FrancophonIA/ELRC3.0 huggingface dataset:
English: The Concerned Member States considered that the authorisation of Combisyn may present a potential serious risk to human and animal health since the safety and efficacy of the product had not been sufficiently demonstrated.
Danish: De berørte medlemsstater var af den opfattelse, at godkendelsen af Combisyn kunne udgøre en potentiel alvorlig risiko for menneskers og dyrs sundhed, eftersom lægemidlets sikkerhed og virkning ikke var blevet tilstrækkeligt påvist.
English: Therefore the CVMP concluded that the particulars submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC and recommended the refusal of granting the Marketing Authorisation in the Concerned Member States and the suspension of the existing Marketing Authorisation in the Reference Member State.
Danish: CVMP konkluderede således, at de oplysninger, der er fremsendt til støtte for ansøgningen, ikke er i overensstemmelse med artikel 13 i direktiv 2001/82/EF, og anbefalede afslag på ansøgningen om markedsføringstilladelse i de berørte medlemsstater og suspendering af den eksisterende markedsføringstilladelse i referencemedlemsstaten.
English: The applicant presented comparative viscosity data between the ‘old' and ‘new' formulations of Combisyn.
Danish: Ansøgeren fremlagde komparative viskositetsdata for de "gamle" og de "nye" formuleringer af Combisyn.
English: • the proposed withdrawal period for Combisyn was insufficiently substantiated;
Danish: • den foreslåede tilbageholdelsestid for Combisyn var utilstrækkeligt dokumenteret;
English: A residue depletion study in milk should be performed in accordance with the ‘Note for guidance for the determination of withdrawal periods for milk' (EMEA/CVMP/473/98-FINAL)
Danish: Der bør foretages en restkoncentrationsundersøgelse for mælk i henhold til vejledningen om fastlæggelse af tilbageholdelsestider for mælk, "Note for guidance for the determination of withdrawal periods for milk" (EMEA/CVMP/473/98-FINAL).
English: Overall summary of the scientific evaluation of Combisyn Lactating Cow Intramammary Suspension
Danish: Samlet resumé af den videnskabelige vurdering af Combisyn Lactating Cow Intramammary Suspension
English: It was concluded that the data set and statistical analyses used to extrapolate the proposed withdrawal period to 120 hours were flawed and did not provide an adequate basis upon which to derive a withdrawal period.
Danish: Det blev konkluderet, at det datasæt og de statistiske analyser, der blev anvendt til at ekstrapolere den foreslåede tilbageholdelsestid på 120 timer, var fejlagtige og ikke gav et tilstrækkeligt grundlag at fastsætte en tilbageholdelsestid ud fra.
English: During the procedure, there was disagreement between the Reference Member State and Concerned Member States on the applicability of demonstrating systemic bioequivalence for a locally-applied, locally-acting product, as well as an additional concern on the adequacy of the proposed withdrawal period.
Danish: Under proceduren opstod der uenighed mellem referencemedlemsstaten og de berørte medlemsstater om relevansen af at påvise systemisk bioækvivalens for et lokalt anvendt og lokalt virkende lægemiddel samt yderligere betænkeligheder med hensyn til tilstrækkeligheden af den foreslåede tilbageholdelsestid.
English: • 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.
Danish: • på baggrund af de data, der er fremsendt til støtte for denne ansøgning, er det ikke muligt at fastlægge et positivt risk/benefit-forhold for dette lægemiddel.
English: The dissolution data in particular were inconclusive due to limitations of the study design.
Danish: Navnlig opløsningsdataene var ikke fyldestgørende, hvilket skyldtes begrænsninger i forsøgets tilrettelæggelse.
English: At the time of initial authorisation, the difficulties of attempting to demonstrate bioequivalence of intramammary preparations were less well known and the general principles applied by the applicant in conducting their package of pharmacokinetic studies were accepted.
Danish: På tidspunktet for den første godkendelse var vanskelighederne med at påvise bioækvivalens for intramammære præparater mindre velkendte, og de generelle principper, som ansøgeren anvendte ved gennemførelsen af sine farmakokinetiske undersøgelser, blev accepteret.
English: The plasma data showed that, overall, the confidence intervals were within the acceptance limits for amoxicillin and prednisolone.
Danish: Plasmadataene viste, at konfidensintervallerne samlet set lå inden for acceptgrænserne for amoxicillin og prednisolon.
English: An additional issue reviewed by the CVMP was a change in the formulation of Combisyn during development to increase the stability of the product, which was identified as potentially affecting the release of the active substances from the product into the tissue.
Danish: Et yderligere spørgsmål, som CVMP gennemgik, var en ændring i formuleringen af Combisyn under udviklingen for at øge lægemidlets stabilitet, hvilket blev identificeret som havende en potentiel indflydelse på de aktive stoffers frigivelse fra lægemidlet og ind i vævet.
English: Furthermore, the applicant contended that milk was not excluded from the CVMP guideline for the conduct of bioequivalence studies (reference in section 5.1 to “other biological fluid”).
Danish: Desuden fremførte ansøgeren det argument, at mælk ikke var udelukket fra CVMP's retningslinjer for udførelsen af bioækvivalensundersøgelser (henvisningen til "anden biologisk væske" i punkt 5.1).
English: • the data submitted in support of this application failed to show that bioequivalence had been demonstrated by appropriate bioavailability studies between the test and reference products;
Danish: • de data, der er fremsendt til støtte for denne ansøgning, ikke viste, at der var blevet påvist bioækvivalens ved hjælp af passende biotilgængelighedsundersøgelser for testlægemidlet og referencelægemidlet;
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisation(s)
Danish: Videnskabelige konklusioner og begrundelser for afslag på ansøgningen om markedsføringstilladelse(r)
English: It was concluded that, although Combisyn was shown to be similar to the reference product with respect to formulation, particle size and viscosity, this could only be seen as supportive in this case and could not substitute clinical studies to demonstrate efficacy.
Danish: Det blev konkluderet, at selv om det var påvist, at Combisyn er identisk med referencelægemidlet, når det gælder formulering, partikelstørrelse og viskositet, kunne dette kun betragtes som underbyggende i dette tilfælde og ikke erstatte kliniske undersøgelser for at dokumentere virkningen.
English: Three comparative pharmacokinetic studies were carried out with Combisyn and the reference product, all with a two-period cross-over design.
Danish: Der blev foretaget tre komparative farmakokinetiske undersøgelser med Combisyn og referencelægemidlet, alle med et toperiodes overkrydsningsdesign.
English: Applicant/ Marketing Authorisation Holder
Danish: Ansøger/ indehaver af markedsføringstilladelse
English: Thus the current bioequivalence guidelines were not intended to apply to intramammary products as it is unclear to what extent a certain kinetic profile in milk correlates to behaviour at the site of action.
Danish: De nuværende retningslinjer for bioækvivalens var således ikke beregnet på at gælde for intramammære lægemidler, eftersom det er uklart, i hvilket omfang en vis kinetisk profil for mælk hænger sammen med adfærden på virkningsstedet.
English: The main principle behind bioequivalence is to compare the rate and extent of exposure so sampling cannot be made from the same compartment as administration and excretion.
Danish: Grundprincippet bag bioækvivalens er, at man sammenligner eksponeringens hastighed og omfang, så prøvetagning kan ikke ske fra samme område som indgivelse og udskillelse.
English: Recommended dose, frequency and route of administration
Danish: Anbefalet dosis, doseringshyppighed og indgivelsesvej
English: Appropriate clinical data should be provided to confirm the efficacy of Combisyn Lactating Cow Intramammary Suspension.
Danish: Der skal fremlægges tilstrækkelige kliniske data for at dokumentere virkningen af Combisyn Lactating Cow Intramammary Suspension.
English: The dose-limiting pathogen is penicillinase-producing Staphylococcus aureus.
Danish: Det dosisbegrænsende patogen er penicillinaseproducerende Staphylococcus aureus.
English: When preparing the approach used to investigate similarity in terms of efficacy for Combisyn, the applicant had not pursued conducting comparative clinical studies since it was expected that clinical trials would not be sensitive enough to pick up differences between Combisyn and the reference product.
Danish: Ved tilrettelæggelsen af den tilgang, der skulle anvendes til at undersøge, om Combisyn havde samme virkning, havde ansøgeren ikke foretaget komparative kliniske undersøgelser, eftersom det forventedes, at de kliniske undersøgelser ikke ville være følsomme nok til at spore forskellene mellem Combisyn og referencelægemidlet.
English: Combisyn is intended for the treatment of mastitis in lactating cows caused by the major pathogens commonly occurring from the bovine udder (Staphylococci, Streptococci and Escherichia coli).
Danish: Combisyn er beregnet til behandling af mastitis hos diegivende kvæg, som er forårsaget af de væsentligste patogener, der almindeligvis forekommer i kvægs yver (Staphylococci, Streptococci og Escherichia coli).
English: As a result of this data showing that the MRL was exceeded at timepoints beyond the withdrawal period, the applicant proposed a new withdrawal period of 120 hours, based on statistical extrapolation of their comparative data in milk.
Danish: Som et resultat af disse data, der viste, at maksimalgrænseværdien blev overskredet på tidspunkter efter tilbageholdelsestiden, foreslog ansøgeren en ny tilbageholdelsestid på 120 timer baseret på en statistisk ekstrapolering af ansøgerens komparative data for mælk.
English: When asked to further substantiate this claim, the applicant provided comparative data on the physico-chemical characteristics of the product, including viscosity, particle size and dissolution in milk, between Combisyn and the reference product.
Danish: Da ansøgeren blev bedt om at underbygge denne påstand yderligere, fremlagde ansøgeren komparative data om lægemidlets fysisk-kemiske karakteristika, herunder viskositet, partikelstørrelse og opløsning i mælk, for så vidt angår Combisyn og referencelægemidlet.
English: The results of the milk studies demonstrated that the concentrations of the active substances were similar to those of the reference product following the intramammary infusion of Combisyn, although it was noted that there was considerable inter-quarter and inter-animal variability in each of the pharmacokinetic parameters measured.
Danish: Resultaterne af mælkeundersøgelserne viste, at koncentrationerne af de aktive stoffer svarede til koncentrationerne i referencelægemidlet efter intramammær infusion of Combisyn, selv om der var betydelig variabilitet mellem områderne og mellem dyrene for hvert af de målte farmakokinetiske parametre.
English: Combisyn Lactating Cow Intramammary Suspension (hereinafter referred to as Combisyn) is an intramammary suspension containing amoxicillin (as amoxicillin trihydrate), clavulanic acid (as potassium clavulanate) and prednisolone.
Danish: Combisyn Lactating Cow Intramammary Suspension (herefter kaldet Combisyn) er en intramammær suspension, der indeholder amoxicillin (som amoxicillintrihydrat), clavulansyre (som kaliumclavulanat) og prednisolon.
English: Clavulanic acid, a naturally-occurring substance is a beta-lactamase inhibitor and chemical synergist for amoxicillin.
Danish: Clavulansyre, som er et naturligt forekommende stof, er en beta-lactamasehæmmer og en kemisk synergist for amoxicillin.
English: Grounds for refusal of the granting of the marketing authorisations and suspension of the existing marketing authorisation
Danish: Begrundelser for afslag på ansøgningen om markedsføringstilladelser og suspendering af den eksisterende markedsføringstilladelse
English: A design of non-inferiority to the reference product should be considered, with particular attention to assay sensitivity (e.g. a three-arm study with placebo).
Danish: Det bør overvejes at anvende et undersøgelsesdesign, hvor der tages højde for non-inferioritet sammenlignet med referencelægemidlet, idet der lægges særlig vægt på analysesensitivitet (f.eks. en trearmet undersøgelse med placebo).
English: Consequently the applicant argued that in vivo comparative pharmacokinetic data in milk and plasma was an appropriate approach for the investigation of bioequivalence for an intramammary product.
Danish: Ansøgeren hævdede derfor, at komparative farmakokinetiske in vivo-data for mælk og plasma var en passende tilgang til undersøgelsen af et intramammært lægemiddels bioækvivalens.
English: A tolerance study was presented to evaluate the safety of the product in lactating cows.
Danish: Der blev fremlagt en toleranceundersøgelse for at evaluere lægemidlets sikkerhed og virkning hos diegivende køer.
English: Amoxicillin is a semi-synthetic aminopenicillin with broad-spectrum bactericidal activity.
Danish: Amoxicillin er et semisyntetisk aminopenicillin med en bredspektret baktericid virkning.
English: There was discussion by the CVMP on applying the same pharmacokinetic parameters from classical plasma bioequivalence studies to comparative data in milk.
Danish: CVMP drøftede anvendelsen af de samme farmakokinetiske parametre fra klassiske plasmabioækvivalensundersøgelser på de komparative data for mælk.
English: This study also served to provide data on the residues of amoxicillin and clavulanic measured in the (udder) quarter milk samples obtained at regular timepoints after infusion of Combisyn and the reference product.
Danish: Denne undersøgelse tog også sigte på at give data om resterne af amoxicillin og clavulansyre i mælkeprøver fra (yver)området, der blev taget på regelmæssige tidspunkter efter infusion af Combisyn og referencelægemidlet.
English: Regarding residues, the data from the comparative milk studies showed that, at the timepoint corresponding to the proposed withdrawal period of 60 hours, all quarter milk samples had concentrations of amoxicillin above the MRL for milk (4 µg/kg) and a proportion of the milk samples contained clavulanic acid at or above the MRL for milk of 200 µg/kg.
Danish: Hvad resterne angår, viste dataene fra de komparative mælkeundersøgelser, at på det tidspunkt, der svarer til den foreslåede tilbageholdelsestid på 60 timer, havde alle områdemælkeprøver amoxicillinkoncentrationer over maksimalgrænseværdien for mælk (4 µg/kg), og en del af mælkeprøverne indeholdt clavulansyre på eller over maksimalgrænseværdien for mælk på 200 µg/kg.
English: The applicant further claimed that the formulation of Combisyn was sufficiently similar to the reference product to allow a waiver from the need to present in vivo data.
Danish: Ansøgeren fremførte endvidere, at Combisyns formulering lignede referencelægemidlets formulering så meget, at det muliggjorde en dispensation fra kravet om at fremlægge in vivo-data.
English: Grounds for the lifting of the suspension of the Marketing Authorisation
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen
English: • A comparative plasma study was carried out to measure plasma concentrations of amoxicillin, clavulanate and prednisolone following intramammary infusion.
Danish: • Der blev foretaget en komparativ plasmaundersøgelse for at måle plasmakoncentrationerne af amoxicillin, clavulanat og prednisolon efter intramammær infusion.
English: • A comparative milk study was carried out to measure milk concentrations of prednisolone following intramammary infusion.
Danish: • Der blev foretaget en komparativ mælkeundersøgelse for at måle mælkekoncentrationerne af prednisolon efter intramammær infusion.
English: • A comparative milk study was carried out to measure milk concentrations of amoxicillin and clavulanic acid.
Danish: • Der blev foretaget en komparativ mælkeundersøgelse for at måle mælkekoncentrationerne af amoxicillin og clavulansyre.
English: In support of Combisyn, studies were submitted to compare milk and plasma pharmacokinetics between the generic and reference products.
Danish: Til støtte for Combisyn blev der fremsendt undersøgelser, hvor man sammenlignede det generiske lægemiddels og referencelægemidlets farmakokinetik for mælk og plasma.
English: Combisyn is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route.
Danish: Combisyn fås i dosissprøjter som en oliesuspension, der skal indgives intramammært.
English: At the last sampling timepoint (108 hours), half of the quarter milk samples had amoxicillin concentrations above the MRL. All quarter milk samples from 84 hours onwards had clavulanic acid concentrations below the milk MRL. For prednisolone, the data showed that the levels were well below the milk MRL of 6 µg/kg from 24 hours onwards.
Danish: På det seneste prøvetagningstidspunkt (108 timer) havde halvdelen af områdemælkeprøverne amoxicillinkoncentrationer over maksimalgrænseværdien.
English: Pharmaceutical form
Danish: Særnavn Lægemiddelform Styrke(r)
English: Baraclude is taken once a day.
Danish: Baraclude tages én gang dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Baraclude on 26 June 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Baraclude den 26. juni 2006.
English: This can happen during the treatment, or after it has been stopped.
Danish: Dette kan ske under behandlingen eller efter behandlingens ophør.
English: The full EPAR for Baraclude can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Baraclude findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Baraclude.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Baraclude.
English: The treatment duration is determined by how the patient responds.
Danish: Behandlingens varighed afhænger af, hvordan patienten reagerer.
English: A risk management plan has been developed to ensure that Baraclude is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Baraclude anvendes så sikkert som muligt.
English: Patients also need to know that they may also suffer a worsening of their liver disease.
Danish: Patienterne skal også vide, at leversygdommen kan forværres.
English: When treatment is considered appropriate in children, the dose depends on their body weight.
Danish: Når behandling anses for hensigtsmæssig for børn, afhænger dosis af legemsvægten.
English: Other information about Baraclude
Danish: Andre oplysninger om Baraclude
English: (a nucleoside analogue, such as lamivudine).
Danish: nukleosidanalog såsom lamivudin).
English: It is available as tablets (0.5 mg and 1 mg) and as an oral solution (0.05 mg/ml).
Danish: Det leveres som tabletter (0,5 mg og 1 mg) og som oral opløsning (0,05 mg/ml).
English: What measures are being taken to ensure the safe and effective use of Baraclude?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Baraclude?
English: Children weighing less than 32.6 kg should be given the oral solution, while those weighing 32.6 kg and above can also be given the 0.5 mg tablets.
Danish: Børn, der vejer mindre end 32,6 kg, skal have den orale opløsning, mens børn, der vejer mere end 32,6 kg, også kan få 0,5 mg-tabletter.
English: The decision to start a child on treatment should be based on careful consideration of their individual needs, as not all children with chronic hepatitis B infection require treatment.
Danish: Beslutningen om at indlede behandling af et barn bør baseres på nøje overvejelse af barnets individuelle behov, og ikke alle børn med kronisk hepatitis B-infektion behøver behandling.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Baraclude.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Baraclude skal anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Baraclude, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Baraclude, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Two of the studies were carried out in 1,363 patients who had not been treated with nucleoside analogues before.
Danish: To af undersøgelserne blev gennemført med 1 363 patienter, som ikke tidligere var blevet behandlet med nukleosidanaloger.
English: The most common side effects seen with Baraclude are headache (seen in 9% of patients), fatigue (tiredness, 6%), dizziness (4%) and nausea (feeling sick, 3%).
Danish: De hyppigste bivirkninger ved Baraclude er hovedpine (som optræder hos 9 % af patienterne), træthed (6 %), svimmelhed (4 %) og kvalme (3 %).
English: For more information about treatment with Baraclude, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Baraclude, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is used in adults with signs of ongoing liver injury (such as inflammation and fibrosis) when the liver is still working properly (compensated liver disease) and also when the liver is no longer working properly (decompensated liver disease).
Danish: Det anvendes hos voksne med tegn på aktiv leversygdom (såsom inflammation og fibrose), når leveren stadig fungerer korrekt (kompenseret leversygdom), men også når leveren ikke længere virker korrekt (dekompenseret leversygdom).
English: This study looked at the reduction in viral DNA in the blood after 24 weeks.
Danish: I denne undersøgelse så man nærmere på faldet i viralt DNA i blodet efter 24 uger.
English: It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Danish: Det kan derudover overvejes at anvende lægemidlet til børn mellem 2 og 8 år, men kun ved kompenseret leversygdom.
English: The CHMP concluded that Baraclude's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Baraclude opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Baraclude.
English: Baraclude is an antiviral medicine that contains the active substance entecavir.
Danish: Baraclude er et antiviralt lægemiddel, der indeholder det aktive stof entecavir.
English: Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Danish: Entecavir standser virussets DNA-produktion og forebygger dermed dets formering og spredning.
English: The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
Danish: Dosen 1 mg anvendes desuden hos voksne med dekompenseret leversygdom, og det frarådes at ophøre med behandlingen hos sådanne patienter.
English: For the full list of side effects and restrictions with Baraclude, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Baraclude fremgår af indlægssedlen.