FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on the HMPC assessment of passion flower 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 passionsblomst, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på det europæiske lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing passion flower.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder passionsblomst.
English: Therefore, the HMPC conclusions on the use of passion flower medicines are based on their long-standing use.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med passionsblomst er derfor baseret på den mangeårige anvendelse.
English: Further information on the risks associated with these passion flower 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 passionsblomst, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This summary is not intended to provide practical advice on how to use medicines containing passion flower.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder passionsblomst, skal anvendes.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of passion flower.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af passionsblomst.
English: Other information about passion flower medicines
Danish: Andre oplysninger om lægemidler, der indeholder passionsblomst
English: Herbal medicines containing these passion flower preparations are usually available as herbal teas to be drunk or as solid or liquid forms to be taken by mouth.
Danish: Plantelægemidler med passionsblomst i disse tilberedninger fås sædvanligvis som urtete beregnet til at drikke eller i flydende eller fast form til anvendelse gennem munden.
English: Extracts are obtained by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Danish: Ekstrakterne ffremstilles ved at udtrække stoffer fra plantematerialet i et opløsningsmiddel (såsom ethanol).
English: How are passion flower medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder passionsblomst, i EU?
English: What are the risks associated with passion flower medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder passionsblomst?
English: What evidence supports the use of passion flower medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af passionsblomst?
English: In its assessment, the HMPC also considered published clinical studies of passion flower medicines.
Danish: HMPC har desuden vurderet publicerede kliniske undersøgelser af lægemidler med passionsblomst.
English: The HMPC concluded that, on the basis of its long-standing use, these passion flower preparations can be used for the relief of mild symptoms of mental stress and to aid sleep.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at passionsblomst kan anvendes til lindring af lette symptomer på mental stress og gøre det lettere at falde i søvn.
English: For more information about treatment with passion flower 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 passionsblomst, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For practical information about using passion flower 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 passionsblomst, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: A doctor or a qualified healthcare practitioner should be consulted if the symptoms last for more than 2 weeks or worsen during the use of the medicine.
Danish: Hvis symptomerne forværres eller varer ved længere end 2 uger under brug af lægemidlet, skal der søges råd hos en læge eller på apoteket.
English: Detailed instructions on how to take passion flower medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: passionsblomst bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: The HMPC conclusions on the use of these passion flower medicines for mild symptoms of mental stress and to aid sleep are based on their ‘traditional use' in these conditions.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med passionsblomst er baseret på deres "traditionelle anvendelse" til til lindring af lettere symptomer på mental stress samt at gøre det lettere at falde i søvn.
English: To obtain a dry extract the solvent is then evaporated.
Danish: Ved fremstilling af tørekstrakt fordampes opløsningsmidlet herefter.
English: The main measure of effectiveness was the response to treatment after 16 weeks.
Danish: Det primære mål for virkning var responset på behandling efter 16 uger.
English: Further information of Targretin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Targretin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Targretin received a marketing authorisation valid throughout the EU on 29 March 2001.
Danish: Targretin fik en markedsføringstilladelse med gyldighed i hele EU den 29. marts 2001.
English: Targretin was not compared with another medicine.
Danish: Targretin blev ikke sammenlignet med et andet lægemiddel.
English: The response rates according to the 5 skin scores were 36% and 27%, respectively.
Danish: Responsraten i henhold til de fem kliniske hudtegn var henholdsvis 36 % og 27 %.
English: This was measured by the doctor's
Danish: Responset blev målt ud fra lægens vurdering af
English: As for all medicines, data on the use of Targretin are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Targretin løbende overvåget.
English: Other information about Targretin
Danish: Andre oplysninger om Targretin
English: The dose is adjusted depending on the patient's response to treatment or side effects.
Danish: Dosen justeres i forhold til patientens respons på behandlingen eller bivirkninger.
English: Ninety-three of these patients had advanced disease that had not responded to other treatment.
Danish: 93 af disse patienter havde fremskreden sygdom, som ikke reagerede på anden behandling.
English: Targretin (bexarotene)
Danish: Targretin (bexaroten)
English: Targretin is available as capsules (75 mg).
Danish: Targretin fås som kapsler (75 mg).
English: Targretin (bexarotene) EMA/234177/2018
Danish: Targretin (bexaroten) EMA/234177/2018
English: The recommended starting dose is 300 mg/m2/day, taken as a single dose once a day with a meal.
Danish: Den anbefalede startdosis er 300 mg/m2/dag i form af en enkelt tablet én gang dagligt sammen med et måltid.
English: An overview of Targretin and why it is authorised in the EU
Danish: En oversigt over Targretin, og hvorfor det er godkendt i EU
English: Side effects reported with Targretin are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Targretin vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Targretin?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Targretin?
English: Sixty-one patients were treated at the starting dose of 300 mg/m2/day.
Danish: 61 patienter blev behandlet med en startdosis på 300 mg/m2/dag.
English: Across the two studies, among the patients who received 300 mg/m2, about half of them responded to treatment, according the doctor's grading.
Danish: Samlet set for de to studier reagerede omkring halvdelen af de patienter, der fik 300 mg/m2, på behandlingen i henhold til lægens vurdering.
English: grading of improvement, as well as by a score of 5 clinical signs (area of skin affected, redness, raised areas, scale-like skin and colour).
Danish: forbedring samt ved hjælp af en vurdering af fem kliniske tegn (størrelsen af det berørte hudområde, rødme, hævede områder, skællignende hud og farve).
English: What is Targretin and what is it used for?
Danish: Hvad er Targretin, og hvad anvendes det til?
English: Targretin can only be obtained with a prescription and treatment should only be initiated and maintained by a doctor who has experience in the treatment of patients with CTCL.
Danish: Targretin udleveres kun efter recept, og behandlingen bør kun iværksættes og vedligeholdes af en læge med erfaring i behandling af patienter med kutane T-cellelymfomer.
English: Why is Targretin authorised in the EU?
Danish: Hvorfor blev Targretin godkendt i EU?
English: CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin.
Danish: Kutant T-cellelymfom er en sjælden form for lymfom (kræft i lymfevævet), hvor nogle hvide blodlegemer (T-celler) vokser i huden.
English: The Agency recommended that Targretin be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Targretin.
English: Targretin must not be used in women who are pregnant or breast-feeding, or women who could become pregnant and who are not using effective contraception; patients who have had pancreatitis (inflammation of the pancreas); patients with uncontrolled hypercholesterolaemia (high blood cholesterol), hypertriglyceridaemia (high blood triglycerides [fat]) or thyroid disease; patients with hypervitaminosis A (high levels of vitamin A); patients with liver disease; patients with an ongoing body infection.
Danish: Targretin må ikke anvendes hos kvinder, der er gravide eller ammer, eller kvinder, der kan blive gravide, og som ikke anvender sikker prævention, patienter, som har haft betændelse i bugspytkirtlen, patienter, som har et ukontrolleret højt kolesterolniveau, højt triglyceridniveau i blodet eller skjoldbruskkirtelsygdom, patienter med for højt niveau af A-vitamin, leversygdom eller infektion i kroppen.
English: What are the risks associated with Targretin?
Danish: Hvilke risici er der forbundet med Targretin?
English: Targretin is used in patients who have an advanced disease and have had at least one other treatment.
Danish: Targretin anvendes hos patienter, der har fremskreden sygdom, og som tidligere har fået mindst én anden behandling.
English: The effectiveness of Targretin has been examined in two studies involving a total of 193 patients with CTCL who received at least two previous treatments.
Danish: Virkningen af Targretin er undersøgt i to studier med i alt 193 patienter med kutant T-cellelymfom, som havde fået mindst to tidligere behandlinger.
English: The dose of Targretin is based on the patient's body surface area in square metres (m2).
Danish: Targretindosen baseres på patientens legemsoverflade målt i kvadratmeter (m2).
English: The European Medicines Agency decided that Targretin's benefits are greater than its risks for the treatment of the skin manifestations of advanced-stage CTCL patients refractory to at least one treatment.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Targretin opvejer risiciene ved behandling af hudmanifestationer hos patienter med fremskredent kutant T-cellelymfom, der er refraktær over for mindst én behandling.
English: The most common side effects with Targretin (which may affect more than 1 patient in 10) are leucopenia (reduced white cell count), hypothyroidism (underactive thyroid gland), hyperlipaemia (high levels of fats in the blood), hypercholesterolaemia (high blood cholesterol), exfoliative dermatitis (skin peeling), pruritus (itching), rash, pain, headache and weakness.
Danish: De hyppigste bivirkninger ved Targretin (som kan forekomme hos flere end 1 ud af 10 patienter) er nedsat antal hvide blodlegemer, underaktiv skjoldbruskkirtel, højt antal fedtstoffer i blodet, forhøjet kolesterolniveau i blodet, hudafskalning, kløe, udslæt, smerter, hovedpine og svaghed.
English: Targretin is a cancer medicine used for the treatment of the visible signs on the skin of cutaneous Tcell lymphoma (CTCL).
Danish: Targretin er et kræftmiddel, der anvendes til behandling af de synlige hudmanifestationer af kutant Tcellelymfom.
English: For the full list of side effects reported with Targretin, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Targretin fremgår af indlægssedlen.
English: For more information about using Targretin, see the package leaflet or contact your doctor or pharmacist.
Danish: Behandlingen bør fortsættes, så længe patienten har gavn af den. For mere information om brug af Targretin, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The active substance in Targretin, bexarotene, belongs to the group of retinoids, substances that are derived from vitamin A. The exact way bexarotene works in CTCL is not known.
Danish: Det aktive stof i Targretin, bexaroten, hører til gruppen af retinoider, der er stoffer, som udledes af Avitamin.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Targretin 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 Targretin.
English: What benefit of Targretin have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Targretin?
English: How is Targretin used?
Danish: Hvordan anvendes Targretin?
English: How does Targretin work?
Danish: Hvordan virker Targretin?
English: The full EPAR for Levetiracetam Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Levetiracetam Hospira findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Hospira on the 08 January 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levetiracetam Hospira den 08. januar 2014.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one side of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Danish: Dette er en form for epilepsi, hvor for stærk elektrisk aktivitet i den ene side af hjernen giver symptomer som f.eks. pludselige, sætvise bevægelser af den ene side af kroppen, forvrænget hørelse, lugt- eller synshallucinationer, følelsesløshed eller pludselig angst.
English: The Committee recommended that Levetiracetam Hospira be approved for use in the EU.
Danish: Udvalget anbefalede, at Levetiracetam Hospira godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Levetiracetam Hospira is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Levetiracetam Hospira anvendes så sikkert som muligt.
English: • partial-onset seizures with or without generalisation in patients from four years of age;
Danish: • partielle anfald med eller uden generalisering hos patienter i alderen fire år og derover
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Hospira.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levetiracetam Hospira.
English: This means that Levetiracetam Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Danish: Det betyder, at Levetiracetam Hospira er identisk med et “referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Keppra.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Danish: Levetiracetam nøjagtige virkemåde er endnu ikke klarlagt, men det ser ud til, at stoffet griber ind i funktionen af proteinet synaptisk vesikelprotein 2A, der findes i spalterne mellem nerverne, og som medvirker ved udskillelsen af kemiske signalstoffer mellem nervecellerne.
English: Lower doses are used in patients who have reduced kidney function.
Danish: Til patienter med nedsat nyrefunktion anvendes lavere doser.
English: What is Levetiracetam Hospira and what is it used for?
Danish: Hvad er Levetiracetam Hospira, og hvad anvendes det til?
English: The company provided data from the published literature on levetiracetam.
Danish: Virksomheden fremlagde oplysninger fra den publicerede litteratur om levetiracetam.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Levetiracetam Hospira has been shown to have comparable quality and to be bioequivalent to Keppra.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) fandt, at det i overensstemmelse med EU's krav er påvist, at Levetiracetam Hospira er af sammenlignelig kvalitet og er bioækvivalent med Keppra.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Levetiracetam Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Levetiracetam, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Danish: • primære generaliserede tonisk-kloniske anfald (alvorlige krampeanfald med bevidsthedstab) hos patienter i alderen 12 år og derover med idiopatisk generaliseret epilepsi (en form for epilepsi, som menes at have en genetisk årsag).
English: This helps Levetiracetam Hospira to stabilise electrical activity in the brain and prevent seizures.
Danish: På denne måde stabiliserer Levetiracetam Hospira den elektriske aktivitet i hjernen og forhindrer anfald.
English: • myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
Danish: • myoklone anfald (kortvarige, rykvise trækninger i en muskel eller muskelgruppe) hos patienter i alderen 12 år og derover med juvenil myoklon epilepsi
English: Other information about Levetiracetam Hospira
Danish: Andre oplysninger om Levetiracetam Hospira
English: No additional studies were needed as Levetiracetam Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Keppra.
Danish: Der var ikke brug for yderligere undersøgelser, da Levetiracetam Hospira er et generisk lægemiddel, der gives ved infusion, og som indeholder samme aktive stof som referencelægemidlet Keppra.
English: What are the benefits and risks of Levetiracetam Hospira?
Danish: Hvilke fordele og risici er der forbundet med Levetiracetam Hospira?
English: Levetiracetam Hospira is a ‘generic medicine'.
Danish: Levetiracetam Hospira er et “generisk lægemiddel”.
English: Levetiracetam Hospira can only be obtained with a prescription and is available as a concentrate (100 mg/ml) that is made up into a solution for infusion (drip) into a vein.
Danish: Levetiracetam Hospira udleveres kun efter recept og fås som et koncentrat (100 mg/ml), der efter opløsning indgives med drop (ved infusion i en vene).
English: What measures are being taken to ensure the safe and effective use of Levetiracetam Hospira?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Levetiracetam Hospira?
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP opfattelse, at fordelene opvejer de identificerede risici som for Keppra.
English: For more information about treatment with Levetiracetam Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levetiracetam Hospira, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In patients aged between four and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Danish: Hos patienter mellem fire og 17 år, som vejer under 50 kg, er startdosis 10 mg pr. kg legemsvægt to gange dagligt, hvilket kan øges til op til 30 mg/kg to gange dagligt.
English: Levetiracetam Hospira can also be used as an add-on to other anti-epileptic medicines to treat:
Danish: Levetiracetam Hospira kan desuden anvendes som tillægsbehandling til andre lægemidler mod epilepsi for at behandle:
English: Levetiracetam Hospira infusion should only be used temporarily, while treatment by mouth is not feasible.
Danish: Levetiracetam Hospira bør kun midlertidigt indgives ved infusion, så længe det ikke er muligt at give lægemidlet gennem munden.
English: It is not intended to provide practical advice on how to use Levetiracetam Hospira.
Danish: Det er ikke en praktisk vejledning i, hvordan Levetiracetam Hospira bør anvendes.
English: Because Levetiracetam Hospira 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 Levetiracetam Hospira er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partialonset seizures (fits) with or without secondary generalisation.
Danish: Levetiracetam Hospira kan uden supplerende behandling anvendes til patienter i alderen 16 år og derover med nydiagnosticeret epilepsi til behandling af partielle anfald med eller uden sekundær generalisering.
English: The active substance in Levetiracetam Hospira, levetiracetam, is an anti-epileptic medicine.
Danish: Det aktive stof i Levetiracetam Hospira, levetiracetam, er et lægemiddel mod epilepsi.