FrancophonIA/ELRC3.0 huggingface dataset:
English: Pitolisant shows greater than 50% inhibition towards OCT1 (organic cation transporters 1) at 1.33 µM, the extrapolated IC50 of pitolisant is 0.795 µM (see section
Maltese: Pitolisant juri inibizzjoni akbar minn 50% lejn OCT1 (trasportaturi tal-cations organiċi 1) f'1.33 µM, l-IC50 estrapolat ta' pitolisant huwa 0.795 µM (ara sezzjoni 4.5).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The results with pitolisant were significantly superior to those in the placebo group (mean difference: -3.33; 95%CI [-5.83 to -0.83]; p < 0.05) but did not differ significantly from the results in the modafinil group (mean difference: 0.12; 95%CI [-2.5 to 2.7]).
Maltese: 83]; p < 0.05) iżda ma kinux ferm differenti mir-riżultati fil-grupp ta' modafinil (differenza medja: 0.12; 95%CI [-2.5 sa 2.7]).
English: Abnormal behaviour Confusional state Depressed mood Excitability Obsessive thoughts Dysphoria Hypnopompic hallucination Depressive symptom Hypnagogic hallucination Mental impairment
Maltese: Imġiba mhux normali Stat ta' konfużjoni Burdata depressa Eċċitabbiltà Ħsibijiet ossessivi Disforja Alluċinazzjoni ipnopompika Sintomu depressiv Alluċinazzjoni ipnagoġika Indeboliment mentali
English: The effectiveness of pitolisant up to 36 mg once a day, for the treatment of narcolepsy with or without cataplexy was established in two main, 8 weeks, multicenter, randomized, double-blind, placebo-controlled, parallel group trials (Harmony I and Harmony CTP).
Maltese: L-effikaċja ta' pitolisant sa 36 mg darba kuljum, għall-kura ta' narkolessija bi jew mingħajr kataplessija ġiet stabbilita f'żewġ provi, ta' 8 ġimgħat, multiċentriċi, randomizzati, double-blind, ikkontrollati bi plaċebo, bi gruppi paralleli ewlenin (Harmony I u Harmony CTP).
English: Pitolisant shows greater than 50% inhibition towards OCT1 (organic cation transporters 1) at 1.33 µM, the extrapolated IC50 of pitolisant is 0.795 µM.
Maltese: Pitolisant juri inibizzjoni akbar minn 50% lejn OCT1 (trasportaturi tal-cations organiċi 1) f'1.33 µM, lIC50 estrapolat ta' pitolisant huwa 0.795 µM.
English: Therefore, the combination of pitolisant with substrates of CYP3A4 and having a narrow therapeutic margin (e.g. immunosuppressants, docetaxel, kinase inhibitors, cisapride, pimozide, halofantrine) should be avoided (see section 4.4).
Maltese: Għalhekk, il-kombinazzjoni ta' pitolisant mas-sottostrati ta' CYP3A4 u li għandhom marġini terapewtiku dejjaq (eż immunosuppressanti, docetaxel, inibituri ta' kinase, cisapride, pimozide, halofantrine) għandha tiġi evitata (ara sezzjoni 4.4).
English: 105 narcoleptic patients with high frequency weekly cataplexy rates at baseline were included (54 patients treated with pitolisant and 51 with placebo).
Maltese: Ġew inklużi 105 pazjenti narkolettiċi b'rati ta' kataplessija fil-ġimgħa bi frekwenza għolja fil-linja bażi (54 pazjent ikkurat b'pitolisant u 51 bi plaċebo).
English: The combination of pitolisant with substrates of CYP3A4 and having a narrow therapeutic margin should be avoided (see section 4.5).
Maltese: Il-kombinazzjoni ta' pitolisant ma' sottostrati ta' CYP3A4 u li għandhom marġni terapewtiku dejjaq għandha tiġi evitata (ara sezzjoni 4.5).
English: Nutrition disorders
Maltese: Disturbi fin-nutrizzjoni
English: Pitolisant exhibits high serum protein binding (>90%) and demonstrates approximately equal distribution between red blood cells and plasma.
Maltese: Pitolisant jesebixxi rbit għoli mal-proteina fis-serum (>90%) u juri bejn wieħed u ieħor distribuzzjoni ugwali bejn iċ-ċelloli ħomor tad-demm u l-plasma.
English: - Week 3: the dose may be increased to 36 mg (two 18 mg tablets) per day.
Maltese: - Ġimgħa 3: id-doża tista' tiżdied għal 36 mg (żewġ pilloli ta' 18 mg) kuljum.
English: During the stable period (until the end of treatment), geometric mean WRC decreased to 6.79 (median=6 [3; 15]) and 3.28 (median=3 [1.3; 6]) in the placebo and pitolisant groups respectively in patients who had experienced at least one episode of cataplexy.
Maltese: Matul il-perjodu stabbli (sal-aħħar tal-kura), idWRC ġeometrika medja naqset għal 6.79 (medjan=6 [3; 15]) u 3.28 (medjan=3 [1.3; 6]) fil-gruppi talplaċebo u pitolisant rispettivament f'pazjenti li esperjenzaw tal-inqas episodju wieħed ta' kataplessija..
English: At baseline, the geometric mean of WRC was 7.31 (median=6.5 [4.5; 12]) and 9.15 (median=8.5 [5.5; 15.5]) in the placebo and pitolisant groups respectively.
Maltese: Fil-linja bażi, il-medja ġeometrika tad-WRC kienet 7.31 (medjan=6.5 [4.5; 12]) u 9.15 (medjan=8.5
English: Wakix may reduce the effectiveness of hormonal contraceptives, an alternative method of effective contraception has to be used (see section “Pregnancy).
Maltese: Wakix jista' jnaqqas l-effikaċja tal-kontraċettivi ormonali, metodu alternattiv ta' kontraċezzjoni effikaċi jrid jintuża (ara s-sezzjoni "Tqala).
English: Figure 3: Changes in Epworth Sleepiness Scale Score (ESS) (mean ± SEM) from Baseline to week 7 in Harmony CTP study
Maltese: Figura 3: Tibdil fil-Punteġġ tal-Iskala ta' Ngħas ta' Epworth (ESS) (medja ± SEM) mil-Linja bażi sa ġimgħa 7 fl-istudju Harmony CTP
English: Pitolisant should be administered with caution in patients with severe obesity or severe anorexia (see section 4.8).
Maltese: Pitolisant għandu jingħata b'attenzjoni f'pazjenti b'obesità severa jew b'anoressija severa (ara sezzjoni 4.8).
English: EU/1/15/1068/002 30 film-coated tablets
Maltese: EU/1/15/1068/002 30 pillola miksija b'rita
English: Given the 2-fold increase of pitolisant exposure, its coadministration with CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, venlafaxine, duloxetine, bupropion, quinidine, terbinafine, cinacalcet) should be done with caution.
Maltese: Minħabba ż-żieda ta' darbtejn flespożizzjoni ta' pitolisant, l-għoti fl-istess ħin tiegħu ma' inibituri ta' CYP2D6 (eż. paroxetine, fluoxetine, venlafaxine, duloxetine, bupropion, quinidine, terbinafine, cinacalcet) għandu jsir b'kawtela.
English: After 1 month in mice, 6 months in rats and 9 months in monkeys, no adverse effect level (NOAEL) were 75, 30 and 12 mg/kg/day, p.o., respectively, providing safety margins of 9, 1 and 0.4, respectively when compared to the drug exposure at therapeutic dose in human.
Maltese: Wara 1 xahar fil-ġrieden, 6 xhur fil-firien u 9 xhur fix-xadini, il-livell ta' ebda effett avvers (NOAELno adverse effect level) kien 75, 30 u 12 mg/kg/kuljum, p.o., rispettivament, u jipprovdi marġini ta' sikurezza ta' 9, 1 u 0.4, rispettivament meta mqabbel mal-espożizzjoni għall-mediċina f'doża terapewtika fil-bnedmin.
English: Co-administration of pitolisant with rifampicin in multiple doses significantly decreases pitolisant mean Cmax and AUC ratio about 39% and 50%, respectively.
Maltese: L-għoti fl-istess ħin ta' pitolisant ma' rifampicin f'dożi multipli jnaqqas b'mod sinifikanti l-proporzjon medju ta' Cmax u ta' AUC ta' pitolisant b'madwar 39% u 50%, rispettivament.
English: Figure 1: Changes in Epworth Sleepiness Scale Score (ESS) (mean ± SEM) from Baseline to week 8 in Harmony 1 study
Maltese: Figura 1: Tibdil fil-Punteġġ ta' l-Iskala ta' Ngħas ta' Epworth (ESS - Epworth Sleepiness Scale Score) (medja ± SEM) mil-Linja bażi għal ġimgħa 8 fl-istudju Harmony 1
English: Gastric disorders reactions have been reported with pitolisant, therefore it should be administered with caution in patients with acid related gastric disorders (see section 4.8) or when co-administered with gastric irritants such as corticosteroids or NSAID.
Maltese: Reazzjonijiet ta' disturbi gastriċi ġew irrapportati b'pitolisant, għaldaqstant għandu jingħata b'attenzjoni f'pazjenti b'disturbi gastriċi relatati mal-aċidu (ara sezzjoni 4.8) jew meta jingħata ma' irritanti tal-istonku bħal kortikosterojdi jew NSAID.
English: In patients with moderate hepatic impairment (Child-Pugh B), AUC increased by a factor 2.4, while half-life doubled (see section 4.2).
Maltese: F'pazjenti b'indeboliment tal-fwied moderat (Child-Pugh B), l-AUC żdiedet b'fattur ta' 2.4, filwaqt li l-half-life rdoppja (ara sezzjoni 4.2).
English: • Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Tri or tetracyclic antidepressants (e.g. imipramine, clomipramine, mirtazapine) may impair the efficacy of pitolisant because they display histamine H1-receptor antagonist activity and possibly cancel the effect of endogenous histamine released in brain by the treatment.
Maltese: Antidepressanti tri jew tetraċikliċi (eż. imipramine, clomipramine, mirtazapine) jistgħu jfixklu leffikaċja ta' pitolisant minħabba li juru attività antagonista ta' riċettur-H1 tal-istamina u possibbilment jikkanċellaw l-effett ta' istamina endoġenuża rilaxxata mill-moħħ mill-kura.
English: - You have heart problems.
Maltese: - Jekk għandek problemi tal-qalb.
English: Neck pain Musculoskeletal chest pain
Maltese: Uġigħ fl-għonq Uġigħ muskuloskeletali fis-sider
English: In the pitolisant group, ESS decreased significantly between baseline and the end of treatment compared to placebo with an observed mean change of -1.9 ± 4.3 and -5.4 ± 4.3 (mean ± sd) for placebo and pitolisant respectively, (p<0.0001) (Figure 3).
Maltese: Filgrupp ta' pitolisant, l-ESS naqas b'mod sinifikanti bejn il-linja bażi u t-tmiem tal-kura meta mqabbel mal-plaċebo b'tibdil medju osservat ta' -1.9 ± 4.3 u -5.4 ± 4.3 (medja ± SD) għal plaċebo u għal pitolisant rispettivament, (p<0.0001) (Figura 3).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: Most patients (65%) reached the 36 mg once a day dosage.
Maltese: Ħafna mill-pazjenti (65%) laħqu d-dożaġġ ta' 36 mg darba kuljum.
English: Renal impairment In patients with impaired renal function (stages 2 to 4 according to the international classification of chronic kidney disease, i.e. creatinine clearance between 15 and 89 ml/min), Cmax and AUC tended to be increased by a factor of 2.5 without any impact on half-life (see section 4.2).
Maltese: Indeboliment tal-kliewi F'pazjenti b'funzjoni tal-kliewi indebolita (fażijiet 2 sa 4 skont il-klassifikazzjoni internazzjonali talmard kroniku tal-kliewi, jiġifieri l-eliminazzjoni tal-kreatinina bejn 15 u 89 ml/min), is-Cmax u l-AUC kellhom it-tendenza li jiżdiedu b'fattur ta' 2.5 mingħajr ebda impatt fuq il-half-life (ara sezzjoni 4.2).
English: Arthralgia Back pain Muscle rigidity Muscular weakness Musculoskeletal pain Myalgia Pain in extremity
Maltese: Artralġja Uġigħ fid-dahar Riġidità fil-muskoli Dgħufija fil-muskoli Uġigħ muskoloskeletriku Mijalġja Uġigħ fl-estremitajiet
English: Wakix is available in a bottle of 30 tablets or 90 tablets.
Maltese: Wakix huwa disponibbli fi flixkun ta' 30 jew 90 pillola.
English: Agitation Hallucination Hallucination visual, auditory Affect lability Abnormal dreams Dyssomnia Middle insomnia Initial insomnia Terminal insomnia Nervousness Tension Apathy Nightmare Restlessness Panic Attack Libido decreased Libido increased
Maltese: Aġitazzjoni Alluċinazzjoni Alluċinazzjoni viżiva, awditorja Bidla kontinwa filburdata Ħolm mhux normali Dissomnija Insomnija medja Insomnja inizjali Insomnja terminali Nervi Tensjoni Apatija Ħmar il-lejl Irrekwitezza Attakk ta' Paniku Tnaqqis fil-libido Żieda fil-libido
English: Asthenia Chest Pain Feeling Abnormal Malaise Oedema Peripheral oedema
Maltese: Astenja Uġigħ fis-Sider Ma Tħossokx Normali Telqa Edema Edema periferali
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets Pitolisant
Maltese: Wakix 4.5 mg pilloli miksijin b'rita Wakix 18 mg pilloli miksijin b'rita
English: For a dose of 36 mg, take two 18 mg tablets.
Maltese: Għal doża ta' 36 mg, ħu żewġ pilloli ta' 18 mg.
English: Harmony CTP, a supportive double blind, randomized, parallel group study of pitolisant versus placebo, was designed to establish pitolisant efficacy in patients with high frequency cataplexy in narcolepsy.
Maltese: Harmony CTP, studju ta' appoġġ double-blind, randomizzat, bi grupp parallel ta' pitolisant kontra plaċebo, ġie ddisinjat sabiex jistabbilixxi l-effikaċja ta' pitolisant f'pazjenti b'kataplessija bi frekwenza għolja f'nakrolessija.
English: No rebound effect was reported during clinical trials.
Maltese: L-ebda effett rebound ma kien irrapportat matul il-provi kliniċi.
English: Pitolisant is contra-indicated in patients with severe hepatic impairment (Child-Pugh C) (see section
Maltese: Pitolisant huwa kontraindikat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh C) (ara sezzjoni 4.3).
English: Each film-coated tablet of Wakix 4.5 mg contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant.
Maltese: Kull pillola ta' Wakix 4.5 mg fiha 5 mg ta' pitolisant hydrochloride, ekwivalenti għal 4.45 mg ta' pitolisant.
English: In particular, you should be cautious if you take Wakix together with some antidepressants (e.g. imipramine, clomipramine and mirtazapine) and some medicines to treat allergic conditions (antihistamines, e.g. pheniramine maleate, chlorpheniramine, diphenydramine, promethazine, mepyramine).
Maltese: B'mod partikolari, għandek toqgħod attent/a jekk tkun qed tieħu Wakix flimkien ma' xi antidepressanti (eż. imipramine, clomipramine u mirtazapine) u xi mediċini biex jikkuraw kundizzjonijiet allerġiċi (antiħistamini, eż. pheniramine maleate, chlorpheniramine, diphenydramine, promethazine, mepyramine).
English: Women of childbearing potential have to use effective contraception during treatment and at least up to 21 days after treatment discontinuation (based on pitolisant/metabolites half-life).
Maltese: Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effikaċi waqt il-kura u għal tal-inqas sa 21 jum wara t-twaqqif tal-kura (ibbażata fuq il-half-life ta' pitolisant/metaboliti).
English: In a clinical multiple dose study, the combination of pitolisant with probenecid decreases the AUC of pitolisant by about 34%.
Maltese: Fi studju kliniku b'dożi multipli, il-kombinazzjoni ta' pitolisant ma' probenecid tnaqqas l-AUC ta' pitolisant b'madwar 34%.
English: For a dose of 9 mg, take two 4.5 mg tablets.
Maltese: Għal doża ta' 9 mg, ħu żewġ pilloli ta' 4.5 mg.
English: The effect size of pitolisant compared with placebo based on a model for WRC based on BOCF with centre as a fixed effect was 0.581, 95%CI [0.493 to 0.686]; p<0.0001.
Maltese: 0001). Id-daqs tal-effett ta' pitolisant meta mqabbel ma' plaċebo bbażat fuq mudell għal WRC ibbażat fuq BOCF b'ċentru bħala effett fiss kien 0.581, 95% CI [0.493-0.686]; p
English: Most patients (60%) reached the 36 mg once a day dosage.
Maltese: Ħafna mill-pazjenti (60%) laħqu d-dożaġġ ta' 36 mg darba kuljum.
English: Visual acuity reduced Blepharospasm
Maltese: Tnaqqis fl-akutezza viżwali Blefarospażmu
English: Wakix 4.5 mg comes in a white, round, film-coated tablet of 3.7 mm, biconvex marked with “5” on one side.
Maltese: Wakix 4.5 mg jiġi bħala pillola bajda, tonda, miksija b'rita ta' 3.7 mm, mżaqqa fuq żewġ naħat immarkata b'“5” fuq naħa waħda.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Antidipressanti
English: Wakix 18 mg film-coated tablets Pitolisant
Maltese: Wakix 18 mg pilloli miksijin b'rita Pitolisant
English: - Week 2: the dose may be increased to 18 mg (one 18 mg tablet) per day or decreased to 4.5 mg (one 4.5 mg tablet) per day.
Maltese: - Ġimgħa 2: id-doża tista' tiżdied għal 18 mg (pillola waħda ta' 18 mg) kuljum jew titnaqqas għal 4.5 mg (pillola waħda ta' 4.5 mg) kuljum.
English: LABEL
Maltese: KARTUNA
English: Wakix 4.5 mg film-coated tablet Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.
Maltese: Wakix 4.5 mg pillola Kull pillola fiha 5 mg ta' pitolisant hydrochloride ekwivalenti għal 4.45 mg ta' pitolisant.
English: CYP2D6 poor metabolizers
Maltese: Metabolizzaturi mhux daqstant tajbin ta' CYP2D6
English: White, round, biconvex film-coated tablet, 7.5 mm diameter marked with “20” on one side.
Maltese: Pillola miksija b'rita bajda, tonda mżaqqa miż-żewġ naħat, b'dijametru ta' 7.5 mm, immarkata b'“20” fuq naħa waħda.
English: In vitro studies indicate that pitolisant is neither a substrate nor an inhibitor of human P-glycoprotein and breast cancer resistance protein (BCRP).
Maltese: Studji in vitro jindikaw li pitolisant la huwa sottostrat u lanqas inibitur ta' P-glycoproteina umana u tal-proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein) Pitolisant mhuwiex sottostrat ta' OATP1B1, OATP1B3.
English: With St John's Wort (Hypericum Perforatum), due to its strong CYP3A4 inducing effect, caution should be exercised when taken concurrently with pitolisant.
Maltese: B'St John's Wort (Hypericum Perforatum), minħabba l-effett induttur ta' CYP3A4 b'saħħtu tiegħu, għandha tiġi eżerċitata l-kawtela meta jittieħed fl-istess ħin ma' pitolisant.
English: Upon repeated administrations, the steady state is achieved after 5-6 days of administration leading to an increased serum level around 100%.
Maltese: Wara għoti ripetut, l-istat fiss jintlaħaq wara 5-6 ijiem mill-għoti u dan iwassal għal żieda fil-livell fis-serum ta' madwar 100%.
English: Even if the clinical relevance of this effect is not established, caution is advised when pitolisant is administered with a substrate of OCT1 (e.g. metformin (biguanides)) (see section 5.2).
Maltese: Anki jekk ir-relevanza klinika ta' dan l-effett ma tkunx ġiet stabbilita, hija rrakkomandata l-kawtela meta pitolisant jingħata ma' sottostrat ta' OCT1 (eż. metformin (biguanides)) (ara sezzjoni 5.2).
English: They are formed under the action of CYP3A4 and CYP2D6.
Maltese: Dawn huma fformati taħt l-azzjoni ta' CYP3A4 u CYP2D6.
English: Uncommon side effects (may affect up to 1 in 100 people): - Sweating - Decrease or increase of appetite - Oedema - Feeling jittery, nervousness, seeing or hearing things that are not really there - Changing emotions - Abnormal dreams - Tension - Difficulty in falling asleep at the beginning of the night or in the middle of the night or at the end of the night, difficulty in staying asleep, excessive sleepiness, somnolence - State of indifference with lack of emotion - Nightmare - Feeling restless and unable to keep still - Panic reaction - Altered or increased sexual interest - Sudden and transient episode of muscle weakness, uncontrollable muscle spasms or movement of one leg - Disturbance in attention - Migraine - Epilepsy - Weakness - Movement disturbance, slow body movement - Sensation of tingling, tickling, pricking, or burning of the skin - Sudden and unpredictable phases of mobility and immobility - Feeling unsteady - Reduced visual acuity, abnormal contraction or twitch of the eyelid - Hearing of sound when no external sound is present - Abnormal heart beat, slow or fast heart rate, raised or decrease blood pressure , hot flush - Yawning - Dry mouth - Diarrhoea, abdominal pain, discomfort or pain in the belly (abdomen), constipation, heartburn,
Maltese: rieqed, ngħas eċċessiv, ħedla - Stat ta' indifferenza b'nuqqas ta' emozzjoni - Ħmar il-lejl - Tħossok irrekwet u ma tistax toqgħod kwiet - Reazzjoni ta' paniku - Tibdil jew żieda fl-interess sesswali - Episodju f'daqqa u temporanju ta' dgħufija fil-muskoli, spażmi fil-muskoli inkontrollabbli jew moviment ta' riġel wieħed - Disturb fl-attenzjoni - Emigranja - Epilessija - Dgħufija - Disturb fil-moviment, moviment tal-ġisem bil-mod - Sensazzjoni ta' tnemnim, tagħrix, tingiż, jew ħruq tal-ġilda - Fażijiet f'daqqa u imprevedibbli ta' mobilità u immobilità - Tħossok instabbli - Tnaqqis fl-akutezza tal-vista, kontrazzjoni anormali jew tiġbid ta' tebqet il-għajn - Tisma' ħoss meta ma jkun hemm l-ebda ħoss estern - Rata ta' taħbit tal-qalb mhux normali, rata ta' taħbit tal-qalb bil-mod jew mgħaġġla, żieda jew tnaqqis fil-pressjoni, fwawar ta' sħana - Titwib - Ħalq xott - Dijarea, uġigħ addominali, skonfort jew uġigħ fiż-żaqq (addome), stitikezza, ħruq ta' stonku,
English: The combination of pitolisant with modafinil or sodium oxybate, usual treatments of narcolepsy was evaluated in healthy volunteers, at therapeutic doses.
Maltese: Il-kombinazzjoni ta' pitolisant ma' modafinil jew sodium oxybate, il-kuri li jintużaw normalment għan-narkolepsija, kienet evalwata f'voluntiera f'saħħithom, fid-dożi terapewtiċi.
English: White, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “5” on one side.
Maltese: Pillola miksija b'rita bajda, tonda mżaqqa miż-żewġ naħat, b'dijametru ta' 3.7 mm, immarkata b'“5” fuq naħa waħda.
English: On the primary efficacy endpoint, Weekly Rate of Cataplexy episodes (WRC), the results with pitolisant were significantly superior to those in the placebo group (p < 0.0001), with a progressive 64% decrease from baseline to end of treatment (Figure 2).
Maltese: Fuq il-punt ta' tmiem tal-effikaċja primarja, ir-Rata fil-Ġimgħa ta' Episodji ta' Kataplessija (WRCWeekly Rate of Cataplexy), ir-riżultati b'pitolisant kienu ferm superjuri għal dawk fil-grupp talplaċebo (p < 0.0001), bi tnaqqis progressiv ta' 64 % mil-linja bażi sa tmiem il-kura (Figura 2).
English: Wakix 18 mg tablet Each tablet contains 20 mg of pitolisant hydrochloride, equivalent to 17.8 mg of pitolisant.
Maltese: Kull pillola ta' Wakix 18 mg fiha 20 mg ta' pitolisant hydrochloride, ekwivalenti għal 17.8 mg ta' pitolisant.
English: Wakix 18 mg film-coated tablet Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
Maltese: Wakix 18 mg pillola Kull pillola fiha 20 mg ta' pitolisant hydrochloride ekwivalenti għal 17.8 mg ta' pitolisant.
English: Nevertheless, patients with cardiac disease, co-medicated with other QT-prolonging medicinal products or known to increase the risk of repolarization disorders, or co-medicated with medicinal products that significantly increase pitolisant Cmax and AUC ratio (see section 4.5) or patients with severe renal or moderate hepatic impairment (see section 4.4) should be carefully monitored (see section 4.5).
Maltese: Madankollu, pazjenti b'mard kardijaku, komedikati bi prodotti mediċinali oħra li jtawwlu lQT jew magħrufa li jżidu r-riskju ta' disturbi ta' ripolarizzazzjoni, jew komedikati bi prodotti mediċinali li jżidu b'mod sinifikanti l-proporzjon ta' Cmax u AUC ta' pitolisant (ara sezzjoni 4.5) jew pazjenti b'indeboliment tal-kliewi sever jew tal-fwied moderat (ara sezzjoni 4.4) għandhom jiġu sorveljati b'attenzjoni (ara sezzjoni 4.5).
English: Wakix 18 mg comes in a white, round, film-coated tablet of 7.5 mm, biconvex marked with “20” on one side.
Maltese: Wakix 18 mg jiġi bħala pillola bajda, tonda, miksija b'rita ta' 7.5 mm, mżaqqa fuq żew naħat immarkata b'“20” fuq naħa waħda.
English: When pitolisant dose is doubled from 27 to 54 mg, AUC0-∞ is increased by about 2.3.
Maltese: Meta doża ta' pitolisant tiġi rduppjata minn 27 għal 54 mg, l-AUC0-∞ jiżdied b'madwar 2.3.
English: Pitolisant/metabolites were shown to cross the placenta barrier in animals.
Maltese: Pitolisant/il-metaboliti ntwerew li jaqsmu l-barriera tal-plaċenta fl-annimali.
English: Wakix 4.5 mg film-coated tablets Pitolisant
Maltese: Wakix 4.5 mg pilloli miksijin b'rita Pitolisant