FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 6-month double-blind, placebo-controlled monotherapy study of Zurampic, renal-related adverse reactions and serious renal-related adverse reactions (including acute renal failure) were reported in 17.8% and 4.7% of patients respectively, receiving Zurampic 400 mg alone and in no patients receiving placebo (see sections 4.2 and 4.4).
Danish: I et dobbeltblindt placebokontrolleret monoterapistudie af 6 måneders varighed med Zurampic blev der rapporteret nyrerelaterede bivirkninger hos 17,8 % og alvorlige nyrerelaterede bivirkninger (herunder akut nyresvigt) hos 4,7 % af de patienter, som fik Zurampic 400 mg alene, og ikke hos nogen af de patienter, der fik placebo (se pkt.
English: Each film-coated tablet contains 200 mg of lesinurad.
Danish: En filmovertrukket tablet indeholder 200 mg lesinurad.
English: Zurampic 200 mg tablets lesinurad
Danish: Zurampic 200 mg tabletter lesinurad
English: Primary end-point in patients with renal impairment Consistent with the overall population, the proportion of patients with mild to moderate renal impairment (eCrCL 30-89 mL/min) who achieved target serum uric acid levels at Month 6 was 56% for Zurampic 200 mg versus 29% for placebo when added to allopurinol, and 40% for Zurampic 200 mg versus 26% for placebo when added to febuxostat in patients with baseline sUA ≥5.0 mg/dL.
Danish: Primært endepunkt hos patienter med nedsat nyrefunktion I overensstemmelse med den samlede population var andelen af patienter med baseline-sUA ≥ 5,0 mg/dl og let til moderat nedsat nyrefunktion (eCrCL 30-89 ml/min), som opnåede det tilsigtede serumurinsyreniveau efter Måned 6, 56 % for Zurampic 200 mg versus 29 % for placebo ved administration sammen med allopurinol, og 40 % for Zurampic 200 mg versus 26 % for placebo ved administration sammen med febuxostat.
English: Patients who are known or suspected to be CYP2C9 poor metabolisers based on previous history or experience with other CYP2C9 substrates should use Zurampic with caution (see section 4.4).
Danish: Zurampic bør anvendes med forsigtighed hos patienter, som på baggrund af tidligere tilfælde eller erfaring med andre CYP2C9-substrater vides at være eller mistænkes at være langsomme CYP2C9-omsættere (se pkt.
English: Each film-coated tablet contains 200 mg lesinurad
Danish: En filmovertrukket tablet indeholder 200 mg lesinurad
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Zurampic indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: Consistent serum uric acid lowering was observed in patients who were receiving thiazide diuretics in the placebo-controlled clinical studies in combination with allopurinol or febuxostat.
Danish: Der blev observeret konsistent reduktion af serumurinsyre hos patienter, som fik thiaziddiuretika i kombination med allopurinol eller febuxostat i de placebokontrollerede kliniske studier.
English: Zurampic must not be initiated in patients with severe renal impairment (CrCL less than 30 mL/min), with end-stage renal disease or in patients on dialysis (see sections 4.3 and 4.4).
Danish: Behandling med Zurampic må ikke påbegyndes hos patienter med svært nedsat nyrefunktion (CrCL < 30 ml/min), patienter i slutstadiet af nyresygdom og hos patienter i dialyse (se pkt.
English: The efficacy of Zurampic 200 mg and 400 mg once daily was studied in 3 multicentre, randomised, double-blind, placebo-controlled clinical studies in 1,537 adult patients (13% of these patients were elderly, ≥65 years old) with hyperuricaemia and gout in combination with a xanthine oxidase inhibitor, allopurinol (CLEAR1 and CLEAR2) or febuxostat (CRYSTAL).
Danish: 3 randomiserede, dobbeltblinde, placebokontrollerede kliniske multicenterstudier undersøgte effekten af Zurampic 200 mg og 400 mg én gang dagligt i kombination med en xanthinoxidasehæmmer, allopurinol (CLEAR1 og CLEAR2) eller febuxostat (CRYSTAL) hos 1.537 voksne patienter (13 % af disse patienter var ældre, ≥65 år gamle) med hyperurikæmi og urinsyregigt.
English: - the other ingredients are: - tablet core: hypromellose, microcrystalline cellulose, lactose monohydrate (see section 2),
Danish: - Aktivt stof: lesinurad - én Zurampic 200 mg filmovertrukket tablet (tablet) indeholder 200 mg lesinurad - Øvrige indholdsstoffer: - tabletkerne: hypromellose, mikrokrystallinsk cellulose, lactosemonohydrat (se punkt 2),
English: CYP2C9 inhibitors and inducers
Danish: CYP2C9-hæmmere og -induktorer
English: Lesinurad undergoes oxidative metabolism mainly via cytochrome P450 (CYP) 2C9 to intermediate metabolite M3c (not detected in vivo) and is subsequently metabolised by mEH to metabolite M4; there is minimal contribution from CYP1A1, CYP2C19, and CYP3A to the metabolism of lesinurad.
Danish: Lesinurad undergår oxidativ metabolisme hovedsageligt via CYP2C9 til mellemstadiemetabolitten M3c (ikke påvist in vivo) og metaboliseres efterfølgende af mEH til metabolitten M4.
English: In these studies, kidney stone adverse reactions (nephrolithiasis being the most frequent) were reported in patients treated with Zurampic 200 mg (0.6%), Zurampic 400 mg (2.5%) and placebo (1.7%).
Danish: I disse studier blev nyrestensrelaterede bivirkninger rapporteret (nefrolitiasis var den hyppigste) hos 0,6 % i Zurampic 200 mg-armen, 2,5 % i Zurampic 400 mg-armen og 1,7 % i placebo-armen.
English: If you take more Zurampic than you should If you take more of this medicine than you should, talk to a doctor or go to the nearest hospital.
Danish: Hvis du har taget for mange Zurampic Kontakt lægen eller nærmeste skadestue, hvis du har taget mere af denne medicin, end du skal.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Zurampic.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Zurampic.
English: Zieglerstraße 6
Danish: Grünenthal GmbH Zieglerstraße 6
English: In three 12-month placebo-controlled trials of Zurampic in combination with a xanthine oxidase inhibitor versus a xanthine oxidase inhibitor alone (placebo), serum creatinine elevations between 1.5fold and 2-fold over baseline occurred in 3.9% of patients on Zurampic 200 mg, 10.0% of patients on Zurampic 400 mg and 2.3% on placebo; serum creatinine elevations 2-fold or greater over baseline occurred in 1.8% of patients on Zurampic 200 mg, 6.7% of patients on Zurampic 400 mg and 0% on placebo.
Danish: I tre placebokontrollerede studier af 12 måneders varighed med Zurampic i kombination med en xanthinoxidasehæmmer versus en xanthinoxidasehæmmer (placebo-gruppen) alene, blev der observeret serumkreatininstigninger, der var mellem 1,5 gange og 2 gange over baseline hos 3,9 % af patienterne på Zurampic 200 mg, 10,0 % af patienterne på Zurampic 400 mg og 2,3 % af patienterne på placebo.
English: Zurampic 200 mg film-coated tablets lesinurad
Danish: Zurampic 200 mg filmovertrukne tabletter lesinurad
English: The most common adverse reaction leading to discontinuation of Zurampic was blood creatinine increased
Danish: Den bivirkning, som hyppigst medførte seponering af Zurampic, var forhøjet kreatinin i blodet (0,8 %).
English: Zurampic 200 mg film-coated tablets
Danish: Zurampic 200 mg filmovertrukne tabletter
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Zurampic Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: EU/1/15/1080/005 100x1 film-coated tablets (unit dose)
Danish: EU/1/15/1080/005 100x1 filmovertrukne tabletter (enkeltdosis)
English: No dose adjustment is necessary in patients with mild or moderate renal impairment (CrCL of 30-89 mL/min) (see sections 4.8, 5.1 and 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion (CrCL 30-89 ml/min) (se pkt.
English: Over time, your gout attacks will happen less often if you keep taking Zurampic as advised by your doctor.
Danish: Hvis du bliver ved med at tage Zurampic, sådan som lægen har forklaret dig, vil dine anfald af urinsyregigt med tiden komme sjældnere.
English: Zurampic when added to febuxostat caused an immediate reduction of the mean serum uric acid levels, as compared to placebo, which was sustained in the long term in those patients who continued treatment.
Danish: Zurampic administreret sammen med febuxostat medførte en øjeblikkelig reduktion i det gennemsnitlige serumurinsyreniveau i sammenligning med placebo.
English: EU/1/15/1080/004 98 film-coated tablets
Danish: EU/1/15/1080/004 98 filmovertrukne tabletter
English: - if you have ‘tumour lysis syndrome' - a fast breakdown of cancer cells which can cause high uric acid levels - if you have ‘Lesch-Nyhan syndrome' -a rare inherited illness that starts in childhood where there is too much uric acid in the blood - if your kidneys work very poorly or you have ‘End-Stage Kidney Disease' - if you have received a kidney transplant - if you are on kidney dialysis.
Danish: - hvis dine nyrer virker meget dårligt, eller hvis du har nyresygdom i slutstadiet - hvis du har gennemgået en nyretransplantation - hvis du er i dialyse
English: In vivo, lesinurad is neither an inhibitor nor an inducer of CYP2C9 and 2C8, but a mild to moderate inducer of CYP3A.
Danish: Lesinurad hverken hæmmer eller inducerer CYP2C9 og 2C8 in vivo, men inducerer CYP3A i let til moderat grad. CYP2B6 er ikke undersøgt in vivo.
English: EU/1/15/1080/003 30 film-coated tablets
Danish: EU/1/15/1080/003 30 filmovertrukne tabletter
English: Gout flares may occur after initiation of therapy with Zurampic.
Danish: Akut anfald af urinsyregigt (udbrud af urinsyregigt) Der kan forekomme udbrud af urinsyregigt efter behandlingsstart med Zurampic.
English: DD month YYYY
Danish: DD/MM/ÅÅÅÅ
English: EU/1/15/1080/001 10 film-coated tablets
Danish: EU/1/15/1080/001 10 filmovertrukne tabletter
English: EU/1/15/1080/002 28 film-coated tablets
Danish: EU/1/15/1080/002 28 filmovertrukne tabletter
English: If you are not sure, talk to your doctor or pharmacist before taking Zurampic.
Danish: Tal med lægen eller apotekspersonalet, før du tager Zurampic, hvis du er i tvivl.
English: Your doctor will check how well your kidneys are working before starting and during treatment with Zurampic.
Danish: Før og under behandlingen med Zurampic vil lægen undersøge, hvor godt dine nyrer virker.
English: Zurampic when added to allopurinol caused an immediate reduction of the mean serum uric acid levels, as compared to placebo, which was sustained in the long term in those patients who continued treatment (see Figure 1).
Danish: Zurampic administreret sammen med allopurinol medførte en øjeblikkelig reduktion i det gennemsnitlige serumurinsyreniveau i sammenligning med placebo.
English: A.
Danish: Søn.
English: Including the combination long-term extension studies, the incidences of serious renal-related adverse reactions (including acute renal failure) per 100 patientyears of exposure were 0.4 and 1.4 for Zurampic 200 mg and Zurampic 400 mg in combination with a xanthine oxidase inhibitor, respectively (see sections 4.2 and 4.4).
Danish: Alvorlige nyrerelaterede bivirkninger, fx akut nyresvigt og nedsat nyrefunktion, blev rapporteret hos patienter, der fik lesinurad 400 mg (1 %) og placebo (0,4 %), og ikke hos nogen patienter, der fik lesinurad 200 mg. Medregnet de langvarige udvidelsesstudier med kombinationsbehandling var forekomsten af alvorlige nyrerelaterede bivirkninger (herunder akut nyresvigt) pr. 100 patienteksponeringsår hhv. 0,4 og 1,4 for Zurampic 200 mg og Zurampic 400 mg i kombination med en xanthinoxidasehæmmer (se pkt.
English: CYP2C9 poor metabolisers
Danish: Langsomme CYP2C9-omsættere
English: C.
Danish: Tors.
English: Adverse reactions related to renal function can occur after initiating Zurampic (see section 4.8).
Danish: Efter start på behandling med Zurampic kan der opstå bivirkninger, som er forbundet med nyrefunktionen (se pkt.
English: What Zurampic is and what it is used for What you need to know before you take Zurampic How to take Zurampic
Danish: Det skal du vide, før du begynder at tage Zurampic Sådan skal du tage Zurampic Bivirkninger
English: Zurampic contains lactose
Danish: Nedsat nyrefunktion
English: As a result, the cancer cells cannot divide, slowing down the growth of tumours.
Danish: Som et resultat heraf kan kræftcellerne ikke dele sig, hvilket hæmmer svulsternes vækst.
English: The full EPAR for Temozolomide Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Temozolomide Hexal findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: MTIC binds to the DNA of cells while they are reproducing, which stops cell division.
Danish: MTIC binder sig til DNA i cellerne, mens disse reproducerer sig selv, hvorved celledelingen standses.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Hexal on 15 March 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Temozolomide Hexal den 15. marts 2010.
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Danish: • Voksne og børn på 3 år og derover med ondartet gliom, såsom glioblastoma multiforme eller anaplastisk astrocytoma, når svulsten er kommet tilbage eller er blevet værre efter standardbehandling.
English: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour).
Danish: • Voksne med nydiagnosticeret glioblastoma multiforme (en aggressiv type hjernesvulst).
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Hexal is being used alone or with other treatments, and how the patient responds to treatment.
Danish: Dosis og antallet af doser afhænger af, hvilken kræfttype der skal behandles, om patienten er blevet behandlet før, om Temozolomide Hexal anvendes alene eller sammen med andre behandlinger, og hvordan patienten responderer på behandlingen.
English: The dose of Temozolomide Hexal depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Danish: Dosis af Temozolomide Hexal afhænger af kropsoverfladen (beregnet ud fra patientens højde og vægt) og ligger på mellem 75 mg og 200 mg pr. kvadratmeter en gang dagligt.
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Hexal.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Temozolomide Hexal.
English: Temozolomide Hexal should be taken without food.
Danish: Temozolomide Hexal skal tages uden mad.
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 Temozolomide Hexal.
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 Temozolomide Hexal.
English: It is used to treat malignant glioma (brain tumours) in the following groups of patients:
Danish: Det anvendes til at behandle ondartet gliom (svulster i hjernen) hos følgende patientgrupper:
English: For more information about treatment with Temozolomide Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Temozolomide Hexal, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Temozolomide Hexal is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Danish: Det betyder, at Temozolomide Hexal er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Temodal.
English: Temozolomide Hexal is used on its own in these patients.
Danish: Temozolomide Hexal anvendes alene hos disse patienter.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Hexal has been shown to have comparable quality and to be bioequivalent to Temodal.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Temozolomide Hexal er af sammenlignelig kvalitet og er bioækvivalent med Temodal.
English: Temozolomide Hexal is used first with radiotherapy and then on its own;
Danish: Temozolomide Hexal bruges først sammen med strålebehandling og herefter alene.
English: For full details, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet (også en del af EPAR).
English: Treatment with Temozolomide Hexal should be prescribed by a doctor with experience in the treatment of brain tumours.
Danish: Behandling med Temozolomide Hexal skal ordineres af en læge, som har erfaring med behandling af hjernesvulster.
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Hexal.
Danish: Det kan ligeledes være nødvendigt at give patienten et middel mod opkastninger inden indtagelsen af Temozolomide Hexal.
English: In the body, temozolomide is converted to another compound called MTIC.
Danish: I kroppen omdannes temozolomid til et andet stof kaldet MTIC.
English: The Committee recommended that Temozolomide Hexal be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Temozolomide Hexal.
English: Other information about Temozolomide Hexal
Danish: Andre oplysninger om Temozolomide Hexal
English: Because Temozolomide Hexal is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Temozolomide Hexal er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses risk/benefit-forholdet for at være det samme som for referencelægemidlet.
English: Temozolomide Hexal is a ‘generic medicine'.
Danish: Temozolomide Hexal er et "generisk lægemiddel".
English: What are the benefit and risk of Temozolomide Hexal?
Danish: Hvilken fordel og risiko er der forbundet med Temozolomide Hexal?
English: The active substance in Temozolomide Hexal, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Danish: Det aktive stof i Temozolomide Hexal, temozolomid, tilhører en gruppe lægemidler mod kræft kaldet alkylerende midler.
English: Temozolomide Hexal is a medicine that contains the active substance temozolomide.
Danish: Temozolomide Hexal er et lægemiddel, der indeholder det aktive stof temozolomid.
English: Because Temozolomide Hexal is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Danish: Da Temozolomide Hexal er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Temodal.
English: Temozolomide Hexal temozolomide
Danish: Temozolomide Hexal temozolomid
English: Temozolomide Hexal is an anticancer medicine.
Danish: Temozolomide Hexal er et lægemiddel mod kræft.
English: Why has Temozolomide Hexal been approved?
Danish: Hvorfor blev Temozolomide Hexal godkendt?
English: What is Temozolomide Hexal?
Danish: Hvad er Temozolomide Hexal?
English: How has Temozolomide Hexal been studied?
Danish: Hvordan blev Temozolomide Hexal undersøgt?
English: How is Temozolomide Hexal used?
Danish: Hvordan anvendes Temozolomide Hexal?
English: What is Temozolomide Hexal used for?
Danish: Hvad anvendes Temozolomide Hexal til?
English: How does Temozolomide Hexal work?
Danish: Hvordan virker Temozolomide Hexal?
English: 1 spray container
Danish: 1 spraybeholder
English: (meat and milk)
Danish: (kød og mælk)
English: Meat: 7 days Milk: 60 hours
Danish: Kød: 7 dage Mælk: 60 timer
English: The CVMP considered that:
Danish: CVMP var af den opfattelse, at:
English: Assessment of the data submitted
Danish: Vurdering af de fremsendte data
English: Combisyn was authorised in the United Kingdom on 30 January 2003 under Article 13(1) of Directive 2001/82/EC.
Danish: Combisyn blev godkendt i Det Forenede Kongerige den 30. januar 2003 i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF.
English: The CVMP was unable to conclude positively on this approach.
Danish: CVMP var ikke i stand til at drage en positiv konklusion om denne tilgang.
English: The conditions for lifting the suspension are outlined in Annex III.
Danish: Betingelserne for ophævelse af suspenderingen fremgår af bilag III.
English: The application was submitted to the Concerned Member States under the mutual recognition procedure.
Danish: Ansøgningen blev indgivet til de berørte medlemsstater i henhold til den gensidige anerkendelsesprocedure.
English: Consequently the matter was referred to the CVMP.
Danish: Som følge heraf blev sagen indbragt for CVMP.
English: • the efficacy of Combisyn was not confirmed;
Danish: • Combisyns virkning var ikke bekræftet;
English: A user risk assessment and a Phase I environmental risk assessment were also provided.
Danish: Der blev ligeledes fremlagt en brugerrisikovurdering og en fase I-miljørisikovurdering.
English: Prior to the lifting of the suspension of the marketing authorisation, the national competent authority of the Reference Member State shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Danish: Inden ophævelse af suspenderingen af markedsføringstilladelsen skal den nationale kompetente myndighed i referencemedlemsstaten sikre, at følgende betingelser opfyldes af indehaveren af markedsføringstilladelsen:
English: This study also served to provide data on the residues of this active substance.
Danish: Denne undersøgelse tog også sigte på at tilvejebringe data om resterne af dette aktive stof.
English: No conclusions could be reached for clavulanic acid since levels were mostly below the limit of quantification.
Danish: Der kunne ikke drages nogen konklusioner om clavulansyre, eftersom niveauerne for det meste lå under kvantificeringsgrænsen.
English: For applications made under Article 13(1) of Directive 2001/82/EC the applicant is not required to submit results of pharmacological, toxicological and clinical trials.
Danish: For ansøgninger, som er indgivet i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF, er ansøgeren ikke forpligtet til at fremsende resultaterne af farmakologiske, toksikologiske og kliniske undersøgelser.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, withdrawal periods, applicant, marketing authorisation holder in the member states
Danish: Liste over veterinærlægemidlets navn, lægemiddelform, styrke, dyrearter, indgivelsesvej, tilbageholdelsestid, ansøger og indehaver af markedsføringstilladelse i medlemsstaterne
English: The CVMP was asked to give its opinion on the concerns raised by the Concerned Member States and to conclude on the benefit/risk balance for Combisyn.
Danish: CVMP blev anmodet om at afgive udtalelse om de betænkeligheder, som de berørte medlemsstater havde givet udtryk for, og om at drage en konklusion om risk/benefit-forholdet for Combisyn.