FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 1 mg of repaglinide
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 1 mg repaglinid
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 2 mg of repaglinide
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2 mg repaglinid
English: If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed.
Danish: Hvis det er nødvendigt at give trimetoprim og repaglin samtidig, skal blodglucosen måles omhyggeligt, og der skal være tæt klinisk observation.
English: Allergic reactions*
Danish: Allergiske reaktioner* Meget sjælden
English: Prandin tablets are round and convex and engraved with the Novo Nordisk logo (Apis bull).
Danish: Prandin tabletter er runde og konvekse og er præget med Novo Nordisk logo (Apis-tyren).
English: Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.
Danish: Brugen af repaglinid til patienter med sekundært behandlingssvigt overfor andre β -celle stimulerende orale antidiabetika er ikke undersøgt i kliniske studier.
English: (cannot be estimated from the available data).
Danish: (angivet i punkt 6).
English: What Prandin is and what it is used for What you need to know before you take Prandin How to take Prandin
Danish: Det skal du vide, før du begynder at tage Prandin Sådan skal du tage Prandin Bivirkninger
English: Repaglinide tablets are yellow, round and convex and engraved with Novo Nordisk logo (Apis bull).
Danish: Repaglinid tabletter er gule, runde og konvekse og er præget med Novo Nordisk logo (Apis-tyren).
English: Repaglinide tablets are white, round and convex and engraved with Novo Nordisk logo (Apis bull).
Danish: Repaglinid tabletter er hvide, runde og konvekse og er præget med Novo Nordisk logo (Apis-tyren).
English: Repaglinide tablets are peach-coloured, round and convex and engraved with Novo Nordisk logo (Apis bull).
Danish: Repaglinid tabletter er ferskenfarvede, runde og konvekse og er præget med Novo Nordisk logo (Apis-tyren).
English: Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as: common (≥1/100 to <1/10);
Danish: På baggrund af erfaringerne med repaglinid og andre hypoglykæmiske lægemidler er følgende bivirkninger set.
English: (Invented) Name
Danish: (Sær)navn
English: ANNEX III CONDITIONS FOR THE LIFTING OF THE MARKETING AUTHORISATION SUSPENSIONS
Danish: BILAG III BETINGELSER FOR OPHÆVELSE AF SUSPENDERINGEN AF MARKEDSFØRINGSTILLADELSEN
English: 08013-Barcelona Spain
Danish: 08013-Barcelona Spanien
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holder(s):
Danish: De nationale kompetente myndigheder, koordineret af referencemedlemsstaten, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelsen:
English: This situation should have been foreseen and included in the study protocol and the CHMP therefore considers this to constitute a major objection.
Danish: Denne situation burde have været forudset og medtaget i undersøgelsesprotokollen, og CHMP vurderer derfor, at dette udgør en væsentlig indsigelse.
English: Histamine is a major mediator of the allergic reaction.
Danish: Histamin er en væsentlig mediator i den allergiske reaktion.
English: - retrospective widening of the confidence interval is not accepted according to the current guidelines,
Danish: Retrospektiv udvidelse af konfidensintervallet accepteres ikke i overensstemmelse med de nuværende retningslinjer
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR NEGATIVE OPINION
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR NEGATIV UDTALELSE
English: No clinically significant abnormalities were observed and the results confirmed the absence of significant changes in the subjects' state of health.
Danish: Ingen klinisk væsentlige abnormiteter blev observeret, og resultaterne bekræftede fraværet af væsentlige forandringer i undersøgelsespersonernes helbredstilstand.
English: In order to consider the parent compound as inactive, a significantly lower level of activity would have been required.
Danish: For at udgangsstoffet kunne anses for inaktivt skulle der have været et betydeligt lavere niveau af aktivitet.
English: The Applicant requested an oral explanation in front of the committee in order to discuss the outcome of the CHMP assessment.
Danish: Ansøgeren udbad sig en mundtlig forklaring foran udvalget for at drøfte resultatet af CHMP-vurderingen.
English: The majority of adverse event were considered mild and the most commonly reported was headache (8.8% of subjects).
Danish: Størstedelen af bivirkningerne blev anset for at være milde, og den mest almindeligt indberettede bivirkning var hovedpine (8,8 % af undersøgelsespersonerne).
English: The statistic analysis was described adequately, and the methods for statistical assessment of this bioequivalence study were acceptable.
Danish: Den statistiske analyse blev beskrevet tilstrækkeligt, og metoderne for statistisk vurdering af denne bioækvivalensundersøgelse var acceptable.
English: A post hoc justification for widening the acceptance range as was done for study SZ190/08 can therefore not be accepted.
Danish: En post-hoc begrundelse for et større godkendelsesinterval, som blev udført for undersøgelsen SZ190/08, kan derfor ikke accepteres.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LORATADINE SANDOZ 10 AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LORATADIN SANDOZ 10 OG TILKNYTTEDE NAVNE (SE BILAG I)
English: This increase justifies either an additional increase of subjects included in the study or a widening of the acceptance criteria.
Danish: Denne øgning kan begrunde enten en yderligere stigning i antallet af undersøgelsespersoner i undersøgelsen eller en udvidelse af acceptkriteriet.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I LISTE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGERE/INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: The guidelines state that “In principle, evaluation of bioequivalence should be based upon measured concentrations of the parent compound.
Danish: I retningslinjerne fastslås det, at "I princippet skal evaluering af bioækvivalens baseres på målte koncentrationer af udgangsstoffet.
English: 80 subjects were enrolled in the study and randomly assigned to a treatment.
Danish: 80 undersøgelsespersoner var tilmeldt undersøgelsen og randomiseret til en behandling.
English: Because major objections on bioequivalence remained unresolved, an Article 29(4) referral was triggered and the procedure was referred to the CHMP.
Danish: Da væsentlige indsigelser mod bioækvivalens forblev uafklarede, blev der indbragt en sag i henhold til artikel 29, stk. 4, og sagen blev henvist til CHMP.
English: A total of 30 post-dose adverse events were reported, with 6 adverse events probably related to the study treatment, 11 possibly related, 2 remotely related, and 11 unrelated.
Danish: Der blev indberettet i alt 30 tilfælde af bivirkninger efter dosering, hvoraf seks bivirkninger sandsynligvis var relaterede til undersøgelsesbehandlingen, 11 muligvis var relaterede, to var fjernt relaterede og 11 ikke var relaterede.
English: It was concluded that any arguments for the widening of the acceptance range must be discussed prospectively, and reflected in the protocol.
Danish: Det blev konkluderet, at ethvert argument for at udvide godkendelsesintervallet skal drøftes prospektivt og afspejles i protokollen.
English: The Applicant assumption that the parent compound is inactive was not accepted, as the absolute activity should be taken into account, rather than the ratio of activity compared to the metabolite.
Danish: Ansøgerens antagelse om, at udgangsstoffet er inaktivt, blev ikke accepteret, da den absolutte aktivitet skal tages i betragtning i stedet for aktivitetsforholdet sammenlignet med metabolitten.
English: The validation process was described in detail and the study and the analyses were made in accordance with GLP principles as well as international regulatory recommendations and guidelines.
Danish: Valideringsprocessen blev beskrevet i enkeltheder, og undersøgelsen og analyserne blev udført i overensstemmelse med GLP-pricipper og internationale forskriftsmæssige anbefalinger og retningslinjer.
English: According to the guideline, a wider interval may be acceptable, but only if prospectively defined and justified, addressing in particular any safety or efficacy concerns for patients switched between formulations.
Danish: Ifølge retningslinjerne kan et større interval accepteres, men kun hvis det defineres og begrundes prospektivt og især tager hensyn til sikkerhedseller virkningsproblemer for patienter, der skifter mellem formuleringer.
English: Strength Pharmaceutical Form
Danish: Styrke LægemiddelformIndgivelsesvej
English: The CHMP noted that the study site had been satisfactorily inspected and that the study was performed according to GCP guidelines.
Danish: CHMP bemærkede, at undersøgelsesstedet var kontrolleret tilfredsstillende, og at undersøgelsen blev udført i overensstemmelse med GCP-retningslinjerne.
English: The metabolite can be used as a surrogate only if the Applicant presents convincing arguments demonstrating that it is not possible to reliably measure the parent compound after a single administration, which is not the case for loratadine.
Danish: Metabolit kan kun anvendes som surrogat, hvis ansøgeren fremlægger overbevisende argumenter, der viser, at det ikke er muligt at måle udgangsstoffet sikkert efter en enkelt indgift, hvilket ikke er tilfældet for loratadin.
English: The following pharmacokinetic parameters were determined: AUC0-t, Cmax (primary) and AUC residual area, tmax, Ke;, t1/2 (secondary).
Danish: Følgende farmakokinetiske parametre blev fastsat: AUC0-t, Cmax (primær) og AUC residualområde, tmax, Ke;, t1/2 (sekundær).
English: The data showed that for loratadine, the 90% confidence interval for Cmax is outside the predefined acceptance range of 80-125% (although the 90% confidence intervals for AUC0-t, AUC0-∞ were respected).
Danish: Dataene viste, at for loratadin er 90 %-konfidensintervallet for Cmax uden for det prædefinerede godkendelsesinterval på 80-125 % (selv om 90 %-konfidensintervallet for AUC0-t, AUC0-∞ blev respekteret).
English: The arguments used by the Applicant that the increase of about 5% in the intra-individual variability of Cmax in the second study (CV of 46.4%) justifies the post-hoc widening of the acceptance criteria cannot be accepted.
Danish: Ansøgerens argumenter om, at en øgning på ca. 5 % i den intraindividuelle variation af Cmax i den anden undersøgelse (CV på 46,4 %) retfærdiggør post-hoc-udvidelsen af acceptkriteriet, kan ikke accepteres.
English: Detailed explanations of the statistical calculations and the improved bio-analytical methods used were provided and in addition, the Applicant explained that the pharmacokinetics of loratadine increased its intra-individual variability.
Danish: Der var blevet afgivet detaljerede forklaringer på de statistiske beregninger og de forbedrede bioanalytiske metoder, der blev anvendt, og samtidig forklarede ansøgeren, at det farmakokinetiske loratadin øgede den intraindividuelle variation heraf.
English: The CHMP also considered that the choice of pharmacokinetic variables was adequate for this study and that the pharmacokinetic calculation was presented correctly.
Danish: CHMP vurderede også, at valget af farmakokinetiske variabler var passende for denne undersøgelse, og at den farmakokinetiske beregning blev korrekt præsenteret.
English: Treatment with H1 - antagonists for the sought indication requires sufficient therapeutic drug levels for a period superior to 24 hours in order to provide relief from symptoms and the Applicant therefore argued that the therapeutic effect is best represented by the AUC of the unchanged loratadine and the metabolite rather than the peak concentration of parent compound alone.
Danish: Behandling med H1-antagonister for de indikationer, hvorom der er indgivet ansøgning, kræver tilstrækkelige terapeutiske lægemiddelniveauer for en periode på mere end 24 timer for at afhjælpe symptomer, og ansøgeren mente derfor, at den terapeutiske virkning er bedst repræsenteret ved AUC af uændret loratadin og metabolit i stedet for den maksimale koncentration af udgangsstoffet alene.
English: Loratadine is a potent, long acting antihistaminic which has a high selectivity for peripheral histamine H1-receptors and low affinity for H1-receptors in the central nervous system (CNS) in vitro or in vivo.
Danish: Loratadin er et potent, langtidsvirkende antihistaminikum, der har en høj selektivitet for perifere histamin H1-receptorer og lav affinitet for H1-receptorer i centralnervesystemet (CNS) in vitro eller in vivo.
English: The Applicant submitted an application for a repeat use procedure of Loratadine Sandoz 10 and associated names, 10 mg tablets on the basis of the marketing authorisation granted by The Netherlands on 12 July 2001.
Danish: Ansøgeren indsendte en ansøgning om en procedure for gentagen brug af Loratadin Sandoz 10 og tilknyttede navne, 10 mg tabletter, på baggrund af den markedsføringstilladelse, som blev udstedt af Holland den 12. juli 2001.
English: The Applicant considered that due to the large intra-subject variability of loratadine, the use of a wider CI (0,75 - 1,33) was justified, and that differences in Cmax do not have a major clinical effect on the use of this product in humans.
Danish: Ansøgeren vurderede, at på grund af den store variabilitet af loratadin hos den enkelte undersøgelsesperson var brugen af et øget CI (0,75 - 1,33) berettiget, og at forskelle i Cmax ikke har nogen større klinisk indvirkning på anvendelsen af dette lægemiddel til mennesker.
English: Regarding the basic statistical parameter analysis of AUC∞, AUCt and Cmax, both AUCs and Cmax values were subjected to analysis of variance (ANOVA), following the logarithmic transformation.
Danish: I forbindelse med den grundlæggende statistiske parameteranalyse af AUC∞, AUCt og Cmax blev både AUCs- og Cmax-værdier underlagt variansanalyse (ANOVA) efter den logaritmiske transformation.
English: The Applicant emphasised that bioequivalence was shown for the metabolite, which is responsible for the main effect.
Danish: Ansøgeren understregede, at der var påvist bioækvivalens for metabolitten, som har den største virkning.
English: The CHMP also noted the statement on GLP compliance in bio-analysis and considered that the analytical methods are acceptable and validated appropriately and seem adequate to accurately determine the concentration of loratadine and descarboethoxyloratadine in plasma.
Danish: CHMP bemærkede også udtalelsen om overensstemmelse med GLP i bioanalyse og vurderede, at de analytiske metoder var acceptable og korrekt validerede og virkede tilstrækkelige til nøjagtigt at fastsætte koncentrationen af loratadin og descarboethoxyloratadin i plasma.
English: In addition, the widening of the Confidence Intervals should be agreed prospectively in the study design.
Danish: Derudover skal udvidelsen af konfidensintervallerne drøftes prospektivt i udformningen af undersøgelsen.
English: The data available shows that the parent compound is measurable, and therefore must be measured, in order to assess bioequivalence.
Danish: De foreliggende data viser, at udgangsstoffet er målbart og derfor skal måles for at vurdere bioækvivalens.
English: The samples were handled adequately and plausible reasons were presented for analysis repetition.
Danish: Prøverne blev håndteret korrekt, og sandsynlige årsager blev præsenteret til analysegentagelse.
English: Loratadine is an antagonist of histamine at H1 receptor sites (competitive, reversible) leading to the relief of allergic symptoms.
Danish: Loratadin er en antagonist af histamin på H1-receptorsteder (kompetitive, reversible), der lindrer allergiske symptomer.
English: The Applicant was requested to provide the CHMP with the parent compound data from the submitted bioequivalence study or to provide satisfactory justifications for the absence of these data.
Danish: Ansøgeren blev anmodet om at fremsende data om udgangsstoffet fra den indsendte bioækvivalensundersøgelse til CHMP eller fremsende tilfredsstillende begrundelser for manglende data.
English: Therefore, in view of the results obtained from the original study, demonstrating an intra-individual CV of 41.2% for Cmax, a widening of the confidence interval should have been predefined in the study protocol of the second study (justifying any safety or efficacy concerns for patients switched between formulations).
Danish: I lyset af de resultater, der er opnået i den oprindelige undersøgelse, som viser et intraindividuelt CV på 41,2 % for Cmax, skulle en udvidelse af konfidensintervallet derfor have været prædefineret i undersøgelsesprotokollen i den anden undersøgelse (og begrunde sikkerheds- eller virkningsproblemer for patienter, der skiftede mellem formuleringer).
English: Regarding the results, the Applicant provided the pharmacokinetic parameters for loratadine and for descarboethoxyloratadine as well as all the individual plasma concentrations, pharmacokinetic variables and individual graphs.
Danish: Med hensyn til resultaterne fremsendte ansøgeren de farmakokinetiske parametre for loratadin og descarboethoxyloratadin og alle individuelle plasmakoncentrationer, farmakokinetiske variabler og individuelle diagrammer.
English: The CHMP confirmed that the Guideline and the Q&A document (which were valid and available on the EMEA website at the time when the protocol for the bioequivalence study was finalized) state that a retrospective widening of the acceptance criteria for Cmax results is not allowed.
Danish: CHMP bekræftede, at retningslinjerne og dokumentet med spørgsmål og svar (som var gyldige og tilgængelige på EMEA-webstedet på det tidspunkt, hvor protokollen for bioækvivalensundersøgelsen var færdig) viser, at en retrospektiv udvidelse af acceptkriteriet for Cmax-resultater ikke er tilladt.
English: The calculated 90% CI for AUC0-t, AUCinf and Cmax for the metabolite descarboethoxyloratadine were within the 0.80- 1.25 acceptance range, but bioequivalence for loratadine tablets should also be based on parent compound data and because the 90% CI for Cmax and AUC of the parent compound were outside the standard 0.80 - 1.25 acceptance criterion, the objecting concerned member states considered that bioequivalence between Loratadine Sandoz 10 and the reference product could not be established.
Danish: De beregnede 90 % CI for AUC0-t, AUCinf og Cmax for metabolit descarboethoxyloratadin var inden for godkendelsesintervallet på 0,80-1,25, men bioækvivalensen for loratidintabletter bør også baseres på data for udgangsstoffet, og da de 90 % CI for Cmax og AUC i udgangsstoffet var uden for standardacceptkriteriet på 0,80-1,25, var de berørte medlemsstater, der gjorde indsigelser, af den opfattelse, at bioækvivalensen mellem Loratadin Sandoz 10 og referencelægemidlet ikke kunne fastlægges.
English: The CHMP noted the presented data and stated that according to the current guideline (Questions & Answers on the Bioavailability and Bioequivalence Guideline CHMP/EWP/40326/06), bioequivalence should preferably be based on data for the parent drug, loratadine, as confirmed in the most recent draft guideline on bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1).
Danish: CHMP noterede sig de fremlagte data og udtalte, at ifølge de gældende retningslinjer (spørgsmål og svar vedrørende retningslinjer for biotilgængelighed og bioækvivalens CHMP/EWP/40326/06), skal bioækvivalens fortrinsvis baseres på data for moderstoffet, loratadin, som det er bekræftet i det seneste udkast til retningslinjer for bioækvivalens (CPMP/EWP/QWP/1401/98 Rev. 1).
English: Verovskova 57 SI-1000 Ljubljana Slovenia
Danish: SI-1000 Ljubljana Slovenien
English: The Applicant, taking into account the lack of serious safety or efficacy concerns, therefore concluded that Loratadine Sandoz 10 can be considered to be efficacious and safe.
Danish: I betragtning af manglende alvorlige sikkerheds- eller virkningsproblemer konkluderede ansøgeren derfor, at Loratadin Sandoz 10 kan anses for at være effektivt og sikkert.
English: The reason for this is that Cmax of a parent compound is usually more sensitive to detect differences between formulations in absorption rate than Cmax of a metabolite”.
Danish: Dette skyldes, at Cmax i udgangsstoffet som regel lettere afslører forskelle mellem formuleringer i absorptionshastigheden end
English: According to the current applicable guidelines, bioequivalence must be demonstrated for the parent compound for generic products.
Danish: Ifølge de nu gældende retningslinjer skal bioækvivalens påvises for udgangsstoffet for generiske produkter.
English: The Applicant should submit the results of a correctly planned study that demonstrates the bioequivalence between Loratadine Sandoz 10 and the reference product in accordance with the current guidelines.
Danish: Ansøgeren skal indsende resultaterne af den behørigt planlagte undersøgelse, der påviser bioækvivalensen mellem Loratadin Sandoz 10 og referencelægemidlet i overensstemmelse med de nuværende retningslinjer.
English: Therefore, the products cannot be considered bioequivalent and the CHMP concluded that the benefit-risk of Loratadine Sandoz 10 is negative.
Danish: Derfor kan lægemidlerne ikke anses for bioækvivalente, og CHMP konkluderede, at benefit/risk-forholdet for Loratadin Sandoz 10 er negativt.
English: Treatment phases were separated by a washout period of 21 days and subjects were administered a single oral dose as a 1 x 10 mg tablet and blood sampling was carried out prior to dosing (0) and at regular intervals post-dose.
Danish: Behandlingsfaserne blev adskilt af en udvaskningsperiode på 21 dage, undersøgelsespersonerne fik en enkelt oral dosis som 1 x 10 mg tablet, og der blev taget blodprøver før dosering (0) og med regelmæssige intervaller efter dosering.
English: For parametric analysis, the 90% confidence interval was calculated.
Danish: 90 %-konfidensintervallet blev beregnet for parametrisk analyse.
English: In the clinical setting, loratadine has been used for over 10 years in the treatment of allergic disorders such as conjunctivitis, atopic dermatitis, urticaria, asthma, and anaphylaxis.
Danish: I det kliniske miljø har loratadin været anvendt i over 10 år i behandlingen af allergiske sygdomme, som f.eks. konjunktivitis, atopisk dermatit, nældefeber, astma og anafylaksi.
English: In addition, Sandoz pharmacovigilance database indicates that there are no unaddressed safety or efficacy concerns for Loratadine Sandoz 10.
Danish: Samtidig viser Sandoz-lægemiddelovervågningsdatabasen, at der ikke er nogen sikkerheds- eller virkningsproblemer for Loratadin Sandoz 10.
English: Loratadine Sandoz 10 is used for the long term treatment of allergies and both parent compound and metabolite contribute to the clinical efficacy.
Danish: Loratadin Sandoz 10 anvendes til langvarig behandling af allergier, og både udgangsstof og metabolit bidrager til den kliniske virkning.
English: In conclusion, the submitted study demonstrates the bioequivalence of Loratadine Sandoz 10mg tablets to the reference product for AUC0-t and AUC0-∞ of loratadine, but not for the Cmax parameter.
Danish: De indsendte resultater af undersøgelse viser således bioækvivalensen af Loratadin Sandoz 10 mg tabletter til referencelægemidlet for AUC0-t og AUC0-∞ af loratadin, men ikke for Cmax-parameteret.
English: Additionally, the results for AUC0-t, AUC0-∞ and Cmax of descarboethoxyloratadine demonstrated bioequivalence.
Danish: Desuden viste resultaterne for AUC0-t, AUC0-∞ og Cmax af descarboethoxyloratadin bioækvivalens.