FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Teva has been shown to have comparable quality and to be bioequivalent to Xeloda.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Capecitabine Teva primerljivo raven kakovosti kot zdravilo Xeloda ter da mu je biološko enakovredno.
English: The Committee recommended that Capecitabine Teva be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Capecitabine Teva odobri dovoljenje za promet.
English: Because Capecitabine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Xeloda.
Slovenian: Ker je zdravilo Capecitabine Teva generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Xeloda.
English: Capecitabine Teva should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Slovenian: Zdravilo Capecitabine Teva sme predpisati samo zdravnik, ki je usposobljen za uporabo zdravil proti raku.
English: Capecitabine Teva is a ‘generic medicine'.
Slovenian: Capecitabine Teva je „generično zdravilo“.
English: Capecitabine Teva is a medicine that contains the active substance capecitabine.
Slovenian: Capecitabine Teva je zdravilo, ki vsebuje zdravilno učinkovino kapecitabin.
English: Capecitabine Teva is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Slovenian: Zdravilo Capecitabine Teva se uporablja sočasno z drugimi zdravili proti raku, vključno z zdravilom proti raku, ki vsebuje platino, kot je na primer cisplatin,
English: Capecitabine Teva is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Slovenian: Zdravilo Capecitabine Teva se uporablja sočasno z docetakselom (drugim zdravilom proti raku), potem ko zdravljenje z antraciklini (drugo vrsto zdravil proti raku) ni bilo uspešno.
English: Why has Capecitabine Teva been approved?
Slovenian: Zakaj je bilo zdravilo Capecitabine Teva odobreno?
English: The active substance in Capecitabine Teva, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Slovenian: Zdravilna učinkovina zdravila Capecitabine Teva, kapecitabin, je citotoksik (zdravilo, ki uničuje celice v fazi delitve, kot na primer rakave celice) iz skupine antimetabolitov.
English: Capecitabine Teva is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Slovenian: Zdravilo Capecitabine Teva se uporablja sočasno z drugimi zdravili proti raku ali pa kot samostojno zdravilo pri bolnikih po operaciji raka kolona stadija III ali stadija Dukes C,
English: How has Capecitabine Teva been studied?
Slovenian: Kako je bilo zdravilo Capecitabine Teva raziskano?
English: What is Capecitabine Teva?
Slovenian: Kaj je zdravilo Capecitabine Teva?
English: Capecitabine Teva is an anticancer medicine.
Slovenian: Capecitabine Teva je zdravilo proti raku.
English: Capecitabine Teva is used with or without other anticancer medicines;
Slovenian: Zdravilo Capecitabine Teva se uporablja sočasno z drugimi zdravili proti raku ali pa kot samostojno zdravilo,
English: How is Capecitabine Teva used?
Slovenian: Kako se zdravilo Capecitabine Teva uporablja?
English: What is Capecitabine Teva used for?
Slovenian: Za kaj se zdravilo Capecitabine Teva uporablja?
English: How does Capecitabine Teva work?
Slovenian: Kako zdravilo Capecitabine Teva deluje?
English: Steady-state is reached within one week.
Slovenian: Stanje dinamičnega ravnovesja je doseženo v enem tednu.
English: Via della Chimica, 9 36100 Vicenza Italy
Slovenian: Via della Chimica, 9 36100 Vicenza Italija
English: A risk for the breast-fed child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ne moremo izključiti.
English: 4 years
Slovenian: 4 leti.
English: This daily dose may be increased to 100 mg/day on the basis of individual clinical need.
Slovenian: Ta dnevni odmerek je mogoče povečati na 100 mg/dan na podlagi posameznikovih kliničnih potreb.
English: If you suffer from moderately reduced liver function, you should not take more than 50 mg a day; your doctor will advise if this applies to you.
Slovenian: Če imate zmerno poslabšano delovanje jeter, ne smete vzeti več kot 50 mg na dan; vaš zdravnik vam bo povedal, če to velja za vas.
English: Date of first authorisation: 24 February 2015 Date of latest renewal:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 24. februar 2015 Datum zadnjega podaljšanja:
English: If necessary, the concomitant use of these medicinal products should be at the lowest effective dose.
Slovenian: Če je sočasna uporaba potrebna, je treba ta zdravila uporabljati v najnižjem učinkovitem odmerku.
English: (2 years)
Slovenian: (2 leti)
English: The terminal elimination half-life of total radioactivity was approximately 80 hours.
Slovenian: Končni razpolovni čas izločanja skupne radioaktivnosti je znašal približno 80 ur.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Contact your doctor immediately and take the Xadago pack with you.
Slovenian: Nemudoma se obrnite na svojega zdravnika in vzemite embalažo zdravila Xadago s seboj.
English: To what extent the nondopaminergic effects contribute to the overall effect has not been established.
Slovenian: V kakšnem obsegu nedopaminergični učinki prispevajo k celokupnemu učinku, ni bilo ugotovljeno.
English: Change LSM (SE)
Slovenian: Sprememba LSM (SE)
English: (24 weeks)
Slovenian: (24 tednov)
English: Safinamide should be taken with water.
Slovenian: Safinamid je treba zaužiti z vodo.
English: Substance-related radioactivity was largely excreted in urine (76%) and only to a low extent in faeces (1.5%) after 192 hours.
Slovenian: S snovjo povezana radioaktivnost se je večinoma izločila z urinom (76 %) in le v manjšem obsegu z blatom (1,5 %) po 192 urah.
English: The elimination half-life of safinamide is 20-30 hours.
Slovenian: Razpolovni čas izločanja safinamida znaša 20-30 ur.
English: Plasma protein binding of safinamide is 88-90%.
Slovenian: Vezava safinamida na proteine v plazmi je 88-90 %.
English: Impulse control disorders (ICDs)
Slovenian: Motnje nadzora impulzov (Impulse control disorders, ICD)
English: Experience of use of safinamide in patients over 75 years of age is limited.
Slovenian: Izkušnje z uporabo safinamida pri bolnikih, starejših od 75 let, so omejene.
English: No time-dependency was observed.
Slovenian: Opazili niso nobene odvisnosti od časa.
English: Do not stop taking Xadago without first talking to your doctor.
Slovenian: Zdravila Xadago ne prenehajte jemati, ne da bi se pred tem pogovorili z zdravnikom.
English: Do not take Xadago - If you are allergic to safinamide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Xadago - če ste alergični na safinamid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: None of these metabolites are pharmacologically active.
Slovenian: Noben od teh presnovkov ni farmakološko aktiven.
English: Treatment with safinamide should be started at 50 mg per day.
Slovenian: Zdravljenje s safinamidom je treba začeti z odmerkom 50 mg na dan.
English: Studies were not stratified for co-medication, and no randomized interaction studies were performed for these medicinal products.
Slovenian: Študije niso bile stratificirane za sočasno uporabo zdravil, prav tako niso bile opravljene nobene randomizirane študije medsebojnega delovanja za ta zdravila.
English: There is no known antidote to safinamide or any specific treatment for safinamide overdose.
Slovenian: Ni znanega antidota za safinamid ali specifičnega zdravljenja za preveliko odmerjanje safinamida.
English: Xadago is used for the treatment of Parkinson's disease in adults.
Slovenian: Zdravilo Xadago se uporablja za zdravljenje parkinsonove bolezni pri odraslih.
English: The relevant plasma concentrations of safinamide are substantially lower, therefore a clinically relevant interaction with co-administered substrates of these transporters is unlikely.
Slovenian: Relevantne plazemske koncentracije safinamida so bistveno nižje, zato klinično pomembno medsebojno delovanje s sočasno dajanimi substrati teh prenašalcev ni verjetno.
English: Adverse reactions are ranked under headings of frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so navedeni glede na pogostnost ob upoštevanju naslednjega dogovora: zelo pogosti (> 1/10), pogosti (> 1/100 do < 1/10); občasni (> 1/1.000 do < 1/100), redki (> 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Do not throw away any medicines via wastewater or household waste.
Slovenian: Zdravila ne smete odvreči v odpadnevode ali med gospodinjske odpadke.
English: What Xadago is and what it is used for
Slovenian: Kaj je zdravilo Xadago in za kaj ga uporabljamo
English: Other medicines and Xadago
Slovenian: Druga zdravila in zdravilo Xadago
English: The volume of distribution (Vss) is approximately 165 L which is 2.5-fold of body volume indicating extensive extravascular distribution of safinamide.
Slovenian: Volumen porazdelitve (Vss) znaša približno 165 l, kar je 2,5-kratnik telesnega volumna in kaže na izdatno zunajžilno porazdelitev safinamida.
English: The pharmacodynamic effects of safinamide have not been assessed in children and adolescents.
Slovenian: Farmakodinamični učinki safinamida pri otrocih in mladostnikih niso bili ocenjeni.
English: The safety and efficacy of safinamide in children and adolescents under 18 years of age have not been established.
Slovenian: Varnost in učinkovitost safinamida pri otrocih in mladostnikih, mlajših od 18 let, nista bili ugotovljeni.
English: Long-term studies in animals have shown convulsions (1.6 to 12.8 times human clinical exposure, based on plasma AUC).
Slovenian: Dolgoročne študije na živalih so pokazale konvulzije (pri izpostavljenostih, ki ustrezajo 1,6- do 12,8-kratniku izpostavljenosti človeka pri klinični uporabi na podlagi plazemske vrednosti AUC).
English: Safinamide is eliminated mainly in the urine.
Slovenian: Safinamid se izloči pretežno z urinom.
English: (SETTLE) (24 weeks)
Slovenian: 27919 (SETTLE) (24 tednov)
English: Safinamide did not present genotoxic potential in in vivo and in several in vitro systems using bacteria or mammalian cells.
Slovenian: Safinamid ne izraža genotoksičnega potenciala v in vivo in v številnih in vitro sistemih, ki uporabljajo bakterije ali celice sesalcev.
English: Amidase present in blood, plasma, serum, simulated gastric fluid and simulated intestinal fluid as well as human carboxylesterases hCE-1 and hCE-2 are not responsible for the biotransformation of safinamide to NW-1153.
Slovenian: Amidaze, ki so prisotne v krvi, plazmi, serumu, simuliranem želodčnem soku in simuliranem črevesnem soku, in človeške karboksilesteraze hCE-1 in hCE-2 niso odgovorne za biotransformacijo safinamida v NW-1153.
English: PVC/PVDC/Aluminium blister packs of 14, 28, 30, 90 and 100 tablets.
Slovenian: Pretisni omoti iz PVC-ja/PVDC-ja/aluminija, ki vsebujejo 14, 28, 30, 90 ali 100 tablet.
English: Safinamide's metabolism is not dependent on Cytochrome P450 (CYP) based enzymes.
Slovenian: Presnova safinamida ni odvisna od encimov, ki temeljijo na citokromu P450 (CYP).
English: Safinamide does not appear to significantly induce or inhibit enzymes at clinically relevant systemic concentrations.
Slovenian: Safinamid ne kaže, da bi bistveno induciral ali zaviral encime v klinično pomembnih sistemskih koncentracijah.
English: Safinamide may be taken with or without food.
Slovenian: Safinamid se lahko jemlje s hrano ali brez.
English: Safinamide is a highly selective and reversible MAO-B inhibitor causing an increase in extracellular levels of dopamine in the striatum.
Slovenian: Safinamid je visoko selektiven in reverzibilen zaviralec MAO-B, ki povzroča zvišanje zunajceličnih ravni dopamina v striatumu.
English: If an important overdose occurs, safinamide treatment should be discontinued and supportive treatment should be administered as clinically indicated.
Slovenian: Če pride do pomembnega prevelikega odmerjanja, je treba zdravljenje s safinamidomprekiniti in začeti podporno zdravljenje, kot je klinično indicirano.
English: Therefore, caution is necessary when safinamide is taken concomitantly with medicinal products that are OCT1 substrates and have a tmax similar to safinamide (2 hours) (e.g. metformin, aciclovir, ganciclovir) as exposure to these substrates might be increased as a consequence.
Slovenian: Zato je potrebna previdnost ob sočasnem jemanju safinamida z zdravili, ki so substrati za OCT1 in imajo Tmax podoben kot safinamid (2 uri) (npr. metformin, aciklovir, ganciklovir), saj se lahko posledično poveča izpostavljenost tem substratom.
English: Responder analyses (post-hoc) (e) n(%) ON time increase ≥60 minutes p-value ≥60 minutes increase ON time and decrease in OFF time and ≥ 30% improvement UPDRS III p-value
Slovenian: Analize odziva (post-hoc) (e) n (%) Zvečanje obdobja brez težav z gibanjem ≥ 60 minut p-vrednost minutnozvečanje obdobja brez težav z gibanjem in zmanjšanje obdobja s težavami z gibanjem in ≥ 30odstotno izboljšanje lestvice UPDRS
English: Impulse control disorders can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Slovenian: Motnje nadzora impulzov se lahko pojavijo pri bolnikih, ki prejemajo dopaminske agoniste in/ali dopaminergična zdravila.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of safinamide in milk (for details see 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje safinamida v mleko (za podrobnosti glejte poglavje 5.3).
English: Safinamide absorption is rapid after single and multiple oral dosing, reaching Tmax in the time range 1.82.8 h after dosing under fasting conditions.
Slovenian: Absorpcija safinamida je po enkratnem in večkratnem peroralnem odmerjanju hitra, saj doseže Tmax v časovnem razponu 1,8-2,8 ure po odmerjanju na tešče.
English: Xadago is not recommended for use in children and adolescents, below 18 years old due to the lack of data on safety and efficacy in this population.
Slovenian: Jemanje zdravila Xadago ni priporočeno pri otrocih in mladostnikih, mlajših od 18 let, saj pri tej populaciji ni zadostnih podatkov o varnosti in učinkovitosti zdravila.
English: If a dose is missed the next dose should be taken at the usual time the next day.
Slovenian: Če bolnik izpusti odmerek, naj naslednji odmerek zdravila vzame naslednji dan ob običajnem času.
English: Animal studies indicate that safinamide treatment is associated with adverse reactions on female rat reproductive performance and sperm quality.
Slovenian: Študije na živalih nakazujejo, da je zdravljenje s safinamidom povezano z neželenimi reakcijami na sposobnost razmnoževanja pri podganjih samicah in na kakovost sperme.
English: Pharmacotherapeutic group: Anti-Parkinson-Drugs, monoamine oxidase -B inhibitors, ATC code: N04BD03.
Slovenian: Farmakoterapevtska skupina: Antiparkinsoniká, Inhibítory monoaminooxidázy typu B, oznaka ATC: N04BD03.
English: Toxic effects on the liver and accompanying symptoms as yellow/orange skin and skull, in pups exposed to safinamide during lactation are mediated mainly via in utero exposure, whereas exposure via the mother's milk had only a minor influence.
Slovenian: Toksični učinki na jetra in spremljajoči simptomi, kot so rumena/oranžna koža in lobanja pri mladičih, ki so bili med laktacijo izpostavljeni safinamidu, so predvsem posledica izpostavljenosti v maternici, medtem ko je imela izpostavljenost prek materinega mleka le manjši vpliv.
English: Secondary efficacy parameters included OFF Time, UPDRS II and III (Unified Parkinson's Disease Rating Scale - sections II and III), and CGI-C (Clinical Global Impression of Change)
Slovenian: Sekundarni parametri učinkovitosti so vključevali obdobje brez težav z gibanjem, UPDRS II in III (Unified Parkinson's Disease Rating Scale; Združena ocenjevalna lestvica Parkinsonove boleznirubriki II in III) ter CGI-C (Clinical Global Impression of Change; Celostni klinični odziv).
English: It acts to increase the level of a substance called dopamine in the brain, which is involved in the control of movement and is present in reduced amounts in the brain of patients with Parkinson's disease.
Slovenian: Ta deluje tako, da zviša raven snovi, imenovane dopamin, v možganih, ki sodeluje pri nadziranju gibov, in je v možganih bolnikov s parkinsonovo boleznijo prisotna v nižjih ravneh.
English: Moderate or severe renal impairment did not alter the exposure to safinamide, compared to healthy subjects (see section 4.2).
Slovenian: Zmerna ali huda ledvična okvara ni spremenila izpostavljenosti safinamidu v primerjavi z zdravimi preskušanci (glejte poglavje 4.2).
English: Xadago is supplied in packs containing 14, 28, 30, 90 or 100 film coated tablets.
Slovenian: Xadago je na voljo v škatlah, ki vsebujejo 14, 28, 30, 90 ali 100 filmsko obloženih tablet.
English: Potential for retinal degeneration in patients with prior history of retinal disease
Slovenian: Potencial za degeneracijo mrežnice pri bolnikih z boleznijo mrežnice v anamnezi
English: Safinamide exposure in patients with mild hepatic disease increased marginally (30% in AUC), while in patients with moderate hepatic impairment exposure increased by approximately 80% (see section
Slovenian: Izpostavljenost safinamidu pri bolnikih z blago jetrno okvaro se je rahlo povečala (30 % AUC), medtem ko se je pri bolnikih z zmerno jetrno okvaro izpostavljenost povečala za približno 80 % (glejte poglavje 4.2).
English: The systemic exposure of NW-1153 is low (1/10 of parent safinamide).
Slovenian: Sistemska izpostavljenost NW1153 je nizka (1/10 parenteralnega safinamida).
English: What you need to know before you take Xadago
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Xadago
English: In vitro experiments indicated that inhibition of amidases in human hepatocytes led to complete suppression of the NW-1153 formation.
Slovenian: In vitro eksperimenti so pokazali, da je inhibicija amidaz v človeških hepatocitih povzročila popolno supresijo tvorjenja NW-1153.
English: The pharmacokinetics of safinamide are linear after single and repeated doses.
Slovenian: Farmakokinetika safinamida je linearna po enkratnem in večkratnih odmerkih.
English: Medicinal products that are inhibitors of OAT3 given concomitantly with safinamide may reduce clearance of NW-1153, i.e., and thus may increase its systemic exposure.
Slovenian: Zdravila, ki so inhibitorji OAT3 in jih dajemo sočasno s safinamidom, lahko zmanjšajo npr. očistek NW-1153 in lahko na ta način povečajo sistemsko izpostavljenost.
English: Absolute bioavailability is high (95%), showing that safinamide is almost completely absorbed after oral administration and first pass metabolism is negligible.
Slovenian: Absolutna biološka uporabnost je visoka (95 %), kar pomeni, da se safinamid po peroralnem dajanju skoraj v celoti absorbira in da je presnova prvega prehoda zanemarljiva.
English: D- 73614 Schorndorf Germany
Slovenian: D- 73614 Schorndorf, Nemčija
English: Somnolence and dizziness may occur during safinamide treatment, therefore patients should be cautioned about using hazardous machines, including motor vehicles, until they are reasonably certain that safinamide does not affect them adversely.
Slovenian: Med zdravljenjem s safinamidom se lahko pojavita zaspanost in omotica, zato je treba bolnike opozoriti na previdnost pri upravljanju z nevarnimi stroji, vključno z motornimi vozili, dokler ne bodo prepričani, da safinamid nanje nima neželenih učinkov.
English: The primary efficacy parameter was the change from baseline to endpoint in ‘ON Time without troublesome dyskinesia'.
Slovenian: Parameter primarne učinkovitosti je bila sprememba od izhodišča do končne točke v trajanju obdobja brez težav z gibanjem (»vklop«), brez moteče diskinezije.
English: In one patient suspected of consuming more than the daily prescribed dose of 100 mg for one month, symptoms of confusion, sleepiness, forgetfulness and dilated pupils were reported.
Slovenian: Pri enem bolniku, za katerega so domnevali, da je en mesec užival večji odmerek od predpisanega 100 mg/dan, so poročali o naslednjih simptomih: zmedenost, zaspanost, pozabljivost in razširjene zenice.
English: Xadago is a medicine that contains the active substance safinamide.
Slovenian: Xadago je zdravilo, ki vsebuje učinkovino safinamid.
English: Dose (mg/day) (a)
Slovenian: Odmerek (mg/dan) (a)
English: This effect was not seen when safinamide was used as an adjunct to dopamine agonists in early stage PD patients.
Slovenian: Tega učinka niso opazili pri uporabi safinamida kot dodatka dopaminskim agonistom pri bolnikih s parkinsonovo boleznijo v zgodnjem stadiju.
English: Hypromellose Macrogol (6000) Titanium dioxide (E171) Iron oxide red (E172) Mica (E555)
Slovenian: Filmska obloga hipromeloza makrogol (6000) titanov dioksid (E171) rdeč železov oksid (E172) sljuda (E555)
English: At concentrations of 50µM, safinamide inhibited OATP1A2 and OATP2P1.
Slovenian: Pri koncentracijah 50µM je safinamid zaviral OATP1A2 in OATP2P1.
English: Dedicated drug-drug interaction studies performed with ketoconazole, L-dopa and CYP1A2 and CYP3A4 substrates (caffeine and midazolam), did not detect any clinically significant effects on the pharmacokinetics of safinamide, or L-dopa, caffeine and midazolam.
Slovenian: V namenskih študijah medsebojnega delovanja zdravil, ki so jih opravili s ketokonazolom, L-dopo ter substrati CYP1A2 in CYP3A4 (kofein in midazolam), niso opazili nobenih klinično pomembnih učinkov na farmakokinetiko safinamida ali L-dope, kofeina in midazolama.
English: When safinamide is co-administered with products that are BCRP substrates, please refer to the SmPC for that particular medicinal product.
Slovenian: Če je safinamid uporabljen sočasno z zdravili, ki so substrati BCRP, prosimo upoštevajte Povzetek glavnih značilnosti zdravila tistega določenega to zdravila.
English: Total clearance was determined to be 4.6 L/h classifying safinamide as a low clearance substance.
Slovenian: Ugotovljeno je bilo, da je celotni očistek 4,6 l/h, zato se safinamid uvršča med snovi z nizkim očistkom.
English: The tabulation below includes all adverse reactions in clinical trials where adverse reactions were considered related.
Slovenian: V spodnji preglednici so navedene vse neželene reakcije v kliničnih preskušanjih, v katerih so neželene učinke opredelili kot povezane z zdravilom.
English: This potential increase is most likely of no clinical relevance as NW-1153, the first product in the metabolic pathway, is further transformed to secondary and tertiary metabolites.
Slovenian: To potencialno povečanje najverjetneje nima klinične pomembnosti, saj se NW-1153, prvi produkt v presnovni poti, nadalje transformira v sekundarne in terciarne presnovke.
English: Phospholipidosis was seen mainly in the lungs in rodents (at exposures similar to humans) and monkeys (at exposures greater than 12 fold higher than human).
Slovenian: Fosfolipidozo so opazili zlasti v pljučih glodavcev (pri izpostavljenostih, podobnim izpostavljenostim človeka), in opic (pri izpostavljenosti, ki več kot 12krat presega izpostavljenost človeka.
English: Breast Feeding Xadago is likely to be excreted in breast milk.
Slovenian: Velika verjetnost je, da se zdravilo Xadago izloča v materino mleko.