natgillin/translations-raw huggingface dataset:
The aprepitant regimen in combination with an ondansetron/dexamethasone regimen (see section 4.2) was compared with standard therapy (placebo in combination with ondansetron 8 mg orally (twice on Day 1, and every 12 hours on Days 2 and 3) plus dexamethasone 20 mg orally on Day 1).
Aprepitant v kombinaciji z ondansetronom/deksametazonom (glejte poglavje 4.2) so primerjali s standardno obliko zdravljenja (placebo v kombinaciji z ondansetronom 8 mg peroralno (dvakrat 1. dan in vsakih 12 ur 2. in 3. dan) in deksametazon 20 mg peroralno 1. dan).
The plasma clearance of aprepitant is dose-dependent, decreasing with increased dose and ranged from approximately 60 to 72 mL/min in the therapeutic dose range.
V območju terapevtskih odmerkov znaša od približno 60 do 72 ml/min.
Nervous system disorders dysarthria, hypoaesthesia, sensory disturbance uncommon
Bolezni živčevja disartrija, hipestezija, senzorične motnje občasni
What EMEND is and what it is used for What you need to know before you take or give EMEND How to take EMEND
Kaj je zdravilo EMEND in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli ali dali zdravilo EMEND Kako jemati zdravilo EMEND
Aprepitant is a substrate, and a dose-dependent inhibitor, and an inducer of CYP3A4.
Aprepitant je substrat in od odmerka odvisen zaviralec in induktor CYP3A4.
Table 2 Percent of adult patients responding by treatment group and phase - Cycle 1 Moderately Emetogenic Chemotherapy
Preglednica 2 Odstotek odraslih bolnikov z odzivom po zdravljenih skupinah in fazi - 1. ciklus Zmerno emetogena kemoterapija
After treatment with EMEND, the doctor may ask the child to continue taking other medicines for preventing nausea and vomiting which may include: - a corticosteroid - such as dexamethasone and - a ‘5-HT3 antagonist' - such as ondansetron Check with the doctor, pharmacist or nurse if you are not sure.
Po zdravljenju z zdravilom EMEND lahko zdravnik otroku naroči, naj nadaljuje z jemanjem drugih zdravil za preprečevanje siljenja na bruhanje in bruhanja, med katerimi so lahko: - kortikosteroid - na primer deksametazon in - antagonist 5-HT3 - na primer ondansetron
Excipient with known effect Each capsule contains 165 mg of sucrose.
Pomožna snov z znanim učinkom Ena kapsula vsebuje 165 mg saharoze.
The most common adverse reaction reported at a greater incidence in adults treated with 40 mg aprepitant (1.1 %) than with ondansetron (1.0 %) was ALT increased.
Povečanje vrednosti ALT je bila najpogostejša neželena reakcija, katere pogostnost je bila pri odraslih, ki so prejemali 40 mg aprepitanta večja (1,1 %) od pogostnosti pri odraslih, ki so prejemali ondansetron (1,0 %).
Paediatric population: In a study using a powder for oral suspension formulation, a single dose of 40 mg aprepitant administered to adolescent patients (aged 12 through 17 years) resulted in a mean AUC0-48hr of 6 µg/mL with a mean peak plasma concentration (Cmax) of 0.5 µg/mL occurring at approximately 4 hours.
Pediatrična populacija: V študiji s praškom za peroralno suspenzijo je bila po enkratnem odmerku 40 mg aprepitanta pri bolnikih mladostnikih (starih od 12 do 17 let) dosežena povprečna AUC0-48h 6 µg/ml, povprečna najvišja koncentracija v plazmi (Cmax) 0,5 µg/ml pa se je pojavila po približno 4 urah.
When a single 125 mg dose of 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 odmerku 125 mg aprepitanta 5. dan 10-dnevnega zdravljenja s ketokonazolom (ki je močan zaviralec CYP3A4) 400 mg/dan se je AUC aprepitanta povečal za približno 5-krat, srednji končni razpolovni čas aprepitanta pa se je podaljšal za približno 3-krat.
- If chemotherapy is given, take EMEND 1 hour before you start your chemotherapy session.
- Če boste dobili kemoterapijo, zdravilo EMEND vzemite 1 uro pred začetkom kemoterapije.
Renal impairment: A single 240 mg dose of 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 s končno odpovedjo ledvic, ki potrebujejo hemodializo, so dali po en sam 240 mg odmerek aprepitanta.
Tell the doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika ali farmacevta, če vi ali otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
In 2 randomised, double-blind studies encompassing a total of 1,094 adult patients receiving chemotherapy that included cisplatin  70 mg/m2, aprepitant in combination with an ondansetron/dexamethasone regimen (see section 4.2) was compared with a standard regimen (placebo plus ondansetron 32 mg intravenously administered on Day 1 plus dexamethasone 20 mg orally on Day 1 and 8 mg orally twice daily on Days 2 to 4).
3-dnevni režim zdravljenja z aprepitantom pri odraslih V 2 randomiziranih, dvojno slepih študijah, ki sta skupaj zajeli 1.094 odraslih bolnikov na kemoterapiji, ki je vključevala cisplatin  70 mg/m2, so primerjali aprepitant v kombinaciji z ondansetronom/deksametazonom (glejte poglavje 4.2) in standardno terapijo (placebo in ondansetron 32 mg intravensko 1. dan ter deksametazon 20 mg peroralno 1. dan in 8 mg peroralno dvakrat na dan od 2. do 4. dne).
In an additional active-controlled clinical study in 1,169 patients receiving aprepitant and HEC, the adverse reactions profile was generally similar to that seen in the other HEC studies with aprepitant.
V dodatni z zdravilno učinkovino nadzorovani klinični študiji, kjer je 1.169 bolnikov prejemalo aprepitant in HEC, je bil profil neželenih učinkov na splošno podoben kot pri drugih študijah HEC z aprepitantom.
IMMEDIATE PACKAGING - TRIFOLD - 2-day treatment pack
PRIMARNA OVOJNINA - pakiranje za 2-dnevno zdravljenje
EMEND is used in adults in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) containing cisplatin (a strong trigger of nausea and vomiting) and with chemotherapy that is a moderate trigger of nausea and vomiting (such as cyclophosphamide, doxorubicin or epirubicin).
Zdravilo EMEND uporabljamo pri odraslih v kombinaciji z drugimi zdravili za preprečevanje navzee (siljenja na bruhanje) in bruhanja zaradi kemoterapije (zdravljenje raka), ki vključuje cisplatin (močan povzročitelj navzee in bruhanja), in pri kemoterapiji, ki povzroča zmerno navzeo in bruhanje (kot so ciklofosfamid, doksorubicin ali epirubicin).
Excipient with known effect Each capsule contains 40 mg of sucrose.
Pomožna snov z znanim učinkom Ena kapsula vsebuje 40 mg saharoze.
EMEND, when given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 23 % on Day 4, 28 % on Day 8, and 15 % on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of EMEND and on Days 4, 8, and 15.
Zdravilo EMEND je pri jemanju po shemi 125 mg 1. dan ter 80 mg/dan 2. in 3. dan zmanjšalo vrednost AUC tolbutamida (ki je substrat za CYP2C9), ki so ga bolniki prejemali v enkratnem odmerku 500 mg peroralno pred začetkom 3-dnevne sheme odmerjanja zdravila EMEND ter 4., 8. in 15. dan, in sicer za 23 % 4. dan, za 28 % 8. dan in za 15 % 15. dan.
This medicine should not be used during pregnancy unless clearly necessary.
Tega zdravila se ne sme uporabljati med nosečnostjo, razen če je izrecno potrebno.
*Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
*Navzea in bruhanje sta bila parametra učinkovitosti prvih 5 dni po kemoterapiji; o njih so kot o neželenih učinkih poročali šele po tem času.
The 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 %).
Najpogostejša neželena učinka, o katerih so med prejemanjem emetogene kemoterapije raka pogosteje poročali pri pediatričnih bolnikih, zdravljenih s shemo z aprepitantom, kot pri zdravljenih s kontrolno shemo, sta bila kolcanje (3,3 % v primerjavi z 0,0 %) in zardevanje (1,1 % v primerjavi z 0,0 %).
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
Bolezni kože in podkožja izpuščaj, akne občasni fotosenzitivnostna reakcija, hiperhidroza, seboreja, lezije kože, srbeč izpuščaj, Stevens-Johnsonov sindrom/toksična epidermalna nekroliza redki pruritus, urtikarija neznana
Pack size of one carton contains one sachet, one 1 mL and one 5 mL oral dispenser (polypropylene with silicone o-ring), one cap and one mixing cup (polypropylene).
Ena škatla vsebuje eno vrečko, en 1-ml in en 5-ml odmernik (iz polipropilena in s silikonskim oobročkom), eno zaporko in eno čašo za mešanje (iz polipropilena).
Figure 1 Percent of adult patients receiving Highly Emetogenic Chemotherapy who remain emesis free over time - Cycle 1
Slika 1 Odstotek odraslih bolnikov, ki so prejemali zelo emetogeno kemoterapijo, pri katerih se bruhanje ne pojavi, glede na čas - 1. ciklus
EMEND 80 mg hard capsules are taken just once a day for 2 consecutive days.
EMEND 80 mg trde kapsule se jemlje 2 dni zapored enkrat na dan. EMEND kapsule lahko vzamete s hrano ali brez.
- Take the cap off the oral dispenser.
- Zaporko odstranite z odmernika.
- The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, and black iron oxide (E 172); the 125 mg hard capsule also contains red iron oxide (E 172) and yellow iron oxide (E 172).
- Druge sestavine zdravila so: saharoza, mikrokristalna celuloza (E 460), hidroksipropilceluloza (E 463), natrijev lavrilsulfat, želatina, titanov dioksid (E 171), šelak, kalijev hidroksid in črni železov oksid (E 172); 125 mg trda kapsula vsebuje še rdeči železov oksid (E 172) in rumeni železov oksid (E 172).
In an additional active-controlled clinical study in 1,169 adult patients receiving aprepitant and HEC, the adverse reactions profile was generally similar to that seen in the other HEC studies with aprepitant.
V dodatni z zdravilno učinkovino nadzorovani klinični študiji, kjer je 1.169 odraslih bolnikov prejemalo aprepitant in HEC, je bil profil neželenih učinkov na splošno podoben kot pri drugih študijah HEC z aprepitantom.
It belongs to a group of medicines called ‘neurokinin 1 (NK1) receptor antagonists'.
To zdravilo spada v skupino zdravil imenovanih "antagonisti receptorjev za nevrokinin 1 (NK1)".
Elderly: Following oral administration of a single 125 mg dose of aprepitant on Day 1 and 80 mg once daily on Days 2 through 5, the AUC0-24hr of aprepitant was 21 % higher on Day 1 and 36 % higher on Day 5 in elderly ( 65 years) relative to younger adults.
Starejši: Po enem peroralnem odmerku 125 mg aprepitanta 1. dan ter 80 mg enkrat na dan od 2. do 5. dne je bila vrednost AUC0-24 h aprepitanta pri starejših preiskovancih ( 65 let) večja kot pri mlajših odraslih preiskovancih, in sicer 1. dan za 21 %, 5. dan pa za 36 %.
The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), Indigo carmine (E 132), shellac, potassium hydroxide, and black iron oxide (E 172).
Druge sestavine zdravila so: saharoza, mikrokristalna celuloza (E 460), hidroksipropilceluloza (E 463), natrijev lavrilsulfat, želatina, titanov dioksid (E 171), indigotin (E 132), šelak, kalijev hidroksid in črni železov oksid (E 172).
In patients on chronic warfarin therapy, the prothrombin time (INR) should be monitored closely during treatment with EMEND and for 2 weeks following each 3-day course of EMEND for chemotherapy induced nausea and vomiting (see section 4.4).
Pri bolnikih na kroničnem zdravljenju z varfarinom, je treba protrombinski čas (INR) skrbno nadzorovati med zdravljenjem z zdravilom EMEND in 2 tedna po vsakem 3-dnevnem ciklusu zdravljenja navzee in bruhanja zaradi kemoterapije z zdravilom EMEND (glejte poglavje 4.4).
Lactose (anhydrous) Red iron oxide (E 172) Sodium stearyl fumarate (E 485)
rdeči železov oksid (E 172) natrijev stearilfumarat (E 485)
Interaction studies with aprepitant 165 mg and midazolam have not been conducted; however, the following study with 200 mg of aprepitant should be considered when using EMEND 165 mg with medicinal products metabolised via CYP3A4.
Študije medsebojnega delovanja aprepitanta 165 mg in midazolama niso bile izvedene, vendar pa je pri uporabi zdravila EMEND 165 mg in zdravil, ki se presnavljajo preko CYP3A4, treba upoštevati sledečo študijo z 200 mg aprepitanta.
Table 4 Percent of adult patients receiving Highly Emetogenic Chemotherapy responding by treatment group and phase - Cycle 1
Preglednica 4 Odstotek odraslih bolnikov, ki so prejemali zelo emetogeno kemoterapijo, z odzivom po zdravljenih skupinah in fazi - 1. ciklus
3-day treatment pack containing: 1 x 125 mg hard capsule and 2 x 80 mg hard capsule
Pakiranje za 3-dnevno zdravljenje vsebuje: 1 x 125 mg trda kapsula 2 x 80 mg trda kapsula
EMEND should not be used during pregnancy unless clearly necessary.
Zdravila EMEND se med nosečnostjo ne sme uporabljati, razen če je to nujno potrebno.
Pink to light pink powder.
prašek za peroralno suspenzijo prašek rožnate do svetlorožnate barve
Co-administration with warfarin (a CYP2C9 substrate) In patients on chronic warfarin therapy, the International Normalised Ratio (INR) should be monitored closely during treatment with EMEND and for 14 days following each 3-day course of EMEND (see section 4.5).
Sočasna uporaba z varfarinom (substratom CYP2C9) Pri bolnikih na kroničnem zdravljenju z varfarinom, je treba internacionalno normalizirano razmerje (INR) skrbno spremljati med zdravljenjem z zdravilom EMEND in še 14 dni po vsakem 3-dnevnem ciklusu zdravljenja z zdravilom EMEND (glejte poglavje 4.5).
bloating - urinating more often or passing more urine than normal, sugar or blood in urine - chest discomfort, swelling, change in the manner of walking - cough, mucus in the back of the throat, throat irritation, sneezing, sore throat - eye discharge and itching - ringing in the ears - muscle spasms, muscle weakness - feeling very thirsty - slow heartbeat, heart and blood vessel disease - low number of white blood cells, low sodium levels in the blood, weight loss.
napihnjenost - pogostejše uriniranje ali izločanje več urina kot običajno, sladkor ali kri v urinu - nelagodje v prsnem košu, otekanje, sprememba v načinu hoje - kašelj, sluz na zadnji steni žrela, draženje žrela, kihanje, vnetje žrela - izcedek iz očesa in srbenje - zvonjenje v ušesih - mišični krči, šibkost mišic - občutek hude žeje - počasno bitje srca, srčno in žilno obolenje - nizko število belih krvnih celic, nizka vrednost natrija v krvi, izguba telesne mase.
†Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
†Navzea in bruhanje sta bila parametra učinkovitosti prvih 5 dni po kemoterapiji; o njih so kot o neželenih učinkih poročali šele po tem času.
Always take EMEND together with other medicines, to prevent nausea and vomiting.
Zdravilo EMEND vedno jemljite skupaj z drugimi zdravili za preprečevanje navzee in bruhanja.
No dose adjustment is necessary based on gender (see section 5.2).
Odmerka ni treba prilagoditi glede na spol bolnika (glejte poglavje 5.2).
Do not give this medicine to the child after the expiry date which is stated on the carton and sachet after EXP.
Tega zdravila otroku ne smete dati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
General disorders and administration site conditions fatigue common asthenia, malaise uncommon oedema, chest discomfort, gait disturbance rare
Splošne težave in spremembe na mestu aplikacije utrujenost pogosti astenija, splošno slabo počutje občasni edem, nelagodje v prsnem košu, motnja hoje redki
Table 1 Percent of adult patients receiving Highly Emetogenic Chemotherapy responding by treatment group and phase - Cycle 1
Preglednica 1 Odstotek odraslih bolnikov, ki so prejemali zelo emetogeno kemoterapijo, z odzivom po zdravljenih skupinah in fazi - 1. ciklus
Potassium hydroxide Black iron oxide (E 172)
Črnilo za tisk šelak kalijev hidroksid črni železov oksid (E 172)
Overall phase: 0 to 120 hours following initiation of chemotherapy.
Celotna faza: od 0 do 120 ur po začetku kemoterapije.
Single-use carton
Škatla za enkratno uporabo
IMMEDIATE PACKAGING - TRIFOLD - 3-day treatment pack
PRIMARNA OVOJNINA - pakiranje za 3-dnevno zdravljenje
The fosaprepitant regimen consisted of fosaprepitant 150 mg on Day 1 in combination with intravenous ondansetron 32 mg on Day 1 and dexamethasone 12 mg on Day 1, 8 mg on Day 2, and 8 mg twice daily on Days 3 and 4.
Režim zdravljenja s fosaprepitantom je vključeval fosaprepitant 150 mg 1. dan v kombinaciji z intravenskim ondansetronom 32 mg 1. dan in deksametazonom 12 mg 1. dan, 8 mg 2. dan in 8 mg dvakrat na dan 3. in 4. dan.
As a weak inhibitor of CYP3A4, aprepitant (40 mg) can increase plasma concentrations of orally co-administered active substances that are metabolised through CYP3A4.
Kot šibek zaviralec CYP3A4 lahko aprepitant (40 mg) zviša plazemske koncentracije sočasno uporabljenih peroralnih zdravilnih učinkovin, ki se presnavljajo s CYP3A4.
Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.
Preprečevanje navzee in bruhanja, povezanih z zmerno emetogeno kemoterapijo raka pri odraslih.
Stop taking EMEND and see a doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment: - Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data); these are signs of an allergic reaction.
Prenehajte jemati zdravilo EMEND in se takoj posvetujte z zdravnikom, če opazite katerega od naslednjih neželenih učinkov, ki so lahko resni in zaradi katerih boste lahko nujno potrebovali zdravljenje: - koprivnico, izpuščaj, srbenje, težave z dihanjem ali požiranjem - (neznana pogostnost; ni je mogoče oceniti iz razpoložljivih podatkov); to so znaki alergijske reakcije.
In animal studies there was no indication of direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Pri študijah na živalih ni bilo znakov neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
After the treatment, EMEND causes a transient mild induction of CYP2C9, CYP3A4 and glucuronidation.
Zdravilo EMEND po zdravljenju povzroči prehodno blago indukcijo CYP2C9, CYP3A4 in glukuronidacije.
Methylprednisolone: The usual intravenously administered methylprednisolone dose should be reduced approximately 25 %, and the usual oral methylprednisolone dose should be reduced approximately 50 % when co-administered with EMEND 125 mg/80 mg regimen.
Metilprednizolon: Pri sočasni uporabi z zdravilom EMEND (režim 125 mg/80 mg) je treba običajni intravenski odmerek metilprednizolona zmanjšati za približno 25 %, običajni peroralni odmerek metilprednizolona pa za približno 50 %.
Prevention nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12.
Preprečevanje navzee in bruhanja, ki spremljata zelo emetogeno ter zmerno emetogeno kemoterapijo raka pri odraslih in mladostnikih od 12. leta starosti.
The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of EMEND.
Med jemanjem zdravila EMEND in še 28 dni po koncu jemanja se lahko zmanjša učinkovitost hormonskih kontraceptivov.
What EMEND contains The active substance is aprepitant.
Kaj vsebuje zdravilo EMEND Zdravilna učinkovina je aprepitant.
Following oral administration of a single 125 mg dose of EMEND on Day 1 and 80 mg once daily on Days 2 and 3, the AUC0-24hr (mean±SD) was 19.6 ± 2.5 µg•h/mL and 21.2 ± 6.3 µg •h/mL on Days 1 and 3, respectively.
Po peroralnem zaužitju enega 125 mg odmerka zdravila EMEND 1. dan ter 80 mg enkrat na dan 2. in 3. dan je AUC0-24 ur (povprečje  SD) znašal 19,6  2,5 μg•h/ml 1. dan ter 21,2  6,3 μg•h/ml 3. dan. Cmax je znašala 1,6  0,36 μg/ml 1. dan ter 1,4  0,22 μg/ml 3. dan.
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*, gastroezofagealna refluksna bolezen, bolečine v trebuhu, suha usta, flatulenca občasni perforacija duodenalnega ulkusa, stomatitis, napihnjen trebuh, trdo blato, nevtropenični kolitis redki
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 odraslih je 72 ur po enkratnem 100 mg intravenskem odmerku 
In an additional active-controlled clinical study in 1,169 adult patients receiving the 3-day oral aprepitant regimen and HEC, the adverse reactions profile was generally similar to that seen in the other HEC studies with the 3-day oral aprepitant regimen.
V dodatni z zdravilno učinkovino nadzorovani klinični študiji pri 1.169 odraslih bolnikih, ki so prejemali peroralni aprepitant po 3-dnevni shemi in zelo emetogeno kemoterapijo, je bil profil neželenih učinkov na splošno podoben tistemu v drugih HEC študijah s peroralnim aprepitantom po 3-dnevni shemi.
Alternative non-hormonal back-up methods of contraception should be used during treatment with EMEND and for 2 months following the last dose of EMEND.
Med zdravljenjem z zdravilom EMEND in še 2 meseca po zadnjem odmerku zdravila EMEND je treba uporabljati alternativno nehormonsko kontracepcijsko metodo.
The following adverse reactions were observed in a pooled analysis of the HEC and MEC studies at a greater incidence with aprepitant than with standard therapy in adults or paediatric patients or in postmarketing use.
Spodaj so navedeni neželeni učinki, ki so jih v metaanalizi študij HEC in MEC pri aprepitantu opazili pogosteje kot pri standardnem zdravljenju pri odraslih ali pediatričnih bolnikih, in neželeni učinki iz obdobja trženja zdravila.
In a clinical study, single doses of an oral contraceptive containing ethinyl estradiol and norethindrone were administered on Days 1 through 21 with EMEND, given as a regimen of 125 mg on Day 8 and 80 mg/day on Days 9 and 10 with ondansetron 32 mg 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 klinični študiji so enkratne odmerke peroralnega kontraceptiva, ki je vseboval etinilestradiol in noretindron, od 1. do 21. dne dajali skupaj z zdravilom EMEND po shemi 125 mg 8. dan in 80 mg/dan 9. in 10. dan, z ondansetronom 32 mg intravensko 8. dan in s peroralnim deksametazonom v obliki 12 mg odmerka 8. dan in 8 mg/dan 9., 10. in 11. dan.
Always take this medicine or give this medicine to the child exactly as the doctor, pharmacist or nurse has told you.
Pri jemanju tega zdravila oziroma dajanju tega zdravila otroku natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
What EMEND is and what it is used for What you need to know before you give EMEND How to give EMEND
Kaj je zdravilo EMEND in za kaj ga uporabljamo Kaj morate vedeti, preden boste dali zdravilo EMEND Kako dajati zdravilo EMEND Možni neželeni učinki