FrancophonIA/ELRC3.0 huggingface dataset:
English: In 3 active-controlled, open-label clinical studies, paediatric patients aged 6 months to 17 years received either highly or moderately emetogenic chemotherapy and a single dose of fosaprepitant at or above the recommended 1-day regimen dose (139 patients) or 3-day regimen (199 patients), in combination with ondansetron with or without dexamethasone.
Slovenian: V 3 odprtih in z zdravilno učinkovino nadzorovanih kliničnih študijah so pediatrični bolniki v starosti od 6 mesecev do 17 let prejemali ali zelo ali zmerno emetogeno kemoterapijo in en odmerek fosaprepitanta po priporočeni 1-odmerni shemi odmerjanja (139 bolnikov) ali 3-dnevni shemi odmerjanja (199 bolnikov), v kombinaciji z ondansetronom in z ali brez deksametazona.
English: Death of skin tissue (necrosis) has happened in some people getting this type of chemotherapy medicine.
Slovenian: Pri nekaterih osebah, ki so prejele to vrsto kemoterapije, se je pojavilo odmrtje kožnega tkiva (nekroza).
English: Tell your doctor about any other medicines or herbal medicines you are taking, have recently taken, or might take.
Slovenian: Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo ali zdravilo rastlinskega izvora.
English: Some adverse reactions that are commonly observed in the adult population were not observed in the paediatric studies.
Slovenian: Nekaterih pogostih neželenih učinkov, zabeleženih pri odrasli populaciji, v študijah pri pediatričnih bolnikih niso opazili.
English: Alternative Dosing for Single Day Chemotherapy Regimens For paediatric patients receiving single day HEC or MEC, IVEMEND may be administered as an intravenous infusion through a central venous catheter on Day 1.
Slovenian: Alternativno odmerjanje pri enodnevnih shemah kemoterapije Pediatrični bolniki, ki prejemajo enodnevne sheme HEC ali MEC, lahko zdravilo IVEMEND dobijo v intravenski infuziji po centralnem venskem katetru 1. dan.
English: Psychiatric disorders anxiety uncommon disorientation, euphoric mood rare
Slovenian: Psihiatrične motnje anksioznost občasni dezorientiranost, evforično razpoloženje redki
English: Pre-clinical data obtained with intravenous administration of fosaprepitant and oral administration of aprepitant reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity (including in vitro tests), and toxicity to reproduction and development.
Slovenian: Predklinični podatki, pridobljeni pri intravenski uporabi fosaprepitanta in peroralni uporabi aprepitanta, na osnovi običajnih študij toksičnosti pri enkratnem odmerku in ponavljajočih se odmerkih, genotoksičnosti (vključno z in vitro testi), vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: In a pooled analysis of 3 active-controlled clinical studies in paediatric patients (aged 6 months to 17 years) receiving either HEC or MEC and a single dose of IVEMEND at or above the recommended 1day regimen dose, safety was evaluated for 139 patients receiving the 1-day regimen of IVEMEND.
Slovenian: V združeni analizi treh z zdravilno učinkovino nadzorovanih kliničnih študij pri pediatričnih bolnikih (starih od 6 mesecev do 17 let), ki so prejemali HEC ali MEC in enkratni odmerek zdravila IVEMEND v priporočeni 1-dnevni odmerni shemi ali več, so varnost ocenili pri 139 bolnikih, ki so prejeli 1-dnevno shemo zdravila IVEMEND.
English: The geometric mean volume of distribution at steady state (Vdss) of aprepitant estimated from a single 150 mg intravenous dose of fosaprepitant is approximately 82 l in humans.
Slovenian: Geometrični povprečni volumen porazdelitve v stanju dinamičnega ravnovesja (Vdss) aprepitanta, ocenjen na podlagi enkratnega 150 mg intravenskega odmerka fosaprepitanta, je pri človeku približno 82 litrov.
English: No dose adjustment is necessary for the elderly (see section 5.2).
Slovenian: Pri starejših odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: ** Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1.
Slovenian: ** Deksametazon je treba vzeti 1. dan 30 minut pred kemoterapijo.
English: Table 8: Percent of adult patients receiving Moderately Emetogenic Chemotherapy responding by treatment group and phase
Slovenian: Preglednica 8: Odstotek odraslih bolnikov, ki so prejemali zmerno emetogeno kemoterapijo z odzivom po zdravljenih skupinah in fazi
English: Co-administration with warfarin (a CYP2C9 substrate) In patients on chronic warfarin therapy, the International Normalised Ratio (INR) should be monitored closely for 14 days following the use of fosaprepitant (see section 4.5).
Slovenian: Sočasna uporaba z varfarinom (substrat za CYP2C9) Pri bolnikih, ki so na kroničnem zdravljenju z varfarinom, je treba 14 dni po uporabi fosaprepitanta vrednosti internacionalnega normaliziranega razmerja (INR) skrbno spremljati (glejte poglavje 4.5).
English: Rare side effects (may affect up to 1 in 1,000 people) are: - difficulty thinking, lack of energy, taste disturbance, - sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, itching rash,
Slovenian: Redki neželeni učinki (pojavijo se pri največ 1 od 1.000 bolnikov) so: - težave pri razmišljanju, pomanjkanje energije, motnje okušanja, - občutljivost kože na sonce, prekomerno znojenje, mastna koža, razjede po koži, srbeč izpuščaj,
English: Mild hepatic impairment (Child-Pugh class A) does not affect the pharmacokinetics of aprepitant to a clinically relevant extent.
Slovenian: Blaga okvara jeter (razred A po Child-Pugh-ovi klasifikaciji) na farmakokinetiko aprepitanta ne vpliva v tolikšni meri, da bi bilo to klinično pomembno.
English: Interaction studies with fosaprepitant 150 mg and chemotherapeutic medicinal products have not been conducted; however, based on studies with oral aprepitant and docetaxel and vinorelbine, IVEMEND 150 mg is not expected to have a clinically relevant interaction with intravenously administered docetaxel and vinorelbine.
Slovenian: Študij medsebojnega delovanja fosaprepitanta 150 mg in kemoterapevtikov niso izvedli; vendar pa glede na študije s peroralnim aprepitantom in z docetakselom ter vinorelbinom ne pričakujemo, da zdravilo IVEMEND 150 mg vstopa v klinično pomembne interakcije z intravensko danim docetakselom ter vinorelbinom.
English: Table 9: Pharmacokinetic parameters of aprepitant for 3-day IV fosaprepitant regimen in paediatric patients
Slovenian: Preglednica 9: Farmakokinetični parametri aprepitanta za 3-dnevno intravensko shemo fosaprepitanta pri pediatričnih bolnikih
English: What IVEMEND contains - The active substance is fosaprepitant.
Slovenian: Kaj vsebuje zdravilo IVEMEND - Zdravilna učinkovina je fosaprepitant.
English: Table 10: Pharmacokinetic parameters of aprepitant for 1-day IV fosaprepitant regimen in paediatric patients
Slovenian: Preglednica 10: Farmakokinetični parametri aprepitanta za 1-dnevno intravensko shemo fosaprepitanta pri pediatričnih bolnikih
English: In an active-controlled clinical study in adult patients receiving HEC, safety was evaluated for 1,143 patients receiving the 1-day regimen of IVEMEND 150 mg compared to 1,169 patients receiving the 3-day regimen of aprepitant.
Slovenian: V z zdravilno učinkovino nadzorovani klinični študiji pri odraslih bolnikih, ki so prejemali zelo emetogeno kemoterapijo, so varnost ovrednotili pri 1.143 bolnikih, ki so prejeli 1-dnevni režim zdravljenja z zdravilom IVEMEND 150 mg, in pri 1.169 bolnikih, ki so prejeli 3-dnevni režim zdravljenja z aprepitantom.
English: Fosaprepitant regimen (N =1,106) **
Slovenian: Fosaprepitant (N = 1.106) **
English: Day 1
Slovenian: 1. dan
English: IVEMEND should be used with caution in these patients (see section 5.2).
Slovenian: Pri teh bolnikih je treba zdravilo IVEMEND uporabljati previdno (glejte poglavje 5.2).
English: 6 months<2 years old
Slovenian: 6 mesecev - < 2 leti
English: For paediatric patients less than 12 years, administer IVEMEND intravenously over 60 minutes, completing the infusion approximately 30 minutes prior to chemotherapy.
Slovenian: Pediatričnim bolnikom, mlajšim od 12 let, dajte zdravilo IVEMEND intravensko v 60 minutah; infundiranje naj bo dokončano približno 30 minut pred kemoterapijo.
English: Table 6: Tabulated list of adverse reactions - fosaprepitant
Slovenian: Preglednica 6: Seznam neželenih učinkov - fosaprepitant
English: Some less common ADRs in the adult population were not observed in the paediatric studies.
Slovenian: Nekaterih manj pogostih neželenih učinkov, zabeleženih pri odrasli populaciji, v študijah pri pediatričnih bolnikih niso opazili.
English: Tell your doctor if you are taking these medicines since the treatment must be modified before you start using IVEMEND.
Slovenian: Če jemljete ta zdravila, morate to pred začetkom zdravljenja z zdravilom IVEMEND povedati zdravniku, saj je treba v tem primeru zdravljenje spremeniti.
English: The most common adverse reactions reported at a greater incidence in paediatric patients treated with the aprepitant regimen than with the control regimen while receiving emetogenic cancer chemotherapy were hiccups (3.3 % versus 0.0 %) and flushing (1.1 % versus 0.0 %).
Slovenian: Najpogostejša neželena učinka, ki sta imela pri pediatričnih bolnikih, zdravljenih s shemo z aprepitantom, večjo pojavnost kot pri tistih, zdravljenih s kontrolno shemo, ob hkratnem prejemanju emetogene kemoterapije rakavih bolezni, sta bila kolcanje (3,3 % oz. 0,0 %) in zardevanje (1,1 % oz.
English: If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on days 1 and 2.
Slovenian: Ob sočasni uporabi kortikosteroida, kot je deksametazon, 1. in 2. dan uporabite 50 % priporočenega odmerka kortikosteroida.
English: Common side effects (may affect up to 1 in 10 people) are: - constipation, indigestion, - headache, - tiredness, - loss of appetite, - hiccups, - increased amount of liver enzymes in your blood.
Slovenian: Pogosti neželeni učinki (pojavijo se pri največ 1 od 10 bolnikov) so: - zaprtost, prebavne motnje, - glavobol, - utrujenost, - izguba apetita, - kolcanje, - povečane količine jetrnih encimov v krvi.
English: Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant, which corresponds to 130.5 mg of aprepitant.
Slovenian: Ena viala vsebuje dimegluminijev fosaprepitant, ki ustreza 150 mg fosaprepitanta, kar ustreza 130,5 mg aprepitanta.
English: Paediatric Patients Receiving 3-Day Fosaprepitant Regimen The efficacy of the 3-day fosaprepitant regimen in paediatric patients was based on that demonstrated in paediatric patients receiving the 3-day oral aprepitant regimen.
Slovenian: Pediatrični bolniki, ki so prejemali 3-dnevno shemo fosaprepitanta Učinkovitost 3-dnevne sheme fosaprepitanta pri pediatričnih bolnikih temelji na učinkovitosti, ugotovljeni pri pediatričnih bolnikih, ki so prejemali 3-dnevno peroralno shemo aprepitanta.
English: Delayed phase No vomiting Overall
Slovenian: Popoln odziv Celotna faza Zapoznela faza Brez bruhanja Celotna faza
English: Each vial contains 150 mg of fosaprepitant.
Slovenian: Ena viala vsebuje 150 mg fosaprepitanta.
English: Caution is advised and additional monitoring may be appropriate in patients receiving medicinal products metabolized primarily or partly by CYP3A4 (see section 4.4).
Slovenian: Pri bolnikih, ki dobivajo zdravila, ki se primarno ali delno presnavljajo s CYP3A4, svetujemo previdnost, lahko je primeren tudi dodaten nadzor (glejte poglavje 4.4).
English: IVEMEND should not be given as a bolus injection, but should always be diluted and given as a slow intravenous infusion (see section 4.2).
Slovenian: Vedno ga je treba dajati razredčenega v obliki počasne intravenske infuzije (glejte poglavje 4.2).
English: The powder is contained in a clear glass vial with a rubber stopper and an aluminum seal with a grey plastic flip off cap.
Slovenian: Prašek je na voljo v prozorni stekleni viali z gumijastim zamaškom, ki je prekrit z aluminijastim obročkom in dvižno sivo zaporko.
English: C]- fosaprepitant to healthy subjects, 57 % of the radioactivity was recovered in urine and 45 % in faeces.
Slovenian: Pri zdravih preiskovancih se je po enem intravenskem odmerku 100 mg C-fosaprepitanta 57 % radioaktivnosti izločilo v urinu, 45 % pa v blatu.
English: In the 1-day IV fosaprepitant setting, 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 < 12 years old) and observed mean AUC0-24hr with median peak plasma concentration (Cmax) on Day 1 and mean concentrations at the end of Day 1, Day 2 and Day 3 in paediatric patients (12 to 17 years old) are shown in Table 10.
Slovenian: V preglednici 10 so v okviru 1-dnevne intravenske sheme fosaprepitanta 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 < 12 let) ter opažena povprečna AUC0-24h z mediano najvišjo koncentracijo v plazmi (Cmax) 1. dan in povprečnimi koncentracijami ob koncu 1., 2. in 3. dne pri pediatričnih bolnikih (starih od 12 do 17 let).
English: Table 5: Tabulated list of adverse reactions - aprepitant
Slovenian: Preglednica 5: Seznam neželenih učinkov - aprepitant
English: Determine the volume to be administered from this prepared infusion bag, based on the recommended dose (see section 4.2).
Slovenian: Na podlagi priporočenega odmerka določite volumen, ki ga je treba aplicirati iz te pripravljene vrečke za infundiranje (glejte poglavje 4.2).
English: Metabolism and nutrition disorders decreased appetite common polydipsia rare
Slovenian: Presnovne in prehranske motnje zmanjšan apetit pogosti polidipsija redki
English: The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of fosaprepitant.
Slovenian: Med in še 28 dni po uporabi fosaprepitanta se lahko zmanjša učinkovitost hormonskih kontraceptivov.
English: The following adverse reactions were observed in a pooled analysis of the HEC and MEC studies at a greater incidence with oral aprepitant than with standard therapy in adults or paediatric patients or in postmarketing use.
Slovenian: V nadaljevanju so navedeni neželeni učinki iz združene analize HEC in MEC študij pri odraslih in pediatričnih bolnikih, ki so jih pri peroralnemu aprepitantu opazili pogosteje kot pri standardni obliki zdravljenja, ali iz obdobja trženja zdravila.
English: Dizziness and fatigue may occur following administration of IVEMEND (see section 4.8).
Slovenian: Po uporabi zdravila IVEMEND se lahko pojavita omotica in utrujenost (glejte poglavje 4.8).
English: Determine the volume to be administered from this prepared infusion bag, based on the recommended dose (see Summary of Product Characteristic (SmPC), section 4.2).
Slovenian: Na podlagi priporočenega odmerka določite volumen, ki ga je treba aplicirati iz te pripravljene vrečke za infundiranje (glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila (SmPC)).
English: Conclusions regarding the influence of moderate hepatic impairment (Child-Pugh class B) on aprepitant pharmacokinetics cannot be drawn from available data.
Slovenian: Iz razpoložljivih podatkov ni mogoče sklepati, kakšen je vpliv zmerne okvare jeter (razred B po Child-Pugh-ovi klasifikaciji) na farmakokinetiko aprepitanta.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
Slovenian: Pripravljene raztopine se običajno ne sme shranjevati dlje kot 24 ur pri temperaturi od 2 °C do 8 °C.
English: Infection and infestations candidiasis, staphylococcal infection rare
Slovenian: Infekcijske in parazitske bolezni kandidoza, stafilokokna okužba redki
English: EMEND capsules or EMEND for oral suspension may be used on Days 2 and 3 instead of IVEMEND, as shown in
Slovenian: Drugi in tretji dan je mogoče namesto zdravila IVEMEND uporabiti zdravilo EMEND v obliki kapsul ali peroralne suspenzije, kot je prikazano v preglednici 3.
English: 150 mg intravenously
Slovenian: 150 mg intravensko
English: 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.
Slovenian: 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).
English: 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
Slovenian: Preglednica 3: Priporočeno odmerjanje za preprečevanje navzee in bruhanja, povezanih z enodnevnimi ali večdnevnimi shemami HEC ali MEC, pri pediatričnih bolnikih
English: It is not recommended to reinitiate the infusion in patients who experience hypersensitivity reactions.
Slovenian: Pri bolnikih, pri katerih se pojavijo preobčutljivostne reakcije, ne priporočamo ponovnega začetka infuzije.
English: Fosaprepitant 150 mg, given as a single dose, is a weak inhibitor of CYP3A4.
Slovenian: Fosaprepitant 150 mg, dan v obliki enkratnega odmerka, je šibek zaviralec CYP3A4.
English: Eye disorders conjunctivitis rare
Slovenian: Očesne bolezni konjunktivitis redki
English: 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.
Slovenian: 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.
English: In rabbits, fosaprepitant caused initial transient local acute inflammation following paravenous, subcutaneous and intramuscular administration.
Slovenian: Pri kuncih je fosaprepitant po paravenski, subkutani in intramuskularni aplikaciji povzročilo začetno prehodno lokalno akutno vnetje.
English: Furthermore, fosaprepitant underwent rapid and nearly complete conversion to aprepitant in S9 preparations from other human tissues including kidney, lung and ileum.
Slovenian: 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.
English: If a corticosteroid, such as dexamethasone, is coadministered, administer 50% of the recommended corticosteroid dose on days 1 through 4
Slovenian: Pri sočasni uporabi kortikosteroida, kot je deksametazon, od 1. do 4. dne uporabite 50 % priporočenega odmerka kortikosteroida.
English: Figure 1: Percent of adult patients receiving Moderately Emetogenic Chemotherapy who remain emesis free over time
Slovenian: Slika 1: Odstotek odraslih bolnikov, ki so prejemali zmerno emetogeno kemoterapijo, pri katerih se bruhanje ne pojavi, glede na čas
English: VIAL LABEL 150 mg
Slovenian: NALEPKA NA VIALI 150 mg
English: Day 1 IVEMEND 150 mg intravenously Dexamethasone
Slovenian: 1. dan zdravilo IVEMEND 150 mg intravensko deksametazon
English: 8 mg orally twice daily
Slovenian: 8 mg peroralno dvakrat na dan antagonist 5-HT3
English: Interactions with other medicinal products following administration of intravenous fosaprepitant are likely to occur with active substances that interact with oral aprepitant.
Slovenian: Po intravenski aplikaciji fosaprepitanta se lahko pojavijo interakcije z drugimi zdravili, ki medsebojno delujejo s peroralnim aprepitantom.
English: No data are available following the administration of a 3-day IV fosaprepitant regimen in paediatric patients.
Slovenian: Podatkov po uporabi 3-dnevne intravenske sheme fosaprepitanta pri pediatričnih bolnikih ni na voljo.
English: See the Summary of Product Characteristics (SmPC) for EMEND capsules or EMEND for oral suspension for appropriate dosing instructions.
Slovenian: Za ustrezna navodila glede odmerjanja glejte Povzetek glavnih značilnosti zdravila (SmPC) za kapsule ali peroralno suspenzijo zdravila EMEND.
English: Table 4: Alternative dosing for the prevention of nausea and vomiting associated with single day regimens of HEC or MEC in paediatric patients
Slovenian: Preglednica 4: Alternativno odmerjanje za preprečevanje navzee in bruhanja, povezanih z enodnevnimi shemami HEC ali MEC, pri pediatričnih bolnikih
English: Post-marketing events of neurotoxicity, a potential adverse reaction of ifosfamide, have been reported after aprepitant and ifosfamide co-administration.
Slovenian: V obdobju trženja zdravila so pri sočasni uporabi aprepitanta in ifosfamida poročali o pojavu nevrotoksičnosti, možnega neželenega učinka ifosfamida.
English: Refer to the Summary of Product Characteristics of co-administered 5-HT3 antagonist medicinal products.
Slovenian: Glejte tudi Povzetek glavnih značilnosti zdravila za antagoniste 5-HT3, ki se uporabljajo sočasno.
English: 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 %).
Slovenian: 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 %).
English: Day 3
Slovenian: 3. dan
English: The reconstituted and diluted final solution is stable for 24 hours at 25C.
Slovenian: Rekonstituirana in razredčena končna raztopina je stabilna 24 ur pri temperaturi 25 C.
English: Infusion site reactions (ISRs) have been reported with the use of IVEMEND (see section 4.8).
Slovenian: Pri uporabi zdravila IVEMEND so poročali o reakcijah na mestu infundiranja (glejte poglavje 4.8).
English: Aprepitant undergoes extensive metabolism.
Slovenian: Aprepitant se v veliki meri presnavlja.
English: Paediatric patients 6 months to less than 2 years and not less than 6 kg
Slovenian: Pediatrični bolniki, stari od 6 mesecev do manj kot 2 leti in s telesno maso vsaj 6 kg
English: *Nausea and vomiting were efficacy parameters in the first 5-days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
Slovenian: *Navzea in bruhanje sta bila prvih 5 dni po kemoterapiji parametra učinkovitosti.
English: The dose of dexamethasone accounts for active substance interactions.
Slovenian: Odmerek deksametazona že upošteva medsebojno delovanje zdravilnih učinkovin.
English: 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
Slovenian: Pogostnost fotosenzitivna reakcija, hiperhidroza, seboreja, kožne lezije, srbeč izpuščaj, Stevens-Johnsonov sindrom/toksična epidermalna nekroliza redki srbenje, urtikarija neznana
English: Tabulated list of adverse reactions - aprepitant
Slovenian: Seznam neželenih učinkov - aprepitant
English: No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).
Slovenian: Pri bolnikih z okvaro ledvic in bolnikih s končno odpovedjo ledvic na hemodializi odmerka ni treba prilagoditi (glejte poglavje 5.2).