natgillin/translations-raw huggingface dataset:
Paediatric patients aged 6 months and older, and not less than 6 kg The recommended dose regimen of IVEMEND, to be administered with a 5-HT3 antagonist, with or without a corticosteroid, for the prevention of nausea and vomiting associated with administration of single or multi-day chemotherapy regimens of Highly Emetogenic Chemotherapy (HEC) or Moderately Emetogenic Chemotherapy (MEC), is shown in Table 3.
Pediatrični bolniki, stari 6 mesecev ali več in s telesno maso vsaj 6 kg Preglednica 3 prikazuje priporočeno odmerno shemo zdravila IVEMEND, ki ga je treba uporabiti z antagonistom 5-HT3 (s kortikosteroidom ali brez njega) za preprečevanje navzee in bruhanja, povezanih z uporabo enodnevnih ali večdnevnih shem zelo emetogene (HEC - Highly Emetogenic Chemotherapy) ali zmerno emetogene kemoterapije (MEC - Moderately Emetogenic Chemotherapy).
Table 3: Recommended dosing for the prevention of nausea and vomiting associated with single or multi-day regimens of HEC or MEC in paediatric patients
Preglednica 3: Priporočeno odmerjanje za preprečevanje navzee in bruhanja, povezanih z enodnevnimi ali večdnevnimi shemami HEC ali MEC, pri pediatričnih bolnikih
It is not recommended to reinitiate the infusion in patients who experience hypersensitivity reactions.
Pri bolnikih, pri katerih se pojavijo preobčutljivostne reakcije, ne priporočamo ponovnega začetka infuzije.
Fosaprepitant 150 mg, given as a single dose, is a weak inhibitor of CYP3A4.
Fosaprepitant 150 mg, dan v obliki enkratnega odmerka, je šibek zaviralec CYP3A4.
Eye disorders conjunctivitis rare
Očesne bolezni konjunktivitis redki
The potential for reproductive toxicities of fosaprepitant and aprepitant have not been fully characterised, since exposure levels above the therapeutic exposure in humans could not be attained in animal studies.
Možnost vpliva fosaprepitanta in aprepitanta na sposobnost razmnoževanja ni v celoti raziskana, saj med študijami na živalih niso mogli doseči stopenj izpostavljenosti, ki bi bile višje od stopenj terapevtske izpostavljenosti pri človeku.
In rabbits, fosaprepitant caused initial transient local acute inflammation following paravenous, subcutaneous and intramuscular administration.
Pri kuncih je fosaprepitant po paravenski, subkutani in intramuskularni aplikaciji povzročilo začetno prehodno lokalno akutno vnetje.
Furthermore, fosaprepitant underwent rapid and nearly complete conversion to aprepitant in S9 preparations from other human tissues including kidney, lung and ileum.
Pretvorba fosaprepitanta v aprepitant je bila hitra in skoraj popolna tudi pri frakcijah S9, pridobljenih iz drugih človeških tkiv, vključno z ledvicami, s pljuči in z ileumom, kar kaže, da pretvorba fosaprepitanta v aprepitant lahko poteka v različnih tkivih.
If a corticosteroid, such as dexamethasone, is coadministered, administer 50% of the recommended corticosteroid dose on days 1 through 4
Pri sočasni uporabi kortikosteroida, kot je deksametazon, od 1. do 4. dne uporabite 50 % priporočenega odmerka kortikosteroida.
Figure 1: Percent of adult patients receiving Moderately Emetogenic Chemotherapy who remain emesis free over time
Slika 1: Odstotek odraslih bolnikov, ki so prejemali zmerno emetogeno kemoterapijo, pri katerih se bruhanje ne pojavi, glede na čas
VIAL LABEL 150 mg
NALEPKA NA VIALI 150 mg
Day 1 IVEMEND 150 mg intravenously Dexamethasone
1. dan zdravilo IVEMEND 150 mg intravensko deksametazon
8 mg orally twice daily
8 mg peroralno dvakrat na dan antagonist 5-HT3
Interactions with other medicinal products following administration of intravenous fosaprepitant are likely to occur with active substances that interact with oral aprepitant.
Po intravenski aplikaciji fosaprepitanta se lahko pojavijo interakcije z drugimi zdravili, ki medsebojno delujejo s peroralnim aprepitantom.
No data are available following the administration of a 3-day IV fosaprepitant regimen in paediatric patients.
Podatkov po uporabi 3-dnevne intravenske sheme fosaprepitanta pri pediatričnih bolnikih ni na voljo.
See the Summary of Product Characteristics (SmPC) for EMEND capsules or EMEND for oral suspension for appropriate dosing instructions.
Za ustrezna navodila glede odmerjanja glejte Povzetek glavnih značilnosti zdravila (SmPC) za kapsule ali peroralno suspenzijo zdravila EMEND.
Table 4: Alternative dosing for the prevention of nausea and vomiting associated with single day regimens of HEC or MEC in paediatric patients
Preglednica 4: Alternativno odmerjanje za preprečevanje navzee in bruhanja, povezanih z enodnevnimi shemami HEC ali MEC, pri pediatričnih bolnikih
Post-marketing events of neurotoxicity, a potential adverse reaction of ifosfamide, have been reported after aprepitant and ifosfamide co-administration.
V obdobju trženja zdravila so pri sočasni uporabi aprepitanta in ifosfamida poročali o pojavu nevrotoksičnosti, možnega neželenega učinka ifosfamida.
Refer to the Summary of Product Characteristics of co-administered 5-HT3 antagonist medicinal products.
Glejte tudi Povzetek glavnih značilnosti zdravila za antagoniste 5-HT3, ki se uporabljajo sočasno.
The most common adverse reaction reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving MEC was fatigue (1.4 % versus 0.9 %).
Najpogostejši neželeni učinek, o katerem so pri zmerno emetogeni kemoterapiji (MEC) poročali pogosteje pri bolnikih, ki so se zdravili z aprepitantom, kot bolnikih s standardno obliko zdravljenja, je bila utrujenost (1,4 % proti 0,9 %).
The reconstituted and diluted final solution is stable for 24 hours at 25C.
Rekonstituirana in razredčena končna raztopina je stabilna 24 ur pri temperaturi 25 C.
Infusion site reactions (ISRs) have been reported with the use of IVEMEND (see section 4.8).
Pri uporabi zdravila IVEMEND so poročali o reakcijah na mestu infundiranja (glejte poglavje 4.8).
Aprepitant undergoes extensive metabolism.
Aprepitant se v veliki meri presnavlja.
Paediatric patients 6 months to less than 2 years and not less than 6 kg
Pediatrični bolniki, stari od 6 mesecev do manj kot 2 leti in s telesno maso vsaj 6 kg
*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 prvih 5 dni po kemoterapiji parametra učinkovitosti.
The dose of dexamethasone accounts for active substance interactions.
Odmerek deksametazona že upošteva medsebojno delovanje zdravilnih učinkovin.
Skin and subcutaneous tissue disorders rash, acne uncommon photosensitivity reaction, hyperhidrosis, seborrhoea, skin lesion, rash pruritic, Stevens-Johnson syndrome/toxic epidermal necrolysis rare pruritus, urticaria not known
Pogostnost fotosenzitivna reakcija, hiperhidroza, seboreja, kožne lezije, srbeč izpuščaj, Stevens-Johnsonov sindrom/toksična epidermalna nekroliza redki srbenje, urtikarija neznana
Tabulated list of adverse reactions - aprepitant
Seznam neželenih učinkov - aprepitant
No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).
Pri bolnikih z okvaro ledvic in bolnikih s končno odpovedjo ledvic na hemodializi odmerka ni treba prilagoditi (glejte poglavje 5.2).
In a randomized, parallel, double-blind, placebo-controlled study, IVEMEND 150 mg (N=502) in combination with ondansetron and dexamethasone was compared with ondansetron and dexamethasone alone (control regimen) (N=498) in adult patients receiving a moderately emetogenic chemotherapy regimen.
V randomizirani, vzporedni, dvojno slepi, s placebom nadzorovani študiji so pri odraslih bolnikih, ki so prejemali zmerno emetogeno kemoterapijo, zdravilo IVEMEND 150 mg (N = 502) v kombinaciji z ondansetronom in deksametazonom primerjali z ondansetronom in deksametazonom samima (kontrolna shema) (N = 498).
Tabulated list of adverse reactions - fosaprepitant The following are adverse reactions reported in adult patients receiving fosaprepitant in clinical studies or postmarketing that have not been reported with aprepitant as described above.
Spodaj so našteti neželeni učinki, o katerih so poročali pri odraslih bolnikih, ki so v kliničnih študijah ali v obdobju trženja zdravila prejeli fosaprepitant, in o katerih niso poročali pri aprepitantu.
Alternative non-hormonal back-up methods of contraception should be used during treatment with fosaprepitant and for 2 months following the last dose of fosaprepitant (see sections 4.4 and 4.5).
Med zdravljenjem s fosaprepitantom in 2 meseca po zadnjem odmerku fosaprepitanta je treba uporabljati alternativno nehormonsko kontracepcijsko metodo (glejte poglavji 4.4 in 4.5).
Paediatric population: As part of a 3-day IV/IV/IV regimen, simulated median AUC0-24hr of aprepitant with median peak plasma concentration (Cmax) on Day 1 and the median concentrations at the end of Day 1, Day 2 and Day 3 in paediatric patients (6 months to 17 years old) are shown in Table 9.
sheme prikazane simulirane mediane AUC0-24h aprepitanta, mediane najvišje koncentracije v plazmi (Cmax) 1. dan in mediane koncentracije ob koncu 1., 2. in 3. dne pri pediatričnih bolnikih (starih od 6 mesecev do 17 let).
White to off-white amorphous powder.
prašek za raztopino za infundiranje bel do sivo-bel amorfni prašek
Chemotherapeutic medicinal products
Kemoterapevtiki
Cardiac disorders palpitations uncommon bradycardia, cardiovascular disorder rare
Srčne bolezni palpitacije občasni bradikardija, bolezen srca in ožilja redki
In patients on chronic warfarin therapy, the prothrombin time (INR) should be monitored closely during treatment with and for 14 days following the use of IVEMEND for the prevention of chemotherapy induced nausea and vomiting (see section 4.4).
Pri bolnikih, ki se dolgotrajno zdravijo z varfarinom, je treba protrombinski čas (INR) med zdravljenjem z zdravilom IVEMEND za preprečitev navzee in buhanja zaradi kemoterapije (glejte poglavje 4.4) in še 14 dni po njem skrbno spremljati.
The first 2 numbers indicate the month; the next 4 numbers indicate the year.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Prvi 2 številki pomenita mesec, naslednje 4 številke pa leto izteka roka uporabnosti.
Patients with moderate to severe hepatic impairment There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Za bolnike z zmerno okvaro jeter je podatkov malo, za bolnike s hudo okvaro jeter pa podatkov ni.
Paediatric patients 6 months to less than 12 years and not less than 6 kg
Pediatrični bolniki, stari od 6 mesecev do manj kot 12 let in s telesno maso vsaj 6 kg
Fosaprepitant regimen (N =502) **
OPAZOVANI DOGODKI* Fosaprepitant (N = 502) **
C]- fosaprepitant, a prodrug for aprepitant, indicating a substantial presence of metabolites in the plasma.
C-fosaprepitanta, predzdravila aprepitanta, približno 19 % radioaktivnosti v plazmi prispeval aprepitant, kar kaže na znatno prisotnost presnovkov v plazmi.
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these medicinal products with IVEMEND.
Pri sočasni uporabi zdravila IVEMEND je treba upoštevati možne učinke zvišanih plazemskih koncentracij midazolama ali drugih benzodiazepinov, ki se presnavljajo s CYP3A4 (alprazolam, triazolam).
Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant.
Ena viala vsebuje dimegluminijev fosaprepitant, ki ustreza 150 mg fosaprepitanta.
Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant.
Fosaprepitant, predzdravilo aprepitanta, se po intravenski aplikaciji hitro pretvori v aprepitant.
Do not administer IVEMEND as a bolus injection or undiluted solution.
Zdravila IVEMEND se ne sme aplicirati v obliki bolus injekcije ali nerazredčene raztopine.
Dosing for Single or Multi-Day Chemotherapy Regimens For paediatric patients receiving single or multi-day regimens of HEC or MEC, administer IVEMEND as an intravenous infusion through a central venous catheter on Days 1, 2, and 3.
Odmerjanje pri enodnevnih ali večdnevnih shemah kemoterapije Pediatričnim bolnikom, pri katerih se uprabljata enodnevna ali večdnevna shema HEC ali MEC, zdravilo IVEMEND infundirajte po centralnem venskem katetru 1., 2. in 3. dan.
The efficacy of a 1-day fosaprepitant regimen in paediatric patients is expected to be similar to that of the 1-day adult fosaprepitant regimen.
Učinkovitost 1-dnevne sheme fosaprepitanta je pri pediatričnih bolnikih predvidoma podobna kot učinkovitost 1-dnevne sheme fosaprepitanta pri odraslih.
When administered intravenously fosaprepitant is rapidly converted to aprepitant.
Po intravenski aplikaciji se fosaprepitant hitro pretvori v aprepitant.
Infusion site reactions (ISRs) have been reported with the use of IVEMEND (see section 4.4).
Pri uporabi zdravila IVEMEND so poročali o reakcijah na mestu infundiranja (glejte poglavje 4.4).
Fosaprepitant 150 mg is a weak CYP3A4 inhibitor as a single dose on Day 1 with no evidence of inhibition or induction of CYP3A4 observed on Day 4.
Fosaprepitant 150 mg v obliki enkratnega odmerka je 1. dan šibek zaviralec CYP3A4, za 4. dan pa ni dokazov za zaviranje ali indukcijo CYP3A4.
Table 1: Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy regimen in adults
Preglednica 1: Priporočeno odmerjanje za preprečevanje navzee in bruhanja zaradi zelo emetogene kemoterapije pri odraslih
Multiday chemotherapy regimens include chemotherapy regimens in which HEC or MEC is administered for 2 or more days.
Enodnevne sheme kemoterapije obsegajo sheme, v katerih se HEC ali MEC uporablja le en dan. Večdnevne sheme kemoterapije obsegajo sheme, v katerih se HEC ali MEC uporablja 2 dni ali več.
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Za bolnike z zmerno okvaro jeter je podatkov o uporabi zdravila malo, za bolnike s hudo okvaro jeter pa podatkov ni.
Nervous system disorders headache common dizziness, somnolence uncommon cognitive disorder, lethargy, dysgeusia rare
Bolezni živčevja glavobol pogosti omotica, zaspanost občasni motnje kognitivne funkcije, letargija, disgevzija redki
General disorders and administration site conditions infusion site erythema, infusion site pain, infusion site pruritus uncommon infusion site induration rare immediate hypersensitivity reactions including flushing, erythema, dyspnoea, anaphylactic reactions/anaphylactic shock not known
Splošne težave in spremembe na mestu aplikacije eritem na mestu infundiranja, bolečina na mestu infundiranja, pruritus na mestu infundiranja občasni induracija na mestu infundiranja redki takojšnje preobčutljivostne reakcije, vključno z zardevanjem, eritemom, dispnejo, anafilaktičnimi reakcijami/anafilaktičnim šokom neznana
Table 2: Recommended dosing for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy regimen in adults
Preglednica 2: Priporočeno odmerjanje za preprečevanje navzee in bruhanja zaradi zmerno emetogene kemoterapije pri odraslih
1-day IV dose
4. dan zdravilo IVEMEND
In a juvenile toxicity study in rats treated with aprepitant from postnatal day 10 to day 63, earlier vaginal opening in females from 250 mg/kg b.i.d.
V študiji toksičnosti pri mladih podganah, ki so od 10. do 63. dne po skotitvi dobivale aprepitant, so pri samicah opazili zgodnejše odprtje nožnice pri odmerkih od 250 mg/kg dvakrat na dan in pri samcih zapoznelo ločitev prepucija pri odmerkih od 10 mg/kg dvakrat na dan.
Renal impairment: A single 240 mg dose of oral aprepitant was administered to patients with severe renal impairment (CrCl< 30 ml/min) and to patients with end stage renal disease (ESRD) requiring haemodialysis.
Okvara ledvic: Bolnikom s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ter bolnikom z odpovedjo ledvic v končnem stadiju na hemodializi so dali en sam 240 mg odmerek peroralnega aprepitanta.
Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction), - euphoria (feeling of extreme happiness), disorientation, - bacterial infection, fungal infection, - severe constipation, stomach ulcer, inflammation of the small intestine and colon, sores in mouth, bloating, - frequent urination, passing more urine than normal, presence of sugar or blood in urine, - chest discomfort, swelling, change in the manner of walking, - cough, mucus in back of throat, throat irritation, sneezing, sore throat, - eye discharge and itching, - ringing in the ear, - muscle spasms, muscle weakness, - excessive thirst, - slow heartbeat, heart and blood vessel disease, - lowering of white blood cells, low sodium levels in the blood, weight loss, - hardening of site of infusion.
napihnjenost, - pogosto uriniranje, izločanje večje količine urina kot normalno, prisotnost sladkorja ali krvi v urinu, - nelagodje v prsnem košu, otekanje, sprememba v načinu hoje, - kašelj, sluz na zadnji strani žrela, draženje žrela, kihanje, bolečine v žrelu, - izcedek iz oči in srbenje oči, - zvonjenje v ušesih, - mišični krči, mišična oslabelost, - prekomerna žeja, - počasen srčni utrip, bolezen srca in ožilja, - znižanje števila belih krvnih celic, nizka vrednost natrija v krvi, zmanjšanje telesne mase, - zatrdlina na mestu infundiranja.
AST increased, blood alkaline phosphatase increased uncommon red blood cells urine positive, blood sodium decreased, weight decreased, neutrophil count decreased, glucose urine present, urine output increased rare
občasni prisotnost rdečih krvnih celic v urinu, znižana vrednost natrija v krvi, zmanjšanje telesne mase, zmanjšano število nevtrofilcev, pristotnost glukoze v urinu, povečano izločanje urina redki
Since fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant are expected to occur with fosaprepitant.
Fosaprepitant se pretvori v aprepitant, zato pri uporabi fosaprepitanta pričakujemo pojav neželenih učinkov, ki so povezani z aprepitantom.
Fosaprepitant 150 mg administered as a single intravenous dose on Day 1 increased the AUC0-24hr of dexamethasone, a CYP3A4 substrate, by 100 % on Day 1, 86 % on Day 2 and 18 % on Day 3 when dexamethasone was co-administered as a single 8 mg oral dose on Days 1, 2, and 3.
Pri sočasni uporabi fosaprepitanta 150 mg, danega v obliki enkratnega intravenskega odmerka 1. dan, in deksametazona v obliki enkratnega 8 mg peroralnega odmerka 1., 2. in 3. dan, je fosaprepitant povečal AUC0-24h deksametazona, ki je substrat za CYP3A4, in sicer za 100 % 1. dan, za 86 % 2. dan ter za 18 % 3. dan.
Additional adverse reactions were observed in adult patients treated with aprepitant for postoperative nausea and vomiting (PONV) and a greater incidence than with ondansetron: abdominal pain upper, bowel sounds abnormal, constipation*, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, sub-ileus*, visual acuity reduced, wheezing.
Drugi neželeni učinki, ki so bili pri odraslih bolnikih, ki so prejemali aprepitant zaradi preprečevanja pooperacijske navzee in bruhanja (PONV - postoperative nausea and vomiting) pogostejši kot pri bolnikih, ki so prejemali ondansetron, so: bolečina v zgornjem predelu trebuha, nenormalni črevesni zvoki, zaprtje*, disartrija, dispneja, hipestezija, nespečnost, mioza, navzea, senzorične motnje, nelagodje v želodcu, delna zapora pretoka črevesne vsebine*, zmanjšana ostrina vida in piskanje.
Respiratory, thoracic and mediastinal disorders hiccups common oropharyngeal pain, sneezing, cough, postnasal drip, throat irritation rare
Bolezni dihal, prsnega koša in mediastinalnega prostora kolcanje pogosti orofaringealna bolečina, kihanje, kašelj, postnazalni izcedek, draženje žrela redki
The fosaprepitant 150 mg single dose did not induce CYP3A4 on Days 1 and 4 in the midazolam interaction study.
V študiji medsebojnega delovanja z midazolamom fosaprepitant v obliki enkratnega 150 mg odmerka 1. in 4. dan ni induciral CYP3A4.
In healthy young adults, aprepitant accounts for approximately 19 % of the radioactivity in plasma over 72 hours following a single intravenous administration 100 mg dose of [
Pri zdravih mladih preiskovancih je, 72 ur po eni intravenski infuziji 100 mg odmerka 
Immediate hypersensitivity reactions including flushing, erythema, dyspnoea, and anaphylaxis/anaphylactic shock have occurred during or soon after infusion of fosaprepitant.
Med ali kmalu po infuziji fosaprepitanta so se pojavile takojšnje preobčutljivostne reakcije, vključno z zardevanjem, eritemom, dispnejo in anafilaksijo/anafilaktičnim šokom.
Caution is advised during concomitant administration of fosaprepitant and active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine (see section 4.4).
Pri sočasni uporabi fosaprepitanta in zdravilnih učinkovin, ki se primarno presnavljajo s CYP3A4 in z ozkim terapevtskim območjem, kot so ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanil in kinidin, je potrebna previdnost (glejte poglavje 4.4).
Inhibition of CYP3A4 by fosaprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious or lifethreatening reactions.
Fosaprepitant zavira CYP3A4, zato se lahko zvišajo plazemske koncentracije teh zdravilnih učinkovin, kar lahko povzroči pojav resnih ali življenjsko nevarnih reakcij (glejte poglavje 4.3).
Fosaprepitant 150 mg administered as a single intravenous dose on Day 1 increased the AUC0-∞ of midazolam by 77 % on Day 1 and had no effect on Day 4 when midazolam was co-administered as a single oral dose of 2 mg on Days 1 and 4.
Pri sočasni uporabi fosaprepitanta 150 mg v obliki enkratnega intravenskega odmerka 1. dan in midazolama v obliki enkratnega peroralnega 2 mg odmerka 1. in 4. dan je fosaprepitant povečal AUC0-∞ midazolama 1. dan za 77 %, 4. dan pa na AUC0-∞ midazolama ni imel učinka.
Fosaprepitant does not seem to interact with the P-glycoprotein transporter, as demonstrated by the lack of interaction of oral aprepitant with digoxin.
Peroralni aprepitant medsebojno ne deluje z digoksinom, zato fosaprepitant verjetno ne vpliva na P-glikoproteinski prenašalec.
The reconstituted and diluted medicinal product should be inspected visually for particulate matter and discoloration before administration.
Pred aplikacijo morate rekonstituirano in razredčeno zdravilo pregledati glede tujih delcev ali spremembe barve.
Gastrointestinal disorders constipation, dyspepsia common eructation, nausea*, vomiting*, gastroesophageal reflux disease, abdominal pain, dry mouth, flatulence uncommon duodenal ulcer perforation, stomatitis, abdominal distension, faeces hard, neutropenic colitis rare
Bolezni prebavil zaprtje, dispepsija pogosti spahovanje, navzea*, bruhanje*, gastroezofagealni refluks, bolečina v trebuhu, suha usta, flatulenca občasni perforirajoča razjeda dvanajstnika, vnetje ustne sluznice, napihnjen trebuh, trdo blato, nevtropenični kolitis redki
General disorders and administration site conditions fatigue common asthaenia, malaise uncommon oedema, chest discomfort, gait disturbance rare
Splošne težave in spremembe na mestu aplikacije utrujenost pogosti astenija, splošno slabo počutje občasni edem, neugodje v prsnem košu, motnja hoje redki
The pharmacokinetics of aprepitant is non-linear across the clinical dose range.
V razponu kliničnih odmerkov je farmakokinetika aprepitanta nelinearna.
12 - 17 years old 150 mg 30400
150 mg 30.400 3.500 735
‡ Delayed phase = 25 to 120 hours post-initiation of chemotherapy.
‡ Zapoznela faza = 25 do 120 ur po začetku kemoterapije.
No hemolysis was found with the commercial formulation up to a fosaprepitant concentration of 1 mg/ml in human whole blood and washed human erythrocytes.
V polni človeški krvi in spranih človeških eritrocitih niso odkrili nobene hemolize s komercialnimi pripravki do koncentracije fosaprepitanta 1 mg/ml.