FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC concluded that the risk of severe diarrhoea associated with the use of diacerein containing medicinal products and the occurrence of potentially severe hepatic reactions could be mitigated by the above mentioned risk minimisation measures to be reflected in the SmPC and adequately monitored with yearly PSUR submissions.
Danish: • PRAC konkluderede, at risikoen for svær diarré ved anvendelse af lægemidler indeholdende diacerein og forekomsten af potentielt svære leverreaktioner kunne afbødes ved ovennævnte risikominimeringsforanstaltninger, som skal afspejles i produktresuméet og overvåges tilstrækkeligt gennem årlige periodiske sikkerhedsopdateringsrapporter,
English: In addition, and according to the clinical trials and bibliographical data, the efficacy appeared weak in the symptomatic treatment of osteoarthritis with low impact on pain and functional symptoms and with no demonstration of a decrease of NSAIDs intake in the population treated with diacerein.
Danish: I henhold til de kliniske undersøgelser og bibliografiske data syntes diacerein desuden kun at have svag virkning ved symptomatisk behandling af osteoartritis, med lav virkning på smerter og funktionelle symptomer og manglende påvisning af nedsat brug af NSAID hos den behandlede patientgruppe.
English: The structure-modifying effects of diacerein have also been assessed in few studies as well as its NSAIDs sparing effect (secondary endpoint).
Danish: Enkelte undersøgelser har ligeledes vedrørt de strukturmodificerende virkninger af diacerein og dets NSAID-besparende virkning (som sekundært endepunkt).
English: Package Leaflet (PL) to better reflect the PRAC recommendations and to correct minor discrepancies.
Danish: CMD(h) fandt det dog nødvendigt med ændringer i produktresuméet og indlægssedlen for bedre at afspejle PRAC's anbefalinger og samtidig rette mindre uoverensstemmelser.
English: The MAHs considered that there is adequate data supporting the efficacy of diacerein in the symptomatic treatment of osteoarthritis of the hip and the knee and proposed further risk minimisation measures to reduce the risk of diarrhoea and potential risk of hepatic reactions associated with diacerein.
Danish: De pågældende markedsføringstilladelsesindehavere fandt, at der er tilstrækkelige data til støtte for virkningen af diacerein til symptomatisk behandling af osteoartritis i hofte og knæ, og foreslog yderligere foranstaltninger til nedsættelse af risikoen for diarré og den potentielle risiko for leverreaktioner forbundet med diacerein.
English: The PRAC reviewed all available data from clinical studies, published literature, and post-marketing experience on the safety of the diacerein containing products, in particular in relation to the risk of hepatotoxicity, gastro-intestinal disorders and cutaneous disorders.
Danish: PRAC gennemgik alle foreliggende data fra kliniske undersøgelser, den publicerede litteratur og erfaringer efter markedsføring vedrørende sikkerheden af lægemidler indeholdende diacerein, navnlig hvad angår risikoen for hepatotoksicitet, gastrointestinale lidelser og hudlidelser.
English: Furthermore, cases of hepatic enzymes elevations have been reported and as well as serious cases, including a fatal hepatic reaction in a patient treated with diacerein.
Danish: Desuden er der beskrevet forhøjede leverenzymer og alvorlige tilfælde, herunder en fatal leverreaktion hos en patient behandlet med diacerein.
English: Having reviewed the final PRAC recommendation dated 6 March 2014 and the revised final PRAC recommendation , the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Danish: Efter at have gennemgået PRAC's endelige anbefaling af 6. marts 2014 samt PRAC's endelige reviderede anbefaling tilsluttede CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) sig de overordnede videnskabelige konklusioner og begrundelsen for anbefalingen.
English: However, treatment with diacerein is not recommended in patients with rapidly progressive hip osteoarthritis, as they may have a weaker response to diacerein.
Danish: Behandling med diacerein frarådes dog til patienter med hurtigt progredierende osteoartritis i hoften, da de kan udvise svagere respons over for diacerein,
English: • The PRAC reviewed all the available data on the efficacy and safety of diacerein-containing medicines in particular data in relation to the risk of hepatotoxicity, gastrointestinal disorders and cutaneous reactions provided by the MAHs in writing and in the oral explanations;
Danish: • PRAC gennemgik alle foreliggende data om virkning og sikkerhed af lægemidler indeholdende diacerein, herunder data om risikoen for hepatotoksicitet, gastrointestinale lidelser og hudreaktioner, som indehaverne af markedsføringstilladelse havde fremlagt skriftligt og ved de mundtlige fremlæggelser,
English: Some cases of hospitalisation to further investigate the event of diarrhoea were also reported.
Danish: Der blev endvidere beskrevet tilfælde, hvor patienterne blev indlagt til nærmere undersøgelse af diarréhændelsen.
English: In addition, given the gastrointestinal risk and potential risk of hepatic reactions, the PRAC considered necessary to restrict prescription to specialists experienced in the treatment of osteoarthritis.
Danish: På baggrund af den gastrointestinale risiko og den potentielle risiko for leverreaktioner fandt PRAC det derudover nødvendigt at begrænse ordinationsretten til specialister med erfaring i behandling af osteoartritis.
English: In addition, given the gastrointestinal risk and potential risk of hepatic reactions, the PRAC considered limiting prescription by specialists experienced in the treatment of osteoarthritis.
Danish: På baggrund af den gastrointestinale risiko og den potentielle risiko for leverreaktioner overvejede PRAC desuden at begrænse ordinationsretten til specialister med erfaring i behandling af osteoartritis.
English: The PRAC confirmed it had considered the totality of the data submitted by the MAHs in the context of the initial referral procedure.
Danish: PRAC erklærede at have gennemgået samtlige data, der var forelagt af markedsføringstilladelsesindehaverne i forbindelse med den første indbringelsesprocedure PRAC erklærede at have gennemgået samtlige data, der var forelagt af markedsføringstilladelsesindehaverne i forbindelse med den første indbringelsesprocedure
English: Furthermore, evidence of hepatic reactions was reported, including symptomatic acute liver injury.
Danish: Desuden blev der beskrevet tegn på leverreaktioner i form af symptomgivende akut leverskade.
English: Finally, several double-blind randomised clinical trials analysed the alleged NSAID sparing effect of diacerein as a secondary endpoint.
Danish: Endelig blev den hævdede NSAID-besparende virkning af diacerein analyseret som sekundært endepunkt i flere dobbeltblindede, randomiserede kliniske undersøgelser.
English: Finally, information on the cutaneous risk in the Summary of Product Characteristics (SmPC) was considered necessary.
Danish: Endelig fandtes det nødvendigt at indsætte oplysninger om hudreaktioner i produktresuméet,
English: The CMDh, having considered the revised final PRAC recommendation dated 10 July 2014 with regards to diacerein containing medicinal products, agrees with the recommendation therein as stated below:
Danish: CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) har gennemgået PRAC's (Udvalget for Risikovurdering inden for Lægemiddelvurdering) endelige reviderede anbefaling af 10. juli 2014 for lægemidler indeholdende diacerein, og CMD(h) tilslutter sig anbefalingen, således som det fremgår af følgende:
English: The recommended starting dose is three tablets once daily and can be increased to 5 tablets once daily after 4 weeks depending on the patient's response.
Danish: Den anbefalede startdosis er tre tabletter én gang dagligt og kan øges til fem tabletter én gang dagligt efter fire uger afhængigt af patientens respons.
English: Other information about Xospata
Danish: Andre oplysninger om Xospata
English: The doctor will also carry out regular blood tests and check the patient's heart function before and during treatment.
Danish: Lægen vil også tage regelmæssige blodprøver og kontrollere patientens hjertefunktion før og under behandlingen.
English: Xospata is available as tablets (40 mg).
Danish: Xospata findes som tabletter (40 mg).
English: As for all medicines, data on the use of Xospata are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Xospata løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Xospata?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xospata?
English: Patients will also receive a patient card with information on when to seek medical advice if differentiation syndrome is suspected.
Danish: Patienter vil også få udleveret et patientkort med oplysninger om, hvornår der bør søges lægehjælp, hvis der er mistanke om differentieringssyndrom.
English: The active substance in Xospata is gilteritinib.
Danish: Det aktive stof i Xospata er gilteritinib.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3171961.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/eu3171961.
English: Patients receiving Xospata lived on average 9.3 months compared with 5.6 months for those receiving various types of chemotherapy.
Danish: Patienter, der fik Xospata, overlevede i gennemsnit 9,3 måneder sammenlignet med 5,6 måneder for dem, der undergik forskellige former for kemoterapi.
English: Before starting treatment, doctors will use a genetic test to confirm that the patient has an FLT3 mutation.
Danish: Før behandlingen indledes, vil lægerne foretage en genetisk test for at bekræfte, at patienten har en FLT3-mutation.
English: The European Medicines Agency therefore decided that Xospata's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Xospata opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Xospata and why it is authorised in the EU
Danish: En oversigt over Xospata, og hvorfor det er godkendt i EU
English: Why is Xospata authorised in the EU?
Danish: Hvorfor er Xospata godkendt i EU?
English: What is Xospata and what is it used for?
Danish: Hvad er Xospata, og hvad anvendes det til?
English: The company that markets Xospata will provide educational materials to healthcare professionals and patients about the signs and symptoms of differentiation syndrome.
Danish: Den virksomhed, der markedsfører Xospata, vil udlevere oplysningsmateriale til sundhedspersoner og patienter om tegnene og symptomerne på differentieringssyndrom.
English: AML is rare, and Xospata was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 January 2018.
Danish: AML er sjælden, og Xospata blev udpeget som "lægemiddel til sjældne sygdomme" den 17. januar 2018.
English: Xospata can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in using cancer medicines.
Danish: Xospata fås kun på recept, og behandling bør indledes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: Side effects reported with Xospata are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Xospata vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Side effects with Xospata are those expected of this class of medicines and considered manageable.
Danish: Bivirkningerne ved Xospata er de forventede for denne kategori af lægemidler og anses for at være håndterbare.
English: Other serious side effects include a disorder related to white blood cells known as differentiation syndrome, a brain condition known as posterior reversible encephalopathy syndrome (PRES) and heart rhythm problems.
Danish: Andre alvorlige bivirkninger omfatter en tilstand relateret til de hvide blodlegemer kendt som differentieringssyndrom, en hjernetilstand kendt som posteriort reversibelt encefalopatisyndrom (PRES) og hjerterytmeproblemer.
English: What are the risks associated with Xospata?
Danish: Hvilke risici er der forbundet med Xospata?
English: The most common side effects with Xospata (which may affect more than 1 in 10 people) are increased levels of some enzymes in the blood (creatine phosphokinase, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase), diarrhoea, tiredness, nausea (feeling sick), constipation, cough, peripheral oedema (swelling, especially of the ankles and feet), dyspnoea (shortness of breath), dizziness, hypotension (low blood pressure), pain in the extremities, weakness, joint pain and muscle pain.
Danish: De hyppigste bivirkninger ved Xospata (som kan forekomme hos mere end 1 ud af 10 personer) er forhøjede niveauer af visse enzymer i blodet (kreatin-fosfokinase, alanin-aminotransferase, aspartataminotransferase, alkalisk fosfatase), diarré, træthed, kvalme, forstoppelse, hoste, perifert ødem (hævelse, især af ankler og fødder), dyspnø (åndenød), svimmelhed, hypotension (nedsat blodtryk), smerter i ekstremiteterne, svaghed, ledsmerter og muskelsmerter.
English: For more information about using Xospata, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Xospata, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: In patients who have an FLT3 mutation, FLT3 is overactive and stimulates the growth of too many white blood cells.
Danish: Hos patienter med en FT3-mutation er FLT3 overaktivt og stimulerer væksten af for mange hvide blodlegemer.
English: The most common serious side effects (which may affect up to 1 in 10 people) are diarrhoea, increased levels of liver enzymes in the blood, dyspnoea and hypotension.
Danish: De hyppigste alvorlige bivirkninger (som kan forekomme hos op til 1 ud af 10 personer) er forhøjede niveauer af leverenzymer i blodet, dyspnø og hypotension.
English: Xospata was shown to prolong patients' lives in comparison to other cancer therapies.
Danish: Behandling med Xospata viste sig at forlænge patienternes overlevelse set i forhold til andre kræftbehandlinger.
English: If certain side effects develop, the doctor may decide to reduce the dose or stop the treatment intermittently or entirely.
Danish: Behandlingen bør fortsætte, så længe patienten har gavn af den. Ved visse bivirkninger kan lægen beslutte at nedsætte dosis eller afbryde behandlingen helt eller med mellemrum.
English: For the full list of side effects and restrictions of Xospata, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Xospata fremgår af indlægssedlen.
English: The active substance in Xospata, gilteritinib, blocks the action of enzymes known as tyrosine kinases, in particular a tyrosine kinase called FLT3 which normally controls growth and division of white blood cells.
Danish: Det aktive stof i Xospata, gilteritinib, hæmmer virkningen af enzymer kendt som tyrosinkinaser, navnlig tyrosinkinase FLT3, som normalt styrer væksten og delingen af hvide blodlegemer.
English: Xospata is used when AML has either come back or has not improved following previous treatment and is only given to patients whose cancer cells have a particular change (mutation) in the gene for a protein called FLT3.
Danish: Xospata anvendes, når AML enten er vendt tilbage eller ikke er i bedring efter forudgående behandling, og gives kun til patienter, hvis kræftceller udviser en bestemt ændring (mutation) i genet for proteinet FLT3.
English: By blocking FLT3, gilteritinib is expected to stop white blood cell growth and thus slow down the development of the cancer.
Danish: Ved at hæmme FLT3 forventes gilteritinib at stoppe væksten af hvide blodlegemer og dermed nedbremse udviklingen af kræft.
English: Patients with AML who have an FLT3 mutation, and whose disease has come back or has not improved following previous treatment, have a poor prognosis and treatment options are limited.
Danish: AML-patienter med en FLT3-mutation, hvis sygdom er vendt tilbage eller ikke er i bedring efter forudgående behandling, har en dårlig prognose og begrænsede behandlingsmuligheder.
English: In a main study with 371 patients with AML who have an FLT3 mutation, and whose disease had come back or had not improved following previous treatment, Xospata prolonged patients' lives compared with patients receiving chemotherapy.
Danish: I et hovedstudie med 371 AML-patienter med en FLT3-mutation, hvis sygdom var vendt tilbage eller ikke var i bedring efter forudgående behandling, forlængede behandling med Xospata patienternes overlevelse set i forhold til behandling med kemoterapi.
English: Further information on Xospata can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xospata This overview was last updated in 10-2019.
Danish: Yderligere information om Xospata findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/xospata
English: Xospata is a cancer medicine used to treat adults with acute myeloid leukaemia (AML), a cancer of white blood cells.
Danish: Xospata anvendes til at behandle patienter med akut myeloid leukæmi (AML), en form for kræft i de hvide blodlegemer.
English: What benefits of Xospata have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xospata?
English: How is Xospata used?
Danish: Hvordan anvendes Xospata?
English: How does Xospata work?
Danish: Hvordan virker Xospata?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xospata 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 Xospata.
English: Xospata received a marketing authorisation valid throughout the EU on 24 October 2019.
Danish: Denne oversigt blev sidst ajourført i 10-2019.
English: Date of opening:__________
Danish: Dato for åbning:____________
English: Date of first authorisation: 28 November 2011 Date of latest renewal: 16 August 2016
Danish: Dato for første markedsføringstilladelse: 28. november 2011 Dato for seneste fornyelse: 16. august 2016
English: Do not give this medicine to children less than 12 years of age.
Danish: Giv ikke dette lægemiddel til børn under 12 år.
English: The tablet can be taken with or without food.
Danish: Tabletten kan tages med eller uden mad.
English: Shelf life after first opening of the tablet container: 3 months.
Danish: Holdbarhed efter første åbning af tabletbeholderen: 3 måneder.
English: If you forget to take Dasselta
Danish: Hvis du har glemt at tage Dasselta
English: - abnormal behaviour, - aggression, - weight increased, - increased appetite.
Danish: - unormal adfærd, - aggression, - vægtforøgelse, - øget appetit.
English: and talc (E553b).
Danish: og talcum (E553b).
English: The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products can not be fully excluded.
Danish: Enzymet, der er ansvarlig for metaboliseringen af desloratadin, er endnu ikke blevet identificeret, og nogle interaktioner med andre lægemidler kan derfor ikke fuldstændigt udelukkes.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Kravet for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og efterfølgende opdateringer eroffentliggjort på den europæiske webportal for lægemidler.
English: Desloratadine effectively controlled symptoms for 24 hours.
Danish: Desloratadin regulerede effektivt symptomerne i 24 timer.
English: Dasselta is an antiallergy medicine that does not make you drowsy.
Danish: Dasselta er et lægemiddel mod allergi, som ikke gør dig døsig.
English: Dasselta with food, drink and alcohol Dasselta may be taken with or without a meal.
Danish: Brug af Dasselta sammen med mad, drikke og alkohol Dasselta kan tages med eller uden mad.
English: However, cases of alcohol intolerance and intoxication have been reported during post marketing use.
Danish: Der er dog rapporteret tilfælde af alkoholintolerans og alkoholforgiftning i forbindelse med brug efter markedsføring.
English: There are no known interactions of Dasselta with other medicines.
Danish: Der er ingen kendte interaktioner mellem Dasselta og andre lægemidler.
English: 7 film-coated tablets: EU/1/11/739/001 10 film-coated tablets: EU/1/11/739/002 20 film-coated tablets: EU/1/11/739/003 30 film-coated tablets: EU/1/11/739/004 50 film-coated tablets: EU/1/11/739/005 90 film-coated tablets: EU/1/11/739/006 100 film-coated tablets: EU/1/11/739/007 250 film-coated tablets: EU/1/11/739/008
Danish: 7 filmovertrukne tabletter: EU/1/11/739/001 10 filmovertrukne tabletter: EU/1/11/739/002 20 filmovertrukne tabletter: EU/1/11/739/003 30 filmovertrukne tabletter: EU/1/11/739/004 50 filmovertrukne tabletter: EU/1/11/739/005 90 filmovertrukne tabletter: EU/1/11/739/006 100 filmovertrukne tabletter: EU/1/11/739/007 250 filmovertrukne tabletter: EU/1/11/739/008
English: Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Dasselta.
Danish: Med hensyn til varigheden af behandlingen, vil din læge bestemme hvilken type allergisk snue, du lider af, og vil fastsætte, hvor længe du skal tage Dasselta.
English: Pharmacotherapeutic group: Other antihistamines for systemic use, ATC code: R06AX27
Danish: Farmakoterapeutisk klassifikation: Antihistaminer til systemisk brug, ATC-kode: R06AX27
English: The safety and efficacy of Dasselta 5 mg film-coated tablets in children below the age of 12 years have not been established.
Danish: Sikkerhed og virkning af Dassleta 5 mg filmovertrukne tabletter hos børn under 12 år er ikke klarlagt.
English: Very rare (the following may affect up to 1 in 10,000 people): - severe allergic reactions, - rash, - pounding or irregular heartbeat, - fast heartbeat, - stomach ache, - feeling sick (nausea), - vomiting, - upset stomach, - diarrhoea, - dizziness, - drowsiness, - inability to sleep, - muscle pain, - hallucinations, - seizures, - restlessness with increased body movement, - liver inflammation, - abnormal liver function tests.
Danish: Meget sjældne: følgende kan forekomme hos op til 1 ud af 10.000 personer - alvorlige allergiske reaktioner - udslæt - hjertebanken eller uregelmæssig hjerterytme - hurtig hjerterytme (puls) - mavesmerter - kvalme - opkastning - mavebesvær - diarré - svimmelhed - døsighed - søvnbesvær - muskelsmerter - hallucinationer - krampeanfald - rastløshed med øget kropsbevægelse - leverbetændelse - unormale prøver for leverfunktion.
English: Not known: frequency cannot be estimated from the available data - slow heartbeat, - change in the way the heart beats, - abnormal behaviour, - aggression.
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data - langsomme hjerteslag, - ændring i måden hjertet slår, - unormal adfærd, - aggression.
English: In adolescents, headache was the most commonly reported side effect.
Danish: Hovedpine var den mest hyppigst rapporterede bivirkning hos unge.
English: Adults and adolescents (12 years of age and over) The recommended dose of Dasselta is one tablet once a day.
Danish: Voksne og unge (i alderen 12 år og derover) Den anbefalede dosis Dasselta er en tablet en gang daglig.