FrancophonIA/ELRC3.0 huggingface dataset:
English: These cases were considered to have resulted from animals grooming each other.
Slovenian: Menili so, da je do teh primerov prišlo, ker so živali negovale druga drugo.
English: This led to the identification of 251 products.
Slovenian: Pri tem je ugotovil 251 zdravil.
English: Available data
Slovenian: Razpoložljivi podatki
English: The statement ‘do not use during the last trimester of pregnancy' was considered appropriate to overcome uncertainties resulting from the identified deficiencies.
Slovenian: Izjava „Ne uporabite v zadnjem trimesečju brejosti“ se šteje za primerno, da se obvladajo negotovosti, ki izhajajo iz ugotovljenih pomanjkljivosti.
English: 20093 Cologno Monzese (MI) ITALY
Slovenian: 20093 Cologno Monzese (MI) ITALIJA
English: It is noted that, in practice, the dry period is generally considerably shorter than 20 weeks.
Slovenian: Ugotavlja se, da je v praksi doba presušitve po navadi bistveno krajša kot 20 tednov.
English: Available data Study 1.
Slovenian: Razpoložljivi podatki 1. študija.
English: Issues related to availability of veterinary medicines and animal welfare are outside the scope of this referral.
Slovenian: Vprašanja v zvezi z razpoložljivostjo zdravil za uporabo v veterinarski medicini in zdravjem živali so zunaj obsega te napotitve.
English: Other deficiencies in the study, including the fact that it was not GLP compliant and that only the draft study report was provided also reduce the robustness of the study.
Slovenian: Druge pomanjkljivosti študije, kot sta dejstvi, da študija ni bila skladna z GLP in da je bil predložen samo osnutek poročila o študiji, tudi zmanjšajo njeno robustnost.
English: The Committee was also asked to recommend whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Slovenian: Odbor je bil naprošen tudi za priporočilo o ohranitvi, spremembi, zadržanju ali umiku dovoljenj za promet z zdravili.
English: 8501 Novo Mesto SLOVENIA
Slovenian: 8501 Novo Mesto SLOVENIJA
English: The following equation describes the elimination process in the terminal phase:
Slovenian: Proces izločanja v končni fazi opisuje naslednja enačba:
English: In view of the limited data available the Committee considered it appropriate to round these minimum time spans upwards in order to arrive at general recommendations.
Slovenian: Ker je razpoložljivih podatkov malo, je Odbor menil, da je primerno te najkrajše časovne presledke zaokrožiti navzgor in izpeljati splošna priporočila.
English: 40064 Ozzano Emilia (BO) ITALY
Slovenian: 40064 Ozzano Emilia (BO)ITALIJA
English: Furthermore, available data suggest that the parent compound is present in milk at comparable or lower levels than in plasma.
Slovenian: Poleg tega razpoložljivi podatki kažejo, da je izvorna spojina prisotna v mleku v primerljivih ali nižjih ravneh kot v plazmi.
English: The CVMP collected information from national competent authorities on veterinary medicinal products containing these substances.
Slovenian: Odbor je od nacionalnih pristojnih organov pridobil podatke o zdravilih za uporabo v veterinarski medicini, ki vsebujejo te snovi.
English: This analysis used the ‘SCLR' (Safe concentrations based on linear regression) method.
Slovenian: V tej analizi je bila uporabljena metoda „SCLR“ (varne koncentracije na podlagi linearne regresije).
English: Fasciola hepatica (common name: liver fluke), is the causative agent of fasciolosis, one of the most economically important helminth diseases of livestock worldwide.
Slovenian: Fasciola hepatica (navadno ime: veliki metljaj) je povzročitelj fascioloze, ene od gospodarsko najpomembnejših okužb s črvi pri živini v svetu.
English: For the purposes of this referral this can be equated to 1 year.
Slovenian: Za namen te napotitve lahko to izenačimo z 1 letom.
English: Esteve Farma LDA Av. Do Forte, 3
Slovenian: Portugalska Esteve Farma LDA Av. Do Forte, 3
English: It is noted that, in practice, the dry period is generally considerably shorter than 81 days or 12 weeks.
Slovenian: Ugotavlja se, da je v praksi doba presušitve po navadi bistveno krajša kot 81 dni oziroma 12 tednov.
English: However, residue levels in milk from the first milkings were in the range of 50 to 730 μg/l.
Slovenian: Vendar so bile ravni ostankov v mleku prvih molž od 50 do 730 μg/l.
English: It should be noted that while the recommended time spans reflect safe exposure levels for the consumer, residues (at safe levels) may still be found in milk upon control.
Slovenian: Treba je upoštevati, da čeprav priporočeni časovni presledki odražajo varne ravni izpostavljenosti za potrošnika, se lahko ostanki (v varnih ravneh) še vedno lahko odkrijejo pri nadzoru mleka.
English: However, because the type of data are similar the method is also considered appropriate for use here.
Slovenian: Ker je vrsta podatkov podobna, se uporaba te metode na tem mestu šteje za primerno.
English: 15 Fleming Street Maroussi 15123 GREECE
Slovenian: 15 Fleming Street Maroussi 15123GRČIJA
English: A period of one year is therefore considered to represent a conservative default value that can be used where no substance/route specific data are available.
Slovenian: Obdobje enega leta se torej šteje za konservativno privzeto vrednost, ki se lahko uporabi, če niso na voljo specifični podatki za snov oziroma pot uporabe.
English: D-81379 München GERMANY
Slovenian: D-81379 MünchenNEMČIJA
English: Av. Maria Lamas, Lt.19 - BL APiso 2 - Serra das Minas 2635-432 Rio de Mouro PORTUGAL
Slovenian: Av. Maria Lamas, Lt.19 - BL APiso 2 - Serra das Minas 2635-432 Rio de
English: 2909 LD Capelle a/d Ijssel THE NETHERLANDS
Slovenian: 2909 LD Capelle a/d
English: Bury St Edmunds Suffolk IP30 9UP UNITED KINGDOM
Slovenian: Bury St Edmunds Suffolk IP30 9UP ZDRUŽENO KRALJESTVO
English: Floridsdorfer Hauptstrasse 1 A-1210 Wien
Slovenian: Floridsdorfer Hauptstrasse 1 A-1210 WienAVSTRIJA
English: 92787 Issy Les Moulineaux Cedex 9
Slovenian: 92787 Issy Les Moulineaux Cedex 9FRANCIJA
English: It is also noteworthy that the CVMP recommendation relating to the use of nitroxinil in cattle is meant to be applicable to all nitroxinil containing products including those with different formulations and strengths.
Slovenian: Treba je tudi izpostaviti, da je priporočilo Odbora glede uporabe nitroksinila pri govedu namenjeno uporabi pri vseh zdravilih z nitroksinilom, vključno s tistimi, ki imajo drugačne formulacije in jakosti.
English: This can be done by using empirically derived milk to plasma ratios or, in principle, by using appropriate pharmacokinetic data (as described by Rasmussen, 19661).
Slovenian: To je mogoče z uporabo izkustveno izpeljanega razmerja med mlekom in plazmo ali načeloma z uporabo ustreznih farmakokinetičnih podatkov (kot je opisano v Rasmussenu, 19661).
English: However, as it is common practice to keep animals in a group, there is a risk that concentrations of triclabendazole in milk will exceed 10 μg/l, possibly even in untreated (lactating) animals.
Slovenian: Ker je splošna praksa, da so živali v skupini, obstaja tveganje, da koncentracije triklabendazola v mleku presežejo 10 μg/l, tudi v nezdravljenih živalih (v laktaciji).
English: Nitroxinil was therefore considered to be an appropriate marker residue for use in milk.
Slovenian: Nitroksinil se zato šteje za primernega označevalca ostankov za uporabo v mleku.
English: Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE
Slovenian: Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil MalmaisonFRANCIJA
English: 5 Pharmaceutical form for oral administration - bolus
Slovenian: 5Farmacevtska oblika za peroralno uporabo - bolus
English: For the purposes of this referral the time interval of 119 days can be equated to half of the gestation period.
Slovenian: Za namen te napotitve se lahko presledek 119 dni enači s polovico trajanja brejosti.
English: E-08950 Esplugues de Llobregat (Barselona) SPAIN
Slovenian: E-08950 Esplugues de Llobregat (BarselonaŠPANIJA
English: Half-lives reported for rafoxanide range between 7 and 16.6 days.
Slovenian: Ugotavljajo, da je razpolovna doba rafoksanida od 7 do 16,6 dneva.
English: The time required for plasma closantel levels to deplete to 2250 μg/l was calculated to be 1780 hours (approximately 75 days) for one formulation and 1931 hours (approximately 81 days) for the other formulation.
Slovenian: Čas, potreben za upad plazemskih ravni klozantela na 2250 μg/l, je po izračunu 1780 ur (približno 75 dni) za eno formulacijo in 1931 ur (približno 81 dni) za drugo formulacijo.
English: Provet Aspropyrgos 19300, Attik GREECE
Slovenian: Aspropyrgos 19300, AttikGRČIJA
English: Consequently, it is concluded that residues in milk can only be expected to be below 10 µg/l if animals are prevented from grooming other (treated) animals.
Slovenian: Posledično lahko sklepamo, da bodo ostanki v mleku pod 10 µg/l, le če se prepreči negovanje med (zdravljenimi) živalmi.
English: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss GERMANY
Slovenian: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 NeussNEMČIJA
English: Northern Ireland UNITED KINGDOM
Slovenian: Northern Ireland ZDRUŽENO KRALJESTVO
English: However, it must be emphasised that these data are limited, with very few studies specifically addressing the depletion of residues of relevant substances in dry cattle/sheep/goats.
Slovenian: Kljub temu je treba poudariti, da so ti podatki skopi, saj obstaja zelo malo študij, ki so posebej obravnavale izločanje ostankov zadevnih snovi pri govedu/ovcah/kozah v dobi presušitve.
English: While residues of nitroxinil in milk may be present largely as nitroxinil (as is the case in fat), there have also been reports of nitroxinil conjugates in milk (Whelan et al., 2011).
Slovenian: Čeprav so lahko ostanki nitroksinila v mleku večinoma prisotni kot nitroksinil (kakor v maščobi), obstajajo poročila o konjugatih nitroksinila v mleku (Whelan et al., 2011).
English: Merial Italia S.p.A. via Vittorio Pisani, 16 20100 Milano ITALY
Slovenian: via Vittorio Pisani, 16 20100 Milano ITALIJA
English: In the majority of cases transfer of substances from blood plasma to milk (and vice versa) is governed by simple diffusion across the mammary gland epithelium (Rasmussen, 1966); active transport has been rarely reported (Ito and Lee, 2003)3.
Slovenian: V večini primerov prenos snovi iz krvne plazme v mleko (in obratno) ureja preprosta difuzija skozi epitel mlečne žleze (Rasmussen, 1966), aktivni transport je bil ugotovljen redko (Ito in Lee, 2003)3.
English: Luxembourg Pfizer Animal Health S.A. rue Laid Burniat 1
Slovenian: Luksemburg Pfizer Animal Health S.A. rue Laid Burniat 1
English: While no evidence was available to indicate that the pharmacokinetic and residue depletion behaviour following administration of the different nitroxinil containing products would be identical to that seen in the available study, the conservative approach adopted in the interpretation of the available data ensures that the resulting recommendation is valid for all nitroxinil containing products.
Slovenian: Čeprav ni bilo dokazov, ki bi kazali, da je obnašanje farmakokinetike in izločanja ostankov po uporabi različnih zdravil z nitroksinilom enako kot v razpoložljivi študiji, konservativni pristop, sprejet pri interpretaciji razpoložljivih podatkov, zagotavlja veljavnost priporočila za vsa zdravila, ki vsebujejo nitroksinil.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe zdravila in predlagateljev/imetnikov dovoljenj za promet z zdravilom v državah članicah
English: Rua do Centro Empresarial Ed. 13, Quinta da Beloura 2710-693 Sintra PORTUGAL
Slovenian: Rua do Centro Empresarial Ed. 13, Quinta da Beloura 2710-693 Sintra PORTUGALSKA
English: 4 The SCLR method (CVMP 2000) is intended for use in milk withdrawal period calculations.
Slovenian: 4Metoda SCLR (CVMP 2000) je namenjena izračunom karence za mleko.
English: The CVMP recommendation does not represent a formal withdrawal period.
Slovenian: Priporočilo Odbora ne predstavlja uradne karence.
English: 75014 Paris
Slovenian: 75014 ParisFRANCIJA
English: 00330 Helsinki FINLAND
Slovenian: 00330 HelsinkiFINSKA
English: 1348 Luvain-la-Neuve BELGIUM
Slovenian: 1348 Luvain-la-NeuveBELGIJA
English: 2080-104 Almeirim PORTUGAL
Slovenian: 2080-104 Almeirim PORTUGALSKA
English: Merial Portuguesa Saúde Animal, Lda
Slovenian: Portugalska Merial Portuguesa Saúde Animal, Lda
English: On 14 February 2011, the European Commission initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no MRL has been established in milk intended for use in all ruminants producing milk for human consumption.
Slovenian: Evropska komisija je 14. februarja 2011 sprožila napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES, kakor je bila spremenjena, za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilne učinkovine proti metljajem, za katere ni bila določena mejna vrednost ostankov v mleku, in ki se uporabljajo pri vseh prežvekovalcih, katerih mleko je namenjeno prehrani ljudi.
English: D-10785 Berlin GERMANY
Slovenian: D-10785 BerlinNEMČIJA
English: Using linear regression to extrapolate from these data suggests that treatment would need to occur 136 days (i.e. 20 weeks) before calving (i.e. during the first half of the gestation period) in order to ensure that closantel levels in milk from the first milking would be below 45 μg/l.
Slovenian: Ekstrapolacija iz teh podatkov z linearno regresijo kaže, da se mora zdravljenje izvesti 136 dni (tj. 20 tednov) pred telitvijo (tj. med prvo polovico brejosti), da so ravni klozantela v mleku prve molže pod 45 μg/l.
English: From these 251 veterinary medicinal products, 96 contain one of the substances mentioned above as a single active substance and the remaining 155 are combination products containing a second non-flukicidal active substance.
Slovenian: Od teh 251 zdravil za uporabo v veterinarski medicini jih je 96 vsebovalo eno od omenjenih snovi kot samostojno zdravilno učinkovino, preostalih 155 zdravil pa je bilo kombiniranih in so vsebovala še zdravilno učinkovino, ki ni usmerjena proti metljajem.
English: The Committee agreed that, in such cases, and where possible, milk concentrations could be estimated by extrapolation from plasma concentrations.
Slovenian: Odbor je menil, da se lahko v takih primerih koncentracije v mleku ocenijo z ekstrapolacijo iz plazemskih koncentracij, če je mogoče.
English: Moxidektin/ Triklabendazol Fort Dodge
Slovenian: Moxidektin/ Triklabendazol Fort Dodge triklabendazol moksidektin peroralna raztopina
English: While this period of one year is markedly longer than the period of 12 days established for subcutaneously administered clorsulon, it is noteworthy that the only identified oral administration pharmaceutical form containing clorsulon as a single active substance is a bolus, for which the conservative default value is considered appropriate.
Slovenian: Čeprav je obdobje enega leta bistveno daljše od obdobja 12 dni, določenih za subkutano uporabljen klorsulon, je pomembno, da je bolus edina ugotovljena farmacevtska oblika za peroralno dajanje s klorsulonom kot edino zdravilno učinkovino, in zanj se konservativna privzeta vrednost šteje kot primerna.
English: Using this value and the plasma concentrations of clorsulon recorded in study 2 reported above, the time required for depletion of residues to a safe concentration was calculated.
Slovenian: Z uporabo vrednosti in koncentracij klorsulona v plazmi, ugotovljenih v zgoraj omenjeni 2. študiji, je bil izračunan čas, potreben za upad ravni ostankov na varno koncentracijo.
English: The length of the dry period was monitored, as well as milk levels of nitroxinil for up to 120 days post treatment (non GCP study) - Danaher et al, 2010
Slovenian: Spremljali so trajanje dobe presušitve in ravni nitroksinila v mleku do 120 dni po zdravljenju (študija brez GCP) - Danaher et al, 2010
English: The milk to plasma ratio for a substance can be established based on empirical data (i.e. measured levels of the substance in plasma and milk at equal time points).
Slovenian: Razmerje med mlekom in plazmo za določeno snov lahko določimo na podlagi izkustvenih podatkov (tj. izmerjenih ravni snovi v plazmi in mleku v istih časovnih točkah).
English: The marketing authorisation holder concluded that a period of 71 days between product administration and calving would be sufficient to ensure consumer safety and that such a time span would still allow use of nitroxinil in dry cattle, thus improving treatment options.
Slovenian: Imetnik dovoljenja za promet je zaključil, da časovni presledek 71 dni med uporabo zdravila in telitvijo zadostuje za zagotovitev varnosti potrošnika ter da ta časovni presledek še omogoča uporabo nitroksinila pri govedu v dobi presušenosti, kar izboljša možnosti zdravljenja.
English: It was concluded that residues in pasma would be below 0.18 μg/l 78 days (11 weeks) after administration.
Slovenian: Sledi zaključek, da bodo ostanki v plazmi pod koncentracijo 0,18 μg/l 78 dni (11 tednov) po uporabi.
English: The marker residue established for tissues is the ‘sum of extractable residues which may be oxidised to ketotriclabendazole'.
Slovenian: Za tkiva je kot označevalni ostanek določena „vsota ostankov, ki jih je mogoče ekstrahirati in oksidirati v ketotriklabendazol“.
English: However, in study 4 longer pre-calving periods were investigated.
Slovenian: Vendar pa so v 4. študiji preučili daljša obdobje pred telitvijo.
English: The available data relating to residues in milk following oral administration (study 3) showed a slow but clear depletion of residues in milk in the days after calving.
Slovenian: Razpoložljivi podatki v zvezi z ostanki v mleku po peroralnem dajanju (3. študija) kažejo počasno, vendar jasno upadanje ravni ostankov v mleka v dnevih po telitvi.
English: Predicting residue levels in milk based on data in plasma
Slovenian: Napovedovanje ravni ostankov v mleku na osnovi podatkov za plazmo
English: This could result in consumer exposure to residues of closantel over the ADI.
Slovenian: To lahko privede do izpostavljenosti potrošnika ostankom klozantela, ki presega vrednost ADI.
English: To calculate the total number of molecules administered the following information is required: the total treatment dose given to the animal; the bodyweight of the animal; the molar weight of the drug substance; and Avogadro's number.
Slovenian: Za izračun skupnega števila vnesenih molekul so potrebni naslednji podatki: celotni terapevtski odmerek, ki ga prejme žival; telesna masa živali; molska masa zdravilne učinkovine in Avogadrovo število.
English: If no such data are available, the milk to plasma ratio could, in principle, be calculated on the basis of the pKa, degree of lipid solubility (ie the relative concentrations of ionised and unionised free drug), the degree of protein binding in plasma and milk, and assuming standard pH values for plasma and milk (Rasmussen, 1966).
Slovenian: Če taki podatki niso na voljo, je razmerje med mlekom in plazmo načeloma mogoče izračunati na podlagi vrednosti pKa, stopnje topnosti v maščobah (tj. relativnih koncentracij ioniziranega in neioniziranega prostega zdravila), stopnje vezave na beljakovine v plazmi in mleku ter predpostavke standardnih vrednosti pH v plazmi in mleku (Rasmussen, 1966).
English: 78 days
Slovenian: 78 dni
English: The conclusions of this referral will remain appropriate even if the recommended milk MRLs are established for the above substances, unless product specific data are submitted to the national competent authorities for the establishment of milk withdrawal periods.
Slovenian: Zaključki te napotitve ostajajo ustrezni tudi, če se potrdijo priporočene mejne vrednosti ostankov za navedene snovi, razen če se nacionalnim pristojnim organom predložijo specifični podatki za določitev karence za mleko.
English: 300 mg/tab Tablets oral
Slovenian: 300 mg/tab tablete
English: The ‘SCLR' (Safe concentrations based on linear regression)4 method was used to extrapolate from the combined plasma depletion data available for the two formulations used in study 2.
Slovenian: Z metodo „SCLR“ (varne koncentracije na podlagi linearne regresije)4 je izvedena ekstrapolacija kombiniranih podatkov izločanja iz plazme za obe formulaciji iz 2. študije.
English: The amount and quality of available data are not comparable with that which would normally form the basis for the establishment of MRLs or withdrawal periods and as a result, the recommendations made are general and conservative, and are not product specific - no distinction is made to account for formulation or strength differences, or for dosage differences.
Slovenian: Količina in kakovost razpoložljivih podatkov nista primerljivi s količino in kakovostjo podatkov, ki se navadno zberejo kot osnova za določanje mejne vrednosti ostankov ali karenc, zato so priporočila splošna in konservativna ter niso specifična za zdravilo - brez upoštevanja razlik v formulaciji, jakosti in odmerjanju.
English: Helmizol Plus Clorsulon mg/bolus
Slovenian: Helmizol Plus klorsulon mg/bolus bolus
English: Romavermectina B1 1% Plus
Slovenian: Romavermectina B1 1% Plus klorsulon ivermektin
English: Based on the data from study 1 the ratio of rafoxanide to total residues in milk of cattle was approximately 0.25 to 0.35.
Slovenian: Na podlagi podatkov 1. študije je razmerje rafoksanida proti skupnim ostankom v mleku govedi približno od 0,25 do 0,35.
English: The data from this residue study in milk were not suitable for determination of a safe pre-calving interval.
Slovenian: Podatki iz te študije ostankov v mleku niso primerni za določanje varnega presledka pred telitvijo.
English: However, based on the results of study 1 the milk/serum concentration ratio of rafoxanide (measured as radiolabelled Iodine in chloroform extract) was approximately 1/30.
Slovenian: Vendar rezultati 1. študije kažejo, da je razmerje koncentracije rafoksanida v mleku in koncentracije v serumu (izmerjeno z radioaktivnim jodom v ekstraktu s kloroformom) približno 1/30.
English: It is acknowledged that the guidance relates to methods for establishing withdrawal periods for milk, however, because the type of data to be evaluated in this referral is similar to that typically evaluated for the establishment of withdrawal periods, the use of these approaches is considered appropriate here.
Slovenian: Priznava se, da se navodilo nanaša na metode za določanje karenc za mleko, vendar je vrsta podatkov, vrednotenih v tej napotitvi, podobna tistim, ki se navadno vrednotijo pri določanju karenc, zato se uporaba teh pristopov šteje za primerno.
English: el equation 1
Slovenian: el enačba 1,
English: Quinn's Chemist Bridge Street Crossmolina Co. Mayo IRELAND
Slovenian: Quinn's Chemist Bridge Street Crossmolina Co. MayoIRSKA
English: While this approach was acknowledged to be conservative, in the absence of alternative relevant data, it does provide a means for estimating a time point at which residues in milk can be concluded to be safe.
Slovenian: Čeprav se priznava, da je ta pristop konservativen, v odsotnosti drugih pomembnih podatkov zagotavlja oceno časovne točke, ko se ostanki v mleku lahko štejejo za varne.
English: Pasteur - Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
Slovenian: Pasteur - Filiala Filipesti SRL Str. Principala nr. 944
English: The results showed that the marker residue in milk at the first milking is below the safe concentration when a pre-calving period of 2 months is respected.
Slovenian: Rezultati so pokazali, da je raven označevalnega ostanka v mleku prve molže pod varno koncentracijo, če se uporabi 2-mesečni presledek pred telitvijo.