FrancophonIA/ELRC3.0 huggingface dataset:
English: In the EU study Osurnia was as effective as the comparator medicine with both treatments resulting in 63% reduction in severity of otitis externa.
Danish: I EU-undersøgelsen var Osurnia lige så effektivt som sammenligningslægemidlet, idet begge behandlinger resulterede i 63 % mindskelse i sværhedsgraden af ørebetændelse.
English: Osurnia is used to treat short lived or recurrent ear infections (otitis externa) due to Staphylococcus pseudintermedius (a bacterium) and Malassezia pachydermatitis (a yeast).
Danish: Osurnia anvendes til behandling af kortvarig eller tilbagevendende ørebetændelse (otitis externa) forårsaget af bakterien Staphylococcus pseudintermedius og gærsvampen Malassezia pachydermatitis.
English: Ear infections in dogs can be caused by bacteria or yeasts/fungi.
Danish: Ørebetændelse hos hunde kan skyldes bakterier eller gærsvampe/skimmelsvampe.
English: What is Osurnia used for?
Danish: Hvad anvendes Osurnia til?
English: In the Japanese study Osurnia was as effective as the other medicine with 78% improvement in otitis externa in both treatment groups.
Danish: I den japanske undersøgelse var Osurnia lige så effektivt som det andet lægemiddel, idet begge behandlinger resulterede i 78 % bedring af ørebetændelsen.
English: How has Osurnia been studied?
Danish: Hvordan blev Osurnia undersøgt?
English: The Japanese study involved 71 dogs; 49 dogs were treated with Osurnia and 22 dogs with another ear medicine containing clotrimazole (for fungal infections), gentamicin (an antibiotic) and betamethasone valerate (corticosteroid).
Danish: Den japanske undersøgelse omfattede 71 hunde, hvoraf 49 blev behandlet med Osurnia, og 22 blev behandlet med en anden øremedicin, der indeholdt svampemidlet clotrimazol, antibiotikummet gentamycin og binyrebarkhormonet betamethasonvalerat.
English: The main measure of effectiveness in the EU and Japanese studies was the reduction in severity of otitis externa 28 days after initial treatment; in the US study clinical success was measured after 45 days.
Danish: I EU-undersøgelsen og den japanske undersøgelse blev virkningen hovedsagelig bedømt på mindskelsen af sværhedsgraden af ørebetændelse 28 dage efter den indledende behandling.
English: If accidental exposure to the eyes occurs, the eyes should be rinsed with water and in case of accidental exposure to the skin, the skin should be washed with soap and water.
Danish: Ved utilsigtet kontakt med huden vaskes huden med vand og sæbe.
English: In the US study the Osurnia treated dogs had a success rate of 65% which was significantly higher than the placebo treated dogs with a success rate of 44%.
Danish: I USA-undersøgelsen virkede behandling med Osurnia hos 65 % af hundene.
English: What benefit has Osurnia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Osurnia?
English: The first was an EU study involving 286 dogs in which 148 dogs given Osurnia were compared with 138 dogs treated with another ear medicine containing miconazole (a medicine against fungal infections), gentamicin (an antibiotic) and hydrocortisone aceponate (a corticosteroid) for five consecutive days.
Danish: 148 af hundene fik Osurnia og blev sammenlignet med 138 hunde, der i fem på hinanden følgende dage blev behandlet med en anden øremedicin, som indeholdt svampemidlet miconazol, antibiotikummet gentamycin og binyrebarkhormonet hydrocortisonaceseponat.
English: How does Osurnia work?
Danish: Hvordan virker Osurnia?
English: Three field studies were conducted in dogs with otitis externa caused by bacterial or fungal infections, investigating the effect of treatment following cleaning out of the ear with saline solution; treatment with two doses of Osurnia, one week apart, was compared with another comparable ear medicine or with placebo (dummy treatment).
Danish: Osurnia, givet som to doser med en uges mellemrum, blev sammenlignet med en anden tilsvarende øremedicin og med virkningsløs behandling (placebo).
English: MA (EU) Number (Invented) name
Danish: MF (EU)nummer
English: Overall summary of the scientific evaluation of didanosine and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af didanosin og relaterede navne (se bilag I)
English: the Netherlands and France considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Danish: Nederlandene og Frankrig fandt, at udstedelse af markedsføringstilladelsen udgør en potentiel alvorlig risiko for den offentlige sundhed,
English: However, the 90% CI for Cmax was 100.36132.76%.
Danish: 90 % SI for Cmax var imidlertid 100,36-132,76 %.
English: • The Committee considered the notification of the referral triggered by the United Kingdom under article 29(4) of Directive 2001/83/EC.
Danish: • udvalget behandlede anmeldelsen af den indbringelse, der var indledt af Det Forenede Kongerige i medfør af artikel 29, stk. 4, i direktiv 2001/83/EF.
English: The only difference is the magnitude of the decrease, which is less for the test than for the reference product.
Danish: Den eneste forskel er størrelsen af nedsættelsen, som er mindre for testproduktet end for referenceproduktet.
English: Results of the bioequivalence studies
Danish: Resultater af bioækvivalensundersøgelserne
English: • Dosing recommendations for didanosine
Danish: • Doseringsanbefalinger for didanosin
English: A referral was thus triggered at the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMD(h)).
Danish: Der blev således foretaget en indbringelse for Koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMD(h)).
English: The reference product in EU is Videx EC (200, 250 and 400 mg) hard capsules, first authorised in the United Kingdom (UK) on 19 September 2000.
Danish: Referenceproduktet i EU er Videx EC, hårde kapsler (200, 250 og 400 mg), der første gang blev godkendt i Det Forenede Kongerige den 19. september 2000.
English: • Clinical significance of Cmax with Didanosine
Danish: • Klinisk betydning af Cmax med didanosin
English: The major concern raised by France and the Netherlands could not be solved during the CMD(h) referral and the issue was therefore referred to the Committee for Medicinal Products for Human Use (CHMP).
Danish: Den væsentlige betænkelighed, der var rejst af Frankrig og Nederlandene, kunne ikke afklares ved indbringelsen for CMD(h), og sagen blev derfor indbragt for Udvalget for Lægemidler til Mennesker (CHMP).
English: • The Committee is of the opinion that bioequivalence has been demonstrated under fasting conditions which is the recommended state for administration of didanosine.
Danish: • udvalget er af den opfattelse, at der er påvist bioækvivalens under fastende betingelser, som er den anbefalede tilstand ved administration af didanosin,
English: Irrespective of whether Didanosine is taken with or without food, the virological response is based on the total drug exposure.
Danish: Uanset om didanosin indtages med eller uden føde, er den virologiske respons bestemt af den totale eksponering for lægemidlet.
English: However, both formulations are equivalent in terms of extent of absorption (i.e. AUC).
Danish: De to formuleringer er imidlertid ækvivalente i absorptionsgrad (dvs. AUC).
English: The applicant provided literature references which showed that for the action of Didanosine, AUC is the most important parameter9,10,11,12,13.
Danish: Ansøgeren forelagde litteraturhenvisninger, der viste, at AUC er den vigtigste parameter for virkningen af didanosin 9,10,11,12,13.
English: It is acknowledged that these results were outside the standard range of 80 - 125%; however these were within the wider acceptance criteria of 70 - 143% which may be used for highly variable drugs.
Danish: Det vedgås, at disse resultater var uden for standardområdet 80125 %, men de var inden for det bredere acceptkriterium på 70-143 %, som kan anvendes for stærkt variable lægemidler.
English: Relation between plasma concentrations of didanosine and markers of antiviral efficacy in adults with AIDS and AIDS related complex.
Danish: Relation between plasma concentrations of didanosin and markers of antiviral efficacy in adults with AIDS and AIDS related complex.
English: The fed study was conducted during an extended clock-stop.
Danish: Den postprandiale undersøgelse blev udført på forlænget tid.
English: Considering this, the sample size that may be required to meet the standard bio-equivalence criteria would be as high as 232 subjects to obtain power of at least 80%.
Danish: På dette grundlag kan den nødvendige stikprøvestørrelse til opfyldelse af standardkriterierne for bioækvivalens være så stor som 232 forsøgspersoner for at opnå en styrke på mindst 80 %.
English: • The Committee reviewed all the data submitted by the applicant in order to support the bioequivalence between Didanosine and associated names and the reference product.
Danish: • udvalget gennemgik alle de af ansøgeren forelagte data til dokumentation af bioækvivalensen mellem didanosin og relaterede navne og referenceproduktet.
English: Since the product is to be administrated at least 2 hours before or after food intake, it is unlikely that the product ingested will be exposed to in vivo conditions, prevailing under fed state.
Danish: Da produktet skal administreres mindst to timer før eller efter et måltid, er det usandsynligt, at det indtagne produkt vil blive udsat for in vivobetingelser, der svarer til betingelserne i postprandial tilstand.
English: The applicant claimed that differences in plasma concentrations of didanosine are not of clinical relevance as such since it may not result in changes in the intracellular triphosphate concentrations.
Danish: Ansøgeren hævdede, at forskellene i plasmakoncentrationerne af didanosin ikke har klinisk relevans som sådan, da de ikke nødvendigvis medfører ændringer i de intracellulære koncentrationer af trifosfat.
English: The results were satisfactory in terms of extent of absorption (i.e. AUC).
Danish: Resultaterne var tilfredsstillende hvad angår absorptionsgraden (dvs. AUC).
English: The application for Didanosine and associated names was considered under Article 10.3 of Directive 2001/83/EC in all Concerned Members States (CMSs).
Danish: Ansøgningen for didanosin og relaterede navne blev vurderet i overensstemmelse med artikel 10, stk. 3 i direktiv 2001/83/EF i alle de berørte medlemsstater.
English: However, the observed effect of food is lower and the Committee is of the opinion that this is not clinically relevant based on considerations relating to the mechanism of action and, in particular, that Didanosine and associated names is to be administrated on an empty stomach.
Danish: Den iagttagne virkning af fødeindtagelse er imidlertid lavere, og det er udvalgets opfattelse, at den ikke er klinisk relevant i betragtning af virkningsmekanismen og navnlig af, at didanosin og relaterede navne skal administreres på tom mave,
English: 1 Note for Guidance on the investigation of bioavailability and bioequivalence (EMA/CPMP/EWP/QWP/1401/98) 2 Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms
Danish: 1 Retningslinjer for undersøgelse af biotilgængelighed og bioækvivalens (EMA/CPMP/EWP/QWP/1401/98) 2 Retningslinjer for farmakokinetisk og klinisk vurdering af lægemiddelformer med modificeret udløsning
English: The decentralised procedure was closed on day 210, with most of the CMSs agreeing with the conclusions of the reference Member State (RMS)'s assessment report except France and the Netherlands which raised a potential serious risk to public health (PSRPH).
Danish: Den decentrale procedure blev afsluttet på dag 210, hvor konklusionerne i referencemedlemsstatens vurderingsrapport fik tilslutning fra størstedelen af de berørte medlemsstater bortset fra Frankrig og Nederlandene, som rejste betænkelighed ved en potentiel alvorlig risiko for den offentlige sundhed.
English: Of note, bioequivalence in fasted state is considered to be the most important as this product is intended to be taken on an empty stomach.
Danish: Det bemærkes, at bioækvivalens ved fastende betingelser anses for at have størst betydning, da produktet er bestemt til indtagelse på tom mave.
English: This observation is in line with the results presented in the current application where AUC and Cmax of the test product significantly decrease under fed conditions.
Danish: Denne iagttagelse er på linje med de fremlagte resultater i den aktuelle ansøgning, hvor AUC og Cmax af testproduktet nedsættes væsentligt under postprandiale betingelser.
English: the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Didanosine and associated names (see Annex I).
Danish: anbefalede CHMP udstedelse af markedsføringstilladelserne, for hvilke produktresuméet, etiketteringen og indlægssedlen er uændrede svarende til endelige version, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III for didanosin og relaterede navne (se bilag I).
English: The administration of the reference product with a high fat meal significantly decreases the AUC (19%) and Cmax (46%) of didanosine.
Danish: For referenceproduktet medfører administration sammen med et fedtrigt måltid en væsentlig nedsættelse af AUC (19 %) og af Cmax (46 %) for didanosin.
English: Didanosine and associated names is indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infected patients.
Danish: Didanosin og relaterede navne er i kombination med andre antiretrovirale lægemidler indiceret til behandling af hiv-1-smittede patienter.
English: Both studies were carried out using open label, randomised, two treatment, two sequence, two period, single dose cross-over design.
Danish: Begge undersøgelser blev udført i et åbent, randomiseret enkeltdosis-overkrydsningsdesign med to behandlinger, to sekvenser og to perioder.
English: Comparison of HIV RNA suppression produced by triple regimens containing either didanosine enteric-coated or didanosine tablet formulations each administered once daily.
Danish: 8 Schrader S et al. Comparison of HIV RNA suppression produced by triple regimens containing either didanosin enteric-coated or didanosin tablet formulations each administered once daily.
English: didanosine in treatment of HIV infecting were conducted using buffered tablets3,4,5,6,7,8.
Danish: De indledende kliniske undersøgelser til påvisning af virkningen af didanosin til behandling af hiv-infektion blev udført med bufrede tabletter3,4,5,6,7,8.
English: The Applicant claimed that the significant decrease observed under fed conditions for Cmax for the test product (90% CI outside the standard range) may be attributed to high inter-individual variability with respect to Cmax which was 36% in the study conducted under fed conditions.
Danish: Ansøgeren fremførte, at det betydelige fald, der under postprandiale betingelser iagttages i Cmax af testproduktet (90 % SI uden for standard område), kan tilskrives interindividuel variabilitet af Cmax, som var 36 % i den postprandiale undersøgelse.
English: The bioequivalence studies confirmed that dose dumping did not occur with Didanosine and associated names.
Danish: Bioækvivalensundersøgelserne bekræftede, at der ikke forekom dose-dumping med didanosin og relaterede navne.
English: Didanosine is intended to be administrated on en empty stomach as stated in the proposed Summary of Product Characteristics (SmPC): “Didanosine absorption is reduced in the presence of food, and hence Didanosine gastro-resistant capsules should be administrated on an empty stomach (at least 2 hours before or 2 hours after a meal)”.
Danish: Didanosin er bestemt til administration på tom mave som angivet i det ansøgte produktresumé: “Absorptionen af didanosin er nedsat i tilstedeværelse af føde, hvorfor didanosin enterokapsler skal administreres på tom mave (mindst to timer før eller to timer efter et måltid)”.
English: This is attributed to the delay in absorption rate of enteric coated formulation which is reflected in the Tmax which is about 2 hours for the enteric coated formulation compared to 0.67 hours for the buffered tablet.
Danish: Dette tilskrives den langsommere absorptionshastighed for den enterocoatede formulering, hvilket afspejler sig i Tmax, som er ca. 2 timer for enteroformuleringen mod 0,67 timer for den bufrede tablet.
English: • Observed food effect for test and reference products As per the current recommendations for modified release formulations1,2, bioequivalence studies in fasted and fed conditions are required.
Danish: • Den iagttagne effekt af fødeindtagelse for test- og referenceproduktet I henhold til de gældende anbefalinger for formuleringer med modificeret udløsning1,2 kræves der bioækvivalensundersøgelser ved fastende og postprandiale betingelser.
English: The presented data does not give evidence of in vivo dose-dumping from the formulation under fed conditions.
Danish: De forelagte data fra giver ikke evidens for, at der optræder in vivo-dose-dumping fra formuleringen under postprandiale betingelser.
English: 13 Stevens RC et al. Effect of food and pharmacokinetic variability on didanosine systemic exposure in HIV-infected children.
Danish: 13 Stevens RC et al. Effect of food and pharmacokinetic variability on didanosin systemic exposure in HIV-infected children.
English: Didanosine (2', 3'-dideoxyinosine) is an inhibitor of the in vitro replication of human immunodeficiency virus (HIV) in cultured human cells and cell lines.
Danish: Didanosin (2', 3'-dideoxyinosin) er en hæmmer af in vitro-replikationen af humant immundefektvirus (hiv) i dyrkede humane celler og cellelinjer.
English: During the decentralised procedure France and the Netherlands expressed the opinion that bioequivalence had not been demonstrated in the fed conditions as Cmax was outside the 80-125% acceptability limits1.
Danish: Under den decentrale procedure anførte Frankrig og Nederlandene, at der ikke var påvist bioækvivalens under postprandiale betingelser, da Cmax var uden for godkendelsesgrænserne på 80-125 %1.
English: Didanosine has to be first converted intracellularly to its active metabolite ddATP (responsible for antiviral activity) which has a significantly longer intracellular half-life (about 43 hours) as compared with plasma half-life of didanosine.
Danish: Didanosin skal først intracellulært omdannes til sin aktive metabolit, ddATP (der er ansvarlig for den antivirale aktivitet), som har en væsentligt længere intracellulær halveringstid (ca. 43 timer) end plasmahalveringstiden for didanosin.
English: The main purpose of conducting bioequivalence fed study is to exclude food related effects, such as dose-dumping (in particular for gastro-resistant formulations) or failure of protection from acid mediated degradation in the stomach.
Danish: Hovedformålet med den postprandiale bioækvivalensundersøgelse er at udelukke fødemiddeleffekt såsom “dose-dumping” (hurtig udløsning) (navnlig for enteroformuleringer) og manglende beskyttelse mod syremedieret nedbrydning i ventriklen.
English: Therefore, it is considered that the fact that both formulations have been used for the same indications and at similar doses suggests that AUC is more relevant for ensuring efficacy of didanosine in antiviral therapy, and the changes in Cmax are unlikely to compromise antiviral efficacy.
Danish: Det forhold, at begge formuleringer er blevet anvendt til samme indikationer og i samme doser, anses derfor for at tyde på, at AUC er mere relevant til sikring af virkningen af didanosin ved antiviral behandling, og at ændringerne i Cmax næppe vil forringe den antivirale virkning.
English: 7 Perry CM, Balfour JA. Didanosine: An Update on its Antiviral Activity, Pharmacokinetic Properties and Therapeutic
Danish: 7 Perry CM, Balfour JA. Didanosine: An Update on its Antiviral Activity, Pharmacokinetic Properties and Therapeutic Efficacy in the Management of HIV Disease.
English: Didanosine and associated names (Gastro-resistant capsules 400 mg) was compared to the reference product Videx EC (Gastro-resistant capsules 400 mg) in 60 healthy adults under fasting conditions.
Danish: Didanosin og relaterede navne (enterokapsler, 400 mg) blev sammenlignet med referenceproduktet Videx EC (enterokapsler, 400 mg) hos 60 voksne forsøgspersoner under fastende betingelser.
English: Damle BD et al. Bioequivalence of two formulations of didanosine, encapsulated enteric-coated beads and buffered tablet, in healthy volunteers and HIV-infected subjects.
Danish: 4 Damle BD et al. Bioequivalence of two formulations of didanosin, encapsulated enteric-coated beads and buffered tablet, in healthy volunteers and HIV-infected subjects.
English: In addition, the objecting Members States considered that the arguments provided by the applicant did not sufficiently address the consequences of the difference observed in didanosine pharmacokinetics in the fed state between test and reference products.
Danish: De indsigende medlemsstater fandt desuden, at ansøgerens argumenter ikke tog tilstrækkeligt hensyn til konsekvenserne af den iagttagne forskel mellem testproduktet og referenceproduktet i farmakokinetikken af didanosin under postprandiale betingelser.
English: Pharmacokinetics studies conducted on Didanosine formulations reveal that administration of the product with food or immediately after food results in decreased in vivo availability of the drug.
Danish: De farmakokinetiske undersøgelser, der er udført med formuleringer af didanosin, viser, at administration af produktet sammen med et måltid eller umiddelbart efter et måltid medfører nedsat in vivo-biotilgængelighed af lægemidlet.
English: The pharmacokinetics data reveals that the plasma concentration (Cmax) obtained from enteric-coated capsule formulation of didanosine is about 40% lower as compared to the buffered tablet formulation.
Danish: De farmakokinetiske data viser, at den plasmakoncentration (C max), der opnås med didanosin formuleret som enterokapsler, er ca. 40 % lavere end med den bufrede tabletformulering.
English: In order to demonstrate the safety and efficacy of Didanosine and associated names in combination with other antiretroviral drugs in the treatment of HIV-1 infected patients, the application dossier was based on two single dose bioequivalence studies, one under fasting state and one under fed state.
Danish: Vurdering Til påvisning af sikkerheden og virkningen af didanosin og relaterede navne i kombination med andre antiretrovirale lægemidler til behandling af hiv-1-smittede patienter var ansøgningsdossieret baseret på to enkeltdosis-bioækvivalensundersøgelser, den ene under fastende betingelser, den anden under postprandiale betingelser.
English: In addition, ddATP inhibits HIV-reverse transcriptase by competing with deoxyadenosine-triphosphate (dATP) for binding to the enzyme's active site, preventing proviral DNA synthesis.
Danish: ddATP hæmmer desuden hivrevers transkriptase ved at konkurrere med deoxyadenosintrifosfat (dATP) om binding til enzymets aktive sæde, hvorved det hindrer den provirale DNA-syntese.
English: In the fed study, the results were satisfactory in terms of extent of absorption (i.e. AUC) with 90% CI within standard range of 80.00 - 125.00%.
Danish: I den postprandiale undersøgelse var resultaterne tilfredsstillende hvad angår absorptionsgraden (dvs. AUC), idet 90 % SI var inden for standardområdet 80,00-125,00 %.
English: After didanosine enters the cell, it is enzymatically converted to dideoxyadenosine-triphosphate (ddATP), its active metabolite.
Danish: Når didanosin er trådt ind i cellen, omdannes det enzymatisk til dideoxyadenosintrifosfat (ddATP), som er den aktive metabolit.
English: Damle BD et al. Pharmacokinetics and gamma scintigraphy evaluation of two enteric coated formulations of didanosine in healthy volunteers.
Danish: 3 Damle BD et al. Pharmacokinetics and gamma scintigraphy evaluation of two enteric coated formulations of didanosin in healthy volunteers.