FrancophonIA/ELRC3.0 huggingface dataset:
English: Dinotefuran and pyriproxyfen are partially absorbed by the cat skin (30% and 12% respectively), but this systemic absorption is not relevant for the clinical efficacy of the product.
Maltese: Dinotefuran u pyriproxyfen jiġu assorbiti parzjalment minn ġol-ġilda tal-qattus (30% u 12% rispettivament), imma l-assorbiment sistemiku mhux rilevanti għall-effikaċja klinika tal-prodott.
English: EU/2/14/165/001 (1 spot-on applicator) EU/2/14/165/002 (3 spot-on applicators) EU/2/14/165/006 (4 spot-on applicators) EU/2/14/165/003 (6 spot-on applicators) EU/2/14/165/004 (12 spot-on applicators) EU/2/14/165/007 (24 spot-on applicators)
Maltese: EU/2/14/165/001 (applikatur lokalizzat 1) EU/2/14/165/001 (3 applikaturi lokalizzati)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/165/001-004
Maltese: FIS-SUQ EU/2/14/165/001-004
English: ROUTE(S) OF ADMINISTRATION Spot-on use
Maltese: MOD(I) TA' AMMINISTRAZZJONI Użu lokalizzat
English: For animal treatment only.
Maltese: Ceva Santé Animale
English: Cardboard box of 1, 3, 4, 6, 12 or 24 spot-on applicator(s).
Maltese: Kaxxa tal-kartun b'applikatur lokalizzat 1, 3, 4, 6, 12 jew 24 applikatur lokalizzat.
English: Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, other ectoparasiticides for topical use.
Maltese: Prodotti antiparasitiċi, insettiċidi u repellanti; ektoparasiticidi oħra għal użu topikali.
English: Hyperactivity and tachypnoea may occur very rarely.
Maltese: Iperattività u takipnea jistgħu jseħħu b'mod rari ħafna.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Vectra Felis 423 mg/42.3 mg spot-on solution for cats dinotefuran/pyriproxyfen
Maltese: VETERINARJU Vectra Felis 423 mg/42.3 mg soluzzjoni għall-użu lokalizzat għal qtates dinotefuran/pyriproxyfen
English: MANUFACTURER'S BATCH NUMBER Lot:
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott:
English: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Maltese: Uża biss skont l-istima ta' benefiċċju/riskju mill-veterinarju responssabbli.
English: Laboratory studies with the active substances, dinotefuran or pyriproxyfen, in rats and rabbits have not produced any evidence of birth defects or other harmful effects in the developing embryo or foetus (teratogenic, foetotoxic) or harmful effects for the mother (maternotoxic effects).
Maltese: Studji tal-laboratorju bis-sustanzi attivi, dinotefuran u pyriproxyfen, fil-firien u fniek ma pproduċewx evidenza ta' mankamenti fit-twelid jew effetti oħra ta' ħsara fl-embrijun jew fetu li qed jiżviluppa (teratoġeniku, fetotossiku) jew effetti ta' ġrieħi fuq l-omm (effetti maternotossiċi).
English: Its structure is derived from the neurotransmitter acetylcholine and it acts on nicotinic acetylcholine receptors of the insect nerve synapse.
Maltese: L-istruttura tiegħu hija derivata min-newrotrasmettitur acetylcholine u jaġixxi fuq riċettaturi nikotiniċi ta' acetylcholine fuq is-synapse tan-nerv tal-insett.
English: Treatment and prevention of flea infestations (Ctenocephalides felis) on cats.
Maltese: Trattament u prevenzjoni ta' infestazzjoni minn briegħed (Ctenocephalides felis) fuq il-qtates.
English: Dinotefuran………………….. 423 mg Pyriproxyfen………………… 42.3 mg For the full list of excipients, see section 6.1.
Maltese: Dinotefuran………………….. 423 mg Pyriproxyfen…………………
English: In laboratory species, after intra-peritoneal administration, dinotefuran is rapidly eliminated as the unchanged parent molecule mainly via the urine.
Maltese: Fi speċi tal-laboratorju, wara għoti ġol-peritonew, dinotefuran jiġi eliminat malajr bħala l-molekula oriġinali mhux mibdula prinċipalment mill-awrina.
English: (The minimum recommended dose is 42.3 mg dinotefuran/kg bodyweight and 4.23 mg pyriproxyfen/kg bodyweight.
Maltese: (Id-doża minima rakkomandata hi ta' 42.3 mg dinotefuran/kg piż ta' ġisem u 4.23 mg pyriproxyfen/kg piż ta' ġisem.
English: Do not use in cats or kittens weighing less than 0.6 kg.
Maltese: għal qtates li jiżnu bejn 0.6 kg u 10 kg).
English: SPECIAL WARNING(S)
Maltese: NUMR(U/I)
English: In case of suspicion of dermatitis (itch and skin irritation), seek for veterinary advice.
Maltese: F'każ li d-dermatite (ħakk u irritazzjoni tal-ġilda) hija suspettata, fittex parir veterinarju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 1, 3, 4, 6, 12 and 24 spot-on applicators
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun b'applikatur lokalizzat 1, 3, 4, 6, 12 u 24 applikatur lokalizzat
English: Pyriproxyfen targets the immature stages of insects (eggs, larvae, pupae) by disruption of their reproduction and development.
Maltese: Pyriproxyfen jimmira l-istadji immaturi tal-insetti (bajd, larve, pupe) billi jħarbat ir-riproduzjoni u liżvilupp tagħhom.
English: The treatment dose range is 42.3 to 705 mg dinotefuran/kg bodyweight (bw) and 4.23 to 70.5 mg pyriproxyfen/kg bodyweight (bw) for cats of 0.6 kg to 10 kg bodyweight.
Maltese: Il-firxa tad-doża ta' trattament hi minn 42.3 sa 705 mg dinotefuran/kg piż tal-ġisem u 4.23 sa 70.5 mg pyriproxyfen/kg piż ta' ġisem (bw) għal qtates ta' 0.6 sa 10 kg piż tal-ġisem.
English: Transient cosmetic effects such as wet hair and a white dry residue may occur at the application site very rarely and may persist up to 7 days; however, these effects are usually not noticeable after 48 hours.
Maltese: Effetti kosmetiċi għaddiena bħal pil imxarrab u residwu abjad xott jistgħu jseħħu fis-sit t'applikazzjoni b'mod rari ħafna u jistgħu jippersistu għal sa 7 ijiem, madanakollu, dawn l-effetti ġeneralment ma jintgħarfux sa wara 48 siegħa.
English: Each 0.9 ml spot-on applicator delivers:
Maltese: Kull applikatur lokalizzat ta' 0.9 ml jagħti:
English: The safety of this veterinary medicine has not been established in cats younger than 7 weeks of age or weighing less than 0.6 kg (see section “Contraindications”).
Maltese: Is-sigurtà ta' din il-mediċina veterinarja ma ġietx stabbilita fi qtates iżgħar minn 7 ġimgħat jew li jiżnu inqas minn 0.6 kg (ara sezzjoni “Kontraindikazzjonijiet).
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each 0.9 ml spot-on applicator delivers: 423 mg dinotefuran and 42.3 mg pyriproxyfen.
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI U INGREDJENTI OĦRA Kull applikatur lokalizzat ta' 0.9 ml jagħti: 423 mg dinotefuran u 42.3 mg pyriproxyfen.
English: To avoid adverse reactions:
Maltese: Sabiex tevita reazzjonijiet avversi:
English: The minimum recommended dose is 42.3 mg dinotefuran/kg bodyweight and 4.23 mg pyriproxyfen/kg bodyweight.
Maltese: Id-doża minima rakkomandata hi ta' 42.3 mg dinotefuran/kg piż ta' ġisem u 4.23 mg pyriproxyfen/kg piż ta' ġisem.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Vectra Felis 423 mg/42.3 mg spot-on solution for cats
Maltese: VETERINARJU Vectra Felis 423 mg/42.3 mg soluzzjoni għall-użu lokalizzat għal qtates
English: Once bound to these receptors, the full agonist action of repeated excitatory impulses kills the insect.
Maltese: Ġaladarba jingħaqad ma' dawn ir-riċettaturi, l-azzjoni agonista sħiħa ta' impulsi eċitati ripetuti joqtlu lill-insett.
English: EXP {month/year}
Maltese: JIS {xahar/sena}
English: B. PACKAGE LEAFLET
Maltese: Applikatur lokalizzat
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Each 0.9 ml spot-on applicator contains dinotefuran 423 mg and pyriproxyfen 42.3 mg.
Maltese: Kull applikatur lokalizzat ta' 0.9 ml fih dinotefuran 423 mg u pyriproxyfen 42.3 mg
English: STATEMENT OF ACTIVE SUBSTANCES Each 0.9 ml spot-on applicator contains dinotefuran 423 mg and pyriproxyfen 42.3 mg.
Maltese: Kull applikatur lokalizzat ta' 0.9 ml fih 423 mg dinotefuran u 42.3 mg pyriproxyfen.
English: People with known hypersensitivity to dinotefuran, pyriproxyfen or dimethyl sulfoxide should avoid contact with this veterinary medicinal product.
Maltese: Persuni li jafu li għandhom sensittività eċċessiva għal dinotefuran, pyriproxyfen jew dimethyl sulfoxide għandhom jevitaw il-kuntatt ma' dan il-prodott mediċinali veterinarju.
English: No clinically important adverse reactions were observed in healthy kittens aged 7 weeks or more, topically treated 7 times at 2 week intervals and with up to 4 times the highest recommended dose except transient oedema or dry skin at the application site.
Maltese: Ma kienx hemm reazzjonijiet mhux mixtieqa importanti fi qtates frieħ b'saħħithom li kellhom 7 ġimgħat jew aktar, trattati topikament 7 darbiet f'intervalli ta' ġimagħtejn u b'doża sa 4 darbiet logħla doża rakkomandata għajr għal edema temporanja jew ġilda xotta fis-sit t'applikazzjoni.
English: Dinotefuran has a low affinity for mammalian acetylcholine receptor sites.
Maltese: Dinotefuran għandu affinità baxxa għal siti ta' riċettatur ta' acetylcholine tal-mammiferi.
English: The treatment dose range is 42.3 to 705 mg dinotefuran/kg bodyweight and 4.23 to 70.5 mg pyriproxyfen/kg bodyweight for cats which weigh between 0.6 kg and 10 kg).
Maltese: Il-firxa tad-doża ta' trattament hi minn 42.3 sa 705 mg dinotefuran/kg piż ta' ġisem u 4.23 sa 70.5 mg pyriproxyfen/kg piż ta' ġisem.
English: PACKAGE LEAFLET: Vectra Felis 423 mg/42.3 mg spot-on solution for cats
Maltese: Vectra Felis 423 mg/42.3 mg soluzzjoni għall-użu lokalizzat għal qtates
English: The need to re-treat cats which are likely to be re-infested, and the time interval between such treatments, should be based on an assessment by a veterinarian.
Maltese: Il-bżonn li jiġu trattati qtates li x'aktarx jiġu infestati mill-ġdid, u l-intervall bejn dawn it-trattamenti, għandhom ikunu bażati fuq stima minn veterinarju.
English: After oral administration, pyriproxyfen is rapidly metabolized, principally by hydroxylation, and eliminated mainly in the faeces, and to a lesser extent in the urine.
Maltese: Wara għoti mill-ħalq, pyriproxyfen jiġi metabolizzat malajr, prinċipalment b'idrosilazzjoni u jiġi eliminat prinċipalment fl-ippurgar, u sa ċertu punt anke fl-awrina.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and spot-on applicator after “EXP”.
Maltese: Tużax dan il-prodott mediċinali veterinarju wara d-data ta' skadenza murija fuq il-kartuna u lapplikatur lokalizzat wara “Jiskadi”.
English: Colourless to pale yellow spot-on solution.
Maltese: Użu lokalizzat għal applikazzjoni fuq barra tal-ġilda.
English: 6.5 Nature and composition of immediate packaging Spot-on applicator made of a multilayered complex of aluminium and polyethylene (PE) with a head made of HDPE, top-sealed with a liner complex (aluminium/polyester/sealable PE layer).
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mal-prodott L-applikatur lokalizzat hu magħmul minn kumpless ta' diversi saffi ta' aluminju u polyethylene (PE) b'ras magħmul minn HDPE, bl-għatu ssiġillat b'kumpless inforrat (aluminju/polyester/saff ta' PE). Daqsijiet tal-pakkett
English: Flea eggs, larvae and pupae are present in the environment.
Maltese: Bajd tal-briegħed, larve u pupe huma preżenti fl-ambjent.
English: In rats, dinotefuran has been shown to cross the blood-milk barrier and is excreted in the milk.
Maltese: Fil-firien, dinotefuran intwera li jaqsam il-barriera bejn id-demm u l-ħalib u jiġi eliminat mal-ħalib.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Maltese: .6 Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar-rimi li huwa derivat minn dawn il-prodotti
English: Treatment schedule:
Maltese: Skeda ta' trattament:
English: (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Maltese: (≥1/10,000 sa ≤1/1,000); rari ħafna: (≤1/10,000).
English: Grape flavour Citric acid monohydrate Sodium hydroxide Purified water
Maltese: Citric acid monohydrate Sodium hydroxide Ilma purifikat
English: Date of first authorisation: 26 August 2011 Date of latest renewal: 28 April 2016
Maltese: Data tal-aħħar tiġdid: 28 ta' April 2016
English: Poly(vinyl alcohol), Titanium dioxide (E171), Macrogol, Talc, Blue indigo carmine aluminium lake (E132)
Maltese: Poly(vinyl alcohol), Titanium dioxide (E171), Macrogol, Talc, Blue indigo carmine aluminaluminium lake ( E132)
English: 4+ years
Maltese: 4+ snin
English: Levetiracetam ratiopharm contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, potassium and sodium.
Maltese: Levetiracetam ratiopharm fih methyl parahydroxybenzoate, propyl parahydroxybenzoate, potassium u sodium.
English: Tablet core: Macrogol 6000, Colloidal anhydrous silica, Crospovidone, Cellulose powdered, Magnesium stearate.
Maltese: Il-qalba tal-pillola: Macrogol 6000, Colloidal anhydrous silica, Crospovidone, Cellulose powdered, Magnesium stearate.
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Maltese: Clcr (ml/min) = ------------------------------------------------ (x 0.85 għan-nisa) 72 x livell ta' kreatinina fis-serum (mg/dl)
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletrici u tattessuti konnettivi
English: Oral solution 150 ml oral solution
Maltese: Soluzzjoni orali 150 ml ta' soluzzjoni orali
English: 500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily (2)
Maltese: 500 sa 1,000 mg darbtejn kuljum250 sa 750 mg darbtejn kuljum250 sa 500 mg darbtejn kuljum
English: Τηλ: +30 2118805000
Maltese: Ελλάς Α.Ε. Τηλ: +30 2118805000
English: Each ml contains 1.4 mg methyl parahydroxybenzoate (E 218), 0.27 mg propyl parahydroxybenzoate (E 216) and 3.1 mg potassium.
Maltese: Kull ml fih 1.4 mg methyl parahydroxybenzoate (E 218), 0.27 mg propyl parahydroxybenzoate (E 216) u 3.1 mg potassium
English: ks= 0.45 in Term infants to 1 year old; ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Maltese: ks= 0.45 f'Trabi li twieldu fiż-żmien sa età ta' sena; ks= 0.55 fi tfal sa inqas minn 13-il sena u fl-adoloxxenti feminili; ks= 0.7 f'adoloxxenti maskili.
English: Multipack: 200 (2 packs of 100) film-coated tablets Multipack: 120 (2 packs of 60) film-coated tablets
Maltese: Multipack: 200 (2 pakketti ta' 100) pillola miksija b'rita Multipack: 120 (2 pakketti ta' 60) pillola miksija b'rita
English: • severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction],
Maltese: • reazzjonijiet allerġiċi serji (DRESS, reazzjoni anafillattika [reazzjoni severa u importanti],
English: 6-48 months
Maltese: 6-48 xahar
English: Oral solution 300 ml oral solution
Maltese: Soluzzjoni orali 300 ml ta' soluzzjoni orali
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Maltese: impediment talmemorja, koordinazzjoni abnormali/ataxja, paraestesija, disturbi fl' attenzjoni
English: Component of a multipack, can't be sold separately
Maltese: Komponent mill-multipack, ma jistax jinbiegħ separatament
English: CLcr (ml/min/1.73 m2) = ------------------------------------------Serum Creatinine (mg/dl)
Maltese: CLcr (ml/min/1.73 m2) = -------------------------------Kreatinina fis-serum (mg/dl)
English: The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, sodium hydroxide, purified water, acesulfame potassium (E 950), grape flavour.
Maltese: Is-sustanzi l-oħra huma: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, sodium hydroxide, purified water, acesulfame potassium (E 950), grape flavour.
English: Levetiracetam ratiopharm 250 mg film-coated tablets Poly(vinyl alcohol), Titanium dioxide (E171), Macrogol, Talc, Blue indigo carmine aluminium lake (E132)
Maltese: Levetiracetam ratiopharm 250 mg pilloli miksija b'rita Poly(vinyl alcohol), Titanium dioxide (E171), Macrogol, Talc, Blue indigo carmine aluminium lake (E132)
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur ratiopharm GmbH Graf-Arco-Straße 3
English: PVC/Aluminium blister packs.
Maltese: Pakketti ta' folji tal-PVC/aluminju.
English: This presentation should be prescribed for children aged 4 years and older, adolescents and adults.
Maltese: Din il-preżentazzjoni għandha tiġi preskritta lil tfal ta' età t'4 snin u aktar, adoloxxenti u adulti.
English: For children aged 6 months to less than 4 years.
Maltese: Għal tfal ta' età minn 6 xhur sa inqas minn 4 snin.
English: Your doctor will establish the best possible treatment of overdose.
Maltese: It-tabib tiegħek ser jiddeċiedi l-aħjar trattament possibbli għat-trattament tal-overdose.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Maltese: Ir-reazzjonijiet avversi kienu ppreżentati f'ordni ta' gravita` minn ħafna għal ftit u il-frekwenza giet mfissra b'dan il-mod: komuni hafna (≥1/10); komuni: (>1/100 sa ≤1/10); mhux komuni: (>1/1,000 sa ≤1/100) u rari:
English: This medicine contains 1.2 mmol (or 46.65 mg) potassium per 15 ml.
Maltese: Din il-mediċina fiha 1.2 mmol (jew 46.65 mg) potassium kull 15 ml.
English: Creatinine clearance (ml/min/1.73 m2)
Maltese: Rata ta' tneħħija tal-kreatinina (ml/min/1.73 m2)
English: Date of first authorisation: 26 August 2011 Date of latest renewal: 28.
Maltese: Data ta' l-ewwel awtorizzazzjoni: 26 ta' Awwissu 2011
English: 47.4 % of the patients were free of tonic-clonic seizures for at least 6 months and 31.5 % were free of tonic-clonic seizures for at least 1 year.
Maltese: 4 % tal-pazjenti ma kellhomx aċċessjonijiet tat-tip tonic-clonic għal mill-inqas 6 xhur u 31.5 % ma kellhomx aċċessjonijiet tat-tip tonic-clonic għal mill-inqas sena.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Maltese: Riżultati li għandhom x'jaqsmu mal-funzjoni tal-imġiba u dik emozjonali juru aggravament fil-pazjenti trattati b'levetiracetam f'imġiba aggressiva kif imkejjel b'mod standardizzat u sistematiku bl-użu ta' strument validat (CBCL - Achenbach Child Behaviour Checklist).
English: Film-coating:
Maltese: Tnaqqis fil-piz,
English: The NOAEL was < 200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m2 basis).
Maltese: In-NOAEL kien ta' <200 mg/kg/ġurnata fl-ommijiet u 200 mg/kg/ġurnata għal-feti (ugwali għal MRHD fuq bażi ta' mg/m2).
English: In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7 %) and coordination abnormal (common, 3.3 %) were reported more frequently than in other age groups or in the overall safety profile.
Maltese: F'trabi u tfal t'eta` minn xahar sa inqas minn 4 snin, irritabilta` (komuni ħafna, 11.7 %) u koordinazzjoni abnormali (komuni, 3.3 %) kienu rappurtati iżjed frekwentament minn fil-gruppi t'etajjiet oħra jew mill-profil ta' sigurta` totali.
English: Levetiracetam ratiopharm is used:
Maltese: Levetiracetam ratiopharm huwa użat:
English: Levetiracetam ratiopharm 250 mg film-coated tablets Levetiracetam ratiopharm 500 mg film-coated tablets Levetiracetam ratiopharm 750 mg film-coated tablets Levetiracetam ratiopharm 1000 mg film-coated tablets
Maltese: Levetiracetam ratiopharm 250 mg pilloli miksija b'rita Levetiracetam ratiopharm 500 mg pilloli miksija b'rita Levetiracetam ratiopharm 750 mg pilloli miksija b'rita Levetiracetam ratiopharm 1000 mg pilloli miksija b'rita
English: Levetiracetam ratiopharm 100 mg/ml oral solution Levetiracetam
Maltese: Levetiracetam ratiopharm 100 mg/ml soluzzjoni orali Levetiracetam
English: Oral solution.
Maltese: Soluzzjoni orali
English: Dose in adults and adolescents (from 16 years of age):
Maltese: Doża fl-adulti u adoloxxenti (minn 16-il sena):
English: Three presentations are available: - A 300 ml bottle with a 10 ml oral syringe (delivering up to 1000 mg levetiracetam) graduated every 0.25 ml (corresponding to 25 mg).
Maltese: Flixkun ta' 300 ml b'siringa orali ta' 10 ml (li tagħti sa 1000 mg levetiracetam) iggradata kull 0.25 ml (li jikkorispondi għal 25 mg)..
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew derivattivi oħrajn ta' pyrrolidone, jew għal kwalunkwe wieћed mill-eċċipjenti elenkati f'sezzjoni 6.1.
English: In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2 %), agitation (common, 3.4 %), mood swings (common, 2.1 %), affect lability (common, 1.7 %), aggression (common, 8.2 %), abnormal behaviour (common, 5.6 %), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile.
Maltese: Fit-tfal u addoloxxenti t'eta` ta' 4-16-il sena, ir-rimettar (komuni ħafna, 11.2 %), aġitazzjoni (komuni, 3.4 %), tibdil fil-burdati (komuni, 2.1 %), tibdil spiss ta' emozzjonijiet (komuni, 1.7 %), aggressjoni (komuni, 8.2 %), mġieba abnormali (komuni, 5.6 %), u telqa (komuni, 3.9 %)
English: This medicine contains less than 1 mmol sodium (23 mg) per 15 ml that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull 15-il ml, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (3) (5)
Maltese: 10 sa 20 mg/kg darba kuljum (3) (5)
English: Pliva Hrvatska d.o.o Tel: +385 1 37 20 000
Maltese: Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
English: 3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
Maltese: 5 mg/kg (0.035 sa 0.105 ml/kg) darbtejn kuljum
English: Add-on therapy for infants aged 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Maltese: Terapija miżjuda fit-trabi minn età ta' 6 sa 23 xahar, tfal (2 sa 11-il sena) u adoloxxenti (12 sa 17-il sena) li jiżnu inqas minn 50 kg
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg)once daily (2) (4)
Maltese: 7 sa 14 mg/kg darba kuljum (2)
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Maltese: Is-sustanza attiva, levetiracetam hija derivattiva ta' pyrrolidone (S-enantiomer ta' α-ethyl-2- oxo-1
English: - A 150 ml bottle with a 3 ml oral syringe (delivering up to 300 mg levetiracetam) graduated every 0.1 ml (corresponding to 10 mg)
Maltese: Flixkun ta' 150 ml b'siringa orali ta' 3 ml (li tagħti sa 300 mg levetiracetam) iggradata kull 0.1 ml (li jikkorispondi għal 10 mg).
English: It may harm them,
Maltese: Disturbi fis
English: Levetiracetam ratiopharm 250 mg film-coated tablets EU/1/11/702/004
Maltese: Levetiracetam ratiopharm 250 mg pilloli miksija b'rita EU/1/11/702/004
English: Pancytopenia , neutropenia, agranulocytosis
Maltese: Diplopja, viżjoni mċajpra
English: Macrogol 6000, Colloidal anhydrous silica, Crospovidone A, Cellulose powdered, Magnesium stearate.
Maltese: Colloidal anhydrous, silica Crospovidone A Cellulose powdered Magnesium stearate
English: EXP See outer carton
Maltese: EXP Ara l-kartuna ta' barra
English: Levetiracetam ratiopharm 750 mg film-coated tablets EU/1/11/702/018
Maltese: Levetiracetam ratiopharm 750 mg pilloli miksija b'rita EU/1/11/702/018
English: Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).
Maltese: Stevens-Johnson), u forma iżjed severa li tikkawża ġilda li titqaxxar f'iżjed minn 30% tal-wiċċ tal-ġilda (nekroliżi tossiku epidermali);
English: Levetiracetam ratiopharm 100 mg/ml oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Maltese: Soluzzjoni orali ta' 100 mg/ml ta' Levetiracetam ratiopharm hija l-formulazzjoni preferuta għall-użu fi tfal li għadhom m'għalqux 6 snin.