FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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).
English: 5-HT3 antagonists
Slovenian: Antagonist 5-HT3
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Day 2
Slovenian: 2. dan
English: 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.
Slovenian: 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).
English: White to off-white amorphous powder.
Slovenian: prašek za raztopino za infundiranje bel do sivo-bel amorfni prašek
English: Chemotherapeutic medicinal products
Slovenian: Kemoterapevtiki
English: Cardiac disorders palpitations uncommon bradycardia, cardiovascular disorder rare
Slovenian: Srčne bolezni palpitacije občasni bradikardija, bolezen srca in ožilja redki
English: 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).
Slovenian: 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.
English: The first 2 numbers indicate the month; the next 4 numbers indicate the year.
Slovenian: 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.
English: 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.
Slovenian: Za bolnike z zmerno okvaro jeter je podatkov malo, za bolnike s hudo okvaro jeter pa podatkov ni.
English: Paediatric patients 6 months to less than 12 years and not less than 6 kg
Slovenian: Pediatrični bolniki, stari od 6 mesecev do manj kot 12 let in s telesno maso vsaj 6 kg
English: Fosaprepitant regimen (N =502) **
Slovenian: OPAZOVANI DOGODKI* Fosaprepitant (N = 502) **
English: C]- fosaprepitant, a prodrug for aprepitant, indicating a substantial presence of metabolites in the plasma.
Slovenian: C-fosaprepitanta, predzdravila aprepitanta, približno 19 % radioaktivnosti v plazmi prispeval aprepitant, kar kaže na znatno prisotnost presnovkov v plazmi.
English: 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.
Slovenian: Pri sočasni uporabi zdravila IVEMEND je treba upoštevati možne učinke zvišanih plazemskih koncentracij midazolama ali drugih benzodiazepinov, ki se presnavljajo s CYP3A4 (alprazolam, triazolam).
English: Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant.
Slovenian: Ena viala vsebuje dimegluminijev fosaprepitant, ki ustreza 150 mg fosaprepitanta.
English: Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant.
Slovenian: Fosaprepitant, predzdravilo aprepitanta, se po intravenski aplikaciji hitro pretvori v aprepitant.
English: Do not administer IVEMEND as a bolus injection or undiluted solution.
Slovenian: Zdravila IVEMEND se ne sme aplicirati v obliki bolus injekcije ali nerazredčene raztopine.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Učinkovitost 1-dnevne sheme fosaprepitanta je pri pediatričnih bolnikih predvidoma podobna kot učinkovitost 1-dnevne sheme fosaprepitanta pri odraslih.
English: When administered intravenously fosaprepitant is rapidly converted to aprepitant.
Slovenian: Po intravenski aplikaciji se fosaprepitant hitro pretvori v aprepitant.
English: Infusion site reactions (ISRs) have been reported with the use of IVEMEND (see section 4.4).
Slovenian: Pri uporabi zdravila IVEMEND so poročali o reakcijah na mestu infundiranja (glejte poglavje 4.4).
English: 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.
Slovenian: Fosaprepitant 150 mg v obliki enkratnega odmerka je 1. dan šibek zaviralec CYP3A4, za 4. dan pa ni dokazov za zaviranje ali indukcijo CYP3A4.
English: Table 1: Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy regimen in adults
Slovenian: Preglednica 1: Priporočeno odmerjanje za preprečevanje navzee in bruhanja zaradi zelo emetogene kemoterapije pri odraslih
English: Multiday chemotherapy regimens include chemotherapy regimens in which HEC or MEC is administered for 2 or more days.
Slovenian: 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.
English: Oral aprepitant
Slovenian: Peroralni aprepitant
English: There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Slovenian: Za bolnike z zmerno okvaro jeter je podatkov o uporabi zdravila malo, za bolnike s hudo okvaro jeter pa podatkov ni.
English: Nervous system disorders headache common dizziness, somnolence uncommon cognitive disorder, lethargy, dysgeusia rare
Slovenian: Bolezni živčevja glavobol pogosti omotica, zaspanost občasni motnje kognitivne funkcije, letargija, disgevzija redki
English: 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
Slovenian: 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
English: Table 2: Recommended dosing for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy regimen in adults
Slovenian: Preglednica 2: Priporočeno odmerjanje za preprečevanje navzee in bruhanja zaradi zmerno emetogene kemoterapije pri odraslih
English: 1-day IV dose
Slovenian: 4. dan zdravilo IVEMEND
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: Since fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant are expected to occur with fosaprepitant.
Slovenian: Fosaprepitant se pretvori v aprepitant, zato pri uporabi fosaprepitanta pričakujemo pojav neželenih učinkov, ki so povezani z aprepitantom.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Respiratory, thoracic and mediastinal disorders hiccups common oropharyngeal pain, sneezing, cough, postnasal drip, throat irritation rare
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kolcanje pogosti orofaringealna bolečina, kihanje, kašelj, postnazalni izcedek, draženje žrela redki
English: The fosaprepitant 150 mg single dose did not induce CYP3A4 on Days 1 and 4 in the midazolam interaction study.
Slovenian: V študiji medsebojnega delovanja z midazolamom fosaprepitant v obliki enkratnega 150 mg odmerka 1. in 4. dan ni induciral CYP3A4.
English: 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 [
Slovenian: Pri zdravih mladih preiskovancih je, 72 ur po eni intravenski infuziji 100 mg odmerka 
English: Immediate hypersensitivity reactions including flushing, erythema, dyspnoea, and anaphylaxis/anaphylactic shock have occurred during or soon after infusion of fosaprepitant.
Slovenian: Med ali kmalu po infuziji fosaprepitanta so se pojavile takojšnje preobčutljivostne reakcije, vključno z zardevanjem, eritemom, dispnejo in anafilaksijo/anafilaktičnim šokom.
English: 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).
Slovenian: 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).
English: Inhibition of CYP3A4 by fosaprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious or lifethreatening reactions.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Fosaprepitant does not seem to interact with the P-glycoprotein transporter, as demonstrated by the lack of interaction of oral aprepitant with digoxin.
Slovenian: Peroralni aprepitant medsebojno ne deluje z digoksinom, zato fosaprepitant verjetno ne vpliva na P-glikoproteinski prenašalec.
English: The reconstituted and diluted medicinal product should be inspected visually for particulate matter and discoloration before administration.
Slovenian: Pred aplikacijo morate rekonstituirano in razredčeno zdravilo pregledati glede tujih delcev ali spremembe barve.
English: Dexamethasone
Slovenian: Deksametazon
English: 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
Slovenian: 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
English: General disorders and administration site conditions fatigue common asthaenia, malaise uncommon oedema, chest discomfort, gait disturbance rare
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost pogosti astenija, splošno slabo počutje občasni edem, neugodje v prsnem košu, motnja hoje redki
English: The pharmacokinetics of aprepitant is non-linear across the clinical dose range.
Slovenian: V razponu kliničnih odmerkov je farmakokinetika aprepitanta nelinearna.
English: 12 - 17 years old 150 mg 30400
Slovenian: 150 mg 30.400 3.500 735
English: ‡ Delayed phase = 25 to 120 hours post-initiation of chemotherapy.
Slovenian: ‡ Zapoznela faza = 25 do 120 ur po začetku kemoterapije.
English: 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.
Slovenian: V polni človeški krvi in spranih človeških eritrocitih niso odkrili nobene hemolize s komercialnimi pripravki do koncentracije fosaprepitanta 1 mg/ml.
English: See the summary of product characteristics for EMEND capsules and EMEND powder for oral suspension for complete clinical information regarding studies performed with oral aprepitant.
Slovenian: Za popolne klinične informacije o študijah s peroralnim aprepitantom glejte Povzetek glavnih značilnosti zdravila za kapsule EMEND in peroralno suspenzijo EMEND.
English: The effects of IVEMEND or other medicines might be influenced if you take IVEMEND together with other medicines including those listed below.
Slovenian: Če jemljete zdravilo IVEMEND skupaj z drugimi zdravili, vključno s spodaj naštetimi, to lahko vpliva na učinek zdravila IVEMEND ali teh zdravil.
English: IVEMEND 150 mg powder for solution for infusion Fosaprepitant
Slovenian: IVEMEND 150 mg prašek za raztopino za infundiranje fosaprepitant
English: Renal and urinary disorders dysuria uncommon pollakisuria rare
Slovenian: Bolezni sečil disurija občasni polakisurija redki
English: The efficacy of a 3-day fosaprepitant regimen in paediatric patients is expected to be similar to that of the 3-day oral aprepitant regimen.
Slovenian: Učinkovitost 3-dnevne sheme fosaprepitanta je pri pediatričnih bolnikih predvidoma podobna kot med uporabo 3-dnevne peroralne sheme aprepitanta.
English: §§Delayed phase = 25 to 120 hours post-initiation of cisplatin chemotherapy.
Slovenian: §§Zapoznela faza = 25 do 120 ur po začetku kemoterapije s cisplatinom.
English: It is important to tell your doctor if you are breastfeeding or are planning to breast-feed before receiving this medicine.
Slovenian: Pomembno je, da pred začetkom zdravljenja s tem zdravilom zdravniku poveste, če dojite ali nameravate dojiti.
English: IVEMEND should be used with caution in patients receiving concomitant active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, ergot alkaloid derivatives, fentanyl, and quinidine (see section 4.5).
Slovenian: Pri bolnikih, ki sočasno prejemajo zdravilne učinkovine, ki se primarno presnavljajo s CYP3A4 in z ozkim terapevtskim območjem, kot so ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, derivati ergot alkaloidov, fentanil in kinidin, je treba zdravilo IVEMEND uporabljati previdno (glejte poglavje 4.5).
English: Inject 5 ml sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial.
Slovenian: V vialo dodajte 5 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje.
English: IVEMEND 150 mg was shown to be non-inferior to that of the 3-day regimen of aprepitant.
Slovenian: Izkazalo se je, da zdravilo IVEMEND ni slabše v primerjavi s 3-dnevnim režimom zdravljenja z aprepitantom.
English: §Overall = 0 to 120 hours post-initiation of cisplatin chemotherapy.
Slovenian: §Celotna faza = 0 do 120 ur po začetku kemoterapije s cisplatinom.
English: Interaction studies with fosaprepitant 150 mg and diltiazem have not been conducted; however, the following study with 100 mg of fosaprepitant should be considered when using IVEMEND 150 mg with diltiazem.
Slovenian: Študij medsebojnega delovanja fosaprepitanta 150 mg in diltiazema niso izvedli; vendar pa je treba pri uporabi zdravila IVEMEND 150 mg in diltiazema upoštevati naslednjo študijo s 100 mg fosaprepitanta: 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.
English: The aprepitant regimen consisted of aprepitant 125 mg on Day 1 and 80 mg/day on Days 2 and 3 in combination with ondansetron 32 mg IV on Day 1 and dexamethasone 12 mg on Day 1 and 8 mg daily on Days 2 through 4.
Slovenian: Režim zdravljenja z aprepitantom je vključeval aprepitant 125 mg 1. dan, 80 mg/dan 2. in 3. dan v kombinaciji z ondansetronom 32 mg i.v.
English: §§Acute= 0 to 24 hours post-initiation of chemotherapy.
Slovenian: §§Akutna faza = 0 do 24 ur po začetku kemoterapije.
English: IVEMEND 150 mg powder for solution for infusion fosaprepitant
Slovenian: IVEMEND 150 mg prašek za raztopino za infundiranje fosaprepitant intravenska uporaba
English: IVEMEND 150 mg powder for solution for infusion.
Slovenian: IVEMEND 150 mg prašek za raztopino za infundiranje
English: Talk to your doctor, pharmacist, or nurse before using IVEMEND.
Slovenian: Pred začetkom uporabe zdravila IVEMEND se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: IVEMEND*
Slovenian: Zdravilo IVEMEND*
English: The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.
Slovenian: Za preprečevanje navzee in bruhanja zaradi emetogene kemoterapije rakavih bolezni priporočamo naslednje režime zdravljenja.
English: Assure that sodium chloride 9 mg/ml (0.9 %) solution for injection is added to the vial along the vial wall in order to prevent foaming.
Slovenian: Za preprečitev penjenja morate 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje dodajati po steni viale.
English: Alternative non-hormonal back-up methods of contraception should be used during treatment with fosaprepitant and for 2 months following the use of fosaprepitant (see section 4.5).
Slovenian: Med zdravljenjem s fosaprepitantom in še 2 meseca po uporabi fosaprepitanta mora bolnica uporabljati alternativno nehormonsko kontracepcijsko metodo (glejte poglavje 4.5).
English: Alternative non-hormonal back-up methods of contraception should be used during treatment with fosaprepitant and for 2 months following the use of fosaprepitant.
Slovenian: Med zdravljenjem s fosaprepitantom in še 2 meseca po njem morajo bolnice uporabljati alternativno nehormonsko kontracepcijsko metodo.
English: It should be taken into account that some people get dizzy and get sleepy after using IVEMEND.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Upoštevati morate, da se pri posameznih bolnikih po zdravljenju z zdravilom IVEMEND lahko pojavita omotica ali zaspanost.