FrancophonIA/ELRC3.0 huggingface dataset:
English: Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 26 or ≥ 22-fold, times the human clinical exposure of umeclidinium 55 micrograms, based on AUC, respectively.
Maltese: Effett tossiku fuq il-ġeni u riskju ta' kanċer Umeclidinium ma kienx ġenotossiku f'batterija standard ta' studji u ma kienx karċinoġeniku fi studji tal inalazzjoni tul il-ħajja fil-ġrieden jew fil-firien b'esponimenti ta' ≥ 26 jew ≥ 22 darba akbar mill-esponiment kliniku tal-bniedem għal umeclidinium 55 mikrogramma, fuq il-bażi tal-AUC, rispettivament.
English: Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol, which could lead to an increase in the potential for adverse reactions.
Maltese: ketoconazole u inibituri qawwija magħrufa oħra ta' CYP3A4 billi hemm potenzjal ta' esponiment sistemiku akbar għal vilanterol, li jista' jwassal għal żieda fil-potenzjal għar-reazzjonijiet avversi.
English: Patients with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with moderate hepatic impairment and healthy volunteers.
Maltese: Pazjenti b'indeboliment moderat tal-fwied (Child-Pugh tal-Klassi B) ma wrew l-ebda evidenza ta' żieda flesponiment sistemiku għal umeclidinium jew vilanterol (Cmax u AUC) wara li ngħataw umeclidinium/vilanterol b'umeclidinium fid-doppju tad-doża rakkomandata u vilanterol fid-doża rakkomandata u l-ebda evidenza ta' tibdil fit-twaħħil mal-plażma bejn pazjenti b'indeboliment moderat tal fwied u voluntiera b'saħħithom.
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 24 was greater for ANORO ELLIPTA (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Maltese: (34%) u kull komponent ta' monoterapija (44% għal umeclidinium u 48% għal vilanterol).
English: No effect on umeclidinium AUC or Cmax was observed at a 8-fold higher dose.
Maltese: Ma kien osservat lebda effett fuq l-AUC jew is-Cmax ta' umeclidinium b'doża 8 darbiet ogħla.
English: Inhalation powder, pre-dispensed.
Maltese: ipokalimja fid-doża terapewtika rakkomandata.
English: In one active-comparator study, a higher percentage of patients receiving ANORO ELLIPTA responded with a clinically meaningful improvement in SGRQ score at Week 24 (53%) compared to tiotropium (46%).
Maltese: Fi studju b'sustanza attiva ta' tqabbil, proporzjon akbar ta' pazjenti li kienu qed jirċievu ANORO ELLIPTA rrispondew b'titjib klinikament sinifikanti fil-punteġġ tal-SGRQ f'Ġimgħa 24 (53%) meta mqabbla ma' tiotropium (46%).
English: There was no increase in tumour incidence in rats or mice at exposures 0.5- or 13-fold, times the human clinical exposure of vilanterol 22 micrograms based on AUC, respectively.
Maltese: Ma kien hemm l-ebda żieda fl-inċidenza ta' tumuri fil-firien u l-ġrieden b'esponimenti 0.5 jew 13-il darba akbar mill-esponiment kliniku tal-bniedem għal vilanterol 22 mikrogramma, fuq il-bażi tal-AUC, rispettivament.
English: In Phase III, 6-month studies umeclidinium/vilanterol provided clinically meaningful improvements over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which were evident at 15 minutes following administration of the first dose (improvement over placebo by 112 ml (p <0.001*).
Maltese: fuq perjodu ta' 24 siegħa wara għoti darba kuljum, li kien evidenti kwarta wara l-għoti tal-ewwel doża (titjib ta'112 ml (p <0.001*) fuq plaċebo.
English: These belong to a group of medicines called bronchodilators.
Maltese: Dawn jagħmlu parti minn grupp ta' mediċini msejħa bronkodilaturi.
English: These may affect up to 1 in 1,000 people:
Maltese: Dawn jistgħu jaffettwaw sa 1 minn kull 1,000 persuna:
English: The instructions for use of the inhaler provided below can be used for either the 30-dose inhaler (30 day supply) or the 7-dose inhaler (7 day supply).
Maltese: L-istruzzjonijiet li ġejjin għall-inalatur bi 30 doża (provvista ta' 30 jum) japplikaw ukoll għall-inalatur b'7 dożi (provvista ta '7 ijiem).
English: From the three active-comparator studies in patients with symptomatic COPD, the risk of a moderate/severe COPD exacerbation compared with tiotropium was reduced by 50% in one study (HR 0.5; 95% CI: 0.3, 1.0; p=0.044).
Maltese: Mit-tliet studji b'sustanza attiva ta' tqabbil f'pazjenti b'COPD sintomatiku, ir-riskju ta' taħrix tas-COPD moderat/sever meta mqabbel ma' tiotropium tnaqqas b'50% fi studju wieħed (HR 0.5; 95%
English: In the three 6-month active-comparator-controlled studies, ANORO ELLIPTA reduced the use of rescue medication with salbutamol compared with tiotropium, with statistically significant reductions observed in two of the studies (see Table 1).
Maltese: Fit-tliet studji ta' 6 xhur ikkontrollati bis-sustanza attiva ta' tqabbil, ANORO ELLIPTA naqqas l-użu tal medikazzjoni ta' salvataġġ b'salbutamol meta mqabbel ma' tiotropium, bi tnaqqis statistikament sinifikanti osservat fi tnejn mill-istudji (ara Tabella 1).
English: Medicinal products containing beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol.
Maltese: Il-prodotti mediċinali li fihom imblokkaturi beta-adrenerġiċi jistgħu jdgħajfu jew jantagonizzaw l-effett talagonisti beta2-adrenerġiċi, bħal vilanterol.
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution (see section 4.4).
Maltese: Kura konkomitanti ipokalimika b'derivati ta' methylxanthine, sterojdi jew dijuretiċi li jħallu il-potassju joħroġ fl-awrina tista' żżid l-effett ipokalimiku possibbli ta' agonisti beta2-adrenerġiċi, għalhekk uża b'kawtela (ara sezzjoni 4.4).
English: Not for acute use Umeclidinium/vilanterol is not indicated for the treatment of acute episodes of bronchospasm.
Maltese: Mhux għall-użu akut Umeclidinium/vilanterol mhuwiex indikat għat-trattament ta' episodji akuti ta' bronkospażmu.
English: The primary metabolic routes for vilanterol are O-dealkylation to a range of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity.
Maltese: Ir-rotot metaboliċi primarji għal vilanterol huma d-dealkilazzjoni-O għal firxa ta' metaboliti b'attività agonista beta1- u beta2-adrenerġika konsiderevolment imnaqqsa.
English: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Maltese: Ieqaf tieħu din il-mediċina u fittex għajnuna medika immedjatament, billi jista' jkollok kondizzjoni serja magħrufa bħala bronkospażmu paradossali.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium/vilanterol.
Maltese: Jistgħu jidhru effetti kardjovaskulari, bħal arritmiji tal-qalb, eż. fibrillazzjoni atrijali u takikardija, wara lgħoti ta' antagonisti tar-riċetturi muskariniċi u simpatomimetiċi, fosthom umeclidinium/vilanterol.
English: When given subcutaneously there were no effects at 36-times the human clinical exposure of vilanterol 22 micrograms, based on AUC.
Maltese: darba aktar mill-esponiment kliniku fil-bniedem ta' vilanterol 22 mikrogramma, fuq il-bażi tal-AUC.
English: Use of rescue medication3
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: ANORO ELLIPTA contains lactose
Maltese: Kif jidher ANORO ELLIPTA u l-kontenut tal-pakkett
English: The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.
Maltese: 2,354 pazjent li rċevew umeclidinium/vilanterol darba kuljum fl-istudji kliniċi tal-Fażi III ta' 24 ġimgħa jew aktar, li minnhom 1,296 pazjent irċevew id-doża rakkomandata ta' 55/22 mikrogramma fi studji ta' 24
English: Umeclidinium plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours in healthy volunteers, with 3% to 4% excreted unchanged in urine at steady-state.
Maltese: Il-half-life tal-eliminazzjoni ta' umeclidinium mill-plażma wara t-teħid man-nifs tad-doża għal 10 ijiem kienet bħala medja 19-il siegħa f'voluntiera b'saħħithom, bi 3% sa 4% mneħħi mhux mibdul fl-awrina fl-istat fiss.
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered radioactivity) was excreted in faeces by 192 hours post-dose.
Maltese: Wara għoti fil-vini, madwar 58% taddoża radjutikkettata mogħtija (jew 73% tar-radjuattività rkuprata) tneħħiet fl-ippurgar sa 192 siegħa wara d doża.
English: Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant after administration of vilanterol (see section 5.3).
Maltese: Studji f'annimali wrew effett tossiku fuq is-sistema riproduttiva f'espożizzjonijiet li mhumiex klinikament rilevanti wara l-għoti ta' vilanterol (ara sezzjoni 5.3).
English: EXP
Maltese: Disfonja
English: The effect of umeclidinium/vilanterol on the QT interval was evaluated in a placebo and active (moxifloxacin) controlled QT study involving once daily administration of umeclidinium/vilanterol 113/22 micrograms or 500/100 micrograms (pre-dispensed dose with umeclidinium at eight times the recommended dose and vilanterol at four times the recommended dose) for 10 days in 103 healthy volunteers.
Maltese: umeclidinium/vilanterol 113/22 mikrogramma jew 500/100 mikrogramma (doża lesta minn qabel b'umeclidinium f'doża tmien darbiet dik rakkomandata u vilanterol f'doża erba' darbiet dik rakkomandata)
English: medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems ketoconazole or itraconazole, to treat fungal infections clarithromycin or telithromycin, to treat bacterial infections ritonavir, to treat HIV infection medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids) other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. tiotropium, indacaterol.
Maltese: mediċini msejħa imblokkaturi beta (bħal propranolol), għall-kura tal-pressjoni għolja tad-demm jew problemi fil-qalb oħrajn ketoconazole jew itraconazole, għall-kura ta' infezzjonijiet fungali clarithromycin jew telithromycin, għall-kura ta' infezzjonijiet batteriċi ritonavir, għall-kura ta' infezzjoni tal-HIV
English: Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Anoro Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Maltese: Magħżula f'Pazjenti b'COPD b'Anoro Ellipta imqabbel ma' tiotropium (studju 201038), skont protokoll li sar qbil fuqu mil-PRAC.
English: Immediate breathing difficulties after using ANORO ELLIPTA are rare.
Maltese: Diffikultajiet immedjati biex tieħu n-nifs wara l-użu ta' ANORO ELLIPTA huma rari.
English: • taste disturbance
Maltese: Twissijiet u prekawzjonijiet
English: Pack sizes of 7 or 30 dose inhalers.
Maltese: Pakketti ta' inalaturi ta' 7 jew ta' 30 doża.
English: • headache
Maltese: • stitikezza
English: Your ANORO ELLIPTA inhaler carton contains
Maltese: X'inhu ANORO ELLIPTA u għalxiex jintuża
English: Patients with severe renal impairment showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with severe renal impairment and healthy volunteers.
Maltese: Pazjenti b'indeboliment sever tal-kliewi ma wrew l-ebda evidenza ta' żieda fl-esponiment sistemiku għal umeclidinium jew vilanterol (Cmax u AUC) wara li ngħataw umeclidinium/vilanterol b'umeclidinium fiddoppju tad-doża rakkomandata u vilanterol fid-doża rakkomandata u l-ebda evidenza ta' tibdil fit-twaħħil mal-proteini bejn pazjenti b'indeboliment sever tal-kliewi u voluntiera b'saħħithom.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10);
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10);
English: Umeclidinium is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Maltese: Umeclidinium huwa antagonist tar-riċetturi muskariniċi li jaħdem fit-tul (imsejjaħ ukoll antikolinerġiku).
English: In use shelf-life: 6 weeks.
Maltese: Kemm idum tajjeb wara li jinfetaħ: 6 ġimgħat.
English: Lung function, symptomatic and health related quality of life outcomes at Week 24 Treatment comparisons with ANORO
Maltese: Tabella 1.Il-funzjoni tal-pulmun, eżiti sintomatiċi u tal-kwalità tal-ħajja relatata mas-saħħa f'Ġimgħa 24
English: Following inhaled administration of vilanterol in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Maltese: Wara t-teħid man-nifs ta' umeclidinium f'voluntiera b'saħħithom, is-Cmax seħħet wara 5 sa 15-il minuta.
English: one 6-month study, or in a further 55 patients who received umeclidinium/vilanterol 113/22 micrograms once daily in another 6-month study and 226 patients who received 113/22 micrograms once daily in the 12-month study.
Maltese: ġimgħa, 832 pazjent irċevew doża ogħla ta' 113/22 mikrogramma fi studji ta' 24 ġimgħa u 226 pazjent irċevew 113/22 mikrogramma fi studju ta' 12-il xahar.
English: Plasma clearance of vilanterol following intravenous administration was 108 litres/hour.
Maltese: It-tneħħija ta' vilanterol mill-plażma wara għoti fil-vini kienet ta' 108 litri/siegħa.
English: Administration of umeclidinium/vilanterol may produce paradoxical bronchospasm that may be lifethreatening.
Maltese: L-għoti ta' umeclidinium/vilanterol jista' jipproduċi bronkospażmu paradossali li jista' jkun ta' periklu għallħajja.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in CYP2D6 activity (poor metabolisers).
Maltese: Abbażi tal-kobor ta' dawn il-bidliet, ma hija mistennija l-ebda interazzjoni klinikament rilevanti bejn il-mediċini meta umeclidinium/vilanterol jingħata fl-istess ħin ma' inibituri ta' CYP2D6 jew meta jingħata lill-pazjenti ġenetikament defiċjenti fl-attività ta' CYP2D6 (metabolizzaturi ħżiena).
English: Other medicines and ANORO ELLIPTA
Maltese: Għalxiex jintuża ANORO ELLIPTA
English: Excipients
Maltese: Glawkoma
English: Other medicinal products for COPD
Maltese: Prodotti mediċinali oħra għas-COPD
English: In addition, ANORO ELLIPTA demonstrated clinically meaningful and statistically significant improvements in trough FEV1 compared with tiotropium in two of the three 6-month active-comparator studies and numerically greater improvements from tiotropium in the third active-comparator study (see Table 1).
Maltese: Barra minn hekk, ANORO ELLIPTA wera titjib statistikament sinifikanti u klinikament sinifikanti fil-livell minimu tal-FEV1 meta mqabbel ma' tiotropium fi tnejn mit-tliet studji b'sustanza attiva ta' tqabbil ta' 6-xhur u titjib numerikament akbar minn tiotropium fit-tielet studju b'sustanza attiva ta' tqabbil (ara Tabella 1).
English: ANORO ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung volume measures compared with placebo in both studies in adult COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Maltese: kif evalwat bl-endurance shuttle walk test (ESWT), fi studju wieħed iżda mhux fit-tieni u tejjeb il-kejl talvolum tal-pulmun meta mqabbel ma' plaċebo fiż-żewġ studji f'pazjenti adulti b'COPD b'iperinflazzjoni (kapaċità residwa funzjonali
English: Adults and adolescents
Maltese: Persuni adulti u adolexxenti
English: Systemic Symptoms (DRESS)*
Maltese: Systemic Symptoms)*
English: The active substance is perampanel.
Maltese: Is-sustanza attiva hi perampanel.
English: * See section 4.4
Maltese: * Ara sezzjoni 4.4
English: 2 oral syringes
Maltese: 2 siringi orali
English: 35% increase
Maltese: Żieda ta' 35%
English: 19% decrease
Maltese: Tnaqqis ta' 19%
English: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom
Maltese: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ir-Renju Unit
English: - Oral contraceptives (also called “hormonal contraceptives”).
Maltese: - Kontraċettivi orali (imsejħa wkoll “kontraċettivi ormonali”).
English: <10% decrease
Maltese: Tnaqqis ta' <10%
English: Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN United Kingdom
Maltese: European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN
English: Valproic Acid No influence
Maltese: Valproic Acid L-ebda influwenza
English: Conversion to monotherapy
Maltese: Konverżjoni għal monoterapija
English: Fycompa contains sorbitol
Maltese: Fycompa fih sorbitol
English: The population included 164 patients (perampanel N = 82, placebo N = 82).
Maltese: Il-popolazzjoni kienet tinkludi 164 pazjent (perampanel N=82, plaċebo N=82).
English: CDR System Global Cognition t-Scores for placebo and perampanel were 41.2 (10.7) and 40.8 (13.0), respectively at the baseline.
Maltese: Is-CDR System Global Cognition t-Scores għall-plaċebo u perampanel kienu ta' 41.2 (10.7) u 40.8 (13.0), rispettivament fil-linja bażi.
English: The pooled 50% responder rates were placebo 19%, 4 mg 29%, 8 mg 35% and 12 mg 35%.
Maltese: Ir-rati miġbura ta' 50% ta' dawk li rrispondew kienu: plaċebo 19%, 4 mg 29%, 8 mg 35% u 12 mg 35%.
English: You may experience confusion, agitation and aggressive behaviour.
Maltese: Jista' jkollok konfużjoni, aġitazzjoni u mġiba aggressiva.
English: There was no statistically significant difference between the treatment groups (p = 0.145).
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti bejn il-gruppi tal-kura (p=0.145).
English: Excipient with known effect: Each ml of oral suspension contains 175 mg sorbitol (E420).
Maltese: Kull ml ta' suspensjoni orali fih 175 mg ta' sorbitol (E420).
English: Aggression Anger
Maltese: Aggressjoni Rabja
English: Carbamazepine 2.75 fold decrease
Maltese: Carbamazepine Tnaqqis ta' 2.75 darbiet
English: What Fycompa contains - The active substance is perampanel.
Maltese: X'fih Fycompa - Is-sustanza attiva hi perampanel.
English: Oxcarbazepine is rapidly metabolised by cytosolic reductase enzyme to the active metabolite, monohydroxycarbazepine.
Maltese: Oxcarbazepine jiġi metabolizzat malajr minn enzima ċitostolika reductase għall-metabolit attiv, monohydroxycarbazepine.
English: Diplopia Vision blurred
Maltese: Diplopja Vista mċajpra
English: Simethicone emulsion 30%, containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid Citric acid, anhydrous (E330)
Maltese: Simethicone emulsion 30%, li fiha ilma ppurifikat, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid u sulfuric acid Citric acid, anhydrous (E330)
English: In vitro assessment of drug interactions
Maltese: Evalwazzjoni in vitro ta' interazzjonijiet tal-mediċina
English: Date of first authorisation: 23/07/2012 Date of latest renewal: 6 April 2017
Maltese: Data tal-aħħar tiġdid: 6 ta' April, 2017
English: Oral suspension 340 ml.
Maltese: Suspensjoni orali 340 ml. 1 flixkun
English: Study 332 included 22 adolescents between the ages of 12 and 18.
Maltese: Studju 332 kien jinkludi 22 adoloxxent bejn l-etajiet ta' 12 u 18-il sena.
English: In vitro studies show that perampanel is not a substrate or significant inhibitor of organic anion transporting polypeptides (OATP) 1B1 and 1B3, organic anion transporters (OAT) 1, 2, 3, and 4, organic cation transporters (OCT) 1, 2, and 3, and the efflux transporters P-glycoprotein and Breast Cancer Resistance Protein (BCRP).
Maltese: Studji in vitro juru li perampanel mhuwiex substrat jew inibitur sinifikanti ta' organic anion transporting polypeptides (OATP) 1B1 u 1B3, organic anion transporters (OAT) 1, 2, 3, u 4, organic cation transporters (OCT) 1, 2, u 3, u t-trasportaturi tal-effluss P-glycoprotein u Proteina tar-Reżistenza għall-Kanċer tas-Sider (BCRP).
English: - Fycompa may make you aggressive, angry or violent.
Maltese: - Fycompa jista' jagħmlek aggressiv, irrabjat jew vjolenti.
English: Data from in vitro studies indicate that perampanel is approximately 95% bound to plasma proteins.
Maltese: Dejta minn studji in vitro tindika li perampanel jeħel b'rata ta' madwar 95% mal-proteini fil-plażma.
English: Fycompa contains sorbitol (E420); therefore patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Maltese: Fycompa fih sorbitol (E420); u għalhekk pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose m'għandhomx jieħdu dan il-prodott mediċinali.
English: The 50% responder rates in the 4 mg, 8 mg and 12 mg groups were respectively 23.0%, 31.5%, and 30.0% in combination with enzyme-inducing anti-epileptic medicinal products and were 33.3%, 46.5% and 50.0% when perampanel was given in combination with non-enzyme-inducing anti-epileptic medicinal products.
Maltese: Ir-rati ta' 50% ta' dawk li rrispondew fil-gruppi ta' 4 mg, 8 mg u 12 mg kienu rispettivament 23.0%, 31.5%, u 30.0% flimkien ma' prodotti mediċinali antiepilettiċi li jinduċu lenzimi, u kienu 33.3%, 46.5% u 50.0% meta perampanel ingħata flimkien ma' prodotti mediċinali antiepilettiċi li ma jinduċux l-enzimi.
English: Effect of perampanel on CYP3A substrates
Maltese: L-effett ta' perampanel fuq substrati ta' CYP3A
English: This was not statistically significant (p = 0.96).
Maltese: Dan ma kienx statistikament sinifikanti (p=0.96).
English: Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets) Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colourants*
Maltese: Kisja tar-rita (pilloli ta' 2 mg, 4 mg, 6 mg, 8 mg, 10 mg u 12 mg) Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), koloranti*
English: In healthy subjects, Fycompa (6 mg once daily for 20 days) decreased midazolam AUC by 13%.
Maltese: F'persuni f'saħħithom, Fycompa (6 mg darba kuljum għal 20 jum) naqqas l-AUC ta' midazolam bi 13%.
English: Cognitive function
Maltese: Funzjoni konoxxittiva
English: Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets) Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)
Maltese: Qalba tal-pillola (pilloli ta' 6 mg, 8 mg, 10 mg u 12 mg) Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)