FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Temozolomide Hexal is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Estonian: Et Temozolomide Hexal on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Temozolomide Hexali bioekvivalentsust võrdlusravimiga Temodal.
English: Temozolomide Hexal temozolomide
Estonian: Temozolomide Hexal temosolomiid
English: Temozolomide Hexal is a medicine that contains the active substance temozolomide.
Estonian: Temozolomide Hexal on ravim, mis sisaldab toimeainena temosolomiidi.
English: Temozolomide Hexal is a ‘generic medicine'.
Estonian: Temozolomide Hexal on geneeriline ravim.
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Hexal.
Estonian: Enne Temozolomide Hexali võtmist võib olla vaja võtta oksendamist ennetavaid ravimeid.
English: Why has Temozolomide Hexal been approved?
Estonian: Miks Temozolomide Hexal heaks kiideti?
English: The active substance in Temozolomide Hexal, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Estonian: Temozolomide Hexali toimeaine temosolomiid kuulub alküleerivateks aineteks nimetatavate vähiravimite rühma.
English: What is Temozolomide Hexal?
Estonian: Mis on Temozolomide Hexal?
English: Temozolomide Hexal is used on its own in these patients.
Estonian: Nendel patsientidel kasutatakse Temozolomide Hexalit ainsa raviviisina.
English: How has Temozolomide Hexal been studied?
Estonian: Kuidas Temozolomide Hexalit uuriti?
English: What are the benefit and risk of Temozolomide Hexal?
Estonian: Milles seisneb Temozolomide Hexali kasulikkus ja mis riskid ravimiga kaasnevad?
English: How is Temozolomide Hexal used?
Estonian: Kuidas Temozolomide Hexalit kasutatakse?
English: Temozolomide Hexal is an anticancer medicine.
Estonian: Temozolomide Hexal on vähiravim.
English: How does Temozolomide Hexal work?
Estonian: Kuidas Temozolomide Hexal toimib?
English: What is Temozolomide Hexal used for?
Estonian: Milleks Temozolomide Hexalit kasutatakse?
English: In the body, temozolomide is converted to another compound called MTIC.
Estonian: Organismis muundub temosolomiid ühendiks MTIC (5-(3-metüül-1-triaseno-)imidasool-4-karboksamiid).
English: 1 spray container
Estonian: Pakendis 1 sprei
English: (meat and milk)
Estonian: (liha ja piim)
English: Meat: 7 days Milk: 60 hours
Estonian: Liha: 7 päeva Piim: 60 tundi
English: The CVMP considered that:
Estonian: Veterinaarravimite komitee võttis arvesse, et:
English: The application was submitted to the Concerned Member States under the mutual recognition procedure.
Estonian: Asjaomastele liikmesriikidele esitati vastastikuse tunnustamise menetluse raames taotlus.
English: Combisyn was authorised in the United Kingdom on 30 January 2003 under Article 13(1) of Directive 2001/82/EC.
Estonian: Combisynile anti Ühendkuningriigis müügiluba 30. jaanuaril 2003 vastavalt direktiivi 2001/82/EÜ artikli 13 lõikele 1.
English: • the efficacy of Combisyn was not confirmed;
Estonian: • Combisyni efektiivsust ei tõendatud;
English: Prior to the lifting of the suspension of the marketing authorisation, the national competent authority of the Reference Member State shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Estonian: Enne müügiloa peatamise lõpetamist peab viiteliikmesriigi pädev asutus kontrollima, et müügiloa hoidja on täitnud järgmised tingimused:
English: For applications made under Article 13(1) of Directive 2001/82/EC the applicant is not required to submit results of pharmacological, toxicological and clinical trials.
Estonian: Direktiivi 2001/82/EÜ artikli 13 lõike 1 kohaste taotluste korral ei pea taotleja esitama farmakoloogiliste, toksikoloogiliste ega kliiniliste uuringute tulemusi.
English: • the proposed withdrawal period for Combisyn was insufficiently substantiated;
Estonian: • Combisyni väljapakutud keeluaeg oli ebapiisavalt põhjendatud;
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, withdrawal periods, applicant, marketing authorisation holder in the member states
Estonian: Ravimi nimetuste, ravimvormide, tugevuste, loomaliikide, manustamisviiside, keeluaegade, müügiloa taotlejate ja müügiloa hoidjate loetelu liikmesriikides
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)
Estonian: Ravimijääkide piimast kadumise uuring tuleb teha vastavalt piima keeluaegade määramise suunisele (Note for guidance for the determination of withdrawal periods for milk, EMEA/CVMP/473/98-lõplik).
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.
Estonian: Seetõttu otsustas veterinaarravimite komitee, et taotluse põhjenduseks esitatud andmed ei ole kooskõlas direktiivi 2001/82/EÜ artikliga 13, ning soovitas asjaomastes liikmesriikides müügiloa andmisest keelduda ja viiteliikmesriigis kehtiv müügiluba peatada.
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.
Estonian: Asjaomased liikmesriigid leidsid, et müügiloa andmine Combisynile võib ohustada inim- ja loomatervist, kuna ravimi ohutus ja efektiivsus ei ole piisavalt tõendatud.
English: The CVMP was unable to conclude positively on this approach.
Estonian: Veterinaarravimite komitee ei saanud lugeda seda lähenemisviisi õigeks.
English: The conditions for lifting the suspension are outlined in Annex III.
Estonian: Müügiloa peatamise lõpetamise alused on esitatud III lisas.
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”).
Estonian: Lisaks sellele väitis taotleja, et veterinaarravimite komitee suunisega ei välistatud piima kasutamist bioekvivalentsuse uuringute tegemiseks (lõigus 5.1 on viide „teisele bioloogilisele vedelikule”).
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.
Estonian: Veterinaarravimite komiteel paluti esitada oma arvamus asjaomaste liikmesriikide tõstatatud probleemide kohta ja teha järeldused Combisyni kasulikkuse ja riski suhte kohta.
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.
Estonian: • käesoleva taotluse põhjenduseks esitatud andmete põhjal ei ole võimalik kindlaks teha ravimi positiivset kasulikkuse ja riski suhet.
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.
Estonian: Menetluse käigus tekkis viiteliikmesriigi ja asjaomaste liikmesriikide vahel lahkarvamus nii paikselt kasutatava paikse toimega ravimi süsteemse bioekvivalentsuse tõendamise kohaldatavuse osas kui ka täiendav probleem väljapakutud keeluaja piisava pikkuse osas.
English: Recommended dose, frequency and route of administration
Estonian: Soovituslik annus, manustamise sagedus ja viis
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisation(s)
Estonian: Teaduslikud järeldused ja müügiloa (müügilubade) andmisest keeldumise alused
English: A user risk assessment and a Phase I environmental risk assessment were also provided.
Estonian: Esitati ka andmed kasutajariski hindamise ja keskkonnariski I faasi hindamise kohta.
English: No conclusions could be reached for clavulanic acid since levels were mostly below the limit of quantification.
Estonian: Klavulaanhappe osas ei olnud võimalik järeldust teha, sest selle tase oli enamasti määramispiirist madalam.
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.
Estonian: Seega ei saa kehtivaid bioekvivalentsuse tõestamise suunised kasutada intramammaarsete ravimite korral, sest ei ole selge, mis määral teatud kineetikaprofiil piimas vastab ravimi käitumisele toimekohas.
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.
Estonian: Bioekvivalentsuse tõestamise põhimõte on võrrelda ekspositsiooni kiirust ja ulatust, mistõttu ei tohi proove võtta samast kohast, kus toimub manustamine ja väljutamine.
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.
Estonian: Veterinaarravimite komitee jõudis järeldusele, et andmekogum ja statistilised analüüsid, mida kasutati väljapakutud keeluaja ekstrapoleerimiseks 120 tunnini, olid ebakorrektsed ja ei andnud piisavat põhjendust keeluaja kehtestamiseks.
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.
Estonian: Combisyni efektiivsuse sarnasuse uurimise meetodi valimisel ei olnud taotleja teinud võrdlevaid kliinilisi uuringuid, sest eeldati, et kliinilised uuringud ei ole Combisyni ja võrdlusravimi vaheliste erinevuste kindlakstegemiseks piisavalt tundlikud.
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.
Estonian: Esmase müügiloa andmise ajal ei olnud nii hästi teada raskused intramammaarse ravimi bioekvivalentsuse tõendamisel ja taotleja kohaldatud üldpõhimõtted farmakokineetika uuringute tegemisel kiideti heaks.
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;
Estonian: • käesoleva taotluse põhjenduseks esitatud andmed ei näidanud, et uuritava ja võrdlusravimi bioekvivalentsus oleks tõendatud nõuetekohastes biosaadavuse uuringutes;
English: This study also served to provide data on the residues of this active substance.
Estonian: Selles uuringus koguti ka andmeid toimeaine jääkide sisalduse kohta.
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.
Estonian: Seetõttu väitis taotleja, et piimast ja plasmast saadud farmakokineetiliste andmete in vivo võrdlemine oli sobiv lähenemine intramammaarse ravimi bioekvivalentsuse uurimiseks.
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.
Estonian: Veterinaarravimite komitee jõudis järeldusele, et vaatamata Combisyni võrdlusravimiga sarnasele koostisele, osakeste suurusele ja viskoossusele, tuleb seda kõnealusel juhul käsitleda vaid toetava asjaoluna ja see ei asenda efektiivsuse tõendamisel kliinilisi uuringuid.
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.
Estonian: Piimauuringute tulemused näitasid, et toimeainete kontsentratsioon oli pärast Combisyni intramammaarset infundeerimist sarnane võrdlusravimi kontsentratsiooniga, kuid märgiti, et kõikide mõõdetud farmakokineetiliste näitajate puhul esines märkimisväärne udaraveerandite- ja loomadevaheline varieeruvus.
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.
Estonian: Veterinaarravimite komitee vaatas läbi ka küsimuse, mis oli seotud Combisyni ravimvormi muutmisega ravimi väljatöötamise käigus eesmärgiga suurendada ravimi stabiilsust, mille puhul aga tehti kindlaks, et see võib mõjutada toimeainete vabanemist ravimist kudedesse.
English: A tolerance study was presented to evaluate the safety of the product in lactating cows.
Estonian: Esitati taluvusuuringu andmed, et hinnata ravimi ohutust lakteerivatel veistel.
English: The plasma data showed that, overall, the confidence intervals were within the acceptance limits for amoxicillin and prednisolone.
Estonian: Plasma andmed näitasid, et kokkuvõttes oli amoksitsilliini ja prednisolooni usaldusvahemik aktsepteeritavates piirides.
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).
Estonian: Soovitatav on teha võrdlusravimiga samaväärsust tõendav uuring, pöörates erilist tähelepanu uuringu tundlikkusele (nt kolme rühmaga platseebokontrolliga uuring).
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.
Estonian: Lisaks väitis taotleja, et Combisyni koostis oli võrdlusravimiga piisavalt sarnane, et vabastada taotleja in vivo andmete esitamise nõudest.
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.
Estonian: Et andmed näitasid, et keeluajale järgnevates ajapunktides ületati ravimijääkide piirnorme, pakkus taotleja välja uue 120-tunnise keeluaja, põhinedes piima võrdlevate näitajate statistilise ekstrapoleerimise tulemustele.
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.
Estonian: Lakteerivate veiste intramammaarsuspensiooni Combisyn (edaspidi Combisyn) on intramammaarsuspensioon, mis sisaldab amoksitsilliini (amoksitsilliintrihüdraadina), klavulaanhapet (kaaliumklavulanaadina) ja prednisolooni.
English: Overall summary of the scientific evaluation of Combisyn Lactating Cow Intramammary Suspension
Estonian: Lakteerivate veiste intramammaarsuspensiooni Combisyn teadusliku hindamise üldkokkuvõte
English: Animal species
Estonian: Strengths Loomaliigid
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.
Estonian: Ravimijääkide puhul näitasid võrdlevate piimauuringute andmed, et ajahetkel, mis vastas väljapakutud 60-tunnise keeluaja lõpule, ületas amoksitsilliini kontsentratsioon kõikides udaraveerandi piimaproovides ravimijääkide piirnormi piimas (4 µg/kg) ja osa piimaproove sisaldas klavulaanhapet sama palju või rohkem, kui on ravimijääkide piirnorm piimas (200 µg/kg).
English: The dose-limiting pathogen is penicillinase-producing Staphylococcus aureus.
Estonian: Annuse piirmäär tuleb kindlaks teha penitsillinaasi tootva patogeeni Staphylococcus aureus järgi.
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.
Estonian: Selles uuringus koguti ka andmeid amoksitsilliini ja klavulaanhappe jääkide kohta udaraveerandi piimaproovides, mis võeti korrapäraste ajavahemike järel pärast Combisyni ja võrdlusravimi infundeerimist.
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.
Estonian: Kui taotlejal paluti seda väidet põhjendada, esitas taotleja võrdlevad andmed Combisyni ja võrdlusravimi füüsikalis-keemiliste omaduste kohta, sealhulgas viskoossuse, osakeste suuruse ja piimas lahustuvuse kohta.
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).
Estonian: Combisyn on ette nähtud sageli lehma udaras esinevate peamiste patogeenide (stafülokokid, streptokokid ja bakter Escherichia coli) põhjustatud mastiidi raviks lakteerivatel veistel.
English: Appropriate clinical data should be provided to confirm the efficacy of Combisyn Lactating Cow Intramammary Suspension.
Estonian: Lakteerivate veiste intramammaarsuspensiooni Combisyn efektiivsuse tõendamiseks tuleb esitada asjakohased kliinilised andmed.
English: There was discussion by the CVMP on applying the same pharmacokinetic parameters from classical plasma bioequivalence studies to comparative data in milk.
Estonian: Veterinaarravimite komiteega toimunud arutelus käsitleti samade farmakokineetiliste näitajate mõõtmist nii klassikalistes bioekvivalentsusuuringutes plasmaga kui ka võrdlevates uuringutes piimaga.
English: Grounds for refusal of the granting of the marketing authorisations and suspension of the existing marketing authorisation
Estonian: Müügiloa andmisest keeldumise ja kehtiva müügiloa peatamise alused
English: In support of Combisyn, studies were submitted to compare milk and plasma pharmacokinetics between the generic and reference products.
Estonian: Combisyni taotluse toetuseks esitati andmed uuringute kohta, kus võrreldi geneerilise ravimi ja võrdlusravimite farmakokineetikat piimas ja plasmas.
English: • A comparative milk study was carried out to measure milk concentrations of prednisolone following intramammary infusion.
Estonian: • Tehti võrdlev piimauuring, kus mõõdeti prednisolooni kontsentratsiooni plasmas pärast intramammaarset infundeerimist.
English: • A comparative plasma study was carried out to measure plasma concentrations of amoxicillin, clavulanate and prednisolone following intramammary infusion.
Estonian: • Tehti võrdlev plasmauuring, kus mõõdeti amoksitsilliini, klavulanaadi ja prednisolooni kontsentratsiooni plasmas pärast intramammaarset infundeerimist.
English: Three comparative pharmacokinetic studies were carried out with Combisyn and the reference product, all with a two-period cross-over design.
Estonian: Combisyni ja võrdlusravimit uuriti kolmes võrdlevas farmakokineetika uuringus, mis kõik olid kaheperioodilised ristuuringud.
English: The dissolution data in particular were inconclusive due to limitations of the study design.
Estonian: Uuringu ülesehituse puuduste tõttu osutusid ebaselgeks just lahustuvuse andmed.
English: • A comparative milk study was carried out to measure milk concentrations of amoxicillin and clavulanic acid.
Estonian: • Tehti võrdlev piimauuring, kus mõõdeti amoksitsilliini ja klavulaanhappe kontsentratsiooni piimas.
English: Clavulanic acid, a naturally-occurring substance is a beta-lactamase inhibitor and chemical synergist for amoxicillin.
Estonian: Organismis looduslikult esinev aine klavulaanhape on beetalaktamaasi inhibiitor ja amoksitsilliini sünergist.
English: Combisyn is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route.
Estonian: Combisyni turustatakse süstaldes, mis sisaldavad ühikannust õlisuspensioonina intramammaarseks manustamiseks.
English: Grounds for the lifting of the suspension of the Marketing Authorisation
Estonian: Müügiloa peatamise lõpetamise alused
English: The applicant presented comparative viscosity data between the ‘old' and ‘new' formulations of Combisyn.
Estonian: Taotleja esitas Combisyni vana ja uue ravimvormi võrdlevad viskoossusandmed.
English: Strengths
Estonian: Lakteerivad veised
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.
Estonian: Viimases proovivõtmise ajapunktis (108 tundi) ületas amoksitsilliini kontsentratsioon ravimijääkide piirnormi pooltes udaraveerandi piimaproovides.
English: This can happen during the treatment, or after it has been stopped.
Estonian: See võib toimuda ravi ajal või pärast selle lõppu.
English: Baraclude is taken once a day.
Estonian: Baracludet võetakse üks kord ööpäevas.
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.
Estonian: Euroopa avaliku hindamisaruande täistekst Baraclude kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A risk management plan has been developed to ensure that Baraclude is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Baraclude võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Baraclude on 26 June 2006.
Estonian: Euroopa Komisjon andis Baraclude müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. juunil
English: What measures are being taken to ensure the safe and effective use of Baraclude?
Estonian: Mis meetmed võetakse, et tagada Baraclude ohutu ja efektiivne kasutamine?
English: Baraclude entecavir
Estonian: Baraclude entekaviir
English: Patients also need to know that they may also suffer a worsening of their liver disease.
Estonian: Patsiente tuleb ka hoiatada, et nende maksahaigus võib süveneda.
English: Viral suppression has also been shown in children.
Estonian: Viirust pärssivat toimet on näidatud ka laste puhul.
English: Other information about Baraclude
Estonian: Muu teave Baraclude kohta
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.
Estonian: 0,5 mg annust võib võtta koos toiduga või ilma, kuid 1 mg annus tuleb võtta vähemalt 2 tundi enne või 2 tundi pärast sööki.
English: It is available as tablets (0.5 mg and 1 mg) and as an oral solution (0.05 mg/ml).
Estonian: Seda turustatakse tablettidena (0,5 mg ja 1 mg) ja suukaudse lahusena (0,05 mg/ml).
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.
Estonian: Lapse ravi alustamise otsus peaks põhinema tema individuaalsete vajaduste hoolikal kaalumisel, sest kõik kroonilise B-hepatiidi nakkusega lapsed ei pruugi vajada ravi.