FrancophonIA/ELRC3.0 huggingface dataset:
English: PACKAGE LEAFLET FOR: TruScient 0.66 mg kit for implant for dogs
Danish: INDLÆGSSEDDEL TIL: TruScient 0,66 mg, sæt til implantation til hunde
English: Use care to ensure that accurate volumes are used in reconstitution and application of the dibotermin alfa (rhBMP-2) solution to the sponge.
Danish: Udvis omhu for at sikre at der anvendes nøjagtige mængder til rekonstitution og applikation af dibotermin alfa (rhBMP-2)-opløsning på matrix.
English: During placement, use forceps to handle the prepared sponge to avoid excessive fluid loss.
Danish: Under implantation håndteres matrix med pincet for at undgå for stort væsketab.
English: Uncommon (more than 1 but less than 10 animals in 1000 animals) Mild to moderate Exuberant bony callus associated with persistent (>10 weeks) moderate soft tissue swelling and excessive licking of the incision area.
Danish: Ikke almindelig (hos mellem 1 og 10 ud af 1000 dyr) Let til moderat hypertrofisk forbenet callus i forbindelse med vedvarende (>10 uger) moderat bløddelshævelse og overdreven slikken af incisionsområdet.
English: Leaving the sponges in the tray, UNIFORMLY distribute onto each sponge 1.4 ml dibotermin alfa (rhBMP-2) solution as shown in the illustration (Figure 2).
Danish: Lad matrixerne ligge i bakken og fordel JÆVNT 1,4 ml dibotermin alfa (rhBMP-2)-opløsning på hver matrix som vist på illustrationen (Figur 2).
English: Kit for implant
Danish: Sæt til implantation
English: Swirl the vial gently to aid reconstitution.
Danish: Sving forsigtigt hætteglasset for at fremme opløsningen.
English: Spain
Danish: España
English: One vial of lyophilisate contains 0.66 mg of dibotermin alfa (rhBMP-2) After reconstitution, TruScient solution contains 0.2 mg/ml of dibotermin alfa (rhBMP-2).
Danish: Et hætteglas med lyofilisat indeholder 0,66 mg dibotermin alfa (rhBMP-2) Efter rekonstitution indeholder TruScient opløsningen 0,2 mg/ml dibotermin alfa (rhBMP-2).
English: Irrigation will wash away the dibotermin alfa (rhBMP-2) solution.
Danish: Skylning udvasker dibotermin alfa (rhBMP-2)-opløsningen.
English: One vial of lyophilisate contains 0.66 mg of dibotermin alfa (rhBMP-2)*
Danish: Et hætteglas med lyofilisat indeholder 0,66 mg dibotermin alfa (rhBMP-2)*
English: Do not use in dogs with a known hypersensitivity to the active substance or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Instructions for preparation and use
Danish: Anvisninger for klargøring og anvendelseError!
English: After reconstitution, TruScient solution contains 0.2 mg/ml of dibotermin alfa (rhBMP-2).
Danish: Efter rekonstitution indeholder TruScient 0,2 mg/ml dibotermin alfa (rhBMP-2).
English: D. After Placement
Danish: D. Efter implantation:
English: Failure to follow the TruScient instructions for preparation and use may compromise safety and effectiveness.
Danish: Manglende overholdelse af anvisningerne for klargøring og anvendelse af TruScient kan være kompromitterende for sikkerhed og virkning.
English: Following placement, achieve complete soft-tissue coverage of the prepared sponges.
Danish: Efter implantation skal den klargjorte matrix være fuldstændigt dækket af bløddele.
English: SOLVENT VIAL LABEL
Danish: SOLVENS - ETIKET TIL HÆTTEGLAS
English: 10 ml Type I glass vial with a bromobutyl elastomeric closure sealed with an aluminum flipoff seal and plastic cap.
Danish: 10 ml hætteglas type I med en bromobutylgummiprop, der er forseglet med en aluminium flipoff forsegling og plasthætte.
English: 10 ml Type I glass vial with a chlorobutyl elastomeric closure sealed with an aluminum flipoff seal and plastic cap.
Danish: 10 ml hætteglas type I med en chlorobutylgummiprop, der er forseglet med en aluminium flipoff forsegling og plasthætte.
English: Failure to follow the product preparation instructions may compromise its safety and effectiveness.
Danish: Manglende overholdelse af anvisningerne for klargøring kan være kompromitterende for sikkerhed og virkning.
English: Sponge:
Danish: Matrix:
English: During handling avoid excessive fluid loss from the prepared sponges.
Danish: Undgå for stort væsketab under håndtering af klargjorte matrixer.
English: Using aseptic technique, follow the directions below to reconstitute dibotermin alfa (rhBMP-2) for application to the sponges.
Danish: Hyperlink reference not valid.Følg anvisningerne nedenfor til rekonstitution af dibotermin alfa (rhBMP-2) for applikation på matrix under anvendelse af aseptisk teknik.
English: Seroma, excessive licking of incision area, joint stiffness, local swelling, skin ulcer, incisional discharge, incisional dehiscence.
Danish: Almindelig (hos mellem 1 og 10 ud af 100 dyr) Let til moderat seroma, overdreven slikken af incisionsområdet, stive led, lokal hævelse, sår i huden, udsivning fra incisionsstedet, ruptur af incisionsstedet blød hævelse, der generelt er svundet 6 uger efter operationen
English: Two sterile 3 ml disposable polypropylene syringes with stainless steel needles attached.
Danish: To sterile 3 ml engangssprøjter af polypropylen med påsatte kanyler i rustfrit stål.
English: If only a portion of a prepared sponge is required, first prepare the entire package (following steps 1 - 9 above), then cut or fold the prepared sponge as needed prior to implantation.
Danish: 1-9 ovenfor), klip eller fold derefter den klargjorte matrix efter behov før implantation.
English: One sterile 6 ml disposable polypropylene syringe with stainless steel needle attached.
Danish: En steril 6 ml engangssprøjte af polypropoylen med påsat kanyle i rustfrit stål.
English: If only a portion of a prepared sponges is required, first prepare the entire package (following steps 1 - 9 above), then cut the prepared sponge as needed prior to implantation.
Danish: Hvis kun en del af en klargjort matrix skal anvendes, skal hele sættet først klargøres (følg trin
English: Do not irrigate the wound once the prepared sponge is placed across the fracture.
Danish: Når matrix er implanteret over frakturen, må såret ikke skylles.
English: Treatment TruScient + SOC (n=84) SOC (n=42) SOC = standard of care
Danish: Behandling TruScient + standardbehandling (n=84) 9,5 83,3 92,9 97,6 98,8 100,0 Standardbehandling (n=42)
English: Do not squeeze.
Danish: Må ikke trykkes.
English: LYOPHILISATE VIAL LABEL
Danish: LYOFILISAT-ETIKET TIL HÆTTEGLAS
English: Using aseptic transfer technique and for each 3 ml syringe with needle, withdraw 1.4 ml from the reconstituted vial of dibotermin alfa (rhBMP-2) in the non-sterile field.
Danish: ml af det rekonstituerede hætteglas med dibotermin alfa (rhBMP-2) i det ikke-sterile område.
English: The two important criteria were:
Danish: De to vigtige kriterier var:
English: CHMP's position
Danish: CHMP's holdning
English: Therefore the clinical conclusions should remain the same.
Danish: Derfor skulle de kliniske konklusioner være de samme.
English: Data generated and reported in connection with these two studies had to be classified as not credible.
Danish: Data, som er genereret og rapporteret i forbindelse med disse to undersøgelser, måtte klassificeres som ikke troværdige.
English: During the GCP inspection 19 findings were identified, of which 9 were classified as critical, 7 as major, and 3 as minor.
Danish: Under GCP-inspektionen blev der identificeret 19 fund, hvoraf 9 blev klassificeret som kritiske, 7 som større og 3 som mindre.
English: Any argumentation based on the data generated at the contract laboratory is inappropriate in view of the number and seriousness of deficiencies.
Danish: Enhver argumentation, som er baseret på de data, der er genereret på kontraktlaboratoriet, er uhensigtsmæssig i lyset af antallet og alvoren af manglerne.
English: It needs to be emphasized that the unique small (n=40) pharmacodynamic study performed by the sponsor is meant to substitute for a full clinical development.
Danish: Det skal understreges, at det er hensigten, at den unikke lille (n=40) farmakodynamiske undersøgelse, som er udført af sponsor, skal erstatte en fuld klinisk udvikling.
English: • testosterone levels below castration for both products.
Danish: • testosteronniveauer under kastrationsniveau for begge lægemidler.
English: Revalidation of the testosterone method confirmed the confidence in the reliability of the results obtained earlier.
Danish: Fornyet godkendelse af testosteronmetoden bekræftede tilliden til de tidligere opnåede resultater.
English: Therefore, the Committee recommends the suspension of the marketing authorisations, subject to the conditions outlined in Annex III of the Opinion.
Danish: Udvalget anbefaler derfor en suspendering af markedsføringstilladelserne, indtil betingelserne i bilag III til udtalelsen er opfyldt.
English: The magnitude of deviation of results from actual serum concentration cannot be estimated.
Danish: Omfanget af resultaternes afvigelse fra den faktiske serumkoncentration kan ikke estimeres.
English: Overall, the value and reliability of a retrospective method-validation more than five years after end of GOS/001 and more than two years after end of GOS/002 is highly questionable.
Danish: Samlet set er værdien og pålideligheden af en retrospektiv metodegodkendelse mere end fem år efter afslutningen af GOS/001 og mere end to år efter afslutningen af GOS/002 stærkt tvivlsom.
English: Goserelin is among others, authorised for patients with advanced prostate cancer where an endocrine treatment is indicated.
Danish: Goserelin er blandt andet godkendt til patienter med fremskreden prostatacancer, hvor en endokrin behandling er indiceret.
English: It is an LHRH agonist (analogue of the natural luteinizing hormone-releasing hormone) and suppresses the serum testosterone to castration level to inhibit the growth of hormone-depending prostate carcinoma.
Danish: Det er en LHRH-agonist (analog af det naturlige luteiniserende hormonfrigivende hormon) og supprimerer serumtestosteron til kastrationsniveau for at hæmme væksten af hormonafhængigt prostatakarcinom.
English: These inconsistencies led to a Good Clinical Practice (GCP) inspection of the contract laboratory by the German authority (BfArM).
Danish: Disse uregelmæssigheder førte til en GCP-inspektion af kontraktlaboratoriet fra den tyske myndigheds side (BfArM).
English: Considering the above, the CHMP is of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Danish: På baggrund af ovennævnte er CHMP af den opfattelse, at de oplysninger, der blev fremsendt til støtte for ansøgningen, ikke er i overensstemmelse med artikel 10 i direktiv 2001/83/EF med senere ændringer.
English: Scientific conclusions and grounds for suspension of the marketing authorisation(s) presented by the EMA
Danish: Videnskabelige konklusioner og begrundelser for suspendering af markedsføringstilladelse(rne) fremlagt af EMA
English: Overall summary of the scientific evaluation of Goserelin cell pharm 3,6 mg Implantat and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Goserelin cell pharm 3,6 mg implantat og relaterede navne (se bilag I)
English: These included insufficient validation of the bioanalytical methods, deletion of raw data by re-injection of samples, inconsistent manual reintegration of chromatograms, lack of crucial acceptance criteria for analyses and an insufficient quality management by the sponsor.
Danish: Der var tale om utilstrækkelig godkendelse af de bioanalytiske metoder, sletning af rådata ved reinjektion af prøver, inkonsekvent manuel reintegration af kromatogrammer, manglende fundamentale acceptkriterier for analyser og utilstrækkelig kvalitetsstyring fra sponsors side.
English: In view of the number and the seriousness of the deficiencies, the extent of deviations of the measured serum concentrations of both, goserelin and testosterone from the actual concentrations, cannot be estimated.
Danish: I lyset af antallet og alvoren af manglerne kan omfanget af afvigelserne af de målte serumkoncentrationer af både goserelin og testosteron fra de faktiske koncentrationer ikke estimeres.
English: Since testosterone levels measured were either below or close to limit of quantitation (0.1 ng/ml) and clearly below the castration level of 0.5 ng/ml clinical efficacy is ensured even if the analytical method is not sufficiently precise.
Danish: Da de målte testosteronniveauer enten lå under eller tæt på kvantificeringsgrænsen (0,1 ng/ml) og klart under kastrationsniveauet på 0,5 ng/ml, er den kliniske virkning sikker, også selvom analysemetoden ikke er tilstrækkeligt præcis.
English: Important aspects such as the difficulty of endogeneous testosterone levels in female blank plasma were only considered in the retrospective validation report with additional testing on either pre-treated or pre-selected matrix.
Danish: Vigtige aspekter som vanskeligheden ved endogene testosteronniveauer i blankplasma fra kvinder blev kun overvejet i den retrospektive godkendelsesrapport med yderligere test af enten forbehandlet eller forvalgt matrix.
English: • comparable AUC of testosterone after sufficient treatment days for MAH's product and comparator
Danish: • sammenlignelig AUC for testosteron efter tilstrækkelige behandlingsdage for indehaveren af markedsføringstilladelsens lægemiddel og sammenligningslægemidlet
English: It was the aim of the inspection to verify whether the clinical studies GOS/001/C and GOS/002/C were conducted in compliance with GCP and applicable regulations and whether the validity and quality of the submitted data are adequate.
Danish: Formålet med inspektionen var at verificere, om de kliniske undersøgelser GOS/001/C og GOS/002/C var gennemført i overensstemmelse med GCP og gældende regler, og om gyldigheden og kvaliteten af de indsendte data er tilstrækkelig.
English: The main objective of a method validation is to demonstrate the reliability of a particular method for the determination of an analyte concentration in a specific bioanalytical matrix and should appropriately be performed before analysis of study/subject samples.
Danish: Hovedformålet med en metodegodkendelse er at vise pålideligheden ved en bestemt metode med henblik på at bestemme en analytkoncentration i en specifik bioanalytisk matrix, og den skal udføres korrekt, før prøver fra en undersøgelse/deltager analyseres.
English: • The Committee agreed that the bioanalytical studies submitted by the MAHs were not conducted in accordance with GCP as required by Annex I of Directive 2001/83/EC as amended and the nature of the findings is such that the conduct of the studies and their results cannot be relied on to maintain the marketing authorisation.
Danish: • Udvalget var enigt i, at de bioanalytiske undersøgelser, som blev indsendt af indehaverne af markedsføringstilladelsen, ikke var gennemført i henhold til GCP som foreskrevet i bilag I til direktiv 2001/83/EF med senere ændringer, og fundene er af en sådan karakter, at undersøgelsernes tilrettelæggelse og deres resultater ikke udgør et pålideligt grundlag for at opretholde markedsføringstilladelsen.
English: The performance of a GCP-valid clinical and bioanalytical study is required to support application under such legal basis.
Danish: Der kræves en klinisk og bioanalytisk undersøgelse udført i overensstemmelse med GCP til støtte for en ansøgning på et sådant juridisk grundlag.
English: Critical violations of fundamental standards of ICH GCP and internationally accepted laboratory standards during the bioanalytical analyses of the blood samples from both GOS/001 (1-month depot formulation) and GOS/002 (1 and 3-month depot formulation) were uncovered.
Danish: Der blev fundet kritiske overtrædelser af grundlæggende ICH GCPstandarder og internationalt anerkendte laboratoriestandarder under de bioanalytiske analyser af blodprøverne fra både GOS/001 (1-måneds depotformulering) og GOS/002 (1- og 3-måneders depotformulering).
English: • The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Goserelin cell pharm 3,6 mg Implantat and associated names as listed in Annex I.
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 36 i direktiv 2001/83/EF for Goserelin cell pharm 3,6 mg implantat og relaterede navne som anført i bilag 1.
English: During the evaluation of the marketing authorisation application of some goserelin-containing medicinal products inconsistencies were recognised (e.g. assignment of patients to blood samples unclear).
Danish: Under vurderingen af ansøgningen om markedsføringstilladelse for visse goserelinholdige lægemidler fandt man nogle uregelmæssigheder (f.eks. uklarhed om tildeling af patienter til blodprøver).
English: Therefore, neither the comparative study design nor the cited results of the study can compensate for the breach of the legal requirements to provide GCPcompliant studies in support of a MAA.
Danish: Derfor kan hverken det komparative undersøgelsesdesign eller de anførte resultater kompensere for overtrædelsen af de juridiske krav til at levere undersøgelser, som overholder GCP, til støtte for en ansøgning om markedsføringstilladelse.
English: In view of all these facts the MAH requested the CHMP to confirm the acceptability of the existing clinical package for goserelin and maintain the marketing authorization for the concerned products.
Danish: I lyset af alle disse kendsgerninger anmodede indehaveren af markedsføringstilladelsen CHMP om at bekræfte, at den eksisterende kliniske pakke for goserelin er acceptabel, og opretholde markedsføringstilladelsen for de berørte lægemidler.
English: The contract laboratory performed the analysis of the plasma samples for the clinical studies GOS/001/C and GOS/002/C.
Danish: Kontraktlaboratoriet udførte analysen af plasmaprøverne til de kliniske undersøgelser GOS/001/C og GOS/002/C.
English: Due to the observed critical and major findings in the studies GOS/001/C and GOS/002/C, a GCP compliant conduct could not be confirmed.
Danish: På grund af de observerede kritiske og større fund i undersøgelserne GOS/001/C og GOS/002/C kan adfærd i overensstemmelse med GCP ikke bekræftes.
English: The Committee further considers that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and that, in these circumstances, the marketing of the product constitutes a risk to public health.
Danish: CHMP mener desuden ikke, at det på grundlag af de data, som var fremsendt til støtte for denne ansøgning, var muligt at fastslå et positivt benefit/risk-forhold for dette lægemiddel, og at markedsføringen af lægemidlet under disse omstændigheder udgør en risiko for folkesundheden.
English: Based on the totality of data submitted, the CHMP considered that therapeutic equivalence with Zoladex had not been demonstrated and as such the benefit risk ratio for this generic product was considered negative until the MAH can demonstrate therapeutic equivalence with the reference product.
Danish: På baggrund af de samlede indsendte data var CHMP af den opfattelse, at den terapeutiske ækvivalens med Zoladex ikke er påvist, og at benefit/risk-forholdet for dette generiske lægemiddel var negativt, indtil indehaveren af markedsføringstilladelsen kan påvise terapeutisk ækvivalens med referencelægemidlet.
English: The MAH believes that the impact of these analytical findings on the conclusions of the clinical studies is limited, because clinical efficacy in both studies is based on a comparison of testosterone levels attained during treatment for the MAH's product and the comparator drug.
Danish: Indehaveren af markedsføringstilladelsen mener, at konsekvenserne af disse analysefund i forhold til konklusionerne er begrænsede, da den kliniske virkning i begge undersøgelser er baseret på testosteronniveauer, som opnås under behandling for indehaveren af markedsføringstilladelsens lægemiddel og sammenligningslægemidlet.
English: The results of these studies were submitted in a number of marketing authorisation applications of goserelin-containing generic medicinal products to demonstrate therapeutic equivalence with the reference product Zoladex in the course of a MAA under Article.
Danish: Resultaterne af disse undersøgelser blev indsendt i en række ansøgninger om markedsføringstilladelse for generiske goserelinholdige lægemidler for at påvise den terapeutiske ækvivalens med referencelægemidlet Zoladex i forbindelse med en ansøgning om markedsføringstilladelse i henhold til artikel 10, stk. 3, dvs. en hybridansøgning.
English: The MAH agreed with the authorities that GCP violations have happened at the bioanalytical testing facility of the contract laboratory and has taken extensive measures to correct these facts for future clinical trials.
Danish: Indehaveren af markedsføringstilladelsen var enig med myndighederne i, at der er sket GCPovertrædelser på kontraktlaboratoriets bioanalytiske testanlæg, og indehaveren af markedsføringstilladelsen har iværksat omfattende foranstaltninger for at korrigere dette inden fremtidige kliniske undersøgelser.
English: Analytical inadequacies would affect comparator and MAH's product in the same way: Since the clinical efficacy was based on a comparison between two products analytical errors would be expected to affect both products in the same way.
Danish: Da den kliniske virkning var baseret på en sammenligning mellem to lægemidler, ville analysefejl forventes at påvirke begge lægemidler på samme måde.
English: Invented Name Strength Pharmaceutical Form
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: 3 pre-filled pens
Danish: 3 fyldte penne
English: 3 pre-filled syringes
Danish: 3 fyldte injektionssprøjter
English: This summary was last updated in October 2017.
Danish: Dette sammendrag blev sidst ajourført i oktober 2017.
English: There are no known side effects.
Danish: Der er ingen kendte bivirkninger.
English: Vaccination campaigns are conducted normally twice a year in spring and autumn for consecutive years, until at least 2 years after the last confirmed case of rabies in the area.
Danish: Vaccinationskampagner gennemføres normalt to gange om året (forår og efterår) i flere år i træk indtil mindst to år efter det seneste bekræftede tilfælde af rabies i området.
English: The protection against the virus lasts at least 6 months.
Danish: Beskyttelsen mod virussen varer i mindst 6 måneder.
English: The full EPAR for Rabitec can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Rabitec findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Protection lasts at least 6 months after vaccination.
Danish: Beskyttelsen varer i mindst 6 måneder efter vaccineringen.
English: This is a summary of the European public assessment report (EPAR) for Rabitec.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rabitec.
English: The European Commission granted a marketing authorisation valid throughout the EU for Rabitec on 1 December 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rabitec den 01/12/2017.
English: Laboratory studies showed that around 90% of foxes and raccoon dogs produce antibodies against the rabies virus within 15 days of eating the bait.
Danish: Laboratorieundersøgelser har vist, at ca. 90 % af rævene og mårhundene danner antistoffer mod rabiesvirussen inden for 15 dage efter at have spist lokkemaden.
English: Rabitec is a vaccine.
Danish: Rabitec er en vaccine.
English: The baits are distributed by land or air and the vaccination area should be larger than 5,000 km2.
Danish: Lokkemadsenhederne udlægges på jorden eller fra luften, og vaccinationsområdet bør være større end 5 000 km2.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Rabitec's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Rabitec opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.