natgillin/translations-raw huggingface dataset:
The usual oral dexamethasone dose should be reduced by approximately 50% when co-administered with a regimen of fosaprepitant followed by aprepitant.
Pri uporabi fosaprepitanta, ki mu sledi zdravljenje s peroralnim aprepitantom, je treba običajni peroralni odmerek deksametazona zmanjšati za približno 50%.
The dose of dexamethasone in clinical chemotherapy induced nausea and vomiting trials was chosen to account for medicinal product interactions (see section 4.2).
Odmerek deksametazona je bil v kliničnih študijah navzee in bruhanja zaradi kemoterapije določen z upoštevanjem medsebojnega delovanja zdravil (glejte poglavje 4. 2).
Oral aprepitant, when given as a regimen of 125 mg with dexamethasone co-administered orally as 20 mg on Day 1, and oral aprepitant 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 peroralni aprepitant v odmerku 125 mg skupaj z deksametazonom v odmerku 20 mg peroralno prvi dan ter peroralni aprepitant v odmerku 80 mg/ dan skupaj z deksametazonom v odmerku 8 mg peroralno od drugega do petega dne, je peroralni aprepitant 1. in 5. dan zdravljenja za 2, 2- krat zvišal AUC deksametazona, ki je substrat za 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 a regimen of fosaprepitant followed by aprepitant.
Pri sočasni uporabi s fosaprepitantom, ki mu sledi zdravljenje s peroralnim aprepitantom, je treba običajni intravenski odmerek metilprednizolona zmanjšati za približno 25%, običajni peroralni odmerek metilprednizolona pa za približno 50%.
Oral aprepitant, 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.
Pri uporabi po shemi peroralni aprepitant v odmerku 125 mg prvi dan in 80 mg/ dan drugi in tretji dan skupaj z metilprednizolonom v odmerku 125 mg intravensko prvi dan in 40 mg peroralno drugi in tretji dan, je peroralni aprepitant 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 oral aprepitant, due to the inducing effect of aprepitant on CYP3A4.
Pri kontinuiranem zdravljenju z metilprednizolonom se lahko kasneje, v dveh tednih po začetku zdravljenja s peroralnim aprepitantom, AUC metilprednizolona zmanjša zaradi indukcijskega učinka aprepitanta na CYP3A4.
This effect may be expected to be more pronounced for orally administered methylprednisolone.
Pričakujemo lahko, da bo ta učinek pri peroralni uporabi metilprednizolona izrazitejši.
5 intravenously on Day 1 or vinorelbine administered intravenously on Day 1 or Day 8.
V farmakokinetičnih študijah peroralni aprepitant, 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 aprepitant on the pharmacokinetics of orally administered CYP3A4 substrates is greater than the effect of aprepitant 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.
Svetujemo previdnost.
Caution is advised and additional monitoring may be appropriate in patients receiving such agents (see section 4.4).
Pri bolnikih, ki dobivajo taka zdravila peroralno, bo morda 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 a 3-day regimen of fosaprepitant followed by aprepitant.
Pri sočasni uporabi s 3- dnevnim fosaprepitantom, ki mu sledi zdravljenje z aprepitantom, je treba upoštevati možne učinke zvišanih plazemskih koncentracij midazolama in drugih benzodiazepinov, ki se presnavljajo s CYP3A4 (alprazolam, triazolam).
Fosaprepitant given at a dose of 100 mg over 15 minutes with a single dose of midazolam 2 mg increased the AUC of midazolam 1.6-fold.
Pri sočasni uporabi fosaprepitanta v odmerku 100 mg v obliki 15- minutne infuzije in midazolama v enkratnem 2 mg odmerku, se je AUC midazolama povečala za 1, 6- krat.
This effect was not considered clinically important.
Ta učinek ni klinično pomemben.
Oral aprepitant increased the AUC of midazolam 2.3-fold on Day 1 and 3.3-fold on Day 5, when a single oral dose of midazolam 2 mg was co-administered on Days 1 and 5 of a regimen of oral aprepitant 125 mg on Day 1 and 80 mg/ day on Days 2 to 5.
Peroralni aprepitant je povečal AUC midazolama, ki je občutljiv substrat za CYP3A4, in sicer za 2, 3 - krat prvi dan in za 3, 3- krat peti dan po enkratnem 2 mg peroralnem odmerku midazolama prvi in peti dan zdravljenja s peroralnim aprepitantom po shemi 125 mg prvi dan in 80 mg/ dan od drugega do petega dne.
In another study with intravenous administration of midazolam, oral aprepitant was given as 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, and midazolam 2 mg was given intravenously prior to the administration of the 3-day regimen of oral aprepitant and on Days 4, 8, and 15.
V drugi študiji z intravensko uporabo midazolama so peroralni aprepitant dajali po shemi 125 mg prvi dan ter 80 mg/ dan drugi in tretji dan, midazolam pa v odmerku 2 mg intravensko pred začetkom 3 - dnevne sheme zdravljenja s peroralnim aprepitantom, nato pa še 4., 8. in 15. dan.
Oral aprepitant increased the AUC of midazolam 25% on Day 4 and decreased the AUC of midazolam 19% on Day 8 and 4% on Day 15.
Peroralni aprepitant je 4. dan povečal vrednost AUC midazolama za 25%, 8. dan vrednost AUC midazolama zmanjšal za 19%, 15. dan pa za 4%.
These effects were not considered clinically important.
Ti učinki niso klinično pomembni.
In a third study with intravenous and oral administration of midazolam, oral aprepitant 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 intravensko in s peroralno uporabo midazolama so peroralni aprepitant dajali po shemi 125 mg prvi dan ter 80 mg/ dan drugi in tretji dan, skupaj z ondansetronom v odmerku 32 mg prvi dan in deksametazonom v odmerku 12 mg prvi dan ter 8 mg od drugega do četrtega dne.
This combination (i. e. oral aprepitant, 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 peroralni aprepitant, 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%.
A fourth study was completed with intravenous administration of midazolam and oral aprepitant.
Dokončana je bila tudi četrta študija, v kateri so bolniki prejeli midazolam intravensko in peroralni aprepitant.
Intravenous midazolam 2 mg was given 1 hour after oral administration of a single dose of oral aprepitant 125 mg.
Bolniki so prejeli midazolam v odmerku 2 mg intravensko 1 uro po prejemu enkratnega 125 mg odmerka peroralnega aprepitanta.
In patients with mild to moderate hypertension, infusion of 100 mg fosaprepitant over 15 minutes with diltiazem 120 mg 3 times daily, resulted in a 1.4-fold increase in diltiazem AUC and a small but clinically meaningful decrease in blood pressure, but did not result in a clinically meaningful change in heart rate, or PR interval.
Spremembe srčne frekvence in intervala PR niso bile klinično pomembne.
In patients on chronic warfarin therapy, the prothrombin time (INR) should be monitored closely during treatment with fosaprepitant or aprepitant and for 2 weeks following each 3-day regimen 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 s fosaprepitantom ali aprepitantom in še 2 tedna po vsakem 3 - dnevnem ciklusu zdravljenja navzee in bruhanja zaradi kemoterapije (glejte poglavje 4. 4).
When a single 125 mg dose of oral aprepitant 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 oral aprepitant 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 oral aprepitant.
Vendar pa je bila 5 dni po koncu zdravljenja s peroralnim aprepitantom serumska raven S (-) varfarina (ki je substrat za CYP2C9) tik pred naslednjim odmerkom za 34% nižja, pri čemer je bil INR za 14% nižji.
Oral aprepitant, 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 oral aprepitant and on Days 4, 8, and 15.
Peroralni aprepitant je pri dajanju 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 prejeli v enkratnem 500 mg peroralnem odmerku pred začetkom 3- dnevne sheme odmerjanja aprepitanta ter 4., 8. in 15. dan, in sicer za 23% 4. dan, za 28% 8. dan in za 15% 15. dan.
Oral contraceptives:
6 Peroralni kontraceptivi:
The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of oral aprepitant.
Med uporabo in še 28 dni po koncu uporabe peroralnega aprepitanta, se lahko zmanjša učinkovitost hormonskih kontraceptivov.
Alternative or back-up methods of contraception should be used during treatment with fosaprepitant or oral aprepitant and for 2 months following the last dose of aprepitant.
Med zdravljenjem s fosaprepitantom ali peroralnim aprepitantom in še 2 meseca po zadnjem odmerku aprepitanta morajo bolnice uporabljati alternativno ali dodatno kontracepcijsko metodo.
6 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 ena 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 withoral aprepitant, given as a regimen of 125 mg on Day 8 and 80 mg/ day on Days 9 and 10 with ondansetron 32 mg intravenously on 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 1. do 21. dne dajali skupaj peroralnim aprepitantom po shemi 125 mg 8. dan in 80 mg/ dan 9. in 10. dan, z ondansetronom v odmerku 32 mg intravensko 8. dan in s peroralnim 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.
V tej študiji so se med 9. in 21. dnem najnižje koncentracije etinilestradiola v stanju dinamičnega ravnovesja zmanjšale za 64%, najnižje koncentracije noretindrona v stanju dinamičnega ravnovesja pa za 60%.
Effect of other agents on the pharmacokinetics of aprepitant Concomitant administration of fosaprepitant or aprepitant with medicinal products that inhibit CYP3A4 activity (e. g., ritonavir, ketoconazole, clarithromycin, telithromycin) should be approached cautiously, as the combination results in increased plasma concentrations of aprepitant.
Vpliv drugih zdravil na farmakokinetiko aprepitanta Pri sočasni uporabi fosaprepitanta ali aprepitanta in zdravil, ki zavirajo aktivnost CYP3A4 (npr. ritonavir, ketokonazol, klaritromicin, telitromicin), je potrebna previdnost, saj se pri sočasni uporabi zvišajo plazemske koncentracije aprepitanta.
Concomitant administration of fosaprepitant or aprepitant with medicinal products 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.
Sočasni uporabi fosaprepitanta ali aprepitanta in zdravil, ki močno inducirajo aktivnost CYP3A4 (npr. rifampicin, fenitoin, karbamazepin, fenobarbital), se je treba izogibati, saj se pri sočasni uporabi zmanjšajo plazemske koncentracije aprepitanta, zaradi česar se lahko zmanjša učinkovitost zdravila.
John’ s Wort is not recommended.
Sočasna uporaba fosaprepitanta in šentjanževke ni priporočljiva.
When a single 125 mg dose of oral 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 125 mg odmerku peroralnega aprepitanta na 5. dan 10- dnevnega zdravljenja s ketokonazolom (ki je močan zaviralec CYP3A4) v odmerku 400 mg na dan, se je AUC aprepitanta povečala za približno 5- krat, srednji končni razpolovni čas aprepitanta pa podaljšal za približno 3- krat.
Infusion of 100 mg fosaprepitant over 15 minutes with diltiazem 120 mg 3 times daily, resulted in a 1.5-fold increase of aprepitant AUC.
Pri uporabi fosaprepitanta v odmerku 100 mg v obliki 15- minutne intravenske infuzije in diltiazema v odmerku 120 mg trikrat na dan se je AUC aprepitanta povečala za 1, 5- krat.
When a single 375 mg dose of oral 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 375 mg odmerku peroralnega aprepitanta na 9. dan 14- dnevnega zdravljenja z rifampicinom (ki je močan induktor CYP3A4) v odmerku 600 mg na dan, se je AUC aprepitanta zmanjšala za 91%, srednji končni razpolovni čas aprepitanta pa skrajšal za 68%.
For fosaprepitant and aprepitant no clinical data on exposed pregnancies are available.
Za fosaprepitant in aprepitant ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
The potential for reproductive toxicities of fosaprepitant and aprepitant have not been fully characterized, since exposure levels above the therapeutic exposure in humans were not attained in animal studies.
Možnost škodljivega vpliva fosaprepitanta in aprepitanta na sposobnost razmnoževanja ni v celoti raziskana, saj med študijami na živalih raven izpostavljenosti ni bila večja od izpostavljenosti človeka pri uporabi terapevtskih odmerkov.
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).
Te študije ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
The potential effects on reproduction of alterations in neurokinin regulation are unknown.
Morebitni učinki zaradi sprememb regulacije nevrokininov na sposobnost razmnoževanja niso znani.
IVEMEND should not be used during pregnancy unless clearly necessary.
Zdravila IVEMEND ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Aprepitant is excreted in the milk of lactating rats after intravenous administration of fosaprepitant as well as after oral administration of aprepitant.
Aprepitant so zasledili v mleku doječih podgan tako po intravenskem dajanju fosaprepitanta kot peroralnem dajanju aprepitanta.
It is not known whether aprepitant is excreted in human milk.
Ni znano, če se aprepitant izloča z mlekom doječih mater.
Therefore, breast-feeding is not recommended during treatment with IVEMEND and oral aprepitant.
Med zdravljenjem z zdravilom IVEMEND ali peroralnim aprepitantom dojenje ni priporočljivo.
No studies on the effects of IVEMEND on the ability to drive and use machines have been performed.
Študij o vplivu zdravila IVEMEND na sposobnost vožnje in upravljanja s stroji niso izvedli.
However, when driving vehicles or operating machines, it should be taken into account that dizziness and fatigue have been reported after using IVEMEND (see section 4.8).
Pri vožnji vozil ali upravljanju s stroji je treba upoštevati, da so po uporabi zdravila IVEMEND poročali o pojavu omotice in utrujenosti (glejte poglavje 4. 8).
Since fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant are expected to occur with fosaprepitant.
4. 8 Neželeni učinki
The safety profile of aprepitant was evaluated in approximately 4900 individuals.
Fosaprepitant preide v aprepitant, zato pri uporabi fosaprepitanta pričakujemo pojav neželenih učinkov aprepitanta.
Various formulations of fosaprepitant have been administered to a total of 729 individuals including 347 healthy subjects and 149 patients with CINV.
Različne farmacevtske oblike fosaprepitanta je prejelo 729 oseb, vključno s 347 zdravimi osebami in 149 bolniki pri preprečevanju s kemoterapijo povzročene navzee in bruhanja.
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.
Pri zelo emetogeni kemoterapiji so o neželenih učinkih, ki so jih raziskovalci pripisali zdravilu, poročali pri približno 17% bolnikov, ki so se zdravili z aprepitantom, in približno 13% bolnikov, ki so se zdravili s standardno obliko zdravljenja.
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 je bilo zdravljenje z aprepitantom prekinjeno pri 0, 6% bolnikov, standardna oblika zdravljenja pa pri 0, 4% bolnikov.
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 pri bolnikih z zmerno emetogeno kemoterapijo, so o kliničnih neželenih učinkih poročali pri približno 21% bolnikov, ki so se zdravili z aprepitantom, in pri približno 20% bolnikov, ki so se zdravili s standardno obliko zdravljenja.
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.
Zaradi neželenih učinkov je bilo zdravljenje z aprepitantom prekinjeno pri 1, 1% bolnikov, standardna oblika zdravljenja pa pri 0, 5% bolnikov.
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%), asthenia/ fatigue (2.9%), ALT increased (2.8%), constipation (2.2%), headache (2.2%), and anorexia (2.0%).
Najpogostejši neželeni učinki pri zelo emetogeni kemoterapiji, o katerih so pri bolnikih, ki so se zdravili z aprepitantom, poročali pogosteje kot pri bolnikih med standardno obliko zdravljenja so: kolcanje (4, 6%), astenija/ utrujenost (2, 9%), zvišana vrednost ALT (2, 8%), obstipacija (2, 2%), glavobol (2, 2%) in neješčnost (2, 0%).
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%).
Najpogostejši neželeni učinek, o katerem so pri zmerno emetogeni kemoterapiji poročali pogosteje pri bolnikih, ki so se zdravili z aprepitantom, kot bolnikih s standardno obliko zdravljenja, je bila utrujenost (2, 5%).
The following adverse reactions were observed in patients treated with the aprepitant regimen and at a greater incidence than with standard therapy:
V nadaljevanju so navedeni neželeni učinki, ki so bili pogostejši pri bolnikih, ki so se zdravili z aprepitantom, kot bolnikih, ki so se zdravili s standardno obliko zdravljenja.
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 definirana 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), zelo redki (< 1/ 10. 000) ter neznana (ni mogoče oceniti iz razpoložljivih podatkov).
ALT increased, AST increased.
Pogosti: zvišana vrednost ALT, zvišana vrednost AST.
Uncommon: alkaline phosphatase increased, hyperglycaemia, microscopic haematuria, hyponatraemia, weight decreased.
Občasni: zvišana vrednost alkalne fosfataze, hiperglikemija, mikrohematurija, hiponatriemija, zmanjšanje telesne mase.
Uncommon: bradycardia.
Občasni: bradikardija.
Uncommon: anaemia, febrile neutropenia.
Občasni: anemija, febrilna nevtropenija.
Common: headache, dizziness.
Pogosti: glavobol, omotica.
Uncommon: dream abnormality, cognitive disorder.
Občasni: neobičajne sanje, motnje kognitivne funkcije.
Uncommon: conjunctivitis.
Občasni: konjunktivitis.
Uncommon: tinnitus.
Občasni: tinitus.
Respiratory, thoracic and mediastinal disorders:
8 Bolezni dihal, prsnega koša in mediastinalnega prostora:
Common: hiccups.
Pogosti: kolcanje.
Uncommon: pharyngitis, sneezing, cough, postnasal drip, throat irritation.
Občasni: faringitis, kihanje, kašelj, postnazalni izcedek, draženje žrela.
8 Common: constipation, diarrhoea, dyspepsia, eructation Uncommon: nausea*, vomiting*, acid reflux, dysgeusia, epigastric discomfort, obstipation, gastroesophageal reflux disease, perforating duodenal ulcer, abdominal pain, dry mouth, enterocolitis, flatulence, stomatitis.
Občasni: navzea *, bruhanje *, regurgitacija kisline, paragevzija, neugodje v epigastrični regiji, obstipacija, gastroezofagealni refluks, perforirajoča razjeda dvanajstnika, bolečina v trebuhu, suha usta, enterokolitis, flatulenca, vnetje ustne sluznice.
Uncommon: polyuria, dysuria, pollakiuria.
Občasni: poliurija, disurija, polakisurija.
Uncommon: rash, acne, photosensitivity, hyperhidrosis, oily skin, pruritus, skin lesion.
Občasni: izpuščaj, akna, fotosenzitivnost, hiperhidroza, mastna koža, srbenje, kožne spremembe.
Uncommon: muscle cramp, myalgia.
Občasni: mišični krči, mialgija.
Common: anorexia.
Pogosti: anoreksija.
Uncommon: weight gain, polydipsia.
Občasni: zvišanje telesne mase, polidipsija.
Infection and infestations:
Infekcijske in parazitske bolezni:
Uncommon: candidiasis, staphylococcal infection.
Občasni: kandidoza, stafilokokna okužba.
Uncommon: flushing/ hot flush.
Občasni: zardevanje/ navali vročine.
Common: asthaenia/ fatigue.
Pogosti: astenija/ utrujenost.
Uncommon: oedema, chest discomfort, lethargy, thirst.
Občasni: edem, neugodje v prsnem košu, letargija, žeja.
Uncommon: disorientation, euphoria, anxiety.
Občasni: dezorientiranost, 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.
O njih so kot o neželenih učinkih poročali šele po tem času.