FrancophonIA/ELRC3.0 huggingface dataset:
English: For the reference product mean cumulative failure rates were 13.5% and 27.3% on Day 5 and Day 11, respectively.
Maltese: Għall-prodott ta' referenza, ir-rati kumulattivi medji ta' falliment kienu ta' 13.5% u ta' 27.3% f'Jum 5 u f'Jum 11, rispettivament.
English: The failure rate for Nuflor Swine Once varied from 0 to 56% at Day 11 and was similar to the comparator enrofloxacin with 0 to 42%.
Maltese: Ir-rata ta' falliment għal Nuflor Swine Once kienet tvarja minn 0 għal 56% f'Jum 11 u kienet simili għall-komparatur enrofloxacin b'0 għal 42%.
English: Florfenicol is bacteriostatic and exerts time-dependent activity.
Maltese: Florfenicol huwa batterjostatiku u jeżerċita attività dipendenti fuq iż-żmien.
English: Nuflor Swine Once is indicated for the treatment of swine respiratory disease associated with susceptible Actinobacillus pleuropneumoniae, Haemophilus parasuis and Pasteurella multocida at a single intramuscular dose of 30 mg/kg bodyweight.
Maltese: Nuflor Swine Once huwa indikat għall-kura ta' mard respiratorju tal-majjali assoċjat ma' Actinobacillus pleuropneumoniae, Haemophilus parasuis u Pasteurella multocida suxxettibbli f'doża unika ġol-muskoli ta' 30 mg/kg tal-piż tal-ġisem.
English: The mean failure rate at Day 11 was 20.7% and 27.3% for Nuflor Swine Once and the reference product (Enrofloxacin 5% solution for injection), respectively, but a large variation in the failure rates at Day 11 from 0 to 56% was observed between sites.
Maltese: 7% u ta' 27.3% għal Nuflor Swine Once u l-prodott ta' referenza (Enrofloxacin 5% soluzzjoni għal injezzjoni), rispettivament, imma kienet osservata varjazzjoni kbira fir-rati ta' falliment f'Jum 11 minn 0 għal 56% bejn is-siti.
English: Several studies reveal that the MIC value for A. pleuropneumoniae and P. multocida vary from 0.25 to 1 µg/ml with MIC90 of 0.5 µg/ml.
Maltese: Bosta studji juru li l-valur MIC għal A. pleuropneumoniae u P. multocida jvarja minn 0.25 għal 1 µg /ml b'MIC90 ta' 0.5 µg/ml.
English: Notwithstanding, Nuflor Swine Once 450 mg/ml solution for injection at the proposed posology cannot fulfil the principles of responsible use of antimicrobials as stated in the CVMP strategy on antimicrobials 2011-2015 due to concerns for lack of efficacy.
Maltese: Minkejja dan, fil-pożoloġija proposta Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni ma jistax jissodisfa lprinċipji ta' użu responsabbli ta' antimikrobiċi kif iddikjarat fl-istrateġija tas-CVMP dwar antimikrobiċi 2011-2015 minħabba tħassib dwar nuqqas ta' effikaċja.
English: The mean cumulative failure rate for Nuflor Swine Once 450 mg/ml solution for injection in this field study was 8.9% on Day 5 and 20.7% on Day 11.
Maltese: Ir-rata kumulattiva medja ta' falliment għal Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni f'dan l-istudju fuq il-post kienet ta' 8.9% f'Jum 5 u ta' 20.7% f'Jum 11.
English: No robust information is available about the distribution of florfenicol to the site of infection.
Maltese: Ma hemm l-ebda informazzjoni robusta dwar id-distribuzzjoni ta' florfenicol lis-sit ta' infezzjoni.
English: The dose of enrofloxacin was 2.5 mg/kg IM for 3 days according to the label.
Maltese: Id-doża ta' enrofloxacin kienet ta' 2.5 mg/kg ġol-muskoli għal 3 ijiem skont it-tikketta.
English: Bulgaria
Maltese: Bulgarija1
English: Correlation between plasma concentrations and pulmonary concentrations or high failure rate
Maltese: Korrelazzjoni bejn konċentrazzjonijiet fil-plasma u konċentrazzjonijiet pulmonari jew rata għolja ta' falliment
English: Nuflor Swine Once at a single dose of 30 mg/kg bw IM leads to plasma concentration of florfenicol above 0.5 µg/ml for about 72 hours.
Maltese: Nuflor Swine Once f'doża unika ta' 30 mg/kg tal-piż tal-ġisem ġol-muskoli jwassal għal konċentrazzjoni ta' florfenicol fil-plasma ta' aktar minn 0.5 µg/ml għal madwar 72 siegħa.
English: The applicant submitted a multicentre randomised controlled field study including a total of seven study sites in Spain, Germany and France to confirm the efficacy and field safety of Nuflor Swine Once 450 mg/ml solution for injection in the treatment of swine respiratory disease associated with A. pleuropneumoniae, P. multocida and H. parasuis.
Maltese: L-applikant issottometta studju multiċentriku randomizzat u kkontrollat fuq il-post li fih ħadu sehem total ta' seba' siti ta' studju fi Spanja, il-Ġermanja u Franza biex jikkonferma l-effikaċja u s-sigurtà fuq il-post ta' Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni fil-kura ta' mard respiratorju talmajjali assoċjat ma' A. pleuropneumoniae, P. multocida u H. parasuis.
English: Potential serious risks were identified during the decentralised procedure by Denmark regarding the high failure rate observed in the pivotal clinical field trial and potential for development of antimicrobial resistance to florfenicol.
Maltese: Matul il-proċedura deċentralizzata mid-Danimarka ġew identifikati riskji serji potenzjali dwar ir-rata għolja ta' falliment osservata fil-prova klinika pivotali fuq il-post u l-potenzjali għall-iżvilupp ta' reżistenza antimikrobika għal florfenicol.
English: Considering the MIC data from most recent isolates, obtained from pigs suffering from respiratory disease in the last 5 years florfenicol exhibited consistent MICs with MIC ranges of 0.06-1 µg/ml for each of P. multocida and A. pleuropneumoniae, and 0.125-0.5 µg/ml for H. parasuis.
Maltese: Meta wieħed iqis id-dejta tal-MIC minn l-aktar iżolati riċenti, li nkisbet minn majjali li jbatu minn mard respiratorju fl-aħħar 5 snin, florfenicol wera MICs konsistenti b'firxiet tal-MIC ta' 0.06-1 µg/ml kemm għal P. multocida kif ukoll għal A. pleuropneumoniae, u ta' 0.125-0.5 µg/ml għal H. parasuis.
English: Nuflor Swine Once 450 mg/ml solution for injection contains florfenicol as active ingredient.
Maltese: Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni fih florfenicol bħala sustanza attiva.
English: Nuflor Swine Once 450 mg/ml solution for injection differs from the reference veterinary medicinal product by a higher concentration of active substance, single administration, a change in therapeutic indication but also by a different co-solvent.
Maltese: Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni jvarja mill-prodott mediċinali veterinarju ta' referenza minħabba konċentrazzjoni ogħla ta' sustanza attiva, għoti uniku, bidla fl-indikazzjoni terapewtika imma wkoll minħabba ko-solvent differenti.
English: However, no pharmacokinetic data of the terminal phases are available which could allow for a robust comparison between Nuflor Swine Once 450 mg/ml solution for injection and conventional formulations in regard to duration of sub-therapeutic concentrations.
Maltese: Madankollu, ma hemm l-ebda dejta farmakokinetika tal-fażijiet terminali li tista' tippermetti tqabbil robust bejn Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni u formulazzjonijiet konvenzjonali fir-rigward tat-tul ta' konċentrazzjonijiet sub-terapewtiċi.
English: Marketing authorisation granted
Maltese: 1 Marketing awtorizzazzjoni mogħtija
English: The proposed dose is 30 mg florfenicol/kg bodyweight given by intramuscular administration as a single injection.
Maltese: Id-doża proposta hija ta' 30 mg florfenicol/kg tal-piż tal-ġisem li tingħata ġol-muskoli bħala injezzjoni unika.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodott veterinarju mediċinali, speċi tal-annimal,mod ta'amministrazzjoni, applikant fl-Istati Membri.
English: The marketing authorisation holder should provide a GCP-compliant clinical field study.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jipprovdi studju kliniku fil-prattika, konformi mal-GCP.
English: Post-antibiotic effect and post-antibiotic sub inhibitory effect against florfenicol were observed for three P. multocida and three A. pleuropneumoniae strains with a MIC of 0.5 µg/ml in vitro.
Maltese: Kien osservat effett wara l-għoti ta' antibijotiċi u effett sub inibitorju wara l-għoti ta' antibijotiċi kontra florfenicol għal tliet razez ta' P. multocida u tliet razez ta' A. pleuropneumoniae b'MIC ta' 0.5 µg/ml in vitro.
English: Infection sites for the pathogens in question include bronchial epithelia lining fluid, bronchial epithelium and alveolar macrophages.
Maltese: Siti tal-infezzjoni għall-patoġeni nvoluti jinkludu l-inforra fluwida epiteljali tal-bronki, l-epitelju tal-bronki u l-makrofaġi alveolari.
English: It should be noted that since the commencement of this referral procedure, marketing authorisations for Nuflor Swine Once 450 mg/ml solution for injection have been granted in Austria, Bulgaria, France, Germany and Romania.
Maltese: Għandu jiġi nnotat li sa mill-bidu ta' din il-proċedura ta' riferiment, awtorizzazzjonijiet għat-tqegħid fissuq għal Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni ngħataw fl-Awstrija, fil-Bulgarija, fi Franza, fil-Ġermanja u fir-Rumanija.
English: Belgium Intervet International B.V. Wim de Körverstraat 35
Maltese: Denmark Intervet International B.V.
English: Pharmacokinetic/pharmacodynamic models using the raw data provided by the applicant could give another explanation for the different treatment failure rates in the clinical field study.
Maltese: Mudelli farmakokinetiċi/farmakodinamiċi li użaw id-dejta pprovduta mill-applikant jistgħu jagħtu spjegazzjoni oħra għar-rati ta' falliment tal-kura differenti fl-istudju kliniku fuq il-post.
English: The persistence of A. pleuropneumoniae in alveolar macrophages might be one possible explanation for these results, but is not verified by clinical data.
Maltese: Il-persistenza ta' A. pleuropneumoniae f'makrofaġi alveolari tista' tkun spjegazzjoni waħda possibbli għal dawn ir-riżultati, imma ma ġietx verifikata minn dejta klinika.
English: Czech Republic Intervet International B.V. Wim de Körverstraat 35
Maltese: Slovakkja Intervet International B.V.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the clinical efficacy of Nuflor Swine Once 450 mg/ml solution for injection at a single intramuscular dose of 30 mg/kg bw in the treatment of swine respiratory disease.
Maltese: Dan ir-riferiment skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE sar minħabba tħassib li l-applikant ma kienx wera b'mod sodisfaċenti l-effikaċja klinika ta' Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni f'doża unika ta' 30 mg/kg tal-piż tal-ġisem ġol-muskoli fil-kura ta' mard respiratorju talmajjali.
English: A. pleuropneumoniae is the only organism out of the three target pathogens which is taken up by alveolar macrophages and stored intracellularly in vesicles and possibly gives rise to a re-infection when the macrophages die.
Maltese: A. pleuropneumoniae huwa l-unika organiżmu mit-tliet patoġeni fil-mira li jittieħed minn makrofaġi alveolari u li jinħażen fiċ-ċelloli fil-vexxikuli u possibbilment iwassal għal infezzjoni mill-ġdid meta lmakrofaġi jmutu.
English: Clinical efficacy was assessed based on mean cumulative failure rates on Day 5 and Day 11 post-treatment.
Maltese: Leffikaċja klinika kienet evalwata abbażi ta' rati kumulattivi medji ta' falliment f'Jum 5 u f'Jum 11 wara l-kura.
English: On 31 August 2012, during the written phase of the Standing Committee procedure, the Netherlands submitted an objection to the opinion adopted by CVMP on 13 June 2012.
Maltese: Fil-31 ta' Awwissu 2012, matul il-fażi bil-miktub tal-proċedura tal-Kumitat Permanenti, l-Olanda ppreżentat oġġezzjoni għallopinjoni adottata mis-CVMP fit-13 ta' Ġunju 2012.
English: For approximately 36 hours 1 µg/ml may be covered, whereas 2 µg/ml is covered only for a very short time.
Maltese: Għal madwar 36 siegħa, jista' jkun kopert 1 µg/ml, filwaqt li 2 µg /ml jiġi kopert biss għal perjodu ta' żmien qasir ħafna.
English: Nuflor Swine Once per se is not a classic long acting preparation and a single dose of 30 mg/ml is considered not sufficient to treat respiratory tract infections where some pathogens have a MIC of 1 µg/ml.
Maltese: Nuflor Swine Once per se mhuwiex taħlita klassika li taġixxi fit-tul u doża unika ta' 30 mg/ml mhijiex ikkunsidrata biżżejjed fil-kura ta' infezzjonijiet tal-apparat respiratorju fejn ċerti patoġeni għandhom MIC ta' 1 µg/ml.
English: Based on these results, Nuflor Swine Once 450 mg/ml solution for injection at a single intramuscular dose of 30 mg/kg bodyweight proved to be non-inferior to the positive control enrofloxacin 5% solution for injection.
Maltese: Abbażi ta' dawn ir-riżultati ġie ppruvat li Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni f'doża unika ta' 30 mg/kg tal-piż tal-ġisem ġol-muskoli ma kienx inferjuri għall-kontroll pożittiv enrofloxacin 5% soluzzjoni għal injezzjoni.
English: These higher doses and duration of treatment are authorised in a number of EU Member States, e.g. Denmark, the Netherlands and the United Kingdom.
Maltese: Dawn l-ogħla dożi u t-tul tal-kura huma awtorizzati f'għadd ta' Stati Membri tal-UE, eż. id-Danimarka, l-Olanda u r-Renju Unit.
English: This product is intended for use in pigs for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae, Haemophilus parasuis and Pasteurella multocida susceptible to florfenicol.
Maltese: Dan il-prodott huwa maħsub għall-użu fuq il-majjali għall-kura ta' infezzjonijiet respiratorji kkawżati minn razez ta' Actinobacillus pleuropneumoniae, Haemophilus parasuis u Pasteurella multocida suxxettibbli għal florfenicol.
English: Having considered all data submitted in writing and in the oral explanation the CVMP concluded that:
Maltese: Raġunijiet għar-rifjut tal-awtorizzazzjonijiet għat-tqegħid fis-suq Wara li kkunsidra d-dejta kollha sottomessa bil-miktub u fl-ispjegazzjoni orali, is-CVMP ikkonkluda li:
English: It is well known that a dose of enrofloxacin of 2.5 mg/kg does not follow the current knowledge of the optimal dosing for a fluoroquinolone, which requires high doses of 5 mg/kg for a treatment period of 3-5 days.
Maltese: Huwa magħruf sew li jekk doża ta' enrofloxacin ta' 2.5 mg/kg ma ssegwix l-għarfien attwali tad-dożaġġ ottimali għal fluoroquinolone, li jeħtieġ dożi għoljin ta' 5 mg/kg għal perjodu ta' kura ta' 3-5 ijiem.
English: Theoretically, the ability of an antibiotic to induce a post-antibiotic effect is an attractive property since antibiotic concentrations could fall below the MIC for the bacterium and yet retain their effectiveness in their ability to suppress bacterial growth.
Maltese: Teoretikament, il-kapaċità ta' antibijotiku li jinduċi effett wara l-għoti ta' antibijotiku hija karatteristika attraenti peress li l-konċentrazzjonijiet tal-antibijotiċi jistgħu jaqgħu taħt il-MIC talbatterju imma xorta jibqgħu iżommu l-effikaċja tagħhom fil-kapaċità tagħhom li jrażżnu tkabbir batterjali.
English: • the observed high and variable clinical failure rates in the clinical field study on Day 11 posttreatment are considered unacceptable;
Maltese: • ir-rati għoljin u varjabbli ta' falliment kliniċi fl-istudju kliniku fuq il-post f'Jum 11 wara l-kura huma kkunsidrati inaċċettabbli;
English: The applicant submitted an application for a decentralised procedure for Nuflor Swine Once 450 mg/ml solution for injection.
Maltese: L-applikant issottometta applikazzjoni għal proċedura deċentralizzata għal Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni.
English: The CVMP therefore considers that Nuflor Swine Once cannot fulfil the principles of responsible use of antimicrobials and concludes that the benefit-risk balance is negative.
Maltese: Is-CVMP għalhekk jikkunsidra li Nuflor Swine Once ma jistax jissodisfa l-prinċipji ta' użu responsabbli ta' antimikrobiċi u jikkonkludi li l-bilanċ tal-benefiċċju-riskju huwa negattiv.
English: No information is available about the florfenicol distribution to these sites in pigs but limited experiments in other species indicate that the concentration may be approximately similar to the concentration in plasma.
Maltese: Ma hemm l-ebda informazzjoni disponibbli dwar id-distribuzzjoni ta' florfenicol lejn dawn is-siti fil-majjali imma esperimenti limitati fuq speċi oħra jindikaw li l-konċentrazzjoni tista' tkun kważi simili għall-konċentrazzjoni fil-plasma.
English: The Committee considered whether the plasma concentrations of Nuflor Swine Once 450 mg/ml solution for injection, when corrected for plasma protein binding, adequately correlate to pulmonary concentrations (e.g. target site) and whether this explains the high failure rate.
Maltese: Il-Kumitat ikkunsidra jekk il-konċentrazzjonijiet ta' Nuflor Swine Once 450 mg/ml soluzzjoni għal injezzjoni fil-plasma, ladarba kkoreġuti għall-irbit tal-proteini tal-plasma, jikkorrelatawx b'mod adegwat mal-konċentrazzjonijiet pulmonari (eż. is-sit fil-mira) u jekk dan jispjegax ir-rata għolja ta' falliment.
English: INN Pharmaceutical form
Maltese: Isem inventat Għamla farmaċewtika
English: Having considered all the data submitted in writing and in the oral explanations the CVMP concluded that the observed high and variable clinical failure rates in the clinical field study on Day 11 posttreatment are considered unacceptable.
Maltese: Wara li kkunsidra d-dejta kollha sottomessa bil-miktub u fl-ispjegazzjonijiet orali, is-CVMP ikkonkluda li r-rati għoljin u varjabbli ta' falliment kliniku li kienu osservati fl-istudju kliniku fuq il-post f'Jum 11 wara l-kura mhumiex ikkunsidrati aċċettabbli.
English: The marketing authorisation holder should reconsider the selection of the treatment dose and should provide further clinical data to confirm the efficacy of the intended dosage in the treatment of Swine Respiratory Disease associated with the target pathogens A. pleuropneumoniae, P. multocida and H. parasuis under field conditions.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jikkunsidra l-għażla tad-doża ta' kura u għandu jipprovdi dejta klinika ulterjuri biex jikkonferma l-effikaċja tad-dożaġġ maħsub fil-kura ta' Mard Respiratorju tal-Majjali assoċjat mal-patoġeni fil-mira A. pleuropneumoniae, P. multocida u H. parasuis taħt kundizzjonijiet fil-prattika.
English: Pharmacokinetic data suggest that the elimination of the active ingredient is independent of the formulation and the dosage as long as the absorption phase is completed.
Maltese: Dejta farmakokinetika tissuġġerixxi li l-eliminazzjoni tas-sustanza attiva hija indipendenti millformulazzjoni u d-dożaġġ sakemm il-fażi ta' assorbiment tkun kompluta.
English: Treatment of acute respiratory tract infection in pigs with Nufor Swine Once at a single intramuscular dose of 30 mg/kg bw revealed high failure rates at Day 11 after treatment.
Maltese: Il-kura ta' infezzjoni akuta tal-passaġġ respiratorju fil-majjali bi Nufor Swine Once f'doża unika ta' 30 mg/kg tal-piż tal-ġisem ġol muskoli wriet rati għolja ta' falliment f'Jum 11 wara l-kura.
English: No further guidance on the selection of an appropriate control product, e.g. time-dependent versus concentration-dependent antimicrobials is included in the relevant guideline EMEA/CVMP/627/01-FINAL.
Maltese: Fil-linja gwida rilevanti EMEA/CVMP/627/01-FINALI ma ġiet inkluża l-ebda gwida ulterjuri dwar l-għażla ta' prodott xieraq ta' kontroll, eż. antimikrobiċi li jiddependu fuq iż-żmien kontra antimikrobiċi li jiddependu fuq ilkonċentrazzjoni.
English: • it cannot be ruled out that a single intramuscular dose of 30 mg/kg bw of this time-dependent antimicrobial may not be sufficient to treat respiratory tract infections, in particular when pathogens are associated with MIC values ≥1 μg/ml;
Maltese: • ma jistax jiġi eskluż li doża unika ta' 30 mg/kg tal-piż tal-ġisem ġol-muskoli ta' dan l-antimikrobiku dipendenti fuq iż-żmien tista' ma tkunx biżżejjed fil-kura ta' infezzjonijiet tal-passaġġ respiratorju,
English: This control should preferably belong to a different class of antimicrobials for which sufficient efficacy has been demonstrated, e.g. tulathromycin.
Maltese: Preferibbilment dan il-kontroll għandu jkun jagħmel parti minn klassi differenti ta' antimikrobiċi li għalihom tkun intweriet effikaċja suffiċjenti eż. tulathromycin.
English: In the field studies some isolates show a MIC of 1 µg/ml.
Maltese: Fl-istudji fuq il-post xi iżolati juru MIC ta' 1 µg/ml.
English: Based on the available pharmacokinetic data in swine and limited experiments in other species it is reasonable to predict that florfenicol concentrations may be equal at the level as in plasma.
Maltese: Abbażi tad-dejta farmakokinetika disponibbli fil-majjali u esperimenti limitati fuq speċi oħra huwa raġonevoli li jiġi previst li l-konċentrazzjonijiet ta' florfenicol jistgħu jkunu ugwali għal-livell fil-plasma.
English: The Standing Committee noted that there are serious uncertainties in CVMP's opinion on Nuflor Swine Once 450 mg/kg solution for injection in relation to the benefit-risk assessment, in particular regarding the efficacy of the product and the appropriate dosing.
Maltese: Il-Kumitat Permanenti nnota li hemm inċertezzi serji fl-opinjoni tas-CVMP dwar Nuflor Swine Once 450 mg/kg soluzzjoni għal injezzjoni firrigward tal-evalwazzjoni tal-benefiċċju-riskju, b'mod partikulari dwar l-effikaċja tal-prodott u d-dożaġġ adegwat.
English: Date of latest renewal: 09 January 2012
Maltese: Data tal-aħħar tiġdid: 09 ta' Jannar 2012
English: Pharmacotherapeutic group: antiepileptics, carboxamide derivatives; ATC code: N03AF03.
Maltese: Kategorija farmakoterapewtika: antiepilettiċi, derivattivi tal-carboxamide, Kodiċi ATC: N03AF03.
English: - The active substance is rufinamide.
Maltese: - Is-sustanza attiva hi rufinamide.
English: Risk related to rufinamide:
Maltese: Riskju relatat ma' rufinamide:
English: Manufacturer: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK.
Maltese: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10
English: PHARMACEUTICAL FORM AND CONTENTS Oral suspension 460 ml.
Maltese: U KONTENUT Suspensjoni orali 460 ml.
English: The effect was modest to moderate.
Maltese: L-effett kien bejn modest u moderat.
English: Inovelon contains sorbitol
Maltese: Inovelon fih sorbitol
English: Central Nervous System reactions
Maltese: Reazzjonijiet fis-Sistema Nervuza Ċentrali
English: Psychomotor hyperactivity
Maltese: Iperattività psikomotorea
English: *Cross reference to section 4.4.
Maltese: *Referenza inkroċjata ma' sezzjoni 4.4.
English: 1.2 mg methyl parahydroxybenzoate (E218), 0.3 mg propyl parahydroxybenzoate (E216), 250 mg sorbitol (E420)
Maltese: 1.2 mg ta' methyl parahydroxybenzoate (E218), 0.3 mg propyl parahydroxybenzoate (E216), 250 mg sorbitol (E420).
English: All seizures were classified according to the International League Against Epilepsy Revised Classification of Seizures.
Maltese: L-aċċessjonijiet kollha ġew ikklassifikati skont l-International League Against Epilepsy Revised Classification of Seizures.
English: Each carton contains 1 bottle, 2 syringes and 1 press-in-bottle adapter (PIBA).
Maltese: Kull kaxxa tal-kartun fiha 1 flixkun, 2 siringi u 1 press-in-bottle adapter (PIBA).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta' Jannar 2007
English: Environmental Risk Assessment (ERA):
Maltese: Valutazzjoni tar-Riskju Ambjentali (ERA):
English: Do not take Inovelon:
Maltese: Tiħux Inevolon:
English: Inovelon 40 mg/ml oral suspension Rufinamide
Maltese: Inovelon 40 mg/ml suspensjoni orali Rufinamide
English: Children (1-12 years)
Maltese: Tfal (1-12-il sena)
English: Simeticone emulsion, 30% containing benzoic acid, cyclotetrasiloxane, dimethicone, glycol stearate and glyceryl distearate, methylcellulose, PEG-40 stearate (polyethylene glycol stearate), polysorbate 65, silica gel, sorbic acid, sulphuric acid and water.
Maltese: Emulsjoni ta' simeticone, 30% li fiha benzoic acid, cyclotetrasiloxane, dimethicone, glycol stearate and glyceryl distearate, methylcellulose, PEG-40 stearate (polyethylene glycol stearate), polysorbate 65, silica gel, sorbic acid, sulphuric acid u ilma.
English: Ferric oxide red (E172)
Maltese: Ferric oxide aħmar (E172).