FrancophonIA/ELRC3.0 huggingface dataset:
English: QUADRAMET should not be used in people who may be hypersensitive (allergic) to EDTMP or to phosphonates (similar chemical compounds).
Maltese: QUADRAMET m'għandux jingħata lil nies li għandhom sensittività eċċessiva (allerġiċi) għal EDTMP jew għal fosfonati (komposti kimiċi simili).
English: QUADRAMET has been studied in 373 patients in three main studies.
Maltese: Għal QUADRAMET saru tliet studji ewlenin bis-sehem ta' 373 pazjent.
English: Why has QUADRAMET been approved?
Maltese: Għalxiex ġie approvat QUADRAMET?
English: QUADRAMET is a solution for injection containing the active substance samarium [153Sm]
Maltese: Is-sustanza attiva tiegħu hi samarium [153Sm]
English: The dose of QUADRAMET is calculated based on the patient's body weight to provide a specific dose of radioactivity (37 mega becquerels per kilogram body weight).
Maltese: Id-doża ta' QUADRAMET hi kkalkulata skond kemm jiżen il-pazjent biex tkun ipprovvduta d-doża speċifika ta' radjuattività (37 mega becquerels għal kull kilogramma li jiżen il-pazjent).
English: QUADRAMET is a radiopharmaceutical product.
Maltese: QUADRAMET hu prodott radjufarmaċewtiku.
English: What is QUADRAMET?
Maltese: X'inhu QUADRAMET?
English: This was measured using various means, such as visual or descriptive scales, analgesic (painkiller) use, and assessment by the doctor.
Maltese: Dan tkejjel permezz ta' diversi mezzi, bħal skali viżivi jew deskrittivi, l-użu ta' analġeżiċi (mediċini ta' kontra l-uġigħ), u eżaminar mit-tabib.
English: What is the risk associated with QUADRAMET?
Maltese: X'inhuma r-riskji assoċjati ma' QUADRAMET?
English: For the full list of all side effects reported with QUADRAMET, see the Package Leaflet.
Maltese: Ara l-Fuljett ta' Tagħrif għal lista sħiħa ta' effetti sekondarji rrappurtati ma' QUADRAMET.
English: In one of the studies, which involved patients with bone metastases from prostate cancer, the patients' use of opioid analgesics (such as morphine) was also reduced following treatment with QUADRAMET.
Maltese: F'wieħed mill-istudji, li fih ħadu sehem pazjenti b'metastasi fil-għadam minn kankru fil-prostata, kien hemm tnaqqis fl-użu ta' analġeżiċi (bħall-morfina) wara t-trattament b'QUADRAMET.
English: Before receiving QUADRAMET patients should have a bone scan using bisphosphonates radiolabelled with technetium-99m [99mTc] as markers, to check that their metastases are of the type that QUADRAMET can be used for.
Maltese: Qabel ma jingħataw QUADRAMET, il-pazjenti jkun irid isirilhom skan tal-għadam bl-użu ta' bifosfonati radjutikkettati b'technetium-99m [99mTc] bħala markaturi biex ikun magħruf jekk il-metastasi tagħhom humiex tat-tip li jista' jintuża QUADRAMET għalihom.
English: This summary was last updated in 12-2007.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi:12-2007.
English: How has QUADRAMET been studied?
Maltese: Kif ġie studjat QUADRAMET?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that QUADRAMET's benefits are greater than its risks for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' QUADRAMET fis-serħan mill-uġigħ fil-għadam huma ikbar mir-riskji f'pazjenti b'metastasi skeletriċi osteoblastiċi multipli.
English: The European Commission granted a marketing authorisation valid throughout the European Union for QUADRAMET to CIS bio international on 5 February 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal QUADRAMET lil CIS bio international fil-5 ta' Frar 1998.
English: Final report: 3Q 2023
Maltese: Rapport finali: 3Q 2023
English: 40 Boulevard de Champaret 38300 Bourgoin-Jallieu France
Maltese: 40 Boulevard de Champaret 38300 Bourgoin-Jallieu Franza
English: *p<0.0001 vs placebo
Maltese: *p<0.0001 vs plaċebo
English: Extrasystoles Bradycardia
Maltese: Ekstrasistoli Bradikardija
English: - Substrates of OCT1
Maltese: - Sottostrati ta' OCT1
English: Microcrystalline cellulose Crospovidone type A Talc
Maltese: Microcrystalline cellulose Crospovidone tip A Talc
English: Bioprojet Pharma 9, rue Rameau 75002 Paris France
Maltese: Bioprojet Pharma 9, rue Rameau 75002 Paris Franza
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX11.
Maltese: Mediċini oħrajn tas-sistema nervuża, Kodiċi ATC: N07XX11.
English: Tel: +33 (0)1 47 03 66 33 Fax: +33 (0)1 47 03 66 30 e-mail: contact@bioprojet.com
Maltese: Tel: +33 (0)1 47 03 66 33 Fax:
English: Severe hepatic impairment (Child-Pugh C).
Maltese: Indeboliment sever tal-fwied (Child-Pugh C).
English: Breastfeeding (see section 4.6).
Maltese: Treddigħ (ara s-sezzjoni 4.6).
English: The most serious ADRs are abnormal weight decrease (0.09%) and abortion spontaneous (0.09%).
Maltese: L-iktar ADRs serji huma tnaqqis anormali fil-piż (0.09%) u abort spontanju (0.09%).
English: Toxic skin eruption Photosensitivity
Maltese: Eruzzjoni tossika talġilda Fotosensittività
English: - You have severe epilepsy.
Maltese: - Għandek epilessija severa.
English: The other ingredients are microcrystalline cellulose, crospovidone, talc, magnesium stearate, colloidal anhydrous silica, polyvinyl alcohol, titanium dioxide, macrogol 3350.
Maltese: Is-sustanzi l-oħrajn huma microcrystalline cellulose, crospovidone, talc, magnesium stearate, colloidal anhydrous silica, polyvinyl alcohol, titanium dioxide, macrogol 3350.
English: Headache and insomnia During clinical studies, episodes of headache and insomnia have been reported (7.7 % to 8.4%).
Maltese: Uġigħ ta' ras u insomnija Matul studji kliniċi, ġew irrapportati episodji ta' uġigħ ta' ras u insomnija (7.7 % sa 8.4 %).
English: Pitolisant induces CYP3A4, CYP1A2 and CYP2B6 in vitro.
Maltese: Pitolisant jinduċi CYP3A4, CYP1A2 u CYP2B6 in vitro.
English: The second pivotal study (Harmony Ibis) included 165 patients (67 treated with pitolisant, 33 with placebo and 65 with modafinil).
Maltese: It-tieni studju pivotali (Harmony Ibis) inkluda 165 pazjent (67 ikkurati b'pitolisant, 33 bi plaċebo u 65 b'modafinil).
English: The most frequent adverse drug reactions (ADRs) reported with pitolisant were insomnia (8.4%), headache (7.7%), nausea (4.8%), anxiety (2.1%), irritability (1.8%), dizziness (1.4%), depression (1.3%), tremor (1.2%), sleep disorders (1.1%), fatigue (1.1%), vomiting (1.0%), vertigo (1.0%), dyspepsia (1.0%), weight increase (0.9%), abdominal pain upper (0.9%).
Maltese: L-aktar reazzjonijiet frekwenti avversi għall-mediċina (ADRs) irrapportati b'pitolisant kienu insomnija (8.4%), uġigħ ta' ras (7.7%), dardir (4.8%), ansjetà (2.1%), irritabilità (1.8%), sturdament (1.4%), depressjoni (1.3%), rogħda (1.2%), disturbi fl-irqad (1.1%), għeja (1.1%), rimettar (1.0%), vertiġini (1.0%), dispepsija (1.0%), żieda fil-piż (0.9%), uġigħ fil-parti ta' fuq tal-addome (0.9%).
English: Pitolisant has a plasma half-life of 10-12 hours.
Maltese: Pitolisant għandu half-life tal-plasma ta' 10-12-il siegħa.
English: Pitolisant/metabolites may reduce the effectiveness of hormonal contraceptives.
Maltese: Pitolisant/metaboliti jistgħu jnaqqsu l-effikaċja tal-kontraċettivi ormonali.
English: The geometric mean of the ratios (MWTFinal/MWTBaseline) was 1.8 (95%CI 1.19; 2.71, p=0.005).
Maltese: Il-medja ġeometrika tal-proporzjonijiet (MWTFinali/ MWTfil-Linja Bażi) kienet 1.8 (95%CI 1.19; 2.71, p=0.005).
English: Pitolisant is an inhibitor of CYP2D6 with moderate potency (IC50 = 2.6 µM).
Maltese: Pitolisant huwa inibitur ta' CYP2D6 b'qawwa moderata (IC50 = 2.6 µM).
English: In 68 to 80 years old patients the pharmacokinetics of pitolisant is not different compared to younger patients (18 to 45 years of age).
Maltese: F'pazjenti ta' bejn 68 u 80 sena, il-farmakokinetiċi ta' pitolisant mhumiex differenti meta mqabbla ma' dawk ta' pazjenti iżgħar fl-età (18 sa 45 sena).
English: Metrorrhagia
Maltese: Metrorraġja
English: Anorexia Hyperphagia Appetite disorder
Maltese: Anoressija Iperfaġja Disturb fl-aptit
English: The pivotal study (Harmony 1), double-blind, randomized, vs placebo and modafinil (400 mg/day), parallel group studies with flexible dose adaptation, included 94 patients (31 patients treated with pitolisant, 30 with placebo and 33 with modafinil).
Maltese: L-istudju pivotali (Harmony 1), double-blind, randomizzat, vs plaċebo u modafinil (400 mg/kuljum), studji ta' gruppi paralleli b'adattament għal doża flessibbli, inkluż 94 pazjent (31 pazjent ikkurati b'pitolisant, 30 bi plaċebo u 33 b'modafinil).
English: Anti-histamines
Maltese: Anti-istamini
English: In two dedicated QT studies, supra-therapeutic doses of pitolisant (3-6-times the therapeutic dose, that is 108 mg to 216 mg) produced mild to moderate prolongation of QTc interval (10-13 ms).
Maltese: QT iddedikati, dożi supraterapewtiċi ta' pitolisant (3-6 drabi d-doża terapewtika, jiġifieri 108 mg sa 216 mg) ipproduċew prolungament ħafif għal moderat tal-intervall tal-QTc (10-13 ms).
English: Harmony Ibis, study with a similar design, was limited to 18 mg once a day.
Maltese: Harmony Ibis, studju b'disinn simili, kien limitat għal 18 mg darba kuljum.
English: The active substance is pitolisant.
Maltese: Is-sustanza attiva hija pitolisant.
English: On liver microsomes, pitolisant and its major metabolites do not significantly inhibit the activities of the cytochromes CYP1A2, CYP2C9, CYP2C19, CYP2C8, CYP2B6, CYP2E1 or CYP3A4 and of uridine diphosphate glucuronosyl transferases isoforms UGT1A1, UGT1A4, UGT1A6, UGT1A9 and UGT2B7 up to the concentration of 13.3 µM, a level considerably higher than the levels achieved with therapeutic dose.
Maltese: Fuq il-mikrosomi tal-fwied, pitolisant u l-metaboliti maġġuri tiegħu ma jinibixxix b'mod sinifikanti lattivitajiet taċ-ċitokromi CYP1A2, CYP2C9, CYP2C19, CYP2C8, CYP2B6, CYP2E1 jew CYP3A4 u tal-isoforom ta' uridine diphosphate glucuronosyl transferases UGT1A1, UGT1A4, UGT1A6, UGT1A9 u UGT2B7 sa konċentrazzjoni ta' 13.3µM, livell ferm ogħla mil-livelli milħuqin bid-doża terapewtika.
English: Wakix 18 mg: Available in packs containing 1 bottle of 30 tablets or packs containing 1 bottle of 90 tablets or multi-packs containing 90 (3 bottles of 30) tablets.
Maltese: Wakix 18 mg: Disponibbli f'pakketti li fihom flixkun wieħed ta' 30 pillola jew f'pakketti li fihom flixkun wieħed ta' 90 pillola jew pakketti multipli li fihom 90 (3 fliexken ta' 30) pillola.
English: Abdominal distension Dysphagia Flatulence Odynophagia Enterocolitis
Maltese: Nefħa fl-addome Disfaġja Gass Odinofaġja Enterokolite
English: Wakix contains the active ingredient pitolisant.
Maltese: Wakix fih is-sustanza attiva pitolisant.
English: Pitolisant is not a significant inhibitor of OAT1, OAT3, OCT2, OATP1B1, OATP1B3, MATE1, or MATE2K at the tested concentration.
Maltese: Pitolisant mhuwiex inibitur sinifkanti ta' OAT1, OAT3, OCT2, OATP1B1, OATP1B3, MATE1, jew MATE2K fil-konċentrazzjoni ttestjata.
English: Anti-histamines (H1-receptor antagonists) crossing the haemato-encephalic barrier (e.g. pheniramine maleate, chlorpheniramine, diphenydramine, promethazine, mepyramine) may impair the efficacy of pitolisant.
Maltese: Anti-istamini (antagonisti tar-riċettur H1) li jaqsmu l-barriera emato-enċefalika (eż. pheniramine maleate, chlorpheniramine, diphenydramine, promethazine, mepyramine) jistgħu jfixklu l-effikaċja ta' pitolisant.
English: Poor metabolizers By comparison to CYP2D6 extensive metabolisers, higher systemic exposure (up to 3 fold) is observed in CYP2D6 poor metabolisers.
Maltese: Metabolizzaturi mhux daqstant tajbin Mqabbla ma' metabolizzaturi estensivi ta' CYP2D6, huwa osservat esponiment sistematiku ogħla (sa 3 darbiet aktar) f'metabolizzaturi mhux daqstant tajbin ta' CYP2D6.
English: With other CYP3A4, CYP2B6 (e.g. efavirenz, bupropion), CYP2C (e.g. repaglinide, phenytoin, warfarin), P-gp (e.g. dabigatran, digoxin) and UGT (e.g. morphine, paracetamol, irinotecan) susbtrates, caution should be made with a clinical monitoring of their efficacy.
Maltese: B'sottostrati CYP3A4, CYP2B6 (eż. efavirenz, bupropion), CYP2C (eż repaglinide, phenytoin, warfarin), P-gp (eż. dabigatran, digoxin) u UGT (eż. morfina, paracetamol, irinotecan) oħrajn, għandha tintuża kawtela b'monitoraġġ kliniku tal-effikaċja tagħhom.
English: Gastric disorders Gastric disorders caused by hyperacidity have been reported during clinical studies in 3.5% of the patients receiving pitolisant.
Maltese: Disturbi gastriċi Disturbi gastriċi kkawżati minn aċidità eċċessiva ġew irrapportati matul studji kliniċi fi 3.5% talpazjenti li rċevew pitolisant.
English: Insomnia Anxiety Irritability Depression Sleep disorder
Maltese: Insomnja Ansjetà Irritabilità Depressjoni Disturb fl-irqad
English: - CYP2D6 inhibitors
Maltese: - Inibituri ta' CYP2D6
English: - Enzyme inducers
Maltese: - Indutturi tal-enzima
English: The daily cataplexy rate (geometric means) was 0.52 at baseline and 0.18 at final visit for pitolisant and 0.43 at baseline and 0.39 at final visit for placebo, with a rate ratio rR=0.38 [0.16 ; 0.93] (p=0.034).
Maltese: Ir-rata ta' kuljum ta' kataplessija (medji ġeometriċi) kienet 0.52 fil-linja bażi u 0.18 fiż-żjara finali għal pitolisant u 0.43 fil-linja bażi u 0.39 fiż-żjara finali għall-plaċebo, bil-proporzjon tar-rata rR = 0.38 [0.16; 0.93] (p = 0.034).
English: Cataplexy attacks frequency in patients displaying this symptom was decreased significantly (p=0.034) with pitolisant (-65%) compared to placebo (-10%).
Maltese: Il-frekwenza ta' attakki ta' kataplessija f'pazjenti li juru dan is-sintomu tnaqqset b'mod sinifikanti (p=0.034) b'pitolisant (-65%) meta mqabbel ma' plaċebo (-10%).
English: Pollakiuria
Maltese: Pollakurja
English: Multipack: 90 (3 bottles of 30) film-coated tablets
Maltese: Pakkett multiplu: 90 (3 fliexken ta' 30) pillola miksija b'rita
English: Creatine phosphokinase increased
Maltese: Żieda fil-creatine phosphokinase
English: - CYP3A4 and CYP2B6 substrates
Maltese: - Sottostrati ta' CYP3A4 u CYP2B6
English: Pitolisant may reduce the effectiveness of hormonal contraceptives.
Maltese: Pitolisant jista' jnaqqas l-effikaċja tal-kontraċettivi ormonali.
English: Improvement of the two objective tests of wakefulness and attention, MWT and SART, with pitolisant was significant versus placebo (p=0.009 and p=0.002 respectively) and non-significant versus modafinil (p=0.713 and p=0.294 respectively).
Maltese: It-titjib taż-żewġ testijiet objettivi ta' stat imqajjem u attenzjoni, MWT u SART, b'pitolisant kien sinifikanti meta mqabbel ma' plaċebo (p=0.009 u p=0.002 rispettivament) u mhux sinifikanti meta mqabbel ma' modafinil (p=0.713 u p=0.294 rispettivament).
English: No clinically relevant pharmacokinetic drug-drug interaction was evidenced either with modafinil or with sodium oxybate.
Maltese: Ma kienet osservata l-ebda interazzjoni klinikament rilevanti bejn il-mediċini, la b'modafinil u lanqas b'sodium oxybate.
English: The observed WRC in pitolisant group was about half of WRC in the placebo group: the effect size of pitolisant compared with placebo was summarized by the ratio rate rR(Pt/Pb), rR=0.512; 95%CI [0.435 to 0.603]; p < 0.0001).
Maltese: Id-WRC osservata fil-grupp ta' pitolisant kienet madwar nofs id-WRC fil-grupp ta' plaċebo: id-daqs tal-effett ta' pitolisant meta mqabbel mal-plaċebo tqassar mir-rata ta' proporzjon rR (Pt/Pb), rR=0.512; 95% CI [0.435-0.603]; p <0.
English: Wakix 4.5 mg: Available in packs containing 1 bottle of 30 tablets.
Maltese: Wakix 4.5 mg: Disponibbli f'pakketti li fihom flixkun wieħed ta' 30 pillola.
English: Co-administration of pitolisant with paroxetine significantly increases pitolisant mean Cmax and AUC0-72h ratio about 47% and 105%, respectively.
Maltese: L-għoti fl-istess ħin ta' pitolisant ma' paroxetine iżid b'mod sinifikanti l-proporzjon medju ta' Cmax u AUC0-72h ta' pitolisant b'madwar 47% u 105% rispettivament.
English: The effect on Epworth was supported in two laboratory tests of vigilance and attention (Maintenance of Wakefulness Test (MWT) (p=0.044) and Sustained Attention to Response (SART) (p=0.053, almost but not significant)).
Maltese: L-effett fuq Epworth ġie appoġġjat f'żewġ testijiet tal-laboratorju ta' viġilanza u attenzjoni (Test ta' Kemm Wieħed Jibqa' Mqajjem (MWT) (p=0.044) u Attenzjoni Sostnuta għall-Kompitu ta' Rispons (SART) (p=0.053, kważi iżda mhux sinifikanti)).
English: EU/1/15/1068/003 90 film-coated tablets (3 bottles of 30)
Maltese: EU/1/15/1068/003 90 pillola miksija b'rita (3 fliexken ta' 30)
English: The following adverse reactions have been reported with pitolisant during clinical studies enrolling more than 1094 patients in narcolepsy and other indications and are listed below as MedDRA preferred term by system organ class and frequency; frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000); within each frequency group, adverse reactions are presented in order of decreasing seriousness:
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrapportati b'pitolisant matul studji kliniċi li rreġistraw għalihom aktar minn 1094 pazjent f'narkolessija u indikazzjonijiet oħrajn, u huma elenkati hawn taħt skont itterminu ppreferut ta' MedDRA skont is-sistema ta' klassifika tal-organi u l-frekwenza; il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥ 1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000); fi ħdan kull grupp ta' frekwenza, irreazzjoniiet avversi huma ppreżentati f'ordni li fiha s-serjetà dejjem tonqos:
English: Studies in animals have shown reproductive toxicity, including teratogenicity.
Maltese: Studji f'annimali wrew tossiċità riproduttiva, b'inklużjoni tat-teratoġenoċità.
English: Dyskinesia Balance disorder Cataplexy Disturbance in attention Dystonia On and off phenomenon Hypersomnia Migraine Psychomotor hyperactivity Restless Legs Syndrome Somnolence Epilepsy Bradykinesia Paresthesia
Maltese: Diskinesija Disturb fil-bilanċ Kataplessija Disturb fl-attenzjoni Distonja Fenomenu ġieli jidher u ġieli le Ipersomnja Emigranja Iperattività psikomotorja Sindrome ta' Riġlejn bla Kwiet Ngħas Epilessija Bradikajniżja Parestesija
English: Clinically relevant interactions are expected with CYP3A4 and CYP2B6 substrates and by extrapolation, UGTs, CYP2C and P-gp substrates (see section 4.5).
Maltese: Interazzjonijiet rilevanti b'mod kliniku huma mistennija mas-sottostrati ta' CYP3A4 u CYP2B6 u permezz tal-estrapolazzjoni, l-UGTs, u ssottostrati ta' CYP2C u P-gp (ara sezzjoni 4.5).
English: The study design was similar to study Harmony I except that the maximum dose for pitolisant reached by 75% of patients was 18 mg once a day instead of 36 mg in Harmony I. As an important unbalance led to comparison of results with or without cluster grouping of sites, the most conservative approach showed non-significant ESS score decrease with pitolisant compared to placebo (pitolisant-placebo=-1.94 with p=0.065).
Maltese: Id-disinn tal-istudju kien simili għall-istudju Harmony I għajr li d-doża massima għal pitolisant milħuqa minn 75% tal-pazjenti kienet ta' 18 mg darba kuljum minflok ta' 36 mg f'Harmony I. Minħabba li żbilanċ importanti wassal għal tqabbil tar-riżultati bi jew mingħajr ragruppament ta' siti f'daqqa, l-aktar approċċ konservattiv wera tnaqqis fil-punteġġ ESS mhux sinifikanti b'pitolisant meta mqabbel ma' plaċebo (pitolisant-plaċebo=-1.94 b'p=0.065).
English: In rats, pitolisant/metabolites were shown to cross the placenta (see section 5.3).
Maltese: Fil-firien, pitolisant/metaboliti ntwerew li jaqsmu l-barriera tal-plaċenta (ara sezzjoni 5.3).
English: EU/1/15/1068/004 90 film-coated tablets
Maltese: EU/1/15/1068/004 90 pillola miksija b'rita
English: In monkeys, at the highest doses, transient CNS related clinical signs including emesis, tremors and convulsions were reported.
Maltese: Fix-xadini, fl-ogħla dożi, sinjali kliniċi relatati mas-CNS temporanji inkluż emesi, rogħda u konvulsjonijiet ġew irrapportati.
English: Tell your doctor or pharmacist if you are taking any of the following medicines: rifampicin (an antibiotic), phenytoin, carbamazepine and phenobarbital (mainly used to control seizures), quinidine, digoxin (used to treat abnormal heart rhythms), paroxetine, fluoxetine, venlafaxine, duloxetine (antidepressants), St John's Wort (Hypericum perforatum) a herbal remedy for depression, bupropion (antidepressant or aid to smoking cessation), cinacalcet (for treatment of disorders of the parathyroid gland), terbinafine (used to treat fungal infections), metformin, repaglinide (used to treat diabete), docetaxel, irinotecan (used to treat cancer), cisapride (used to treat gastric reflux), pimozide (used to treat some mental disorders), halofantrine (to treat malaria), efavirenz (antiviral medicine to treat HIV), morphine, paracetamol (used to treat pain), dabigatran (used to treat problems of the veins), warfarin (used to treat heart diseases), probenecid (used to treat gout and gouty arthritis).Pitolisant can be used with modafinil or sodium oxybate.
Maltese: Għid lit-tabib jew lill-ispiżjar tiegħek jekk qed tieħu xi waħda minn dawn il-mediċini: rifampicin (antibijotiku), phenytoin, carbamazepine u phenobarbital (użati b'mod ewlieni għall-kontroll ta' aċċessjonijiet), quinidine, digoxin (użat biex jikkontrolla ritmi mhux normali ta' taħbit tal-qalb), paroxetine, fluoxetine, venlafaxine, duloxetine (antidepressanti), St John's Wort (Hypericum perforatum) rimedju erbali għad-depressjoni, bupropion (antidepressant jew għajnuna biex wieħed jieqaf ipejjep), cinacalcet (għall-kura ta' disturbi tal-glandola tal-paratirojde), terbinafine (użat għallkura ta' infezzjonijiet fungali), metformin, repaglinide (użat għall-kura tad-dijabete), docetaxel, irinotecan (użati għall-kura tal-kanċer), cisapride (użat għall-kura ta' rifluss gastriku), pimozide (użat għall-kura ta' xi mard mentali), halofantrine (għall-kura tal-malarja), efavirenz (mediċina antivirali għall-kura tal-HIV), morfina, paracetamol (użati għall-kura tal-uġigħ), dabigatran (użat għall-kura ta' problemi tal-vini), warfarin (użat għall-kura ta' mard tal-qalb), probenecid (użat għall-kura tal-gotta u l-artrite bil-gotta).Pitolisant jista' jintuża ma' modafinil jew sodium oxybate.
English: Headache Dizziness Tremor
Maltese: Tqala u treddigħ
English: Several conjugated metabolites were identified, the major ones (inactive) being two glycine conjugates of the acid metabolite of pitolisant and a glucuronide of a ketone metabolite of monohydroxy desaturated pitolisant.
Maltese: Ġew identifikati bosta metaboliti kkonjugati, dawk maġġuri (inattivi) jkunu żewġ konjugati tal-gliċina tal-metabolit tal-aċidu ta' pitolisant u glucuronide ta' metabolit tal-ketone ta' pitolisant desaturat ta' monohydroxy.
English: Above 80 years old, kinetics show a slight variation without clinical relevance.
Maltese: F'età ta' aktar minn 80 sena, il-kinetiċi wrew varjazzjoni ħafifa mingħajr relevanza klinika.
English: Wakix 18 mg tablet 3 years
Maltese: Wakix 18 mg pillola 3 snin
English: The serum Pitolisant half-life was longer in CYP2D6 poor metabolisers compared to the extensive metabolisers.
Maltese: Il-half-life fis-serum ta' Pitolisant kienet itwal filmetabolizzaturi mhux daqstant tajbin ta' CYP2D6 mqabbla mal-metabolizzaturi estensivi.
English: The exposure to Pitolisant was higher in the CYP2D6 poor metabolisers after a single dose and at steady state; Cmax and AUC(0-tau) was approximately 2.7-fold and 3.2-fold greater on Day 1 and 2.1fold and 2.4-fold on Day 7.
Maltese: L-esponiment għal Pitolisant kien ogħla fil-metabolizzaturi mhux daqstant tajbin ta' CYP2D6 wara doża waħda u fl-istat fiss; Cmax u AUC(0-tau) kienu madwar 2.7 darbiet u 3.2 darbiet ikbar f'Jum 1 u 2.1 darbiet u 2.4 darbiet ikbar f'Jum 7.
English: Wakix 4.5 mg tablet 3 years
Maltese: Wakix 4.5 mg pillola 3 snin
English: As Wakix may reduce the effectiveness of hormonal contraceptive, an alternative method of effective contraception has to be used.
Maltese: Peress li Wakix jista' jnaqqas l-effikaċja tal-kontraċettiviormonali, jrid jintuża metodu alternattiv ta' kontraċezzjoni effikaċi.