FrancophonIA/ELRC3.0 huggingface dataset:
English: Interaction studies with aprepitant 165 mg and chemotherapeutic medicinal products have not been conducted; however, based on studies with 3-day regimen of oral aprepitant and docetaxel and vinorelbine, EMEND 165 mg is not expected to have a clinically relevant interaction with intravenously administered docetaxel and vinorelbine.
Maltese: Ma sarux studji dwar interazzjoni bejn 165 mg ta' aprepitant u prodotti mediċinali kimoterapewtiċi; madankollu, fuq bażi ta' studji bi skeda ta' għoti ta' aprepitant mill-ħalq u docetaxel u vinorelbine għal 3 ijiem, 165 mg ta' EMEND mhuwiex mistenni li jkollu interazzjoni rilevanti b'mod kliniku ma' docetaxel u vinorelbine mogħtijin minn ġol-vina.
English: 165 mg orally
Maltese: 165 mg mill-ħalq
English: The majority of adults were women (> 90 %), mainly undergoing gynaecological surgery.
Maltese: Il-maġġoranza tal-adulti kienu nisa (> 90 %), fil-parti l-kbira tagħhom kienu għaddejin minn kirurġija ġinekoloġika.
English: oC and 8
Maltese: Jiem 4, 8 u 15.
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.
Maltese: Pazjenti b'indeboliment epatiku minn moderat sa sever Hemm data limitata f'pazjenti li għandhom indeboliment epatiku moderat u m'hemmx data f'pazjenti li għandhom indeboliment epatiku serju.
English: The control regimen in adolescents aged 12 through 17 years (n=48) and children aged 6 months to less than 12 years (n=102) consisted of placebo for aprepitant on Days 1, 2 and 3 in combination with ondansetron on Day 1.
Maltese: Il-kors terapewtiku ta' trattament b'kontroll fl-adolexxenti ta' età minn 12 sa 17-il sena (n=48) u tfal ta' età minn 6 xhur sa inqas minn 12-il sena (n=102) kien jikkonsisti fi plaċebo għal aprepitant fil-Jiem 1, 2 u 3 flimkien ma' ondansetron f'Jum 1.
English: 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.
Maltese: Wara l-għoti mill-ħalq ta' doża waħda ta' 125 mg ta' aprepitant f'Jum 1 u 80 mg darba kuljum fil-Jiem 2 sa 5, l-AUC0-24hr ta' aprepitant kienet 21 % ogħla f'Jum 1 u 36 % ogħla f'Jum 5 flanzjani (≥ 65 sena) meta mqabbla ma' adulti iżgħar fl-età.
English: Dexamethasone: A single 40 mg dose of aprepitant, when co-administered with a single oral dose of dexamethasone 20 mg, increased the AUC of dexamethasone by 1.45-fold.
Maltese: Doża waħda ta' aprepitant 40 mg, meta mogħtija flimkien ma' doża orali waħda ta' dexamethasone 20 mg, żiedet l-AUC ta' dexamethasone b'1.45 drabi.
English: 2 mg/kg orally Maximum dose 80 mg
Maltese: Doża massima 80 mg
English: Aprepitant regimen (N =1,134) **
Maltese: L-iskeda ta' għoti ta' Aprepitant (N =1,134) **
English: Administer the dose orally.
Maltese: - Neħħi l-għatu mid-dispenser orali.
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.
Maltese: Reazzjonijiet avversi addizzjonali ġew osservati f'pazjenti adulti ttrattati b'aprepitant għal nawseja u remettar (PONV) ta' wara l-operazzjoni u f'inċidenza akbar milli b'ondansetron: uġigħ fil-parti ta' fuq tal-addome, ħsejjes anormali fil-musrana, stitikezza*, disartrija, dispneja, ipoestesja, insomnja, mijożi, nawseja, disturbi fis-seni, skonfort fl-istonku, sub-ileus*, tnaqqis fl-akutezza tal-vista, tħarħir.
English: Aprepitant is a substrate, and a dose-dependent inhibitor, and an inducer of CYP3A4.
Maltese: Aprepitant huwa sottostrat, u inibitur dipendenti fuq id-doża, u jinduċi CYP3A4.
English: The aprepitant regimen for adolescents aged 12 through 17 years (n=47) consisted of EMEND capsules 125 mg orally on Day 1 and 80 mg/day on Days 2 and 3 in combination with ondansetron on Day 1.
Maltese: Il-kors terapewtiku ta' trattament b'aprepitant għal adolexxenti ta' età minn 12 sa 17- il sena (n=47) kien jikkonsisti f'għoti ta' kapsuli EMEND 125 mg mill-ħalq f'Jum 1 u 80 mg/jum fil-Jiem 2 u 3 flimkien ma' ondansetron f'Jum 1.
English: Fosaprepitant 150 mg, a lyophilised prodrug of aprepitant for intravenous administration, is also available as a single dose and may be used as an alternative to oral EMEND 165 mg.
Maltese: Fosaprepitant 150 mg, promediċina lijofilizzata ta' aprepitant għal għoti minn ġol-vina, hija disponibbli wkoll bħala doża singola u tista' tintuża minflok EMEND 165 mg mill-ħalq.
English: Paediatric population: As part of a 3-day regimen, dosing of aprepitant capsules (125/80/80-mg) in adolescent patients (aged 12 through 17 years) achieved an AUC0-24hr above 17 µg•hr/mL on Day 1 with concentrations (Cmin) at the end of Days 2 and 3 above 0.4 µg/mL in a majority of patients.
Maltese: Bħala parti minn kors terapewtiku ta' 3 ijiem, l-għoti ta' dożi ta' kapsuli aprepitant (125/80/80-mg) f'pazjenti adolexxenti (b'etajiet minn 12 sa 17-il sena) kiseb AUC0-24hr ta' aktar minn 17 µg•siegħa/mL f'Jum 1 b'konċentrazzjonijiet (Cmin) fi tmiem Jiem 2 u 3 ta' aktar minn 0.4 µg/mL f'maġġoranza ta' pazjenti.
English: Each capsule contains 165 mg of aprepitant.
Maltese: Kull kapsula iebsa fiha 165 mg ta' aprepitant.
English: Contains sucrose.
Maltese: TA' EĊĊIPJENTI Fih sucrose.
English: In the same clinical study, 744 adult patients continued into the Multiple-Cycle extension for up to 3 additional cycles of chemotherapy.
Maltese: Fl-istess studju kliniku, 744 pazjent adult komplew fl-estensjoni taċ-Ċiklu Multiplu sa 3 ċikli ta' kimoterapija addizzjonali.
English: In pharmacokinetic studies, EMEND, when given as a regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3, did not influence the pharmacokinetics of docetaxel administered intravenously on Day 1 or vinorelbine administered intravenously on Day 1 or Day 8.
Maltese: Fi studji farmakokinetiċi, EMEND, meta ngħata bi skeda ta' 125 mg f'Jum 1 u 80 mg/jum fil-Jiem 2 u 3, ma influwenzatx il-farmakokinetika ta' docetaxel mogħti fil-vina f'Jum 1 jew ta' vinorelbine mogħti ġol-vina f'Jum 1 jew Jum 8.
English: Aprepitant does not seem to interact with the P-glycoprotein transporter, as suggested by the lack of interaction of aprepitant with digoxin.
Maltese: Aprepitant ma jidhirx li jinteraġixxi mat-trasportatur ta' P-glycoprotein, kif issuġġerit min-nuqqas ta' interazzjoni ta' aprepitant ma' digoxin.
English: Following oral administration of a single 40 mg dose of EMEND in the fasted state, the AUC0- (mean ± SD) was 8.0 ± 2.1 µg • h/mL and the Cmax was 0.7 ± 0.24 µg/mL.
Maltese: Wara l-għoti ta' doża waħda orali ta' 40 mg ta' EMEND fi stat ta' sawm, l-AUC0-∞ (medja±SD) kienet 8.0±2.1 µg • sigħat/mL u s-Cmax kien 0.
English: EMEND, when given as a regimen of 125 mg with dexamethasone co-administered orally as 20 mg on Day 1, and EMEND when given as 80 mg/day with dexamethasone co-administered orally as 8 mg on Days 2 through 5, increased the AUC of dexamethasone, a CYP3A4 substrate, 2.2-fold on Days 1 and 5.
Maltese: EMEND, meta mogħti bħala kors ta' 125 mg flimkien ma' dexamethasone orali f'doża ta' 20 mg f'Jum 1, u EMEND meta mogħti bħala 80 mg kuljum day flimkien ma' 8 mg dexamethasone orali fil-Jiem 2 sa 5, żied l-AUC ta' dexamethasone, sottostrat ta' CYP3A4, bi 2.2 drabi fil-Jiem 1 u 5.
English: §Overall = 0 to 120 hours post-initiation of cisplatin chemotherapy.
Maltese: Fażi totali: 0 sa 120 siegħa mill-bidu tal-kimoterapija.
English: EMEND increased the AUC of midazolam, a sensitive CYP3A4 substrate, 2.3-fold on Day 1 and 3.3-fold on Day 5, when a single oral dose of 2 mg midazolam was co-administered on Days 1 and 5 of a regimen of EMEND 125 mg on Day 1 and 80 mg/day on Days 2 to 5.
Maltese: EMEND żied l-AUC ta' midazolam, sottostrat sensittiv ta' CYP3A4, bi 2.3 drabi f'Jum1 u bi 3.3 drabi f'Jum 5, meta ngħatat miegħu doża waħda ta' 2mg midazolam fil-Jiem 1 u 5 ta' kors ta' EMEND 125 mg f'Jum 1 u 80 mg kuljum fil-Jiem 2 sa 5.
English: Each 125 mg capsule contains 125 mg of aprepitant.
Maltese: Kull kapsula ta' 125 mg fiha 125 mg ta' aprepitant.
English: Each carton contains one sachet with the powder for oral suspension, one 1 ml and one 5 mL oral dispenser (polypropylene with silicone o-ring), one cap, and one mixing cup (polypropylene).
Maltese: Kull kartuna fiha qartas wieħed bit-trab għas-suspensjoni orali, dispenser orali wieħed ta' 1 mL u wieħed ta' 5 mL (tal-polypropylene b'o-ring tas-silikon), għatu wieħed, u tazza waħda li tħallat fiha (tal-polypropylene).
English: Concomitant intake of a 40 mg dose with a standard breakfast decreased the aprepitant Cmax by 18 % but did not affect AUC.
Maltese: It-teħid fl-istess ħin ta' doża ta' 40 mg ma' kolazzjon standard naqqset is-Cmax ta' aprepitant bi 18 % iżda ma affettwatx l-AUC.
English: Aprepitant, when given as a single dose of 200 mg in the fed state (standard light breakfast) on Day 1 with oral dexamethasone, co-administered orally as 12 mg on Day 1 and 8 mg on Days 2 through 4, increased the AUC0-24hr of dexamethasone by 2.1- and 2.3-fold on Days 1 and 2, to a lesser extent (1.4-fold increase) on Day 3, and had no effect on Day 4 (1.1-fold).
Maltese: Aprepitant, meta jingħata bħala doża waħda ta' 200 mg flistat mitmugħ (kolazzjon ħafif standard) fil-Jum 1 ma' dexamethasone mill-ħalq, mogħti flimkien miegħu mill-ħalq bħala 12-il mg f'Jum 1 u 8 mg fil-Jiem 2 sa 4, żied l-AUC0-24siegħa ta' dexamethasone b'2.1 u 2.3 drabi aktar fil-Jiem 1 u 2, u fi grad anqas (żieda ta' 1.4 darba aktar) fil-Jum 3, u ma kellu lebda effett fil-Jum 4 (1.1 darba ogħla).
English: Respiratory, thoracic and mediastinal disorders dyspnoea, wheezing uncommon
Maltese: Disturbi respiratorji, toraċiċi u medjastinali dispneja, tħarħir mhux komuni
English: EMEND 125 mg hard capsules Aprepitant
Maltese: EMEND 125 mg kapsuli iebsin Aprepitant
English: 3 mg/kg orally Maximum dose 125 mg
Maltese: Doża massima 125 mg
English: Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant.
Maltese: Fosaprepitant, promediċina ta' aprepitant, meta jingħata minn ġol-vina jinbidel malajr f'aprepitant.
English: EMEND contains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists" (antiemetics and antinauseants).
Maltese: EMEND fih is-sustanza attiva aprepitant u jagħmel parti minn grupp ta' mediċini msejħa "antagonisti tar-riċettur ta' neurokinin 1 (NK1)" (kontra r-rimettar u kontra d-dardir).
English: In the same 2 clinical studies, 851 adult patients continued into the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy.
Maltese: Fl-istess 2 studji kliniċi, 851 pazjent adult komplew fl-estensjoni taċ-Ċiklu Multiplu sa 5 ċikli ta' kimoterapija addizzjonali.
English: In patients on chronic warfarin therapy, the prothrombin time (INR) should be monitored closely during treatment and for 14 days following the use of EMEND 165 mg for chemotherapy induced nausea and vomiting (see section 4.4).
Maltese: F'pazjenti li qegħdin fuq terapija kronika ta' warfarin, il-ħin tal-prothrombin (INR) għandu jiġi sorveljat mill-qrib waqt il-kura b'EMEND u għal 14-il jum wara l-użu ta' 165 mg ta' EMEND għal nawseja u rimettar ikkawżati mill-kimoterapija (ara sezzjoni 4.4).
English: Methylprednisolone: Although the concomitant administration of methylprednisolone with the single 40 mg dose of aprepitant has not been studied, a single 40 mg dose of aprepitant produces a weak inhibition of CYP3A4 and it is not expected to alter the plasma concentrations of methylprednisolone to a clinically significant degree.
Maltese: Għalkemm l-għoti fl-istess ħin ta' methylprednisolone ma' doża waħda ta' 40mg ta' aprepitant ma ġiex studjat, doża waħda ta' 40 mg ta' aprepitant tikkawża inibizzjoni dgħajfa ta' CYP3A4 u m'hijiex mistennija li tibdel il-konċentrazzjonijiet fil-plażma ta' methylprednisolone filplażma sa xi grad klinikament sinifikattiv.
English: PET/aluminium/LLDPE sachets
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: Please refer to the Summary of Product Characteristics of co-administered 5-HT3 antagonist medicinal products.
Maltese: Jekk jogħġbok irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott tal-prodotti mediċinali antagonisti ta' 5-HT3 mogħtija flimkien miegħu.
English: cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants), - alfentanil, fentanyl (used to treat pain), - quinidine (used to treat an irregular heart beat), - irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer), - medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating migraines), - warfarin, acenocoumarol (blood thinners; blood tests may be required), - rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections), - phenytoin (a medicine used to treat seizures), - carbamazepine (used to treat depression and epilepsy), - midazolam, triazolam, phenobarbital (medicines used to produce calmness or help you sleep), - St. John's Wort (an herbal preparation used to treat depression), - protease inhibitors (used to treat HIV infections) - ketoconazole except shampoo (used to treat Cushing's syndrome - when the body produces an excess of cortisol), - itraconazole, voriconazole, posaconazole (antifungals), - nefazodone (used to treat depression), - corticosteroids (such as dexamethasone and methylprednisolone), - anti-anxiety medicines (such as alprazolam), - tolbutamide (a medicine used to treat diabetes)
Maltese: - alfentanil, fentanyl (użat għall-kura tal-uġigħ), - quindine (użat għall-kura ta' taħbit irregolari tal-qalb), - irinotecan, etoposide, vinorelbine, ifosfamide (mediċini użati biex tittratta l-kanċer), - mediċini li fihom derivattivi ta' alkalojde ergot bħal ergotamine u diergotamine (użati għall kura ta' emikranji), - warfarin, acenocoumarol (sustanzi li jraqqu d-demm; jista' jkun hemm bżonn ta' testijiet tad demm), - rifampicin, clarithromycin, telithromycin (antibijotiċi użati biex jittrattaw infezzjonijiet), - phenytoin, (mediċina użata għall-kura ta' attakki ta' puplesija), - carbamazepine (użat għall-kura ta' depressjoni u epilessija), - midazolam, triazolam, phenobarbital (mediċini użati biex jipproduċu kalmezza jew jgħinuk torqod), - St.
English: The median peak plasma concentration (Cmax) was approximately 1.2 µg/mL on Day 1, occurring between 5 and 7 hours.
Maltese: Il-medjan tal-ogħla konċentrazzjoni fil-plażma (Cmax) kien madwar 1.2 µg/mL f'Jum 1, li seħħ f'bejn 5 u 7 sigħat.
English: No clinically important effect resulted on Day 4 (midazolam AUC0-∞ 1.2-fold increase) and a slight change in midazolam AUC0-∞ was observed on Day 8 (35 % decrease).
Maltese: Ma rriżulta l-ebda effett importanti b'mod kliniku fil-Jum 4 (żieda ta' 1.2 drabi aktar fl-AUC0-∞ ta' midazolam) u bidla żgħira fl- AUC0-∞ ta' midazolam kienet osservata fil-Jum 8 (tnaqqis ta' 35 %).
English: EMEND 125 mg hard capsule EMEND 80 mg hard capsules Aprepitant
Maltese: EMEND 125 mg kapsuli iebsin EMEND 80 mg kapsuli iebsin Aprepitant
English: Co-administration of EMEND with active substances that are known to be metabolized by CYP2C9 (e.g., phenytoin, warfarin), may result in lower plasma concentrations of these active substances.
Maltese: L-għoti fl-istess ħin ta' EMEND ma' sustanzi attivi li huma magħrufin li jiġu metabolizzati b'CYP2C9 (eż., phenytoin, warfarin), jista' jirriżulta f'konċentrazzjonijiet aktar baxxi ta' dawn is-sustanzi fil-plasma.
English: No significant nausea (maximum VAS < 25 mm on a scale of 0-100 mm) Overall (0-120 hours)
Maltese: L-Ebda nawsja sinifikanti (VAS massimu < 25 mm fuq skala ta' 0-100 mm)
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
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda raxx, akne mhux komuni reazzjoni ta' fotosensittività, għaraq eċċessiv, ġilda żejtnija, ferita fil-ġilda, raxx bil-ħakk, sindrome ta' Stevens-Johnson/nekroliżi tossika tal-epidermide rari ħakk, urtikarja mhux magħrufa
English: The adverse reactions profiles in adults in the Multiple-Cycle extension of HEC and MEC studies for up to 6 additional cycles of chemotherapy were generally similar to those observed in Cycle 1.
Maltese: Il-profili tar-reazzjonijiet avversi fl-adulti fl-estensjoni Multiple-Cycle tal-istudji ta' HEC u MEC sa 6 ċikli addizzjonali ta' kimoterapija kienu ġeneralment simili għal dawk osservati f'Ċiklu 1.
English: Each 80 mg capsule contains 80 mg of aprepitant.
Maltese: Kull kapsula ta' 80 mg fiha 80 mg ta' aprepitant.
English: When a single 125 mg dose of EMEND was administered on Day 1 and 80 mg/day on Days 2 and 3 to healthy subjects who were stabilised on chronic warfarin therapy, there was no effect of EMEND on the plasma AUC of R(+) or S(-) warfarin determined on Day 3; however, there was a 34 % decrease in S(-) warfarin (a CYP2C9 substrate) trough concentration accompanied by a 14 % decrease in INR 5 days after completion of treatment with EMEND.
Maltese: Meta doża waħda ta' 125 mg ta' EMEND ingħatat f'Jum 1 u 80 mg/kuljum fil-Jiem 2 u 3 f'individwi b'saħħithom li kienu stabbilizzati fuq terapija ta' warfarina kronika, ma kien hemm l-ebda effett ta' EMEND fuq l- AUC filplażma ta' warfarin R(+) jew S(-) stabbilita fil-Jum 3; madankollu, kien hemm tnaqqis ta' 34 % filkonċentrazzjoni l-aktar baxxa ta' warfarin S(-) (sottostrat ta' CYP2C9) li kien akkumpanjat bi tnaqqis ta' 14 % f'INR 5 ijiem wara t-tmiem tal-kura b'EMEND.
English: As a moderate inhibitor of CYP3A4, aprepitant (125 mg/80 mg) can increase plasma concentrations of co-administered active substances that are metabolised through CYP3A4.
Maltese: Bħala inibitur moderat ta' CYP3A4, aprepitant (125 mg/80 mg) jista' jżid l-konċenterazzjonijiet filplażma ta' sustanzi attivi oħra mogħtija flimkien, mill-ħalq li huma metabolizzati permezz ta' CYP3A4.
English: Data are lacking regarding effects on CYP2C8 and CYP2C19.
Maltese: M'hemmx biżżejjed dejta dwar l-effetti fuq CYP2C8 u CYP2C19.
English: Other medicines and EMEND
Maltese: Mediċini oħra u EMEND
English: 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.
Maltese: Fi studju kliniku ieħor ikkontrollat b'mod attiv fuq 1,169 pazjent adult li kienu qed jirċievu aprepitant u HEC, il-profil ta' reazzjonijiet avversi ġeneralment kien simili għal dak li deher fl-istudji HEC oħra b'aprepitant.
English: - Keep this leaflet.
Maltese: - sulluzzu,
English: The aprepitant regimen consisted of aprepitant 125 mg on Day 1 and 80 mg/day on Days 2 and 3 in combination with intravenous ondansetron 32 mg on Day 1 and dexamethasone 12 mg on Day 1 and 8 mg daily on Days 2 through 4.
Maltese: Fit-tielet stħarriġ fejn midazolam ingħata mil-vina u mill-ħalq, EMEND ingħata bħala 125 mg f'Jum 1 u 80 mg kuljum fil-Jiem 2 u 3, flimkien ma' 32 mg ondansetron f'Jum 1, 12 mg dexamethasone f'Jum 1 u 8 mg fil-Jiem 2-4.
English: Table 1 Percent of post-operative adults responding by treatment group Combined results from 2 Phase III trials
Maltese: Perċentwal ta' adulti wara operazzjoni li rrispondew skont il-grupp ta' kura Riżultati kkombinati minn 2 Provi ta' Fażi
English: The most common adverse reactions reported at a greater incidence in adults treated with the 3-day oral aprepitant regimen than with standard therapy in patients receiving Highly Emetogenic Chemotherapy (HEC) were: hiccups (4.6 % versus 2.9 %), alanine aminotransferase (ALT) increased (2.8 % versus 1.1 %), dyspepsia (2.6 % versus 2.0 %), constipation (2.4 % versus 2.0 %), headache (2.0 % versus 1.8 %), and decreased appetite (2.0 % versus 0.5 %).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni rrappurtati f'inċidenza akbar f'pazjenti adulti kkurati bl-iskeda ta' għoti ta' aprepitant mill-ħalq għal 3 ijiem milli bit-terapija standard, f'pazjenti li kienu qed jirċievu Kimoterapija Emetoġenika Ħafna (HEC) kienu: sulluzzu (4.6 % kontra 2.9 %), żieda fl-alanine aminotransferase (ALT)
English: EMEND contains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists".
Maltese: EMEND fih is-sustanza attiva aprepitant u jagħmel parti minn grupp ta' mediċini msejħa "antagonisti tar-riċettur ta' neurokinin 1 (NK1)".
English: Common side effects (may affect up to 1 in 10 people) are: - constipation, indigestion, - headache, - tiredness, - loss of appetite, - hiccups,
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) huma: - stitikezza, indiġestjoni, - uġigħ ta' ras, - għeja, - telf ta' aptit,
English: 3-day treatment pack containing: 1 x 125 mg hard capsule and 2 x 80 mg hard capsule
Maltese: U KONTENUT Pakkett ta' trattament ta' tlett ijiem li fih: kapsula iebsa ta' 1 x 125 mg u kapsula iebsa ta' 2 x 80 mg
English: 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.
Maltese: Meta doża waħda ta' 125 mg ta' aprepitant ingħatat f'Jum 5 ta' kors ta' 10 ijiem ta' 400 mg kuljum ta' ketoconazole, impeditur qawwi ta' CYP3A4, l-AUC ta' aprepitant żdiedet bejn wieħed u ieħor b' ħames darbiet u l-half-life terminali medja żdiedet bejn wieħed u ieħor bi 3 darbiet.
English: Based on a comparable pharmacokinetic/pharmacodynamic profile, the 1-day oral regimen of EMEND 165 mg is anticipated to have a similar safety and tolerability profile to that of the 1-day regimen of fosaprepitant 150 mg and the 3-day oral aprepitant regimen in chemotherapy patients (see section 5.2).
Maltese: Fuq bażi ta' profil farmakokinetiku/farmakodinamiku jixxiebah, l-iskeda ta' għoti ta' 165 mg ta' EMEND mill-ħalq għal jum wieħed huwa mistenni li jkollu profil ta' sigurtà u tollerabbiltà jixbah lil dak tal-iskeda ta' għoti ta' 150 mg ta' fosaprepitant għal jum wieħed u l-iskeda ta' għoti ta' aprepitant għal 3 ijiem f'pazjenti li qed jieħdu l-kimoterapija (ara sezzjoni 5.2).
English: everolimus - alfentanil, fentanyl - for pain - quinidine - for irregular heart beat - medicines for cancer - such as irinotecan, etoposide, vinorelbine, ifosfamide - medicines containing ‘ergot alkaloid derivatives' - such as ergotamine and diergotamine - for migraines - medicines that thin the blood - such as warfarin, acenocoumarol.
Maltese: - alfentanil, fentanyl - għall-uġigħ - quinidine - għal taħbit mhux regolari tal-qalb - mediċini għall-kanċer -bħal irinotecan, etoposide, vinorelbine, ifosfamide - mediċini li fihom ‘derivattivi tal-alkalojdi ergot' - bħal ergotamine u diergotamine - għall emigranji - mediċini li jraqqu d-demm - bħal warfarin, acenocoumarol.
English: Each hard capsule contains 125 mg of aprepitant.
Maltese: Kull kapsula iebsa fiha 125 mg ta' aprepitant.
English: The safety and efficacy of EMEND 40 mg in children and adolescents below 18 years of age has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' EMEND 40 mg fit-tfal u adoloxxenti b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in Figure 1.
Maltese: Il-ħin stmat għall-ewwel emesi fl-analiżi kkombinata hu muri bil-Kaplan-Meier plot f'Figura 1.
English: For CYP2C9 and CYP3A4 substrates the induction is transient with a maximum effect reached after 3-5 days.
Maltese: Għas-substrati ta' CYP2C9 u CYP3A4 l-induzzjoni hija waħda temporanja bl-effett massimu jintlaħaq wara 3-5 ijiem.
English: EMEND 80 mg
Maltese: IEBSIN TA' 80 MG)
English: 125 mg orally 80 mg orally 80 mg orally none
Maltese: EMEND 125 mg mill-ħalq 80 mg mill-ħalq