pioglitazone Accord been studied?
Danish: Hvordan blev Pioglitazone Accord undersøgt?
English: How is Pioglitazone Accord used?
Danish: Hvordan anvendes Pioglitazone Accord?
English: How does Pioglitazone Accord work?
Danish: Hvordan virker Pioglitazone Accord?
English: Opsumit received a marketing authorisation valid throughout the EU on 20 December 2013.
Danish: Opsumit fik en markedsføringstilladelse med gyldighed i hele EU den 20. december 2013.
English: Other information about Opsumit
Danish: Andre oplysninger om Opsumit
English: As for all medicines, data on the use of Opsumit are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Opsumit løbende overvåget.
English: The medicine is available as 10 mg tablets and taken at a dose of one tablet every day.
Danish: Lægemidlet fås som 10 mg-tabletter, og dosen er én tablet hver dag.
English: What is Opsumit and what is it used for?
Danish: Hvad er Opsumit, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Opsumit?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Opsumit?
English: An overview of Opsumit and why it is authorised in the EU
Danish: En oversigt over Opsumit, og hvorfor det er godkendt i EU
English: Why is Opsumit authorised in the EU?
Danish: Hvorfor blev Opsumit godkendt i EU?
English: The European Medicines Agency decided that Opsumit's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Opsumit opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Women should also not become pregnant for one month after stopping treatment.
Danish: Kvinder må heller blive gravide inden for en måned efter behandlingsophør.
English: Opsumit is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH).
Danish: Opsumit er et lægemiddel, der anvendes til langvarig behandling af pulmonal arteriel hypertension (PAH).
English: In a main study involving 742 patients, Opsumit has been shown to reduce the risk of PAH-related illness, particularly the worsening of PAH symptoms.
Danish: I et hovedstudie med 742 patienter er det påvist, at Opsumit reducerer risikoen for PAH-relateret sygdom, navnlig forværring af PAH-symptomer.
English: In animal studies, Opsumit was shown to have an adverse effect on the development of embryos.
Danish: I dyrestudier er det påvist, at Opsumit har en negativ indvirkning på udviklingen af fostre.
English: Most side effects are mild to moderate in severity.
Danish: De fleste bivirkninger er milde til moderate.
English: For more information about using Opsumit, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Opsumit, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: These are part of a natural mechanism in the body that can cause arteries to narrow.
Danish: Disse receptorer er en del af en naturlig mekanisme i kroppen, som kan få arterierne til at snævre ind.
English: Opsumit is used for adults whose PAH is classified as WHO functional class II to class III.
Danish: Opsumit anvendes hos voksne, hvis PAH er klassificeret som WHO-funktionsklasse II-III.
English: Opsumit contains the active substance macitentan.
Danish: Opsumit indeholder det aktive stof macitentan.
English: Side effects reported with Opsumit are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Opsumit vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Further information on Opsumit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Opsumit findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: PAH is ‘rare', and Opsumit was designated an ‘orphan medicine' (a medicine used in rare diseases) for PAH on 27 September 2011.
Danish: PAH er sjælden, og Opsumit blev udpeget som "lægemiddel til sjældne sygdomme" den 27. september 2011.
English: Around 37% of patients taking placebo had a worsening of their PAH symptoms compared with 24% of those who took Opsumit 10 mg.
Danish: Ca. 37 % af de patienter, der fik placebo, oplevede en forværring af deres PAH-symptomer sammenholdt med 24 % blandt dem, der fik Opsumit (10 mg).
English: What are the risks associated with Opsumit?
Danish: Hvilke risici er der forbundet med Opsumit?
English: Opsumit has been shown to be effective in reducing illness or deaths due to PAH and the side effects reported are similar to those reported with other medicines of its class and are considered to be manageable.
Danish: Det er påvist, at Opsumit er effektivt til at reducere sygdom eller død som følge af PAH, og de indberettede bivirkninger svarer til dem, der er indberettet for andre lægemidler i denne klasse, og anses for at være håndterbare.
English: The most common side effects with Opsumit (which may affect more than 1 in 10 people) include nasopharyngitis (inflammation of the nose and throat), anaemia (low red blood cell counts) and headache.
Danish: De hyppigste bivirkninger ved Opsumit (som kan forekomme hos mere end 1 ud af 10 patienter) omfatter betændelse i næse og svælg, blodmangel (anæmi) og hovedpine.
English: Opsumit can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in treating PAH.
Danish: Opsumit udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en speciallæge med erfaring i behandling af PAH.
English: The class reflects the seriousness of the disease: patients with class II PAH have slight limitation of physical activity and those with class III disease have marked limitation of physical activity.
Danish: Klassen afspejler sværhedsgraden af sygdommen: Patienter med klasse II-PAH har et let begrænset fysisk aktivitetsniveau, mens patienter med klasse III-PAH har en udtalt begrænsning af deres fysiske aktivitetsniveau.
English: Because more pressure is needed to force blood through the narrowed artery, this leads to high blood pressure in the lungs.
Danish: Da der er behov for et større tryk for at presse blodet gennem de forsnævrede arterier, medfører dette et højt blodtryk i lungerne.
English: In patients with PAH, this mechanism is overactive and, by blocking these receptors, macitentan helps widen the arteries in the lungs and thereby bring down the blood pressure.
Danish: Hos patienter med PAH er denne mekanisme overaktiv, og ved at blokere receptorerne medvirker macitentan til at udvide arterierne i lungerne og dermed sænke blodtrykket.
English: The company that markets Opsumit will send educational material to patients and healthcare professionals with information on the precautions to be taken when using Opsumit.
Danish: Den virksomhed, der markedsfører Opsumit, skal udarbejde informationsmateriale til patienter og sundhedspersoner med oplysninger om de sikkerhedsforanstaltninger, der skal tages ved anvendelse af Opsumit.
English: Further information on the orphan designation can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Yderligere oplysninger om lægemidler til sjældne sygdomme findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The active substance in Opsumit, macitentan, works by blocking endothelin receptors.
Danish: Det aktive stof i Opsumit, macitentan, virker ved at blokere endothelin-receptorerne.
English: Patients in the study received either Opsumit or placebo (a dummy treatment) in addition to other PAH treatments for an average of 2 years.
Danish: Patienterne i forsøget fik enten Opsumit eller placebo (ikke-aktivt stof) som tillæg til andre PAH-lægemidler i gennemsnitligt 2 år.
English: PAH is a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue.
Danish: PAH er en sygdom, hvor blodtrykket i lungerne er unormalt højt, hvilket giver symptomer som f.eks. åndenød og træthed.
English: It must also not be used in patients with severe reduction in liver function or high levels of liver enzymes in the blood.
Danish: Opsumit må heller ikke anvendes hos patienter, der har svært nedsat leverfunktion eller forhøjede mængder af leverenzymer i blodet.
English: Opsumit must therefore not be used in pregnant or breastfeeding women or in women who could become pregnant and who are not using reliable contraception.
Danish: Opsumit må derfor ikke anvendes hos kvinder, der er gravide eller ammer, eller hos kvinder, der kan blive gravide, og som ikke anvender sikker prævention.
English: How is Opsumit used?
Danish: Hvordan anvendes Opsumit?
English: Patients' reminder cards will include a warning that the medicine must never be used in pregnant women and that women who could become pregnant must be using reliable contraception and should undergo monthly pregnancy tests.
Danish: Patientkortet skal indeholde en advarsel om, at lægemidlet aldrig må anvendes hos gravide kvinder, og at kvinder, der kan blive gravide, skal anvende sikker prævention og bør have taget en graviditetstest en gang om måneden.
English: In PAH there is severe narrowing of the arteries of the lungs.
Danish: Ved PAH sker der en forsnævring af arterierne i lungerne.
English: What benefits of Opsumit have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Opsumit?
English: For the full list of side effects reported with Opsumit, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Opsumit fremgår af indlægssedlen.
English: However, as animal studies showed an adverse effect on the development of embryos, Opsumit must never be used in pregnant women or women who could become pregnant and are not using reliable contraception.
Danish: Da det er påvist i dyrestudier, at Opsumit har en negativ indvirkning på fosterudviklingen, må lægemidlet ikke anvendes hos gravide kvinder eller kvinder, der kan blive gravide, og som ikke anvender sikker prævention.
English: Opsumit can be used alone or in combination with other PAH medicines; for further information, see the package leaflet.
Danish: Opsumit kan anvendes alene eller i kombination med andre PAH-lægemidler.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opsumit 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 Opsumit.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh on 23 February 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax RCPCh den 23. februar 2005.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis, and every three years for rhinotracheitis, calicivirosis and panleucopenia.
Danish: Katten bør revaccineres for alle komponenter ét år efter det første vaccinationsforløb, derefter hvert år for klamydia, og hvert tredje år for rhinotracheitis, calicivirose og panleukopeni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh exceed the risks for the approved indications and recommended that Purevax RCPCh be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Purevax RCPCh overstiger risiciene til de godkendte anvendelser, og anbefalede udstedelse af markedsføringstilladelse for Purevax RCPCh.