FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP prepared a simple guide on veterinary pharmacovigilance, targeted primarily at veterinarians, in order to encourage reporting of adverse drug reactions.
Maltese: Il-CVMP ħejja gwida sempliċi fuq il-farmakoviġilanza veterinarja, immirata primarjament lejn ilveterinarji sabiex iħeġġeġ ir-rappurtaġġ ta' reazzjonijiet mhux mixtieqa għall-mediċni.
English: The number of adverse drug reaction (ADR) reports for centrally authorised medicinal products received by the EMEA in 2005 was significantly greater than in previous years.
Maltese: Innumru ta' rapporti dwar reazzjonijiet mhux mixtieqa għall-mediċini (ADR - Adverse Drug Reactions), fil-każ ta' prodotti mediċinali awtorizzati b'mod ċentrali, irċevuti mill-EMEA fl-2005, kien relattivament ikbar mis-snin ta' qabel.
English: Positive opinions
Maltese: Opinjonijiet pożittivi
English: Following a period of external consultation with stakeholders, the Agency finalised and published a procedure for the development of pharmaceutical guidelines and related documents, proposing a consistent and transparent approach to their development, consultation and publication.
Maltese: Wara perjodu ta' konsultazzjoni esterna mal-persuni parteċipanti, l-Aġenzija ffinalizzat u ppubblikat proċedura għall-iżvilupp ta' linji gwida farmaċewtiċi u dokumenti relatati, li fihom ipproponiet approċċ konsistenti u trasparenti għall-iżvilupp, għall-konsultazzjoni u għall-pubblikazzjoni tagħhom.
English: There was a substantial increase in the number of requests for scientific advice and protocol assistance in 2005 - up 60% on the number received in 2004.
Maltese: Kien hemm żieda sostanzjali fin-numru ta' talbiet għal parir xjentifiku u għajnuna għall-protokoll fl2005 - sa 60% iktar min-numru rċevut fl-2004.
English: New medicines for the treatment of HIV/AIDS
Maltese: Mediċini ġodda għall-kura ta' l-HIV/AIDS
English: In order to allow the development of these activities within a broader and more structured environment, the Management Board adopted, in December 2005, a ‘Framework of Interaction' between the EMEA and patients' and consumers' organisations.
Maltese: Sabiex ikun permess liżvilupp ta' dawn l-attivitajiet f'ambjent usa u aktar stutturat, il-Bord ta' Tmexxija adotta, f'Diċembru 2005, 'Qafas ta' Interazzjoni' bejn l-EMEA u l-organizzazzjonijiet tal-pazjenti u l-konsumaturi.
English: Strengthening the Agency's interaction with European industry associations representing the innovative, generic and self-medication industries
Maltese: Tisħiħ ta' l-interazzjoni ta' l-Aġenzija ma' l-assoċjazzjonijiet ta' l-industrija Ewropej li jirrappreżentaw l-industriji innovattivi, ġeneriċi u ta' prodotti li għalihom mhemmx bżonn ta' riċetta
English: EMA/109796/2014 EMEA/H/C/002779
Maltese: EMEA/H/C/002779
English: The active substance in Vimizim, elosulfase alfa, is a copy of the human enzyme N-acetylgalactosamine-6-sulfatase.
Maltese: Is-sustanza attiva f'Vimizim, l-elosulfase alfa, hija kopja tal-enzima tal-bniedem N-acetylgalactosamine-6-sulfatase.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Vimizim jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Vimizim is a medicine that contains the active substance elosulfase alfa.
Maltese: Vimizim huwa mediċina li fiha s-sustanza attiva elosulfase alfa.
English: Why is Vimizim approved?
Maltese: Għaliex ġie approvat Vimizim?
English: Vimizim is an enzyme replacement therapy.
Maltese: Vimizim huwa terapija ta' sostituzzjoni tal-enzimi.
English: The full EPAR and risk management plan summary for Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Vimizim.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vimizim.
English: Elosulfase alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce the enzyme.
Maltese: L-losulfase alfa hija prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': issir minn ċelloli li jkun ġie introdott fihom ġene (DNA), li permezz tiegħu jkunu jistgħu jipproduċu l-enzima.
English: The recommended dose is 2 mg per kilogram body weight, given once a week.
Maltese: Id-doża rakkomandata hija ta' 2 mg għal kull kilogramma ta' piż tal-ġisem, li tingħata darba kuljum.
English: After 6 months, patients treated with the recommended dose of Vimizim could walk an extra 37 metres on average in six minutes, compared with an increase of 14 metres in patients receiving placebo.
Maltese: Wara 6 xhur, il-pazjenti kkurati bid-doża rrakkomandata ta' Vimizim setgħu jimxu 37 metru oħra bħala medja f'sitt minuti, meta mqabbla ma' żieda ta' 14-il metru f'pazjenti li rċievew il-plaċebo.
English: This disease is caused by the lack of an enzyme called N-acetylgalactosamine-6-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
Maltese: Din ilmarda hija kkawżata min-nuqqas ta' enzima msejħa N-acetylgalactosamine-6-sulfatase, li hija meħtieġa biex jitkissru s-sustanzi fil-ġisem imsejħa glycosaminoglycans (GAGs).
English: What are the risks associated with Vimizim?
Maltese: X'inhuma r-riskji assoċjati ma' Vimizim?
English: The most common side effects with Vimizim (which may affect more than 1 in 10 people) are infusionrelated reactions, including headache, nausea (feeling sick), vomiting, fever, chills and abdominal pain (stomach ache).
Maltese: L-effetti sekondarji l-aktar komuni b'Vimizim (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) huma reazzjonijiet relatati mal-infużjoni, inkluż uġigħ ta' ras, nawżja (tħossok ma tiflaħx), rimettar, deni, tertir ta' bard u uġigħ addominali (uġigħ fl-istonku).
English: It is used to treat patients with mucopolysaccharidosis type IVA (MPS IVA, also known as Morquio A syndrome).
Maltese: Huwa jintuża biex jikkura pazjenti bilmarda ta' mukopolisakkaridosi tip IVA (MPS IVA, magħrufa wkoll bħala sindrome ta' Morquio A).
English: Other information about Vimizim
Maltese: Informazzjoni oħra dwar Vimizim
English: Vimizim has been investigated in one main study involving 176 patients with MPS IVA, which compared Vimizim with placebo (a dummy treatment).
Maltese: Vimizim ġie investigat fi studju wieħed ewlieni li kien jinvolvi 176 pazjent b'MPS IVA, li qabbel Vimizim ma' plaċebo (kura finta).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vimizim on 28 April 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vimizim fit-28 ta' April 2014.
English: Because the number of patients with MPS IVA is low, the disease is considered ‘rare', and Vimizim was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009.
Maltese: Minħabba li n-numru ta' pazjenti b'MPS IVA huwa wieħed baxx, il-marda hija kkunsidrata bħala waħda ‘rari', u Vimizim ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl24 ta' Lulju 2009.
English: Serious but uncommon infusion-related reactions include anaphylaxis (severe allergic reaction).
Maltese: Reazzjonijiet serji iżda mhux komuni relatati mal-infużjoni jinkludu anafilassi (reazzjoni allerġika qawwija).
English: Before receiving Vimizim, the patient should be given a medicine to prevent an allergic reaction to Vimizim.
Maltese: prevenzjoni ta' reazzjoni allerġika għal Vimizim.
English: The replacement enzyme helps to break down GAGs and stop them building up in cells, thereby improving the symptoms of MPS IVA.
Maltese: L-enzima ta' sostituzzjoni tgħin biex tkisser il-GAGs u twaqqafhom milli jakkumulaw fiċ-ċelloli, u b'hekk ittejjeb is-sintomi ta' MPS IVA.
English: The CHMP concluded that, following 6 months of treatment, Vimizim was shown to be effective at improving the distance patients could walk in six minutes, and this was accompanied by other beneficial effects, including improved ability to carry out daily activities.
Maltese: Is-CHMP ikkonkluda li, wara 6 xhur ta' kura, Vimizim intwera li huwa effikaċi biex itejjeb id-distanza li l-pazjenti setgħu jimxu f'sitt minuti, u dan kien akkumpanjat minn effetti oħrajn ta' benefiċċju, inkluż titjib filkapaċità biex iwettqu l-attivitajiet ta' kuljum.
English: How does Vimizim work?
Maltese: Kif jaħdem Vimizim?
English: Treatment with Vimizim should be supervised by a doctor experienced in MPS IVA or similar diseases.
Maltese: Il-pazjenti jistgħu jingħataw ukoll mediċina li tipprevjeni d-deni.
English: Enzyme replacement therapy provides patients with the enzyme they are lacking.
Maltese: It-terapija ta' sostituzzjoni tal-enzimi tipprovdi lillpazjenti bl-enzima li tkun nieqsa.
English: The Committee also considered that the safety profile of Vimizim appears manageable and serious side effects are uncommon, but further long-term safety data are to be collected.
Maltese: Il-Kumitat ikkunsidra wkoll li l-profil tas-sigurtà ta' Vimizim jidher maniġġabbli u l-effetti sekondarji serji mhumiex komuni, iżda għandha tinġabar aktar dejta dwar is-sigurtà fit-tul.
English: For the full list of all side effects reported with Vimizim, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Vimizim, ara l-fuljett ta' tagħrif.
English: ATCvet code: QP53BX03.
Maltese: QP53BX03.
English: EU/2/10/115/017 (90 mg, 6 tablets)
Maltese: EU/2/10/115/017 (90 mg, 6 pilloli)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/02/2011.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 11/02/2011.
English: There is no antidote available.
Maltese: M'hemm ebda antidot disponibbli.
English: Microcrystalline cellulose Artificial beef flavour Hydroxypropylcellulose Colloidal silicon, anhydrous Croscarmellose sodium Magnesium stearate
Maltese: Hydroxypropylcellulose Colloidal silicon, anhydrous Croscarmellose sodium Magnesium stearate
English: Bioavailability was shown to be approximately 70%.
Maltese: Il-bijodisponibilità ntweriet li hi ta' madwar 70%.
English: Spinosad has been shown to be a substrate for P-glycoprotein (PgP).
Maltese: Spinosad intwera li hu substrat għal P-glycoprotein (PgP).
English: Plasma protein binding is high (~99%).
Maltese: Ittwaħħil tal-proteina fil-plażma hu għoli (~99%).
English: The mean Tmax for spinosyns A and D ranged from 2-4 hours and the mean elimination half-life ranged from 127.5 to 162.6 hours and 101.3 to 131.9 hours respectively.
Maltese: 2-4 sigħat u l-half life ta' eliminazzjoni kienet minn 127.5 sa 162.6 sigħat u 101.3 sa 131.
English: Interaction with other medicinal products and other forms of interaction:
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni:
English: Seizures were rare adverse reactions.
Maltese: Aċċessjonijiet kienu reazzjonijiet avversi rari.
English: PACKAGE SIZE 3 tablets
Maltese: DAQS TAL-PAKKETT 3 pilloli
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Ewropea dwar il-Mediċini (http://www.emea.europa.eu/).
English: Insecticidal activity against new infestations persists for up to 4 weeks.
Maltese: L-attività insettiċida kontra infestazzjonijiet ġodda tippersisti għal sa 4 ġimgħat.
English: Pharmacotherapeutic group: other ectoparasiticides for systemic use.
Maltese: Grupp farmako-terapewtiku: ektoparassitiċidi oħra għal użu sistemiku.
English: It does not interact with known binding sites of other nicotinic or GABAergic insecticides such as neonicotinides (imidacloprid or nitenpyram), fiproles (fipronil), milbemycins, avermectins (e.g. selamectin) or cyclodienes, but through a novel insecticidal mechanism.
Maltese: Ma jirreaġixxix ma' siti ta' rabta magħrufin ta' insettiċidi nikotiniċi jew GABAerġiċi oħra, bħal neonicotinides (imidacloprid jew nitenpyram), fiproles (fipronil), milbemycins, avermectins (eż selamectin) jew cyclodienes imma permezz ta' mekkaniżmu insettiċida ġdid.
English: Approximately 90% of spinosad is comprised of spinosyns A and D. Of that 90%, the ratio of spinosyn A to A+D is 0.85 when calculated as spinosyn A/spinosyn A+D.
Maltese: spinosyn A għal A+D hu 0.85 meta kkalkulat bħala spinosyn A/spinosyn A+D.
English: EU/2/10/115/018 (140 mg, 3 tablets) EU/2/10/115/019 (140 mg, 6 tablets) EU/2/10/115/020 (180 mg, 3 tablets) EU/2/10/115/021 (180 mg, 6 tablets) EU/2/10/115/011 (270 mg, 3 tablets) EU/2/10/115/001 (270 mg, 6 tablets) EU/2/10/115/012 (425 mg, 3 tablets) EU/2/10/115/003 (425 mg, 6 tablets) EU/2/10/115/013 (665 mg, 3 tablets) EU/2/10/115/005 (665 mg, 6 tablets) EU/2/10/115/014 (1040 mg, 3 tablets) EU/2/10/115/007 (1040 mg, 6 tablets) EU/2/10/115/015 (1620 mg, 3 tablets) EU/2/10/115/009 (1620 mg, 6 tablets)
Maltese: EU/2/10/115/018 (140 mg, 3 pilloli) EU/2/10/115/019 (140 mg, 6 pilloli) EU/2/10/115/020 (180 mg, 3 pilloli) EU/2/10/115/021 (180 mg, 6 pilloli) EU/2/10/115/011 (270 mg, 3 pilloli) EU/2/10/115/001 (270 mg, 6 pilloli) EU/2/10/115/012 (425 mg, 3 pilloli) EU/2/10/115/003 (425 mg, 6 pilloli) EU/2/10/115/013 (665 mg, 3 pilloli) EU/2/10/115/005 (665 mg, 6 pilloli) EU/2/10/115/014 (1040 mg, 3 pilloli) EU/2/10/115/007 (1040 mg, 6 pilloli) EU/2/10/115/015 (1620 mg, 3 pilloli) EU/2/10/115/009 (1620 mg, 6 pilloli)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/115/016 (90 mg, 3 tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/10/115/016 (90 mg, 3 pilloli)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Maltese: KOMPOŻIZZJONI KWALITTATIVA
English: These effects are caused primarily by activation of nicotinic acetylcholine receptors (nAChRs).
Maltese: Dawn l-effetti huma kkawżati prinċipalment mill-attivazzjoni ta' riċetturi ta' nicotinic acetylcholine (nAChRs).
English: Treatment and prevention of flea infestations (Ctenocephalides felis).
Maltese: Kura u prevenzjoni minn infestazzjonijiet tal-briegħed (Ctenocephalides felis).
English: EU/2/10/115/016 (90 mg, 3 tablets) EU/2/10/115/017 (90 mg, 6 tablets) EU/2/10/115/018 (140 mg, 3 tablets) EU/2/10/115/019 (140 mg, 6 tablets) EU/2/10/115/020 (180 mg, 3 tablets) EU/2/10/115/021 (180 mg, 6 tablets) EU/2/10/115/011 (270 mg, 3 tablets) EU/2/10/115/001 (270 mg, 6 tablets) EU/2/10/115/012 (425 mg, 3 tablets) EU/2/10/115/003 (425 mg, 6 tablets) EU/2/10/115/013 (665 mg, 3 tablets) EU/2/10/115/005 (665 mg, 6 tablets) EU/2/10/115/014 (1040 mg, 3 tablets) EU/2/10/115/007 (1040 mg, 6 tablets) EU/2/10/115/015 (1620 mg, 3 tablets) EU/2/10/115/009 (1620 mg, 6 tablets)
Maltese: EU/2/10/115/016 (90 mg, 3 pilloli) EU/2/10/115/017 (90 mg, 6 pilloli) EU/2/10/115/018 (140 mg, 3 pilloli) EU/2/10/115/019 (140 mg, 6 pilloli) EU/2/10/115/020 (180 mg, 3 pilloli) EU/2/10/115/021 (180 mg, 6 pilloli) EU/2/10/115/011 (270 mg, 3 pilloli) EU/2/10/115/001 (270 mg, 6 pilloli) EU/2/10/115/012 (425 mg, 3 pilloli) EU/2/10/115/003 (425 mg, 6 pilloli) EU/2/10/115/013 (665 mg, 3 pilloli)
English: Comfortis 1620 mg chewable tablets for dogs spinosad
Maltese: Comfortis 1620 mg pilloli li jintmagħdu għal klieb spinosad
English: Phospholipidosis (vacuolation of the cells of the liver, adrenal gland and lung) also occurred.
Maltese: Fosfolipidosi (vakuwolazzjoni taċ-ċelluli tal-fwied, glandoli adrenali u l pulmun) seħħet ukoll.
English: Dispose of waste material in accordance with local requirements.
Maltese: Armi l-materjal ta' skart b'mod konformi mar-regolamenti lokali.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Elanco
Maltese: FIS-SUQ Elanco
English: The recommended dosage regimen should be followed (see section 4.10 for information regarding overdose).
Maltese: Il-programm ta' kura bid-doża rakkomandata għandu jiġi segwit ( ara sezzjoni 4.10 għal informazzjoni dwar doża eċċessiva).
English: Cat bodyweight (kg)
Maltese: Piż tal-ġisem tal-kelb (kg)
English: Other commonly observed adverse reactions in cats were diarrhoea and anorexia.
Maltese: Reazzjonijiet avversi osservati komunament fil-qtates kienu dijarea u anoressija.
English: The veterinary medicinal product may safely be given at monthly intervals at the recommended dose.
Maltese: Il-prodott mediċinali veterinarju jista' jingħata b'mod sigur f'intervalli ta' kull xahar fid-doża rakkomandata.
English: Number of tablets and strength (mg spinosad) 1 x 90 mg tablet 1 x 140 mg tablet 1 x 180 mg tablet 1 x 270 mg tablet 1 x 425 mg tablet 1 x 665 mg tablet 1 x 1040 mg tablet 1 x 1620 mg tablet 1 x 1620 mg tablet + 1 x 665 mg tablet 2 x 1620 mg tablets
Maltese: Numru ta' Pilloli u Qawwa tal-Pillola (mg spinosad) Pillola 1 x 90 mg Pillola 1 x 140 mg Pillola 1 x 180 mg Pillola 1 x 270 mg Pillola 1 x 425 mg Pillola 1 x 665 mg Pillola 1 x 1040 mg Pillola 1 x 1620 mg Pillola 1 x 1620 mg + Pillola 1 x 665 mg 2 pilloli x 1620 mg
English: The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.
Maltese: L-effett preventiv kontra infestazzjonijiet mill-ġdid huwa dovut għall-attività adultiċida u t-tnaqqis fil-produzzjoni ta' bajd u jippersisti għal sa 4 ġimgħat wara li l-prodott jingħata darba biss.
English: The primary biliary, faecal and urinary metabolites in both the rat and the dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and Ndemethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and also to a lesser extent in the urine.
Maltese: Il-metaboliti prinċipali fil-marrara, l-ippurgar u l-awrina kemm fil-firien u l-klieb kienu identifikati bħala demethylated spinosyns, konjugati ta' glutathione tal-komposti ġenituri u N-demethylated spinosyns A u D.
English: Accurate dosing is not possible in dogs weighing less than 1.3 kg and in cats weighing less than 1.2 kg.
Maltese: Dożaġġ preċiż mhuwiex possibbli fi klieb żgħar li jiżnu inqas minn 1.3 kg u fi qtates li jiżnu inqas minn 1.2 kg.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' ingredjenti Microcrystalline cellulose
English: The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Maltese: dermatite minn allerġija tal-briegħed (flea allergy dermatitis - FAD).
English: Spinosad therefore has a different mode of action to other flea control or insect control products.
Maltese: Għalhekk, spinosad jaħdem b'mod differenti minn prodotti oħra li jikkontrollaw il-briegħed jew l-insetti.
English: Bioavailability was shown to be approximately 100%, with maximum plasma concentrations attained approximately 4-12 hours post treatment, and with half-lives of spinosyn A and spinosyn D ranging between 5 days and 20 days in cats dosed at 50-100 mg spinosad/kg bodyweight.
Maltese: b'konċentrazzjonijiet massimi fil-plażma li jintlaħqu madwar 4 sigħat - 12-il siegħa wara l-kura, u b'half-lives ta' spinosyn A u spinosyn D li jkunu bejn 5 ijiem u 20 jum fil-qatates iddożati b'50 mg100 mg spinosad/kg ta' piż tal-ġisem.
English: The product starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment in dogs, and in cats within 24 hours.
Maltese: Il-prodott jibda joqtol il-briegħed 30 minuta wara l-għoti; 100% tal-briegħed ikunu mejta/moribondi fi żmien 4 sigħat minn wara t-trattament fil-klieb, u fi żmien 24 siegħa fil-qtates.
English: On the day of, or the day following administration of spinosad at a dose of 50-75 mg/kg bodyweight, the observed incidence of vomiting in the global field trial was between 6% and 11% in the first three months of treatment.
Maltese: Dakinhar,jew l-għada li ġie amministrat l-ispinosad f'doża ta' 50-75 mg/kg piż tal-ġisem, l-inċidenza osservata ta' rimettar fil-prova fil-kamp globali kienet ta' bejn 6% u 11% fl-ewwel tliet xhur ta' kura.
English: On the day of, or the day following administration of spinosad at a dose of 45-70 mg/kg bodyweight, the observed incidence of vomiting in the field trial was 5.6%, 4.2% and 3.6% after the first, second and third monthly treatments respectively.
Maltese: rimettar fil-prova fuq il-post kienet ta' 5.6%, 4.2% u 3.6% wara l-ewwel, it-tieni u t-tielet xahar ta'
English: 6.5 Nature and composition of immediate packaging Clear PCTFE/PE/PVC blister sealed with aluminium foil containing 3 or 6 chewable tablets in cardboard box.
Maltese: Pakketti tal-kartun li fih pakketti ta' folji ċari tal-PCTFE/PE/PVC issiġillat b'fojl tal-aluminju li fih minn 3 sa 6 pilloli li jistgħu jintmagħdu.
English: Chewable tablets
Maltese: Kull pillola fiha:
English: The safety of spinosad in pregnant cats (queens) has not been evaluated.
Maltese: Is-sigurtà ta' spinosad fi qtates nisa (irġejjen) ma ġietx evalwata.
English: The preventive effect against re-infestations is a result of the activity against adult fleas and the reduction in their production of eggs.
Maltese: L-effett preventiv kontra infestazzjonijiet mill-ġdid huwa dovut għall-attività ta' kontra l-briegħed adulti u t-tnaqqis fil-produzzjoni tagħhom ta' bajd.
English: Number of tablets and strength (mg spinosad) 1 x 90 mg tablet 1 x 140 mg tablet 1 x 180 mg tablet 1 x 270 mg tablet 1 x 425 mg tablet †Cats over 8.5 kg: give the appropriate combination of tablets.
Maltese: Numru ta' Pilloli u qawwa tal-pillola (mg spinosad) pillola 1 x 90 mg pillola 1 x 140 mg pillola 1 x 180 mg pillola 1 x 270 mg pillola 1 x 425 mg †Qtates li jiżnu aktar minn 8.5 kg: agħti l-kombinazzjoni xierqa ta' pilloli.
English: Special precautions for use in animals:
Maltese: Kodiċi veterinarja ATC:
English: Spinosad could therefore interact with other PgP-substrates (for example, digoxin, doxorubicin) and possibly enhance adverse reactions from such molecules or compromise efficacy.
Maltese: Għalhekk spinosad jista' jirreaġixxi ma' substrati oħra ta' PgP (pereżempju, digoxin, doxorubicin) u possibilment iħarrax ir-reazzjonijiet avversi minn molekuli bħal dawn jew jikkomprometti l-effikaċja.
English: Cardboard box containing blister, each containing 3 or 6 chewable tablets.
Maltese: Pakketti tal-kartun li fihom il-pakketti bil-folji, li kull wieħed fih 3 jew 6 pilloli li jistgħu jintmagħdu.
English: The primary faecal and urinary metabolites in both the rat and the cat were identified as the glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the faeces, and also to a lesser extent in the urine.
Maltese: Il-metaboliti prinċipali fl-ippurgar u l-awrina kemm fil-firien u l-qtates kienu identifikati bħala lkonjugati ta' glutathione tal-komposti ewlenin u N-demethylated spinosyns A u D.
English: In dogs, spinosyns A and D are rapidly absorbed and extensively distributed after oral administration.
Maltese: Spinosad jikkonsisti minn spinosyn A u spinosyn D.
English: In dogs lethargy, anorexia and diarrhoea were uncommon and muscle tremor, ataxia and seizures were rare.
Maltese: Fil-klieb, il-letarġija, anoressija u dijarea ma kinux komuni, u rogħda tal-muskoli, atassija u aċċessjonijiet kienu rari.
English: PHARMACEUTICAL FORM Chewable tablets.
Maltese: U METODU TA' AMMINISTRAZZJONI Għal użu orali.
English: SPECIAL STORAGE CONDITIONS Keep the blister in the outer carton.
Maltese: Aħsel idejk wara li tuża.
English: Pregnancy:
Maltese: Klieb:
English: Outer carton
Maltese: TIKKETTA
English: Post marketing reports, following the concomitant use of Comfortis with ‘off label' high dose ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Maltese: Rapporti ta' wara t-tqegħid fis-suq, wara użu konkomitanti ta' Comfortis u doża għolja ta' ivermectin mingħajr kas tat-tikketta jindikaw li l-klieb esperjenzaw rogħda/kontrazzjonijiet, żieda fir-rieq/legħib, attakki ta' puplesija, atassja, mijadrijasi, għama u diżorjentazzjoni.