natgillin/translations-raw huggingface dataset:
The Committee for Medicinal Products for Human Use (CHMP) decided that Emend’ s benefits are greater than its risks for the prevention of PONV in adults, and of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Emend večje od z njim povezanih tveganj pri preprečevanju pooperacijske navzeje in bruhanja pri odraslih ter akutne in zapoznele navzeje in bruhanja, povezanih z močno emetogeno kemoterapijo proti raku, pri kateri se uporablja cisplatin, in zmerno emetogene kemoterapije proti raku pri odraslih.
The Committee recommended that Emend be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Emend odobri dovoljenje za promet.
Other information about Emend:
Druge informacije o zdravilu Emend:
The European Commission granted a marketing authorisation valid throughout the European Union for Emend to Merck Sharp & Dohme Ltd on 11 November 2003.
Evropska komisija je dovoljenje za promet z zdravilom Emend, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd dne 11. novembra 2003.
The marketing authorisation was renewed on 11 November 2008.
Dovoljenje za promet je bilo obnovljeno dne 11. novembra 2008.
2/ 3 This summary was last updated in 11-2008.
2/ 3 Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Emend je na voljo tukaj.
EU Number EU/ 1/ 03/ 262/ 001 EU/ 1/ 03/ 262/ 002 EU/ 1/ 03/ 262/ 003 EU/ 1/ 03/ 262/ 004 EU/ 1/ 03/ 262/ 005 EU/ 1/ 03/ 262/ 006 EU/ 1/ 03/ 262/ 007 EU/ 1/ 03/ 262/ 008
EU/ 1/ 03/ 262/ 001 EU/ 1/ 03/ 262/ 002 EU/ 1/ 03/ 262/ 003 EU/ 1/ 03/ 262/ 004 EU/ 1/ 03/ 262/ 005 EU/ 1/ 03/ 262/ 006
Invented name Emend Emend Emend Emend Emend Emend Emend Emend
EMEND EMEND EMEND EMEND EMEND EMEND
Strength 80 mg 80 mg 80 mg 125 mg 125 mg 125 mg + 80 mg 40 mg 40 mg
80 mg 80 mg 80 mg 125 mg 125 mg 125 mg + 80 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, trda Kapsula, trda Kapsula, trda Kapsula, trda Kapsula, trda Kapsula, trda
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
Packaging blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu)
aluminijev pretisni omot aluminijev pretisni omot aluminijev pretisni omot aluminijev pretisni omot aluminijev pretisni omot aluminijev pretisni omot
Package size 1 capsule 2 capsules 5 x 1 capsule 1 capsule 5 x 1 capsule 1 capsule (125 mg) + 2 capsules (80 mg) 1 capsule 5 x 1 capsule
1 kapsula 2 kapsuli 5 x 1 kapsula 1 kapsula 5 x 1 kapsula 1 kapsula (125 mg) + 2 kapsuli (80 mg)
Each capsule contains 40 mg of aprepitant.
Ena 40 mg kapsula vsebuje 40 mg aprepitanta.
40 mg sucrose.
40 mg saharoze.
Capsules are opaque with a white body and mustard yellow cap with “ 464” and “ 40 mg” printed radially in black ink on the body.
40 mg kapsule so neprozorne; telo je bele barve, pokrovček gorčično rumene barve; na sredini imajo oznaki "464" in "40 mg" v črni barvi.
EMEND 40 mg is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.
Zdravilo EMEND 40 mg je indicirano za preprečevanje pooperacijske navzee in bruhanja (PONB – postoperative nausea and vomiting) pri odraslih.
Posology Clinical treatment guidelines should be considered as regards the need for prophylactic treatment against postoperative nausea and vomiting (PONV).
Odmerjanje Pri presojanju o potrebi po profilaktičnem zdravljenju pooperacijske navzee in bruhanja (PONB) je treba upoštevati smernice kliničnega zdravljenja.
The recommended oral dosage of EMEND is a single 40 mg dose within 3 hours prior to induction of anesthesia.
Priporočeni peroralni odmerek zdravila EMEND je enkratni 40 mg odmerek, ki ga bolnik prejme do 3 ure pred uvodom v anestezijo.
Elderly (≥ 65 years) No dose adjustment is necessary for the elderly (see section 5.2).
Starostniki (≥ 65 let) Pri starostnikih odmerka ni treba prilagajati (glejte poglavje 5. 2).
Gender No dosage adjustment is necessary based on gender (see section 5.2).
Spol Odmerka ni treba prilagajati glede na spol bolnika (glejte poglavje 5. 2).
Renal impairment No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).
Okvara ledvic Pri bolnikih z okvaro ledvic in pri bolnikih s končno ledvično odpovedjo, ki se zdravijo s hemodializo, odmerka ni treba prilagoditi (glejte poglavje 5. 2).
Hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment.
Okvara jeter Pri bolnikih z blago okvaro jeter odmerka ni treba prilagajati.
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Pri bolnikih z zmerno okvaro jeter so podatki omejeni, pri bolnikih s hudo okvaro jeter pa podatki niso na voljo (glejte poglavji 4. 4 in 5. 2).
Children and adolescents EMEND is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Otroci in mladostniki Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba pri otrocih pod 18 let ni priporočlijiva.
2 Method of administration The hard capsule should be swallowed whole.
2 Način uporabe Trdo kapsulo je treba pogoltniti celo.
EMEND may be taken with or without food.
Zdravilo EMEND se lahko jemlje skupaj s hrano ali brez nje.
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Podatkov o uporabi pri bolnikih s hudo okvaro jeter ni na voljo.
EMEND should be used with caution in these patients (see section 5.2).
Pri teh bolnikih je treba zdravilo EMEND uporabljati previdno (glejte poglavje 5. 2).
EMEND (40 mg) should be used with caution in patients receiving concomitant administration of pimozide, terfenadine, astemizole, cisapride or ergot alkaloid derivatives.
Zdravilo EMEND (40 mg) je treba previdno uporabljati pri bolnikih, ki sočasno jemljejo pimozid, terfenadin, astemizol, cisaprid ali derivate alkaloidov rženega rožička (ergot alkaloide).
Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by aprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious adverse reactions (see section 4.5).
Aprepitant zavira delovanje izoencima 3A4 citokroma P450 (CYP3A4), zaradi česar bi se lahko zvišale plazemske koncentracije teh zdravilnih učinkovin, kar bi lahko povzročilo resne neželene reakcije (glejte poglavje 4. 5).
Concomitant administration of EMEND with active substances that strongly induce CYP3A4 activity (e. g. rifampicin, phenytoin, carbamazepine, phenobarbital) should be avoided as the combination results in reductions of the plasma concentrations of aprepitant (see section 4.5).
Sočasnemu jemanju zdravila EMEND in zdravilnih učinkovin, ki močno inducirajo aktivnost CYP3A4 (npr. rifampicin, fenitoin, karbamazepin, fenobarbital), se je treba izogibati, ker kombinacija povzroči zmanjšanje plazemskih koncentracij aprepitanta (glejte poglavje 4. 5).
John’ s Wort (Hypericum perforatum) is not recommended.
Sočasna uporaba zdravila EMEND in zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum) ni priporočljiva.
Concomitant administration of EMEND with active substances that inhibit CYP3A4 activity (e. g. ritonavir, ketoconazole, clarithromycin, telithromycin) should be approached cautiously, as the combination results in increased plasma concentrations of aprepitant (see section 4.5).
Potrebna je previdnost pri sočasni uporabi zdravila EMEND in zdravilnih učinkovin, ki zavirajo aktivnost CYP3A4 (npr. ritonavir, ketokonazol, klaritromicin, telitromicin), ker kombinacija povzroči zvišanje plazemskih koncentracij aprepitanta (glejte poglavje 4. 5).
EMEND contains sucrose.
Zdravilo EMEND vsebuje saharozo.
Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Bolniki z redkimi dednimi motnjami – fruktozno intoleranco, malabsorpcijo glukoze in galaktoze ali insuficienco saharaze- izomaltaze – ne smejo jemati tega zdravila.
For further information on interaction potential of aprepitant at higher and multiple doses, please refer to the Summary of Product Characteristics for EMEND 80 mg hard capsules and EMEND 125 mg hard capsules.
Za dodatne informacije o interakcijah aprepitanta pri višjih ali večkratnih odmerkih glejte Povzetek glavnih značilnosti zdravila o zdravilu EMEND 80 mg trde kapsule in 125 mg trde kapsule.
Aprepitant is a substrate and a dose-dependent inhibitor of CYP3A4.
Aprepitant je substrat in od odmerka odvisen zaviralec CYP3A4.
During treatment for chemotherapy induced nausea and vomiting (CINV), the 3-day 125 mg/ 80 mg regimen of aprepitant is a moderate inhibitor of CYP3A4.
Pri 3- dnevnem zdravljenju navzee in bruhanja zaradi kemoterapije (CINV; chemotherapy induced nausea and vomiting) po režimu 125 mg/ 80 mg je aprepitant zmerni zaviralec CYP3A4.
The effects of induction by a single 40 mg dose of aprepitant have not been studied, but it is unlikely that a 40 mg single dose will cause any clinically relevant induction.
Učinkov indukcije z enkratnim 40 mg odmerkom aprepitanta niso raziskovali, vendar ni verjetno, da bi enkratni 40 mg odmerek povzročil klinično pomembno indukcijo.
After the end of treatment with the 3-day CINV regimen, aprepitant causes a transient moderate induction of CYP2C9 and a transient mild induction of CYP3A4 and glucuronidation.
Po koncu zdravljenja s tem 3- dnevnim CINV režimom zdravilo EMEND povzroči prehodno zmerno indukcijo CYP2C9 ter blago prehodno indukcijo CYP3A4 in glukuronidacijo.
Effect of CYP3A4 inhibition by aprepitant on the pharmacokinetics of other active substances As a weak inhibitor of CYP3A4, aprepitant (40 mg) can increase plasma concentrations of orally co-administered active substances that are metabolised through CYP3A4.
Učinek aprepitanta preko inhibicije CYP3A4 na farmakokinetiko drugih zdravilnih učinkovin CYP3A4 inhibicija Kot šibek zaviralec CYP3A4 lahko aprepitant (40 mg) zviša plazemske koncentracije sočasno uporabljenih peroralnih zdravilnih učinkovin, ki se presnavljajo s CYP3A4.
The area under the curve (AUC) of orally administered CYP3A4 substrates may increase up to approximately 1.5-fold after a single 40 mg dose of aprepitant; the effect of aprepitant on the plasma concentrations of intravenously administered CYP3A4 substrates is expected to be smaller.
Pričakuje se manjši vpliv aprepitanta na plazemske koncentracije intravensko uporabljenih substratov za CYP3A4.
3 EMEND 40 mg should be used with caution in patients receiving pimozide, terfenadine, astemizole, cisapride, or ergot alkaloid derivatives.
3 Zdravilo EMEND 40 mg je treba previdno uporabljati pri bolnikih, ki prejemajo pimozid, terfenadin, astemizol, cisaprid ali derivate alkaloidov rženega rožička (ergot alkaloide).
Corticosteroids:
Kortikosteroidi:
Dexamethasone:
Deksametazon:
A single 40 mg dose of aprepitant, when co-administered with a single oral dose of dexamethasone 20 mg, increased the AUC of dexamethasone by 1.45-fold.
Enkratni odmerek 40 mg aprepitanta pri sočasnem dajanju z enkratnim peroralnim odmerkom deksametazona 20 mg, poveča AUC deksametazona za 1, 45- krat.
Although the concomitant administration of methylprednisolone with the single 40 mg dose of aprepitant has not been studied, a single 40 mg dose of aprepitant produces a weak inhibition of CYP3A4 and it is not expected to alter the plasma concentrations of methylprednisolone to a clinically significant degree.
Sprememb plazemskih koncentracij metilprednizolona v klinično pomembnem obsegu ne pričakujemo.
The AUC of orally administrated midazolam increased by 1.2-fold when a single dose of 40 mg aprepitant was co-administered with a single oral dose of 2 mg midazolam; this effect was not considered clinically important.
Menimo, da ta vpliv nima kliničnega pomena.
The effect of a single 40 mg dose of aprepitant on oral contraceptives is unknown.
Učinek enkratnega 40 mg odmerka aprepitanta na peroralne kontraceptive ni znan.
With higher dose and multiple doses of aprepitant, the efficacy of hormonal contraceptives may be reduced during and for 28 days after administration.
Pri jemanju višjih ali večkratnih odmerkov aprepitanta, se lahko med jemanjem in še 28 dni po koncu jemanja zdravila EMEND zmanjša učinkovitost hormonskih kontraceptivov.
For the single 40 mg aprepitant dose, no special precautions are considered necessary.
Ob jemanju enkratnega 40 mg odmerka aprepitanta ni potrebna dodatna previdnost.
Aprepitant does not seem to interact with the P-glycoprotein transporter, as suggested by the lack of interaction of aprepitant with digoxin.
Aprepitant nima medsebojnega vpliva z digoksinom, zato verjetno ne intereagira s P- glikoproteinskim prenašalcem.
Effect of other active substances on the pharmacokinetics of aprepitant CYP3A4 inhibitors Concomitant administration of EMEND with active substances that inhibit CYP3A4 activity (e. g., ritonavir, ketoconazole, clarithromycin, telithromycin) should be approached cautiously, as the combination results in increased plasma concentrations of aprepitant.
Vplivi drugih aktivnih učinkovin na farmakokinetiko aprepitanta CYP3A4 zaviralci Pri sočasni uporabi zdravila EMEND in zdravilnih učinkovin, ki zavirajo aktivnost CYP3A4 (npr. ritonavir, ketokonazol, klaritromicin, telitromicin) je potrebna previdnost, ker se zaradi kombinacije zvišajo plazemske koncentracije aprepitanta.
CYP3A4 inducers Concomitant administration of EMEND with active substances that strongly induce CYP3A4 activity (e. g. rifampicin, phenytoin, carbamazepine, phenobarbital) should be avoided as the combination results in reductions of the plasma concentrations of aprepitant that may result in decreased efficacy.
CYP3A4 induktorji Sočasnemu dajanju zdravila EMEND in zdravilnih učinkovin, ki močno inducirajo aktivnost CYP3A4 (npr. rifampicin, fenitoin, karbamazepin, fenobarbital), se je treba izogibati, saj se pri kombiniranju zmanjšajo plazemske koncentracije aprepitanta, zaradi česar se lahko zmanjša učinkovitost.
John’ s Wort (Hypericum perforatum) is not recommended.
Sočasno uporabo zdravila EMEND in zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum) odsvetujemo.
When a single 125 mg dose of aprepitant was administered on Day 5 of a 10-day regimen of 400 mg/ day of ketoconazole, a strong CYP3A4 inhibitor, the AUC of aprepitant increased approximately 5-fold and the mean terminal half-life of aprepitant increased approximately 3-fold.
Pri enkratnem odmerku 125 mg aprepitanta 5. dan 10- dnevnega zdravljenja s ketokonazolom (ki je močan zaviralec CYP3A4) 400 mg na dan, se je AUC aprepitanta povečal za približno 5- krat, srednja terminalna razpolovna doba aprepitanta pa se je skrajšala za približno 3- krat.
When a single 375 mg dose of aprepitant was administered on Day 9 of a 14-day regimen of 600 mg/ day of rifampicin, a strong CYP3A4 inducer, the AUC of aprepitant decreased 91% and the mean terminal half-life decreased 68%.
Pri enkratnem odmerku 375 mg zdravila aprepitanta 9. dan 14- dnevnega zdravljenja z rifampicinom (ki je močan induktor CYP3A4) 600 mg na dan, se je AUC aprepitanta zmanjšal za 91%, srednja razpolovna doba aprepitanta pa se je skrajšala za 68%.
In animal studies there was no indication of direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Morebitni učinki sprememb
The potential effects on reproduction of alterations in neurokinin regulation are unknown.
4 regulacije nevrokininov na sposobnost razmnoževanja niso znani.
4 Aprepitant is excreted in the milk of lactating rats.
Aprepitant se izloča v mleku podgan.
It is not known whether aprepitant is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND.
Ni znano, ali se aprepitant izloča v mleku doječih mater, zato dojenje med zdravljenjem z zdravilom EMEND odsvetujemo.
However, when driving vehicles or operating machines, it should be taken into account that dizziness and fatigue have been reported after taking EMEND (see section 4.8).
Študij o vplivu zdravila EMEND na sposobnost vožnje in upravljanja s stroji niso izvedli, vendar pa so pri nekaterih bolnikih, ki so se zdravili z zdravilom EMEND, poročali o pojavu omotice in utrujenosti, ki lahko vpliva na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4. 8).
The safety profile of aprepitant was evaluated in approximately 4,900 individuals.
Varnost aprepitanta so ocenjevali pri približno 4. 900 preiskovancih.
Adverse reactions considered as drug-related by the investigator were reported in approximately 4% of patients treated with 40 mg aprepitant compared with approximately 6% of patients treated with 4 mg ondansetron IV.
O neželenih učinkih, ki so jih raziskovalci ocenili kot povezane z zdravilom, so poročali pri približno 4% bolnikov, ki so se zdravili z aprepitantom v odmerku 40 mg in pri približno 6% bolnikov, ki so se zdravili z ondansetronom v odmerku 4 mg intravensko.
In controlled clinical studies in patients receiving general anesthesia, 564 patients were administered 40 mg aprepitant orally and 538 patients were administered 4 mg ondansetron IV.
V nadzorovanih kliničnih študijah pri bolnikih s splošno anestezijo je 564 bolnikov prejelo aprepitant v odmerku 40 mg peroralno, 538 bolnikov pa ondansetron v odmerku 4 mg intravensko.
The most common adverse reaction reported at a greater incidence in patients treated with aprepitant (1.1%) than with ondansetron (1.0%) was ALT increased.
Povečanje vrednosti ALT (1, 1%) je bila najpogostejša neželena reakcija, katere pogostnost je bila pri bolnikih, ki so prejemali aprepitant večja (1, 1%) od pogostnosti pri bolnikih, ki so prejemali ondansetron (1, 0%).
The following adverse reactions were observed in patients treated with aprepitant and at a greater incidence than with ondansetron:
Pri bolnikih, zdravljenih z aprepitantom, so opazili naslednje neželene učinke, ki so se pojavljali pogosteje kot pri ondansetronu:
Frequencies are defined as: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000) and very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Pogostnost je opredeljena kot: 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) in zelo redki (≥1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Cardiac disorders Nervous system disorders Eye disorders Respiratory, thoracic and mediastinal disorders
Preiskave Srčne bolezni Bolezni živčevja Očesne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Bradycardia dysarthria, hypoaesthesia, sensory disturbance miosis, visual acuity reduced dyspnoea, wheezing
zvišanje vrednosti ALT bradikardija disartrija, hipestezija, čutilne motnje mioza, zmanjšanje ostrine vida dispneja, sopenje
uncommon uncommon uncommon uncommon
pogoste občasne občasne občasne občasne
abdominal pain upper, bowel sounds abnormal, dry mouth, nausea, stomach discomfort
bolečine v zgornjem predelu trebuha, nenormalni črevesni zvoki, suha usta, navzea, neugodje v želodcu
uncommon
občasne
In addition, two serious reactions were reported in clinical studies in postoperative nausea and vomiting (PONV) in patients taking a higher dose of aprepitant: one case of constipation, and one case of sub-ileus.
Dodatno so v kliničnih študijah, v katerih so bolniki zaradi preprečevanja pooperacijske navzee in bruhanja (PONV- postoperative nausea and vomiting) prejemali večji odmerek aprepitanta, poročali tudi o dveh resnih reakcijah: enem primeru obstipacije in enem primeru subileusa.
Additional adverse reactions were observed in patients treated with the aprepitant (125 mg/ 80 mg) regimen for chemotherapy induced nausea and vomiting and at a greater incidence than with standard therapy: abdominal pain, acid reflux, acne, alkaline phosphatase increased, anaemia, anorexia, anxiety, AST increased, asthaenia/ fatigue, candidiasis, chest discomfort, cognitive disorder, conjunctivitis, constipation, cough, diarrhoea, disorientation, dizziness, dream abnormality, dysgeusia, dyspepsia, dysuria, enterocolitis, epigastric discomfort, eructation, euphoria, febrile neutropenia, flatulence, flushing, gastroesophageal reflux disease, headache, hiccups, hot flush, hyperglycaemia, hyperhidrosis, hyponatraemia, lethargy, microscopic haematuria, muscle cramp, myalgia, nausea*, obstipation, oedema, oily skin, perforating duodenal ulcer, pharyngitis, photosensitivity, pollakiuria,
Pri bolnikih, ki so se zdravili z aprepitantom zaradi navzee in bruhanja zaradi kemoterapije (režim 125 mg/ 80 mg) so poročali še o drugih neželenih učinkih, katerih incidenca je bila večja kot pri standardnem zdravljenju: bolečine v trebuhu, refluks kisline, akne, zvišanje vrednosti alkalne fosfataze, anemija, anoreksija, anksioznost, zvišanje vrednosti AST, astenija/ utrujenost, kandidoza, nelagodje v prsnem košu, motnje mišljenja, konjunktivitis, obstipacija, kašelj, driska, dezorientacija, omotica, neobičajne sanje, motnje okusa, dispepsija, disurija, enterokolitis, neugodje v epigastriju,
5 polydipsia, polyuria, postnasal drip, pruritus, rash, skin lesion, sneezing, staphylococcal infection, stomatitis, thirst, throat irritation, tinnitus, vomiting*, weight decreased, weight gain. *Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as reactions only thereafter.
5 izpahovanje, evforija, febrilna nevtropenija, flatulenca, zardevanje, gastroezofagealna refluksna bolezen, glavobol, kolcanje, navali vročine, hiperglikemija, hiperhidroza, hiponatriemija, letargija, mikrohematurija, mišični krči, bolečine v mišicah, navzea *, obstipacija, edem, mastna koža, predrtje razjede dvanajstnika, faringitis, fotosenzitivnost, polakisurija, polidipsija, poliurija, zatekanje izcedka iz nosu v žrela, srbenje, izpuščaji, lezije kože, kihanje, stafilokokne okužbe, stomatitis, žeja, draženje žrela, tinitis, bruhanje * in zmanjšanje ter povečanje telesne mase.
One case of Stevens-Johnson syndrome was reported as a serious adverse event in a patient receiving aprepitant with cancer chemotherapy.
Pri enem bolniku, ki je dobival aprepitant ob kemoterapiji zaradi raka, so poročali o pojavu Stevens - Johnsonovega sindroma kot o resnem neželenem učinku.
One case of angioedema and urticaria was reported as a serious adverse event in a patient receiving aprepitant in a non-CINV/ non-PONV study.
Poročali so o enem primeru angioedema in urtikarije kot o resnem neželenem učinku, vendar pa ne v študiji CINV (Cisplatin- Induced Nausea and Vomiting) / PONV.
Post-marketing experience During post-marketing experience the following side effects have been reported (frequency not known):
Izkušnje iz obdobja trženja zdravila Neželeni učinki, o katerih so spontano poročali v času trženja zdravila (pogostnost je neznana):
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria Immune system disorders: hypersensitivity reactions including anaphylactic reactions
Bolezni imunskega sistema: preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami.
No specific information is available on the treatment of overdose with EMEND.
O zdravljenju zaradi prevelikega odmerjanja zdravila EMEND ni specifičnih podatkov.
Drowsiness and headache were reported in one patient who ingested 1,440 mg of aprepitant.
Pri bolniku, ki je zaužil 1. 440 mg aprepitanta, so poročali o zaspanosti in glavobolu.
Because of the antiemetic activity of aprepitant, drug-induced emesis may not be effective.
Sprožitev bruhanja z zdravili, zaradi antiemetičnega delovanja aprepitanta morda ne bo učinkovito.
Antiemetics and antinauseants, ATC code:
5. 1 Farmakodinamične lastnosti