FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/839/001
English: ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit juice.
Maltese: Għandha tingħata attenzjoni u għandu jiġi kkunsidrat tnaqqis fid-doża tal-bidu ta' Iclusig għal 30 mg bl-użu fl-istess waqt ta' impedituri qawwija ta' CYP3A bħal clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, u meraq tal-grejpfrut.
English: • a 45 mg film-coated tablet for the recommended dose.
Maltese: • pillola miksija b'rita ta' 45 mg għad-doża rakkomandata.
English: Bottles of Iclusig 15 mg contain either 60 or 180 film-coated tablets.
Maltese: Fliexken ta' Iclusig 15 mg fihom jew 60 jew 180 pillola miksija b'rita.
English: Dose adjustments to 30 mg once daily or 15 mg once daily were allowed for the management of treatment toxicity.
Maltese: Aġġustamenti tad-doża għal 30 mg darba kuljum jew 15 mg darba kuljum kienu permessi għall-ġestjoni ta' tossiċità waqt it-trattament.
English: Iclusig is associated with severe (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4) thrombocytopenia, neutropenia, and anaemia.
Maltese: Iclusig huwa assoċjat ma' tromboċitopenja, newtropenja, u anemija severa (Kriterji ta' Terminoloġija Komuni għall-Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kanċer Grad 3 jew 4).
English: The following medicines can affect or be affected by Iclusig:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: Table 7 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Maltese: Tabella 7 L-effikaċja ta' Iclusig f'pazjenti b'CML fil-fażi avvanzata reżistenti jew intolleranti Fażi Aċċelerata ta' CML
English: For the standard dose of 45 mg once daily, a 45 mg film-coated tablet is available.
Maltese: Għad-doża standard ta' 45 mg darba kuljum, hemm disponibbli pillola miksija b'rita ta' 45 mg.
English: Co administration of strong CYP3A4 inducers such as carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, and St. John's Wort with ponatinib should be avoided, and alternatives to the CYP3A4 inducer should be sought, unless the benefit outweighs the possible risk of ponatinib underexposure.
Maltese: Għoti ta' indutturi qawwija ta' CYP3A4 bħal carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, u St.
English: An alternative or additional method of contraception should be used.
Maltese: Għandu jintuża metodu alternattiv jew addizzjonali ta' kontraċezzjoni.
English: • circulatory problems in the spleen
Maltese: • problemi taċ-ċirkolazzjoni fil-milsa
English: (95% CI) a Primary endpoint for CP-CML Cohorts was MCyR, which combines both complete (No detectable Ph+
Maltese: (95% CI) a Il-punt tat-tmiem primarju għal Koorti CP-CML kien MCyR li jikkombina risponsi ċitoġenetiċi kemm kompluti (l-ebda ċellula ta' Ph+ osservata) u parzjali (1% sa 35% ċelluli ta' Ph+).
English: Uncommon poor peripheral circulation, splenic infarction, embolism venous, venous thrombosis
Maltese: Mhux komuni ċirkolazzjoni periferali ħażina, infart tal-milsa, embolu fil-vini, trombożi fil-vini
English: BATCH NUMBER
Maltese: Numru ta' Pazjenti
English: • chills, flu-like illness
Maltese: • sirdat, mard jixbaħ lill-influwenza
English: The primary efficacy endpoint in CP-CML was major cytogenetic response (MCyR), which included complete and partial cytogenetic responses (CCyR and PCyR).
Maltese: Il-punt tat-tmiem ta' effikaċja primarja fis-CP-CML kien rispons ċitoġeniku maġġuri (MCyR - major cytogenic response), li kien jinkludi rispons ċitoġeniku komplut jew parzjali (CCyR u PCyR).
English: The analysis of the dose intensity-safety relationship in the phase 2 trial concluded that after adjusting for covariates, the overall dose intensity is significantly associated with an increased risk of vascular occlusion, with an odds ratio of approximately 1.6 for each 15 mg increase.
Maltese: L-analiżi tar-relazzjoni bejn l-intensità u s-sigurtà tad-doża fil-prova ta' fażi 2 ikkonkludiet li wara aġġustament għall-kovarjanti, l-intensità globali tad-doża hija assoċjata b'mod sinifikanti ma' riskju akbar ta' okklużjoni vaskulari, b'odds ratio ta' madwar 1.6 għal kull żieda ta' 15-il mg.
English: • obstruction of the blood vessels in the eye, visual disturbance
Maltese: • disturb fil-vista
English: Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased
Maltese: Komuni deidratazzjoni, żamma ta' fluwidu, ipokalċemija, ipergliċemija, iperuriċemija, ipofosfatemija, ipertrigliċeridemija, ipokalimja, tnaqqis fil-piż
English: • increased blood levels of several liver enzymes called:
Maltese: • livelli ogħla fid-demm ta' enzimi tal-fwied jew tal-frixa:
English: Formal studies of ponatinib with anti-clotting medicinal products have not been conducted.
Maltese: Ma sarux studji formali ta' ponatinib ma' prodotti mediċinali kontra t-tagħqid tad-demm.
English: Close clinical surveillance is recommended when ponatinib is administered with these medicinal products.
Maltese: Sorveljanza klinika mill-qrib hi rakkomandata meta ponatinib jingħata ma' dawn il-prodotti mediċinali.
English: A reduction of the starting dose of Iclusig in patients with hepatic impairment is not necessary (see sections 4.2 and 4.4).
Maltese: Mhux meħtieġ tnaqqis fid-doża tal-bidu ta' Iclusig f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.2 u 4.4).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Iclusig in paediatric patients from 1 year to less than 18 years in CML and Ph+ ALL (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligi li jiġu ppresentati riżultati tal-istudji ta' Iclusig f'pazjenti pedjatriċi minn 1 sena sa inqas minn 18-il sena f'CML u Ph+ ALL (ara sezzjoni 4.2 għal informazzjoni fuq l-użu pedjatriku).
English: Skin changes in the form of crusts, hyperkeratosis, or erythema were observed in toxicity studies in cynomolgus monkeys.
Maltese: It-tessut fetali artab multiplu u l-alterazzjonijiet skeletriċi kienu osservati wkoll f'dożaġġi maternali mhux tossiċi.
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 60 or 180 film-coated tablets, together with one plastic canister containing molecular sieve desiccant.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Fliexken ta' densità għolja ta' polyethylene (HDPE) b'għotjien bil-kamin, li fihom 60 jew 180 pillola miksija b'rita, flimkien ma' kontenitur wieħed tal-plastik li fih desikkant li jgħarbel il-molekuli.
English: The potential risk for humans is unknown.
Maltese: Ir-riskju potenzjali għall-bniedem mhuwiex magħruf.
English: Preliminary data from the phase 2 trial are available on the maintenance of response (MCyR and MMR) in all CP-CML patients who underwent dose reduction for any reason.
Maltese: Dejta preliminari mill-prova ta' fażi 2 hija disponibbli dwar il-manteniment ta' rispons (MCyR u MMR) fil-pazjenti kollha b'CP-CML li kellhom tnaqqis fid-doża għal kwalunkwe raġuni.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use are described below.
Maltese: Reazzjonijiet avversi li ma kienux osservati fl-istudji kliniċi, imma li ġew osservati f'annimali f'livelli ta' espożizzjoni simili għal-livelli ta' espożizzjoni klinika u b'rilevanza possibbli għal użu kliniku huma deskritti taħt.
English: The anti-leukaemic activity of Iclusig was also evaluated in a phase 1 dose escalation study that included 65 CML and Ph+ ALL patients; the study is ongoing.
Maltese: L-attività antilewkimika ta' Iclusig kienet ukoll evalwata fi studju ta' żieda dożali ta' fażi 1 li kienet tinkludi 65 pazjent b'CML u Ph+ ALL; l-istudju għadu għaddej.
English: R/I Cohort (N=203)
Maltese: Reżistenti jew Intolleranti Koorti R/I (N = 203)
English: - pancreas inflammation.
Maltese: Mhux applikabbli.
English: This is a long-term treatment.
Maltese: Waqqaf it-treddigħ waqt it-trattament b'Iclusig.
English: Compared to healthy volunteers with normal liver function, no major differences in ponatinib PK were observed in patients with varying degrees of hepatic impairment.
Maltese: Meta mqabbla ma' voluntiera f'saħħithom b'funzjoni normali tal-fwied, ma kienet osservata l-ebda differenza kbira fil-PK ta' ponatinib f'pazjenti bi gradi varji ta' indeboliment epatiku.
English: In rats, embryo-foetal toxicity in the form of post-implantation loss, reduced foetal body weight, and multiple soft tissue and skeletal alterations were observed at maternal toxic dosages.
Maltese: Fil-firien, tossiċità embriju-fetali fl-għamla ta' telf wara l-impjantazzjoni, naqqset il-piż fetali u tat-tessut multiplu artab u alterazzjonijiet skeletriċi kienu osservati f'dożaġġi maternali tossiċi.
English: Common rash pruritic, exfoliative rash, erythema, alopecia, pruritis, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative
Maltese: Komuni ħafna uġigħ addominali, dijarea, rimettar, stitikezza, dardir, żieda fil-lipase
English: ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Second occurrence:
Maltese: • Waqqaf Iclusig u erġa' ibda b'doża ta' 45 mg wara l-irkupru sa ANC ≥ 1.5 x 109/L u plejtlets ≥ 75 x 109/L It-tieni darba:
English: • rash, dry skin
Maltese: • raxx, ġilda xotta
English: Common vision blurred, dry eye, periorbital oedema, eyelid oedema
Maltese: Komuni vista mċajpra, għajnejn xotti, edima madwar l-għajn, edima fil-kappell tal-għajn
English: Iclusig is associated with pancreatitis.
Maltese: Iclusig huwa assoċjat ma' pankreatite.
English: Of 43 CP-CML patients, 31 CP-CML patients achieved a
Maltese: Minn 43 pazjent b'CP-CML, 31 pazjent b'CP-CML kisbu MCyR bi żmien medjan ta' insegwitu ta' 25.
English: In vitro studies suggested that ponatinib is either not a substrate or is a weak substrate for both P-gp and breast cancer resistance protein BCRP.
Maltese: Studji in vitro jissuġerixxu li ponatinib jew mhuwiex sottostrat jew huwa sottostrat dgħajjef għal P-gp u għal proteina ta' reżistenza għall-kanċer tas-sider BCRP.
English: Isolated reports of unintentional overdose with Iclusig were reported in clinical trials.
Maltese: Rapporti iżolati ta' doża eċċessiva mhux intenzzjonata b' Iclusig kienu rapportati fil-provi kliniċi.
English: Co-administration of Iclusig with a potent inhibitor of gastric acid secretion resulted in a minor reduction in ponatinib Cmax without a reduction in AUC0-∞.
Maltese: Emorraġija ċerebrali u emorraġija gastrointestinali kienu l-aktar avvenimenti ta' fsada serji rrappurtati b'mod komuni.
English: Table 5 Demographics and disease characteristics
Maltese: Karatteristiċi demografiċi u ta' mard
English: Pregnancy
Maltese: ĠENERALI
English: No Dose Reduction Dose reduction to 30 mg only ≥ 90 day reduction at 30 mg ≥ 180 day reduction at 30 mg ≥ 360 day reduction at 30 mg Any dose reduction to 15 mg ≥ 90 day reduction at 15 mg ≥ 180 day reduction at 15 mg ≥ 360 day reduction at 15 mg
Maltese: Il-biċċa l-kbira tal-pazjenti li finalment naqqsu d-doża għal 15 mg inizjalment kellhom id-doża tagħhom imnaqqsa għal 30 mg għal xi perjodu.
English: Pancreatitis Recommended modifications for pancreatic adverse reactions are summarized in Table 2.
Maltese: Modifikazzjonijiet rakkomandati għal reazzjonijiet avversi tal-frixa huma mogħtija fil-qosor f'Tabella 2.
English: Uncommon cerebral artery stenosis
Maltese: • puplesija żgħira, infart ċerebrali
English: Consider discontinuation of ponatinib in patients who develop serious heart failure (see sections 4.2 and 4.8).
Maltese: Għandu jiġi kkunsidrat il-waqfien ta' ponatinib f'pazjenti li jiżviluppaw insuffiċjenza tal-qalb serja (ara sezzjonijiet 4.2 u 4.8).
English: Overall arterial and venous occlusive adverse reactions have occurred in 23% of Iclusig-treated patients from the phase 2 trial, with serious adverse reactions occurring in 18% of patients.
Maltese: B'mod globali reazzjonijiet avversi okklussivi fl-arterji u fil-vini seħħew fi 23% tal-pazjenti kkurati b'Iclusig fil-prova ta' fażi 2, b'reazzjonijiet avversi serji jseħħu fi 18% tal-pazjenti.
English: For a dose of 30 mg or 15 mg once daily, 15 mg film-coated tablets are available.
Maltese: Għal doża ta' 30 mg jew 15 mg darba kuljum, pilloli miksija b'rita ta' 15 mg huma disponibbli.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/839/003
English: Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
Maltese: Trombożi u okklużjoni fl-arterji u fil-vini, inkluż infart mijokardijaku fatali, puplesija, stenosi tal-kanali tal-arterji l-kbar tal-moħħ, mard vaskulari periferali sever, u l-ħtieġa ta' proċeduri ta' rivaskularizzazzjoni urġenti seħħew f'pazjenti kkurati b'Iclusig.
English: White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with "AP4" debossed on one side.
Maltese: Pillola miksija b'rita ta' lewn bajda, mżaqqa fuq iż-żewġ naħat li ta' madwar 9 mm dijametru, b' “AP4” intaljat fuq naħa minnhom.
English: Ponatinib is not displaced by concomitant administration of ibuprofen, nifedipine, propranolol, salicylic acid, or warfarin.
Maltese: Ponatinib ma jinħalx minn dan l-irbit permezz ta' għoti fl-istess waqt ta' ibuprofen, nifedipine, propranolol, salicylic acid, jew warfarin.
English: ATCvet code: QP53BE02.
Maltese: QP53BE02.
English: Fluralaner is highly bound to protein.
Maltese: Fluralaner huwa marbut ħafna mal-proteini.
English: Intervet Productions S.A. Rue de Lyons 27460 Igoville France
Maltese: Intervet Productions S.A. Rue de Lyons 27460
English: Fluralaner Poultry 65 µg/kg 650 µg/kg
Maltese: Fluralaner Tjur 65 µg/kg 650 µg/kg
English: Antiparasitic agents/Agents against ectoparasites
Maltese: Antiparassitarju aġent/Aġenti kontra ektoparassiti
English: Date of first authorisation: 18/08/2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/ TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18/08/2017
English: 1 litre 4 litres
Maltese: 4 litri
English: France
Maltese: Olanda
English: 10 mg/ml fluralaner
Maltese: ATTIVA(I) 10 mg/ml fluralaner
English: 5831 AN Boxmeer The Netherlands
Maltese: 5831 AN Boxmeer
English: The active substance in Exzolt is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Exzolt hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: 10 mg fluralaner For the full list of excipients, see section 6.1.
Maltese: 10mg fluralaner Għall-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Pharmacotherapeutic group: Antiparasitic products, ectoparasiticides for systemic use, isoxazolines.
Maltese: Prodott antiparassitiku, ectoparassitiku għall-użu sistemiku, isoxazolines.
English: EU/2/17/212/001 (1 litre) EU/2/17/212/002 (4 litres)
Maltese: EU/2/17/212/002 (4 litri)
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Olanda
English: {DD/MM/YYYY}
Maltese: JIS {xahar/sena}
English: The apparent elimination half-life is approximately 5 days following oral administration.
Maltese: Il-half-life apparenti hija approssimattivament 5 tijiem wara amministrazzjoni orali.
English: Bottle of 50 ml, 1 litre or 4 litres.
Maltese: Flixkun ta`50ml,1 litru u 4 litri.
English: Pack sizes: bottles of 50 ml, 1 litre or 4 litres.
Maltese: TAGĦRIF IEĦOR Flixkun ta` 50 ml, 1 litru or 4 litri.
English: This procedure should be repeated on each day of administration.
Maltese: Din ilproċedura għandha tiġi ripetuta kull ġurnata ta` amministrazzjoni.
English: In vitro bio-assays show that fluralaner is effective against parasites having proven field resistance, including organophosphates, pyrethroids and carbamates.
Maltese: Fi studji bio-assays in vitro juru li furalaner huwa effettiv kontra l-parassiti li għandhom reżistenza naturali ppruvata, inkluż organophosphates, pyrethroids u carbamates.
English: The bioavailability is high, with approximately 91% of the dose absorbed following oral administration.
Maltese: Ilbijoavibilità hija għolja, bi kważi 91% mid-doża tiġi assorbita wara amministrazzjoni orali.
English: Colourless high density polyethylene (HDPE) bottle closed with an aluminium/polyester foil seal and a blue child-resistant polypropylene screw cap (1 litre and 4 litre presentations) or type III amber glass bottle with a white polypropylene/polyethylene (PP/PE) child-proof screw cap with expanded low density PE/aluminium foil/ PE faced liner (50 ml presentation).
Maltese: (preżentazzjoni tal-1 litru u tal-4 litri) jew flixkun tal-ħġieġ skur tip III b`tapp abjad tal-polypropylene/polyryhylene(PP/PE) bil-kamin u reżistenti għat tfal bl-liner tal-aluminjum fojl b` densita baxxa PE (preżentazzjoni 50ml) Daqs tal-pakett: fliexken ta' 1 litru jew 4 litri.
English: After oral administration, fluralaner is absorbed rapidly from the medicated drinking water, reaching maximum plasma concentrations 36 hours after the first dose and 12 hours after the second dose.
Maltese: Wara amministrazzjoni orali, fluralaner huwa assorbit malajr mill-ilma medikat, jilħaq konċentrazzjoni massima fil-plasma 36 siegħa wara l-ewwel doża u 12-il siegħa wara t-tieni doża.
English: Volume of product (ml) per treatment day = Total body weight (kg) of chickens to be treated x 0.05 ml/kg
Maltese: Volum tal-prodott (ml) għall-kull ġurnata ta`trattament = Il-piż totalital-ġisem (kg) tat tiġieġ li se jiġu trattati x 0.05ml/kg
English: For use in drinking water.
Maltese: U/JEW UŻU Mhux applikabbli.
English: Lot:
Maltese: LOTT
English: Marketing authorisation holder: Intervet International BV Wim de Körverstraat 35
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq Intervet International BV Wim de Körverstraat 35
English: Fluralaner is a potent inhibitor of parts of the arthropod nervous system by acting antagonistically on ligand-gated chloride channels (GABA-receptor and glutamate-receptor).
Maltese: Furalander huwa inibitur qawwi ta` parti mis-sistema nervuża tal-artropod billi taġixxi b`mod antagonistiku fuq il-kanali tal-ligand-gated tal-klorin (riċetturi-GABA u riċetturi-glutamat).
English: Withdrawal periods:
Maltese: Propretajiet ambjentali:
English: EXP {month/year} Once opened, use within 1 year.
Maltese: DATA TA' SKADENZA EXP {month/year}
English: Animal species MRLs
Maltese: MRL Tessuti mmirati
English: One ml contains:
Maltese: Kull 1ml fih:
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f'sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010> <jew> <huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: In molecular on-target studies on insect gamma-aminobutyric acid (GABA) receptors of flea and fly, dieldrin resistance does not affect fluralaner.
Maltese: Fi studji molekolari mmirati fuq riċetturi tal-insetti gamma-aminobutyric acid (GABA) tal-briegħed u ddubbien, reżistenza tad-dieldrin ma taffetwax lill-furalaner.
English: Special warnings for each target species: The following practices should be avoided because they increase the risk of development of resistance and could ultimately result in ineffective therapy: - too frequent and repeated use of acaricides from the same class, over an extended period of time - underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the volume measuring device.
Maltese: Il-prattiċi li ġejjin għandhom jiġu evitati għax iżidu r-riskju li tiżviluppa reżistenza u tista' finalment twassal għall-terapija mhux effettiva. - użu frekwenti u repetut ta` akariċidi tal-istess klassi, fuq perjodu ta` ħin estensiv, - dożaġġ baxx, li jista' jkun minħabba sottuvalutazzjoni tal-piż tat-tjur, amministrazzjoni ħażina tal prodott, jew nuqqas ta` kalibrazzjoni tal-volum tal-apparat tal-kejl.
English: Therefore 500 ml of product treats 10,000 kg body weight (e.g., 5,000 chickens of 2 kg body weight each) per day of treatment administration.
Maltese: Għalhekk 500ml tal-prodott jittratta 10,000kg piż tal-ġisem (e.ż. 5,000 tiġieġ ta` 2kg piż tal-ġisem kull waħda) kull ġurnata ta`amministrazzjoni tat-trattament.
English: • For each day of treatment, medicated water must be freshly prepared.
Maltese: • Għall-kull ġurnata ta` trattament, l-ilma medikat għandu jiġi ppreparat frisk.
English: Withdrawal periods: Meat and offal: 14 days Eggs: 0 days
Maltese: Laħam u ġewwini: 14 ġranet Bajd: 0 ġranet
English: PACKAGE LEAFLET (50-ml presentation): Exzolt 10 mg/ml solution for use in drinking water for chickens
Maltese: FULJETT TA' TAGĦRIF (preżentazzjoni 50ml biss): Exzolt 10 mg/ml soluzzjoni għall-użu fl-ilma tax-xorb għat-tiġieġ
English: Meat and offal: 14 days.
Maltese: Laħam u ġewwieni tal-annimali: 14 ġranet.
English: None.
Maltese: JIS
English: CARTON BOX (50-ml presentation only)
Maltese: TIKETTA TAL-FLIXKUN (preżentazzjoni 50-ml biss) NAME OF THE VETERINARY MEDICINAL PRODUCT
English: Estimate how much water birds will consume during treatment based on the previous day's water consumption.
Maltese: Stima kemm ilma t-tjur jikkunsmaw waqt it-trattament ibbażat fuq il-konsum ta` ilma talġurnata ta` qabel.
English: Determine the duration of time (between 4 and 24 hours) over which to administer the medicated water on the treatment day.
Maltese: Iddetermina t-tul ta` ħin (bejn 4 u 24 siegħa) fejn se tamministra l-ilma medikat fil-ġurnata tattrattament.
English: Fertility and lay:
Maltese: Fertilita` u żmien il-bidien:
English: Therefore 50 ml of product treats 1,000 kg body weight (e.g., 500 chickens of 2 kg body weight each) per day of treatment administration.
Maltese: Għalhekk 50ml tal-prodott jittratta 10,000kg piż tal-ġisem (e.ż. 5,000 tiġieġ ta` 2kg piż tal-ġisem kull waħda) kull ġurnata ta`amministrazzjoni tat-trattament.
English: The dose is 0.5 mg fluralaner per kg body weight (equivalent to 0.05 ml of product) administered twice, 7 days apart.
Maltese: Id-doża hija 0.5ml fluralaner għal kull kilo piż tal-ġisem (ekwivalenti għal 0.05ml tal-prodott) amministrat darbtejn, imbegħdin b`7 ijiem.
English: Fluralaner is an acaricide and an insecticide which has a high potency against poultry mites, mostly by exposure via feeding, i.e. it is systemically active against the target parasites.
Maltese: Fluralaner huwa akariċida u insettiċida li għandu qawwa għolja kontra l-mites tat-tjur, l-aktar b`espożizzjoni mill-ikel i.e. huwa attiv sistemikament kontra l-parassit indikat.
English: Manufacturer responsible for batch release: Intervet Productions SA Rue de Lyons
Maltese: Intervet Productions SA
English: NO ENTRY
Maltese: IL-PROVVISTA
English: The dose is 0.5 mg fluralaner per kg body weight (equivalent to 0.05 ml of solution) administered twice, 7 days apart.
Maltese: Id-doża hija 0.5ml fluralaner għall-kull kilò piż tal-ġisem (ekwivalenti għal 0.05ml tal-prodott) amministrat darbtejn, imbegħdin b`7 ijiem.
English: PHARMACEUTICAL FORM
Maltese: VETERINARJU