FrancophonIA/ELRC3.0 huggingface dataset:
English: The HMPC conclusions on the use of mouse-ear hawkweed medicines for the relief of minor urinary problems are based on their ‘traditional use'.
Danish: HMPC's konklusioner vedrørende brugen af lægemidler med håret gøgeurt til lindring af mindre urinvejsproblemer er baseret på deres "traditionelle anvendelse".
English: Mouse-ear hawkweed EMA/HMPC/331455/2015
Danish: Håret gøgeurt EMA/HMPC/331455/2015
English: Mouse-ear hawkweed is the common name for the above-ground parts (which may include flowers) and parts of the root of the plant Hieracium pilosella L. The plant is cultivated or gathered to obtain the plant parts for medicinal use.
Danish: Håret gøgeurt er det almindelige navn for plantedelene over jorden (som kan omfatte blomster) og dele af roden på planten Hieracium pilosella L. Planten dyrkes eller indsamles for at få plantedelene til medicinsk brug.
English: The HMPC noted the lack of clinical studies with mouse-ear hawkweed, but took into account the well documented use of this herbal medicine for the above uses.
Danish: HMPC bemærkede de manglende kliniske studier med håret gøgeurt, men henholdt sig til den veldokumenterede brug af dette plantelægemiddel til ovennævnte anvendelser.
English: Mouse-ear hawkweed medicines must not be used in patients with conditions in which a reduced fluid intake is recommended (such as severe heart or kidney disease).
Danish: Lægemidler med håret gøgeurt må ikke anvendes til patienter med sygdomme, hvor en reduceret væskeindtagelse anbefales (f.eks. svære hjerte- eller nyresygdomme).
English: Information on the use and licensing of mouse-ear hawkweed medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om anvendelse og godkendelse i EU's medlemsstater af lægemidler, der indeholder håret gøgeurt, skal indhentes fra de relevante nationale myndigheder.
English: Any applications for the licensing of medicines containing mouse-ear hawkweed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder håret gøgeurt, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of mouse-ear hawkweed.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af håret gøgeurt.
English: Mouse-ear hawkweed medicines are generally well tolerated.
Danish: Lægemidler, der indeholder håret gøgeurt, er generelt veltolereret.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing mouse-ear hawkweed.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder håret gøgeurt.
English: Further information on the risks associated with mouse-ear hawkweed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder håret gøgeurt, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på agenturets websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Mouse-ear hawkweed preparations are obtained by comminuting (reducing into tiny pieces) or powdering the dried plant parts.
Danish: Præparater af håret gøgeurt opnås ved at findele (reducere til småstykker) eller pulverisere de tørrede plantedele.
English: Further information on the HMPC assessment of mouse-ear hawkweed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder håret gøgeurt, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på det europæiske ægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that, on the basis of its long-standing use, mouse-ear hawkweed can be used as a mild diuretic (a medicine to increase production of urine) for the relief of minor problems of the urinary tract (the structures that carry urine).
Danish: HMPC konkluderede, at håret gøgeurt på grundlag af sin langvarige brug kan anvendes som et mildt, vanddrivende middel (et lægemiddel, der øger urinproduktionen) til lindring af mindre problemer i urinvejene (urinlederne).
English: How are mouse-ear hawkweed medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder håret gøgeurt, i EU?
English: This summary is not intended to provide practical advice on how to use medicines containing mouseear hawkweed.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder håret gøgeurt, anvendes.
English: Herbal medicines containing mouse-ear hawkweed are usually available as a herbal tea to be drunk and in solid forms to be taken by mouth.
Danish: Plantelægemidler indeholdende håret gøgeurt fås normalt som en urtete til drikkebrug samt i fast til indtagelse gennem munden.
English: What evidence supports the use of mouse-ear hawkweed medicines?
Danish: Hvilken dokumentation underbygger anvendelsen af lægemidler med håret gøgeurt?
English: Detailed instructions on how to take mouse-ear hawkweed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: hvordan lægemidler med håret gøgeurt skal tages, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: What is mouse-ear hawkweed?
Danish: Hvad er håret gøgeurt?
English: For further information, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelser, HMPC har vurderet, findes i HMPC's vurderingsrapport.
English: Other information about mouse-ear hawkweed medicines
Danish: Andre oplysninger om lægemidler, der indeholder håret gøgeurt
English: What are the risks associated with mouse-ear hawkweed medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder håret gøgeurt?
English: For more information about treatment with mouse-ear hawkweed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder håret gøgeurt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For practical information about using mouse-ear hawkweed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med håret gøgeurt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Mouse-ear hawkweed
Danish: Håret gøgeurt
English: The recommended dose is 300 mg twice a day on the first day followed by 300 mg once a day thereafter; the duration of treatment depends on the severity of the disease and the patient's response.
Danish: Den anbefalede dosis er 300 mg to gange dagligt den første dag efterfulgt af 300 mg én gang dagligt; behandlingens varighed afhænger af sygdommens sværhedsgrad og patientens respons.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden har også udført studier, der har vist, at det er "bioækvivalent" med referencelægemidlet.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Danish: Det virker ved at forhindre dannelsen af ergosterol, som er en vigtig del af svampecellemembranerne.
English: Further information on Posaconazole Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/posaconazole-accord.
Danish: Yderligere information vedrørende Posaconazole Accord findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/posaconazole-accord.
English: Posaconazole Accord (posaconazole) EMA/320670/2019
Danish: Posaconazole Accord (posaconazol) EMA/320670/2019
English: Posaconazole Accord is an antifungal medicine used to treat adults with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Danish: Posaconazole Accord er et svampemiddel, der anvendes til behandling af voksne med følgende svampesygdomme, når behandling med andre svampemidler (amphotericin B, itraconazol eller fluconazol) ikke kan tolereres eller har slået fejl:
English: Side effects reported with Posaconazole Accord are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Posaconazole Accord vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: • chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
Danish: • chromoblastomykose og mycetom (langvarige svampeinfektioner i huden eller vævet lige under huden, som normalt forårsages af svampesporer, der inficerer sår på grund af torne eller splinter)
English: Because Posaconazole 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 Posaconazole Accord er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Noxafil, and do not need to be repeated for Posaconazole Accord.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Noxafil, og de behøver ikke at blive gentaget for Posaconazole Accord.
English: Posaconazole Accord is also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow).
Danish: Posaconazole Accord anvendes også til at forhindre invasive svampeinfektioner hos patienter, hvis immunsystem er svækket på grund af igangværende behandling for blodkræft eller knoglemarvskræft eller behandling med lægemidler, der anvendes i hæmatopoietisk stamcelletransplantation (en procedure, hvor patientens knoglemarv erstattes af stamceller fra en donor for at danne ny knoglemarv).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Posaconazole Accord has been shown to have comparable quality and to be bioequivalent to Noxafil.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Posaconazole Accord er af sammenlignelig kvalitet og er bioækvivalent med Noxafil.
English: Posaconazole Accord can only be obtained with a prescription and treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Danish: Posaconazole Accord fås kun på recept, og behandlingen bør indledes af en læge med erfaring i behandling af invasive svampeinfektioner eller i behandling af patienter med høj risiko for invasive svampeinfektioner.
English: Gastro-resistant means that the tablets pass through the stomach without being broken down until they reach the intestine.
Danish: "Enterotabletter" er tabletter, hvis indhold passerer gennem mavesækken uden at nedbrydes, før det når frem til tarmen.
English: This means that Posaconazole Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Noxafil.
Danish: Det betyder, at Posaconazole Accord indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Noxafil.
English: As for every medicine, the company provided studies on the quality of Posaconazole Accord.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Posaconazole Accord.
English: As for all medicines, data on the use of Posaconazole Accord are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Posaconazole Accord løbende overvåget.
English: For more information about using Posaconazole Accord, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Posaconazole Accord, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: An overview of Posaconazole Accord and why it is authorised in the EU
Danish: En oversigt over Posaconazole Accord, og hvorfor det er godkendt i EU
English: Posaconazole Accord (posaconazole)
Danish: Posaconazole Accord (posaconazol)
English: Without ergosterol, the fungus dies or is prevented from spreading.
Danish: Svampen dør eller forhindres i at brede sig uden ergosterol.
English: What measures are being taken to ensure the safe and effective use of Posaconazole Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Posaconazole Accord?
English: Posaconazole Accord contains the active substance posaconazole and is a ‘generic medicine'.
Danish: Posaconazole Accord indeholder det aktive stof posaconazol og er et "generisk lægemiddel".
English: • fusariosis (fungal infection caused by Fusarium),
Danish: • fusariose (svampeinfektion forårsaget af Fusarium
English: • invasive aspergillosis (fungal infection caused by Aspergillus),
Danish: • invasiv aspergillose (svampeinfektion forårsaget af Aspergillus
English: Therefore, the Agency's view was that, as for Noxafil, the benefit of Posaconazole Accord outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Posaconazole Accord opvejer de identificerede risici som for Noxafil, og at det kan godkendes til anvendelse i EU.
English: Other information about Posaconazole Accord
Danish: Andre oplysninger om Posaconazole Accord
English: What are the benefits and risks of Posaconazole Accord?
Danish: Hvilke fordele og risici er der forbundet med Posaconazole Accord?
English: Posaconazole Accord is available as gastro-resistant tablets (100 mg).
Danish: Posaconazole Accord findes som enterotabletter (100 mg).
English: • coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
Danish: • coccidioidomykose (svampeinfektion i lungerne på grund af indånding af sporer).
English: The active substance in Posaconazole Accord, posaconazole, is an antifungal medicine that belongs to the triazole group.
Danish: Det aktive stof i Posaconazole Accord, posaconazol, er et svampemiddel i triazolgruppen.
English: Why is Posaconazole Accord authorised in the EU?
Danish: Hvorfor er Posaconazole Accord godkendt i EU?
English: What is Posaconazole Accord and what is it used for?
Danish: Hvad er Posaconazole Accord, og hvad anvendes det til?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Posaconazole Accord 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 Posaconazole Accord.
English: How has Posaconazole Accord been studied?
Danish: Hvordan er Posaconazole Accord blevet undersøgt?
English: The list of fungi Posaconazole Accord is active against can be found in the summary of product characteristics.
Danish: Listen over svampe, som Posaconazole Accord virker mod, findes i produktresuméet.
English: How is Posaconazole Accord used?
Danish: Hvordan anvendes Posaconazole Accord?
English: How does Posaconazole Accord work?
Danish: Hvordan virker Posaconazole Accord?
English: DATE OF REVISION OF THE TEXT 11.
Danish: DATO FOR ÆNDRING AF TEKSTEN 11.
English: Cases should be histopathologically confirmed, if possible.
Danish: Cases bør være histopatologisk bekræftede, hvis det er muligt.
English: The training programme should contain the following key elements:
Danish: Uddannelsesprogrammet skal indeholde følgende hovedelementer:
English: Up to 10 hours from the end of the synthesis.
Danish: Op til 10 timer efter endt syntese.
English: Training should include a sufficient number of clearly positive and negative cases as well as intermediate level cases.
Danish: Oplæringen skal inkludere et tilstrækkeligt antal klart positive og negative cases samt cases på mellemniveau.
English: • Expertise and qualification of trainers should be ensured.
Danish: • Instruktørernes ekspertise og kvalifikation skal sikres.
English: 20052 Monza Italy
Danish: 20052 Monza Italien
English: Possible side effects include:
Danish: Mulige bivirkninger omfatter:
English: Neuraceq will only be used in specially controlled areas.
Danish: Neuraceq vil kun blive anvendt i specielt kontrollerede områder.
English: It will be the smallest amount necessary to get the desired information.
Danish: Det bliver den mindst mulige mængde for at opnå de ønskede oplysninger.
English: • Information on amyloid pathology in Alzheimer's disease;
Danish: • Information om amyloid patologi ved Alzheimers sygdom
English: However, in the case of an overdose, you will receive the appropriate treatment.
Danish: Skulle du imidlertid få en overdosis, vil du få passende behandling.
English: Radioactive material.
Danish: Radioaktivt materiale.
English: <Not applicable>
Danish: <Ikke relevant.>
English: EXP: ToC + 6 h
Danish: EXP: ToC + 6 t
English: After the procedure
Danish: Efter proceduren
English: Dosimetry calculations were adapted to the adult model (with a body weight of 70 kg).
Danish: Dosimetriberegningerne blev tilpasset den voksne model (med en legemsvægt på 70 kg).
English: The histopathology criteria did not match the CERAD criteria.
Danish: De histopatologiske kriterier stemte ikke overens med CERAD-kriterierne.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Danish: Modtagelse, opbevaring, anvendelse, overførsel og bortskaffelse er underlagt bestemmelser og/eller licenser udstedt af det relevante myndighedsorgan.
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Danish: Der er streng lovgivning vedrørende anvendelse, håndtering og bortskaffelse af radioaktive lægemidler.
English: Administration of Neuraceq and conduct of the procedure
Danish: Administration af Neuraceq og udførelse af proceduren
English: The overall safety profile of Neuraceq is based on data from 1,295 administrations of Neuraceq to 1,077 subjects and 12 subjects who received vehicle.
Danish: Den samlede sikkerhedsprofil for Neuraceq er baseret på data fra 1.295 administrationer af Neuraceq til 1.077 personer og 12 personer, der fik vehikel.
English: You will not have to store this medicine.
Danish: Du vil ikke få brug for at opbevare dette lægemiddel.
English: Dose absorbed per activity administered [mGy/MBq]
Danish: Dosis absorberet pr. administreret aktivitet [mGy/MBq]
English: Neuraceq is not intended for use in children and adolescents below the age of 18 years old.
Danish: Neuraceq er ikke beregnet til brug hos børn og unge under 18 år.
English: Appropriate aseptic precautions should be taken.
Danish: Passende aseptiske forsigtighedsregler skal overholdes.
English: One injection is sufficient to carry out the scan that your doctor needs.
Danish: Det er nok med en enkelt indsprøjtning til at udføre den scanning, som lægen har brug for.
English: Remaining organs
Danish: Resterende organer
English: Repeat dosing in yearly intervals showed that there was no difference in safety profile after first, second or third dosing.
Danish: Gentagen dosering hvert år viste, at der ikke var nogen forskel i sikkerhedsprofilen efter første, anden og tredje dosis.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Danish: Alle kvinder, der har sprunget en menstruation over, skal antages at være gravide, indtil det modsatte er bevist.
English: Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Danish: Der bør derfor kun udføres essentielle undersøgelser under graviditet, i tilfælde hvor den sandsynlige fordel i høj grad overstiger risikoen for moderen og fosteret.
English: Time points beyond that time frame did not allow for further quantitation of activity in urine.
Danish: Tidspunkter efter den tidsramme gav ikke mulighed for yderligere kvantificering af aktiviteten i urin.
English: The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Danish: Den administrerede aktivitet skal i hvert tilfælde være så lav som rimelig muligt for at få de nødvendige, diagnostiske oplysninger.
English: This leaflet was last revised in {month YYYY}.
Danish: Denne indlægsseddel blev senest revideret {måned ÅÅÅÅ}.
English: Germany e-mail: gra@life-mi.com
Danish: Tyskland e-mail: gra@life-mi.com
English: The table below shows the dosimetry as calculated using the OLINDA (Organ Level INternal Dose Assessment) software.
Danish: Skemaet nedenfor viser dosimetrien, beregnet ved brug af OLINDA (Organ Level INternal Dose Assessment) softwaren.
English: This medicine will only be handled and given to you by professionals who are trained and qualified to use it safely.
Danish: Lægemidlet vil kun blive håndteret og givet til dig af sundhedspersonale, der er oplært og kvalificerede til at anvende det på sikker vis.
English: Reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2.0 and 3.0 mm.
Danish: Rekonstruktion bør inkludere korrektion af attenuation med resulterende transaksiale pixelstørrelser på 2,0 og 3,0 mm.
English: Activity: {XXX} MBq in {XX} mL ToC: {DDMMYYYY} {XX}h{XX} {Time zone} Volume: {XX} mL
Danish: Aktivitet: {XXX} MBq i {XX} ml ToC: {DD/MM/ÅÅÅÅ}kl. {XX}:{XX} {tidszone} Volumen: {XX} ml
English: Only clear solutions, free of visible particles should be used.
Danish: Der må kun anvendes klar væske uden synlige partikler.
English: In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P450 enzyme system.
Danish: In vitro-studier med brug af humane levermikrosomer indikerede ikke noget potentiale for at hæmme cytokrom P450-enzymsystemet.
English: No studies have been conducted in pregnant women.
Danish: Der er ikke udført studier af gravide kvinder.
English: These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
Danish: Disse personer vil udvise særlig forsigtighed for at anvende lægemidlet på en sikker måde, og de vil holde dig informeret om, hvad de foretager sig.
English: Interpretation of Neuraceq images
Danish: Fortolkning af Neuraceq-billeder