FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX IV Conclusions on the granting of the conditional marketing authorisation presented by the European Medicines Agency
Slovenian: ZAKLJUČKI O ODOBRITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM,
English: • Conditional marketing authorisation
Slovenian: PRILOGA IV
English: Powder for concentrate for solution for infusion
Slovenian: 1 mg prašek za koncentrat za raztopino za infundiranje intravenska uporaba viala (steklo)
English: Administration Immediate Packaging
Slovenian: Velikost pakiranja
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Slovenian: (Izmišljeno) ime Jakost
English: Strength Pharmaceutical Form Route of Administration
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika
English: The Committee considered that the second approach was the most appropriate in this case.
Slovenian: Odbor je menil, da bi bil v tem primeru najprimernejši drugi pristop.
English: The worksharing procedure started on 6 January 2012.
Slovenian: Postopek z delitvijo dela se je začel 6. januarja 2012.
English: The application was submitted to the United Kingdom as reference Member State and to Austria, Czech Republic, Estonia, Finland, France, Germany, Greece, Italy, Latvia, the Netherlands, Slovakia and Spain as concerned Member States.
Slovenian: Vloga je bila predložena Združenemu kraljestvu kot referenčni državi članici ter Avstriji, Češki republiki, Estoniji, Finski, Franciji, Nemčiji, Grčiji, Italiji, Latviji, Nizozemski, Slovaški in Španiji kot zadevnim državam članicam.
English: The detailed grounds for re-examination were submitted on 26 April 2013.
Slovenian: Podrobni razlogi za ponoven pregled so bili podani 26. aprila 2013.
English: The study was well conducted and reported.
Slovenian: Študijo so dobro izvedli in o njej ustrezno poročali.
English: Member State EU/EEA
Slovenian: Država članica/EGP
English: INN Pharmaceutical form
Slovenian: Farmacevtska oblika
English: The main shortcoming of the study was the use of a microbiological assay.
Slovenian: Glavna pomanjkljivost študije je bila uporaba mikrobiološkega postopka.
English: Two options for deriving an overall withdrawal period were therefore considered:
Slovenian: Tako sta bili obravnavani dve možnosti za določitev splošne karence:
English: Strength Animal species
Slovenian: Živalska vrsta
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 30 October 2012, the United Kingdom initiated a referral procedure under Article 13(2) of Commission Regulation (EC) No 1234/2008.
Slovenian: Ker referenčna in zadevne države članice niso mogle doseči soglasja v zvezi s spremembo, je 30. oktobra 2012 Združeno kraljestvo sprožilo napotitveni postopek v skladu s členom 13(2) Uredbe Komisije (ES) št. 1234/2008.
English: Moreover, these older studies are superseded if data derived using more up to date and more accurate analytical methods based on chromatography and mass spectroscopy are available.
Slovenian: Poleg tega lahko te starejše študije nadomestijo nove, če so na voljo podatki, pridobljeni z uporabo sodobnejših in natančnejših analitičnih metod na osnovi kromatografije in masne spektroskopije.
English: The correct number of animals was used and all of the other study details were in accordance with current requirements.
Slovenian: Vključili so ustrezno število živali in tudi vsi ostali vidiki študije so bili skladni s trenutnimi zahtevami.
English: In particular, there is no reason to disregard this study considering that, within the European Union, chickens used for food production may differ considerably by breed, size and age.
Slovenian: Še zlasti ni nobenega razloga za neupoštevanje te študije ob dejstvu, da se znotraj Evropske unije piščanci za proizvodnjo hrane lahko zelo razlikujejo glede na pasmo, velikost in starost.
English: Therefore, it is concluded that data from all available studies should be considered relevant, and as such, must be taken into account.
Slovenian: Zato je Odbor zaključil, da so pomembni podatki iz vseh razpoložljivih študij, ki jih je zato treba upoštevati.
English: The combined muscle data using the actual values including those below the limit of quantification, a statistically derived meat withdrawal period of 9 days is obtained (F-test: <0.025; Cochran: >0.05; Bartlett: >0.05; Shapiro: >0.10).
Slovenian: Po združitvi podatkov za mišice z uporabo dejanskih vrednosti, vključno s tistimi pod mejo kvantifikacije, se dobi statistično izpeljano karenco za meso 9 dni (F-preizkus: < 0,025; Cochran: > 0,05; Bartlett: > 0,05; Shapiro: > 0,10).
English: When microbiological methods of analysis are used, the data they generate can be used in support of a proposal, depending on how well the method had been validated.
Slovenian: Kadar se uporabi mikrobiološka analizna metoda, se pridobljene podatke lahko uporabi za utemeljitev predloga, če je bila metoda ustrezno validirana.
English: The MAH has claimed that the findings from the 2011 study were in line with all other studies with similar and bioequivalent products conducted in Europe in recent years.
Slovenian: Imetnik dovoljenja za promet z zdravilom je trdil, da so bile ugotovitve iz študije iz leta 2011 skladne z vsemi drugimi študijami s podobnimi in biološko enakovrednimi zdravili, ki so jih v zadnjih letih izvedli v Evropi.
English: In this particular case, two residue studies from 1999 and 2011 using the actual formulation at the recommended dose were available.
Slovenian: V tem primeru sta bili na voljo dve študiji o ostankih iz leta 1999 in 2011, v katerih so uporabili dejansko zdravilo v priporočenem odmerku.
English: This approach would then result in an overall withdrawal period of 12 days.
Slovenian: S tem pristopom bi nato dobili splošno karenco 12 dni;
English: The CVMP agreed that there is likely to be no significant difference in the solubility of the products on the market regardless of whether they contain tartaric acid or citric acid.
Slovenian: CVMP se je strinjal, da po vsej verjetnosti ni pomembnih razlik v topnosti zdravil na trgu, ne glede na to, ali vsebujejo vinsko kislino ali citronsko kislino.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: This revised withdrawal period of 9 days is considered appropriate to ensure the safety of the consumer.
Slovenian: Spremenjena karenca 9 dni naj bi bila primerna za zagotovitev varnosti potrošnika.
English: It is indicated in chickens to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale.
Slovenian: Zdravilo je indicirano za uporabo pri piščancih za zmanjšanje smrtnosti, obolevnosti in kliničnih znakov ter za zmanjšanje lezij, ki so posledica pastereloze, ki jo povzroča bakterija Pasteurella multocida, ali za zmanjšanje obolevnosti in lezij pri okužbah dihal, ki jih povzroča bakterija Ornithobacterium rhinotracheale.
English: This issue remained unsolved and therefore a CMD(v) procedure under Article 13(2) of Commission Regulation (EC) No 1234/2008 has started on 20 August 2012.
Slovenian: Ker je to vprašanje ostalo nerešeno, je skupina CMD(v) dne 20. avgusta 2012 začela postopek v skladu s členom 13(2) Uredbe Komisije (ES) št. 1234/2008.
English: Option (2) - combine the data from the two studies as, provided that the studies are of acceptable quality, two experiments could result in a better estimate of the ‘true' withdrawal period.
Slovenian: možnost (2) - združiti podatke iz obeh študij, saj bi lahko ob sprejemljivi kakovosti študij na podlagi obeh preskusov bolje ocenili „pravo‟ karenco.
English: Summary of Product Characteristics:
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA:
English: This withdrawal period takes into account all the available data and is determined using the statistical approach.
Slovenian: Pri tej karenci so upoštevani vsi razpoložljivi podatki in je bila določena z uporabo statističnega pristopa.
English: Residue depletion studies
Slovenian: Študije o izločanju ostankov
English: The CVMP assessed the detailed grounds for re-examination presented by Eurovet Animal Health BV related to formulation effects and bioequivalence claims, and also to the available residue depletion studies.
Slovenian: CVMP je preučil podrobne razloge družbe Eurovet Animal Health BV za zahtevo za ponoven pregled, povezane z vplivi sestave in trditvami o biološki enakovrednosti ter tudi z razpoložljivimi študijami o izločanju ostankov.
English: Residue levels in the other tissues were below their respective MRLs from 4 days onwards.
Slovenian: Vrednosti ostankov v drugih tkivih so bile pod zadevnimi mejnimi vrednostmi od 4. dneva naprej.
English: Doxycycline residue levels in muscle were below the muscle MRL from 5 days onwards.
Slovenian: Vrednosti ostankov doksiciklina v mišicah so bile pod mejno vrednostjo za mišice od 5. dneva naprej.
English: The CVMP has considered whether the differences in the conduct between the two latter residue depletion studies could be used to explain the disparity seen in the resulting withdrawal periods.
Slovenian: CVMP je preučil, ali bi lahko razlike v izvedbi zadnjih dveh študij o izločanju ostankov pojasnile neskladje, ki so ga zabeležili pri ugotovljenih karencah.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
English: One possibility which could partially explain this difference was argued to be the fact that in the 1999 study, the litter was not removed, leading to a recirculation of doxycycline through the natural pecking behaviour of the chickens.
Slovenian: Ena možnost, ki bi lahko delno pojasnila to razliko, naj bi bila dejstvo, da v študiji iz leta 1999 niso odstranili stelje, kar je povzročilo recirkulacijo doksiciklina zaradi zobanja, značilnega za piščance.
English: The current CVMP guidance on the establishment of withdrawal periods had to be taken into account.
Slovenian: Pri tem je moral upoštevati trenutne smernice CVMP za določanje karence.
English: As to the comparison to other powders for use in drinking water containing doxycycline it is not possible to extrapolate the kinetics of doxycycline from the powders for use in drinking water containing doxycycline and citric acid to Soludox.
Slovenian: Kar se tiče primerjave z drugimi praški za uporabo v vodi za pitje, ki vsebujejo doksiciklin, ni mogoče ekstrapolirati kinetike doksiciklina iz praškov za uporabo v vodi za pitje, ki vsebujejo doksiciklin in citronsko kislino, v zdravilo Soludox.
English: In the opinion of the MAH the pH of the medicated drinking water solutions is mainly dependant on the quality of the water used, while the formulation of the powder, i.e. which acid is used as a stabiliser, has only a limited effect.
Slovenian: Po mnenju imetnika dovoljenja za promet je pH vode za pitje z raztopljenim zdravilom odvisen predvsem od kakovosti uporabljene vode, medtem ko ima sestava praška, tj. katera kislina je uporabljena kot stabilizator, le majhen vpliv.
English: Because of the presence of tartaric acid in this formulation, the results from the two residue studies are considered valid for assessment, pivotal and necessary in establishing a withdrawal period.
Slovenian: Zaradi prisotnosti vinske kisline v tem zdravilu so rezultati iz dveh študij o ostankih primerni za ocenjevanje, ključni in potrebni za določitev karence.
English: It was not possible to calculate the meat withdrawal period using the alternative approach as one sample contained residue levels at the MRL level at the last time point (8 days).
Slovenian: Karence za meso ni bilo mogoče izračunati z alternativnim pristopom, saj je en vzorec ob zadnji časovni točki (8 dni) vseboval maksimalne vrednosti ostankov.
English: The data from the 1999 study could be analysed using the statistical approach, leading to a withdrawal period of 12 days.
Slovenian: Podatke iz študije iz leta 1999 bi lahko analizirali z uporabo statističnega pristopa, pri čemer bi bil rezultat 12-dnevna karenca.
English: As a result, the withdrawal period of 6 days, as proposed by the MAH, is considered to be inadequate to ensure consumer safety.
Slovenian: Posledično karenca 6 dni, ki jo je predlagal imetnik dovoljenja za promet, ni primerna, saj ne zagotavlja varnosti potrošnika.
English: Option (1) - evaluate each study independently and choose the longer withdrawal period as the overall withdrawal period for the product, as this would represent the worst-case scenario.
Slovenian: možnost (1) - oceniti vsako študijo posebej in za splošno karenco za to zdravilo izbrati daljšo karenco, saj bi ta predstavljala najslabši možen primer.
English: Following the CVMP opinion of 7 March 2013 recommending a 9 days withdrawal period for chicken meat and offal following a dose rate of 20 mg/kg body weight for 4 consecutive days, on 22 March 2013, Eurovet Animal Health BV notified the Agency of their intention to request a re-examination of the CVMP opinion.
Slovenian: Potem ko je CVMP dne 7. marca 2013 izdal mnenje, v katerem je priporočil 9-dnevno karenco za piščančje meso in drobovino po odmerku 20 mg/kg telesne mase 4 dni zapored, je družba Eurovet Animal Health BV 22. marca 2013 obvestila Agencijo, da namerava zahtevati ponoven pregled mnenja CVMP.
English: Since the arguments presented in relation to lack of formulation effect and bioequivalence are not considered to be conclusive, the withdrawal period must be based on the assessment of the residue depletion studies.
Slovenian: Ker argumenti, ki so bili predstavljeni v zvezi z odsotnostjo vpliva sestave in biološko enakovrednostjo, niso prepričljivi, mora karenca temeljiti na oceni študij o izločanju ostankov.
English: The only significant differences between the conduct of the 1999 and 2011 studies were with the age and weight of the birds used.
Slovenian: Edini pomembni razliki v izvedbi študij iz leta 1999 in 2011 sta bili starost in telesna masa perutnine.
English: The CVMP considers that the MAH has not provided a sound justification as to why the findings from the 1999 residue depletion study should be ignored.
Slovenian: CVMP meni, da imetnik dovoljenja za promet z zdravilom ni v zadostni meri utemeljil razlogov, zakaj bi morali prezreti ugotovitve iz študije o izločanju ostankov iz leta 1999.
English: The MAH could not provide a sound scientific justification for dismissing the results from the 1999 study and considering only the most recent study.
Slovenian: Imetnik dovoljenja za promet z zdravilom ni mogel dovolj dobro znanstveno utemeljiti, zakaj bi bilo treba zanemariti rezultate iz študije iz leta 1999 in upoštevati zgolj najnovejšo študijo.
English: Benefit-risk assessment
Slovenian: Ocena razmerja med tveganji in koristmi
English: Since in the 2011 study, the statistical method could not be used, a withdrawal period of 6 days could be calculated, using the alternative approach.
Slovenian: Ker v študiji iz leta 2011 ni bilo mogoče uporabiti statistične metode, bi lahko z alternativnim pristopom izračunali karenco 6 dni.
English: The type II variation has been subject to a worksharing procedure (UK/V/xxxx/WS/006) by the veterinary Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(v)) according to Article 20 of Commission Regulation (EC) No 1234/2008 involving Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/DC) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/DC).
Slovenian: Spremembo tipa II je obravnavala Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)) v postopku z delitvijo dela (UK/V/xxxx/WS/006) v skladu s členom 20 Uredbe Komisije (ES) št. 1234/2008, ki je vključeval zdravili Soludox 500 mg/g prašek za uporabo v vodi za pitje za prašiče in piščance (NL/V/0141/001/DC) ter Soludox 500 mg/g prašek za uporabo v vodi za pitje za prašiče in piščance (UK/V/0349/001/DC).
English: The animals were given the correct dose and the product was administered appropriately and sufficient numbers of animals were used.
Slovenian: Živalim so dajali ustrezen odmerek in uporabili pravilen način odmerjanja ter vključili zadostno število živali.
English: The end result of that study was a withdrawal period of 12 days, whereas the 2011 study and all other studies for products that the MAH considered bioequivalent lead to a shorter withdrawal period.
Slovenian: Končni rezultat te študije je bila 12-dnevna karenca, medtem ko so rezultati študije iz leta 2011 in vseh drugih študij za zdravila, ki so po mnenju imetnika dovoljenja za promet biološko enakovredna, pokazali krajšo karenco.
English: The MAH has provided data from three residue depletion studies.
Slovenian: Imetnik dovoljenja za promet je predložil podatke iz treh študij o izločanju ostankov.
English: The MAH argued that even though Soludox contains tartaric acid as a stabiliser while all other doxycycline powders contain citric acid, the solubility of all products is the same and hence the amount of active substance in the chicken's tissues would be the same.
Slovenian: Imetnik dovoljenja za promet je trdil, da čeprav zdravilo Soludox vsebuje stabilizator vinsko kislino, medtem ko vsi drugi praški z vsebnostjo doksiciklina vsebujejo citronsko kislino, je topnost vseh zdravil enaka, zato bi bila enaka tudi količina zdravilne učinkovine v tkivih piščancev.
English: Labelling:
Slovenian: BESEDILO ZA OZNAKE:
English: Czech Republic Eurovet Animal Health BV Handelsweg 25
Slovenian: Nizozemska Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel Nizozemska
English: CVMP conclusions after the re-examination
Slovenian: Zaključki Odbora po ponovnem pregledu
English: In this case, where comparison is made between a product containing tartaric acid and another containing citric acid, and a formulation effect cannot be excluded due to the unknown impact of tartaric acid in the intestine, bioequivalence would have to be established through in vivo studies.
Slovenian: Ker gre v tem primeru za primerjavo med zdravilom, ki vsebuje vinsko kislino, in zdravilom, ki vsebuje citronsko kislino, in ker zaradi neznanega učinka vinske kisline v črevesu ni mogoče izključiti vpliva sestave, bi bilo treba biološko enakovrednost potrditi v študijah in vivo.
English: The only significant differences between the conduct of the two studies was with the age and weight of the birds used.
Slovenian: Edini pomembni razliki v izvedbi teh dveh študij sta bili starost in telesna masa perutnine.
English: In order to address the concerns raised by the Netherlands, the MAH was requested to provide all available residue data for use of the product in chickens at the dose of 20 mg/kg body weight, together with an expert comment on the data and a justification for the meat withdrawal period in chickens.
Slovenian: Da bi razrešili vprašanja, ki jih je izpostavila Nizozemska, so imetnika dovoljenja za promet z zdravilom zaprosili, naj predloži vse razpoložljive podatke o ostankih za uporabo zdravila pri piščancih pri odmerku 20 mg/kg telesne mase, skupaj z mnenjem strokovnjaka in utemeljitvijo karence za piščančje meso.
English: Annex III
Slovenian: DODATEK III
English: Based on the results from this study which was assessed during the variation application and was deemed adequately performed a chicken meat withdrawal period of 6 days was supported using the CVMP accepted alternative approach.
Slovenian: Glede na rezultate iz te študije, ki so jo preučili med obravnavo vloge za spremembo in ugotovili, da je bila ustrezno izvedena, so z uporabo alternativnega pristopa, ki ga je odobril CVMP, za piščančje meso izračunali karenco 6 dni.
English: • the CVMP on the basis of the available residue depletion data considered that a withdrawal period of 9 days should be established for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days; the CVMP recommended the granting of the variation to the terms of the marketing authorisations for Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/DC) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/DC) in accordance with the recommended changes in the relevant sections of the product information as set out in Annex III.
Slovenian: • CVMP je na podlagi razpoložljivih podatkov o izločanju ostankov menil, da bi morala biti pri odmerku 20 mg/kg telesne mase 4 dni zapored karenca za piščančje meso in drobovino 9 dni; je CVMP priporočil odobritev spremembe pogojev dovoljenj za promet z zdravilom Soludox 500 mg/g prašek za uporabo v vodi za pitje za prašiče in piščance (NL/V/0141/001/DC) in Soludox 500 mg/g prašek za uporabo v vodi za pitje za prašiče in piščance (UK/V/0349/001/DC) v skladu s priporočenimi spremembami ustreznih poglavij informacij o zdravilu, določenimi v Prilogi III.
English: The MAH's grounds for re-examination focused on the fact that, as a powder for oral administration via the drinking water, Soludox can be considered to be bioequivalent to all other doxyclycline containing products for use in drinking water, and that therefore, the shorter withdrawal periods approved for these products would also be appropriate for Soludox.
Slovenian: Razlogi imetnika dovoljenja za promet za zahtevo ponovnega pregleda so temeljili na dejstvu, da je zdravilo Soludox kot prašek za peroralno uporabo z vodo za pitje mogoče obravnavati kot biološko enakovredno vsem drugim zdravilom za uporabo v vodi za pitje, ki vsebujejo doksiciklin, in da bi bile zato krajše karence, odobrene za ta zdravila, primerne tudi za zdravilo Soludox.
English: However, the apparent similarity of solubility within drinking water should not be understood as providing an argument for ruling out definitively a formulation effect due to the presence of tartaric acid.
Slovenian: Vendar pa očitna podobna topnost v vodi za pitje ne more biti razlog za dokončno izključitev vpliva sestave zdravila zaradi vsebnosti vinske kisline.
English: Estonia
Slovenian: Estoniji
English: There are two authorised dosages: 10 mg/kg body weight for 4 consecutive days, for which the withdrawal period is 3 days, and 20 mg/kg body weight for 4 consecutive days for which the withdrawal period is 12 days.
Slovenian: Odobrena sta dva odmerka: 10 mg/kg telesne mase 4 dni zapored, pri čemer je karenca 3 dni, in 20 mg/kg telesne mase 4 dni zapored, pri čemer je karenca 12 dni.
English: Annex I
Slovenian: DODATEK I
English: Regarding the residue depletion studies that were submitted, the MAH could not explain why the studies lead to different withdrawal periods.
Slovenian: V zvezi s predloženimi študijami o izločanju ostankov imetnik dovoljenja za promet ni mogel pojasniti, zakaj so v študijah izračunali različne karence.
English: Therefore, the MAH concluded that the 1999 study should be disregarded and only the results of the 2011 study should be taken into account in establishing a withdrawal period, as these also correspond with the conclusions drawn in relation to other marketed products.
Slovenian: Zato je imetnik dovoljenja za promet z zdravilom menil, da bi bilo treba študijo iz leta 1999 prezreti in pri določanju karence upoštevati zgolj rezultate študije iz leta 2011, ki se ujemajo z zaključki v zvezi z drugimi zdravili na trgu.
English: During the worksharing procedure a potential serious risk to human health was identified by the Netherlands regarding the appropriate withdrawal period for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days.
Slovenian: Med postopkom z delitvijo dela je Nizozemska ugotovila možno resno tveganje za zdravje ljudi, povezano z ustrezno karenco za piščančje meso in drobovino pri odmerku 20 mg/kg telesne mase 4 dni zapored.