FrancophonIA/ELRC3.0 huggingface dataset:
English: During its February 2007 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.
Danish: På sit møde i februar 2007 var CHMP på baggrund af alle de foreliggende oplysninger og de faglige drøftelser i udvalget af den opfattelse, at forslaget om harmonisering af produktresume, etikettering og indlægsseddel var acceptabelt, og at ændringerne burde foretages.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics of Xefo and associated names approved across EU Member States, with respect to the short-term relief of acute mild to moderate pain, symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis.
Danish: Grundlaget for indbringelsen var, at der var forskelle mellem medlemsstaternes produktresuméer for Xefo og tilknyttede navne hvad angår korttidsbehandling af akutte lette til moderate smerter, smertelindring og mindskelse af betændelse ved osteoartritis samt smertelindring og mindskelse af betændelse ved reumatoid artritis.
English: The CHMP gave a positive opinion on 22 February 2007 recommending the harmonisation of the SPC, labelling and package leaflet for Xefo and associated names.
Danish: CHMP afgav den 22. februar 2007 en positiv udtalelse, hvori udvalget anbefalede harmonisering af produktresumé, etikettering og indlægsseddel for Xefo og tilknyttede navne.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II.
English: Atripla received a marketing authorisation valid throughout the EU on 13 December 2007.
Danish: Atripla fik en markedsføringstilladelse med gyldighed i hele EU den 13. december 2007.
English: The recommended dose of Atripla is one tablet once a day.
Danish: Den anbefalede dosis af Atripla er én tablet én gang dagligt.
English: • certain medicines whose breakdown is blocked or accelerated by Atripla;
Danish: • visse lægemidler, hvis nedbrydning blokeres eller fremskyndes af Atripla
English: • medicines that cause QT prolongation;
Danish: • lægemidler, der medfører QT-forlængelse
English: Other information about Atripla
Danish: Andre oplysninger om Atripla
English: Further information on Atripla can be found on the Agency's website ema.europa.eu/en/medicines/human/EPAR/Atripla.
Danish: Yderligere information om Atripla findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/Atripla.
English: Patients should take the medicine regularly and not miss doses.
Danish: Patienterne bør tage lægemidlet regelmæssigt og ikke springe doser over.
English: As for all medicines, data on the use of Atripla are continuously monitored.
Danish: Som for alle lægemidler, bliver data vedrørende brug af Atripla løbende overvåget.
English: What is Atripla and what is it used for?
Danish: Hvad er Atripla, og hvad anvendes det til?
English: After 48 weeks, 89% of the patients taking Atripla (181 out of 203) and 88% of those remaining on previous treatment (85 out of 97) had viral loads below 200 copies/ml.
Danish: Efter 48 uger havde 89 % af de patienter, der fik Atripla (181 ud af 203), og 88 % af de patienter, der fortsatte med den tidligere behandling (85 ud af 97), en virusbelastning på mindre end 200 kopier/ml.
English: It does not cure HIV infection or AIDS, but it holds off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Det helbreder ikke hivinfektion eller aids, men sinker den skade på immunsystemet og udviklingen af de infektioner og sygdomme, der er forbundet med aids.
English: For more information about using Atripla, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Atripla, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The Agency decided that Atripla's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Danish: Agenturet konkluderede, at fordelene ved Atripla opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: An overview of Atripla and why it is authorised in the EU
Danish: En oversigt over Atripla og hvorfor det er godkendt i EU
English: Atripla keeps the amount of HIV in the blood at a low level.
Danish: Atripla holder indholdet af hiv i blodet nede.
English: Side effects reported with Atripla are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Atripla vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: It must not be used in patients in whom previous HIV treatment combinations have not worked or have stopped working.
Danish: Det må ikke anvendes til patienter, hos hvem tidligere hivbehandlingskombinationer ikke har virket eller er ophørt med at virke.
English: It is recommended that Atripla is taken on an empty stomach, preferably at bedtime.
Danish: Det anbefales, at Atripla tages på tom mave og helst ved sengetid.
English: In the European Union (EU), efavirenz has been approved since 1999, emtricitabine has been approved since 2003, and tenofovir disoproxil has been approved since 2002.
Danish: I Den Europæiske Union (EU) har efavirenz været godkendt siden 1999, emtricitabin siden 2003, og tenofovirdisoproxil siden 2002.
English: Why is Atripla authorised in the EU?
Danish: Hvorfor blev Atripla godkendt i EU?
English: What measures are being taken to ensure the safe use of Atripla?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Atripla?
English: All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and make more viruses.
Danish: Alle tre aktive stoffer virker ved at blokere enzymet revers transkriptase, som produceres af hiv og gør det muligt for virusset at inficere cellerne og producere flere virus.
English: Another study, which looked at how the combined tablet was absorbed in the body, showed that the combination tablet was absorbed in the same way as the separate medicines, when they were taken on an empty stomach.
Danish: Et andet studie, der vedrørte, hvordan den kombinerede tablet blev absorberet i kroppen, viste, at den kombinerede tablet blev absorberet på samme måde som de separate lægemidler indtaget på tom mave.
English: The main measure of effectiveness was the proportion of patients whose viral loads were below 200 copies/ml after 48 weeks.
Danish: Det primære effektmål var andelen af patienter, hvis virusbelastning var under 200 kopier/ml efter 48 uger.
English: • voriconazole (used to treat fungal infections).
Danish: • voriconazol (anvendes ved svampeinfektioner)
English: Atripla must also not be used in patients who are taking any of the following:
Danish: Atripla må heller ikke anvendes hos patienter, der får noget af nedenstående:
English: Atripla (efavirenz / emtricitabine / tenofovir disoproxil)
Danish: Atripla (efavirenz/emtricitabin/tenofovirdisoproxil)
English: The main study of Atripla included 300 patients whose HIV infection was already being successfully treated with various combinations of antiviral medicines.
Danish: Hovedstudiet af Atripla omfattede 300 patienter, hvis hivinfektion allerede var under effektiv behandling med forskellige kombinationer af antivirale lægemidler.
English: Because taking the medicine on an empty stomach could result in the component tenofovir being less effective, the Agency could not recommend Atripla for general use in patients with HIV and with high viral loads.
Danish: Fordi det, at lægemidlet skal tages på tom mave, kan gøre bestanddelen tenofovir mindre effektiv, kunne agenturet ikke anbefale Atripla til almindelig anvendelse hos patienter med hiv og med stor virusbelastning.
English: The European Medicines Agency noted that Atripla needs to be taken on an empty stomach to prevent certain side effects of one of its components, efavirenz.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at Atripla skal tages på tom mave for at forhindre visse bivirkninger af en af lægemidlets bestanddele, efavirenz.
English: The three active substances in Atripla are: efavirenz (600 mg), emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Danish: De tre aktive stoffer i Atripla er: efavirenz (600 mg), emtricitabin (200 mg) og tenofovirdisoproxil (245 mg).
English: What are the risks associated with Atripla?
Danish: Hvilke risici er der forbundet med Atripla?
English: It is only used in patients whose levels of HIV in the blood (viral loads) have been below 50 copies/ml for more than three months on their current HIV treatment combination.
Danish: Det anvendes kun til patienter, hos hvem koncentrationen af hiv i blodet (virusbelastningen) har været under 50 kopier/ml i mere end tre måneder med deres nuværende hivbehandlingskombination.
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Danish: Både nukleosid- og nukleotid-revers transkriptase-hæmmere betegnes sædvanligvis NRTI'er.
English: The company that markets Atripla will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as Atripla.
Danish: Virksomheden, der markedsfører Atripla, skal sikre, at alle læger, som forventes at ordinere lægemidlet, får udleveret informationsmateriale om den øgede risiko for nyresygdom, som er forbundet med lægemidler, der indeholder tenofovirdisoproxil, herunder Atripla.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Danish: Tenofovir er en nukleotid-revers transkriptase-hæmmer.
English: The most common side effects with Atripla (which may affect more than 1 patient in 10) are dizziness, headache, diarrhoea, nausea (feeling sick), vomiting, rash, asthenia (weakness), hypophosphataemia (low blood levels of phosphates) and elevated levels of creatine kinase (an enzyme found in muscles).
Danish: De hyppigste bivirkninger ved Atripla (som optræder hos mere end 1 ud af 10 patienter) er svimmelhed, hovedpine, diarré, kvalme, opkast, udslæt, kraftesløshed (asteni), for lavt fosfatindhold i blodet (hypofosfatæmi) og forhøjet indhold af kreatinkinase (et enzym, der findes i musklerne).
English: Atripla must not be used in patients with severe liver disease and patients with a family member who has had QT prolongation (an alteration of the electrical activity of the heart) or has died unexpectedly.
Danish: Atripla må ikke anvendes hos patienter med alvorlig leversygdom eller patienter med et familiemedlem, der har haft en ændring af hjertets elektriske aktivitet (QT-forlængelse), eller som uventet er død.
English: Atripla can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Atripla udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion.
English: Atripla is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Atripla er et lægemiddel mod virus og anvendes til behandling af voksne, der er smittet med humant immundefektvirus type 1 (hiv-1), som er årsag til erhvervet immundefektsyndrom (aids).
English: It must also not be used in patients who have had arrhythmia (abnormal heartbeat) and patients with abnormal levels of electrolytes in the blood (for example, potassium or magnesium).
Danish: Det må heller ikke anvendes hos patienter, der har haft unormal hjerterytme (arytmi), eller patienter med unormalt indhold af elektrolytter i blodet (f.eks. kalium eller magnesium).
English: Atripla contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Danish: Lægemidlet indeholder tre aktive stoffer: efavirenz, som er en såkaldt non-nukleosid-revers transkriptase-hæmmer (NNRTI), emtricitabin, som er en nukleosid-revers transkriptase-hæmmer, og tenofovirdisoproxil, som er et "prodrug" (forstadium) til tenofovir, dvs. det omdannes til det aktive stof tenofovir i kroppen.
English: Based on the data available it could only recommend Atripla as a convenient ‘once-a-day tablet' treatment for maintaining viral loads in patients whose viral loads have already been reduced with other HIV treatment.
Danish: På baggrund af de foreliggende data kunne det kun anbefale Atripla som en bekvem daglig tablet-behandling til at vedligeholde virusbelastningen hos patienter, hvis virusbelastning allerede er nedbragt med anden hivbehandling.
English: How is Atripla used?
Danish: Hvordan anvendes Atripla?
English: Atripla must not be started in patients with HIV that is resistant to any of the three active substances in Atripla.
Danish: Atripla må heller ikke anvendes til patienter, som tidligere har været inficeret med hiv, der er resistent over for et eller flere af de tre aktive stoffer i Atripla.
English: The study compared the effectiveness of switching to Atripla tablets with that of continuing the successful HIV treatment combination.
Danish: I studiet sammenlignedes effektiviteten af at skifte til Atripla-tabletter med at fortsætte med den velfungerende kombinerede hivbehandling.
English: The study showed that switching to Atripla was as effective as remaining on the previous treatment combination.
Danish: Hovedstudiet viste, at det var lige så effektivt at skifte til Atripla som at fortsætte med den tidligere behandlingskombination.
English: For the full list of side effects reported with Atripla, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Atripla fremgår af indlægssedlen.
English: What benefits of Atripla have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Atripla?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atripla have also 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 Atripla.
English: • St John's wort (a herbal preparation used to treat depression);
Danish: • perikon (et naturlægemiddel til behandling af depression)
English: See the package leaflet for further details and for the full list of restrictions.
Danish: Yderligere oplysninger og den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: How does Atripla work?
Danish: Hvordan virker Atripla?
English: Trisenox has been authorised in the European Union since November 2016.
Danish: Trisenox har været godkendt i EU siden november 2016.
English: A letter with this information will be sent to healthcare professionals.
Danish: Der vil blive udsendt et brev med disse oplysninger til sundhedspersoner.
English: More information on Trisenox can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/trisenox
Danish: Yderligere oplysninger om Trisenox findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/trisenox
English: • To help differentiate between the two presentations, the packages have distinctive features shown below.
Danish: • For at skelne mellem de to styrker har pakningerne forskellige karakteristika som vist nedenfor.
English: Whereas underdosing may result in an inadequate effect overdose can result in serious and potentially fatal complications such as bleeding, severe infections and cardiac arrest.
Danish: Hvor underdosering kan medføre utilstrækkelig virkning, kan overdosering medføre alvorlige og potentielt fatale komplikationer som f.eks. blødning, alvorlige infektioner og hjertestop.
English: EMA issues alert on the risk of dosing errors with the cancer medicine Trisenox
Danish: EMA advarer om risikoen for fejldosering af kræftlægemidlet Trisenox
English: Ampoule of 10 ml
Danish: Ampul med 10 ml
English: Trisenox is a medicine used to treat adults with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic translocation (when there is a swap of genes between two chromosomes).
Danish: Trisenox anvendes til behandling af voksne med akut promyelocytleukæmi (APL), en sjælden form for leukæmi (kræft i de hvide blodlegemer), som skyldes en genetisk translokation (når to kromosomer bytter gener).
English: Both should be diluted with 100-250 ml of either glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection
Danish: Begge formuleringer skal fortyndes med 100-250 ml af enten glukose 50 mg/ml (5 %), injektionsvæske, opløsning, eller natriumchlorid 9 mg/ml (0,9 %), injektionsvæske, opløsning.
English: EMA is therefore alerting healthcare professionals using Trisenox of the risk of dosing errors and is reminding them to check the strength of the available presentation and follow the instructions for use carefully.
Danish: EMA advarer derfor sundhedspersoner, der anvender Trisenox, om risikoen for doseringsfejl og minder dem om at tjekke styrken af den enkelte formulering og følge brugsanvisningen nøje.
English: Label of the immediate container
Danish: Etiket for den indre beholder
English: Vial of 6 ml
Danish: Hætteglas med 6 ml
English: • To avoid any mix-ups while both presentations coexist, healthcare professionals must carefully check the concentration of the available presentation when calculating the volume of Trisenox to withdraw for dilution and infusion to ensure that the patient receives the correct dose of arsenic trioxide.
Danish: • For at undgå forveksling af de to formuleringer skal sundhedspersoner grundigt tjekke koncentrationen af den enkelte formulering, når de beregner mængden af Trisenox, der skal trækkes op til fortynding og infusion, for at sikre, at patienten får den korrekte dosis arsentrioxid.
English: After dilution Trisenox is given by an infusion (drip) into a vein over 1 to 2 hours.
Danish: Efter fortynding indgives Trisenox ved infusion (drop) i en blodåre over et tidsrum på 1-2 timer.
English: The European Medicines Agency (EMA) has recommended the approval of a new presentation of the injectable cancer medicine Trisenox (arsenic trioxide) that contains 2 mg/ml of the active substance in each vial.
Danish: Det Europæiske Lægemiddelagentur (EMA) har anbefalet godkendelse af en ny styrke af det injicerbare kræftlægemiddel Trisenox (arsentrioxid), der indeholder 2 mg/ml af det aktive stof i hvert hætteglas.
English: Total content
Danish: Indhold i alt
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein, and contains the active ingredient arsenic trioxide.
Danish: Det fås som et koncentrat, der blandes til en opløsning til infusion (drop) i en blodåre, og som indeholder det aktive stof arsentrioxid.
English: The new presentation will replace the existing one, which contains 1 mg/ml in each ampoule.
Danish: Den nye styrke vil erstatte den eksisterende, der indeholder 1 mg/ml arsentrioxid i hver ampul.
English: Front of the carton
Danish: Æskens forside
English: • A new presentation of Trisenox (vial containing 2 mg/ml arsenic trioxide) will be introduced to replace the existing presentation (ampoule containing 1 mg/ml arsenic trioxide).
Danish: • En ny styrke af Trisenox (hætteglas med 2 mg/ml arsentrioxid) vil blive markedsført for at erstatte den eksisterende styrke (ampul med 1 mg/ml arsentrioxid).
English: New presentation
Danish: Ny formulering
English: • Both formulations will coexist until stocks of the one containing 1 mg/ml have all been used.
Danish: • Begge formuleringer vil være samtidigt på markedet, indtil forsyningerne af 1 mg/mlformuleringen er brugt op.
English: Current presentation
Danish: Aktuel formulering
English: The Agency is concerned that the coexistence of the two strengths may result in healthcare professionals inadvertently giving their patients too much (overdose) or not enough (underdose) of the active substance.
Danish: De to styrker vil være på markedet samtidig, indtil alle forsyninger af den, der indeholder 1 mg/ml, er brugt op. Agenturet er betænkeligt ved, at tilstedeværelsen af begge styrker på samme tid kan medføre, at sundhedspersoner utilsigtet kommer til at give deres patienter for meget (overdosering) eller for lidt (underdosering) af det aktive stof.
English: In addition, the new presentation contains a total volume of 6 ml (and a total content of 12 mg) whereas the existing presentation contains 10 ml (and a total content of 10 mg).
Danish: Desuden har den nye formulering et samlet volumen på 6 ml (og indeholder i alt 12 mg arsentrioxid), hvor den eksisterende formulering har et samlet volumen på 10 ml (og indeholder i alt 10 mg arsentrioxid).
English: In addition, the new vial contains a total volume of 6 ml (and a total content of 12 mg arsenic trioxide) whereas the existing ampoule contains 10 ml (and a total content of 10 mg).
Danish: Desuden har det nye hætteglas et samlet volumen på 6 ml (og indeholder i alt 12 mg arsentrioxid), hvor den eksisterende ampul har et samlet volumen på 10 ml (og indeholder i alt 10 mg arsentrioxid).
English: PC: {number} SN: {number} NN: {number}
Danish: < PC: {nummer} SN: {nummer}
English: Date of first authorisation: 10 June 2010 Date of latest renewal: 11 February 2015
Danish: Dato for første markedsføringstilladelse: 10. juni 2010 Dato for seneste fornyelse: 11 februar 2015
English: Bilirubin - Indirect
Danish: Bilirubin - Indirekte
English: However, a return to higher doses is not recommended.
Danish: Dog anbefales det ikke at vende tilbage til højere doser.
English: Paediatric population: Growth and development:
Danish: Pædiatrisk population: Vækst og udvikling:
English: 117 Allée des Parcs 69800 Saint-Priest France
Danish: 117 Allée des Parcs 69 800 Saint Priest Frankrig
English: - had a serious heart problem during the past 6 months.
Danish: • har haft en alvorlig hjertelidelse inden for de sidste 6 måneder.
English: Take/administer the missed dose as soon as possible during the same day.
Danish: Tag/administrer den glemte dosis hurtigst muligt på samme dag.
English: However, absolute bioavailability is approximately 45%-65%, which appears to be due to first pass metabolism.
Danish: Den absolutte bioavailabilitet er imidlertid omkring 45 % - 65 %, hvilket synes at skyldes first pass metabolisme.
English: Do not chew the hard capsules.
Danish: Tyg ikke de hårde kapslerne.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage dobbelt dosis for at udligne en glemt dosis.
English: Like all medicines, this medicine used in combination with other medicines can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan dette lægemiddel i kombination med andre lægemidler give bivirkninger, men ikke alle får dem.
English: By reporting side effects, you can also help provide more information on the safety of this medicine.
Danish: Ved at indberette bivirkninger kan du bidrage til at fremskaffe mere information om dette lægemiddels sikkerhed.
English: Another approximately 4% had a transient decrease below the lower limit of normal.
Danish: Omtrent 4 % andre havde et forbigående fald til under den nedre normalgrænse.
English: Do not use this medicine without advice of your doctor or pharmacist if you notice any change in the appearance of the hard capsules.
Danish: Brug ikke dette lægemiddel uden rådgivning fra din læge eller apoteker, hvis du bemærker ændringer i udseendet af de hårde kapsler.