FrancophonIA/ELRC3.0 huggingface dataset:
English: Advate is similar to another medicine approved in the EU called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine.
Danish: Advate ligner lægemidlet Recombinate, som er godkendt i EU, men det fremstilles på en anden måde, så lægemidlet ikke indeholder proteiner af human eller animalsk oprindelse.
English: It contains the active substance octocog alfa (human coagulation factor VIII).
Danish: Det indeholder det aktive stof octocog alfa (human koagulationsfaktor VIII).
English: The Agency decided that Advate's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturet konkluderede, at fordelene ved Advate opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Advate.
English: Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of 6 years.
Danish: I tre yderligere undersøgelser så man nærmere på anvendelsen af lægemidlet til forebyggelse af blødninger og under operation hos patienter med svær eller moderat svær hæmofili A, herunder en undersøgelse med 53 børn under seks år.
English: The dose and duration of treatment depend on whether Advate 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 Advate skal anvendes til behandling eller forebyggelse af blødning eller under en operation, sygdommens sværhedsgrad, blødningens omfang og beliggenhed samt patientens tilstand og kropsvægt.
English: What are the risks associated with Advate?
Danish: Hvilke risici er der forbundet med Advate?
English: The Agency concluded that Advate has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Danish: Agenturet besluttede, at det er påvist, at Advate er effektivt til at behandle og forebygge blødning hos patienter med hæmofili A og har en acceptabel sikkerhedsprofil.
English: For more information about treatment with Advate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Advate, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Advate, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Danish: Det aktive stof i Advate, octocog alfa (human koagulationsfaktor VIII), er et stof, der hjælper blodet med at størkne.
English: What is Advate and what is it used for?
Danish: Hvad er Advate, og hvad anvendes det til?
English: Because of this Advate has been compared with Recombinate to show that the two medicines are equivalent in one main study including 111 patients with haemophilia A.
Danish: For at vise, at de to lægemidler svarer til hinanden, er Advate derfor blevet sammenlignet med Recombinate i en hovedundersøgelse, der omfattede 111 patienter med hæmofili A.
English: Advate is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Danish: Advate anvendes til at korrigere manglen på faktor VIII ved at erstatte den manglende faktor VIII, hvorved der opnås midlertidig kontrol med blødersygdommen.
English: Advate 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: Advate er et lægemiddel, der anvendes til behandling og forebyggelse af blødning hos patienter i alle aldre med hæmofili A (en arvelig blødersygdom, der skyldes mangel på faktor VIII).
English: Advate can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia and with resuscitation equipment available in case of severe allergic reaction (anaphylaxis).
Danish: Advate udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hæmofili og brug af genoplivningsudstyr, hvis der opstår en alvorlig allergisk reaktion (anafylakse).
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Danish: Patienter med hæmofili A mangler faktor VIII, og det medfører problemer med blodets størkning, såsom blødning i led, muskler eller indre organer.
English: Advate must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Danish: Advate bør ikke anvendes af personer, som kan være allergiske over for human koagulationsfaktor VIII, museeller hamsterproteiner eller andre af indholdsstofferne.
English: Advate 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: Advate givet i høj dosis er blevet undersøgt for at se, om det nedbryder antistoffer mod faktor VIII i blodet (en proces, der kaldes immuntoleransinduktion), så behandlingen med faktor VIII forbliver effektiv.
English: For the full list of all side effects reported with Advate, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Advate fremgår af indlægssedlen.
English: Advate is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Danish: Advate fås som pulver og solvens, der blandes sammen til en opløsning, som gives ved injektion i en vene.
English: For practical information about using Advate, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Advate, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Advate used?
Danish: Hvordan anvendes Advate?
English: What benefits of Advate have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Advate?
English: The study went on to look at the number of bleeding episodes and rated Advate's effectiveness in stopping bleeding on a scale from ‘none' to ‘excellent' in 107 patients, all of whom received Advate.
Danish: Formålet med undersøgelsen var at se nærmere på antallet af blødningsepisoder hos 107 patienter, der alle blev behandlet med Advate, idet Advates virkning på standsningen af blødningen blev vurderet på en skala fra "ingen virkning" til "udmærket".
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 den risiko ved faktor VIII-lægemidler, at visse patienter danner antistoffer mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker, og kontrollen med blødning svigter.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Advate 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 Advate.
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: Hos nogle patienter kan immunsystemet danne faktor VIII-antistoffer (proteiner), som hæmmer lægemidlets virkning, så blødningen ikke længere er under kontrol.
English: EU/1/06/350/001 Savene
Danish: EU/1/06/350/001 Savene mg/ml
English: Powder and solvent for concentrate for solution for infusion
Danish: Pulver og solvens til koncentrat til infusionsvæske, opløsning
English: concentrate: 25 ml (20 mg/ml); diluent: 500 ml
Danish: 25 ml (20 mg/ml) Solvens: 500 ml hætteglas 3 flasker
English: Intravenous use powder: vial (glass); bottle (glass)
Danish: Solvens: flaske (glas)
English: Content (concentration)
Danish: Koncentrat:
English: 7 (7 x 1) vials + 7 (7 x 1) pre-filled solvent syringes + 7 (7 x 1) vial adapters + 7 (7 x 1) needles + 14 (7 x 2) swabs (multipack)
Danish: 7 (7x1) hætteglas + 7 (7x1) fyldte injektionssprøjter med solvens + 7 (7x1) hætteglasadaptere + 7 (7x1) kanyler + 14 (7x2) servietter (flerstyks pakning)
English: 7 (7 kits x (1 vial + 1 pre-filled solvent syringe + 1 vial adapter + 1 needle + 2 swabs)) (multipack)
Danish: 7 (7 pakker x (1 hætteglas + 1 fyldt injektionssprøjte med solvens + 1 hætteglasadapter + 1 kanyle + 2 servietter) (flerstyks pakning)
English: 1 vial + 1 pre-filled solvent syringe + 1 vial adapter + 1 needle + 2 swabs
Danish: 1 hætteglas + 1 fyldt injektionssprøjte med solvens + 1 hætteglasadapter + 1 kanyle + 2 servietter
English: EU Number
Danish: EU-nummre
English: Blister (PVC/alu) 60
Danish: Filmovertrukne tabletter Oral anvendelse blisterpakning (PVC/alu)
English: Bottle (HDPE)
Danish: Filmovertrukne tabletter Oral anvendelse Flaske (HDPE)
English: Tradename Strength
Danish: Handelsnavn Styrke
English: The European Commission issued a decision on 2 June 2010.
Danish: Europa-Kommissionen traf en afgørelse den 4. juni 2010.
English: Prof Pieter de Graeff (the Netherlands)
Danish: Prof. Pieter de Graeff (Nederlandene)
English: As, the Member States were not able to reach an agreement, the German medicines regulatory agency referred the matter to the CHMP for arbitration on 29 October 2009.
Danish: Da medlemsstaterne ikke kunne nå til enighed, indbragte den tyske lægemiddelmyndighed sagen for CHMP med henblik på voldgift den 29. oktober 2009.
English: The grounds for the referral were concerns from Sweden that patients would be exposed to the antioxidant butylated hydroxyanisole (BHA) unnecessarily.
Danish: Begrundelsen for indbringelsen var Sveriges betænkeligheder over, at patienterne ville blive unødigt udsat for antioxidanten butyleret hydroxyanisol (BHA).
English: What is Clopidogrel Teva?
Danish: Hvad er Clopidogrel Teva?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Clopidogrel Teva outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden and the United Kingdom.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Clopidogrel Teva er større end risiciene, og at der kan udstedes markedsføringstilladelse i Tyskland og i følgende EU-medlemsstater: Østrig, Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Finland, Frankrig, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Nederlandene, Norge, Polen, Rumænien, Slovakiet, Spanien, Sverige og Det Forenede Kongerige.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Clopidogrel Teva outweigh its risks and recommended that the marketing authorisation be granted in all the concerned Member States.
Danish: På basis af en vurdering af de tilgængelige data og den videnskabelige drøftelse i Udvalget er CHMP af den opfattelse, at fordelene ved Clopidogrel Teva er større end risiciene, og at der derfor bør udstedes markedsføringstilladelse for Clopidogrel Teva i alle berørte medlemsstater.
English: Why was Clopidogrel Teva reviewed?
Danish: Hvorfor blev Clopidogrel Teva vurderet igen?
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Clopidogrel Teva and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for lægemidlet Clopidogrel Teva og relaterede navne.
English: The company had chosen to use ‘clopidogrel base' as the form of the active substance in the medicine, and not a salt such as the ‘hydrogen sulfate salt' used in Plavix.
Danish: Virksomheden havde valgt at bruge "clopidogrelbase" som det aktive stofs form i lægemidlet og ikke et salt ligesom det "hydrogensulfatsalt", der anvendes i Plavix.
English: in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden and the United Kingdom).
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Tyskland) vurderer et lægemiddel med henblik på at udstede en markedsføringstilladelse, som gælder i dette land og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Østrig, Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Finland, Frankrig, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Nederlandene, Norge, Polen, Rumænien, Slovakiet, Spanien, Sverige og Det Forenede Kongerige).
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Danish: Det får blodpladerne til at holde op med at "klæbe sammen", hvilket mindsker risikoen for, at der opstår en blodprop, og er med til at forebygge endnu et hjerteanfald og slagtilfælde.
English: Clopidogrel base is less stable than the salt form, and BHA is included in the medicine to stabilise it.
Danish: Clopidogrelbase er mindre stabilt end saltformen, og lægemidlet indeholder BHA for at stabilisere det.
English: It is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as a heart attack or stroke.
Danish: Det anvendes hos voksne til forebyggelse af aterotrombotiske hændelser (problemer, der skyldes blodpropper og åreforkalkning) såsom hjerteanfald og slagtilfælde.
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Danish: Når blodet danner propper, skyldes det, at nogle særlige celler i blodet, der kaldes blodpladerne, aggregerer (klæber sammen).
English: Clopidogrel Teva is a generic medicine based on a ‘reference medicine', Plavix which is authorised in the EU.
Danish: Clopidogrel Teva er et generisk lægemiddel, der er baseret på et "referencelægemiddel", som er godkendt i EU.
English: Teva Pharma B.V. submitted Clopidogrel Teva to Germany for a decentralised procedure.
Danish: indgav en ansøgning om Clopidogrel Teva til Tyskland med henblik på en decentral procedure.
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Danish: Clopidogrel forhindrer blodpladerne i at aggregere ved at forhindre et stof, der kaldes ADP, i at binde sig til en særlig receptor på blodpladernes overflade.
English: Clopidogrel Teva is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Teva er et lægemiddel, som indeholder det aktive stof clopidogrel.
English: 4 June 2010
Danish: 4. juni 2010
English: 18 February 2010
Danish: 18. februar 2010
English: The active substance, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof, clopidogrel, hæmmer blodpladernes aggregation.
English: 18 January 2010
Danish: 18. januar 2010
English: • There is insufficient data on Abseamed to know the size of any increased immunogenicity risk with sc use
Danish: • information om, at der ikke findes tilstrækkelig data om Abseamed til at kunne fastslå størrelse af den øgede risiko for immunogenicitet ved subkutan anvendelse
English: On 11 March 2016, pursuant to Article 20 of Regulation (EC) No 726/2004, the European Commission requested the opinion of the Agency on whether the marketing authorisation of Zydelig (idelalisib) should be maintained, varied, suspended or revoked.
Danish: Den 11. marts 2016 anmodede Europa-Kommissionen i henhold til artikel 20 i forordning (EF) nr. 726/2004 agenturet om at udtale sig om, hvorvidt markedsføringstilladelsen for Zydelig (idelalisib) burde opretholdes, ændres, suspenderes eller inddrages.
English: In addition, neutrophil count monitoring is recommended.
Danish: Derudover anbefales overvågning af neutrofiltal.
English: The PRAC concluded that the same risk minimisation measures should be applied.
Danish: PRAC konkluderede, at de samme risikominimeringsforanstaltninger bør anvendes.
English: Patients' blood counts should also be monitored during the first 6 months of treatment, adapting the frequency to the absolute neutrophil count (ANC).
Danish: Ligeledes bør patienternes blodtal overvåges i de første seks måneder af behandlingen, med en hyppighed der er tilpasset det absolutte neutrofiltal (ANC).
English: The wording of the indication in first line CLL should be amended to reflect the above recommendation and it should be specified that this is linked to the limited data available in this setting.
Danish: Ordlyden af indikationen ved førstevalgsbehandling af CLL bør ændres, så den afspejler ovenstående anbefaling, og det bør angives, at den er baseret på de begrænsede foreliggende data for dette scenarie.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zydelig (idelalisib).
Danish: • PRAC behandlede proceduren i henhold til artikel 20 i forordning (EF) nr. 726/2004, der var foranlediget af lægemiddelovervågningsdata for Zydelig (idelalisib),
English: In addition, the data suggest that these results reflect the fact that the known toxicity of the treatment was not outweighed by its benefits due to the good prognosis and therefore low disease-related mortality of previously untreated CLL patients.
Danish: Desuden tyder dataene på, at disse resultater afspejler, at behandlingens velkendte toksicitet ikke blev opvejet af dens fordele som følge af den gode prognose og derfor lave sygdomsrelaterede mortalitet hos tidligere ubehandlede CLL-patienter.
English: The CHMP therefore concluded that it is not needed to include this statement in the SmPC.
Danish: CHMP konkluderede derfor, at denne angivelse ikke behøves i produktresuméet.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Zydelig.
Danish: anbefalede udvalget ændring af betingelserne for markedsføringstilladelsen for Zydelig.
English: There was however no indication that treatment-naïve CLL patients constitute a population more at risk of developing idelalisib-related adverse events compared to relapsed/refractory patients.
Danish: Der var dog intet tegn på, at behandlingsnaive CLL-patienter udgør en population med større risiko for at udvikle idelalisib-relaterede bivirkninger end patienter med recidiv/refraktær sygdom.
English: Further, these two studies included patients with earlier disease characteristics than the population for which idelalisib is authorised.
Danish: I disse to undersøgelser blev der desuden inkluderet patienter med karakteristika på tidligere sygdomsstadie end den population, idelalisib er godkendt til.
English: While CMV and PJP are important risks, in the studies they accounted for a relatively small proportion of the serious infections observed, therefore the PRAC considered that more general measures to minimise the risk of serious infections as implemented as part of the provisional measures were justified.
Danish: Skønt CMV og PJP er vigtige risici, tegner de sig i undersøgelserne kun for en relativt lille andel af de iagttagne alvorlige infektioner, hvorfor PRAC fandt det berettiget at anvende mere generelle foranstaltninger til at minimere risikoen for alvorlige infektioner, således som de er gennemført ved de foreløbige foranstaltninger.
English: • The PRAC noted that most of the serious adverse events reported in studies -0123, -0124 and -0125 were related to infections.
Danish: • PRAC bemærkede, at de fleste af de alvorlige bivirkninger i undersøgelse 0123, 0124 og 0125 vedrørte infektioner.
English: If clinical signs of CMV infection appear, consideration should be given to interrupting idelalisib until the infection has resolved.
Danish: Hvis der viser sig kliniske tegn på CMV-infektion, bør det overvejes at seponere idelalisib indtil infektionen har fortaget sig.
English: These recommendations should be reflected in the product information together with a description of the infectious events and the MAH should conduct a study to assess healthcare practitioners' awareness to these risk minimisation measures.
Danish: Disse anbefalinger bør afspejles i produktinformationen sammen med en beskrivelse af infektionshændelserne, og indehaveren af markedsføringstilladelsen skal udføre en undersøgelse for at vurdere sundhedspersoners kendskab til disse risikominimeringsforanstaltninger.
English: Idelalisib is known to cause very commonly infections and neutropenia and these risks are reflected in the product information.
Danish: Idelalisib vides meget hyppigt at medføre infektioner og neutropeni, og disse risici afspejles i produktinformationen.
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended in patients with evidence of prior infection.
Danish: Desuden anbefales regelmæssig klinisk og laboratoriemæssig overvågning for cytomegalovirus-infektion hos patienter med tegn på tidligere infektion.
English: Characteristics of patients in those studies are compatible with a good prognosis, including slow disease progression, hence leading as in study -0123 to an unmasking of the idelalisib toxicity.
Danish: I disse undersøgelser er patientkarakteristika forenelige med en god prognose, herunder langsom sygdomsprogression, hvilket ligesom i undersøgelse -0123 fører til en afsløring af idelalisibs toksicitet.
English: This text was considered not to be contributory as adequate information on the benefit-risk balance of idelalisib in these patients is already included in other sections of the product information.
Danish: Denne tekst blev ikke anset for at bidrage til oplysningernes tilstrækkelighed, da der allerede er tilstrækkelige oplysninger om benefit/risk-forholdet for idelalisib hos disse patienter i andre punkter af produktinformationen.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Zydelig (idelalisib).
Danish: CHMP anbefaler derfor ændring af betingelserne for markedsføringstilladelsen for Zydelig (idelalisib).
English: These results highlight nonetheless the importance of ensuring that the risk of serious infection is adequately minimised in the authorised indications, in line with the measures employed in studies that demonstrated the positive benefit-risk balance of idelalisib.
Danish: Disse resultater afspejler dog ikke desto mindre vigtigheden af at sikre, at risikoen for alvorlig infektion er tilstrækkeligt minimeret ved de godkendte indikationer på linje med de anvendte foranstaltninger i de undersøgelser, der godtgjorde det positive benefit/risk-forhold for idelalisib.