FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardalis 5 mg/40 mg tablets
Danish: Cardalis 5 mg/40 mg tabletter
English: Cardalis 10 mg/80 mg tablets
Danish: Cardalis 10 mg/80 mg tabletter
English: Do not use during pregnancy and lactation (see section 4.7).
Danish: Bør ikke anvendes i forbindelse med drægtighed og laktation (se afsnit 4,7) Bør ikke anvendes til dyr, der anvendes eller påtænkes anvendt til avl.
English: Do not use during pregnancy and lactation.Embryotoxic effects (foetal urinary tract malformation) were seen in trials of benazepril with laboratory animals (rats) at maternally non-toxic doses.
Danish: Bør ikke anvendes til drægtige og lakterende dyr, da der i kliniske studier med benazepril hos laboratoriedyr (rotter) er observeret tegn på udviklingsrelateret toksicitet (føtal misdannelse af urinvejene).
English: The concomitant administration of this veterinary medicinal product with other potassium-sparing treatments (such as ß-blockers, calcium channels blockers, angiotensin receptor blockers) may potentially lead to hyperkalaemia (see section 4.5).
Danish: Samtidig administration af veterinærlægemidlet med andre kaliumbesparende lægemidler (som angiotensionreceptorblokkere, β-blokkere, kalciumkanalblokkere) kan potentielt føre til hyperkaliæmi.
English: Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable tablets for dogs
Danish: Cardalis 2,5 mg/20 mg tyggetabletter til hund Cardalis 5 mg/40 mg tyggetabletter til hund Cardalis 10 mg/80 mg tyggetabletter til hund
English: Absorption
Danish: Optagelse
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 30 tablets
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Glas à 30 tabletter
English: 4.4 Special warnings
Danish: 6.4 Særlige opbevaringsforhold
English: Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable tablets for dogs benazepril HCl/spironolactone
Danish: Cardalis 2,5 mg/20 mg tyggetabletter til hund Cardalis 5 mg/40 mg tyggetabletter til hund Cardalis 10 mg/80 mg tyggetabletter til hund benazepril HCl/spironolactone
English: After coadministration of spironolactone (2 mg/kg bw) and benazepril hydrochloride (0.25 mg/kg bw) the terminal plasma half-lives (t½) were 7 hours and 6 hours for canrenone and 7-α-thiomethylspironolactone respectively.
Danish: var den terminale plasmahalveringstid (t) hhv. 7 timer og 6 timer for canrenon og 7-α-thiomethylspironolakton.
English: Cardalis 2.5 mg/20 mg chewable tablets for dogs Benazepril hydrochloride 2.5 mg, spironolactone 20 mg Cardalis 5 mg/40 mg chewable tablets for dogs Benazepril hydrochloride 5 mg, spironolactone 40 mg Cardalis 10 mg/80 mg chewable tablets for dogs Benazepril hydrochloride 10 mg, spironolactone 80 mg
Danish: Cardalis 2,5 mg/20 mg tyggetabletter til hund Cardalis 5 mg/40 mg tyggetabletter til hund Cardalis 10 mg/80 mg tyggetabletter til hund benazepril hydroklorid/spironolakton
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stelara on 16 January 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Stelara den 16. januar 2009.
English: Other information about Stelara
Danish: Andre oplysninger om Stelara
English: This is a summary of the European public assessment report (EPAR) for Stelara.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Stelara.
English: The first injection is followed by a further injection four weeks later, and then an injection every 12 weeks.
Danish: Den første injektion følges op med en ny injektion fire uger senere, hvorefter der gives en injektion hver 12. uge.
English: Stelara is a medicine used to treat the following diseases:
Danish: Stelara er et lægemiddel, der anvendes til at behandle følgende sygdomme:
English: The infusion lasts at least one hour and the dose depends on the patient's bodyweight.
Danish: Infusionen varer mindst én time, og dosen afhænger af patientens kropsvægt.
English: These will focus on the safety of Stelara, particularly the risks of developing tuberculosis, other infections and cancers.
Danish: Disse vil sætte fokus på sikkerheden ved Stelara, særlig risikoen for tuberkulose, andre infektioner og cancer.
English: The side effects of the medicine were considered tolerable and manageable.
Danish: Bivirkningerne ved lægemidlet blev anset for at være tålelige og håndterbare.
English: Most of these effects were considered mild and did not require treatment to be stopped.
Danish: De fleste bivirkninger blev anset for at være milde og krævede ikke ophør af behandlingen.
English: Stelara may be used alone or combined with methotrexate (a DMARD);
Danish: Stelara kan anvendes alene eller i kombination med methotrexat (et DMARD).
English: However, patients in some studies had unexpected increases in problems affecting the heart and blood vessels and psychiatric problems such as depression which might be related to Stelara.
Danish: Patienter i enkelte undersøgelser oplevede dog uventede stigninger i problemer, der påvirker hjertet og blodkarrene, samt psykiske problemer, såsom depression, hvilket kan være relateret til Stelara.
English: Psoriatic arthritis
Danish: Psoriatisk artritis
English: What measures are being taken to ensure the safe and effective use of Stelara?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Stelara?
English: Stelara must not be used in patients who have an active infection that the doctor considers important.
Danish: Stelara må ikke anvendes til patienter, som har en aktiv infektion, som lægen anser for at være betydningsfuld.
English: Why is Stelara approved?
Danish: Hvorfor blev Stelara godkendt?
English: What is Stelara and what is it used for?
Danish: Hvad er Stelara, og hvad anvendes det til?
English: PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet light.
Danish: PUVA er en form for behandling, hvor patienten modtager et lægemiddel, der indeholder et stof, som kaldes "psoralen", inden patienten eksponeres for ultraviolet lys.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Stelara's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Stelara opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The most serious side effect reported with Stelara is serious hypersensitivity (allergic reaction).
Danish: De mest alvorlige bivirkninger, der er indberettet med Stelara, er alvorlige overfølsomhedsreaktioner (allergiske reaktioner).
English: Stelara was more effective than placebo at improving the symptoms of plaque psoriasis.
Danish: Stelara var mere effektivt end placebo til at forbedre symptomerne på plaquepsoriasis.
English: By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.
Danish: Ved at blokere deres aktivitet mindsker ustekinumab aktiviteten i immunsystemet og symptomerne på sygdommen.
English: What are the risks associated with Stelara?
Danish: Hvilke risici er der forbundet med Stelara?
English: It is not intended to provide practical advice on how to use Stelara.
Danish: Det er ikke en praktisk vejledning i, hvordan Stelara bør anvendes.
English: Patients weighing over 100 kg should be given Stelara in 90-mg doses for psoriasis, and this should also be considered for psoriatic arthritis.
Danish: Patienter på over 100 kg bør gives Stelara i doser på 90 mg for psoriasis, hvilket også bør overvejes for psoriatisk artritis.
English: It is used in adults and children above the age of 12 years whose condition has not responded to or who cannot use other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A).
Danish: Det anvendes til voksne og børn over 12 år, som ikke har responderet på eller ikke kan bruge anden systemisk (helkrops-)behandling for psoriasis, såsom ciclosporin, methotrexat eller PUVA (psoralen ultraviolet-A).
English: A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Danish: Et monoklonalt antistof er et antistof (en form for protein), der er udformet, så det genkender og binder sig til en særlig struktur (et antigen) i kroppen.
English: The comparative study showed that Stelara is more effective than etanercept after 12 weeks of treatment.
Danish: Den sammenlignende undersøgelse viste, at Stelara er mere effektivt end etanercept efter 12 ugers behandling.
English: Eight weeks after the first infusion patients should receive 90 mg Stelara by injection under the skin.
Danish: 8 uger efter den første infusion skal patienter modtage 90 mg Stelara ved injektion under huden.
English: The company that makes Stelara will also provide educational material for healthcare providers and patients.
Danish: Den virksomhed, der fremstiller Stelara, sørger også for at udlevere informationsmateriale til sundhedsfagligt personale og patienter.
English: Some of the patients from the two main studies went on to receive Stelara (injection under the skin) every 8 or 12 weeks, or placebo.
Danish: Nogle af patienterne fra de to hovedundersøgelser fortsatte med at tage Stelara (injektion under huden) hver 8. eller 12. uge, eller placebo.
English: Ustekinumab attaches to two cytokines (messenger molecules) in the immune system called interleukin 12 and interleukin 23.
Danish: Ustekinumab binder sig til to cytokiner (signalstoffer) i immunsystemet, nemlig interleukin-12 og interleukin-23.
English: In the second study the figures were 56% for Stelara and 29% for placebo.
Danish: I den anden undersøgelse var tallene 56 % for Stelara og 29 % for placebo.
English: The company subsequently provided the longer-term results of the studies (after 5 years of treatment), and the results of a study comparing Stelara with etanercept (another medicine for psoriasis).
Danish: Virksomheden forelagde efterfølgende de langsigtede resultater af undersøgelserne (efter fem års behandling) samt resultaterne af en undersøgelse, hvor Stelara sammenlignes med etanercept (et andet psoriasislægemiddel).
English: The most common side effects with Stelara (seen in more than 5% of patients during clinical trials) are headache and nasopharyngitis (inflammation of the nose and throat).
Danish: De hyppigste bivirkninger ved Stelara (som optræder hos flere end 5 % af patienterne under kliniske undersøgelser) er hovedpine og nasopharyngitis (betændelse i næse og hals).
English: An additional study involved 110 children with moderate to severe plaque psoriasis aged between 12 and 18 years.
Danish: En yderligere undersøgelse omfattede 110 børn med moderat til svær plaquepsoriasis i alderen mellem 12 og 18 år.
English: In Crohn's disease, treatment is started with Stelara concentrate.
Danish: Ved Crohns sygdom indledes behandling med Stelara-koncentrat.
English: These cytokines are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis and Crohn's disease.
Danish: Disse cytokiner medvirker til inflammation og andre processer, der er meget kendetegnende for psoriasis og psoriatisk artritis og Crohns sygdom.
English: Stelara contains the active substance ustekinumab.
Danish: Stelara indeholder det aktive stof ustekinumab.
English: EPAR summary for the public
Danish: EPAR - sammendrag for offentligheden ustekinumab
English: • moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin).
Danish: • moderat til svær plaquepsoriasis (en sygdom, som fremkalder røde, afskallende pletter på huden).
English: The patient material will also include details of how Stelara should be injected under the skin.
Danish: Informationsmaterialet til patienter vil også indeholde oplysninger om, hvordan Stelara injiceres under huden.
English: In over half of these patients other treatments for psoriasis had failed or the patients could not receive them.
Danish: Over halvdelen af disse patienter har ikke responderet på andre psoriasis-behandlinger, eller har ikke kunnet modtage andre behandlinger.
English: Patients then continue with Stelara given under the skin every 8 or 12 weeks depending on response to treatment.
Danish: Patienterne fortætter derefter med at modtage Stelara under huden hver 8. eller 12. uge, afhængig af hvordan de responderer på behandlingen.
English: For adults with psoriatic arthritis who have not responded well to DMARDs the CHMP noted the limited treatments available and considered that Stelara would be of benefit in these patients.
Danish: Til patienter med psoriatisk artritis, som ikke har responderet godt på DMARD'er, bemærkede CHMP de tilgængelige behandlingers begrænsede omfang og konstaterede, at Stelara ville være til fordel for disse patienter.
English: For adults the usual dose is 45 mg, whereas the dose in children depends on bodyweight.
Danish: Den almindelige dosis til voksne er 45 mg. Dosen til børn afhænger af kropsvægten.
English: In plaque psoriasis and psoriatic arthritis, Stelara is given as an injection under the skin.
Danish: Til behandling af plaquepsoriasis og psoriatisk artritis gives Stelara som en injektion under huden.
English: Stelara is available as a solution for injection (45 and 90 mg) in vials or prefilled syringes and as a concentrate (130 mg) to make a solution for infusion (drip) into a vein.
Danish: Stelara fås som injektionsvæske (45 and 90 mg) i hætteglas eller fyldte injektionssprøjter og som et koncentrat (130 mg), der fortyndes til en opløsning, som gives som infusion (drop) i en vene.
English: In Crohn's disease, the effects of Stelara in reducing symptoms in patients in whom other treatments had failed or who could not receive them were considered important, also given the unmet medical need of these patients.
Danish: Ved Crohns sygdom blev Stelaras virkning i form af nedsættelse af symptomer hos patienter, som ikke responderede på andre behandlinger, eller som ikke kunne modtage andre behandlinger, anset for væsentlig, også i lyset af disse patienters uopfyldte medicinsk behov.
English: The active substance in Stelara, ustekinumab, is a monoclonal antibody.
Danish: Det aktive stof i Stelara, ustekinumab, er et monoklonalt antistof.
English: The CHMP considered that studies had shown that Stelara was effective in the treatment of adults and children over 12 years of age with moderate to severe plaque psoriasis.
Danish: CHMP konstaterede, at Stelara i undersøgelser er blevet påvist at være effektivt til behandling af voksne og børn over 12 år med moderat til svær plaquepsoriasis.
English: • active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not responded well enough to other treatments called disease-modifying antirheumatic drugs' (DMARDs).
Danish: • aktiv psoriatisk artritis (ledbetændelse forbundet med psoriasis) hos voksne, når sygdommen ikke har responderet tilstrækkeligt på andre behandlinger kaldet sygdomsmodificerende antireumatiske lægemidler (DMARD'er).
English: Stelara can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Stelara is used for.
Danish: Stelara udleveres kun efter recept, og behandlingen bør kun iværksættes og overvåges af en læge med erfaring i diagnose og behandling af de lidelser, som Stelara anvendes mod.
English: After 44 weeks of starting treatment by injection under the skin, 53% of patients on Stelara every 8 weeks and 49% of patients on Stelara every 12 weeks had a significant reduction in symptoms of Crohn's disease, compared with 36% of patients on placebo.
Danish: 44 uger efter påbegyndt behandling ved injektion under huden havde 53% af de patienter, der fik Stelara hver 8. uge, og 49 af de patienter, der fik Stelara hver 12. uge, et signifikant fald i symptomerne på Crohns sygdom sammenlignet med 36 % af de patienter, der fik placebo.
English: For the full list of restrictions please see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: The longer-term results showed that with continuous treatment, the response to Stelara is maintained over 5 years.
Danish: De langsigtede resultater viste, at behandlingsresponsen på Stelara ved fortsat behandling opretholdes gennem fem år.
English: The children received placebo or Stelara and the main measure of effectiveness was the number of patients who responded to treatment after 12 weeks as shown by an improvement in symptom scores.
Danish: Børnene fik placebo eller Stelara, og virkningen blev hovedsageligt bedømt på antallet af patienter, der havde responderet på behandlingen efter 12 uger, hvilket blev påvist ved en forbedring i symptomscoren.
English: For practical information about using Stelara, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Stelara, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Therefore, the CHMP decided to restrict the use of the medicine in moderate to severe plaque psoriasis to patients aged 12 years and above in whom other treatments had failed or who could not receive them.
Danish: CHMP besluttede således at begrænse anvendelsen af lægemidlet til moderat til svær plaquepsoriasis til patienter på 12 år og derover, som ikke har reageret på anden behandling, eller som ikke har kunnet modtage anden behandling.
English: • moderately to severely active Crohn's disease (a disease causing inflammation of the gut) in adults whose condition has not responded well enough to other treatments for Crohn's disease or who cannot receive such treatments.
Danish: • moderat til svært aktiv Crohns sygdom (en sygdom, der forårsager betændelse i tarmen)hos voksne, som ikke har responderet tilstrækkeligt på andre behandlinger, eller som ikke kan modtage andre behandlinger.
English: In around 69% of children (25 out of 36) who received Stelara responded, compared with 5% of patients receiving placebo (2 out of 37).
Danish: Ca. 69 % af de børn (25 ud af 36), der modtog Stelara, reagerede positivt, sammenlignet med 5% af de patienter, som modtog placebo (2 ud af 37).
English: How is Stelara used?
Danish: Hvordan anvendes Stelara?
English: In the treatment of Crohn's disease, Stelara (concentrate for infusion) was compared with placebo in two main studies involving 1,369 patients with moderately to severely active disease.
Danish: I behandlingen af Crohns sygdom blev Stelara (koncentrat til infusion) sammenlignet med placebo i to hovedundersøgelser af 1 369 patienter med moderat til alvorlig aktiv sygdom.
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment after 12 weeks, meaning that symptom scores improved by 75% or more.
Danish: Virkningen blev hovedsageligt bedømt på antallet af patienter, som "responderede" på behandlingen inden for 12 uger, dvs. hvis symptomscore forbedredes med mindst 75 %.
English: In both studies the main measure of effectiveness was the number of patients who responded to treatment after 24 weeks as shown by an improvement in symptom scores.
Danish: I begge undersøgelser blev virkningen hovedsageligt bedømt på antallet af patienter, der responderede på behandlingen efter 24 uger, hvilket blev påvist ved en forbedring i symptomscoren.
English: What benefits of Stelara have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Stelara?
English: For the full list of all side effects reported with Stelara, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Stelara fremgår af indlægssedlen.
English: In the treatment of active psoriatic arthritis, Stelara was compared with placebo in two main studies involving a total of 927 adults with the condition who did not have an adequate response with previous treatments.
Danish: Til behandling af aktiv psoriatisk artritis blev Stelara sammenlignet med placebo i to hovedundersøgelser, som omfattede i alt 927 sygdomsramte voksne, der ikke havde responderet tilstrækkeligt på tidligere behandlinger.
English: In the first study, around 34% patients who received Stelara (at a dose calculated based on bodyweight) responded to treatment compared with 21% of patients who were given placebo.
Danish: I den første undersøgelse responderede ca. 34 % af de patienter, som modtog Stelara (i en dosis beregnet ud fra deres kropsvægt) på behandling, sammenlignet med 21 % af patienter, som fik placebo.
English: In the first study, around 42% of those given Stelara 45 mg and 50% of those given 90 mg responded, compared with around 23% of those given placebo.
Danish: I den første undersøgelse responderede cirka 42 % af de patienter, der fik 45 mg Stelara, og 50 % af dem, der fik en dosis på 90 mg, sammenlignet med cirka 23 % af dem, der fik placebo.
English: The full EPAR for Stelara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Stelara findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Hvis du ønsker yderligere oplysninger om behandling med Stelara, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Looking at the results of the two main studies in adults taken together, around 69% of the patients receiving Stelara responded to treatment after 12 weeks, compared with around 3% of the patients receiving placebo.
Danish: Ser man på de samlede resultater af de to hovedundersøgelser, responderede ca. 69 % af de patienter, som fik Stelara, på behandlingen inden for 12 uger sammenlignet med ca. 3 % af de patienter, der blev behandlet med placebo.
English: Plaque psoriasis
Danish: Plaquepsoriasis
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stelara have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Stelara.
English: In the treatment of moderate to severe plaque psoriasis, Stelara has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,996 adults with the condition.
Danish: Til behandling af moderat til svær plaquepsoriasis er Stelara blevet sammenlignet med placebo (en virkningsløs behandling) i to hovedundersøgelser, der omfattede i alt 1 996 voksne med ovennævnte sygdom.
English: How does Stelara work?
Danish: Hvordan virker Stelara?
English: Patients or their caregivers may inject Stelara under the skin once they have been trained, if their doctor thinks that this is appropriate.
Danish: Når patienterne har fået undervisning, kan de selv begynde at foretage injektionen af Stelara, hvis deres læge tilråder det.
English: In the second study, around 44% of those given either dose of Stelara responded, compared with around 20% of those given placebo.
Danish: I den anden undersøgelse var responsraten for begge doser Stelara cirka 44 % af patienterne sammenlignet med cirka 20 % af dem, der fik placebo.
English: Date of first authorisation: 15 October 1998 Date of latest renewal: 15 October 2008
Danish: Dato for første markedsføringstilladelse: 15. oktober 1998 Dato for seneste fornyelse: 15. oktober 2008
English: CoAprovel should be taken at least one hour before or four hours after these medications;
Danish: CoAprovel bør tages mindst en time før eller fire timer efter disse lægemidler;
English: Risk Management Plan (RMP)
Danish: • Risikostyringsplan (RMP)