FrancophonIA/ELRC3.0 huggingface dataset:
English: IM, IV: Meat and offal: 103 days.
Maltese: IM, IV: Laħam u ġewwieni tal-annimal: 103 ijiem.
English: Germany CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Maltese: Il-Ġermanja CP-Pharma Handelsgesellschaft mbH Ostlandring 13
English: E-08950 Esplugues de Llobregat (Barcelona) Spain
Maltese: Esplugues de Llobregat (Barcelona) Spain
English: CVMP EPMAR for gentamicin (EMEA/MRL/803/01)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500014350.pdf statistical method as per CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)
Maltese: CVMP EPMAR for gentamicin (EMEA/MRL/803/01)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500014350.pdf ta' metodu HPLC/MS-MS validat.
English: Using the alternative method, applied to data in kidney, and with a 10% safety margin, leads to a withdrawal period of 139 days.
Maltese: L-użu tal-metodu alternattiv, applikat għad-data fil-kliewi, u b'marġini ta' sigurtà ta' 10 %, iwassal għal perjodu talirtirar ta' 139 jum.
English: PROPHARMA VET d.o.o.
Maltese: Il-Kroazja PROPHARMA VET d.o.o. Vijenac A. Cesarca 16
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
Maltese: Il-prodotti Forticine Solution 1 % u 4 % (MAH: Vetoquinol), ġew investigati fi studju wieħed ewlieni b'fokus fuq il-kliewi, il-fwied u l-muskoli, u bl-użu tas-soluzzjoni 1 %, u fi studju konfermatorju bl-użu tas-soluzzjoni 4 %, wara turija tal-bijoekwivalenza tal-plażma għall-qawwa 1 %, u fejn ġie analizzat biss is-sit ta' injezzjoni.
English: Interchemie werken "De Adelaar" Eesti AS Vanapere tee 14, Pringi 74001 Viimsi Harju County Estonia
Maltese: Vanapere tee 14, Pringi 74001 Viimsi
English: 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).
Maltese: Il-metodu analitiku kien assaġġ batterjoloġiku li għalih ma kien hemm ebda data ta' validazzjoni xierqa disponibbli, b'LLOQ ta' 100 µg/kg, jiġifieri, id-doppju tal-MRL applikabbli attwali (50 µg/kg għall-muskoli).
English: IM, IV: Meat and offal: 139 days.
Maltese: IM, IV: Laħam u ġewwieni tal-annimal: 139 jum.
English: E. For Gentamicin Bremer Pharma listed in Annex I (Marketing Authorisation Holder: Bremer Pharma GmbH)
Maltese: Għal Gentamicin Bremer Pharma elenkat fl-Anness I (Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Only one product (Gentamicin Bremer Pharma, authorised in Latvia, MAH: Bremer Pharma) recommends a higher total dose, of 80 mg gentamicin base per kg bw.
Maltese: Bremer Pharma) jirrakkomanda doża totali ogħla, ta' 80 mg gentamicin bażi għal kull kg bw.
English: 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)
Maltese: In-numru baxx ta' annimali u ta' punti ta' data ma tax lok għall-analiżi tar-riżultati bl-użu tal-metodi ta' statistika TTSC (time to safe concentrationżmien għal konċentrazzjoni sigura) jew SCLR (safe concentrations - konċentrazzjonijiet siguri, ibbażati fuq rigressjoni lineari, u li jagħtu lok għal kejl taħt il-limitu ta' kwantifikazzjoni), skont in-Nota tasCVMP għal gwida dwar id-determinazzjoni ta' perjodi ta' tiżmim għall-ħalib (EMEA/CVMP/473/98)
English: No full study report and analytical method validation report are available.
Maltese: Ebda rapport ta' studju sħiħ u rapport ta' validazzjoni tal-metodu analitiku mhu disponibbli.
English: The dose received was 3 mg/kg bw every 8 hours for 3 days.
Maltese: Id-doża li rċivew kienet ta' 3 mg/kg bw kull 8 sigħat għal 3 ijiem.
English: Belgium KELA NV Sint Lenaartseweg 48 2320 Hoogstraten Belgium
Maltese: Il-Belġju KELA NV Sint Lenaartseweg 48 2320
English: 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
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali veterinarji, speċijiet ta' annimali, mnejn jingħata, applikanti/detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: 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.
Maltese: Barra minn hekk, ilparagun tal-istudji ma' Aagent 50 mg/ml soluzzjoni għall-injezzjoni (MAH: Fatro) u Genta-ject 10 % (MAH: Dopharma) juri li t-tnaqqis ta' residwu ma jsirx aktar bil-mod fl-annimali żgħar ħafna fl-età, peress li l-perjodu ta' tiżmim hu aktar baxx (103 ijiem) fl-għoġġiela ta' inqas minn xahar li jirċevu sostitut tal-ħalib u suppliment solidu, milli f'għoġġiela ikbar fl-età li jirċievu ikel solidu.
English: The study was conducted in ruminating cattle (350-380 kg) and pigs of 35-40 kg.
Maltese: L-istudju sar fi frat tal-ixtarr (350-380 kg) u fi ħnieżer ta' 35-40 kg.
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).
Maltese: Dawk huma l-istudji li saru bil-prodotti Gentavall 5 mg/ml (MAH: Mevet), Aagent 50 mg/ml soluzzjoni għall-injezzjoni (MAH: Fatro), u Gentaveto-5 (MAH:
English: Meat and offal: 44 days.
Maltese: Laħam u ġewwieni tal-annimal: 44 jum.
English: Meat and offal: 146 days.
Maltese: Laħam u ġewwieni tal-annimal: 146 jum.
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.
Maltese: Gruppi ta' 5 annimali ġew ikkurati b'doża ta' 4 mg/kg piż tal-ġisem (bw) darba kuljum għal 3 ijiem, u nqatlu f'jiem 30, 40, 50, 60, 70, 80 u 90 wara l-aħħar għotja.
English: Gentamicin residues in edible tissues and milk were determined by a microbiological assay with a limit of quantification being 50 μg/kg (1/2 MRL).
Maltese: Ir-residwi ta' gentamicin f'tessuti li jittieklu u fil-ħalib ġew stabbiliti b'assaġġ mikrobijoloġiku bil-limitu ta' kwantifikazzjoni li kien 50 μg/kg (1/2 MRL).
English: PURMICINA 40 MG/ML SOLUCIÓN INYECTABLE - 2922 ESP
Maltese: INYECTABLE - 2922 ESP
English: IM, IV: Meat and offal: 228 days.
Maltese: IM, IV: Laħam u ġewwieni tal-annimal: 228 jum.
English: Calves:
Maltese: Qżieqeż:
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.
Maltese: L-istudju għal Gentaveto-5 (MAH: VMD sar fi ħnieżer li jiżnu bejn 3.75 u 8 kg, u li ġew ikkurati b'5 mg/kg btw, kull 12-il siegħa għal 5 ijiem.
English: IM, IV: Meat and offal: 192 days.
Maltese: IM, IV: Laħam u ġewwieni tal-annimal: 192 jum.
English: • a repeated course of treatment within a certain timescale is highly likely to lead to accumulation of gentamicin residues in liver, kidneys, and potentially injection sites of treated animals, the CVMP considered that 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;
Maltese: • kors ta' kura ripetut f'ċertu żmien għandu probabbiltà kbira li jwassal għal akkumulazzjoni ta' residwi ta' gentamicin fil-fwied, fil-kliewi u potenzjalment fis-siti ta' injezzjoni tal-annimali kkurati, is-CVMP qies li għandha tiżdied sentenza ta' twissija biex twissi li għandu jiġi evitat kwalunkwe kors ta' kura ripetut matul il-perjodu ta' tiżmim;
English: D. For Gentaveto-5 (50 mg/ml) listed in Annex I (Marketing Authorisation Holder: V.M.D.
Maltese: Għal Gentaveto-5 (50 mg/ml) elenkat fl-Anness I (Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Laboratorios Maymo, S.A.
Maltese: Laboratorios Maymo, S.A. Via Augusta, 302
English: Kidney, liver, and the injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Maltese: Il-kliewi, il-fwied u s-sit ta' injezzjoni (il-qalba u madwarha) ġew analizzati bl-użu ta' metodu HPLC/MS-MS validat.
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.
Maltese: Ir-residwu kkalkulat (gentamicin) ma kienx ir-residwu indikatur stabbilit, u l-limitu aktar baxx ta' kwantifikazzjoni (LLOQ) tal-metodu HPLC-MS/MS kien daqs l-MRL għall-muskoli u x-xaħam.
English: 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.
Maltese: Għalhekk, fit-8 ta' Jannar 2016, il-Belġju beda proċedura skont l-Artikolu 35 tad-Direttiva 2001/82/KE għall-prodotti mediċinali veterinarji li fihom gentamicin li huma ppreżentati bħala soluzzjonijiet għallinjezzjoni li għandhom jingħataw lill-frat u lill-ħnieżer.
English: The dose administered was 4 mg/kg bw once a day for a duration of 5 days.
Maltese: Id-doża mogħtija kienet ta' 4 mg/kg bw darba kuljum għal durata ta' 5 ijiem.
English: 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).
Maltese: F'rapporti ta' valutazzjoni ta' tiġdid kif ivvalutat mill-NCA Belġjana, ġie identifikat studju li jappoġġa lperjodu ta' tiżmim għal Genta-kel 5 % fl-għoġġiela (MAH: Kela).
English: Applicant/Marketing Authorisation Holder
Maltese: Applikant/Detentur talAwtorizzazzjoni għatTqegħid fis-Suq
English: Cattle, dogs, cats IM, IV, SC
Maltese: Frat, klieb, qtates IM, IV, SC
English: Calves up to 13 weeks of age
Maltese: Għoġġiela sa età ta' 13-il ġimgħa
English: Groups of pigs were slaughtered 14, 28, 35 and 40 days after the last administration.
Maltese: Gruppi ta' ħnieżer inqatlu 14, 28, 35 u 40 jum wara l-aħħar għotja.
English: Only two animals per slaughter time were involved (14 hours, 7 days, 14 days, 28 days).
Maltese: Kienu involuti biss żewġ annimali ma' kull ħin ta' qatla (14-il siegħa, 7 ijiem, 14-il jum, 28 jum).
English: IM, IV: Meat and offal: 214 days.
Maltese: IM, IV: Laħam u ġewwieni tal-annimal: 214-il jum.
English: Kidney, liver, skin+fat, muscle, and injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Maltese: Il-kliewi, il-fwied, ilġilda u x-xaħam, il-muskoli u s-sit ta' injezzjoni (il-qalba u madwarha) ġew analizzati bl-użu ta' metodu HPLC/MS-MS validat.
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.
Maltese: Gruppi ta' 4 ħnieżer adulti li kienu qed jirċievu doża ta' 4 mg/kg bw darba kuljum għal 5 ijiem, inqatlu f'jiem 7, 21, 35, u 49 wara l-aħħar għotja, u ġew analizzati l-kliewi, il-fwied, ix-xaħam, il-muskoli u s-sit ta' injezzjoni.
English: Quality, target animals safety, user safety, environmental risk and efficacy have not been assessed in this referral procedure.
Maltese: Il-kwalità, is-sigurtà tal-annimali fil-mira, is-sigurtà tal-utent, ir-riskju ambjentali u l-effikaċja ma ġewx ivvalutati f'din il-proċedura ta' referenza.
English: Slovak Republic
Maltese: Repubblika Ċeka
English: Pigs:
Maltese: Fejn:
English: Lithuania Bela-Pharm GmbH & Co. KG Lohner Str. 19
Maltese: Il-Litwanja Bela-Pharm GmbH & Co.
English: B. For Genta-ject 10% listed in Annex I (Marketing Authorisation Holder: Dopharma Research B.V.)
Maltese: B. Għal Genta-ject 10 % elenkat fl-Anness I (Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq:
English: 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.
Maltese: Hi r-responsabbiltà ta' kull Awtorità Nazzjonali Kompetenti li tapplika r-rakkomandazzjonijiet ta' din l-opinjoni abbażi tad-doża massima rakkomandata skont is-SPC approvat, u li tieħu azzjoni f'każ li r-rakkomandazzjonijiet flinformazzjoni dwar il-prodott ma jkunux jistgħu jiġu interpretati sew.
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.
Maltese: Listudju involva gruppi ta' 4 annimali li rċievew doża ta' 4 mg/kg bw darba kuljum għal 5 ijiem, u li nqatlu f'jiem 21, 35, 49 u 70 wara l-aħħar għotja.
English: Meat and offal: 66 days.
Maltese: Laħam u ġewwieni tal-annimal: 66 jum.
English: C-17, Km 17 08150 Parets del Valles (Barcelona)
Maltese: SUPER´S DIANA, S.L. Ctra. C-17, Km 17 08150
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.
Maltese: Fl-aħħar punt ta' qatla, jiġifieri, jum 60, il-livelli ta' residwi kienu aktar baxxi mill-MRL fil-fwied u fil-kliewi, iżda ma tista' tinstilet ebda konklużjoni konkreta għax-xaħam, il-muskoli u b'mod partikolari, is-sit ta' injezzjoni, peress li l-limitu tas-sensittività relatat kien id-doppju tal-MRL.
English: 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.
Maltese: Gruppi ta' 5 annimali kienu kkurati b'doża ta' 4 mg/kg bw darba kuljum għal 3 ijiem, u nqatlu f'jiem 30, 40, 50 u 60 wara l-aħħar għotja.
English: Bela-Pharm GmbH & Co. KG Lohner Str. 19
Maltese: Bela-Pharm GmbH & Co.
English: Finally, a repeated course of treatment within a certain timescale is highly likely to lead to accumulation of gentamicin residues in liver, kidneys, and potentially injection sites of treated animals, and therefore it should be made clear in product information that any repeated course of treatment during the withdrawal period must be avoided.
Maltese: Finalment, kors ripetut ta' kura f'ċertu żmien għandu probabbiltà kbira li jwassal għal akkumulazzjoni ta' residwi ta' gentamicin fil-fwied, fil-kliewi u potenzjalment fis-siti ta' injezzjoni tal-annimali kkurati, u għalhekk fl-informazzjoni dwar il-prodott għandu jiġi stabbilit b'mod ċar li għandu jiġi evitat kwalunkwe kors ta' kura ripetut matul il-perjodu ta' tiżmim.
English: Package leaflet:
Maltese: Għoġġiela:
English: Cattle, dogs, cats IM, SC, slow IV
Maltese: Frat, klieb, qtates IM, SC, IV bilmod
English: Vana GmbH
Maltese: GmbH)
English: Animal species Route of administration
Maltese: Handelsweg 25
English: This withdrawal period includes a wide safety margin with regard to the available data.
Maltese: Dan il-perjodu ta' tiżmim jinkludi marġini ta' sigurtà wiesgħa firrigward tad-data disponibbli.
English: A study is available concerning the product Aagent 50 mg/ml solution for injection (MAH: Fatro).
Maltese: Hemm studju disponibbli dwar il-prodott Aagent 50 mg/ml soluzzjoni għall-injezzjoni (MAH: Fatro).
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.
Maltese: Gruppi ta' 4 annimali ġew ikkurati b'doża ta' 2 mg/kg bw kull 12-il siegħa għal 3 ijiem, u nqatlu f'jiem 76, 90, 104, u 126 wara l-aħħar għotja.
English: 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).
Maltese: Għalhekk, il-Belġju kkunsidra li s-sikurezza tal-konsumatur mhijiex żgurata mill-perjodi ta' tiżmim stabbiliti għall-prodott ta' referenza Genta 100 mg/ml (detentur għall-awtorizzazzjoni għat-tqegħid fis-suq (MAH): CP-Pharma) u konsegwentament, għall-prodott ġeneriku tagħha Emdogent 100 (applikant: Emdoka).
English: 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.
Maltese: Sa ċertu punt, dan hu kkonfermat mit-tnaqqis rapidu osservat b'Forticine Solution 1 % (MAH: Vetoquinol), li sar ukoll f'għoġġiela żgħar mitmugħin b'sostitut tal-ħalib.
English: The study involves non ruminating calves of 8-11 weeks of age, which received 3 mg/kg bw gentamicin twice a day for 3 consecutive days.
Maltese: Listudju jinvolvi għoġġiela mhux tal-ixtarr ta' età ta' 8-11-il ġimgħa, li rċivew 3 mg/kg bw gentamicin darbtejn kuljum għal
English: The same rationale used as a basis for the withdrawal periods for products containing gentamicin as the sole active substance may also be applied to gentamicin in combination with trimethoprim and sulfadimethoxine.
Maltese: L-istess razzjonalità użata bħala bażi għall-perjodi ta' tiżmim għal prodotti li fihom gentamicin bħala lunika sustanza attiva, tista' tiġi applikata wkoll għal gentamicin flimkien ma' trimethoprim u sulfadimethoxine.
English: IM, slow IV, SC
Maltese: IM, IV bil-mod, SC
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.
Maltese: Il-kliewi, il-fwied, ix-xaħam, ilmuskoli u s-sit ta' injezzjoni, mingħajr ebda kampjun tal-madwar ta' kontroll, ġew analizzati bl-użu ta' metodu mikrobijoloġiku, u m'hemm ebda data ta' validazzjoni adegwata disponibbli dwarhom.
English: 1, it was not possible for Belgium to confirm that the withdrawal periods of 95 days for cattle and 60 days for pigs are safe.
Maltese: 1, ma kienx possibbli għall-Belġju li jikkonferma li lperjodi tal-irtirar ta' 95 jum għall-frat u 60 jum għall-ħnieżer huma siguri.
English: Cattle (calves), pigs (piglets), birds (chicks, turkeys), dogs, cats
Maltese: Frat (għoġġiela), ħnieżer (qżieqeż), għasafar (flieles, dundjani), klieb, qtates
English: 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.
Maltese: Il-metodu analitiku uża kromatografija likwidu-likwidu b'ditezzjoni fluworometrika iżda d-data li turi l-validità tal-metodu ma kinitx disponibbli, ġew issorveljati biss 3 minn 4 komponenti tar-residwu indikati ta' gentamicin rakkomandati.
English: Belgium also noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pigs meat and offal from 28 days to 150 days.
Maltese: Il-Belġju nnota wkoll li hemm perjodi ta' tiżmim approvati differenti għall-frat u l-ħnieżer għal prodotti mediċinali veterinarji li fihom gentamicin li huma ppreżentati bħala soluzzjonijiet għall-injezzjoni madwar l-Unjoni Ewropea, eż, minn 28 jum sa 210 jum għal-laħam tal-frat u l-ġewwieni tal-annimal, minn 2 sa 7 ijiem għall-ħalib tal-frat, b'xi wħud mill-prodotti li jiddikjaraw “tużahx f'baqar li l-ħalib tagħhom hu intiż għall-konsum mill-bniedem”; u minn 28 jum sa 150 jum għal-laħam tal-ħnieżer u lġewwieni tal-annimal.
English: Calves, piglets, dogs, cats
Maltese: Frat, żwiemel, klieb, qtates
English: This relates to a dosing regimen of 4 mg/kg bw each 12 hours for 3 days, and an injection volume of 20 ml for a concentration of 40 mg/ml.
Maltese: Dan jirrelata ma' kors ta' dożaġġ ta' 4 mg/kg bw kull 12-il siegħa għal 3 ijiem, u volum ta' injezzjoni ta' 20 ml għal konċentrazzjoni ta' 40 mg/ml.
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.
Maltese: Gruppi ta' 4 annimali ġew ikkurati b'doża ta' 4 mg/kg bw kull 12-il siegħa għal 3 ijiem, u nqatlu f'jiem 80, 100, 130, u 170 wara l-aħħar għotja.
English: GENDIAN 60mg/ml SOLUCIÓN INYECTABLE - 690 ESP
Maltese: GENDIAN 60mg/ml SOLUCIÓN
English: Calves, dogs
Maltese: Frat, ħnieżer
English: Zalmweg 24
Maltese: 41 jum.
English: Germany Bela-Pharm GmbH & Co. KG Lohner Str. 19
Maltese: Il-Ġermanja Bela-Pharm GmbH & Co.
English: Following a marketing authorisation application to the Belgian Federal Agency for Medicines and Health Product, under Article 13(1) of Directive 2001/82/EC as amended, i.e., a generic application, it appeared that no product-specific residue data were generated in support of the cattle and pigs' meat and offal withdrawal periods for the reference product Genta 100 mg/ml, as authorised in Germany.
Maltese: Wara applikazzjoni għall-awtorizzazjoni għat-tqegħid fis-suq lill-Aġenzija Federali Belġjana għallMediċini u l-Prodotti tas-Saħħa, skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE kif emendata, jiġifieri, applikazzjoni ġenerika, deher li ma ġiet iġġenerata ebda data ta' residwu speċifika għal xi prodott b'appoġġ tal-perjodi ta' tiżmim tal-laħam tal-frat u l-ħnieżer u l-ġewwieni tal-annimal għall-prodott ta' referenza Genta 100 mg/ml, kif awtorizzat fil-Ġermanja.
English: 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.
Maltese: Għalhekk, il-volum tal-injezzjoni għandu jiġi limitat għal massimu ta' 1 ml għal kull sit ta' injezzjoni, jew għal 50 mg gentamicin għal kull sit ta' injezzjoni għal prodotti b'qawwa li taqbeż 50 mg gentamicin għal kull ml.
English: In both studies, calves of maximum 1.5 months, presumably nonruminating, were involved.
Maltese: Fiż-żewġ studji, kienu involuti għoġġiela ta' età massima ta' 1.5 xhur, x'aktarx mhux tal-ixtarr.
English: Kidney, liver, skin+fat and injection sites were analysed for residue depletion, using a validated LC-MS/MS method.
Maltese: Il-kliewi, il-fwied, il-ġilda u x-xaħam u s-siti ta' injezzjoni ġew analizzati għal tnaqqis ta' residwi, bl-użu ta' metodu LC-MS/MS validat.
English: 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.
Maltese: Madankollu, mid-data kollha kkunsidrata, jidher, li għallinqas għal volum ta' injezzjoni sa 20 ml fl-għoġġiela, is-sit ta' injezzjoni ma jillimitax it-tessuti u għalhekk, jista' jitqies li r-riskju għall-konsumatur fir-rigward talvolumi ogħla ta' injezzjoni jibqgħu baxxi.
English: GENTACEN 100mg/ml SOLUCIÓN INYECTABLE - 2583 ESP
Maltese: INYECTABLE - 2583 ESP
English: Whereas
Maltese: Ir
English: GENTAVALL 40 MG/ML SOLUCIÓN INYECTABLE - 307 ESP
Maltese: INYECTABLE - 307 ESP
English: Intramuscular or intravenous use: Meat and offal: 103 days.
Maltese: Laħam u ġewwieni tal-annimal: 103 ijiem.
English: 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.
Maltese: Madankollu, fid-dawl tad-data ġenerali disponibbli dwar it-tnaqqis ta' residwu f'gentamicin, hu magħruf li x-xaħam u l-muskoli (minbarra l-muskolu tas-sit ta' injezzjoni) mhumiex tessuti ta' limitazzjoni.