FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Imnovid Keep this medicine out of the sight and reach of children.
Danish: Opbevar lægemidlet utilgængeligt for børn.
English: EU/1/13/850/006 (Pack size of 14 hard capsules) EU/1/13/850/002 (Pack size of 21 hard capsules)
Danish: EU/1/13/850/006 (Pakningsstørrelse på 14 hårde kapsler) EU/1/13/850/002 (Pakningsstørrelse på 21 hårde kapsler)
English: • Stroke.
Danish: • Slagtilfælde.
English: EU/1/13/850/007 (Pack size of 14 hard capsules) EU/1/13/850/003 (Pack size of 21 hard capsules)
Danish: EU/1/13/850/007 (Pakningsstørrelse på 14 hårde kapsler) EU/1/13/850/003 (Pakningsstørrelse på 21 hårde kapsler)
English: EU/1/13/850/008 (Pack size of 14 hard capsules) EU/1/13/850/004 (Pack size of 21 hard capsules)
Danish: EU/1/13/850/008 (Pakningsstørrelse på 14 hårde kapsler) EU/1/13/850/004 (Pakningsstørrelse på 21 hårde kapsler)
English: EU/1/13/850/005 (Pack size of 14 hard capsules) EU/1/13/850/001 (Pack size of 21 hard capsules)
Danish: EU/1/13/850/005 (Pakningsstørrelse på 14 hårde kapsler) EU/1/13/850/001 (Pakningsstørrelse på 21 hårde kapsler)
English: Common Atrial fibrillation
Danish: Almindelig Atrieflimmer
English: Hepatic impairment
Danish: Ikke almindelig Hepatitis
English: Progression Free Survival Based on IRAC Review of Response by IMWG Criteria (Stratified Log Rank Test) (ITT Population).
Danish: IMWGkriterier (stratificeret log rank-test) (ITT-population).
English: Progressed/Died, n (%)
Danish: Progression/død, n (%) Progressionsfri overlevelsestid (uger) Mediana
English: Peripheral sensorimotor neuropathy Paraesthesia
Danish: Perifer sensomotorisk neuropati Paræstesi
English: Route of Administration
Danish: Lægemiddelform Administrations vej
English: London, 25 June 2009 Doc.
Danish: London, den 25. juni 2009 Dok.
English: Questions and answers on the withdrawal of the marketing authorisation application for Factive gemifloxacin
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Factive gemifloxacin
English: The application was at day 196 when the company withdrew.
Danish: Ansøgningen var på dag 196, da virksomheden trak den tilbage.
English: The effects of Factive were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Factive blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The seven-day treatment was not considered acceptable because of the risk of side effects.
Danish: 7-dagesbehandlingen blev ikke vurderet som acceptabel på grund af risikoen for bivirkninger.
English: What is Factive?
Danish: Hvad er Factive?
English: Factive was expected to be used to treat the following bacterial infections in adults:
Danish: Factive skulle være anvendt til behandling af følgende bakterieinfektioner hos voksne:
English: When these enzymes are blocked, the bacteria cannot multiply and they eventually die.
Danish: Når disse enzymer blokeres, kan bakterierne ikke formere sig og vil til sidst dø.
English: The main measures of effectiveness for the studies were based on the number of patients who got better after treatment.
Danish: I undersøgelserne var det vigtigste mål for virkningen antallet af patienter, som fik det bedre efter behandling.
English: Factive is a medicine that contains the active substance gemifloxacin.
Danish: Factive er et lægemiddel, der indeholder det aktive stof gemifloxacin.
English: The CHMP was concerned that Factive may be more genotoxic (harmful to the DNA, the genetic material in cells) and that it may therefore cause more damage to the DNA than other fluoroquinolones.
Danish: CHMP var betænkelig ved, at Factive kunne være mere genotoksisk (skadelig for DNA'et, det genetiske materiale i cellerne) og derfor ville beskadige DNA'et mere end andre fluoroquinoloner.
English: What was Factive expected to be used for?
Danish: Hvad forventedes Factive anvendt til?
English: The Committee also noted that the information presented did not support the use of Factive for chronic bronchitis because no studies were carried out to investigate whether Factive was better than other treatments for this type of infection and because there were problems with the studies that were performed.
Danish: Udvalget bemærkede endvidere, at de indsendte oplysninger ikke understøttede anvendelsen af Factive til kronisk bronkitis, eftersom der ikke var gennemført undersøgelser af, hvorvidt Factive var bedre end andre behandlinger til denne type infektion, og eftersom der var problemer med de gennemførte undersøgelser.
English: The active substance in Factive, gemifloxacin, is an antibiotic belonging to the class ‘fluoroquinolones'.
Danish: Det aktive stof i Factive, gemifloxacin, er et antibiotikum tilhørende gruppen af "fluoroquinoloner".
English: • acute exacerbation (flare-up) of chronic bronchitis (inflammation of the airways in the lungs).
Danish: • akut eksacerbation (opblussen) af kronisk bronkitis (betændelse i luftvejene i lungerne).
English: It is expected to work by blocking the action of two bacterial enzymes called DNA gyrase and topoisomerase IV, which are needed to make and repair bacterial DNA.
Danish: Det forventes at virke ved at blokere virkningen af to bakterieenzymer kaldet DNA-gyrase ogtopoisomerase IV, som er vigtige for, at bakterier kan reparere og lave kopier af deres DNA.
English: On 17 June 2009, Menarini International Operations Luxembourg S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Factive, for the treatment of the bacterial infections, communityacquired pneumonia and acute exacerbation of chronic bronchitis.
Danish: Den 17. juni 2009 meddelte Menarini International Operations Luxembourg S.A. officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Factive til behandling af bakterieinfektioner, samfundserhvervet lungebetændelse og akut eksacerbation tilbage.
English: How is Factive expected to work?
Danish: Hvordan forventes Factive at virke?
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Factive?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Factive eller i programmer for anvendelse af Factive med særlig udleveringstilladelse?
English: The Committee was also concerned there was not enough evidence of effectiveness of Factive in patients with moderate community-acquired pneumonia when given as a five-day treatment.
Danish: Udvalget havde også betænkeligheder med hensyn til, at det ikke var tilstrækkeligt påvist, at Factive virkede hos patienter med moderat samfundserhvervet lungebetændelse, når det blev givet som en 5dages behandling.
English: In four main studies, 1,874 adults with mild to moderate community-acquired pneumonia were treated for at least seven days with Factive or other antibiotics.
Danish: I fire hovedundersøgelser blev 1 874 voksne med mild til moderat samfundserhvervet lungebetændelse behandlet med Factive eller andre antibiotika i mindst syv dage.
English: In three other main studies, 1,652 adults with acute exacerbation of chronic bronchitis were treated with Factive for five days or with other antibiotics.
Danish: I tre andre hovedundersøgelser blev 1 652 voksne med akut opblussen af kronisk bronkitis behandlet i fem dage med Factive eller andre antibiotika.
English: In another study of patients with communityacquired pneumonia, 510 adults were given Factive either as a five- or seven-day treatment.
Danish: I en anden undersøgelse af patienter med samfundserhvervet lungebetændelse fik 510 voksne Factive enten som en 5- eller 7-dages behandling.
English: • mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital);
Danish: • mild til moderat samfundserhvervet lungebetændelse (en lungeinfektion, der ikke er erhvervet i et hospitalsmiljø)
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes with Factive in Europe.
Danish: Virksomheden har til CHMP oplyst, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Factive i Europa.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Factive in the treatment of community-acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection did not outweigh its risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP derfor af den opfattelse, at fordelene ved Factive ved behandling af samfundserhvervet lungebetændelse og akut opblussen af kronisk bronkitis, der er fremkaldt af en bakterieinfektion, ikke opvejede risiciene.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Factive could not have been approved for the treatment of community acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's lister med spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Factive ikke kunne være blevet godkendt til behandling af samfundserhvervet lungebetændelse og akut opblussen af kronisk bronkitis, der er fremkaldt af en bakterieinfektion.
English: The main measure of effectiveness was how far the patients could walk after 24 weeks of treatment.
Danish: Det primære effektmål var, hvor langt patienterne kunne gå efter 24 ugers behandling.
English: The recommended dose is 1 mg per kilogram bodyweight.
Danish: Den anbefalede dosis er 1 mg pr. kg kropsvægt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Naglazyme to BioMarin Europe Limited on 24 January 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Naglazyme til BioMarin Europe Limited den 24. januar 2006.
English: The disease is usually diagnosed in infants between one and five years of age.
Danish: Sygdommen diagnosticeres sædvanligvis hos børn, når de er mellem et og fem år gamle.
English: The company is also carrying out studies to determine the best dose to give to patients on a regular longterm basis.
Danish: Den gennemfører også undersøgelser for at bestemme, hvilken dosis der bedst gives regelmæssigt til patienter på lang sigt.
English: Naglazyme is given as a four-hour infusion once a week.
Danish: Naglazyme indgives som en fire timers infusion én gang om ugen.
English: Naglazyme was more effective than placebo.
Danish: Naglazyme var mere effektivt end placebo.
English: Patients may also be given a medicine to prevent fever.
Danish: Patienterne kan også gives et lægemiddel for at forebygge feber.
English: This can improve the symptoms of MPS VI, including the ability of patients to move about.
Danish: Det kan forbedre symptomerne på MPS VI, herunder patienternes bevægelsesevne.
English: This is a summary of the European public assessment report (EPAR) for Naglazyme.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Naglazyme.
English: Before each infusion, patients should be given an antihistamine to reduce the risk of an allergic reaction.
Danish: Inden hver infusion skal patienterne gives et antihistamin for at nedsætte risikoen for en allergisk reaktion.
English: It should be given where resuscitation equipment is available in case of a medical emergency.
Danish: Det skal indgives et sted, hvor der forefindes genoplivningsudstyr i tilfælde af en livstruende situation.
English: After 24 weeks, the average distance walked over 12 minutes increased by 109 metres in the patients treated with Naglazyme and by 18 metres in those receiving placebo.
Danish: Efter 24 uger voksede gennemsnitsafstanden, som kunne tilbagelægges til fods på 12 minutter, med 109 meter hos patienter behandlet med Naglazyme og med 18 meter hos dem, der fik placebo.
English: If the enzyme is not present, GAGs cannot be broken down and they build up in the cells.
Danish: Hvis enzymet ikke er til stede, kan GAG ikke nedbrydes, men ophobes i cellerne.
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 Naglazyme.
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 Naglazyme.
English: Enzyme replacement therapy provides patients with the enzyme they are lacking.
Danish: Enzymsubstitutionsbehandlingen giver patienterne det enzym, de mangler.
English: Galsulfase is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce the enzyme.
Danish: Galsulfase produceres via en metode, der er kendt som ‘rekombinant DNA-teknologi': Det fremstilles af en celle, som har modtaget et gen (DNA), der sætter den i stand til at producere enzymet.
English: The company that makes Naglazyme is carrying out studies looking at the long-term safety and effectiveness of Naglazyme in pregnant and breast-feeding women and in children under the age of five years, to see if they develop antibodies (proteins that are produced in the body in response to Naglazyme that could affect the response to treatment) and to look at the medicine's side effects.
Danish: Virksomheden, der fremstiller Naglazyme, gennemfører undersøgelser af dels langtidssikkerheden og effektiviteten af Naglazyme hos gravide og ammende kvinder og børn under fem år for at se, om de udvikler antistoffer (proteiner, der dannes i kroppen som respons på Naglazyme, og som kan indvirke på behandlingsresponsen), dels lægemidlets bivirkninger.
English: For more information about treatment with Naglazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Naglazyme, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The Committee noted that, although patients under five years of age were not included in the main study of Naglazyme, it is important that they are treated if they have a severe form of MPS VI. Naglazyme has been authorised under ‘exceptional circumstances'.
Danish: Udvalget bemærkede, at der ikke havde deltaget patienter på under fem år i hovedundersøgelsen for Naglazyme, men at det imidlertid er vigtigt at behandle dem, hvis de lider af en svær form for MPS VI. Naglazyme er blevet godkendt under ”særlige omstændigheder”.
English: This causes the signs of the disease, the most noticeable being a short body, a large head and difficulty moving about.
Danish: Dette forårsager sygdomstegn, af hvilke de mest iøjnefaldende er lav kropshøjde, stort hoved og nedsat bevægelsesevne.
English: Patients can also have reactions to the infusion (such as fever, chills, rash and hives).
Danish: Der kan desuden opstå reaktioner på infusionen (så som feber, kulderystelser, udslæt og nældefeber).
English: Naglazyme has been compared with placebo (a dummy treatment) in one main study involving 39 patients with MPS VI aged between five and 29 years.
Danish: Naglazyme blev sammenlignet med placebo (en uvirksom behandling) i en hovedundersøgelse, der omfattede 39 patienter med MPS VI i alderen fem til 29 år.
English: Naglazyme is used to treat patients who have mucopolysaccharidosis VI (MPS VI or Maroteaux-Lamy syndrome).
Danish: Naglazyme anvendes til behandling af patienter med mucopolysaccharidose VI (MPS VI eller Maroteaux-Lamy syndrom).
English: Naglazyme helps to break down the GAGs and stop them building up in the cells.
Danish: Naglazyme medvirker til at nedbryde GAG og forhindre dem i at ophobe sig i cellerne.
English: This means that because the disease is rare, it has not been possible to obtain complete information about Naglazyme.
Danish: Dette betyder, at det ikke har været muligt at opnå fuldstændige oplysninger om Naglazyme, fordi sygdommen er sjælden.
English: The CHMP decided that Naglazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP fandt, at fordelene ved Naglazyme opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
English: Naglazyme should not be used in people who may be hypersensitive (allergic) to galsulfase or any of the other ingredients.
Danish: Naglazyme må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for galsulfase eller andre af indholdsstofferne.
English: Other information about Naglazyme
Danish: Andre oplysninger om Naglazyme:
English: Naglazyme treatment should be supervised by a doctor who has experience in the management of patients with MPS VI or similar diseases.
Danish: Behandlingen med Naglazyme skal overvåges af en læge med erfaring i behandling af patienter med MPS VI eller lignende sygdomme.
English: The full EPAR for Naglazyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Nagalzyme findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This disease is caused by the lack of an enzyme called N-acetylgalactosamine 4-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
Danish: Denne sygdom forårsages af mangel på et enzym kaldet Nacetylgalaktosamin 4-sulfatase, som er nødvendigt for at nedbryde stoffer i kroppen kaldet glycosaminoglycaner (GAG).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Nagalzyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Nagalzyme findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In studies, the most common side effects with Naglazyme (seen in more than 1 patient in 10) were ear pain, dyspnoea (difficulty breathing), abdominal pain and general pain.
Danish: De hyppigste bivirkninger ved Naglazyme, der kunne observeres i undersøgelserne, (som optræder hos flere end 1 ud af 10 patienter) var ørepine, dyspnø (åndedrætsbesvær), mavesmerter og almindelige smerter.
English: For the full list of all side effects reported with Naglazyme, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Naglazyme fremgår af indlægssedlen.
English: What is the risk associated with Naglazyme?
Danish: Hvilken risiko er der forbundet med Naglazyme?
English: Because the number of patients with MPS VI is low, the disease is considered ‘rare', and Naglazyme was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 February 2001.
Danish: Da der kun findes få patienter med MPS VI, blev Naglazyme udpeget som "lægemiddel til sjældne sygdomme" den 14. februar 2001.
English: The active substance in Naglazyme, galsulfase, is a copy of the human enzyme N-acetylgalactosamine 4-sulfatase.
Danish: Det aktive stof i Naglazyme, galsulfase, er en kopi af det humane enzym N-acetylgalaktosamin 4-sulfatase.
English: Naglazyme is an enzyme replacement therapy.
Danish: Behandling med Naglazyme er enzymsubstitutionsterapi.
English: What information is still awaited for Naglazyme?
Danish: Hvilke oplysninger afventes der stadig for Naglazyme?
English: Naglazyme is a solution for infusion (drip into a vein) that contains the active substance galsulfase (1 mg/ml).
Danish: Naglazyme er en infusionsvæske, opløsning (drop i en vene), der indeholder det aktive stof galsulfase (1 mg/ml).
English: Why has Naglazyme been approved?
Danish: Hvorfor blev Naglazyme godkendt?
English: What is Naglazyme?
Danish: Hvad er Naglazyme?
English: How has Naglazyme been studied?
Danish: Hvordan blev Naglazyme undersøgt?
English: What is Naglazyme used for?
Danish: Hvad anvendes Naglazyme til?
English: What benefit has Naglazyme shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Naglazyme?
English: How is Naglazyme used?
Danish: Hvordan anvendes Naglazyme?
English: How does Naglazyme work?
Danish: Hvordan virker Naglazyme?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dafiro HCT on 4 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dafiro HCT den 4. november 2009.
English: The full EPAR for Dafiro HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Dafiro HCT 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 Dafiro HCT.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dafiro HCT.
English: Dafiro HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Danish: Dafiro HCT indtages gennem munden, og dosis er en tablet dagligt på samme tidspunkt hver dag og helst om morgenen.
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 Dafiro HCT.
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 Dafiro HCT.
English: For more information about treatment with Dafiro HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Dafiro HCT, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The main study showed the benefit of the highest strength of Dafiro HCT in lowering the blood pressure.
Danish: Hovedundersøgelsen påviste den gavnlige virkning af den højeste styrke af Dafiro HCT til nedsættelse af blodtrykket.
English: Patients received either Dafiro HCT or one of the three combinations containing only two of the active substances for eight weeks.
Danish: Patienterne fik enten Dafiro HCT eller en af de tre kombinationer, som kun indeholdt to af de aktive stoffer, i otte uger.
English: The three active substances in Dafiro HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Danish: De tre aktive stoffer i Dafiro HCT er lægemidler mod forhøjet blodtryk, som allerede anvendes i Den Europæiske Union (EU).
English: The dose of Dafiro HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Danish: Den dosis af Dafiro HCT, som skal anvendes, er den samme som doserne af tre individuelt aktive stoffer, som patienten fik tidligere.
English: The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Dafiro HCT which combines the three substances in a single tablet.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) bemærkede, at der var større sandsynlighed for, at patienter, der allerede fik de tre aktive stoffer, ville overholde behandlingen, hvis de fik ordineret Dafiro HCT, hvor de tre stoffer er kombineret i en enkelt tablet.