natgillin/translations-raw huggingface dataset:
Maintenance of efficacy
Vzdrževanje učinkovitosti
Take Wakix once a day by mouth, in the morning with your breakfast.
Zdravilo Wakix jemljite enkrat na dan skozi usta, in sicer zjutraj ob zajtrku.
Pitolisant should not be used during pregnancy unless the potential benefit outweighs the potential risk for foetus.
Pitolizant se ne sme uporabljati med nosečnostjo, razen če je morebitna korist večja od morebitnega tveganja za plod.
As long-term efficacy data are limited (see section 5.1), the continued efficacy of treatment should be regularly evaluated by the physician.
Ker so podatki o dolgoročni učinkovitosti omejeni (glejte poglavje 5.1), jo mora zdravnik med zdravljenjem redno ocenjevati.
Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to suddenly fall asleep in inappropriate situations (sleep attacks).
Narkolepsija je bolezen, ki povzroča čezmerno dnevno zaspanost in nagnjenost k temu, da oseba nenadoma zaspi v neprimernih situacijah (napadi spanja).
Any change in dosage must be prescribed and monitored by your doctor.
Vsako spremembo odmerjanja mora predpisati in nadzorovati zdravnik.
If you are unsure whether your condition has a negative effect on your ability to drive, talk to your doctor.
Če niste prepričani, ali vaše stanje negativno vpliva na vašo sposobnost vožnje, se posvetujte z zdravnikom.
There is not enough information available to know whether any particular risk is associated with the use of Wakix during pregnancy.
Na voljo je premalo podatkov, da bi lahko vedeli, ali je z uporabo zdravila Wakix med nosečnostjo povezano kakšno posebno tveganje.
However, no definitive conclusion could be drawn on tolerance, dependence and self-administration studies.
Vendar glede tolerance, odvisnosti in nenadzorovane zlorabe ni mogoče postaviti gotovih zaključkov.
• 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.
• Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
*p<0.0001 vs placebo
*p < 0,0001 v primerjavi s placebom
The MWT value in the pitolisant group was 80% higher than in the placebo group.
Vrednost TSTB v skupini s pitolizantom je bila 80 % večja kot v skupini s placebom.
Take this leaflet and any remaining tablets with you.
S seboj vzemite to navodilo za uporabo in preostale tablete.
The most serious ADRs are abnormal weight decrease (0.09%) and abortion spontaneous (0.09%).
Najresnejša neželena učinka sta nenormalno zmanjšanje telesne mase (0,09 %) in spontani splav (0,09 %).
Narcolepsy (with or without cataplexy) is a chronic condition.
Narkolepsija (s katapleksijo ali brez nje) je kronično stanje.
Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX11.
Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje, oznaka ATC: N07XX11.
Pitolisant was neither genotoxic nor carcinogenic.
Pitolizant ni bil genotoksičen in kancerogen.
In 68 to 80 years old patients the pharmacokinetics of pitolisant is not different compared to younger patients (18 to 45 years of age).
Farmakokinetika pitolizanta pri bolnikih, starih od 68 do 80 let, ni drugačna kot pri mlajših bolnikih (starih od 18 do 45 let).
The total daily dose should be administered as a single dose in the morning during breakfast.
Skupni dnevni odmerek je treba dajati v enkratnem odmerku zjutraj med zajtrkom.
It caused a delay in post-natal development (safety margin of 1).
Povzročil je zapoznel postnatalni razvoj (varnostni indeks 1).
If symptoms persist a reduced daily dose or discontinuation should be considered.
Če simptomi trajajo dlje časa, je treba razmisliti o zmanjšanju dnevnega odmerka ali prekinitvi zdravljenja.
Headache and insomnia During clinical studies, episodes of headache and insomnia have been reported (7.7 % to 8.4%).
Glavobol in nespečnost Med kliničnimi študijami so poročali o epizodah glavobolov in nespečnosti (7,7 % do 8,4 %).
This helps to combat daytime sleepiness and cataplexy and promote wakefulness.
To pomaga pri premagovanju dnevne zaspanosti in katapleksije ter poveča budnost.
Pitolisant has minor influence on the ability to drive and use machines.
Pitolizant ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
Treatment should be initiated by a physician experienced in the treatment of sleep disorders.
Zdravljenje sme uvesti zdravnik, ki ima izkušnje z zdravljenjem motenj spanja.
Treatment is normally started with a dose of 9 mg once per day, and gradually increased over three weeks to the most appropriate dose.
Zdravljenje se običajno začne z odmerkom 9 mg enkrat na dan, ki se nato tri tedne postopoma povečuje do najprimernejšega odmerka.
Pitolisant has a plasma half-life of 10-12 hours.
Plazemski razpolovni čas pitolizanta je 10-12 ur.
When pitolisant dose is doubled from 27 to 54 mg, AUC0-∞ is increased by about 2.3.
Po podvojitvi odmerka pitolizanta s 27 na 54 mg se AUC0-∞ poveča za približno 2,3-krat.
What Wakix is and what it is used for
Kaj je zdravilo Wakix in za kaj ga uporabljamo
Non-interventional post-authorisation safety study (PASS): A multi-center, observational post-authorization safety study to document the drug utilisation of Wakix and to collect information on the safety of Wakix when used in routine medical practice
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): multicentrična, opazovalna varnostna študija v obdobju trženja zdravila za dokumentiranje uporabe zdravila Wakix in zbiranje podatkov o varnosti zdravila Wakix, kadar se uporablja v redni klinični praksi.
Wakix can affect the way other medicines work and other medicines can affect the way Wakix works.
Zdravilo Wakix lahko vpliva na način delovanja drugih zdravil in druga zdravila lahko vplivajo na način delovanja zdravila Wakix.
- Enzyme inducers
- Induktorji encimov
Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise.
Katapleksija je nenadna izguba mišične moči ali paraliza brez izgube zavesti, ki se pojavi ob nenadnem čustvenem odzivu, kot je jeza, strah, veselje, smeh ali presenečenje.
Wakix should not be used during pregnancy unless your doctor says so.
Nosečnost Zdravila Wakix ne smete uporabljati med nosečnostjo, razen če vam to naroči zdravnik.
In case of significant weight change, treatment should be re-evaluated by the physician.
Ob večji spremembi telesne mase mora zdravnik ponovno oceniti zdravljenje.
What is in this leaflet?
Kaj vsebuje navodilo?
In vitro studies indicate that pitolisant is neither a substrate nor an inhibitor of human P-glycoprotein and breast cancer resistance protein (BCRP).
Študije in vitro so pokazale, da pitolizant ni ne substrat ne zaviralec humanega P-glikoproteina in proteina odpornosti pri raku dojke (BCRP).
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.
Pri bolnikih s čezmerno dnevno zaspanostjo, vključno s tistimi, ki jemljejo pitolizant, je treba pogosto ponovno oceniti njihovo stopnjo zaspanosti in jim po potrebi svetovati, naj se izogibajo vožnji in drugim dejavnostim, ki so lahko nevarne.
Patients with abnormal levels of sleepiness who take pitolisant should be advised that their level of wakefulness may not return to normal.
Bolnike z nenormalno stopnjo zaspanosti, ki jemljejo pitolizant, je treba opozoriti, da se njihova stopnja budnosti morda ne bo vrnila na normalno raven.
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 presnovki so hidroksilirani derivati na več mestih in razcepljene oblike pitolizanta, ki vodijo do neaktivnega glavnega presnovka karboksilne kisline, ki se nahaja v urinu in serumu.
It is a medicine used to treat adult patients with narcolepsy, with or without cataplexy.
Je zdravilo, ki se uporablja za zdravljenje odraslih bolnikov, ki imajo narkolepsijo s katapleksijo ali brez nje.
This effect on EDS was confirmed by the results on Maintenance of Wakefulness Test (MWT).
Ta učinek na ČDZ so potrdili rezultati testa srednjega trajanja budnosti (TSTB).
Wakix passes into breast milk in animal.
Zdravilo Wakix prehaja v mleko pri živalih.
If you take too many tablets of Wakix, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.
Če ste vzeli preveč tablet zdravila Wakix, takoj pokličite na oddelek za nujno medicinsko pomoč v najbližji bolnišnici ali se posvetujte z zdravnikom ali farmacevtom.
The elimination is mainly achieved via urine (approximately 63%) through an inactive non conjugated metabolite (BP2.951) and a glycine conjugated metabolite.
Izločanje v glavnem poteka z urinom (približno 63 %) prek neaktivnega nekonjugiranega presnovka (BP2.951) in presnovka, konjugiranega z glicinom.
Most patients (65%) reached the 36 mg once a day dosage.
Večina bolnikov (65 %) je na koncu prejemala odmerek 36 mg enkrat na dan.
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 glede deleža katapleksije pri odmerku 18 mg enkrat na dan niso bili skladni z rezultati prve ključne študije (36 mg enkrat na dan).
In clinical trials, one epilepsy aggravation was reported in one epileptic patient.
V kliničnih preskušanjih so pri enem bolniku z epilepsijo poročali o poslabšanju epilepsije.
QR code to be included URL {EMA website corresponding product information not yet known}.
Koda QR bo vstavljena pozneje URL {ustrezne informacije o zdravilu na spletni strani EMA še niso znane}.
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.
Izpostavljenost pitolizantu pri zdravih prostovoljcih so ocenjevali v študijah, v katerih je sodelovalo več kot 200 preskušancev, ki so prejemali enkratne odmerke pitolizanta do 216 mg največ 28 dni.
Component of a multipack, cannot be sold separately.
Enota v skupnem pakiranju, prodaja posameznih enot ni možna.
In preclinical studies, drug dependence and drug abuse liability studies were conducted in mice, monkeys and rats.
V predkliničnih študijah so odvisnost od zdravila in nagnjenost k zlorabi zdravila preučevali pri miših, opicah in podganah.
Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Obloga polivinilalkohol titanov dioksid (E 171) makrogol 3350 smukec
Caution should be taken for patients with severe epilepsy.
Pri bolnikih s hudo epilepsijo je potrebna previdnost.
Pitolisant exhibits high serum protein binding (>90%) and demonstrates approximately equal distribution between red blood cells and plasma.
Pitolizant se v zelo velikem obsegu veže na beljakovine v serumu (> 90 %) in se približno enakovredno porazdeli med krvne celice in plazmo.
Other medicines and Wakix
Druga zdravila in zdravilo Wakix
The European Medicines Agency has deferred the obligation to submit the results of studies with Wakix in one or more subsets of the paediatric population in narcolepsy with or without cataplexy (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Wakix pri eni ali več podskupin pediatrične populacije z narkolepsijo s katapleksijo ali brez nje (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Upon repeated administrations, the steady state is achieved after 5-6 days of administration leading to an increased serum level around 100%.
Pri ponavljajočem dajanju zdravila se stanje dinamičnega ravnovesja vzpostavi po 5-6 dneh dajanja, kar povzroči povečanje serumske koncentracije za približno 100 %.
Studies in animals have shown reproductive toxicity, including teratogenicity.
Študije na živalih kažejo na škodljiv vpliv na sposobnost razmnoževanja, vključno s teratogenostjo.
Pitolisant also modulates various neurotransmitter systems, increasing acetylcholine, noradrenaline and dopamine release in the brain.
Poleg tega pitolizant uravnava različne sisteme živčnih prenašalcev, tako da poveča sproščanje acetilholina, noradrenalina in dopamina v možganih.
The waking effect of the two active substances was established at similar rates (Figure 1).
Stopnja prebujevalnega učinka obeh zdravilnih učinkovin je bila podobna (slika 1).
Bottle of 30 or 90 film-coated tablets.
Steklenička s 30 ali 90 filmsko obloženimi tabletami.
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).
Čeprav klinična pomembnost tega učinka ni ugotovljena, se priporoča previdnost, kadar se pitolizant uporablja sočasno s substratom OCT1 (npr. z metforminom (bigvanidi)) (glejte poglavje 5.2).
If you take more Wakix than you should
Če ste vzeli večji odmerek zdravila Wakix, kot bi smeli
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.
25 % odmerka se izloči z izdihanim zrakom, majhen delež (< 3 %) pa se izloči z blatom, v katerem je količina pitolizanta ali BP2.951 zanemarljiva.
Pitolisant is well and rapidly absorbed with peak plasma concentration reached approximately three hours after administration.
Pitolizant se dobro in hitro absorbira, pri čemer se največja plazemska koncentracija pojavi približno tri ure po odmerjanju.
The active substance, pitolisant, attaches to receptors on cells in the brain that are involved in stimulating alertness.
Zdravilna učinkovina, pitolizant, se veže na receptorje na celicah v možganih, ki sodelujejo pri spodbujanju budnosti.
With oral contraceptives, the combination with pitolisant should be avoided and a further reliable contraceptive method used.
Kombinaciji peroralnih kontracepcijskih sredstev in pitolizanta se je treba izogibati in uporabiti dodatno zanesljivo kontracepcijsko metodo.
Patients taking Wakix must stop breastfeeding.
Bolnice, ki jemljejo zdravilo Wakix, morajo prenehati z dojenjem.
If they persist a corrective treatment with proton pump inhibitor could be initiated.
Če trajajo dlje časa, se lahko uvede korektivno zdravljenje z zaviralcem protonske črpalke.
Above 80 years old, kinetics show a slight variation without clinical relevance.
Pri starejših od 80 let je kinetika rahlo drugačna, vendar ne v klinično pomembni meri.
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 je treba previdno uporabljati pri bolnikih, ki so že kdaj imeli psihiatrične motnje, kot sta huda tesnoba ali huda depresija s tveganjem za samomorilne misli.
The second pivotal study (Harmony Ibis) included 165 patients (67 treated with pitolisant, 33 with placebo and 65 with modafinil).
V drugo ključno študijo (Harmony Ibis) so vključili 165 bolnikov (67 zdravljenih s pitolizantom, 33 s placebom in 65 z modafinilom).
Bioprojet Pharma 9, rue Rameau 75002 Paris France
Bioprojet Pharma 9, rue Rameau 75002 Paris Francija
Teratogenic effect of pitolisant was observed at maternally toxic doses (teratogenicity safety margins < 1 in rats and in rabbits).
Teratogeni učinek pitolizanta so opazili pri odmerkih, toksičnih za mater (varnostni faktor teratogenosti < 1 pri podganah in kuncih).
A clinical monitoring should be made when both active substances are combined and, eventually a dosage adjustment during the combination and one week after the inducer treatment.
Ob kombiniranju teh dveh zdravilnih učinkovin je potrebno klinično spremljanje in morebiti tudi prilagoditev odmerka med kombiniranim zdravljenjem ter še en teden po zdravljenju z induktorjem.
You may experience headaches, stomach pain, feeling sick or irritable.
Pojavijo se lahko glavoboli, bolečina v želodcu, slabost ali razdražljivost.
The other ingredients are microcrystalline cellulose, crospovidone, talc, magnesium stearate, colloidal anhydrous silica, polyvinyl alcohol, titanium dioxide, macrogol 3350.
Druge sestavine zdravila so mikrokristalna celuloza, krospovidon, smukec, magnezijev stearat, koloidni brezvodni silicijev dioksid, polivinilalkohol, titanov dioksid in makrogol 3350.
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.
Kar zadeva jetrne mikrosome, pitolizant in njegovi glavni presnovki bistveno ne zavirajo delovanja citokromov CYP1A2, CYP2C9, CYP2C19, CYP2C8, CYP2B6, CYP2E1 in CYP3A4 ter izooblik uridin difosfat glukuronoziltransferaz UGT1A1, UGT1A4, UGT1A6, UGT1A9 in UGT2B7 pri koncentracijah do 13,3 µM, kar je bistveno večja koncentracija od tistih, ki se pojavijo pri terapevtskih odmerkih.
What you need to know before you take Wakix
Kaj morate vedeti, preden boste vzeli zdravilo Wakix
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: na voljo v pakiranjih, ki vsebujejo po 1 plastenko s 30 tabletami ali v pakiranjih, ki vsebujejo po 1 plastenko s 90 tabletami ali v skupnem pakiranju, ki vsebuje po 90 tablet (3 plastenke s 30 tabletami).
Symptoms of Wakix overdose may include headache, insomnia, irritability, nausea and abdominal pain.
Simptomi prevelikega odmerjanja zdravila Wakix lahko vključujejo glavobol, nespečnost, razdražljivost, navzeo in bolečino v trebuhu.
The combination of pitolisant with modafinil or sodium oxybate, usual treatments of narcolepsy was evaluated in healthy volunteers, at therapeutic doses.
Pri kombinaciji pitolizanta z modafinilom ali natrijevim oksibatom so ocenjevali običajna zdravljenja za narkolepsijo pri zdravih prostovoljcih in v terapevtskih odmerkih.
In a clinical multiple dose study, the combination of pitolisant with probenecid decreases the AUC of pitolisant by about 34%.
V klinični študiji z večkratnimi odmerki je kombinacija pitolizanta s probenecidom znižala AUC pitolizanta za približno 34 %.
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).
Načrt študije je bil podoben študiji Harmony I, čeprav je bil največji odmerek pitolizanta, ki ga je doseglo 75 % bolnikov, 18 mg enkrat na dan namesto 36 mg pri študiji Harmony I. Ker je pomembno neravnovesje privedlo do primerjave rezultatov z razvrščanjem centrov v skupine oziroma brez tega razvrščanja, je najbolj konzervativni pristop pokazal statistično neznačilno zmanjšanje rezultata ESS pri pitolizantu v primerjavi s placebom (pitolizantplacebo = 1,94 z vrednostjo p = 0,065).
Pitolisant pharmacokinetics after repeated administration in patients with hepatic impairment has not been evaluated yet.
Farmakokinetike pitolizanta po ponavljajočem odmerjanju pri bolnikih z okvaro jeter še niso ovrednotili.
Wakix 4.5 mg: Available in packs containing 1 bottle of 30 tablets.
Wakix 4,5 mg: na voljo v pakiranjih, ki vsebujejo po 1 plastenko s 30 tabletami.
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).
V dveh namenskih študijah intervala QT so supraterapevtski odmerki pitolizanta (3- do 6-krat večji od terapevtskega, tj. od 108 mg do 216 mg) povzročili majhno do zmerno podaljšanje intervala QTc (1013 ms).
Race The effect of race on metabolism of pitolisant has not been evaluated.
Rasa Vpliv rase na presnovo pitolizanta ni bil ovrednoten.
Inter individual variability is rather high, some volunteers showing outlier high profile (without tolerance issues).
Interindividualna variabilnost je precej velika, saj so pri nekaterih prostovoljcih opazili velika odstopanja (brez težav s prenašanjem zdravila).
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 v odmerku do 36 mg enkrat na dan pri zdravljenju narkolepsije s katapleksijo ali brez nje so dokazali v dveh glavnih, 8-tedenskih, multicentričnih, randomiziranih, dvojno slepih, s placebom kontroliranih preskušanjih z vzporednimi skupinami (Harmony I in Harmony CTP).
Breastfeeding (see section 4.6).
Dojenje (glejte poglavje 4.6).
Pitolisant blocked hERG channel with an IC50 exceeding therapeutic concentrations and induced a slight QTc prolongation in dogs.
Pri psih je pitolizant zaviral kanalčke hERG, pri čemer je IC50 presegel terapevtske koncentracije, in sprožil rahlo podaljšanje intervala QTc.
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).
V velikih odmerkih je pitolizant sprožil abnormalnosti morfologije sperme in zmanjšal gibljivost brez kakršnega koli pomembnega učinka na indekse plodnosti pri podganjih samcih ter zmanjšal odstotek živih zanositev in povečal izgubo po nidaciji pri podganjih samicah (varnostni indeks 1).
In clinical trials, no specific cardiac safety signal was identified at therapeutic doses of pitolisant.
V kliničnih preskušanjih pri uporabi terapevtskih odmerkov pitolizanta niso opazili nobenih posebnih varnostnih signalov, povezanih s srcem.
You should continue to take Wakix for as long as instructed by your doctor.
Zdravilo Wakix jemljite toliko časa, kot vam je naročil zdravnik.
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)).
Učinek, izmerjen po Epworthovi lestvici, so podprli v dveh laboratorijskih testih budnosti in pozornosti (testu srednjega trajanja budnosti (TSTB) (p = 0,044) in testu ohranjanja pozornosti na nalogo odzivanja (Sustained Attention to Response Task - SART) (p = 0,053, statistična značilnost skoraj dosežena).
Pitolisant is not a substrate of OATP1B1, OATP1B3.
Pitolizant ni substrat OATP1B1 in OATP1B3.
In patients with mild hepatic impairment (Child-Pugh A), there was no significant changes in pharmacokinetics compared with normal healthy volunteers.
Pri bolnikih z blago okvaro jeter (stopnje A po Child-Pughovi lestvici) farmakokinetika ni bila bistveno drugačna kot pri normalnih zdravih prostovoljcih.
Wakix may reduce the effectiveness of hormonal contraceptives, an alternative method of effective contraception has to be used (see section “Pregnancy).
Zdravilo Wakix lahko zmanjša učinkovitost hormonske kontracepcije, zato je treba uporabljati dodatno metodo učinkovite kontracepcije (glejte poglavje „Nosečnost“).
OUTER CARTON WITH BLUE BOX
ZUNANJI ŠKATLA - S PODATKI ZA 'MODRO OKENCE'
Renal impairment In patients with renal impairment, the maximum daily dose should be 18 mg.
Okvara ledvic Pri bolnikih z okvaro ledvic je največji dnevni odmerek 18 mg.