FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevnimi državami članicami glede uporabnosti dokazovanja sistemske biološke enakovrednosti za lokalno uporabljeno in lokalno delujoče zdravilo, pojavili pa so se tudi dodatni zadržki glede ustreznosti predlagane karence.
English: The CVMP was asked to give its opinion on the concerns raised by the Concerned Member States and to conclude on the benefit/risk balance for Combisyn.
Slovenian: CVMP je bil naprošen, da poda mnenje v zvezi z zadržki, ki so jih izrazile zadevne države članice, in sprejme sklep glede razmerja med tveganji in koristmi za zdravilo Combisyn.
English: Overall summary of the scientific evaluation of Combisyn Lactating Cow Intramammary Suspension
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Combisyn Lactating Cow Intramammary Suspension
English: This study also served to provide data on the residues of this active substance.
Slovenian: S to študijo so dobili tudi podatke o ostankih te zdravilne učinkovine.
English: The plasma data showed that, overall, the confidence intervals were within the acceptance limits for amoxicillin and prednisolone.
Slovenian: Podatki o plazmi so pokazali, da so bili na splošno intervali zaupanja v mejah sprejemljivosti za amoksicilin in prednizolon.
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.
Slovenian: • Na podlagi predloženih podatkov v podporo vlogi ni mogoče določiti pozitivnega razmerja med tveganji in koristmi za to zdravilo.
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.
Slovenian: Veljavne smernice za biološko enakovrednost tako niso bile namenjene uporabi v zvezi z intramamarnimi zdravili, saj ni jasno, v kolikšni meri je določen kinetični profil v mleku soodvisen od odziva na mestu delovanja.
English: Appropriate clinical data should be provided to confirm the efficacy of Combisyn Lactating Cow Intramammary Suspension.
Slovenian: Predložiti je treba ustrezne klinične podatke za potrditev učinkovitosti zdravila Combisyn Lactating Cow Intramammary Suspension.
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;
Slovenian: • Podatki, predloženi v podporo tej vlogi, niso pokazali, da je bila z ustreznimi študijami biološke razpoložljivosti dokazana biološka enakovrednost med preskušanim in referenčnim zdravilom.
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.
Slovenian: Ugotovljeno je bilo, da so bili podatki in statistične analize, ki so jih uporabili za ekstrapolacijo predlagane karence na 120 ur, pomanjkljivi in niso zagotovili ustrezne podlage za določitev karence.
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.
Slovenian: Dodatno vprašanje, ki ga je CVMP preučil, je bila sprememba formulacije zdravila Combisyn med razvojem, s čimer so želeli povečati stabilnost zdravila in za kar je bilo ugotovljeno, da bi lahko vplivalo na sproščanje zdravilne učinkovine iz zdravila v tkivo.
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.
Slovenian: Sklenjeno je bilo, da je bilo sicer dokazano, da je zdravilo Combisyn podobno referenčnemu zdravilu glede formulacije, velikosti delcev in viskoznosti, vendar pa so v tem primeru to lahko le podporni podatki in ne morejo nadomestiti kliničnih študij za dokazovanje učinkovitosti.
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.
Slovenian: Glavno načelo biološke enakovrednosti je primerjava stopnje in obsega izpostavljenosti, tako da se vzorčenje ne more izvajati na istem mestu, kot se zdravilo daje in izloča.
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisation(s)
Slovenian: Znanstveni zaključki in podlaga za zavrnitev odobritve dovoljenj(a) za promet z zdravilom
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.
Slovenian: Predlagatelj pri pripravi pristopa, ki ga je uporabil za preučevanje podobnosti v zvezi z učinkovitostjo zdravila Combisyn, ni izvedel primerjalnih kliničnih študij, saj je bilo pričakovano, da klinični preskusi ne bodo dovolj občutljivi, da bi odkrili razlike med zdravilom Combisyn in referenčnim zdravilom.
English: There was discussion by the CVMP on applying the same pharmacokinetic parameters from classical plasma bioequivalence studies to comparative data in milk.
Slovenian: V CVMP je potekala razprava o uporabi enakih farmakokinetičnih parametrov iz klasičnih študij biološke enakovrednosti plazme pri primerjalnih podatkih za mleko.
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.
Slovenian: Predlagatelj je trdil tudi, da je formulacija zdravila Combisyn dovolj podobna referenčnemu zdravilu, da dopušča opustitev potrebe po predstavitvi podatkov in vivo.
English: The dissolution data in particular were inconclusive due to limitations of the study design.
Slovenian: Dokončne zaključke so zaradi omejitev pri načrtovanju študije onemogočali predvsem podatki o raztapljanju.
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.
Slovenian: Rezultati študij pri mleku so pokazali, da so bile koncentracije zdravilne učinkovine po intramamarni infuziji zdravila Combisyn podobne kot pri referenčnem zdravilu, čeprav je bilo ugotovljeno, da so se pri vsakem merjenem farmakokinetičnem parametru pojavljale bistvene razlike med četrtinami in živalmi.
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).
Slovenian: Zdravilo Combisyn je namenjeno zdravljenju mastitisa pri kravah v obdobju laktacije, ki ga povzročajo poglavitni patogeni, ki se običajno pojavljajo na vimenu govedi (stafilokoki, streptokoki in Escerichia coli).
English: The dose-limiting pathogen is penicillinase-producing Staphylococcus aureus.
Slovenian: Patogen, ki omejuje odmerek, je Staphylococcus aureus, ki proizvaja penicilinazo.
English: In support of Combisyn, studies were submitted to compare milk and plasma pharmacokinetics between the generic and reference products.
Slovenian: V podporo zdravilu Combisyn so bile predložene študije, v katerih so primerjali farmakokinetiko pri mleku in plazmi med generičnimi in referenčnimi zdravili.
English: Clavulanic acid, a naturally-occurring substance is a beta-lactamase inhibitor and chemical synergist for amoxicillin.
Slovenian: Klavulanska kislina, naravno prisotna snov, je zaviralec laktamaze beta in kemični sinergist za amoksicilin.
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.
Slovenian: Tako je predlagatelj zagovarjal stališče, da so primerjalni farmakokinetični podatki in vivo za mleko in plazmo ustrezen pristop za preučevanje biološke enakovrednosti intramamarnih zdravil.
English: Combisyn is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route.
Slovenian: Zdravilo Combisyn je na voljo v enoodmernih brizgah kot oljna suspenzija, ki se daje po intramamarni poti.
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.
Slovenian: Zdravilo Combisyn Lactating Cow Intramammary Suspension (v nadaljevanju zdravilo Combisyn) je intramamarna suspenzija, ki vsebuje amoksicilin (v obliki amoksicilin trihidrata), klavulansko kislino (v obliki kalijevega klavulanata) in prednizolon.
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.
Slovenian: S to študijo so dobili tudi podatke o ostankih amoksicilina in klavulanske kisline, izmerjenih v vzorcih mleka iz četrtin (vimen), ki so bili pridobljeni v rednih obdobjih po infundiranju zdravila Combisyn in referenčnega zdravila.
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.
Slovenian: V zvezi z ostanki so podatki iz primerjalnih študij pri mleku pokazali, da so bile v obdobju, ki ustreza predlagani karenci 60 ur, koncentracije amoksicilina v vzorcih mleka, vzetega iz vseh četrtin, nad mejno vrednostjo ostankov za mleko (4 µg/kg), del mlečnih vzorcev pa je tudi vseboval klavulansko kislino v mejni vrednosti ostankov za mleko, ki je 200 µg/kg, ali nad njo.
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.
Slovenian: Ko so od predlagatelja zahtevali, da to trditev podrobneje utemelji, je predložil primerjalne podatke med zdravilom Combisyn in referenčnim zdravilom o fizikalno-kemičnih lastnostih zdravila, vključno z viskoznostjo, velikostjo delcev in raztapljanjem v mleku.
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.
Slovenian: Zaradi teh podatkov, ki so pokazali, da so bile mejne vrednosti ostankov prekoračene v časovnih obdobjih, daljših od karence, je predlagatelj na podlagi statistične ekstrapolacije primerjalnih podatkov za mleko predlagal novo karenco 120 ur.
English: • the proposed withdrawal period for Combisyn was insufficiently substantiated;
Slovenian: • Predlagana karenca za zdravilo Combisyn ni bila ustrezno utemeljena.
English: A tolerance study was presented to evaluate the safety of the product in lactating cows.
Slovenian: Predstavili so študijo prenašanja za ocenjevanje varnosti zdravila pri kravah v obdobju laktacije.
English: Strengths
Slovenian: Jakosti
English: • A comparative plasma study was carried out to measure plasma concentrations of amoxicillin, clavulanate and prednisolone following intramammary infusion.
Slovenian: • Izvedena je bila primerjalna študija plazme, s katero so merili koncentracijo amoksicilina, klavulanata in prednizolona v plazmi po intramamarni infuziji.
English: Grounds for refusal of the granting of the marketing authorisations and suspension of the existing marketing authorisation
Slovenian: Podlaga za zavrnitev odobritve dovoljenja za promet z zdravilom in začasni umik obstoječih dovoljenj za promet z zdravilom
English: Grounds for the lifting of the suspension of the Marketing Authorisation
Slovenian: Podlaga za preklic začasnega umika dovoljenja za promet z zdravilom
English: • A comparative milk study was carried out to measure milk concentrations of amoxicillin and clavulanic acid.
Slovenian: • Izvedena je bila primerjalna študija mleka, s katero so merili koncentracijo amoksicilina in klavulanske kisline v mleku.
English: • A comparative milk study was carried out to measure milk concentrations of prednisolone following intramammary infusion.
Slovenian: • Izvedena je bila primerjalna študija mleka, s katero so merili koncentracijo prednizolona v mleku po intramamarni infuziji.
English: Three comparative pharmacokinetic studies were carried out with Combisyn and the reference product, all with a two-period cross-over design.
Slovenian: Izvedene so bile tudi tri navzkrižne primerjalne farmakokinetične študije z dvema obdobjema, v katerih so primerjali zdravilo Combisyn in referenčno zdravilo.
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.
Slovenian: V zadnjem obdobju vzorčenja (108 ur) je bila pri vzorcih mleka, vzetega iz polovice četrtin, koncentracija amoksicilina nad mejno vrednostjo ostankov.
English: Portugal
Slovenian: Ireland
English: The European Commission granted a marketing authorisation valid throughout the European Union for Baraclude on 26 June 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Baraclude, veljavno po vsej Evropski uniji, izdala 26. junija 2006.
English: Patients also need to know that they may also suffer a worsening of their liver disease.
Slovenian: Bolniki se morajo zavedati tudi, da lahko pride do poslabšanja njihove bolezni jeter.
English: Baraclude is taken once a day.
Slovenian: Zdravilo Baraclude se jemlje enkrat na dan.
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Baraclude je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The treatment duration is determined by how the patient responds.
Slovenian: Trajanje zdravljenja je odvisno od bolnikovega odziva.
English: What measures are being taken to ensure the safe and effective use of Baraclude?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Baraclude?
English: It is available as tablets (0.5 mg and 1 mg) and as an oral solution (0.05 mg/ml).
Slovenian: Na voljo je v obliki tablet (0,5 mg in 1 mg) in kot peroralna raztopina (0,05 mg/ml).
English: This can happen during the treatment, or after it has been stopped.
Slovenian: Do tega lahko pride med samim zdravljenjem ali po njem.
English: Baraclude entecavir
Slovenian: Baraclude entekavir
English: When treatment is considered appropriate in children, the dose depends on their body weight.
Slovenian: Kadar je zdravljenje ocenjeno kot primerno za otroke, je odmerek odvisen od njihove telesne mase.
English: It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Slovenian: Daje se lahko tudi otrokom v starosti od 2 do 18 let, vendar le tistim s kompenzirano boleznijo jeter.
English: Other information about Baraclude
Slovenian: Druge informacije o zdravilu Baraclude
English: This is a summary of the European public assessment report (EPAR) for Baraclude.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Baraclude.
English: The CHMP concluded that Baraclude's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Baraclude večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: A risk management plan has been developed to ensure that Baraclude is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Baraclude je bil pripravljen načrt obvladovanja tveganj.
English: What benefit has Baraclude shown during the studies?
Slovenian: Kakšne koristi je zdravilo Baraclude izkazalo med študijami?
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.
Slovenian: Otroci, ki tehtajo manj kot 32,6 kg, naj prejemajo peroralno raztopino, medtem ko se tistim, ki imajo 32,6 kg ali več, lahko dajejo tudi 0,5-miligramske tablete.
English: Two of the studies were carried out in 1,363 patients who had not been treated with nucleoside analogues before.
Slovenian: Dve od teh študij sta bili izvedeni pri 1 363 bolnikih, ki še niso bili zdravljeni z nukleozidnimi analogi.
English: The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal.
Slovenian: Bolnik lahko 0,5-miligramski odmerek jemlje s hrano ali brez nje, medtem ko mora 1-miligramski odmerek vzeti vsaj 2 uri pred obrokom ali 2 uri po njem.
English: For more information on the use of the medicine in children, see the summary of product characteristics (also part of the EPAR).
Slovenian: Več informacij o uporabi zdravila pri otrocih najdete v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: This study looked at the reduction in viral DNA in the blood after 24 weeks.
Slovenian: V tej študiji so proučevali zmanjšanje ravni virusne DNK v krvi po 24 tednih zdravljenja.
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.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
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%).
Slovenian: Najpogostejši neželeni učinki zdravila Baraclude so glavobol (opažen pri 9 % bolnikov), utrujenost (6 %), omotica (4 %) in slabost (3 %).
English: Viral suppression has also been shown in children.
Slovenian: Zavrtje virusa je bilo potrjeno tudi pri otrocih.
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.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Baraclude in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
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).
Slovenian: Uporablja se pri odraslih, ki kažejo znake okvare jeter (kot sta vnetje in fibroza), bodisi kadar jetra še delujejo pravilno (kompenzirana bolezen jeter) bodisi kadar ta ne delujejo več pravilno (dekompenzirana bolezen jeter).
English: For more information about treatment with Baraclude, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Baraclude preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Slovenian: Entekavir virusu onemogoči, da bi tvoril DNK, s čimer prepreči njegovo razmnoževanje in širjenje.
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.
Slovenian: Odločitev za uvedbo zdravljenja pri otroku mora temeljiti na tehtnem premisleku o posameznikovih potrebah, saj zdravljenje ni potrebno pri vseh otrocih s kronično okužbo z virusom hepatitisa B.
English: Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose.
Slovenian: Bolnikom, ki še niso bili zdravljeni z nukleozidnim analogom, se daje 0,5-miligramski odmerek, medtem ko se bolnikom, ki so pred tem že prejemali zdravilo lamivudin, a se okužba pri njih nanj več ne odziva, daje 1-miligramski odmerek.
English: What is the risk associated with Baraclude?
Slovenian: Kakšna tveganja so povezana z zdravilom Baraclude?
English: The third study was carried out in 293 patients whose infection was no longer responding to lamivudine treatment.
Slovenian: Tretja študija je bila izvedena pri 293 bolnikih, pri katerih se je okužba prenehala odzivati na zdravljenje z lamivudinom.
English: The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
Slovenian: 1-miligramski dnevni odmerek se uporablja tudi pri odraslih z dekompenzirano boleznijo jeter in zanje je priporočljivo, da zdravljenja ne prekinejo.
English: The studies looked at how the liver damage had evolved after 48 weeks treatment by examining samples of liver tissue and measuring signs of the disease such as the levels of a liver enzyme (ALT) or viral DNA in the blood.
Slovenian: V študijah so opazovali napredovanje poškodbe jeter po 48 tednih zdravljenja, pri čemer so proučili vzorce jetrnega tkiva in merili znake bolezni, kot so ravni jetrnega encima (ALT) ali virusne DNK v krvi.
English: At the end of the study, 55% of the patients treated with Baraclude had both a normal ALT level and undetectable viral DNA in their blood, while 4% of those treated with lamivudine showed the same results.
Slovenian: Ob koncu študije je 55 % bolnikov, zdravljenih z zdravilom Baraclude, imelo normalno raven ALT in nezaznavno raven virusne DNK v krvi, medtem ko je enake rezultate izkazalo 4 % tistih, zdravljenih z zdravilom lamivudin.
English: Resistance to entecavir (when a virus becomes insensitive to the antiviral) has been seen in lamivudine-refractory patients.
Slovenian: Odpornost na entekavir (virus postane neobčutljiv na protivirusno zdravilo) so opazili pri bolnikih, neodzivnih na lamivudin.
English: Why has Baraclude been approved?
Slovenian: Zakaj je bilo zdravilo Baraclude odobreno?
English: Baraclude has been shown to be effective at suppressing the virus in adults with both compensated and decompensated liver disease.
Slovenian: Zdravilo Baraclude se je izkazalo za učinkovito pri zaviranju virusa pri odraslih s kompenzirano in dekompenzirano boleznijo jeter.