FrancophonIA/ELRC3.0 huggingface dataset:
English: The embryofetal development study in rats does not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Rotteforsøg tyder hverken på direkte eller indirekte reproduktionstoksiske virkninger.
English: Because of the immunogenicity of KRYSTEXXA, patients receiving retreatment may be at increased risk of infusion-related reactions, including anaphylaxis.
Danish: Som følge af immunogeniciteten af KRYSTEXXA kan patienter i behandling have øget risiko for infusionsrelaterede reaktioner, herunder anafylaksi.
English: The primary endpoint in both trials was the proportion of responder patients that achieved plasma uric acid (PUA) less than 0.36 mmol/L (6 mg/dl) for at least 80% of the time during Month 3 and Month 6.
Danish: Det primære endepunkt i begge undersøgelser var andelen af responderende patienter, der opnåede en plasmaurinsyre (PUA) på under 0,36 mmol/l (6 mg/dl) i mindst 80 % af tiden i måned 3 og måned 6.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen i modul 1.8.2 i markedsføringstilladelsen), og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
English: • a shortness of breath, wheezing or breathing problems
Danish: • kortåndethed, pibende vejrtrækning eller vejrtrækningsproblemer
English: Patients should be pre-treated with antihistamines, corticosteroids, and paracetamol, and closely monitored for the onset of adverse reactions suggesting severe hypersensitivity reactions including anaphylaxis for at least 1 hour after the end of the infusion (see section 4.8).
Danish: Patienterne bør forbehandles med antihistaminer, kortikosteroider og paracetamol og overvåges tæt for indsætten af bivirkninger, der tyder på svære hypersensitivitetsreaktioner, herunder anafylaksi, i mindst 1 time efter afslutningen af infusionen (se pkt.
English: KRYSTEXXA was administered by intravenous infusion with a Tmax of 2.25 h (range: 1.92 - 4.25 h for initial dose).
Danish: KRYSTEXXA blev administreret ved intravenøs infusion med Tmax 2,25 h (område: 1,92-4,25 h for initialdosis).
English: The mean area under the KRYSTEXXA plasma concentration versus time curve at steady-state (AUC0-t) was 445 h*µg/ml (range: 223 - 1040 h*µg/ml).
Danish: Det gennemsnitlige areal under plasmakoncentrationskurven over KRYSTEXXA som funktion af tiden i steady state (AUC0-t) var 445 h*µg/ml (område: 223-1040 h*µg/ml).
English: • Before administration, the diluted solution of KRYSTEXXA should be allowed to reach room temperature.
Danish: • Før administration skal den fortyndede opløsning af KRYSTEXXA henstå, til den har nået rumtemperatur.
English: • The infusion bag containing the diluted KRYSTEXXA solution should be inverted a number of times gently to ensure thorough mixing.
Danish: • Infusionsposen med den fortyndede opløsning af KRYSTEXXA vendes nogle gange forsigtigt for at sikre grundig opblanding.
English: The strength indicates the quantity of the uricase moiety of pegloticase without consideration of the PEGylation.
Danish: Styrkeangivelsen henviser til uricase-delen af pegloticase uden hensyn til PEGyleringen.
English: Patients were randomised in a 2:2:1 ratio to receive 8 mg every 2 weeks or every 4 weeks or placebo for 6 months.
Danish: Patienterne blev randomiseret i forholdet 2:2:1 til henholdsvis 8 mg hver 2. uge eller hver 4. uge eller placebo i seks måneder.
English: KRYSTEXXA has not been studied in children or adolescents under 18 years of age.
Danish: KRYSTEXXA er ikke undersøgt hos børn og unge under 18 år.
English: Pegloticase is a uricase enzyme conjugated with mPEG at an average degree of substitution of 40.8 moles of mPEG/mole of protein (10.2 moles of mPEG/monomeric sub-unit of the mature homotetrameric uricase protein).
Danish: Pegloticase er et uricaseenzym, der er konjugeret med mPEG med en gennemsnitlig substitutionsgrad på 40,8 mol mPEG pr. mol protein (10,2 mol mPEG pr. monomer subunit af det modne homotetramere uricaseprotein).
English: There was also a higher incidence of infusion reactions in patients with high anti-pegloticase antibody titres: 46% (18 of 39) in the KRYSTEXXA every 2 weeks group compared to 9% (4 of 46) in patients with low or no antibody titres.
Danish: Patienter med høj anti-pegloticase-antistoftiter havde ligeledes højere forekomst af infusionsreaktioner: 46 % (18 ud af 39) af gruppen, der fik KRYSTEXXA hver 2. uge, sammenholdt med 9 % (fire ud af 46) hos patienter med lav eller ingen antistoftiter.
English: KRYSTEXXA has no or negligible influence on the ability to drive and use machines.
Danish: KRYSTEXXA påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The first infusion reaction usually occurs after the 2
Danish: Den første infusionsreaktion indtræder sædvanligvis efter 2. til 4. infusion.
English: As the development of these adverse events may have been prevented in at least some of these cases if the patients would not have been treated with concomitant urate lowering substances, an amendment of the summary of product characteristics focusing on the importance of stopping treatment with uric acid lowering agents with regard to masking the results of serum uric acid values (and therefore increasing the risk for infusion reactions and anaphylactic reactions) should be implemented.
Danish: Da det kunne være forhindret, at disse uønskede hændelser blev udviklet i det mindste i nogle af disse tilfælde, hvis patienterne ikke sideløbende var blevet behandlet med brug af uratsænkende midler, bør der implementeres en ændring af produktresuméet, som fokuserer på vigtigheden af at stoppe behandling med uratsænkende medicin, så resultaterne af niveauerne af serumurinsyre ikke maskeres (og risikoen for infusionsreaktioner og anafylaktiske reaktioner derfor forhøjes).
English: No formal studies were conducted to examine the effects of renal insufficiency on pegloticase pharmacokinetics.
Danish: Der er ikke udført formelle undersøgelser af virkningerne af nyreinsufficiens på farmakokinetikken af pegloticase.
English: What you need to know before you receive KRYSTEXXA Do not use KRYSTEXXA
Danish: Det skal du vide, før du begynder at få KRYSTEXXA Du må ikke få KRYSTEXXA
English: As anti-pegloticase antibodies can bind to the PEG moiety of KRYSTEXXA, there may be potential for binding to other PEGylated products.
Danish: Anti-pegloticase-antistoffer kan bindes til PEG-delen af KRYSTEXXA og kan derfor potentielt bindes til andre PEGylerede produkter.
English: Caution should be exercised in patients who have congestive heart failure and patients should be monitored closely following infusion.
Danish: Ved venstresidig hjerteinsufficiens bør udvises forsigtighed, og patienten bør overvåges tæt efter infusionen.
English: The benefit/risk balance should be assessed for each individual patient on an on-going basis considering the effect on tophus resolution as well as the risk of infusion reactions, gout flares, and potentially increased cardiac risk.
Danish: Benefit/risk-forholdet bør løbende vurderes for den enkelte patient på grundlag af virkningen på svind af tophi samt risikoen for infusionsreaktioner, akutte anfald af artritis urica og potentielt øget kardiel risiko.
English: Uric acid deposits as crystals in joints, kidneys, and other organs which may cause profound pain, redness and swelling (inflammation).
Danish: Urinsyre aflejres som krystaller i leddene, nyrerne og andre organer og kan give stærke smerter, rødme og hævelse (inflammation).
English: Prior to infusion, patients should receive pre-medication to minimize the risk of infusion-related reactions, e.g. antihistamine the evening before, and again approximately 30 minutes before the infusion, as well as paracetamol and a corticosteroid immediately before each infusion (see section 4.4).
Danish: Før infusionen gives præmedicinering til minimering af risikoen for infusionsrelaterede reaktioner, f.eks. antihistaminer aftenen forinden og igen ca. 30 minutter før infusionen, samt paracetamol og et kortikosteroid umiddelbart før hver infusion (se pkt.
English: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but a small number of patients with pre-existing cardiovascular conditions who were treated with pegloticase in the clinical trials had exacerbations of their congestive heart failure.
Danish: KRYSTEXXA er ikke formelt undersøgt hos patienter med venstresidig hjerteinsufficiens, men der forekom eksacerbationer af hjerteinsufficiens hos et lille antal patienter med præeksisterende kardiovaskulær sygdom, der blev behandlet med pegloticase i kliniske undersøgelser.
English: The infusion bag containing diluted KRYSTEXXA should not be shaken.
Danish: Infusionsposen med den fortyndede opløsning af KRYSTEXXA må ikke omrystes.
English: Antibodies to pegloticase associated with clearance of pegloticase resulted in a small stimulation in the elimination of urate.
Danish: Antistoffer mod pegloticase i forbindelse med clearance af pegloticase medførte en lille stimulation af uratudskillelsen.
English: 1 95% confidence interval for differences in responder rate between pegloticase group vs. placebo 2 P-value using Fisher's exact test to compare pegloticase group vs. placebo 3GOUT = Gout Outcomes and Urate-lowering Therapy
Danish: 1 95 % sikkerhedsinterval for forskel i responsrate mellem grupperne på KRYSTEXXA og placebo 2 P-værdi beregnet med Fishers eksakte test til sammenligning af gruppen på KRYSTEXXA med placebogruppen 3GOUT = Gout Outcomes and Urate-lowering Therapy
English: Neither body weight nor baseline creatinine clearance had a significant effect on the PD response.
Danish: Hverken legemsvægt eller baseline-kreatininclearance havde nævneværdig betydning for den farmakodynamiske respons.
English: The active substance pegloticase is a covalent conjugate of uricase produced by a genetically modified strain of Escherichia coli and monomethoxypoly (ethylene glycol).
Danish: Det aktive stof pegloticase er et kovalent konjugat af uricase, som er fremstillet ved hjælp af en genetisk modificeret stamme af Escherichia coli og monomethoxypolyethylenglycol.
English: There was potential for some accumulation with the KRYSTEXXA 8 mg every two weeks dosing regimen due to the long half-life of pegloticase (214 h; range: 123 - 444 h for terminal half-life).
Danish: Regimet KRYSTEXXA, 8 mg hver 2. uge, havde potentiale for nogen akkumulering som følge af den lange halveringstid af pegloticase (terminal halveringstid 214 h; område: 123-444 h).
English: Pegloticase is used to treat severe long-term gout in adult patients who also have one or more painful deposits of uric acid crystals under the skin that cause difficulty in carrying out daily activities and who do not respond or cannot take other anti-gout medicines.
Danish: Pegloticase anvendes til behandling af svær, kronisk urinsyregigt hos voksne, som har en eller flere smertefulde aflejringer af urinsyrekrystaller under huden, så de har vanskeligt ved at klare daglige aktiviteter, og hos hvem andre midler mod urinsyregigt ikke virker eller ikke tåles.
English: • If you are allergic to pegloticase, or other uricases or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for pegloticase eller andre uricaser eller et af de øvrige indholdsstoffer i
English: If an infusion reaction occurs during the administration, the infusion may be slowed, or stopped and restarted at a slower rate, at the discretion of the physician.
Danish: Hvis der opstår en uønsket reaktion under administrationen, kan infusionshastigheden nedsættes, eller infusionen kan standses og genoptages med lavere hastighed efter lægens skøn.
English: If patients experience treatment-related symptoms affecting their ability to concentrate and react (i.e. headache or dizziness), it is recommended that they do not drive or use machines until the effect subsides.
Danish: Ved behandlingsrelaterede symptomer, der berører koncentrations- og reaktionsevnen (f.eks. hovedpine eller svimmelhed), tilrådes det, at patienten undlader at føre motorkøretøj eller betjene maskiner, indtil symptomerne er svundet.
English: The safety and efficacy of KRYSTEXXA in children and adolescents aged below 18 years has not been established.
Danish: KRYSTEXXA's sikkerhed og virkning hos børn og unge under 18 år er ikke undersøgt.
English: KRYSTEXXA is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated (see section 4.4).
Danish: KRYSTEXXA er indiceret til behandling af svær, invaliderende kronisk toføs artritis urica hos voksne patienter, hos hvem der også kan forekomme lederosion, hos hvem serumurinsyre ikke har kunnet normaliseres med xanthinoxidasehæmmere i maksimal terapeutisk dosis, eller hos hvem sådanne midler er kontraindiceret (se pkt.
English: It is therefore recommended to discontinue oral urate-lowering medications before starting treatment and not institute therapy with oral uratelowering agents while taking KRYSTEXXA.
Danish: Det anbefales derfor at seponere oral uratsænkende medicin før påbegyndelse af behandlingen og undlade at sætte patienten i oral uratsænkende behandling under behandlingen med KRYSTEXXA.
English: Contents of the pack and other information What KRYSTEXXA contains
Danish: Pakningsstørrelser og yderligere oplysninger KRYSTEXXA indeholder:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: 1 Number of patients with available data 2 Patients with missing data were considered as a failure 3 p values based on Fisher's exact test to compare pegloticase versus placebo
Danish: 2 Patienter med manglende data blev anset for behandlingssvigt 3 p-værdi beregnet med Fishers eksakte test til sammenligning af gruppen på pegloticase med placebogruppen
English: Infusion-related reactions
Danish: Infusionsreaktioner
English: To reduce the likelihood of gout flares after initiation of KRYSTEXXA prophylaxis with colchicine or a non-steroidal anti-inflammatory drug (NSAID) is recommended.
Danish: For at mindske sandsynligheden for akutte anfald af artritis urica efter iværksættelse af behandlingen med KRYSTEXXA anbefales forebyggende behandling med colchicin eller et non-steroidt antiinflammatorisk lægemiddel (NSAID).
English: Glucose-6-phosphate dehydrogenase (G6PD) deficiency and other cellular metabolic disorders known to cause haemolysis and methemoglobinemia.
Danish: Glukose-6-fosfatdehydrogenase-(G6PD)-mangel og andre sygdomme i cellernes stofskifte, der medfører hæmolyse og methæmoglobinæmi.
English: Severe allergic reactions (common) include fainting, sudden drop in blood pressure, and cardiac arrest.
Danish: Svære allergiske reaktioner (almindelige) er besvimelse, pludseligt blodtryksfald og hjertestop.
English: 2 ml vial (Type I glass) with a Teflon coated bromobutyl rubber stopper and aluminium seal with polypropylene flip-off cap, containing 1 ml concentrate for solution for infusion.
Danish: 2 ml hætteglas (glas type I) med teflonbelagt prop af brombutylgummi og aluminiumkapsel med afrivningshætte af polypropylen, indeholdende 1 ml koncentrat til infusionsvæske, opløsning.
English: Among the other secondary endpoints, reduction from baseline in the number of tender and swollen joints were observed in patients treated with KRYSTEXXA every 2 weeks while there was little change in patients on placebo.
Danish: Af de andre sekundære endepunkter sås reduktion fra baseline i antal ømme og hævede led hos patienter, der blev behandlet med KRYSTEXXA hver 2. uge, men kun lille ændring hos patienter på placebo.
English: This induces a concentration gradient between serum uric acid and tissue/joints deposits of monosodium urate resulting in the migration of urate from tissues/joints, which makes it accessible to conversion to allantoin.
Danish: Dette medfører en koncentrationsgradient mellem urinsyreindholdet i serum og aflejringerne af mononatriumurat i vævet og leddene, hvilket får urat til at dissociere ud fra væv og led, så det bliver tilgængeligt for omdannelse til allantoin.
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of severe refractory chronic gout.
Danish: Behandlingen bør påbegyndes og overvåges af speciallæger med erfaring i diagnose og behandling af svær, refraktær kronisk artritis urica.
English: Many infusion-related reactions resolved with slowing, or stopping the infusion, before restarting the infusion at a slower rate.
Danish: Mange infusionsrelaterede reaktioner svandt, når infusionshastigheden blev nedsat eller infusionen standset for derefter at blive genoptaget med lavere hastighed.
English: Store in a refrigerator (2°C to 8°C).
Danish: Opbevares i køleskab (2° C til 8° C).
English: KRYSTEXXA is a clear to slightly opalescent colourless solution.
Danish: KRYSTEXXA er en klar til let mælkeagtig, farveløs opløsning.
English: An increase in gout flares is frequently observed upon treatment initiation, probably as a result of mobilization of urate from tissue deposits.
Danish: Ved behandlingens begyndelse ses ofte et øget antal akutte artritis urica-anfald, antagelig som følge af mobilisering af urat fra vævsdepoterne.
English: Fertility Effect on male and female fertility has not been studied.
Danish: Fertilitet Effekten på fertiliteten af han- og hundyr er ikke undersøgt.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: Continuous treatment with pegloticase decreases frequency and intensity of gout flares.
Danish: Kontinuerlig behandling med pegloticase mindsker frekvensen og intensiteten af akutte anfald af artritis urica.
English: No dose adjustment is needed for patients 65 years of age and older (see section 5.2).
Danish: Der behøves ingen dosisjustering for patienter over 65 år (se pkt.
English: Very common: Infusion related reaction Common: Anaphylaxis, influenza like illness
Danish: Meget almindelig: infusionsreaktion Almindelig: anafylaksi, influenzalignende sygdom
English: Plasma Uric Acid < 6 mg/dl for at Least 80% of the Time During Months 3 and 6 Treatment Group
Danish: Plasmaurinsyre < 0,360 mmol/l (< 6 mg/dl) i mindst 80 % af tiden i måned 3 og 6 Behandlingsgruppe
English: The duration of treatment should be based upon maintenance of response (serum uric acid levels < 6 mg/dl) and clinical judgment.
Danish: Behandlingsvarigheden bør baseres på opretholdelse af respons (serumurinsyre < 0,360 mmol/l (6 mg/dl) og en klinisk vurdering.
English: Sodium intake KRYSTEXXA contains 4.2 mg sodium (less than 1 mmol) per dose (essentially sodium free).
Danish: Natriumindtagelse KRYSTEXXA indeholder 4,2 mg natrium (mindre end 1 mmol) pr. dosis (i det væsentlige natriumfri).
English: The volume of distribution was 4.45 L with a range of 2.625.89 for no increase in anti-pegloticase antibodies and 5.77 L with a range of 2.77 - 10.6 for an increase in anti-pegloticase antibodies.
Danish: Fordelingsvolumenet var 4,45 l med område 2,62-5,89 ved fravær af stigning i anti-pegloticase-antistoffer og 5,77 l med område 2,77-10,6 ved stigning i antipegloticase-antistoffer.
English: Those subjects that did not have anti- pegloticase antibodies that cleared pegloticase had a significant effect on the stimulation in the elimination of urate.
Danish: Hos deltagere, som ikke havde antipegloticase-antistoffer, der medførte clearance af pegloticase, var der en betydelig stimulerende virkning på uratudskillelsen.
English: Clearance was 0.0145 L/h with a range of 0.00904 - 0.0229 for no increase in anti-pegloticase antibodies and 0.0193 L/h with a range of 0.00675 - 0.0340 for an increase in anti-pegloticase antibodies.
Danish: Clearance var 0,0145 l/h med område 0,00904-0,0229 ved fravær af stigning i anti-pegloticase-antistoffer, og 0,0193 l/h med område 0,00675-0,0340 ved stigning i anti-pegloticase-antistoffer.
English: The frequency of gout flares may increase after initiation of treatment with KRYSTEXXA, despite gout prophylaxis with colchicine or NSAIDs, but the frequency and severity of gout flares diminishes after 3 months of KRYSTEXXA therapy.
Danish: Akutte anfald af artritis urica kan optræde med øget hyppighed efter påbegyndelse af behandlingen med KRYSTEXXA trods artritis urica-profylakse med colchicin eller NSAID, men aftager i hyppighed og sværhed efter tre måneders behandling med KRYSTEXXA.
English: Allantoin is eliminated by renal excretion, thereby lowering serum uric acid.
Danish: Allantoin udskilles renalt, hvorved serumurinsyre sænkes.
English: High anti-pegloticase antibody titres were associated with a failure to maintain normalisation of uric acid (<6 mg/dl).
Danish: Høj titer af anti-pegloticase-antistoffer var forbundet med manglende normalisering af urinsyreniveau (< 0,360 mmol/l).
English: Since concomitant use of oral urate-lowering therapy may potentially mask the rise of serum uric acid associated with the loss of response, patients taking concomitant oral urate-lowering therapy may be at increased risk of infusion reactions and/or anaphylaxis.
Danish: Da sideløbende brug af oral uratsænkende behandling potentielt kan maskere stigningen i serumurinsyre som følge af manglende respons, kan patienter, der får oral uratsænkende medicin, have øget risiko for infusionsreaktioner og/eller anafylaksi.
English: • Appropriate aseptic technique should be used when preparing the infusion.
Danish: • Ved fremstilling af infusionsvæsken skal anvendes aseptisk teknik.
English: The solution should be used within 4 hours of dilution.
Danish: Opløsningen skal bruges senest 4 timer efter fortynding
English: Your doctor will also test your blood to measure uric acid before your next dose to make sure that you should continue receiving KRYSTEXXA.
Danish: Lægen vil desuden måle urinsyreindholdet i dit blod før din næste dosis for at sikre, at du skal fortsætte med KRYSTEXXA.
English: Instructions for preparation:
Danish: Anvisninger for klargøring
English: KRYSTEXXA has little or no effect on your ability to drive.
Danish: KRYSTEXXA påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj.
English: Read the package leaflet before use.
Danish: Til intravenøs anvendelse Læs indlægssedlen inden brug.
English: • 1 ml of KRYSTEXXA should be withdrawn from the vial into a sterile syringe.
Danish: • Der trækkes 1 ml KRYSTEXXA op af hætteglasset i en steril sprøjte.
English: If the diluted solution is not used immediately, it can be stored refrigerated (2°C to 8°C).
Danish: Hvis den fortyndede opløsning ikke bruges straks, kan den opbevares i køleskab (2° C til 8° C).
English: The vial should not be shaken.
Danish: Hætteglasset må ikke omrystes.
English: Infusion-related reactions can occur after initiation of any infusion, in spite of patients being premedicated with oral antihistamine, intravenous corticosteroid and/or paracetamol, and generally during or within 1 hour after the infusion is completed.
Danish: Infusionsreaktioner kan forekomme efter påbegyndelse af enhver infusion, uanset om patienterne er præmedicineret med oralt antihistamin, intravenøst kortikosteroid og/eller paracetamol.
English: Very common: Nausea
Danish: Meget almindelig: kvalme Almindelig: opkastning