FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Trydonis significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Trydonis and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06).
Maltese: Barra dan, meta mqabbel kemm ma' kombinazzjoni fissa ta' beclometasone dipropionate u formoterol kif ukoll ma' tiotropium, Trydonis tawwal b'mod sinifikanti ż-żmien sal-ewwel episodju ta' aggravar (proporzjon ta' periklu 0.80 u 0.84 rispettivament; p = 0.020 u 0.015 rispettivament), bl-ebda differenzi bejn Trydonis u l-kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol flimkien ma' tiotropium (proporzjon ta' periklu 1.06).
English: Compared with tiotropium, Trydonis significantly improved IC by 39 mL (p = 0.025) and 60 mL (p = 0.001) after 26 and 52 weeks of treatment respectively.
Maltese: Meta mqabbel ma' tiotropium, Trydonis tejjeb l-IC b'mod sinifikanti b'39 mL (p = 0.025) u 60 mL
English: Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Trydonis with the AeroChamber Plus spacer device increased the total systemic exposure (AUC0-t) to glycopyrronium.
Maltese: Data farmakokinetika b'doża waħda (ara sezzjoni 5.2) uriet li meta mqabbel ma' użu ta' rutina mingħajr apparat spacer, l-użu ta' Trydonis flimkien mal-apparat spacer AeroChamber Plus, żied lesponiment sistemiku totali (AUC0-t) għal glycopyrronium.
English: Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females), either congenital or induced by medicinal products as these patients were excluded from clinical trials with Trydonis.
Maltese: Għandu jkun hemm kawtela wkoll meta jiġu ttrattati pazjenti b'titwil magħruf jew issuspettat tal intervall QTc (QTc > 450 millisekonda għall-irġiel, jew > 470 millisekonda għan-nisa), li jista' jkun konġenitali jew ikkaġunat minn prodotti mediċinali għax dawn il-pazjenti kienu esklużi minn provi kliniċi bi Trydonis.
English: TRISTAR was a 26-week active-controlled open label study comparing Trydonis with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Maltese: fluticasone/vilanterol 92/22 mikrogramma, inalazzjoni waħda darba kuljum flimkien ma' trab li jittieħed man-nifs ta' tiotropium 18-il mikrogramma, kapsula iebsa, inalazzjoni waħda darba kuljum (1,157 pazjent randomised).
English: In repeat dose inhalation studies with Trydonis in rats and dogs of up to 13 weeks duration, the main observed alterations were related to effects on the immune system (probably due to systemic corticosteroid effects of beclometasone dipropionate and its active metabolite beclometasone17-monopropionate) and on the cardiovascular system (probably related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium).
Maltese: Fi studji bi Trydonis dwar dożi ripetuti li jittieħdu man-nifs fil-firien u l-klieb li damu sa 13-il ġimgħa, il-bidliet ewlenin osservati kienu relatati ma' effetti fuq is-sistema immuni (probabbilment minħabba l-effetti sistemiċi tal-kortikosterojdi ta' beclometasone dipropionate u l-metabolit attiv tiegħu beclometasone-17-monopropionate) u fuq is-sistema kardjovaskulari (probabbilment relatati malattività beta2-adrenerġika ta' formoterol u l-attività anti-muskarinika ta' glycopyrronium).
English: The study compared data obtained after treatment with a single dose of Trydonis (4 inhalations of 100/6/25 micrograms, a non-marketed formulation containing twice the approved strength of glycopyrronium) or a single dose of the extemporary combination of beclometasone dipropionate/formoterol (4 inhalations of 100/6 micrograms) plus glycopyrronium (4 inhalations of 25 micrograms).
Maltese: L-istudju qabbel data miksuba wara trattament b'doża waħda ta' Trydonis (4 inalazzjonijiet ta' 100/6/25 mikrogramma, formulazzjoni li ma tqegħditx fis-suq li fiha qawwa ta' glycopyrronium id-doppju ta' dak approvat) jew doża waħda tal-kombinazzjoni estemporanja ta' beclometasone dipropionate/formoterol (4 inalazzjonijiet ta' 100/6 mikrogrammi) flimkien ma' glycopyrronium (4 inalazzjonijiet ta' 25 mikrogramma).
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trydonis significantly improved 2-hour post dose FEV1 by 117 mL after 26 weeks of treatment and by 103 mL after 52 weeks of treatment (p < 0.001).
Maltese: FEV1 sagħtejn wara doża b'mod sinifikanti b'117 mL wara 26 ġimgħa ta' trattament u b'103 mL wara 52 ġimgħa ta' trattament (p < 0.001).
English: Trydonis was also statistically significantly superior to a fixed combination of beclometasone dipropionate and formoterol, to tiotropium and to a fixed combination of indacaterol and glycopyrronium in terms of improvement in quality of life (measured by the Saint George Respiratory Questionnaire - SGRQ - total score).
Maltese: Trydonis kien ukoll superjuri b'mod statistikament sinifikanti għall-kombinazzjoni fissa ta' beclometasone dipropionate u formoterol, għal tiotropium u għall-kombinazzjoni fissa ta' indacaterol u glycopyrronium f'termini ta' titjib fil-kwalità tal-ħajja (imkejjel permezz tal-punteġġ totali tal
English: The most frequently reported adverse reactions with Trydonis were oral candidiasis (which occurred in 0.8% of the exposed subjects), which is normally associated with inhaled corticosteroids; muscle spasms (0.4%), which can be attributed to the long-acting beta2-agonist component; dry mouth (0.4%), which is a typical anticholinergic effect.
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjonijiet avversi rrappurtati l-aktar frekwenti bi Trydonis kienu kandidjasi tal-ħalq (li seħħet f'0.8% tal-individwi esposti), li normalment hija assoċjata ma' kortikosterojdi li jittieħdu man-nifs; spażmi fil-muskoli (0.4%), li jistgħu jiġu attribwiti għall-komponent agonist tar-riċetturi beta2 li jaħdem fit-tul; ħalq xott (0.4%), li huwa effett antikolinerġiku tipiku.
English: Trydonis 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Maltese: TAL-PRODOTT MEDIĊINALI Trydonis 87/5/9 mikrogrammi sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
English: Trydonis is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Maltese: Trydonis mhux indikat għat-trattament ta' episodji akuti ta' bronkospażmu, jew biex jittratta aggravar akut ta' COPD (jiġifieri bħala terapija ta' salvataġġ).
English: Simulations performed with a pharmacokinetic model showed that even when covariates had extreme values (body weight less than 40 kg and concomitant glomerular filtration rate below 27 mL/min/1.73 m²), exposure to Trydonis active substances remains in approximately a 2.5-fold range compared to the exposure in a typical patient with median covariate values.
Maltese: Simulazzjonijiet imwettqa b'mudell farmakokinetiku wrew li anke meta kovarjabbli kellhom valuri estremi (piż tal-ġisem inqas minn 40 kg u rata ta' filtrazzjoni glomerulari taħt 27 mL/min/1.73 m² fl-istess waqt), esponiment għas sustanzi attivi ta' Trydonis jibqa' fil-firxa ta' madwar 2.5 darbiet meta mqabbel mal-esponiment f'pazjent tipiku b'valuri medjana ta' kovarjabbli.
English: Following glycopyrronium inhalation, the lung bioavailability was 10.5% (with activated charcoal ingestion) while the absolute bioavailability was 12.8% (without activated charcoal ingestion) confirming the limited gastrointestinal absorption and indicating that more than 80% of glycopyrronium systemic exposure was from lung absorption.
Maltese: 5% (ma' inġestjoni ta' faħam attivat) filwaqt li l-bijodisponibilità assoluta kienet ta' 12.8% (mingħajr inġestjoni ta' faħam attivat) li tikkonferma assorbiment gastrointestinali limitat u tindika li aktar minn 80% tal-esponiment sistemiku għal glycopyrronium kien minn assorbiment mill-pulmun.
English: Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists (see section 4.4).
Maltese: Trattament flimkien ma' derivattivi ta' xanthine, sterojdi, jew dijuretiċi jista' jsaħħaħ effett ta' ipokalemija possibbli ta' agonisti tar-riċetturi beta2 (ara sezzjoni 4.4).
English: This incorporates a mouthpiece provided with a plastic protective cap, and either a dose counter (containers with 60 and 120 puffs) or a dose indicator (containers with 180 puffs).
Maltese: Dan jinkorpora biċċa tal-ħalq huwa pprovdut b'għatu protettiv tal-plastik, u apparat li jgħodd id-dożi (kontenituri b'60 u 120 nefħa) jew indikatur tad-doża (kontenituri b'180 nefħa).
English: For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Trydonis are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation).
Maltese: (100 mikrogramma ta' beclometasone dipropionate fin ħafna f'Trydonis huma ekwivalenti għal 250 mikrogramma ta' beclometasone dipropionate f'formulazzjoni mhux fina ħafna).
English: A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (focal score greater than or equal to 1) after 26 weeks with Trydonis than with a fixed combination of beclometasone dipropionate and formoterol (57.4% versus 51.8%; p = 0.027).
Maltese: 26 ġimgħa bi Trydonis milli b'kombinazzjoni fissa ta' beclometasone dipropionate u formoterol (57.4% kontra 51.8%; p = 0.027).
English: 60 actuation pressurised container: 21 months.
Maltese: Kontenitur għal kontenut taħt pressjoni għolja b'60 attwazzjoni: 21 xahar.
English: Package leaflet: Information for the user Trydonis 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Maltese: Informazzjoni għall-utent Trydonis 87 mikrogramma/5 mikrogrammi/9 mikrogrammi sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
English: • medicines for treating - abnormal heart rhythms (quinidine, disopyramide, procainamide), - allergic reactions (antihistamines), - symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines can cause some changes in the electrocardiogram (ECG, heart trace).
Maltese: - sintomi ta' depressjoni jew disturbi mentali bħal inibituri ta' monoamine oxidase (pereżempju, phenelzine u isocarboxazid), antidepressanti triċikliċi (pereżempju,
English: No differences were observed when comparing Trydonis and the extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol plus tiotropium (difference of 3 mL in pre-dose FEV1 after 52 weeks of treatment).
Maltese: Ma kienu osservati l-ebda differenzi meta Trydonis kien imqabbel mal-kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol flimkien ma' tiotropium (differenza ta' 3 mL f'FEV1 qabel id-doża wara 52 ġimgħa ta' trattament).
English: Diarrhoea1, dry mouth, dysphagia1, nausea, dyspepsia1, burning sensation of the lips1, dental caries1, (aphthous) stomatitis
Maltese: ansjetà, depressjoni1, aggressjoni1, tibdil fl-imġiba (laktar fit-tfal)1
English: This endpoint was only measured in study TRINITY.
Maltese: Dan il-punt aħħari kien imkejjel biss fl-istudju TRINITY.
English: It is preferable to avoid the use of Trydonis during labour due to the inhibitory effects of formoterol on uterine contractions.
Maltese: Huwa preferibbli li jiġi evitat l-użu ta' Trydonis waqt il-ħlas minħabba l-effetti inibitorji ta' formoterol fuq il-kontrazzjonijiet tal-utru.
English: Trydonis 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Maltese: Trydonis 87 mikrogramma/5 mikrogrammi/9 mikrogrammi, sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni
English: Cleaning of the Trydonis inhaler
Maltese: Jekk diġà qed tuża Trydonis
English: An overdose of Trydonis may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists or anticholinergics and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Maltese: Doża eċċessiva ta' Trydonis tista' tipproduċi sinjali u sintomi minħabba azzjonijiet tal-komponenti individwali, inklużi dawk osservati b'doża eċċessiva ta' agonisti tar-riċetturi beta2 jew antikolinerġiċi oħra u konsistenti mal-effetti magħrufa tal-klassi tal-kortikosterojdi li jittieħdu man-nifs (ara sezzjoni 4.4).
English: Trydonis comes in a pressurised container (coated aluminium), with a metering valve.
Maltese: Trydonis huwa disponibbli f'kontenitur għal kontenut taħt pressjoni għolja (aluminju miksi), b'valv tal-kejl.
English: Compared with tiotropium, Trydonis improved pre-dose FEV1 by 51 mL after 26 weeks of treatment and by 61 mL after 52 weeks of treatment.
Maltese: Meta mqabbel ma' tiotropium, Trydonis tejjeb FEV1 qabel id-doża b'51 mL wara 26 ġimgħa ta' trattament u b'61 mL wara 52 ġimgħa ta' trattament.
English: Glycopyrronium is a high-affinity, long-acting muscarinic receptor antagonist (anticholinergic) used for inhalation as bronchodilator treatment of COPD.
Maltese: M'hemm l-ebda użu rilevanti ta' Trydonis fil-popolazzjoni pedjatrika (ta' età inqas minn 18-il sena) għall-indikazzjoni ta' marda kronika ostruttiva tal-pulmun (COPD - chronic obstructive pulmonary disease).
English: Trydonis should be used with caution in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure), occlusive vascular diseases (particularly arteriosclerosis), arterial hypertension and aneurysm.
Maltese: Trydonis għandu jintuża b'kawtela f'pazjenti b'arritmiji kardijaċi, speċjalment imblokk atrijoventrikulari tat-tielet grad u takiarritmiji (taħbit tal-qalb mgħaġġel u/jew irregolari), stenosi idjopatika subvalvulari tal-aorta, kardjomijopatija ipertrofika ostruttiva, mard sever tal-qalb
English: The long-term co-administration of Trydonis with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Maltese: L-għoti fit-tul ta' Trydonis flimkien ma' prodotti mediċinali oħra li fihom antikolinerġiċi ma ġiex studjat u għalhekk mhux rakkomandat (ara sezzjoni 4.4).
English: Trydonis should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Maltese: Trydonis għandu jitwaqqaf minnufih, il-pazjent għandu jiġi evalwat u jekk ikun meħtieġ għandha tinbeda terapija alternattiva.
English: No differences were observed when comparing Trydonis and the extemporary triple combination made of fluticasone and vilanterol fixed combination plus tiotropium.
Maltese: Ma ġew osservati l-ebda differenzi meta Trydonis kien imqabbel mal-kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' fluticasone u vilanterol flimkien ma'
English: However, in a 104-week rat inhalation carcinogenicity study and an oral 26-week carcinogenicity study in transgenic Tg.rasH2 mice, glycopyrronium bromide showed no carcinogenic potential and published data concerning longterm studies conducted with beclometasone dipropionate and formoterol fumarate in rats do not indicate a clinically relevant carcinogenic potential.
Maltese: Madankollu, fi studju dwar il-karċinoġeniċità tat-teħid man-nifs ta' 104 ġimgħat fil-firien, u fi studju dwar il-karċinoġeniċità orali ta' 26 ġimgħa fi ġrieden Tg.rasH2 transġeniċi, glycopyrronium bromide ma wera l-ebda potenzjal karċinoġeniku, u data ppubblikata dwar studji fit-tul li twettqu bi beclometasone dipropionate u formoterol fumarate fil firien, ma jindikawx potenzjal karċinoġeniku klinikament rilevanti.
English: Some medicines may increase the effects of Trydonis and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Maltese: Xi mediċini jistgħu jżidu l-effetti ta' Trydonis, u t-tabib tiegħek għandu mnejn ikun irid jimmonitorjak b'attenzjoni jekk tkun qed tieħu dawn il-mediċini (inklużi xi mediċini għall-HIV: ritonavir, cobicistat).
English: Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however, the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such medicinal products.
Maltese: Beclomethasone huwa anqas dipendenti fuq il-metaboliżmu tas-CYP3A minn xi kortikosterojdi oħra, u b'mod ġenerali l-interazzjonijiet mhumiex probabbli; madankollu l-possibbiltà ta' effetti sistemiċi blużu konkomitanti ta' inibituri tas-CYP3A qawwija (eż. ritonavir, cobicistat) ma tistax tiġi eskluża, u għalhekk hija rrakkomandata kemm il-kawtela kif ukoll monitoraġġ xieraq meta jintużaw prodotti mediċinali bħal dawn.
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Maltese: Disturb fil-vista Jista' jiġi rrappurtat disturb fil-vista bl-użu sistemiku u topiku tal-kortikosterojdi.
English: In addition, two Phase IIIb studies were conducted to support the clinical efficacy and safety of Trydonis.
Maltese: IIIb biex isostnu l-effikaċja klinika u s-sigurtà ta' Trydonis.
English: • inflammation of the sinuses
Maltese: • influwenza • infjammazzjoni tas-sinus
English: • crushing chest pain
Maltese: • diffikultajiet biex tibla'
English: The full EPAR for Matever 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: Matever is a ‘generic medicine'.
Maltese: Matever huwa ‘mediċina ġenerika'.
English: The active substance in Matever, levetiracetam, is an anti-epileptic medicine.
Maltese: Is-sustanza attiva f'Matever, il-levetiracetam, hija mediċina antiepilettika.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1000 mg) and as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Maltese: Matever jiġi bħala pilloli (250 mg, 500 mg, 750 mg u 1,000 mg) u bħala konċentrat li jsir soluzzjoni għall-infużjoni (dripp fil-vina, 100 mg/ml).
English: Matever is a medicine that contains the active substance levetiracetam.
Maltese: Matever huwa mediċina li fiha s-sustanza attiva levetiracetam.
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, inklużi t-telfien mis-sensi) f'pazjenti minn 12-il sena 'l fuq li jbatu bl-epilessija ġenerali idjopatika (it-tip ta' epilessija li huwa maħsub li ġġor il-kawża ġenetika).
English: In patients aged between six months 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 sitt xhur u 17-il sena li jiżnu inqas minn 50 kg, id-doża inizjali għandha tkun 10 mg għal kull kilogramm tal-piż tal-ġisem darbtejn kuljum, li tista' tiżdied sa 30 mg/kg darbtejn kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Matever on 03 October 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Matever fil-03 ta' Ottubru 2011.
English: This is a summary of the European public assessment report (EPAR) for Matever.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Matever.
English: Because Matever is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Maltese: Minħabba li Matever huwa mediċina ġenerika, l-istudji f'pazjenti kienu limitati għal testijiet sabiex jiġi stabbilit li huwa bioekwivalenti għall-mediċina ta' referenza, Keppra.
English: The CHMP concluded that, in accordance with EU requirements, Matever has been shown to have comparable quality and to be bioequivalent to Keppra.
Maltese: Is-CHMP ikkonkluda li, f'konformità mar-rekwiżiti tal-UE, Matever wera li għandu kwalità komparabbli u li huwa bijoekwivalenti ma' Keppra.
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 ta' kif jaħdem levetiracetam għadu mhux ċar iżda jidher li jinterferixxi ma' proteina msejħa proteina sinaptika vexxili 2A, li tinsab fl-ispazju bejn innervituri u hija involuta fir-rilaxx tal-messaġġiera kimiċi miċ-ċelloli tan-nervituri.
English: This means that Matever is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Maltese: Dan ifisser li Matever huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha 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 ħafna attività elettrika f'naħa waħda talmoħħ tikkawża sintomi bħal movimenti spasmodiċi għall-għarrieda ta' xi parti mill-ġisem, smigħ, xamm, jew vista mhux ċari, tirżiħ jew sens ta' biża' f'daqqa.
English: Why has Matever been approved?
Maltese: Għaliex ġie approvat Matever?
English: When Matever 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 Matever jingħata flimkien ma' trattamenti antiepilettiċi oħra, id-doża inizjali f'pazjenti minn 12-il sena 'l fuq li jiżnu iktar minn 50 kg għandha tkun ta' 500 mg darbtejn kuljum.
English: How has Matever been studied?
Maltese: Kif ġie studjat Matever?
English: Because Matever 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 Matever huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: What is Matever?
Maltese: X'inhu Matever?
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Maltese: • aċċessjonijiet mijokloniċi (qosra, movimenti spasmodiċi donnhom xokkijiet ta' muskolu jew ta' grupp ta' muskoli) f'pazjenti minn tnax-il sena 'l fuq li jbatu bl-epilessija mijoklonika ġuvenili;
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsijiet u tweġibiet hawnhekk