FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore the main point for discussion was whether the free fraction immediately after infusion of Taxotere and Docetaxel Teva Generics is the same, and whether the docetaxel is released at a sufficiently equal rate from the Taxotere micelles and the Docetaxel Teva Generics HP-b-CD.
Danish: Derfor var det vigtigste diskussionspunkt, om den frie fraktion er den samme umiddelbart efter infusion af Taxotere og Docetaxel Teva Generics, og om docetaxel frigives i tilstrækkeligt samme hastighed fra Taxoteres miceller og Docetaxel Teva Generics' HP-b-CD.
English: Pharmaceutical quality of Docetaxel Teva Generics is comparable to that of Taxotere.
Danish: Docetaxel Teva Generics' farmaceutiske kvalitet kan sammenlignes med Taxoteres.
English: The reference formulation contains polysorbate 80 as an excipient, while the generic formulation contains povidone K12, hydroxypropylbetadex (HP-b-CD) and glucose monohydrate as excipients.
Danish: Referenceformuleringen indeholder polysorbat 80 som hjælpestof, mens den generiske formulering indeholder povidon K-12, hydroxypropylbetadex (HP-b-CD) og glukosemonohydrat som hjælpestoffer.
English: According to the QWP, it is considered demonstrated that docetaxel in the Docetaxel Teva Generics formulation is surrounded by a number of cyclodextrin molecules, so is an exclusion complex rather than an inclusion complex, with weak interaction forces expected between the docetaxel and cyclodextrin molecules.
Danish: Ifølge QWP anses det for dokumenteret, at docetaxel i Docetaxel Teva Genericsformuleringen er omgivet af en række cyclodextrinmolekyler, så det i højere grad er et eksklusionskompleks end et inklusionskompleks, og hvor der forventes svage interaktionskræfter mellem docetaxel og cyclodextrinmolekylerne.
English: During the decentralised procedure the reference member state (RMS) was of the view that based on the in vitro protein binding data provided by the Applicant, no differences with respect to unbound and protein bound docetaxel after infusion are expected.
Danish: Under den decentrale procedure var referencemedlemsstaten af den opfattelse, at der på baggrund af de in vitro-proteinbindingsdata, som ansøgeren havde fremlagt, ikke forventes nogen forskelle med hensyn til ubundet og proteinbundet docetaxel efter infusionen.
English: Molecular modelling data describing the relative weak affinity for HP-b-CD, and high binding affinity for plasma proteins, indicate that plasma protein binding will be the driving force for distribution of docetaxel in the bloodstream, with only minor - if at all- effect of HP-b-CD.
Danish: Molekylære modeldata, der beskriver den relativt svage affinitet for HP-b-CD og den høje bindende affinitet for plasmaproteiner, tyder på, at plasmaproteinbinding er drivkraften for docetaxels distribution i blodet, med en ringe - hvis nogen overhovedet - effekt af HP-b-CD.
English: Since the formulation of Docetaxel Teva Generics is different from the originator, different release characteristics and in vivo pharmacokinetic profile cannot be ruled out.
Danish: Eftersom Docetaxel Teva Generics' formulering er anderledes end originallægemidlets, kan det ikke udelukkes, at frigivelseskarakteristikaene og de farmakokinetiske profiler in vivo er forskellige.
English: Supportive PD and PK data were obtained from animal models, and indicate comparability with respect to docetaxel pharmacokinetics (rat, monkey), pharmacodynamics and toxicological parameters.
Danish: Der blev indhentet underbyggende farmakodynamiske og farmakokinetiske data fra dyremodeller, og de tyder på sammenlignelighed med hensyn til docetaxels farmakokinetik (rotter og aber), farmakodynamik og toksikologiske parametre.
English: In this respect it was the RMS's view that, the fact that a different methodology was applied to avoid docetaxel precipitation in the infusion bag (i.e., using HP-b-CD aggregates and povidone K-12 in case of Docetaxel Teva Generics instead of polysorbate micelles in case of Taxotere), does not impair this conclusion of comparable efficacy, since this conclusion is based on the final exposure of the identical active substance -docetaxel, in both formulations.
Danish: I den forbindelse var referencemedlemsstaten af den opfattelse, at den kendsgerning, at der anvendes en anden metode for at undgå docetaxelbundfældning i infusionsposen (dvs. ved at anvende HP-b-CD-aggregater og povidon K12 i Docetaxel Teva Generics i stedet for at anvende polysorbatmiceller ligesom i Taxotere), ikke har indflydelse på den konklusion, at virkningen er sammenlignelig, eftersom denne konklusion bygger på den endelige eksponering for det identiske aktive stof, docetaxel, i begge formuleringer.
English: Nevertheless taking into account all the information available in the case of Docetaxel Teva Generics, i.e the applicant's data, the evidence from literature submitted in support, as well the arguments presented at the oral explanation, the majority of the CHMP was of the view that sufficient reassurance is provided by the applicant that systemic exposure to the active ingredient between the innovator Taxotere and Docetaxel Teva Generics indeed is the same, and therefore safety and efficacy related to docetaxel will be the same as well.
Danish: Under hensyntagen til alle de tilgængelige oplysninger i forbindelse med Docetaxel Teva Generics, dvs. ansøgerens data, evidensen fra den litteratur, der blev fremlagt til støtte herfor, og de argumenter, der blev fremført under den mundtlige redegørelse, var flertallet af CHMP's medlemmer dog af den opfattelse, at ansøgeren giver tilstrækkelig dokumentation for, at den systemiske eksponering for det aktive stof rent faktisk er den samme for både originallægemidlet Taxotere og Docetaxel Teva Generics, og derfor vil docetaxels sikkerhed og virkning ligeledes være den samme.
English: To conclude, an approval could not be recommended unless the applicant could demonstrate comparable PK-profiles in vivo in man. Until now, no study in man has been conducted with this new formulation.
Danish: Som konklusion kunne en godkendelse ikke anbefales, medmindre ansøgeren kunne påvise, at der var sammenlignelige PK-profiler in vivo hos mennesker.
English: The function of the excipients polysorbate 80 in Taxotere, and of HP-b-CD and povidone K12 in Docetaxel Teva Generics, is to solubilise docetaxel to produce a solution for infusion that is stable on storage, and to protect against the active compound sticking to container walls or precipitating during storing, during the dilution into an infusate, and during the initial infusion procedure.
Danish: Funktionen af hjælpestofferne polysorbat 80 i Taxotere og HP-b-CD og povidon K-12 i Docetaxel Teva Generics er at gøre docetaxel opløseligt, så der kan fremstilles en infusionsvæske, opløsning, som er stabil ved opbevaringen, samt at beskytte mod den aktive forbindelse, der klæber til beholderens vægge eller danner bundfald ved opbevaringen, ved fortyndingen til et infusat og under den indledende infusionsprocedure.
English: In vitro protein binding data submitted during the initial procedure, CMD(h) referral procedure and the current CHMP referral procedure indicated that the dissociation pattern and protein binding is similar for docetaxel from Docetaxel Teva Generics and Taxotere at clinically relevant concentrations.
Danish: De in vitro-proteinbindingsdata, som blev fremlagt under den indledende procedure, CMD(h)-indbringelsesproceduren og den aktuelle CHMP-indbringelsesprocedure, tydede på, at dissociationsmønstret og proteinbindingen for docetaxel er den samme i Docetaxel Teva Generics og Taxotere i klinisk relevante koncentrationer.
English: • With regard to safety related to the excipients, it was considered that the different excipients povidone K-12 and HP-b-CD are used in other medicinal products for intravenous use, and thus have been previously applied in humans.
Danish: • Hvad angår hjælpestoffernes sikkerhed, var man af den opfattelse, at de andre hjælpestoffer povidon K-12 og HP-b-CD anvendes i andre lægemidler til intravenøs brug, og at de derfor tidligere er blevet anvendt til mennesker.
English: The aim of the assessment has been to clarify if systemic exposure to docetaxel from Taxotere and Docetaxel Teva Generics is equal.
Danish: Formålet med vurderingen var at klarlægge, om den systemiske eksponering for docetaxel fra Taxotere og Docetaxel Teva Generics er den samme.
English: The micelle forming polysorbate used in the originator is exchanged for a cyclodextrin derivative in Docetaxel Teva Generics, which has a different form of interaction with the drug substance.
Danish: Det micelledannende polysorbat, der anvendes i originallægemidlet, er i Docetaxel Teva Generics erstattet med et cyclodextrinderivat, som har en anden form for interaktion med lægemiddelstoffet.
English: The assessment for this Docetaxel Teva Generics is in line with earlier applications for generic docetaxel products, where known but different excipients were applied.
Danish: Vurderingen af Docetaxel Teva Generics er i overensstemmelse med tidligere anvendelser af generiske docetaxellægemidler, hvor der er brugt kendte, men forskellige hjælpestoffer.
English: However according to the objecting concerned member state (CMS), the in vitro data provided were insufficient to demonstrate similar in vivo behaviour.
Danish: Den berørte medlemsstat, der gjorde indsigelse, var dog af den opfattelse, at de fremlagte in vitrodata var utilstrækkelige til at påvise en lignende in vivo-adfærd.
English: It is assumed that if sufficient reassurance is provided that systemic exposure to the active ingredient between the innovator Taxotere and Docetaxel Teva Generics is the same, then safety and efficacy related to docetaxel will be the same as well.
Danish: Det antages, at hvis der er tilstrækkelig dokumentation for, at den systemiske eksponering for det aktive stof er den samme i originalllægemidlet Taxotere og i Docetaxel Teva Generics, vil sikkerheden og virkningen i forbindelse med docetaxel ligeledes være den samme.
English: This assumption is also supported by animal data.
Danish: Denne antagelse underbygges ligeledes af data fra dyreforsøg.
English: This assumption is supported by the provided animal data.
Danish: Denne formodning støttes af de fremlagte data fra dyreforsøg.
English: With regard to safety related to the excipients, it was considered by the RMS that the different excipients povidone K12 and HP-b-CD are being used in other medicinal products for intravenous use, and thus have been applied in humans.
Danish: Hvad angår hjælpestoffernes sikkerhed, mente referencemedlemsstaten, at de andre hjælpestoffer povidon K-12 og HP-b-CD anvendes i andre lægemidler til intravenøs brug, og at de således er blevet anvendt til mennesker.
English: The RMS was therefore of the view that the in vitro data provided, supported by the animal PK and PD data, are sufficient to demonstrate a comparable in vivo behaviour.
Danish: Derfor mente referencemedlemsstaten, at de fremlagte in vitro-data, som underbygges af farmakokinetiske og farmakodynamiske data fra dyreforsøg, er tilstrækkelige til at påvise en sammenlignelig in vivo-adfærd.
English: The formulation of Docetaxel Teva Generics is not the same as the reference product as a different excipient is used.
Danish: Docetaxel Teva Generics' formulering er ikke den samme som referencelægemidlets, eftersom der anvendes et andet hjælpestof.
English: The objecting CMSs argued that the formulation of Docetaxel Teva Generics is not equivalent to the originator as a different excipient is used.
Danish: Den berørte medlemsstat, der gjorde indsigelse, fremførte, at Docetaxel Teva Generics' formulering ikke svarer til originallægemidlets, eftersom der anvendes et andet hjælpestof.
English: All data considered collectively were thought to strongly suggest comparable docetaxel exposure obtained from Taxotere and Docetaxel Teva Generics.
Danish: Samlet set tydede alle data stærkt på en sammenlignelig docetaxeleksponering fra Taxotere og Docetaxel Teva Generics.
English: • The in vitro protein binding data point at comparable docetaxel exposure obtained from Taxotere and Docetaxel Teva Generics;
Danish: • In vitro-proteinbindingsdata tyder på, at eksponeringen for docetaxel er sammenlignelig for
English: The lack of safety issues caused by these excipients was also supported by animal data.
Danish: Data fra dyreforsøg underbygger ligeledes, at der ikke er nogen sikkerhedsproblemer med disse hjælpestoffer.
English: This should therefore be acceptable.
Danish: Dette kan derfor anses for acceptabelt.
English: The responses were submitted to the EMEA on 19 December 2006.
Danish: Besvarelserne blev indleveret til EMEA den 19. december 2006.
English: Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia
Danish: Belgien, Tjekkiet, Tyskland, Grækenland, Spanien, Frankrig, Italien, Nederlandene, Polen, Portugal og Slovakiet
English: If it occurs, it is recommended to wash the area with plenty of water.
Danish: Hvis det sker, anbefales det at vaske området med rigeligt vand.
English: This is in agreement with the German Competent National Authority (BVL) and expert opinion.
Danish: Dette er i overensstemmelse med de tyske kompetente myndigheder (BVL) og den tyske ekspertudtalelse.
English: After oral administration, in most species values higher than 70% are reached.
Danish: Efter oral administration nås værdier over 70% i de fleste arter.
English: Do not use after the expiry date.
Danish: Må ikke anvendes efter udløbsdatoen.
English: MANUFACTURER'S BATCH NUMBER Batch: {number}
Danish: FREMSTILLERENS BATCHNUMMER Batch: {nummer}
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert gram indeholder:
English: During the Mutual Recognition Procedure this statistical evaluation was questioned and found to be inappropriate.
Danish: Under den gensidige anerkendelsesprocedure blev denne statistiske vurdering draget i tvivl og fundet uhensigtsmæssig.
English: Do not smoke, eat or drink while handling the product.
Danish: Der må ikke ryges, spises eller drikkes, mens produktet håndteres.
English: Germany notified the EMEA on 30 May 2006 that the CMD(v) failed to reach an agreement regarding the product.
Danish: Tyskland underrettede den 30. maj 2006 EMEA om, at CMD(v) ikke havde kunnet nå til enighed om dette produkt.
English: Avoid skin and eye contact.
Danish: Undgå hud- og øjenkontakt.
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Semoline q.s.
Danish: Semulje q.s.
English: For these reasons, the appropriate proposed indication is suggested as follows:
Danish: Af disse grunde foreslås følgende indikation:
English: The presence was assumed.
Danish: Det antoges, at den var til stede.
English: The following calculation can be used to calculate dosage:
Danish: Følgende beregning kan bruges til at beregne dosering:
English: Tetracyclines, ATCvet code: QJ01AA02.
Danish: Tetracycliner, ATCvet kode: QJ01AA02.
English: The applicant has explained the choice of dose.
Danish: Ansøgeren har forklaret valget af dosis.
English: Before granulation, flour should not reach a temperature higher than 55 ºC.
Danish: Før granulering bør melet ikke nå en temperatur højere end 55 ºC.
English: Once absorbed, the drug is bound in a very high percentage (93%) to plasmatic proteins.
Danish: Når det er absorberet, bindes lægemidlet i en meget høj procentdel (93%) til plasmaproteiner.
English: Absorption after oral and intramuscular administration shows a high bioavailability.
Danish: Absorption efter oral og intramuskulær administration udviser en høj biotilgængelighed.
English: Binding to plasmatic proteins is about 90-92%.
Danish: Binding til plasmaproteiner er omkring 90-92%.
English: After first opening, keep the pack tightly closed.
Danish: Efter den første åbning skal pakken holdes tæt lukket.
English: Global evaluations were justified because the statistical guideline incorporates them.
Danish: Globale evalueringer var berettigede, da de er indeholdt i de statistiske retningslinjer.
English: Concentrations that reaches in lung are always higher than in plasma.
Danish: Koncentrationer, der nås i lunge, er altid højere end i plasma.
English: Annex I of Directive 2001/82/EC as amended by directive 2004/28/EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
Danish: I bilag I til direktiv 2001/82/EF, som ændret ved direktiv 2004/28/EF, er anført, at erfaringer efter markedsføring med andre produkter indeholdende de samme indholdsstoffer er særligt vigtige, og at ansøgerne skal lægge speciel vægt på dette punkt.
English: Conclusion and recommendation
Danish: Konklusion og anbefaling
English: Alteration in the transport system is produced by inducible proteins codified in plasmids and transposons.
Danish: Ændring i transportsystemet produceres af inducerbare proteiner kodificeret i plasmider og transposoner.
English: It reaches well irrigated and peripheral tissues.
Danish: Det når veludskyllede og perifere væv.
English: The submitted post marketing experience consists of:
Danish: De forelagte oplysninger om erfaringer efter markedsføring består af:
English: In case of insufficient feed intake, animals should be treated parenterally.
Danish: I tilfælde af utilstrækkelig foderindtagelse bør dyrene behandles parenteralt.
English: It is recommended to use a non-powder mask (according to the EN140FFP1 regulation), gloves, working suit and approved safety glasses.
Danish: Det anbefales at bruge en pulvermaske (i henhold til EN140FFP1 forordningen), handsker, arbejdsdragt og godkendt øjenværn.
English: However, the study was conducted and assessed prior to these requirements and the applicant has attempted many additional analyses on the original data and has justified various deficiencies.
Danish: Undersøgelsen blev imidlertid udført og vurderet inden disse krav blev gældende, og ansøgeren har forsøgt at udføre mange supplerende analyser på de oprindelige data og har begrundet en række mangler.
English: The CVMP/627/01 and GCP guideline stated that the response to therapy must be based on clinical and microbiological criteria wherever possible.
Danish: I CVMP/627/01 og GCP-retningslinjerne anføres, at vurderingen af respons skal være baseret på kliniske og mikrobiologiske kriterier så vidt det er muligt.
English: Therefore, the recommendation is to remove this pathogen from the indications.
Danish: Denne patogen anbefales derfor slettet fra indikationerne.
English: Therefore the applicant performed another statistical evaluation using the original database.
Danish: Ansøgeren foretog derfor en ny statistisk vurdering med anvendelse af den oprindelige database.
English: The applicant felt that this was more adapted towards the Guideline EMEA/CVMP/816/00 and obtained greater clinical significance.
Danish: Ansøgeren fandt, at denne stemte bedre overens med retningslinjerne EMEA/CVMP/816/00 og havde større klinisk relevans.
English: Similar products with 8 or 10 days treatment durations are also available within the EU.
Danish: Desuden markedsføres der i EU tilsvarende produkter med 8 eller 10 dages behandlingsvarighed.
English: Time to clinical cure was considered the primary end point.
Danish: Tiden til klinisk helbredelse blev anset for at være det primære endepunkt.
English: Pulmodox is indicated for prevention of clinical respiratory disease and not for treatment,
Danish: Pulmodox er indiceret til forebyggelse af klinisk luftvejssygdom, ikke til behandling.
English: The choice of positive control products and the dosing regiment applied were discussed:
Danish: Valget af positive kontrolgrupper og det anvendte doseringsregime blev drøftet:
English: The feed consumption will depend on the clinical condition of the animal.
Danish: Foderindtagelsen vil afhænge af dyrets kliniske tilstand.
English: The following complete feeding stuffs for pigs can be used for the manufacturing of medicated feeds:
Danish: Følgende komplette fodermateriale til svin kan bruges til fremstilling af medicineret foder:
English: Pharmacotherapeutic group: Antibacterials for systemic use.
Danish: Farmakoterapeutisk gruppe: Antimikrobielt lægemiddel til systemisk brug.
English: Allergic reactions and photosensitivity may appear, as for all tetracyclines.
Danish: Der kan forekomme allergiske reaktioner og lysfølsomhed, som det er tilfældet for alle tetracycliner.
English: Semolinea (declared on labelling as carrier)
Danish: Semulje (deklareret på mærkningen som bærestof)
English: Inflammation of the face, lips and eyes or respiratory difficulty are more severe signs that require urgent medical attention.
Danish: Inflammation af ansigtet, læberne og øjnene eller vejrtrækningsvanskeligheder er mere alvorlige tegn, som kræver akut lægehjælp.
English: Pelleting conditions involve preconditioning ingredients with steam at 55-65ºC and 10% moisture.
Danish: Pelleteringsbetingelser omfatter forberedelse af ingredienser med damp ved 55-65ºC og 10% fugt.
English: If you notice any serious effects or other effects not mentioned in this label, please inform your veterinary surgeon.
Danish: Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes De kontakte Deres dyrlæge.
English: The applicant has submitted a scientific report on Porcine Respiratory Disease Complex (PRDC) and also pointed out that the above mentioned Guideline were not in effect at time of the study or the initial submission to the Spanish Authority.
Danish: Ansøgeren har forelagt en videnskabelig rapport om Porcine Respiratory Disease Complex (PRDC) og har også påpeget, at ovennævnte retningslinjer ikke var i kraft på det tidspunkt, da undersøgelsen blev gennemført eller da den oprindelige ansøgning blev indgivet til de spanske myndigheder.
English: The uptake of medicated feed by animals can be altered as a consequence of illness.
Danish: Dyrs optagelse af medicineret foder kan blive ændret som følge af sygdom.
English: The most important mechanism is due to the decrease of the cellular accumulation of the drug.
Danish: Den vigtigste mekanisme skyldes reduktionen af lægemidlets celleakkummulation.
English: The Committee agreed that all prudent use recommendations should be put under 4.5.
Danish: Udvalget fastslog, at alle anbefalinger for forsigtig brug burde indsættes under pkt.
English: Farms were selected if at least 20% of pigs were showing clinical signs of respiratory disease.
Danish: De pågældende svineopdræt blev udvalgt, hvis mindst 20 % af dyrene viste kliniske symptomer på luftvejssygdomme.
English: Resistance was covered adequately in literature.
Danish: Resistens var fyldestgørende dækket ved litteraturreferencer.
English: Cross-resistance is frequent between tetracyclines.
Danish: Krydsresistens er hyppig mellem tetracycliner.
English: (1) Pharmacovigilance - reporting a nil return for suspected adverse drugs reactions and lack of efficacy; and
Danish: (1) lægemiddelovervågning - der blev meldt om en indberetningshyppighed på nul vedrørende formodede uønskede lægemiddelreaktioner eller manglende virkning, og
English: This is also the indication applied for at the start of the mutual recognition procedure (MRP).
Danish: Dette var også indikationen i ansøgningen ved indledningen af den gensidige anerkendelsesprocedure.
English: Oral bioavailability of doxycycline ranges between 50-60% values.
Danish: Doxycyclins orale biotilgængelighed ligger mellem 50-60% værdier.
English: Do not administer in conjunction with bactericidal antibiotics like beta-lactames.
Danish: Må ikke administreres samtidig med bakteriedræbende antibiotika som beta-lactamer.
English: These are all references provided with the original submission.
Danish: Der er tale om referencer, der alle er indeholdt i den oprindelige ansøgning.