FrancophonIA/ELRC3.0 huggingface dataset:
English: ANCOVA); 26% of patients receiving Esbriet showed a decline of ≥50 m in 6MWT distance compared to 36% of patients receiving placebo.
Danish: 26 % af de patienter, som fik Esbriet, viste et fald på ≥50 m i 6MWT-distancen sammenlignet med 36 % af de patienter, som fik placebo.
English: Posology
Danish: Povidon
English: Fatigue has been reported in patients taking Esbriet.
Danish: Der er indberetninger om træthed hos patienter, som tager Esbriet.
English: Table 1 shows the adverse reactions reported at a frequency of ≥2% in 623 patients receiving Esbriet at the recommended dose of 2,403 mg/day in three pooled pivotal Phase 3 studies.
Danish: Tabel 1 viser de bivirkninger, der er indberettet med en hyppighed på ≥2 % hos 623 patienter, som fik
English: In study PIPF-004, the decline of percent predicted FVC from Baseline at Week 72 of treatment was significantly reduced in patients receiving Esbriet (N=174) compared with patients receiving placebo (N=174; p=0.001, rank ANCOVA).
Danish: I studie PIPF-004 var faldet i procent forventet FVC fra udgangspunktet til uge 72 med behandling signifikant nedsat hos patienter, som fik Esbriet (N=174), sammenlignet med patienter, som fik placebo (N=174, p=0,001,rank ANCOVA).
English: NAME OF THE MEDICINAL PRODUCT Esbriet 534 mg film-coated tablets Pirfenidone
Danish: LÆGEMIDLETS NAVN Esbriet 534 mg filmovertrukne tabletter Pirfenidon
English: 3 How to take Esbriet
Danish: Sådan skal du tage Esbriet
English: Each film-coated tablet contains 267 mg pirfenidone.
Danish: En filmovertrukket tablet indeholder 267 mg pirfenidon.
English: NAME OF THE MEDICINAL PRODUCT Esbriet 801 mg film-coated tablets Pirfenidone
Danish: LÆGEMIDLETS NAVN Esbriet 801 mg filmovertrukne tabletter Pirfenidon
English: Clinical particulars
Danish: KLINISKE OPLYSNINGER
English: ● Physician information (safety checklists)
Danish: · Produktoplysninger (produktresumé) · Lægeinformation (sikkerhedstjeklister) · Patientinformation (indlægsseddel)
English: Each film-coated tablet contains 801 mg pirfenidone.
Danish: En filmovertrukket tablet indeholder 801 mg pirfenidon.
English: Each film-coated tablet contains 534 mg pirfenidone.
Danish: En filmovertrukket tablet indeholder 534 mg pirfenidon.
English: The capsules are to be swallowed whole with water and taken with food to reduce the possibility of nausea and dizziness (see sections 4.8 and 5.2).
Danish: Kapslerne skal sluges hele med vand og indtages med føde for at mindske muligheden for kvalme og svimmelhed (se pkt.
English: ● Severe hepatic impairment or end stage liver disease (see sections 4.2 and 4.4).
Danish: · Svært nedsat leverfunktion eller leversygdom i sidste stadie (se pkt.
English: Dizziness has been reported in patients taking Esbriet.
Danish: Der er indberetninger om svimmelhed hos patienter, som tager Esbriet.
English: There are 7 blister strips with 3 capsules per strip (1 capsule per pocket for Week 1) and 7 blister strips with 6 capsules per strip (2 capsules per pocket for Week 2).
Danish: Initieringspakningen til 2 ugers behandling indeholder 63 kapsler i alt. Der er 7 blisterstrip med 3 kapsler pr. strip (1 kapsel pr. lomme til uge 1) og 7 blisterstrip med 6 kapsler pr. strip (2 kapsler pr. lomme til uge 2).
English: Treatment with Esbriet also significantly reduced the decline of percent predicted FVC from Baseline at Weeks 13 (p<0.000001), 26 (p<0.000001), and 39 (p=0.000002).
Danish: Behandling med Esbriet reducerede også faldet i procent forventet FVC fra udgangspunktet til uge 13 (p<0,000001), 26 (p<0,000001) og 39 (p=0,000002) signifikant.
English: Discontinue Esbriet if necessary (see sections 4.2 and 4.4).
Danish: Om nødvendigt seponeres Esbriet (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated tablets in Blisters
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - filmovertrukne tabletter i blister
English: Dose reduction due to side effects
Danish: Tabel over bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules Pirfenidone
Danish: LÆGEMIDLETS NAVN Esbriet 267 mg hårde kapsler Pirfenidon
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - BOTTLE 250 ML
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - BEHOLDER 250 ML
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated tablets in Blisters 252 Multipack (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - filmovertrukne tabletter i blister 252 multipakning (MED BLÅ BOKS)
English: Capsule shell
Danish: Kapslens indhold
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 534 mg pirfenidone.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 534 mg pirfenidon.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated Tablets in Blisters Multi Pack 63 - (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - filmovertrukne tabletter i blister multipakning 63 - (MED BLÅ BOKS)
English: EU/1/11/667/005 EU/1/11/667/006 EU/1/11/667/007 EU/1/11/667/008 EU/1/11/667/009
Danish: EU/1/11/667/005 EU/1/11/667/006 EU/1/11/667/007 EU/1/11/667/008 EU/1/11/667/009 EU/1/11/667/010 EU/1/11/667/011 EU/1/11/667/012 EU/1/11/667/013 EU/1/11/667/014 EU/1/11/667/015 EU/1/11/667/016 EU/1/11/667/017 EU/1/11/667/018 EU/1/11/667/019 EU/1/11/667/020 EU/1/11/667/021
English: ● if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6)
Danish: Tag ikke Esbriet · hvis du er allergisk over for pirfenidon eller et af de øvrige indholdsstoffer i Esbriet (angivet i punkt 6) · hvis du tidligere har fået angioødem i forbindelse med brug af pirfenidon.
English: However, treatment with Esbriet reduced the decline of percent predicted FVC from Baseline at Weeks 24 (p<0.001), 36 (p=0.011), and 48 (p=0.005).
Danish: Behandling med Esbriet reducerede dog faldet i procent forventet FVC fra udgangspunktet til uge 24 (P<0,001), 36 (p=0,011) og 48 (p=0,005).
English: Table 4 Categorical assessment of change from Baseline to Week 52 in percent predicted FVC in study PIPF-016
Danish: Tabel 4 Ændring i procent forventet FVC fra udgangspunktet til uge 52 i studie PIPF-016
English: ● Capsule brown printing ink: shellac, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), propylene glycol, ammonium hydroxide
Danish: magnesiumstearat · Kapselskal: gelatine, titandioxid (E171) · Kapsels brune tryksværte: shellac, sort jernoxid (E172), rød jernoxid (E172), gul jernoxid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/011 90 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/011 90 tabletter
English: In repeated dose toxicity studies increases in liver weight were observed in mice, rats and dogs; this was often accompanied by hepatic centrilobular hypertrophy.
Danish: I studier af toksicitet efter gentagne doser blev der observeret stigninger i levervægten hos mus, rotter og hunde.
English: Treatment with Esbriet also significantly reduced the decline of percent predicted FVC from Baseline at Weeks 24 (p=0.014), 36 (p<0.001), 48 (p<0.001), and 60 (p<0.001).
Danish: Behandling med Esbriet reducerede også signifikant faldet i procent forventet FVC fra udgangspunktet til uge 24 (P=0,014), 36 (p<0,001), 48 (p<0,001) og 60 (p<0,001).
English: The tablets are to be swallowed whole with water and taken with food to reduce the possibility of nausea and dizziness (see sections 4.8 and 5.2).
Danish: Tabletterne skal sluges hele med vand og indtages med føde for at mindske muligheden for kvalme og svimmelhed (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 70 ML
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET - BEHOLDER 70 ML
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg film-coated tablets Pirfenidone
Danish: LÆGEMIDLETS NAVN Esbriet 267 mg filmovertrukne tabletter Pirfenidon
English: Although there was no difference between patients receiving Esbriet compared to placebo in change from Baseline to Week 72 of distance walked during a six minute walk test (6MWT) by the prespecified rank ANCOVA, in an ad hoc analysis, 37% of patients receiving Esbriet showed a decline of ≥50 m in 6MWT distance, compared to 47% of patients receiving placebo in PIPF-004.
Danish: Der var ingen forskel på de patienter, som fik Esbriet, sammenlignet med de patienter, som fik placebo, med hensyn til ændring fra udgangspunktet til uge 72 i den distance, patienterne kunne gå under en seks minutters gangtest (6MWT) i den præspecificerede rank ANCOVA.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/009 21 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/009 21 tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 801 mg pirfenidone.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 801 mg pirfenidon.
English: ● Capsule filling: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate
Danish: Øvrige indholdsstoffer: · Kapslens indhold: Mikrokrystallinsk cellulose, croscarmellosenatrium, povidon,
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule content
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated Tablets in Blisters Multi Pack 252 - (INCLUDING BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - filmovertrukne tabletter i blister multipakning 252 - (MED BLÅ BOKS)
English: Esbriet 534 mg film-coated tablets are orange, oval, biconvex film-coated tablets, debossed with “PFD”.
Danish: Esbriet 534 mg filmovertrukne tabletter er orange, ovale, bikonvekse filmovertrukne tabletter præget med "PFD".
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/016 63 tablets (21 + 42)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/016 63 tabletter (21 + 42)
English: Mutlipack: 63 (1 pack containing 1 blister of 21 and 1 pack containing 2 blisters of 21) filmcoated tablets
Danish: Multipakning: 63 filmovertrukne tabletter (1 pakning indeholdende 1 blister af 21 og 1 pakning indeholdende 2 blister af 21)
English: Esbriet 534 mg film-coated tablets are orange, oval, approximately 1.6 x 0.8 cm biconvex film-coated tablets, debossed with “PFD”.
Danish: Esbriet 534 mg filmovertrukne tabletter er orange, ovale, omtrent 1,6 x 0,8 cm bikonvekse filmovertrukne tabletter præget med ”PFD”.
English: Esbriet 267 mg film-coated tablets are yellow, oval, biconvex film-coated tablets, debossed with “PFD”.
Danish: Esbriet 267 mg filmovertrukne tabletter er gule, ovale, bikonvekse filmovertrukne tabletter præget med "PFD".
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 267 mg pirfenidone.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En tablet indeholder 267 mg pirfenidon.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 200 ML
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET - BEHOLDER 200 ML
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) and iron oxide black (E172)
Danish: Filmovertrækket består af: polyvinyl alkohol, titandioxid (E171), makrogol 3350, talkum, rød jernoxid (E172) og sort jernoxid (E172).
English: Esbriet 267 mg film-coated tablets are yellow, oval, approximately 1.3 x 0.6. cm biconvex film-coated tablets, debossed with “PFD”.
Danish: Esbriet 267 mg filmovertrukne tabletter er gule, ovale, omtrent 1,3 x 0,6 cm bikonvekse filmovertrukne tabletter præget med ”PFD”.
English: Esbriet therapy should not be used in patients with severe hepatic impairment or end stage liver disease (see section 4.3, 4.4 and 5.2).
Danish: Esbriet-behandling bør ikke anvendes hos patienter med svært nedsat leverfunktion eller leversygdom i sidste stadie (se pkt.
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172) and iron oxide red (E172)
Danish: Filmovertrækket består af: polyvinyl alkohol, titandioxid (E171), makrogol 3350, talkum, gul jernoxid (E172) og rød jernoxid (E172).
English: Esbriet 801 mg film-coated tablets are brown, oval, biconvex film-coated tablets, debossed with “PFD”.
Danish: Esbriet 801 mg filmovertrukne tabletter er brune, ovale, bikonvekse filmovertrukne tabletter præget med "PFD".
English: Mild
Danish: Vægttab
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172)
Danish: Filmovertrækket består af: polyvinyl alkohol, titandioxid (E171), makrogol 3350, talkum, gul jernoxid (E172).
English: Esbriet 801 mg film-coated tablets are brown, oval, approximately 2 x 0.9 cm biconvex film-coated tablets, debossed with “PFD”.
Danish: Esbriet 801 mg filmovertrukne tabletter er brune, ovale, omtrent 2 x 0,9 cm bikonvekse filmovertrukne tabletter præget med ”PFD”.
English: Film-coated tablet 21 film-coated tablets.
Danish: 21 filmovertrukne tabletter.
English: Dizziness; somnolence; dysgeusia; lethargy
Danish: Svimmelhed, døsighed, dysgeusi, letargi Vaskulære sygdomme Almindelig
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 250 ML
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET - BEHOLDER 250 ML
English: ● You may become more sensitive to sunlight (photosensitivity reaction) when taking Esbriet.
Danish: Kontakt lægen eller apoteketspersonalet, før du tager Esbriet · Du kan blive mere følsom over for sollys (lysfølsomhedsreaktion), når du tager Esbriet.
English: ● This medicine has been prescribed for you only.
Danish: · Lægen har ordineret Esbriet til dig personligt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 267 mg pirfenidone.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En kapsel indeholder 267 mg pirfenidon.
English: Continuation pack: multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated tablets
Danish: Vedligeholdelsespakning: multipakning indeholdende 252 filmovertrukne tabletter (3 pakninger hver indeholdende 4 blister a 21)
English: The decline in distance walked during a 6MWT from Baseline to Week 52 was significantly reduced in patients receiving Esbriet compared with patients receiving placebo in PIPF-016 (p=0.036, rank
Danish: I PIPF-016 var faldet i den distance, patienterne kunne gå i en seks minutters gangtest (6MWT) fra udgangspunktet til uge 52, signifikant reduceret hos patienter, som fik Esbriet, sammenlignet med patienter, som fik placebo (p=0,036, rank ANCOVA).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/018 84 tablets (4x21)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/018 84 tabletter (4 x 21)
English: Dyspnoea; cough; productive cough Gastrointestinal disorders Very Common Dyspepsia; nausea; diarrhoea Common
Danish: Meget almindelig Dyspepsi, kvalme, diarré Almindelig
English: Film-coated tablet Multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated Tablets
Danish: Multipakning indeholdende 252 filmovertrukne tabletter (3 pakninger hver indeholdende 4 blister af
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/019 252 tablets (3 x 84)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/019 252 tabletter (3 x 84)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/017 252 tablets (3 x 84)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/017 252 tabletter (3 x 84)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/020
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/020
English: However, treatment with Esbriet reduced the decline of percent predicted FVC from Baseline at Weeks 24 (p<0.001),
Danish: Behandling med Esbriet reducerede dog faldet i procent forventet FVC fra udgangspunktet til uge 24 (P<0,001), 36 (p=0,011)
English: EU/1/11/667/005 21 tablets EU/1/11/667/006 42 tablets (2 x 21) EU/1/11/667/020 42 tablets EU/1/11/667/007 90 tablets EU/1/11/667/008 180 tablets (2 x 90) EU/1/11/667/021 180 tablets
Danish: EU/1/11/667/008 180 tabletter (2 x 90)EU/1/11/667/021 180 tabletter
English: These hepatic findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving Esbriet.
Danish: Disse leverfund er overensstemmende med en induktion af mikrosomale leverenzymer.
English: Skin and subcutaneous tissue disorders Very Common Photosensitivity reaction; rash Common
Danish: Meget almindelig Lysfølsomhedsreaktion, udslæt Almindelig
English: ● omeprazole (used in the treatment of conditions such as indigestion, gastroesophageal reflux disease)
Danish: Lægemidler, som kan gøre Esbriets virkning dårligere: · omeprazol (bruges til at behandle lidelser som fordøjelsesbesvær, opstød) · rifampicin (et antibiotikum).
English: What Esbriet is and what it is used for What you need to know before you take Esbriet How to take Esbriet
Danish: Det skal du vide, før du begynder at tage Esbriet Sådan skal du tage Esbriet Bivirkninger
English: ● if you have severe or end stage kidney disease requiring dialysis.
Danish: eller nyresygdom i sidste stadie, som kræver dialyse (se pkt.
English: ● Days 8 to 14: two capsules, three times a day (1602 mg/day)
Danish: · Dag 1-7: en kapsel tre gange dagligt (801 mg/dag) · Dag 8-14: to kapsler tre gange dagligt (1602 mg/dag) · Dag 15 og fremefter: tre kapsler tre gange dagligt (2403 mg/dag)
English: ● Any other clinically significant ADRs based on the judgment of the prescriber
Danish: · Lysfølsomhedsreaktioner og hududslæt · Unormale leverfunktionstest · Evt. andre klinisk signifikante uønskede bivirkninger baseret på den ordinerende læges skøn
English: ● stomach problems such as acid reflux, vomiting, feeling bloated, abdominal pain and discomfort, heart burn, feeling constipated and passing wind
Danish: halsbrand, følelse af forstoppelse og luft i maven · blodprøver kan vise forhøjede leverenzymer · hudproblemer som kløe i huden, rødme af huden, tør hud, hududslæt · muskelsmerter, ømme led/ledsmerter · følelse af svaghed eller mangel på energi · brystsmerter · solskoldning.
English: ● if you are taking a medicine called fluvoxamine (used to treat depression and obsessive compulsive disorder [OCD])
Danish: Lægemidler, som kan øge Esbriets bivirkninger: · enoxacin (et antibiotikum) · ciprofloxacin (et antibiotikum) · amiodaron (bruges til at behandle visse former for hjertesygdom) · propafenon (bruges til at behandle visse former for hjertesygdom) · fluvoxamin (bruges til at behandle depression og tvangssyndrom (OCD)).
English: ● If you have any further questions, ask your doctor or pharmacist.
Danish: · Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: ● bladder infections
Danish: · Gem indlægssedlen.
English: 4-week treatment pack of 252 capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pakning til 4 uger med 252 kapsler
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/021
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/021
English: Moderate
Danish: Prægeblæk
English: b n = 6
Danish: Svært n = 6
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/009
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/667/007
English: ● Abnormal liver function tests
Danish: Gruppe med nedsat nyrefunktion
English: ● for the first 7 days take 1 capsule, 3 times a day with food (a total of 801 mg/day)
Danish: Du får normalt medicinen i stigende doser, nemlig følgende: · i de første syv dage tager du én kapsel tre gange om dagen sammen med mad (i alt 801 mg/dag) · fra dag 8 til 14 tager du to kapsler tre gange om dagen sammen med mad (i alt 1.602 mg/dag)
English: Roche Pharma AG Emil-Barell-Str. 1
Danish: Roche Pharma AG Emil Barell-Strasse 1 D-79639 Grenzach-Wyhlen Tyskland
English: ● feeling sick (nausea)
Danish: Gennemsnit (standardafvigelse)
English: EU/1/11/667/020EU/1/11/667/021
Danish: EU/1/11/667/020 42 tabletter
English: Patients should drink plenty of water throughout the day.
Danish: Patienterne bør drikke rigeligt med vand dagen igennem.
English: The recommended dose is one tablet once daily, in the morning.
Danish: Den anbefalede dosis er én tablet én gang dagligt om morgenen.
English: Further information on Duzallo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Duzallo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Allopurinol has been marketed in the EU since the 1960s.
Danish: Allopurinol har været på markedet i EU siden 1960'erne.
English: Other information about Duzallo
Danish: Andre oplysninger om Duzallo
English: As for all medicines, data on the use of Duzallo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Duzallo løbende overvåget.
English: Adding lesinurad 200 mg once daily to the treatment led to 55% patients having levels below 60 mg/litre after 6 months.
Danish: Tilføjelse af 200 mg lesinurad én gang dagligt til behandlingen medførte, at 55 % af patienterne havde et niveau under 60 mg/l efter 6 måneder.
English: For more information about using Duzallo, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Duzallo, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Combining the active substances in a single tablet has the advantage of simplifying treatment.
Danish: Kombinationen af de aktive stoffer i én tablet gør behandlingen enklere.
English: What measures are being taken to ensure the safe and effective use of Duzallo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Duzallo?
English: Lesinurad has been authorized in the EU as Zurampic since 2016.
Danish: Lesinurad har været godkendt i EU under navnet Zurampic siden 2016.
English: The European Medicines Agency decided that Duzallo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Duzallo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Duzallo is available as tablets containing either 200 or 300 mg of allopurinol in combination with 200 mg of lesinurad.
Danish: Duzallo fås som tabletter med enten 200 eller 300 mg allopurinol i kombination med 200 mg lesinurad.
English: Side effects reported with Duzallo are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Duzallo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: It must also not be taken in patients with tumour lysis syndrome (a complication due to the rapid breakdown of cancer cells during cancer treatment) or Lesch-Nyhan syndrome (a rare genetic disease).
Danish: Det må heller ikke tages af patienter med tumorlysesyndrom (en komplikation, der skyldes for hurtig nedbrydning af kræftceller under kræftbehandling) eller LeschNyhan-syndrom (en sjælden genetisk sygdom).
English: The active substances in Duzallo have already been shown to be effective when used as separate tablets.
Danish: Det er allerede påvist, at de aktive stoffer i Duzallo er effektive, når de bruges som separate tabletter.
English: Duzallo contains the active substances allopurinol and lesinurad.
Danish: Duzallo indeholder de aktive stoffer allopurinol og lesinurad.