natgillin/translations-raw huggingface dataset:
Det "generiske" princip er, at der på sådanne betingelser, hvor eksponeringen er sammenlignelig, ikke forventes nogen forskel i virkning og sikkerhed for det aktive stof (docetaxel). 
The ‘generic' principle is that under those conditions of comparable exposure, no difference in efficacy and active substance (docetaxel)-related safety is expected.
Dette forhøjede CMC gør det mindre sandsynligt, at polysorbatmiceller rent faktisk er til stede i blodet, selv meget kort tid efter infusionen. 
This increased CMC makes it less likely that polysorbate micelles are indeed present in the blood stream, even very shortly after infusion.
Hjælpestofferne povidon K-12 og HP-b-CD, som anvendes i Docetaxel Teva Generics, men som ikke anvendes i Taxotere, er kendt fra andre lægemidler, og der forventes ingen sikkerhedsproblemer. 
The excipients povidone K-12 and HP-b-CD that are used in Docetaxel Teva Generics, but are not used in Taxotere, are known from other medicinal products, and no safety issues are expected.
• Denne antagelse underbygges af ikke-kliniske data fra dyreforsøg; 
• This assumption is supported by the non-clinical animal data;
Der blev givet udtryk for betænkelighed med hensyn til, at formuleringerne er forskellige (cyclodextrinkomplekser i forhold til traditionelle miceller), og at denne generiske docetaxelformulering aldrig er blevet givet til mennesker. 
Concerns were expressed that the formulations (cyclodextrin complexes vs. traditional micelles) are different, and that this generic docetaxel formulation had never been given to man.
Resultaterne af in vitro-undersøgelserne kan nu betragtes som værende i overensstemmelse med de aktuelle forventninger baseret på en grundig evaluering af de tilgængelige fysiskkemiske data i den forbindelse, sådan som det fremgår af svarene på indbringelsens liste med uafklarede spørgsmål (LoOI). 
The results of the in vitro studies can now be considered in line with current expectations based on thorough evaluation of the available physicochemical data on this subject, as provided in the responses to the referral LoOI.
Desuden vurderede man pålideligheden af de fremlagte data fra dyreforsøg og niveauet af ekstrapolering fra in vitro-dataene til in vivo-situationen. 
Furthermore, the robustness of the provided animal data, and the level of extrapolation from the in vitro data to the in vivo situation was assessed.
Det lader således ikke til, at den formodede forhøjede frie docetaxelfraktion af polysorbat 80-miceller er til stede, og det betyder, at den ikke er relevant for den aktuelle situation. 
Therefore, the putative increased free docetaxel fraction by polysorbate 80 micelles does not appear to be present, and thus not relevant for the actual situation.
Under hensyntagen til de litteraturdata, som ansøgeren fremlagde, var der dog nogle af CHMP's medlemmer, som bemærkede, at ifølge dataene fra Wang et al. (2010) var CMC for polysorbat 80 i plasmaproteinkoncentrationen hos mennesker ikke væsentligt større end det klinisk relevante postinfusionsniveauområde for polysorbat 80 (fra Taxotere), som blev rapporteret af Webster et al. (1997). 
However taking into account the literature data presented by the applicant, it was noted by some members of the CHMP that according to the data by Wang et al (2010), the CMC of polysorbate 80 in human plasma protein concentration was not substantially greater than the clinically relevant range of post-infusion levels of polysorbate 80 (from Taxotere) reported by Webster et al (1997).
Desuden blev der fremlagt yderligere evidens for, at de kliniske data om den frie fraktion under infusionen ikke underbygger nogen forbigående virkninger på den frie fraktion (Acharya et al., 
Further evidence was also presented that the clinical data on free fraction during infusion do not support any transient effects on free fraction (Acharya et al., 2004).
anbefalede CHMP udstedelse af en markedsføringstilladelse, for hvilken produktresuméet, mærkningen og indlægssedlen bevares i henhold til de endelige udgaver, der blev fastlagt under koordinationsgruppens procedure som nævnt i bilag III for Docetaxel Teva Generics og relaterede navne (se bilag I). 
The CHMP has recommended the granting of the marketing authorisation 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 Docetaxel Teva Generics and associated names (see Annex I).
Manglen på en relevant indvirkning er i overensstemmelse med de in vitro-data, der er opnået for denne anvendelse, hvor der i en head-to-head-sammenligning ikke blev observeret nogen forskel i frit docetaxel med hensyn til fortyndende faktorer for Taxotere, og den samme manglende indvirkning blev observeret for Docetaxel Teva Generics. 
The absence of a relevant effect is in line with in vitro data obtained within this application, where in a head to head comparison no difference in free docetaxel in relation to dilution factors was observed for Taxotere, and the same lack of effect was observed for Docetaxel Teva Generics.
Et af de punkter, som ansøgeren understregede, var, at de gennemgåede data fra Loos et al. ikke underbygger ændringer i den frie fraktion over et klinisk relevant koncentrationsområde in vitro. 
One of the points highlighted by the applicant was that the Loos et al data reviewed do not support changes in free fraction over a clinically relevant concentration range in vitro.
Referencelægemidlet er Taxotere, koncentrat og solvens til infusionsvæske, opløsning (20 mg og 80 mg), som fremstilles af Sanofi-Aventis France. 
The reference product is Taxotere, concentrate and solvent for solution for infusion (20 mg and 80 mg), by Sanofi-Aventis France.
Eftersom lægemiddelformen af Docetaxel Teva Generics (pulver til infusionsvæske, opløsning) adskiller sig fra referencelægemidlet (koncentrat til infusionsvæske, opløsning), blev der indgivet en hybridansøgning om markedsføringstilladelse for Docetaxel Teva Generics 20 mg / 80 mg, pulver og solvens til infusionsvæske, opløsning, 20 mg og 80 mg, i henhold til direktiv 2001/83/EF, artikel 10, stk. 3. 
Since the pharmaceutical form of the Docetaxel Teva Generics (powder for solution for infusion) differs from the reference product (concentrate for solution for infusion) a hybrid application marketing authorisation application (MAA) for Docetaxel Teva Generics 20 mg / 80 mg, Powder and Solvent for Solution for Infusion, 20 mg and 80 mg was submitted, in accordance with Directive 2001/83/EC, article 10(3).
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. 
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.
Docetaxel Teva Generics' farmaceutiske kvalitet kan sammenlignes med Taxoteres. 
Pharmaceutical quality of Docetaxel Teva Generics is comparable to that of Taxotere.
Referenceformuleringen indeholder polysorbat 80 som hjælpestof, mens den generiske formulering indeholder povidon K-12, hydroxypropylbetadex (HP-b-CD) og glukosemonohydrat som hjælpestoffer. 
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.
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. 
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.
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. 
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.
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. 
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.
Eftersom Docetaxel Teva Generics' formulering er anderledes end originallægemidlets, kan det ikke udelukkes, at frigivelseskarakteristikaene og de farmakokinetiske profiler in vivo er forskellige. 
Since the formulation of Docetaxel Teva Generics is different from the originator, different release characteristics and in vivo pharmacokinetic profile cannot be ruled out.
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. 
Supportive PD and PK data were obtained from animal models, and indicate comparability with respect to docetaxel pharmacokinetics (rat, monkey), pharmacodynamics and toxicological parameters.
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. 
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.
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. 
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.
Som konklusion kunne en godkendelse ikke anbefales, medmindre ansøgeren kunne påvise, at der var sammenlignelige PK-profiler in vivo hos mennesker. 
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.
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. 
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.
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. 
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.
• 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. 
• 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.
Formålet med vurderingen var at klarlægge, om den systemiske eksponering for docetaxel fra Taxotere og Docetaxel Teva Generics er den samme. 
The aim of the assessment has been to clarify if systemic exposure to docetaxel from Taxotere and Docetaxel Teva Generics is equal.
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. 
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.
Vurderingen af Docetaxel Teva Generics er i overensstemmelse med tidligere anvendelser af generiske docetaxellægemidler, hvor der er brugt kendte, men forskellige hjælpestoffer. 
The assessment for this Docetaxel Teva Generics is in line with earlier applications for generic docetaxel products, where known but different excipients were applied.
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. 
However according to the objecting concerned member state (CMS), the in vitro data provided were insufficient to demonstrate similar in vivo behaviour.
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. 
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.
Denne antagelse underbygges ligeledes af data fra dyreforsøg. 
This assumption is also supported by animal data.
Denne formodning støttes af de fremlagte data fra dyreforsøg. 
This assumption is supported by the provided animal data.
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. 
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.
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. 
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.
Docetaxel Teva Generics' formulering er ikke den samme som referencelægemidlets, eftersom der anvendes et andet hjælpestof. 
The formulation of Docetaxel Teva Generics is not the same as the reference product as a different excipient is used.
Den berørte medlemsstat, der gjorde indsigelse, fremførte, at Docetaxel Teva Generics' formulering ikke svarer til originallægemidlets, eftersom der anvendes et andet hjælpestof. 
The objecting CMSs argued that the formulation of Docetaxel Teva Generics is not equivalent to the originator as a different excipient is used.
Samlet set tydede alle data stærkt på en sammenlignelig docetaxeleksponering fra Taxotere og Docetaxel Teva Generics. 
All data considered collectively were thought to strongly suggest comparable docetaxel exposure obtained from Taxotere and Docetaxel Teva Generics.
• In vitro-proteinbindingsdata tyder på, at eksponeringen for docetaxel er sammenlignelig for 
• The in vitro protein binding data point at comparable docetaxel exposure obtained from Taxotere and Docetaxel Teva Generics;
Data fra dyreforsøg underbygger ligeledes, at der ikke er nogen sikkerhedsproblemer med disse hjælpestoffer. 
The lack of safety issues caused by these excipients was also supported by animal data.
Dette kan derfor anses for acceptabelt. 
This should therefore be acceptable.
Besvarelserne blev indleveret til EMEA den 19. december 2006. 
The responses were submitted to the EMEA on 19 December 2006.
Belgien, Tjekkiet, Tyskland, Grækenland, Spanien, Frankrig, Italien, Nederlandene, Polen, Portugal og Slovakiet 
Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia
Hvis det sker, anbefales det at vaske området med rigeligt vand. 
If it occurs, it is recommended to wash the area with plenty of water.
Dette er i overensstemmelse med de tyske kompetente myndigheder (BVL) og den tyske ekspertudtalelse. 
This is in agreement with the German Competent National Authority (BVL) and expert opinion.
Efter oral administration nås værdier over 70% i de fleste arter. 
After oral administration, in most species values higher than 70% are reached.
Må ikke anvendes efter udløbsdatoen. 
Do not use after the expiry date.
FREMSTILLERENS BATCHNUMMER Batch: {nummer} 
MANUFACTURER'S BATCH NUMBER Batch: {number}
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert gram indeholder: 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains:
Under den gensidige anerkendelsesprocedure blev denne statistiske vurdering draget i tvivl og fundet uhensigtsmæssig. 
During the Mutual Recognition Procedure this statistical evaluation was questioned and found to be inappropriate.
Der må ikke ryges, spises eller drikkes, mens produktet håndteres. 
Do not smoke, eat or drink while handling the product.
Tyskland underrettede den 30. maj 2006 EMEA om, at CMD(v) ikke havde kunnet nå til enighed om dette produkt. 
Germany notified the EMEA on 30 May 2006 that the CMD(v) failed to reach an agreement regarding the product.
Undgå hud- og øjenkontakt. 
Avoid skin and eye contact.
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Semulje q.s. 
Semoline q.s.
Af disse grunde foreslås følgende indikation: 
For these reasons, the appropriate proposed indication is suggested as follows:
Det antoges, at den var til stede. 
The presence was assumed.
Følgende beregning kan bruges til at beregne dosering: 
The following calculation can be used to calculate dosage:
Tetracycliner, ATCvet kode: QJ01AA02. 
Tetracyclines, ATCvet code: QJ01AA02.
Ansøgeren har forklaret valget af dosis. 
The applicant has explained the choice of dose.
Før granulering bør melet ikke nå en temperatur højere end 55 ºC. 
Before granulation, flour should not reach a temperature higher than 55 ºC.
Når det er absorberet, bindes lægemidlet i en meget høj procentdel (93%) til plasmaproteiner. 
Once absorbed, the drug is bound in a very high percentage (93%) to plasmatic proteins.
Absorption efter oral og intramuskulær administration udviser en høj biotilgængelighed. 
Absorption after oral and intramuscular administration shows a high bioavailability.
Binding til plasmaproteiner er omkring 90-92%. 
Binding to plasmatic proteins is about 90-92%.
Efter den første åbning skal pakken holdes tæt lukket. 
After first opening, keep the pack tightly closed.
Globale evalueringer var berettigede, da de er indeholdt i de statistiske retningslinjer. 
Global evaluations were justified because the statistical guideline incorporates them.
Koncentrationer, der nås i lunge, er altid højere end i plasma. 
Concentrations that reaches in lung are always higher than in plasma.
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. 
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.
Konklusion og anbefaling 
Conclusion and recommendation
Ændring i transportsystemet produceres af inducerbare proteiner kodificeret i plasmider og transposoner. 
Alteration in the transport system is produced by inducible proteins codified in plasmids and transposons.
Det når veludskyllede og perifere væv. 
It reaches well irrigated and peripheral tissues.
De forelagte oplysninger om erfaringer efter markedsføring består af: 
The submitted post marketing experience consists of:
I tilfælde af utilstrækkelig foderindtagelse bør dyrene behandles parenteralt. 
In case of insufficient feed intake, animals should be treated parenterally.
Det anbefales at bruge en pulvermaske (i henhold til EN140FFP1 forordningen), handsker, arbejdsdragt og godkendt øjenværn. 
It is recommended to use a non-powder mask (according to the EN140FFP1 regulation), gloves, working suit and approved safety glasses.
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. 
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.
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. 
The CVMP/627/01 and GCP guideline stated that the response to therapy must be based on clinical and microbiological criteria wherever possible.
Denne patogen anbefales derfor slettet fra indikationerne. 
Therefore, the recommendation is to remove this pathogen from the indications.