FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Bortezomib Sun is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Bortezomib Sun huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: No additional studies were needed as Bortezomib Sun is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Velcade.
Maltese: Ma kien jinħtieġ lebda studju addizzjonali peress li Bortezomib Sun huwa mediċina ġenerika mogħtija permezz ta' injezzjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Velcade.
English: It blocks proteasome, which is a system in cells that breaks down proteins that are no longer needed.
Maltese: Din timblokka proteasome, li hija sistema fiċ-ċelloli li tkisser il-proteini li m'għadux hemm il-ħtieġa għalihom.
English: In these patients, Bortezomib Sun is used in combination with melphalan and prednisone;
Maltese: F'dawn il-pazjenti, Bortezomib Sun jintuża flimkien ma' melfalan u predniżon;
English: The Committee recommended that Bortezomib Sun be approved for use in the EU.
Maltese: IlKumitat irrakkomanda li Bortezomib Sun ikun approvat għall-użu fl-UE.
English: Bortezomib Sun is available in vials as a 3.5 mg powder to be made up into a solution for injection into a vein or under the skin.
Maltese: Bortezomib Sun jiġi f'kunjetti bħala trab ta' 3.5 mg biex isir f'soluzzjoni għall-injezzjoni ġol-vina jew taħt il-ġilda.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Bortezomib Sun has been shown to be comparable to Velcade.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Bortezomib Sun wera li huwa komparabbli ma' Velcade.
English: How is Bortezomib Sun used?
Maltese: Kif jaħdem Bortezomib Sun?
English: For more information on the use of Bortezomib Sun see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar l-użu ta' Bortezomib Sun, ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: The company that markets Bortezomib Sun will supply educational material to healthcare professionals on making up and giving the injection, calculating the dose, and prescribing and giving the correct treatment for patients receiving blood stem-cell transplantation.
Maltese: Il-kumpanija li tqiegħed Bortezomib Sun fis-suq sejra tipprovdi materjal edukattiv lill-professjonisti filqasam tal-kura tas-saħħa dwar l-għamla u l-għoti tal-injezzjoni, il-kalkolu tad-doża, u l-għoti b'riċetta u l-għoti tal-kura korretta għall-pazjenti li qed jirċievu trapjant taċ-ċelloli staminali tad-demm.
English: In this group of patients, Bortezomib Sun is used in combination with dexamethasone, or with dexamethasone plus thalidomide.
Maltese: F'dan il-grupp ta' pazjenti, Bortezomib Sun jintuża flimkien ma' dessametażon, jew ma' dessametażon u talidomide f'daqqa.
English: By 25th November 2013 at the latest
Maltese: Mhux aktar tard mill25 ta' Novembru 2013
English: The products with only obstetric indications and for which revocation is applicable (instead of variation to the terms of the marketing authorisation) should be recalled from the market by the Marketing Authorisation Holders by 25th November 2013 at the latest.
Maltese: Il-prodotti b'indikazzjonijiet ostetriċi biss u li għalihom ir-revoka hija applikabbli (minflok il-varjazzjoni lit-termini tal-awtorizzazzjoni għat-tqegħid fis-suq) għandhom jiġu rtirati mis-suq mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq sa mhux aktar tard mill-25 ta' Novembru 2013.
English: National Competent Authorities (NCAs) of Member States or Reference Member States (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti (NCAs) tal-Istati Membri jew l-Istati Membri ta' Referenza (RMS) fejn applikabbli, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu sodisfatti mill-MAH(s):
English: Within 30 days after CMDh agreement
Maltese: Fi żmien 30 jum wara lftehim tas-CMDh
English: DHPC Communication circulation according to the CMDh agreed communication plan and conditions.
Maltese: Komunikazzjoni DHPC li tiċċirkola skont il-pjan ta' komunikazzjoni u lkundizzjonijiet miftiehma mis-CMDh.
English: Annex IV Conditions to the marketing authorisation
Maltese: Anness IV
English: Centurii, nr. 7
Maltese: Şos. Centurii, nr. 7
English: Carl Fr. Mortensen, Copenhagen 1966.
Maltese: Carl Fr. Mortensen, Kopenħagen 1966.
English: Pol. Ind. De Vallecas Madrid
Maltese: Ind. De Vallecas Madrid
English: Romavermectina B1 1% Plus
Maltese: B1 1% Plus
English: Active substance
Maltese: Sustanza attiva
English: D-81379 München GERMANY
Maltese: D-81379 München
English: Av. Maria Lamas, Lt.19 - BL APiso 2 - Serra das Minas 2635-432 Rio de Mouro PORTUGAL
Maltese: Maria Lamas, Lt.19 - BL APiso 2 - Serra das Minas 2635-432 Rio de Mouro PORTUGAL
English: 8501 Novo Mesto SLOVENIA
Maltese: 8501 Novo Mesto
English: Available data
Maltese: Dejta disponibbli
English: Merial Italia S.p.A. via Vittorio Pisani, 16 20100 Milano ITALY
Maltese: Merial Italia S.p.A. via Vittorio Pisani, 16 20100
English: Available data Study 1.
Maltese: Dejta disponibbli Studju 1.
English: AniMedica GmbH Im Südfeld 9
Maltese: Il-Ġermanja AniMedica GmbH Im Südfeld 9
English: KRKA tovarna zdravil, d.d.
Maltese: Is-Slovenja KRKA tovarna zdravil, d.d.
English: Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd.
Maltese: Il-Ġermanja Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd.
English: bw duration equation 2
Maltese: bw duration ekwazzjoni 2
English: Via M. Buonarroti 23
Maltese: Buonarroti 23
English: 78 days
Maltese: 78 jum
English: Laboratorios Cenavisa, s.a. Cami Pedro Estela, S/N 43205 Reus (Tarragona) SPAIN
Maltese: Laboratorios Cenavisa, s.a. Cami Pedro Estela, S/N 43205 Reus (Tarragona)
English: Luxembourg Pfizer Animal Health S.A. rue Laid Burniat 1
Maltese: Pfizer Animal Health S.A. rue Laid Burniat 1
English: S.P. Veterinaria S.A. Ctra Reus a Vinyols Km.4,1 43330 Riudoms (Tarragona) SPAIN
Maltese: S.P. Veterinaria S.A. Ctra Reus a Vinyols Km.4,1 43330 Riudoms (Tarragona)
English: Novartis Tiergesundheit GmbH Zielstattstr.
Maltese: Il-Ġermanja Novartis Tiergesundheit GmbH Zielstattstr.
English: CT13 9NJ UNITED KINGDOM
Maltese: CT13 9NJ
English: Bomac Laboratories Limited Cnr Wiri Station Road & Hobill Ave
Maltese: Ir-Rumanija Bomac Laboratories Limited Cnr Wiri Station Road & Hobill Ave
English: 60 days
Maltese: 60 jum
English: 1 Rasmussen, F. (1966) Studies on the mammary excretion and absorption of drugs.
Maltese: 1 Rasmussen, F. (1966) Studji dwar l-eliminazzjoni mammarja u l-assorbiment tal-mediċini.
English: Flukiver Bovis Closantel
Maltese: Flukiver Bovis Klożantel
English: el equation 1
Maltese: el ekwazzjoni 1
English: Frumos, km.
Maltese: Frumos, km. 10 Iaşi
English: Broomhill Road TALLAGHT
Maltese: Broomhill Road
English: E-08950 Esplugues de Llobregat (Barselona) SPAIN
Maltese: Esplugues de Llobregat (Barselona) SPAIN
English: Not possible to determine
Maltese: Mhux possibbli li tiġi ddeterminata
English: S.C. Romvac Company s.a. Şos.
Maltese: Romvac Company s.a.
English: Co. Kildare
Maltese: Kildare
English: in which D is the number of molecules.
Maltese: fejn D huwa n-numru ta' molekuli.
English: VIM Spectrum S.R.L.
Maltese: Ir-Rumanija VIM Spectrum S.R.L.
English: Endex Suspensie Triclabendazole Levamisole
Maltese: Endex Suspensie Triklabendażol Levamisole
English: 300 mg/tab Tablets oral
Maltese: 300 mg/tab Pilloli
English: Belgium Chanelle Pharmaceuticals Manufacturing Ltd.
Maltese: Chanelle Pharmaceuticals Manufacturing Ltd.
English: ad us.vet.
Maltese: Ivomec Super inj. ad us.vet.
English: Clorsulon
Maltese: Klorsulon
English: Via Isonzo 71 LATINA
Maltese: Pfizer Italia s.r.l. Via Isonzo 71 LATINA
English: Vermifor Ecto Closantel
Maltese: Vermifor Ecto Klożantel
English: Pharmacokinetic study following oral administration of 14C-triclabendazole.
Maltese: Studju farmakokinetiku wara l-għoti orali ta' 14C-Triklabendażol.
English: Maagdenburgstraat 38 7421 ZE Deventer THE NETHERLANDS
Maltese: 7421 ZE Deventer THE NETHERLANDS
English: Flukiver 5% Closantel
Maltese: Flukiver 5% Klożantel
English: Closantel Invermectine
Maltese: Klożantel Invermectine
English: Half-lives reported for rafoxanide range between 7 and 16.6 days.
Maltese: Half-lives rapportati għal rafoxanide għandhom medda bejn 7 u 16.6 ijiem.
English: Sighisoarei nr.409 Tg.
Maltese: Sighisoarei nr.409
English: Pfizer GmbH Linkstr.
Maltese: Il-Ġermanja Pfizer GmbH Linkstr. 10
English: Adv Drug Deliv Rev. 55(5): 617-627
Maltese: (2003) Eliminazzjoni tal-mediċina fil-ħalib tal-omm - ħarsa ġenerali. Adv Drug Deliv Rev. 55(5): 617-627
English: Flukiver 50 mg/ml solução injectável para bovinos e ovinos
Maltese: 50 mg/ml solução injectável para bovinos e ovinos
English: Parsifal Bovins Triclabendazole Levamisole
Maltese: Parsifal Bovins Triklabendażol Levamisole
English: 5 Pharmaceutical form for oral administration - bolus
Maltese: Forma farmaċewtika għall-għoti orali - bolus
English: Pfizer Ltd Ramsgate Road Sandwich Kent
Maltese: Ir-Renju Unit Pfizer Ltd Ramsgate Road Sandwich
English: Co. Galway
Maltese: Galway
English: The remaining 20% of the ADI corresponds to 60 µg of nitroxinil residues.
Maltese: L-20% tal-ADI li fadal jikkorrispondi għal 60 µg ta' residwi ta' nitroxinil.
English: Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Maltese: Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
English: Woolpit Business Park Windmill Avenue Woolpit
Maltese: Ir-Renju Unit Virbac Ltd Woolpit Business Park Windmill Avenue Woolpit
English: Michiels, M., Meuldermans, W., Heykants, J. (1987) The metabolism and fate of closantel (Flukiver) in sheep and cattle.
Maltese: Michiels, M., Meuldermans, W., Heykants, J.
English: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss GERMANY
Maltese: Il-Ġermanja Janssen-Cilag GmbH Johnson & Johnson Platz 1
English: Vanelli S.R.L.
Maltese: Ir-Rumanija Vanelli S.R.L.
English: Belgium Chanelle Animal Health Limited 7 Rodney Street
Maltese: Ir-Renju Unit Chanelle Animal Health Limited 7 Rodney Street
English: Triclabendazole Levamisole
Maltese: Triklabendażol Levamisole
English: Triclabendazole Abamectin
Maltese: Triklabendażol Abamectin
English: In the majority of cases transfer of substances from blood plasma to milk (and vice versa) is governed by simple diffusion across the mammary gland epithelium (Rasmussen, 1966); active transport has been rarely reported (Ito and Lee, 2003)3.
Maltese: Fil-maġġoranza tal-każijiet it-trasferiment ta' sustanzi mill-plażma tad-demm għall-ħalib (u vice versa) jiġi rregolat b'diffużjoni sempliċi bejn l-epitelju tal-glandola mammarja (Rasmussen, 1966); it-trasport attiv ġie rarament irrapportat (Ito u Lee, 2003)3.
English: Plasma levels of rafoxanide were measured for up to 672 hours post treatment (GCP for animal phase and GLP for analytical phase)Bloomfield, 1991
Maltese: Il-livelli ta' rafoxanide fil-plażma kienu mkejla sa 672 siegħa wara l-kura (PKT għall-fażi tal-annimali u GLP għallfażi analitika) - Bloomfield, 1991
English: This analysis used the ‘SCLR' (Safe concentrations based on linear regression) method.
Maltese: Din l-analiżi użat il-metodu "SCLR" (Konċentrazzjonijiet siguri bbażati fuq rigressjoni lineari).
English: Study 5.
Maltese: Studju 5.
English: It should be noted that many (155) of the clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole containing products are combination products containing other active substances.
Maltese: Għandu jiġi nnotat li ħafna (155) mill-prodotti li fihom Klorsulon, Klożantel, nitroxinil, rafoxanide jew Triklabendażol huma prodotti ta' kombinazzjoni li fihom sustanzi attivi oħra.
English: The remaining 52% of the ADI corresponds to 62 µg of clorsulon residues.
Maltese: Il-52% tal-ADI li fadal jikkorrispondi għal 62 µg ta' residwi ta' Klorsulon.
English: Following the CVMP opinion of 8 March 2012 recomending amendments of section 4.11 Withdrawal period(s) of the SPC for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as a single active substance (see Annex I) and for the veterinary medicinal products administered as pour-on to cattle containing triclabendazole and moxidectin (see Annex I), on 23 March 2012, MERIAL notified the Agency of ther intention to request a re-examination of the CVMP opinion.
Maltese: Wara l-opinjoni tas-CVMP tat-8 ta' Marzu 2012 li tirrakkomanda l-emendi tas-sezzjoni 4.11 Perjodu(i) ta' tiżmim tal-SPC għall-prodotti mediċinali veterinarji li fihom Klorsulon, Klożantel, nitroxinil, rafoxanide jew Triklabendażol bħala sustanza attiva unika (ara Anness I) u għall-prodotti mediċinali veterinarji li jingħataw bħala sustanza li titferra' lill-baqar li fihom Triklabendażol u moxidectin (ara Anness I), fit-23 ta' Marzu 2012, MERIAL innotifikat lill-Aġenzija bl-intenzjoni tagħhom li jitolbu eżaminazzjoni mill-ġdid tal-opinjoni tas-CVMP.
English: Parsifal Ovins Triclabendazole Levamisole
Maltese: Parsifal Ovins Triklabendażol Levamisole
English: in which T = time (days), dose = total dose (g/kg bw/day), duration = treatment duration (days), bw = bodyweight (kg), A = Avogadro's number = 6.0 * 1023, M = Molar mass (g/mol), t1/2 = terminal elimination half-life (h), and in which
Maltese: fejn T = żmien (ġranet), doża = doża totali (g/kg tal-piż-tal-ġisem/jum), tul = tul tal-kura (jiem), bw = piż tal-ġisem (kg), numru ta' Avogadro = 6.0 * 10 23, M = massa molari (g/mol),
English: Loughrea, Co. Galway IRELAND
Maltese: Galway IRELAND
English: Luxembourg Merial Belgium S.A. Boulevard Sylvain Dupuis 243 B-1070 Bruxelles
Maltese: Boulevard Sylvain Dupuis 243
English: Belgium Janssen Pharmaceutica N.V. 30 Turnhoutseweg
Maltese: L-Ungerija Janssen Pharmaceutica N.V. 30
English: Seponver Plus Closantel Mebendazole
Maltese: Seponver Plus Klożantel Mebendazole
English: Belgium Norbrook Laboratories Ltd Station Works
Maltese: In-Norveġja Norbrook Laboratories Ltd Station Works
English: Triclabendazole Ivermectin
Maltese: Triklabendażol Ivermectin
English: Triclabendazole
Maltese: Triklabendażol
English: Belgium Cross Vet Pharm Group Ltd Broomhill Road
Maltese: Id-Danimarka Cross Vet Pharm Group Ltd Broomhill Road
English: Flukicides play a critical role in the prevention and control of trematode infections.
Maltese: Flukicides għandhom rwol kritiku fil-prevenzjoni u l-kontroll ta' infezzjonijiet minn trematode.
English: Pasteur - Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
Maltese: Ir-Rumanija Pasteur - Filiala Filipesti SRL Str.
English: Study 1.
Maltese: Studju 1.
English: Norofas Pour on Closantel Ivermectine
Maltese: Norofas Pour on Klożantel Ivermectine
English: Norofas Pour-On Closantel Ivermectin
Maltese: Norofas Pour-On Klożantel Ivermectin
English: C/ De La Marina 206
Maltese: Novartis Sanidad Animal S.L. C/ De La Marina 206
English: The remaining 25% of the ADI corresponds to 30 µg rafoxanide residues.
Maltese: Il-25% tal-ADI li fadal jikkorrispondi għal 30 µg ta' residwi ta' rafoxanide.
English: Plasma clorsulon levels were monitored for up to 35 days after administration (GLP compliant).
Maltese: Il-livelli ta' Klorsulon fil-plażma ġew immonitorjati sa 35 jum wara l-għoti (konformi mal-GLP).
English: Study 4.
Maltese: Studju 4.
English: Study 6.
Maltese: Studju 6.
English: Study 2.
Maltese: Studju 2.
English: The CVMP collected information from national competent authorities on veterinary medicinal products containing these substances.
Maltese: Is-CVMP ġabar informazzjoni mill-awtoritajiet nazzjonali kompetenti dwar il-prodotti mediċinali veterinarji li fihom dawn is-sustanzi.
English: The remaining 5.6% of the ADI corresponds to 100 µg of closantel residues.
Maltese: Il-5.6% tal-ADI li fadal jikkorrispondi għal 100 µg ta' residwi ta' Klożantel.
English: 25 g/100ml injectable solution
Maltese: 25 g/100ml soluzzjoni injettabbli
English: Closantel Oxfendazol
Maltese: Klożantel Oxfendazol
English: Maximec Plus Clorsulon Ivermectin
Maltese: Maximec Plus Klorsulon Ivermectin
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi ta' annimali, mnejn għandhom jingħataw, applikanti/detenturi tal-awtorizzazzjoni għattqegħid fis-suq fl-Istati Membri
English: Residue depletion study in plasma following single oral administrations of one of two formulations of 7.5 mg/kg bw rafoxanide to 6 cattle and 6 sheep.
Maltese: Studju ta' tnaqqis tar-residwi fil-plażma wara l-għotjiet orali uniċi ta' wieħed miż-żewġ formulazzjonijiet ta' 7.5 mg/kg tal-piż tal-ġisem ta' rafoxanide lil 6 baqar u 6 nagħaġiet.
English: Residue depletion study following a single oral administration of 10 mg/kg bw closantel to 11 pregnant cows 40 to 45 days before expected calving.
Maltese: Studju ta' tnaqqis tar-residwi wara għoti uniku orali ta' 10 mg/kg tal-piż tal-ġisem ta' Klożantel lil 11-il baqra tqila 40 sa 45 jum qabel ma kienu mistennija li jwelldu.
English: via Nettunense km 20,300
Maltese: Intervet Production s.r.l. via Nettunense km 20,300
English: Closantel Oxfendazole
Maltese: Klożantel Oxfendazole
English: Triclabendazole Moxidectin
Maltese: Triklabendażol Moxidectin
English: Esteve Farma LDA Av. Do Forte, 3
Maltese: Esteve Farma LDA Av.
English: M g in amount safe µ equation 3 in which M = Molar mass (g/mol), A = Avogadro's number = 6.0 * 1023
Maltese: fejn M = Massa molari (g/mol), A = Numru ta' Avogadro = 6.0 * 1023 Ir-riżultat tal-ekwazzjoni 2 jiġi dejjem imqarreb għal numru sħiħ ta' ġranet.
English: Supaverm Closantel Mebendazole
Maltese: Supaverm Klożantel Mebendazole
English: Tablets oral
Maltese: Pilloli
English: The length of the dry period was monitored, as well as milk levels of nitroxinil for up to 120 days post treatment (non GCP study) - Danaher et al, 2010
Maltese: It-tul tal-perjodu xott ġie mmonitorjat, kif ukoll il-livelli ta' nitroxinil filħalib sa 120 jum wara l-kura (studju mhux GCP) - Danaher et al, 2010
English: Plasma closantel concentrations were monitored for up to 1848 hours after administration (GLP study).
Maltese: Il-konċentrazzjonijiet ta' Klożantel fil-plażma ġew immonitorjati sa 1848 siegħa wara l-għoti (studju GLP).
English: Closantel Mebendazol
Maltese: Klożantel Mebendazol
English: Flukiver 5 Injection
Maltese: Flukiver 5
English: Plasma closantel levels were monitored for up to 1488 hours after administration (GLP study).
Maltese: Il-livelli ta' Klożantel fil-plażma ġew immonitorjati sa 1488 siegħa wara l-għoti (studju GLP).
English: Bimectin Plus Clorsulon Ivermectin
Maltese: Bimectin Plus Klorsulon Ivermectin
English: While residues of nitroxinil in milk may be present largely as nitroxinil (as is the case in fat), there have also been reports of nitroxinil conjugates in milk (Whelan et al., 2011).
Maltese: Filwaqt li r-residwi ta' nitroxinil fil-ħalib jistgħu jkunu l-aktar preżenti bħala nitroxinil (bħal fil-każ tax-xaħam), kien hemm ukoll rapporti ta' konjugati ta' nitroxinil fil-ħalib (Whelan et al., 2011).
English: Using the longest reported figure of 16.6 days, a molecular weight of 626, a dose of 7.5 mg/kg bw, and a body weight of 50kg, the time needed to ensure a total residue burden equal to a safe number of molecules in 1.5 l milk was calculated to be 272 days which, for the purposes of this referral, can be rounded up to 1 year.
Maltese: Bl-użu tal-itwal figura rrapportata ta' 16.6 ijiem, piż molekulari ta' 626, doża ta' 7.5 mg/kg tal-piż-tal-ġisem, u piż tal-ġisem ta' 50 kg, iż-żmien meħtieġ biex jiġi żgurat piż residwu totali ugwali għal numru sigur ta' molekuli f'1.5 l ta' ħalib kien ikkalkolat li kien ta' 272 jum, li għall-fini ta' dan ir-riferiment, jista' jiġi mqarreb għal sena.
English: Fasinex 24% Triclabendazole 240 mg/ml
Maltese: Fasinex 24% Triklabendażol
English: MRLs established in muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 75 % of the ADI (CVMP, 2001).
Maltese: L-MRLs stabbiliti fl-muskoli, fix-xaħam, fil-fwied u fil-kliewi jwasslu għal konsum massimu teoretiku ta' kuljum ta' residwi ekwivalenti għal 75% tal-ADI (CVMP, 2001).
English: It was concluded that residues in pasma would be below 0.18 μg/l 78 days (11 weeks) after administration.
Maltese: Ġie konkluż li residwi fil-plażma jkunu anqas minn 0.18 µg/ml/l 78 jum (11-il ġimgħa) wara l-għoti.
English: However, closantel depletion profiles have been shown to be similar in milk and plasma, with a milk to plasma ratio of 0.02 (study 5 above).
Maltese: Madankollu, il-profili ta' tnaqqis ta' Klożantel intwerew li kienu simili fil-ħalib u fil-plażma, bi proporzjon tal-ħalib għall-plażma ta' 0.02 (studju 5 hawn fuq).
English: The following equation describes the elimination process in the terminal phase:
Maltese: L-ekwazzjoni li ġejja tiddeskrivi l-proċess ta' eliminazzjoni fil-fażi terminali:
English: A tissue residue depletion including data on plasma clorsulon levels was provided, in which forty cattle were administered single subcutaneous injections of 2 mg/kg bw clorsulon.
Maltese: Ġie pprovdut tnaqqis tar-residwi fit-tessut inkluż dejta dwar il-livelli ta' Klorsulon fil-plażma, fejn erbgħin baqra ngħataw injezzjonijiet uniċi ta' 2 mg/kg tal-piż-tal-ġisem ta' Klorsulon taħt il-ġilda.
English: Clorsulon Ivermectin
Maltese: Klorsulon Ivermectin
English: Endex 8,57% Triclabendazole Levamisole
Maltese: Endex 8,57% Triklabendażol Levamisole
English: MRLs established in muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 94.4% of the ADI.
Maltese: L-MRLs stabbiliti fl-muskoli, fix-xaħam, fil-fwied u fil-kliewi jwasslu għal konsum massimu teoretiku ta' kuljum ta' residwi ekwivalenti għal 94.4% tal-ADI.
English: Bimectin Fluke Clorsulon Ivermectin subcutaneous Cattle
Maltese: Bimectin Fluke Klorsulon Ivermectin
English: Chanectin Super Clorsulon Ivermectin subcutaneous Cattle
Maltese: Chanectin Super Klorsulon Ivermectin
English: Endex 8.75% Triclabendazole Levamisole
Maltese: Endex 8.75% Triklabendażol Levamisole
English: After reviewing the documentation submitted by the marketing authorisation holder and after considering the information provided during the oral explanation, the CVMP concluded that there were not sufficient scientific grounds to revise its conclusions of 8 March 2012 on the restrictions that should be applied to the use of nitroxinil in dairy cattle in order to avoid residues in milk occurring at levels that could compromise consumer safety.
Maltese: Wara li rreveda d-dokumentazzjoni sottomessa mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq u wara li kkunsidra l-informazzjoni pprovduta waqt l-ispjegazzjoni orali, is-CVMP ikkonkluda li ma kienx hemm biżżejjed raġunijiet xjentifiċi biex jirrevedi l-konklużjonijiet tiegħu tat-8 ta' Marzu 2012 dwar irrestrizzjonijiet li għandhom jiġu applikati għall-użu ta' nitroxinil fil-baqar tal-ħalib sabiex jiġu evitati residwi fil-ħalib f'livelli li jistgħu jikkompromettu s-sigurtà tal-konsumatur.
English: Residue depletion study in milk following a single pour-on application of 20 mg/kg bw triclabendazole to 18 pregnant cows 60 days prior to expected calving.
Maltese: Studju ta' tnaqqis tar-residwi fil-ħalib wara applikazzjoni unika permezz ta' ta' 20 mg/kg talpiż tal-ġisem ta' Triklabendażol bħala sustanza li titferra' lil 18-il baqra tqila 60 jum qabel ma kienu mistennija li jwelldu.
English: Pharmacokinetic study in which 5 heifers and 4 steers were administered a single (oral) dose 10 mg/kg bw 14C-labelled closantel by intubation into the rumen.
Maltese: Studju farmakokinetiku li fih 5 għoġġiela u 4 gniedes ingħataw doża unika (orali)