FrancophonIA/ELRC3.0 huggingface dataset:
English: Scan Vet Poland Sp. z o.o.
Maltese: Scan Vet Poland Sp. z o.o. Skiereszewo, ul.
English: C/ Esmeralda, 19
Maltese: Esmeralda 19
English: 3440 AB Woerden, The Netherlands
Maltese: 3440 AB Woerden,
English: Bremer Pharma GmbH Cherbourger Str. 25 27540 Bremerhaven Germany
Maltese: Bremer Pharma GmbH Cherbourger Str. 25 27540
English: Animec injection Injektionslöng für Rinder und Schweine
Maltese: Animec injection Injektionslön g für Rinder und Schweine
English: Este é
Maltese: Inj. Este é
English: BIOWET GORZOW PHARMACEUTICALS COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK
Maltese: Ir-Rumanija BIOWET GORZOW PHARMACEUTICALS COMPANY- Kosynierów Gdyńskich 13/14
English: United Kingdom Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland
Maltese: Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland
English: Ivermectin is a broad spectrum endectocide of the avermectin family.
Maltese: Ivermectin huwa endektoċide ta' spettru wiesa' li ġej mill-familja ta' avermectin.
English: Centurii, nr. 7, Voluntari Romania
Maltese: ROMVAC COMPANY S.A. Şos. Centurii, nr. 7, Voluntari Romania
English: Vet. Parasitol.
Maltese: Parasitol.
English: NoromectinInjektionslösung für Tiere
Maltese: NoromectinInjektionslös ung für Tiere
English: Cattle, Sheep, Goats, Pigs
Maltese: Rinder, Schafe, Schweine
English: AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas
Maltese: Merial Portuguesa - Saúde Animal, Lda AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas 2635-432 Rio de Mouro Portugal
English: CEVAMEC BOVINS OVINS SOLUTION INJECTABLE
Maltese: CEVAMEC BOVINS OVINS SOLUTION INJECTABL E
English: Czech Republic Bremer Pharma GmbH Cherbourger Str. 25
Maltese: Ir-Rumanija Bremer Pharma GmbH Cherbourger Str. 25
English: BIOVET JSC 39 Petar Rakov Str. 4550 Pesthera Bulgaria
Maltese: Il-Bulgarija BIOVET JSC 39 Petar Rakov Str.
English: In cattle injectable veterinary medicinal products containing ivermectin, either as a single active ingredient or in combination with a second active substance, are used against infestations with endoparasites and ectoparasites by administering 200 μg ivermectin/kg bw subcutaneously.
Maltese: Fil-każ tal-ifrat prodotti mediċinali injettabbli li fihom ivermectin, jew bħala sustanza attiva unika jew f'taħlita ma' sustanza attiva oħra, jintużaw kontra infestazzjonijiet minn endoparassiti u ektoparassiti billi jingħata 200 μg ivermectin/kg tal-piż tal-ġisem minn taħt il-ġilda.
English: DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD.
Maltese: Ir-Rumanija DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co.
English: Ivomec vet, injeksjonsvæske, oppløsning 10 mg/ml
Maltese: Ivomec vet, injeksjonsvæ ske, oppløsning 10 mg/ml
English: 2.2 Derivation of the withdrawal period for injectable veterinary medicinal products contains ivermectin as well as a second active substance (combination products)
Maltese: 2.2 Derivazzjoni tal-perjodu ta' rtirar għal prodotti mediċinali veterinarji injettabbli li fihom ivermectin flimkien ma' sustanza attiva oħra (prodotti kkumbinati)
English: DIVAMECTIN 1% SOLUCION
Maltese: IN 1% SOLUCION
English: Residue depletion data submitted for the formulation group containing ivermectin and closantel led to a withdrawal period of 36 days for closantel, calculated using the alternative approach and applying a safety span of 30%.
Maltese: Id-dejta dwar it-tnaqqis tar-residwi sottomessa għall-grupp ta' formulazzjonijiet li fihom ivermectin u closantel wasslet għal perjodu ta' rtirar ta' 36 jum għal closantel, ikkalkulat bl-użu tal-approċċ alternattiv u bl-applikazzjoni ta' perjodu ta' sigurtà ta' 30%.
English: TIZOVAL VACUNO INYECTABLE
Maltese: TIZOVAL VACUNO INYECTAB LE
English: Calier Portugal S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro Estrada de Albarraque 2710 - 335 Sintra Portugal
Maltese: Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro
English: Virbamec vet. 10 mg/ml injektionsvätska, lösning
Maltese: Virbamec vet. 10 mg/ml injektionsväts ka, lösning
English: DUTCH FARM VETERINARY PHARMACEUTICALS B.V.
Maltese: Ir-Rumanija DUTCH FARM VETERINARY PHARMACEUTICALS
English: Vectimax 10 mg/Ml Sol. Inj.
Maltese: Vectimax 10 mg/Ml Sol.
English: Discussion of specific issues raised in the referral notification
Maltese: Diskussjoni dwar kwistjonijiet speċifiċi mqajma fin-notifika ta' referenza
English: 1 CVMP Note for guidance:
Maltese: Nota għall-gwida CVMP:
English: Ganzestaartsedijk 8 - 5525 KC Duizel
Maltese: Ir-Rumanija PANTEX Ganzestaartsedijk 8 - 5525
English: Wherever possible the CVMP used the statistical method for calculating the individual withdrawal periods based on single studies, but in line with the CVMP Note for Guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1, where the necessary parameters were not shown to be valid for the statistical analysis, the alternative approach was used for calculating withdrawal periods.
Maltese: Kull fejn kien possibbli s-CVMP uża l-metodu statistiku għall-kalkolu tal-perjodi ta' rtirar individwali bbażat fuq studji uniċi, iżda skont in-Nota għall-Gwida tas-CVMP: approċċ lejn l-armonizzazzjoni talperjodi ta' rtirar (Note for Guidance: approach towards harmonisation of withdrawal periods, EMEA/CVMP/036/95)1, fejn il-parametri meħtieġa ma dehrux li kienu validi għall-analiżi statistika, intuża l-approċċ alternattiv għall-kalkolu tal-perjodi ta' rtirar.
English: The procedure involved 293 authorised injectable veterinary medicinal products containing ivermectin (see Annex I).
Maltese: Il-proċedura kienet tinvolvi 293 prodott mediċinali veterinarju injettabbli awtorizzat li fihom ivermectin (ara Anness I).
English: z.o.o., Dzierzoniwska street 21
Maltese: Pharmaceutical Company PFO "VETOS-FARMA" sp. z.o.o., Dzierzoniwska street 21
English: 3 Othellou Street, 2540 Dhali Industrial Estate Nicosia
Maltese: 3 Othellou Street, 2540
English: II.
Maltese: III.
English: Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),
Maltese: Id-Danimarka Bimeda (a division of Cross Vetpharm Group Limited)
English: Ivomec vet., injektionsvæske 10 mg/ml
Maltese: Ivomec vet., injektionsvæs ke 10 mg/ml
English: 3 Lo, P-K.A., Fink, D.W., Williams, J.B., Blondinger, J. (1985) Pharmacokinetic studies of ivermectin: effects of formulation.
Maltese: 3 Lo, P-K.A., Fink, D.W., Williams, J.B., Blondinger, J.
English: Subcutaneous 200 μg ivermectin/kg bw, 5 mg closantel/kg bw
Maltese: Subkutanju 200 μg ivermectin/kg bw, 5 mg closantel/kg bw
English: Interchemie werken “de Adelaar” BV
Maltese: Interchemie werken “de Adelaar” BV Horsterweg 26A
English: Route of administration
Maltese: Estrada de Albarraque
English: Qualimec, 10 mg/ml, Injektionsvätska, lösning
Maltese: Qualimec, 10 mg/ml, Injektionsvät ska, lösning
English: Szállás u. 5
Maltese: Chindiei, nr. 5
English: Ecomectin, 10 mg/ml, Injektionsvätska, lösning
Maltese: Ecomectin, 10 mg/ml, Injektionsvät ska, lösning
English: In fact, a small and pharmacologically insignificant difference in absorbed fraction (e.g. 99.5% versus 99.9%) at a certain time point may imply a significant difference in the amount remaining in the injection site (a factor of 5 in this example).
Maltese: Fil-fatt, differenza żgħira u farmakoloġikament insinifikanti fil-frazzjoni assorbita (eż. 99.5% kontra 99.9%) f'ċertu punt ta' ħin tista' timplika differenza sinifikanti fl-ammont li jifdal fis-sit tal-injezzjoni (f'dan l-eżempju fattur ta'
English: (1993) Effect of formulation on the pharmacokinetics and efficacy of doramectin.
Maltese: (1985) Pharmacokinetic studies of ivermectin: effects of formulation.
English: 6 Lifschitz, A., Sallovitz, J., Imperiale, F., Pis, A., Jauregui Lorda, J., Lanusse, C. (2004) Pharmacokinetic evaluation of four ivermectin generic formulations in calves.
Maltese: Parasitol. 6 Lifschitz, A., Sallovitz, J., Imperiale, F., Pis, A., Jauregui Lorda, J., Lanusse, C.
English: Subcutaneous 200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw
Maltese: Subkutanju 200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw
English: All products containing ivermectin and clorsulon had similar formulations and a number of residue depletion studies were submitted for the clorsulon component of products in this group.
Maltese: Il-prodotti kollha li kien fihom ivermectin u clorsulon kellhom formulazzjonijiet simili u ġew ippreżentati għadd ta' studji dwar it-tnaqqis tar-residwi għall-komponent clorsulon tal-prodotti f'dan il-grupp.
English: Bremer Pharma GmbH.
Maltese: Bremer Pharma
English: Gerbičeva 50, 1000 Ljubljana Slovenia
Maltese: 1000 Ljubljana
English: An attempt was made to find a correlation between the slopes or intercepts of the depletion curves and any of the following parameters: formulation group, bodyweight, breed, sex, age, and injection volume, using ANOVA or Pearson's methodology.
Maltese: Sar tentattiv biex tinstab korrelazzjoni bejn koeffiċjenti angolari (slopes) jew interċetti (intercepts) talkurvi tat-tnaqqis u kwalunkwe wieħed mill-parametri li ġejjin: grupp ta' formulazzjoni, piż tal-ġisem, razza, sess, età, u volum injettat bl-użu tal-metodoloġija ANOVA jew ta' Pearson.
English: The individual withdrawal periods calculated by the CVMP ranged from 21 days to 78 days.
Maltese: Il-perjodi individwali ta' rtirar kkalkulati misCVMP varjaw minn 21 jum sa 78 jum.
English: Marketing Authorisations for injectable veterinary medicinal products containing ivermectin for use in cattle have been granted in all Member States of the European Union via different authorisation procedures (mutual recognition procedures and national procedures) and under various legal bases (full, generic, bibliographic, informed consent).
Maltese: Ingħataw Awtorizzazzjonijiet għat-Tqegħid fis-Suq tal-prodotti mediċinali veterinarji injettabbli li fihom ivermectin għall-użu fl-ifrat fl-Istati Membri kollha tal-Unjoni Ewropea permezz ta' proċeduri ta' awtorizzazzjoni differenti (proċeduri ta' rikonoxximent reċiproku u proċeduri nazzjonali) u skont diversi bażijiet ġuridiċi (sħiħa, ġenerika, bibljografika, kunsens infurmat).
English: The harmonised withdrawal period of 49 days is relevant only to the ivermectin component of injectable products containing ivermectin.
Maltese: Il-perjodu ta' rtirar armonizzat ta' 49 jum huwa rilevanti biss għall-komponent ivermectin ta' prodotti injettabbli li fihom ivermectin.
English: A toxicological Acceptable Daily Intake (ADI) of 10 µg/kg bw/day (600 µg/person per day) was established based on the NOEL of 0.5 mg/kg bw/day retained from a 14-week dog study, applying a safety factor of 50.
Maltese: Id-doża ta' kuljum tossikoloġikament aċċettabbli (ADI) ġiet stabbilita għal 10 µg/kg tal-piż tal-ġisem/jum (600 µg/persuna kuljum) ikkalkulata fuq il-bażi tan-NOEL ta' 0.5 mg/kg tal-piż talġisem/kuljum miksub minn studju ta' 14-il ġimgħa fuq kelb, bl-applikazzjoni ta' fattur tas-sigurtà ta'
English: Tizoval Bovinos
Maltese: POUR BOVINS
English: 4 Wicks, S.R., Kaye, B., Weatherley, A.J., Lewis, D., Davison, E., Gibson, S.P., Smith, D.G.
Maltese: Wicks, S.R., Kaye, B., Weatherley, A.J., Lewis, D., Davison, E., Gibson, S.P., Smith, D.G. (1993) Effect of formulation on the pharmacokinetics and efficacy of doramectin.
English: 5 Lifschitz, A., Virkel, G. Pis, A., Imperiale, F., Sanchez, S., Alvarez, L., Kujanek, R, Lanusse, C. (1999) Ivermectin disposition kinetics after subcutaneous and intramuscular administration of an oil-based formulation to cattle.
Maltese: Pis, A., Imperiale, F., Sanchez, S., Alvarez, L., Kujanek, R, Lanusse, C.
English: MERIAL GmbH Am Söldnermoos 6 D-85399 Hallbergmoos Germany
Maltese: D-85399 Hallbergmoos Germany
English: SUMEX INYECTABLE BOVINO
Maltese: SUMEX INYECTAB LE BOVINO
English: ECOMECTIN 10 MG/ML SOLUCION INYECTABLE
Maltese: ECOMECTI N 10 MG/ML SOLUCION INYECTAB LE
English: Bimeda (a division of Cross Vetpharm Group Limited) Broomhill Road Tallaght
Maltese: Bimeda (a division of Cross Vetpharm Group Limited)
English: VIRBAMEC D SOLUTION INJECTABLE
Maltese: VIRBAMEC D SOLUTION INJECTABL E
English: Since this is below the 49 days limit applied for the ivermectin component, a withdrawal period of 49 days is recommended for the combination products containing ivermectin and closantel.
Maltese: Minħabba li dan huwa taħt il-limitu ta' 49 jum applikat għall-komponent ivermectin, huwa rrakkomandat perjodu ta' rtirar ta' 49 jum għallprodotti kkumbinati li fihom ivermectin u closantel.
English: VMD Animal Health Ltd. Közraktár u. 22/b.
Maltese: VMD Animal Health Ltd.
English: Panomec Injectievloeistof
Maltese: Panomec Injectievloeis tof
English: Of the formulation groups to which products were allocated in this procedure, two contained combination products; one with products containing the active substances ivermectin and clorsulon, and the second with products containing the active substances ivermectin and closantel.
Maltese: Mill-gruppi tal-formulazzjonijiet li għalihom ġew allokati l-prodotti f'din il-proċedura, tnejn kien fihom prodotti kkumbinati, wieħed bi prodotti li kien fihom is-sustanzi attivi ivermectin u clorsulon, u l-ieħor bi prodotti li kien fihom is-sustanzi attivi ivermectin u closantel.
English: Virbamec inj.
Maltese: INYECTAB LE
English: Therefore, the Committee concluded that a harmonised withdrawal period of 49 days could be established for the ivermectin component of all injectable products containing ivermectin, for use in cattle.
Maltese: Għaldaqstant, il-Kumitat ikkonkluda li perjodu ta' rtirar armonizzat ta' 49 jum jista' jiġi stabbilit għall-komponent ivermectin tal-prodotti injettabbli kollha li fihom ivermectin, għall-użu fl-ifrat.
English: United Kingdom Chanelle Animal Health Ltd 7 Rodney Street
Maltese: Il-Finlandja Chanelle Animal Health Ltd 7 Rodney Street
English: United Kingdom VIRBAC DE PORTUGAL Laboratorios LdaRua Dionísio Saraiva, Lote 1,
Maltese: Il-Ġermanja VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionísio Saraiva, Lote 1,
English: Slovak Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Maltese: Is-Slovenja MERIAL 29 avenue Tony Garnier 69007 LYON
English: Vetamectin
Maltese: VETERMEC
English: Noromectin 1% inj.sol.
Maltese: Cevamec 1 % inj. ad us. vet.
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 4.11 Withdrawal period(s)
Maltese: Għall-prodotti elenkati fl-Anness I li fihom ivermectin u clorsulon bħala sustanzi attivi: 4.11 Perjodu/i ta' Rtirar
English: From the overall data submitted by the MAHs and the National Competent Authorities of the Member States only 11 ivermectin residue depletion studies were considered of adequate quality for the purpose of calculating withdrawal periods, as only in these studies the relevant tissues including the injection sites were sampled and analysed.
Maltese: Mid-dejta globali sottomessa mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) u lAwtoritajiet Kompetenti Nazzjonali tal-Istati Membri, 11-il studju biss tat-tnaqqis tar-residwi ta' ivermectin kienu kkunsidrati ta' kwalità adegwata għall-iskop ta' kalkolu tal-perjodi ta' rtirar, minħabba li kien f'dawn l-istudji biss li t-tessuti rilevanti li kienu jinkludu s-siti tal-injezzjoni ttieħdu kampjuni tagħhom u ġew analizzati.
English: Skiereszewo, ul.
Maltese: Zo.o. Ul.
English: On a log-scale, the total ivermectin residue intake (µg) for a consumer, calculated from data of each animal (data points), compared with the ADI (µg/person, horizontal line).
Maltese: Fuq skala logaritmika, id-doża kumplessiva ta' residwi ta' ivermectin (µg) ta' konsumatur, ikkalkulata minn dejta ta' kull annimal (punti ta' dejta), imqabbla mal-ADI (µg/persuna, linja orizzontali).
English: PANTEX
Maltese: Sumex
English: Formulation groups allocated for the 293 products that are the subject of this referral.
Maltese: Gruppi tal-formulazzjonijiet stabbiliti għall-293 prodott suġġetti għal din ir-referenza.
English: Czech Republic Vétoquinol s.r.o., Zámečnícka 411,
Maltese: Vétoquinol s.r.o., Zámečnícka 411, 288 02 Nymburk, Czech Republic
English: Divasa Farmavic Hungaria Ltd. H-6070 Izsák, Kossuth L. u. 60.
Maltese: Izsák, Kossuth L. u. 60.
English: The Committee considered that based on the totality of the data, and based on the fact that at and beyond day 49 the intake calculation remains above the ADI for only two animals, a withdrawal period of 49 days would provide a degree of safety comparable to that provided using the statistical approach (and a withdrawal period based on the 95% tolerance limit).
Maltese: sigurtà komparabbli ma' dak pprovdut permezz tal-metodu statistiku (u perjodu ta' rtirar ibbażat fuq il-limitu ta' tolleranza ta' 95%).
English: Ivermectin was previously evaluated by the CVMP in order to establish maximum residue limits (MRLs).
Maltese: Ivermectin ġie evalwat minn qabel mis-CVMP sabiex jiġu stabbiliti l-limiti massimi ta' residwi (MRLs).
English: However, literature data indicate that the formulation can have an impact on the absorption rate of avermectins from the injection sites.
Maltese: Madankollu, id-dejta mil-letteratura tindika li l-formulazzjoni jista' jkollha impatt fuq ir-rata ta' assorbiment tal-avermectins mis-siti tal-injezzjoni.
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 10.
Maltese: Għall-prodotti elenkati fl-Anness I li fihom ivermectin u clorsulon bħala sustanzi attivi: 10.
English: FARMAVET S.A. Str. Petricani 198, Chişinău
Maltese: Petricani 198,
English: Czech Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Maltese: Ir-Rumanija MERIAL 29 avenue Tony Garnier 69007 LYON
English: Bimectin
Maltese: DIVAMECT
English: Ivermectin is currently included in Annex I of Council Regulation (EEC) No 2377/90 with MRLs for all food producing species as follows:
Maltese: Ivermectin fil-preżent huwa inkluż fl-Aness I tar-Regolament tal-Kunsill (KEE) Nru 2377/90 b'MRLs għall-ispeċi kollha li jipproduċu l-ikel kif ġej:
English: INDUSTRIAL VETERINARIA, S.A.
Maltese: INDUSTRIAL VETERINARIA, S.A. C/ Esmeralda, 19
English: • the CVMP considered that sources of variation linked to the subcutaneous use of ivermectin in cattle are present that lead to different depletion profiles in residue studies, and this variation is of much more importance than any variation that may be caused by formulation differences.
Maltese: • is-CVMP kkunsidra li hemm preżenti sorsi ta' varjazzjoni marbuta mal-użu subkutanju ta' ivermectin fl-ifrat li jistgħu jwasslu għal profili ta' tnaqqis differenti fi studji tar-residwi, u din il-varjazzjoni hija ħafna aktar importanti minn kwalunkwe varjazzjoni li tista' tiġi kkawżata minn differenzi ta' formulazzjoni.
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients:
Maltese: Għall-prodotti elenkati fl-Anness I li fihom ivermectin u clorsulon bħala sustanzi attivi:
English: Centrovet Ltd.
Maltese: LTD.
English: Since there is no muscle MRL for ivermectin, the ADI-based approach was used for evaluating the total daily intake of residues that may arise from the consumption of tissues of each animal (EMEA/CVMP/542/03-Final)2.
Maltese: Minħabba li m'hemmx MRL tal-muskolu għall-ivermectin, intuża l-approċċ ibbażat fuq l-ADI għallvalutazzjoni tad-doża totali ta' kuljum ta' residwi li jistgħu jirriżultaw mill-konsum ta' tessuti ta' kull annimal (EMEA/CVMP/542/03-Final)2.
English: For injectable veterinary medicinal products containing ivermectin in combination with another active substance residue depletion of the second active substance must also be considered, and a withdrawal period for the second active substance derived.
Maltese: Għal prodotti mediċinali veterinarji injettabbli li fihom ivermectin flimkien ma' sustanza attiva oħra it-tnaqqis ta' residwi tat-tieni sustanza attiva għandu jkun ikkunsidrat ukoll, u għandu jkun stabbilit perjodu ta' rtirar għat-tieni sustanza attiva.
English: Animec Inj.
Maltese: Animec Inj. Sol.
English: Bremamectin
Maltese: Bremerhaven
English: Considering the totality of the data on clorsulon residue depletion, the statistical method could not be used for calculating the withdrawal periods as the relevant statistical assumptions were not met.
Maltese: Ma kienx possibbli li jintuża l-metodu statistiku għall-analiżi ta' din id-dejta miġbura minħabba li ma ntlaħqux għadd ta' ipoteżijiet statistikament rilevanti.
English: Cattle: Meat and offal - 66 days.
Maltese: Laħam u ġewwieni - 66 jum.
English: Target tissue
Maltese: TATTIKKETTA
English: Belgium Norbrook Laboratories Limited Station Works
Maltese: Il-Finlandja Norbrook Laboratories Limited Station Works
English: QUALIMEC 10 MG/ML SOLUTION INJECTABLE
Maltese: QUALIMEC 10 MG/ML SOLUTION INJECTABL E
English: While the data examined by the CVMP did lead to the calculation of different withdrawal periods for products that are essentially the same, this variability is not considered to reflect product specific effects but is rather a feature of the way the products were used (i.e. the variation results from differences such as animal bodyweight, breed, sex, age, injection volume and sampling procedure).
Maltese: Għalkemm id-dejta analizzata mis-CVMP wasslet fil-fatt għall-kalkolu ta' perjodi ta' tnaqqis differenti għal prodotti li huma essenzjalment l-istess, din il-varjabilità mhix ikkunsidrata li tirrifletti effetti speċifiċi tal-prodott iżda hija pjuttost karatteristika tal-mod kif intużaw il-prodotti (jiġifieri l-varjazzjoni tirriżulta minn differenzi bħalma huma l-piż tal-ġisem tal-annimal, ir-razza, is-sess, l-età, il-volum ta' injezzjoni u l-proċedura tal-ittestjar).
English: Subcutaneous Cattle, Reindeer: 200 μg ivermectin/kg bw
Maltese: Subkutanju Frat: 200 μg ivermectin/kg bw
English: Because the equivalence of local residue levels at the injection site cannot be predicted based on plasma bioequivalence, and because published data indicate that formulation can have an impact on residue depletion profiles for ivermectin, the CVMP considered that, in general, there is no basis for automatically extrapolating a withdrawal period established for one formulation to a second formulation, even if plasma bioequivalence has been shown.
Maltese: Mid-dejta disponibbli ma nstabu l-ebda korrelazzjonijiet li setgħu jispjegaw id-differenza fil-profili tat-tnaqqis jew fil-perjodi stmati ta' rtirar, u l-ebda wieħed mill-parametri rreġistrati ma seta' jiġi identifikat bħala sors uniku kbir ta' varjazzjoni.
English: • the CVMP considered that for combination products containing ivermectin as well as a second active substance, residue depletion of the second active substance must also be considered when setting the withdrawal period and the withdrawal period for the product shall be the longest established for the individual components.
Maltese: • is-CVMP kkunsidra li għal prodotti kkumbinati li fihom ivermectin flimkien ma' sustanza attiva oħra, it-tnaqqis tar-residwi tat-tieni sustanza attiva għandu jkun ikkunsidrat ukoll meta jkun qed jiġi stabbilit il-perjodu ta' rtirar u l-perjodu ta' rtirar għall-prodott għandu jkun litwal wieħed stabbilit għall-komponenti individwali.
English: Ivomec 1% inj.
Maltese: Ivomec 1% inj. ad us.vet.
English: Tolomec
Maltese: Ċipru
English: Belgium ECO Animal Health Ltd 78 Coombe Road
Maltese: Il-Bulgarija ECO Animal Health Ltd 78 Coombe Road
English: IVERMECTINE ECO 10 MG/ML SOLUTION I NJECTABLE
Maltese: IVERMECTI NE ECO 10 MG/ML SOLUTION I NJECTABL E
English: Rua Dionísio Saraiva, Lote 1, 1° Andar, Sala 2,
Maltese: VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionísio Saraiva, Lote 1, 1° Andar, Sala 2,
English: VETERMEC Ivermectin 10 mg/ml
Maltese: Vetamectin Ivermectin 10 mg/ml
English: ECOMECTIN 10MG/ML
Maltese: ECOMECTI N 10MG/ML
English: The variability in calculated withdrawal periods reflects the variability in the depletion profiles and particularly the variability in depletion of residues from the injection site.
Maltese: Ilvarjabilità fil-perjodi ta' rtirar ikkalkulati tirrifletti l-varjabilità fil-profili tat-tnaqqis u b'mod partikolari l-varjabilità fit-tnaqqis tar-residwi mis-sit tal-injezzjoni.
English: Galmectin
Maltese: Skovlunde
English: VIRBAMEC Ivermectin 10 mg/ml
Maltese: Bremamectin Ivermectin 10 mg/ml
English: 2635-432 Rio de Mouro Portugal
Maltese: 2710 - 335 Sintra
English: Harlow
Maltese: Qawwiet