FrancophonIA/ELRC3.0 huggingface dataset:
English: • the CVMP considered that the recommended dose in feed is 12.5 mg/kg bw/day for 7 days for rabbits in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica.
Maltese: • is-CVMP qies li d-doża rakkomandata fl-għalf hija ta' 12.5 mg/kg bw/jum għal 7 ijiem għallfniek fil-prevenzjoni u t-trattament ta' marda respiratorja kkaġunata minn Pasteurella multocida u Bordetella bronchiseptica.
English: The marketing authorisation holders should conduct conditioning/pelleting stability studies with three batches of medicated rabbit feeds (manufactured using tilmicosin 200 g per kg pre-mix) in order to confirm that if meal rabbit feed was correctly formulated with a concentration of 200 ppm, tilmicosin content in the pelleted feed would still be within the specification range of ±15 % of nominal value over a period of 3 months.
Maltese: Id-detenturi tal-awtorizzazzjoni għall-kummerċ għandhom iwettqu studji tal-istabilità talkundizzjonament/tiswir f'gerbubiet bi tliet porzjonijiet ta' għalf medikat għall-fniek (manifatturat bl-użu ta' tilmicosin 200 g għal kull kg taħlita minn qabel) sabiex jiġi kkonfermat jekk il-kontenut ta' tilmicosin fl-għalf f'gerbubiet jibqax jaqa' taħt il-medda ta' speċifikazzjoni ta' ±15 % tal-valur nominali fuq perjodu ta' 3 xhur, wara li l-għalf magħġun għall-fniek jiġi fformulat kif suppost b'konċentrazzjoni ta' 200 ppm.
English: Lyngby
Maltese: IL-BELĠJU
English: Note: The text in grey shading below is not applicable for MICLOZAN 200 premix (see Annex I of the opinion)
Maltese: Nota: It-test ta' hawn taħt bl-isfond griż mhuwiex applikabbli għal MICLOZAN 200 taħlita minn qabel (ara l-Anness I tal-opinjoni)
English: Taking into account the information provided, the CVMP considered that the requirement for the dose being in at least half the daily ration was fulfilled, and that the target of 200 ppm of tilmicosin per ton of feed could be achieved with all the pack sizes of the different strengths (40 g, 100 g and 200 g).
Maltese: Filwaqt li ħa f'kunsiderazzjoni t-tagħrif ipprovdut, is-CVMP qies li r-rekwiżit għad-doża li, bħala minimu, tkun f'nofs il-porzjon ta' kuljum kien sodisfatt, u li l-mira ta' 200 ppm ta' tilmicosin għal kull tunnellata għalf tista' tinkiseb fid-daqsijiet kollha tal-pakketti b'saħħiet differenti (40 g, 100 g u 200 g).
English: 2 kg tilmicosin 100 g pre-mix/ton
Maltese: 2 kg tilmicosin 100 g taħlita minn qabel /tunnellata
English: 1 kg tilmicosin 200 g pre-mix /ton
Maltese: 1 kg tilmicosin 200 g taħlita minn qabel /tunnellata
English: When comparing tilmicosin content in the meal feeds during the mixing uniformity test (i.e. prior to pelleting) versus tilmicosin content of the pelleted feeds, a significant decrease in tilmicosin content was observed, although that decrease was within the ± 15% preset acceptance range.
Maltese: Meta tqabbel il-kontenut ta' tilmicosin fl-għalf magħġun matul it-test ta' uniformità tat-taħlita (jiġifieri qabel it-tiswir f'gerbubiet) mal-kontenut ta' tilmicosin tal-għalf f'gerbubiet, ġie osservat tnaqqis sinifikanti fil-kontenut ta' tilmicosin, għad li t-tnaqqis kien jaqa' fil-medda ta' aċċetazzjoni stabbilita minn qabel ta' ± 15%.
English: The pharmakokinetic/pharmacodynamic study and MIC data to support use in respiratory disease in rabbits at dose of 12.5 mg/kg bw/day for 7 days (submitted previously) were referenced in the answers to the CVMP list of questions and were found to be acceptable.
Maltese: L-istudju farmakokinetiku/farmakodinamiku u d-dejta tal-MIC bħala appoġġ għall-użu f'marda respiratorja fil-fniek b'doża ta' 12.5 mg/kg bw/jum għal 7 ijiem (sottomessi qabel) ġew referenzjati fittweġibiet għal-lista ta' mistoqsijiet tas-CVMP u tqiesu aċċettabbli.
English: The effective dosage in feed is 12.5 mg/kg bw/day for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in the minor species rabbits.
Maltese: Huwa maqbul li d-dożaġġ effettiv fl-għalf huwa ta' 12.5 mg/kg bw/jum għal 7 ijiem fil-prevenzjoni u ttrattament ta' marda respiratorja kkaġunata minn Pasteurella multocida u Bordetella bronchiseptica flispeċi minuri tal-fniek.
English: With regard to the recommended dose it is agreed that the effective dosage in feed is 12.5 mg per kg BW per day for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in the minor species rabbits.
Maltese: Fir-rigward tad-doża rakkomandata, huwa maqbul li d-dożaġġ effettiv huwa ta' 12.5 mg għal kull kg BW kuljum għal 7 ijiem fil-prevenzjoni u t-trattament ta' marda respiratorja kkaġunata minn Pasteurella multocida u Bordetella bronchiseptica fl-ispeċi minuri tal-fniek.
English: CVMP assessed the efficacy of tilmicosin in rabbits and considered that, notwithstanding the fact that the clinical field study using dosage of the product had some shortcomings, the pre-clinical studies and the minimal inhibitory concentration (MICs) data suggested the effective dosage in feed is 12.5 mg/kg bw/day for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in rabbits.
Maltese: 2, is-CVMP evalwa l-effikaċja ta' tilmicosin fil-fniek u qies li, minkejja l-fatt li l-istudju tad-dejta klinika li juża d-dożaġġ tal-prodott kellu xi nuqqasijiet, l-istudji prekliniċi u d-dejta talkonċentrazzjoni inibitorja minima (MICs) issuġġerew li d-dożaġġ effettiv fl-għalf huwa ta' 12.5 mg/kg bw/jum għal 7 ijiem fil-prevenzjoni u t-trattament ta' marda respiratorja kkaġunata minn Pasteurella multocida u Bordetella bronchiseptica fil-fniek.
English: Eli Lilly Regional Operations GmbH Elanco Animal HealthKolblgasse 8-10
Maltese: Il-Greċja Eli Lilly Regional Operations GmbH Elanco Animal
English: In a study provided on the homogeneity of a 200 g pre-mix two different batches of 200 g premix were used to prepare 4 pilot batches of medicated feedingstuff (2 batches of crumble feed and 2 batches of pelleted feed).
Maltese: Fi studju pprovdut dwar l-omoġenità ta' 200 g taħlita minn qabel, intużaw żewġ porzjonijiet ta' 200 g taħlita minn qabel sabiex jitħejjew 4 porzjonijiet pilota ta' għalf medikat (2 porzjonijiet ta' għalf imfarrak u 2 porzjonijiet ta' għalf f'gerbubiet).
English: Portugal
Maltese: IL-PORTUGALL
English: • the CVMP considered the data provided regarding the inclusion rates and agreed that the requirement for the dose being in at least half the daily ration was fulfilled, and that the target of 200 ppm of tilmicosin per ton of feed could be achieved with all the pack sizes of the different strengths (40 g, 100 g and 200 g).
Maltese: • is-CVMP qies id-dejta pprovduta rigward ir-rati ta' inklużjoni u qabel li ġie sodisfatt ir-rekwiżit li d-doża tkun f'tal-inqas nofs il-porzjon ta' kuljum, u li l-mira ta' 200 ppm ta' tilmicosin għal kull tunnellata għalf tista' tinkiseb fid-daqsijiet kollha tal-pakketti b'saħħiet differenti (40 g, 100 g u 200 g).
English: Regarding meal feeds, concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
Maltese: Rigward l-għalf magħġun, il-konċentrazzjonijiet huma 10 - 13% ogħla mill-konċentrazzjoni nominali mistennija ta' 200 mg/kg.
English: The incorporation rate of Tilmicosin 40 g pre-mix in the feed would be 5 kg per ton (the requirement of the European Pharmacopoeia monograph on pre-mixes for medicated feedingstuffs for veterinary use).
Maltese: Ir-rata ta' inkorporazzjoni ta' Tilmicosin 40 g taħlita minn qabel fl-għalf tkun ta' 5 kg għal kull tunnellata (ir-rekwiżit tal-monografu tal-Farmakopea Ewropea dwar it-taħlitiet minn qabel għall-għalf medikat għal użu veterinarju).
English: Regarding the target species feeding behaviour, it is known that rabbits feed frequently (up to 30 times per day of 2-8 g of feed over 4-6 minute periods
Maltese: Rigward l-imġiba ta' kif jieklu l-ispeċi fil-mira, huwa magħruf li l-fniek jieklu spiss (sa 30 darba kuljum bi 2-8 g għalf tul perjodi ta' 4-6 minuti
English: Amendments in the relevant sections of the Summary of Product Characteristics and labelling
Maltese: Emendi fis-sezzjonijiet relevanti tas-Sommarju talKaratteristiċi tal-Prodott
English: • the CVMP considered the recommended dose and inclusion rates in feed for pre-mixes for medicated feedingstuffs containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits.
Maltese: • is-CVMP qies id-doża u r-rati ta' inklużjoni rakkomandati fl-għalf għat-taħlitet minn qabel għallgħalf medikat li fih 40, 100 jew 200 g tilmicosin għal kull kg taħlita minn qabel u amministrat lill-fniek.
English: Date of last renewal: 01/10/2009.
Maltese: Data tal-aħħar tiġdid: 01/10/2009.
English: 3 pipettes 6 pipettes
Maltese: 3 pipetti 6 pipetti
English: Rose
Maltese: Roża
English: 3 pipettes 15 pipettes
Maltese: 3 pipetti 15-il pipetta.
English: Administered volume (nominal pipette size, ml)
Maltese: Volum amministrat (daqs nominali tal-pipetta, ml)
English: 2.6-7.5 Blue 7.6-10.0 Taupe
Maltese: Ikħal 7.6-10.0
English: selamectin 30 mg selamectin 60 mg selamectin 120 mg selamectin 240 mg selamectin 360 mg
Maltese: selamektin 30 mg selamektin 60 mg selamektin 120 mg selamektin 240 mg selamektin 360 mg
English: Remove the Stronghold pipette from its protective package.
Maltese: Neħħi l-pipetta ta' Stronghold mill-pakkett protettiv.
English: Date of first authorisation: 25/11/1999.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 25/11/1999.
English: Activity has also been demonstrated against heartworm larvae.
Maltese: Instab ukoll li jkun hemm effett kontra l-larvi tal-heartworm.
English: The frequency of adverse reactions is defined using the following convention: - 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: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimalittrattati li juru effetti mhux mixtieqa matul il perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat ) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: EU/2/99/014/001 (3 pipettes) EU/2/99/014/012 (15 pipettes)
Maltese: EU/2/99/014/013 (3 pipetti)
English: selamectin 45 mg selamectin 60 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA selamektin 45 mg selamektin 60 mg
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu topikali.
English: • Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
Maltese: • Prevenzjoni tal-marda tal-heartworm ikkawżata mid-Dirofilaria immitis b'amministrazzjoni kull xahar.
English: selamectin 15 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA 15 mg selamektin
English: Interactions with other medicinal products and other forms of interaction:
Maltese: Interazzjoni ma' prodotti mediċinali oħrajn u forom oħra ta' interazzjoni:
English: The veterinary medicinal product is in translucent polypropylene single-dose pipettes in an aluminium and aluminium/PVC blister overwrap.
Maltese: Il-prodott mediċinali veterinarju jkun f'pipetti trasparenti tal-polypropilin, ta' doża waħda, f'folja b'kisja ta' aluminju u aluminju/PVC.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL LABEL, 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg
Maltese: TIKKETTA FUQ IL-FOLJA, 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg
English: Treatment of hookworm infections (cats)
Maltese: Kura għal infezzjonijiet tal-hookworm (qtates)
English: The prolonged persistence and slow elimination of selamectin from plasma is reflected in the terminal elimination half-life values of 8 and 11 days in cats and dogs respectively.
Maltese: Il-persistenza fit-tul tas-selamektin u leliminazzjoni mid-demm bil-mod huma riflessi f'valuri tat-terminal elimination half-life ta' 8 ijiem filqtates u 11-il jum fil-klieb.
English: Stronghold is available in packs of three pipettes (for all pipette sizes), six pipettes (for all pipette sizes except 15 mg selamectin), or fifteen pipettes (for 15 mg selamectin pipette size only).
Maltese: Stronghold jiġi f'pakketti ta' tliet pipetti (pipetti tad-daqsijiet kollha), ta' sitt pipetti (pipetti taddaqsijiet kollha ħlief 15 mg selamektin), jew ta' ħmistax-il pipetta (pipetti ta' 15 mg selamektin biss).
English: Stronghold 45 mg spot-on solution for cats 2.6-7.5 kg Stronghold 60 mg spot-on solution for cats 7.6-10.0 kg selamectin
Maltese: VETERINARJU Stronghold 45 mg soluzzjoni għal użu topikali għall-qtates 2.6-7.5 kg Stronghhold 60 mg soluzzjoni għal użu topikali għall-qtates 7.6-10.0 kg selamektin
English: Pipettes with rose caps contain 0.25 ml of 6% w/v solution and deliver 15 mg of selamectin Pipettes with blue caps contain 0.75 ml of 6% w/v solution and deliver 45 mg of selamectin Pipettes with taupe caps contain 1.0 ml of 6% w/v solution and deliver 60 mg of selamectin Pipettes with violet caps contain 0.25 ml of 12% w/v solution and deliver 30 mg of selamectin Pipettes with brown caps contain 0.5 ml of 12% w/v solution and deliver 60 mg of selamectin Pipettes with red caps contain 1.0 ml of 12% w/v solution and deliver 120 mg of selamectin Pipettes with green caps contain 2.0 ml of 12% w/v solution and deliver 240 mg of selamectin Pipettes with plum caps contain 3.0 ml of 12% w/v solution and deliver 360 mg of selamectin.
Maltese: Pipetti b'tappijiet roża fihom 0.25 ml ta' soluzzjoni 6% w/v u jagħtu 15 mg selamektin Pipetti b'tappijiet koħol fihom 0.75 ml ta' soluzzjoni 6% w/v u jagħtu 45 mg selamektin Pipetti b'tappijiet taupe fihom 1.0 ml ta' soluzzjoni 6% w/v u jagħtu 60 mg selamektin Pipetti b'tappijiet vjola fihom 0.25 ml ta' soluzzjoni 12% w/v u jagħtu 30 mg selamektin Pipetti b'tappijiet kannella fihom 0.5 ml ta' soluzzjoni 12% w/v u jagħtu 60 mg selamektin Pipetti b'tappijiet ħomor fihom 1.0 ml ta' soluzzjoni 12% w/v u jagħtu 120 mg selamektin Pipetti b'tappijiet ħodor fihom 2.0 ml ta' soluzzjoni 12% w/v u jagħtu 240 mg selamektin Pipetti b'tappijiet plum fihom 3.0 ml ta' soluzzjoni 12% w/v u jagħtu 360 mg selamektin
English: Cats (kg) Pipette cap colour mg of selamectin dispensed
Maltese: Klieb (kg) Kulur tattapp tal pipetta mg ta' selamektin mogħtija
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://ema.europa.eu/.
English: Stronghold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg selamectin
Maltese: VETERINARJU Stronghold 15 mg soluzzjoni għal użu topikali għall-qtates u l-klieb ≤ 2.5 kg. selamektin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL, 15 mg (3 and 15 pipettes)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TAL-KAXXA, 15 mg (3 u 15-il pipetta)
English: 12% w/v solution selamectin 240 mg
Maltese: Stronghold 240 mg għall-klieb soluzzjoni 12% w/v selamektin 240 mg
English: 12% w/v solution selamectin 120 mg
Maltese: Stronghold 120 mg għall-klieb soluzzjoni 12% w/v selamektin 120 mg
English: The pipettes are colour coded as follows:
Maltese: Qtates u klieb:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg (3 and 6 pipettes)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TAL-KAXXA, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg (3 u 6 pipetti)
English: 12% w/v solution selamectin 360 mg
Maltese: Stronghold 360 mg għall-klieb soluzzjoni 12% w/v selamektin 360 mg
English: EU/2/99/014/002 (3 pipettes) EU/2/99/014/008 (6 pipettes) EU/2/99/014/013 (3 pipettes) EU/2/99/014/014 (6 pipettes)
Maltese: EU/2/99/014/002 (3 pipetti)
English: 6% w/v solution selamectin 45 mg
Maltese: Stronghold 45 mg għall-qtates soluzzjoni 6% w/v selamektin 45 mg
English: Spot-on use
Maltese: L-ISEM
English: In extensive field testing no interactions between the veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures were observed.
Maltese: Fi studji estensivi waqt l-użu ma kinux osservati effetti bejn il-prodott mediċinali veterinarju u prodotti mediċinali veterinarji komuni jew proċeduri mediċi u kirurġiċi.
English: Cats weighing 2.6-7.5 kg. Cats weighing 7.6-10.0 kg.
Maltese: SPEĊI GĦAL XIEX HUWA INDIKAT IL-PRODOTT Qtates li jiżnu bejn 2.6 kg u 7.5 kg.
English: BELGIUM
Maltese: Kannella
English: Treatment of biting lice infestations (Felicola subrostratus) Treatment of adult roundworms (Toxocara cati) Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
Maltese: Persuni b'ġilda sensittiva jew b'allerġija magħrufa għal prodotti mediċinali veterinarji ta' dan it-tip għandhom joqogħdu attenti meta jmissu l-prodott mediċinali veterinarju.
English: 6% w/v solution selamectin 15 mg
Maltese: Stronghold 15 mg għall-klieb u l-qtates soluzzjoni 6% w/v selamektin 15 mg
English: 12% w/v solution selamectin 30 mg
Maltese: Stronghold 30 mg għall-klieb soluzzjoni 12% w/v selamektin 30 mg
English: 6% w/v solution selamectin 60 mg
Maltese: Stronghold 60 mg għall-qtates soluzzjoni 6% w/v selamektin 60 mg
English: PACKAGE LEAFLET: Stronghold spot-on solution
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: Stronghold should be administered topically as a single application of a single-dose delivering a minimum of 6 mg/kg selamectin.
Maltese: Stronghold għandu jingħata f'applikazzjoni ta' doża waħda li tagħti mill-anqas 6 mg/kg selamektin.
English: 12% w/v solution selamectin 60 mg
Maltese: Stronghold 60 mg għall-klieb soluzzjoni 12% w/v selamektin 60 mg
English: Treatment of biting lice infestations (Trichodectes canis) Treatment of sarcoptic mange (caused by Sarcoptes scabiei) Treatment of adult intestinal roundworms (Toxocara canis).
Maltese: Kwalunkwe prodott mediċinali veterinarju li ma ġiex użat jew materjal għar-rimi li huwa derivat minn dan il-prodott mediċinali veterinarju għandhom jintremew skont kif jitolbu r-regolamenti tal-pajjiż.
English: The veterinary medicinal product was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed.
Maltese: Il-prodott mediċinali veterinarju ingħata f'doża 3 darbiet aktar minn dik rakkomandata fi qtates u klieb li kellhom heartworms adulti u ma dehrux effetti mhux mixtieqa.
English: Stronghold 15 mg spot-on for cats and dogs ≤ 2.5 kg Stronghold 30 mg spot-on for dogs 2.6-5.0 kg Stronghold 45 mg spot-on for cats 2.6-7.5 kg Stronghold 60 mg spot-on for cats 7.6-10.0 kg Stronghold 60 mg spot-on for dogs 5.1-10.0 kg Stronghold 120 mg spot-on for dogs 10.1-20.0 kg Stronghold 240 mg spot-on for dogs 20.1-40.0 kg Stronghold 360 mg spot-on for dogs 40.1-60.0 kg selamectin
Maltese: Stronghold 15 mg soluzzjoni għal użu topikali għall-qtates u għall-klieb ≤2.5 kg Stronghold 30 mg soluzzjoni għal użu topikali għall-klieb 2.6-5.0 kg Stronghold 45 mg soluzzjoni għal użu topikali għall-qtates 2.6-7.5 kg Stronghold 60 mg soluzzjoni għal użu topikali għall-qtates 7.6-10.0 kg Stronghold 60 mg soluzzjoni għal użu topikali għall-klieb 5.1-10.0 kg Stronghold 120 mg soluzzjoni għal użu topikali għall-klieb 10.
English: 4.9 Amounts to be administered and administration route
Maltese: Metodu u mod ta' amministrazzjoni
English: Selamectin paralyses and/or kills a wide range of invertebrate parasites through interference with their chloride channel conductance causing disruption of normal neurotransmission.
Maltese: Selamektin tipparaliżża u/jew toqtol firxa wiesgħa ta' parassiti invertebrati billi tfixkel il-konduttività tal-kanali tal-kloru u b'hekk tikkawża tħarbit fin-newrotrasmissjoni normali.
English: Dogs (kg) Pipette cap colour mg of selamectin dispensed
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mall-prodott
English: Stronghold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg Stronghold 45 mg spot-on solution for cats 2.6-7.5 kg Stronghold 60 mg spot-on solution for cats 7.6-10.0 kg Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Maltese: Stronghold 15 mg soluzzjoni għal użu topikali għall-qtates u l-klieb ≤ 2.5 kg Stronghold 30 mg soluzzjoni għal użu topikali għall-klieb 2.6-5.0 kg Stronghold 45 mg soluzzjoni għal użu topikali għall-qtates 2.6-7.5 kg Stronghold 60 mg soluzzjoni għal użu topikali għall-qtates 7.6-10.0 kg Stronghold 60 mg soluzzjoni għal użu topikali għall-klieb 5.1-10.0 kg Stronghold 120 mg soluzzjoni għal użu topikali għall-klieb 10.
English: Special precautions for use in animals:
Maltese: Kodiċi ATC veterinarja:
English: Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Maltese: 1-20.0 kg Stronghold 240 mg soluzzjoni għal użu topikali għall-klieb 20.1-40.0 kg Stronghold 360 mg soluzzjoni għal użu topikali għall-klieb 40.
English: Dogs weighing 5.1-10.0 kg.
Maltese: Klieb li jiżnu bejn 5.1 kg u 10.
English: EMA/741298/2015 EMEA/H/C/000674
Maltese: EMA/H/C/000674
English: The full EPAR for Zostavax is available on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Zostavax jinsab fis-sit web tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Zostavax.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Zostavax.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zostavax on 19 May 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zostavax fid-19 ta' Mejju 2006.
English: Why has Zostavax been approved?
Maltese: Għaliex ġie approvat Zostavax?
English: Fewer people developed shingles after vaccination with Zostavax than placebo: 315 of the 19,254 patients who received Zostavax had shingles during the study, compared with 642 of the 19,247 who received placebo.
Maltese: 315 mid-19,254 pazjent li ngħataw Zostavax matul l-istudju ħarġilhom il-ħruq ta' Sant'Antnin, mentri mid-19,247 pazjent li ngħataw plaċebo kien hemm 642.
English: Zostavax was also more effective than placebo in preventing post-herpetic neuralgia: 27 of the Zostavax patients had post-herpetic neuralgia, compared with 80 in the placebo group.
Maltese: Zostavax kien ukoll iżjed effikaċi mill-plaċebo filprevenzjoni tal-nevralġija post-ħerpetika: fost dawk li ngħataw Zostavax 27 pazjent kellhom innevralġija post-ħerpetika, filwaqt li fil-grupp tal-plaċebo kien hemm 80.
English: A risk management plan has been developed to ensure that Zostavax is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Zostavax jintuża bl-aktar mod sigur possibbli.
English: Zostavax shingles (herpes zoster) vaccine (live)
Maltese: Vaċċin (ħaj) kontra l-ħruq ta' Sant'Antnin (herpes zoster)