FrancophonIA/ELRC3.0 huggingface dataset:
English: Chenodeoxycholic acid Leadiant should be used under medical supervision.
Danish: Behandling med Chenodeoxycholic acid Leadiant skal kontrolleres af en læge.
English: If you forget to take Chenodeoxycholic acid Leadiant
Danish: Hvis du har glemt at tage Chenodeoxycholic acid Leadiant
English: How to take Chenodeoxycholic acid Leadiant 4.
Danish: Sådan skal du tage Chenodeoxycholic acid Leadiant 4.
English: If you stop taking Chenodeoxycholic acid Leadiant
Danish: Hvis du holder op med at tage Chenodeoxycholic acid Leadiant
English: Each hard capsule contains 250 mg of chenodeoxycholic acid.
Danish: Hver hårde kapsel indeholder 250 mg chenodeoxycholsyre.
English: Chenodeoxycholic acid Leadiant capsules can be used from the age of one month and patients with CTX will require treatment for the rest of their life.
Danish: Patienter med CTX har behov for behandling resten af livet.
English: - Each capsule contains 250 mg of chenodeoxycholic acid.
Danish: - Hver kapsel indeholder 250 mg chenodeoxycholsyre.
English: Oral contraceptives are not recommended.
Danish: P-piller anbefales ikke.
English: Other medicines and Chenodeoxycholic acid Leadiant
Danish: Brug af anden medicin sammen med Chenodeoxycholic acid Leadiant
English: Co-administration with oral contraceptives is not recommended, see section 4.5 for further details.
Danish: Samtidig administration af orale antikonceptiva anbefales ikke, se pkt.
English: It is not recommended to take oral contraceptives whilst taking Chenodeoxycholic acid Leadiant.
Danish: Det anbefales, at du ikke tager p-piller, mens du tager Chenodeoxycholic acid Leadiant.
English: Each capsule contains 250 mg chenodeoxycholic acid.
Danish: En kapsel indeholder 250 mg chenodeoxycholsyre.
English: (Daily dose in mg) = Divided dose in mg (Dose frequency) Volume to administer: (Divided dose in mg x 1 ml) = Amount of suspension to give
Danish: (Daglig dosis i mg/doseringshyppighed) = Opdelt dosis i mg
English: In order to collect long term safety and efficacy data in patients treated with Protocol - by chenodeoxycholic acid, the MAH will submit the results of a study deriving from a registry of patients with inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
Danish: Protokol - senest over patienter med medfødte fejl i den primære galdesyresyntese som følge af sterol 27-hydroxylasemangel (spædbørn, børn og unge i alderen 1 måned til 18 år samt voksne).
English: (Daily dose in mg) = Divided dose in mg (Dose frequency) Volume to administer: (Divided dose in mg) x 1 ml = Amount of suspension to give
Danish: (Opdelt dosis i mg ∙ 1 ml)/10 mg = Volumen suspension, der skal gives
English: How to take Chenodeoxycholic acid Leadiant
Danish: Sådan skal du tage Chenodeoxycholic acid Leadiant
English: Capsule content Maize starch
Danish: Mave-tarm-kanalen
English: This was confirmed within the framework of this article 30 procedure.
Danish: Dette blev bekræftet inden for rammerne af denne artikel 30-procedure.
English: The stability data at these testing conditions has shown that the results are within the acceptance criteria and the product is stable.
Danish: Stabilitetsdata ved disse forsøgsbetingelser har vist, at resultaterne overholder godkendelseskriterierne, og at produktet er stabilt.
English: Overall summary of the scientific evaluation of Sandimmun and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Sandimmun og relaterede navne (se bilag I)
English: Moreover, recent trials have confirmed the benefit of Sandimmun in different forms of nephrotic syndrome in children and adults.
Danish: Desuden har nylige undersøgelser bekræftet fordelene ved Sandimmun til forskellige former af nefrotisk syndrom hos børn og voksne.
English: The MAH confirmed that the stability studies have been performed at the long term conditions at 25°C/60%RH and accelerated conditions also at 40°C/75% RH.
Danish: Indehaveren af markedsføringstilladelsen bekræftede, at der er udført stabilitetsundersøgelser ved langvarig opbevaring ved 25 °C/60 % RH og ved accelererede betingelser ved 40 °C/75 % RH.
English: However the statement “The daily doses of Sandimmum should always be given in two divided doses” was partly endorsed by the CHMP since the word “always” should be omitted (in some cases, three times daily administration may be needed).
Danish: Angivelsen “Den daglige dosis af Sandimmun bør altid fordeles på to separate doser” blev delvis godkendt af CHMP, da ordet “altid” bør udelades (i nogle tilfælde kan administration tre gange dagligt være nødvendig).
English: The MAH confirmed that the storage conditions in the SmPCs of Sandimmun soft gelatin capsules and oral solutions are already aligned with the requirements set in the Guideline on Declaration of Storage Conditions (CPMP/QWP/609/96/Rev 2 dated 19 Nov 2007).
Danish: Indehaveren af markedsføringstilladelsen fastslog, at opbevaringsbetingelserne i produktresuméerne for Sandimmun, bløde gelatinekapsler og orale opløsninger, i forvejen er rettet ind efter kravene i “Guideline on Declaration of Storage Conditions” (CPMP/QWP/609/96/Rev 2, dateret den 19. november 2007).
English: Sandimmun is an oil-based formulation of ciclosporin.
Danish: Sandimmun er en oliebaseret formulering af ciclosporin.
English: The registration of Sandimmun Neoral was based on efficacy and safety data from clinical studies performed with the oil-based formulation (Sandimmun), first registered in Switzerland in December 1982.
Danish: Registreringen af Sandimmun Neoral byggede på data vedrørende virkning og sikkerhed fra kliniske undersøgelser med den oliebaserede formulering (Sandimmun), der første gang blevet registreret i Schweiz i december 1982.
English: The MAH proposed the following wording for this indication: “Sandimmun is indicated in patients with severe atopic dermatitis when systemic therapy is required.” The MAH's proposed indication wording for the Atopic dermatis is approved in 15 EU countries.
Danish: Indehaveren af markedsføringstilladelsen foreslog følgende ordlyd til denne indikation: “Sandimmun er indiceret til patienter med svær atopisk dermatitis, når systemisk behandling er påkrævet.” Indikationen atopisk dermatitis er godkendt i 15 EU-lande med den ordlyd, der er foreslået af indehaveren af markedsføringstilladelsen.
English: The dossier of Sandimmun was used as a basis of the review as the dossier supporting the approval of the new ciclosporin formulation (Sandimmun Neoral) was based on pharmacokinetics evaluation that demonstrated equivalence between the 2 forms of ciclosporin (oil-based formulation versus microemulsified formulation).
Danish: Dossieret for Sandimmun dannede grundlag for gennemgangen, da dossieret til ansøgningen for den nye formulering af ciclosporin (Sandimmun Neoral) byggede på en farmakokinetisk vurdering, som viste ækvivalens mellem de to former af ciclosporin (oliebaseret formulering versus mikroemulgeret formulering).
English: The MAH therefore agreed to revise the wording, recommending that Sandimmun should be administered on a consistent schedule with regard to time of day and relation to meals, as follows: “The daily doses of Sandimmun/Sandimmun Neoral always should be given in two divided doses equally distributed throughout the day, taken at the same time of the day, e.g., in the morning and in the evening.
Danish: Indehaveren af markedsføringstilladelsen indvilligede derfor i at revidere ordlyden som følger med anbefaling af ensartet administration af Sandimmun hvad angår klokkeslæt og i forhold til måltiderne: “Dagsdosis af Sandimmun/Sandimmun Neoral gives altid som to separate doser, der fordeles ligeligt over døgnet, og tages på samme klokkeslæt, dvs. aften og morgen.
English: Therefore, The MAH adhered to the statement on SPC and PL as “This medicinal product does not require any special temperature storage conditions” in accordance with the guideline.
Danish: Indehaveren af markedsføringstilladelsen bibeholdt derfor erklæringen i produktresuméet og indlægssedlen med ordlyden “Der er ingen særlige krav til opbevaringstemperatur for dette lægemiddel” i overensstemmelse med retningslinjerne.
English: The CHMP noted that Marketing Authorisations for Sandimmum and associated names 50mg/ml concentrate for solution for infusion are solely granted for the above-mentioned transplantation indications (namely, the solid organ transplantation and the bone marrow transplantation).
Danish: CHMP bemærkede, at markedsføringstilladelserne for Sandimmun og relaterede navne, koncentrat til infusionsvæske, opløsning, 50 mg/ml, alene dækker ovennævnte transplantationsindikationer (dvs. organtransplantation og knoglemarvstransplantation).
English: The CHMP is of the view that introducing Sandimmun for the treatment of rejection is most appropriate for cellular rather than humoral rejection, based on the mechanism of action of CNI's.
Danish: CHMP er af den opfattelse, at anvendelse af Sandimmun til behandling af afstødning er mere hensigtsmæssig til cellulær end til humoral afstødning, baseret på virkningsmekanismen af calcineurinhæmmere.
English: Finally the MAH was also requested to update this section with more information concerning the inhibitory potential of ciclosporin on other transporters than P-gp.
Danish: Endelig blev indehaveren af markedsføringstilladelsen anmodet om at ajourføre dette afsnit med flere oplysninger om ciclosporins potentiale for at hæmme andre transportproteiner end P-gp.
English: The daily doses of Sandimmum should always be given in two divided doses.” The MAH's statement “The dose ranges given for oral administration are intended to serve as guidelines only” is endorsed by the CHMP.
Danish: Den daglige dosis af Sandimmun bør altid fordeles på to separate doser.” Markedsføringstilladelsesindehaverens erklæring “De angivne dosisintervaller for oral administration er kun vejledende” kan godkendes af CHMP.
English: • Sandimmum and associated names 50mg/ml concentrate for solution for infusion
Danish: • Sandimmun og relaterede navne, koncentrat til infusionsvæske, opløsning, 50 mg/ml
English: Based on the above the CHMP considers the benefit/risk ratio of Sandimmun to be favourable and the harmonised PI to be approvable.
Danish: På ovenstående grundlag finder CHMP, at benefit/risk-forholdet for Sandimmun og relaterede navne er positivt, og at de harmoniserede produktinformationer kan godkendes.
English: In addition, the MAH proposed a correction in the wording of the “Special precautions for storage” in the SmPC for Sandimmun 50 mg/ml concentrate for solution for infusion, also in conformance to the above-mentioned Guideline.
Danish: Indehaveren af markedsføringstilladelsen foreslog desuden en ændring i ordlyden af “Særlige opbevaringsbetingelser” i produktresuméet for Sandimmun, koncentrat til infusionsvæske, opløsning, 50 mg/ml, hvilket ligeledes er i overensstemmelse med de nævnte retningslinjer.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holder(s) have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Sandimmum and associated names (see Annex I).
Danish: • det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaveren (indehaverne) af markedsføringstilladelserne, blev vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelser i udvalget,
English: In conclusion, based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon and adopted harmonised sets of PI documents for the various presentations of Sandimmun and associated names.
Danish: Efter vurderingen af forslaget fra markedsføringstilladelsesindehaveren, besvarelserne til LoQ og LoOI og drøftelserne i udvalget vedtog CHMP til sidst et harmoniseret sæt dokumenter til produktinformation for de forskellige pakningsstørrelser af Sandimmun og relaterede navne.
English: A new wording was proposed by the MAH and agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen foreslog en ny ordlyd, som blev godkendt af CHMP.
English: It is recommended that Sandimmun be administered on a consistent schedule with regard to time of day and relation to meals.
Danish: Det anbefales, at Sandimmun administreres på samme klokkeslæt og med samme relation til måltiderne fra dag til dag.” Denne ordlyd blev godkendt af CHMP.
English: Its side effects seem manageable.
Danish: Bivirkningerne ved lægemidlet synes håndterbare.
English: The maximum dose is 90 mg every two weeks.
Danish: Den maksimale dosis er 90 mg hver anden uge.
English: This is a summary of the European public assessment report (EPAR) for Crysvita.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Crysvita.
English: All the children received Crysvita either every two weeks or every four weeks.
Danish: Alle børn fik Crysvita enten hver 2. uge eller hver 4. uge.
English: Crysvita has been given ‘conditional approval'.
Danish: Crysvita har fået en "betinget godkendelse".
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Danish: Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet, som virksomheden er blevet bedt om at forelægge.
English: Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Danish: Europæiske Lægemiddelagentur alle nye oplysninger, der måtte foreligge, og ajourfører om nødvendigt dette sammendrag.
English: Crysvita is given as an injection under the skin.
Danish: Crysvita gives som en injektion under huden.
English: The average score before treatment was 1.9 points in those given Crysvita every 2 weeks, and this fell by 1.0 point after 64 weeks of treatment; in those given the medicine every 4 weeks the baseline score of 1.7 fell by 0.8 point.
Danish: Den gennemsnitlige score før behandling var 1,9 point hos dem, der fik Crysvita hver 2. uge, og det faldt med 1,0 point efter 64 ugers behandling; hos dem, der fik lægemidlet hver 4. uge faldt scoren med 0,8 point fra baseline-scoren på 1,7.
English: Crysvita contains the active substance burosumab.
Danish: Crysvita indeholder det aktive stof burosumab.
English: The medicine was assessed in one main ongoing study in 52 children aged between 5 and 12 years.
Danish: Lægemidlet blev vurderet i en igangværende hovedundersøgelse af 52 børn i alderen 5-12 år.
English: The European Medicines Agency therefore decided that Crysvita's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Crysvita opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The recommended dose at the start of treatment is 0.4 mg per kg of body weight, and then 0.8 mg/kg every two weeks to continue treatment.
Danish: Den anbefalede dosis ved starten af behandlingen er 0,4 mg pr. kg legemsvægt og derefter 0,8 mg/kg hver anden uge.
English: Side effects with Crysvita (which may affect more than 1 in 10 people) are injection site reactions (such as skin redness, itching, rash, pain and bruising), headache, pain in arms and legs, decreased vitamin D level, rash, toothache, tooth abscess, muscle pain and dizziness.
Danish: Bivirkninger ved Crysvita (som kan forekomme hos flere end 1 ud af 10 patienter) er reaktioner på injektionsstedet (f.eks. rødme, kløe, udslæt, ømhed og blå mærker), hovedpine, smerter i arme og ben, nedsat D-vitaminniveau, udslæt, tandpine, tandbylder, muskelsmerter og svimmelhed.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor experienced in the management of patients with bone diseases caused by alterations in the body's chemical processes.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af patienter med knoglesygdomme, der er forårsaget af forandringer i kroppens kemiske processer.
English: In addition, phosphate levels in the blood improved over time in both groups, particularly those given Crysvita every 2 weeks.
Danish: Derudover forbedredes fosfatniveauet efterhånden i begge grupper, især hos dem, der fik Crysvita hver 2. uge.
English: The dose is adjusted according to the patient's phosphate levels in the blood.
Danish: Dosen justeres i henhold til patientens fosfatniveau i blodet.
English: Oral phosphate and vitamin D medicines must not be used during treatment with Crysvita.
Danish: Lægemidler med oralt fosfat og D-vitamin må ikke anvendes under behandlingen med Crysvita.
English: The main measure of effectiveness was a reduction in the severity of rickets (bone deformities) in the wrist and knee measured on a scale from 0 (normal) to 10 (severe).
Danish: Det primære mål for virkningen var en reduktion i sværhedsgraden af rakitis (knogledeformiteter) i håndled og knæ målt på en skala fra 0 (normal) til 10 (svær).
English: What measures are being taken to ensure the safe and effective use of Crysvita?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Crysvita?
English: An additional ongoing study in 13 younger children shows that Crysvita is effective in those aged between 1 and 4 years.
Danish: En anden igangværende undersøgelse af 13 yngre børn har vist, at Crysvita er effektivt hos børn i alderen 1-4 år.
English: The full EPAR for Crysvita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Crysvita findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Crysvita and what is it used for?
Danish: Hvad er Crysvita, og hvad anvendes det til?
English: Other information about Crysvita
Danish: Andre oplysninger om Crysvita
English: Because the number of patients with X-linked hypophosphataemia is low, the disease is considered ‘rare', and Crysvita was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 October 2014.
Danish: Da antallet af patienter med X-bundet hypofosfatæmi er lavt, betragtes sygdommen som "sjælden", og Crysvita blev udpeget som "lægemiddel til sjældne sygdomme" den 15. oktober 2014.
English: The company is also required to conduct and submit the results of a study comparing Crysvita with oral phosphate and vitamin D in children aged between 1 and 12 years with X-linked hypophosphataemia.
Danish: Virksomheden skal også gennemføre og indsende resultaterne af en undersøgelse, der sammenligner Crysvita med oralt fosfat og D-vitamin hos børn i alderen 1-12 år med X-bundet hypofosfatæmi.
English: Since Crysvita has been granted a conditional approval, the company that markets Crysvita will provide updated results from two ongoing studies in children aged between 5 and 12 years and between 1 and 4 years.
Danish: Da Crysvita har fået en betinget godkendelse, skal virksomheden, der markedsfører Crysvita, fremlægge opdaterede resultater af to igangværende undersøgelser hos børn i alderen 5-12 år og 14 år.
English: Why is Crysvita approved?
Danish: Hvorfor blev Crysvita godkendt?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Crysvita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Crysvita findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For more information about treatment with Crysvita, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Crysvita, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Crysvita.
Danish: Det er ikke en praktisk vejledning i, hvordan Crysvita bør anvendes.
English: Also, Crysvita must not be used in patients with high phosphate levels in the blood or in patients with severe kidney disease.
Danish: Crysvita må heller ikke anvendes hos patienter med et højt fosfatniveau i blodet eller hos patienter med svær nyresygdom.
English: Crysvita is a monoclonal antibody (a type of protein) designed to recognise and attach to the FGF23 protein.
Danish: Crysvita er et monoklonalt antistof (et protein), der er designet til at genkende og binde til FGF23proteinet.
English: Phosphate levels are largely controlled by the kidneys, which either remove excess phosphate or reabsorb it into the bloodstream when needed.
Danish: Fosfatniveauet styres i vid udstrækning af nyrerne, der enten fjerner overskydende fosfat eller reabsorberer det til blodbanen efter behov.
English: Crysvita can be used in children over 1 year of age and adolescents with growing skeletons.
Danish: Crysvita kan anvendes hos børn i alderen 1 år og opefter samt unge, der stadig vokser.
English: What information is still awaited for Crysvita?
Danish: Hvilke oplysninger afventes der stadig for Crysvita?
English: What are the risks associated with Crysvita?
Danish: Hvilke risici er der forbundet med Crysvita?
English: For the full list of restrictions with Crysvita see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Crysvita fremgår af indlægssedlen.
English: For practical information about using Crysvita, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Crysvita, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: By attaching to the FGF23 protein, the medicine blocks its activity, allowing the kidneys to reabsorb phosphate and restore normal levels of phosphate in the blood.
Danish: Ved at binde til FGF23 blokerer lægemidlet proteinets aktivitet, hvilket gør det muligt for nyrerne at reabsorbere fosfat og genskabe et normalt fosfatniveau i blodet.
English: It is used if signs of bone disease are seen on X-rays.
Danish: Det anvendes, hvis en røntgenundersøgelse viser tegn på knoglesygdom.
English: Crysvita is a medicine used for the treatment of X-linked hypophosphataemia, a hereditary disorder characterised by low levels of phosphate in the blood (hypophosphataemia).
Danish: Crysvita er et lægemiddel, der anvendes til behandling af X-bundet hypofosfatæmi, som er en arvelig sygdom karakteriseret ved et lavt fosfatniveau i blodet.
English: Patients with X-linked hypophosphataemia have abnormally high levels of a protein called FGF23 which causes the kidneys to stop reabsorbing phosphate into the bloodstream.
Danish: Patienter med X-bundet hypofosfatæmi har et unormalt højt niveau af proteinet FGF23, der får nyrerne til at holde op med at reabsorbere fosfat til blodbanen.
English: Crysvita reduced the severity of rickets as shown in X-rays in children with X-linked hypophosphataemia.
Danish: Crysvita reducerede sværhedsgraden af rakitis som påvist ved røntgen hos børn med X-bundet hypofosfatæmi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Crysvita have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Crysvita.
English: How is Crysvita used?
Danish: Hvordan anvendes Crysvita?
English: Phosphate is essential to build bones and teeth and to maintain their strength, so patients may develop rickets and other bone deformities and growth problems.
Danish: Ved mangel på fosfat kan patienterne udvikle rakitis og andre knogledeformiteter og vækstproblemer.