natgillin/translations-raw huggingface dataset:
The European Commission issued a decision on 28 February 2014. 
Evropska komisija je izdala odločbo dne 28. februarja 2014.
Outcome of a procedure under Article 29(4) of Directive 2001/83/EC 
Izid postopka iz člena 29(4) Direktive 2001/83/ES
The company wanted the authorisation of Nanotop to be recognised in Austria, Finland, France, Italy, Norway, Portugal, Spain, Sweden and the United Kingdom (the ‘concerned Member States'). 
Družba je želela, da se dovoljenje za zdravilo Nanotop prizna v Avstriji, na Finskem, v Franciji, Italiji, na Norveškem, Portugalskem, v Španiji, na Švedskem in v Združenem kraljestvu („zadevne države članice“).
Why was Nanotop reviewed? 
Zakaj je bilo zdravilo Nanotop pregledano?
However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 26 September 2013. 
Vendar države članice niso mogle doseči soglasja, zato je nemška regulativna agencija za zdravila 26. septembra 2013 zadevo napotila na odbor CHMP v arbitražo.
On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Nanotop. 
Evropska agencija za zdravila je dne 19. decembra 2013 zaključila arbitražni postopek, potem ko so države članice Evropske unije (EU) izrazile nestrinjanje glede odobritve zdravila Nanotop.
It contains particles of the human protein albumin which are attached to radioactive technetium (99mTc) before use. 
Vsebuje delce človeške beljakovine, imenovane albumin, ki se pred uporabo vežejo na radioaktivni tehnecij [99mTc].
It recommended that Nanotop be granted marketing authorisation in the concerned Member States. 
Priporočil je, da se za zdravilo Nanotop odobri dovoljenje za promet v zadevnih državah članicah.
ROTOP Pharmaka AG submitted Nanotop for mutual recognition on the basis of the initial authorisation granted by the German medicines regulatory agency on 8 December 2011. 
Družba ROTOP Pharmaka AG je za zdravilo Nanotop predložila vlogo za pridobitev dovoljenja za promet z zdravilom po postopku z medsebojnim priznavanjem, ki je temeljila na prvotnem dovoljenju, ki ga je dne 8. decembra 2011 odobrila nemška regulativna agencija za zdravila.
The initial authorisation was based on a well-established-use application, which relied on published data with a similar product named Nanocoll. 
Prvotna odobritev je temeljila na vlogi za pridobitev dovoljenja za promet na podlagi dobro uveljavljene uporabe, ki so jo podprli z objavljenimi podatki za podobno zdravilo, imenovano Nanocoll.
Particle size is critical for the way the medicine works as it affects how well the medicine is taken up by the lymphatic system. 
Velikost delcev ima ključno vlogo pri načinu delovanja zdravila, saj vpliva na to, kako dober bo privzem zdravila v limfatični sistem.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Nanotop outweigh its risks, and that the marketing authorisation granted in Germany can be recognised in other Member States of the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje v okviru agencije, je zaključil, da so koristi zdravila Nanotop večje od z njim povezanih tveganj in da se dovoljenje za promet, ki je bilo odobreno v Nemčiji, lahko prizna tudi v drugih državah članicah EU.
Nanotop is a kit for the preparation of a radioactive suspension for injection. 
Nanotop je komplet za pripravo radioaktivne raztopine za injiciranje.
Questions and answers on Nanotop and associated names (human albumin colloidal particles, kit for radiopharmaceutical preparation) EMA/795874/2013 
Vprašanja in odgovori o zdravilu Nanotop in povezanih imenih (koloidni delci humanega albumina, komplet za pripravo radiofarmaka) EMA/795874/2013
Nanotop is for diagnostic use. 
Zdravilo Nanotop je namenjeno samo za diagnostično uporabo.
What is Nanotop? 
Kaj je zdravilo Nanotop?
During a scan the radioactive technetium can be detected, which help to obtain a clear image of the lymphatic system and to detect whether tumours have spread to the lymph nodes in patients with breast cancer or malignant melanoma (a type of skin cancer). 
Radioaktivni tehnecij je mogoče zaznati med slikanjem, kar omogoča, da pridobimo jasno sliko limfatičnega sistema in ugotovimo, ali so se tumorji pri bolnikih z rakom dojke ali malignim melanomom (vrsto kožnega raka) razširili na bezgavke.
Questions and answers on Nanotop and associated names (human albumin colloidal particles, kit for radiopharmaceutical preparation) 
Vprašanja in odgovori o zdravilu Nanotop in povezanih imenih (koloidni delci humanega albumina, komplet za pripravo radiofarmaka)
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that particle size and its batch variability are similar for Nanotop and Nanocoll. 
Na podlagi ocene trenutno razpoložljivih podatkov in interne znanstvene razprave je odbor CHMP zaključil, da imata zdravili Nanotop in Nanocoll podobno velikost delcev in variabilnost med serijami.
When injected, it passes through in the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream). 
Po injiciranju potuje skozi limfatični sistem (tj. mrežo žil, ki prenašajo tekočino iz tkiv skozi bezgavke v krvni obtok).
The grounds for the referral were concerns raised by Sweden that Nanotop could not be considered comparable in quality to Nanocoll, particularly because of supposed differences in particle sizes between the two products. 
Podlaga za napotitev so bili zadržki Švedske, ki je menila, da kakovost zdravila Nanotop ni primerljiva s kakovostjo zdravila Nanocoll, zlasti zaradi razlik v velikosti delcev, ki naj bi obstajale med zdraviloma.
The CHMP assessed additional supportive data provided by the company comparing the particle size of Nanotop with that of Nanocoll and the variability in particle size between different batches of each medicine. 
Odbor CHMP je ocenil dodatne spremljajoče podatke, ki jih je predložila družba in ki omogočajo primerjavo velikosti delcev v zdravilu Nanotop in zdravilu Nanocoll ter variabilnosti velikosti delcev med različnimi serijami posameznega zdravila.
The CHMP therefore considered that these medicines can be considered comparable in quality and that the benefits of Nanotop outweigh its risks. 
Posledično je menil, da je kakovost obeh zdravil primerljiva in da so koristi zdravila Nanotop večje od z njim povezanih tveganj.
Date of first authorisation: 20 April 2017 
Datum prve odobritve: 20 April 2017
Elderly people (≥ 65 years) 
Starejši ljudje (≥ 65 let)
If this happens, do not drive or use any tools or machines. 
Če pride do tega, ne vozite in ne uporabljajte kakršnega koli orodja ali strojev.
Do not take Varuby more than once every two weeks. 
Ne jemljite zdravila Varuby več kot enkrat na vsaka dva tedna.
This is not expected to be clinically relevant. 
Ni pričakovano, da je to klinično pomembno.
They will provide appropriate treatment. 
Poskrbela bosta za ustrezno zdravljenje.
The results were evaluated for each individual study and for the two studies combined. 
Rezultate so ovrednotili za vsako posamezno študijo in za obe študiji skupaj.
Relationship between concentration and effect 
Razmerje med koncentracijo in učinkom
Dialysis studies have not been performed. 
Študije z dializo niso bile izvedene.
Age, Sex and Race/Ethnicity 
Starost, spol in rasa/narodnost
Varuby should not be taken by children and adolescents under 18 years because it has not been studied in this group. 
Zdravila Varuby ne smejo uporabljati otroci in mladostniki, mlajši od 18 let, ker pri tej skupini zdravilo ni bilo raziskano.
The lowest effective dose of rosuvastatin is to be used. 
Uporabiti je treba najnižji učinkoviti odmerek rosuvastatina.
The most common adverse reactions were fatigue (1.9%) and headache (1.5%). 
Najpogostejša neželena učinka sta bila utrujenost (1,9 %) in glavobol (1,5 %).
The safety and efficacy of rolapitant in children and adolescents below 18 years of age has not yet been established. 
Pediatrična populacija Varnost in učinkovitost rolapitanta pri otrocih in mladostnikih, mlajših od 18 let, še ni bila dokazana.
NK1 Receptor Occupancy 
Zasedenost receptorja NK1
Varuby may affect how some other medicines work. 
Zdravilo Varuby lahko vpliva na delovanje nekaterih drugih zdravil.
Wallet card, each containing 2 film-coated tablets - WITH BLUE BOX 
Zgibanka, ki vsaka vsebuje 2 filmsko obloženi tableti - Z BLUE BOX
Therefore, the potential interactions associated with the inhibition of these UGT enzymes in the intestine cannot be excluded. 
Zato ni mogoče izključiti morebitnih interakcij, povezanih z zaviranjem teh encimov UGT v črevesju.
The relevance of convulsions for humans is unknown. 
Pomembnost teh krčev za ljudi ni znana.
Complete Response 
Popoln odziv
The tablets should be swallowed whole, with some water and may be taken with or without food. 
Tablete je treba pogoltniti cele z nekaj vode, jemljejo se lahko s hrano ali brez nje.
Of these 1332 patients, 629 received non-AC chemotherapy. 
Od teh 1.332 bolnikov jih je 629 prejelo kemoterapijo brez AC.
Rolapitant doses up to 720 mg have been used in clinical studies without any safety concerns. 
Odmerki rolapitanta do 720 mg so bili uporabljeni v kliničnih študijah brez varnostnih zadržkov.
The absolute bioavailability of rolapitant is approximately 100%, indicating minimal first pass effect. 
Absolutna biološka uporabnost rolapitanta je približno 100 %, kar kaže na minimalen učinek prvega prehoda.
In case of overdose, the medicinal product should be discontinued and general supportive treatment and monitoring should be provided. 
primeru prevelikega odmerjanja je treba prenehati z uporabo zdravila ter uvesti splošno podporno zdravljenje in spremljanje.
Do not take this medicine in the days after you have chemotherapy - unless you are about to have another chemotherapy cycle. 
Ne jemljite tega zdravila v dneh po kemoterapiji - razen če je pred vami nov ciklus kemoterapije.
Recent guidance has updated these regimens to highly emetogenic. 
Po nedavno posodobljeni smernici ti režimi veljajo za zelo emetogene.
to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known: frequency cannot be estimated from the available data. 
do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana: ni mogoče oceniti iz razpoložljivih podatkov.
Individual results from Studies 1 and 2 as well as a summary of the key results from the combined analysis are shown in Table 1 below. 
Posamezni rezultati študije 1 in 2 in povzetek ključnih rezultatov kombinirane analize so prikazani v preglednici 1 spodaj.
If you do not want to take this medicine, discuss this with your doctor. 
Če ne želite jemati tega zdravila, se o tem pogovorite z zdravnikom.
What you need to know before you take Varuby Do not take Varuby: 
Kaj morate vedeti, preden boste vzeli zdravilo Varuby Ne jemljite zdravila Varuby:
Varuby should be used with caution in these patients. 
Zdravilo Varuby je pri teh bolnikih treba uporabljati previdno.
If you think you may have taken more than you should, tell your doctor straight away. 
Če mislite, da ste vzeli več, kot bi smeli, takoj obvestite zdravnika.
Excipient(s) with known effect 
Pomožna(e) snov(i) z znanim učinkom
Varuby should not be used during pregnancy unless clearly necessary. 
Zdravila Varuby se med nosečnostjo ne sme uporabljati, če to ni nujno potrebno.
- The recommended dose is 180 mg (two 90 mg tablets). 
• Priporočeni odmerek je 180 mg (dve 90 mg tableti).
No dose adjustment is necessary for the elderly. 
Prilagoditev odmerka pri starejših ni potrebna.
Swallow the tablets whole, with some water. 
Tableti pogoltnite celi z nekaj vode.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
Rolapitant was highly protein bound to human plasma (99.8%). 
Rolapitant se je v veliki meri vezal na beljakovine v človeški plazmi (99,8 %).
8 mg orally twice daily 
8 mg peroralno dvakrat dnevno
What Varuby is and what it is used for What you need to know before you take Varuby How to take Varuby 
Kaj je zdravilo Varuby in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Varuby Kako jemati zdravilo Varuby
At Day 6 to 8 following initiation of chemotherapy, patients were asked to recall whether they had any episode of vomiting or retching or nausea that interfered with normal daily life. 
Od 6. do 8. dne po začetku kemoterapije so bolnike vprašali, ali so doživeli epizodo bruhanja, spahovanja ali navzee, ki je ovirala normalno vsakdanje življenje.
Over 4,375 patients have been treated with Varuby or a comparator across Phase 1, 2, and 3 clinical studies. 
Več kot 4.375 bolnikov je bilo zdravljenih z zdravilom Varuby ali primerjalnim zdravilom v kliničnih študijah 1., 2. in 3. faze .
Antiemetic activity of rolapitant was maintained throughout repeat cycles for those patients continuing in each of the multiple cycles. 
Antiemetično delovanje rolapitanta se je vzdrževalo skozi ponovljene cikluse pri tistih bolnikih, ki so nadaljevali v vseh ciklusih.
Increased plasma concentration of CYP2D6 substrates may result in potential adverse reactions. 
Povečana plazemska koncentracija substratov CYP2D6 lahko privede do morebitnih neželenih učinkov.
It is not known whether Varuby is present in milk; therefore, breast-feeding is not recommended during treatment with this medicine. 
Ni znano, ali je zdravilo Varuby prisotno v materinem mleku, zato dojenje med zdravljenjem s tem zdravilom ni priporočeno.
A total of 1332 patients were included in the evaluation of efficacy, 80% were women and 20% were men. 
Skupno 1.332 bolnikov je bilo vključenih v ocenjevanje učinkovitosti; 80 % je bilo žensk in 20 % moških.
Rolapitant is slowly eliminated with a mean terminal half-life of approximately 7 days. 
Rolapitant se izloča počasi s povprečnim končnim razpolovnim časom približno 7 dni.
Population pharmacokinetic analyses indicated that age, sex and race had no significant impact on the pharmacokinetics of Varuby. 
Analize populacijske farmakokinetike so pokazale, da starost, spol in rasa nimajo pomembnega vpliva na farmakokinetiko zdravila Varuby.
Frequencies are defined as: Very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000
They may be caused by an abnormal muscle breakdown (a condition called rhabdomyolysis). 
Vzrok je lahko nenormalen razkroj mišic (tako imenovana rabdomioliza).
If the combination cannot be avoided, clinical and biological monitoring for adverse reactions related to the concomitant medicinal product must be made. 
Če se kombinaciji ni mogoče izogniti, je treba klinično in biološko spremljati neželene učinke, povezane s sočasno uporabljenim zdravilom.
Because of the antiemetic activity of rolapitant, emesis induced by a medicinal product may not be effective. 
Zaradi antiemetičnega delovanja rolapitanta je lahko z zdravilom povzročena emeza neučinkovita.
If use cannot be avoided, patients should be monitored for adverse reactions to Varuby (see section 4.8). 
Če se uporabi ni mogoče izogniti, je treba bolnike spremljati glede neželenih učinkov zdravila Varuby (glejte poglavje 4.8).
OATP1B1 and 1B3 substrates 
Substrati OATP1B1 in 1B3
Multiple-Cycle Extension: In each study, patients had the option of continuing into a multiple-cycle extension for up to 5 additional cycles of chemotherapy receiving the same treatment as assigned in cycle 1. 
Podaljšek z več ciklusi: V vsaki študiji so bolniki imeli možnost nadaljevati s sodelovanjem v podaljšku z več ciklusi, to je do 5 dodatnih ciklusov kemoterapije ob enakem režimu zdravljenja kot jim je bil dodeljen v ciklusu 1.
If you have forgotten to take your dose, tell your doctor straight away. 
Če ste pozabili vzeti svoj odmerek, takoj obvestite zdravnika.
The percentage of patients who received carboplatin in Cycle 1 was 30%. 
Odstotek bolnikov, ki so prejeli karboplatin v 1. ciklusu, je bil
A summary of the study results from the MEC Study (Study 3) is shown in Table 2 below. 
Povzetek rezultatov študije MEC (študija 3) je prikazan v preglednici 2 spodaj.
You may feel dizzy or tired after taking this medicine. 
Morda boste po jemanju tega zdravila omotični ali utrujeni.
The apparent volume of distribution (Vd/F) was 460 L in healthy subjects, indicating an extensive tissue distribution of rolapitant. 
Navidezni volumen porazdelitve (Vd/F) je bil 460 l pri zdravih osebah, kar kaže na obsežno porazdelitev rolapitanta v tkivu.
Pharmacotherapeutic group: Antiemetics and antinauseants, other antiemetics, ATC code: A04AD14 
Farmakoterapevtska skupina: antiemetiki in zdravila proti slabosti, drugi antiemetiki, oznaka ATC: A04AD14
Based on the environmental risk assessment, rolapitant is considered as very persistent, bioaccumulative and not readily biodegradable. 
Na osnovi ocene tveganja za okolje velja, da je rolapitant zelo obstojen, bioakumulativen in težko biološko razgradljiv.
Studies in animals have shown no teratogenic or embryo-foetal effects. 
Študije na živalih niso pokazale teratogenih učinkov ali učinkov za zarodek ali plod.
The formation of M19 was significantly delayed with the median Tmax of 120 hours (range: 24-168 hours) and the mean half-life of M19 was 158 hours. 
Tvorba M19 je bila pomembno zakasnjena z medianim tmax 120 ur (razpon: 24-168 ur) in srednji razpolovni čas M19 je bil 158 ur.
Rolapitant did not affect the fertility or general reproductive performance of male rats. 
Rolapitant ni vplival na plodnost ali splošno sposobnost za razmnoževanje podganjih samcev.
There is no information on the effects of this medicine if taken during pregnancy. 
Podatkov o učinkih tega zdravila pri jemanju med nosečnostjo ni.
- You can take Varuby with or without food. 
• Zdravilo Varuby se lahko jemlje s hrano ali brez nje.
N.S. a Primary endpoint was complete response in the delayed phase. 
N. Z. a Primarni končni cilj je bil popoln odziv v zapozneli fazi.
Study 1 and 2 Combined 
Študija 1 in študija 2 združeno
Concomitant administration of rifampicin, a strong enzyme inducer significantly decreased the systemic exposure to rolapitant and to its active metabolite. 
Sočasna uporaba rifampicina, močnega induktorja encimov, je znatno zmanjšala sistemsko izpostavljenost rolapitantu in njegovemu aktivnemu presnovku.
2 film-coated tablets 
2 filmsko obloženi tableti
A summary of the results from the non-AC and AC subsets are provided in Table 3. 
Povzetek rezultatov podskupin z AC in brez AC je prikazan v preglednici 3.
A human Positron Emission Tomography (PET) study with rolapitant demonstrated that rolapitant crosses the blood brain barrier and occupies brain NK1 receptors. 
Študija s pozitronsko emisijsko tomografijo (PET) z rolapitantom pri ljudeh je pokazala, da rolapitant prehaja skozi krvno-možgansko pregrado in zaseda receptorje NK1 v možganih.
The mechanism of the significant difference of half-lives observed between the rat and monkey (6-8 h) and human (7 days) is not elucidated. 
Mehanizem pomembne razlike v razpolovnih časih med podgano in opico (6-8 ur) ter človekom (7
There is no medicinal product interaction between rolapitant and dexamethasone, so no dosage adjustment for dexamethasone is required. 
Med rolapitantom in deksametazonom ni medsebojnega delovanja, zato ni potrebna prilagoditev odmerka deksametazona.
The proportion of patients with no impact on daily life was higher in the Varuby group than in the control group (MEC: 73.2% vs. 67.4%; p=0.027). 
Delež bolnikov brez vpliva na vsakdanje življenje je bil v skupini z zdravilom Varuby večji kot v kontrolni skupini (MEC: 73,2 % v primerjavi s 67,4 %;
A total of 1369 patients were randomised to either the rolapitant regimen (N=684) or control therapy (N=685). 
Skupno 1.369 bolnikov so naključno razporedili v režim z rolapitantom (N = 684) ali v kontrolno terapijo (N = 685).
Rare: may affect up to 1 in 1,000 people 
Redki: pojavijo se lahko pri največ 1 od 1.000 ljudi:
- Take the tablets within 2 hours before you start your chemotherapy cycle. 
• Tableti vzemite v času 2 ur pred začetkom ciklusa kemoterapije.
Effects on offspring at this dose included decreased postnatal survival, and decreased body weights and body weight gain, and may be related to the maternal toxicity observed. 
Vplivi na potomstvo pri tem odmerku bili med drugim zmanjšana stopnja postnatalnega preživetja in zmanjšana telesna masa ter zmanjšan prirast telesne mase, kar je lahko povezano z opaženimi škodljivimi vplivi na mater.
The exposure ratio of M19 to rolapitant was approximately 50% in plasma. 
Razmerje izpostavljenosti M19 v primerjavi z rolapitantom v plazmi je bilo približno 50 %.
Of the 1070 patients, 26% were greater than 65 years of age and 3% were greater than 75 years of age. 
Od 1.070 bolnikov je bilo 26 % starih več kot 65 let in 3 % starih več kot 75 let.
Of these 1332 patients, 28% were greater than 65 years of age and 6% were greater than 75 years of age. 
Med temi 1.332 bolniki je bilo 28 % starih več kot 65 let in 6 % starih več kot 75 let.
Each dose (two tablets) contains 230 mg of lactose. 
Odmerek (dve tableti) vsebuje 230 mg laktoze.
If you stop taking Varuby 
Če ste prenehali jemati zdravilo Varuby
Single dose = 2 tablets 
enkratni odmerek =2 tableti
The safety profile in the multiple-cycle extensions of highly and moderately emetogenic chemotherapy studies for up to 6 cycles of chemotherapy is similar to the profile observed in Cycle 1. 
Varnostni profil pri podaljških študij z več ciklusi zelo in zmerno emetogene kemoterapije na do 6 ciklusov kemoterapije je bil podoben profilu, opaženem v 1. ciklusu.
There are no available data on rolapitant use in pregnant women. 
Podatkov o uporabi rolapitanta pri nosečnicah ni na voljo.
Varuby is given as part of a regimen that includes dexamethasone and a 5-HT3 receptor antagonist. 
Zdravilo Varuby se daje kot del režima, ki vključuje deksametazon in antagonist receptorja 5-HT3.
180 mg (two tablets) should be administered within 2 hours prior to initiation of each chemotherapy cycle but at no less than 2-week intervals. 
180 mg (dve tableti) je treba vzeti 2 uri pred začetkom vsakega ciklusa kemoterapije, vendar vsaj z 2
This medicinal product contains 230 mg of lactose (as monohydrate) per dose (two tablets). 
To zdravilo vsebuje 230 mg laktoze (v obliki monohidrata) na odmerek (dve tableti).
Limited data in patients aged 75 years and older are available. 
Na voljo so omejeni podatki za bolnike, stare 75 let in starejše.
There are no data on the presence of rolapitant in human milk. 
Ni podatkov o prisotnosti rolapitanta v materinem mleku.
Standard dose of 5-HT3 receptor antagonist. 
Standardni odmerek antagonista receptorja 5-HT3.
The European Medicines Agency has deferred the obligation to submit the results of studies with rolapitant in all subsets of the paediatric population in prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cisplatin-based cancer therapy and moderately emetogenic cancer therapy (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z rolapitantom za vse podskupine pediatrične populacije pri preprečevanju akutne in zapoznele navzee in bruhanja, povezanih z začetnimi in ponovnimi ciklusi visoko emetogenega zdravljenja raka na osnovi cisplatina in zmerno emetogenega zdravljenja raka (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Unchanged rolapitant or M19 were not found in pooled urine sample. 
Nespremenjenega rolapitanta ali M19 v zbirnem vzorcu urina niso odkrili.