FrancophonIA/ELRC3.0 huggingface dataset:
English: Allergic reactions usually happen within 2 hours of the infusion, but may also happen at a later time.
Danish: Allergiske reaktioner opstår sædvanligvis inden for to timer efter infusionen, men kan også forekomme senere.
English: Number (%) of Subjects Who Met Response Criteria
Danish: Antal ( %) af deltagerne, der opfyldte responskriterierne sikkerhedsinterval1
English: Do not use KRYSTEXXA if you are pregnant or breast-feeding, since it is not known how it will affect you or your baby.
Danish: Brug ikke KRYSTEXXA, hvis du er gravid eller ammer, da det ikke vides, hvordan det vil påvirke dit barn.
English: The average molecular mass of pegloticase is approximately 545 kDa of which the protein moiety constitutes approximately 137 kDa.
Danish: Den gennemsnitlige molmasse af pegloticase er ca. 545 kDa, hvoraf proteindelen udgør ca. 137 kDa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL ENHEDER
English: KRYSTEXXA is not recommended during pregnancy.
Danish: KRYSTEXXA anbefales ikke under graviditet.
English: Taking into account the PRAC Assessment Report on the PSUR for pegloticase, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en for pegloticase, er CHMP nået frem til følgende videnskabelige konklusioner:
English: 4.6 Fertility, Pregnancy and Lactation
Danish: 4.6 Fertilitet, graviditet og amning
English: Patients over 100 kg body weight
Danish: Patienter med legemsvægt over 100 kg
English: The potency of this product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Danish: Produktets potens kan ikke sammenholdes med potensen af andre pegylerede eller ikke pegylerede proteiner af samme farmakoterapeutiske klasse.
English: Adverse Reactions System Organ Class
Danish: Bivirkninger Systemorganklasse
English: The optimal treatment duration has not been established (see section 4.4).
Danish: Den optimale behandlingsvarighed er ikke fastlagt (se pkt.
English: This should be considered when the decision is made for a therapy longer than 6 months.
Danish: Dette bør tages i betragtning ved stillingtagen til behandling i længere end seks måneder.
English: Assessment Time point
Danish: Vurderingstidspunkt
English: Keep the vial in the outer carton in order to protect from light.
Danish: Hætteglasset opbevares i yderpakningen for at beskytte det mod lys.
English: However, due to variability in the AUC values, AUC proportionality was not seen which might be a reflection of antibody clearance for some of the subjects.
Danish: Som følge af variabiliteten af AUC-værdierne var der ikke proportionalitet af AUC, hvilket muligvis afspejler clearance af antistoffer for nogle deltageres vedkommende.
English: PSURs The PSUR cycle for the medicinal product should follow the standard requirements.
Danish: PSUR'er Lægemidlets PSUR-cyklus skal følge standardbestemmelserne.
English: It is unknown whether pegloticase or its metabolites are excreted in human milk.
Danish: Det vides ikke, om pegloticase eller dets metabolitter udskilles i modermælk.
English: Overall Complete Tophus Resolution (Pooled Analysis of GOUT 1 and GOUT 2)
Danish: Totalt fuldstændigt svind af tophi (poolet analyse af GOUT 1 og GOUT 2)
English: Clear to slightly opalescent, colourless solution at pH 7.3±0.3.
Danish: Klar til let opaliserende, farveløs opløsning med pH 7,3±0,3.
English: These medicines may put you at higher risk of infusion reaction.
Danish: Disse lægemidler kan øge risikoen for, at du får en infusionsreaktion.
English: The effect of treatment on tophi was assessed using standardized digital photography and image analysis by a Central Reader blinded to treatment assignment.
Danish: Behandlingens virkning på tophi blev vurderet ved standardiseret digital fotografering og central billedanalyse, der var blindet for behandlingsarm.
English: The MAH shall complete, within the stated timeframe, the following measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme træffe følgende foranstaltninger:
English: Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe og systemorganklasse er bivirkningerne opstillet i rækkefølge efter aftagende alvorlighed.
English: It is especially important to tell your doctor if you are currently taking other urate-lowering medicines (such as allopurinol or Febuxostat) or medicines containing polyethylene glycol (PEG) (such as pegylated interferon or Doxorubicin).
Danish: Det er især vigtigt, at du fortæller det til lægen, hvis du får andre uratsænkende lægemidler (såsom allopurinol eller febuxostat) eller lægemidler, der indeholder polyethylenglycol (PEG) (såsom pegyleret interferon eller doxorubicin).
English: Study protocol within 2 months after Commission Decision
Danish: Undersøgelsens protokol foreligger senest to måneder efter
English: The decision to treat with KRYSTEXXA should be based on an on-going assessment of the benefits and risks for the individual patient (see section 4.4).
Danish: Beslutningen om anvendelse af KRYSTEXXA bør baseres på en løbende vurdering af fordele og risici for den enkelte patient (se pkt.
English: All patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) should be screened for G6PD deficiency before starting KRYSTEXXA.
Danish: Alle patienter med forhøjet risiko for G6PD-mangel (f.eks. patienter med oprindelse i Afrika eller Middelhavsområdet) bør screenes for G6PD-mangel før påbegyndelse af behandling med KRYSTEXXA.
English: If you have a reaction during the infusion, your doctor may stop or adjust the treatment.
Danish: Hvis du får en reaktion under infusionen, vil lægen muligvis standse eller korrigere behandlingen.
English: People with gout have too much uric acid in their body.
Danish: Ved urinsyregigt har man for meget urinsyre i kroppen.
English: Uncommon: Cellulitis
Danish: Ikke almindelig: cellulitis
English: Your doctor may test you for G6PD before you start KRYSTEXXA.
Danish: Lægen vil muligvis undersøge dig for G6PD, før du begynder at få KRYSTEXXA.
English: The recommended dose is 8 mg pegloticase given as an intravenous infusion every two weeks.
Danish: Den anbefalede dosis er 8 mg pegloticase, der gives som en intravenøs infusion hver 2. uge.
English: The population PK analyses showed that age, sex and weight did not influence the pharmacokinetics of pegloticase.
Danish: De populationsfarmakokinetiske analyser viste, at alder, køn og vægt var uden betydning for farmakokinetikken af pegloticase.
English: Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på etiketten og på kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: infusion) and your treatment will take about 2 hours or sometimes longer.
Danish: Behandlingen varer ca. 2 timer, undertiden længere.
English: Warnings and precautions Talk to your doctor or nurse before using KRYSTEXXA:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du bruger KRYSTEXXA:
English: Prenatal and postnatal development study in rats, as well as the embryofetal development study in rabbits are ongoing.
Danish: Der pågår undersøgelser af den prænatale og postnatale udvikling hos rotter og den embryoføtale udvikling hos kaniner.
English: Reports of infusion related reactions or anaphylaxis coincident with concomitant use of oral urate lowering agents were submitted in this Periodic Safety Update Report, where infusion reactions in 28 cases and 9 cases with anaphylactic reactions were reported.
Danish: Rapporter om infusionsrelaterede reaktioner eller anafylakse sammenfaldende med sideløbende brug af oral uratsænkende medicin blev indsendt i denne periodiske opdaterede sikkerhedsindberetning, hvor der blev rapporteret infusionsreaktioner i 28 tilfælde og anafylaktiske reaktioner i 9 tilfælde.
English: Therefore, in view of available data regarding anaphylaxis and infusion reactions, the Pharmacovigilance Risk Assessment Committee considered that changes to the product information were warranted.
Danish: Derfor, baseret på tilgængelige data for anafylakse og infusionsreaktioner, anså Udvalget for risikovurdering ved lægemiddelovervågning (PRAC) ændringerne til produktinformationen som berettigede.
English: Bio-Technology General (Israel) Ltd. Be'er Tuvia Industrial Park Kiryat Malachi 83104
Danish: Bio-Technology General (Israel) Ltd. Be'er Tuvia Industrial Zone P.O. Box 571
English: Week 25
Danish: Uge 25
English: The results of the on-going reproductive toxicity studies are not available (see section 5.3).
Danish: Resultaterne af de igangværende reproduktionstoksicitetsundersøgelser foreligger endnu ikke (se pkt.
English: For instructions on the preparation of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om klargøring af lægemidlet før administration, se pkt.
English: KRYSTEXXA contains the active substance pegloticase.
Danish: KRYSTEXXA indeholder det aktive stof pegloticase.
English: Infusion-related reactions showed a tendency to occur in a greater proportion of patients with over 100 kg bodyweight.
Danish: Infusionsrelaterede reaktioner havde tendens til at optræde hos en større andel af de patienter, hvis legemsvægt var over 100 kg.
English: How much KRYSTEXXA is given
Danish: Hvor meget KRYSTEXXA der gives
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin, har gjort det for nylig eller påtænker at gøre det.
English: The Phase 1 pharmacokinetics showed proportionality within the dose interval (0.5 - 8 mg) as reflected in Cmax values.
Danish: Fase 1-farmakokinetikken viste proportionalitet i dosisområdet 0,5-8 mg, hvilket afspejles i værdierne af Cmax.
English: The PK/PD analysis showed that higher doses were associated with lower uric acid levels and a more rapid decrease in these levels than lower doses.
Danish: PK/PD-analysen viste, at højere doser var forbundet med lavere og hurtigere aftagende værdier af serumurinsyre end lavere doser.
English: The applicant should conduct a long-term EU observational study to end December 2018 on safety of pegloticase use in adult hyperuricemic patients with severe debilitating chronic tophaceous gout and efficacy and safety data in reexposed patients.
Danish: Ansøgeren udfører en langsigtet EU-observationsundersøgelse med afslutning i december 2018 vedrørende sikkerheden for anvendelse af pecloticase hos voksne hyperurikæmiske patienter med svær invaliderende kronisk toføs artritis urica og vedrørende virkningen og sikkerheden hos patienter, der reeksponeres.
English: • KRYSTEXXA vial should be visually inspected for particles and discolouration prior to dilution and administration.
Danish: • Hætteglasset med KRYSTEXXA skal kontrolleres visuelt for partikler og misfarvning inden fortynding og administration.
English: Week 13
Danish: Uge 13
English: • a swelling of the throat, tongue or other part of your body
Danish: • hævelse af svælget, tungen eller andre områder af kroppen
English: Anti-pegloticase antibodies were associated with an increase in CL and Vc as determined by compartmental analysis.
Danish: Anti-pegloticase-antistoffer er forbundet med en stigning i CL og Vc, bestemt ved compartmentel analyse.
English: For the PEG moiety, urinary excretion is likely to be the major route of elimination.
Danish: For PEG-delen er renal udskillelse antagelig den vigtigste eliminationsvej.
English: • If you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism.
Danish: • hvis du har den sjældne blodsygdom glukose-6-fosfatdehydrogenase-(G6PD)-mangel (favisme).
English: One patient treated with KRYSTEXXA 8 mg every 4 weeks experienced a delayed type hypersensitivity reaction.
Danish: Hos én patient, der blev behandlet med KRYSTEXXA, 8 mg hver 4. uge, optrådte en forsinket hypersensitivitetsreaktion.
English: KRYSTEXXA in a vial or in an intravenous infusion fluid must never be subjected to artificial heating (e.g., hot water, microwave).
Danish: KRYSTEXXA må hverken i hætteglasset eller i infusionsvæsken nogensinde opvarmes kunstigt (f.eks. med varmt vand eller mikroovn).
English: The degree of vacuolization and the number of tissues affected appeared to be dependent both on the applied pegloticase dose and the duration of exposure.
Danish: Graden af vakuolisering og antallet af berørte typer væv afhang tilsyneladende både af dosis og eksponeringsvarighed af pegloticase.
English: Anaphylaxis (characterized by stridor, wheezing, peri-oral/lingual oedema, or hemodynamic instability, with or without rash or urticaria) occurred in 14 (5.1%) of 273 total patients treated with KRYSTEXXA in clinical studies.
Danish: Der optrådte anafylaksi (karakteriseret af stridor, ronchi, perioralt/lingualt ødem eller hæmodynamisk ustabilitet, med eller uden rødme eller urticaria) hos 14 (5,1 %) ud af i alt 273 patienter, der blev behandlet med KRYSTEXXA i kliniske undersøgelser.
English: Before you start treatment with KRYSTEXXA, your doctor may recommend that you take other medicines (such as an antihistamine, paracetamol and a corticosteroid) to help reduce the risk that you will get infusion-related reactions due to this treatment.
Danish: Før du begynder behandlingen med KRYSTEXXA, vil din læge muligvis anbefale, at du får anden medicin (såsom et antihistamin, paracetamol og et kortikosteroid) for at mindske risikoen for, at du får infusionsbetingede reaktioner ved behandlingen.
English: On the basis of the scientific conclusions for pegloticase the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing pegloticase is favourable subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for pegloticase er CHMP af den opfattelse, at benefit/risk-forholdet for det/de lægemiddel/lægemidler, der indeholder pegloticase, er gunstigt under forudsætning af, at de foreslåede ændringer indføres i produktinformationen
English: No case of overdose with KRYSTEXXA has been reported during clinical development.
Danish: Der er ikke beskrevet tilfælde af overdosering med KRYSTEXXA i den kliniske udviklingsperiode.
English: They were reported in 54% of the patients in the 70 to ≤100 kg weight group, 70% of the patients in the >100 to ≤120 kg weight group, and 75% of patients in the >120 kg weight group, respectively.
Danish: Sådanne reaktioner blev indberettet hos 54 % af patienter i vægtgruppen 70 til ≤100 kg, 70 % af patienterne i vægtgruppen >100 til ≤120 kg og 75 % af patienterne i vægtgruppen >120kg.
English: Pegloticase belongs to the class anti-gout medicines.
Danish: Pegloticase tilhører klassen af lægemidler mod urinsyregigt.
English: Medicinal product subject to medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet er receptpligtigt (se bilag I: Produktresumé, pkt.
English: If you do not feel well, experience symptoms such as dizziness or headache, or are tired after receiving KRYSTEXXA, you should not drive or operate any machines.
Danish: Hvis du er utilpas eller har symptomer som svimmelhed og hovedpine eller bliver træt efter at fået KRYSTEXXA, skal du undgå at føre motorkøretøj eller betjene maskiner.
English: The revised order of the two corresponding paragraphs is to emphasize the correlation between concomitant medication with urate lowering products and serum uric acid measurement.
Danish: Den reviderede rækkefølge af de to tilhørende afsnit er foretaget for at fremhæve sammenhængen mellem sideløbende brug af uratsænkende lægemidler og måling af serumurinsyre.
English: If haemolysis and/or methemoglobinemia occur in patients receiving KRYSTEXXA, treatment should be immediately and permanently discontinued and appropriate measures initiated.
Danish: Hvis der indtræder hæmolyse og/eller methæmoglobinæmi hos patienter i behandling med KRYSTEXXA, bør behandlingen straks og permanent seponeres og passende foranstaltninger iværksættes.
English: No dose adjustment is needed for patients 65 years of age and older.
Danish: Der behøves ingen dosisjustering for patienter over 65 år.
English: The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-erne ændres.
English: KRYSTEXXA contains sodium
Danish: KRYSTEXXA indeholder natrium
English: Intravenous use
Danish: Til intravenøs anvendelse
English: • OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES
Danish: • Forpligtelse til træffe foranstaltninger efter udstedelse af markedsføringstilladelse
English: KRYSTEXXA will be administered by a doctor or nurse who will monitor you for side effects while you receive KRYSTEXXA and for some time afterwards.
Danish: Lægen eller sygeplejersken, som giver dig KRYSTEXXA, vil overvåge dig for bivirkninger, mens du får KRYSTEXXA og et stykke tid efterfølgende.
English: It is recommended that patients suspected of receiving an overdose be monitored, and general supportive measures be initiated as no specific antidote has been identified.
Danish: Ved mistanke om overdosis anbefales overvågning af patienten og almindelig støttende behandling, da der ikke er fundet nogen specifik antidot.
English: The average number of gout flares per patient was 10 during the 18 months prior to study entry.
Danish: Det gennemsnitlige antal akutte anfald af artritis urica pr. patient var 10 i løbet af de 18 måneder forud for inklusionen i undersøgelsen.
English: The most commonly reported serious side effects are: severe acute allergic reactions (common), infusion reactions (very common), and gout flares (very common).
Danish: De hyppigst indberettede alvorlige bivirkninger er: svære akutte allergiske reaktioner (almindelige), infusionsreaktioner (meget almindelige) og akutte anfald af urinsyregigt (meget almindelige).
English: Week 19
Danish: Uge 19
English: Only solutions which are clear to slightly opalescent, colourless and free of visible particles should be used.
Danish: Opløsningen må kun anvendes, hvis den er klar til let opaliserende og farveløs uden synlige partikler.
English: • When new information is received that may impact on the current Safety Specification,
Danish: • når der modtages nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation eller lægemiddelovervågningsplan eller på risikominimeringsaktiviteterne
English: Very common: Dermatitis, urticaria, pruritus, skin irritation, dry skin
Danish: Meget almindelig: dermatitis, urticaria, pruritus, hudirritation, tør hud
English: In the post-marketing setting, severe anaphylactic reactions have been reported, including loss of consciousness, circulatory collapse, and cardiac arrest, which required transfer to hospital emergency department.
Danish: Efter markedsføring er indberettet svære anafylaktiske reaktioner, herunder bevidsthedstab, kredsløbskollaps og hjertestop, som krævede overførsel til akutafdeling.
English: The mean Cmax calculated on the last infusion was 2.17 µg/ml (range: 1.25 - 4.77).
Danish: Den gennemsnitlige Cmax, beregnet for sidste infusion, var 2,17 µg/ml (område: 1,25-4,77).
English: p-Value3
Danish: p-værdi3
English: The pharmacokinetics of KRYSTEXXA has not been studied in children and adolescents.
Danish: Farmakokinetikken af KRYSTEXXA er ikke undersøgt hos børn og unge.
English: In repeated dose toxicity studies with KRYSTEXXA in rats and dogs, the occurrence of pegloticase-containing vacuoles was observed in different tissues.
Danish: I toksicitetsundersøgelserne med gentagen dosering af KRYSTEXXA til rotter og hunde fandtes pegloticase-holdige vakuoler i forskellige typer væv.
English: The medicinal product should be administered in a healthcare setting and by healthcare professionals prepared to manage anaphylaxis and infusion reactions.
Danish: Administrationen af lægemidlet bør foretages på et behandlingscenter af sundhedspersoner, der er forberedt på at behandle anafylaksi og infusionsreaktioner.
English: Allergic reactions may be more likely to occur in patients who weigh more than 100 kg. An increase in gout flares is frequently observed when starting KRYSTEXXA.
Danish: Allergiske reaktioner kan have større tendens til at optræde hos patienter, der vejer over 100 kg. Ved begyndelsen af behandlingen med KRYSTEXXA ses ofte en stigning i akutte anfald af urinsyregigt.
English: Special attention is recommended for patients with pre-existing cardiopulmonary disease.
Danish: Behandleren bør være særligt opmærksom herpå ved præeksisterende kardiopulmonal sygdom.
English: Pegloticase catalyses the conversion of uric acid into the inert highly water-soluble metabolite allantoin, with hydrogen peroxide and carbon dioxide as oxidative by-products.
Danish: Pegloticase katalyserer omdannelsen af urinsyre til den inaktive, meget vandopløselige metabolit allantoin, med hydrogenperoxid og kuldioxid som oxidative biprodukter.
English: KRYSTEXXA can induce severe allergic responses, including anaphylactic shock with cardiac arrest.
Danish: KRYSTEXXA kan udløse svære allergiske reaktioner, herunder anafylaktisk shock med hjertestop.
English: The long-term risk of prophylactic medications to prevent infusion reactions, such as glucocorticoids, should also be taken into consideration.
Danish: Den langsigtede risiko med glukokortikoider ved profylaktisk medicinering til forebyggelse af infusionsreaktioner, bør ligeledes tages i betragtning.
English: Plasma uric acid decreased with increasing pegloticase dose or concentration.
Danish: Plasmaurinsyre faldt med stigende dosis og koncentration af pegloticase.
English: Name and address of the manufacturer(s) of the biological active substance
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer)
English: The efficacy and safety of KRYSTEXXA was assessed in two replicate Phase III pivotal trials (GOUT 1 and GOUT 2) that were conducted in 212 adult patients with chronic gout refractory to allopurinol.
Danish: Virkningen og sikkerheden af KRYSTEXXA blev vurderet i to gentagne fase III-hovedundersøgelser (GOUT 1 og GOUT 2), der omfattede 212 voksne patienter med allopurinol-refraktær kronisk artritis urica.
English: Pharmacotherapeutic group: Anti-gout preparations, other anti-gout preparations, ATC code: M04AX02
Danish: Farmakoterapeutisk klassifikation: Midler mod artritis urica, andre midler mod artritis urica, ATCkode: M04AX02
English: The European Medicines Agency has deferred the obligation to submit the results of studies with KRYSTEXXA in one or more subset of the paediatric population in the treatment and/or prevention of hyperuricaemia related to Tumour Lysis Syndrome (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af undersøgelser med KRYSTEXXA hos en eller flere undergrupper af den pædiatriske population til behandling og/eller forebyggelse af hyperurikæmi i forbindelse med tumorlysesyndrom (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS
English: KRYSTEXXA contains an enzyme called uricase that transforms the uric acid into a substance called allantoin, which can be removed easily in the urine.
Danish: KRYSTEXXA indeholder enzymet uricase, der omdanner urinsyren til allantoin, et stof, der let kan udskilles i urinen.
English: Very limited data are available about retreatment after interruption of therapy for more than 4 weeks.
Danish: Genoptagelse af behandlingen med KRYSTEXXA Der foreligger meget begrænsede data om genoptagelse af behandlingen, efter at denne har været afbrudt længere end fire uger.
English: Congestive heart failure
Danish: Venstresidig hjerteinsufficiens
English: KRYSTEXXA is injected slowly into a vein (i.v.
Danish: KRYSTEXXA indsprøjtes langsomt i en vene (intravenøs infusion).