FrancophonIA/ELRC3.0 huggingface dataset:
English: Pylobactell is used to diagnose Helicobacter pylori (H. pylori) infection in the stomach and duodenum (the part of the gut just below the stomach).
Danish: Pylobactell anvendes til diagnosticering af infektion med Helicobacter pylori (H. pylori) i maven og tolvfingertarmen (den del af tarmen, som ligger lige under mavesækken).
English: What is the risk associated with Pylobactell?
Danish: Hvilken risiko er der forbundet med Pylobactell?
English: If the patient has , the 13C-urea contained in the Pylobactell tablet is broken down and the carbon dioxide in the breath also contains 13C.
Danish: Hvis patienten har en infektion med H. pylori i i maven eller tolvfingertarmen, nedbrydes den 13C-urea, som er i tabletten med Pylobactell, og kuldioxiden i udåndingsluften indeholder også 13C.
English: Why has Pylobactell been approved?
Danish: Hvorfor blev Pylobactell godkendt?
English: H. pylori produces enzymes called ureases that break down urea into ammonia and carbon dioxide.
Danish: H. pylori producerer enzymer, der kaldes ureaser.
English: What is Pylobactell?
Danish: Hvad er Pylobactell?
English: What is Pylobactell used for?
Danish: Hvad anvendes Pylobactell til?
English: How has Pylobactell been studied?
Danish: Hvordan blev Pylobactell undersøgt?
English: What benefit has Pylobactell shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pylobactell?
English: How is Pylobactell used?
Danish: Hvordan anvendes Pylobactell?
English: How does Pylobactell work?
Danish: Hvordan virker Pylobactell?
English: The full EPAR for Kogenate Bayer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Kogenate Bayer findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Kogenate Bayer on 4 August 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Kogenate Bayer den 4. august 2000.
English: This is a summary of the European public assessment report (EPAR) for Kogenate Bayer.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kogenate Bayer.
English: Skin- associated hypersensitivity reactions (itching, hives and rash) may occur commonly (in between 1 and 10 patients in 100) but a severe allergic reaction is rare (between 1 and 10 in 10,000 patients).
Danish: Hudrelaterede overfølsomhedsreaktioner (kløe, nældefeber og udslæt) er almindelige (optræder hos mellem 1 og 10 patienter ud af 100), men alvorlige allergiske reaktioner er sjældne (ses hos mellem 1 og 10 ud af 10 000 patienter).
English: Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Danish: Octocog alfa fremstilles ved hjælp af en metode kaldet "rekombinant dna-teknologi": Det fremstilles af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere det.
English: The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Danish: Virkningen blev i undersøgelserne hovedsagelig målt på antallet af behandlinger, som var nødvendige for at standse hver ny blødning.
English: The main measure of effectiveness was the doctor's assessment of how well bleeding was stopped.
Danish: Virkningen blev hovedsagelig målt på lægens vurdering af, hvor godt blødningen blev standset.
English: The dose and duration of treatment depend on whether it is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Danish: Dosis og varighed af behandlingen afhænger af, om den skal anvendes til behandling eller til forebyggelse af blødning eller i forbindelse med operation, såvel som på patientens faktor VIII-niveauer, hæmofiliens sværhedsgrad, blødningens omfang og beliggenhed samt patientens tilstand og legemsvægt.
English: Patients or their carers may be able to administer Kogenate Bayer themselves at home once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsgiver har mulighed for selv at give Kogenate Bayer i hjemmet efter at have fået passende instruktion.
English: Because of this, Kogenate Bayer has been compared with Kogenate to show that the two medicines are equivalent.
Danish: Derfor er Kogenate Bayer blevet sammenlignet med Kogenate for at vise, at de to lægemidler svarer til hinanden.
English: Stopping bleeding was assessed as ‘excellent' in all 15 patients.
Danish: Evnen til at standse blødning blev bedømt som værende virkelig god hos alle 15 patienter.
English: Other information about Kogenate Bayer
Danish: Andre oplysninger om Kogenate Bayer
English: The Agency concluded that Kogenate Bayer has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Danish: Agenturet konkluderede, at Kogenate Bayer er påvist at være effektivt til at behandle og forebygge blødning hos patienter med hæmofili A og har en acceptabel sikkerhedsprofil.
English: What measures are being taken to ensure the safe and effective use of Kogenate Bayer?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kogenate Bayer?
English: The Agency decided that Kogenate Bayer's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturet konkluderede, at fordelene ved Kogenate Bayer opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Kogenate Bayer.
English: Kogenate Bayer is intended for either short-term or long-term use.
Danish: Kogenate Bayer er beregnet enten til kortvarig eller til langvarig behandling.
English: Kogenate Bayer is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Danish: Kogenate Bayer anvendes til at korrigere manglen på faktor VIII ved at erstatte den manglende faktor VIII, hvorved der opnås midlertidig kontrol med blødningsforstyrrelser.
English: What is Kogenate Bayer and what is it used for?
Danish: Hvad er Kogenate Bayer, og hvad anvendes det til?
English: The active substance in Kogenate Bayer, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Danish: Det aktive stof i Kogenate Bayer, octocog alfa (human koagulationsfaktor VIII), er et stof, der hjælper blodet med at størkne.
English: For more information about treatment with Kogenate Bayer, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kogenate Bayer, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The dose may need to be adjusted if Kogenate Bayer is to be given continuously as an infusion into a vein.
Danish: Dosen tilpasses, hvis Kogenate Bayer gives kontinuerligt som infusion i en vene.
English: Kogenate Bayer given as an injection into a vein has been studied in 66 patients who had previously been treated with recombinant human coagulation factor VIII and 61 children who had not.
Danish: Kogenate Bayer givet som en injektion i en vene er blevet undersøgt hos 66 patienter, som tidligere var blevet behandlet med rekombinant human koagulationsfaktor VIII, og hos 61 børn, som ikke havde modtaget denne behandling.
English: It is not intended to provide practical advice on how to use Kogenate Bayer.
Danish: Det er ikke en praktisk vejledning i, hvordan Kogenate Bayer bør anvendes.
English: Kogenate Bayer is similar to another medicine that was previously authorised in the EU called Kogenate, but it is prepared differently so that there are no human-derived proteins in the medicine.
Danish: Kogenate Bayer ligner et andet lægemiddel, som tidligere er godkendt i Den Europæiske Union (EU), kaldet Kogenate, men fremstilles på en anden måde, så lægemidlet ikke indeholder humant afledte proteiner.
English: Kogenate Bayer can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia.
Danish: Lægemidlet Kogenate Bayer udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hæmofili.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles and internal organs.
Danish: Patienter med hæmofili A mangler faktor VIII, hvilket medfører blodstørkningsproblemer såsom blødning i led, muskler eller indre organer.
English: Why is Kogenate Bayer approved?
Danish: Hvorfor blev Kogenate Bayer godkendt?
English: Kogenate Bayer is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Danish: Kogenate Bayer er et lægemiddel, der anvendes til behandling og forebyggelse af blødning hos patienter i alle aldre med hæmofili A (en arvelig blødningsforstyrrelse, der skyldes mangel på faktor VIII).
English: For the full list of all side effects reported with Kogenate Bayer, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Kogenate Bayer fremgår af indlægssedlen.
English: Kogenate Bayer given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Danish: Kogenate Bayer givet ved høj dosis er blevet undersøgt for at se, om det virker til nedbrydning af antistoffer mod faktor VIII fra blodet (en proces, der kaldes immuntoleransinduktion), så behandlingen med faktor VIII forbliver effektiv.
English: In the previously treated patients, overall, 95% of bleeds responded to one or two injections of Kogenate Bayer into a vein.
Danish: Som helhed reagerede 95 % af blødningerne hos de tidligere behandlede patienter på en eller to injektioner af Kogenate Bayer i en vene.
English: Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control.
Danish: Enkelte patienter kan udvikle faktor VIII-inhibitorer, dvs. antistoffer (proteiner), som kroppens immunsystem producerer mod faktor VIII, og som kan være årsag til, at lægemidlet holder op med at virke, hvilket medfører manglende kontrol med blødninger.
English: Kogenate Bayer as a continuous infusion has also been studied in 15 patients with haemophilia A undergoing major surgery.
Danish: Kogenate Bayer givet som en kontinuerlig infusion er også blevet undersøgt hos 15 patienter med hæmofili A, der gennemgik større kirurgiske indgreb.
English: The data provided on immune tolerance induction in patients with inhibitors showed that some patients benefit from the high dosage and the inhibitor could be eliminated, nevertheless the data were not considered sufficient to specifically approve the medicine for this use.
Danish: De data, der blev fremlagt om immuntoleransinduktion hos patienter med inhibitorer, viste, at den høje dosering gavner nogle patienter, og at inhibitoren ville kunne elimineres.
English: What are the risks associated with Kogenate Bayer?
Danish: Hvilke risici er der forbundet med Kogenate Bayer?
English: For practical information about using Kogenate Bayer, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kogenate Bayer, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Kogenate Bayer is available as a powder and solvent that are mixed together to make a solution for injection or infusion (drip) into a vein.
Danish: Kogenate Bayer leveres som et pulver med en solvens, der blandes sammen til en opløsning, som gives ved injektion eller infusion (drop) i en vene.
English: There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Danish: Der er desuden den risiko ved faktor VIII-lægemidler, at visse patienter danner antistoffer (inhibitorer) mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker, så kontrollen med blødning svigter.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kogenate Bayer 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 Kogenate Bayer.
English: How is Kogenate Bayer used?
Danish: Hvordan anvendes Kogenate Bayer?
English: Kogenate Bayer must not be used in people who are known to be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Danish: (allergiske) over for human koagulationsfaktor VIII, muse- eller hamsterproteiner eller nogen af de øvrige indholdsstoffer.
English: What benefits of Kogenate Bayer have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kogenate Bayer?
English: How does Kogenate Bayer work?
Danish: Hvordan virker Kogenate Bayer?
English: 2 patches + 1 cleansing gel
Danish: 2 plastre + 1 rensegel
English: 1 patch + 1 cleansing gel
Danish: 1 plaster + 1 rensegel
English: Packaging Package size
Danish: Emballage
English: The European Commission granted a marketing authorisation valid throughout the European Union for Competact on 28 July 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Competact den 28. juli 2006.
English: The studies lasted from 4 months to 2 years and involved 1,305 patients who took the combination.
Danish: Undersøgelserne varede fra fire måneder til to år og omfattede 1 305 patienter, som tog denne kombination.
English: The full EPAR for Competact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Competact 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 Competact.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Competact.
English: Other information about Competact
Danish: Andre oplysninger om Competact
English: Competact contains two active substances which each have a different mode of action.
Danish: Competact indeholder to aktive stoffer, som hver især virker forskelligt.
English: A risk management plan has been developed to ensure that Competact is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Competact anvendes så sikkert som muligt.
English: The usual dose of Competact is one tablet taken twice a day.
Danish: Den normale dosis af Competact er en tablet to gange dagligt.
English: It is possible to change to Competact directly from metformin if appropriate.
Danish: Det er muligt at skifte til Competact direkte fra metformin, når det er hensigtsmæssigt.
English: Treatment with Competact should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Danish: Behandling med Competact skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke har tilstrækkelig gavn af behandlingen.
English: Competact is a medicine that is available as tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).
Danish: Competact er et lægemiddel, der fås som tabletter, der indeholder to aktive stoffer, pioglitazon (15 mg) og metforminhydrochlorid (850 mg).
English: For more information about treatment with Competact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Competact, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Competact?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Competact?
English: Taking Competact with or just after food may reduce any stomach problems caused by metformin.
Danish: Hvis Competact tages sammen med mad eller lige efter et måltid, kan dette reducere eventuelle maveproblemer forårsaget af metformin.
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 Competact.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om hvordan Competact skal anvendes.
English: Competact is used in adults (particularly those who are overweight) who have type 2 diabetes.
Danish: Competact anvendes til voksne (navnlig overvægtige patienter) med type 2-diabetes.
English: Patients changing from metformin only to Competact may need to slowly introduce pioglitazone until a dose of 30 mg per day is reached.
Danish: Patienter, der skifter fra udelukkende at have taget metformin til Competact, kan blive nødt til gradvist at øge dosis af pioglitazon, indtil der opnås en dosis på 30 mg pr. dag.
English: Three studies of Actos used with metformin as separate tablets were used to support the use of Competact in the same indication.
Danish: Der blev gennemført tre undersøgelser af Actos taget sammen med metformin som separate tabletter til at understøtte brugen af Competact til samme indikation.
English: The Committee decided that Competact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede, at fordelene ved Competact opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Competact.
English: The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Competact simplifies treatment and improves compliance when a combination of the active substances is required.
Danish: CHMP konkluderede, at der var påvist tilstrækkelig effekt af pioglitazon og metformin ved type 2diabetes, og at Competact forenkler behandlingen og forbedrer overholdelsen af anvendelsesbestemmelserne, når der kræves en kombination af de aktive indholdsstoffer.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Competact, 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 Competact, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Competact must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may effects the kidneys, and during breast-feeding.
Danish: Competact bør ikke anvendes i tilfælde af alkoholforgiftning, diabetisk ketoacidose (højt ketonindhold), sygdomme, der kan påvirke nyrerne, og under amning.
English: Competact is used in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own and at the maximum possible dose.
Danish: Competact anvendes til patienter, som ikke er tilfredsstillende kontrolleret udelukkende med metformin (et lægemiddel mod sukkersyge) ved den højest mulige dosis.
English: Why has Competact been approved?
Danish: Hvorfor blev Competact godkendt?
English: What is the risk associated with Competact?
Danish: Hvilken risiko er der forbundet med Competact?
English: Competact must not be used in patients who have a disease that causes lack of oxygen to the tissues such as a recent heart attack or shock.
Danish: Competact bør ikke anvendes til patienter med sygdomme, der medfører mangelfuld ilttilførsel til vævet, f.eks. som følge af et nyligt hjertetilfælde eller chok.
English: In addition, the company that markets Competact will produce educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Danish: Materialet skal omfatte den mulige risiko for hjertesvigt og blærekræft ved lægemidler, der indeholder pioglitazon, kriterier for udvælgelse af patienterne og behovet for regelmæssig gennemgang og indstilling af behandlingen, hvis patienten ikke længere har gavn af den.
English: Competact must not be used in patients who have heart failure, or problems with their liver or their kidneys.
Danish: Competact må ikke anvendes til patienter, som har svære problemer med deres lever eller nyrer.
English: For the full list of side effects reported with Competact, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Competact fremgår af indlægssedlen.
English: In all studies, adding pioglitazone 30 mg to metformin led to an improvement in the control of blood glucose, with levels of HbA1c further decreasing by 0.64 to 0.89% compared with the levels on metformin alone.
Danish: HbA1c-niveauerne faldt yderligere med 0,64 til 0,89 % i forhold til niveauerne, når der kun anvendtes metformin.
English: What benefit has Competact shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Competact?
English: What is Competact?
Danish: Hvad er Competact?
English: How has Competact been studied?
Danish: Hvordan blev Competact undersøgt?
English: What is Competact used for?
Danish: Hvad anvendes Competact til?
English: How is Competact used?
Danish: Hvordan anvendes Competact?
English: How does Competact work?
Danish: Hvordan virker Competact?
English: Strength Pharmaceutical Form Route of administration
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage
English: Adults, including the elderly
Danish: Voksne, herunder ældre
English: In addition, fever was very common in children aged 3-5 years.
Danish: Derudover var feber meget almindeligt hos børn i alderen 3-5 år.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Danish: Hvis dette er tilfældet for dig, vil vaccinationen normalt blive udsat, indtil du har det bedre.
English: Clinical data suggest that a single dose may be sufficient.
Danish: Kliniske data viser, at en enkelt dosis kan være tilstrækkeligt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/452/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/452/001
English: The MAH submitted the data requested above on 5 August 2015 and an opinion was adopted by the CHMP on 28 April 2016.
Danish: Indehaveren af markedsføringstilladelsen indsendte d. 5. august 2015 de efterspurgte data her ovenfor, og der blev vedtaget en opinion fra CHMP d. 28. april 2016.
English: Pandemrix has been administered to women in each trimester of pregnancy.
Danish: Pandemrix er administreret til kvinder i alle trimestre af graviditeten.
English: Vaccination is not recommended in this age group.
Danish: Vaccination i denne aldersgruppe anbefales ikke.