FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/2/13/157/001 0.3 ml EU/2/13/157/002 3 x 0.3 ml EU/2/13/157/003 4 x 0.3 ml EU/2/13/157/008 15 x 0.3 ml EU/2/13/157/004 0.9 ml EU/2/13/157/005 3 x 0.9 ml EU/2/13/157/006 4 x 0.9 ml EU/2/13/157/007 6 x 0.9 ml EU/2/13/157/009 15 x 0.9 ml
Maltese: EU/2/13/157/004 0.9 ml EU/2/13/157/005 3 x 0.9 ml EU/2/13/157/006 4 x 0.9 ml EU/2/13/157/007 6 x 0.9 ml EU/2/13/157/009 15 x 0.9 ml
English: - Treatment of notoedric mange (Notoedres cati).
Maltese: - Kura tan-notoedric mange (Notoedres cati).
English: Pharmacotherapeutic group: antiparasitic products, insecticides, avermectins, eprinomectin in combinations.
Maltese: Grupp farmako-terapewtiku: prodotti antiparassitiċi, insettiċidi, avermektini, eprinomectin f'kombinazzjonijiet.
English: Date of first authorisation: 04/12/2013 Date of latest renewal: 24/09/2018
Maltese: Data tal-ewwel awtorizazzjoni: 04/12/2013 Data tal-aħħar tiġdid: 24/09/2018
English: Echinococcus multilocularis, Joyeuxiella pasqualei (adult), Joyeuxiella fuhrmanni (adult)).
Maltese: Echinococcus multilocularis Joyeuxiella pasqualei (adulti), u Joyeuxiella fuhrmanni (adulti).
English: {MM/YYYY}
Maltese: U/JEW UŻU
English: < 2.5 kg 2.5-7.5 kg > 7.5 kg appropriate combination of applicators
Maltese: < 2.5 kg 2.5-7.5 kg > 7.5 kg
English: 48 hours.
Maltese: 3 x0.
English: Cats <2.5 kg Cats 2.5-7.5 kg
Maltese: Qtates <2.5 kg Qtates 2.5-7.5 kg
English: (FAD).
Maltese: (ml)
English: Aelurostrongylus abstrusus , L4 larvae and adults of Troglostrongylus brevior).
Maltese: Aelurostrongylus abstrusus, L4 larvae u adulti tat-Troglostrongylus brevior).
English: Box, pack sizes of 1, 3, 4, 6 or 15 applicators
Maltese: KAXXA, daqsijiet tal-pakkett ta' 1,3, 4, 6 jew15 applikaturi.
English: Eprinomectin is a member of the macrocyclic lactone class of endectocides.
Maltese: Eprinomectin jagħmel parti mill-klassi lactone makroċiklika ta' endektoċidi.
English: (S)-methoprene, once absorbed, is very quickly metabolised and excreted.
Maltese: (S)-Methoprene, ladarba assorbita, tiġi metabolizzata u eliminata malajr ħafna.
English: Praziquantel has a moderate tissue distribution, and about 64-84% of praziquantel is bound to plasma proteins.
Maltese: 64-84% tal-praziquantel huwa marbut mal-proteini tal-plażma.
English: Treatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis , Joyeuxiella pasqualei (adult), and Joyeuxiella fuhrmanni (adult)).
Maltese: - Kura ta' infestazzjonijiet bid-duda (Dipylidium caninum , Tænia tæniæformis, Echinococcus multilocularisJoyeuxiella pasqualei (adulti), u Joyeuxiella fuhrmanni (adulti)).
English: - Treatment and prevention of infestations by ticks (Ixodes ricinus).
Maltese: - Kura u prevenzjoni ta' infestazzjonijiet b'qurdien (Ixodes ricinus).
English: Aelurostrongylus abstrusus, L4 larvae and adults of Troglostrongylus brevior).
Maltese: Aelurostrongylus abstrusus L4 larvae u adulti tat-Troglostrongylus brevior).
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: - Komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effett/i mhux mixtieq/a - Komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - Mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - Rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - Rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: The recommended minimum doses are 10 mg/kg bodyweight for fipronil, 12 mg/kg for (S)-methoprene, 0.5 mg/kg for eprinomectin and 10 mg/kg for praziquantel.
Maltese: Id-dożi minimi rrikmandati huma 10mg/kg tal-piż tal-ġisem għal fiponil, 12 mg/kg għal (S)-methoprene, 0.5 mg/kg għal eprinomectin u 10mg/kg għal praziquantel.
English: Spot-on application only.
Maltese: Mhux applikabbli.
English: Fipronil and its metabolite fipronil sulfone act at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA) as well as desensitising (D) and nondesensitising (N) channels gated by glutamate (Glu, unique invertebrate ligand-gated chloride channels), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Maltese: Fipronil u l-metabolit fipronil sulfone jaġixxu fil-kanali ta' ligand-gated chloride, b'mod partikulari dawk miftuħa min-newrotrasmettitur gamma-aminobutyric acid (GABA) kif ukoll minn kanali ta' desensitizzazzjoni (D) u nondesensitizzazzjoni (N) miftuħa minn glutamate (Glu, kanali ta' ligand gated chloride ta' invertebrati), b'hekk jiġi mblukkat it-trasferiment tal-joni tal-chloride tul ilmembrani taċ-ċelluli qabel u wara t-trasferiment sinattiku.
English: Cestodes - Treatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis,
Maltese: Cestodes - Kura ta' infestazzjonijiet bid-duda (cestodes) (Dipylidium caninum , Tænia tæniæformis,
English: Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family.
Maltese: Fipronil huwa insettiċida u acariċida li jappartjeni għall-familja ta' phenylpyrazole.
English: Excipient: Butylhydroxytoluene (E321) 1 mg/ml.
Maltese: Ingredjent mhux attiv:Butylhydroxytoluene (E321) 1 mg/ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Maltese: U KWANTITATTIVA Sustanzi Attivi :
English: In vitro metabolism assays and in vivo studies have demonstrated that there are no pharmacodynamic or pharmacokinetic interactions between fipronil, (S)-methoprene, eprinomectin and praziquantel.
Maltese: Analiżi tal-metaboliżmu in vitro u studji in vivo wrew li m'hemm l-ebda interazzjoni farmakodinamika jew farmakokinetika bejn fipronil, (S)-methoprene, eprinomectin u praziquantel.
English: - Treatment of infestations with feline lungworms (L3 larvae, L4 larvae and adults of
Maltese: - Kura ta' infestazzjonijiet bil-lungworms tal-qtates (L3 larvae, L4 larvae u adulti tal
English: 0.3 ml 3 x 0.3 ml 4 x 0.3 ml 15 x 0.3 ml
Maltese: 4 x0.3 ml15 x 0.3ml
English: The veterinary medicinal product is a spot-on solution for topical use containing the insecticidal and acaricidal active ingredients fipronil (adulticide) and (S)-methoprene (ovicidal and larvicidal), combined with the endectocide eprinomectin and the cestocide praziquantel to complete the broad spectrum with activity against gastrointestinal nematodes, lungworms and tapeworms, and vesical worms.
Maltese: Il-prodott huwa soluzzjoni għall-użu lokalizzat u topikali li fiha s-sustanzi attivi insettiċidjali u akariċidjali fipronil (adultiċidjali) u (S) - methoprene (oviċidjali u larviċidjali) ikkombinat mal endektoċida eprinomectin u l-cestoċida praziquantel biex titlesta l-ispektrum wiesgħa b'attività kontra n-nematodes gastrointestinali, lungworms u duda, u dud vexxikali.
English: Ectoparasites - Treatment and prevention of infestations by fleas (Ctenocephalides felis).
Maltese: Ektoparassiti - Kura u prevenzjoni ta' infestazzjonijiet bi briegħed (Ctenocephalides felis).
English: One treatment prevents further infestations for up to 3 weeks.
Maltese: Kura wahda timpedixxi aktar infestazzjonijiet sa 3 gimghat.
English: (S)-Methoprene is an insect growth regulator (IGR) of the class of compounds known as juvenile hormone analogues that inhibit the development of immature stages of insects.
Maltese: (S)-Methoprene huwa regolatur tat-tkabbir tal-insetti (IGR) tal-klassi ta' komposti magħrufa bħala analogi tal-ormoni ġovanili li jinibixxu l-iżvilupp tal-fażijiet immaturi tal-insetti.
English: Praziquantel undergoes hepatic metabolism followed by renal excretion.
Maltese: Praziquantel jgħaddi minn metaboliżmu epatiku segwit minn tneħħija renali.
English: The ectoparasitic activity of fipronil and (S)-methoprene is mediated by direct contact with the ectoparasites rather than by systemic exposure.
Maltese: L-attività ektoparassitika tal-Fipronil u (S) methoprene hija medjata b‘kuntatt dirett mal-ektoparassiti milli b'esponiment sistemiku.
English: Digestive tract and/or neurological disorders may result following an accidental oral ingestion of the veterinary medicinal product (see section 4.5).
Maltese: Disturbi fis-sistema diġestiva u/jew disturbi newroloġiċi jistgħu jirriżultaw wara inġestjoni orali talprodott veterinarju mediċinali aċċidentalment (ara sezzjoni 4.5).
English: 3 x 0.9 ml 4 x 0.9 ml 6 x 0.9 ml 15 x 0.9 ml
Maltese: 9 ml 15 x 0.9 ml
English: Unit dose syringe-shaped applicators (clear siliconised cyclic olefin copolymer (COC)) containing 0.3 ml or 0.9 ml of product, closed with a polymer cap and placed in individual plastic blisters.
Maltese: magħluqin b'tapp tal-polymer, li fihom 0.3 ml jew 0.9 ml tal-prodott, u mqiegħdin fi folji individwali tal-plastik.
English: Cardboard box containing 1, 3, 4, 6 or 15 applicator(s) (0.9 ml each).
Maltese: Kaxxa tal-kartun li fiha 1, 3, 4, 6 jew 15 applikatur(i) (0.9 ml kull wieħed).
English: Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve or muscle cells.
Maltese: Komposti tal-klassi jingħaqdu b'mod selettiv u b'affinita' kbira ma' kanali tal-joni tal-glutamate-gated chloride li jseħħu fiċ-ċelluli tan-nervituri jew tal-muskoli invertebrati.
English: Elimination of fleas within 24 hours.
Maltese: L-eliminazzjoni ta' briegħed fi żmien 24 siegħa.
English: Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms.
Maltese: Qtates f'postijiet endemiċi għal heartworm, jew dawk li marru f'postijet endemiċi, jistgħu jkunu infettati bi heartworms adulti.
English: Cardboard box containing 1, 3, 4 or 15 applicator(s) (0.3 ml each).
Maltese: Kaxxa tal-kartun li fiha 1, 3, 4 jew 15 applikatur(i) (0.3 ml kull wieħed).
English: C. STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TA L-MRLs
English: Use only according to the benefit-risk assessment by the prescribing veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal-beneficcju u r-riskju mill-veterinarju responsabbli.
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 veterinarju mediċinali tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu).
English: BROADLINE spot-on solution for cats < 2.5 kg BROADLINE spot-on solution for cats 2.5-7.5 kg
Maltese: VETERINARJU BROADLINE soluzzjoni għall-użu lokalizzat < 2.5 kg BROADLINE soluzzjoni għall-użu lokalizzat 2.5-7.5 kg
English: Nematodes - Treatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, adults of Toxascaris leonina , L4 larvae and adults of Ancylostoma tubaeforme and
Maltese: Nematodes - Kura ta' infestazzjonijiet b'nematodes gastrointestinali (L3, L4 larvae u adulti ta' Toxocara cati,
English: - Treatment of infestations with vesical worms (Capillaria plica).
Maltese: - Kura ta' infestazzjonijiet b'dud vexxikali (Capillaria plica).
English: - Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
Maltese: - Prevenzjoni ta' heartworm disease (larvae ta' Dirofilaria immitis) għal xahar.
English: Eprinomectin and praziquantel act systemically, with plasma concentrations reaching a maximum within 48 hours and 6 hours after treatment, respectively, reaching mean maximum concentrations (Cmax) of 20.1 ng/ml for eprinomectin and 157 ng/ml for praziquantel.
Maltese: Eprinomectin u praziquantel jaġixxu sistemikament, bil-konċentrazzjonijiet tal-plażma jilħqu l-massimu fi żmien 48 siegħa u 6 siegħat wara l-kura rispettivament, li jilħqu l-konċentrazzjoni massima medja (Cmax) ta' 20.
English: For cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites.
Maltese: Għall-qtates bi, jew f'risku minn, infestazzjonijiet imħallta bi cestodes, nematodes u ektoparassiti.
English: Oral ingestion of the veterinary medicinal product resulted in common to uncommon vomiting, hypersalivation and/or in transient neurological signs such as ataxia, disorientation, apathy and pupil dilation in safety studies.
Maltese: Fi studji dwar is-sigurtà, inġestjoni orali irriżulta f'remettar komuni sa mhux komuni, salivazzjoni eccessiva, u/jew sinjali newroloġiċi transitorji bħal atassja, diżorjentament, apatija u dilatazzjoni tal pupilla.
English: Ancylostoma ceylanicum, and adults of Ancylostoma brazilienze).
Maltese: adulti ta' Toxascaris leonina L4 larvae u adulti ta' Ancylostoma tubaeforme u Ancylostoma ceylanicum,u adulti ta'Ancylostoma brazilienze).
English: Cardboard box containing 1, 3, 4, 6 or 15 unit dose applicator(s) of 0.9 ml each.
Maltese: Kaxxa tal-kartun li fiha applikatur(i) b'1, 3, 4, 6 jew 15-il doża unika ta' 0.9ml kull waħda.
English: PACKAGE LEAFLET: BROADLINE spot-on solution for cats < 2.5 kg BROADLINE spot-on solution for cats 2.5-7.5 kg
Maltese: VETERINARJU BROADLINE soluzzjoni għall-użu lokalizzat għall-qtates < 2.5 kg BROADLINE soluzzjoni għall-użu lokalizzat għall-qtates 2.5-7.5 kg
English: Manufacturer responsible for batch release: MERIAL
Maltese: Praziquantel għandu distribuzzjoni moderata fit-tessuti, u madwar
English: Although the veterinary medicinal product may be safely administered to cats infected with adult heartworms, no therapeutic effect against adult Dirofilaria immitis has been established.
Maltese: Għalkemm il-prodott jista' jkun amministrat b'mod sigur lill-qtates infettati bi heartworms adulti, l-ebda effett terapewtiku kontra Dirofilaria immitis ma ġie stabbilit.
English: Praziquantel is rapidly adsorbed via the surface of the parasites and affects membrane permeability in cestodes, influencing divalent cation fluxes, particularly calcium ion homeostasis, which is thought to contribute to the rapid muscle contraction and vacuolisation.
Maltese: Praziquantel jiġi assorbit malajr permezz tal-wiċċ tal-parassita u jeffettwa il-permejabilità tal-membrana fi cestodes, li jinfluwenza flussi ta' divalent cation, partikolarment calcium ion homeostasis, li hu mifhum li jikkontribwixxi għal kontrazzjoni ta' malajr tal-muskolu u vakwolizzazjoni.
English: Correct application will minimise the occurrence of such events (see section 4.9).
Maltese: Applikazzjoni korretta tnaqqas il-possibilità ta' dawn l-effetti (ara sezzjoni 4.9).
English: Temporary excessive salivation was commonly observed following licking the application site after treatment in clinical trials.
Maltese: Fi provi kliniċi salivazzjoni eċċessiva temporanja ġiet osservata b'mod komuni wara li l-qattus laq is sit tal-applikazzjoni wara l-kura.
English: Spot-on solution
Maltese: NUMRU TAL-LOTT
English: This results in uncontrolled activity of the central nervous system and death of insects or acarians.
Maltese: Dan jirriżulta f'attività mhux ikkontrollata tas-sistema nervuża ċentrali u l-mewt ta' insetti u akari.
English: Spot-on solution.
Maltese: L-eliminazzjoni ta'
English: On very rare occasions, symptomatic treatment can be required.
Maltese: F'okkażjonijiet rari ħafna, tkun meħtieġa kura sintomatika.
English: Mild and transient neurological signs such as ataxia, disorientation, apathy and pupil dilation may be observed, with spontaneous recovery the day after.
Maltese: Sinjali newroloġiċi ħfief u transitorji bħal atassja, diżorjentament, apatija u dilatazzjoni tal-pupilla jistgħu jiġu osservati, b'fejqan spontanju l-għada.
English: ADVICE ON CORRECT ADMINISTRATION
Maltese: MOD(I) TA' AMMINISTRAZZJONI
English: Cardboard box containing 1, 3, 4 or 15 unit dose applicator(s) of 0.3 ml each.
Maltese: Kaxxa tal-kartun li fiha applikatur(i) b'1, 3, 4 jew 15-il doża unika ta' 0.3ml kull waħda.
English: Safety has been demonstrated with up to 5 times the maximum exposure dose (i.e. up to 15 times the recommended dose) in healthy kittens aged 7 weeks and older treated up to 6 times at four-week intervals.
Maltese: Is-sigurta' ntweriet b'sa 5 darbiet id-doża għal esponiment massimu (ie. sa 15 ‘il darba d-doża rrikmandata ) fi frieħ f'saħħithom ta' 7 ġimgħat ‘l fuq li ħadu l-kura sa 6 darbiet f'intervalli ta' 4 ġimgħat.
English: The use of the veterinary medicinal product should exclusively be based on the confirmed mixed infestations or significant risk of such mixed infestation with ectoparasites and nematodes (including for heartworm disease prevention) and where concurrent treatment against cestodes is indicated.
Maltese: L-użu tal-prodott veterinarju mediċinali għandu jkun esklusivament ibbażat fuq l-infestazzjonijiet imħallta ikkonfermati jew fuq riskju sinifikanti ta' infestazzjonijiet imħallta ta' dan it-tip b'ektoparassiti u nematodes (inkluż għal prevenzjoni ta' heartworm disease) u fejn kura fl-istess waqt kontra cestodes hija indikata.
English: The full EPAR for Levetiracetam Sun 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: Levetiracetam Sun is a ‘generic medicine'.
Maltese: Levetiracetam Sun huwa ‘mediċina ġenerika'.
English: It is available as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Maltese: Jiġi bħala konċentrat biex jitħallat f'soluzzjoni għal infużjoni (drip ġol-vina, 100 mg/ml).
English: In patients aged between four and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Maltese: F'pazjenti bejn erba' snin u 17-il sena li jiżnu inqas minn 50 kg, id-doża tal-bidu għandha tkun 10 mg għal kull kilogramm tal-piż tal-ġisem darbtejn kuljum, li tista' tiżdied sa 30mg/kg darbtejn kuljum.
English: The active substance in Levetiracetam Sun, levetiracetam, is an anti epileptic medicine.
Maltese: Is-sustanza attiva f'Levetiracetam Sun, il-levetiracetam, hija mediċina antiepilettika.
English: EPAR summary for the public levetiracetam
Maltese: Sommarju tal-EPAR għall-pubbliku levetiracetam
English: The daily dose can be increased up to 1,500 mg twice a day.
Maltese: Iddoża ta' kuljum tista' tiżdied sa 1,500 mg darbtejn kuljum.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Sun.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Levetiracetam Sun.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Maltese: Il-mod preċiż kif taħdem il-levetiracetam għadu mhux ċar iżda jidher li din tinterferixxi ma' proteina msejħa proteina sinaptika vexxili 2A, li tinstab flispazji ta' bejn in-nervituri, u għandha sehem fir-rilaxx ta' messaġġiera kimiċi miċ-ċelloli tan-nervituri.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Sun on 14 December 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Levetiracetam Sun fl-14 ta' Diċembru 2011.
English: Levetiracetam Sun is a medicine that contains the active substance levetiracetam.
Maltese: Levetiracetam Sun huwa mediċina li fiha s-sustanza attiva levetiracetam.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Sun has been shown to have comparable quality and to be bioequivalent to Keppra.
Maltese: Is-CHMP ikkonkluda li, b'konformità mar-rekwiżiti tal-UE, intwera li l-kwalità ta' Levetiracetam Sun hija kumparabbli u li huwa bijoekwivalenti għal Keppra.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Maltese: Din hija tip ta' epilessija fejn attività elettrika eċċessiva f'naħa waħda tal-moħħ tikkawża sintomi bħal movimenti spażmodiċi għal għarrieda ta' xi parti millġisem, smigħ, xamm, jew viżta mhux ċari, tirżiħ jew sens ta' biża' f'daqqa.
English: This means that Levetiracetam Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Maltese: Dan ifisser li Levetiracetam Sun huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Keppra.
English: When Levetiracetam Sun is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Maltese: Meta Levetiracetam Sun jingħata flimkien ma' trattament antiepilettiku ieħor, id-doża tal-bidu f'pazjenti minn 12-il sena 'l fuq li jiżnu aktar minn 50 kg għandha tkun 500 mg darbtejn kuljum.
English: When Levetiracetam Sun is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Maltese: Meta Levetiracetam Sun jintuża waħdu, id-doża tal-bidu hija 250 mg darbtejn kuljum, u tiżdied ġimgħatejn wara għal 500 mg darbtejn kuljum.
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Maltese: • aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji (attakki severi, inkluż it-telf tal-koxjenza)
English: What is Levetiracetam Sun?
Maltese: Kif jaħdem Levetiracetam Sun?
English: The company provided data from the published literature on levetiracetam.
Maltese: Il-kumpannija pprovdiet dejta minn dokumentazzjoni ppubblikata dwar levetiracetam.
English: Because Levetiracetam Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Levetiracetam Sun huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Other information about Levetiracetam Sun
Maltese: Aktar tagħrif dwar Levetiracetam Sun
English: Why has Levetiracetam Sun been approved?
Maltese: Għaliex ġie approvat Levetiracetam Sun?
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Maltese: • aċċessjonijiet mijokloniċi (qosra, movimenti spażmodiċi donnhom xokkijiet ta' muskolu jew ta'
English: years of age with juvenile myoclonic epilepsy;
Maltese: grupp ta' muskoli) f'pazjenti minn tnax-il sena 'l fuq li jbatu bl-epilessija mijoklonika ġuvenili;
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal filkaż ta' Keppra, il-benefiċċju huwa akbar mir-riskju identifikat.
English: How has Levetiracetam Sun been studied?
Maltese: Kif ġie studjat Levetiracetam Sun?
English: No additional studies in patients were needed as Levetiracetam Sun is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Keppra.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali fuq pazjenti peress li Levetiravetam Sun huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fiha l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Keppra.
English: Levetiracetam Sun can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Maltese: Levetiracetam Sun jista' jintuża waħdu f'pazjenti minn 16-il sena 'l fuq li ġew dijanjostikati għall-ewwel darba bl-epilessija, għall-kura ta' aċċessjonijiet parzjali tal-bidu (attakki ta' epilessija) b'ġeneralizzazzjoni sekondarja jew mingħajrha.