natgillin/translations-raw huggingface dataset:
Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of theseactive substances, potentially causing serious or life-threatening reactions.
Aprepitant zavira CYP3A4, zaradi česar bi se lahko zvišale plazemske koncentracije teh zdravilnih učinkovin, kar bi lahko povzročilo resne ali življenje ogrožujoče reakcije.
13 Induction As a moderate inducer of CYP2C9 and a mild inducer of CYP3A4 and glucuronidation, aprepitant can decrease plasma concentrations of substrates eliminated by these routes.
Indukcija Kot zmeren induktor CYP2C9 in blag induktor CYP3A4 in glukuronidacije, lahko aprepitant zniža plazemske koncentracije substratov, ki se izločajo po teh poteh.
This effect may become apparent only after the end of treatment with EMEND.
Ta učinek se lahko pokaže šele po koncu zdravljenja z zdravilom EMEND.
For CYP2C9 and CYP3A4 substrates, the induction is transient with a maximum effect reached 3-5 days after end of the EMEND 3-day treatment.
Indukcija substratov CYP2C9 in CYP3A4 je prehodna, največji učinek pa je dosežen v 3- 5 dneh po koncu 3 dnevnega zdravljenja z zdravilom EMEND.
The effect is maintained for a few days, thereafter slowly declines and is clinically insignificant by two weeks after end of EMEND treatment.
Učinek traja nekaj dni, potem pa počasi upada in je klinično nesignifikanten v dveh tednih po koncu zdravljenja z zdravilom EMEND.
Mild induction of glucuronidation is also seen with 80 mg oral aprepitant given for 7 days.
Blaga indukcija in glukuronidacija je vidna tudi pri 80 mg peroralnem aprepitantu, ki se ga daje 7 dni.
Data are lacking regarding effects on CYP2C8 and CYP2C19.
V
Caution is advised when warfarin, acenocoumarol, tolbutamide, phenytoin or other active substances that are known to be metabolised by CYP2C9 are administered during this time period.
13 tem obdobju svetujemo previdnost pri dajanju varfarina, acenokumarola, tolbutamida, fenitoina in drugih zdravilnih učinkovin, ki se presnavljajo s CYP2C9.
The usual oral dexamethasone dose should be reduced by approximately 50% when co-administered with EMEND 125 mg/ 80 mg regimen.
Pri sočasnem jemanju z zdravilom EMEND (režim 125 mg/ 80 mg) je treba običajni peroralni odmerek deksametazona zmanjšati za približno 50%.
The dose of dexamethasone in chemotherapy induced nausea and vomiting clinical trials was chosen to account for active substance interactions (see section 4.2).
Odmerek deksametazona je bil v kliničnih študijah navzee in bruhanja zaradi kemoterapije določen z upoštevanjem medsebojnega delovanja zdravilnih učinkovin (glejte poglavje 4. 2).
EMEND, when given as a regimen of 125 mg with dexamethasone co-administered orally as 20 mg on Day 1, and EMEND when given as 80 mg/ day with dexamethasone co- administered orally as 8 mg on Days 2 through 5, increased the AUC of dexamethasone, a CYP3A4 substrate, 2.2-fold on Days 1 and 5.
Pri uporabi po shemi EMEND 125 mg skupaj z deksametazonom 20 mg per os prvi dan ter EMEND 80 mg/ dan skupaj z deksametazonom 8 mg per os od drugega do petega dne, je EMEND 1. in 5. dan zdravljenja za 2, 2- krat zvišal AUC deksametazona, ki je substrat CYP3A4.
The usual intravenously administered methylprednisolone dose should be reduced approximately 25%, and the usual oral methylprednisolone dose should be reduced approximately 50% when co-administered with EMEND 125 mg/ 80 mg regimen.
Pri sočasni uporabi z zdravilom EMEND (režim 125 mg/ 80 mg) je treba običajni intravenski odmerek metilprednizolona zmanjšati za približno 25%, običajni peroralni odmerek metilprednizolona pa za približno 50%.
EMEND, when given as a regimen of 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, increased the AUC of methylprednisolone, a CYP3A4 substrate, by 1.3-fold on Day 1 and by 2.5-fold on Day 3, when methylprednisolone was co-administered intravenously as 125 mg on Day 1 and orally as 40 mg on Days 2 and 3.
125 mg prvi dan in 40 mg per os drugi in tretji dan je EMEND povečal AUC metilprednizolona, ki je substrat CYP3A4, in sicer za 1, 3- krat prvi dan ter za 2, 5- krat tretji dan.
During continuous treatment with methylprednisolone, the AUC of methylprednisolone may decrease at later time points within 2 weeks following initiation of dosing with EMEND, due to the inducing effect of aprepitant on CYP3A4.
Pri nepretrganem zdravljenju z metilprednizolonom se lahko pozneje, v času dveh tednov po začetku zdravljenja z zdravilom EMEND, AUC metilprednizolona zmanjša zaradi indukcijskega učinka aprepitanta na CYP3A4.
Chemotherapeutic agents:
Kemoterapevtiki:
In pharmacokinetic studies, EMEND, when given as a regimen of 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, did not influence the pharmacokinetics of docetaxel administered intravenously on Day 1 or vinorelbine administered intravenously on Day 1 or Day 8.
V farmakokinetičnih študijah EMEND, ki so ga dajali po shemi 125 mg prvi dan in 80 mg drugi in tretji dan, ni vplival na farmakokinetiko docetaksela, danega intravensko prvi dan ali vinorelbina, danega intravensko prvi in osmi dan.
Because the effect of EMEND on the pharmacokinetics of orally administered CYP3A4 substrates is greater than the effect of EMEND on the pharmacokinetics of intravenously administered CYP3A4 substrates, an interaction with orally administered chemotherapeutic agents metabolised primarily or in part by CYP3A4 (e. g. etoposide, vinorelbine) cannot be excluded.
Ker je učinek zdravila EMEND na farmakokinetiko substratov za CYP3A4, če so dani peroralno, večji kot če so dani intravensko, interakcije s peroralno danimi kemoterapevtiki, ki se predvsem ali delno presnavljajo s CYP3A4 (npr. etopozid, vinorelbin), ne moremo izključiti.
Caution is advised and additional monitoring may be appropriate in patients receiving such agents orally (see section 4.4).
Pri bolnikih, ki dobivajo taka zdravila peroralno, je lahko potreben dodaten nadzor (glejte poglavje 4. 4).
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co- administering these agents with EMEND (125 mg/ 80 mg).
Pri sočasni uporabi z zdravilom EMEND (125 mg/ 80 mg) je treba upoštevati možne učinke zvišanih plazemskih koncentracij midazolama in drugih benzodiazepinov, ki se presnavljajo s CYP3A4 (alprazolam, triazolam).
EMEND increased the AUC of midazolam, a sensitive CYP3A4 substrate, 2.3-fold on Day 1 and 3.3- fold on Day 5, when a single oral dose of 2 mg midazolam was co-administered on Days 1 and 5 of a regimen of EMEND 125 mg on Day 1 and 80 mg/ day on Days 2 to 5.
Zdravilo EMEND je povečalo AUC midazolama, ki je občutljiv substrat za CYP3A4, in sicer za 2, 3- krat prvi dan in za 3, 3- krat peti dan po enem peroralnem odmerku midazolama 2 mg prvi in peti dan zdravljenja z zdravilom EMEND po shemi 125 mg prvi dan in 80 mg na dan od drugega do petega dne.
In another study with intravenous administration of midazolam, EMEND was given as 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, and 2 mg midazolam was given intravenously prior to the administration of the 3-day regimen of EMEND and on Days 4, 8, and 15.
V drugi študiji z intravenskim odmerjanjem midazolama so EMEND dajali po shemi 125 mg prvi dan ter 80 mg/ dan drugi in tretji dan, midazolam pa v odmerku 2 mg i. v. pred začetkom 3- dnevne sheme odmerjanja zdravila EMEND, nato pa še 4., 8. in 15. dan.
EMEND increased the AUC of midazolam 25% on Day 4 and decreased the AUC of midazolam 19% on Day 8 and 4% on Day 15.
EMEND je 4. dan povečal AUC midazolama za 25%, 8. dan ga je zmanjšal za 19%, 15. dan pa še za 4%.
14 In a third study with intravenous and oral administration of midazolam, EMEND was given as 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, together with ondansetron 32 mg Day 1, dexamethasone 12 mg Day 1 and 8 mg Days 2-4.
V tretji študiji z intravenskim in s peroralnim odmerjanjem midazolama so EMEND dajali po shemi 125 mg prvi dan ter 80 mg/ dan drugi in tretji dan, skupaj z ondansentronom 32 mg prvi dan in deksametazonom 12 mg prvi dan ter 8 mg drugi do četrti dan.
EMEND, ondansetron and dexamethasone) decreased the AUC of oral midazolam 16% on Day 6, 9% on Day 8, 7% on Day 15 and 17% on Day 22.
Ta kombinacija (to je EMEND, ondansetron in deksametazon) je zmanjšala AUC peroralnega midazolama 6. dan za 16%, 8. dan za 9%, 15. dan za 7% in 22. dan za 17%.
The plasma AUC of midazolam was increased by 1.5-fold.
Plazemske vrednosti AUC midazolama so se povečale za 1, 5- krat.
This effect was not considered clinically important.
Menimo da ta vpliv nima kliničnega pomena.
Warfarin:
14 Varfarin:
In patients on chronic warfarin therapy, the prothrombin time (INR) should be monitored closely during treatment with EMEND and for 2 weeks following each 3-day course of EMEND for chemotherapy induced nausea and vomiting (see section 4.4).
Pri bolnikih, ki se dolgotrajno zdravijo z varfarinom, je treba protrombinski čas (INR) skrbno nadzorovati med zdravljenjem z zdravilom EMEND in 2 tedna po vsakem 3- dnevnem ciklusu zdravljenja navzee in bruhanja zaradi kemoterapije z zdravilom EMEND (glejte poglavje 4. 4).
When a single 125 mg dose of EMEND was administered on Day 1 and 80 mg/ day on Days 2 and 3 to healthy subjects who were stabilised on chronic warfarin therapy, there was no effect of EMEND on the plasma AUC of R(+) or S(-) warfarin determined on Day 3; however, there was a 34% decrease in S(-) warfarin (a CYP2C9 substrate) trough concentration accompanied by a 14% decrease in INR 5 days after completion of dosing with EMEND.
Vendar pa je bila 5 dni po koncu zdravljenja z zdravilom EMEND serumska raven S (-) varfarina (ki je substrat za CYP2C9) tik pred naslednjim odmerkom za 34% nižja, pri čemer je bil INR za 14% nižji.
EMEND, when given as 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 23% on Day 4, 28% on Day 8, and 15% on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of EMEND and on Days 4, 8, and 15.
EMEND je pri jemanju po shemi 125 mg prvi dan ter 80 mg/ dan drugi in tretji dan zmanjšal AUC tolbutamida (ki je substrat za CYP2C9), ki so ga bolniki prejemali v enkratnem odmerku 500 mg per os pred začetkom 3- dnevne sheme odmerjanja zdravila EMEND ter 4., 8. in 15. dan, in sicer za 23% 4. dan, za 28% 8. dan in za 15% 15. dan.
The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of EMEND.
Med jemanjem in še 28 dni po koncu jemanja zdravila EMEND, se lahko zmanjša učinkovitost hormonskih kontraceptivov.
Alternative or back-up methods of contraception should be used during treatment with EMEND and for 2 months following the last dose of EMEND.
Med zdravljenjem z zdravilom EMEND in še 2 meseca po zadnjem odmerku zdravila EMEND je treba uporabljati alternativno ali dodatno kontracepcijsko metodo.
Aprepitant, when given once daily for 14 days as a 100 mg capsule with an oral contraceptive containing 35 μ g of ethinyl estradiol and 1 mg of norethindrone, decreased the AUC of ethinyl estradiol by 43%, and decreased the AUC of norethindrone by 8%.
Aprepitant v odmerku 100 mg kapsula enkrat na dan 14 dni skupaj s peroralnim kontraceptivom, ki je vseboval 35 μg etinilestradiola in 1 mg noretindrona, je zmanjšal AUC etinilestradiola za 43%, AUC noretindrona pa za 8%.
In another study, single doses of an oral contraceptive containing ethinyl estradiol and norethindrone were administered on Days 1 through 21 with EMEND, given as a regimen of 125 mg on Day 8 and 80 mg/ day on Days 9 and 10 with ondansetron 32 mg intravenouslyon Day 8 and oral dexamethasone given as 12 mg on Day 8 and 8 mg/ day on Days 9, 10, and 11.
V drugi študiji so enkratne odmerke peroralnega kontraceptiva, ki je vseboval etinilestradiol in noretindron od dne 1- 21 dajali skupaj z zdravilom EMEND po shemi 125 mg 8. dan in 80 mg/ dan 9. in 10. dan, z ondansetronom 32 mg intravensko 8. dan in z oralnim deksametazonom v obliki 12 mg odmerka 8. dan in 8 mg / dan 9., 10. in 11. dan.
During days 9 through 21 in this study, there was as much as a 64% decrease in ethinyl estradiol trough concentrations and as much as a 60% decrease in norethindrone trough concentrations.
Med 9. in 21. dnem je v tej študiji prišlo do 64% znižanja v koncentraciji etinilestradiola pred naslednjim odmerkom in do 60% znižanja noretindrona pred naslednjim odmerkom.
Aprepitant does not seem to interact with the P-glycoprotein transporter, as suggested by the lack of interaction of aprepitant with digoxin.
EMEND nima medsebojnega vpliva z digoksinom, zato verjetno ne intereagira s P- glikoproteinskim prenašalcem.
Effect of other agents on the pharmacokinetics of aprepitant 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 zdravil na farmakokinetiko aprepitanta 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.
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 of EMEND.
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 zdravila EMEND.
John’ s Wort (Hypericum perforatum) is not recommended.
Sočasno uporabo zdravila EMEND in zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum), odsvetujemo.
15 Ketoconazole:
Ketokonazol:
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 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%.
4.6 Pregnancy and lactation
15 4. 6 Nosečnost in dojenje
The potential for reproductive toxicity of aprepitant has not been fully characterized, since exposure levels above the therapeutic exposure in humans at the 125 mg/ 80 mg dose were not attained in animal studies.
Možnost škodljivega vpliva aprepitanta na sposobnost razmnoževanja ni v celoti raziskana, saj med študijami na živalih niso dosegli ravni izpostavljenosti, ki bi bila višja od terapevtske izpostavljenosti pri uporabi 125 mg/ 80 mg odmerka pri ljudeh.
These studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
Aprepitant is excreted in the milk of lactating rats.
Aprepitant se izloča v mleku podgan.
Adverse reactions considered as drug-related by the investigator were reported in approximately 17% of patients treated with the aprepitant regimen compared with approximately 13% of patients treated with standard therapy in patients receiving highly emetogenic chemotherapy.
O neželenih učinkih, ki so jih raziskovalci ocenili kot povezane z zdravilom, so poročali pri približno 17% bolnikov, zdravljenih z aprepitantom, ter pri 13% bolnikov, zdravljenih z običajno terapijo (pri bolnikih, ki se zaradi raka zdravijo z zelo emetogeno kemoterapijo).
Aprepitant was discontinued due to adverse reactions in 0.6% of patients treated with the aprepitant regimen compared with 0.4% of patients treated with standard therapy.
Zaradi neželenih učinkov so zdravljenje prekinili pri 0, 6% bolnikov, zdravljenih z aprepitantom, ter pri 0, 4% bolnikov, zdravljenih s standardno terapijo.
In a clinical study of patients receiving moderately emetogenic chemotherapy, clinical adverse reactions were reported in approximately 21% of patients treated with the aprepitant regimen compared with approximately 20% of patients treated with standard therapy.
V klinični študiji bolnikov, ki so dobivali zmerno emetogeno kemoterapijo, so o kliničnih neželenih učinkih poročali pri približno 21% bolnikov, zdravljenih z aprepitantom, ter pri približno 20% bolnikih, zdravljenih s standardno terapijo.
Aprepitant was discontinued due to adverse reactions in 1.1% of patients treated with the aprepitant regimen compared with 0.5% of patients treated with standard therapy.
Zdravljenje z aprepitantom so zaradi neželenih učinkov prekinili pri 1, 1% bolnikov, zdravljenih z aprepitantom, ter pri 0, 5% bolnikov, zdravljenih s standardno terapijo.
The most common adverse reactions reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving highly emetogenic chemotherapy were: hiccups (4.6% versus 2.9%), asthenia/ fatigue (2.9% versus 1.6%), alanine aminotransferase (ALT) increased (2.8% versus 1.5%), constipation (2.2% versus 2.0%), headache (2.2% versus 1.8%), and anorexia (2.0% versus 0.5%).
Najpogostejši neželeni učinki, o katerih so pri zdravljenju z aprepitantom pri bolnikih, ki so dobivali zelo emetogeno kemoterapijo, poročali pogosteje kot pri običajni terapiji, so bili: kolcanje (4, 6% versus 2, 9%), astenija/ utrujenost (2, 9% versus 1, 6%), zvišanje alanin- aminotransferaze (ALT) (2, 8% versus 1, 5%), zaprtje (2, 2% versus 2, 0%), glavobol (2, 2% versus 1, 8%) ter anoreksija (2, 0% versus 0, 5%).
The most common adverse reaction reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving moderately emetogenic chemotherapy was fatigue (2.5% versus 1.6%).
Najpogostejši neželeni učinek, o katerem so pri bolnikih, ki so dobivali zmerno emetogeno kemoterapijo, poročali pogosteje kot pri bolnikih, ki so bili zdravljeni s standardno terapijo, je bila utrujenost (2, 5% versus 1, 6%).
The following adverse reactions were observed in patients treated with the aprepitant regimen and at a greater incidence than with standard therapy:
Pri bolnikih, zdravljenih z aprepitantom, so opazili naslednje neželene učinke, ki so se pojavljali pogosteje kot pri običajni terapiji:
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).
Frequency
Pogostnost pogoste
ALT increased, AST increased
zvišanje ALT, zvišanje AST, zvišanje alkalne fosfataze, hiperglikemija, mikrohematurija, hiponatriemija, zmanjšanje telesne mase
common
občasne
alkaline phosphatase increased, hyperglycaemia, microscopic haematuria, hyponatraemia, weight decreased
bradikardija
Cardiac disorders Blood and lymphatic system disorders
Bolezni krvi in sistema
bradycardia febrile neutropenia, anaemia
limfatičnega febrilna nevtropenija, anemija,
Uncommon Uncommon
občasne
dream abnormality, cognitive disorder
glavobol, omotica 16 neobičajne sanje, motnje mišljenja
uncommon
pogoste občasne
conjunctivitis
konjunktivitis
Ear and labyrinth disorders Respiratory, thoracic and mediastinal disorders
Ušesne bolezni, vključno motnjami labirinta
tinnitus hiccups
z tinitus
Uncommon common
občasne
pharyngitis, sneezing, cough, postnasal drip, throat irritation
Bolezni dihal, prsnega koša in mediastinalnega prostora
uncommon
pogoste občasne pogoste
constipation, diarrhoea, dyspepsia, eructation
zaprtje, driska, dispepsija, eruktacija
perforating duodenal ulcer, nausea*, vomiting*, acid reflux, dysgeusia, epigastric discomfort, obstipation, gastroesophageal reflux disease, abdominal pain, dry mouth, enterocolitis, flatulence, stomatitis
perforirajoč duodenalen ulkus, navzea *, bruhanje *, refluks kisline, motnje okusa, neugodje v epigastriju, zaprtje, gastroezofagalna refluksna bolezen, predrtje razjede dvanajstnika, bolečine v trebuhu, suha usta, enterokolitis, vetrovi, stomatitis
polyuria, dysuria, pollakiuria rash, acne, photosensitivity, hyperhidrosis, oily skin, pruritus, skin lesion
poliurija, disurija, polakisurija izpuščaji, akne, fotosenzitivnost, prekomerno znojenje, mastna koža, srbenje, lezije kože
Uncommon Uncommon
občasne občasne
muscle cramp, myalgia
mišični krči, bolečine v mišicah
common
pogoste
weight gain, polydipsia
povečanje telesne mase, polidipsija
Infection and infestations Vascular disorders General disorders and administration site conditions
Infekcijske in parazitske bolezni Žilne bolezni
candidiasis, staphylococcal infection flushing/ hot flush asthaenia/ fatigue
kandidoza, okužbe s stafilokoki navali vročine
Uncommon Uncommon common
občasne občasne pogoste
oedema, chest discomfort, lethargy, thirst
Splošne težave in spremembe na mestu aplikacije
disorientation, euphoria, anxiety
dezorientacija, evforija, anksioznost
*Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
* Navzea in bruhanje sta bila parametra učinkovitosti prvih 5 dni po kemoterapiji; o njih so kot o neželenih učinkih poročali šele po tem času.
The adverse reactions profiles in the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy were generally similar to those observed in Cycle 1.
Profili neželenih učinkov so bili v podaljšku študije z več ciklusi zdravljenja (do 5 dodatnih ciklusov kemoterapije) na splošno podobni tistim po prvem ciklusu.
Additional adverse reactions were observed in patients treated with aprepitant (40 mg) for postoperative nausea and vomiting and a greater incidence than with ondansetron: abdominal pain upper, bowel sounds abnormal, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, visual acuity reduced, wheezing.
Drugi neželeni učinki, ki so bili pri bolnikih, ki so prejemali aprepitant (40 mg) zaradi preprečevanja pooperacijske navzee in bruhanja pogostejši kot pri bolnikih, ki so prejemali ondansetron so: bolečina v zgornjem predelu trebuha, nenormalni črevesni zvoki, disartrija, dispneja, hipestezija, nespečnost, mioza, navzea, čutilne motnje, neugodje v želodcu, zmanjšanje ostrine vida in sopenje.
In addition, two serious adverse 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.
17 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 dogodku, vendar pa ne v študiji CINV (Chemotherapy- Induced Nausea and Vomiting) / PONV.
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria Immune system disorders: hypersensitivity reactions including anaphylactic reactions
17 Bolezni imunskega sistema: preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami.