FrancophonIA/ELRC3.0 huggingface dataset:
English: The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. In addition, a single booster dose of Bexsero at 12 months of age produced a stronger immune response in children who had already received Bexsero than the first of two ‘catchup' doses in children of the same age who had not.
Danish: Undersøgelserne viste, at Bexsero var effektivt til at fremkalde en immunrespons mod N. meningitidis gruppe B. Undersøgelsen hos børn viste desuden, at en enkelt boosterdosis af Bexsero i 12-månedersalderen gav en kraftigere immunrespons hos børn, der allerede havde fået Bexsero, end de to første "indhentningsdoser" hos børn i samme alder, der ikke havde fået Bexsero.
English: The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B and that two doses were needed to produce an adequate immune response.
Danish: Studiet viste, at Bexsero var effektivt til at frembringe en immunrespons over for N. meningitidis gruppe B, og at der behøvedes to doser for at frembringe tilstrækkelig immunrespons.
English: The most common side effects with Bexsero in adolescents from 11 years of age and adults (seen in more than 1 patient in 10) are headache, nausea (feeling sick) and malaise (feeling unwell), myalgia (muscle pain) and arthralgia as well as pain, swelling, hardness and redness of the skin at the injection site.
Danish: Hos unge er de hyppigste bivirkninger ved Bexsero (som optræder hos flere end 1 ud af 10 patienter) hovedpine, kvalme, utilpashed, muskelsmerter (myalgi) og ledsmerter (artralgi) samt smerte, hævelse, hårdhed og rødme af huden på injektionsstedet.
English: What benefits of Bexsero have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Bexsero?
English: How does Bexsero work?
Danish: Hvordan virker Bexsero?
English: Bexsero contains parts of the bacteria N. meningitidis group B.
Danish: Den indeholder dele af bakterien Neisseria meningitidis gruppe B.
English: For the full list of side effects and restrictions with Bexsero, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Bexsero fremgår af indlægssedlen.
English: Bexsero contains four proteins which are found on the surfaces of cells of the N. meningitidis group B bacterium.
Danish: Bexsero indeholder fire proteiner, der findes på overfladen af cellerne af bakterien N. meningitidis gruppe B. Vaccinen er "adsorberet".
English: ‘Essential' means that the disease has no obvious cause.
Danish: "Essentiel" betyder, at sygdommen ikke har nogen umiddelbar årsag.
English: This summary was last updated in 06-2018.
Danish: Denne oversigt blev sidst ajourført i 06-2018.
English: Xagrid was originally authorised under ‘exceptional circumstances'.
Danish: Xagrid blev oprindeligt godkendt under "særlige omstændigheder".
English: In the other three studies, between 60 and 82% of patients had a complete response.
Danish: I de tre øvrige studier havde 60-82 % af patienterne en komplet respons.
English: Further information on Xagrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Xagrid findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended starting dose is 1 capsule twice a day.
Danish: Den anbefalede startdosis er én kapsel to gange dagligt.
English: Xagrid received a marketing authorisation valid throughout the EU on 16 November 2004.
Danish: Xagrid fik en markedsføringstilladelse med gyldighed i hele EU den 16. november 2004.
English: Patients were treated with Xagrid for up to five years.
Danish: Nogle af patienterne blev behandlet med Xagrid i op til fem år.
English: Xagrid (anagrelide) EMA/326376/2018
Danish: Xagrid (anagrelid) EMA/326376/2018
English: As for all medicines, data on the use of Xagrid are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Xagrid løbende overvåget.
English: Treatment should only be started by a doctor who has experience in the treatment of essential thrombocythaemia.
Danish: Behandling bør kun iværksættes af en læge med erfaring i behandling af essentiel trombocytæmi.
English: Other information about Xagrid
Danish: Andre oplysninger om Xagrid
English: In the largest study, 67% of the patients with essential thrombocythaemia (628 out of 934), and 66% of those who could not tolerate other treatments or whose condition did not respond to them (480 out of 725) had a complete response to Xagrid.
Danish: I det største af studierne opnåede 67 % af patienterne med essentiel trombocytæmi (628 ud af 934) og 66 % af dem, der ikke tålte eller ikke havde gavn af andre behandlinger (480 ud af 725), en komplet respons på Xagrid.
English: For more information about using Xagrid, see the package leaflet or contact a doctor or a pharmacist.
Danish: For mere information om anvendelse af Xagrid, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Xagrid?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xagrid?
English: The most common side effect with Xagrid (which may affect more than 1 in 10 people) is headache.
Danish: Den hyppigste bivirkning ved Xagrid (som kan forekomme hos mere end 1 ud af 10 patienter) er hovedpine.
English: Xagrid is available as capsules (0.5 mg).
Danish: Xagrid fås som kapsler (0,5 mg).
English: The dose can then be increased every week by 1 capsule a day, until the patient's platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the usual level in healthy people).
Danish: Dosen kan øges dosis hver uge med én kapsel dagligt, indtil patienten når ned på et blodpladetal på under 600 mio. blodplader pr. ml, og ideelt mellem 150 og 400 mio. ml (det sædvanlige niveau hos sunde personer).
English: An overview of Xagrid and why it is authorised in the EU
Danish: En oversigt over Xagrid, og hvorfor det er godkendt i EU
English: Side effects reported with Xagrid are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Xagrid vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency decided that Xagrid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Xagrid opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Xagrid.
English: The maximum recommended dose of Xagrid is 5 capsules at a time.
Danish: Den anbefalede maksimumsdosis Xagrid er fem kapsler ad gangen.
English: Xagrid contains the active substance anagrelide.
Danish: Xagrid indeholder det aktive stof anagrelid.
English: Xagrid (anagrelide)
Danish: Xagrid (anagrelid)
English: The active substance in Xagrid, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes', which produce platelets.
Danish: Det aktive stof i Xagrid, anagrelid, blokerer for udviklingen og væksten af celler i knoglemarven kaldet "megakaryocyter", som producerer blodplader.
English: The main measure of effectiveness was the number of patients who had a ‘complete response', when platelet counts fell either by at least 50% from the start of treatment or to below 600 million/ml.
Danish: Det primære mål for virkning var antallet af patienter, som havde en "komplet respons", dvs. en reduktion i blodpladetallet på mindst 50 % fra behandlingsstart eller ned til under 600 mio. ml.
English: What is Xagrid and what is it used for?
Danish: Hvad er Xagrid, og hvad anvendes det til?
English: This is because, as a result of the disease's rarity, it had not been possible to obtain full information about it. As the company has supplied the additional information requested, the ‘exceptional circumstances' ended on 11.07.2018.
Danish: Da virksomheden har fremlagt de yderligere oplysninger, den var blevet anmodet om, blev de "særlige omstændigheder" ophævet den 11.07.2018.
English: Why is Xagrid authorised in the EU?
Danish: Hvorfor blev Xagrid godkendt i EU?
English: Xagrid is used when patients do not respond to or do not tolerate their current treatment, and when they are ‘at risk' because of their age (over 60 years), very high platelet counts or previous clotting problems.
Danish: Xagrid anvendes, når den hidtidige behandling ikke virker eller ikke tåles af patienten, og når patienten tilhører "risikogruppen" enten på grund af alder (over 60 år), meget højt blodpladetal eller tidligere koagulationsproblemer.
English: Xagrid is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets in the blood).
Danish: Xagrid er et lægemiddel, der anvendes til at mindske antallet af blodplader (bestanddele, der hjælper blodet til at størkne) hos patienter med essentiel trombocytæmi (en sygdom, hvor der er for mange blodplader i blodet).
English: Almost 3,000 of the patients in the studies had essential thrombocythaemia, with a platelet count of more than 600 million/ml.
Danish: Næsten 3.000 af patienterne i studierne havde essentiel trombocytæmi, med et blodpladetal på mere end 600 mio. ml.
English: Xagrid can only be obtained with a prescription.
Danish: Xagrid udleveres kun efter recept.
English: Most patients had previously received other medicines but could not continue with them.
Danish: De fleste patienter havde tidligere fået andre lægemidler, men kunne ikke fortsætte på dem. Xagrid blev ikke sammenlignet med andre lægemidler.
English: Xagrid must not be used in patients with moderate or severe liver or kidney disease.
Danish: Xagrid må ikke anvendes af patienter med moderat til svær lever- eller nyresygdom.
English: What are the risks associated with Xagrid?
Danish: Hvilke risici er der forbundet med Xagrid?
English: How is Xagrid used?
Danish: Hvordan anvendes Xagrid?
English: In essential thrombocythaemia the bone marrow produces too many platelets.
Danish: Ved essentiel trombocytæmi danner knoglemarven for mange blodplader.
English: For the full list of all side effects of Xagrid, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Xagrid fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xagrid 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 Xagrid.
English: What benefits of Xagrid have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xagrid?
English: How does Xagrid work?
Danish: Hvordan virker Xagrid?
English: Xagrid was effective in lowering platelet counts in four main studies involving patients with various diseases in which the bone marrow produces too many cells.
Danish: Af fire hovedstudier hos patienter med forskellige sygdomme, hvor knoglemarven producerede for mange celler, fremgik det, at Xagrid var effektivt til at sænke blodpladetallet.
English: ● and is advanced.
Danish: ● og er fremskreden
English: Do not open or dissolve the capsules.
Danish: Du må ikke åbne eller opløse kapslerne.
English: There are no available data on patients over 80 years of age.
Danish: Der foreligger ingen data for patienter over 80 år.
English: Extreme body weight (>130 kg)
Danish: Ekstrem kropsvægt (>130 kg)
English: ● The other ingredients are:
Danish: ● Øvrige indholdsstoffer:
English: This is because it may harm your baby.
Danish: Det kan skade barnet.
English: The hard capsules should be swallowed whole, and must not be opened or dissolved.
Danish: De hårde kapsler skal synkes hele og må ikke åbnes eller opløses.
English: ● Do not take Alecensa if you are pregnant.
Danish: ● Tag ikke Alecensa, hvis du er gravid.
English: Frequency category (all grades)
Danish: Hyppighedskategori (alle grader)
English: Dose modification advice is provided in Tables 1 and 2 below.
Danish: Anbefalinger vedrørende dosisændringer fremgår af Tabel 1 og 2 nedenfor.
English: Contraception, pregnancy, and breast-feeding - information for women Contraception - information for women
Danish: Graviditet, amning og frugtbarhed - information til kvinder Prævention - information til kvinder
English: Swallow each capsule whole.
Danish: Synk hver enkelt kapsel hel.
English: Increased alkaline phosphatase**
Danish: Forhøjet alkalisk fosfatase**
English: A lower confidence limit for the estimated ORR above the pre-specified threshold of 35% would achieve a statistically significant result.
Danish: Med en lavere konfidensgrænse for den estimerede objektive responsrate over den præspecificerede tærskel på 35% ville der opnås et statistisk signifikant resultat.
English: The following side effects may happen with this medicine.
Danish: Følgende bivirkninger kan forekomme med medicinen.
English: The corresponding values for M4 were 217 L/hour and 30.7 hours, respectively.
Danish: De tilsvarende værdier for M4 var henholdsvis 217 l/time og 30,7 timer.
English: Abnormal forms of this enzyme (due to fault in the gene that makes it) help encourage cancer cell growth.
Danish: Unormale former af dette enzym (på grund af fejl i det gen, der er med til at lave det) er med til at øge kræftcellernes vækst.
English: Medicinal products that increase gastric pH
Danish: Lægemidler, som øger gastrisk pH
English: Patients who experience overdose should be closely supervised and general supportive care instituted.
Danish: Patienter, som oplever overdosering, skal monitoreres tæt, og generel understøttende behandling bør initieres.
English: Alecensa can cause side effects that you need to tell your doctor about straight away.
Danish: Alecensa kan give bivirkninger, som du straks skal informere lægen om.
English: Treatment with Alecensa should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandling med Alecensa bør initieres og superviseres af en læge med erfaring i brug af lægemidler mod kræft.
English: Duration of treatment Treatment with Alecensa should be continued until disease progression or unacceptable toxicity.
Danish: Behandlingsvarighed Behandling med Alecensa bør fortsætte indtil sygdomsprogression eller uacceptabel toksicitet.
English: Do not stop taking this medicine without talking to your doctor first.
Danish: Du må ikke holde op med at tage medicinen uden først at have talt med din læge.
English: Talk to your doctor about the right methods of contraception for you and your partner.
Danish: Tal med lægen om, hvilken former for prævention, der er bedst for dig og din partner.
English: The majority of these events occurred during the first 3 months of treatment.
Danish: De fleste af disse hændelser opstod inden for de første 3 behandlingsmåneder.
English: ● is ‘ALK-positive' - this means your cancer cells have a fault in a gene that makes an enzyme called
Danish: ● er ALK-positiv - det vil sige, at kræftcellerne har en fejl i det gen, der laver et enzym, der kaldes
English: There are no or limited amount of data from the use of Alecensa in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af Alecensa til gravide kvinder.
English: It is important to take Alecensa twice a day for as long as your doctor prescribes it for you.
Danish: Det er vigtigt at blive ved med at tage Alecensa 2 gange dagligt lige så længe, lægen har ordineret det.
English: Within each system organ class, undesirable effects are presented in order of decreasing frequency.
Danish: Inden for de enkelte systemorganklasser præsenteres bivirkningerne efter faldende hyppighed.
English: ● You should not become pregnant while taking this medicine.
Danish: ● Du må ikke blive gravid, mens du tager dette lægemiddel.
English: There is no specific antidote for overdose with Alecensa.
Danish: Der er ingen specifik antidot mod overdosering med Alecensa.
English: Alecensa with food and drink
Danish: Brug af Alecensa sammen med mad og drikke
English: It is used if your lung cancer:
Danish: Det kan bruges, hvis lungekræften:
English: This is equivalent to 2.4% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Det svarer til 2,4% af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: Aluminium/aluminium (PA/Alu/PVC/Alu) blisters containing 8 hard capsules.
Danish: Aluminium/aluminium (PA/Alu/PVC/Alu) blisterkort med 8 hårde kapsler.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du eller dine pårørende hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Take the medicine pack and this leaflet with you.
Danish: Tag medicinpakningen og denne indlægsseddel med.
English: Do not take Alecensa:
Danish: Tag ikke Alecensa:
English: It is unknown whether alectinib and its metabolites are excreted in human milk.
Danish: Det vides ikke, om alectinib og dets metabolitter udskilles i human mælk.
English: White shellac
Danish: Hvid shellac
English: Median duration of follow-up (months)
Danish: Median-varighed af opfølgning (måneder)
English: Investigations Weight increased
Danish: Undersøgelser Vægtstigning
English: Thereafter, monitoring should be performed periodically, since events may occur later than 3 months, with more frequent testing in patients who develop aminotransferase and bilirubin elevations.
Danish: Herefter bør periodisk monitorering finde sted, da bivirkningerne kan forekomme senere end efter 3 måneder, med hyppigere målinger hos patienter, der udvikler stigninger i aminotransferase og bilirubin.
English: If you take more Alecensa than you should, talk to a doctor or go to hospital straight away.
Danish: Hvis du har taget mere Alecensa, end du skulle, skal du kontakte lægen eller straks tage på hospitalet.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du ikke tåler eller kan fordøje visse sukkerarter, skal du kontakte lægen, inden du begynder at tage dette lægemiddel.
English: The geometric mean Metabolite/Parent ratio at steady state is 0.399.
Danish: Den geometrisk gennemsnitlige metabolit:moderstof-ratio ved steady state er 0,399.
English: The effectiveness of concomitant administration of oral contraceptives may be reduced.
Danish: Virkningen af samtidigt administrerede orale kontraceptiva kan være reduceret.
English: Patients should not take two doses at the same time to make up for a missed dose.
Danish: Patienten må ikke tage 2 doser på samme tid for at kompensere for en manglende dosis.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 patienter)
English: Sensitivity to sunlight
Danish: Øget følsomhed for sollys
English: It may also help to shrink your cancer.
Danish: Det kan også gøre, at kræften svinder.
English: A risk to the newborn/infant cannot be excluded.
Danish: Det kan ikke udelukkes, at amning vil indebære en risiko for den nyfødte/spædbarnet.
English: Nervous system disorders Dysgeusia 2)
Danish: Nervesystemet Dysgeusi 2)
English: The capsules are also available in plastic bottles containing 240 hard capsules.
Danish: Kapslerne er også tilgængelige i plastbeholder indeholdende 240 hårde kapsler.
English: The majority of patients had no history of smoking (62%).
Danish: Størstedelen af patienterne havde ikke røget (62%).
English: Alecensa has minor influence on the ability to drive and use machines.
Danish: Alecensa påvirker i beskeden grad evnen til at føre motorkøretøj og betjene maskiner.
English: The geometric mean of the individual elimination half-life estimates for alectinib was 32.5 hours.
Danish: Det geometriske gennemsnit af estimaterne for alectinibs individuelle halveringstid var 32,5 time.
English: Alecensa treatment
Danish: Alecensa-behandling
English: The safety and efficacy of Alecensa in children and adolescents below 18 years of age have not been established.
Danish: Alecensas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Alecensa may slow down or stop the growth of your cancer.
Danish: Alecensa kan hæmme eller stoppe væksten af kræftceller.
English: The events generally occurred during the first 3 months of treatment, were usually transient and the majority resolved upon dose modification.
Danish: Tilfældene opstod som regel inden for de første 3 behandlingsmåneder, var oftest forbigående og de fleste forsvandt ved dosisændring.
English: Heart rate and blood pressure should be monitored as clinically indicated.
Danish: Hjertefrekvens og blodtryk bør monitoreres i det omfang, det er klinisk relevant.
English: This includes medicines obtained without a prescription, and herbal medicines.
Danish: Det gælder også medicin, der kan købes uden recept, og naturlægemidler.
English: See ‘Side effects' in section 4 for more information.
Danish: Læs afsnit 4 ‘Bivirkninger' for mere information.
English: * Includes one Grade 5 event ** Increased alkaline phosphatase was reported in the post-marketing period and in pivotal phase II and phase III clinical trials.
Danish: * Inklusiv en bivirkning af grad 5 ** Forhøjet alkalisk fosfatase blev rapporteret i perioden efter markedsføring og i pivotale fase II og fase III kliniske studier.
English: ● if you are allergic to alectinib or any of the other ingredients of this medicine (listed in section 6).
Danish: ● hvis du er allergisk over for alectinib eller et af de øvrige indholdsstoffer i Alecensa (angivet i afsnit 6).
English: Permanently discontinue if no contributing concomitant medicinal product is identified.
Danish: Seponér behandlingen permanent, såfremt der ikke identificeres bidragende samtidig behandling.
English: The majority of patients had no history of smoking (70%).
Danish: Størstedelen af patienterne havde ikke røget (70%).
English: Alecensa can be prescribed to you as first treatment of your lung cancer, or if you have been previously treated with a medicine containing ‘crizotinib'.
Danish: Alecensa kan ordineres til dig som første behandling af lungekræft, eller hvis du tidligere er blevet behandlet med medicin, som indeholder 'crizotinib'.
English: ● alteration in sense of taste
Danish: ● ændring i smagssans
English: Alectinib caused embryo-foetal toxicity in pregnant rats and rabbits.
Danish: Alectinib forårsagede embryo-føtal toksicitet hos drægtige rotter og kaniner.
English: Grades 3-4
Danish: Grad 3-4*
English: ● Do not take a double dose to make up for a missed dose.
Danish: ● Tag aldrig en dobbeltdosis som erstatning for en glemt dosis.
English: Permanently discontinue Alecensa.
Danish: Seponér Alecensa permanent.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 February 2017
Danish: Dato for første markedsføringstilladelse: 16. februar 2017 Dato for fornyelse af tilladelsen: 1. december 2017
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}.
English: Tell your doctor straight away if you notice any of the following side effects.
Danish: Kontakt straks lægen, hvis du bemærker en eller flere af nedenstående bivirkninger.
English: If you have severe liver problems before starting your treatment with Alecensa:
Danish: Hvis du har svært nedsat leverfunktion før du begynder i behandling med Alecensa: