natgillin/translations-raw huggingface dataset:
Where: WPnew is the withdrawal period for the product for which a withdrawal period is to be derived; WPold is the withdrawal period for the product from which extrapolation is proposed; Dnew is the dose of the product for which a withdrawal period is to be derived; Dold is the dose of the product from which extrapolation is proposed; T1/2(final phase) is the terminal half-life.
zaokroženo pri čemer je: WPnova karenca za zdravilo, za katero je treba izpeljati karenco, WPstara karenca za zdravilo, za katero je predlagana ekstrapolacija, Dnovi odmerek zdravila, za katero je treba izpeljati karenco, Dstari odmerek zdravila, za katero je predlagana ekstrapolacija, in T1/2(končna faza) končna razpolovna doba.
A GLP compliant study conducted with Genta-ject 10% (MAH: Dopharma), was provided.
Predložena je bila študija, opravljena v skladu z dobro laboratorijsko prakso, z zdravilom Genta-ject 10% (imetnik dovoljenja za promet: Dopharma).
Those are the studies conducted with the products Gentavall 5 mg/ml (MAH: Mevet), Aagent 50 mg/ml solution for injection (MAH: Fatro), and Gentaveto-5 (MAH: VMD).
To so študije, opravljene z zdravili Gentavall 5 mg/ml (imetnik dovoljenja za promet: Mevet), Aagent 50 mg/ml raztopina za injiciranje (imetnik dovoljenja za promet: Fatro) in Gentaveto-5 (imetnik dovoljenja za promet: VMD).
The withdrawal period of 192 days cannot be applied to products for which the total recommended dose exceeds the dose used in the residues study, i.e., 24 mg gentamicin base per kg bw.
Karence 192 dni ni mogoče uporabiti za zdravila, pri katerih skupni priporočeni odmerek presega odmerek, uporabljen v študiji ostankov, tj. 24 mg gentamicinijeve baze na kg telesne mase.
Use of the statistical method for evaluation of the liver data is not considered appropriate, as the homoscedasticity assumption is not met. For the other tissues, the alternative method could be applied.
Uporaba statistične metode za ovrednotenje podatkov iz jeter ni ustrezna, saj predpostavka o homoskedastičnosti ni izpolnjena.
Meat and offal: 66 days.
Meso in organi: 66 dni.
Delete, where applicable, any references to subcutaneous use in cattle.
Kjer je ustrezno, pri govedu izbrišite vse sklice na subkutano uporabo.
The withdrawal period of 146 days can also be applied to other products, provided the total dose as per the recommendations does not exceed the total dose administered in the corresponding study (50 mg gentamicin base per kg bw).
Karenca 146 dni se lahko uporabi tudi za druga zdravila, pod pogojem, da skupni odmerek v skladu s priporočili ne presega skupnega odmerka, danega v ustrezni študiji (50 mg gentamicinijeve baze na kg telesne mase).
The residue measured (gentamicin) was not the established marker residue, and the lower limit of quantification (LLOQ) of the HPLC-MS/MS method was equal to the MRL for muscle and fat.
Izmerjeni ostanek (gentamicin) ni bil uveljavljeni označevalni ostanek in spodnja meja določljivosti (LLOQ) metode HPLC-MS/MS je bila enaka najvišji mejni vrednosti ostanka za mišice in maščobo.
This study is GLP-compliant and it is considered by the MAH (Fatro) as a preliminary study.
Študija je bila opravljene v skladu z dobro laboratorijsko prakso, imetnik dovoljenja za promet (Fatro) pa jo šteje za preliminarno študijo.
The study for Gentaveto-5 (MAH: VMD) was conducted in pigs weighing 3.75 to 8 kg, and dosed at 5 mg/kg bw, every 12 hours for 5 days.
Študija z zdravilom Gentaveto-5 (imetnik dovoljenja za promet: VMD) je bila opravljena pri prašičkih s telesno maso od 3,75 do 8 kg, ki so prejemali odmerke po 5 mg/kg telesne mase na 12 ur v obdobju 5 dni.
F. For all other products listed in Annex I for which the recommended total doses do not exceed 24 mg gentamicin base per kg bw for cattle and 50 mg gentamicin base per kg bw for pigs
F. Za vsa druga zdravila, navedena v Prilogi I, pri katerih največji priporočeni odmerki ne presegajo 24 mg gentamicinijeve baze na kg telesne mase pri govedu in 50 mg gentamicinijeve baze na kg telesne mase pri prašičih
Meat and offal: 146 days.
Meso in organi: 146 dni.
The product Aagent 50 mg/ml solution for injection was also tested in depletion studies in adult pigs.
Zdravilo Aagent 50 mg/ml raztopina za injiciranje so preskušali tudi v študijah izločanja pri odraslih prašičih.
At day 70, the last sampling point, the concentration of gentamicin still exceeded the MRLs in all liver and kidney samples, with some values amounting to more than 2x the current MRL in kidney and more than 3x in liver.
70. dan, pri zadnji točki vzorčenja, je koncentracija gentamicina v vseh vzorcih jeter in ledvic še vedno presegala najvišjo mejno vrednost ostanka, pri čemer so bile nekatere vrednosti v ledvicah več kot dvakrat višje od trenutne najvišje mejne vrednosti ostanka, v jetrih pa več kot trikrat višje.
The withdrawal periods for cattle (meat and milk) and pigs should be amended as recommended to provide assurance for consumer safety.
Za zagotavljanje varnosti potrošnikov je treba karence za govedo (meso in mleko) in prašiče spremeniti v skladu s priporočili.
GENTIPRA - 305 ESP gentamicin 50 mg/ml
GENTIPRA - 305 ESP gentamicin 50 mg/ml govedo (teleta do 250 kg)
No reliable withdrawal period can be established from these data.
Iz teh podatkov ni mogoče določiti zanesljive karence.
Calves, piglets (in the 1
teleta, prašički (v 1. mesecu starosti)
The dose administered was 4 mg/kg bw at a 12-hour interval on the first day, and afterwards at 24-hour intervals, until day 5 included.
Prvi dan je odmerek 4 mg/kg telesne mase prejemalo na 12 ur, nato pa v 24-urnih intervalih do vključno 5. dneva.
For products with a strength up to 50 mg gentamicin per ml: In pigs do not administer more than 1 ml per injection site.
Za zdravila z jakostjo do 50 mg gentamicina na ml: Pri prašičih ne dajajte več kot 1 ml na mesto injiciranja.
GENTAMICIN KRKA 80 mg/ml raztopina za injiciranje za govedo, prašiče, pse in mačke
GENTAMICIN KRKA 80 mg/ml raztopina za injiciranje za govedo, prašiče, pse in mačke govedo, prašiči, psi, mačke i.m.
In pigs do not administer more than 50 mg gentamicin per injection site.
Pri prašičih ne dajajte več kot 50 mg gentamicina na mesto injiciranja.
Belgium KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium
Madžarska KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium
The residue measured, gentamicin, was not the marker residue, and the LLOQ of the HPLC-MS/MS method was equal to the MRL for muscle and fat.
Izmerjeni ostanek, gentamicin, ni bil označevalni ostanek in spodnja meja določljivosti metode HPLCMS/MS je bila enaka najvišji mejni vrednosti ostanka za mišice in maščobo.
For products with a strength exceeding 50 mg gentamicin per ml: In pigs do not administer more than 50 mg gentamicin per injection site.
Za zdravila z jakostjo nad 50 mg gentamicina na ml: Pri prašičih ne dajajte več kot 50 mg gentamicina na mesto injiciranja.
In pigs do not administer more than 1 ml per injection site.
Pri prašičih ne dajajte več kot 1 ml na mesto injiciranja.
In renewal assessment reports as assessed by the Belgian NCA, a study was identified supporting the withdrawal period for Genta-kel 5% in calves (MAH: Kela).
V poročilih o oceni za podaljšanje dovoljenja za promet z zdravilom, ki jih je ocenjeval belgijski pristojni nacionalni organ, so našli študijo s podpornimi podatki za karenco za zdravilo Genta-kel 5% pri teletih (imetnik dovoljenja za promet: Kela).
The study is considered by the MAH as a pilot study and involves only 8 animals.
Študijo, ki vključuje samo 8 živali, šteje imetnik dovoljenja za promet za pilotno študijo.
At day 49, the last sampling point, levels in kidney and liver were above the MRLs in all samples, with some values being more than 2x MRL in kidney and more than 3x MRL in liver.
49. dan, pri zadnji točki vzorčenja, je bila raven v vseh vzorcih ledvic in jeter nad najvišjimi mejnimi vrednostmi ostanka, pri čemer so bile nekatere vrednosti v ledvicah več kot dvakrat višje od najvišje mejne vrednosti ostanka, v jetrih pa več kot trikrat višje.
Residue depletion in cattle meat and offal
Izločanje ostankov v govejem mesu in organih
FORTICINE SOLUTION gentamicin 40000 UI/ml
FORTICINE SOLUTION gentamicin 40000 UI/ml teleta i.m., i.v.
G. For products listed in Annex I for which the recommended total dose is between 24 mg gentamicin base per kg bw and 50 mg gentamicin base per kg bw for cattle
G. Za zdravila, navedena v Prilogi I, pri katerih je največji priporočeni odmerek pri govedu med 24 mg gentamicinijeve baze na kg telesne mase in 50 mg gentamicinijeve baze na kg telesne mase
The study involved groups of 4 animals receiving a dose of 4 mg/kg bw once a day for 5 days, which were slaughtered at days 21, 35, 49 and 70 after the last administration.
Študija je vključevala skupine po 4 živali, ki so prejemale odmerek 4 mg/kg telesne mase enkrat na dan v obdobju 5 dni in so jih zaklali 21., 35., 49. oziroma 70. dan po zadnjem odmerku.
D. For Gentaveto-5 (50 mg/ml) listed in Annex I (Marketing Authorisation Holder: V.M.D.
D. Za zdravilo Gentaveto-5 (50 mg/ml), navedeno v Prilogi I (imetnik dovoljenja za promet z zdravilom: V.M.D.
The product Aagent 50 mg/ml solution for injection was also tested in a depletion studies in adult cattle.
Zdravilo Aagent 50 mg/ml raztopina za injiciranje so preskušali tudi v študijah izločanja pri odraslem govedu.
In renewal assessment reports as assessed by the Belgian NCA, two studies were identified, respectively supporting the withdrawal periods for Genta-kel 5% (MAH: Kela), and for Gentaveto-5 in calves (MAH: VMD).
V poročilih o oceni za podaljšanje dovoljenja za promet z zdravilom, ki jih je ocenjeval belgijski pristojni nacionalni organ, so našli dve študiji s podpornimi podatki za karenco za zdravilo Genta-kel 5% p(imetnik dovoljenja za promet: Kela) in zdravilo Gentaveto-5 pri teletih (imetnik dovoljenja za promet: VMD).
For those products mentioned in the above paragraph that have maximum recommended doses that exceed those used in the residue studies, the worst case withdrawal period derived directly from residue data, i.e. 146 days, should be applied provided the total dose as per the SPC recommendations does not exceed the total dose administered in the study that yielded this withdrawal period (i.e. 50 mg gentamicin base per kg bw).
Za zdravila, navedena v zgornjem odstavku, ki imajo največje priporočene odmerke, ki presegajo odmerke, uporabljene v študiji ostankov, je treba uporabiti karenco za najslabši primer, izpeljano neposredno iz podatkov o ostankih, tj. 146 dni, pod pogojem, da skupni odmerek v skladu s priporočili iz povzetka glavnih značilnosti zdravila ne presega skupnega odmerka, danega v študiji, iz katere so izpeljali to karenco (tj. 50 mg gentamicinijeve baze na kg telesne mase).
The study concerns animals weighing 23 to 27 kg. Groups of only 3 animals were treated at a dose of 4 mg/kg bw every 12 hours for 4.5 days (9 injections), and slaughtered at days 15 and 60 after the last administration.
Študija je vključevala živali, težke od 23 do 27 kg. Skupine po samo 3 živali so zdravili z odmerkom 4 mg/kg telesne mase na 12 ur v obdobju 4,5 dneva (9 injekcij), nato pa so jih zaklali 15. oziroma 60. dan po zadnjem odmerku.
Groups of 4 animals were slaughtered at days 40, 45 and 50 after the last administration.
Skupine po 4 živali so zaklali 40, 45 oziroma 50 dni po zadnjem odmerku.
For those products mentioned in the above paragraph that have maximum recommended doses that exceed those used in the corresponding residue studies, the worst case withdrawal period derived directly from residue data, i.e. 192 days, should be applied provided the total dose as per the SPC recommendations does not exceed the total dose administered in the study that yielded this withdrawal period (i.e. 24 mg gentamicin base per kg bw).
Za zdravila, navedena v zgornjem odstavku, ki imajo največje priporočene odmerke, ki presegajo odmerke, uporabljene v ustrezni študiji ostankov, je treba uporabiti karenco za najslabši primer, izpeljano neposredno iz podatkov o ostankih, tj. 192 dni, pod pogojem, da skupni odmerek v skladu s priporočili iz povzetka glavnih značilnosti zdravila ne presega skupnega odmerka, danega v študiji, iz katere so izpeljali to karenco (tj. 24 mg gentamicinijeve baze na kg telesne mase).
Residue depletion in pig meat and offal
Izločanje ostankov v prašičjem mesu in organih
A study is available concerning the product Aagent 50 mg/ml solution for injection (MAH: Fatro).
Študija je na voljo za zdravilo Aagent 50 mg/ml raztopina za injiciranje (imetnik dovoljenja za promet: Fatro).
The study concerns non-ruminating animals weighing approximately 50-60 kg. Groups of only 3 animals were treated at a dose of 4 mg/kg bw every 12 hours for 4.5 days (9 injections), and slaughtered at days 15 and 60 after the last administration.
Ta študija zadeva živali pred začetkom prežvekovanja s telesno maso približno 50-60 kg. Skupine po samo 3 živali so zdravili z odmerkom 4 mg/kg telesne mase na 12 ur v obdobju 4,5 dneva (9 injekcij), nato pa so jih zaklali 15. oziroma 60. dan po zadnjem odmerku.
Another study in pigs is available in relation to the product Vetrigen (MAH: Ceva Sante Animale).
V povezavi z zdravilom Vetrigen (imetnik dovoljenja za promet: Ceva Sante Animale) je na voljo še ena študija pri prašičih.
Groups of 4 animals were treated at a dose of 2 mg/kg bw every 12 hours for 3 days, and slaughtered at days 76, 90, 104, and 126 after the last administration.
Skupine po 4 živali so zdravili z odmerkom 2 mg/kg telesne mase na 12 ur v obdobju 3 dni, nato pa so jih zaklali 76., 90., 104. oziroma 126. dan po zadnjem odmerku.
4.11 Withdrawal period(s)
Mednarodn o nelastniško ime (INN)
Delete, where applicable, any references to subcutaneous use in cattle and pigs.
Kjer je ustrezno, pri govedu in prašičih izbrišite vse sklice na subkutano uporabo.
GENTA 100 mg/ml injekcinis tirpalas galvijams ir kiaulėms
GENTA 100 mg/ml injekcinis tirpalas galvijams ir kiaulėms govedo, teleta, prašiči i.m.
Residues in both kidney and liver fall below the MRL at day 80.
Ostanki v ledvicah in jetrih so bili 80. dan pod najvišjo mejno vrednostjo ostanka.
Gentamycin 5% 50mg/ml ενέσιμο διάλυμα για βοοειδή, σκύλους και γάτες
Gentamycin 5% 50mg/ml ενέσιμο διάλυμα για βοοειδή, σκύλους και γάτες govedo, psi, mačke i.m., s.c., počasi i.v.
In the main study, the dose administered was 4 mg/kg bw once, followed by three injections of 2 mg/kg bw every 12 hours.
V glavni študiji so živalim prvič dali odmerek 4 mg/kg telesne mase, nato pa so na 12 ur sledile tri injekcije z 2 mg/kg telesne mase.
Where cattle and/or pigs have already been approved as target species and provided that the maximum total dose of gentamicin, as recommended in the product information, does not exceed 24 mg gentamicin base per kg bw in cattle and 50 mg gentamicin base per kg bw in pigs, the wording below relating to the relevant species should be used:
Kjer so govedo in/ali prašiči že odobreni kot ciljna vrsta in pod pogojem, da največji skupni odmerek gentamicina, kot je priporočen v informacijah o zdravilu, ne presega 24 mg gentamicinijeve baze na kg telesne mase pri govedu in 50 mg gentamicinijeve baze na kg telesne mase pri prašičih, je treba uporabiti spodnje besedilo, ki se nanaša na ustrezno vrsto:
Gentaprim trimethoprim gentamicin sulphate sulfadimethoxinum
Gentaprim trimetoprim gentamicinij ev sulfat sulfadimetok sin
Groups of 4 animals were treated at a dose of 4 mg/kg bw every 12 hours for 3 days, and slaughtered at days 80, 100, 130, and 170 after the last administration.
Skupine po 4 živali so zdravili z odmerkom 4 mg/kg telesne mase na 12 ur v obdobju 3 dni, nato pa so jih zaklali 80., 100., 130. oziroma 170. dan po zadnjem odmerku.
GENTA-kel 05, solução injectável para bovinos, suínos, cães, gatos
GENTA-kel 05, solução injectável para bovinos, suínos, cães, gatos govedo, prašiči, psi, mačke i.m., s.c. (samo psi)
4.9 Amounts to be administered and administration route
Odmerjanje in pot uporabe
Residues in both kidney and liver fall below the MRL at day 28.
Raven ostankov v ledvicah in jetrih je bila 28. dan pod najvišjo mejno vrednostjo ostanka.
Groups of 5 animals were treated at a dose of 4 mg/kg body weight (bw) once a day for 3 days, and slaughtered at days 30, 40, 50, 60, 70, 80 and 90 after the last administration.
Skupine po 5 živali so zdravili z odmerkom 4 mg/kg telesne mase enkrat na dan v obdobju 3 dni, nato pa so jih zaklali 30., 40., 50., 60., 70., 80. oziroma 90. dan po zadnjem odmerku.
C. For Gentavall 5 mg/ml listed in Annex I (Marketing Authorisation Holder: Mevet S.A.U.)
C. Za zdravilo Gentavall 5 mg/ml, navedeno v Prilogi I (imetnik dovoljenja za promet z zdravilom: Mevet S.A.U.)
Where cattle and/or pigs have already been approved as target species and provided that the maximum total dose, as recommended in the product information, does not exceed 12 mg gentamicin base per kg bw in cattle and 50 mg gentamicin base per kg bw in pigs, the wording below relating to the relevant species should be used:
Kjer so govedo in/ali prašiči že odobreni kot ciljna vrsta in pod pogojem, da največji skupni odmerek, kot je priporočen v informacijah o zdravilu, ne presega 12 mg gentamicinijeve baze na kg telesne mase pri govedu in 50 mg gentamicinijeve baze na kg telesne mase pri prašičih, je treba uporabiti spodnje besedilo, ki se nanaša na ustrezno vrsto:
A further GLP study concerning both cattle and pigs was conducted with Gentamicin 40 mg/ml solution for injection (MAH: Vetprom), using an enzyme-linked immunoassay as the analytical method.
Naslednja študija, ki je bila opravljena v skladu z dobro laboratorijsko prakso in je vključevala govedo in prašiče, z zdravilom Gentamicin 40 mg/ml raztopina za injiciranje (imetnik dovoljenja za prometf: Vetprom) je kot analizno metodo uporabljala encimski imunski test.
A GLP study concerning both cattle and pigs was conducted with Gentamicin 40 mg/ml solution for injection (MAH: Vetprom), using an enzyme-linked immunoassay as the analytical method.
Študija, ki je bila opravljena v skladu z dobro laboratorijsko prakso in je vključevala govedo in prašiče, z zdravilom Gentamicin 40 mg/ml raztopina za injiciranje (imetnik dovoljenja za promet: Vetprom) je kot analizno metodo uporabljala encimski imunski test.
Groups of 5 animals were treated at a dose of 4 mg/kg bw once a day for 3 days, and slaughtered at days 30, 40, 50 and 60 after the last administration.
Skupine po 5 živali so zdravili z odmerkom 4 mg/kg telesne mase enkrat na dan v obdobju 3 dni, nato pa so jih zaklali 30., 40., 50. oziroma 60. dan po zadnjem odmerku.
Genta-kel 5% gentamicin 50 mg/ml
Genta-Kel 5% gentamicin 50 mg/ml govedo (teleta) i.m.
Another study in calves was submitted in relation to the product Vetrigen (MAH: Ceva Sante Animale), but is not GLP-compliant.
V povezavi z zdravilom Vetrigen (imetnik dovoljenja za promet: Ceva Sante Animale) je bila predložena še ena študija na teletih, vendar ni bila opravljena v skladu z dobro laboratorijsko prakso.
IM, SC, slow IV
i.m., s.c., počasi i.v.
A. For Aagent 50 mg/ml listed in Annex I (Marketing Authorisation Holder: Fatro S.p.A.)
A. Za zdravilo Aagent 50 mg/ml, navedeno v Prilogi I (imetnik dovoljenja za promet z zdravilom: Fatro S.p.A.)
No surrounding control injection site was sampled.
Iz okolice mesta injiciranja niso odvzeli kontrolnega vzorca.
Calves and piglets in the first month of life, horses declared as not intended for slaughter for human consumption
Aagent 50 mg/ml injekčný roztok teleta in prašički v prvem mesecu življenja, konji, ki niso namenjeni za zakol in prehrano ljudi i.m., s.c., počasi i.v.
Cattle (calves up to 250 kg), pigs (suckling pigs), horses not intended for human consumption, dogs, cats
govedo (teleta do 250 kg), prašiči (sesni prašiči), konji, ki niso namenjeni za prehrano ljudi, psi, mačke i.m., počasi i.v.
Kidney, liver, muscle, fat and the injection site were analysed.
Analizirali so ledvice, jetra, mišice, maščobo in mesto injiciranja.
Kidney, liver, fat, muscle, and injection site were analysed.
Analizirali so ledvice, jetra, maščobo, mišice in mesto injiciranja.
Intramuscular or intravenous use: Meat and offal: 139 days.
Intramuskularna ali intravenska uporaba: Meso in organi: 139 dni.
Cattle, pigs, dogs cattle, pigs: IM dogs: IM or SC
govedo, prašiči, psi govedo, prašiči: i.m.
Intramuscular or intravenous use: Meat and offal: 103 days.
Intramuskularna ali intravenska uporaba: Meso in organi: 103 dni.
Delete, where applicable, any references to subcutaneous use in calves and piglets.
Kjer je ustrezno, pri teletih in prašičkih izbrišite vse sklice na subkutano uporabo.
Overall, a withdrawal period cannot be derived from this study.
V celoti iz te študije ni mogoče izpeljati karence.
The withdrawal period derived from those data, based on the alternative method with a 10% safety span, and relating to a single dose of 5 mg/animal, is 44 days for piglets.
Kot je pričakovano glede na dani odmerek, je izločanje očitno hitro v vseh tkivih, ravni pa so bile pod najvišjo mejno vrednostjo ostanka že v prvi časovni točki, tj. 40. dan. Karenca za prašičke, izpeljana iz teh podatkov na podlagi alternativne metode z 10-odstotno varnostno mejo in pri enkratnem odmerku 5 mg/žival, je 44 dni.
Intramuscular or intravenous use: Meat and offal: 192 days.
Intramuskularna ali intravenska uporaba: Meso in organi: 192 dni.
Where the maximum total dose, as recommended in the product information, is up to 80 mg gentamicin base per kg bw in cattle, the wording below should be used:
Kadar je največji skupni odmerek, kot je priporočen v informacijah o zdravilu, pri govedu do največ 80 mg gentamicinijeve baze na kg telesne mase, je treba uporabiti spodnje besedilo:
Kidney, liver, fat, muscle and injection site (with no surrounding sample) were analysed using a validated LC-MS/MS method; however the results for fat are not available.
MS/MS so analizirali ledvice, jetra, maščobo, mišice in mesto injiciranja (brez vzorca iz okolice), vendarrezultati za maščobo niso na voljo.
Cattle, pigs, horses
govedo, prašiči, konji i.m.
Cattle, pigs
Karenca za prašiče
Intramuscular or intravenous use: Meat and offal: 228 days.
Intramuskularna ali intravenska uporaba: Meso in organi: 228 dni.
IM, SC (only dogs)
(konji), s.c. (psi, mačke)
IM, slow IV
i.m., počasi i.v.
Kidney, liver, skin+fat and injection sites were analysed for residue depletion, using a validated LC-MS/MS method.
Izločanje ostankov so analizirali z validirano metodo LC-MS/MS v ledvicah, jetrih, koži z maščobo in mestu injiciranja.
Due to a LLOQ which is unclear and possibly higher than the respective MRLs no conclusion can be drawn as to residues in muscle and liver.
Sklepa o ostankih v mišicah in jetrih ni mogoče oblikovati zaradi spodnje meje določljivosti, ki ni jasna in je morda višja od ustreznih najvišjih mejnih vrednosti ostanka.
Cattle (calves), pigs (piglets), birds (chicks, turkeys), dogs, cats
GENTAVET solução injectavel govedo (teleta), prašiči (prašički), ptice (piščanci, purani), psi, mačke i.m., počasi i.v.
Intramuscular or intravenous use: Meat and offal: 214 days.
Intramuskularna ali intravenska uporaba: Meso in organi: 214 dni.
Kidney, liver, fat, muscle and the injection site, with no control surrounding sample, were analysed using a microbiological method, for which no adequate validation data are available.
Z mikrobiološko metodo, za katero niso na voljo ustrezni podatki o validaciji, so analizirali ledvice, jetra, maščobo, mišice in mesto injiciranja brez kontrolnega vzorca iz okolice.
PANGRAM 4 % gentamicin 40000 UI/ml
PANGRAM 4 % gentamicin 40000 UI/ml teleta, psi, mačke i.m., i.v.
Cattle, dogs, cats IM, SC, slow IV
govedo, psi, mačke i.m., s.c., počasi i.v.
40 mg/ml 30 mg/ml 200 mg/ml
40 mg/ml 30 mg/ml 200 mg/ml govedo, prašiči i.m.
Kidney, liver, and the injection site were analysed.
Analizirali so ledvice, jetra in mesto injiciranja.
IM, IV: Meat and offal: 139 days.
: Meso in organi: 139 dni.
IM, IV: Meat and offal: 192 days.
: Meso in organi: 192 dni.
IM, IV: Meat and offal: 103 days.
: Meso in organi: 103 dni.