FrancophonIA/ELRC3.0 huggingface dataset:
English: This was accepted but may need to be revised in the future as a consequence of an ongoing procedure under Art. 45 of Regulation 1901/2006 as amended specifically to assess this data.
Maltese: Dan kien aċċettat iżda fil-futur jista' jkollu bżonn jiġi rivedut bħala konsegwenza ta' proċedura li għaddejja skont Art. 45 tar-Regolament 1901/2006 kif emendat b'mod speċifiku biex jivvaluta din id-dejta.
English: There is limited clinical experience of accidental overdose.
Maltese: L-esperjenza klinika ta' doża eċċessiva aċċidentali hija limitata.
English: The Committee considered that available study results and current scientific knowledge allow for more detailed and informative wording on the potential for cytochrome P450 interactions.
Maltese: Il-Kumitat ikkunsidra li r-riżultati disponibbli mill-istudji u l-għarfien xjentifiku attwali jippermettu formolazzjoni ta' kliem aktar dettaljata u informattiva dwar il-potenzjal għal interazzjonijiet b'cytochrome P450.
English: Information on severe renal impairment and moderate or severe hepatic impairment was also moved to section 4.4, as based on the latest studies a significant increase in exposure is not expected with renal impairment, and only a modest increase in exposure was observed in patients with hepatic impairment.
Maltese: ‘Nisa qabel il-menopawża' u ‘pazjenti b'terapija konkomittanti b'tamoxifen' tneħħew minn din is-sezzjoni u l-informazzjoni tressqet għal sezzjoni 4.4. Linformazzjoni dwar l-indeboliment renali sever u l-indeboliment epatiku moderat jew sever tressqet ukoll għal sezzjoni 4.4, għaliex skont l-istudji riċenti ma hijiex mistennija żieda sinifikanti flespożizzjoni b'indeboliment renali, u żieda moderata biss kienet osservata fl-espożizzjoni f'pazjenti b'indeboliment epatiku.
English: The CHMP noted that the MAH did not suggest its inclusion as part of the harmonised indication, and agreed to this.
Maltese: Is-CHMP innota li l-MAH ma ssuġġeriex din l-inklużjoni bħala parti mill-indikazzjoni armonizzata, u qabel ma' dan.
English: Arimidex has not been investigated in breast cancer patients with moderate or severe hepatic impairment.
Maltese: Arimidex ma ġiex investigat f'pazjenti bil-kanċer tas-sider b'indeboliment epatiku minn moderat sa sever.
English: The list of manufacturers in the harmonised version of the dossier has been updated and the sites no longer in use have not been included.
Maltese: Il-lista ta' manifatturi fil-verżjoni armonizzata tad-dossier ġiet aġġornata u s-siti li ma għadhomx jintużaw ma ġewx inklużi.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Maltese: • l-iskop tar-referenza kien l-armonizzazzjoni tas-sommarju tal-karatteristiċi tal-prodott, it-tikketti u l-fuljett ta' tagħrif
English: • Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
Maltese: • Kura aġġuvanti tal-kanċer tas-sider invażif fi stadju bikri pożittiv għar-riċettur tal-ormoni f'nisa wara l-menopawża li rċevew 2 sa 3 snin ta' tamoxifen bħala sustanza miżjuda.
English: However, CHMP considered that this could be misinterpreted as implying an effect in hormone receptor negative patients, when in fact it merely reflects the inclusion criteria of clinical studies.
Maltese: Madanakollu, is-CHMP ikkunsidra li dan seta' jiġi interpretat ħażin li jimplika effett f'pazjenti negattivi għar-riċettur tal-ormoni, meta fil-fatt dan sempliċiment jirrifletti l-kriterji ta' inklużjoni talistudji kliniċi.
English: Revised warnings were suggested regarding renal and hepatic impairment.
Maltese: Ġew issuġġeriti twissijiet riveduti dwar l-indebolimenti renali u epatiku.
English: Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed at the commencement of treatment and at regular intervals thereafter.
Maltese: Nisa bl-osteoporożi jew f'riskju ta' osteoporożi, għandu jkollhom id-densità minerali tal-għadam tagħhom eżaminata b'mod formali bil-bidu tal-kura u f'intervalli regolari wara dan.
English: The remaining 10 countries do not currently have wording to this effect.
Maltese: L-effett tal-inibituri qawwijin ta' CYP ma huwiex magħruf.
English: • Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1.
Maltese: • Pazjenti b'ipersensittività magħrufa għal anastrozole jew għal xi waħda mis-sustanzi mhux attivi skont ir-referenza f'sezzjoni 6.1.
English: In one country the SPC contained the warning ‘slight increases in total cholesterol have been observed in patients treated with Arimidex.
Maltese: F'pajjiż wieħed l-SPC kien fih it-twissija ‘żidiet żgħar fil-kolesterol totali ġew osservati f'pazjenti li rċevew kura b'Arimidex.
English: A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with Arimidex who also received other commonly prescribed medicinal products.
Maltese: Reviżjoni tad-database dwar is-sigurtà tal-prova klinika ma wrietx evidenza ta' interazzjoni klinikament sinifikanti f'pazjenti li rċevew kura b'Arimidex li wkoll irċevew prodotti mediċinali oħra mogħtija b'mod komuni minn tobba.
English: The CHMP agreed with the following wording proposed by the MAH:
Maltese: Is-CHMP qabel mal-formolazzjoni tal-kliem li ġejja proposta mill-MAH:
English: There are no data to support the use of Arimidex with LHRH analogues.
Maltese: Arimidex ma għandux jintuża f'nisa qabel il-menopawża.
English: The CHMP noted and agreed with the MAH proposal for this section:
Maltese: IsCHMP innota u qabel mal-proposta tal-MAH għal din is-sezzjoni:
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product,the European Commission notified the CHMP/European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC as amended, in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti li ttieħdu mill-Istati Membri dwar l-awtorizzazzjoni tal-prodott hawn fuq imsemmi, il-Kummissjoni Ewropea nnotifikat lis-CHMP/l-Aġenzija Ewropea talMediċini b'referenza uffiċjali skont l-Artikolu 30 tad-Direttiva 2001/83/KE kif emendata, biex issolvi d-diverġenzi fost l-SPCs awtorizzati fuq livell nazzjonali u b'hekk tarmonizza l-SPCs diverġenti tagħha madwar l-UE.
English: The effects of Arimidex on fertility in humans have not been studied.
Maltese: L-effetti ta' Arimidex fuq il-fertilità fil-bnedmin ma ġewx studjati.
English: Nematodes:
Maltese: Nematodi:
English: Store below 30 °C.
Maltese: Aħżen f'temperaturi taħt it-30 °C.
English: ATC vet code: QP54AA55.
Maltese: QP54AA55
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/04/2019
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 26/04/2019
English: BATCH NUMBER Lot {number}
Maltese: NUMRU TAL-LOTT Lot {numru}
English: Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, macrocyclic lactones, combinations.
Maltese: Grupp farmako-terapewtiku: prodotti kontra l-parassiti, insettiċidi u repellenti, kombinazzjonijiet ta' macrocyclic lactones.
English: selamectin (mg)
Maltese: selamektin (mg)
English: Pipette content
Maltese: Kontenut tal-pipetta
English: Ectoparasites:
Maltese: Ektoparassiti:
English: Dipropyleneglycol monomethyl ether
Maltese: Dipropylene glycol methyl ether
English: - Treatment of ear mites (Otodectes cynotis).
Maltese: Trattament għal-mites tal-widnejn (Otodectes cynotis).
English: Felisecto Plus 60 mg/10 mg (green cap)
Maltese: Felisecto Plus 60 mg/10 mg (tap aħdar)
English: Pipette content (ml)
Maltese: Kontenut talpipetta (ml)
English: The primary route of elimination for sarolaner is biliary elimination of parent sarolaner, with contributions by metabolic clearance.
Maltese: Ir-rotta prinċipali ta' eliminazzjoni ta' sarolaner hija eliminazzjoni biljari ta' sarolaner primarju b'kontribuzzjoni ta' clearance metaboliku.
English: This veterinary medicinal product is not effective against adult D. immitis.
Maltese: Dan il-prodott mediċinali veterinarju mhuwiex effettiv kontra D. immitis adulti.
English: Method and route of administration
Maltese: Metodu u rotta ta' amministrazzjoni
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/238/001-003
Maltese: EU/2/19/238/001-003
English: Selamectin is a semi-synthetic compound of the avermectin class.
Maltese: Selamektin hija sustanza semi-sintetika tal-klassi ta' l-avermektin.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Spot-on use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu spot-on.
English: Sarolaner does not interact with known insecticidal binding sites of nicotinic or other GABAergic insecticides such as neonicotinoids, fiproles, milbemycins, avermectins, and cyclodienes.
Maltese: Sarolaner ma jirrejaġixxix ma' reċetturi insettiċidi nikotiniċi jew insettiċidi GABAerġiċi oħra bħal neonicotinoids, fiproles, milbemycins, avermectins, u cyclodienes.
English: Sarolaner is an acaricide and insecticide belonging to the isoxazoline family.
Maltese: Sarolaner huwa akaraċida u insettiċida tal-familja tal-isoxazoline.
English: - Treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme).
Maltese: Trattament għal-roundworms adulti (Toxocara cati) u hookworms intestinali adulti (Ancylostoma tubaeforme).
English: >2.5-5 kg >5-10 kg selamectin/sarolaner
Maltese: ≤2.5 kg >2.5-5 kg >5-10 kg selamektin/sarolaner
English: Cats ≤2.5 kg Cats >2.5-5 kg Cats >5-10 kg
Maltese: Qtates ≤2.5 kg Qtates >2.5-5 kg Qtates >5-10 kg
English: EXPIRY DATE EXP {month/year}
Maltese: DATA TA' SKADENZA EXP {xahar/sena}
English: Spot-on solution.
Maltese: Soluzzjoni spot-on
English: 0.2 mg/ml butylated hydroxytoluene.
Maltese: 0.2mg/ml butylated hydroxytoluene Soluzzjoni spot-on.
English: Activity has also been demonstrated against heartworm (D. immitis) larvae.
Maltese: Instab ukoll li hemm effett kontra l-larve tal-heartworm (D. immitis).
English: Following topical administration of the Felisecto Plus both selamectin and sarolaner are well absorbed with bioavailability mean values of 40.5% and 57.9%, respectively and distribute systemically.
Maltese: Wara amministrazzjoni topikali ta' Felisecto Plus kemm selamekti kif ukoll sarolaner jiġu assorbiti sew b'valuri medji ta' biodisponibilità ta' 40.5% u 57.9% rispettivament u jiġu ddistribwiti b'mod sistemiku.
English: - The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Maltese: - Il-prodott jista' jintuża bħala parti minn strateġija ta' kura għal flea allergic dermatitis (FAD).
English: - Treatment of biting lice infestations (Felicola subrostratus).
Maltese: - Trattament għall-qamel li jigdem (Felicola subrostratus).
English: Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines.
Maltese: Sarolaner jimblokka l-kanali tal-kloru li huma GABA u glutamate-gated fis-sistema nervuża ċentrali tal-insetti u l-akarini.
English: Excipients: 0.2 mg/ml butylated hydroxytoluene.
Maltese: 0.2mg/ml Butylated hydroxytoluene 0.08%
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/238/001 (3 x 0.25 ml) EU/2/19/238/002 (3 x 0.5 ml) EU/2/19/238/003 (3 x 1 ml)
Maltese: EU/2/19/238/001 (3 x 0.25 ml)
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 annimali ittrattati li juru effetti mhux mixtieqa matul il perjodu ta' kura) - 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: as well as mites (Otodectes cynotis), lice (Felicola subrostratus) and gastrointestinal nematodes (Toxocara cati, Ancylostoma tubaeforme).
Maltese: Selamektin huwa attiv kontra l-briegħed adulti (Ctenocephalides spp.) kif ukoll il-mites (Otodectes cynotis), qamel (Felicola subrostratus) u nematode gastrointestinal (Toxocara cati, Ancylostoma tubaeforme).
English: Translucent polypropylene unit dose pipettes individually packed in aluminium and aluminium/PVC blisters.
Maltese: Pipetti tal-polypropylene transluċidi b'doża waħda, ippakkjati individwalment f'folji tal-aluminju u aluminju / PVC.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 15 mg selamectin / 2.5 mg sarolaner 30 mg selamectin / 5 mg sarolaner 60 mg selamectin / 10 mg sarolaner
Maltese: ATTIVA(I) 15 mg selamectin / 2.5 mg sarolaner 30 mg selamectin / 5 mg sarolaner 60 mg selamectin / 10 mg sarolaner
English: Felisecto Plus 30 mg/5 mg (orange cap)
Maltese: 30 mg/5 mg (tap oranġjo)
English: Strength and number of pipettes to be administered Felisecto Plus 15 mg/2.5 mg (yellow cap)
Maltese: Saħħa u numru ta' pipetti li għandhom jiġu amministrati Felisecto Plus 15 mg/2.5 mg (tapp isfar)
English: PACKAGE SIZE 3 pipettes 0.25 ml
Maltese: DAQS TAL-PAKKETT 3 pipetti
English: Felisecto Plus >2.5-5 kg
Maltese: Felisecto Plus ≤ 2.5 kg Felisecto Plus >2.5-5.0 kg Felisecto Plus >5-10 kg
English: Fleas and ticks
Maltese: ŻMIEN TA' TIŻMIM
English: The veterinary medicinal product has immediate and persistent acaricidal effect for 5 weeks against Ixodes ricinus and Ixodes hexagonus, and 4 weeks against Dermacentor reticulatus and Rhipicephalus sanguineus.
Maltese: Il-prodott mediċinali veterinarju għandu attività qattiela immedjata u persistenti għal 5 ġimgħat kontra l-qurdien Ixodes ricinus u Ixodes hexagonus, u 4 ġimgħat kontra l-qurdien Dermacentor reticulatus u Rhipicephalus sanguineus.
English: No clinically significant adverse reactions were observed in kittens from 8 weeks of age treated with up to 5 times the maximum recommended dose of the product for up to 8 consecutive treatments at 28 day intervals, apart from a single cat administered 5 times the maximum dose that displayed transient hypersensitivity to touch, piloerection, mydriasis and mild tremor which resolved without treatment.
Maltese: Ma dehrux effetti mhux mixtieq sinifikanti fi friegħ tal-qtates minn età ta' 8 ġimgħat ittrattati b'sa 5 darbiet aktar mid-doża rakkomandata tal-prodott sa 8 trattamenti wara xulxin f'intervalli ta' 28 ġurnata, ħlief għal qattusa waħda amministrata b'5 darbiet id-doża massima li wriet ipersensitività għall-kuntatt li tgħaddi, pil imwaqqaf, midriażi u rogħda ħafifa li għaddew mingħajr kura.
English: For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm.
Maltese: Għall-qtates b'infestazzjoni jew f'riskju ta' infestazzjoni ta' qurdien u briegħed, qamel, mites, nematodi gastrointestinali jew heartworm.
English: In cats, selamectin and sarolaner are low clearance compounds with long half-life values, 12.5 days and 41.5 days respectively, following topical administration.
Maltese: Fil-qtates, selamektin u sarolaner huma sustanzi li jiġu kklerjati bil-mod u għandhom valuri twal ta' half-life, ta' 12.5 ġurnata u 41.5 ġurnata rispettivament.
English: Felisecto Plus should be administered as a single spot-on (topical) application in accordance with the following table (corresponding to a minimum of 6 mg/kg selamectin and 1 mg/kg sarolaner).
Maltese: Felisecto Plus għandu jingħata bħala applikazzjoni spot-on (fuq il-ġilda) ta' doża waħda skont din ittabella (tikkorrispondi għal doża minima ta' 6 mg/kg selamektin u 1 mg/kg sarolaner).
English: Interactions with other medicinal products and other forms of interactions:
Maltese: Interazzjoni ma' prodotti mediċinali oħra jew forom oħra ta' interazzjoni:
English: Identification of selamectin metabolites in faeces indicated that metabolic clearance also contributes to the elimination.
Maltese: L-identifikazzjoni ta' metaboliti ta' selamektin fl-ippurgar juri li clearance metaboliku jikkontribwixxi ukoll għall-eliminazzjoni.
English: The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors).
Maltese: Il-mira primarja tal-azzjoni ta' sarolaner fl-insetti u l-akarini hija l-imblokk funzjonali tal-kanali tal-kloru li huma ligand-gated (reċetturi GABA u reċetturi glutamate).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose (pipette) delivers: Active substances: Felisecto Plus spot-on solution
Maltese: Sustanzi Attivi Felisecto Plus soluzzjoni spot-on
English: - For the treatment and prevention of flea infestations (Ctenocephalides spp.).
Maltese: - Għal kura u prevenzjoni minn infestazzjonijiet tal-briegħed (Ctenocephalides spp.).
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://ema.europa.eu/.
English: Pipettes with yellow caps contain 0.25 ml of product and deliver 15 mg selamectin and 2.5 mg sarolaner Pipettes with orange caps contain 0.5 ml of product and deliver 30 mg selamectin and 5 mg sarolaner Pipettes with green caps contain 1 ml of product and deliver 60 mg selamectin and 10 mg sarolaner
Maltese: Pipetti b'tappijiet sofor fihom 0.25 ml tal-prodott u jagħtu 15 mg selamektin u 2.5 mg sarolaner Pipetti b'tappijiet oranġjo fihom 0.5 ml tal-prodott u jagħtu 30 mg selamektin u 5 mg sarolaner Pipetti b'tappijiet ħodor fihom 1 ml tal-prodott u jagħtu 60 mg selamektin u 10 mg sarolaner
English: For ticks (I. ricinus), the onset of efficacy is within 24 hours of attachment for one month after product application.
Maltese: Għall-qurdien (I. ricinus), l-effett jibda minn 24 siegħa minn meta teħel u jdum għal xahar wara lapplikazzjoni tal-prodott.
English: Bodyweight of cat (kg)
Maltese: Piż talqattus (kg)
English: B. PACKAGE LEAFLET
Maltese: FIL-PAKETT
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.emea.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Use of this veterinary medicinal product is indicated in cats aged at least 8 weeks old and weighing at least 1.25 kg bodyweight.
Maltese: L-użu ta' dan il-prodott mediċinali veterinarju huwa indikat fi qtates ta' età mhux anqas minn 8 ġimgħat u li jiżnu tal-anqas 1.25 kg.
English: Sarolaner exhibits higher functional potency to block insect/acarine receptors compared to mammalian receptors.
Maltese: Sarolaner għandu saħħa potenzjali ogħla biex jimblokka reċetturi tal-insetti/akarini meta kkomparat mar-reċetturi tal-mammiferi.
English: Special precautions for storage
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: During clinical field testing, no interactions between this veterinary medicinal product and routinely used veterinary medicinal products were observed.
Maltese: Fi studji kliniċi waqt l-użu, ma kinux osservati effetti bejn dan il-prodott mediċinali veterinarju u prodotti mediċinali veterinarji li jintużaw regolarment.
English: The veterinary medicinal product has immediate and persistent acaricidal effect for 5 weeks against Ixodes ricinus and Ixodes hexagonus, and 4 weeks against
Maltese: Il-prodott mediċinali veterinarju għandu attività qattiela immedjat u persistent kontra l-briegħed għal 5
English: AUTHORISATION
Maltese: TAMMINISTRA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Felisecto Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Felisecto Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Felisecto Plus 60 mg/10 mg spot-on solution for cats >5-10 kg Selamectin/sarolaner
Maltese: Felisecto Plus 15 mg/2.5 mg soluzzjoni spot-on għall-qtates ≤ 2.5 kg Felisecto Plus 30 mg/5 mg soluzzjoni spot-on għall-qtates >2.5-5.0 kg Felisecto Plus 60 mg/10 mg soluzzjoni spot-on għall-qtates >5-10 kg selamektin/sarolaner
English: Specific pharmacovigilance requirements:
Maltese: Ħtiġijiet speċifiċi ta' farmakoviġilanza:
English: The product may cause eye irritation.
Maltese: Il-prodott jista' jikkawża irritazzjoni fl-għajnejn.
English: The product is available in packs of three pipettes (all pipette sizes).
Maltese: Il-prodott jiġi f'pakketti ta' tlett pipetti (pipetti tad-daqsijiet kollha).
English: - Treatment of tick infestations.
Maltese: - Trattament ta' infestazzjonijiet tal-qurdien.
English: The pipette should be removed from the protective package immediately prior to administration.
Maltese: Il-pipetta għandha tinħareġ mill-pakkett protettiv immedjatament qabel l-amministrazzjoni.
English: Treatment of ear mites
Maltese: Trattament għal-mites tal-widnejn
English: PACKAGE LEAFLET: Felisecto Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Felisecto Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Felisecto Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
Maltese: Felisecto Plus 15 mg/2.5 mg soluzzjoni spot-on għall-qtates ≤ 2.5 kg Felisecto Plus 30 mg/5 mg soluzzjoni spot-on għall-qtates >2.5-5.0 kg Felisecto Plus 60 mg/10 mg soluzzjoni spot-on għall-qtates >5-10 kg
English: Mild to moderate alopecia at the application site, erythema and drooling have been uncommonly observed.
Maltese: Evita kuntatt dirett ma' annimali kkurati sakemm tinxef ir-roqgħa fejn ġie applikat.
English: - Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
Maltese: - prevenzjoni tal-marda tal-heartworm ikkawżata minn Dirofilaria immitis b'amministrazzjoni ta' kull xahar.
English: as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, and Rhipicephalus sanguineus.
Maltese: Huwa important li d-doża tiġi applikata kif indikat biex tevita li l-annimal jilaq u jibla l-prodott.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Felisecto Plus 15 mg/2.5 mg spot-on solution for cats Felisecto Plus 30 mg/5 mg spot-on solution for cats Felisecto Plus 60 mg/10 mg spot-on solution for cats
Maltese: Felisecto Plus 15 mg/2.5 mg soluzzjoni spot-on għall-qtates Felisecto Plus 30 mg/5 mg soluzzjoni spot-on għall-qtates Felisecto Plus 60 mg/10 mg soluzzjoni spot-on għall-qtates
English: Prevention of heartworm disease
Maltese: Prevenzjoni tal-marda tal-heartworm
English: The administration to animals with adult heartworm infection did not pose safety concerns.
Maltese: L-amministrazzjoni lill-annimali bl-infezzjoni tal-heartworm ma ppreżentatx perikli ta' sigurtà.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: The product is highly flammable.
Maltese: ġimgħat f'infestazzjonijiet ġodda.
English: STATEMENT OF ACTIVE SUBSTANCES 15 mg selamectin/2.5 mg sarolaner 30 mg selamectin/5 mg sarolaner 60 mg selamectin/10 mg sarolaner
Maltese: 30 mg selamektin/5 mg sarolaner
English: Selamectin paralyzes 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-kunduttivita' tal-kanali tal-kloru u b'hekk tikkawża tħarbit fin-newrotrasmissjoni normali.