FrancophonIA/ELRC3.0 huggingface dataset:
English: The application was submitted as a generic hybrid application under Article 13(3), as there is currently no authorised product with the same concentration of meloxicam.
Maltese: L-applikazzjoni ġiet sottomessa bħala applikazzjoni ibrida ġenerika skont l-Artikolu 13(3), peress li attwalment ma hemm l-ebda prodott awtorizzat bl-istess konċentrazzjoni ta' meloxicam.
English: It should be noted that for cattle and horses, the applicant is exempt from providing an in vivo bioequivalence study under waiver 7.1.a of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2)1 (Bioequivalence GL).
Maltese: Għandu jiġi nnotat li għall-baqar u ż-żwiemel, l-applikant ġie eżentat milli jipprovdi studju ta' bijoekwivalenza in vivo skont ir-rinunzja 7.1.a tal-linja gwida tas-CVMP dwar it-twettiq ta' studji ta' bijoekwivalenza għal prodotti mediċinali veterinarji (EMA/CVMP/016/00-Rev.
English: • Residues studies would suffice as a substitute for bioequivalence, considering that as the meloxicam residues in liver and muscle were comparable at the 4 hour sampling point and as the withdrawal times for Melosolute 40 mg/ml and Metacam 20 mg/ml are the same, the pharmacokinetic parameters will be comparable.
Maltese: • Studji tar-residwi jkunu biżżejjed bħala sostitut ta' bijoekwivalenza, meta wieħed iqis li peress li r residwi ta' meloxicam fil-fwied u fil-muskoli kienu komparabbli fil-punt ta' kampjunar ta' 4 sigħat u peress li l-perjodi ta' tiżmim għal Melosolute 40 mg/ml u Metacam 20 mg/ml huma l-istess, il parametri farmakokinetiċi sejrin ikunu komparabbli.
English: This is supported by the evidence from the bioequivalence study between Metacam 5 mg/ml and Metacam 20 mg/ml which showed that Cmax and AUC were higher for the higher concentration formulation, and the findings in residues studies that suggest more rapid absorption from the 40 mg/ml product.
Maltese: Dan huwa appoġġjat minn evidenza mill-istudju ta' bijoekwivalenza bejn Metacam 5 mg/ml u Metacam 20 mg/ml li wera li s-Cmax u l-AUC kienu ogħla għall-formulazzjoni bl-ogħla konċentrazzjoni, u s-sejbiet fl-istudji tar-residwi li jissuġġerixxu assorbiment aktar malajr mill-prodott ta' 40 mg/ml.
English: The active substance is included in veterinary medicinal products currently authorised in the European Union via the centralised authorisation procedure, as well as nationally, for use in cattle, pigs, horses, dogs and cats.
Maltese: Is-sustanza attiva hija inkluża fil-prodotti mediċinali veterinarji attwalment awtorizzati fl-Unjoni Ewropea permezz tal-proċedura ta' awtorizzazzjoni ċentralizzata, kif ukoll fuq livell nazzjonali, għall-użu fil-baqar, majjali, żwiemel, klieb u qtates.
English: • In cattle, the proposed indications are for use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs; for use in diarrhoea in combination with oral re hydration therapy to reduce clinical signs in calves of over one week of age and in young, non lactating cattle, and for adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Maltese: • Fil-baqar, l-indikazzjonijiet proposti huma għall-użu f'infezzjoni respiratorja akuta b'terapija antibijotika adegwata biex inaqqas is-sinjali kliniċi; għall-użu fid-dijarea f'kombinazzjoni ma'
English: I. Effect of comparing results from separately conducted studies The applicant has provided references that broadly show comparability of pharmacokinetic data derived in studies conducted at different times.
Maltese: I. Effett tat-tqabbil ta' riżultat minn studji li saru separatament L-applikant ipprovda referenzi li ġeneralment juru l-komparabbiltà ta' dejta farmakokinetika li nkisbet fi studji li saru fi żminijiet differenti.
English: In the absence of such a study, the residues depletion data provide no firm evidence that allows quantification of any difference in rate and extent of absorption of meloxicam between Melosolute 40 mg/ml and Metacam 20 mg/ml, and consequently the identification of its impact on clinical safety and efficacy is not possible.
Maltese: Finnuqqas ta' studju bħal dan, id-dejta dwar it-tnaqqis tar-residwi ma tipprovdi l-ebda evidenza soda li tippermetti l-kwantifikazzjoni ta' xi differenza fir-rata u l-limitu ta' assorbiment ta' meloxicam bejn Melosolute 40 mg/ml u Metacam 20 mg/ml, u konsegwentement l-identifikazzjoni tal-impatt tiegħu fuq is-sigurtà klinika u l-effikaċja mhijiex possibbli.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Maltese: Lista tal-isem, għamla farmaċewtika, qawwa tal-prodott veterinarju mediċinali, speċi tal-annimali, mod ta' kif jingħata, applikant fl-Istati Membri
English: Timing and number of sampling points and how this relates to characterisation of the rate and extent of absorption and IV. Meloxicam concentrations in the tissues sampled (liver, kidney, muscle and injection site) and their relation to plasma pharmacokinetics.
Maltese: Il-konċentrazzjonijiet ta' Meloxicam fit-tessuti kampjunati (fwied, kliewi, muskoli u sit tal-injezzjoni) u r-relazzjoni tagħhom mal-farmakokinetika fil-plasma.
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 bioequivalence of Melosolute 40 mg/ml solution for injection with the reference product, Metacam 20 mg/ml solution for injection for the target species pigs, or provided other satisfactory justification to extrapolate the data of the reference product.
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 suffiċjenti l-bijoekwivalenza ta' Melosolute 40 mg/ml soluzzjoni għal injezzjoni malprodott ta' referenza, Metacam 20 mg/ml soluzzjoni għal injezzjoni għall-majjali bħala l-ispeċi fil-mira, jew ipprovda ġustifikazzjoni sodisfaċenti oħra biex tiġi estrapolata d-dejta tal-prodott ta' referenza.
English: Metacam 5 mg/ml formulation.
Maltese: Dan kien ġie preċedentement aċċettat mill-Kumitat għall-formulazzjoni ta' Metacam 5 mg/ml.
English: For this generic ‘hybrid' application, the benefits are extrapolated from the safety and efficacy data for the reference product, Metacam 20 mg/ml.
Maltese: Għal din l-applikazzjoni ‘ibrida' ġenerika, il-benefiċċji ġew estrapolati mid-dejta tas-sigurtà u l-effikaċja tal-prodott ta' referenza, Metacam 20 mg/ml.
English: The proposed indications in cattle, pigs and horses for Melosolute 40 mg/ml are identical to the approved indications for the reference product, Metacam 20 mg/ml solution for injection for cattle, pigs and horses.
Maltese: L-indikazzjonijiet proposti fil-baqar, majjali u żwiemel għal Melosolute 40 mg/ml huma identiċi għall-indikazzjonijiet approvati għall-prodott ta' referenza, Metacam 20 mg/ml soluzzjoni għal injezzjoni għall-baqar, majjali u żwiemel.
English: The applicant submitted an application for a decentralised procedure for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses.
Maltese: L-applikant issottometta applikazzjoni għal proċedura deċentralizzata għal Melosolute 40 mg/ml soluzzjoni għal injezzjoni għall-baqar, majjali u żwiemel.
English: This is a ‘hybrid' application and the requirements differ from those of a generic product due to the fact that the test formulation contains an increase in concentration of the active substance compared to the reference formulation.
Maltese: Din hija applikazzjoni ‘ibrida' u rrekwiżiti huma differenti minn dawk ta' prodott ġeneriku minħabba l-fatt li l-formulazzjoni tat-test fiha żieda fil-konċentrazzjoni tas-sustanza attiva meta mqabbla mal-formulazzjoni tar-referenza.
English: The applicant should have provided a blood-level comparative pharmacokinetic study between Melosolute 40 mg/ml and the reference product.
Maltese: Lapplikant messu pprovda studju farmakokinetiku komparattiv fuq livell tad-demm bejn Melosolute 40 mg/ml u l-prodott ta' referenza.
English: Relevance of the results from a residue depletion study as a demonstration of bioequivalence
Maltese: Rilevanza tar-riżultat minn studju dwar it-tnaqqis tar-residwi bħala turija ta' bijoekwivalenza
English: Potential serious risks were identified during the decentralised procedure by Ireland and the United Kingdom as they considered the bioequivalence of Melosolute 40 mg/ml solution for injection with the reference product, Metacam 20 mg/ml solution for injection had not been sufficiently demonstrated for the target species pigs, and no other satisfactory data had been provided to enable extrapolation of safety and efficacy data from the reference product for this species.
Maltese: Matul il-proċedura deċentralizzata l-Irlanda u r-Renju Unit identifikaw riskji serji potenzjali peress li kkunsidraw li l-bijoekwivalenza ta' Melosolute 40 mg/ml soluzzjoni għal injezzjoni mal-prodott ta' referenza, Metacam 20 mg/ml soluzzjoni għal injezzjoni ma kinitx intweriet b'mod suffiċjenti għallmajjali bħala l-ispeċi fil-mira, u ma ġiet ipprovduta l-ebda dejta sodisfaċenti oħra biex tippermetti lestrapolazzjoni ta' dejta ta' sigurtà u ta' effikaċja mill-prodott ta' referenza għal din l-ispeċi.
English: This is the standard approach that has been applied in the past for intramuscularly or subcutaneously administered injections when the concentration of the active substance is changed, and it would be possible and scientifically valid for the applicant to conduct a comparative pharmacokinetic study to compare the Melosolute 40 mg/ml formulation with the Metacam 20 mg/ml formulation.
Maltese: Dan huwa l-approċċ standard li filpassat ġie applikat għal injezzjonijiet mogħtija ġol-muskoli jew taħt il-ġilda meta l-konċentrazzjoni tassustanza attiva tkun inbidlet, u jkun possibbli u xjentifikament validu għall-applikant li jwettaq studju farmakokinetiku komparattiv biex iqabbel il-formulazzjoni ta' Melosolute 40 mg/ml mal-formulazzjoni ta' Metacam 20 mg/ml.
English: In order to address the concerns raised by the referral, the applicant presented a justification for the omission of a bioequivalence study for Melosolute 40 mg/ml solution for injection and the reference product, Metacam 20 mg/ml solution for injection.
Maltese: Sabiex jindirizza t-tħassib imqajjem mir-riferiment, l-applikant ippreżenta ġustifikazzjoni għallommissjoni ta' studju ta' bijoekwivalenza għal Melosolute 40 mg/ml soluzzjoni għal injezzjoni u lprodott ta' referenza, Metacam 20 mg/ml soluzzjoni għal injezzjoni.
English: It also has anti-endotoxic properties which inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Maltese: Għandu wkoll karatteristiċi anti-endotossiċi li jinibixxu l-produzzjoni ta' thromboxane B2 indott mill-għoti tal-endotossin ta' E. coli fl-għoġġiela, filbaqar li qegħdin ireddgħu u fil-majjali.
English: Overall summary of the scientific evaluation of Melosolute 40 mg/ml solution for injection
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Melosolute 40 mg/ml soluzzjoni għal injezzjoni
English: Meloxicam appeared to be more rapidly absorbed from the 40 mg/ml compared to the 20 mg/ml injection site, as suggested from the residue depletion data at the first (4 hours) sampling time-point, where the injection site levels were lower and kidney levels higher for the 40 mg/ml formulation.
Maltese: Meloxicam deher li ġie assorbit aktar malajr mis-sit tal-injezzjoni tal-40 mg/ml meta mqabbel ma' tal-20 mg/ml, kif issuġġerit mid-dejta dwar it-tneħħija tar-residwi fl-ewwel punt fiż-żmien ta' kampjunar (4 sigħat), fejn il-livelli fissit tal-injezzjoni kienu aktar baxxi u l-livelli fil-kliewi ogħla għall-formulazzjoni ta' 40 mg/ml.
English: However, the difference in concentration of the active substance also needs to be considered.
Maltese: Madankollu, id-differenza fil-konċentrazzjoni tas-sustanza attiva teħtieġ tiġi kkunsidrata wkoll.
English: In instances where it is not possible or scientifically relevant to conduct a blood-level bioequivalence/pharmacokinetic study, then alternative means (such as clinical end point studies) have to be used to demonstrate therapeutic equivalence.
Maltese: F'każijiet fejn ma jkunx possibbli jew xjentifikament rilevanti li jsir studju ta' bijoekwivalenza/farmakokinetiku fuq livell tad-demm, allura għandhom jintużaw mezzi alternattivi (bħal studji kliniċi tal-punt aħħari) biex juru ekwivalenza terapewtika.
English: Based on the data presented and the responses to questions, the CVMP concluded that the data for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses were not in accordance with the requirements of Directive 2001/82/EC, and that the benefit-risk balance is currently not favourable with respect to its proposed indications in the target species pigs.
Maltese: Abbażi tad-dejta ppreżentata u t-tweġibiet għal mistoqsijiet, is-CVMP ikkonkluda li d-dejta għal Melosolute 40 mg/ml soluzzjoni għal injezzjoni għall-baqar, majjali u żwiemel ma kinitx skont irrekwiżiti tad-Direttiva 2001/82/KE, u li attwalment il-bilanċ tal-benfiċċju-riskju mhuwiex favorevoli.
English: Bioequivalence between the test product and the originator
Maltese: 2.1. Bijoekwivalenza bejn il-prodott tat-test u l-oriġinatur
English: These issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the CMD(v) was started.
Maltese: Dawn ilkwistjonijiet baqgħu ma ġewx riżolti u għalhekk inbeda riferiment skont l-Artikolu 33(1) tadDirettiva 2001/82/KE lis-CMD(v).
English: The current guideline on the conduct of bioequivalence studies (EMA/CVMP/016/00-Rev.2) gives no exemption from the need to conduct in vivo bioequivalence studies for parenterally administered solutions when the strength of the active substance differs from that of the reference product and evidence suggests that this change does have the potential to influence the rate and possibly the extent of absorption;
Maltese: Illinja gwida attwali dwar it-twettiq ta' studji ta' bijoekwivalenza (EMA/CVMP/016/00-Rev.2) ma tagħti l-ebda eżenzjoni mill-ħtieġa li jsiru studji ta' bijoekwivalenza in vivo għal soluzzjonijiet mogħtija b'mod parenterali fejn il-qawwa tas-sustanza attiva hija differenti minn dik tal-prodott ta' referenza u l-evidenza tissuġġerixxi li din il-bidla għandha l-potenzjal li tinfluwenza r-rata u possibbilment l-ammont ta' assorbiment;
English: System organ class
Maltese: Sistema tal-Klassi talOrgani
English: Depression, anxiety, insomnia, irritability
Maltese: Depressjoni, anzieta`, insomnia, irritabilita`
English: None (monohydroxy derivative, MHD)
Maltese: Xejn (monohydroxy derivative, MHD)
English: Convulsion, vertigo
Maltese: Aċċessjonijiet, vertigo
English: - sorbitol (a type of sugar).
Maltese: - sorbitol (tip ta' zokkor).
English: Fructose intolerance
Maltese: Intolleranza ta' fructose
English: Raspberry flavour (propylene glycol 90 % - 98 %) Purified water.
Maltese: Togħma ta' raspberry (propylene glycol 90 % - 98 %) Ilma purifikat.
English: 50 % Responder rate
Maltese: 50 % Rata ta' rispons
English: See also section 4.8, paediatric data.
Maltese: Ara wkoll sezzjoni 4.8; data pedjatrika.
English: Citric acid anhydrous (for pH-adjustment) Methyl parahydroxybenzoate (E218) Carmellose sodium
Maltese: Citric acid anhydrous (for pH-adjustement) Methyl parahydroxybenzoate (E218) Carmellose sodium
English: The three metabolites are not pharmacologically active.
Maltese: It-tlett metaboliti mhumiex farmakoloġikament attivi.
English: There was generally no change in the concentration-time profiles of the endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), and sex hormone binding globulin (SHBG).
Maltese: Ġeneralment ma kienx hemm tibdil fil-profili ta' konċentrazzjoni-ħin ta' endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), u sex hormone binding globulin (SHBG).
English: Ireland UCB (Pharma) Ireland Ltd.
Maltese: UCB (Pharma) Ireland Ltd.
English: The most commonly taken AEDs at the time of study entry were carbamazepine (40.6 %), lamotrigine (25.2 %), valproate (20.5 %), oxcarbazepine (16.0 %), topiramate (13.5 %), phenytoin (10.2 %) and levetiracetam (9.8 %).
Maltese: L-iżjed AED li komunament ittieħed waqt l-istudju kien carbamazepine (40.6 %), lamotrigine (25.2 %), valproate (20.5 %), oxcarbazepine (16.0 %), topiramate (13.5 %), phenytoin (10.2 %) u levetiracetam (9.8 %).
English: Belgium (name and address only for outer carton, logo on carton and etiquette)
Maltese: Belgium (isem u indirizz għall-kartuna ta' barra biss, logo fuq il-kartuna u etikett)
English: Percent reduction over placebo (%)
Maltese: Perċentaġġ ta' tnaqqis fuq il-plaċebo (%)
English: Each ml of oral solution contains 239.8 mg sorbitol (E420), 1mg methyl parahydroxybenzoate (E218) and 1.16 mg sodium.
Maltese: Kull ml ta' soluzzjoni orali fih 239.8 mg sorbitol (E420), 1mg methyl parahydroxybenzoate (E218) u 1.16 mg sodium.
English: Date of first authorisation: 14 January 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni : 14 Jannar 2016
English: Children (≥4 years) and adolescents <50 kg
Maltese: Tfal (≥4 snin) u adolexxenti <50 kg
English: (see section 4.2)
Maltese: (ara sezzjoni 5.1)
English: The oral solution contains sorbitol (E420).
Maltese: Is-soluzzjoni orali fiha sorbitol (E420).
English: In vitro, brivaracetam is not a substrate of human Pglycoprotein (P-gp), multidrug resistance proteins (MRP) 1 and 2, and likely not organic anion transporter polypeptide 1B1 (OATP1B1) and OATP1B3.
Maltese: In vitro, brivaracetam mhux substrate ta' Pglycoprotein (P-gp) uman, protejini reżistenti għal mediċini multipli (MRP) 1 u 2, u x'aktarx mhux organic anion transporter polypeptide 1B1 (OATP1B1) u OATP1B3.
English: Pharmacokinetics is dose-proportional from 10 to at least 600 mg.
Maltese: Il-farmakokinetika hija proporzjonali għad-doża minn 10 sa mill-inqas 600 mg.
English: Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam).
Maltese: Brivaractam jista' jżid konċentrazzjonijiet tal-plażma ta prodotti mediċinali mmetabolizzati b' CPY2C19( eż. lanzoprazole, omeprazole, diazepam).
English: Allée de la Recherche 60 (address only for outer carton) B-1070 Brussels
Maltese: Allée de la Recherche 60 (indirizz għall-kartuna ta' barra biss) B-1070 Brussels
English: Brivaracetam oral solution contains sodium.
Maltese: Brivaracetam soluzzjoni orali fiha sodium.
English: In vitro, brivaracetam did ot induce CYP1A2.
Maltese: In vitro, brivaracetam ma attivax CYP1A2..
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Maltese: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
English: No CYP3A4 induction was found in vivo (see midazolam above).
Maltese: CYP3A4 ma nstagħbet in vivo (ara midazolam hawn fuq).
English: Recommended maintenance dose
Maltese: Doża rakkomandata ta' manteniment
English: Component of a multipack, can be sold separatly.
Maltese: Parti minn pakkett multiplu, ma jistax jinbiegħ separatament.
English: The safety profile of brivaracetam observed in children was consistent with the safety profile observed in adults.
Maltese: Il-profil tas-sigurtà ta' brivaracetam osservat fit-tfal kien konsistenti mal-profil tas-sigurtà osservat f'pazjenti adulti.
English: Each film-coated tablet contains 10 mg, 25 mg, 50mg, 75 mg, or 100 mg brivaracetam.
Maltese: Kull pillola miksija b'rita fiha 10 mg, 25 mg, 50mg, 75 mg, jew 100 mg brivaracetam.
English: In children aged 4 years and older, partial onset seizures have a similar clinical expression to those in adolescents and adults.
Maltese: Fi tfal ta' età ta' 4 snin jew aktar, aċċessjonijiet tat-tip partial onset għandhom espressjoni klinika simili għal dawk f'adolexxenti u adulti.
English: A second disposition pathway involves hydroxylation mediated by CYP2C19 (see section 5.2).
Maltese: It-tieni mod ta' dispozizzjoni tinvolvi idroxilazzjoni li hu medjat minn CYP2C19 (ara sezzjoni 5.2).
English: The median baseline seizure frequency across the 3 studies was 9 seizures per 28 days.
Maltese: Il-frekwenza tal-aċċessjonijiet medja fil-linja bażi fit-3 studji kien 9 aċċessjonijiet kull 28 ġurnata.
English: In vitro, brivaracetam was not an inhibitor of the CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4, or the transporters P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 and OCT1 at clinically relevant concentrations.
Maltese: In vitro, brivaracetam ma kienx inhibitur ta' CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4, jew ittransportaturi P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 u OCT1 f'konċentrazzjonijiet klinikament relevanti.
English: There are limited safety data from open-label studies in children from 1 month to <4 years of age.
Maltese: Hemm dejta ta'sigurta` limitata minn studji open-label f'tfal t'eta` minn xahar sa <4 snin.
English: Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance.
Maltese: It-teħid flimkien ta' brivaracetam (100 mg/ġurnata) b' kontraċettiv orali li fih ethinylestradiol (0.03 mg) u levonorgestrel (0.15 mg) ma influwenzax il-farmakokinetika ta ebda sustanza.
English: Risk related to brivaracetam
Maltese: Riskju relatat ma' brivaracetam
English: The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenzi kienu definiti hekk: komuni ħafna (≥1/10), komuni (≥1/100 to <1/10), mhux komuni (≥1/1,000 to <1/100).
English: Sorbitol liquid
Maltese: Likwidu Sorbitol
English: Each millilitre (ml) contains 10 milligrams (mg) brivaracetam.
Maltese: Kull millilitru (ml) fih 10 milligrammi (mg) brivaracetam.
English: The terminal plasma half-life (t1/2) is approximately 9 hours.
Maltese: Il-half-life (t1/2) terminali fil-plażma hija approssimament 9 siegħa.
English: Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous.
Maltese: Fih croscarmellose sodium, lactose monohydrate u lactose anhydrous.
English: Contains sodium citrate, carmellose sodium, methyl parahydroxybenzoate (E218), sorbitol liquid and glycerol (E422).
Maltese: Fih sodium citrate, carmellose sodium, methyl parahydroxybenzoate (E218), likwidu sorbitol u glycerol (E422).
English: Treatment with levetiracetam
Maltese: Trattament b' levetiracetam
English: In vivo, in human subjects possessing ineffective mutations of CYP2C19, production of the hydroxy metabolite is decreased 10-fold while brivaracetam itself is increased by 22 % or 42 % in individuals with one or both mutated alleles.
Maltese: In vivo, f'suġġetti umani li għandhom mutazzjonijiet ineffettivi ta' CYP2C19, il-produzzjoni tal-hydroxy metabolite huwa mnaqqas b' 10 darbiet waqt li brivaracetam innifsu żdied b' 22 % jew 42 % f' individwi b'alleles wieħed jew it-tnejn mutati.
English: Multipack: 168 (3 packs of 56) film-coated tablets
Maltese: U KONTENUT Pakkett multiplu: 168 (3 pakketti ta' 56) pilloli miksija b'rita
English: Two oral syringes (5 ml and 10 ml) are included in the carton.
Maltese: Żewġ siringi orali (5 mL u 10 mL) huma inklużi fil-kartuna.
English: Volume per administration (ml) = [weight (kg) x daily dose (mg/kg/day) ] x 0.05
Maltese: Volum kull għotja (mL) = [piż (kg) x doża ta' kuljum (mg/kg/jum) ] x 0.05
English: 1 - 4 mg/kg/day
Maltese: 1 - 4 mg/kg/jum
English: The EC50 (brivaracetam plasma concentration corresponding to 50 % of the maximum effect) was estimated to be 0.57 mg/L.
Maltese: L'EC50 (il-konċentrazzjoni fil-plażma ta' brivaracetam li tikkorrespondi għal 50 % tal-effett massimu) kien stmat li hu 0.57 mg/L.
English: Contains sodium acetate (trihydrate), sodium chloride.
Maltese: TA' EĊĊIPJENTI Fih sodium acetate (trihydrate), sodium chloride.
English: • Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters
Maltese: • Pakketti ta' 14 x 1 u 100 x 1 pillola miksija b'rita f'folja tal-aluminju - PVC/PCTFE