FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis.
Danish: I kliniske farmakologiske undersøgelser med enkelt-indgift af tadalafil (5 mg til 20 mg) var eksponeringen for tadalafil (AUC) ca. fordoblet hos forsøgspersoner med mild (kreatinin-clearance 51 til 80 ml/min) eller moderat (kreatinin-clearance 31 til 50 ml/min) nyrefunktionsnedsættelse samt hos dialysepatienter med nyresvigt i slutstadie.
English: In patients who are taking alpha1 blockers concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see section 4.5).
Danish: For patienter, som er i behandling med alfa1-blokkere, kan samtidig administration af tadalafil give symptomatisk hypotension hos nogle patienter (se pkt.
English: PDE5 inhibitors are also used for the treatment of erectile dysfunction in men.
Danish: PDE5-hæmmere bruges også ved behandling af potensproblemer (erektil dysfunktion) hos mænd.
English: Therefore, caution is recommended in case of co-administration.
Danish: Derfor bør der udvises forsigtighed ved kombination af disse.
English: The proportion of patients with improvement in WHO functional class by week 16 was similar in the tadalafil 40 mg and placebo groups (23 % vs. 21 %).
Danish: Antallet af patienter med forbedring i WHO-funktionsklasse efter uge 16 var ens i gruppen, der fik tadalafil 40 mg, og placebogruppen (23 % versus 21 %).
English: Do not use this medicine after the expiry date stated on the carton and blister after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The placebo-adjusted median increase in 6MWD was 17 metres (p=0.09; 95 % CI: : -7.1, 43.0; Prespecified Hodges-Lehman method) (mean 23 metres, 95 % CI; -2.4, 47.8) in those patients who received tadalafil 40 mg in addition to their concomitant bosentan (n=39), and was 39 metres (p<0.01, 95 % CI:13.0, 66.0; Pre-specified Hodges-Lehman method) (mean 44 metres, 95 % CI: 19.7, 69.0) in those patients who received tadalafil 40 mg alone (n=37).
Danish: Den placebokorrigerede gennemsnitlige stigning i 6MWD var 17 meter (p=0,09; 95 % CI: -7,1-43,0; præspeciferet Hodges-Lehman metode) (gennemsnitlig 23 meter, 95 % CI; -2,4-47,8) hos de patienter, der fik tadalafil 40 mg i tillæg til deres samtidige medicin bosentan (n=39), og var 39 meter (p<0,01, 95 % CI: 13,0-66,0; præspeficiceret Hodges-Lehman metode) (gennemsnit 44 meter, 95 % CI: 19,769,0) hos de patienter, som kun fik tadalafil 40 mg (n=37).
English: Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance.
Danish: Patienterne skal instrueres i at søge læge straks, hvis de oplever erektioner, der varer i 4 timer eller mere.
English: CYP1A2 substrates (e.g. theophylline)
Danish: CYP1A2-substancer (f.eks. theophyllin)
English: Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600
Danish: Produtos Farmacêuticos, Lda Tel: + 351-21-4126600
English: PDE5 inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effects of this medicine.
Danish: PDE5-hæmmere, så som ADCIRCA, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
English: The usual dose is two 20 mg tablets taken once a day.
Danish: Den normale dosis er 2 tabletter på 20 mg en gang om dagen.
English: Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction.
Danish: Nogle bivirkninger er set hos mænd, som tog tadalafil for behandling af erektil dysfunktion.
English: Also included in the table are some adverse reactions which have been reported in clinical studies and/or post marketing with tadalafil in the treatment of male erectile dysfunction.
Danish: I tabellen er også inkluderet nogle bivirkninger, som er set i kliniske studier og/eller post marketing med tadalafil til behandling af mænd med erektil dysfunktion.
English: In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates.
Danish: Det er vist i kliniske studier, at tadalafil (5, 10 og 20 mg) øger den hypotensive virkning af nitrater.
English: Less than 0.0005 % of the administered dose appeared in the semen of healthy subjects.
Danish: Hos raske forsøgspersoner genfandt man mindre end 0,0005 % af den administrerede dosis i sperma.
English: Tadalafil 20 mg administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no significant change in heart rate.
Danish: Administreret til raske forsøgspersoner, viste tadalafil 20 mg ingen signifikant forskel i forhold til placebo på det liggende systoliske og diastoliske blodtryk (gennemsnitligt maksimalt fald på henholdsvis 1,6 og 0,8 mm Hg), på det stående systoliske og diastoliske blodtryk (gennemsnitligt maksimalt fald på henholdsvis 0,2 og 4,6 mm Hg) og ingen signifikant ændring i hjertefrekvens.
English: ADCIRCA contains lactose monohydrate.
Danish: ADCIRCA indeholder lactosemonohydrat.
English: Tadalafil exposure (AUC) in patients with diabetes was approximately 19 % lower than the AUC value for healthy subjects after a 10 mg dose.
Danish: Eksponeringen for tadalafil (AUC) efter en dosis på 10 mg hos patienter med diabetes var ca. 19 % lavere end AUC hos raske forsøgspersoner.
English: Inhibition of PDE5 by tadalafil increases the concentrations of cGMP resulting in relaxation of the pulmonary vascular smooth muscle cell and vasodilation of the pulmonary vascular bed.
Danish: Tadalafils hæmning af PDE5 øger koncentrationen af cGMP og resulterer i afslapning af de glatte muskelceller i blodkarrene i lungerne og dilatation af den pulmonale karseng.
English: In clinical pharmacology studies, the potential for tadalafil (10 and 20 mg) to augment the hypotensive effects of antihypertensive medicinal products was examined.
Danish: Det er undersøgt i kliniske farmakologiske studier, om tadalafil (10 og 20 mg) forstærker den hypotensive effekt af antihypertensiva.
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Danish: Derfor er behandling med tadalafil kontraindiceret hos patienter, der bruger nogen form for organisk nitrat (se pkt 4.3).
English: If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
Danish: Hvis du får sådan en rejsning, som vedvarer i mere end 4 timer,
English: At steady-state, tadalafil (40 mg once per day) increased ethinylestradiol exposure (AUC) by 26 % and Cmax by 70 % relative to oral contraceptive administered with placebo.
Danish: Ved stady-state øger tadalafil (40 mg en gang daglig) ethinylestradioleksponeringen (AUC) med 26 % og Cmax med 70 % relativt til oral kontraception givet sammen med placebo.
English: Uncommon (may affect up to 1in 100 people) - seizures, passing memory loss, hives, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, fast heart rate, sudden cardiac death and ringing in the ears.
Danish: Ikke almindelig (sker for op til 1 ud af 100 patienter) - Kramper, forbigående hukommelsestab, nældefeber, overdreven tendens til at svede, blødning fra penis, blod i sæd og/eller urin, højt blodtryk, høj puls, pludselig hjertedød og ringen for ørerne (tinnitus).
English: Anti-hypertensives (including Calcium channel blockers) The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Danish: Samtidig indgift af doxazosin (4 og 8 mg dagligt) og tadalafil (5 mg daglig dosis og 20 mg som en enkeltdosis) øger signifikant den blodtrykssænkende virkning af denne alfa-blokker.
English: Bosentan (125 mg twice daily), a substrate of CYP2C9 and CYP3A4 and a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19, reduced tadalafil (40 mg once per day) systemic exposure by 42 % and Cmax by 27 % following multiple dose co-administration.
Danish: Endotelin 1- receptorantagonister (f.eks. bosentan) Flere gange samtidig indgift af bosentan (125 mg to gange daglig), substrat for CYP2C9 og CYP3A4 og en moderat induktor af CYP3A4, CYP2C9 og sandsynligvis CYP2C19, og tadalafil (40 mg en gang daglig) reducerede den systemiske eksponering af tadalafil med 42 % og Cmax med 27 %.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: ADCIRCA bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: The following side effects have been very commonly reported in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (blocked nose), nausea, indigestion (including abdominal pain or discomfort), muscle aches, back pain and pain in the extremity (including limb discomfort)
Danish: Følgende bivirkninger er indberettet med frekvensen meget almindelig for patienter, der tager ADCIRCA (sker for flere end 1 ud af 10 patienter): Hovedpine, rødmen, tilstoppet næse, kvalme, fordøjelsesbesvær (inklusive mavesmerter eller ubehag), muskelsmerter, rygsmerter og smerter i lemmerne (inklusive ubehag i benene).
English: How to take ADCIRCA
Danish: Sådan skal du tage ADCIRCA
English: Ritonavir (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) single dose exposure (AUC) 2-fold with no change in Cmax.
Danish: Ritonavir (200 mg to gange daglig), som er en hæmmer af CYP3A4, CYP2C9, CYP2C19 og CYP2D6, øger tadalafil (20 mg) enkeltdosiseksponering (AUC) 2 gange uden ændringer i Cmax.
English: Priapism5, Penile haemorrhage,
Danish: Priapisme5 Blødning fra penis,
English: The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction.
Danish: Bivirkningerne i tabellen er data fra postmarketing eller kliniske studier, hvor tadalafil blev brugt til behandling af erektil dysfunktion.
English: Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32 % and decreased Cmax by 30 %.
Danish: Ritonavir (500 mg eller 600 mg to gange daglig) øger tadalafil (20 mg) enkelt-dosis-eksponering (AUC) med 32 % og nedsætter Cmax med 30 %.
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.5).
Danish: Derfor er administration af tadalafil kontraindiceret til patienter, som bruger enhver form for organisk nitrat (se pkt.
English: Cytochrome P450 Inhibitors
Danish: Cytochrom P450-hæmmere
English: Film-coated tablet (tablet).
Danish: Filmovertrukne tabletter.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 October 2008
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: - In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates.
Danish: - Det er vist i kliniske studier, at tadalafil forstærker den hypotensive effekt af nitrater.
English: Immune system disorders Hypersensitivity reactions5
Danish: Overfølsomhedsreaktioner5
English: Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis)
Danish: Luftveje, thorax og mediastinum Nasofaryngitis(in klusive tilstopning af næsen, tilstopning af sinus og rhinitis)
English: Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil in these patients is not recommended.
Danish: Der er ikke udført studier med patienter, der lider af svær levercirrose (Child-Pugh klasse C), og derfor anbefales tadalafil ikke til disse patienter.
English: > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Danish: Tadalafil er > 10.000 gange mere potent overfor PDE5 end for PDE3, som er et enzym, der findes i hjerte og blodkar.
English: Antimicrobial medicinal products (e.g. rifampicin) A CYP3A4 inducer, rifampicin (600 mg daily), reduced tadalafil AUC by 88 % and Cmax by 46 %, relative to the AUC and Cmax values for tadalafil alone (10 mg).
Danish: Rifampicin (600 mg daglig), en CYP3A4-induktor, reducerer tadalafil AUC med 88 % og Cmax med 46 %, relativt til AUC og Cmax for tadalafil alene (10 mg).
English: ADCIRCA 20 mg film-coated tablets Tadalafil
Danish: ADCIRCA 20 mg filmovertrukne tabletter Tadalafil
English: Ketoconazole (200 mg daily), increased tadalafil (10 mg) single dose exposure (AUC) 2-fold and Cmax by 15 %, relative to the AUC and Cmax values for tadalafil alone.
Danish: Ketoconazol (200 mg daglig) øger tadalafils (10 mg) enkeltdosiseksponering (AUC) 2 gange og Cmax med 15 %, relativt til AUC og Cmax-værdier for tadalafil alene.
English: If you are taking any form of nitrate or are unsure tell your doctor.
Danish: Fortæl det til din læge, hvis du tager nogen form for nitrat, eller hvis du er i tvivl.
English: Dyspepsia (including abdominal pain/discomfort3)
Danish: Mave-tarmkanalen Kvalme, dyspepsi (inklusive mavesmerter/ube hag3)
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) single dose exposure (AUC) 4-fold and Cmax by 22 %.
Danish: Ketoconazol (400 mg daglig) øger tadalafil (20 mg) enkeltdosiseksponering (AUC) 4 gange og Cmax med 22 %.
English: The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.5 and 5.1).
Danish: Virkningen af tadalafil hos patienter, der allerede er i behandling med bosentan, er ikke påvist endegyldigt (se pkt.
English: Protease inhibitors (e.g. ritonavir)
Danish: Proteasehæmmere (f.eks. ritonavir)
English: NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg tablets tadalafil
Danish: LÆGEMIDLETS NAVN ADCIRCA 20 mg tabletter tadalafil
English: Common (may affect up to 1 in 10 people) - blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat and fainting.
Danish: Almindelig (sker for op til 1 ud af 10 patienter) - Uklart syn, lavt blodtryk, næseblod, opkast, øget eller unormal blødning fra livmoderen,
English: No dose adjustment is warranted.
Danish: Der kræves ingen dosisjustering.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg tadalafil
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 20 mg tadalafil.
English: See also section 5.1.
Danish: 4.5 og 5.1).
English: Eli Lilly Holdings Limited Eesti filiaal Tel: +372 6 817 280
Danish: Eesti filiaal Tel: +372 6 817 280
English: Film-coated tablet core lactose monohydrate croscarmellose sodium hydroxypropylcellulose microcrystalline cellulose sodium laurilsulfate magnesium stearate
Danish: Filmovertrukken tabletkerne: lactosemonohydrat, croscarmellosenatrium, hydroxypropylcellulose, mikrokrystallinsk cellulose, natriumlaurilsulfat, magnesiumstearat.
English: Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Danish: Patienter, som på grund af non-arteritis anterior iskæmisk opticusneuropati (NAION), har nedsættelse af synet på det ene øje.
English: For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the use of tadalafil is not recommended (see section 4.5).
Danish: Tadalafil anbefales ikke til patienter, der samtidig tager potente CYP3A4-hæmmere, såsom ketoconazol eller ritonavir (se pkt.
English: Seizures5, Transient amnesia5
Danish: Kramper5, forbigående hukommelsestab5
English: Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended.
Danish: Behandling med tadalafil anbefales ikke til disse patienter, da der ikke foreligger kliniske data, hvor tadalafil har været givet til patienter med veneokklusiv sygdom.
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V.
Danish: Eli Lilly Nederland B.V.
English: Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended.
Danish: Brug af tadalafil anbefales ikke til disse patienter, da der ikke er kliniske data vedrørende sikkerheden.
English: For patients chronically taking potent inducers of CYP3A4, such as rifampicin, the use of tadalafil is not recommended (see section 4.5).
Danish: Samtidig brug af CYP3A4 induktorer eller hæmmere Brug af tadalafil anbefales ikke til patienter, der kronisk tager potente CYP3A4-inducerende lægemidler, såsom rifampicin (se pkt.
English: NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN ADCIRCA 20 mg filmovertrukne tabletter.
English: Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered.
Danish: PVOD bør overvejes, hvis der ses tegn på pulmonalt ødem ved behandling med tadalafil.
English: Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, contact your doctor immediately.
Danish: Hvis du oplever en pludselig nedsættelse eller tab af hørelsen, skal du straks kontakte din læge, også selvom det er ukendt om hændelsen er direkte relateret til tadalafil.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med ADCIRCA Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: What ADCIRCA looks like and contents of the pack ADCIRCA 20 mg comes as orange film-coated tablets.
Danish: ADCIRCA 20 mg er orange filmovertrukne tabletter.
English: NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg film-coated tablets tadalafil
Danish: LÆGEMIDLETS NAVN ADCIRCA 20 mg filmovertrukne tabletter tadalafil
English: In healthy female and male subjects following single and multiple-doses of tadalafil, no clinically relevant differences in exposure were observed.
Danish: Der er ikke set klinisk relevant forskel på eksponeringen af raske kvinder og mænd ved indtagelse af enkelte og flere tadalafil-doser.
English: Other medicines and ADCIRCA
Danish: Nyrer og urinveje
English: The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.4 and 5.1).
Danish: Virkningen af tadalafil hos patinter, der allerede får bosentanbehandling, er ikke vist endegyldigt (se pkt.
English: It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs.
Danish: Det virker ved at hjælpe blodkarrerne rundt om lungerne med at slappe af, således at blodtilstrømningen til lungerne forbedres.
English: What ADCIRCA is and what it is used for What you need to know before you take ADCIRCA How to take ADCIRCA
Danish: Det skal du vide, før du begynder at tage ADCIRCA Sådan skal du tage ADCIRCA Bivirkninger
English: Vascular disorders Flushing
Danish: Vaskulære sygdomme Rødme
English: Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended (see sections 4.4 and 5.2).
Danish: Brug af tadalafil anbefales ikke hos patienter med svær levercirrose (Child-Pugh klasse C), da der ikke foreligger studier hos denne gruppe (se pkt.
English: Cardiovascular
Danish: Hypertension
English: A.
Danish: Syn
English: In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended.
Danish: Den anbefalede initiale dosis er 20 mg en gang daglig hos patienter med nedsat nyrefunktion.
English: Vision
Danish: Øjne
English: Placebo was not effective in any of the patients.
Danish: Placebo var ikke effektivt hos nogen af patienterne.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Krystexxa on 8 January 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Krystexxa den 8. januar 2013.
English: All patients are monitored for any reactions during the infusion and for at least one hour afterwards.
Danish: Alle patienter overvåges for eventuelle reaktioner under infusionen og i mindst én time derefter.
English: The full EPAR for Krystexxa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Krystexxa 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 Krystexxa.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Krystexxa.
English: Although there may be serious side effects (such as infusion reactions and gout flares) these were considered manageable.
Danish: Skønt der kan være alvorlige bivirkninger (såsom infusionsreaktioner og opblussen af urinsyregigt), blev disse anset for at være håndterbare.
English: The effects of Krystexxa were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Krystexxa blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: To reduce the risk of these reactions, patients are given other medicines before treatment with Krystexxa.
Danish: For at mindske risikoen for sådanne reaktioner får patienterne andre lægemidler før behandlingen med Krystexxa.
English: For more information about treatment with Krystexxa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Krystexxa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Krystexxa.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Krystexxa.
English: The company that makes Krystexxa will carry out a study of the long-term safety of the medicine, including its safety and effectiveness in patients who stop treatment and later restart it.
Danish: Den virksomhed, der fremstiller Krystexxa, skal udføre en langtidsundersøgelse af lægemidlets sikkerhed, herunder sikkerheden og virkningen hos patienter, der ophører med behandlingen og senere genoptager den.
English: Reactions are more common in patients who develop antibodies (proteins produced by the immune system, the body's natural defences) that reduce the effect of the treatment.
Danish: Reaktioner forekommer oftest hos patienter, der udvikler antistoffer (proteiner, der produceres af immunsystemet, kroppens naturlige forsvar).
English: Krystexxa given every two weeks resulted in fewer reactions to the infusion than when it was given every four weeks.
Danish: Når Krystexxa blev givet hver anden uge, medførte det færre reaktioner på infusionen, end når det blev givet hver fjerde uge.