natgillin/translations-raw huggingface dataset:
Wakix can affect the way other medicines work and other medicines can affect the way Wakix works.
Wakix može utjecati na djelovanje drugih lijekova, a drugi lijekovi mogu utjecati na djelovanje Wakixa.
Pitolisant blocked hERG channel with an IC50 exceeding therapeutic concentrations and induced a slight QTc prolongation in dogs.
Pitolizant je blokirao hERG kanal s IC50 koji premašuje terapijske koncentracije i inducirao je lagano produljenje intervala QTc kod pasa.
Pitolisant also modulates various neurotransmitter systems, increasing acetylcholine, noradrenaline and dopamine release in the brain.
Pitolizant također utječe na razne neurotransmiterske sustave, povećano otpuštanje acetilkolina, noradrenalina i dopamina u mozgu.
Maintenance of Wakefulness Test (MWT)) and attention (e.g.
Maintenance of Wakefulness Test, MWT)) i pažnje (npr. test održavanja pažnje za odgovor (engl.
Study in animals has shown effects on semen parameters, without a significant impact on reproductive performance in males and reduction on the percentage of live foetuses in treated females (see section
Ispitivanja na životinjama pokazala su učinak na parametre sjemena, bez značajnog utjecaja na reproduktivnu sposobnost u mužjaka i smanjenje postotka živih fetusa u liječenih ženki (vidjeti dio
Wakix should not be used during pregnancy unless your doctor says so.
Wakix se ne smije primjenjivati tijekom trudnoće, osim prema uputi liječnika.
- Enzyme inducers
- Induktori enzima
At any time the dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day) according to the physician assessment and the patient's response.
Doza se u svakom trenutku može smanjiti (na 4,5 mg dnevno) ili povećati (do 36 mg dnevno) ovisno o procjeni liječnika i odgovoru bolesnika.
Pitolisant has minor influence on the ability to drive and use machines.
Pitolizant malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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).
Čak i ako se klinička relevantnost tog učinka ne ustanovi, savjetuje se oprez kada se pitolizant uzima sa supstratom OCT1 (npr. metformin (bigvanidi)) (vidjeti dio 5.2).
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.
Wakix 18 mg: dostupan u pakiranju koje sadrži 1 bočicu s 30 tableta ili pakiranju koje sadrži 1 bočicu s 90 tableta ili višestrukom pakiranju koje sadrži 90 tableta (3 bočice s 30).
Caution should be taken for patients with severe epilepsy.
Potrebno je biti na oprezu u bolesnika s teškom epilepsijom.
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).
Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i barem 21 dan nakon prekida liječenja (na temelju poluvijeka pitolizanta/metabolita).
Patients with abnormal levels of sleepiness who take pitolisant should be advised that their level of wakefulness may not return to normal.
Bolesnike s abnormalnim stupnjem pospanosti koji uzimaju pitolizant treba upozoriti da se njihov stupanj budnosti možda neće vratiti u normalu.
In vitro studies indicate that pitolisant is neither a substrate nor an inhibitor of human P-glycoprotein and breast cancer resistance protein (BCRP).
In vitro ispitivanja ukazuju da pitolizant nije ni supstrat ni inhibitor ljudskog P-glikoproteina i proteina rezistencije raka dojke (engl. breast cancer resistance protein, BCRP).
Wakix should not be taken by children or adolescents.
Djeca ili adolescenti ne smiju uzimati Wakix.
Wakix contains the active ingredient pitolisant.
Wakix sadrži djelatni sastojak pitolizant.
- You have liver or kidney problems, as your dose may need to be adjusted.
- ako imate problema s jetrom ili bubrezima, jer bi Vam možda trebalo prilagoditi dozu.
Wakix 4.5 mg: Available in packs containing 1 bottle of 30 tablets.
Wakix 4,5 mg: dostupan u pakiranju koje sadrži 1 bočicu s 30 tableta.
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)).
Učinak na Epworthovoj ljestvici poduprla su dva laboratorijska testa pozornosti (engl. vigilance) i pažnje (test održavanja budnosti (MWT) (p=0,044) i test održavanja pažnje za odgovor (SART) (p=0,053, zamalo, ali nije značajno)).
Results from cataplexy rate at 18 mg once a day were not consistent with those of the first pivotal study (36 mg once a day).
Rezultati stope katapleksije pri dozi od 18 mg jednom dnevno nisu se podudarali s rezultatima prvog pivotalnog ispitivanja (36 mg jednom dnevno).
Pitolisant is a potent, orally active histamine H3-receptor antagonist/inverse agonist which, via its blockade of histamine auto-receptors enhances the activity of brain histaminergic neurons, a major arousal system with widespread projections to the whole brain.
Pitolizant je potentan, oralno aktivan antagonist/inverzni agonist histaminskog H3‑receptora koji pomoću blokade histaminskih autoreceptora poboljšava aktivnost histaminergičkih neurona mozga, velikog sustava budnosti s projekcijama proširenim na cijeli mozak.
Pitolisant should be administered with caution in patients with history of psychiatric disorders such as severe anxiety or severe depression with suicidal ideation risk.
Pitolizant treba primjenjivati oprezno u bolesnika koji u anamnezi imaju psihijatrijske poremećaje, kao što su teška anksioznost ili teška depresija s rizikom od suicidalne ideacije.
Pitolisant pharmacokinetics after repeated administration in patients with hepatic impairment has not been evaluated yet.
Farmakokinetika pitolizanta nakon ponovljene primjene kod bolesnika s oštećenjem jetre još nije procijenjena.
Symptoms of Wakix overdose may include headache, insomnia, irritability, nausea and abdominal pain.
Simptomi predoziranja lijekom Wakix mogu uključivati glavobolju, nesanicu, razdražljivost, mučninu i bol u abdomenu.
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.
Nakon 1 mjeseca primjene u miševa, 6 mjeseci u štakora i 9 mjeseci u majmuna, razina bez zapaženih štetnih učinaka (engl. no observed adverse effect level, NOAEL) iznosila je 75, 30 i 12 mg/kg na dan, p.o., pružajući sigurnosne granice od 9, 1 i 0,4, kad se usporedi s izloženosti lijeku pri terapijskim dozama u ljudi.
- Week 3: the dose may be increased to 36 mg (two 18 mg tablets) per day.
- 3. tjedan: doza se može povećati na 36 mg (dvije tablete od 18 mg) dnevno.
The metabolisation of pitolisant in humans is fully characterized.
Metabolizam pitolizanta kod ljudi potpuno je okarakteriziran.
Pitolisant is an inhibitor of CYP2D6 with moderate potency (IC50 = 2.6 µM).
Pitolizant je inhibitor CYP2D6 umjerene potentnosti (IC50 = 2,6 µM).
In patients with moderate hepatic impairment (Child-Pugh B) two weeks after initiation of treatment, the daily dose can be increased without exceeding a maximal dose of 18 mg (see section 5.2).
U bolesnika s umjerenim oštećenjem jetre (Child-Pugh B) dva tjedna nakon početka liječenja, dnevna doza se može povećati bez prekoračenja maksimalne doze od 18 mg (vidjeti dio 5.2).
This medicine does not require any special storage conditions
Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
OUTER CARTON WITH BLUE BOX
VANJSKA KUTIJA UKLJUČUJUĆI PLAVI OKVIR
Race The effect of race on metabolism of pitolisant has not been evaluated.
Nije istraživan utjecaj rase na metabolizam pitolizanta.
The exposure to pitolisant in healthy volunteers was assessed in studies involving more than 200 subjects that received doses of pitolisant in single administration up to 216 mg and for a duration up to 28 days.
Izloženost pitolizantu procijenjena je u zdravih dobrovoljaca u ispitivanjima koja su obuhvatila više od 200 ispitanika, koji su primili doze pitolizanta u jednoj primjeni do 216 mg u trajanju do 28 dana.
Wakix should be used at the lowest effective dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day: - Week 1: initial dose of 9 mg (two 4.5 mg tablets) per day.
Wakix treba primjenjivati u najmanjoj učinkovitoj dozi, ovisno o odgovoru i podnošljivosti pojedinog bolesnika, u skladu s planom povećanja doze lijeka, bez prekoračenja doze od 36 mg na dan: - 1. tjedan: početna doza je 9 mg (dvije tablete od 4,5 mg) dnevno.
In preclinical studies, drug dependence and drug abuse liability studies were conducted in mice, monkeys and rats.
U pretkliničkim ispitivanjima, ispitivanja u pogledu ovisnosti o lijeku i zlouporabi lijeka provedena su na miševima, majmunima i štakorima.
Do not stop taking Wakix suddenly on your own.
Nemojte odjednom prestati uzimati Wakix prema vlastitoj odluci.
Breastfeeding (see section 4.6).
Dojenje (vidjeti dio 4.6).
The major non-conjugated metabolites are hydroxylated derivatives in several positions and cleaved forms of pitolisant leading to inactive major carboxylic acid metabolite found in urine and serum.
Glavni nekonjugirani metaboliti su derivati pitolizanata hidroksilirani u nekoliko položaja i metaboliti nastali cijepanjem pitolizanta koji dovode do glavnog neaktivnog metabolita karboksilne kiseline prisutnog u urinu i serumu.
- 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.
- 2. tjedan: doza se može povećati na 18 mg (jedna tableta od 18 mg) dnevno ili smanjiti na 4,5 mg (jedna tableta od 4,5 mg) dnevno.
Common side effects (may affect up to 1 in 10 people): - Difficulty in sleeping, feeling anxious, feeling irritable, feeling depressed, sleeping problems
Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - poteškoće pri spavanju, osjećaj tjeskobe, osjećaj razdražljivosti, depresivnost, problemi sa spavanjem
The effect of pitolisant on EDS was also assessed in this population using the ESS score.
U ovoj populaciji učinak pitolizanta na EDS procijenjen je također na temelju rezultata ESS-a.
In narcoleptic patients with or without cataplexy, pitolisant improves the level and duration of wakefulness and daytime alertness assessed by objective measures of ability to sustain wakefulness (e.g.
Kod narkoleptičnih bolesnika s katapleksijom ili bez nje, pitolizant poboljšava razinu i trajanje budnosti i dnevne pozornosti na temelju procjene objektivnih mjera sposobnosti održavanja budnosti (npr. test održavanja budnosti (engl.
Wakix may reduce the effectiveness of hormonal contraceptives, an alternative method of effective contraception has to be used (see section “Pregnancy).
Budući da Wakix može smanjiti učinkovitost hormonskih kontraceptiva, mora se koristiti alternativna metoda učinkovite kontracepcije (vidjeti dio „Trudnoća”).
Pitolisant/metabolites may reduce the effectiveness of hormonal contraceptives.
Pitolizant/metaboliti mogu smanjiti učinkovitost hormonskih kontraceptiva.
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).
Oštećenje bubrega Kod bolesnika s oštećenom funkcijom bubrega (od 2. do 4. stupnja prema međunarodnoj klasifikaciji kroničnih bolesti bubrega, odnosno klirens kreatinina između 15 i 89 ml/min), Cmax i AUC pokazuju tendenciju povećanja za faktor od 2,5 bez ikakvog utjecaja na poluvijek (vidjeti dio 4.2).
Bottle of 30 or 90 film-coated tablets.
Boca s 30 ili 90 filmom obloženih tableta.
Patients with excessive daytime sleepiness, including those taking pitolisant should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.
U bolesnika s pretjeranom pospanošću tijekom dana, uključujući one koji uzimaju pitolizant, treba često procjenjivati stupanj pospanosti te ih prema potrebi savjetovati da izbjegavaju vožnju ili neku drugu potencijalno opasnu aktivnost.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji nakon oznake Rok valjanosti.
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).
Učinkovitost pitolizanta u dozi do 36 mg jednom dnevno za liječenje narkolepsije s katapleksijom ili bez nje, utvrđena je u dva glavna, 8-tjedna, multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja na usporednim skupinama (Harmony I i Harmony CTP).
As Wakix may reduce the effectiveness of hormonal contraceptive, an alternative method of effective contraception has to be used.
Budući da Wakix može smanjiti učinkovitost hormonskih kontraceptiva, mora se koristiti alternativna metoda učinkovite kontracepcije.
Creatine phosphokinase increased
Povišena vrijednost kreatin fosfokinaza
25% of the dose is excreted through expired air and a small fraction (<3%) recovered in faeces where the amount of pitolisant or BP2.951 was negligible.
Izdahnutim zrakom izlučuje se 25 % doze, a mala frakcija (<3%) nađe se u stolici, gdje je količina pitolizanta ili BP2.951 bila zanemariva.
Bioprojet Pharma 9, rue Rameau 75002 Paris France
Bioprojet Pharma 9, rue Rameau 75002 Pariz Francuska
Most patients (65%) reached the 36 mg once a day dosage.
Većina bolesnika (65 %) dosegla je dozu od 36 mg jednom dnevno.
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%).
Najčešće nuspojave na lijek (ADR) zabilježene kod uzimanja pitolizanta bile su nesanica (8,4 %), glavobolja (7,7 %), mučnina (4,8 %), anksioznost (2,1 %), razdražljivost (1,8 %), omaglica (1,4 %), depresija (1,3 %), tremor (1,2 %), poremećaji spavanja (1,1 %), umor (1,1 %), povraćanje (1,0 %), vrtoglavica (1,0 %), dispepsija (1,0 %), povećanje težine (0,9 %), bol u gornjem abdomenu (0,9 %).
Therefore, dosing should be adjusted according to their renal and hepatic status.
Stoga, doza se treba prilagoditi prema njihovom statusu bubrega i jetre.
With oral contraceptives, the combination with pitolisant should be avoided and a further reliable contraceptive method used.
Kombinaciju pitolizanta i oralnih kontraceptiva treba izbjegavati te je potrebno koristiti drugu pouzdanu kontracepcijsku metodu.
The second pivotal study (Harmony Ibis) included 165 patients (67 treated with pitolisant, 33 with placebo and 65 with modafinil).
Drugo pivotalno ispitivanje (Harmony Ibis) obuhvaćalo je 165 bolesnika (67 je primalo pitolizant, 33 placebo i 65 modafinil).
- You have a gastric ulcer or you take medicines that can irritate your stomach such as medicines against inflammations, since gastric reactions have been reported with Wakix.
- ako imate čir na želucu ili uzimate lijekove koji mogu nadražiti želudac kao što su protuupalni lijekovi, jer su tijekom uzimanja Wakixa zabilježene želučane reakcije.
Therefore, an alternative method of effective contraception should be used if the woman patient is using hormonal contraceptives (see sections 4.5 and 4.6).
Stoga, treba koristiti alternativnu metodu učinkovite kontracepcije ako bolesnica koristi hormonske kontraceptive (vidjeti dijelove 4.5 i 4.6).
Anorexia Hyperphagia Appetite disorder
Anoreksija Hiperfagija Poremećaj apetita
Teratogenic effect of pitolisant was observed at maternally toxic doses (teratogenicity safety margins < 1 in rats and in rabbits).
Teratogeni učinak pitolizanta zabilježen je pri dozama toksičnim za majku (u štakora i kunića teratogenske sigurnosne granice < 1 ).
This helps to combat daytime sleepiness and cataplexy and promote wakefulness.
To pomaže u borbi protiv pospanosti tijekom dana i katapleksije te potiče budnost.
The waking effect of the two active substances was established at similar rates (Figure 1).
Utvrđene su slične stope učinka na budnost dviju djelatnih tvari (slika 1).
Juvenile toxicity studies in rats revealed that the administration of pitolisant at high doses induced a dose related mortality and convulsive episode that may be attributable to a metabolite abundant in rats but not in humans.
Juvenilna ispitivanja toksičnosti kod štakora otkrila su da je primjena pitolizanta u velikim dozama inducirala smrtnost povezanu s dozom i epizodu konvulzije koje se mogu pripisati metabolitu koji je u velikoj mjeri prisutan kod štakora, ali ne kod ljudi.
At high doses, pitolisant induced sperm morphology abnormalities and decreased motility without any significant effect on fertility indexes in male rats and it decreased the percentage of live conceptuses and increased post-implantation loss in female rats (safety margin of 1).
Pri visokim dozama, pitolizant je inducirao abnormalnosti morfologije sperme i smanjenu pokretljivost bez značajnog učinka na indekse plodnosti kod mužjaka štakora te smanjio postotak živih embrija i povećao gubitak nakon implantacije kod ženki štakora (sigurnosna granica 1).
Most of these adverse reactions were mild to moderate.
Većina tih nuspojava bile su blage do umjerene.
The other ingredients are microcrystalline cellulose, crospovidone, talc, magnesium stearate, colloidal anhydrous silica, polyvinyl alcohol, titanium dioxide, macrogol 3350.
Drugi sastojci su mikrokristalična celuloza, krospovidon, talk, magnezijev stearat, bezvodni koloidni silicijev dioksid, poli(vinilni alkohol), titanijev dioksid i makrogol 3350.
Animal study has shown excretion of pitolisant/metabolites in milk.
Ispitivanja na životinjama pokazala su da se pitolizant/metaboliti izlučuju u mlijeko.
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).
U dva ispitivanja provedena u svrhu određivanja QT intervala, supraterapijske doze pitolizanta (3 - 6 puta veće od terapijske doze, odnosno od 108 mg do 216 mg) proizvele su blago do umjereno produljenje QTc intervala (10 - 13 ms).
- You are obese or anorexic, as you may have change of your body weight (increase or decrease)
- ako ste pretili ili anoreksični, jer će možda doći do promjene tjelesne težine (smanjenja ili povećanja) dok uzimate Wakix.
Pitolisant is not a significant inhibitor of OAT1, OAT3, OCT2, OATP1B1, OATP1B3, MATE1, or MATE2K at the tested concentration.
Pitolizant nije značajni inhibitor prijenosnika OAT1, OAT3, OCT2, OATP1B1, OATP1B3, MATE1 ili MATE2K pri ispitivanoj koncentraciji.
In patients with moderate hepatic impairment (Child-Pugh B), AUC increased by a factor 2.4, while half-life doubled (see section 4.2).
Kod bolesnika s umjerenim oštećenjem jetre (Child-Pugh B), AUC se povećao za faktor 2,4, pri čemu se poluvijek udvostručio (vidjeti dio 4.2).
Wakix is available in a bottle of 30 tablets or 90 tablets.
Wakix je dostupan u boci s 30 ili 90 tableta.
There are no or limited amount of data from the use of pitolisant in pregnant women.
Nema podataka ili su podaci o primjeni pitolizanta u trudnica ograničeni.
In a clinical multiple dose study, the combination of pitolisant with probenecid decreases the AUC of pitolisant by about 34%.
U kliničkom ispitivanju višekratnog doziranja, kombinacija pitolizanta s probenecidom smanjuje AUC pitolizanta za otprilike 34 %.
In rats, transient reversible convulsive episodes occurred at Tmax , that may be attributable to a metabolite abundant in this species but not in humans.
U štakora su zabilježene prolazne reverzibilne epizode konvulzija pri Tmax, što se može pripisati metabolitu koji je u velikoj mjeri prisutan kod štakora, ali ne kod ljudi.
Insomnia Anxiety Irritability Depression Sleep disorder
Nesanica Anksioznost Razdražljivost Depresija Poremećaj spavanja
Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy (see also section
Wakix je indiciran za liječenje narkolepsije u odraslih, s katapleksijom ili bez nje (vidjeti također dio
No clinically relevant pharmacokinetic drug-drug interaction was evidenced either with modafinil or with sodium oxybate.
Nije dokazana nijedna klinički relevantna farmakokinetička interakcija lijeka s modafinilom ili natrijevim oksibatom.
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.
Izloženost pitolizantu bila je veća kod sporih CYP2D6 metabolizatora nakon jednokratne doze i u stanju dinamičke ravnoteže; Cmax i AUC(0-tau) bili su približno 2,7 puta odnosno 3,2 puta veći 1. dana, te 2,1 puta odnosno 2,4 puta veći 7. dana.
Pitolisant should be administered with caution in patients with severe obesity or severe anorexia (see section 4.8).
Pitolizant treba primjenjivati oprezno u bolesnika s teškom pretilosti ili teškom anoreksijom (vidjeti dio 4.8).
Renal impairment In patients with renal impairment, the maximum daily dose should be 18 mg.
U bolesnika s oštećenjem bubrega, maksimalna dnevna doza treba iznositi 18 mg.
Therefore, dosing should be adjusted according to their renal hepatic status (see section 4.2 and 4.4).
Stoga dozu treba prilagoditi u skladu sa statusom njihovih bubrega i jetre (vidjeti dio 4.2 i 4.4).
Metrorrhagia
Metroragija
Loss of consciousness Tension headache Memory impairment Poor sleep quality
Gubitak svijesti Tenzijska glavobolja Oštećenje pamćenja Loša kvaliteta sna
Pitolisant is not a substrate of OATP1B1, OATP1B3.
Pitolizant nije supstrat prijenosnika OATP1B1, OATP1B3.
Abortion spontaneous
Spontani pobačaj
If you stop taking Wakix
Ako prestanete uzimati Wakix
Cataplexy attacks frequency in patients displaying this symptom was decreased significantly (p=0.034) with pitolisant (-65%) compared to placebo (-10%).
Učestalost napadaja katapleksije u bolesnika koji su pokazivali taj simptom, značajno je smanjen (p=0,034) primjenom pitolizanta (-65 %), u usporedbi s placebom (-10 %).
The active substance, pitolisant, attaches to receptors on cells in the brain that are involved in stimulating alertness.
Djelatna tvar pitolizant pričvršćuje se za receptore na stanicama mozga koji sudjeluju u poticanju budnosti.
The combination of pitolisant with modafinil or sodium oxybate, usual treatments of narcolepsy was evaluated in healthy volunteers, at therapeutic doses.
Kombinacija pitolizanta s modafinilom ili natrijevim oksibatom, uobičajenim lijekovima za narkolepsiju, ocijenjena je kod zdravih ispitanika pri terapijskim dozama.
Therefore, an alternative method of effective contraception should be used if the woman is using hormonal contraceptives (see section 4.5).
Stoga, treba koristiti alternativnu metodu učinkovite kontracepcije ako bolesnica koristi hormonske kontraceptive (vidjeti dio 4.5).
At the highest doses, no histopathological changes were recorded in monkeys and rats presented some limited histopathological changes in some organs (liver, duodenum, thymus, adrenal gland and lung).
Pri najvećim dozama kod majmuna nisu zabilježene histopatološke promjene, a kod štakora su zabilježene ograničene histopatološke promjene na nekim organima (jetra, dvanaesnik, timus, nadbubrežna žlijezda i pluća).
Convulsions were reported at high doses in animal models (see section 5.3).
Kod životinjskih modela, pri visokim dozama zabilježene su konvulzije (vidjeti dio 5.3).