FrancophonIA/ELRC3.0 huggingface dataset:
English: Quintanrix is used to vaccinate infants under one year of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and ‘invasive' diseases caused by Hib (such as bacterial meningitis).
Danish: Quintanrix anvendes til at vaccinere spædbørn under et år mod difteri, stivkrampe, kighoste, hepatitis B og invasive sygdomme fremkaldt af Hib såsom bakteriel meningitis.
English: In three studies, the effects of Quintarix were compared with those of the combination of Tritanrix HepB and a vaccine containing Hib: two of these studies involved a total of 1,208 infants who were vaccinated at two, four and six months of age and one involved 294 infants vaccinated at three, four and five months of age.
Danish: I to af disse undersøgelser deltog i alt 1 208 spædbørn, som blev vaccineret ved to-, fire- og seks-måneders-alderen, og én undersøgelse omfattede 294 spædbørn, der blev vaccineret ved tre-, fire- og fem-måneders-alderen.
English: What is Quintanrix?
Danish: Hvad er Quintanrix?
English: • polysaccharides extracted from the ‘capsules' that surround the bacterium Hib - the polysaccharides are chemically attached (conjugated) to tetanus toxoid as a carrier protein because this improves the response to the vaccine;
Danish: Polysakkariderne er kemisk bundet til stivkrampetoksoidet som et bærerprotein, da dette forbedrer responset på vaccinen,
English: As for all vaccines, if Quintanrix is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Danish: Ligesom for andre vacciner gælder det for Quintanrix, at der er en risiko for apnø, dvs. korte pauser i vejrtrækningen, hvis vaccinen gives til spædbørn, der er født meget for tidligt.
English: The fourth study compared the effects of Quintarix given at six, 10 and 14 weeks of age in 318 infants who either had or had not received a hepatitis B vaccine at birth.
Danish: I den fjerde undersøgelse, hvor 318 spædbørn deltog, sammenlignede forskerne virkningerne af Quintanrix, når den blev givet ved seks-, 10- og 14-ugers-alderen til disse børn, hvoraf nogle havde fået en hepatitis B-vaccine, da de blev født.
English: How has Quintanrix been studied?
Danish: Hvordan blev Quintanrix undersøgt?
English: What is Quintanrix used for?
Danish: Hvad anvendes Quintanrix til?
English: What benefit has Quintanrix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Quintanrix?
English: How is Quintanrix used?
Danish: Hvordan anvendes Quintanrix?
English: How does Quintanrix work?
Danish: Hvordan virker Quintanrix?
English: Information on the reference medicine can also be found on the Agency's website.
Danish: Information om referencelægemidlet findes også på agenturets websted.
English: Further information on Deferiprone Lipomed can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Deferiprone Lipomed findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Doses above 100 mg/kg a day are not recommended because of a potentially increased risk of side effects.
Danish: Doser på over 100 mg/kg pr. dag frarådes på grund af den mulige øgede risiko for bivirkninger.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Danish: To lægemidler er bioækvivalente, når de giver de samme niveauer af det aktive stof i kroppen, og de forventes derfor at have samme effekt.
English: Patients with thalassaemia major need frequent blood transfusions.
Danish: Patienter med talassæmi major har behov for hyppige blodtransfusioner.
English: The doctor may interrupt treatment if iron levels in the body get too low.
Danish: Lægen kan afbryde behandlingen, hvis jernniveauet i kroppen bliver for lavt.
English: • on its own, when standard iron chelator treatment cannot be used or is inadequate;
Danish: • alene, når en jernchelaterende standardbehandling ikke kan anvendes, eller ikke er tilstrækkelig
English: The doctor may adjust the dose of Deferiprone Lipomed depending on the patient's response, which should be measured every two to three months with blood tests.
Danish: Lægen kan justere dosen af Deferiprone Lipomed afhængigt af patientens respons, som bør måles hver anden eller tredje måned ved hjælp af blodprøver.
English: Over time, the excess iron can damage important organs such as the heart or liver.
Danish: Med tiden kan ophobningen af jern beskadige vitale organer som f.eks. hjerte eller lever.
English: • in combination with another iron chelator, when treatment with one iron chelator on its own is ineffective or when prevention or treatment of life-threatening conditions requires rapid or intensive correction of iron levels.
Danish: • sammen med et andet jernchelaterende middel, når behandling med ét jernchelaterende stof alene ikke virker, eller når forebyggelse eller behandling af livstruende forhold kræver hurtig eller intensiv justering af jernniveauet.
English: The usual dose of Deferiprone Lipomed is 75 mg per kilogram body weight each day, divided into three separate doses.
Danish: Den sædvanlige dosis af Deferiprone Lipomed er 75 mg pr. kg kropsvægt dagligt fordelt på tre separate doser.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden har også gennemført et studie, der viser, at lægemidlet er "bioækvivalent" med referencelægemidlet.
English: It attaches to iron in the body to form a compound that can be excreted by the body, mainly in the urine, and to a lesser extent in the stools.
Danish: Det binder til jernet i kroppen og danner en forbindelse, som kan udskilles af kroppen, hovedsageligt i urinen og i mindre grad i afføringen.
English: Side effects reported with Deferiprone Lipomed are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Deferiprone Lipomed vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: When patients receive repeated transfusions, the transfused red cells bring iron into the body.
Danish: Når patienter får gentagne blodtransfusioner, tilfører de transfunderede røde blodlegemer jern til kroppen.
English: This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body.
Danish: Det er en arvelig sygdom, hvor patienterne ikke er i stand til at danne tilstrækkeligt hæmoglobin, som er et protein i de røde blodlegemer, der transporterer ilt rundt i kroppen.
English: Because Deferiprone Lipomed is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Deferiprone Lipomed er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: However, the body does not have a natural way of removing excess iron, so it builds up.
Danish: Kroppen har imidlertid ikke en naturlig måde, hvorpå den kan fjerne overskydende jern, så jernet ophobes.
English: As for all medicines, data on the use of Deferiprone Lipomed are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Deferiprone Lipomed løbende overvåget.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Deferiprone Lipomed has been shown to have comparable quality and to be bioequivalent to Ferriprox.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Deferiprone Lipomed er af sammenlignelig kvalitet og er bioækvivalent med Ferriprox.
English: For more information about using Deferiprone Lipomed, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Deferiprone Lipomed, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The company that markets Deferiprone Lipomed will ensure that patients taking the medicine, or their carers, are provided with a reminder card with information on how to take the medicine safely.
Danish: Den virksomhed, der markedsfører Deferiprone Lipomed, skal sørge for, at patienter, der anvender lægemidlet, eller deres omsorgspersoner får udleveret et påmindelseskort med oplysninger om, hvordan de skal tage lægemidlet sikkert.
English: What measures are being taken to ensure the safe and effective use of Deferiprone Lipomed?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Deferiprone Lipomed?
English: An overview of Deferiprone Lipomed and why it is authorised in the EU
Danish: En oversigt over Deferiprone Lipomed, og hvorfor det er godkendt i EU
English: As for every medicine, the company provided studies on the quality of Deferiprone Lipomed.
Danish: Som for alle lægemidler har virksomheden fremlagt studier af kvaliteten af Deferiprone Lipomed.
English: This means that Deferiprone Lipomed contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Ferriprox.
Danish: Det betyder, at Deferiprone Lipomed indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU, og som hedder Ferriprox.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Ferriprox, and do not need to be repeated for Deferiprone Lipomed.
Danish: Der er allerede gennemført studier af det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Ferriprox, og de behøver ikke at blive gentaget for Deferiprone Lipomed.
English: Deferiprone Lipomed is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Danish: Deferiprone Lipomed er et "jernchelaterende" stof (et stof, der binder sig til jern), der anvendes til behandling af jernophobning (overskud af jern i kroppen) hos patienter med talassæmi major.
English: Deferiprone Lipomed can only be obtained with a prescription and treatment should be started and maintained by a doctor who has experience in the treatment of patients with thalassaemia.
Danish: Deferiprone Lipomed udleveres kun efter recept, og behandlingen bør iværksættes og opretholdes af en læge med erfaring i behandling af patienter med talassæmi.
English: This helps to correct the iron overload and prevent damage due to excess iron.
Danish: Dette medvirker til at afhjælpe jernophobningen og forebygge skader på grund af ophobning af jern.
English: What are the benefits and risks of Deferiprone Lipomed?
Danish: Hvilke fordele og risici er der forbundet med Deferiprone Lipomed?
English: Deferiprone Lipomed is available as 500 mg tablets to be taken by mouth.
Danish: Deferiprone Lipomed fås som 500 mg-tabletter, der tages gennem munden.
English: What is Deferiprone Lipomed and what is it used for?
Danish: Hvad er Deferiprone Lipomed, og hvad anvendes det til?
English: Deferiprone Lipomed (deferiprone)
Danish: Deferiprone Lipomed (deferipron)
English: Deferiprone Lipomed contains the active substance deferiprone and is a ‘generic medicine'.
Danish: Deferiprone Lipomed indeholder det aktive stof deferiprone og er et "generisk lægemiddel".
English: Other information about Deferiprone Lipomed
Danish: Andre oplysninger om Deferiprone Lipomed
English: Why is Deferiprone Lipomed authorised in the EU?
Danish: Hvorfor blev Deferiprone Lipomed godkendt i EU?
English: The active substance in Deferiprone Lipomed, deferiprone, is an iron chelator.
Danish: Det aktive stof i Deferiprone Lipomed, deferipron, er et jernchelaterende stof.
English: Therefore, the Agency's view was that, as for Ferriprox, the benefit of Deferiprone Lipomed outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Deferiprone Lipomed opvejer de identificerede risici som for Ferriprox, og at det kan godkendes til anvendelse i EU.
English: Deferiprone Lipomed is used:
Danish: Deferiprone Lipomed anvendes:
English: How has Deferiprone Lipomed been studied?
Danish: Hvordan blev Deferiprone Lipomed undersøgt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deferiprone Lipomed 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 Deferiprone Lipomed.
English: How is Deferiprone Lipomed used?
Danish: Hvordan anvendes Deferiprone Lipomed?
English: How does Deferiprone Lipomed work?
Danish: Hvordan virker Deferiprone Lipomed?
English: * Withdrawal period (milk): - Zero hours after calving (when the dry period length is 32 days or more) - 4 days (8 milkings) after calving (when the dry period length is less than 32 days)
Danish: * Tilbageholdelsestid (mælk): - Nul timer efter kælvning (når goldperiodens længde er 32 døgn eller mere) - 4 døgn (8 malkninger) efter kælvning (når goldperiodens længde er under 32 døgn)
English: Packaging Content Package size
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: Withdrawal period
Danish: Tilbageholdelsestid
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: Cattle (dairy cows)
Danish: Kvæg
English: Annex A EU (MA) Number Invented name
Danish: Bilag A
English: Solution for injection
Danish: Opløsning til
English: The applicant requested a re-examination of the opinion.
Danish: Ansøgeren har anmodet om en fornyet overvejelse af udtalelsen.
English: More information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Yderligere oplysninger om udpegelsen til lægemiddel til sjældne sygdomme findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is Dropcys?
Danish: Hvad er Dropcys?
English: During the re-examination, the CHMP looked again at the data from the company.
Danish: I forbindelse med revurderingen har CHMP set på virksomhedens data igen.
English: In addition, the CHMP had concerns regarding other ingredients of the medicine, their impact on long-term safety, particularly in children, and how stable and sterile the solution would be once prepared.
Danish: Desuden havde CHMP betænkeligheder med hensyn til andre af lægemidlets indholdsstoffer og deres indvirkning på den langsigtede sikkerhed, navnlig hos børn, og med hensyn til, hvor stabil og steril opløsningen er, når den er klargjort.
English: The CHMP considered that the studies from the medical literature presented to support the application were insufficient.
Danish: CHMP vurderede, at de undersøgelser fra den medicinske litteratur, som ansøgeren havde fremlagt som støtte, var utilstrækkelige.
English: The Committee confirmed the opinion that the effectiveness of Dropcys in the treatment of corneal deposits had not been sufficiently demonstrated and that there were unresolved issues regarding the formulation and long-term safety and sterility of the medicine.
Danish: Udvalget bekræfter sin udtalelse om, at virkningen af Dropcys til behandling af aflejringer i hornhinden ikke er tilstrækkeligt dokumenteret, og at problemstillingerne med hensyn til lægemidlets formulering, langsigtede sikkerhed og sterilitet stadig ikke er løst.
English: What was Dropcys expected to be used for?
Danish: Hvad forventedes Dropcys anvendt til?
English: Medicines containing mercaptamine hydrochloride are authorised in the EU for use by mouth in the treatment of cystinosis.
Danish: Lægemidler, der indeholder mercaptaminhydrochlorid, er tilladt i EU til anvendelse gennem munden ved behandling af cystinose.
English: Therefore, the CHMP was of the opinion that the benefits of Dropcys did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CHMP var derfor af den opfattelse, at fordelene ved Dropcys ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: Dropcys was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 15 October 2014 for the treatment of cystinosis.
Danish: Dropcys blev udpeget som "lægemiddel til sjældne sygdomme" den 15. oktober 2014 til behandling af cystinose.
English: Because mercaptamine has been used for many years to treat cystinosis and its use is well established, the applicant presented data from the medical literature to support its application for Dropcys.
Danish: Da mercaptamin er blevet brugt i mange år til at behandle cystinose og er almindeligt anerkendt, fremlagde ansøgeren data fra den medicinske litteratur til at understøtte ansøgningen for Dropcys.
English: Dropcys is a medicine that contains the active substance mercaptamine hydrochloride (also known as cysteamine hydrochloride).
Danish: Dropcys er et lægemiddel, der indeholder det aktive stof mercaptaminhydrochlorid (også kaldet cysteaminhydrochlorid).
English: Cystinosis is a rare inherited disease caused by the accumulation of a substance called cystine, which forms crystals inside cells, particularly cells in the cornea and kidneys.
Danish: Cystinose er en sjælden, arvelig sygdom, der skyldes ophobning af stoffet cystin, der danner krystaller inde i cellerne, navnlig celler i hornhinden og nyrerne.
English: On 17 December 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dropcys, intended to prevent and treat the build-up of the amino acid cystine in the cornea (the transparent layer in front of the eye).The company that applied for authorisation in the EU is Lucane Pharma.
Danish: Den 17. december 2015 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, som anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Dropcys, der er beregnet til at forebygge og behandle dannelsen af aminosyren cystin i hornhinden (den gennemsigtige hinde, der dækker det forreste af øjet).
English: Although the role of mercaptamine eye drops in the treatment of corneal deposits appears sufficiently supported by the literature, current clinical recommendations and its routine use in hospital preparations, there were few data supporting the effectiveness of the concentration of mercaptamine used in Dropcys (0.1% solution).
Danish: Selv om administration af mercaptamin-øjendråber til behandling af aflejringer i hornhinden synes at være tilstrækkeligt underbygget af litteraturen, aktuelle kliniske anbefalinger og brug som standardbehandling på hospitaler, foreligger der ikke mange data til at understøtte den mercaptamin-koncentration, der anvendes i Dropcys (0,1 % opløsning).
English: After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 1 April 2016.
Danish: CHMP gennemgik begrundelsen for anmodningen og foretog en fornyet overvejelse af den oprindelige udtalelse, men bekræftede den 1. april 2016 afslaget på ansøgningen om markedsføringstilladelse.
English: The build-up of cystine crystals inside corneal cells can damage the eyes and cause serious vision problems.
Danish: Dannelsen af cystinkrystaller i hornhindecellerne kan beskadige øjet og forårsage alvorlige synsforstyrrelser.
English: The active substance in Dropcys, mercaptamine hydrochloride, was expected to react with cystine to dissolve it and to form substances that could be removed from the cells.
Danish: Det aktive stof i Dropcys, mercaptaminhydrochlorid, skulle reagere med og opløse cystin og danne stoffer, der kunne fjernes fra cellerne.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Dropcys.
Danish: Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Dropcys.
English: Thus, the CHMP reaffirmed its previous recommendation that the medicine be refused marketing authorisation.
Danish: CHMP bekræfter derfor sin tidligere anbefaling om, at der bør gives afslag på ansøgningen om markedsføringstilladelse for lægemidlet.
English: How was Dropcys expected to work?
Danish: Hvordan forventedes Dropcys at virke?
English: When the medicine is applied to the eye, the amount of cystine in the cells of the cornea was expected to be reduced, limiting the amount of eye damage.
Danish: Ved lægemidlets kontakt med øjet skulle mængden af cystin i hornhindens celler reduceres og øjenbeskadigelsen dermed begrænses.
English: Dropcys was expected to be used to prevent and treat cystinosis affecting the cornea.
Danish: Dropcys skulle anvendes til at forebygge og behandle cystinose i hornhinden.
English: Ophthalmic (eye) formulations of mercaptamine are made up locally and used for the management of eye symptoms.
Danish: Øjenpræparater med mercaptamin blandes lokalt og anvendes til behandling af øjensymptomer.
English: It was to be available as a powder and a solvent, to make a solution for eye drops.
Danish: Det var hensigten, at det skulle markedsføres som pulver og opløsningsmiddel, der skulle blandes til en opløsning og anvendes som øjendråber.
English: MA (EU) number (Invented) name Strength
Danish: (Særnavn) Navn Styrke
English: Route of Administration
Danish: EMA's procedurenummer
English: These patients form a large population which currently may have not access to the benefits of metformin across the Union.
Danish: Disse patienter udgør en stor population, der på nuværende tidspunkt ikke nødvendigvis i hele Unionen har adgang til fordelene ved metformin.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for metformin containing medicinal products.
Danish: • CHMP fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende metformin,
English: On 25 January 2016 the Netherlands therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of metformin containing products and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Danish: Den 25. januar 2016 indledte Nederlandene derfor en indbringelse i henhold til artikel 31 i direktiv 2001/83/EF og anmodede CHMP om at vurdere betydningen af ovennævnte betænkeligheder for benefit/risk-forholdet for produkter indeholdende metformin og afgive en udtalelse om, hvorvidt de pågældende markedsføringstilladelser bør opretholdes, ændres, suspenderes eller inddrages.
English: Grounds for CHMP opinion
Danish: Begrundelse for CHMP's udtalelse
English: Metformin, alone or in combination with other medicines, is considered the first choice in the treatment for Type 2 diabetes mellitus (T2DM) and it is widely used in the EU.
Danish: Metformin, anvendt alene eller kombineret med andre lægemidler, anses for førstevalget til behandling af diabetes mellitus type 2 (T2DM) og har udbredt anvendelse i EU.
English: In addition, although causality cannot be ruled out, other factors rather than metformin are most likely the causes of lactic acidosis.
Danish: Skønt årsagssammenhæng ikke kan udelukkes, er andre faktorer end metformin de mest sandsynlige årsager til laktatacidose.