FrancophonIA/ELRC3.0 huggingface dataset:
English: Episalvan contains a dry extract from birch bark.
Danish: Episalvan indeholder tørret ekstrakt af birkebark.
English: It is not intended to provide practical advice on how to use Episalvan.
Danish: Det er ikke en praktisk vejledning i, hvordan Episalvan bør anvendes.
English: Episalvan birch bark extract
Danish: Birkebark-ekstrakt
English: What are the risks associated with Episalvan?
Danish: Hvilke risici er der forbundet med Episalvan?
English: For more information about treatment with Episalvan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Episalvan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is thought that the active substance in Episalvan, birch bark extract, helps the cells that make up the outer layer of the skin (keratinocytes) grow and move quickly towards the gap created by the wound, therefore helping wounds to heal faster.
Danish: Det aktive stof i Episalvan, birkebark-ekstrakt, menes at få de yderste hudceller, (keratinocytterne), til at vokse og hurtigt bevæge sig til det tomrum, der er skabt af såret, så dette heler hurtigere.
English: These are wounds where the upper layers of the skin have been lost, for example by a burn or during surgical skin grafting.
Danish: Ved sådanne sår er de øverste lag af huden gået tabt, f.eks. ved en forbrænding eller hudtransplantation.
English: The average time to wound closure was 8.8 days for the wounds treated with standard disinfectant gel and 7.6 days for the wounds treated with Episalvan.
Danish: Gennemsnitstiden til lukning af såret var 8,8 dage for sår behandlet med sædvanlig desinficerende gel, og 7,6 dage for sår behandlet med Episalvan.
English: Episalvan gel was shown to reduce wound healing times.
Danish: Episalvan gel er påvist at nedsætte helingstiden for sår.
English: Episalvan was studied in two main studies involving 217 patients with partial-thickness skin wounds in patients who underwent skin graft surgery.
Danish: Episalvan blev undersøgt i to hovedundersøgelser med deltagelse af 217 patienter, som havde delhudssår og fik foretaget hudtransplantation.
English: Episalvan is a medicine used in adults to treat partial-thickness skin wounds.
Danish: Episalvan er et lægemiddel til behandling af delhudssår hos voksne.
English: For the full list of all side effects and restrictions reported with Episalvan, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Episalvan og listen over begrænsninger fremgår af indlægssedlen.
English: For practical information about using Episalvan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Episalvan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Episalvan is available as a gel that should be applied as a thin layer (1 mm in thickness) to the wound, which should then be covered by a wound dressing.
Danish: Episalvan fås som en gel, der påføres på såret som et tyndt lag (1 mm tykt), hvorefter der lægges forbinding på såret.
English: The patients received Episalvan together with wound dressing on one half of the wound, while the other half of the wound was treated with standard wound dressing only.
Danish: Patienterne fik Episalvan sammen med forbinding på den ene halvdel af såret, mens den anden halvdel af såret kun blev behandlet med sædvanlig forbinding.
English: In the first study, the average time from surgery to wound closure was 17.1 days for the wounds treated with standard wound dressing only and 15.5 days for the wounds also treated with Episalvan.
Danish: I den første undersøgelse var den gennemsnitlige tid fra operationen til lukning af såret 17,1 dage for sår, der kun blev behandlet med sædvanlig forbinding, og 15,5 dage for sår, der også blev behandlet med Episalvan.
English: A third study involved 57 patients with partial-thickness burn wounds who had half their wound treated with Episalvan and the other half with a standard disinfectant gel.
Danish: En tredje undersøgelse omfattede 57 patienter med delhudssår, der fik behandlet den ene halvdel af såret med Episalvan og den anden halvdel med en sædvanlig desinficerende gel.
English: How is Episalvan used?
Danish: Hvordan anvendes Episalvan?
English: What benefits of Episalvan have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Episalvan?
English: How does Episalvan work?
Danish: Hvordan virker Episalvan?
English: Both wound halves were also covered with a wound dressing.
Danish: Desuden blev der lagt forbinding på begge sårhalvdele.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for mere information om din behandling, kan du kontakte den læge, der behandler dig.
English: It was to be available as a solution for injection under the skin.
Danish: Det skulle markedsføres som en opløsning til indsprøjtning under huden.
English: What was Fulphila expected to be used for?
Danish: Hvad forventedes Fulphila anvendt til?
English: Neutropenia is a side effect of certain cancer treatments and can lead to development of serious infections.
Danish: Neutropeni er en bivirkning ved visse typer kræftmedicin og kan føre til alvorlige infektioner.
English: What is Fulphila?
Danish: Hvad er Fulphila?
English: Other concerns related to the description of the manufacturing process, the control of impurities in the active substance and the sterilisation of the final product.
Danish: Udvalget satte også spørgsmålstegn ved den beskrevne fremstillingsproces, kontrollen af urenheder i det aktive stof og steriliseringen af det endelige produkt.
English: Fulphila was to be used in cancer patients to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever).
Danish: Fulphila skulle anvendes hos kræftpatienter for at nedsætte varigheden af neutropeni (lavt antal neutrofiler, en type hvide blodegemer, der bekæmper infektion) og mindske forekomsten af febril neutropeni (neutropeni med feber).
English: Fulphila was developed as a ‘biosimilar' medicine.
Danish: Fulphila blev udviklet som et "biosimilært" lægemiddel.
English: Fulphila is a medicine that contains the active substance pegfilgrastim.
Danish: Fulphila er et lægemiddel, der indeholder det aktive stof pegfilgrastim.
English: This means that Fulphila was intended to be highly similar to a biological medicine already authorised in the European Union (the ‘reference medicine') called Neulasta.
Danish: Det betyder, at det var hensigten, at Fulphila skulle være identisk med et biologisk "referencelægemiddel", der allerede er godkendt i Den Europæiske Union, og som hedder Neulasta.
English: protein called granulocyte-colony-stimulating factor (G-CSF).
Danish: granulocyt-kolonistimulerende faktor (G-CSF).
English: Because filgrastim is pegylated, its removal from the body is slowed down, allowing the medicine to be given less often.
Danish: Da filgastim er pegyleret, fjernes det langsomt fra kroppen, og det betyder, at lægemidlet ikke skal gives så ofte.
English: The active substance in Fulphila and Neulasta, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Danish: Det aktive stof i Fulphila og Neulasta, pegfilgrastim, består af filgrastim, der er blevet pegyleret, dvs. bundet til det kemiske stof polyethylenglycol.
English: The company presented results of studies designed to show that Fulphila is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Danish: Virksomheden fremlagde resultater fra undersøgelser, der var designet til at demonstrere, at Fulphila svarer nøje til referencelægemidlet Neulasta, hvad angår kemisk opbygning, renhed, virkemåde og kroppens håndtering af lægemidlet.
English: The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Fulphila.
Danish: Virksomheden har oplyst CHMP om, at tilbagetrækningen ikke har nogen betydning for de igangværende kliniske undersøgelser af Fulphila.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fulphila, for reducing neutropenia in patients taking cancer treatments.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Fulphila til nedsættelse af varigheden af neutropeni hos patienter, som får kræftmedicin.
English: In addition, one study in 194 patients receiving cancer medicines compared the safety, effectiveness and immunogenicity, meaning the medicine's ability to trigger the production of antibodies, of Fulphila and Neulasta.
Danish: I en undersøgelse af 194 patienter, der fik kræftmedicin, har man desuden sammenlignet Fulphilas og Neulastas sikkerhed, effekt og immunogenicitet, dvs. evnen til at udløse produktion af antistoffer.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Fulphila could not have been approved to reduce neutropenia in patients taking cancer treatments.
Danish: På baggrund af gennemgangen af de oplysninger, der forelå på tidspunktet for tilbagetrækningen, havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Fulphila ikke kunne være blevet godkendt til nedsættelse af varigheden af neutropeni hos patienter, der får kræftmedicin.
English: Filgrastim is very similar to a human
Danish: Filgrastim minder meget om det menneskelige protein
English: One of the CHMP's main concerns was the lack of a certificate of Good Manufacturing Practice (GMP) for the manufacturing site of the product.
Danish: CHMP var især bekymret over, at fremstillingsstedet ikke havde noget certifikat for god fremstillingspraksis (GMP).
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because a GMP certificate for the manufacturing site of Fulphila could not be obtained in the time available.
Danish: I sit brev til agenturet oplyste virksomheden, at den trak sin ansøgning tilbage, fordi den ikke kunne nå at skaffe et GMP-certifikat for fremstillingsstedet inden for den angivne frist.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the quality of Fulphila had not been demonstrated.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Fulphila ikke opvejede risiciene.
English: Withdrawal of the marketing authorisation application for Fulphila (pegfilgrastim) EMA/577551/2017
Danish: EMA/577551/2017
English: 1 vial
Danish: 1 beholder
English: Powder : 200mg Solvent: 20 ml (10 mg/ml)
Danish: Solvens: 20 ml (10 mg/ml)
English: 1 vial +1 infusion bag +1 syringe +1 vial adaptor
Danish: 1 hætteglas + 1 infusionspose + 1 injektionssprøjte + 1 hætteglasadaptor
English: Powder for oral suspension
Danish: Pulver til oral suspension Oral anvendelse Beholder (HDPE)
English: Intravenous use vial (glass)
Danish: Pulver: hætteglas (glas)
English: Powder and solvent for solution for infusion
Danish: 200 mg Pulver og solvens til infusionsvæske, opløsning
English: Powder for solution for infusion
Danish: Solvens: infusionspose
English: They should be taken within one hour after morning and evening meals.
Danish: De skal tages inden for en time efter morgenmaden og aftensmaden.
English: Lonsurf received a marketing authorisation valid throughout the European Union on 25 April 2016.
Danish: Lonsurf fik en markedsføringstilladelse med gyldighed i hele EU den 25. april 2016.
English: The tablets are taken twice a day on certain days of each treatment cycle.
Danish: Tabletterne tages to gange dagligt på bestemte dage i hver behandlingscyklus.
English: The Agency considered that the measures put in place are adequate to manage these risks.
Danish: Agenturet vurderer, at de trufne foranstaltninger er tilstrækkelige til at håndtere disse risici.
English: Further information on Lonsurf can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lonsurf.
Danish: Yderligere information om Lonsurf findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/lonsurf
English: Other information about Lonsurf
Danish: Andre oplysninger om Lonsurf
English: This therefore boosts trifluridine's effect.
Danish: Dette øger derfor trifluridins virkning.
English: Colorectal cancer
Danish: Mavekræft
English: The doctor may reduce the dose or interrupt treatment if certain side effects develop.
Danish: Lægen kan være nødt til at nedsætte dosen eller afbryde behandlingen, hvis en bestemt type bivirkninger opstår.
English: As for all medicines, data on the use of Lonsurf are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Lonsurf løbende overvåget.
English: Lonsurf is available as tablets (15 mg trifluridine and 6.14 mg tipiracil; 20 mg trifluridine and 8.19 mg tipiracil) and is given in treatment cycles of 28 days.
Danish: Lonsurf fås som tabletter (15 mg trifluridin og 6,14 mg tipiracil, 20 mg trifluridin og 8,19 mg tipiracil) og gives i behandlingscyklusser på 28 dage.
English: Lonsurf (trifluridine / tipiracil)
Danish: Lonsurf (trifluridin/tipiracil)
English: What measures are being taken to ensure the safe and effective use of Lonsurf?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lonsurf?
English: Why is Lonsurf authorised in the EU?
Danish: Hvorfor er Lonsurf godkendt i EU?
English: Tipiracil increases the level of trifluridine in the blood by slowing its breakdown.
Danish: Tipiracil øger mængden af trifluridin i blodet ved at sænke nedbrydningshastigheden.
English: The European Medicines Agency decided that Lonsurf'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 Lonsurf opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What is Lonsurf and what is it used for?
Danish: Hvad er Lonsurf, og hvad anvendes det til?
English: It is used when the cancer is metastatic (has spread to other parts of the body) in patients who have already been treated with, or who cannot be given, other treatments for their cancer.
Danish: Det anvendes, når kræften er metastatisk (har bredt sig til andre dele af kroppen) hos patienter, der allerede har fåeteller som ikke kan gives - andre behandlinger for deres kræftsygdom.
English: Side effects reported with Lonsurf are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Lonsurf vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Lonsurf, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Lonsurf, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: All patients received supportive care.
Danish: Alle patienterne i studiet fik understøttende behandling.
English: Treatment with Lonsurf should be prescribed by a doctor who is experienced in the use of cancer medicines.
Danish: Behandlingen med Lonsurf bør overvåges af en læge med erfaring i brug af kræftlægemidler.
English: Lonsurf is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells).
Danish: Lonsurf er et såkaldt cytotoksisk lægemiddel (et lægemiddel, der dræber celler, som deler sig, f.eks. kræftceller).
English: It contains two active substances: trifluridine and tipiracil.
Danish: Det indeholder to aktive stoffer: trifluridin og tipiracil.
English: What are the risks associated with Lonsurf?
Danish: Hvilke risici er der forbundet med Lonsurf?
English: All patients had previously received other treatments.
Danish: Alle patienter havde fået mindst 2 tidligere behandlinger.
English: In the body, trifluridine is converted into an active form that is incorporated into DNA, the genetic material of cells.
Danish: I kroppen omdannes trifluridin til en aktiv form, der trænger ind i dna'et, cellernes genetiske materiale.
English: The most serious side effects are bone marrow suppression (when the bone marrow produces fewer blood cells than normal) and effects on the gut (diarrhoea and feeling sick).
Danish: De alvorligste bivirkninger er knoglemarvshæmning (når knoglemarven producerer færre blodlegemer end normalt) og indvirkninger på tarmen (diarré og kvalme).
English: As a result, trifluridine interferes with DNA function and prevents the cells from dividing to make more cells.
Danish: På den måde forstyrrer trifluridin dna'ets funktion og forhindrer cellerne i at dele sig og danne flere celler.
English: The most common side effects with Lonsurf (which may affect more than 3 in 10 people) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), feeling sick, tiredness and anaemia (low red blood cell counts).
Danish: De hyppigste bivirkninger ved Lonsurf (der kan forekomme hos mere end 3 ud af 10 behandlede) er neutropeni (lavt antal neutrofiler, dvs. de blodlegemer, der bekæmper infektion), kvalme, træthed og anæmi (lavt antal røde blodlegemer).
English: In a study involving 507 adults with metastatic gastric cancer, patients treated with Lonsurf lived on average for 5.7 months compared with 3.6 months for patients who received placebo.
Danish: I et studie, der omfattede 507 voksne med metastatisk mavekræft, levede de patienter, der blev behandlet med Lonsurf, i gennemsnit i 5,7 måneder sammenlignet med 3,6 måneder for de patienter, der fik placebo.
English: An overview of Lonsurf and why it is authorised
Danish: En oversigt over Lonsurf, og hvorfor det er godkendt i EU
English: For the full list of side effects and restrictions of Lonsurf, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Lonsurf fremgår af indlægssedlen.
English: Lonsurf contains the active substances trifluridine and tipiracil.
Danish: Lonsurf indeholder de aktive stoffer trifluridin og tipiracil.
English: Treatment with Lonsurf should continue for as long as benefits can be seen and the side effects are tolerable.
Danish: Lonsurf-behandlingen bør fortsætte, så længe patienten har positiv effekt af den og kan tåle bivirkningerne.
English: This reduces the growth of cancer cells, while normal cells are only slightly affected.
Danish: Det får kræftcellerne til at vokse langsommere, men har kun ringe virkning på normale celler.
English: In one main study involving 800 patients, those treated with Lonsurf lived on average for 7.1 months compared with 5.3 months for patients who were treated with placebo (a dummy treatment).
Danish: I et hovedstudie, hvori der indgik 800 deltagere, havde de patienter, som fik Lonsurf, en gennemsnitlig overlevelse på 7,1 måneder, mens den gennemsnitlige overlevelse hos de patienter, der fik placebo (et ikke-aktivt stof), var 5,3 måneder.
English: How is Lonsurf used?
Danish: Hvordan anvendes Lonsurf?
English: The Agency considered that the benefit of Lonsurf in prolonging survival in patients with metastatic colorectal and metastatic gastric cancer who have received previous treatment was important.
Danish: Agenturet mener, at Lonsurfs livsforlængende virkning hos patienter med metastatisk tyktarmskræft og metastatisk mavekræft, der tidligere har fået anden behandling, er væsentlig.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lonsurf 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 Lonsurf.
English: What benefits of Lonsurf have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Lonsurf?
English: Regarding its safety, although Lonsurf's side effects can be serious they are in line with what can be expected for this type of medicine.
Danish: Hvad sikkerheden angår, ligger bivirkningerne ved Lonsurf inden for rammerne af, hvad der kan forventes ved brug af et celledræbende lægemiddel, selv om de kan være alvorlige.
English: How does Lonsurf work?
Danish: Hvordan virker Lonsurf?
English: Lonsurf is a medicine used to treat adults with colorectal cancer (cancer of the large bowel) and gastric (stomach) cancer.
Danish: Lonsurf er et lægemiddel til behandling af voksne med kræft i tyktarmen og maven.
English: The conversion of trifluridine into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Danish: Derfor findes den aktive form af lægemidlet i højere koncentration og virker i længere tid i kræftceller end i normale celler.
English: Lonsurf prolonged overall survival of patients with metastatic colorectal cancer and in patients with metastatic gastric cancer.
Danish: Lonsurf forlængede den samlede overlevelse hos patienter med metastatisk tyktarmskræft, der havde fået andre behandlinger tidligere.
English: 2007 to 2014
Danish: 2007 til 2014
English: What is PHN?
Danish: Hvad er PHN?
English: Date of first authorisation: 19 May 2006 Date of latest renewal: 11 February 2016
Danish: Dato for første markedsføringstilladelse: 19. maj 2006 Dato for sidste fornyelse: 11. februar 2016
English: VE over study period‡
Danish: VE i studieperioden‡
English: • if you have a fever
Danish: • hvis De har feber
English: North Carolina 27712 U.S.A
Danish: North Carolina 27712 USA
English: This vaccine may contain traces of neomycin.
Danish: Denne vaccine kan indeholde spor af neomycin.
English: It usually occurs in one part of the body and can last for several weeks.
Danish: Det er normalt begrænset til et bestemt område på kroppen, og det kan vare adskillige uger.
English: Package Leaflet: Information for the user
Danish: Indlægsseddel: information til brugeren
English: d. Special populations
Danish: d. Særlige populationer
English: • if you have HIV infection
Danish: • hvis De har hiv-infektion
English: • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicines, or other treatment
Danish: • hvis lægen har fortalt Dem, at De har et svækket immunsystem som følge af sygdom, lægemidler eller anden behandling
English: The two vaccines should be given as separate injections at different body sites.
Danish: De to vacciner skal gives som separate injektioner forskellige steder på kroppen.
English: e. Other studies
Danish: e. Øvrige studier
English: If you have an allergic reaction, call your doctor right away.
Danish: Hvis du får en allergisk reaktion, skal du omgående søge læge.
English: As these events are reported voluntarily from a population of uncertain size, it is not possible to reliably calculate their frequency or establish a causal relationship to vaccine exposure.
Danish: Da disse hændelser er rapporteret frivilligt fra en population af ukendt størrelse, er det ikke muligt på en pålidelig måde at beregne hyppigheden eller fastslå en årsagssammenhæng med eksponering for vaccinen.
English: The need for a booster dose is not known.
Danish: Nødvendigheden af en boosterdosis kendes ikke.
English: VZV-seronegative adults
Danish: VZV-seronegative voksne
English: After the shingles blisters heal, pain can last for months or years and may be severe.
Danish: Efter at blærerne i forbindelse med helvedesild er helet op, kan smerterne blive ved i månedsvis eller årevis, og de kan være svære.