FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the EU for Tolura to Krka, d.d., Novo mesto on 4 June 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tolura til Krka, d.d., Novo mesto den 4.juni 2010.
English: Other information about Tolura:
Danish: Andre oplysninger om Tolura:
English: This document is a summary of the European Public Assessment Report (EPAR) for Tolura.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tolura.
English: It is available as white tablets (round: 20 mg; oval: 40 mg; capsule-shaped: 80 mg).
Danish: Det fås som hvide tabletter (runde: 20 mg, ovale: 40 mg; kapselformet tablet: 80 mg).
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 Tolura.
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 anvendelsesbetingelserne for Tolura.
English: EPAR summary for the public telmisartan
Danish: EPAR - sammendrag for offentligheden telmisartan
English: The full EPAR for Tolura can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Tolura findes på agenturets websted: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Tolura is a ‘generic medicine'.
Danish: Tolura er et ‘generisk lægemiddel'.
English: For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day.
Danish: Til forebyggelse af kardiovaskulære problemer er den anbefalede dosis 80 mg én gang dagligt.
English: The doctor should monitor the patient's blood pressure closely when starting Tolura, and may decide to adjust the patient's blood pressure-lowering medication.
Danish: Lægen bør overvåge patientens blodtryk nøje, når behandlingen med Tolura påbegyndes, og kan beslutte af justere patientens blodtrykssænkende medicin.
English: What are the benefit and risk of Tolura?
Danish: Hvilken fordel og risiko er der forbundet med Tolura?
English: It is used in patients who have had problems due to blood clots in the past (such as heart disease or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
Danish: Det anvendes til patienter, der tidligere har haft problemer på grund af blodpropper (såsom hjertesygdom, slagtilfælde eller arteriesygdom) eller har type 2-diabetes, som har beskadiget et organ (f.eks. øjne, hjerte eller nyrer).
English: Tolura is used to treat essential hypertension (high blood pressure) in adults.
Danish: Tolura anvendes til behandling af essentiel hypertension (for højt blodtryk) hos voksne.
English: For more information about treatment with Tolura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tolura, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For the treatment of essential hypertension, the recommended dose of Tolura is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Danish: Til behandling af essentiel hypertension er den anbefalede dosis af Tolura 40 mg én gang dagligt, men visse patienter kan have fordel af en 20 mg-dosis.
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Danish: Det betyder også, at hjertet får lettere ved at pumpe blodet rundt, hvilket kan bidrage til at reducere risikoen for fremtidige kardiovaskulære problemer.
English: The Committee recommended that Tolura be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Tolura.
English: This means that Tolura is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Danish: Det betyder, at Tolura er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Micardis.
English: The active substance in Tolura, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Tolura, telmisartan, er en 'angiotensin II-receptorantagonist', hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: Tolura is a medicine that contains the active substance telmisartan.
Danish: Tolura er et lægemiddel, som indeholder det aktive stof telmisartan.
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder sig til, forhindrer telmisartan hormonet i at have nogen virkning, og blodkarrene kan således udvide sig.
English: The CHMP concluded that, in accordance with EU requirements, Tolura has been shown to have comparable quality and to be bioequivalent to Micardis.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Tolura er af sammenlignelig kvalitet og er bioækvivalent med Micardis.
English: dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Danish: til 80 mg, eller der kan anvendes andre lægemidler mod forhøjet blodtryk såsom hydrochlorothiazid, som tillægsbehandling.
English: If the target blood pressure is not reached, the
Danish: Hvis målet for blodtrykket ikke nås, kan dosis øges
English: Tolura is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks.
Danish: Tolura anvendes også til at forebygge kardiovaskulære problemer (problemer med hjertet og blodkarrene) såsom hjerteanfald eller slagtilfælde.
English: Because Tolura 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's.
Danish: Da Tolura er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack.
Danish: Dette medfører, at blodtrykket falder, hvorved de risici, som er forbundet med forhøjet blodtryk, såsom slagtilfælde eller hjerteanfald, reduceres.
English: Because Tolura is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Danish: Da Tolura er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Micardis.
English: Why has Tolura been approved?
Danish: Hvorfor blev Tolura godkendt?
English: What is Tolura?
Danish: Hvad er Tolura?
English: What is Tolura used for?
Danish: Hvad anvendes Tolura til?
English: How has Tolura been studied?
Danish: Hvordan blev Tolura undersøgt?
English: How is Tolura used?
Danish: Hvordan anvendes Tolura?
English: How does Tolura work?
Danish: Hvordan virker Tolura?
English: The usual dose is 60 mg once a day for 12 or 24 weeks.
Danish: Den sædvanlige dosis er 60 mg én gang dagligt i 12 eller 24 uger.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Daklinza on 22 August 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Daklinza den 22. august 2014.
English: The Agency therefore concluded that the benefits of Daklinza outweigh its risks and recommended that
Danish: Agenturet konkluderede derfor, at fordelene ved Daklinza opvejer risiciene, og anbefalede, at det
English: It contains the active substance daclatasvir.
Danish: Det indeholder det aktive stof daclatasvir.
English: The full EPAR and risk management plan summary for Daklinza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Daklinza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Daklinza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Daklinza.
English: The patients in the study were infected with genotypes 1, 2 or 3 and all received treatment for 12 or 24 weeks.
Danish: Patienterne i undersøgelsen var smittet med genotype 1, 2 eller 3 og blev alle behandlet i 12 eller 24 uger.
English: What is Daklinza and what is it used for?
Danish: Hvad er Daklinza, og hvad anvendes det til?
English: Around 99% of patients with genotype 1 infection (125 out of 126), 96% of patients with genotype 2 infection (25 out of 26) and 89% of patients with genotype 3 infection (16 out of 18) did not show any sign of the virus in their blood 12 weeks after the end of their planned treatment.
Danish: Ca. 99 % af de patienter, der var smittet med genotype 1 (125 ud af 126), 96 % af dem, der var smittet med genotype 2 (25 ud af 26), og 89 % af dem, der var smittet med genotype 3 (16 ud af 18), havde ingen tegn på virus i blodet 12 uger efter afslutningen af den planlagte behandling.
English: Other information about Daklinza
Danish: Andre oplysninger om Daklinza
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Danish: Denne undersøgelse gennemføres på baggrund af data, der indikerer, at patienter, som behandles med disse lægemidler, og som har haft leverkræft, kunne være i risiko for, at deres kræft vender hurtigt tilbage.
English: The dose may have to be raised or lowered if the patient is taking other medicines that decrease or increase Daklinza's effects.
Danish: Det kan være nødvendigt at øge eller sænke dosis, hvis patienten får andre lægemidler, der øger eller sænker Daklinzas virkning.
English: Daklinza is available as 30, 60, and 90 mg tablets.
Danish: Daklinza leveres som tabletter med 30, 60 og 90 mg.
English: For more information about treatment with Daklinza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Daklinza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Almost all the patients in the main study had the virus cleared from their blood.
Danish: Næsten alle patienterne i hovedundersøgelsen blev fri for
English: By blocking this protein, the medicine stops the hepatitis C virus from multiplying.
Danish: Ved at blokere dette protein standser lægemidlet hepatitis C-virussets formering.
English: What are the risks associated with Daklinza?
Danish: Hvilke risici er der forbundet med Daklinza?
English: It is not intended to provide practical advice on how to use Daklinza.
Danish: Det er ikke en praktisk vejledning i, hvordan Daklinza bør anvendes.
English: The company that markets Daklinza will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Daklinza.
Danish: Virksomheden, der markedsfører Daklinza, vil gennemføre en undersøgelse blandt patienter, der tidligere har haft leverkræft, for at evaluere risikoen for, at leverkræften vender tilbage efter behandling med direkte virkende antivirale lægemidler som Daklinza.
English: Several varieties (genotypes) of hepatitis C virus exist and Daklinza is recommended for use in patients with virus of genotypes 1, 3 and 4.
Danish: Der findes flere forskellige varianter (genotyper) af hepatitis C-virus, og Daklinza anbefales hos patienter med virus af genotypen 1, 3 og 4.
English: Daklinza must be used in combination with other medicines for chronic hepatitis C, such as sofosbuvir, peginterferon alfa and ribavirin.
Danish: Daklinza skal anvendes i kombination med andre lægemidler mod kronisk hepatitis C, såsom sofosbuvir, peginterferon alfa og ribavirin.
English: Daklinza must not be used together with certain medicines that may reduce the effects of Daklinza.
Danish: Daklinza må ikke anvendes sammen med visse andre lægemidler, der kan nedsætte dets virkning.
English: Most patients had not previously been treated for hepatitis C, though some had genotype 1 infection that was resistant to standard medicines (consisting of either telaprevir or boceprevir - the so-called NS3/4A inhibitors - in combination with peginterferon alfa and ribavirin).
Danish: De fleste patienter var ikke tidligere behandlet for hepatitis C, om end nogle af dem var smittet med virus af genotype 1, der var resistent mod sædvanlige lægemidler (bestående af telaprevir eller boceprevir - de såkaldte NS3/4A-hæmmere - kombineret med peginterferon alfa og ribavirin).
English: The European Medicines Agency noted that Daklinza used in combination with other medicines was shown to be effective against hepatitis C virus, including in patients with genotype 1 resistant to previous treatment.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at Daklinza, anvendt i kombination med andre lægemidler, havde vist sig effektivt mod hepatitis C-virus, også hos patienter med genotype 1, der var resistent mod tidligere behandling.
English: The combination of medicines to use and the duration of treatment will depend on the genotype of hepatitis C virus the patient is infected with and the nature of the liver problem, for example liver cirrhosis (scarring) or the liver not working well enough.
Danish: Den anvendte lægemiddelkombination og behandlingens varighed afhænger af genotypen af det hepatitis C-virus, patienten er smittet med, og af patientens leverproblemer, f.eks. om patienten har skrumpelever (cirrhose), eller leveren ikke fungerer godt nok.
English: Regarding its safety, Daklinza was well tolerated and the side effects were similar to those experienced
Danish: Hvad sikkerheden angår, tåltes Daklinza godt, og bivirkningerne svarede til bivirkningerne hos dem,
English: Daklinza can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Danish: Daklinza udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kronisk hepatitis C.
English: The most common side effects reported with Daklinza in combination with sofosbuvir with or without ribavirin are fatigue (tiredness), nausea (feeling sick) and headache.
Danish: De hyppigste bivirkninger ved Daklinza kombineret med sofosbuvir med eller uden ribavirin, er træthed, kvalme og hovedpine.
English: How does Daklinza work?
Danish: Hvordan virker Daklinza?
English: What measures are being taken to ensure the safe and effective use of
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Daklinza?
English: For more information on the medicines that should not be taken with Daklinza, see the package leaflet.
Danish: Yderligere oplysninger om de lægemidler, der ikke må tages sammen med Daklinza, fremgår af
English: Daklinza is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Danish: Daklinza er et lægemiddel mod virus (et antiviralt lægemiddel), der bruges i kombination med andre lægemidler til behandling af voksne med langvarig (kronisk) hepatitis C, som er en smitsom leversygdom forårsaget af hepatitis C-virus.
English: The active substance in Daklinza, daclatasvir, blocks the action of a protein in the hepatitis C virus called ‘NS5A', which is essential for the virus to multiply.
Danish: Det aktive stof i Daklinza, daclatasvir, blokerer virkningen af proteinet NS5A i hepatitis C-virusset.
English: Additional studies involving patients with genotypes 4 indicate that Daklinza is also as effective against genotype 4 as it is against genotype 1.
Danish: Andre undersøgelser, der omfattede patienter med genotype 4, viste, at Daklinza var lige så effektivt
English: What benefits of Daklinza have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Daklinza?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daklinza have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Daklinza.
English: For practical information about using Daklinza, patients should read the package leaflet or contact their
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Daklinza, kan du læse indlægssedlen eller
English: For the full list of all side effects reported with Daklinza, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Daklinza
English: Daklinza used in combination with sofosbuvir (with or without ribavirin) was effective at clearing the hepatitis C virus from the blood in a main study involving 211 adults.
Danish: Det blev i en hovedundersøgelse med 211 voksne påvist, at Daklinza var effektivt til at fjerne hepatitis C-virusset fra blodet, når det blev anvendt i kombination med sofosbuvir (med eller uden ribavirin).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lymphoseek on 19 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Lymphoseek den 19. november 2014.
English: This is a summary of the European public assessment report (EPAR) for Lymphoseek.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lymphoseek.
English: The full EPAR and risk management plan summary for Lymphoseek can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Lymphoseek findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other side effects seen were uncommon, mild and short-lived.
Danish: Andre bivirkninger var ikke almindelige og var lette og af kort varighed.
English: Other information about Lymphoseek
Danish: Andre oplysninger om Lymphoseek
English: A risk management plan has been developed to ensure that Lymphoseek is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Lymphoseek anvendes så sikkert som muligt.
English: What is Lymphoseek and what is it used for?
Danish: Hvad er Lymphoseek, og hvad anvendes det til?
English: The most common side effects with Lymphoseek seen in clinical studies are pain and irritation at the injection site (seen in less than 1 patient in 100).
Danish: De hyppigste iagttagne bivirkninger med Lymphoseek i de kliniske undersøgelser er smerter og irritation på injektionsstedet (forekommer hos mindre end en patient ud af 100).
English: What measures are being taken to ensure the safe and effective use of Lymphoseek?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lymphoseek?
English: This helps to decide if further surgery to remove more lymph nodes is needed.
Danish: Dette indgår i afgørelsen af, om det er nødvendigt med yderligere operative indgreb for at fjerne flere lymfeknuder.
English: Almost all the patients (38 out of 39) with cancerous lymph nodes were identified by Lymphoseek.
Danish: Næsten alle patienter (38 ud af 39) med kræft i lymfeknuderne blev fundet med Lymphoseek.
English: Why is Lymphoseek approved?
Danish: Hvorfor er Lymphoseek blevet godkendt?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lymphoseek, 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 Lymphoseek, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Lymphoseek should only be used by healthcare professionals with expertise in mapping lymph nodes.
Danish: Lymphoseek bør kun bruges af sundhedspersoner med ekspertise i kortlægning af lymfeknuder.
English: It is not intended to provide practical advice on how to use Lymphoseek.
Danish: Det er ikke en praktisk vejledning i, hvordan Lymphoseek bør anvendes.
English: For more information about treatment with Lymphoseek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lymphoseek, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Lymphoseek?
Danish: Hvilke risici er der forbundet med Lymphoseek ?
English: It contains the active substance tilmanocept.
Danish: Lymphoseek indeholder det aktive stof tilmanocept.
English: The active substance in Lymphoseek, tilmanocept, attaches to proteins called mannose binding proteins which are found in high amounts in certain immune cells in the lymph nodes.
Danish: Det aktive stof i Lymphoseek, tilmanocept, bindes til mannosebindende proteiner, som findes i stor mængde i visse immunceller i lymfeknuderne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that studies showed that the use of Lymphoseek led to a higher detection rate for sentinel lymph nodes than the use of vital blue dye.
Danish: Agenturets udvalg for lægemidler til mennesker bemærkede, at undersøgelserne viste, at brug af Lymphoseek resulterede i højere andel af påviste skildvagtlymfeknuder end brug af vitalblåt.
English: For the full list of all side effects and restrictions with Lymphoseek, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Lymphoseek fremgår af indlægssedlen.
English: The lymph nodes can then be checked for cancer cells.
Danish: Lymfeknuderne kan derefter kontrolleres for kræftceller.
English: The benefits of Lymphoseek were shown in two main studies in which 311 patients with breast or skin cancer had their lymph nodes first mapped with Lymphoseek and then with another method involving the use of a dye known as ‘vital blue dye'.
Danish: Fordelene ved Lymphoseek blev påvist i to hovedundersøgelser, hvor 311 patienter med brystkræft eller hudkræft fik kortlagt deres lymfeknuder, først med Lymphoseek og derefter med en anden metode, hvor der bruges farvestoffet vitalblåt.
English: In these two studies, doctors were able to detect a higher number of sentinel lymph nodes with Lymphoseek than with the blue dye: almost all of the lymph nodes identified using the blue dye (98% in one study and 100% in the other) were identified using Lymphoseek, while only around 70% and 60%, respectively, of the lymph nodes detected using Lymphoseek were detected with the blue dye.
Danish: I disse to undersøgelser kunne lægerne finde et højere antal skildvagtlymfeknuder med Lymphoseek end med den blå farve: Næsten alle de lymfeknuder, der var påvist med blå farve (98 % i den ene undersøgelse og 100 % i den anden) blev påvist med Lymphoseek.
English: The sentinel lymph nodes are the regional lymph nodes where the cancer is likely to spread to first.
Danish: Skildvagtlymfeknuder er de regionale lymfeknuder, som kræften sandsynligvis vil brede sig til først.