natgillin/translations-raw huggingface dataset:
The microbiological assay was adequately validated.
Mikrobiološki test je bil ustrezno validiran.
The study is not provided as a full report but rather as a summary.
Študija ni predložena v obliki celotnega poročila, pač pa kot povzetek.
It should be emphasised that the extrapolation method used is a pragmatic approach aimed at preserving product availability while in the same time ensuring consumer safety.
Poudariti je treba, da je uporabljena metoda ekstrapolacije pragmatični pristop, namenjen ohranjanju razpoložljivosti zdravil in hkratnemu zagotavljanju varnosti potrošnikov.
H. For products listed in Annex I for which lactating cows have already been approved as target species
H. Za zdravila, navedena v Prilogi I, pri katerih so krave v obdobju laktacije že odobrene kot ciljna vrsta
PASTEUR - Filiala Filipesti SRL
Romunija PASTEUR - Filiala Filipesti SRL
DISTRIBUIDORA DE PROD. AGRO-PECUÁRIOS, SA Centro Empresarial da Rainha, Lote 27
Portugalska VETLIMA - SOC. DISTRIBUIDORA DE PROD. AGRO-PECUÁRIOS, SA Centro Empresarial da Rainha, Lote 27
For the target species pigs, three studies were identified from which a sufficiently reliable withdrawal period could be drawn.
Za ciljno vrsto prašiči so našli tri študije, iz katerih je mogoče izpeljati dovolj zanesljive karence.
WPnew = WPold + {log2(Dnew/Dold) x T1/2(final phase)}
WPnova = WPstara + {log2(Dnov/Dstar) x T1/2(končna faza)}
However, in the context of this referral procedure, where products are already authorised and where limited residue depletion data are available, use of this pragmatic approach was considered to be an acceptable way to maintain the availability of medicinal products while ensuring consumer safety.
Vendar je bila v kontekstu tega napotitvenega postopka, kjer so zdravila že odobrena in so na voljo omejeni podatki o izločanju ostankov, uporaba omenjenega pragmatičnega pristopa sprejemljiv način, kako ohraniti razpoložljivost zdravil in hkrati zagotoviti varnost potrošnikov.
Intramuscular or intravenous use:
Intramuskularna ali intravenska uporaba:
The enrolled animals were 6-7 month old ruminating calves.
Vključene živali so bila 6-7 mesecev stara prežvekovalna teleta.
Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections.
Gentamicin je aminoglikozidni antibiotik, indiciran za zdravljenje različnih bakterijskih okužb.
Milk samples were collected up to 90 hours after the last administration.
Vzorce mleka so jemali v času do 90 ur po zadnjem odmerku.
In that case an extrapolated withdrawal period of 228 days is recommended.
V tem primeru je priporočljiva ekstrapolirana karenca 228 dni.
Repeated injections should be made at different injection sites.
Ponovne injekcije dajajte na druga mesta injiciranja.
In both studies, calves of maximum 1.5 months, presumably nonruminating, were involved.
V obe študiji so bila vključena teleta, stara največ 1,5 meseca, domnevno pred začetkom prežvekovanja.
The approved withdrawal period of 146 days was derived using the alternative method with a safety span of 30%, and can be considered as safe for the consumer.
Odobrena karenca 146 dni je bila izpeljana z uporabo alternativne metode z varnostno mejo 30 % in velja za varno za potrošnika.
No complete validation data are available.
Popolni podatki o validaciji niso na voljo.
Overall the data from this study were not considered adequate for the purpose of deriving a milk withdrawal period.
V celoti podatki iz te študije niso bili ocenjeni kot primerni za namen izpeljave karence za mleko.
19 300 Aspropyrgos mailbox 26
Romunija Alapis SA 19 300 Aspropyrgos mailbox 26
Based on the information made available to the CVMP it appears that there are several products for which unclear dosing instructions are given in the product information.
Na osnovi informacij, ki so na voljo odboru CVMP, kaže, da obstaja več zdravil, za katera so navodila o odmerjanju v informacijah o zdravilu nejasna.
Only two animals per slaughter point were involved.
Pri posamezni točki zakola so zaklali le po dve živali.
Indeed, it appears from the available product compositions that products have very similar compositions, including common preservatives and buffer systems which are not likely to influence the absorption rate, and which are present in very low relative amounts.
Dejansko iz sestav razpoložljivih zdravil kaže, da imajo zdravila zelo podobno sestavo, vključno s skupnimi konzervansi in puferskimi sistemi, za katere je malo verjetno, da bi vplivali na hitrost absorpcije, in ki so prisotni v zelo majhnih količinah.
Moreover the residue depletion period is long for gentamicin, and will in most cases cover a period where animals will at least partly, be ruminating.
Poleg tega je čas izločanja ostankov gentamicina dolg in v večini primerov zajema obdobje, ko živali vsaj deloma prežvekujejo.
The study was conducted in ruminating cattle (350-380 kg).
Študija je bila opravljena pri prežvekovalnem govedu (350-380 kg).
Therefore, on 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs.
Zato je Belgija 8. januarja 2016 sprožila postopek v skladu s členom 35 Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje za dajanje govedu in prašičem.
It is acknowledged that there are some uncertainties in the data with respect to the terminal half-life and dose linearity of the depletion kinetics, both being conditions, that have to be fulfilled for a correct use of the extrapolation.
Priznava se, da obstaja nekaj negotovosti pri podatkih glede končne razpolovne dobe in linearnosti odmerka pri kinetiki izločanja, pri čemer sta to pogoja, ki morata biti izpolnjena za pravilno uporabo ekstrapolacije.
The piglets used were less than 1 month of age.
Vključeni prašički so bili mlajši od 1 meseca.
Only two animals per slaughter time were involved (14 hours, 7 days, 14 days, 28 days).
V določeni časovni točki so zaklali le po dve živali hkrati (14 ur, 7 dni, 14 dni, 28 dni).
No antimicrobial active residues could be detected in any milk sample collected, which is indicative of an overall very rapid depletion.
V nobenem od odvzetih vzorcev mleka niso zaznali protimikrobno aktivnih ostankov, kar kaže, da je izločanje na splošno zelo hitro.
They do not relate to the same applied posology.
Ne nanašajo se na enak način odmerjanja.
Applicant/Marketing Authorisation Holder
Predlagatelj/imetnik dovoljenja za promet z zdravilom
The statistical method could not be applied as, for all edible tissues, an insufficient number of data points were available.
Statistične metode niso mogli uporabiti, ker je bilo za vsa užitna tkiva na voljo premalo podatkovnih točk.
The studies were either not GLP-compliant, or the status is unknown.
Študiji bodisi nista bili opravljeni v skladu z dobro laboratorijsko prakso ali pa je njun status neznan.
It is the responsibility of each National Competent Authority to apply the recommendations of this opinion based on the recommended maximum dose as per the approved SPC, and to take action in case the recommendations in the product information cannot be properly interpreted.
Vsak pristojni nacionalni organ je odgovoren, da uporabi priporočila iz tega mnenja na podlagi največjega priporočenega odmerka v skladu z odobrenim povzetkom glavnih značilnosti zdravila in da ukrepa, če priporočil iz informacij o zdravilu ni mogoče ustrezno razložiti.
Indeed, the concerned products are for parenteral injection and therefore the impact of digestive physiology is likely limited.
Ker so zadevna zdravila namenjena parenteralnemu injiciranju, je vpliv prebavne fiziologije verjetno omejen.
No full report is available for the study with Genta-kel 5%, while the study with Gentaveto-5 was provided as a full report.
Za študijo z zdravilom Genta-kel 5% ni na voljo celotnega poročila, študija z zdravilom Gentaveto-5 pa je bila predložena v obliki celotnega poročila.
No full study report and analytical method validation report are available.
Celotno poročilo o študiji in poročilo o validaciji analizne metode nista na voljo.
It is noted that the dose used in the relevant study (50 mg gentamicin base per kg bw) appears to cover all of the currently recommended dosing regimens.
Kaže pa, da odmerek, uporabljen v ustrezni študiji (50 mg gentamicinijeve baze na kg telesne mase), zajema vse trenutno priporočene sheme odmerjanja.
However, it appears from all the data taken together that, at least for an injection volume of up to 20 ml in calves, the injection site is not the limiting tissue and therefore, it may be considered that the risk for the consumer in relation to higher injection volumes would remain low.
Vendar se na podlagi vseh podatkov zdi, da vsaj pri volumnih injiciranja do 20 ml pri teletih mesto injiciranja ni omejujoče tkivo in se zato lahko šteje, da tveganje za potrošnike v povezavi z večjimi volumni injiciranja ostaja majhno.
List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in predlagateljev/imetnikov dovoljenj za promet z zdravilom v državah članicah
Residue concentrations in milk were determined 12, 24, 36, 48, 60, 72, 84 and 96 hours after the last administration.
Koncentracije ostankov v mleku so določali 12, 24, 36, 48, 60, 72, 84 in 96 ur po zadnjem odmerku.
The analytical method used liquid-liquid chromatography with fluorometric detection but data demonstrating the validity of the method were not available; only 3 of the 4 recommended gentamicin marker residue components were monitored.
Analizna metoda je bila porazdelitvena kromatografija s fluorometričnim zaznavanjem, vendar podatki za dokaz veljavnosti metode niso bili na voljo; spremljali so le 3 od 4 priporočenih komponent označevalca ostankov gentamicina.
Taking a pragmatic approach intended to preserve product availability in lactating cows while ensuring consumer safety, it is considered appropriate to apply to the maximum milk withdrawal period currently authorised, i.e., 7 days, to all products that have lactating cows as an indicated species.
S pragmatičnim pristopom, s katerim bi ohranili razpoložljivosti zdravil za krave v obdobju laktacije in hkrati zagotovili varnost potrošnikov, je ustrezna uporaba največje trenutno odobrene karence za mleko, tj. 7 dni, za vsa zdravila, ki so indicirana za uporabo pri kravah v obdobju laktacije.
The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to review all available residue depletion data and recommend withdrawal periods for cattle (meat and milk) and pigs.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je bil zaprošen, naj pregleda vse razpoložljive podatke o izločanju ostankov in priporoči karenci za govedo (meso in mleko) ter prašiče.
The low number of animals and data points did not allow analysis of the results using the TTSC (time to safe concentration) or SCLR (safe concentrations, based on linear regression, and allowing for measurements below the limit of quantification) statistical methods, as per CVMP Note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98)
Majhno število živali in podatkovnih točk ni omogočilo analize rezultatov z uporabo statistične metode TTSC (čas do varne koncentracije) ali SCLR (varne koncentracije na podlagi linearne regresije, ki omogočajo meritve pod mejo določljivosti) v skladu z navodili odbora CVMP za določanje karenc za mleko (EMEA/CVMP/473/98)
Animal species Route of administration
Živalska vrsta Pot uporabe zdravila
For that reason it is not possible to use the study to demonstrate a safe withdrawal period, despite the fact that no residues above the sensitivity limit of 100 µg/kg were detected.
Zato te študije ni mogoče uporabiti za dokaz varne karence, kljub dejstvu, da niso zaznali ostankov nad mejo občutljivosti 100 µg/kg.
The enrolled animals were non-ruminating calves of approximately 3 months, reported to have been fed solid feed during the study.
Vključene živali so bila teleta pred začetkom prežvekovanja, stara približno 3 mesece, ki so po navedbah med študijo prejemala trdno krmo.
Indeed, given the especially long persistence of gentamicin in tissues, which is not the case for the other substances in combination products, in view of the withdrawal periods generally approved for products containing trimethoprim and sulphonamides, there is no reason to expect any long-term effect on residues due to interaction.
Glede na zelo dolgo obstojnost gentamicina v tkivih, kar ne velja za druge učinkovine v kombiniranih zdravilih, in z upoštevanjem karenc, ki so na splošno odobrene za zdravila, ki vsebujejo trimetoprim in sulfonamide, ni razloga, da bi bilo zaradi medsebojnega delovanja pričakovati dolgoročne učinke.
It can be considered that this worst case withdrawal period sufficiently covers possible effects arising from differences in product composition.
Lahko se šteje, da je ta karenca za najslabši primer zadostna, da zajame morebitne učinke, ki izhajajo iz razlik v sestavi zdravila.
However in view of the overall data available on gentamicin residue depletion, it is known that fat and muscle (except injection site muscle) are not limiting tissues.
Glede na celokupne podatke, na voljo za izločanje ostankov gentamicina, je znano, da maščoba in mišice (razen mišic na mestu injiciranja) niso omejujoča tkiva.
A validated HPLC-MS/MS analytical method was used.
Uporabljali so validirano metodo HPLC-MS/MS.
It is not appropriate to pool the residue data in order to calculate an overall withdrawal period for all products as different dosing regimens were applied in the studies.
Podatkov o ostankih ni primerno združevati, da bi tako izračunali celokupno karenco za vsa zdravila, saj so v študijah uporabljali različne sheme odmerjanja.
On day 112 after the last injection, the last time point, all concentrations were below the MRL.
112. dan po zadnji injekciji, v zadnji časovni točki, so bile vse koncentracije pod najvišjo mejno vrednostjo ostanka.
• the CVMP considered that the overall benefit-risk balance for the products under this procedure remains positive subject to amendments in the product information;
• odbor CVMP je menil, da splošno razmerje med tveganji in koristmi za zdravila iz te napotitve ostaja pozitivno, pod pogojem, da se upoštevajo spremembe informacij o zdravilu;
Using the alternative method, applied to data in kidney, and with a 10% safety margin, leads to a withdrawal period of 139 days.
Z alternativno metodo, uporabljeno na podatkih za ledvice, in z 10-odstotno varnostno mejo so določili karenco 139 dni.
This withdrawal period includes a wide safety margin with regard to the available data.
Ta karenca glede na razpoložljive podatke vključuje široko varnostno mejo.
The study meets current standards, although the analytical method was microbiological and no control surrounding injection site sample was collected (on the other hand, two injection sites per animal, one on each side, were analysed).
Študija izpolnjuje trenutne standarde, čeprav je bila analizna metoda mikrobiološka in vzorec s kontrolnega mesta v okolici mesta injiciranja ni bil odvzet (po drugi strani pa so analizirali po dve mesti injiciranja na posamezno žival, po eno na vsaki strani).
The study involved calves of less than 1 month of age.
Študija je vključevala teleta, stara manj kot 1 mesec.
Scientific conclusions and grounds for amendment of the summary of product characteristics
Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila
No combined skin+fat sample was analysed, as only fat was sampled.
Kombiniranega vzorca kože z maščobo niso analizirali, ker so vzorčili samo maščobo.
The residue measured (gentamicin) did not correspond to the established marker residue, and the available data are not sufficient to allow verification of the validity of the HPLC-MS/MS analytical method.
Izmerjeni ostanek (gentamicin) ni ustrezal uveljavljenemu označevalnemu ostanku in razpoložljivi podatki ne zadoščajo za preverjanje veljavnosti analizne metode HPLC-MS/MS.
Some of the concerned products may be used in older animals than those used in the studies, leading to higher total injection volumes, which may entail a slowest depletion rate due to the decreased surface/volume ratio of the injection site bolus.
Nekatera od zadevnih zdravil se lahko uporabljajo pri živalih, ki so starejše od živali v študijah, kar privede do večjih skupnih volumnov injiciranja, to pa do počasnejšega izločanja zaradi manjšega razmerja med površino in volumnom bolusa na mestu injiciranja.
However, in view of the residues above the MRL in liver at day 89, and given that no full study report is available and no analytical method validation report is available, it is not possible to derive a withdrawal period from the study.
Glede na prisotnost ostankov v jetrih nad najvišjo mejno vrednostjo ostanka na 89. dan in glede na to, da celotno poročilo o študiji in poročilo o validaciji analizne metode nista na voljo, iz te študije ni mogoče izpeljati karence.
In the case of pigs, all withdrawal periods determined relate to a maximum injected volume of 1 ml, for a concentration of 50 mg/ml, and cannot be directly extrapolated either to larger volumes or to larger doses per injection site.
V primeru prašičev se vse ugotovljene karence nanašajo na največji volumen injiciranja 1 ml za koncentracijo 50 mg/ml in jih ni mogoče neposredno ekstrapolirati bodisi na večje volumne bodisi na večje odmerke na posamezno mesto injiciranja.
Calves (up to 13 weeks of age)
teleta (do 13. tedna starosti)
However in view of shortcomings in the study a reliable withdrawal period cannot be derived from this study.
Vendar pa glede na pomanjkljivosti študije iz te študije ni mogoče izpeljati zanesljive karence.
The analytical method was a bacteriological assay for which adequate validation data were not available, with a LLOQ of 100 µg/kg, i.e., twice the current applicable MRL (50 µg/kg for muscle).
Analizna metoda je bil bakteriološki test, za katerega ni bilo na voljo ustreznih podatkov o validaciji, spodnja meja določljivosti pa je bila 100 µg/kg, tj. dvakrat višja od trenutno veljavne najvišje mejne vrednosti ostanka (50 µg/kg za mišice).
Furthermore, the comparison of the studies with Aagent 50 mg/ml solution for injection (MAH: Fatro) and Genta-ject 10% (MAH: Dopharma) shows that residue depletion is not slower in very young animals, since the withdrawal period is lower (103 days) for calves less than one month of age receiving a milk replacer and a solid supplement, than for older calves receiving solid food.
Nadalje primerjava študij, opravljenih z zdraviloma Aagent 50 mg/ml raztopina za injiciranje (imetnik dovoljenja za promet: Fatro) in Genta-ject 10% (imetnik dovoljenja za promet: Dopharma), kaže, da izločanje ostankov pri zelo mladih živalih ni počasnejše, saj je karenca pri teletih, mlajših od enega meseca, ki prejemajo mlečni nadomestek in dodatek v trdni obliki, krajša (103 dni) kot pri starejših teletih, ki prejemajo trdno hrano.
This is confirmed to some extent by the rapid depletion observed with Forticine Solution 1% (MAH: Vetoquinol), also conducted in young calves fed with milk replacer.
To v določeni meri potrjuje tudi hitro izločanje zdravila Forticine Solution 1% (imetnik dovoljenja za promet: Vetoquinol), opaženo v študiji, opravljeni z mladimi teleti, hranjenimi z mlečnim nadomestkom.
In kidney, at the last time point i.e., 28 days after the last administration, all residue concentrations were below the current MRL value, although they remained relatively close to the MRL (680 and 700 µg/kg).
V ledvicah so bile v zadnji časovni točki, tj. 28 dni po zadnjem odmerku, vse koncentracije ostankov pod trenutno najvišjo mejno vrednostjo ostanka, vendar so ostajale sorazmerno blizu najvišji mejni vrednosti (680 oziroma 700 µg/kg).
The intention is to address those products concerned by this procedure for which the maximum recommended dose is high and for which no withdrawal period can be set in a conventional manner based on residue data.
Namen tega postopka je obravnavati tista zadevna zdravila, za katera je največji priporočeni odmerek velik in za katera na podlagi podatkov o ostankih ni mogoče določiti karence na običajen način.
Therefore, the injection volume should be limited to a maximum of 1 ml per injection site, or to 50 mg gentamicin per injection site for products with a strength exceeding 50 mg gentamicin per ml.
Zato je treba volumen injiciranja omejiti na največ 1 ml na mesto injiciranja oziroma 50 mg gentamicina na mesto injiciranja za zdravila z jakostjo, ki presega 50 mg gentamicina na ml.
The overall benefit-risk balance of the products under this procedure was deemed positive subject to the recommended amendments in the product information (see Annex III).
Splošno razmerje med tveganji in koristmi za zdravila iz te napotitve je bilo ocenjeno kot pozitivno, pod pogojem, da se upoštevajo priporočene spremembe informacij o zdravilu (glejte Prilogo III).
The withdrawal periods are, respectively, 44, 66 and 146 days.
Karence so 44, 66 oziroma 146 dni.
That study in piglets is GLP-compliant; the design is in accordance with current standards.
Ta študija, opravljena pri prašičkih, je skladna z dobro laboratorijsko prakso, njena zasnova pa je v skladu s trenutnimi standardi.
Furthermore, data available in Belgium for comparable products clearly indicate that residue levels can be above the maximum residue limits (MRLs) at the proposed withdrawal periods.
Tudi podatki, ki so v Belgiji na voljo za primerljiva zdravila, jasno kažejo, da so vrednosti ostankov po preteku predlagane karence lahko nad najvišjo mejno vrednostjo ostanka.
Overall summary of the scientific evaluation of veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje za dajanje govedu in prašičem (glejte Prilogo I)
Therefore, Belgium considered that consumer safety is not ensured by the withdrawal periods set for the reference product Genta 100 mg/ml (marketing authorisation holder (MAH): CP-Pharma) and consequently, for its generic product Emdogent 100 (applicant: Emdoka).
Zato je Belgija menila, da varnost potrošnikov s karenco, določeno za referenčno zdravilo Genta 100 mg/ml (imetnik dovoljenja za promet z zdravilo (imetnik dovoljenja za promet: CPPharma), in torej tudi za generično zdravilo Emdogent 100 (predlagatelj: Emdoka), ni zagotovljena.
It can be considered that this withdrawal period is sufficient to cover differences in product composition that could have an impact on the residue depletion pattern.
Lahko se šteje, da je omenjena karenca zadostna, da zajame razlike v sestavi zdravil, ki bi lahko imele vpliv na vzorec izločanja ostankov.
Due to the size of the animals no control surrounding injection site sample could be collected.
Zaradi velikosti živali ni bilo mogoče odvzeti vzorca iz okolice mesta injiciranja.
the CVMP has recommended variations of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
odbor CVMP je priporočil spremembo dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje za dajanje govedu in prašičem (glejte Prilogo I), in sicer je treba popraviti povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.