FrancophonIA/ELRC3.0 huggingface dataset:
English: The studies presented by the companies show some evidence that valproate is effective in the acute treatment of manic episode, as seen in placebo controlled studies of three-week duration.
Slovenian: Študije, ki so jih predložile družbe, kažejo, da je valproat učinkovit pri akutnem zdravljenju maničnih epizod, kot je razvidno iz tritedenskih, s placebom nadzorovanih študij.
English: The Committee reviewed the information supplied by the companies that make valproate-containing medicines to support the use of valproate-containing medicine in bipolar disorders.
Slovenian: Odbor je pregledal informacije, ki so jih predložile družbe, ki izdelujejo zdravila, vsebujoča valproat, v podporo uporabi zdravil, vsebujočih valproat, pri bipolarnih motnjah.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of valproate-containing medicines in the management of manic episodes in bipolar disorder when lithium is contraindicated or not tolerated continue to outweigh its risks, and therefore recommended that all marketing authorisations for these medicines be varied either to include or to amend the indication.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi zdravil, ki vsebujejo valproat, pri obvladovanju maničnih epizod pri bipolarni motnji v primerih, da je litij kontraindiciran ali ga bolniki slabo prenašajo, še vedno odtehtajo tveganja, zato je priporočil spremembo vseh dovoljenj za promet s temi zdravili tako, da vključujejo ali spreminjajo indikacijo.
English: 3 August and 26 October 2009
Slovenian: 3. avgusta in 26. oktobra 2009
English: Therefore, it asked the CHMP to carry out a full assessment of the benefit-risk balance of valproic acid and valproate in the treatment and prevention of manic episodes in bipolar disorder and to issue an opinion on whether the marketing authorisations for products containing valproate should be changed across the EU.
Slovenian: Zato je pozvala CHMP, naj opravi celotno oceno razmerja med koristmi in tveganji za valprojsko kislino in valproat pri zdravljenju in preprečevanju maničnih epizod pri bipolarni motnji ter naj izda mnenje o tem, ali je potrebna sprememba dovoljenj za promet z zdravili, ki vsebujejo valproat, v EU.
English: The CHMP recommended the use of valproate for the treatment of manic episode in bipolar disorder in patients who cannot take lithium (another medicine used in bipolar disorders).
Slovenian: CHMP je priporočil uporabo valproata za zdravljenje maničnih epizod pri bipolarnih motnjah pri bolnikih, ki slabo prenašajo litij (drugo zdravilo za zdravljenje bipolarnih motenj).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of valproate in this condition outweigh their risks, and that all marketing authorisations for medicines containing valproate throughout Europe should be amended to include the treatment of manic episodes in bipolar disorders when lithium is contraindicated or not tolerated.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da koristi valproata pri tem stanju odtehtajo tveganja ter da je treba vsa dovoljenja za promet z zdravili, ki vsebujejo valproat, v Evropi spremeniti tako, da bodo vključevala zdravljenje maničnih epizod pri bipolarnih motnjah v primerih, kadar je litij kontraindiciran ali ga bolniki ne prenašajo dobro.
English: On 15 April 2008, the company that markets Valproat Ratiopharm Chrono, a generic medicine containing valproate used as anti-epileptic, applied to the German medicines regulatory agency to extend its use to include the ‘acute treatment of manic episode and prevention of recurrence in patients with bipolar disorder'.
Slovenian: Dne 15. aprila 2008 je družba, ki trži generično zdravilo Valproat Ratiopharm Chrono, vsebujoče valproat, ki se uporablja kot antiepileptik, pri nemški regulatorni agenciji za zdravila zaprosila za
English: Milk: 108 hours
Slovenian: Mleko: 108 ur.
English: Hence, extrapolation is not warranted.
Slovenian: Ekstrapolacija zato ni upravičena.
English: Meat and offal: 42 days.
Slovenian: Meso in organi: 42 dni.
English: ad us. vet. Bioveta, Czech Republic)6.
Slovenian: ad us. vet., Bioveta, Češka republika)6.
English: Sheep (meat) is considered a major food producing species.
Slovenian: Ovce (meso) veljajo za glavno vrsto za proizvodnjo živil.
English: Information was received regarding the composition of the affected products (n=50).
Slovenian: Prejete so bile informacije o sestavi zadevnih zdravil (n = 50).
English: This approach was proposed by some of the concerned marketing authorisation holders, and it is supported by the CVMP.
Slovenian: Ta pristop so predlagali nekateri zadevni imetniki dovoljenja za promet z zdravilom in ga je odbor CVMP podprl.
English: Sheep: Intramuscular
Slovenian: ovce: intramuskularna
English: As the animals in the study were treated twice daily, as opposed to once daily as usually recommended, the study design can be considered to represent a worst-case scenario.
Slovenian: Ker so živali v študiji zdravilo prejele dvakrat na dan, v nasprotju z običajnim priporočenim odmerjanjem enkrat na dan, se lahko šteje, da načrt študije predstavlja najslabši možni scenarij.
English: However, two publically available studies were made available to CVMP.
Slovenian: Odboru CVMP pa sta bili na voljo dve javno dostopni študiji.
English: Quality, target animal safety, user safety, and the environmental risk for the concerned veterinary medicinal products have not been assessed in this referral procedure.
Slovenian: Kakovosti, varnosti za ciljno živalsko vrsto, varnosti uporabnikov in tveganja za okolje pri zadevnih zdravilih za uporabo v veterinarski medicini v tem napotitvenem postopku niso ocenjevali.
English: After analysis of the residue data for the injection site using the recommended EMA statistical software (WT 1.4), it was concluded that not all the statistical requirements (i.e., F-test) were met.
Slovenian: Po analizi podatkov o ostankih na mestu injiciranja s priporočeno statistično programsko opremo EMA (WT 1.4) je bilo sklenjeno, da niso bile izpolnjene vse statistične zahteve (tj. F-test).
English: B. For all other products listed in Annex I Summary of product characteristics
Slovenian: B. Za vsa druga zdravila, navedena v Prilogi I Povzetek glavnih značilnosti zdravila
English: Whereas, according to current standards, residue depletion studies should be conducted in animals that are representative of the target population, it has not been possible to obtain such data within the context of this referral procedure.
Slovenian: Ker je treba v skladu s sedanjimi standardi študije o izločanju ostankov izvesti na živalih, ki so reprezentativne za ciljno populacijo, takšnih podatkov v okviru tega napotitvenega postopka ni bilo mogoče pridobiti.
English: From these two published studies, one did not provide data that could be used within the scope of this referral procedure.
Slovenian: V eni od teh dveh objavljenih študij niso bili predloženi podatki, ki bi jih lahko uporabili v okviru tega napotitvenega postopka.
English: Hence, the Committee concluded that the data is considered to have a limited value for the scope of this referral procedure.
Slovenian: Odbor je zato sklenil, da so podatki za namen tega napotitvenega postopka omejenega pomena.
English: Nevertheless, as limiting the injection volume would require adult animals having to be injected 8 to 10 times per treatment dose, this is not considered appropriate for both practical and animal welfare considerations.
Slovenian: Ker pa bi omejitev volumna injiciranja zahtevala, da se ta odraslim živalim injicira od 8- do 10-krat na odmerek zdravljenja, se to ne šteje za primerno tako s praktičnega vidika kot vidika dobrobiti živali.
English: Results from one of the studies could not be used, since data on residue concentrations at the injection site was missing.
Slovenian: Rezultatov ene od študij ni bilo mogoče uporabiti, ker ni bilo podatkov o koncentracijah ostankov na mestu injiciranja.
English: Macrolides are categorised as critically important antimicrobials both in human and veterinary medicine, however tylosin is not used in human medicine.
Slovenian: Makrolidi so kategorizirani kot kritično pomembne protimikrobne učinkovine v zdravilih za uporabo tako v humani kot veterinarski medicini, vendar pa se v humani medicini tilozin ne uporablja.
English: The recommended treatment and dose of Tylosin/Anafasis is 10 mg/kg bw for 3-5 days, although most products recommend only 3 days of treatment.
Slovenian: Priporočeno zdravljenje in odmerek zdravila Tylosin/Anafasis sta 10 mg/kg telesne mase od 3 do 5 dni, čeprav se za večino zdravil priporočajo le 3 dnevi zdravljenja.
English: However, the actual residue concentrations were not given, and the study was done using a single injection rather than repeated injections.
Slovenian: Vendar dejanske koncentracije ostankov niso bile podane, študija pa je bila izvedena z enkratnim in ne večkratnim injiciranjem.
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms.
Slovenian: Tilozin in njegove fosfatne in tartratne soli se uporabljajo v zdravilih za uporabo v veterinarski medicini za zdravljenje stanj, ki jih povzročajo občutljivi organizmi.
English: The reference product is Tylan 200 solution for injection, which has been authorised in various Member States.
Slovenian: Referenčno zdravilo je zdravilo Tylan 200 raztopina za injiciranje, ki je bilo odobreno v različnih državah članicah.
English: Consequently, for this product the Committee recommends the variation of the existing marketing authorisations in order to remove any reference to the target species sheep.
Slovenian: Odbor zato za to zdravilo priporoča spremembo obstoječih dovoljenj za promet z zdravilom z odpravo vsakršnega sklicevanja na ciljno vrsto ovce.
English: Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae.
Slovenian: Tilozin je makrolidni antibiotik, ki ga proizvajajo bakterije Streptomyces fradiae.
English: Applicant / Marketing authorisation holder
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom
English: It is active mostly against Gram-positive bacteria and mycoplasmas.
Slovenian: Deluje predvsem proti grampozitivnim bakterijam in mikoplazmam.
English: Data extrapolation was done based on the excipients composition of the products concerned.
Slovenian: Ekstrapolacija podatkov je bila opravljena na podlagi sestave pomožnih snovi zadevnih zdravil.
English: In accordance with the current legislation and relevant guidelines, maximum residue limits withdrawal periods have to be established on the basis of species-specific residue depletion data for all major food producing species.
Slovenian: V skladu z veljavno zakonodajo in ustreznimi smernicami je treba karence za mejne vrednosti ostankov določiti na podlagi podatkov o izločanju ostankov, specifičnih za vrsto, za vse glavne vrste za proizvodnjo živil.
English: It is noted that this product can be used in adult sheep and that adult sheep would require treatment with higher injection volumes.
Slovenian: Opozoriti je treba, da se to zdravilo lahko uporablja pri odraslih ovcah in da bi morali odrasle ovce zdraviti z večjimi volumni injiciranja.
English: Whereas these theoretical calculations are not scientifically substantiated by data, it is reasonable to assume that a withdrawal period of 42 days would ensure that consumers would not be exposed to residues of concern if the injection volume was to be restricted to 2.5 ml per injection site.
Slovenian: Medtem ko ti teoretični izračuni niso znanstveno utemeljeni s podatki, je smiselno domnevati, da bi 42-dnevna karenca zagotovila, da potrošniki ne bi bili izpostavljeni zaskrbljujočim ostankom, če bi bil volumen injiciranja omejen na 2,5 ml na mesto injiciranja.
English: To ensure the safety of consumers of food and food products derived from animals treated with products containing tylosin, the European Commission has set MRLs for tylosin in the edible tissues of sheep.
Slovenian: Da bi zagotovili varnost potrošnikov živil in prehrambnih izdelkov, proizvedenih iz živali, zdravljenih z zdravili, ki vsebujejo tilozin, je Evropska komisija določila MRL za tilozin v tkivih ovac, namenjenih prehrani.
English: Tylozyna Biovet JSC Tylosin base
Slovenian: Tylozyna Biovet JSC tilozinova baza
English: Hence, the chemical form is not considered to effect residue absorption from tissues (including the injection site).
Slovenian: Zato velja, da kemična oblika ne vpliva na absorpcijo ostankov iz tkiv (vključno z mestom injiciranja).
English: Indeed, published data has shown that the rate of absorption from the injection site is inversely proportional to the viscosity of the product, i.e. the higher the viscosity, the slower the rate of absorption (Kakemi et al.,19723).
Slovenian: Dejansko so objavljeni podatki pokazali, da je hitrost absorpcije z mesta injiciranja obratno sorazmerna viskoznosti zdravila, tj. večja ko je viskoznost, počasnejša je absorpcija (Kakemi in sod., 19723).
English: For these 49 concerned veterinary medicinal products, the overall benefit-risk balance remains positive subject to the recommended changes in the product information (see Annex III).
Slovenian: Pri teh 49 zadevnih zdravilih za uporabo v veterinarski medicini je splošno razmerje med koristmi in tveganji ob upoštevanju priporočenih sprememb informacij o zdravilu (glej Prilogo III) pozitivno.
English: However, to address certain deficiencies in the data set, an additional safety factor of 30% was considered necessary resulting in a withdrawal period of 28 days.
Slovenian: Vendar se je za odpravo nekaterih pomanjkljivosti v naboru podatkov upošteval dodaten 30-odstotni varnostni faktor, kar je privedlo do karence 28 dni.
English: The results from this residue study have been used for establishing the withdrawal periods for the remaining 49 out of the 50 products concerned, i.e. for all those products considered to be comparable qualitatively regarding excipients.
Slovenian: Rezultati te študije o ostankih so bili uporabljeni za določitev karenc za preostalih 49 od 50 zadevnih zdravil, tj. za vsa tista zdravila, ki se štejejo za kvalitativno primerljiva glede pomožnih snovi.
English: Within this group of 49 products, most products contain tylosin base as active substance, whereas only five products contain tylosin tartrate.
Slovenian: V okviru te skupine 49 zdravil vsebuje večina zdravil kot učinkovino tilozinovo bazo, samo pet zdravil pa kot učinkovino vsebuje tilozinijev tartrat.
English: In order for tylosin-derived residues to deplete below the MRLs, a sufficient time between treatment and slaughter must be allowed.
Slovenian: Da bi se lahko koncentracija ostankov tilozina znižala pod MRL, mora med zdravljenjem in zakolom miniti zadosten čas.
English: While the efficacy of the concerned products in sheep has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and prevention of infestations, which include respiratory infections caused by Gram-positive microorganisms, and mastitis caused by Gram-positive microorganisms.
Slovenian: Čeprav učinkovitost zadevnih zdravil pri ovcah v okviru te napotitve ni bila natančno ocenjena, se šteje, da so ocenjevana zdravila učinkovita pri zdravljenju in preprečevanju infestacij, kar vključuje okužbe dihal z grampozitivnimi mikroorganizmi in mastitis, ki ga povzročajo grampozitivni mikroorganizmi.
English: Regardless of the tylosin strength, the formulation of 49 of the concerned products is very similar.
Slovenian: Ne glede na koncentracijo tilozina je formulacija 49 zadevnih zdravil zelo podobna.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, predlagateljev in imetnikov dovoljenj za promet z zdravilom v državah članicah
English: Two days after the last dose, tylosin could no longer be detected in sheep milk.
Slovenian: Dva dni po zadnjem odmerku v ovčjem mleku ni bilo več mogoče zaznati tilozina.
English: An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e., a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product Tylovectin, containing 200 mg of tylosin per ml, with France as Reference Member State (FR/V/0323/001/DC).
Slovenian: V skladu s členom 13(1) Direktive 2001/82/ES je bila predložena vloga, tj. generična vloga za izdajo dovoljenja za promet z zdravilom v skladu z decentraliziranim postopkom za zdravilo za uporabo v veterinarski medicini Tylovectin, ki vsebuje 200 mg tilozina na ml, s Francijo kot referenčno državo članico (FR/V/0323/001/DC).
English: Therefore, the Netherlands considered that it is necessary to refer the matter to
Slovenian: Nizozemska je zato menila, da je treba zadevo zaradi varstva potrošnikov v Uniji napotiti na Odbor za zdravila za
English: The formulation of 49 of the concerned products is very similar.
Slovenian: Formulacija 49 zadevnih zdravil je zelo podobna.
English: Milk samples were analysed using a high-performance liquid chromatography method with solid phase extraction.
Slovenian: Vzorci mleka so bili analizirani s tekočinsko kromatografijo visoke ločljivosti z ekstrakcijo na trdni fazi.
English: A second study was conducted with Najdi ewes with 200 mg/ml tylosin (Tylan 200)7.
Slovenian: Druga študija je bila izvedena z ovcami pasme najdi z 200 mg/ml tilozina (Tylan 200)7.
English: No specific residue data were available for the target species sheep.
Slovenian: Za ciljno vrsto, ovce, ni bilo na voljo specifičnih podatkov o ostankih.
English: Hence, an option to overcome the lack of data in adult sheep would be to limit the injection volume, to the volume used in the residue study available with Tylosin/Anafasis (of 0.6 ml).
Slovenian: Pomanjkanje podatkov pri odraslih ovcah bi bilo torej mogoče premostiti z omejitvijo volumna injiciranja na volumen, uporabljen v študiji ostankov, ki je na voljo za zdravilo Tylosin/Anafasis (0,6 ml).
English: If, theoretically, a larger injection would have the same absorption rate as established for a volume of 0.6 ml, then the withdrawal period would need to be extended by approximately 5 days, i.e., a total of 33 days (resulting from 21 days, plus a 30% safety span, and the additional 5 days).
Slovenian: Če bi se teoretično večja injekcija absorbirala enako hitro kot pri volumnu 0,6 ml, bi bilo treba karenco podaljšati za približno 5 dni, tj. na skupno 33 dni (zaradi 21 dni plus 30-odstotnega varnostnega razpona in dodatnih 5 dni).
English: The residue study was performed in sheep at a dose of 10 mg/kg bodyweight (bw), administered every 12 hours for 3 consecutive days.
Slovenian: Študija ostankov je bila izvedena pri ovcah v odmerku 10 mg/kg telesne mase, ki so ga 3 dni zaporedoma dajali vsakih 12 ur.
English: The Committee considered that for the 49 products containing benzyl alcohol and propylene glycol, the differences in concentrations will not lead to different rates of absorption from the injection site.
Slovenian: Odbor je menil, da za 49 zdravil, ki vsebujejo benzilalkohol in propilenglikol, razlike v koncentracijah ne bodo povzročile različnih hitrosti absorpcije z mesta injiciranja.
English: As the withdrawal period is established taking into account persistence of residues in the injection sites, and a higher injection volume may cause higher local residues in injection sites, a longer withdrawal period would be required for adult sheep treated with tylosin intramuscularly.
Slovenian: Ker je bila karenca ugotovljena ob upoštevanju obstojnosti ostankov na mestih injiciranja in lahko večji volumen injiciranja povzroči več lokalnih ostankov na mestih injiciranja, bi bila pri odraslih ovcah, ki jih zdravijo z intramuskularnim tilozinom, potrebna daljša karenca.
English: For three of the products the concentration of tylosin is 50 mg/ml, whereas for the other 47 products it is 200 mg/ml.
Slovenian: Tri zdravila vsebujejo tilozin v koncentraciji 50 mg/ml, preostalih 47 zdravil pa v koncentraciji 200 mg/ml.
English: From the information on the reference product (Tylan 200) provided by the Reference Member State France, it became clear that the withdrawal period for sheep was based on an extrapolation from the withdrawal period for cattle of 28 days.
Slovenian: Iz podatkov o referenčnem zdravilu (zdravilu Tylan 200), ki jih je predložila referenčna država članica Francija, je postalo jasno, da karenca pri ovcah temelji na ekstrapolaciji 28-dnevne karence pri govedu.
English: Theoretically, a withdrawal period of 42 days would accommodate for a decrease in release rate of more than 250%.
Slovenian: Teoretično bi 42-dnevna karenca dopuščala zmanjšanje hitrosti sproščanja
English: In addition, publically available data showed that residues in sheep milk deplete faster than in cow's milk, and could not be detected 48 hours after the last treatment dose.
Slovenian: Poleg tega so javno dostopni podatki pokazali, da se ostanki iz ovčjega mleka izločijo hitreje kot iz kravjega mleka in jih 48 ur po zadnjem odmerku zdravljenja ni bilo več mogoče zaznati.
English: It is worth noting that the withdrawal period for sheep meat for many of the products that fall within the scope of this procedure, including the generic product Tylovectin and the reference product Tylan 200 as authorised in France, is 42 days.
Slovenian: Treba je omeniti, da znaša karenca za meso ovac pri številnih zdravilih, ki spadajo v okvir tega postopka, vključno z generičnim zdravilom Tylovectin in referenčnim zdravilom Tylan 200, kot je odobren v Franciji, 42 dni.
English: However, the rate of absorption from the injection site depends on a complexity of factors, and without specific residue data, the influence of increasing the injection volume/ site of injection on the absorption rate is difficult to quantify.
Slovenian: Vendar je hitrost absorpcije z mesta injiciranja odvisna od številnih dejavnikov in brez specifičnih podatkov o ostankih je težko izmeriti vpliv povečanja volumna injiciranja/mesta injiciranja na hitrost absorpcije.
English: Thus, these data indicate that a 1:1 extrapolation of the milk withdrawal period from cows to ewes is justified.
Slovenian: Tako ti podatki kažejo, da je ekstrapolacija karenc za mleko s krav na ovčje samice v razmerju 1 : 1 upravičena.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo tilozin in so v obliki raztopine za injiciranje za dajanje ovcam (glejte Prilogo I)
English: The proposed sheep meat withdrawal period for the generic product Tylovectin was 42 days, in line with the French reference product, Tylan 200.
Slovenian: Predlagana karenca za meso ovac za generično zdravilo Tylovectin je bila 42 dni, v skladu s francoskim referenčnim zdravilom Tylan 200.
English: Residue depletion in sheep milk
Slovenian: Podatki o izločanju ostankov v mleko ovac
English: Two residue depletion studies were submitted by two of the concerned marketing authorisation holders.
Slovenian: Dva zadevna imetnika dovoljenja za promet z zdravilom sta predložila dve študiji izločanja ostankov.
English: From the residue data available, the treatment of a 50 kg sheep would require an injection volume of 2.5 ml.
Slovenian: Glede na razpoložljive podatke o ostankih bi bil za zdravljenje ovac s telesno maso 50 kg potreben volumen injiciranja 2,5 ml.
English: This study was conducted with the product Tylosin/Anafasis, containing benzyl alcohol and propylene glycol as excipients.
Slovenian: Ta študija je bila izvedena z zdravilom Tylosin/Anafasis, ki je kot pomožni snovi vsebovalo benzilalkohol in propilenglikol.