FrancophonIA/ELRC3.0 huggingface dataset:
English: [Product name] capsules should be used in addition to other medicines, such as medicines called ‘statins' or ‘fibrates' or instead of these medicines where they may not be appropriate or of expected benefit.
Maltese: [Product name] kapsuli għandhom jintużaw flimkien ma' mediċini oħrajn, bħal mediċini li jissejħu “statins” jew “fibrates” jew inkella minflok dawn il-mediċini fejn jistgħu ma jkunux xierqa jew ta' benefiċċju mistenni.
English: • Tell your doctor immediately if you have unexplained muscle pain, muscle tenderness or muscle weakness while you are taking this medicine
Maltese: • Għid lit-tabib tiegħek immedjatament jekk ikollok uġigħ fil-muskoli, sensittività fil-muskoli jew dgħufija fil-muskoli mingħajr spjegazzjoni waqt li tkun qed tieħu din il-mediċina
English: [Product name] is indicated as alternative or adjunct treatment to reduce triglyceride levels in patients who have not responded adequately to other treatments such as statin or fibrate treatment for:
Maltese: [Product name] huwa indikat bħala kura alternattiva jew bħala kura aġġunta biex jitnaqqsu l-livelli ta' trigliċeridi f'pazjenti li ma wiġbux b'mod xieraq għal kura oħra bħal kura bi statin jew b'fibrate għal:
English: In one study, Chinese patients taking nicotinic acid plus laropiprant concomitantly with simvastatin were reported to have a higher incidence of myopathy and rhabdomyolysis compared to Caucasians.
Maltese: Fi studju wieħed, pazjenti Ċiniżi li kienu qegħdin jieħdu nicotinic acid flimkien ma' laropiprant fl-istess ħin ma' simvastatin ġew irrappurtati li kellhom inċidenza ogħla ta' mijopatija u rabdomijolożi meta mqabbla mal-Kawkasi.
English: Section 4.4 - Special warnings and precautions
Maltese: Sezzjoni 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu
English: It has not been shown that treatment of hyperlipoproteinaemia with acipimox leads to a reduction of cardiac morbidity or mortality.
Maltese: Ma ntweriex li l-kura għal iperlipoproteinemija b'acipimox twassal għal tnaqqis fil-morbidità jew filmortalità kardijaka.
English: • This medicine is not effective for all lipid disorders.
Maltese: • Din il-mediċina mhijiex effettiva għad-disturbi lipidi kollha.
English: Ref. EMEA/CHMP/411086/2008
Maltese: EMEA/CHMP/411078/2008
English: London, 11 July 2008 Doc.
Maltese: Londra, 11 ta' Lulju 2008 Dok. Ref.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Singulair and associated names International Non-Proprietary Name (INN): montelukast
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): montelukast
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Singulair and associated names approved across EU Member States, with respect to the following indications: Treatment of asthma as add-on therapy in patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma; as an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids; prophylaxis of asthma in paediatric patients in which the predominant component is exercise-induced bronchoconstriction.
Maltese: Trattament ta' l-ażma bħala terapija addizzjonali f'pazjenti b'ażma persistenti minn ħafifa għal moderata li mhumiex adegwatament ikkontrollati bil-kortikosterojdi inalati u li fihom l-β-agonisti b'effett qasir li jittieħdu "skond il-bżonn" jipprovdu kontroll kliniku inadegwat ta' l-ażma; bħala opzjoni ta' trattament alternattiva għall-kortikosterojdi b'dożaġġ baxx li jittieħdu bin-nifs għall-pazjenti b'ażma ħafifa persistenti li ma għandhomx storja reċenti ta' attakki ta' l-ażma serji li għalihom kellhom bżonn l-użu tal-kortikosterojdi orali u li jkunu wrew li mhumiex kapaċi jużaw kortikosterojdi li jittieħdu man-nifs; fil-profilassi ta' l-ażma f'pazjenti pedjatriċi li fihom il-komponent predominanti huwa l-bronkokostrizzjoni mqanqla mill-eżerċizzju.
English: Singulair and associated names, 4mg, chewable tablets and oral granules, is a leukotriene-1 receptor antagonist used for the add-on treatment (concomitantly with inhaled steroids), as alternative monotherapy to low-dose inhaled corticosteroids, and to prevent exercise-induced bronchoconstriction.
Maltese: Singulair u ismijiet assoċjati, 4 mg, pilloli li jintmagħdu u granuli orali, huwa antagonista tar-riċetturi leukotriene-1 użat għat-trattament addizzjonali (flimkien ma' sterojdi inalati), bħala monoterapija alternattiva għall-kortikosterojdi inalati b'dożaġġ baxx u għall-prevenzjoni tal-bronkokostrizzjoni mqanqla mill-eżerċizzju.
English: The Marketing Authorisation Holder provided supplementary information on 6 December 2007.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda tagħrif supplimentari fis-6 ta' Diċembru 2007.
English: On 13 September 2007, Merck Sharp & Dohme presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Singulair and associated names.
Maltese: Fit-13 ta' Settembru 2007 Merck Sharp & Dohme ippreżentat referenza lill-EMEA skond l-Artikolu 30 tadDirettiva 2001/83/KE, kif emendata, sabiex tarmonizza s-Sommarji tal-Karatteristiċi tal-Prodott (SPC), itTikketta u l-Fuljett ta' Tagħrif awtorizzati fuq livell nazzjonali li jinkludu l-aspetti dwar il-kwalità tal-prodott mediċinali Singulair u ismijiet assoċjati.
English: The procedure started on 20 September 2007.
Maltese: Il-proċedura bdiet fl-20 ta' Settembru 2007.
English: The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Singulair and associated names.
Maltese: Is-CHMP ta opinjoni pożittiva fl-24 ta' April 2008 fejn irrakkomanda l-armonizzazzjoni ta' l-SPC, it-Tikketta u l-Fuljett ta' Tagħrif li inkludew l-aspetti dwar il-kwalità għal Singulair u ismijiet assoċjati.
English: During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Maltese: Matul il-laqgħa tiegħu li saret fil-21 - 24 ta' April, is-CHMP, fid-dawl tat-tagħrif kumplessiv ippreżentat u tad-diskussjoni xjentifika fi ħdan il-Kumitat, kien ta' l-opinjoni li l-proposta għal armonizzazzjoni ta' l-SPC, it-Tikketta u l-Fuljett ta' Tagħrif li inkludew l-aspetti dwar il-kwalità kienet aċċettabbli u għalhekk għandhom jiġu emendati.
English: de Europa 20 B.
Maltese: Avda. de Europa 20 B.
English: Postępu 17 B 02-676 Warszawa POLAND
Maltese: Postępu 17 B 02-676 Warszawa
English: Member State EU/EEA
Maltese: Stat Membru UE/ZEE
English: 811 09 Bratislava SLOVAK REPUBLIC
Maltese: 811 09 Bratislava
English: 13 Rue Pages 92158 Suresnes Cedex FRANCE
Maltese: 13 Rue Pages 92158 Suresnes Cedex FRANZA
English: Doramectin is an antiparasitic agent.
Maltese: Doramectin huwa aġent antiparasitiku.
English: Lagoas Park - Edifício 10 2740-244 Porto Salvo PORTUGAL
Maltese: Lagoas Park - Edifício 10 2740-244
English: PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GREECE
Maltese: PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens
English: 00330 Helsinki FINLAND
Maltese: 00330 Helsinki FINLANDJA
English: Lilly Deutschland GmbH Teichweg 3
Maltese: Il-Ġermanja Lilly Deutschland GmbH Teichweg 3
English: 1123 Budapest HUNGARY
Maltese: 1123 Budapest L-Ungerija
English: Pfizer Trading Polska s.p. z o.o.
Maltese: Pfizer Trading Polska s.p. z o.o. ul.
English: 35396 Gießen GERMANY
Maltese: 35396 Gießen
English: 5.3 Environmental properties
Maltese: 5.3 Kwalitajiet ambjentali
English: 2909 LD Capelle a/d IJssel THE NETHERLANDS
Maltese: 2909 LD Capelle a/d IJssel IL-PAJJIŻI L-BAXXI
English: Name
Maltese: ISem
English: Pfizer Luxemburg SARL, o.z.
Maltese: Is-Slovakkja Pfizer Luxemburg SARL, o.z.
English: Czech republic Pfizer Limited Veterinary Medical Research & Development
Maltese: Ir-Rumanija Pfizer Limited Veterinary Medical Research & Development
English: 3 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004581.pdf
Maltese: 3 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004581.pdf terminu medju sa twil għall-insetti tad-demel.
English: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 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 withdrawal period of 70 days for cattle meat and offal is therefore recommended for injectable veterinary medicinal products containing doramectin.
Maltese: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 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 kampjunat kif xieraq).
English: Route of administration
Maltese: Mod Ta' Amministrazzj oni
English: Via Isonzo, 71 04100 Latina ITALY
Maltese: Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina L-ITALJA
English: Pfizer Animal Health B.V. Rivium Westlaan 142
Maltese: Pfizer Animal Health B.V. Rivium
English: ZEARL PORCS Doramectin 10 mg/ml intramuscular Pigs
Maltese: ZEARL PORCS Doramectin 10 mg/ml fil-muskolu Pigs
English: Injektionslösung für Schweine intramuscular Pigs
Maltese: Injektionslösung für Schweine fil-muskolu Pigs
English: Pfizer Animal Health S.A., Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIUM
Maltese: Pfizer Animal Health S.A., Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, IL-BELĠJU
English: Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM
Maltese: Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, IL-BELĠJU
English: Belgium Eli Lilly Benelux S.A. Division Elanco Animal Health Stoofstraat 52
Maltese: Division Elanco Animal Health Stoofstraat 52
English: Reindeer:
Maltese: Renni:
English: BIOVET AD 39 Petar Rakov str. Peshtera 4550
Maltese: Il-Bulgarija BIOVET AD 39 Petar Rakov str.
English: SPAIN
Maltese: Spanja
English: Spain
Maltese: SPANJA
English: Pfizer Luxembourg SARL 51, Avenue J.F.
Maltese: Is-Slovenja Pfizer Luxembourg SARL 51, Avenue J.F. Kennedy L-1855 Luxembourg
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Maltese: Dawn iż-żewġ komposti għandhom komuni bejniethom medda wiesgħa ta' attività antiparasitika u jipproduċu paraliżi simili f'nematodi u artropodi parasitiċi.
English: This withdrawal period (70 days) is recommended for both doses in sheep (i.e. 200 µg/kg bw and 300 µg/kg bw) approved for intramuscular administration.
Maltese: Dan il-perjodu ta' tiżmim (70 jum) huwa rakkomandat għaż-żewġ dożi finnagħaġ (jiġifieri 200 μg/kg bw u 300 μg/kg bw) approvati għall-għoti intramuskolari.
English: Meat and offal: 70 days
Maltese: Laħam u ġewwieni: 70 jum
English: Slovakia
Maltese: IS-SLOVAKKJA
English: Dectomax-S Injektionslösung intramuscular Pigs
Maltese: Dectomax-S Injektionslösung fil-muskolu Pigs
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perjodu(i) ta' Tiżmim
English: Amendments in the relevant sections of the product information for pour-on veterinary medicinal products containing doramectin:
Maltese: Emendi fis-sezzjonijiet relevanti tal-informazzjoni tal-prodott għall-prodotti mediċinali veterinarji pour-on li fihom doramectin
English: Strength Pharmaceutical form
Maltese: Saħħa Għamla Farmaċewtika
English: Labelling:
Maltese: Tikketta:
English: By applying this ratio to milk and using 6 µg as the total amount of doramectin residues that can be considered safe in 1.5 litres of milk (i.e. the amount of milk considered to be consumed on a daily basis), one can calculate the concentration of doramectin in milk that can be considered safe to be 3.44 µg/l (6 µg x 0.86/1.5 l).
Maltese: Bl-applikazzjoni ta' dan il-proporzjon għallħalib u l-użu ta' 6 μg bħala l-ammont totali ta' residwi ta' doramectin li jistgħu jitqiesu sikuri f'1.5 litri ħalib (jiġifieri l-ammont ta' ħalib meqjus bħala kkunsmat kuljum), jista' jiġi kkalkulat li lkonċentrazzjoni ta' doramectin fil-ħalib li tista' titqies bħala sikura hija ta' 3.44 μg/l (6 μg x 0.86/1.5 l).
English: In terms of bioaccumulation the log Pow value is not considered to be robust given the method employed (shake flask), but nevertheless indicates doramectin being potentially bioaccumulative.
Maltese: F'termini ta' bijoakkumulazzjoni, il-valur tal-log Pow ma jitqiesx robust minħabba l-metodu użat (shake flask), iżda xorta waħda jindika li doramectin huwa potenzjalment bijoakkumulattiv.
English: Injectable veterinary medicinal product containing doramectin
Maltese: Prodott mediċinali veterinarju injettabbli li fih doramectin Frat
English: intramuscular Pigs
Maltese: fil-muskolu Pigs
English: Add, to all products:
Maltese: Żid, għall-prodotti kollha:
English: Zearl 10 mg/ml Solution for Injection for Pigs intramuscular Pigs
Maltese: Zearl 10 mg/ml Solution for Injection for Pigs fil-muskolu Pigs
English: Bulgaria
Maltese: IL-BULGARIJA
English: Doramectin is administered by subcutaneous injection to cattle at a dose of 200 μg/kg body weight (bw) for the treatment and control of gastrointestinal nematodes, lungworms, eyeworms, warbles, lice, mange mites and ticks.
Maltese: Doramectin jingħata permezz ta' tilqima taħt il-ġilda lill-frat b'doża ta' 200 μg/kg tal-piż tal-ġisem (bw) għat-trattament u l-kontroll ta' nematodi gastrointestinali, dud nematode tal-pulmun, loa loa, mard tal-ipoderma, qamel, mange mites u qurdien.
English: Whereas:
Maltese: Baqar:
English: Meat and offal: 77 days
Maltese: Laħam u ġewwieni: 77 jum
English: The benefit-risk evaluation for the products concerned is deemed to be positive provided that (i) for the injectable products the withdrawal periods for meat and offal are set for cattle at 70 days, for sheep at 70 days, for pigs at 77 days and for reindeer at 70 days, (ii) for the injectable and pour-on products the following periods with regard to milk are set as the minimum time spans that must elapse between treatment and calving/lambing: 2 months for cattle and reindeer and 70 days for sheep and (iii) for the injectable and pour-on products risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna.
Maltese: L-evalwazzjoni tal-benefiċċji u r-riskji għall-prodotti kkonċernati titqies li hija waħda pożittiva diment li (i) għall-prodotti injettabbli, il-perjodi ta' tiżmim għal-laħam u l-ġewwieni huma stabbiliti għal 70 jum għall-frat, 70 jum għan-nagħaġ, 77 jum għall-majjali u 70 jum għar-renni, (ii) għall-prodotti injettabbli u għat-tferrigħ, il-perjodi li ġejjin fir-rigward tal-ħalib huma stabbiliti bħala l-perjodi minimi ta' żmien li jridu jgħaddu bejn it-trattament u t-twellid ta' għoġġiela/ta' nagħaġ: xahrejn għall-frat u r-renni u 70 jum għan-nagħaġ u (iii) għall-prodotti injettabbli u għat-tferrigħ, żdiedu miżuri ta' mitigazzjoni tarriskji mat-tagħrif dwar il-prodott rigward ir-riskju għall-organiżmi akwatiċi u l-fawna tad-demel.
English: This would yield a withdrawal period of 105 days for reindeer.
Maltese: Dan jagħti perjodu ta' tiżmim ta' 105 ijiem għar-renni.
English: Alkotás u. 53.
Maltese: L-Ungerija Pfizer Kft. Alkotás u. 53.
English: ul.
Maltese: Nagħaġ
English: Like other macrocyclic lactones, doramectin has the potential to adversely affect non-target organisms.
Maltese: Bħal macrocyclic lactones oħra, doramectin għandu potenzjal li jaffettwa ħażin organiżmi mhux immirati.
English: Z.l.
Maltese: L-Italja
English: Dectomax 10 mg/ml Solution for Injection for Pigs intramuscular Pigs
Maltese: Dectomax 10 mg/ml Solution for Injection for Pigs fil-muskolu Pigs
English: Reindeer
Maltese: Renni
English: Czech republic Pfizer s.r.o.
Maltese: Pfizer s.r.o.
English: Sheep
Maltese: Cattle
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 ta' ismijiet, għamla farmaċewtika, saħħa tal-prodott mediċinali veterinarju, speċi ta' annimal, metodu ta' amministrazzjoni, perjodi ta' tiżmim, applicant/detenturi talawtorizzazzjoni għal-tqegħid fis-suq fl-iStati Membri
English: Considering the highest residue levels seen at 10 days and taking account of the estimated half it was calculated that by 66 days after product administration doramectin levels at the injection site would be present at levels below half the MRL.
Maltese: Wara li tqiesu l-ogħla livelli ta' residwi li dehru wara 10 ijiem u filwaqt li ġie kkunsidrat in-nofs stmat, ġie kkalkolat li sa 66 jum wara l-għoti talprodott, il-livelli ta' doramectin fis-sit tat-tilqima jkunu preżenti f'livelli inqas min-nofs l-MRL.
English: Following treatment, excretion of potentially toxic levels of doramectin may take place over a period of several weeks.
Maltese: Wara t-trattament, l-eskrezzjoni ta' livelli potenzjalment tossiċi ta' doramectin tista' sseħħ tul perjodu ta' bosta ġimgħat.
English: Amendments in the relevant sections of the product information for injectable veterinary medicinal products containing doramectin:
Maltese: Emendi fis-sezzjonijiet relevanti tal-informazzjoni tal-prodott għall-prodotti mediċinali veterinarji għall-injezzjoni li fihom doramectin
English: For the run-off scenario, as the highest PECcattle (0.84 µg/kg) is higher than the highest PECsheep (0.48 µg/kg), the conclusion from the cattle can be extrapolated to sheep.
Maltese: Għax-xenarju ta' skol, peress li l-ogħla PECfrat (0.84 μg/kg) huwa ogħla mill-ogħla PECnagħaġ (0.48 μg/kg), il-konklużjoni mill-frat tista' tiġi estrapolata għan-nagħaġ.
English: The MRLs currently established for doramectin in tissues use 90% (60 μg/person per day) of the ADI, leaving 10% (6 μg) available to cover exposure to residues resulting from other sources, such as via milk.
Maltese: L-MRLs li bħalissa huma stabbiliti għal doramectin fit-tessuti jużaw 90% (60 μg/persuna f'jum) tal-ADI, u jħallu 10% (6 μg) disponibbli biex ikopru l-esponiment għal residwi li ġejjin minn sorsi oħrajn, bħal permezz tal-ħalib.
English: In addition to the fact that the available data do not allow to rule out bioaccumulation of doramectin, a risk to aquatic organisms has been identified based on available toxicity data (acute toxicity for Daphnia magna) as well as a risk to dung fauna exposed to residue-containing dung when the products are used in accordance with the recommended posology.
Maltese: Minbarra l-fatt li d-dejta disponibbli ma tippermettix li tiġi eliminata l-possibilità ta' bijoakkumulazzjoni ta' doramectin, ġie identifikat riskju għall-organiżmi akwatiċi fuq il-bażi ta' dejta disponibbli dwar ittossiċità (tossiċità akuta għal Daphnia magna) kif ukoll riskju għall-fawna tad-demel esposta għal demel li fih residwu meta l-prodotti jintużaw skont il-pożoloġija rakkomandata.
English: The value of 3.44 µg/l was rounded down to 3 µg/l, which was considered to represent a safe doramectin level in milk.
Maltese: Il-valur ta' 3.44 μg/l tqarreb għal 3 μg/l, li tqies li jirrappreżenta livell sikur ta' doramectin fil-ħalib.
English: One GLP residue study (1998) in reindeer was available for evaluation by the CVMP but could not be used to determine the withdrawal period as there were only two slaughter time points, the number of animals/group was relatively small and at the last time point one of the injection site samples contained residues above the MRL for muscle (40 μg/kg).
Maltese: Studju GLP wieħed dwar ir-residwi (1998) fir-renni kien disponibbli sabiex jiġi evalwat mis-CVMP iżda ma setax jintuża biex jiġi ddeterminat il-perjodu ta' tiżmim peress li kien hemm biss żewġ punti ta' żmien għat-tbiċċir, in-numru ta' annimali/grupp kien relattivament żgħir u fl-aħħar punt ta' żmien wieħed mill-kampjuni mis-sit tat-tilqima kien fih residwi ogħla mill-MRL għall-muskolu (40 μg/kg).
English: In addition, in cattle doramectin is administered topically on the back of the animal at a dose of 500 μg/kg bw for treatment of infestations of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly.
Maltese: Barra minn hekk, fil-frat, doramectin jingħata fuq il-ġilda ta' dahar l-annimal b'doża ta' 500 μg/kg bw għat-trattament ta' infestazzjonijiet ta' dud nematode gastrointestinali, dud nematode tal-pulmun, loa loa, mard tal-ipoderma, qamel li jerda' u jigdem, mange mites u hornfly.
English: Sheep:
Maltese: Ħnieżer:
English: • On the basis of the residue depletion data in cattle and sheep submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, and in the absence of maximum residue limits for doramectin in milk, the CVMP considered the minimum time spans of 2 months for cattle and reindeer and 70 days for sheep must elapse between administration of these doramectin containing products and calving or lambing;
Maltese: • Fuq il-bażi tad-dejta dwar it-tnaqqis tar-residwi fil-frat u n-nagħaġ ippreżentata millapplikanti/detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji injettabbli li fihom doramectin, u fin-nuqqas ta' limiti massimi tar-residwu għal doramectin fil-ħalib, is-CVMP qies li bejn l-għoti ta' dawn il-prodotti li fihom doramectin u t-twellid ta' għoġġiela jew ittwellid ta' nagħaġ iridu jgħaddu l-perjodi minimi ta' żmien ta' xahrejn għall-frat u r-renni u 70 jum għan-nagħaġ;
English: In sheep it is administered as a single intramuscular injection at a dose of 200 or 300 μg/kg bw for treatment and control of gastrointestinal roundworms, mange mites and nasal bots.
Maltese: Fin-nagħaġ jingħata bħala tilqima intramuskolari unika b'doża ta' 200 jew 300 μg/kg bw għattrattament u l-kontroll ta' dud nematode gastrointestinali, mange mites u qurdien nażali.
English: Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.
Maltese: Doramectin huwa tossiku ħafna għall-ħlejjaq akwatiċi u jista' jakkumula fis-sedimenti.
English: 109 37401 Amboise Cedex, FRANCE
Maltese: Il-Bulgarija Pfizer S.A., Z.l. De Poce-sur-Cisse, B.P. 109 37401 Amboise Cedex, FRANZA
English: In pigs it is administered as a single intramuscular injection at a dose of 300 μg/kg bw for treatment of mange mites, gastrointestinal roundworms, lungworms, kidney worms and sucking lice.
Maltese: Fil-majjali jingħata bħala tilqima intramuskolari unika b'doża ta' 300 μg/kg bw għat-trattament ta' mange mites, dud nematode gastrointestinali, dud nematode tal-pulmun, dud tal-kliewi u qamel li jerda'.