FrancophonIA/ELRC3.0 huggingface dataset:
English: A warning sentence should be added to the product information to advise that any repeated course of treatment during the withdrawal period must be avoided.
Croatian: U informacije o VMP-u potrebno je dodati upozorenje u kojem se navodi da se mora izbjegavati bilo kakvo ponavljanje liječenja tijekom razdoblja karencije.
English: No control surrounding sample was collected for the injection site, but 2 sites per animal were analysed and the sites were considered as sufficiently close to each other.
Croatian: Nisu uzeti kontrolni uzorci okolnog područja mjesta injiciranja, ali je provedena analiza dvaju mjesta injiciranja po životinji, a smatralo se da je razmak između mjesta injiciranja dostatan.
English: Meat and offal: 66 days.
Croatian: Meso i iznutrice: 66 dana.
English: 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.
Croatian: Ispitivanje u kojem je primijenjen VMP Gentaveto-5 (nositelj odobrenja za stavljanje VMP-a u promet: VMD) provedeno je na svinjama od 3,75 do 8 kg težine, s dozama od 5 mg/kg tjelesne težine, svakih 12 sati tijekom pet dana.
English: Groups of 4 to 5 animals were slaughtered at days 3, 10, 17, 27, 67 and 89 after the last administration.
Croatian: Skupine od četiri do pet životinja zaklane su 3, 10, 17, 27, 67 i 89 dana nakon posljednje primjene.
English: Belgium KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium
Croatian: Mađarska KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium
English: The dose administered was 4 mg/kg bw once a day for a duration of 5 days.
Croatian: Primijenjena doza bila je 4 mg/kg tjelesne težine jedanput na dan tijekom pet dana.
English: The study meets current standards, although fat and muscle (other than injection site) were not analysed.
Croatian: Ispitivanje ispunjava postojeće standarde, iako nije provedena analiza masnog tkiva i mišića (osim na mjestu injiciranja).
English: The products Forticine Solution 1% and 4% (MAH: Vetoquinol), were investigated in one main study focusing kidney, liver and muscle, and using the 1% solution, and one confirmatory study using the
Croatian: VMP-ovi Forticine Solution 1% i Forticine Solution 4% (nositelj odobrenja za stavljanje VMP-a u promet: Vetoquinol) ispitivani su u jednom glavnom ispitivanju usmjerenom na bubrege, jetru i mišić, u kojem je upotrijebljena otopina od 1 %, i u jednom potvrdnom ispitivanju u kojem je upotrijebljena otopina od 4 % nakon što je dokazana bioekvivalentnost otopine od 1 % u plazmi, a provedena je samo analiza mjesta injiciranja.
English: The method leads to a recommended extrapolated withdrawal period of 214 days based on the maximum recommended total dose for most concerned products, i.e., 50 mg gentamicin base per kg bw.
Croatian: Navedenom metodom dobiva se ekstrapolirano preporučeno razdoblje karencije od 214 dana na temelju najveće preporučene ukupne doze za većinu dotičnih proizvoda, tj. 50 mg gentamicina po kg tjelesne težine.
English: 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.
Croatian: Uporaba statističke metode za ocjenjivanje podataka o jetri ne smatra se odgovarajućom jer nije ispunjena pretpostavka homoskedastičnosti.
English: Residue depletion data in cattle milk
Croatian: Izlučivanje rezidua u kravljem mlijeku
English: Dopharma Research B.V. Zalmweg 24m 4941 VX Raamsdonksveer The Netherlands
Croatian: Zalmweg 24m 4941 VX Raamsdonksveer The Netherlands
English: Groups of 4 adult pigs receiving a dose of 4 mg/kg bw once a day for 5 days, were slaughtered at days 7, 21, 35, and 49 after the last administration, and kidney, liver, fat, muscle, and injection site were analysed.
Croatian: Skupine od četiri odrasle svinje dobivale su dozu od 4 mg/kg tjelesne težine jedanput na dan tijekom pet dana, zaklane su 7, 21, 35, i 49 dana nakon posljednje primjene, te je provedena analiza bubrega, jetre, masnog tkiva, mišića i mjesta injiciranja.
English: Groups of 5 animals each were slaughtered at 14, 42, 70 and 112 days after the last administration.
Croatian: Skupine od pet životinja zaklane su 14, 42, 70 i 112 dana nakon posljednje primjene.
English: Meat and offal: 146 days.
Croatian: Meso i iznutrice: 146 dana.
English: The 192 days withdrawal period was established in ruminating animals; however the Committee considers that it is applicable also to non-ruminating calves.
Croatian: Razdoblje karencije od 192 dana utvrđeno je za preživače; međutim Odbor smatra da je ono primjenjivo i na telad prije početka preživanja.
English: For the products where the residues depletion study provided does not cover the recommended dosing regimen, or for products where no data have been provided, the worst case withdrawal period calculated directly from residue depletion data, i.e., 192 days, should apply.
Croatian: Kod proizvoda čiji režim doziranja nije obuhvaćen dostavljenim ispitivanjem o izlučivanju rezidua ili proizvoda za koje nisu dostavljeni podaci treba primijeniti razdoblje karencije za najgori mogući scenarij izvedeno izravno iz podataka o reziduama, tj. 192 dana.
English: Analysis of the results for each tissue leads to a maximum withdrawal period of 192 days, relating to residue depletion in the liver and calculated with the statistical method.
Croatian: Analizom rezultata za svako od navedenih tkiva ustanovljeno je najdulje razdoblje karencije od 192 dana koje se odnosi na izlučivanje rezidua u jetri, a dobiveno je statističkom metodom.
English: 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.
Croatian: Koncentracija gentamicina 70. dana, na posljednjoj vremenskoj točki uzorkovanja, još uvijek je premašivala NDK u svim uzorcima jetre i bubrega, a neke su vrijednosti premašivale trenutačni NDK za više od dva puta u bubrezima i za više od tri puta u jetri.
English: Gentaprim trimethoprim gentamicin sulfadimethoxin
Croatian: Gentaprim trimetoprim gentamicin sulfadimetok sin
English: A study conducted with Gentavall 5 mg/ml (MAH: Mevet), was not clearly GLP-compliant (the study used a surprisingly low dose of 5 mg per animal, in newborn piglets (3-5 days old), administered once).
Croatian: Ispitivanje u kojem je primijenjen VMP Gentavall 5 mg/ml (nositelj odobrenja za stavljanje VMP-a u promet: Mevet), očito nije bilo u skladu sa zahtjevima DLP-a (u ispitivanju je korištena iznenađujuće niska jednokratna doza od 5 mg po životinji, na prasadi od tri do pet dana starosti).
English: It is of note that the withdrawal period of 44 days in piglets based on the study with Gentavall 5 mg/ml (MAH: Mevet) corresponds to very particular conditions of use (one single 5 mg injection in neonates).
Croatian: Treba napomenuti da se razdoblje karencije od 44 dana u prasadi utemeljeno na ispitivanju u kojem je primijenjen VMP Gentavall 5 mg/ml (nositelj odobrenja za stavljanje VMP-a u promet: Mevet) odnosi na posebne uvjete primjene (jednokratna injekcija od 5 mg u oprašene prasadi).
English: It is concluded that the withdrawal periods of 44, 66 and 146 days should be applied to the aforementioned products used in the corresponding studies, insofar as the recommended dosing regimen is identical to the one applied in the relevant study, or amounts to a lesser or equivalent dosing in terms of total exposure.
Croatian: Zaključak je da za prethodno navedene proizvode koji su korišteni u odgovarajućim ispitivanjima treba primijeniti razdoblja karencije od 44, 66 i 146 dana ako je preporučeni režim doziranja istovjetan onom koji je primijenjen u odgovarajućem ispitivanju ili u smislu ukupne izloženosti predstavlja manje ili istovjetno doziranje.
English: No combined skin+fat sample was analysed, as only fat was sampled.
Croatian: Nije provedena analiza kombiniranog uzorka kože i masnog tkiva, nego samo masnog tkiva.
English: 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).
Croatian: Razdoblje karencije od 146 dana može se primijeniti i na druge proizvode, uz uvjet da ukupna preporučena doza ne premašuje ukupnu dozu primijenjenu u odgovarajućem ispitivanju (50 mg gentamicina po kg tjelesne težine).
English: The only residue depletion in cow milk is provided with Aagent 50 mg/ml solution for injection (MAH: Fatro), although the product is not authorised for use in lactating cows.
Croatian: Podaci o izlučivanju rezidua u kravljem mlijeku dostavljeni su samo za VMP Aagent 50 mg/ml otopinu za injekciju (nositelj odobrenja za stavljanje VMP-a u promet: Fatro), iako nije izdano odobrenje za primjenu tog proizvoda u krava tijekom laktacije.
English: MEVET, S.A.U.
Croatian: Španjolska MEVET, S.A.U.
English: Cattle (calves)
Croatian: Goveda (telad) IM
English: However, in view of study shortcomings a reliable withdrawal period could not be derived from this study.
Croatian: Međutim, s obzirom na nedostatke u ispitivanju nije moguće izvesti pouzdano razdoblje karencije iz ovog ispitivanja.
English: CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf
Croatian: CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf jedne strane životinje).
English: No control injection site surrounding sample was analysed.
Croatian: Nije provedena analiza kontrolnih uzoraka okolnog područja mjesta injiciranja.
English: Belgium EMDOKA bvba John Lijsenstraat 16
Croatian: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium
English: 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.
Croatian: Izmjerene rezidue gentamicina nisu bile marker rezidue gentamicina, a donja granica kvantifikacije (LLOQ) HPLC-MS/MS metode jednaka je NDK-u za mišić i masno tkivo.
English: At the last time point i.e., day 89, residues above the MRL were still detected in the liver (2 in 5 samples).
Croatian: Na posljednjoj vremenskoj točki, tj. 89. dana, otkrivene su rezidue u jetri (dva od pet uzoraka) koje su još uvijek premašivale NDK.
English: In all residue depletion studies provided, gentamicin was used as an injectable aqueous solution and was administered by the intramuscular route.
Croatian: U svim dostavljenim ispitivanjima o izlučivanju rezidua gentamicin se primjenjivao kao vodena otopina za intramuskularno ubrizgavanje.
English: In addition, for the injection site, one concentration was still slightly above the MRL at day 49.
Croatian: Osim toga, koncentracija jednog uzorka s mjesta injiciranja 49. dana još je uvijek neznatno premašivala NDK.
English: The dose administered was 4 mg/kg bw with a 12 hours interval on the first day, and afterwards at 24 hours intervals, until day 5 inclusive.
Croatian: Primijenjena doza bila je 4 mg/kg tjelesne težine svakih 12 sati prvog dana, a kasnije svaka 24 sata, uključujući i peti dan.
English: Groups of 4 animals were slaughtered at days 40, 45 and 50 after the last administration.
Croatian: Skupine od četiri životinje zaklane su 40, 45 i 50 dana nakon posljednje primjene.
English: Applicant/Marketing Authorisation Holder
Croatian: Podnositelj zahtjeva / nositelj odobrenja za stavljanje VMP-a u promet
English: This calculation is applicable provided that the depletion kinetics are linear and that when residues deplete below the MRLs, the tissue distribution is complete.
Croatian: Ovaj je izračun primjenjiv ako je kinetika izlučivanja linearna i ako je raspodjela u tkivu završena kada se količina rezidua spusti ispod NDK-a.
English: Germany Bremer Pharma GmbH Werkstr.
Croatian: Njemačka Bremer Pharma GmbH Werkstr.
English: Calves, piglets IM
Croatian: Telad, prasad IM
English: 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.
Croatian: Ispitivanje je obuhvaćalo skupine od četiri životinje koje su dobivale dozu od 4 mg/kg tjelesne težine jedanput na dan tijekom pet dana te su zaklane 21, 35, 49 i 70 dana nakon posljednje primjene.
English: For products with a strength up to 50 mg gentamicin per ml: In pigs do not administer more than 1 ml per injection site.
Croatian: Kod proizvoda jačine do 50 mg gentamicina po ml: Ne primjenjuje se više od 1 ml po mjestu injiciranja u svinja.
English: S.P. VETERINARIA, S.A. Ctra Reus Vinyols, km 4.1 Riudoms (Tarragona) 43330 Spain
Croatian: Španjolska S.P. VETERINARIA, S.A. Ctra Reus Vinyols, km 4.1
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Croatian: Izmjena relevantnih dijelova sažetka opisa svojstava, označivanja i upute o lijeku
English: At the last slaughter point i.e. day 60, residue levels were below the MRL in liver and kidney, but no firm conclusion can be drawn as to fat, muscle and in particular the injection site, since the relating sensitivity limit was twice the MRL.
Croatian: Prilikom klanja na posljednjoj vremenskoj točki, tj. 60. dana, razine rezidua u jetri i bubrezima bile su ispod najveće dopuštene količine, ali nije moguće izvesti pouzdane zaključke u pogledu masnog tkiva i mišića i osobito mjesta injekcije jer je određena granica detekcije bila dvostruko veća od najveće dopuštene količine.
English: For products with a strength exceeding 50 mg gentamicin per ml: In pigs do not administer more than 50 mg gentamicin per injection site.
Croatian: Kod proizvoda čija jačina premašuje 50 mg gentamicina po ml: Ne primjenjuje se više od 50 mg gentamicina po mjestu injiciranja u svinja.
English: Delete, where applicable, any references to subcutaneous use in cattle.
Croatian: Gdje je to primjenjivo, potrebno je izbrisati sva upućivanja na supkutanu primjenu u goveda.
English: LABORATORIOS HIPRA, S.A. Avda.
Croatian: Španjolska LABORATORIOS HIPRA, S.A. Avda. la Selva 135
English: The product Aagent 50 mg/ml solution for injection was also tested in a depletion studies in adult cattle.
Croatian: VMP Aagent 50 mg/ml otopina za injekciju također je ispitivan u ispitivanjima o izlučivanju rezidua u odraslih goveda.
English: 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.
Croatian: Razdoblje karencije od 192 dana ne može se primijeniti na proizvode kod kojih ukupna preporučena doza premašuje dozu primijenjenu u ispitivanju o izlučivanju rezidua, tj. 24 mg gentamicina po kg tjelesne težine.
English: Residue depletion in cattle meat and offal
Croatian: Izlučivanje rezidua u mesu i iznutricama goveda
English: 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
Croatian: Za sve druge proizvode navedene u Prilogu I. čija preporučena ukupna doza ne prelazi 24 mg gentamicina po kilogramu tjelesne težine u goveda i 50 mg gentamicina po kilogramu tjelesne težine u svinja
English: The product Aagent 50 mg/ml solution for injection was also tested in depletion studies in adult pigs.
Croatian: VMP Aagent 50 mg/ml otopina za injekciju također je ispitivan u ispitivanjima o izlučivanju rezidua u odraslih svinja.
English: Delete, where applicable, any references to subcutaneous use in cattle and pigs.
Croatian: Gdje je to primjenjivo, potrebno je izbrisati sva upućivanja na supkutanu primjenu u goveda i svinja.
English: The withdrawal periods for cattle (meat and milk) and pigs should be amended as recommended to provide assurance for consumer safety.
Croatian: Kako bi se zajamčila sigurnost potrošača, razdoblja karencije za goveda (meso i mlijeko) i svinje treba izmijeniti u skladu s preporukama.
English: Residues in both kidney and liver fall below the MRL at day 80.
Croatian: Rezidue u bubrezima i jetri spustile su se 80. dana ispod najveće dopuštene količine.
English: 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.
Croatian: Izmjerene rezidue gentamicina nisu bile marker rezidue gentamicina, a LLOQ HPLC-MS/MS metode jednak je NDK-u za mišić i masno tkivo.
English: Another study in pigs is available in relation to the product Vetrigen (MAH: Ceva Sante Animale).
Croatian: Drugo dostupno ispitivanje na svinjama odnosi se na VMP Vetrigen (nositelj odobrenja za stavljanje VMP-a u promet: Ceva Sante Animale).
English: 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).
Croatian: Riječ je o ispitivanjima u kojima su primijenjeni VMP Gentavall 5 mg/ml (nositelj odobrenja za stavljanje VMP-a u promet: Mevet), VMP Aagent 50 mg/ml otopina za injekciju (nositelj odobrenja za stavljanje VMP-a u promet: Fatro) i VMP Gentaveto-5 (nositelj odobrenja za stavljanje VMP-a u promet: VMD).
English: 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).
Croatian: U izvješćima o ocjeni produljenja koje je provelo belgijsko nacionalno nadležno tijelo utvrđena su dva ispitivanja koja podupiru razdoblja karencije za VMP Genta-kel 5% (nositelj odobrenja za stavljanje VMP-a u promet: Kela), te za VMP Gentaveto-5 u teladi (nositelj odobrenja za stavljanje VMP-a u promet: VMD).
English: A GLP compliant study conducted with Genta-ject 10% (MAH: Dopharma), was provided.
Croatian: Dostavljeno je ispitivanje usklađeno sa zahtjevima DLP-a u kojem je primijenjen VMP Genta-ject 10% (nositelj odobrenja za stavljanje VMP-a u promet: Dopharma).
English: Calves:
Croatian: Prasad:
English: 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.
Croatian: Skupine od četiri životinje tretirane su dozom od 2 mg/kg tjelesne težine svakih 12 sati tijekom tri dana te su zaklane 76, 90, 104, i 126 dana nakon posljednje primjene.
English: D. For Gentaveto-5 (50 mg/ml) listed in Annex I (Marketing Authorisation Holder: V.M.D.
Croatian: Za Gentaveto-5 (50 mg/ml) naveden u Prilogu I. (nositelj odobrenja za stavljanje VMP-a u promet: V.M.D. n.v.)
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Croatian: Razlozi za izmjenu sažetka opisa svojstava, označavanja i upute o lijeku
English: 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:
Croatian: Ako su goveda i/ili svinje već odobrene kao ciljna vrsta i uz uvjet da najveća ukupna doza gentamicina sukladno preporukama iz informacija o VMP-u ne prelazi 24 mg gentamicina po kilogramu tjelesne težine u goveda i 50 mg gentamicina po kilogramu tjelesne težine u svinja, potrebno je koristiti tekst u nastavku koji se odnosi na odgovarajuće vrste:
English: 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
Croatian: Kod proizvoda navedenih u Prilogu I. čija je preporučena ukupna doza između 24 i 50 mg gentamicina po kg tjelesne težine u goveda
English: In pigs do not administer more than 1 ml per injection site.
Croatian: Ne primjenjuje se više od 1 ml po mjestu injiciranja u svinja.
English: 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).
Croatian: Kod proizvoda navedenih u prethodnom odjeljku čije najveće preporučene doze premašuju one koje su korištene u odgovarajućim ispitivanjima o izlučivanju rezidua treba primijeniti razdoblje karencije za najgori mogući scenarij izvedeno izravno iz podataka o reziduama, tj. 192 dana, uz uvjet da ukupna doza preporučena u sažetku opisa svojstava VMP-a ne premašuje ukupnu dozu primijenjenu u ispitivanju koje je rezultiralo tim razdobljem karencije (tj. 24 mg gentamicina po kg tjelesne težine).
English: 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.
Croatian: Provedena je analiza bubrega, jetre, masnog tkiva, mišića i mjesta injiciranja, bez kontrolnog uzorka okolnog područja, pomoću mikrobiološke metode za koju nema odgovarajućih podataka o validaciji.
English: Withdrawal periods for cattle meat and offal
Croatian: Razdoblja karencije za meso i iznutrice goveda
English: WITHDRAWAL PERIOD
Croatian: RAZDOBLJE KARENCIJE
English: Residue depletion in pig meat and offal
Croatian: Izlučivanje rezidua u mesu i iznutricama svinja
English: The study is GLP-compliant; it is considered by the MAH (Fatro) as a preliminary study.
Croatian: Ispitivanje je usklađeno sa zahtjevima DLP-a; nositelj odobrenja za stavljanje VMP-a u promet (Fatro) smatra ga pripremnim ispitivanjem.
English: 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.
Croatian: Skupine od pet životinja tretirane su dozom od 4 mg/kg tjelesne težine jedanput na dan tijekom tri dana te su zaklane 30, 40, 50, 60, 70, 80 i 90 dana nakon posljednje primjene.
English: 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.
Croatian: Skupine od četiri životinje tretirane su dozom od 4 mg/kg tjelesne težine svakih 12 sati tijekom tri dana te su zaklane 80, 100, 130, i 170 dana nakon posljednje primjene.
English: 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).
Croatian: Kod proizvoda navedenih u prethodnom odjeljku čije najveće preporučene doze premašuju one koje su korištene u ispitivanjima o izlučivanju rezidua valja primijeniti razdoblje karencije za najgori mogući scenarij izvedeno izravno iz podataka o reziduama, tj. 146 dana, uz uvjet da ukupna doza preporučena u sažetku opisa svojstava VMP-a ne premašuje ukupnu dozu primijenjenu u ispitivanju koje je rezultiralo tim razdobljem karencije (tj. 50 mg gentamicina po kg tjelesne težine).