FrancophonIA/ELRC3.0 huggingface dataset:
English: Primary means that the hypercholesterolaemia does not have any identifiable cause.
Maltese: Primarja tfisser li l-iperkolesterolemija ma jkollhiex kawża identifikabbli.
English: Fluvastatin belongs to a group of medicines called ‘statins', which are cholesterol-lowering agents.
Maltese: Il-fluvastatina tagħmel parti minn grupp ta' mediċini li jissejħu ‘statins', li huma sustanzi li jbaxxu l-kolesterol.
English: It works by blocking the activity of an enzyme called HMG-CoA reductase.
Maltese: Dan jaħdem billi jimblokka l-attività ta' enzima li tissejjaħ HMG-CoA reduttażi.
English: Secondary prevention in coronary heart disease Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).” The Committee noted that the indication “to slow the progression of coronary atherosclerosis in patients with primary hypercholesterolemia, including mild forms, and coronary heart disease”, which was not approved in some Member States, should be removed because the results from the clinical study did not supported this indication.
Maltese: Prevenzjoni sekondarja fil-mard koronarju tal-qalb Prevenzjoni sekondarja ta' avvenimenti kardijaċi avversi maġġuri f'adulti b'mard koronarju talqalb wara interventi koronarji perkutanji (ara sezzjoni 5.1).”
English: On 9 February 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Lescol in the EU.
Maltese: Fid-9 ta' Frar 2009, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP biex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Lescol fl-UE.
English: The CHMP noted that for the treatment of dyslipidaemia, the main differences in dosing recommendations were related to the starting dose.
Maltese: Is-CHMP innota li għall-kura tad-dislipidemja, id-differenzi ewlenin fir-rakkomandazzjonijiet tad-dożi kienu relatati mad-doża inizjali.
English: For patients with coronary heart disease after percutaneous coronary interventions, the CHMP agreed that the recommended daily dose is 80 mg.
Maltese: Għal pazjenti b'mard koronarju tal-qalb wara interventi koronarji perkutanji, is-CHMP qabel li d-doża rrakkomandata ta' kuljum hija 80 mg.
English: Lescol is also used to prevent further serious cardiac events (such as a heart attack) in patients after they went through percutaneous coronary intervention (a surgical procedure that is used to unblock narrowed coronary arteries).
Maltese: Lescol jintuża wkoll biex jevita l-iżvilupp ta' avvenimenti kardijaċi serji oħra (bħal attakk tal-qalb) f'pazjenti li jkunu għaddew minn intervent koronarju perkutanju (proċedura kirurġika li tintuża biex tiftaħ arterji koronarji li jkunu djiequ).
English: The CHMP harmonised the SPC section on special warnings and included warnings related to the use of Lescol in children.
Maltese: Is-CHMP armonizza s-sezzjoni tal-SPC dwar twissijiet speċjali u żied twissijiet relatati mal-użu ta' Lescol fit-tfal.
English: The contra-indications that were removed were: use in children, in patients with myopathic disorders and patient with severe renal impairment, as warnings and cautionary statements are already included in sections 4.2 and 4.4.
Maltese: Il-kontra-indikazzjonijiet li tneħħew kienu: l-użu fit-tfal, f'pazjenti b'disturbi ta' mijopatija u pazjenti b'indeboliment renali sever, għaliex it-twissijiet u l-prekawzjonijiet speċjali huma diġà inklużi fis-sezzjonijiet 4.2 u 4.4.
English: (see sections 4.2, 4.4 and 4.8);
Maltese: - waqt it-tqala u t-treddiegħ (ara sezzjoni 4.6).”
English: Applicant/Marketing Authorisation Holder
Maltese: Applikant / Marketing Authorisation Holder
English: 2 WHO (2004): Background document for development of WHO Guidelines for Drinking-water Quality WHO/SDE/WSH/03.04/114
Maltese: Background document for development of WHO Guidelines for Drinking-water Quality WHO/SDE/WSH/03.04/114
English: Background (MRL status)
Maltese: Sfond (Status tal-MRL)
English: • dietary supplementation.
Maltese: • supplimenti tad-dieta.
English: Co. Kerry
Maltese: Kerry
English: Cattle (young): 3-8 ml
Maltese: Baqar (żgħar): 3-8 ml
English: Calves: 1-2 ml
Maltese: Għoġġiela: 1-2 ml
English: Barium Selenate Injection
Maltese: B.V.P. Barium Selenate Injection
English: Risk characterisation
Maltese: Karatterizzazzjoni tar-riskju
English: The indication of significant oral bioavailability was also supported by an in vivo study in sheep (Archer and Judson, 1994)3.
Maltese: L-indikazzjoni ta' bijodisponibilità orali sinifikanti kienet appoġġjata wkoll minn studju in vivo fuq innagħaġ (Archer u Judson, 1994)3.
English: Ireland Tairgi Tread-Lia Baile na Sceilge Teo
Maltese: Tread-Lia Baile na Sceilge Teo Ballinskelligs Killarney
English: Residues recovered from the injection site in cattle were in the range from 77% to 99% of the injected doses at 30 to 119 days following injection.
Maltese: Ir-residwi rkuprati mis-sit tal-injezzjoni fil-baqar kienu fil-medda ta' bejn 77% u 99% tad-dożi injettati f'30 għal 119-il jum wara l-injezzjoni.
English: In 2000, following the CVMP recommendation barium selenate was included in Annex II of Regulation (EEC) No 2377/90 for bovine and ovine species, and is, subsequent to the implementation of Regulation (EC) 470/2009 replacing Regulation 2377/90, included in Table 1 of the Annex of Regulation (EU) No 37/2010 for bovine and ovine species, with no maximum residue limit (MRL) required.
Maltese: II tar-Regolament (KEE) Nru 2377/90 għall-ispeċi bovini u ovini, u, wara l-implimentazzjoni tar-Regolament (KE) 470/2009 li jissostitwixxi rRegolament 2377/90, ġie inkluż fit-Tabella 1 tal-Anness tar-Regolament (UE) Nru 37/2010 għall-ispeċi bovini u ovini, b'ebda ħtieġa ta' limitu ta' residwu massimu (MRL).
English: 5 CVMP guideline on injection site residues (EMEA/CVMP/542/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004429.pdf considered that this would indeed happen in those cases where the injection sites are still detectable, i.e. at early timepoints.
Maltese: Linja gwida tas-CVMP dwar residwi tas-siti ta' injezzjoni (EMEA/CVMP/542/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004429.pdf valur ta' referenza ibbażat fuq is-saħħa għandu jkun kapaċi jirrifletti effetti avversi li mhumiex serji;
English: Following the CVMP opinion of 10 April 2013 on this referral procedure, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) requested a reexamination of that CVMP opinion.
Maltese: Wara l-opinjoni tas-CVMP tal-10 ta' April 2013 dwar din il-proċedura ta' riferiment, Cross Vetpharm Group Limited u Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) talbu eżami mill-ġdid ta' dik l-opinjoni tas-CVMP.
English: The veterinary medicinal products concerned in the referral are given as single subcutaneous injections and contain 177.48 mg barium selenate/ml suspension for injection, equivalent to 50 mg selenium.
Maltese: Il-prodotti mediċinali veterinarji kkonċernati fir-riferiment jingħataw bħala injezzjonijiet uniċi taħt ilġilda u fihom 177.48 mg ta' selenat tal-barju/ml sospensjoni għall-injezzjoni, ekwivalenti għal 50 mg ta' selenju.
English: Oral bioavailability of selenium from barium selenate
Maltese: Bijodisponibilità orali ta' selenju minn selenat tal-barju
English: Cattle are treated at a dose of 1 mg selenium/kg bw, resulting in doses of 2 ml for calves (i.e. 355 mg barium selenate corresponding to 100 mg selenium) and up to 10 ml for adult cattle (i.e. 1,775 mg barium selenate corresponding to 500 mg selenium).
Maltese: Il-baqar jingħataw kura f'doża ta' 1 mg ta' selenju/kg tal-piż tal-ġisem, li jwassal għal dożi ta' 2 ml għall-għoġġiela (jiġifieri 355 mg ta' selenat tal-barju li jikkorrispondi għal 100 mg ta' selenju) u sa 10 ml għall-baqar adulti (jiġifieri 1,775 mg ta' selenat tal-barju li jikkorrispondi għal 500 mg ta' selenju).
English: CVMP has now been presented with data from an in vitro study simulating conditions in the human gastrointestinal tract.
Maltese: Issa s-CVMP ġie ppreżentat b'dejta minn studju in vitro li ssimula kundizzjonijiet fil-passaġġ gastrointestinali uman.
English: Proc. Aust.
Maltese: Aust.
English: Based on the lowered upper tolerable limit (0.3 mg/person/day) for selenium intake, the new information on bioavailability of residues and additional toxicity data in humans, a review of the MRL opinion for barium selenate is recommended in order to protect human health, in accordance with Article 11 of Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May
Maltese: Fuq il-bażi ta' tnaqqis fl-aktar limitu massimu tollerabbli (0.3 mg/persuna/kuljum) għall-konsum ta' selenju, l-informazzjoni l-ġdida dwar il-bijodisponibilità tar-residwi u dejta addizzjonali dwar it-tossiċità fil-bnedmin, hija rakkomandata li ssir reviżjoni tal-opinjoni tal-MRL għal selenat tal-barju sabiex tiġi protetta s-saħħa tal-bniedem, skont l-Artikolu 11 tar-Regolament (KE) Nru 470/2009 tal-Parlament u tal-Kunsill tas-6 ta' Mejju 2009.
English: • the CVMP acknowledged that consumption of barium selenate injection sites is likely to be a rare event.
Maltese: • is-CVMP irrikonoxxa li l-konsum ta' siti tal-injezzjoni ta' selenat tal-barju huwa probabbli li jkun avvenimenti rari.
English: National Competent Authorities, coordinated by a reference Member State, shall ensure that the following condition is fulfilled by the marketing authorisation holders:
Maltese: L-Awtoritajiet Kompetenti Nazzjonali, ikkoordinati minn Stat Membru ta' referenza, għandhom jiżguraw li l-kondizzjoni li ġejja tkun sodisfatta mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: In 1999 the CVMP assessed barium selenate in the context of an application for the establishment of maximum residue limits under Regulation (EEC) No 2377/90.
Maltese: Fl-1999 is-CVMP kien ivvaluta s-selenat tal-barju fil-kuntest ta' applikazzjoni għall-istabbiliment ta' limiti massimi ta' residwi taħt ir-Regolament (KEE) Nru 2377/90.
English: Ballinskelligs
Maltese: Kwalunkwe
English: • the CVMP acknowledged that pharmacovigilance systems can be expected to detect extremely serious cases of poisoning resulting from use of veterinary medicinal products containing barium selenate.
Maltese: • is-CVMP irrikonoxxa li sistemi ta' farmakoviġilanza jistgħu jkunu mistennija jikxfu każijiet estremament serji ta' avvelenament b'riżultat tal-użu ta' prodotti mediċinali veterinarji li fihom selenat tal-barju.
English: • the validity of the conclusion, based on the in vitro bioavailability study, that bioavailable residues of barium selenate would make up 5-10% of the total residues (the higher figure for lower concentrations);
Maltese: • il-validità tal-konklużjoni, abbażi tal-istudju in vitro ta' bijodisponibilità, li residwi bijodisponibbli ta' selenat tal-barju jikkostitwixxu sa 5-10% tar-residwi totali (l-ogħla figura għall-aktar konċentrazzjonijiet baxxi);
English: 1 mg Se/kg body weight corresponding to the following: Cattle (adult): 6-10 ml
Maltese: Baqar (adulti): 6-10 ml
English: Barium selenate fulfils a valuable role in the treatment and prevention of nutritional muscular dystrophy (white muscle disease), poor reproductive performance and ill thrift due to selenium deficiency.
Maltese: Is-selenat tal-barju jissodisfa rwol importanti fil-kura u l-prevenzjoni ta' distrofija muskolari nutrittiva (marda tal-muskoli l-bojod), prestazzjoni riproduttiva fqira u tkabbir bil-mod (ill thrift) minħabba defiċjenza ta' selenju.
English: With regard to acute toxicity reference is made to studies measuring LD50 values.
Maltese: Fir-rigward ta' tossiċità akuta saret referenza għal studji li kejlu l-valuri LD50.
English: Killarney
Maltese: IrRumanija
English: Also human data give evidence of severe acute effects of selenium at oral dose levels of 5 mg to 22.3 mg selenium/kg (as sodium selenite or sodium selenate), with partly fatal outcomes.
Maltese: Anke d-dejta fuq il-bniedem tagħti evidenza ta' effetti akuti severi ta' selenju f'livelli ta' doża orali ta' 5 mg għal 22.3 g ta' selenju/kg (bħala sodju selenit jew sodju selenat), b'eżiti parzjalment fatali.
English: The findings of the in vitro study are supported by theoretical considerations based on physicochemical properties of barium selenate, indicating that relevant amounts of selenium could be bioavailable from orally ingested barium selenate i.e. the intake of residues from an injection site would, by simple theoretical estimation based on the solubility product constant, lead to a bioavailable exposure of approximately 15 mg selenium (i.e. 3% of the selenium dose at the injection site) in each litre of water in the intestinal tract.
Maltese: Is-sejbiet tal-istudju in vitro huma appoġġati minn konsiderazzjonijiet teoretiċi abbażi tal-karatteristiċi fiżiko-kimiċi ta' selenat tal-barju, li jindikaw li ammonti rilevanti ta' selenju jistgħu jkunu bijodisponibbli minn selenat tal-barju li jiġi inġestit mill-ħalq jiġifieri, permezz ta' stima teoretika sempliċi bbażata fuq is-solubbilità tal-prodott kostanti, il-konsum ta' residwi minn sit tal-injezzjoni, ikun iwassal għal esponiment bijodisponibbli ta' madwar 15 mg ta' selenju (jiġifieri 3% tad-doża ta' selenju fis-sit talinjezzjoni) f'kull litru ta' ilma fil-passaġġ intestinali.
English: This lower-bound estimate did not take into account that under acid pH conditions (gastric acid) and in the presence of sulphate ions (average intake in food of 500 mg/person/day, (WHO, 2004))2 the solubility may considerably increase.
Maltese: Din l-istima aktar baxxa ma kkunsidratx li taħt kundizzjonijiet aċidi tal-pH (aċidu gastriku) u fil-preżenza ta' joni tas-sulfat (konsum medju fl-ikel ta' 500 mg/persuna/kuljum, (WHO, 2004
English: However, in this case no data on acute toxicity using more sensitive acute endpoints were available.
Maltese: Madankollu, f'dan il-każ ma kien hemm lebda dejta disponibbli dwar tossiċità akuta bl-użu ta' punt ta' tmiems akuti aktar sensittivi.
English: Consequently trimming of the injection site is not considered to represent a fully effective risk mitigation measure;
Maltese: Konsegwentement it-tirqim tas-sit tal-injezzjoni mhuwiex meqjus li jirrappreżenta miżura kompletament effettiva għall-mitigazzjoni tar-riskju;
English: • the CVMP considered that based on the new information from an in vitro study simulating conditions in the human gastrointestinal tract, at least 5% of ingested selenium from barium selenate is bioavailable when present in a normal food matrix;
Maltese: • is-CVMP qies li abbażi tal-informazzjoni l-ġdida minn studju in vitro li ssimula kundizzjonijiet filpassaġġ gastrointestinali tal-bniedem, mill-inqas 5% tas-selenju inġestit minn selenat tal-barju huwa bijodisponibbli meta jkun preżenti f'matriċi normali tal-ikel;
English: Lithuania
Maltese: IdDanimarka
English: List of the names, pharmaceutical forms, strength of the veterinary medicinal products, animal species, route of administration, withdrawal period and applicant/marketing authorisation holders in the member states
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi ta' annimali, mnejn għandhom jingħataw, perjodu ta' tiżmim u detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: There is no ADI set for barium selenate but two different upper tolerable levels for selenium intake for chronic toxicity are available.
Maltese: Ma hemm l-ebda ADI stabbilit għas-selenat tal-barju iżda hemm disponibbli żewġ livelli differenti talogħla tollerabbilità għall-konsum ta' selenju għal tossiċità kronika.
English: • the CVMP concluded that the study by Archer and Judson (1994)3 could not be used for the purpose of determining bioavailability.
Maltese: • is-CVMP ikkonkluda li l-istudju minn Archer u Judson (1994)3 ma setax jintuża sabiex tiġi ddeterminata l-bijodisponibilità.
English: Despite the slow rate of residue depletion, a withdrawal period of 31 days for cattle meat and offal has been set for the concerned veterinary medicinal products (see annex I).
Maltese: Minkejja r-rata baxxa ta' tnaqqis tar-residwi, ġie stabbilit perjodu ta' tiżmim ta' 31 jum għal-laħam u lġewwieni tal-baqar għall-prodotti mediċinali veterinarji kkonċernati (ara Anness I).
English: Data has been provided to estimate the oral bioavailability of selenium following ingestion of residues of barium selenate.
Maltese: Ġiet ipprovduta dejta biex tagħti stima tal-bijodisponibilità orali ta' selenju wara l-inġestjoni ta' residwi ta' selenat tal-barju.
English: The grounds for re-examination of the CVMP opinion of 10 April 2013 focused on the following arguments:
Maltese: Ir-raġunijiet għall-eżami mill-ġdid tal-opinjoni tas-CVMP tal-10 ta' April 2013 iffokaw fuq l-argumenti segwenti:
English: The EFSA subsequently set a tolerable upper level at 0.3 mg selenium/person/day based on a no observed effect level (NOEL) of 850 µg/day for clinical selenosis in a human study.
Maltese: Sussegwentement l-EFSA stabbiliet l-ogħla livell tollerabbli f'0.3 mg ta' selenju/persuna/kuljum fuq bażi ta' livell bla ebda effett osservat (NOEL) ta' 850 µg/kuljum għal selenosis klinika fi studju fuq ilbnedmin.
English: In principle LD50 is not accepted as an endpoint from which calculations are made to estimate toxicity relevant for consumer risk assessments, acknowledging that the LD50 is a very severe endpoint (where half of the test animals die).
Maltese: Fil-prinċipju l-LD50 mhuwiex aċċettat bħala punt ta' tmiem li minnu jsiru kalkoli biex tiġi stmata t-tossiċità rilevanti għallvalutazzjonijiet tar-riskju għall-konsumatur, waqt li jiġi rikonoxxut li l-LD50 huwa punt ta' tmiem sever ħafna (fejn nofs l-annimali tat-test imutu).
English: LD50 in rats and mice for selenate and selenite are typically in a range of approximately 1 mg/kg bw to 10 mg/kg bw.
Maltese: Fil-firien u l-ġrieden l-LD50 għal selenat u selenit huma tipikament fil-firxa ta' madwar 1 mg/kg tal-piż tal-ġisem għal 10 mg/kg tal-piż tal-ġisem.
English: Using the upper tolerable level established by EFSA of 0.3 mg selenium/person/day it is concluded that the bioavailable fraction of 5% (25 mg) of one injection site would exceed the reference value more than 80 times.
Maltese: Bl-użu tal-ogħla livell tollerabbli stabbilit millEFSA ta' 0.3 mg ta' selenju/persuna/kuljum ġie konkluż li l-frazzjoni bijodisponibbli ta' 5% (25 mg) ta' sit wieħed tal-injezzjoni tkun taqbeż il-valur ta' referenza aktar minn 80 darba.
English: Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep.
Maltese: Is-selenat tal-barju kien jintuża fi prodotti mediċinali veterinarji injettabbli b'rilaxx bil-mod għall-użu terapewtiku u profilattiku kontra defiċjenzi ta' selenju fil-baqar u n-nagħaġ.
English: This study showed that orally ingested barium selenate (doses of 100 mg or 250 mg per animal similar to those present at injection sites) was absorbed/bioavailable in the gastrointestinal tract.
Maltese: Dan l-istudju wera li selenat tal-barju inġestit mill-ħalq (dożi ta' 100 mg jew 250 mg għal kull annimal simili għal dawk preżenti fis-siti tal-injezzjoni) kien assorbit/bijodisponibbli fil-passaġġ gastrointestinali.
English: The upper tolerable level for selenium intake was established in the EU by the Scientific Committee on Food (in 2000) at a lower level of 0.3 mg selenium/person/day (5 µg/kg bw) and was in 2006 confirmed by the Scientific Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority (EFSA).
Maltese: L-ogħla livell tollerabbli għall-konsum ta' selenju kien stabbilit fl-UE mill-Kumitat Xjentifiku dwar l-Ikel (fl-2000) f'livell aktar baxx ta' 0.3 mg ta' selenju/persuna/kuljum (5 µg/kg/tal-piż tal-ġisem) u fl-2006 kien ikkonfermat mill-Bord Xjentifiku dwar il-Prodotti Djetetiċi, in-Nutrizzjoni u l-Allerġiji tal-Awtorità Ewropea dwar is-Sigurtà fl-Ikel (EFSA).
English: Spain Cross Vetpharm Group Limited
Maltese: Spanja Cross Vetpharm Group Limited
English: Germany
Maltese: Franza
English: This assessment was based on an estimated tolerable upper daily intake in humans corresponding to 0.6 mg selenium/person/day (10 µg/kg bw) and the assumption that oral bioavailability of selenium from barium selenate would be very low (although no quantitative estimate was performed).
Maltese: Din il-valutazzjoni kienet ibbażata fuq stima tal-ogħla konsum tollerabbli ta' kuljum fil-bnedmin li jikkorrispondi għal 0.6 mg ta' selenju/persuna/kuljum (10 µg/kg tal-piż tal-ġisem) u s-suppożizzjoni li l-bijodisponibilità orali ta' selenju minn selenat tal-barju se tkun baxxa ħafna (għalkemm ma saret l-ebda stima kwantitattiva).
English: However, in line with the CVMP guideline on injection site residues (EMEA/CVMP/542/03)5, for substances for which there is no MRL for muscle, the reference value used in the assessment of injection site residues is normally the ADI.
Maltese: Madankollu, f'konformità mal-linja gwida tas-CVMP dwar residwi fis-siti talinjezzjoni (EMEA/CVMP/542/03)5, għal sustanzi li għalihom ma hemm l-ebda MRL għall-muskoli, ilvalur ta' referenza użat fil-valutazzjoni ta' residwi fis-sit tal-injezzjoni normalment huwa l-ADI.
English: • conclusions on bioavailability in sheep drawn from the Archer and Judson (1994)3 study cannot be readily extrapolated to humans;
Maltese: • il-konklużjonijiet dwar il-bijodisponibilità fin-nagħaġ mill-istudju ta' Archer u Judson (1994)3 ma jistgħux jiġu estrapolati faċilment għall-bnedmin;
English: Ireland Cross Vetpharm Group Limited
Maltese: L-Irlanda Cross Vetpharm Group Limited
English: • long acting intraruminal devices containing sodium selenate, authorised for cattle only4;
Maltese: • apparat intraruminali li jaġixxi fit-tul li fihom selenat tas-sodju, awtorizzati għall-baqar biss4;
English: This study indicates that at least 5% to 10% of ingested selenium from barium selenate is bioavailable when present in a normal food matrix.
Maltese: Dan l-istudju jindika li mill-inqas 5% għal 10% tas-selenju inġestit minn selenat tal-barju huwa bijodisponibbli meta jkun preżenti f'matriċi normali tal-ikel.
English: On 14 September 2011, the Federal Office of Consumer Protection and Food Safety of Germany submitted a notification for a referral procedure under Article 35 of Directive 2001/82/EC for all long acting formulations for injection containing barium selenate for all food producing species.
Maltese: Fl-14 ta' Settembru 2011, l-Uffiċċju Federali tal-Protezzjoni tal-Konsumatur u s-Sikurezza tal-Ikel talĠermanja ssottometta notifika għal proċedura ta' riferiment taħt l-Artikolu 35 tad-Direttiva 2001/82/KE għall-formulazzjonijiet kollha li jaġixxu fit-tul għall-injezzjoni li fihom fih selenat tal-barju għall-ispeċi kollha li jipproduċu l-ikel.
English: The withdrawal period of 31 days does not guarantee depletion of residues from the injection site to safe levels as barium selenate residues remain at injection sites for long periods and if ingested, would provide orally bioavailable selenium.
Maltese: Il-perjodu ta' tiżmim ta' 31 jum ma jiggarantixxix tnaqqis ta' residwi mis-sit tal-injezzjoni għal livelli siguri peress li r-residwi ta' selenat tal-barju jibqgħu fis-siti tal-injezzjoni għal perjodi twal u jekk jiġu inġestiti, jipprovdu selenju oralment bijodisponibbli.
English: Considering that the lowest LD50 is less than 10 times the possible consumer's exposure it is obvious that also a fraction of an injection site might cause toxicity if ingested.
Maltese: Meta wieħed iqis li laktar LD50 baxx huwa anqas minn 10 darbiet l-esponiment possibbli tal-konsumatur huwa ovvju li anke frazzjoni ta' sit tal-injezzjoni tista' tikkawża tossiċità jekk tiġi inġestita.
English: This implies that the colourant has the same distribution behaviour and residence time as barium selenate.
Maltese: Dan jimplika li l-kolorant ikollu l-istess imġiba ta' distribuzzjoni u żmien ta' residenza bħas-selenat tal-barju.
English: Estonia Cross Vetpharm Group Limited
Maltese: L-Estonja Cross Vetpharm Group Limited