FrancophonIA/ELRC3.0 huggingface dataset:
English: Common adverse reactions reported with netupitant/palonosetron capsules were headache (3.6%), constipation (3.0%) and fatigue (1.2%).
Slovenian: Pogosti neželeni učinki, o katerih so poročali pri kapsulah netupitanta in palonosetrona, so bili glavobol (3,6 %), zaprtje (3,0 %) in utrujenost (1,2 %).
English: Based on the experience with healthy subjects exposed to oral netupitant 600 mg in combination with palonosetron 1.50 mg the potential acute symptoms of overdose are headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.
Slovenian: Na podlagi izkušenj z zdravimi osebami, ki so bile izpostavljene peroralnemu netupitantu 600 mg v kombinaciji s palonosetronom 1,50 mg, so možni akutni simptomi prevelikega odmerjanja glavobol, omotica, zaprtje, anksioznost, palpitacije, evforično razpoloženje in bolečine v nogah.
English: • ECG (electrocardiogram) problems (called ‘QT and PR interval prolongation', ‘conduction disorder', ‘tachycardia' and ‘atrioventricular block first degree')
Slovenian: • težave v EKG (elektrokardiogramu) (ki jim pravimo 'podaljšanje intervala QT in PR', 'motnja prevajanja', 'tahikardija' in 'atrioventrikularni blok prve stopnje');
English: • spinning sensation (vertigo), feeling dizzy or trouble sleeping (insomnia)
Slovenian: • občutek vrtenja (vrtoglavica), občutek omotičnosti ali težave s spanjem (nespečnost);
English: The third major metabolite, M2, is > 97% bound to plasma proteins.
Slovenian: Tretji glavni presnovek M2 se več kot 97 % veže na beljakovine v plazmi.
English: Chemotherapy medicines can cause the body to release substances called serotonin and substance P. This stimulates the vomiting centre in the brain, making you feel or be sick.
Slovenian: Zdravila za kemoterapijo lahko povzročijo, da telo izloča snovi, ki jima pravimo serotonin in snov P. To spodbuja center v možganih, ki je odgovoren za bruhanje, zaradi česar vam je lahko slabo ali bruhate.
English: The AUC0-24 (Day 1), the AUC24-36 (Day 2) and the AUC84-108 and AUC84-∞ (Day 4) of dexamethasone increased 2.4-fold, with co-administration of 300 mg netupitant.
Slovenian: AUC0-24 (1. dan), AUC24-36 (2. dan) ter AUC84-108 in AUC84-∞ (4. dan) deksametazona povečale za 2,4-krat.
English: Approximately half the radioactivity administered orally as [14C]-netupitant was recovered from urine and faeces within 120 h of dosing.
Slovenian: Približno polovico radioaktivnosti, peroralno dane v obliki [14C]-netupitanta, so odkrili v urinu in blatu v 120 urah od odmerjanja.
English: • ECG (electrocardiogram) problems (called ‘ST segment depression', ‘ST-T segment abnormal'
Slovenian: • težave v EKG (imenujejo se 'depresija segmenta ST', 'nenormalen segment ST-T',
English: Therefore, patients should be monitored for increased toxicity of chemotherapeutic agents that are substrates for CYP3A4, including irinotecan.
Slovenian: Zaradi tega je treba bolnike spremljati glede povečane toksičnosti kemoterapevtskih zdravil, ki so substrati za CYP3A4, vključno z irinotekanom.
English: While the terminal elimination half-life and mean systemic exposure of palonosetron is increased in the subjects with severe hepatic impairment, this does not warrant dose reduction.
Slovenian: Čeprav sta končni razpolovni čas izločanja in povprečna sistemska izpostavljenost palonosetronu pri bolnikih s hudo okvaro jeter povečana, zaradi tega ni potrebna prilagoditev odmerka.
English: After a single oral 300 mg dose administration in cancer patients, netupitant disposition was characterised by a two compartment model with an estimated median systemic clearance of 20.5 L/h and a large distribution volume in the central compartment (486 L).
Slovenian: Po dajanju enkratnega peroralnega odmerka 300 mg pri bolnikih z rakom je bil za porazdelitev netupitanta značilen dvorazdelčni model z ocenjenim medianim sistemskim očistkom 20,5 l/uro in velikim volumnom porazdelitve v centralnem razdelku (486 l).
English: Table 3: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase
Slovenian: Preglednica 3: Delež odziva bolnikov, ki so prejemali kemoterapijo s cisplatinom, po skupinah zdravljenja in fazah
English: In vitro data shows that netupitant inhibits UGT2B7, the magnitude of such an effect in the clinical setting is not established.
Slovenian: Podatki in vitro kažejo, da netupitant zavira UGT2B7, velikost tega učinka v kliničnih okoliščinah pa ni bila ugotovljena.
English: Upper 95% confidence limit of the point estimates of placebo and baseline corrected QTcI was constantly within 10 ms at all time points over 2 days after study substance administration.
Slovenian: Zgornja meja 95-% intervala zaupanja točkovnih ocen QTcI, korigiranih s placebom in izhodiščno vrednostjo, je bila stalno znotraj 10 ms v vseh časovnih točkah v 2 dneh po dajanju preučevane snovi.
English: The hard capsules are opaque with a white body and a caramel cap with ‘HE1' printed on the body.
Slovenian: Trde kapsule so neprozorne z belim telesom in pokrovčkom karamelne barve ter oznako »HE1«, odtisnjeno na telesu.
English: Opaque gelatin capsule of size “0” (length 21.7 mm) with white body and caramel cap with “HE1” printed on the body.
Slovenian: Neprozorna želatinasta kapsula velikosti »0« (dolžina 21,7 mm) z belim telesom in pokrovčkom karamelne barve ter oznako »HE1«, odtisnjeno na telesu.
English: Titanium dioxide (E171)
Slovenian: 1,4 sorbitan titanov dioksid (E171)
English: Breast-feeding should be discontinued during treatment with this medicinal product and for 1 month after the last dose.
Slovenian: Med zdravljenjem s tem zdravilom in do 1 mesec po zadnjem odmerku je treba prenehati z dojenjem.
English: Effects in non-clinical studies based on safety pharmacology and single and repeated dose toxicity were observed only at exposures considered in excess of the maximum human exposure, indicating little relevance to clinical use.
Slovenian: V predkliničnih študijah na osnovi farmakologije varnosti ter toksičnosti enkratnih in ponavljajočih se odmerkov so učinke opazili samo pri izpostavljenosti, ki je presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
English: A total of 1450 patients (Akynzeo n=725; Palonosetron n=725) received study medication.
Slovenian: Preučevano zdravilo je prejelo skupno 1450 bolnikov (Akynzeo n = 725; palonosetron n = 725).
English: Following administration of a single oral 0.75 mg dose of [14C]-palonosetron to six healthy subjects, 85% to 93% of the total radioactivity was excreted in urine, and 5% to 8% was eliminated in faeces.
Slovenian: Po dajanju enkratnega peroralnega 0,75 mg odmerka [14C]-palonosetrona šestim zdravim osebam se je 85 % do 93 % celotne radioaktivnost izločilo v urin in 5 % do 8 % v blato.
English: The pharmacokinetic profile of netupitant was unchanged when administered in combination with dexamethasone.
Slovenian: Farmakokinetični profil netupitanta je bil ob dajanju v kombinaciji z deksametazonom nespremenjen.
English: Reproductive studies in animals with netupitant do not indicate direct or indirect harmful effects with respect to fertility, parturition or postnatal development.
Slovenian: Študije razmnoževanja z netupitantom na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost, kotitev ali postnatalni razvoj.
English: • conjunctivitis (a type of eye inflammation)
Slovenian: • konjuktivitis (vrsta vnetja očesa),
English: Acute psychosis Mood altered Sleep disorder
Slovenian: Psihiatrične motnje nespečnost akutna psihoza sprememba razpoloženja motnja spanja
English: Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction (see section 4.8).
Slovenian: Zaradi tega je treba bolnike z znano preobčutljivostjo na arašide ali sojo skrbno spremljati glede znakov alergijske reakcije (glejte poglavje 4.8).
English: Treatment regimens for the Akynzeo and the palonosetron 0.5 mg arms are displayed in Table below.
Slovenian: Režimi zdravljenja za kraka z zdravilom Akynzeo in palonosetronom 0,5 mg so prikazani v spodnji preglednici.
English: Delayed emesis has been associated with the activation of tachykinin family neurokinin 1 (NK1) receptors (broadly distributed in the central and peripheral nervous systems) by substance P. As shown in in vitro and in vivo studies, netupitant inhibits substance P mediated responses.
Slovenian: Zakasnjeno bruhanje povezujemo z aktivacijo receptorjev za nevrokinin 1 (NK1) iz družine tahikininov (ki so obsežno porazdeljeni po osrednjem in perifernem živčevju) s strani snovi P. Kot so dokazali v študijah in vitro in in vivo, netupitant zavira odzive, ki jih posreduje snov P.
English: This medicine contains less than 1 mmol sodium per (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na trdo kapsulo, kar v bistvu pomeni 'brez natrija'.
English: Very rare: may affect up to 1 in 10,000 people
Slovenian: Zelo redki: lahko se pojavijo pri največ 1 od 10.000 bolnikov
English: Table 5: Proportion of patients receiving anthracycline and cyclophosphamide chemotherapy responding by treatment group and phase - cycle 1
Slovenian: Preglednica 5: Delež odziva bolnikov, ki so prejemali kemoterapijo z antraciklinom in ciklofosfamidom, po skupinah zdravljenja in fazah - 1. cikel
English: • infection and inflammation in the bladder (cystitis)
Slovenian: • okužba in vnetje sečnega mehurja (cistitis),
English: What Akynzeo is and what it is used for What you need to know before you take Akynzeo How to take Akynzeo
Slovenian: Kaj je zdravilo Akynzeo in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Akynzeo Kako jemati zdravilo Akynzeo Možni neželeni učinki
English: • coating of the tongue, difficulty swallowing, dry mouth, belching, abnormal taste after medicine intake
Slovenian: • obložen jezik, težave s požiranjem, suha usta, kolcanje, nenormalen okus po jemanju zdravila;
English: • you have any other heart problems • you have been told you have an imbalance of minerals in your blood such as potassium and magnesium that has not been corrected.
Slovenian: • če so vam povedali, da imate neravnovesje mineralov (na primer kalija ali magnezija) v krvi, ki še ni urejeno.
English: In a separate study, a total of 413 patients undergoing initial and repeat cycles of chemotherapy (including carboplatin, cisplatin, oxaliplatin, and doxorubicin regimens), were randomized to receive either Akynzeo (n=309) or aprepitant and palonosetron (n=104).
Slovenian: V ločeni študiji je bilo skupno 413 bolnikov, ki so prejemali začetne ali ponovljene cikle kemoterapije (vključno z režimi s karboplatinom, cisplatinom, oksaliplatinom in doksorubicinom), randomizirano v skupino za prejemanje zdravila Akynzeo (n = 309) ali skupino za prejemanje aprepitanta in palonosetrona (n = 104).
English: The recommended oral dexamethasone dose should be reduced by approximately 50 % when coadministered with netupitant/palonosetron capsules (see section 4.5 and clinical studies administration schedule in section 5.1).
Slovenian: Priporočeni peroralni odmerek deksametazona je treba ob sočasni uporabi s kapsulami netupitanta in palonosetrona zmanjšati za približno 50 % (glejte poglavje 4.5 in načrt dajanja zdravil v kliničnih študijah v poglavju 5.1).
English: • chest pain (not related to the heart)
Slovenian: • bolečine v prsih (ki niso povezane s srcem),
English: Adverse reactions are listed below by MedDRA body system organ class and frequency.
Slovenian: Neželeni učinki so navedeni spodaj po organskih sistemih in pogostnosti po MedDRA.
English: Netupitant was shown to cross the blood brain barrier with a NK1 receptor occupancy of 92.5%, 86.5%, 85.0%, 78.0%, and 76.0% in striatum at 6, 24, 48, 72, and 96 hours, respectively, after administration of 300 mg netupitant.
Slovenian: NK1 92,5 %, 86,5 %, 85,0 %, 78,0 % oziroma 76,0 % v striatumu po 6, 24, 48, 72 oziroma 96 urah, in sicer po dajanju 300 mg netupitanta.
English: What you need to know before you take Akynzeo
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Akynzeo
English: Interaction with CYP3A4 substrates:
Slovenian: Medsebojno delovanje s substrati za CYP3A4:
English: Chemotherapeutic agents that are substrates for CYP3A4
Slovenian: Kemoterapevtska zdravila, ki so substrati za CYP3A4
English: Netupitant/palonosetron capsules should not be used during breast-feeding.
Slovenian: Kapsule netupitanta in palonosetrona se med dojenjem ne smejo uporabljati.
English: The study demonstrated no clinically important effects on ECG parameters: the largest point estimate of the placebo and baseline corrected QTc interval was 7.0 ms (one-sided upper 95% confidence limit 8.8 ms), observed 16 hours after the administration of supratherapeutic doses (600 mg netupitant and 1.5 mg palonosetron).
Slovenian: Študija ni pokazala klinično pomembnih učinkov na parametre EKG: največja točkovna ocena intervala QTc, korigirana s placebom in izhodiščno vrednostjo, je bila 7,0 ms (zgornja meja 95-% enostranskega intervala zaupanja je bila 8,8 ms), opažena 16 ur po dajanju supraterapevtskih odmerkov (600 mg netupitanta in 1,5 mg palonosetrona).
English: Netupitant No effect on fertility has been observed in animal studies.
Slovenian: Pri študijah na živalih niso opazili vpliva na plodnost.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Akynzeo in all subsets of the paediatric population in prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based and moderately emetogenic cancer chemotherapy (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Akynzeo za vse podskupine pediatrične populacije za preprečevanje akutne in zakasnjene navzee in bruhanja pri zelo emetogeni kemoterapiji na osnovi cisplatina in zmerno emetogeni kemoterapiji za zdravljenje raka (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Furthermore, netupitant may also affect the efficacy of chemotherapeutic agents that need activation by CYP3A4 metabolism.
Slovenian: Poleg tega lahko netupitant vpliva tudi na učinkovitost kemoterapevtskih zdravil, pri katerih je potrebna aktivacija prek presnove s CYP3A4.
English: Therefore, Akynzeo can be administered without dosage adjustment in patients with renal impairment.
Slovenian: Zato lahko zdravilo Akynzeo brez prilagoditve odmerka dajemo bolnikom z okvaro ledvic.
English: Highly Emetogenic Chemotherapy (HEC) study
Slovenian: Študija zelo emetogene kemoterapije (HEC)
English: The medicines in Akynzeo attach to the receptors in the nervous system through which serotonin and substance P work: netupitant (an NK1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5HT3 receptor antagonist) blocks certain receptors for serotonin.
Slovenian: Zdravili, ki ju vsebuje zdravilo Akynzeo, se pritrdita na receptorje v živčevju, prek katerih delujeta serotonin in snov P: netupitant (ki je antagonist receptorjev NK1) zavira receptorje za snov P, palonosetron (ki je antagonist receptorjev 5-HT3) pa zavira določene receptorje za serotonin.
English: This medicinal product should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range (see section 4.5).
Slovenian: To zdravilo je treba uporabljati previdno pri bolnikih, ki sočasno peroralno prejemajo učinkovine, ki se primarno presnavljajo prek CYP3A4 in imajo ozko terapevtsko območje (glejte poglavje 4.5).
English: Serotonin then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex.
Slovenian: Serotonin nato aktivira receptorje 5-HT3 na vagalnih aferentnih vlaknih in s tem sproža refleks bruhanja.
English: In a multicenter, randomized, parallel, double-blind, controlled clinical study of 694 patients, the efficacy and safety of single doses of oral netupitant in combination with oral palonosetron was compared with a single oral dose of palonosetron in cancer patients receiving a chemotherapy regimen that included cisplatin (median dose = 75 mg/m2).
Slovenian: V multicentrični, randomizirani, paralelni, dvojno slepi, aktivno nadzorovani klinični študiji s 694 bolniki so primerjali učinkovitost in varnost enkratnih odmerkov peroralnega netupitanta v kombinaciji s peroralnim palonosetronom in enkratnega peroralnega odmerka palonosetrona pri bolnikih z rakom, ki so prejemali režim kemoterapije, ki je vključeval cisplatin (mediani odmerek = 75 mg/m2).
English: • decreased blood flow to the heart muscle (myocardial ischemia)
Slovenian: • zmanjšan dotok krvi v srčno mišico (miokardna ishemija),
English: Primary endpoint Complete response Overall phase Major secondary endpoints Complete response Acute phase Delayed phase No emesis Acute phase Delayed phase Overall phase No significant nausea Acute phase Delayed phase Overall phase Acute phase: 0 to 24 hours post-cisplatin treatment.
Slovenian: Primarni kriterij Popoln odziv Celotna faza Glavni sekundarni kriteriji Popoln odziv Akutna faza Zakasnjena faza Brez bruhanja Akutna faza Zakasnjena faza Celotna faza Brez znatne navzee Akutna faza Zakasnjena faza
English: Inhibition of the efflux transported BCRP and glucuronidation isozyme UGT2B7 by netupitant and its metabolites is unlikely and, if it occurs, of scarce clinical relevance.
Slovenian: Zaviranje izločevalnega prenašalca BCRP in glukuronidacijskega izocima UGT2B7 s strani netupitanta in njegovih presnovkov ni verjetno, če pa do njega pride, ima zelo majhno klinično pomembnost.
English: Table 2: Oral Antiemetic treatment regimen -- HEC study
Slovenian: Preglednica 2: Režim peroralnega antiemetičnega zdravljenja -- študija HEC
English: In a pooled analysis, females had a higher netupitant exposure compared to males; there was a 1.31-fold increase in Cmax, a 1.02 fold increase for AUC and a 1.36 fold increase in half-life.
Slovenian: V združeni analizi je bila izpostavljenost netupitantu pri ženskah večja kot pri moških; Cmax je bila večja za 1,31-krat, AUC za 1,02-krat in razpolovni čas za 1,36-krat.
English: Do not take Akynzeo if:
Slovenian: Ne jemljite zdravila Akynzeo:
English: When this medicinal product is used concomitantly with medicinal products that induce CYP3A4 activity, netupitant plasma concentrations could be reduced and this may result in decreased efficacy.
Slovenian: Pri sočasni uporabi tega zdravila in zdravil, ki spodbujajo delovanje CYP3A4, lahko pride do znižanja plazemskih koncentracij netupitanta, kar lahko privede do zmanjšane učinkovitosti.
English: In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Slovenian: Še posebej opozorite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete katero od naslednjih zdravil:
English: What Akynzeo is and what it is used for
Slovenian: Kaj je zdravilo Akynzeo in za kaj ga uporabljamo
English: Netupitant is a moderate inhibitor of CYP3A4 and can increase the exposure of chemotherapeutic agents that are substrates for CYP3A4 e.g. docetaxel (see section 4.5).
Slovenian: Netupitant je zmeren zaviralec CYP3A4 in lahko poveča izpostavljenost kemoterapevtskim zdravilom, ki so substrati za CYP3A4, npr. docetakselu (glejte poglavje 4.5).
English: Moderately Emetogenic Chemotherapy (MEC) study
Slovenian: Študija zmerno emetogene kemoterapije (MEC)
English: No relevant changes of netupitant and palonosetron pharmacokinetics were observed.
Slovenian: Relevantnih sprememb farmakokinetike netupitanta in palonosetrona niso opazili.
English: This medicinal product can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4.
Slovenian: To zdravilo lahko zviša plazemske koncentracije sočasno uporabljenih zdravil, ki se presnavljajo prek CYP3A4.
English: Palonosetron is eliminated from the body through both renal excretion and metabolic pathways, with the latter mediated via multiple CYP enzymes.
Slovenian: Palonosetron se izloča iz telesa prek ledvičnega izločanja in presnovnih poti, ki jih posreduje več encimov CYP.
English: Primary endpoint Complete response
Slovenian: Primarni kriterij Popoln odziv
English: • feeling hot, reddening of the face or other areas of the skin (feeling flushed)
Slovenian: • občutek vročine, pordelost obraza ali drugih predelov kože (napad rdečice),
English: Exposure to erythromycin and midazolam was increased approximately 1.3 and 2.4 fold, respectively, when each was co-administered with netupitant.
Slovenian: Izpostavljenost eritromicinu in midazolamu se je ob sočasnem dajanju vsakega od njiju z netupitantom povečala za približno 1,3-krat oziroma 2,4-krat.
English: No specific studies were performed to evaluate netupitant in patients with renal impairment.
Slovenian: Specifične študije za oceno netupitanta pri bolnikih z okvaro ledvic niso bile opravljene.
English: In a multicenter, randomized, parallel, double-blind, active-controlled, superiority study, the efficacy and safety of a single oral dose of Akynzeo was compared with a single oral dose of palonosetron 0.5 mg in cancer patients scheduled to receive the first cycle of an anthracycline and cyclophosphamide regimen for the treatment of a solid malignant tumor.
Slovenian: V multicentrični, randomizirani, paralelni, dvojno slepi, aktivno nadzorovani študiji superiornosti so primerjali učinkovitost in varnost enkratnega peroralnega odmerka zdravila Akynzeo in enkratnega peroralnega odmerka 0,5 mg palonosetrona pri bolnikih z rakom in načrtovanim prejemom prvega cikla režima zdravljenja čvrstega malignega tumorja z antraciklinom in ciklofosfamidom.
English: Delayed phase: 25 to 120 hours post-cisplatin treatment.
Slovenian: Zakasnjena faza: 25 do 120 ur po zdravljenju s cisplatinom.
English: Administration of the CYP3A4 inducer rifampicin with Akynzeo alone decreased the AUC of netupitant 5.2 fold and Cmax 2.6 fold.
Slovenian: Dajanje spodbujevalca CYP3A4 rifampicina samo z zdravilom Akynzeo je zmanjšalo AUC netupitanta za 5,2-krat in Cmax za 2,6-krat.
English: Akynzeo 300 mg/0.5 mg hard capsules netupitant/palonosetron
Slovenian: Akynzeo 300 mg/0,5 mg trde kapsule netupitant/palonosetron
English: Neither netupitant nor palonosetron have been evaluated in patients with end-stage renal disease.
Slovenian: Niti netupitant niti palonosetron nista bila ocenjena pri bolnikih s končnim stadijem okvare ledvic.
English: At the time of the study, anthracyclinecyclophosphamide containing chemotherapy regimens were considered to be moderately emetogenic.
Slovenian: V času študije so režimi kemoterapije z antraciklinom in ciklofosfamidom veljali za zmerno emetogene.
English: • The recommended dose is one capsule (each capsule contains 300 mg of netupitant and 0.5 mg of palonosetron).
Slovenian: • Priporočeni odmerek je ena kapsula (ena kapsula vsebuje 300 mg netupitanta in 0,5 mg palonosetrona).
English: • some chemotherapy medicines - such as docetaxel or etoposide
Slovenian: • nekatera zdravila za kemoterapijo, kot sta docetaksel ali etopozid;
English: • dexamethasone - can be used to treat feeling and being sick
Slovenian: • deksametazon, ki se lahko uporablja za zdravljenje občutka slabosti in bruhanja;
English: Table 4: Oral Antiemetic treatment regimen - MEC study
Slovenian: Preglednica 4: Režim peroralnega antiemetičnega zdravljenja - študija MEC
English: Delayed phase Overall phase No significant nausea Acute phase
Slovenian: Akutna faza Celotna faza Brez bruhanja Akutna faza Zakasnjena faza Celotna faza
English: Consequently, concomitant administration with strong CYP3A4 inhibitors (e.g., ketoconazole) should be approached with caution and concomitant administration with strong CYP3A4 inducers (e.g. rifampicin) should be avoided.
Slovenian: Zato je pri sočasnem dajanju z močnimi zaviralci CYP3A4 (npr. ketokonazol) potrebna previdnost, sočasnemu dajanju z močnimi spodbujevalci CYP3A4 (npr. rifampicin) pa se je treba izogibati.