FrancophonIA/ELRC3.0 huggingface dataset:
English: EMEND is given for 3 days as part of a regimen that includes a 5-HT3 antagonist.
Maltese: EMEND jingħata għal 3 ijiem bħala parti minn kors li jinkludi antagonist ta' 5-HT3.
English: Skin and subcutaneous tissue rash, acne uncommon
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: EMEND 40 mg hard capsules aprepitant
Maltese: EMEND 40 mg kapsuli ibsin Aprepitant
English: Cardiac disorders bradycardia uncommon
Maltese: Disturbi fil-qalb bradikardija mhux komuni
English: 80 mg orally
Maltese: 80 mg mill-ħalq
English: †, vomiting gastroesophageal reflux disease, abdominal pain, dry mouth, flatulence uncommon duodenal ulcer perforation, stomatitis, abdominal distension, faeces hard, neutropenic colitis rare
Maltese: gass mhux komuni perforazzjoni ta' ulċera duwodenali, stomatite, nefħa fl-addome, ippurgar iebes, kolite newtropenika rari
English: 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.
Maltese: Indeboliment renali Doża waħda ta' 240 mg ta' aprepitant ingħatat lill-pazjenti b'indeboliment renali serju (CrCl < 30mL/min) u lil pazjenti b'mard tal-kliewi fl-aħħar stadju (ESRD) li jeħtieġu lemodijaliżi.
English: 500-1,500 mg/m 2 and doxorubicin (< 60 mg/m 2) or epirubicin (< 100 mg/m 2), aprepitant in combination with an ondansetron/dexamethasone regimen (see section 4.2) was compared with standard therapy (placebo plus 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).
Maltese: Fi stħarriġ double-blind, b'mod każwali, f'total ta' 866 pazjent adult (864 mara, 2 irġiel) li kienu qed jingħataw il-kimoterapija li nkludiet cyclophosphamide 750-1,500 mg/m2; jew cyclophosphamide 500-1,500 mg/m2 u doxorubicin (< 60 mg/m2) jew epirubicin (< 100 mg/m2), aprepitant flimkien ma' kors ta' ondansetron/dexamethasone (ara sezzjoni 4.2) tqabbel ma' terapija standard (plaċebo u 8 mg ondansetron oralment (darbtejn f'Jum 1, u kull 12-il siegħa f'Jiem 2 u 3) flimkien ma' 20 mg dexamethasone oralment f'Jum 1).
English: For CYP2C9 and CYP3A4 substrates, the induction is transient with a maximum effect reached 3-5 days after end of the EMEND 3-day treatment.
Maltese: Għal sottostrati ta' CYP2C9 u CYP3A4, l-induzzjoni mhiex permanenti b'effett massimu milħuq 3-5 ijiem wara tmiem it-tlett ijiem trattament b'EMEND.
English: What EMEND contains The active substance is aprepitant.
Maltese: - Is-sustanza attiva hi aprepitant.
English: 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).
Maltese: skeda ta' għoti ta' ondansetron/dexamethasone (ara sezzjoni 4.2) tqabbel ma' terapija standard (plaċebo u 8 mg ta' ondansetron mill-ħalq (darbtejn f'Jum 1, u kull 12-il siegħa fil-Jiem 2 u 3) flimkien ma' 20 mg ta' dexamethasone mill-ħalq f'Jum 1).
English: Prevention nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12.
Maltese: Prevenzjoni ta' nawsja u rimettar assoċjati ma' kimoterapija tal-kanċer emetoġenika ferm u emetoġenika b'mod moderat f'adulti u adolexxenti mill-età ta' 12-il sena.
English: In a juvenile toxicity study in rats treated from post natal day 10 to day 63 aprepitant led to an earlier vaginal opening in females from 250 mg/kg b.i.d.
Maltese: Fi studju dwar it-tossiċità fil-frieħ f'firien ittrattati minn jum 10 sa jum 63 wara t-twelid, aprepitant wassal għall-ftuħ aktar bikri tal-vaġina fil-firien femminili minn 250 mg/kg b.i.d. u għall-firda ttardjata tal-prepuzju fil-firien maskili minn 10 mg/kg b.i.d.
English: What EMEND looks like and contents of the pack The 165 mg hard capsule is opaque with a light blue cap and a white body with “466” and “165 mg” printed radially in black ink on one side of the body and the Merck logo on the other side.
Maltese: Il-kapsula iebsa ta' 165 mg hi opaka b'għatu ċelesti u korp abjad b'“466” u “165 mg” stampati b'mod radjali b'linka sewda fuq naħa waħda tal-korp u l-lowgo ta' Merck fuq in-naħa l-oħra.
English: Renal and urinary disorders dysuria uncommon pollakiuria rare
Maltese: Disturbi fil-kliewi u fis-sistema urinarja disurja mhux komuni pollakjurja rari
English: Patients receiving the aprepitant regimen were receiving chemotherapy for a variety of tumour types including 52 % with breast cancer, 21 % with gastrointestinal cancers including colorectal cancer, 13 % with lung cancer and 6 % with gynaecological cancers.
Maltese: Pazjenti li kienu qed jirċievu r-reġimen ta' aprepitant kienu qed jirċievu kimoterapija għal diversi tipi ta' tumuri li kienu jinkludu 52 % b'kanċer tas-sider, 21 % b'tumuri gastrointestinali li jinkludu kanċer tal-musrana l-kbira u r-rektum, 13 % b'kanċer tal-pulmun u 6 % b'tumuri ġinekoloġiċi.
English: EMEND 125 mg hard capsules EMEND 80 mg hard capsules
Maltese: EMEND 125 mg kapsuli iebsin EMEND 80 mg kapsuli iebsin
English: EMEND 165 mg hard capsules are supplied in cartons in the following pack sizes: - Aluminium blister containing one 165 mg capsule - 6 Aluminium blisters each containing one 165 mg capsule
Maltese: - Folja tal-aluminju li fiha kapsula waħda ta' 165 mg - 6 folji tal-aluminju li kull waħda minnhom fiha kapsula waħda ta' 165 mg
English: As a mild inducer of CYP2C9, CYP3A4 and glucuronidation, aprepitant can decrease plasma concentrations of substrates eliminated by these routes within two weeks following initiation of treatment.
Maltese: Bħala induttur ħafif ta' CYP2C9, CYP3A4 u glukuronidazzjoni, aprepitant jista' jnaqqas ilkonċentrazzjonijiet tal-plasma ta' substrati eliminati permezz ta' dawn ir-rotot fi żmien ġimagħtejn mill-bidu u t-tmiem tal-kura.
English: For information regarding birth control, see ‘Other medicines and EMEND'.
Maltese: Għal aktar informazzjoni dwar il-kontroll tat-twelid, ara ‘Mediċini oħra u EMEND'.
English: Each capsule contains 40 mg of aprepitant.
Maltese: Kull kapsula iebsa fiha 40 mg ta' aprepitant.
English: The total exposure of orally administered CYP3A4 substrates may increase up to approximately 3-fold during the 3-day treatment with EMEND; the effect of aprepitant on the plasma concentrations of intravenously administered CYP3A4 substrates is expected to be smaller.
Maltese: L-espożizzjoni totali ta' sottostrati ta' CYP3A4 mogħtija mill-ħalq tista' tiżdied sa bejn wieħed u ieħor 3 darbiet aktar waqt kors ta' 3 ijiem b'EMEND; l-effett ta' aprepitant fuq konċentrazzjonijiet fil-plażma ta' sottostrati ta' CYP3A4 mogħtija fil-vina huwa mistenni li jkun iċken.
English: The most common adverse reactions reported at a greater incidence in adults treated with the 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 b'inċidenza akbar f'adulti trattati bil-kors ta' aprepitant 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: Recommended dose of EMEND oral suspension in paediatric patients aged 6 months to less than 12 years
Maltese: Doża u volum rakkomandati ta' EMEND suspensjoni orali f'pazjenti pedjatirċi ta' età minn 6 xhur sa inqas minn 12-il sena
English: The safety and efficacy of the 80 mg and 125 mg capsules have not been demonstrated in children less than 12 years of age.
Maltese: Is-sigurtà u l-effikaċja tal-kapsuli ta' 80 mg u 125 mg fit-tfal b'età inqas minn 12-il sena ma ntwerewx.
English: This is not considered to be clinically important.
Maltese: Dan mhuwiex meqjus klinikament importanti.
English: Do not give EMEND powder for oral suspension to children under 6 months of age or who weigh less than 6 kg, or to adolescents between 12 and 18 years, because the powder for oral suspension has not been studied in this population.
Maltese: Tagħtix EMEND trab għal suspensjoni orali lil tfal b'età inqas minn 6 xhur jew li jiżnu inqas minn 6 kg, jew lil adolexxenti bejn l-etajiet ta' 12 u 18-il sena minħabba li t-trab għal suspensjoni orali ma ġiex studjat f'din il-popolazzjoni.
English: Effect aprepitant on the pharmacokinetics of other active substances CYP3A4 inhibition
Maltese: Effett ta' inibizzjoni CYP3A4 b'aprepitant fuq il-farmakokinetiċi ta' sustanzi attivi oħrajn
English: PHARMACEUTICAL FORM
Maltese: Terapija standard
English: The total exposure of orally administered CYP3A4 substrates may increase up to approximately 3-fold for 2 days following a single 165 mg dose of EMEND and decreasing to baseline approximately 4 days after dosing of 165 mg EMEND.
Maltese: L-esponiment totali ta' sustrati ta' CYP3A4 mogħtija mill-ħalq jista' jiżdied sa madwar 3 darbiet aktar għal jumejn wara doża waħda ta' 165 mg ta' EMEND u jonqos sal-linja bażi madwar 4 ijiem wara li tingħata doża ta' 165 mg ta' EMEND.
English: The antiemetic activity of EMEND was evaluated over a 5-day (120 hour) period following the initiation of chemotherapy on Day 1.
Maltese: L-attività antiemetika ta' EMEND ġiet ivvalutata fuq perjodu ta' 5 ijiem (120 siegħa) wara l-bidu talkimoterapija f'Jum 1.
English: Aprepitant plasma concentrations achieved with the 3-day regimen of EMEND are predicted to provide greater than 95 % occupancy of brain NK1 receptors.
Maltese: Konċentrazzjonijiet ta' aprepitant fil-plażma li jinkisbu bl-iskeda ta' tlett ijiem ta' EMEND huma mbassra li jokkupaw aktar minn 95 % tar-riċetturi NK1 tal-moħħ.
English: See the Summary of Product Characteristics (SmPC) for the selected 5-HT3 antagonist for appropriate dosing information.
Maltese: Prodott (SmPC - Summary of Product Characteristics) tal-antagonist ta' 5-HT3 li jintgħażel għal informazzjoni xierqa dwar l-għoti tad-dożi.
English: Haemodialysis conducted 4 or 48 hours after dosing had no significant effect on the pharmacokinetics of aprepitant; less than 0.2 % of the dose was recovered in the dialysate.
Maltese: Emodijaliżi li saret minn 4 sigħat sa 48 siegħa wara li ngħatat id-doża, ma kellha l-ebda effett sinifikanti fuq il-farmakokinetika ta' aprepitant; inqas minn 0.2 % tad-doża ġiet irkuprata milllikwidu tad-dijaliżi.
English: Caution is advised during concomitant administration of EMEND 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).
Maltese: Hija rrikmandata li tingħata attenzjoni meta EMEND jingħata flimkien ma' sustanzi attivi li jingħataw oralment li jiġu metabolizzati primarjament permezz ta' CYP3A4 u b'medda terapewtika dejqa, bħal cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, u quinidine (ara sezzjoni 4.4).
English: EMEND or placebo and ondansetron were administered 1 hour and 30 minutes prior to initiation of chemotherapy, respectively.
Maltese: EMEND jew plaċebo u ondansetron ingħataw siegħa u 30 minuta qabel il-bidu tal-kimoterapija, rispettivament.
English: black iron oxide (E 172), and yellow iron oxide (E 172).
Maltese: Black iron oxide (E 172)
English: Each hard capsule contains 80 mg of aprepitant.
Maltese: Kull kapsula iebsa fiha 80 mg ta' aprepitant.
English: 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.
Maltese: Fi studju kliniku ieħor ikkontrollat b'mod attiv fuq 1,169 pazjent 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: The daily dose of dexamethasone on Days 1 and 2 should be reduced by approximately 50 % when co-administered with EMEND 165 mg on Day 1 to achieve exposures of dexamethasone similar to those obtained when given without EMEND 165 mg.
Maltese: Id-doża ta' dexamethasone kuljum fil-Jiem 1 u 2 għandha titnaqqas b'madwar 50 % meta tingħata flimkien ma' 165 mg ta' EMEND fil-Jum 1 biex jinkisbu esponimenti għal dexamethasone jixbhu lil dawk li jinkisbu meta jingħata mingħajr 165 mg ta'
English: Because the effect of EMEND on the pharmacokinetics of orally administered CYP3A4 substrates is greater than the effect of EMEND on the pharmacokinetics of intravenously administered CYP3A4 substrates, an interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g., etoposide, vinorelbine) cannot be excluded.
Maltese: Minħabba li l-effett ta' EMEND fuq il-farmakokinetika ta' sottostrati ta' CYP3A4 mogħtija mill-ħalq huwa ikbar mill-effett ta' EMEND fuq il-farmakokinetika ta' sottostrati ta' CYP3A4 mogħtija ġol-vini, interazzjoni ma' prodotti mediċinali kimoterapewtiċi metabolizzati prinċipalment jew parzjalment minn CYP3A4 (eż., etoposide, vinorelbine) ma tistax tiġi eskluża.
English: Dexamethasone: Interaction studies with aprepitant 165 mg and dexamethasone have not been conducted; however, the following study with 200 mg of aprepitant should be considered when using EMEND 165 mg with oral dexamethasone.
Maltese: Ma sarux studji dwar interazzjoni bejn 165 mg ta' aprepitant u dexamethasone; madankollu, l-istudju li ġej b'200 mg ta' aprepitant għandu jiġi kkunsidrat meta wieħed juża 165 mg ta' EMEND ma' dexamethasone mill-ħalq.
English: EU/1/03/262/004 1 hard capsule EU/1/03/262/005 5 x 1 hard capsule
Maltese: EU/1/03/262/005 5 x 1 kapsula iebsa
English: The mean peak plasma concentration (Cmax) of aprepitant occurred at approximately 4 hours (Tmax).
Maltese: Il-konċentrazzjoni massima medja fil-plażma (Cmax) ta' aprepitant seħħet bejn wieħed u ieħor fir-4 siegħa (tmax).
English: The 80 mg hard capsule is opaque with a white cap and body with “461” and “80 mg” printed radially in black ink on the body.
Maltese: Il-kapsuli ta' 80 mg huma opaki bojod u b'kappa tal-istess kulur b'“461” u “80 mg” stampati b'mod radjali b'linka sewda fuqhom.
English: Aprepitant regimen (N= 433)
Maltese: aprepitant (N= 425)
English: Using a highly specific NK1-receptor tracer, positron emission tomography (PET) studies in healthy young men have shown that aprepitant penetrates into the brain and occupies NK1 receptors in a doseand plasma-concentration-dependent manner.
Maltese: Bl-użu ta' traċċatur speċifiku ħafna għar-riċettur NK1, studji positron emission tomography (PET) f'irġiel għadhom żgħar u b'saħħithom urew li aprepitant jippenetra fil-moħħ u jokkupa r-riċetturi-NK1 b'mod li jiddipendi fuq id-doża u l-konċentrazzjoni fil-plażma.
English: These effects were not considered clinically important.
Maltese: Dawn l-effetti ma tqiesux klinikament importanti.
English: • Pour entire contents of the sachet into the 4.6 mL of water and mix.
Maltese: • Ferra' l-kontenut kollu tal-qartas ġol-4.6 mL ta' ilma u ħawwad.
English: The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of EMEND.
Maltese: L-effikaċja ta' kontraċettivi tal-ormoni tista' titnaqqas waqt u għal 28 jum wara għoti ta' EMEND.
English: Blood and lymphatic system disorders febrile neutropenia, anaemia uncommon
Maltese: Disturbi tad-demm u tas-sistema limfatika newtropenja bid-deni, anemija mhux komuni
English: EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist.
Maltese: EMEND jingħata għal tlett ijiem bħala parti minn kors li jinkludi kortikosterojd u antagonista ta' 5HT3.
English: EMEND causes a transient mild induction of CYP2C9, CYP3A4 and glucuronidation approximately one week after treatment.
Maltese: EMEND jikkawża induzzjoni ħafifa, temporanja ta' CYP2C9, CYP3A4 u glukorinidazzjoni madwar ġimgħa wara l-kura.
English: The dose of dexamethasone accounts for active substance interactions.
Maltese: Jekk taghti EMEND aktar milli suppost
English: Complete response (0-24 hours)
Maltese: Globalment (0-120 siegħa)
English: - The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropylcellulose
Maltese: Microcrystalline cellulose (E 460) Hydroxypropylcellulose (E 463)
English: 8 mg orally twice daily
Maltese: 8 mg mill ħalq
English: As a mild inducer of CYP2C9, CYP3A4 and glucuronidation, aprepitant can decrease plasma concentrations of substrates eliminated by these routes.
Maltese: Bħala induttur ħafif ta' CYP2C9, CYP3A4 u glukuronidazzjoni, aprepitant jista' jnaqqas ilkonċentrazzjonijiet fil-plażma ta' sustrati mneħħija minn dawn ir-rotot.
English: Co-administration with hormonal contraceptives
Maltese: Kontraċettivi tal-ormoni
English: 12 mg orally
Maltese: Dexamethasone 12 mg millħalq
English: EMEND 40 mg hard capsules
Maltese: EMEND kapsuli iebsin 40 mg
English: 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.
Maltese: Ir-rata tal-eliminazzjoni ta' aprepitant fil-plażma hija dipendenti fuq id-doża, tonqos maż-żieda fiddoża u tvarja minn bejn wieħed u ieħor 60 sa 72 mL/min fil-limiti tad-doża terapewtika.
English: Printing ink
Maltese: Jekk tinsa tieħu EMEND
English: 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).
Maltese: F'pazjenti li qegħdin fuq terapija kronika tal-warfarina, il-prothrombin time (INR) għandu jiġi sorveljat mill-qrib waqt it-trattament b'EMEND u għal ġimagħtejn wara kull kors ta' tlett ijiem ta' EMEND għal nawseja u rimettar ikkawżati mill-kimoterapija (ara sezzjoni 4.4).
English: As part of a 3-day regimen, dosing of aprepitant powder for oral suspension (3/2/2-mg/kg) in patients aged 6 months to less than12 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 0.1 µg/mL in a majority of patients.
Maltese: Bħala parti mill-kors terapewtiku ta' 3 ijiem, l-għoti ta' dożi ta' aprepitant trab għal suspensjoni orali (3/2/2-mg/kg) f'pazjenti ta' età minn 6 xhur sa anqas minn 12-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 0.1 µg/mL f'maġġoranza ta' pazjenti.
English: Standard therapy (N= 424)
Maltese: (N= 424)
English: Because the effect of EMEND on the pharmacokinetics of orally administered CYP3A4 substrates is greater than the effect of EMEND on the pharmacokinetics of intravenously administered CYP3A4 substrates, an interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g.,
Maltese: Huwa rakkomandat li jkun hemm kawtela u jista' jkun xieraq monitoraġġ addizzjonali f'pazjenti li jirċievu prodotti mediċinali metabolizzati prinċipalment jew parzjalment minn CYP3A4 (ara sezzjoni 4.4).
English: The metabolism of aprepitant occurs largely via oxidation at the morpholine ring and its side chains and the resultant metabolites were only weakly active.
Maltese: Il-metaboliżmu ta' aprepitant iseħħ fil-parti l-kbira permezz ta' ossidazzjoni fiċċirku morpholine u s-side chains tiegħu u l-metaboliti li rriżultaw kienu biss ta' attività dgħajfa.
English: EMEND 125 mg powder for oral suspension aprepitant
Maltese: Informazzjoni għall-utent EMEND 125 mg trab għal suspensjoni orali aprepitant
English: EMEND capsules are used in adults and adolescents from the age of 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).
Maltese: Il-kapsuli EMEND jintużaw f'adulti u adolexxenti mill-età ta' 12-il sena f'kombinazzjoni ma' mediċini oħrajn biex jimpedixxu nawsja u rimettar ikkawżati minn kimoterapija (kura kontra l-kanċer) li tikkaġuna nawsja u rimettar qawwi u moderat (bħal cisplatin, cyclophosphamide, doxorubicin jew epirubicin).
English: General disorders and administration site conditions fatigue common asthenia, malaise uncommon oedema, chest discomfort, gait disturbance rare
Maltese: Disturbi psikjatriċi ansjetà mhux komuni diżorjentazzjoni, ewforja rari
English: EU/1/03/262/007 1 hard capsule EU/1/03/262/008 5 x 1 hard capsule
Maltese: EU/1/03/262/003 5 x 1 kapsula iebsa
English: Another or additional non-hormonal form of birth control should be used during treatment with EMEND and for up to 2 months after using EMEND, - pimozide (used to treat psychiatric illnesses), - terfenadine; astemizole (used for hay fever and other allergic conditions), - cisapride (used for treating digestive problems), - medicines containing ergot alkaloid derivatives (used for treating migraines), - rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections), - phenytoin (a medicine used to treat seizures), - carbamazepine (used to treat depression and epilepsy), - midazolam, 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), - nefazodone (used to treat depression), - ketoconazole except shampoo (used to treat Cushing's syndrome - when the body produces an excess of cortisol), - itraconazole, voriconazole, posaconazole (antifungals), - corticosteroids (such as dexamethasone)
Maltese: - mediċini għall-kontroll tat-tqala li jinkludu pilloli għall-kontroll tat-tqala, gareż tal-ġilda, impjanti, u ċertu apparat ta' ġol-ġuf (IUDs) li jerħu ormoni jistgħu ma jaħdmux b'mod adegwat meta jittieħdu flimkien ma' EMEND. Forma ta' kontroll tat-tqala oħra jew addizzjonali mhux bl-ormoni għandha tintuża waqt il-kura b'EMEND u sa xahrejn wara l-użu ta' EMEND, - pimozide (użat għall-kura ta' mard psikjatriku), - terfenadine; astemizole (użati għall-hay fever u għal kundizzjonijiet allerġiċi oħrajn), - cisapride (użat għall-kura ta' problemi diġestivi), - mediċini li fihom derivattivi ta' alkalojde ergot (użati għall-kura ta' emikranji), - rifampicin, clarithromycin, telithromycin (antibijotiċi użati għall-kura ta' infezzjonijiet), - phenytoin (mediċina użata għall-kura ta' attakki ta' puplesija), - carbamazepine (użat għall-kura ta' depressjoni u epilessija), - midazolam, phenobarbital (mediċini użati biex jipproduċu kalmezza jew jgħinuk torqod) - St.
English: Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious reactions.
Maltese: Inibizzjoni ta' CYP3A4 b'aprepitant tista' tirriżulta f'konċentrazzjonijiet ogħla ta' dawn is-sustanzi attivi fil-plażma, li potenzjalment jistgħu jikkaġunaw reazzjonijiet serji.
English: The 125 mg capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.
Maltese: Il-kapsuli iebsin ta' 125 mg huma opaki b'għamla bajda u b'kappa roża b'“462” u “125 mg” stampati b'mod radjali b'linka sewda fuq il-korp.
English: EU/1/03/262/009 1 hard capsule EU/1/03/262/010 6 x 1 hard capsule
Maltese: EU/1/03/262/010 6 x 1 kapsuli ibsin
English: The pharmacokinetics of aprepitant is non-linear across the clinical dose range.
Maltese: Il-farmakokinetiċi ta' aprepitant m'humiex lineari fil-firxa kollha tad-doża klinika.
English: EMEND must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride (see section 4.3).
Maltese: Emend ma għandux jintuża fl-istess ħin ma' pimozide, terfenadine, astemizole, jew cisapride (ara sezzjoni 4.3).