FrancophonIA/ELRC3.0 huggingface dataset:
English: However, continuous vancomycin infusions have a few disadvantages such as that there may be compatibility issues with other IV medications or solutions that are given concurrently; practical problems associated with reduced line availability when infusions are given over a 24-h period; increased risk of infusing a bolus dose of vancomycin when the intravenous solution is changed or when another medication is infused into the same intravenous tubing which is filled with vancomycin 24 h/day etc.
Maltese: Madankollu, infużjonijiet ta' vankomiċina kontinwi għandhom ftit żvantaġġi bħal li jista' jkun hemm kwistjonijiet ta' kompatabbiltà ma' medikazzjonijiet IV oħrajn jew soluzzjonijiet li jingħataw fl-istess ħin; problemi prattiċi assoċjati ma' disponibbiltà tal-linja mnaqqsa meta l-infużjonijiet jingħataw fuq perjodu ta' 24-h; riskju miżjud ta' infużjoni ta' doża bolus ta' vankomiċina meta tinbidel is-soluzzjoni intravenuża jew meta tiġi infuża medikazzjoni oħra fl-istess tubu intravenuż li jimtela b'vankomiċina 24h/jum eċċ.
English: Vancomycin containing products are commercially available as:
Maltese: Prodotti li fihom vankomiċina huma disponibbli fis-suq bħala:
English: • the CHMP considered that the pharmacokinetic and pharmacodynamic data in the product information need to be updated,
Maltese: • is-CHMP ikkunsidra li d-data farmakokinetika u farmakodinamika fl-informazzjoni dwar ilprodott jeħtieġ li tiġi aġġornata,
English: The CHMP noted that the current guidelines for the treatment of acute bacterial meningitis from several learned societies (ESCMID4, IDSA5 guideline and UK joint specialist societies guidelines6, European Federation Neurological Societies (EFNS)) recommend vancomycin for both empirical treatment and etiological treatment of MRSA (alone) and penicillin-resistant Streptococcus pneumoniae (PRSP) in combination with other antibacterials in adults and children.
Maltese: Is-CHMP innota li l-linji gwida attwali għall-kura ta' meninġite batterika akuta minn diversi soċjetajiet edukati (linja gwida tal-ESCMID4, tal-IDSA5 u linji gwida ta' soċjetajiet speċjalisti konġunti tar-Renju Unit6, Federazzjoni Ewropea ta' Soċjetajiet Newroloġiċi (EFNS, European Federation Neurological Societies) jirrakkomandaw vankomiċina kemm għal kura empirika kif ukoll għal kura etjoloġika ta' MRSA (waħdu) u Streptococcus pneumoniae reżistenti għall-peniċillina (PRSP, penicillin-resistant Streptococcus pneumoniae) flimkien ma' antibatteriċi oħrajn fl-adulti u fit-tfal.
English: Overall summary of the scientific evaluation of vancomycin-containing products (see Annex I)
Maltese: Sommarju globali tal-valutazzjoni xjentifika ta' prodotti li fihom vankomiċina (ara l-Anness I)
English: The most commonly used dosage regimen (1 g every 12 hours) was considered adequate by the CHMP from a pharmacokinetic and pharmacodynamic perspective for the majority of patients with normal renal function and based on the usual susceptibility of staphylococci (minimum inhibitory concentration (MIC) ≤1 mg/L).
Maltese: L-iskeda tad-dożaġġ li tintuża l-aktar (1 g kull 12-il siegħa) ġiet ikkunsidrata adegwata mis-CHMP minn perspettiva farmakokinetika u farmakodinamika għallmaġġoranza tal-pazjenti b'funzjoni renali normali u abbażi tas-suxxettibbiltà tas-soltu ta' staphylococci (konċentrazzjoni minima inibitorja (MIC, minimum inhibitory concentration) ≤1 mg/L).
English: It is also noted that staphylococcal enterocolitis is a rare entity and that its diagnosis is controversial.
Maltese: Huwa wkoll innutat li staphylococcal enterocolitis huwa entità rari u li d-dijanjożi tiegħu hija kontroversjali.
English: Currently, there is no evidence that medical prophylaxis for CDI is efficacious and therefore there is not recommended prophylactic antibiotics.
Maltese: Bħalissa, m'hemm l-ebda evidenza li profilassi medika għal CDI hija effikaċi u għalhekk m'hemmx antibijotiċi profilattiċi rakkomandati.
English: • the CHMP carried out a benefit-risk evaluation of vancomycin containing products under Article 31 of Directive 2001/83/EC, reviewing all available data, including responses submitted by the marketing authorisation holders during the procedure and recommendations from the Paediatric Committee (PDCO), the CHMP relevant working parties/groups: Infectious Disease working party (IDWP), the Pharmacokinetics working party (PKWP), the Quality Working Party (QWP), the Modelling and Simulation Working Group (MSWG)) and external experts (the European Committee on Antimicrobial Susceptibility Testing (EUCAST),
Maltese: • is-CHMP wettaq valutazzjoni tal-benefiċċji u r-riskji ta' prodotti li fihom vankomiċina skont lArtikolu 31 tad-Direttiva 2001/83/KE, waqt li rreveda d-data disponibbli kollha, inkluż tweġibiet ippreżentati mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq waqt il-proċedura u rakkomandazzjonijiet mill-Kumitat Pedjatriku (PDCO), il-gruppi ta' ħidma relevanti tas-CHMP:
English: • Treatment of Clostridium difficile infection (CDI), for vancomycin given by oral route of administration.
Maltese: • Kura ta' infezzjoni bi Clostridium difficile (CDI), għal vankomiċina li jingħata permezz ta' rotta orali ta' għoti.
English: Having reviewed all available data, and taking into account the current clinical practice and current clinical guideline recommendations, the CHMP considered that vancomycin is an important therapeutic option in the following indications:
Maltese: Wara li rreveda d-data kollha disponibbli, u kkunsidra l-prattika klinika attwali u r-rakkomandazzjonijiet tal-linja gwida klinika attwali, is-CHMP ikkunsidra li vankomiċina huwa għażla terapewtika importanti flindikazzjonijiet li ġejjin:
English: • Vancomycin-containing medicinal products has an increasingly important role in the treatment of Gram-positive bacterial infections,
Maltese: • Prodotti mediċinali li fihom vankomiċina għandhom rwol importanti li dejjem qed jiżdied fil-kura ta' infezzjonijiet batteriċi Gram-pożittivi,
English: Vancomycin is a glycopeptide antibiotic authorised around six decades ago.
Maltese: Vankomiċina huwa antibijotiku glikopeptidu li ġie awtorizzat madwar sitt deċennji ilu.
English: However, the CHMP noted that the 2 g/day dose often results in Ctrough values below the target of 10 to 20 mg/l; therefore in order to achieve the optimal target concentration, the CHMP agreed that the vancomycin dose should be individually adapted according to weight, age and the underlying type and severity of infection and clinical response; the initial vancomycin doses should be calculated based on the body weight.
Maltese: Madankollu, isCHMP innota li d-doża ta' 2 g/jum spiss tirriżulta f'valuri Cl-iktar baxxi taħt il-mira ta' 10 sa 20 mg/l; għalhekk sabiex tinkiseb il-konċentrazzjoni fil-mira ottimali, is-CHMP qabel li d-doża ta' vankomiċina għandha tiġi adattata individwalment skont il-piż, l-età u t-tip u s-severità sottostanti tal-infezzjoni u rrispons kliniku; id-dożi ta' vankomiċina inizjali għandhom jiġu kkakulkalati abbażi tal-piż tal-ġisem.
English: The CHMP also reviewed the existing data on adverse reactions observed with the use of vancomycin and which confirm that the use of vancomycin for parenteral use is associated with nephrotoxicity and ototoxicity, infusion related adverse reactions like vein and tissue toxicity as well as hypersensitivity reactions.
Maltese: Is-CHMP irreveda wkoll id-data eżistenti dwar reazzjonijiet avversi osservati bl-użu ta' vankomiċina u li tikkonferma li l-użu ta' vankomiċina għal użu parenterali huwa assoċjat ma' nefrotossiċità u ototossiċità, reazzjonijiet avversi relatati mal-infużjoni bħal tossiċità tal-vini u tat-tessuti kif ukoll reazzjonijiet ta' sensittività eċċessiva.
English: However, increases in the rates of heteroresistance and tolerance to vancomycin, combined with its pharmacodynamic (i.e. slow bactericidal activity, variable tissue penetration) and clinical (clinical failures reported in patients with invasive infections produced by Staphylococcus aureus with a MIC above 1 mcg/mL) shortcomings have questioned the current role of vancomycin for the treatment of these infections.
Maltese: Madankollu, żidiet fir-rati ta' eteroreżistenza u tolleranza għal vankomiċina, flimkien man-nuqqasijiet farmakodinamiċi (jiġifieri attività batteriċidali bil-mod, penetrazzjoni ta' tessuti varjabbli) u kliniċi (nuqqasijiet kliniċi rrappurtati f'pazjenti b'infezzjonijiet invażivi prodotti minn Staphylococcus aureus b'MIC ta' aktar minn 1 mcg/mL) tiegħu qajmu dubji dwar ir-rwol attwali ta' vankomiċina għall-kura ta' dawn l-infezzjonijiet.
English: In its assessment, the CHMP reviewed all available data, including submissions by the marketing authorisation holders during the procedure and consulted the Paediatric Committee (PDCO), the CHMP relevant working parties/groups: Infectious Disease working party (IDWP), the Pharmacokinetics working party (PKWP), the Quality Working Party (QWP), the Modelling and Simulation Working Group (MSWG)) and external experts (the European Committee on Antimicrobial Susceptibility Testing (EUCAST)).
Maltese: Immudellar u s-Simulazzjoni (MSWG, Modelling and Simulation Working Group) u esperti esterni (ilKumitat Ewropew dwar it-Testijiet tas-Suxxettibbiltà Antimikrobika) (EUCAST)).
English: The CHMP also reviewed the limits for related substances and impurities in the active substance and in the finished products and it was concluded that the limits for related components and impurities in the drug substance and in the final drug products already authorised are qualified.
Maltese: CHMP irreveda wkoll il-limiti għal sustanzi u impuritajiet relatati fis-sustanza attiva u fil-prodotti lesti u ġie konkluż li l-limiti għal komponenti u impuritajiet relatati fis-sustanza tal-mediċina u fil-prodotti mediċinali finali li diġà huma awtorizzati huma kwalifikati.
English: The data submitted in support of the vancomycin use for decontamination were not deemed as sufficiently robust.
Maltese: Id-data ppreżentata li tappoġġja l-użu ta' vankomiċina għad-dekontaminazzjoni ma tqisitx robusta biżżejjed.
English: In addition, in line with the outcome of the MSWG consultation, the CHMP concluded that Bayesian methods could be clinically useful for more accurate dose predictions as a complementary part of routine therapeutic drug monitoring (TDM), especially for the patient groups with altered pharmacokinetic (PK) profile (i.e. children, haemodynamically unstable patients, intensive care), and acknowledged that this is already in clinical use.
Maltese: Barra minn hekk, f'konformità mal-eżitu tal-konsultazzjoni tal-MSWG, isCHMP ikkonkluda li l-metodi ta' Bayes jistgħu jkunu klinikament utli għal tbassir aktar eżatt tad-doża bħala parti kumplimentarja minn monitoraġġ ta' mediċini terapewtiċi (TDM, therapeutic drug monitoring) ta' rutina, speċjalment għall-gruppi ta' pazjenti bi profil farmakokinetiku (PK, pharmacokinetic) mibdul (jiġifieri, tfal, pazjenti emodinamikament mhux stabbli, kura intensiva), u rrikonoxxa li dan diġà jinstab f'użu kliniku.
English: Current guidelines from the European Society of Clinical Microbiology and Infectious Diseases (ESCMID1,2) and Infectious Diseases Society of America (IDSA3) also support its role in the treatment of MRSA infections.
Maltese: Il-linji gwida attwali mis-Soċjetà Ewropea talMikrobijoloġija Klinika u Mard Li Jittieħed (ESCMID, European Society of Clinical Microbiology and Infectious Diseases1,2) u mis-Soċjetà tal-Amerika għall-Mard Li Jittieħed (IDSA3) ukoll jappoġġjaw ir-rwol tiegħu fil-kura ta' infezzjonijiet tal-MRSA.
English: For both infants, children aged from one month to 18 years old, the CHMP agreed that, as for adults, the vancomycin dose should be individually adapted according to weight, age and the underlying type and severity of infection and clinical response; the initial vancomycin doses should be calculated based on the body weight.
Maltese: Kemm għat-trabi kif ukoll għal tfal ta' età ta' xahar sa 18-il sena, is-CHMP qabel li, l-istess bħall-adulti, id-doża ta' vankomiċina għandha tiġi adattata individwalment skont il-piż, l-età u t-tip u s-severità sottostanti talinfezzjoni u r-rispons kliniku; id-dożi inizjali ta' vankomiċina għandhom jiġu kkalkulati abbażi tal-piż tal-ġisem.
English: Moreover, existing data (including comparative) on the use of a continuous vs. an intermittent infusion are not conclusive.
Maltese: Barra minn hekk, data eżistenti (inkluż komparattiva) dwar l-użu ta' infużjoni kontinwa vs. intermittenti mhijiex konklużiva.
English: Overall, the CHMP considered that, out of the discussed methods, the Bayesian interpolation seemed to be an appropriate alternative; it allows predicting many individual pharmacokinetic parameters for extrapolation, minimizes the number of measurements on a single patient and seems to develop optimal strategies for therapeutic intervention.
Maltese: B'mod globali, is-CHMP ikkunsidra li, mill-metodi diskussi, l-interpolazzjoni ta' Bayes dehret li kienet alternattiva xierqa; din tippermetti t-tbassir ta' bosta parametri farmakokinetiċi individwali għallestrapolazzjoni, timminimizza n-numru ta' kejl fuq pazjent wieħed u tidher li tiżviluppa strateġiji ideali għal invervent terapewtiku.
English: • the CHMP considered that the risks of nephrotoxicity, ototoxicity, infusion related adverse reactions and hypersensitivity reactions observed with vancomycin for intravenous use can be minimised by appropriate warnings and recommendations in the product information,
Maltese: • is-CHMP ikkunsidra li r-riskji ta' nefrotossiċità, ototossiċità, reazzjonijiet avversi relatati malinfużjoni u reazzjonijiet ta' sensittività eċċessiva osservati b'vankomiċina għal użu ġol-vini jistgħu jiġu mminimizzati permezz ta' twissijiet u rakkomandazzjonijiet xierqa fl-informazzjoni dwar il-prodott;
English: The wording on therapeutic drug monitoring in section 4.2 of the SmPC has been amended accordingly by the CHMP.
Maltese: Iddaħħlet dikjarazzjoni fis-sezzjoni 4.2 kif xieraq mis-CHMP.
English: The Netherlands
Maltese: In-Nederland
English: Sodium lauryl sulfate Disodium embonate monohydrate Magnesium stearate Aspartame
Maltese: Lamtu tal-qamħirrun Sodium lauryl sulfate Disodium embonate monohydrate Magnesium stearate Aspartame
English: Diethyltoluamide (DEET) Acetone
Maltese: Diethyltoluamide (DEET)
English: ATCvet code: QP53B E02.
Maltese: QP53B E02
English: Fluralaner is an acaricide and insecticide.
Maltese: Fluralaner huwa akariċida u insettiċida.
English: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Maltese: Uża biss skont ilvalutazzjoni tal-benefiċċju/riskju mill-veterinarju responsabbli.
English: ATCvet code: QP53BE02.
Maltese: QP53BE02
English: No treatment-related clinical signs were observed.
Maltese: Ma ġewx osservati sinjali kliniċi relatati mat-trattament.
English: Soya-bean oil
Maltese: Żejt tas-soya-bean
English: Spot-on solution:
Maltese: Soluzzjoni spot-on:
English: Date of first authorisation: 11/02/2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 11/02/2014
English: Dimethylacetamide Glycofurol
Maltese: Glycofurol
English: In in vitro bio-assays, fluralaner is not affected by proven field resistances against amidines (tick), organophosphates (tick, mite), cyclodienes (tick, flea, fly), macrocyclic lactones (sea lice), phenylpyrazoles (tick, flea), benzophenyl ureas (tick), pyrethroids (tick, mite) and carbamates (mite).
Maltese: F'bio-assays in vitro, fluralaner mhuwiex affettwat minn reżistenza ppruvata kontra l-amidines (qurdien), l-organofosfati (qurdien, majt), is-cyclodienes (qurdien, briegħed, dubbien), il-macrocyclic lactones (qamel tal-baħar), il-phenylpyrazoles (qurdien, briegħed), il-benzophenyl ureas (qurdien), ilpyrethroids (qurdien, majt) u l-carbamates (majt).
English: Intervet GesmbH Siemensstrasse 107 1210 Vienna AUSTRIA
Maltese: Intervet GesmbH Siemensstrasse 107
English: Intervet Productions Rue de Lyons 27460 Igoville FRANCE
Maltese: Intervet Productions Rue de Lyons
English: Convulsions and lethargy has been reported very rarely in spontaneous (pharmacovigilance) reports.
Maltese: Konvulzjonijiet u telqa kienu rrappurtati rari ħafna f'rapporti spontanji (farmakoviġilanza).
English: Intervet UK Limited Walton Manor, Walton, Milton Keynes, Buckinghamshire, MK7 7AJ United Kingdom
Maltese: Milton Keynes, Buckinghamshire, MK7 7AJ
English: The following other signs shortly after administration were uncommonly observed: apathy/tremors/anorexia (0.9% of treated cats) or vomiting/hypersalivation (0.4% of treated cats).
Maltese: Is-sinjali li ġejjin kien osservati b'mod mhux komuni ftit wara l-amministrazzjoni: apatija/rogħda/anoressija (0.9% tal-qtates ittrattati) jew remettar/tbeżliq eċċessiv (0.4% tal-qtates ittrattati).
English: Pregnancy, lactation and fertility:
Maltese: Tqala, treddigħ u fertilità:
English: It is efficacious against ticks (Ixodes spp., Dermacentor spp.
Maltese: Huwa effikaċi kontra l-qurdien (Ixodes spp., Dermacentor spp.
English: and Rhipicephalus sanguineus) and fleas (Ctenocephalides spp.)
Maltese: u Rhipicephalus sanguineus) u l-briegħed (Ctenocephalides spp.) fuq il-kelb.
English: The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Maltese: Il-prodott jista' jintuża bħala parti minn strateġija ta' trattament għal kontroll ta' flea allergy dermatitis (FAD).
English: Convulsions and lethargy has been reported very rarely in spontaneous reports.
Maltese: Konvulzjonijiet u telqa kienu rrappurtati rari ħafna f'rapporti spontanji.
English: Manufacturer responsible for batch release: Intervet Productions
Maltese: Intervet Productions
English: 1 x 0.4 ml 1 x 0.89 ml 1 x 1.79 ml 2 x 0.4 ml 2 x 0.89 ml 2 x 1.79 ml
Maltese: 1 x 0.4 ml 1 x 0.89 ml 1 x 1.79 ml 2 x 0.4 ml 2 x 0.89 ml
English: QUANTITY OF THE ACTIVE SUBSTANCE
Maltese: Sustanza Attiva:
English: Each ml contains 280 mg fluralaner.
Maltese: Kull ml fiha 280 mg fluralaner.
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: Fluralaner huwa inibitur qawwi ta' partijiet mis-sistema nervuża tal-artropodi billi jantagonizza lligand-gated chloride channels (riċetturi tal-GABA u riċetturi tal-glutamate).
English: on the cat.
Maltese: U LUŻU
English: EU/2/13/158/014 EU/2/13/158/015
Maltese: EU/2/13/158/015
English: Method of administration
Maltese: Metodu tal-amministrazzjoni
English: Overdose:
Maltese: Inkompatibilitajiet:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Bravecto 112.5 mg (2-4.5 kg) Bravecto 250 mg (>4.5 -10 kg) Bravecto 500 mg (>10 -20 kg) Bravecto 1,000 mg (>20 -40 kg) Bravecto 1,400 mg (>40 -56 kg) fluralaner
Maltese: Bravecto 112.5 mg (2-4.5 kg) Bravecto 250 mg (4.5-10 kg) Bravecto 500 mg (10-20 kg) Bravecto 1,000 mg (20-40 kg) Bravecto 1,400 mg (40-56 kg)
English: For spot-on use.
Maltese: Użu bħala spot-on.
English: Lot:{number}
Maltese: Lott {numru}
English: 0.4 ml 0.89 ml 1.79 ml 3.57 ml 5.0 ml
Maltese: 1.79 ml 3.57 ml 5.0 ml
English: 1 chewable tablet 2 chewable tablets 4 chewable tablets
Maltese: 2 pilloli li jintmagħdu 4 pilloli li jintmagħdu
English: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer
English: The prolonged persistence and slow elimination from plasma (t1/2 = 21 days) and the lack of extensive metabolism provide effective concentrations of fluralaner for the duration of the inter-dosing interval.
Maltese: Il-persistenza mtawla u l-eliminazzjoni bil-mod mill-plażma (t1/2 = 21 ġurnata) u n-nuqqas ta' metaboliżmu estensiv jipprovdu koncentrazzjonijiet effettivi ta' fluralaner għat-tul tal-interval bejn doża u oħra.
English: Individual variation in Cmax and t1/2 was observed.
Maltese: Kienet osservata varjazzjoni minn individwu għal ieħor f'Cmax u t1/2.
English: The prolonged persistence and slow elimination from plasma (t1/2 = 12 days) and the lack of extensive metabolism provide effective concentrations of fluralaner for the duration of the inter-dosing interval.
Maltese: Il-persistenza mtawla u l-eliminazzjoni bil-mod mill-plażma (t1/2 = 12-il ġurnata) u n-nuqqas ta' metaboliżmu estensiv jipprovdu koncentrazzjonijiet effettivi ta' fluralaner għat-tul tal-interval bejn doża u oħra.
English: The onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for ticks (I. ricinus).
Maltese: L-effett jibda sa 8 sigħat minn meta jeħlu għal briegħed (C.felis) u sa 12-il siegħa għal qurdien (I. ricinus).
English: EXP: {month/year}
Maltese: DATA TA' SKADENZA EXP: {month/year}
English: for small cats 1.2 - 2.8 kg for medium-sized cats >2.8 - 6.25 kg for large cats >6.25 - 12.5 kg
Maltese: għal qtates żgħar 1.2 - 2.8 kg għal qtates ta'daqs medju >2.8 - 6.25 kg għal qtates kbar >6.25 - 12.5 kg
English: Manufacturer responsible for batch release: Intervet GesmbH
Maltese: Intervet GesmbH
English: 0.4 ml 0.89 ml 1.79 ml
Maltese: 2 x 1.79 ml
English: Bravecto should be administered in accordance with the following table (corresponding to a dose of 40 - 94 mg fluralaner/kg body weight):
Maltese: Bravecto għandu jiġi amministrat skont it-tabella li ġejja (li tikkorrispondi għal doża ta' 40 - 94 mg fluralaner/kg piż korporju):
English: The veterinary medicinal product was well tolerated in Collies with a deficient multidrug-resistanceprotein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose (168 mg/kg bodyweight).
Maltese: Il-prodott mediċinali veterinarju kien ittollerat sew f'Collies b'multidrug-resistance-protein 1 (MDR1/-) defiċjenti wara doża waħda amministrata b'mod topikali f'doża 3 darbiet aktar mid-doża rakkomandata (168 mg/kg piż).
English: Fluralaner is readily systemically absorbed from the topical administration site, reaching maximum concentrations in plasma between 3 and 21 days after administration.
Maltese: Fluralaner jiġi assorbit sew mis-sit tal-applikazzjoni topikali biex jilħaq livelli ta' konċentrazzjoni massima fil-plażma bejn 3 u 21 ġurnata wara l-amministrazzjoni .
English: Treatment schedule:
Maltese: Skeda tat-trattament:
English: The major route of elimination is the excretion of unchanged fluralaner in faeces (~90% of the dose).
Maltese: Ir-rotta prinċipali tal-eliminazzjoni hija dik tal-forma mhix mibdula ta' fluralaner fil-feċi (~90% tad-doża).
English: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer IN-NEDERLAND
English: Chewable tablets:
Maltese: Pilloli li jintmagħdu:
English: Chewable tablet.
Maltese: pilloli.
English: 1 x 0.4 ml 1 x 0.89 ml 1 x 1.79 ml 1 x 3.57 ml 1 x 5.0 ml 2 x 0.4 ml 2 x 0.89 ml 2 x 1.79 ml 2 x 3.57 ml 2 x 5.0 ml
Maltese: 1 x 0.4 ml 1 x 0.89 ml 1 x 1.79 ml 1 x 3.57 ml 1 x 5.0 ml
English: Bodyweight of cat (kg)
Maltese: Piż tal-kelb (kg)
English: Fluralaner has a high potency against ticks and fleas by exposure via feeding, i.e. it is systemically active on target parasites.
Maltese: Fluralaner għandu saħħa qawwija kontra l-qurdien u l-briegħed li jkunu esposti għalih waqt li jieklu, i.e. għandu attività sistemika fuq il-parassiti mmirati.
English: PACKAGE LEAFLET:
Maltese: Doża eċċessiva:
English: Mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling were commonly observed in clinical trials (1.6% of treated dogs).
Maltese: Effetti gastrointestinali ħfief u li jgħaddu bħal dijarea, remettar, nuqqas t'aptit u tlegħib ġew osservati b'mod komuni fi studji kliniċi (1.6% tal-klieb ittrattati).
English: and fleas (Ctenocephalides spp.)
Maltese: (Ctenocephalides spp.) fuq il-qtates.
English: Fluralaner is systemically distributed and reaches the highest concentrations in fat, followed by liver, kidney and muscle.
Maltese: Fluralaner jiġi mqassam sistemikament u jilħaq l-ogħla konċentrazzjonijiet fix-xaħam, segwit mill-fwied, il-kliewi u l-muskoli.