FrancophonIA/ELRC3.0 huggingface dataset:
English: Convulsions were reported at high doses in animal models (see section 5.3).
Croatian: Kod životinjskih modela, pri visokim dozama zabilježene su konvulzije (vidjeti dio 5.3).
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.
Croatian: Harmony CTP, potporno dvostruko slijepo, randomizirano pivotalno ispitivanje pitolizanta naspram placebu, provedeno na usporednim skupinama, osmišljeno je radi utvrđivanja djelotvornosti pitolizanta u bolesnika s velikom učestalošću katapleksije u narkolepsiji.
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.
Croatian: Tijekom stabilnog razdoblja (do kraja liječenja), geometrijska sredina WRC-a smanjila se na 6,79 (medijan=6 [3; 15]) za placebo i 3,28 (medijan=3 [1,3; 6]) za pitolizant u bolesnika koji su imali barem jednu epizodu katapleksije.
English: EU/1/15/1068/003 90 film-coated tablets (3 bottles of 30)
Croatian: EU/1/15/1068/003 90 filmom obloženih tableta (3 bočice s 30)
English: General physical condition abnormal Electrocardiogram repolarisation abnormality Electrocardiogram T wave inversion
Croatian: Abnormalno opće fizičko stanje Abnormalnost repolarizacije na elektrokardiogramu Inverzija T vala na elektrokardiogramu
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.
Croatian: Ustanovljeno je nekoliko konjugiranih metabolita, pri čemu su glavni (neaktivni) dva glicinska konjugata kiselinskog metabolita pitolizanta i glukuronid ketonskog monohidroksi nezasićenog pitolizanta.
English: However, no definitive conclusion could be drawn on tolerance, dependence and self-administration studies.
Croatian: Međutim, ispitivanja tolerancije, ovisnosti i samoprimjene lijeka nisu dovela do definitivnog zaključka.
English: Gastric disorders Gastric disorders caused by hyperacidity have been reported during clinical studies in 3.5% of the patients receiving pitolisant.
Croatian: Želučani poremećaji Tijekom kliničkih ispitivanja zabilježeni su želučani poremećaji uzrokovani hiperaciditetom kod 3,5 % bolesnika koji su primali pitolizant.
English: In rats, pitolisant/metabolites were shown to cross the placenta (see section 5.3).
Croatian: U štakora se pokazalo da pitolizant/metaboliti prolaze kroz posteljicu (vidjeti dio 5.3).
English: The geometric mean of the ratios (MWTFinal/MWTBaseline) was 1.8 (95%CI 1.19; 2.71, p=0.005).
Croatian: Geometrijska sredina omjera (MWTkraj/MWTpočetak) iznosila je 1,8 (95 %CI 1,19; 2,71, p=0,005).
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]).
Croatian: Rezultati u skupini koja je primala pitolizant bili su značajno superiorniji u odnosu na rezultate skupine koja je primala placebo (srednja razlika: -3,33; 95 %CI [-5,83 do -0,83]; p < 0,05), ali se nisu značajno razlikovali od rezultata skupine koja je primala modafinil (srednja razlika: 0,12; 95 %CI [-2,5 do 2,7]).
English: INNER CARTON FOR MULTIPACK OF 90 (3 x 30) TABLETS - WITHOUT BLUE BOX
Croatian: UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA SA 90 (3 x 30) TABLETA - BEZ PLAVOG OKVIRA
English: Multipack: 90 (3 bottles of 30) film-coated tablets
Croatian: Višestruko pakiranje : 90 (3 bočice s 30) filmom obloženih tableta.
English: If you notice any side effects, contact your doctor.
Croatian: Ako primijetite bilo kakve nuspojave, javite se svojem liječniku.
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).
Croatian: Dvostruko slijepo, randomizirano pivotalno ispitivanje (Harmony 1), naspram ispitivanja s placebom i modafinilom (400 mg na dan) na usporednim skupinama, s prilagodljivom promjenom doze, obuhvatilo je 94 ispitanika (31 ispitanik primao je pitolizant, 30 ih je primalo placebo, a 33 modafinil).
English: Electrocardiogram QT prolonged Heart rate increased Gammaglutamyltransferase increased
Croatian: Produljeni QT na elektrokardiogramu Ubrzani otkucaji srca Povišena vrijednost gama-glutamil transferaze
English: The serum Pitolisant half-life was longer in CYP2D6 poor metabolisers compared to the extensive metabolisers.
Croatian: Poluvijek pitolizanta u serumu bio je dulji kod sporih CYP2D6 metabolizatora u usporedbi s brzim metabolizatorima.
English: Nausea Vomiting Dyspepsia
Croatian: Mučnina Povraćanje Dispepsija
English: Therefore, breastfeeding is contraindicated during treatment with pitolisant (see section 4.3).
Croatian: Stoga, dojenje je kontraindicirano tijekom liječenja pitolizantom (vidjeti dio 4.3).
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere:
English: Most patients (60%) reached the 36 mg once a day dosage.
Croatian: Većina bolesnika (60 %) dosegla je dozu od 36 mg dnevno.
English: 105 narcoleptic patients with high frequency weekly cataplexy rates at baseline were included (54 patients treated with pitolisant and 51 with placebo).
Croatian: Obuhvaćeno je 105 narkoleptičnih ispitanika s vrlo učestalim tjednim napadajima katapleksije (54 bolesnika primalo je pitolizant, a 51 placebo).
English: - Headaches, feeling of “spinning” (vertigo), loss of balance, trembling - Feeling sick, vomiting, indigestion - Tiredness (fatigue)
Croatian: - glavobolje, osjećaj vrtnje (vrtoglavica), gubitak ravnoteže, drhtanje - mučnina, povraćanje, probavne smetnje - umor
English: Based on in vitro data, pitolisant and its main metabolites may induce CYP3A4 and CYP2B6 at therapeutic concentrations and by extrapolation, CYP2C, UGTs and P-gp.
Croatian: Na temelju in vitro podataka, pitolizant i njegovi glavni metaboliti mogu inducirati CYP3A4 i CYP2B6 pri terapijskim koncentracijama i ekstrapolacijom, CYP2C, UGT-ove i P-gp.
English: Pitolisant may reduce the effectiveness of hormonal contraceptives.
Croatian: Pitolizant može smanjiti učinkovitost hormonskih kontraceptiva.
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).
Croatian: Bez obzira na to, bolesnike sa srčanim bolestima koji uzimaju druge lijekove koji produljuju QT interval ili za koje se zna da povećavju rizik za poremećaje repolarizacije ili koji uzimaju druge lijekove koji značajno povećavaju omjer Cmax i AUC-a pitolizanta (vidjeti dio 4.5), ili bolesnike s teškim oštećenjem bubrega ili umjerenim oštećenjem jetre (vidjeti dio 4.4) treba pažljivo pratiti (vidjeti dio 4.5).
English: It is a medicine used to treat adult patients with narcolepsy, with or without cataplexy.
Croatian: Wakix je lijek koji se koristi za liječenje odraslih bolesnika s narkolepsijom, s katapleksijom ili bez nje.
English: To assess the efficacy of pitolisant on Excessive Daytime Sleepiness (EDS), Epworth Sleepiness Scale (ESS) score was used as primary efficacy criterion.
Croatian: Excessive Daytime Sleepiness, EDS), kao primarni kriterij djelotvornosti korištena je Epworthova ljestvica pospanosti (engl.
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.
Croatian: U pogledu drugih supstrata CYP3A4, CYP2B6 (npr. efavirenz, bupropion), CYP2C (npr. repaglinid, fenitoin, varfarin), P-gp‑a (npr. dabigatran, digoksin) i UGT-a (npr. morfin, paracetamol, irinotekan) potreban je oprez uz klinički nadzor njihove djelotvornosti.
English: Medicinal products affecting pitolisant metabolism
Croatian: Lijekovi koji utječu na metabolizam pitolizanta
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.
Croatian: Uz primjenu pitolizanta zabilježeni su želučani poremećaji te ga stoga treba primjenjivati oprezno u bolesnika sa želučanim poremećajima povezanim s kiselinom (vidjeti dio 4.8) ili kad se uzima u kombinaciji s lijekovima koji nadražuju želudac, kao što su kortikosteroidi ili nesteroidni protuupalni lijekovi (NSAIL).
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).
Croatian: Morate biti posebno oprezni ako Wakix uzimate u kombinaciji s nekim antidepresivima (npr. s imipraminom, klomipraminom i mirtazapinom) i nekim lijekovima za liječenje alergijskih stanja (antihistaminici, npr. feniraminmaleat, klorfeniramin, difenhidramin, prometazin, mepiramin).
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.
Croatian: Antihistaminici (antagonisti H1-receptora) koji prelaze hemato-encefalnu barijeru (npr. feniraminmaleat, klorfeniramin, difenhidramin, prometazin, mepiramin) mogu smanjiti djelotvornost pitolizanta.
English: In monkeys, at the highest doses, transient CNS related clinical signs including emesis, tremors and convulsions were reported.
Croatian: Kod majmuna, pri najvećim dozama zabilježeni su prolazni klinički znakovi povezani sa središnjim živčanim sustavom, uključujući povraćanje, tremor i konvulzije.
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).
Croatian: Weekly Rate of Cataplexy, WRC) kao primarnog ishoda djelotvornosti, rezultati skupine koja je primala pitolizant bili su značajno superiorniji onima u skupini koja je primala placebo (p < 0,0001), uz progresivno smanjenje od 64 % od početka do kraja liječenja (slika 2).
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:
Croatian: Tijekom kliničkih ispitivanja s pitolizantom u kojima je sudjelovalo više od 1094 bolesnika s narkolepsijom i drugim indikacijama, zabilježene su nuspojave navedene u nastavku prema preporučenim izrazima MedDRA-e, klasificirane po organskim sustavima i učestalosti; učestalost je definirana kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko
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.
Croatian: Obavijestite liječnika ili ljekarnika ako uzimate neki od sljedećih lijekova: rifampicin (antibiotik), fenitoin, karbamazepin i fenobarbital (uglavnom se koriste za kontrolu napadaja), kinidin, digoksin (koriste se za liječenje abnormalnog srčanog ritma), paroksetin, fluoksetin, venlafaksin, duloksetin (antidepresivi), gospinu travu (Hypericum perforatum), biljni lijek protiv depresije, bupropion (lijek protiv depresije ili kao pomoć u odvikavanju od pušenja), cinakalcet (za liječenje poremećaja doštitne (paratireoidne) žlijezde), terbinafin (koristi se za liječenje gljivičnih infekcija), metformin, repaglinid (koriste se za liječenje šećerne bolesti), docetaksel, irinotekan (koriste se za liječenje raka), cisaprid (koristi se liječenje želučanog refluksa), pimozid (koristi se liječenje nekih mentalnih poremećaja), halofantrin (za liječenje malarije), efavirenz (antivirusni lijek kojim se liječi HIV), morfin, paracetamol (koriste se za liječenje boli), dabigatran (koristi se za liječenje problema s venama), varfarin (koristi se za liječenje srčanih bolesti), probenecid (koristi se za liječenje gihta ili uričnog artritisa).
English: Co-administration of pitolisant with paroxetine significantly increases pitolisant mean Cmax and AUC0-72h ratio about 47% and 105%, respectively.
Croatian: Istodobna primjena pitolizanta s paroksetinom značajno povećava omjer srednje vrijednosti Cmax i AUC0-72h pitolizanta za 47 % i 105 %.
English: Clinically relevant interactions are expected with CYP3A4 and CYP2B6 substrates and by extrapolation, UGTs, CYP2C and P-gp substrates (see section 4.5).
Croatian: Klinički relevantne interakcije očekuju se sa supstratima CYP3A4 i CYP2B6 te ekstrapolacijom, sa supstratima UGT‑ova, CYP2C i P-gp-a (vidjeti dio 4.5).
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.
Croatian: Pitolizant pokazuje inhibiciju veću od 50 % prema OCT1 (prijenosnik organskih kationa 1) pri 1,33 µM, ekstrapolirani IC50 pitolizanta je 0,795 µM.
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.
Croatian: Uzimajući u obzir dvostruko povećanje izloženosti pitolizantu, njegova istodobna primjena s inhibitorima CYP2D6 (npr. paroksetin, fluoksetin, venlafaksin, duloksetin, bupropion, kinidin, terbinafin, cinakalcet) treba se provesti uz oprez.
English: Pitolisant is contra-indicated in patients with severe hepatic impairment (Child-Pugh C) (see section
Croatian: Pitolizant je kontraindiciran u bolesnika s teškim oštećenjem jetre (Child-Pugh C) (vidjeti dio 4.3).
English: Due date
Croatian: 2. tjedan
English: CYP2D6 poor metabolizers
Croatian: Spori CYP2D6 metabolizatori
English: If you forget to take Wakix
Croatian: Ako ste zaboravili uzeti Wakix
English: Dosage was initiated at 9 mg once a day and was increased, according to efficacy response and tolerance to 18 mg or 36 mg once a day per 1-week interval.
Croatian: Doziranje je započelo s 9 mg jednom dnevno i povećavalo se u skladu s odgovorom djelotvornosti i tolerancijom na 18 mg ili 36 mg jednom dnevno u intervalu od 1 tjedna.
English: Wakix 18 mg tablet 3 years
Croatian: Wakix 18 mg tableta 3 godine
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).
Croatian: Uz pitolizant, poboljšanje dvaju objektivnih testova budnosti i pažnje, MWT i SART, bilo je značajno u usporedbi s placebom (p=0,009 i p=0,002), a nije bilo značajno u usporedbi s modafinilom (p=0,713 i p=0,294).
English: - CYP2D6 inhibitors
Croatian: - Inhibitori CYP2D6
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA
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).
Croatian: Zabilježeni WRC u skupini koja je primala pitolizant iznosio je približno polovicu vrijednosti WRC-a skupine koja je primala placebo: opseg učinka pitolizanta u usporedbi s placebom izražen je relativnom stopom rR(Pt/Pb), rR=0,512; 95 %CI [0,435 do 0,603]; p < 0,0001).
English: Dosage was initiated at 4.5 mg once a day and was increased, according to efficacy response and tolerance to 9 mg, 18 mg or 36 mg once a day per 1-week interval.
Croatian: Doziranje je započelo s 4,5 mg jednom dnevno, a povećavalo se u skladu s odgovorom djelotvornosti i tolerancijom na 9 mg, 18 mg ili 36 mg jednom dnevno u intervalima od 1 tjedna.
English: Pitolisant should be administered with caution in patients with either renal impairment or moderate hepatic impairment (Child-Pugh B) and dosing regimen should be adapted according to section 4.2.
Croatian: Pitolizant treba primjenjivati oprezno u bolesnika s oštećenjem bubrega ili umjerenim oštećenjem jetre (Child-Pugh B), a doziranje treba prilagoditi prema dijelu 4.2.
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).
Croatian: Dnevna stopa katapleksije (geometrijske sredine) iznosila je za pitolizant 0,52 na početku i 0,18 na posljednjem dolasku u ispitivanju, a za placebo 0,43 na početku i 0,39 na posljednjem dolasku, s relativnom stopom rR=0,38 [0,16 ; 0,93] (p=0,034).
English: Poor metabolizers By comparison to CYP2D6 extensive metabolisers, higher systemic exposure (up to 3 fold) is observed in CYP2D6 poor metabolisers.
Croatian: U usporedbi s CYP2D6 brzim metabolizatorima, kod CYP2D6 sporih metabolizatora primijećena je veća sistemska izloženost (do 3 puta).
English: Abdominal distension Dysphagia Flatulence Odynophagia Enterocolitis
Croatian: Distenzija abdomena Disfagija Flatulencija Odinofagija Enterokolitis
English: Headache Dizziness Tremor
Croatian: Glavobolja Omaglica Tremor
English: Co-administration of pitolisant with rifampicin in multiple doses significantly decreases pitolisant mean Cmax and AUC ratio about 39% and 50%, respectively.
Croatian: Istodobna primjena pitolizanta s rifampicinom u višestrukim dozama značajno smanjuje omjer srednje vrijednosti Cmax i AUC-a pitolizanta za približno 39 % i 50 %.
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).
Croatian: Stoga, kombinaciju pitolizanta i supstrata CYP3A4 te onih s uskom terapijskom širinom (npr. imunosupresivi, docetaksel, inhibitori kinaze, cisaprid, pimozid, halofantrin) treba izbjegavati (vidjeti dio 4.4).
English: - High blood level of the enzyme creatinine phosphokinase, abnormal general physical condition, modification of the electrical registration of the heart (ECG)
Croatian: - bol, noćno znojenje, osjećaj opresije - visoka razina enzima kreatina fosfokinaze u krvi, abnormalno opće fizičko stanje, promjena električnog očitavanja srca (EKG)
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.
Croatian: Opseg učinka pitolizanta u usporedbi s placebom prema modelu WRC-a na temelju početnog zapažanja prenesenog dalje (engl. baseline observation carried forward, BOCF) sa središtem kao fiksnim učinkom iznosio je 0,581, 95 %CI [0,493 do 0,686]; p < 0,0001.
English: Rebound effect
Croatian: Povratni učinak
English: They are formed under the action of CYP3A4 and CYP2D6.
Croatian: Nastaju djelovanjem enzima CYP3A4 i CYP2D6.
English: How to take Wakix
Croatian: Kako uzimati Wakix
English: Italia Bioprojet Italia srl info@bioprojet-italia.com
Croatian: Italia srl info@bioprojet-italia.com
English: Wakix 4.5 mg tablet 3 years
Croatian: Wakix 4,5 mg tableta 3 godine
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
Croatian: Pitolizant pokazuje inhibiciju veću od 50 % prema OCT1 (prijenosnik organskih kationa 1) pri 1,33 µM, ekstrapolirani IC50 pitolizanta je 0,795 µM (vidjeti dio 4.5).
English: For a dose of 18 mg, take one 18 mg tablet.
Croatian: Za dozu od 18 mg uzmite jednu tabletu od 18 mg.
English: - CYP3A4 and CYP2B6 substrates
Croatian: - Supstrati CYP3A4 i CYP2B6
English: Anti-histamines
Croatian: Antihistaminici
English: Hypertension Hypotension Hot flush
Croatian: Hipertenzija Hipotenzija
English: Dyskinesia Balance disorder Cataplexy Disturbance in attention Dystonia On and off phenomenon Hypersomnia Migraine Psychomotor hyperactivity Restless Legs Syndrome Somnolence Epilepsy Bradykinesia Paresthesia
Croatian: Diskinezija Poremećaj ravnoteže Katapleksija Poremećaj pažnje Distonija On-off fenomen Hipersomnija Migrena Psihomotorna hiperaktivnost Sindrom nemirnih nogu Somnolencija Epilepsija Bradikinezija Parestezija
English: EU/1/15/1068/004 90 film-coated tablets
Croatian: EU/1/15/1068/004 90 filmom obloženih tableta
English: High density polyethylene (HDPE) bottle with a tamper evident, child-resistant, polypropylene screw cap fitted with desiccant (silica gel).
Croatian: Boca od polietilena visoke gustoće (HDPE) s polipropilenskim navojnim zatvaračem, sigurnim za djecu i s evidencijom otvaranja, napunjenim sredstvom za sušenje (silika gelom).
English: For a dose of 36 mg, take two 18 mg tablets.
Croatian: Za dozu od 36 mg uzmite dvije tablete od 18 mg.
English: For a dose of 4.5 mg, take one 4.5 mg tablet.
Croatian: Za dozu od 4,5 mg uzmite jednu tabletu od 4,5 mg.
English: Therefore, co-administration of pitolisant with potent CYP3A4 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) should be done with caution.
Croatian: Stoga, istodobnu primjenu pitolizanta s jakim induktorima CYP3A4 (npr. rifampicin, fenobarbital, karbamazepin, fenitoin) treba provoditi uz oprez.
English: No rebound effect was reported during clinical trials.
Croatian: U kliničkim ispitivanjima nije zabilježen povratni učinak (engl. rebound effect).
English: For a dose of 9 mg, take two 4.5 mg tablets.
Croatian: Za dozu od 9 mg uzmite dvije tablete od 4,5 mg.
English: With St John's Wort (Hypericum Perforatum), due to its strong CYP3A4 inducing effect, caution should be exercised when taken concurrently with pitolisant.
Croatian: Zbog jakog indukcijskog učinka gospine trave (Hypericum perforatum) na CYP3A4, potreban je oprez kada se uzima istodobno s pitolizantom.
English: Medicinal products that pitolisant may affect metabolism
Croatian: Lijekovi na čiji metabolizam pitolizant može utjecati
English: EU/1/15/1068/002 30 film-coated tablets
Croatian: EU/1/15/1068/002 30 filmom obloženih tableta