FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on the HMPC assessment of bearberry leaf 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 melbærrisblad, 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: Bearberry leaf EMA/181295/2018
Danish: Melbærrisblad EMA/424828/2016
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing bearberry leaf.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder melbærrisblad.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of bearberry leaf.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af melbærrisblad.
English: What is bearberry leaf?
Danish: Hvad er melbærrisblad?
English: No clinical studies are available with preparations containing only bearberry leaf.
Danish: Der foreligger ingen kliniske undersøgelser af tilberedninger, der kun indeholder melbærrisblad.
English: The HMPC concluded that, on the basis of its long-standing use, these bearberry leaf preparations can be used for relief of symptoms of mild, recurrent infections in the lower urinary tract (the structure that carries urine), such as a burning sensation when passing urine and/or frequently passing urine.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at melbærrisblad i disse tilberedninger kan anvendes til behandling af milde, tilbagevendende infektioner i de nedre urinveje i form af f.eks. en brændende fornemmelse under vandladning og/eller hyppig vandladningstrang.
English: This summary is not intended to provide practical advice on how to use medicines containing bearberry leaf.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder melbærrisblad, skal anvendes.
English: How are bearberry leaf medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder melbærrisblade, i EU?
English: Herbal medicines containing these bearberry leaf preparations are usually available as herbal tea to be drunk and in liquid or solid forms to be taken by mouth.
Danish: Plantelægemidler med melbærrisblad i disse tilberedninger fås normalt som urtete beregnet til at drikke samt i fast form til anvendelse gennem munden.
English: Other information about bearberry leaf medicines
Danish: Andre oplysninger om lægemidler, der indeholder melbærrisblade
English: What evidence supports the use of bearberry leaf medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af melbærrisblade?
English: The HMPC conclusions only cover bearberry leaf preparations which are obtained by drying and comminuting (reducing into tiny pieces) or powdering the leaves, or by using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or water) to dissolve compounds and form a liquid extract.
Danish: HMPC's konklusioner omfatter kun tilberedninger af melbærrisblad, som fremstilles ved tørring og findeling eller pulverisering af bladene eller ved at udtrække stoffer fra plantematerialet i ethanol eller vand.
English: What are the risks associated with bearberry leaf medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder melbærrisblade?
English: For more information about treatment with bearberry leaf 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 melbærrisblade, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For practical information about using bearberry leaf 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 melbærrisblad, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For dry extracts, the solvent is then evaporated.
Danish: Ved fremstilling af tørekstrakt fordampes opløsningsmidlet herefter for at opnå det tørre ekstrakt.
English: Bearberry leaf
Danish: Melbærrisblad
English: Nausea, vomiting and stomach ache are side effects that have been reported with bearberry leaf medicines.
Danish: De bivirkninger, der er rapporteret ved brug af lægemidler med melbærrisblade, er kvalme, opkastning og mavepine.
English: The European Commission granted a marketing authorisation valid throughout the EU for Pegasys on 20 June 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pegasys den 20. juni 2002.
English: This is a summary of the European public assessment report (EPAR) for Pegasys.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pegasys.
English: The full EPAR for Pegasys can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pegasys findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The adult dose is usually 180 micrograms but the children's dose varies depending on their height and weight.
Danish: Dosen til voksne er typisk 180 mikrogram, mens dosen til børn afhænger af barnets højde og vægt.
English: Interferons are natural substances produced by the body that help it fight infections caused by viruses.
Danish: Interferoner er naturlige stoffer, der produceres af kroppen, og som hjælper med at bekæmpe virusinfektioner.
English: Alfa interferons may also block the multiplication of viruses.
Danish: Desuden blokerer alfa-interferoner muligvis formeringen af virus.
English: Pegasys is an antiviral medicine used to treat:
Danish: Pegasys er et antiviralt lægemiddel til behandling af:
English: Other information about Pegasys
Danish: Andre oplysninger om Pegasys
English: The exact way alfa interferons work in viral diseases in not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system, the body's defence system, works).
Danish: Det vides ikke nøjagtigt, hvordan alfa-interferoner virker ved virussygdomme, men de menes at virke immunmodulerende (dvs. de ændrer den måde, som immunsystemet (kroppens naturlige forsvar) virker på).
English: What measures are being taken to ensure the safe and effective use of Pegasys?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pegasys?
English: The most common side effects with Pegasys (seen in more than 1 patient in 10) are loss of appetite, headache, insomnia (difficulty sleeping), irritability, gut disorders (diarrhoea, nausea, and belly ache) rash, itching, hair loss, pain in muscles and joints, flu-like illness, reactions at the site of the injection and tiredness.
Danish: De hyppigste bivirkninger ved Pegasys (som optræder hos mere end 1 ud af 10 patienter) er appetitløshed, hovedpine, søvnbesvær, irritabilitet, tarmproblemer (diarré, kvalme og mavesmerter), udslæt, kløe, hårtab, muskel- og ledsmerter, influenzalignende symptomer, reaktioner på injektionsstedet og træthed.
English: This decreases the rate at which interferon is removed from the body and allows the medicine to be given less often.
Danish: Dermed fjernes interferon langsommere fra kroppen, så lægemidlet ikke behøver at blive givet så ofte.
English: It is not intended to provide practical advice on how to use Pegasys.
Danish: Det er ikke en praktisk vejledning i, hvordan Pegasys bør anvendes.
English: Pegasys is given by injection under the skin in the abdomen (belly) or thigh - once a week for 48 weeks for hepatitis B and once a week for between 16 and 72 weeks for hepatitis C.
Danish: Pegasys gives som injektion under huden i maven eller låret én gang om ugen i 48 uger mod hepatitis B og én gang om ugen i 16-72 uger mod hepatitis C.
English: Pegasys was more effective than lamivudine (another antiviral medicine) at clearing the hepatitis B virus in 2 studies of 1,372 adult patients.
Danish: Pegasys var mere effektivt end lamivudin (et andet antiviralt middel) til at fjerne hepatitis B-virus i 2 undersøgelser med 1 372 patienter.
English: Pegasys must not be used in people who are hypersensitive (allergic) to alpha interferons or any of the other ingredients.
Danish: Pegasys må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for alfa-interferoner eller andre af indholdsstofferne.
English: Pegasys must also not be used in patients with certain liver, heart and other conditions.
Danish: Pegasys må heller ikke anvendes hos patienter med visse leversygdomme, hjerteproblemer og andre lidelser.
English: Hepatitis B and C are diseases of the liver due to infection with the hepatitis B and C viruses, respectively.
Danish: Hepatitis B og C er leversygdomme, der skyldes infektion med henholdsvis hepatitis B- og C-virus.
English: • chronic (long-term) hepatitis B in adults and children from 3 years of age
Danish: • kronisk (langvarig) hepatitis B hos voksne og børn i alderen 3 år og opefter
English: For hepatitis C, Pegasys has been studied on its own and in combination with other medicines.
Danish: Hvad angår hepatitis C, er Pegasys blevet undersøgt som enkeltstofbehandling og i kombination med andre lægemidler.
English: What is Pegasys and what is it used for?
Danish: Hvad er Pegasys, og hvad anvendes det til?
English: Among ‘HBeAgnegative' patients (those infected with a virus that has mutated and can be more difficult to treat), the clearance rate was 43% with Pegasys and 29% with lamivudine.
Danish: Blandt HBeAg-negative patienter (dem, der er inficeret med en virus, som er muteret, og som kan være sværere at behandle) var clearance-raten 43 % i Pegasys-gruppen og 29 % i lamivudin-gruppen.
English: Why is Pegasys approved?
Danish: Hvorfor blev Pegasys godkendt?
English: For more information about treatment with Pegasys, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pegasys, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • chronic hepatitis C in adults and children from 5 years of age.
Danish: • kronisk hepatitis C hos voksne og børn i alderen 5 år og opefter.
English: Additional studies showed that peginterferon alfa-2a in combination with telaprevir and ribavirin or with boceprevir and ribavirin significantly increased the proportion of patients who responded to treatment compared with peginterferon alfa-2a plus ribavirin.
Danish: Yderligere undersøgelser har vist, at peginterferon alfa-2a i kombination med telaprevir og ribavirin eller med boceprevir og ribavirin signifikant øgede andelen af patienter, der reagerede på behandling sammenholdt med peginterferon alfa-2a plus ribavirin.
English: Studies show that Pegasys is effective at clearing signs of viral infection in adults and children with chronic hepatitis B or C.
Danish: Undersøgelser har vist, at Pegasys er effektivt til at fjerne tegn på virusinfektion hos voksne og børn med kronisk hepatitis B og C.
English: In a study of 151 children with hepatitis B aged 3 and above, 26% of those treated with Pegasys no longer had viral activity in their blood after 24 weeks, compared with 3% of those not given any treatment.
Danish: I en undersøgelse med 151 børn med hepatitis B i alderen 3 år og opefter havde 26 % af dem, der blev behandlet med Pegasys, ikke længere virusaktivitet i blodet efter 24 uger sammenholdt med 3 % blandt dem, der ikke fik nogen behandling.
English: What are the risks associated with Pegasys?
Danish: Hvilke risici er der forbundet med Pegasys?
English: Studies showed that Pegasys is effective at clearing signs of viral infection in adults and children with chronic hepatitis B or C. The European Medicines Agency (EMA) considered the benefits to outweigh the risks seen with this medicine and therefore recommended that it be given marketing authorisation.
Danish: Undersøgelser har vist, at Pegasys er effektivt til at fjerne tegn på virusinfektion hos voksne og børn med kronisk hepatitis B og C. Det Europæiske Lægemiddelagentur (EMA) konkluderede, at fordelene ved dette lægemiddel opvejer risiciene, og anbefalede derfor, at det godkendes til anvendelse i EU.
English: Finally, a study in 55 children showed similar effectiveness with the combination of Pegasys and ribavirin to that seen in adults treated with Pegasys and ribavirin.
Danish: Endelig har en undersøgelse af 55 børn vist en virkning med kombinationen af Pegasys og ribavirin, som svarer til virkningen med Pegasys og ribavirin hos voksne.
English: Another study in 1,149 adult patients showed that the combination of Pegasys with ribavirin was also more effective than Pegasys alone (45% responders at follow-up compared with 24%) and as effective as the combination of interferon alfa-2a and ribavirin (39% responders).
Danish: I en anden undersøgelse med 1 149 patienter er det påvist, at kombinationen af Pegasys og ribavirin også var mere effektiv end Pegasys alene (45 % respondenter ved opfølgning sammenholdt med 24 %) og lige så effektiv som kombinationen af interferon alfa-2a og ribavirin (39 % respondenter).
English: Pegasys can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of hepatitis B or C. For further information see the package leaflet.
Danish: Pegasys udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af patienter med hepatitis B og C. De nærmere oplysninger fremgår af indlægssedlen.
English: For practical information about using Pegasys, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pegasys, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Three studies of 1,441 adult patients showed that more patients taking Pegasys alone had no signs of hepatitis viral activity in their blood after treatment (28 to 39%) than patients taking interferon alfa-2a (8 to 19%).
Danish: Det er i tre undersøgelser med 1 441 voksne patienter påvist, at der blandt de patienter, som fik Pegasys alene, var flere, som ikke havde nogen tegn på hepatitis-virusaktivitet i blodet efter behandlingen (28-39 %), end blandt dem, der fik interferon alfa-2a (8-19 %).
English: In these studies, the proportions of patients with no signs of viral activity in their blood 6 months after treatment were 32% with Pegasys and 22% with lamivudine among HBeAg-positive patients (those with the common type of the hepatitis B virus).
Danish: I disse undersøgelser var andelen af patienter uden tegn på viral aktivitet i blodet 6 måneder efter behandling 32 % og 22 % blandt henholdsvis Pegasys-behandlede og lamivudin-behandlede HBeAg-positive forsøgspersoner (dvs. dem, der har den almindeligste type hepatitis B-virus).
English: Pegasys is usually used alone for hepatitis B infection but is taken in combination with other medicines for hepatitis C. For more information about when to use this medicine in adults and children, see the summary of product characteristics (SmPC).
Danish: Pegasys anvendes typisk alene mod hepatitis B-infektion, men tages i kombination med andre lægemidler mod hepatitis C. Der findes flere oplysninger om brugen af dette lægemiddel hos voksne og børn i produktresuméet.
English: The active substance in Pegasys, peginterferon alfa-2a, belongs to the group ‘interferons'.
Danish: Det aktive stof i Pegasys, peginterferon alfa-2a, tilhører gruppen af "interferoner".
English: For the full list of restrictions with Pegasys, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Pegasys fremgår af indlægssedlen.
English: How is Pegasys used?
Danish: Hvordan anvendes Pegasys?
English: Pegasys contains the active substance peginterferon alfa-2a.
Danish: Pegasys indeholder det aktive stof peginterferon alfa-2a.
English: For the full list of all side effects reported with Pegasys, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Pegasys fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pegasys 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 Pegasys.
English: What benefits of Pegasys have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Pegasys?
English: Doses may need to be adjusted for patients who experience side effects.
Danish: I tilfælde af bivirkninger kan det være nødvendigt at justere dosen.
English: How does Pegasys work?
Danish: Hvordan virker Pegasys?
English: Peginterferon alfa-2a is similar to interferon alfa-2a, which is widely available in the European Union (EU) as Roferon-A.
Danish: Peginterferon alfa-2a svarer til interferon alfa-2a, der allerede markedsføres i EU under navnet Roferon-A. I Pegasys er interferon alfa-2a blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol).
English: This summary was last updated in 12-2007.
Danish: Dette sammendrag blev sidst ajourført i 12- 2007.
English: The marketing authorisation was renewed on 5 February 2003 and on 5 February 2008.
Danish: Markedsføringstilladelsen blev fornyet den 5. februar 2003 og den 5. februar 2008.
English: QUADRAMET has been studied in 373 patients in three main studies.
Danish: QUADRAMET blev undersøgt hos 373 patienter i tre hovedundersøgelser.
English: The pain relief may last for up to four months.
Danish: Smertelindringen kan vare fra 4 uger op til 4 måneder.
English: The European Commission granted a marketing authorisation valid throughout the European Union for QUADRAMET to CIS bio international on 5 February 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for QUADRAMET til CIS bio international den 5. februar 1998.
English: Other information about QUADRAMET:
Danish: Andre oplysninger om QUADRAMET:
English: The main measure of effectiveness was the reduction of pain.
Danish: Det primære effektmål var smertereduktion.
English: lexidronam pentasodium.
Danish: lexidronam pentanatrium.
English: The Committee recommended that QUADRAMET be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for QUADRAMET.
English: The medicine is given by slow intravenous injection (into a vein) over one minute.
Danish: Lægemidlet indgives ved langsom intravenøs injektion (i en åre) over et tidsrum på 1 minut.
English: QUADRAMET should only be handled and given by someone who is authorised to use radioactive medicines and after full oncological (cancer) evaluation.
Danish: QUADRAMET må kun håndteres og indgives af en person, som er autoriseret til at bruge radioaktive lægemidler, og kun efter fuld onkologisk (cancer) evaluering.
English: The full EPAR for QUADRAMET is available here.
Danish: Den fuldstændige EPAR for QUADRAMET findes her.
English: As a result, the radiation brought by the samarium-153 can act locally and help to relieve the bone pain.
Danish: Som resultat heraf kan strålingen fra samarium-153 virke lokalt og være med til at lindre knoglesmerter.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) QUADRAMET EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) QUADRAMET EPAR - sammendrag for offentligheden
English: The following side effects have also been reported: asthenia (weakness), nausea (feeling sick), vomiting, diarrhoea, peripheral oedema (fluid retention), headaches, hypotension (low blood pressure), dizziness, myasthenia (muscle weakness), confusion and sweating.
Danish: Følgende bivirkninger er også rapporteret: asteni (afkræftelse), kvalme, opkastning, diarré, perifert ødem (væskeansamling), hovedpine, hypotension (lavt blodtryk), svimmelhed, amyosteni (muskelsvaghed), forvirring og perspiration (svedtendens).
English: In two of these, the effectiveness of QUADRAMET was compared with that of placebo (a dummy treatment).
Danish: I to af disse blev effektiviteten af QUADRAMET sammenlignet med placebo (en uvirksom behandling).
English: QUADRAMET is a radiopharmaceutical product.
Danish: QUADRAMET er et terapeutisk radioaktivt lægemiddel.
English: The main side effects of QUADRAMET are a reduction in red and white blood cell and platelet counts.
Danish: De mest almindelige bivirkninger ved QUADRAMET er en reduktion i røde og hvide blodlegemer og trombocyttal.
English: The dose of QUADRAMET is calculated based on the patient's body weight to provide a specific dose of radioactivity (37 mega becquerels per kilogram body weight).
Danish: Dosen af QUADRAMET beregnes ud fra patientens legemsvægt for at få en specifik radioaktivitetsdosis (37 megabecquerel pr. kilo legemsvægt).
English: When QUADRAMET is injected into a patient, the complex is distributed around the body via the bloodstream.
Danish: Når QUADRAMET injiceres i en patient, fordeles komplekset rundt om i kroppen via blodbanen.
English: This was measured using various means, such as visual or descriptive scales, analgesic (painkiller) use, and assessment by the doctor.
Danish: Denne måles ved hjælp af forskellige metoder, såsom visuelle eller beskrivende skalaer, brug af analgetika (smertestillende præparater) og lægeundersøgelse.
English: QUADRAMET should not be used in people who may be hypersensitive (allergic) to EDTMP or to phosphonates (similar chemical compounds).
Danish: QUADRAMET må ikke anvendes til personer, som muligvis er overfølsomme (allergiske) over for EDTMP eller phosphonater (lignende kemiske forbindelser).
English: Osteoblastic metastases are a type of bone metastasis where new bone tissue grows rapidly.
Danish: Osteoblastiske metastaser er en type knoglemetastase, hvor nyt knoglevæv vokser hurtigt.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that QUADRAMET's benefits are greater than its risks for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved QUADRAMET er større end risiciene ved lindring af knoglesmerter hos patienter med multiple smertefulde osteoblastiske knoglemetastaser.
English: It should not be used in pregnant women or in patients who have had chemotherapy or hemi-body external radiotherapy in the previous six weeks.
Danish: Det må ikke anvendes til gravide kvinder eller til patienter, som inden for de sidste 6 uger har fået behandling med kemoterapi eller halvkropsbestrålingsbehandling.
English: Before receiving QUADRAMET patients should have a bone scan using bisphosphonates radiolabelled with technetium-99m [99mTc] as markers, to check that their metastases are of the type that QUADRAMET can be used for.
Danish: Før behandling med QUADRAMET indledes, skal patienterne have foretaget en knoglescanning ved brug af bisphosphonat, der er røntgenmærket med teknetium-99m [99mTc], for at kontrollere, om deres metastaser er af den type, som QUADRAMET
English: The medicine can only be obtained with a prescription.
Danish: kan anvendes mod. Lægemidlet udleveres kun efter recept.