FrancophonIA/ELRC3.0 huggingface dataset:
English: - weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction - swelling of the face, lips, tongue and throat (Quincke's oedema) - flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) - symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function - a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme) - a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) - a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis) - signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
Maltese: - Debbolizza, tħossok rasek qed iddur bik jew stordut jew ikollok diffikultà tieħu nifs, għaliex dawn jistgħu ikunu sinjali ta' reazzjoni allerġika (anafilletika) serja - Nefħa fil-wiċċ, xofftejn, ilsien u ġerżuma (edima ta' Quincke) - Sintomi bħal ta' riħ u raxx fuq il-wiċċ segwit minn raxx mifrux b'temperatura għaolja, żieda fillivelli tal-enżimi tal-fwied murija f' testijiet tad-demm u żieda f' tip ta' ċellola tad-demm bajda (esinofilja) u tkabbir fin-nodi limfatiċi (Reazzjoni tad-Droga b' Esinofilja u Sintomi Sistemiċi [DRESS]) - Sintomi bħal volum tal-awrina baxx, għajja, dardir, rimettar, konfużjoni u nefħa fir-riġlejn, għekiesi jew fis-saqajn, għax dan jista' jkun sinjal ta' tnaqqis f'daqqa fil-funzjoni tal-kliewi - Raxx fil-ġilda li tista' tifforma bżieżaq u li tkun tidher qisha marki tal-mira żgħar (tikka skura ċentrali mdawwra b'erja iżjed ċara, b' ċirku skur max-xifer) (eritema multiforme) - Raxx mifrux bil-bżieżaq u ġilda titqaxxar, partikularment madwar il-ħalq, imnieħer, għajnejn u ġenitali (sindromu Stevens-Johnson)
English: Cough
Maltese: Dilwent
English: PC:
Maltese: Fax:
English: The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1500 mg intravenous infusion for 4 days with twice daily dosing.
Maltese: Il-profil farmakokinetiku li huwa indipendenti mill-ħin kien ikkonfermat wkoll wara infużjoni minn ġol-vina ta' 1500 mg għal 4 ijiem b' doża darbtejn kuljum.
English: Completed suicide, personality disorder, thinking abnormal, delirium
Maltese: Suwiċidju li jsir, mard talpersonalita`, ħsibijiet abnormali, delirju
English: Other ingredients include sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injection.
Maltese: Sustanzi oħra jinkludu Sodium acetate trihydrate, Glacial acetic acid, Sodium chloride, Ilma għall-injezzjoni.
English: In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
Maltese: Fi studju li jirrifletti l-prattika klinika, l-mediċini ta' kontra l-epilessija li ingħataw fl-istess ħin setgħu jiġu mwaqqfa f'numru limitat ta' pazjenti li rrispondew għal terapija miżjuda b' levetiracetam (36 pazjent minn 69).
English: NAME OF THE MEDICINAL PRODUCT Levetiracetam SUN 100 mg/ml concentrate for solution for infusion levetiracetam
Maltese: TAL-PRODOTT MEDIĊINALI Levetiracetam SUN 100 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: Diplopia, vision blurred
Maltese: Konċentrat ċar, bla kulur
English: Levetiracetam SUN concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Maltese: Il-konċentrat Levetiracetam SUN huwa għall-użu minn ġol-vina biss u d-doża rikkmandata trid tiġi dilwita f' mill- inqas 100 ml ta' dilwent kompattibli u tingħata b'infużjoni minn ġol-vina fuq medda ta' 15 il-minuta (ara sezzjoni 6.6).
English: A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
Maltese: Studju retrospettiv ta' interazzjoni farmakokinetika fit-tfal u l-addoloxxenti b'epilessija (4 sa 17 il- sena) ikkonferma li terapija miżjuda b' levetitacetam li jittieħed mill-ħalq ma kellux effett fuq konċentrazzjonijiet tas-serum fi stat fiss ta' carbamazepine u valproate li jingħataw fl-istess ħin.
English: 250 mg twice daily
Maltese: 250 mg darbtejn kuljum
English: The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighting 50 kg or more, the following formula:
Maltese: Din ir-rata tista' tigi kkalkulata mill-livell ta' krejatinina fis-serum (mg/dl), għal adulti u addoloxxenti li jiżnu 50 kg jew aktar, billi tuża din il-formula:
English: Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam.
Maltese: Kontraċettivi orali u interazzjonijiet farmakokinetiċi oħra
English: Ear and labyrinth disorders
Maltese: Mard tal-widna u tas-sistema labirinta
English: For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
Maltese: F' tfal b'indeboliment tal-kliewi, id-doża ta' levetiracetam għandha tiġi aġġustata skond ilfunzjoni renali għaliex clearance ta' levetiracetam huwa marbut mal-funzjoni renali.
English: lethargy (lack of energy and enthusiasm), tremor (involuntary trembling) - vertigo (sensation of rotation) - cough - abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea - rash - asthenia/fatigue (tiredness)
Maltese: (nuqqas ta' enerġija u entużjażmu), rogħda (tirtogħod mingħajr ma trid); - vertigo (sensazzjoni li kollox idur bik); - sogħla; - uġigħ fl-addomenu, dijareja, dispepsja (indigistjoni), rimettar, dardir; - raxx; - astenja/għajja.
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x 6-17 the MRHD on a mg/m2 basis).
Maltese: Studji fl-annimali tat-twelid u ġovanili fil-firien u l-klieb wrew li ma kienx hemm effetti avversi filpunti tat-tmiem standard tal-iżvillup jew maturazzjoni b'dożi sa 1800 mg/kg/ġurnata ( x6 - 17 ilMRHD fuq bażi ta' mg/m2).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Levetiracetam SUN 100 mg/ml sterile concentrate levetiracetam
Maltese: TAL-PRODOTT MEDIĊINALI Levetiracetam SUN 100 mg/ml konċentrat għal soluzzjoni għall-infużjoni levetiracetam
English: What Levetiracetam SUN contains - The active substance is called levetiracetam.
Maltese: X'fih Levetiracetam SUN - Is-sustanza attiva hi levetiracetam.
English: See the package leaflet for further information.
Maltese: Sorsi oħra ta' informazzjoni
English: For storage conditions of the diluted medicinal product, see section 6.3.
Maltese: Dan il-prodott mediċinali ma' jistax jiġi dilwit ma' prodotti oħra mediċinali għajr dawk imsemmija f'sezzjoni 6.6.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea għall ilmediċini http://www.ema.europa.eu
English: The patients were randomized to carbamazepine CR 400 - 1200 mg/day or levetiracetam 1000 - 3000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Maltese: Il-pazjenti kienu maqsuma mingħajr ma ġew magħżula biex jieħdu jew carbamazepine CR 400 - 1200 mg/ġurnata jew levetiracetam 1000 - 3000 mg/ġurnata, b'trattament li dam sa 121 ġimgħa skond kemm kien ir-rispons.
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Maltese: Ebda reazzjonijiet avversi fuq il-fertilita` maskili jew femminili jew abbilta` riproduttiva ma kienu osservati fil-firien f'dożi sa 1800 mg/kg/day (x 6 l-MRHD fuq bażi ta' mg/m2 jew t'esponiment) fil-ġenituri u l-ġenerazzjoni F1.
English: EXP Use immediately after dilution.
Maltese: EXP Uża immedjatament wara li jiġi dilwit.
English: 250 mg 2.5 ml (half 5 ml vial)
Maltese: Doża totali ta' Kuljum250 mg 2.5 ml (nofs vjala ta' 5 ml) 100 ml 15 minuti Darbtejn kuljum
English: Each vial contains 19 mg of sodium For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: 500 mg 5 ml (one 5 ml vial)
Maltese: INDIVIDWALI 500 mg/5 ml
English: A large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
Maltese: Ammont kbir ta' dejta minn wara t-tqegħid fis-suq dwar nisa tqal esposti għal monoterapija b'levetiracetam ('il fuq minn 1800, li fosthom f'iktar minn 1500, l-esponiment seħħ matul l-ewwel trimestru tat-tqala) ma jissuġġerix żieda fir-riskju ta' malformazzjonijiet konġenitali maġġuri.
English: Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Maltese: parallel group, non-inferiority ma' carbamazepine f' għamla li jintreħa b' mod kontrollat (CR) f'576 pazjenti ta' 16 il-sena jew iżjed li għadhom kif ġew dijanjostikati b' epilessija.
English: 10 vials of concentrate for solution for infusion
Maltese: 10 vjali ta' konċentrat għal soluzzjoni għall-infużjoni
English: Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function
Maltese: Regolar tad-doża f'pazjenti adulti u addoloxxenti li jiżnu iżjed minn 50 kg b'indeboliment fil-kliewi: Grupp
English: Levetiracetam SUN concentrate for solution for infusion is packed in a cardboard box containing 10 vials of 5 ml.
Maltese: Il-konċentrat ta' soluzzjoni għall-infużjoni Levetiracetam SUN issibhom f'kaxxi tal-kartun li fiha 10 vjali ta' 5 ml.
English: 1000 mg 10 ml (two 5 ml vials)
Maltese: 1000 mg 10 ml (żewġt vjali ta' 5 ml) 100 ml 15 minuti Darbtejn kuljum2000 mg/ ġurnata
English: In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N-type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
Maltese: Studji in vitro juru li levetiracetam jaffetwa livelli ta' Ca2+ intranewronali billi jinibixxi parzjalment ilkurrenti ta' Ca2+ tat-tip N u billi jnaqqas kemm jintreħa Ca2+ mill-ħażniet intranewronali.
English: Uncommon: may affect up to 1 in 100 people - decreased number of blood platelets, decreased number of white blood cells - weight decrease, weight increase - suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger,
Maltese: Mhux komuni: jista' jaffettwa sa 1 f' 100 persuna - tnaqqis fin-numru ta' plejtlets fid-demm, tnaqqis fin-numru ta' ċelloli bojod fid-demm; - tnaqqis fil-piz, żieda fil-piz; - attentat ta' suwiċidju u ħsibijiet ta' suwiċidju, mġieba abnormali, alluċinazzjonijiet, rabja,
English: Height (cm) x ks
Maltese: .8 Effetti mhux mixtieqa
English: Levetiracetam has been given to you by your doctor to reduce the number of fits - with other antiepileptic medicines (add-on therapy) to treat: partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Maltese: L-epilessija hija kundizzjoni fejn il-pazjent ikollu aċċessjonijiet ripetuti. Levetiracetam huwa użat għat-tip ta' epilessija fejn fil-bidu laċċessjonijiet jaffetwaw naħa waħda biss tal-moħħ (aċċessjoni partial onset kemm bil, kif ukoll mingħajr ġeneralizazzjoni sekondarja). Levetiracetam ingħata lilek mit-tabib sabiex inaqqas innumru ta' aċċessjonijiet. - biex jiżdied ma' mediċini oħra (terapija addizzjonali) ta' kontra l-epilessija fit-trattament ta': - aċċessjonijiet tat-tip parzjali kemm bi kif ukoll mingħajr ġeneralizzazzjoni f' adulti, addoloxxenti u tfal minn 4 snin.
English: 100 ml
Maltese: 1000 mg/ ġurnata
English: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam.
Maltese: Madankollu, studji epidemjoloġiċi kurrenti (fuq madwar 100 tifel u tifla) ma jissuġġerux żieda fir-riskju ta' disturbi ta' jew dewmien fl-iżvilupp newroloġiku.
English: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment.
Maltese: INFORMAZZJONI BIL-BRAILLE <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata> 17.
English: Each ml contains 100 mg of levetiracetam.
Maltese: U KWANTITATTIVA Kull ml fiha 100 mg ta' levetiracetam.
English: A doctor or a nurse will administer you Levetiracetam SUN as an intravenous infusion.
Maltese: Tabib jew infermjier ser tagħtik Levetiracetam SUN bħala infużjoni minn ġol-vina.
English: Levetiracetam and related analogues show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Maltese: Dan it-tagħrif jissuġġerixxi li l-interazzjoni bejn levtiracetam u l-proteina talbużżieqa tas-sinapsi 2A donnhom jikkontribwixxu għall-mekkaniżmu t'azzjoni kontra l-epilessija talprodott mediċinali.
English: Volume of Diluent
Maltese: NUMRU TAL-LOTT
English: Levetiracetam SUN is indicated as adjunctive therapy - in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy - in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy - in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Maltese: - Fit-trattament ta' aċċessjonijiet tat-tip mijoklonika adulti u addoloxxenti minn 12 snin b'epilessija tat-tip Mijoklonika li tibda fiż-zgħożija - Fit-trattament ta' aċċessjonijiet primarji u ġeneralizzati tat-tip tonic-clonic f'adulti u addoloxxenti minn 12 il-sena b'Epilessija Ġeneralizzata Idjopatika.
English: 500 mg twice daily
Maltese: 500 mg darbtejn kuljum
English: The maximum dose is 1500 mg twice daily.
Maltese: Id-doża massima hi ta' 1500 mg darbtejn kuljum.
English: In this study, levetiracetam dose was 3000 mg/day for adults and adolescents or 60 mg/kg/day for children, given in 2 divided doses.
Maltese: F'dan l-istudju, id-doża ta' levetiracetam kienet ta' 3000 mg/ġurnata fl-adulti u l-addoloxxenti jew 60 mg/kg/ġurnata fit-tfal, li ingħataw f'2 dożi separati.
English: The intravenous formulation is an alternative to the oral formulation.
Maltese: L-għamla li tittieħed minn ġol-vina hija alternattiva għal dik orali.
English: Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Maltese: Żiediet linejari u proporzjonali għad-doża kienu osservati bil- konċentrazzjonijiet massimi fil-plażma u l-erja taħt il-kurva.
English: ATCvet code: QP53BE04
Maltese: QP53BE04
English: Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue FRANCE
Maltese: Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue FRANZA
English: 48 mg lotilaner
Maltese: 12 mg lotilaner 48 mg lotilaner
English: Crospovidone Povidone K30 Sodium laurilsulfate
Maltese: Crospovidone Sodium laurilsulfate
English: Manufacturer responsible for batch release: Elanco France S.A.S., 26 rue de la Chapelle, 68330 Huningue, France
Maltese: Elanco France S.A.S., 26 rue de la Chapelle, 68330 Huningue, Franza
English: Pharmacotherapeutic group: ectoparasiticides for systemic use, isoxazolines.
Maltese: Grupp farmako-terapewtiku: ektoparassitiċidi għal użu sistemiku, isoxazolines.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/206/001-015
Maltese: FIS-SUQ EU/2/17/206/001-015
English: Cellulose, powdered Lactose monohydrate Silicified microcrystalline cellulose Meat dry flavour
Maltese: Lactose monohydrate Silicified microcrystalline cellulose
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/206/016-21
Maltese: FIS-SUQ EU/2/17/206/016-21
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: 1 tablet 3 tablets 6 tablets
Maltese: DAQS TAL-PAKKETT pillola 1
English: Credelio 56 mg (1.3-2.5 kg) Credelio 112 mg (>2.5-5.5 kg) Credelio 225 mg (>5.5-11 kg) Credelio 450 mg (>11-22 kg) Credelio 900 mg (>22-45 kg)
Maltese: Credelio 56 mg (1.3-2.5 kg) Credelio 112 mg (>2.5-5.5 kg) Credelio 225 mg (>5.5-11 kg) Credelio 450 mg (>11-22 kg) Credelio 900 mg (>22-45 kg) lotilaner
English: Each tablet strength is available in pack sizes of 1, 3 or 6 tablets.
Maltese: Kull qawwa ta' pillola hi disponibbli f'daqsijiet tal-pakkett ta' 1, 3 jew 6 pilloli.
English: Credelio chewable tablets lotilaner (mg)
Maltese: Credelio pilloli li jintmagħdu għall-klieb lotilaner (mg)
English: Appropriate combination of tablets
Maltese: Kombinazzjoni adattata ta' pilloli
English: EU/2/17/206/014 (900 mg lotilaner; 3 chewable tablets) EU/2/17/206/015 (900 mg lotilaner; 6 chewable tablets)
Maltese: EU/2/17/206/014 (900 mg lotilaner; 3 pilloli li jintmagħdu)
English: Credelio 48 mg (>2.0 -8.0 kg)
Maltese: Credelio 12 mg (0.5-2.0 kg) Credelio 48 mg (>2.0 -8.0 kg)
English: Lotilaner, a pure enantiomer from the isoxazoline class, is active against fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Ixodes ricinus).
Maltese: Lotilaner, enantiomer pur mill-klassi ta' isoxazolines, hu attiv kontra l-briegħed (Ctenocephalides felis u Ctenocephalides canis) u qurdien (Ixodes ricinus).
English: The major route of elimination is biliary excretion, and renal excretion is the minor route of elimination (less than 10 % of the dose).
Maltese: Ir-rotta ewlenija tal-eliminazzjoni hi eskrezzjoni biljari, u t-tneħħija mill-kliewi hi r-rotta minuri tal eliminazzjoni (inqas minn 10% tad-doża).
English: Silicified microcrystalline cellulose Cellulose, powdered Lactose monohydrate Povidone K30
Maltese: Silicified microcrystalline cellulose Cellulose, trab
English: Blisters (dogs)
Maltese: Folja (qtates)
English: Lotilaner, a pure enantiomer from the isoxazoline class is active against fleas (Ctenocephalides felis and Ctenocephalides canis) as well as the tick species Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus.
Maltese: Lotilaner, enantiomer pur mill-klassi ta' isoxazolines, hu attiv kontra l-briegħed (Ctenocephalides felis u Ctenocephalides canis) kif ukoll l-ispeċi ta' qurdien Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus.
English: Lotilaner is a potent inhibitor of gamma-aminobutyric acid (GABA)-gated chloride channels, resulting in rapid death of ticks and fleas.
Maltese: Lotilaner hu inibitur qawwi tal-kanali kloruri ta' gamma-aminobutyric acid (GABA), u jirriżulta filmewt mgħaġġla tal-qurdien u l-briegħed.
English: EU/2/17/206/016 (12 mg lotilaner; 1 chewable tablet) EU/2/17/206/017 (12 mg lotilaner; 3 chewable tablet) EU/2/17/206/018 (12 mg lotilaner; 6 chewable tablet) EU/2/17/206/019 (48 mg lotilaner; 1 chewable tablet) EU/2/17/206/020 (48 mg lotilaner; 3 chewable tablet) EU/2/17/206/021 (48 mg lotilaner; 6 chewable tablet)
Maltese: EU/2/17/206/017 (12 mg lotilaner; 3 pilloli li jintmagħdu) EU/2/17/206/018 (12 mg lotilaner; 6 pilloli li jintmagħdu) EU/2/17/206/019 (48 mg lotilaner; pillola 1 li tintmagħad)
English: During clinical testing, no interactions between Credelio chewable tablets and routinely used veterinary medicinal products were observed.
Maltese: Matul l-ittestjar kliniku, ma ġew osservati l-ebda interazzjonijiet bejn il-pilloli li jintmagħdu Credelio u prodotti mediċinali veterinarji użati bħala rutina.
English: The terminal half-life is approximately 4 weeks (harmonic mean).
Maltese: Il-half-life terminali hi ta' madwar 4 sigħat (medja armonika).
English: This terminal half-life provides effective blood concentrations for the entire duration of the inter-dosing interval.
Maltese: Din il-half-life terminali tipprovdi konċentrazzjonijiet effettivi fid-demm għat-tul kollu tal-intervall bejn id-dożi.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Credelio 12 mg chewable tablets for cats (0.5-2.0 kg) Credelio 48 mg chewable tablets for cats (>2.0-8.0 kg)
Maltese: VETERINARJU Credelio 12 mg pilloli li jintmagħdu għall-qtates (0.5-2.0 kg) Credelio 48 mg pilloli li jintmagħdu għall-qtates (>2.0-8.0 kg)
English: This long terminal half-life provides effective blood concentrations for the entire duration of the interdosing interval.
Maltese: Din il-half life terminali twila tipprovdi konċentrazzjonijiet effettivi fid-demm għat-tul kollu tal-intervall bejn iddożi.
English: The activity of lotilaner was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin).
Maltese: L-attività ta' lotilaner ma ġietx affettwata minn reżistenza għal organochlorines (cyclodienes, eż. dieldrin), phenylpyrazoles (eż. fipronil), neonicotinoids (eż. imidacloprid), formamidines (eż. amitraz) u pyrethroids (eż. cypermethrin).
English: Overdose (symptoms, emergency procedures, antidotes): No adverse reactions were observed following oral administration to puppies aged 8-9 weeks and weighing 1.3-3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) jekk ikun hemm bżonn Ma ġew osservati l-ebda reazzjonijiet avversi wara l-għoti orali lil ġriewi li kellhom 8-9 ġimgħat u li jiżnu 1.3-3.6 kg ikkurati b'dożi eċċessivi ta' sa 5 darbiet tad-doża massima rakkomandata (43 mg, 129 mg u 215 mg ta' lotilaner/kg ta' piż tal-ġisem) fi tmien okkażjonijiet f'intervalli ta' kull xahar.