FrancophonIA/ELRC3.0 huggingface dataset:
English: Gout: The recommended oral dose of Febuxostat Krka is 80 mg once daily without regard to food.
Danish: Arthritis urica: Den anbefalede orale dosis af Febuxostat Krka 80 mg er én gang dagligt uden hensyntagen til fødeindtagelse.
English: IJ
Danish: U2e
English: Febuxostat Krka tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body.
Danish: Febuxostat Krka tabletter indeholder det aktive stof febuxostat og bruges til behandling af urinsyregigt.
English: BOX
Danish: KARTON
English: Febuxostat Krka 80 mg tablets febuxostat
Danish: Febuxostat Krka 80 mg tabletter febuxostat
English: 14C
Danish: 4.4 og
English: Febuxostat Krka 120 mg tablets febuxostat
Danish: Febuxostat Krka 120 mg tabletter febuxostat
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt denne indlægsseddel.
English: Tumor Lysis Syndrome
Danish: Tumorlysesyndrom
English: Febuxostat Krka 80 mg film-coated tablets Febuxostat Krka 120 mg film-coated tablets febuxostat
Danish: Febuxostat Krka 80 mg filmovertrukne tabletter Febuxostat Krka 120 mg filmovertrukne tabletter febuxostat
English: If you miss a dose of Febuxostat Krka take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time.
Danish: Hvis du snart skal tage den næste dosis, så spring den glemte dosis over.
English: There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of febuxostat, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk.
Danish: Der er i sjældne tilfælde indberettet udslæt, som kan være livstruende (Stevens-Johnsons syndrom) ved brug af febuxostat.
English: It is not known if Febuxostat Krka may harm your unborn child. Febuxostat Krka should not be used during pregnancy.
Danish: Det vides ikke, om Febuxostat Krka kan være skadeligt for det ufødte barn.
English: Fatigue, chest pain, chest discomfort Rare
Danish: Træthed, smerter i brystet, trykken for brystet Sjældne
English: Modelling and simulation analysis of data from a pre-clinical study in rats indicates that, in case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose (see section 4.4 and 5.3).
Danish: Modellering og simuleringsanalyser med data fra et præklinisk studie med rotter har vist, at dosen af mercaptopurin/azathioprin bør reduceres til maksimalt 20 % af den tidligere ordinerede dosis ved samtidig administration med febuxostat (se pkt.
English: - abnormal liver test results - diarrhoea - headache - rash (including various types of rash, please see below under “uncommon” and “rare” sections) - nausea - increase in gout symptoms - localised swelling due to retention of fluids in tissues (oedema).
Danish: og 'sjældne bivirkninger') - kvalme - øget forekomst af gigtsymptomer - lokale hævelser pga. væskeophobning i vævene (ødem).
English: In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03;95% CI 0.871.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
Danish: 5.1 for detaljer om forsøget) svarede antallet af alvorlige kardiovaskulære hændelser (MACE) for febuxostat til det for patienter behandlet med allopurinol (HR 1,03; 95 % CI: 0,87-1,23), men der blev observeret et højere antal kardiovaskulære dødsfald (4,3% vs. 3,2 % af patienterne; HR 1,34; 95 % CI: 1,03-1,73).
English: Renal and urinary disorders
Danish: Udbrud af arthritis urica
English: Febuxostat Krka 120 mg film-coated tablets
Danish: Febuxostat Krka 120 mg filmovertrukne tabletter
English: In this subgroup febuxostat achieved the primary efficacy endpoint (sUA < 6.0 mg/dL at the last 3 visits) in 41% (80 mg QD), 48% (120 mg QD), and 66% (240 mg QD) of patients compared to 9% in the allopurinol 300 mg/100 mg QD and 0 % in the placebo groups.
Danish: Primært endepunkt i undergruppen af patienter med serumurinsyre ≥ 595 µg/l (10 mg/dl) Cirka 40 % af patienterne (kombineret APEX og FACT) havde et serumurinsyreniveau ved baseline på ≥ 10 mg/dl. I denne undergruppe blev febuxostats primære effektmål (serumurinsyre < 6,0 mg/dl ved de sidste 3 besøg) opnået hos 41 % (80 mg en gang dagligt), 48 % (120 mg en gang dagligt) og hos 66 % (240 mg en gang dagligt) af patienterne sammenlignet med 9 % af patienterne i grupperne, der fik allopurinol 300 mg/100 mg en gang dagligt, og 0 % af patienterne i placebogrupperne.
English: Febuxostat Krka 80 mg film-coated tablets
Danish: Febuxostat Krka 80 mg filmovertrukne tabletter
English: Febuxostat Krka 120 mg film-coated tablets febuxostat
Danish: Febuxostat Krka 120 mg filmovertrukne tabletter febuxostat
English: Febuxostat Krka 80 mg film-coated tablets febuxostat
Danish: Febuxostat Krka 80 mg filmovertrukne tabletter febuxostat
English: Tablet dimension: approximatelly 16 mm × 8 mm.
Danish: Tabletten måler ca. 16 mm × 8 mm. Delekærven er kun til at dele tabletten, så den er nemmere at sluge.
English: Contact your doctor immediately if you experience muscle pain, tenderness or weakness - severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands,
Danish: Kontakt straks lægen, hvis du får muskelsmerter, -ømhed eller -slaphed - svære hævelser i de dybere lag af huden, især omkring læber, øjne, kønsorganer, hænder, fødder eller tunge, muligvis sammen med pludseligt vejrtrækningsbesvær - høj feber kombineret med mæslingelignende udslæt, forstørrede lymfekirtler, forstørrelse af leveren, leverbetændelse (op til leversvigt), forhøjet antal hvide blodlegemer i blodet
English: Tablet dimension: approximatelly 19 mm × 8 mm.
Danish: Tabletten måler ca. 19 mm × 8 mm. Delekærven er kun til at dele tabletten, så den er nemmere at sluge.
English: Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Febuxostat Krka indeholder lactose og natrium Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with Febuxostat Krka and your doctor may wish to consider necessary measures: - Mercaptopurine (used to treat cancer) - Azathioprine (used to reduce immune response) - Theophylline (used to treat asthma)
Danish: - Mercaptopurin (anvendes til behandling af kræft) - Azathioprin (anvendes til at hæmme immunsystemet) - Theophyllin (anvendes til behandling af astma)
English: What Febuxostat Krka is and what it is used for What you need to know before you take Febuxostat Krka How to take Febuxostat Krka Possible side effects
Danish: Det skal du vide, før du begynder at tage Febuxosat Krka Sådan skal du tage Febuxosat Krka Bivirkninger
English: Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine.
Danish: Forhøjet blodglucose, forlænget aktiveret partiel tromboplastintid, nedsat erytrocyttal, forhøjet basisk phosphatase, forhøjet kreatinphosphokinase i blodet*
English: (hemorrhage, seen only in patients taking chemotherapy for blood disorders) - cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis - dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort - itching, hives, skin inflammation, skin discoloration, small red or purple spots on the skin,
Danish: (leukocytose med eller uden eosinofili) - rødme af huden (erytem), forskellige former for udslæt (f.eks. kløende, med hvide pletter, med blærer, med betændte blærer, med afskalning eller mæslingelignende), udbredt rødme af huden,
English: In conclusion, the CHMP agrees that the responses submitted by the Applicant indicate that the issues are resolved.
Danish: Som konklusion kan CHMP tilslutte sig, at den af ansøgeren forelagte besvarelse viser, at spørgsmålene er afklaret.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VANTAS (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF VANTAS (se bilag I)
English: Marketing Authorisation Holder Applicant
Danish: Indehaver af markedsføringstilladelse
English: There is no indication that any of the members within this class differs with respect to efficacy and safety, and Vantas seems to be no exception in that respect.
Danish: Intet tyder på, at medlemmerne af klassen afviger indbyrdes med hensyn til virkning og sikkerhed, og Vantas synes ikke at danne en undtagelse i denne henseende.
English: The local safety of Vantas is sufficiently investigated and further comparative studies are not necessary.
Danish: Den lokale sikkerhed af Vantas er tilstrækkelig undersøgt, og yderligere sammenlignende undersøgelser er ikke nødvendige.
English: A distinction should be made between safety aspects of androgen suppression therapy in general and the (local) safety of this product.
Danish: Der må skelnes mellem sikkerhedsaspekterne af antiandrogen behandling generelt og den (lokale) sikkerhed af det aktuelle produkt.
English: Denmark Valera Pharmaceuticals Ireland Ltd. 25-28 North Wall Quay, Dublin, Ireland
Danish: 25-28 North Wall Quay, Dublin, Irland
English: With an efficacy of 98-100% in serum testosterone reduction further active comparator studies are redundant and thus not necessary.
Danish: Med en virkning på 98-100 % i reduktion af serum-testosteron er yderligere undersøgelser med aktivt sammenligningspræparat overflødige.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: The safety database seems limited, but no unexpected safety issues have occurred nor in the American post marketing surveillance neither in the trials.
Danish: Sikkerhedsdatabasen forekommer begrænset, men hverken i den amerikanske overvågning efter markedsføring eller i de kliniske undersøgelser er der forekommet uventede sikkerhedsproblemer.
English: The safety of androgen suppression is well known and further information is not necessary for this product.
Danish: Sikkerheden af antiandrogen behandling er veldokumenteret, og yderligere oplysninger er ikke nødvendige for dette produkt.
English: Androgen ablation is considered to be a palliative treatment.
Danish: Antiandrogen behandling betragtes som palliativ.
English: In the past, testosterone suppression was achieved by bilateral orchiectomy (surgical castration).
Danish: Tidligere opnåedes suppression af testosteron ved bilateral orkietomi (kirurgisk kastration).
English: The proposal of the applicant/MAH to include five pharmacovigilance safety concerns in the Risk Management Plan is endorsed (two relate specifically to the unique Vantas formulation while the other three are classified as class effects: expulsions, cellulitis, flare, osteoporosis and QT prolongation).
Danish: Forslaget fra ansøgeren/indehaveren af markedsføringstilladelsen om at medtage fem sikkerhedshensyn i risikostyringsplanen kan godtages (heraf vedrører de to specielt formuleringen af Vantas, mens de andre tre kan klassificeres som klassevirkninger: afstødning, cellulitis, rødme, osteoporose og forlænget QT-interval).
English: Serum testosterone concentrations that correspond to castration levels have generally been set at less than 50 ng/dL (1.7 nmol/L), given the known variability of values in reference laboratories.
Danish: Det niveau af serum-testosteron, der svarer til kastration, er sædvanligvis blevet sat til under 50 ng/dl (1,7 nmol/l), idet der tages højde for den kendte målevariation på referencelaboratorier.
English: In principle, it is important to achieve serum testosterone concentrations as low as possible for ADT to minimize stimulation of prostate cancer cells.
Danish: I princippet er det vigtigt at opnå så lav serumtestosteron som muligt, så den antiandrogene behandling minimerer stimulationen af prostatacancerceller.
English: Another LHRH agonist could be used, but this is superfluous considering the meta-analysis presented by Applicant, orchidectomy is not acceptable when reversible methods are available, DES is obsolete and non-steroidal anti-androgens may have inferior efficacy when used as monotherapy.
Danish: Der kunne have været anvendt en anden GnRH-analog, hvilket dog er overflødigt på baggrund af den af ansøgeren fremlagte metaanalyse; orkiektomi er uacceptabel, når reversible metoder foreligger, diethylstilbestrol er obsolet, og nonsteroide antiandrogener kan have ringere virkning anvendt som monoterapi.
English: The data of the Long Term Extension of Study 301 support long-term safety for patients treated with Vantas for two or more years.
Danish: Data fra langtidsforlængelsen af undersøgelse 301 underbygger den langsigtede sikkerhed ved behandling med Vantas i to år eller længere.
English: Vantas is a new LHRH agonist and this pharmacological class was introduced for the treatment of advanced prostate cancer more than 20 years ago.
Danish: Vantas er en ny GnRH-analog tilhørende en farmakologisk klasse, der er indført til behandling af fremskreden prostatacancer for over 20 år siden.
English: The CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure as mentioned in Annex III for Vantas.
Danish: CHMP anbefalede udstedelse af markedsføringstilladelsen, for hvilken produktresumé, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III for Vantas.
English: The achievement of castrate levels of testosterone is an acceptable surrogate endpoint in hormone sensitive advanced prostate cancer which can be translated into less pain from bone metastases, improvement in urinary flow, and in some cases slowing of tumour progression, although a clear-cut survival benefit has not been demonstrated.
Danish: Opnåelse af et kastratniveau af testosteron er et acceptabelt surrogat-endepunkt ved hormonfølsom fremskreden prostatacancer og resulterer i mindskelse af smerter fra knoglemetastaser, bedre urinflow og undertiden langsommere progression af tumor, dog uden at en fordel i form af klart bedre overlevelse er påvist.
English: However, even in the androgenindependent state, prostate cancer is likely to contain subpopulations of cells that are androgen dependent.
Danish: Selv i den androgenuafhængige tilstand danner prostatacancer dog sandsynligvis underpopulationer af celler, der er androgenafhængige.
English: Thus, the documented pharmacological endpoint serum testosterone < 50 ng/dL, documented for Vantas in studies 302, 301 and in addition in the Long Term Extension of Study 301 is an acceptable primary efficacy endpoint in patients with advanced prostate cancer.
Danish: Det farmakologiske endepunkt, serumtestosteron < 50 ng/dl, der er dokumenteret for Vantas i undersøgelse 302 og 301 foruden i langtidsforlængelsen af undersøgelse 301, er således et acceptabelt primært endepunkt for virkning hos patienter med fremskreden prostatacancer.
English: ANNEX III SUMMARY OF PRODUCT CHARACHTERITICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: Furthermore, reduction of testosterone to castrate levels has been accepted as a valid surrogate for clinical efficacy in advanced prostate cancer by the CHMP in 2004 as part of scientific advice from the SAWP.
Danish: CHMP har da også accepteret reduktion af testosteron til kastratniveau som et gyldigt surrogat for klinisk virkning ved fremskreden prostatacancer, hvilket skete i en faglig udtalelse i 2004 fra arbejdsgruppen vedrørende videnskabelig rådgivning (SAWP).
English: For the last two decades, injection of long-acting luteinizing hormone-releasing hormone agonists (LH-RHas) has been used to achieve androgen ablation.
Danish: I de to seneste tiår er injektion af langtidsvirkende gonadotropinfrigørende hormonanaloger (GnRH-analoger) blevet anvendt til at opnå suppression af testosteron.
English: The data from the Long Term Extension Study 301 concerning efficacy and safety are in support for both long-term efficacy and safety for patients, receiving palliative treatment of advanced prostate cancer with histrelin implant for two or more years.
Danish: Data fra langtidsforlængelsen af undersøgelse 301 vedrørende virkning og sikkerhed underbygger den langsigtede virkning og sikkerhed ved palliativ behandling af fremskreden prostatakræft med histrelin-implantat i to år eller længere.
English: United Kingdom
Danish: Det Forenede Kongerige (Storbritannien)
English: The CHMP requests the inclusion, as proposed by the Applicant/MAH, of the five pharmacovigilance safety concerns in the Risk Management Plan as mentioned above.
Danish: CHMP anmoder om, at de fem sikkerhedshensyn ved lægemiddelovervågningen medtages i risikostyringsplanen som ovenfor nævnt og som foreslået af ansøgeren/indehaveren af markedsføringstilladelsen.
English: On the basis of these limited data, continued androgen suppression in men with androgenindependent prostate cancer (AIPC) is the current standard of care.
Danish: På grundlag af disse begrænsede oplysninger er vedholdende antiandrogen behandling i dag standardbehandlingen af androgen-uafhængig prostatacancer (AIPC).
English: Late in the clinical course, it is androgen independent, and is refractory to hormonal therapy.
Danish: Sent i det kliniske forløb er prostatacancer uafhængig af androgen og refraktær over for hormonbehandling.
English: Early in its natural cycle, prostate cancer is androgen dependent.
Danish: I den tidlige del af sit spontane forløb er prostatacancer androgenafhængig.
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: ASTRAZENECA 1, place Renault 92844 Rueil Malmaison Cedex FRANCE
Danish: ASTRAZENECA 1, place Renault 92844 Rueil Malmaison Cedex
English: AstraZeneca S.p.A. Palazzo Volta Via Francesco SforzaBasiglio (Milano) 20080 Italy
Danish: Palazzo Volta Via Francesco SforzaBasiglio (Milano) 20080 Italy
English: 1180 Bruxelles
Danish: 1180 Ukkel Belgium
English: Emla krém 5% lidocaine prilocaine
Danish: Emla krém 5% lidocain prilocain
English: AstraZeneca GmbH Tinsdaler Weg 183 22876 Wedel Germany
Danish: AstraZeneca GmbH 22876 Wedel Germany
English: 2719 EE Zoetermeer The Netherlands cream; hydrophilic cutaneous use
Danish: Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands creme; hydrofil
English: Luxembourg NV AstraZeneca SA Rue Egide Van Ophem 110
Danish: NV AstraZeneca SA Rue Egide Van Ophem 110 1180 Bruxelles Belgium
English: ASTRAZENECA FARMACEUTICA SPAIN, S.A. Serrano Galvache 56
Danish: ASTRAZENECA FARMACEUTICA SPAIN, S.A.
English: Czech Republic AstraZeneca UK Limited 2 Kingdom Street
Danish: AstraZeneca UK Limited 2 Kingdom Street W2 6BD London United Kingdom
English: EMLA 5% w/w Cream lidocaine prilocaine
Danish: Emla 5% - Creme lidocain prilocain
English: The Netherlands AstraZeneca B.V. Louis Pasteurlaan 5
Danish: AstraZeneca B.V.
English: The European Commission granted a marketing authorisation valid throughout the EU for Advate on 2 March 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Advate den 2. marts 2004.
English: Advate is intended for either short-term or long-term use.
Danish: Advate er beregnet til enten kortvarig eller langvarig brug.
English: In addition, 81% of these bleeding episodes required only a single treatment with Advate.
Danish: Endvidere krævede 81 % af disse blødningsepisoder kun en enkelt behandling med Advate.
English: The full EPAR for Advate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Advate findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Advate.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Advate.
English: Other information about Advate
Danish: Andre oplysninger om Advate
English: Hypersensitivity (allergic) reactions have been reported and may in some cases become severe.
Danish: Der er indberettet allergiske reaktioner, som i visse tilfælde kan være alvorlige.
English: The effectiveness of Advate was rated as ‘excellent' or ‘good' in 86% of 510 new bleeding episodes.
Danish: Advates virkning blev bedømt som "udmærket" eller "god" i 86 % af 510 nye blødningsepisoder.
English: Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Danish: Octocog alfa fremstilles ved hjælp af en metode, der kaldes "rekombinant dna-teknologi", dvs. det fremstilles af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere det.
English: Why is Advate approved?
Danish: Hvorfor blev Advate godkendt?
English: The data provided on immune tolerance induction in patients with inhibitors were not considered sufficient to specifically approve the medicine for this use.
Danish: De data, der blev fremlagt om immuntoleransinduktion hos patienter med antistoffer, blev ikke betragtet som tilstrækkelige til specifikt at godkende lægemidlet til denne anvendelse.
English: Patients or their carers may be able to administer Advate themselves at home once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsgiver har mulighed for selv at indgive Advate hjemme efter at have fået passende instruktion.
English: What measures are being taken to ensure the safe and effective use of Advate?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Advate?
English: It is not intended to provide practical advice on how to use Advate.
Danish: Det er ikke en praktisk vejledning i, hvordan Advate bør anvendes.
English: The additional studies confirmed Advate's effectiveness, including in children under 6 years of age.
Danish: De yderligere undersøgelser bekræftede Advates virkning, herunder hos børn under seks år.
English: Common side effects with Advate (affecting between 1 and 10 patients in 100) are headache and pyrexia (fever).
Danish: Almindelige bivirkninger ved Advate (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine og feber.