FrancophonIA/ELRC3.0 huggingface dataset:
English: The Prescriber Guide should contain the following key safety messages: - Details of populations potentially at higher risk of bleeding - Recommendation not to use Pradaxa in patients with prosthetic heart valves - Recommendation for kidney function measurement - Recommendations for dose reduction in at risk populations - Management of overdose situations - The use of coagulation tests and their interpretation - That all patients should be provided with a Patient alert card and be counselled about:
Maltese: - Dettalji ta' gruppi ta' nies li potenzjalment huma f'riskju ogħla ta' ħruġ ta' demm - Rakkomandazzjoni biex Pradaxa ma jintużax f'pazjenti b'valvoli prostetiċi tal-qalb - Rakkomandazzjoni dwar il-kejl tal-funzjoni tal-kliewi - Rakkomandazzjonijiet għal tnaqqis fid-doża fi gruppi ta' nies li qegħdin f'riskju - Immaniġġjar ta' sitwazzjonijiet ta' doża eċċessiva - L-użu ta' testijiet tal-koagulazzjoni u l-interpretazzjoni tagħhom - Li l-pazjenti kollha għandhom jiġu pprovduti b'Kard ta' allert tal-pazjent, u għandhom jingħataw parir dwar:
English: o An instruction how to take Pradaxa
Maltese: o Istruzzjoni dwar kif tieħu Pradaxa
English: - The content and format of the educational material, together with a communication plan, is agreed with the MAH prior to distribution of the educational pack.
Maltese: - Il-kontenut u l-format tal-materjal edukattiv, flimkien ma' pjan ta' komunikazzjoni, ikun hemm qbil dwarhom mad-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq qabel id-distribuzzjoni talpakkett edukattiv.
English: - An instruction how to take Pradaxa
Maltese: - Istruzzjoni dwar kif tieħu Pradaxa
English: The physician educational pack should contain: - The Summary of Product Characteristics - Prescriber Guide - Patient Alert Cards
Maltese: Il-pakkett edukattiv għat-tobba għandu jkun fih: - Is-Sommarju tal-Karatteristiċi tal-Prodott - Gwida Għal Min Jagħti Riċetta - Kards ta' Allert tal-Pazjent
English: o Importance of treatment compliance o The need to inform Health Care Professionals that they are taking Pradaxa if they need to have any surgery or invasive procedure.
Maltese: Pradaxa jekk ikollhom bżonn ta' kwalunkwe operazzjoni jew proċedura invażiva.
English: The Member States shall ensure that the following conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: - The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Maltese: - Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jipprovdi pakkett edukattiv għal kull indikazzjoni terapewtika, li jkun intenzjonat għat-tobba kollha li huma mistennija li jagħtu riċetta/jużaw Pradaxa.
English: Member State EU/EEA
Maltese: Stat Membru UE/ŻEE
English: Netherlands Bayer B.V., Animal Health Division Energieweg 1
Maltese: Bayer B.V., Animal Health Division Energieweg 1
English: Bayer Hungaria Kft., 1123 Budapest, Alkotás u.50,
Maltese: L-Ungerija Bayer Hungaria Kft., 1123 Budapest, Alkotás u.50,
English: Route of administration
Maltese: Metodu ta' amministrazzjoni
English: Animal species
Maltese: Tiergesundheit
English: Seresto contains the active substances imidacloprid 10% and flumethrin 4.5%.
Maltese: Seresto fih is-sustanzi attivi imidakloprid 10% u flumetrin 4.5%.
English: The dogs were each infested with 80 female sand flies on 13 occasions (D7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215, and 222).
Maltese: Kull wieħed mill-klieb ġew infestati bi 80 nemusa mill-ġenus mutu nisa fi 13-il okkażjoni (D7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215, u 222).
English: Bayer Austria Ges.m.b.H
Maltese: L-Awstrija Bayer Austria Ges.m.b.H
English: Bayer Healthcare, 220 Avenue de la Recherche 59120, Loos, France
Maltese: Avenue de la Recherche 59120, Loos, France
English: Bayer Hispania, S.L., Av. Baix Lobregat, 3-5 08970 Sant Joan Despí (Barcelona) Spain
Maltese: Baix Lobregat, 3-5 08970 Sant Joan Despí (Barcelona) Spain
English: 4 INDICATIONS
Maltese: INDIKAZZJONIJIET
English: A-1160 Wien, Austria
Maltese: A-1160
English: 400 South Oak Way Green Park Reading
Maltese: Ir-Renju Unit Bayer plc, 400 South Oak Way Green Park
English: However, the ratio of fed to unfed sand flies in the laboratory study described above is lower in treated dogs (mean 0.3, range 0.1 to 0.4) when compared to untreated animals (mean 9.0, range 3.3 to 15.6).
Maltese: Madankollu, il-proporzjon ta' nemus mill-ġenus mutu mgħallfin għal mhux mgħallfin fl-istudju tal-laboratorju deskritt hawn fuq huwa aktar baxx fil-klieb ikkurati (medja 0.3, medda 0.1 sa 0.4) meta mqabbel ma' klieb mhux ikkurati (medja 9.0, medda 3.3 sa 15.6).
English: The efficacy threshold of 80-100% (preferably 90%) as recommended in the guideline Demonstration of Efficacy of Ectoparasiticides (7AE17a)1 was not met at sufficient time points.
Maltese: Il-limitu tal-effikaċja ta' 80-100% (preferibbilment 90%) kif rakkomandat fil-linja gwida Demonstration of Efficacy of Ectoparasiticides (Dimostrazzzjoni tal-Effikaċja tal-Ektoparassitiċidi) (7AE17a)1 ma ġiex issodisfat f'punti taż-żmien suffiċjenti.
English: According to Guideline 7AE17a, the threshold of efficacy for Diptera should be 80-100% (preferably more than 90%).
Maltese: Skont il-Linja gwida 7AE17a, il-limitu tal-effikaċja għal Diptera għandu jkun 80-100% (preferibbilment aktar minn 90%).
English: Bayer d.o.o., Bravničarjeva 13 1000 Ljubljana Slovenia
Maltese: Is-Slovenja Bayer d.o.o., Bravničarjeva 13
English: Seresto and its associated name Foresto (thereinafter “Seresto”) is a medicated collar containing 10% imidacloprid and 4.5% flumethrin.
Maltese: Seresto u l-isem assoċjat tiegħu Foresto (minn hawn 'il quddiem jissejjaħ “Seresto”) huwa kullar medikat li fih 10% imidakloprid u 4.5% flumetrin.
English: Assessment of the data submitted
Maltese: Valutazzjoni tad-data ppreżentata
English: Strength
Maltese: IEĦOR
English: Data from efficacy studies against sand flies (Phlebotomus perniciosus) showed a variable sand fly repellent (anti-feeding) efficacy ranging from 65 to 89% for 7-8 months following initial application of the collar.
Maltese: Dejta, minn studji tal-effikaċja kontra s-sand fly (Phlebotomus perniciosus) turi ripellant ta' effikaċja varjabbli kontra s-sand fly (anti-feeding) li tvarja minn 65 għal 89% għal 7-8 xhur wara lapplikazzjoni inizjali tal-kullar.
English: Depending on the infection pressure by sand flies the efficacy in the reduction of the risk of infection with leishmaniosis ranged from 88.3 to 100%.
Maltese: Skont il-pressjoni tal-infezzjoni mis-sand fly l-effikaċja fit-tnaqqis tar-riskju ta' infezzjoni bil-leishmaniosis kienet tvarja minn 88.3 sa 100%.
English: 2 Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMA/CVMP/EWP/005/2000-Rev.2) - link skin tissue being collected on study days 0, 90, 180, 210, and 300 (i.e. in the post-treatment phase), and samples of bone marrow collected on study days 0 and D300.
Maltese: 2 Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMA/CVMP/EWP/005/2000-Rev.2) - link
English: Mommaertslaan 14 1831 Diegem (Machelen),
Maltese: Bayer SA-NV, J.E. Mommaertslaan 14 1831 Diegem (Machelen), Belgium
English: Animals were tested for leishmaniosis with samples of blood and skin tissue being collected on study day 0, in July 2011, September 2011, November 2011, April 2012, and October 2012.
Maltese: Lannimali ġew ittestjati għal-lexmanjożi b'kampjuni tad-demm u tat-tessut tal-ġilda li nġabru fil-jum tal-istudju 0, f'Lulju 2011, Settembru 2011, Novembru 2011, April 2012, u Ottubru 2012.
English: SERESTO, Περιλαίμιο (4,500 + 2,025)g/ περιλαίμιο 70 cm (45)g Για σκύλους (>8kg)
Maltese: SERESTO, Περιλαίμιο (4,500 + 2,025)g/ περιλαίμιο 70 cm (45)g
English: Benefit-risk assessment
Maltese: Valutazzjoni tar-riskji
English: The marketing authorisation holder (MAH) submitted a variation application to add a new therapeutic indication: “Indirect protection against the transmission of pathogen Leishmania infantum by sand flies (Phlebotomus perniciosus) thereby reducing the risk of canine leishmaniosis for 7 to 8 months”.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) ippreżenta applikazzjoni ta' varjazzjoni biex tiżdied indikazzjoni terapewtika ġdida: “Protezzjoni indiretta kontra t-trażmissjoni tal-patoġenu Leishmania infantum minn nemus mill-ġenus mutu (Phlebotomus perniciosus) li b'hekk inaqqas irriskju ta' lexmanjożi tal-klieb għal 7 sa 8 xhur”.
English: Reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months.
Maltese: It-tnaqqis tar-riskju ta' infezzjoni bil-Leishmania infantum permezz tas-sand fly għal perjodu sa 8 xhur.
English: Data from 3 clinical field studies performed in endemic areas indicate a significant reduction in the risk of Leishmania infantum transmission by sand flies in treated dogs compared to non-treated dogs.
Maltese: Dejta minn 3 oqsma kliniċi li twettqu f'żoni endemiċi juru tnaqqis sinifikanti fir-riskju tat-trażmissjoni tal-Leishmania infantum mis-sand fly fi klieb trattati meta mqabbla ma' klieb mhux trattati.
English: The anti-feeding results, when using the absolute numbers of sand flies to calculate efficacy using the Abbott's formula as per the recommendation of Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMA/CVMP/EWP/005/2000-Rev.2)2, averaged 75.1% over the study period (65%-89%).
Maltese: Ir-riżultati ta' kontra l-għalf, meta ntużaw in-numri assoluti ta' nemus mill-ġenus mutu biex tiġi kkalkulata l-effikaċja permezz tal-formula ta' Abbott skont irrakkomandazzjoni tal-Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (Linja gwida għall-ittestjar u l-valutazzjoni tal-effikaċja ta' sustanzi antiparassitiċi għall-kura u l-prevenzjoni ta' infestazzjoni bil-qurdien u l-briegħed fil-klieb u l-qtates) (EMA/CVMP/EWP/005/2000-Rev.
English: A total of 122 dogs, of several breeds aged between 1.5 and 6 months, were enrolled (mostly as litters) on individual start dates between March and May 2011.
Maltese: Total ta' 122 kelb, ta' diversi razez li kellhom bejn 1.5 u 6 xhur, ġew irreġistrati (l-aktar bħala gruppi) f'dati tal-bidu individwali bejn Marzu u Mejju 2011.
English: The MAH also provided an alternative analysis of the laboratory data from all 3 studies using ratios of fed to unfed sand flies for efficacy calculation.
Maltese: L-MAH ipprovda wkoll analiżi alternattiva tad-data tal-laboratorju mit-3 studji kollha permezz ta' proporzjonijiet ta' nemus mill-ġenus mutu mgħallfin għal mhux mgħallfin għall-kalkolu tal-effikaċja.
English: In the same studies, the incidence density rates in untreated dogs (60.7%, 46.2% and 67.0% respectively) demonstrated the high infection pressure present in the field situations used.
Maltese: Fl-istess studji, ir-rati ta' densità ta' inċidenza fil-klieb mhux ikkurati (60.7%, 46.2% u 67.0% rispettivament) urew il-pressjoni talinfezzjoni għolja preżenti fis-sitwazzjonijiet fuq il-post li ntużaw.
English: The second field study was a negatively-controlled, single centre, partially-blinded, clinical field study.
Maltese: It-tieni studju fuq il-post kien studju fuq il-post ikkontrollat b'mod negattiv, ta' ċentru uniku, parzjalment blinded u kliniku.
English: However, it was agreed by the CVMP that the field situations used in the studies submitted represent a ‘worst case scenario' in terms of exposure to infected sand flies: there was a high level of exposure to infected sand flies (incidence density rates in untreated dogs varied between 46.2 to 67.0%); dogs were housed outside throughout the day and night leading to unrestricted contact between the host and the vector; untreated dogs housed at the study area but not enrolled in the study constituted an additional reservoir for leishmaniosis.
Maltese: Madankollu, sar qbil mis-CVMP li s-stiwazzjonijiet fuq il-post li ntużaw fl-istudji ppreżentati jirrappreżentaw “xenarju tal-agħar każ possibbli” f'termini ta' esponiment għal nemus mill-ġenus mutu infettat: kien hemm livell għoli ta' esponiment għal nemus mill-ġenus mutu infettat (ir-rati ta' densità ta' inċidenza fil-klieb mhux ikkurati varjaw bejn 46.2 għal 67.0%); il-klieb tpoġġew barra matul il-jum u l-lejl li wassal għal kuntatt mhux ristrett bejn l-ospitant u l-vettur; il-klieb mhux ikkurati li tpoġġew fiż-żona tal-istudju iżda li ma ġewx irreġistrati fl-istudju kkostitwixxew popolazzjoni addizzjonali għal-lexmanjożi.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Maltese: Lista tal-isem, l-għamla farmaċewtika, il-qawwa tal-prodott mediċinali veterinarju, l-ispeċi tal-annimal, il-metodu ta' amministrazzjoni, id-detentur ta' awtorizzazzjoni għattqegħid fis-suq fl-Istati Membri
English: A total of 279 dogs, of several breeds and aged between 2 and 96 months, were enrolled on day 0, with 219 of these dogs included in the efficacy calculation.
Maltese: Total ta' 279 kelb, ta' diversi razez u li kellhom bejn 2 u 96 xahar, ġew irreġistrati f'jum 0, b'219 minn dawn il-klieb li jiġu inklużi fil-kalkolu tal-effikaċja.
English: Although a significant reduction in the incidence of Leishmania infantum in dogs has been demonstrated, the product has shown variable repellent (anti-feeding) and insecticidal efficacy against the sand fly Phlebotomus perniciosus.
Maltese: Għalkemm jidher li kien hemm tnaqqis sinifikanti fl-inċidenza tal-Leishmania infantum fil-klieb, ilprodott wera ripellant varjabbli (anti-feeding) u insettiċida effikaċja kontra s-sand fly Phlebotomus perniciosus.
English: Bayer Vital GmbH, Geschäftsbereich Tiergesundheit 51368 Leverkusen Germany
Maltese: 51368 Leverkusen
English: • the CVMP considered that the efficacy of Seresto, and its associated name Foresto, relating to repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus) has not been satisfactorily demonstrated in the laboratory studies provided;
Maltese: • is-CVMP ikkunsidra li l-effikaċja ta' Seresto, u l-isem assoċjat tiegħu Foresto, relatata ma' attività repellenti (kontra l-għalf) kontra n-nemus mill-ġenus mutu (Phlebotomus perniciosus) ma ntwerietx b'mod sodisfaċenti fl-istudji tal-laboratorju pprovduti;
English: The indication proposed by the RMS, and agreed by the majority of the concerned Member States (CMSs), at the referral stage was “To significantly reduce the occurrence of infection with Leishmania infantum for up to 8 months due to repellent (anti-feeding) action of the product on sand flies.”
Maltese: L-indikazjzoni proposta mill-RMS, u li sar qbil dwarha mill-maġġoranza tal-Istati Membri kkonċernati (CMSs), fl-istadju ta' referenza kienet “Sabiex inaqqas konsiderevolment l-okkorrenza ta' infezzjoni b'Leishmania infantum sa 8 xhur minħabba azzjoni repellenti (kontra l-għalf) tal-prodott fuq in-nemus mill-ġenus mutu.
English: It is indicated for the treatment and prevention of infestations with fleas, ticks, and lice in dogs and cats, and provides indirect protection against the transmission of the pathogens Babesia canis vogeli and Ehrlichia canis from the vector tick Rhipicephalus sanguineus, thereby reducing the risk of canine babesiosis and canine ehrlichiosis for 7 months.
Maltese: Dan huwa indikat għall-kura u l-prevenzjoni ta' infestazzjonijiet bi briegħed, qurdien u qamel fil-klieb u l-qtates, u jipprovdi protezzjoni indiretta kontra t-trażmissjoni tal-patoġeni Babesia canis vogeli u Ehrlichia canis mill-vettur tal-qurdiena Rhipicephalus sanguineus, b'hekk inaqqas ir-riskju tal-babeżjożi tal-klieb u l-erlikjożi tal-klieb għal 7 xhur.
English: Foresto 4.50 g + 2.03 g, g zgardă antiparazitară pentru câini >8 kg
Maltese: Foresto 4,50 g + 2,03 g, zgardă antiparazitară pentru câini >8 kg
English: The use of fed to unfed female sand flies ratios in Abbott's formula is not considered acceptable as a method for calculation of percentage efficacy as ratios have been used incorrectly to approximate risks (probabilities).
Maltese: L-użu tal-proporzjonijiet ta' nemus mill-ġenus mutu nisa mgħallfin għal mhux mgħallfin fil-formula ta' Abbott mhuwiex meqjus aċċettabbli bħala metodu għall-kalkolu ta' perċentwal ta' effikaċja peress li lproporzjonijiet intużaw b'mod mhux korrett għar-riskji approssimattivi (probabbiltajiet).
English: Animals were defined as noninfected by Leishmania when seronegative for circulating anti-L. infantum antibodies and negative to PCR of skin tissue and bone marrow aspirate samples.
Maltese: Lannimali ġew definiti bħala mhux infettati b'Leishmania meta kienu seronegattivi għall-antikorpi kontra L. infantum li jiċċirkolaw u negattivi għal PCR tat-tessut tal-ġilda u kampjuni ta' aspirat talmudullun.
English: Positive animals were defined as the animals that at study completion were positive to one or more of the following tests: serology for circulating anti-Leishmania-infantum-antibodies (IFAT), cytology/PCR on skin tissue sample, and cytology/PCR of bone marrow aspirate.
Maltese: L-annimali pożittivi ġew definiti bħala l-annimali li meta tlesta l-istudju kienu pożittivi għal wieħed jew aktar mit-testijiet li ġejjin: seroloġija għal antikorpi kontra Leishmania-infantum li jiċċirkolaw (IFAT), ċitoloġija/PCR fuq kampjun tat-tessut tal-ġilda, u ċitoloġija/PCR fuq aspirat talmudullun.
English: During the course of the procedure, the indication was amended by the reference Member State (RMS) who stated that ‘the demonstration of efficacy of the product against the sand flies over the whole season is a prerequisite for the claimed indirect prevention of transmission of L. infantum.
Maltese: Matul il-proċedura, l-indikazzjoni ġiet emendata mill-Istat Membru ta' referenza (RMS) li ddikjara li “d-dimostrazzjoni tal-effikaċja tal-prodott kontra n-nemus millġenus mutu matul l-istaġun kollu hija prerekwiżit għall-prevenzjoni indiretta ddikjarata tattrażmissjoni ta' L. infantum.
English: In this laboratory study, 14 dogs were randomised to either treatment with Seresto collar (n=7) or untreated control (n=7).
Maltese: F'dan l-istudju tal-laboratorju, 14-il kelb ġew randomizzati għal jew kura bil-kullar Seresto (n=7) jew kontroll mhux ikkurat (n=7).
English: Belgium Bayer SA-NV, J.E.
Maltese: Bayer Hispania, S.L., Av.
English: The first study was a negatively-controlled, randomised, multicentre field study, which was partially blinded.
Maltese: L-ewwel studju kien studju fuq il-post ikkontrollat b'mod negattiv, randomizzat, multiċentriku, li kien parzjalment blinded.
English: The consistently low fed to unfed ratios observed in treated dogs, compared to the high and variable fed to unfed ratios in untreated animals, demonstrate that the use of Seresto confers on treated dogs a sustained and consistent anti-feeding effect against sand flies (P. perniciosus).
Maltese: Il-proporzjonijiet konsistentement baxxi ta' mgħallfin għal mhux mgħallfin li ġew osservati fil-klieb ikkurati, meta mqabbel mal-proporzjonijiet għoljin u varjabbli ta' mgħallfin għal mhux mgħallfin fl-annimali mhux ikkurati, juru li l-użu ta' Seresto jikkonferixxi fuq il-klieb ikkurati effett kontra l-għalf sostnut u konsistenti kontra n-nemus mill-ġenus mutu (P. perniciosus).
English: In the case of the sand fly and L. infantum, the active substances in Seresto, imidacloprid and flumethrin, have no known efficacy against the Leishmania parasite and therefore any preventative efficacy against leishmaniosis would be purely as a result of efficacy against the sand fly.
Maltese: Fil-każ tannemusa mill-ġenus mutu u L. infantum, is-sustanzi attivi f'Seresto, imidakloprid u flumetrin, m'għandhom l-ebda effikaċja magħrufa kontra l-parassita Leishmania u għalhekk kwalunkwe effikaċja preventiva kontra l-lexmanjożi tkun biss bħala riżultat tal-effikaċja kontra n-nemusa millġenus mutu.
English: This is a variation application for an already-authorised product (Seresto); no further risks have been identified in the studies provided.
Maltese: Hemm applikazzjoni ta' varjazzjoni għal prodott li diġà huwa awtorizzat (Seresto); ma ġie identifikat l-ebda riskju ulterjuri fl-istudji pprovduti.
English: For the protective claim sought, demonstration of an anti-feeding activity for Seresto against sand flies was considered a prerequisite by the CVMP as the active substances in the Seresto collar, imidacloprid and flumethrin, have no known efficacy against Leishmania and therefore, any preventative efficacy against leishmaniosis is purely a result of efficacy against the sand fly.
Maltese: Għall-istqarrija protettiva mitluba, id-dimostrazzjoni ta' attività kontra l-għalf għal Seresto kontra nemus mill-ġenus mutu tqieset bħala prerekwiżit mis-CVMP peress li s-sustanzi attivi fil-kullar Seresto, l-imidakloprid u l-flumetrin, m'għandhom l-ebda effikaċja magħrufa kontra Leishmania u għalhekk, kwalunkwe effikaċja preventiva kontra l-lexmanjożi hija biss riżultat tal-effikaċja kontra nnemusa mill-ġenus mutu.
English: Therefore, whilst it was concluded that the claim ‘to significantly reduce the occurrence of infection with Leishmania infantum for up to 8 months due to repellent (anti-feeding) action of the product on sand flies' should not be included in the SPC, an amended indication, which accurately reflects the data provided, ‘reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months' was considered acceptable.
Maltese: Għalhekk, filwaqt li ġie konkluż li l-istqarrija ‘sabiex inaqqas konsiderevolment l-okkorrenza ta' infezzjoni b'Leishmania infantum sa 8 xhur minħabba azzjoni repellenti (kontra l-għalf) tal-prodott fuq in-nemus mill-ġenus mutu' m'għandhiex tiġi inkluża fl-SPC, indikazzjoni emendata, li b'mod eżatt tirrifletti d-data pprovduta, ‘tnaqqis tar-riskju ta' infezzjoni b'Leishmania infantum permezz tat-trażmissjoni minnemus mill-ġenus mutu sa 8 xhur' tqieset aċċettabbli.
English: • the CVMP considered that the efficacy of Seresto, and its associated name Foresto, relating to the transmission or occurrence of Leishmania infantum in dogs has been satisfactorily demonstrated in the field studies provided;
Maltese: • is-CMVP qies li l-effikaċja ta' Seresto, u l-isem assoċjat tiegħu Foresto, relatata mat-trażmissjoni jew mal-okkorrenza ta' Leishmania infantum fil-klieb intweriet b'mod sodisfaċenti fl-istudji fuq ilpost ipprovduti;
English: The application was submitted as a Type II variation for the addition of the new therapeutic indication ‘to significantly reduce the occurrence of infection with Leishmania infantum for up to 8 months due to repellent (anti-feeding) action of the product on sand flies'.
Maltese: L-applikazzjoni ġiet ippreżentata bħala varjazzjoni tat-Tip II għaż-żieda tal-indikazzjoni terapewtika ġdida ‘sabiex inaqqas konsiderevolment l-okkorrenza ta' infezzjoni b'Leishmania infantum sa 8 xhur minħabba azzjoni repellenti (kontra l-għalf) tal-prodott fuq in-nemus mill-ġenus mutu'.
English: Having considered all of the data and argumentation submitted, it was the opinion of the CVMP that, although the MAH has not demonstrated that Seresto has satisfactory anti-feeding efficacy against P. perniciosus that would support a direct repellent claim against this parasite, the studies provided demonstrate that dogs treated with Seresto have a significant reduction in the occurrence of infection with L. infantum as a result of reduced transmission by the sand fly vector.
Maltese: Twissijiet speċjali għal kull speċi li għaliha hu indikat il-prodott Għalkemm jidher li kien hemm tnaqqis sinifikanti fl-inċidenza tal-Leishmania infantum fil-klieb, ilprodott wera ripellant varjabbli (anti-feeding) u insettiċida effikaċja kontra s-sand fly Phlebotomus perniciosus.