FrancophonIA/ELRC3.0 huggingface dataset:
English: Temomedac is used on its own in these patients.
Danish: Temomedac anvendes alene hos disse patienter.
English: Temomedac is used first with radiotherapy and then on its own;
Danish: Temomedac anvendes først sammen med radioterapi og herefter alene.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Temomedac.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Temomedac skal anvendes.
English: This means that Temomedac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Danish: Det betyder, at Temomedac er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Temodal.
English: Temomedac is a ‘generic medicine'.
Danish: Temomedac er et ‘generisk lægemiddel'.
English: Patients may also need to take medicines to prevent vomiting before taking Temomedac.
Danish: Det kan også være nødvendigt at give patienten et middel mod opkastninger inden indtagelsen af Temomedac.
English: Temomedac capsules should be taken whole without food.
Danish: Temomedac-kapslerne skal tages hele uden for måltiderne.
English: Temomedac is used to treat malignant glioma (brain tumours) in the following groups of patients:
Danish: Temomedac anvendes til behandling af ondartet gliom (svulster i hjernen) hos følgende patientgrupper:
English: What are the benefits and risks of Temomedac?
Danish: Hvilken fordel og risiko er der forbundet med Temomedac?
English: Treatment with Temomedac should be prescribed by a doctor with experience in the treatment of brain tumours.
Danish: Behandling med Temomedac skal ordineres af en læge med erfaring i behandling af hjernetumorer.
English: The CHMP concluded that, in accordance with EU requirements, Temomedac has been shown to have comparable quality and to be bioequivalent to Temodal.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Temomedac er af sammenlignelig kvalitet og er bioækvivalent med Temodal.
English: For more information about treatment with Temomedac, read the Package Leaflet (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om behandling med Temodal, kan du læse indlægssedlen (også en del af denne EPAR).
English: Temomedac temozolomide
Danish: Temomedac temozolomid
English: The Committee recommended that Temomedac be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Temomedac.
English: Temomedac is a cancer medicine that contains the active substance temozolomide.
Danish: Temomedac er et lægemiddel mod kræft, der indeholder det aktive stof temozolomid.
English: The active substance in Temomedac, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Danish: Det aktive stof i Temomedac, temozolomid, tilhører en gruppe af lægemidler mod kræft kaldet alkylerende midler.
English: Because Temomedac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Danish: Da Temomedac er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Temomedac:
Danish: Andre oplysninger om Temomedac
English: Why has Temomedac been approved?
Danish: Hvorfor blev Temomedac godkendt?
English: Because Temomedac is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Danish: Da Temomedac er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Temodal.
English: What is Temomedac?
Danish: Hvad er Temomedac?
English: How has Temomedac been studied?
Danish: Hvordan blev Temomedac undersøgt?
English: What is Temomedac used for?
Danish: Hvad anvendes Temomedac til?
English: How is Temomedac used?
Danish: Hvordan anvendes Temomedac?
English: How does Temomedac work?
Danish: Hvordan virker Temomedac?
English: 1 vial + 1 filter needle
Danish: 1 hætteglas + 1 filterkanyle
English: Immediate Packaging
Danish: Intavitreal anvendelse
English: 100 x 1 tablet l t o r
Danish: 100 x 1 tablett r l
English: Strength Pharmaceutical Form
Danish: Navn Styrke Pharmaceutical Form
English: Packaging Package size unit dose blister (PVC/PVDC/alu)
Danish: (PVC/PVDC/alu)
English: It has no relevant use in patients under 18 years of age.
Danish: Det har ingen relevant anvendelse hos børn og unge under 18 år.
English: 2 February 2016 EMA/822538/2015
Danish: februar 2016 EMA/822538/2015
English: Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba
Danish: Epilobium angustifolium L. og/eller Epilobium parviflorum Schreb., herba
English: Willow herb should only be used after serious conditions have been excluded by a medical doctor.
Danish: Gederams bør kun anvendes, efter at alvorlige sygdomme er blevet udelukket af en læge.
English: Willow herb may be taken long term.
Danish: Gederams kan tages på langt sigt.
English: Willow herb EMA/822538/2015
Danish: Dueurt EMA/822538/2015
English: Willow herb
Danish: Dueurt
English: Results from laboratory studies indicate that willow herb may have an effect on the growth of prostate cells as well as anti-inflammatory and pain-relieving activity.
Danish: Resultater fra laboratorieundersøgelser angiver, at gederams kan have en virkning på væksten af prostataceller såvel som en anti-inflammatorisk og smertestillende aktivitet.
English: Any applications for the licensing of medicines containing willow herb 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 gederams, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: However, firm conclusions could not be drawn and the HMPC conclusions on the use of willow herb are based on their long-standing use.
Danish: Der kan dog ikke drages endelige konklusioner, og HMPC's konklusioner vedrørende anvendelsen af gederams er derfor baseret på den mangeårige traditionelle anvendelse.
English: Willow herb is the common name for the aerial parts of the plant Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., collected before or during flowering time.
Danish: Gederams er det almindelige navn for de overjordiske dele af planten Epilobium angustifolium L. og/eller Epilobium parviflorum Schreb., indsamlet før eller i løbet af blomstringstiden.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing willow herb.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder gederams.
English: The HMPC conclusions on the use of willow herb medicines for the relief of lower urinary tract symptoms related to BPH are based on their ‘traditional use' in this condition.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med gederams til lindring af symptomer i de nedre urinveje i forbindelse med BPH er baseret på den "almindeligt anerkendte anvendelse" til denne tilstand.
English: The HMPC noted the lack of clinical studies with willow herb.
Danish: HMPC har noteret manglen på kliniske undersøgelser med gederams.
English: Willow herb preparations are obtained by drying and comminuting (reducing into tiny pieces) the aerial parts of the plant.
Danish: Tilberedninger af gederams opnås ved tørring og findeling (reducering til bittesmå dele) af plantens overjordiske dele.
English: Further information on the HMPC assessment of willow herb 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 gederams, 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: Information on the use and licensing of willow herb medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder gederams, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: Willow herb can also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af gederams findes desuden kombineret med andre droger i visse plantelægemidler.
English: This summary is not intended to provide practical advice on how to use medicines containing willow herb.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder gederams, skal anvendes.
English: Further information on the risks associated with willow herb 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 gederams, herunder passende forholdsregler, der 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: BPH is a non-cancerous increase in size of the prostate gland which surrounds the urethra, the tube that carries urine from the bladder out of the body.
Danish: BPH er en godartet forstørret blærehalskirtel, der omkranser den øverste del af urinrøret, som transporterer urinen fra blæren og ud af kroppen.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of willow herb.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af gederams.
English: Detailed instructions on how to take willow herb medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med gederams bør anvendes, og hvem der må bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: The HMPC concluded that, on the basis of its long-standing use, willow herb can be used by patients with benign prostatic hyperplasia (BPH) for the relief of lower urinary tract symptoms such as difficulty starting urination or a frequent need to urinate.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at gederams kan anvendes til patienter med benign prostatahyperplasi (BPH) til lindring af symptomer i de nedre urinveje såsom startvanskeligheder ved vandladning eller hyppig vandladningstrang.
English: Herbal medicines containing willow herb are usually available as herbal tea to be drunk.
Danish: Plantelægemidler, der indeholder gederams, fås normalt som urtete beregnet til at drikke.
English: What is willow herb?
Danish: Hvad er gederams?
English: How are willow herb medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder gederams, i EU?
English: For more information about treatment with willow herb 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 gederams, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What evidence supports the use of willow herb medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af gederams?
English: For practical information about using willow herb 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 gederams, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What are the risks associated with willow herb medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder gederams?
English: Other information about willow herb medicines
Danish: Andre oplysninger om lægemidler, der indeholder gederams
English: 14 July 2017 EMA/463868/2017
Danish: 14. juli 2017 EMA/463868/2017
English: The review of Zinbryta has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Danish: Eftersynet af Zinbryta blev indledt på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: • You should not stop treatment before speaking to your doctor.
Danish: • Du bør ikke standse behandlingen, før du har talt med din læge.
English: • Further information will also be provided once the review is concluded.
Danish: • Yderligere informationer vil også blive stillet til rådighed, når eftersynet er afsluttet.
English: • If you are already being treated with this medicine, your doctor will check whether you should continue or switch to an alternative treatment.
Danish: • Hvis du allerede er i behandling med denne medicin, vil lægen undersøge, om du skal fortsætte eller skifte til en alternativ behandling.
English: • Patients should be informed about the potential risk of serious liver problems and how to recognise them.
Danish: • Patienter bør informeres om den potentielle risiko for alvorlige leverproblemer, og hvordan de genkender dem.
English: • If an adequate therapeutic response has not been achieved, discontinuation of therapy should be considered.
Danish: • Hvis en tilstrækkelig terapeutisk respons ikke opnås, bør seponering af behandlingen overvejes.
English: • Once the review of Zinbryta is concluded, further information will be provided.
Danish: • Når eftersynet af Zinbryta er afsluttet, vil der blive givet yderligere information.
English: If you are being given Zinbryta and have any questions or concerns, speak to your doctor or pharmacist.
Danish: Hvis du får Zinbryta og har spørgsmål eller problemer, skal du tale med din læge eller apoteker.
English: Healthcare professionals have been informed in writing about the provisional measures to be followed by doctors.
Danish: Sundhedspersonale er blevet skriftligt underrettet om de foreløbige forholdsregler, der skal følges af lægerne.
English: If you have signs of liver injury, your doctor will refer you to a liver specialist.
Danish: Hvis du har tegn på leverskader, vil din læge henvise dig til en leverspecialist.
English: • Prior to treatment initiation, ALT, AST and bilirubin levels should be measured.
Danish: • Før behandlingen indledes, bør ALT, AST og bilirubinniveauer måles.
English: As a precaution, changes have been made to the way the medicine is used while this review is ongoing:
Danish: Som en sikkerhedsforanstaltning er der foretaget ændringer af den måde, hvorpå medicinen bruges, medens denne undersøgelse står på:
English: The risk of liver damage with the medicine was already known at time of its approval in the EU, and several measures were in place to manage this risk, including the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage.
Danish: Risikoen for leverskader på grund af medicinen var allerede kendt på tidspunktet for dets godkendelse i EU, og flere foranstaltninger var gennemført med henblik på at håndtere denne risiko, herunder forpligtelsen til at overvåge leverfunktionen og stille undervisningsmateriale til rådighed for sundhedspersonale og patienter med risiko for leverskader.
English: In addition, patients with liver injury must not be given the medicine.
Danish: Derudover må patienter med leverskader ikke få medicinen.
English: In case of signs and symptoms suggestive of hepatic injury, the patient should be promptly referred to a hepatologist.
Danish: I tilfælde af tegn og symptomer på leverskade, bør patienten omgående henvises til en hepatolog.
English: Serum transaminase and bilirubin levels should be monitored at least monthly, and more frequently if clinically indicated, during treatment and for up to 4 months after the last dose.
Danish: Serum transaminase- og bilirubinniveauer skal kontrolleres mindst én gang om måneden eller oftere, hvis det er klinisk indikeret, under behandlingen og indtil 4 måneder efter sidste dosis.
English: These provisional measures have been taken, as a precaution, to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.
Danish: Disse midlertidige foranstaltninger er truffet som en forholdsregel for at sikre, at Zinbryta fortsat anvendes så sikkert som muligt, mens en undersøgelse af dets leversikkerhed foregår.
English: Doctors should continue to monitor the liver function of patients receiving the medicine and closely watch patients for signs and symptoms of liver injury.
Danish: Læger bør fortsat overvåge leverfunktionen hos patienter, der modtager medicinen og holde nøje øje med patienter for tegn og symptomer på leverskader.
English: • While on treatment with this medicine, you should contact your doctor immediately if you develop any symptoms of liver problems, such as unexplained nausea (feeling sick), vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes and dark urine.
Danish: • Når du er under behandling med dette lægemiddel, bør du kontakte din læge omgående, hvis du udvikler symptomer på leverproblemer, f.eks. uforklaret kvalme, opkastning, mavesmerter, træthed, appetitløshed, gulfarvning af hud og øjne og mørk urin.
English: • Healthcare professionals should review promptly any patients who are currently taking Zinbryta to assess whether this medicine continues to be appropriate for them.
Danish: • Sundhedspersonale skal omgående gennemgå alle patienter, der aktuelt tager Zinbryta, med henblik på at vurdere, om denne medicin fortsat er egnet for dem.
English: These were forwarded to the European Commission (EC), which on 14 July 2017 issued a provisional legally binding decision applicable in all EU Members States.
Danish: Disse blev sendt til Europa-Kommissionen, som udstedte en foreløbig retlig bindende beslutning med gyldighed i alle EU's medlemslande den 14. juli 2016.
English: • Your doctor will test your liver function at least monthly, and check for signs and symptoms of liver injury.
Danish: • Din læge vil teste din leverfunktion mindst én gang om måneden og kontrollere for tegn og symptomer på leverskader.
English: Once the review is concluded, EMA will communicate further and provide updated guidance to patients and healthcare professionals.
Danish: Når undersøgelsen er gennemført, vil EMA give ajourført vejledning til patienter og sundhedspersonale.
English: EMA restricts use of multiple sclerosis medicine Zinbryta
Danish: EMA begrænser brugen af multipel sklerose medicinen Zinbryta
English: Restrictions are provisional measures while review of liver safety is ongoing
Danish: Begrænsningerne er midlertidige foranstaltninger, mens eftersynet af leversikkerheden finder sted
English: Once the PRAC review is concluded, any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for evaluating medicines for human use, which will adopt a final opinion.
Danish: Når PRAC-eftersynet er gennemført, vil eventuelt yderligere anbefalinger blive sendt til Udvalget for Humanmedicinske Lægemidler (CHMP), der er ansvarlig for at evaluere medicin til mennesker, og som vil træffe en endelig afgørelse.
English: • Further details on these provisional measures have been provided in writing to healthcare professionals and the product information has been updated accordingly.
Danish: • Yderligere detaljer om disse foreløbige sikkerhedsforanstaltninger er blevet sendt i skriftligt form til sundhedspersonale, og produktinformationen er blevet opdateret, så den afspejler de ovennævnte sikkerhedsforanstaltninger.
English: During the review, the PRAC made a set of provisional recommendations to protect public health.
Danish: Mens eftersynet foregår, har PRAC udstedt en række foreløbige anbefalinger for at beskytte folkesundheden.
English: • Cases of liver injury with Zinbryta have occurred early after treatment initiation, following repeated treatment courses and several months after discontinuation.
Danish: • Tilfælde af leverskader med Zinbryta er opstået tidligt efter indledning af behandlingen, efter gentagne behandlingsforløb og flere måneder efter ophørstidspunktet.
English: • All patients on Zinbryta should also be monitored for signs and symptoms of hepatic injury during treatment.
Danish: • Alle patienter på Zinbryta bør overvåges for tegn og symptomer på nedsat leverskade under behandlingen.
English: This medicine was authorised in the EU in July 2016 to treat adults with relapsing forms of multiple sclerosis (a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord).
Danish: Medicinen blev godkendt i EU i juli 2016 til behandling af voksne patienter med recidiverende former for multipel sklerose (en sygdom, hvor inflammation skader den beskyttende kappe omkring nervecellerne i hjernen og rygmarven).
English: • Patients who already have liver injury will not be treated with this medicine.
Danish: • Patienter, der i forvejen har leverskader, vil ikke blive behandlet med medicinen.
English: Zinbryta is a medicine used to treat adults with relapsing forms of multiple sclerosis.
Danish: Zinbryta er et lægemiddel til behandling af voksne med tilbagevendende former af multipel sklerose.
English: Relapsing means that the patient has flare-ups of the symptoms.
Danish: Tilbagevendende vil sige, at patienterne har opblussen af symptomerne.
English: • In addition, the medicine has been contraindicated in patients with pre-existing hepatic disease or hepatic impairment.
Danish: • Derudover er lægemiddel blevet kontraindiceret til patienter med allerede eksisterende hepatisk sygdom eller leverinsufficiens.
English: • Caution is recommended before giving Zinbryta in combination with medicinal products of known hepatotoxic potential, including non-prescription medicines and herbal supplements.
Danish: • Det anbefales at udvise forsigtighed, før Zinbryta gives i kombination med lægemidler med kendt hepatotoksisk potentiale, herunder ikke-receptpligtige lægemidler og kosttilskud.
English: The safety of the multiple sclerosis medicine Zinbryta is being reviewed.
Danish: Information til patienter Sikkerheden omkring multipel sklerose-medicinen Zinbryta er i færd med at blive gennemgået.
English: • Zinbryta treatment is not recommended in multiple sclerosis patients who have autoimmune diseases other than multiple sclerosis.
Danish: • Zinbryta behandling anbefales ikke til multipel sklerose patienter, der har andre autoimmune sygdomme end multipel sklerose.
English: • Speak to you doctor or pharmacist before you start taking any other medicines, including medicines obtained without a prescription and herbal supplements.
Danish: • Tal med din læge eller apoteket, før du begynder at tage andre lægemidler, herunder ikkereceptpligtige lægemidler og kosttilskud.