FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Clopidogrel Acino
Danish: Andre oplysninger om Clopidogrel Acino
English: What are the benefits and risks of Clopidogrel Acino?
Danish: Hvilke fordele og risici er der forbundet med Clopidogrel Acino?
English: EPAR summary for the public clopidogrel
Danish: EPAR - sammendrag for offentligheden
English: The Committee recommended that Clopidogrel Acino be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Acino.
English: Because Clopidogrel Acino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine.
Danish: Da Clopidogrel Acino er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Clopidogrel Acino is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Acino er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: Clopidogrel Acino can be started between seven days and six months after the stroke;
Danish: Behandling med Clopidogrel Acino kan påbegyndes syv dage efter slagtilfældet og indtil seks måneder efter
English: Because Clopidogrel Acino is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Acino er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: In acute coronary syndrome, Clopidogrel Acino is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Danish: Ved akut koronart syndrom indledes behandlingen normalt med en startdosis på fire 75 mg-tabletter.
English: • patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Danish: • har en sygdom kaldet "akut koronart syndrom", når det skal gives sammen med aspirin (et andet lægemiddel, som forebygger blodpropper).
English: The active substance in Clopidogrel Acino, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Acino, clopidogrel, er en trombocytfunktionshæmmer.
English: Clopidogrel Acino is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel Acino anvendes til at forebygge problemer forårsaget af blodpropper hos voksne, som:
English: Why has Clopidogrel Acino been approved?
Danish: Hvorfor blev Clopidogrel Acino godkendt?
English: What is Clopidogrel Acino?
Danish: Hvad er Clopidogrel Acino?
English: How has Clopidogrel Acino been studied?
Danish: Hvordan blev Clopidogrel Acino undersøgt?
English: What is Clopidogrel Acino used for?
Danish: Hvad anvendes Clopidogrel Acino til?
English: How is Clopidogrel Acino used?
Danish: Hvordan anvendes Clopidogrel Acino?
English: It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
Danish: Det anvendes til patienter, som har mindst en risikofaktor for vaskulære hændelser såsom hjerteanfald eller slagtilfælde, som ikke kan tage vitamin Kantagonister (andre lægemidler, der forebygger blodpropper), og som har en lav blødningsrisiko.
English: How does Clopidogrel Acino work?
Danish: Hvordan virker Clopidogrel Acino?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cholib on 26 August 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cholib den 26. august 2013.
English: Cholib fenofibrate / simvastatin
Danish: Cholib fenofibrat / simvastatin
English: This is a summary of the European public assessment report (EPAR) for Cholib.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cholib.
English: The full EPAR for Cholib can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cholib findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Fenofibrate is a ‘PPARα agonist'.
Danish: Fenofibrat er en “PPARα-agonist”.
English: The recommended dose is one tablet a day to be swallowed whole with a glass of water.
Danish: Den anbefalede dosis er én tablet dagligt, der skal synkes hel med et glas vand.
English: Other information about Cholib
Danish: Andre oplysninger om Cholib
English: A risk management plan has been developed to ensure that Cholib is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Cholib anvendes så risikofrit som muligt.
English: The Committee also noted that the combination of fenofibrate and simvastatin is already being used in clinical practice.
Danish: Udvalget bemærkede desuden, at kombinationen af fenofibrat og simvastatin i forvejen anvendes i klinisk praksis.
English: The Committee therefore concluded that Cholib's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Udvalget konkluderede derfor, at fordelene ved Cholib overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Cholib?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cholib?
English: Cholib can only be obtained with a prescription and is available as tablets (145/20 mg and 145/40 mg).
Danish: Cholib udleveres kun på recept og leveres som tabletter (145/20 mg og 145/40 mg).
English: Two further studies compared Cholib with other statins (atorvastatin and pravastatin) and showed Cholib to be more effective than those statins given alone.
Danish: To yderligere undersøgelser sammenlignede Cholib med andre statiner (atorvastatin og pravastatin) og viste, at Cholib var mere effektivt end disse statiner givet alene.
English: What is Cholib and what is it used for?
Danish: Hvad er Cholib, og hvad anvendes det til?
English: With regard to the safety of Cholib, the side effects reported in the studies were consistent with what is known about the two active substances and there were no major concerns.
Danish: Vedrørende sikkerheden af Cholib svarer de indberettede bivirkninger i undersøgelserne til dem, der kendes for de to aktive stoffer, og der var ingen større betænkeligheder.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the combination of fenofibrate and simvastatin has been shown to be effective at improving blood fat levels.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at kombinationen af fenofibrat og simvastatin er påvist at være effektiv til at forbedre blodets indhold af fedtstoffer.
English: The cholesterol drawn out of the blood in this way is the ‘bad' cholesterol.
Danish: Det kolesterol, der på denne måde trækkes ud af blodet, er det “dårlige” kolesterol.
English: It must also not be used in pregnant or breast-feeding women, in people known to have light-induced reactions to fibrates or ketoprofen, or those who have liver or gallbladder disease, pancreatitis, or moderately or severely reduced kidney function, or who have previously had muscle problems while taking statins or fibrates.
Danish: Det må heller ikke anvendes hos gravide eller ammende kvinder, hos personer med kendte lysforårsagede reaktioner over for fibrater eller ketoprofen, med lever- eller galdeblæresygdom eller moderat eller svært nedsat nyrefunktion, eller hos personer, som tidligere har fået muskelproblemer ved at bruge statiner eller fibrater.
English: Why is Cholib approved?
Danish: Hvorfor er Cholib blevet godkendt?
English: It is not intended to provide practical advice on how to use Cholib.
Danish: Det er ikke en praktisk vejledning i, hvordan Cholib bør anvendes.
English: What are the risks associated with Cholib?
Danish: Hvilke risici er der forbundet med Cholib ?
English: Cholib must not be used in people who are hypersensitive (allergic) to peanuts, soya lecithin or any of the ingredients of the medicine.
Danish: Cholib må ikke anvendes hos personer, der er overfølsomme (allergiske) over for jordnødder, sojalecitin eller nogen af indholdsstofferne i lægemidlet.
English: The second active substance, simvastatin, belongs to the group called ‘statins'.
Danish: Det andet aktive stof, simvastatin, tilhører lægemiddelgruppen statiner.
English: Before starting treatment with Cholib, possible causes of the abnormal levels of blood fats should be adequately treated and patients should be placed on a standard fat-lowering diet.
Danish: Før påbegyndelse af behandling med Cholib skal mulige årsager til det abnorme fedtstofindhold i blodet være behandlet tilstrækkeligt, og patienten skal følge en sædvanlig fedtsænkende diæt.
English: Cholib is to be used in adults at high risk of heart disease whose levels of ‘bad' cholesterol (LDL cholesterol) are already being controlled with the corresponding dose of simvastatin alone.
Danish: Cholib er til anvendelse hos voksne, der har høj risiko for hjertesygdom, og hvis niveau af “dårligt” kolesterol i forvejen er reguleret med den tilsvarende dosis simvastatin alene.
English: Grapefruit juice should be avoided during Cholib treatment as this is known to alter the amount of simvastatin in the blood.
Danish: Grapefrugtjuice bør undgås under behandling med Cholib, da det ændrer indholdet af simvastatin i blodet.
English: Another study compared Cholib 145/40 mg with simvastatin 40 mg in 450 patients not adequately treated with 40 mg simvastatin alone.
Danish: I en anden undersøgelse blev Cholib, 145/40 mg, sammenlignet med simvastatin, 40 mg, hos 450 patienter, der ikke var tilstrækkeligt behandlet med 40 mg simvastatin alene.
English: Cholib is a medicine for improving blood fat levels.
Danish: Cholib er et lægemiddel til forbedring af fordelingen af fedtstoffer i blodet.
English: It contains two active substances, fenofibrate and simvastatin, and is used together with a low fat diet and exercise with the aim of reducing patients' levels of triglycerides (a type of fat) and increasing their levels of ‘good' cholesterol (HDL cholesterol).
Danish: Det indeholder to aktive stoffer, fenofibrat og simvastatin, og anvendes sammen med fedtfattig diæt og motion til at sænke indholdet af triglycerider (en type fedtstoffer) og øge indholdet af det “gode” kolesterol (HDLkolesterol).
English: The most common side effects with Cholib are raised blood creatinine levels, upper respiratory tract infection (colds), increased blood platelet counts, gastroenteritis (diarrhoea and vomiting) and increased levels of alanine aminotransferase (a liver enzyme).
Danish: De hyppigste bivirkninger med Cholib er forhøjet indhold af kreatinin i blodet, øvre luftvejsinfektioner (forkølelse), øget antal blodplader, gastroenteritis (diarré og opkastning) og øget indhold af alaninaminotransferase (et leverenzym).
English: This means that it activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha' (PPARα), which is involved in breaking down fats from diet, especially triglycerides.
Danish: Det vil sige, at det aktiverer receptoren “peroxisomproliferatoraktiveret receptor alpha” (PPARα), der medvirker ved nedbrydning af fedtstofferne i føden, navnlig triglycerider.
English: The active substances in Cholib, fenofibrate and simvastatin, work in different ways and their actions have a complementary effect.
Danish: De aktive stoffer i Cholib, fenofibrat og simvastatin, virker forskelligt og supplerer gensidigt hinandens virkning.
English: For more information about treatment with Cholib, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cholib, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further.
Danish: Da leveren behøver kolesterol til at producere galde, vil det sænkede kolesterolindhold i blodet bevirke, at cellerne danner receptorer, der trækker kolesterol ud af blodet og derved nedsætter indholdet yderligere.
English: Cholib has been shown to be more effective than statins alone in reducing levels of triglycerides and increasing levels of good cholesterol.
Danish: Cholib er påvist at være mere effektivt end statiner alene til at nedsætte indholdet af triglycerider og øge indholdet af det gode kolesterol.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cholib, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Cholib er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: It reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol.
Danish: Det nedsætter det totale kolesterolindhold i blodet ved at blokere virkningen af HMG-CoA-reduktase, et enzym i leveren, der medvirker ved dannelsen af kolesterol.
English: It showed that Cholib led to a greater reduction in triglyceride levels (33% versus 7%) and to higher levels of good cholesterol (6% increase versus a 1% decrease).
Danish: Cholib medførte større fald i triglycerider (33 % mod 7 %) og større indhold af det gode kolesterol (6 % stigning mod et fald på 1 %).
English: For the full list of all side effects reported with Cholib, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Cholib fremgår af indlægssedlen.
English: In addition, levels of good cholesterol increased by around 7% with Cholib compared with around 2% with simvastatin.
Danish: Desuden medførte Cholib en stigning i indholdet af det gode kolesterol på ca. 7 %, sammenholdt med ca. 2 % for simvastatin.
English: For practical information about using Cholib, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cholib, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Cholib used?
Danish: Hvordan anvendes Cholib?
English: What benefits of Cholib have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cholib?
English: In all studies the reductions in triglycerides and the increases in good cholesterol were higher with Cholib than with a statin alone.
Danish: I alle undersøgelserne medførte Cholib større reduktion af triglycerider og større stigning i det gode kolesterol end statin alene.
English: In a main study comparing Cholib 145/20 mg with simvastatin 40 mg in 1,050 patients not adequately treated with 20 mg simvastatin alone, triglyceride levels decreased by around 36% with Cholib after 12 weeks compared with 12% with simvastatin.
Danish: I en hovedundersøgelse blev Cholib, 145/20 mg, sammenlignet med simvastatin, 40 mg, hos 1 050 patienter, der ikke var tilfredsstillende behandlet med 20 mg simvastatin alene.
English: How does Cholib work?
Danish: Hvordan virker Cholib?
English: When these receptors are activated, the breakdown of fats speeds up, which helps clear the blood of ‘bad' cholesterol and triglycerides.
Danish: Når disse receptorer aktiveres, øges fedtstofnedbrydningen.
English: 10 ampoules
Danish: 10 ampuller
English: Intravenous use ampoule (glass) 10 ml
Danish: Hætteglas (glas) 6 ml
English: Intravenous use vial (glass)
Danish: Ampul (glas)
English: Inactivated Mycoplasma hyopneumoniae strain P-5722-3 (inactivated)
Danish: Inaktiveret Mycoplasma hyopneumoniae, stamme P-5722-3
English: --1 Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Danish: --1 Inaktiveret, rekombinant kimært porcint circovirus type 1 med porcint circovirus type 2 ORF2-protein
English: * Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Danish: * Relativ styrke påvist vha. ELISA antigentest (in vitro styrketest) ved sammenligning med referencevaccine.
English: Cartridge (glass) 3 ml (3.5 mg/ml) 1 cartridge
Danish: (3,5 mg/ml)
English: Content (concentration)
Danish: hætteglas (multipakning)
English: Immediate Packaging
Danish: 1 cylinderampul
English: MA (EU) number
Danish: 5 (5 x1)
English: Pack size
Danish: 10 ml
English: Route of administration
Danish: suspension
English: The European Commission granted a marketing authorisation valid throughout the European Union for Topotecan Eagle on 22 December 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Topotecan Eagle den 22 december 2011.
English: The full EPAR for Topotecan Eagle can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Topotecan Eagle findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that it is similar to a ‘reference medicine' containing the same active substance.
Danish: Det betyder, at det svarer til et ‘referencelægemiddel', som indeholder det samme aktive stof.
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 Topotecan Eagle.
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 Topotecan Eagle.
English: This is a summary of the European public assessment report (EPAR) for Topotecan Eagle.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Topotecan Eagle.
English: For lung cancer, Topotecan Eagle is given every day for five days with a three-week interval between the start of each course.
Danish: Ved behandling af lungekræft gives Topotecan Eagle hver dag i fem dage med et interval på tre uger mellem starten på hvert forløb.
English: Topotecan Eagle also has a different (higher) strength from Hycamtin.
Danish: Topotecan Eagle har også en anden (højere) styrke end Hycamtin.
English: The CHMP concluded that, in accordance with EU requirements, Topotecan Eagle has been shown to have comparable quality and to be bioequivalent to Hycamtin.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Topotecan Eagle er af sammenlignelig kvalitet og er bioækvivalent med Hycamtin.
English: For more information about treatment with Topotecan Eagle, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Topotecan Eagle, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Treatment with Topotecan Eagle should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Danish: Behandling med Topotecan Eagle bør kun gives under overvågning af en læge med erfaring i anvendelse af kemoterapi.
English: The dose of Topotecan Eagle to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Danish: Hvilken dosis Topotecan Eagle, som skal anvendes, afhænger af den pågældende kræfttype og patientens vægt og højde.
English: Treatment may continue until the disease gets worse.
Danish: Behandlingen kan fortsætte, indtil
English: What are the benefits and risks of Topotecan Eagle?
Danish: Hvilken fordel og risiko er der forbundet med Topotecan Eagle?
English: It is also used together with cisplatin (another anticancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Danish: Det anvendes også sammen med cisplatin (et andet lægemiddel mod kræft) til behandling af kvinder med livmoderhalskræft ved tilbagefald af sygdommen efter strålebehandling, og når sygdommen er fremskreden (stadium IVB: kræften har bredt sig fra livmoderhalsen til andre dele af kroppen).
English: The company provided data from the published literature on topotecan.
Danish: Virksomheden har fremlagt data fra faglitteraturen om topotecan.
English: When used with cisplatin in cervical cancer, Topotecan Eagle is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Danish: Når Topotecan Eagle anvendes sammen med cisplatin til behandling af livmoderhalskræft, indgives det som en infusion på dag 1, 2 og 3 (cisplatin gives på dag 1).
English: For full details, see the Summary of Product Characteristics, also part of the EPAR.
Danish: De nærmere oplysninger fremgår af produktresumeét, der ligeledes er en del af denne EPAR.
English: While the reference medicine, Hycamtin, is available as a powder to be made up into a concentrate, Topotecan Eagle is available as a ready-made concentrate.
Danish: Mens referencelægemidlet Hycamtin leveres som et pulver, der benyttes til at fremstille et koncentrat, leveres Topotecan Eagle som et færdigfremstillet koncentrat.
English: It is available as a concentrate to be made up into a solution for infusion (drip into a vein).
Danish: Det leveres som et koncentrat, der anvendes til at lave en opløsning, som bruges til infusion (drop i en blodåre).
English: The active substance in Topotecan Eagle, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Danish: Det aktive stof i Topotecan Eagle, topotecan, er et lægemiddel mod kræft, der tilhører gruppen af ‘topoisomerasehæmmere'.
English: Topotecan Eagle is a medicine that contains the active substance topotecan.
Danish: Topotecan Eagle er et lægemiddel, der indeholder det aktive stof topotecan.
English: Topotecan Eagle is a ‘hybrid generic medicine'.
Danish: Topotecan Eagle er et ‘generisk lægemiddel'.
English: Because Topotecan Eagle is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Topotecan Eagle er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at
English: Topotecan Eagle also affects non-cancer cells, which causes side effects.
Danish: Topotecan Eagle påvirker også andre celler end kræftcellerne, hvilket
English: Topotecan Eagle is an anticancer medicine.
Danish: Topotecan Eagle er et lægemiddel mod kræft.
English: No additional studies in patients were needed as Topotecan Eagle is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Topotecan Eagle indgives ved infusion og indeholder det samme aktive stof
English: How is Topotecan Eagle used?
Danish: Hvordan anvendes Topotecan Eagle?
English: Measurement of serum concentration
Danish: Måling af serumkoncentration
English: Overall summary of the scientific evaluation of Targocid and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Targocid og relaterede navne (se bilag I)
English: The shelf-life of the product is supported by relevant stability data.
Danish: Produktets opbevaringstid støttes af relevante stabilitetsdata.