FrancophonIA/ELRC3.0 huggingface dataset:
English: CYP3A4 interactions
Maltese: Interazzjonijiet ma' CYP3A4
English: The safety profile of aprepitant was evaluated in approximately 6,500 adults and 184 children and adolescents.
Maltese: Il-profil ta' sigurtà ta' aprepitant ġie stmat f'madwar 6,500 adult u 184 tifel u tifla u adolexxent.
English: Disodium edetate, polysorbate 80, lactose anhydrous, NaOH and/or HCl diluted (for pH adjustment).
Maltese: Disodium edetate, polysorbate 80, lactose anhydrous, NaOH u/jew HCl iddilwit (għal aġġustament tal-pH).
English: Control regimen (N =498) **
Maltese: Skeda ta' kontroll (N =498) **
English: Co-administration with pimozide, terfenadine, astemizole or cisapride (see section 4.5).
Maltese: Amministrazzjoni flimkien ma' pimozide, terfenadine, astemizole jew cisapride (ara sezzjoni 4.5).
English: 2 mg/kg intravenously OR 2 mg/kg orally (EMEND oral suspension)
Maltese: 2 mg/kg millħalq (EMEND suspensjoni orali)
English: Table 6: Tabulated list of adverse reactions - fosaprepitant
Maltese: Tabella 6: Lista ta' reazzjonijiet avversi miġbura f'tabella - fosaprepitant
English: Sodium hydroxide (E524) (for pH adjustment) and/or Hydrochloric acid diluted (E507) (for pH adjustment)
Maltese: Sodium hydroxide (E524) (għal aġġustament pH) u/jew Hydrochloric acid dilwit (E507) (għal aġġustament pH)
English: IVEMEND 150 mg is given as part of a combination therapy (see section 4.2).
Maltese: IVEMEND 150 mg jingħata bħala parti minn terapija ta' kombinazzjoni (ara sezzjoni 4.2).
English: PC: {number} SN: {number} NN: {number}
Maltese: Għoti tad- Doża għall-Iskedi ta' Kimoterapija ta' Jum Wieħed jew ta' Ħafna Ġranet
English: Corticosteroids
Maltese: Kortikosterojdi
English: Standard dose of 5-HT3 antagonists.
Maltese: Doża standard talantagonisti ta' 5-HT3.
English: Table 9: Pharmacokinetic parameters of aprepitant for 3-day IV fosaprepitant regimen in paediatric patients
Maltese: Tabella 9: Parametri farmakokinetiċi ta' aprepitant għall-iskeda ta' 3 ijiem ta' fosaprepitant IV f'pazjenti pedjatriċi
English: Fosaprepitant regimen (N =502) **
Maltese: Skeda ta' fosaprepitant (N =502) **
English: EU/1/07/437/003 1 x 1 vial EU/1/07/437/004 1 x 10 vials
Maltese: EU/1/07/437/004 1 x 10 kunjetti
English: Aprepitant regimen (N =1,134) **
Maltese: Reġimen ta' aprepitant (N =1,134) **
English: NR = Not Reported
Maltese: NR = Mhux irrappurtati (Not Reported)
English: Intravenous administration in adults occurs preferably through a running intravenous infusion over 20-30 minutes.
Maltese: Amministrazzjoni ġol-vina fl-adulti sseħħ preferibbilment permezz ta' infużjoni kontinwa ġol-vina fuq perjodu ta' 20 sa 30 minuta.
English: - The other ingredients are: disodium edetate (E386), polysorbate 80 (E433), lactose anhydrous, sodium hydroxide (E524) (for pH adjustment) and/or hydrochloric acid diluted (E507) (for pH adjustment).
Maltese: - Is-sustanzi l-oħra huma: disodium edetate (E386), polysorbate 80 (E433), lactose anhydrous, sodium hydroxide (E524) (għal aġġustament tal-pH) u/jew hydrochloric acid dilwit (E507) (għal aġġustament tal-pH).
English: Pack sizes: 1 or 10 vials.
Maltese: Daqsijiet tal-pakkett: kunjett 1 jew 10 kunjetti.
English: The 3-day oral aprepitant regimen resulted in an about 30-35 % reduction in AUC of CYP2C9 substrates and up to a 64 % decrease in ethinyl estradiol trough concentrations.
Maltese: Ir-reġimen ta' 3 ijiem ta' aprepitant mill-ħalq wassal għal tnaqqis ta' madwar 30-35 % fl-AUC tas-substrati ta' CYP2C9 u sa tnaqqis ta' 64 % fil-konċentrazzjonijiet l-aktar baxxi ta' ethinyl estradiol.
English: Preparation of IVEMEND 150 mg for intravenous administration:
Maltese: Preparazzjoni ta' IVEMEND 150 mg għal amministrazzjoni fil-vina:
English: Do not use IVEMEND:
Maltese: Tużax IVEMEND:
English: Fosaprepitant regimen (N =1,106) **
Maltese: Reġimen ta' fosaprepitant (N =1,106) **
English: 1-day IV dose
Maltese: Doża IV ta' jum 1
English: 2 - < 6 years old
Maltese: 2 - < 6 snin
English: In clinical studies, various formulations of fosaprepitant have been administered to a total of 2,687 adults including 371 healthy subjects and 2,084 patients, and 199 children and adolescents with chemotherapy induced nausea and vomiting (CINV).
Maltese: Fl-istudji kliniċi, ingħataw diversi formulazzjonijiet ta' fosaprepitant lil total ta' 2,687 adult inkluż 371 individwu f'saħħtu u 2,084 pazjent, u 199 tifel u tifla u adolexxent b'nawsja u rimettar kaġun talkimoterapija (CINV - chemotherapy induced nausea and vomiting).
English: 245.3 mg of fosaprepitant dimeglumine (equivalent to 150 mg fosaprepitant) to aprepitant, 23.9 mg of phosphoric acid and 95.3 mg of meglumine are liberated.
Maltese: Hekk kif 245.3 mg ta' fosaprepitant dimeglumine (ekwivalenti għal 150 mg ta' fosaprepitant) jinbidlu f'aprepitant, jinħelsu 23.9 mg ta' phosphoric acid u 95.3 mg ta' meglumine.
English: Day 4
Maltese: Jum 4
English: Maximum dose 150mg
Maltese: Doża massima 150mg
English: Rifampicin decreased the mean terminal half-life of oral aprepitant by 68 %.
Maltese: Rifampicin naqqas il-half-life terminali medja ta' aprepitant mill-ħalq b'68 %.
English: In adults (18 years of age and older), the recommended dose of IVEMEND is 150 mg fosaprepitant on Day 1 (day of chemotherapy).
Maltese: Fl-adulti (18-il sena u aktar), id-doża rrikmandata ta' IVEMEND hija 150 mg fosaprepitant fil-Jum 1 (il-jum tal-kimoterapija).
English: Effect of other medicinal products on the pharmacokinetics of aprepitant resulting from administration of fosaprepitant 150 mg
Maltese: Effetti ta' prodotti mediċinali oħra fuq il-farmakokinetika ta' aprepitant minħabba għoti ta' fosaprepitant 150 mg
English: After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml) (see section 6.6).
Maltese: Wara r-rikostituzzjoni u d-dilwizzjoni, 1 ml ta' soluzzjoni jkun fiha 1 mg ta' fosaprepitant (1 mg/ml) (ara sezzjoni 6.6).
English: CARTON 150 mg
Maltese: KARTUNA 150 mg
English: Mild hepatic impairment (Child-Pugh class A) does not affect the pharmacokinetics of aprepitant to a clinically relevant extent.
Maltese: Indeboliment epatiku ħafif (Child-Pugh klassi A) ma jaffettwax il-farmakokinetika ta' aprepitant għal xi medda kbira klinikament relevanti.
English: 80 mg intravenously OR 80 mg orally (EMEND capsules)
Maltese: 80 mg mill-ħalq (kapsuli EMEND)
English: C]
Maltese: A.
English: Aprepitant undergoes extensive metabolism.
Maltese: Aprepitant jgħaddi minn metaboliżmu estensiv.
English: Fosaprepitant placebo, aprepitant placebo, and dexamethasone placebo (in the evenings on Days 3 and 4) were used to maintain blinding (see section 4.2).
Maltese: Plaċebo għal fosaprepitant, plaċebo għal aprepitant, u plaċebo għal dexamethasone (filgħaxijiet tal-Jiem 3 u 4) intużaw biex jinżamm il-‘blinding'(ara sezzjoni 4.2).
English: Day 2
Maltese: Jum 2
English: In vitro studies using human liver microsomes indicate that aprepitant is metabolised primarily by CYP3A4 and potentially with minor contribution by CYP1A2 and CYP2C19.
Maltese: Studji in vitro bl-użu ta' mikrosomi tal-fwied tal-bniedem jindikaw li aprepitant huwa metabolizzat primarjament permezz ta' CYP3A4 u potenzjalment b'kontribuzzjoni minuri minn CYP1A2 u CYP2C19.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, ATC code: A04AD12.
Maltese: Antiemetiċi u antinawsjanti, Kodiċi ATC:
English: Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant (see section 5.2).
Maltese: Fosaprepitant huwa promediċina ta' aprepitant u meta mogħti fil-vina jinqaleb rapidament f'aprepitant (ara sezzjoni 5.2).
English: Tabulated list of adverse reactions - aprepitant
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella - aprepitant
English: Aprepitant is highly protein bound, with a mean of 97 %.
Maltese: Aprepitant jintrabat b'mod qawwi mal-proteini, b'medja ta' 97 %.
English: After reconstitution and dilution: 24 hours at 25°C.
Maltese: Wara r-rikostituzzjoni u d-dilwizzjoni: 24 siegħa f'temperatura ta' 25°C.
English: Therefore, there is no evidence of interaction with the use of IVEMEND 150 mg and 5-HT3 antagonists.
Maltese: Għalhekk, m'hemm l-ebda evidenza ta' interazzjoni bl-użu ta' IVEMEND 150 mg u antagonisti ta' 5-HT3.
English: Vascular disorders flushing, thrombophlebitis (predominantly, infusion-site thrombophlebitis)
Maltese: Disturbi vaskulari fwawar, tromboflebite (il-biċċa l-kbira, tromboflebite fis-sit tal-infużjoni)
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 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: (2.8 % kontra 1.1 %), dispepsja (2.6 % kontra 2.0 %), stitikezza (2.4 % kontra 2.0 %), uġigħ ta' ras (2.0 % kontra 1.8 %), u tnaqqis fl-aptit (2.0 % kontra 0.5 %).
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).
Maltese: Hija irrikmandata l-kawtela waqt amministrazzjoni fl-istess ħin ta' fosaprepitant u sustanzi attivi li jiġu metabolizzati primarjament permezz ta' CYP3A4 u b'medda terapewtika dejqa, bħal cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, u quinidine (ara s-sezzjoni 4.4).
English: AUC 0-24 hr. (ng*hr/mL)
Maltese: AUC 0-24 hr.
English: Musculoskeletal and connective tissue disorders muscular weakness, muscle spasms rare
Maltese: Disturbi muskolu-skeltriċi u tattessuti konnettivi dgħufija tal-muskoli, spażmi fil-muskoli rari
English: The fosaprepitant 150 mg single dose did not induce CYP3A4 on Days 1 and 4 in the midazolam interaction study.
Maltese: Id-doża singola ta' fosaprepitant 150 mg ma induċietx CYP3A4 fil-Jiem 1 u 4 fl-istudju dwar interazzjoni ta' midazolam.
English: Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant.
Maltese: Kull kunjett fih fosaprepitant dimeglumine ekwivalenti għal 150 mg fosaprepitant.
English: In a randomized, parallel, double-blind, active-controlled study, IVEMEND 150 mg (N=1,147) was compared with a 3-day aprepitant regimen (N=1,175) in adult patients receiving a HEC regimen that included cisplatin (≥70 mg/m2).
Maltese: Kimoterapija Emetoġenika ħafna (HEC - Highly Emetogenic Chemotherapy) Fi studju randomised, parallell, double-blind u kkontrollat b'mod attiv, IVEMEND 150 mg (N=1,147) tqabbel ma' reġimen ta' 3 ijiem ta' aprepitant (N=1,175) f'pazjenti adulti li kienu qed jirċievu reġimen ta' HEC li kien jinkludi cisplatin (≥70 mg/m2).
English: Efficacy data in combination with other corticosteroids and 5-HT3 antagonists are limited.
Maltese: Dejta tal-effikaċja f'kombinazzjoni ma' kortikosterojdi u antagonisti 5-HT3 hija limitata.
English: After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml).
Maltese: Wara r-rikostituzzjoni u d-dilwizzjoni 1 ml ta' soluzzjoni jkun fiha 1 mg fosaprepitant (1 mg/ml).
English: IVEMEND contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) f'kull doża, i.e. hija essenzjalment mingħajr sodium.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma ddefiniti bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000) u rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Hepatic impairment: Fosaprepitant is metabolized in various extrahepatic tissues; therefore hepatic impairment is not expected to alter the conversion of fosaprepitant to aprepitant.
Maltese: Fosaprepitant huwa metabolizzat f'diversi tessuti ekstraepataċi; għaldaqstant indeboliment epatiku mhux mistenni li jbiddel il-konverżjoni ta' fosaprepitant għal aprepitant.
English: 6 - < 12 years old
Maltese: 6 - < 12-il sena
English: Infusion site reactions (ISRs) have been reported with the use of IVEMEND (see section 4.8).
Maltese: Ġew irrappurtati reazzjonijiet fil-post tal-infużjoni (ISRs, infusion site reactions) bl-użu ta' IVEMEND (ara sezzjoni 4.8).
English: 1-Day Regimen of Fosaprepitant in Adults
Maltese: L-Iskeda ta' Jum 1 ta' Fosaprepitant fl-Adulti
English: Refer to the Summary of Product Characteristics of co-administered 5-HT3 antagonist medicinal products.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott tal-prodotti mediċinali antagonisti ta' 5-HT3 mogħtija flimkien miegħu.
English: †Difference and confidence interval (CI) were calculated using the method proposed by Miettinen and Nurminen and adjusted for gender.
Maltese: †Differenza u confidence interval (CI) kienu kkalkulati permezz tal-metodu propost minn Miettinen u Nurminenu aġġustat għas-sess.
English: Interaction studies with fosaprepitant 150 mg and 5-HT3 antagonists have not been conducted; however, in clinical interaction studies, the oral aprepitant regimen did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
Maltese: Ma sarux studji dwar interazzjonijiet b'fosaprepitant 150 mg u antagonisti ta' 5-HT3; madankollu, fi studji ta' interazzjoni klinika, ir-reġimen ta' aprepitant mill-ħalq ma kellux effetti klinikament importanti fuq il-farmakokinetika ta' ondansetron, granisetron, jew hydrodolasetron (il-metabolit attiv ta' dolasetron).
English: Prepare an infusion bag filled with 145 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection (for example, by removing 105 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection from a 250 ml sodium chloride 9 mg/ml (0.9 %) solution for injection infusion bag).
Maltese: Ipprepara borża tal-infużjoni mimlija b'145 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %) għall-injezzjoni (pereżempju, billi tneħħi 105 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %) għall-injezzjoni minn borża tal-infużjoni ta' 250 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %) għall-injezzjoni).
English: Co-administration with warfarin (a CYP2C9 substrate) In patients on chronic warfarin therapy, the International Normalised Ratio (INR) should be monitored closely for 14 days following the use of fosaprepitant (see section 4.5).
Maltese: Għoti flimkien ma' warfarin (substrat ta' CYP2C9) F'pazjenti fuq terapija kronika bil-warfarin, il-Proporzjon Normalizzat Internazzjonali (INRInternational Normalised Ratio) għandu jiġi sorveljat mill-qrib għal 14-il jum wara l-użu ta' fosaprepitant (ara sezzjoni 4.5).
English: A summary of the primary and secondary endpoints is shown in Table 7.
Maltese: Sommarju tal-iskopijiet primarji u sekondarji hija murija f'Tabella 7.
English: 5-HT3 antagonists
Maltese: Antagonisti ta' 5-HT3
English: Another or additional non-hormonal form of birth control should be used during treatment with IVEMEND and for up to 2 months after using IVEMEND, - 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), - diltiazem (a medicine used to treat high blood pressure), - corticosteroids (such as dexamethasone), - anti-anxiety medicines (such as alprazolam), - tolbutamide (a medicine used to treat diabetes)
Maltese: kontroll tat-twelid mhux bl-ormoni għandha tintuża waqt kura b'IVEMEND u sa xahrejn wara li jintuża IVEMEND, - cyclosporine, tacrolimus, sirolimus, everolimus (immunosupressanti), - alfentanil, fentanyl (użati biex jikkuraw l-uġigħ), - quinidine (użati biex jikkuraw taħbit tal-qalb irregolari), - irinotecan, etoposide, vinorelbine, ifosfamide (mediċini użati biex jikkuraw il-kanċer), - mediċini li fihom derivattivi alkalojdi tal-ergotina bħal ergotamine u diergotamina (użati għall kura tal-emigranja), - warfarin, acenocoumarol (sustanzi li jraqqu d-demm; jistgħu jkunu meħtieġa testijiet tad demm), - rifampicin, clarithromycin, telithromycin (antibijotiċi użati għall-kura tal-infezzjonijiet), - phenytoin (mediċina użata għall-kura tal-aċċessjonijiet), - carbamazepine (użata għall-kura tal-epilessija), - midazolam, triazolam, phenobarbital (mediċini użati biex jipproduċu l-kalma jew jgħinuk biex torqod), - St.
English: In patients with ESRD undergoing haemodialysis, the AUC0- of total aprepitant decreased by 42 % and Cmax decreased by 32 %.
Maltese: F'pazjenti b'ESRD li qed issirilhom emodijaliżi, l-AUC0-∞ ta' aprepitant totali naqas b'42 % u Cmax naqas b'32 %.
English: Infection and infestations candidiasis, staphylococcal infection rare
Maltese: Infezzjonijiet u infestazzjonijiet kandidjasi, infezzjoni tal-istafilokokku rari
English: Ketoconazole increased the terminal half-life of oral aprepitant about 3-fold.
Maltese: Ketoconazole żied il-half-life terminali ta'aprepitant mill-ħalq b'madwar 3 darbiet aktar.
English: Immune system disorders hypersensitivity reactions including anaphylactic reactions not known
Maltese: Immune system disorders reazzjonijiet ta' sensittività eċċessiva li jinkludu reazzjonijiet anafilattiċi mhux magħruf
English: Chemotherapeutic medicinal products
Maltese: Prodotti mediċinali kimoterapewtiċi
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.
Maltese: Kimoterapija Emetoġenika b'Mod Moderat (MEC - Moderately Emetogenic Chemotherapy) Fi studju randomised, parallell, ikkontrollat bi plaċebo, fejn la l-investigaturi u lanqas il-pazjenti ma kienu jafu liema sustanza qed tintuża, IVEMEND 150 mg (N=502) flimkien ma' ondansetron u dexamethasone tqabbel ma' ondansetron u dexamethasone waħedhom (skeda ta' kontroll) (N=498) f'pazjenti adulti li kienu qed jirċievu skeda ta' kimoterapija emetoġenika b'mod moderat.
English: ‡ Delayed phase = 25 to 120 hours post-initiation of chemotherapy.
Maltese: Fażi mdewma = 25 sa 120 siegħa wara l-bidu tal-kimoterapija.
English: Your doctor may ask you to take other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron) for preventing nausea and vomiting.
Maltese: It-tabib tiegħek jista' jitolbok tieħu mediċini oħra inkluż kortikosterojd (bħal ma huwa dexamethasone) u ‘antagonist ta' 5HT3' (bħal ma huwa ondansetron) li jilqgħu kontra d-dardir u r-rimettar.
English: Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant.
Maltese: Fosaprepitant, promediċina ta' aprepitant, meta amministrat fil-vina huwa rapidament mibdul f'aprepitant.
English: Positron emission tomography (PET) imaging studies, using a highly specific NK1-receptor tracer, in healthy young men administered a single intravenous dose of 150 mg fosaprepitant (N=8) demonstrated brain NK1 receptor occupancy of ≥100 % at Tmax, and 24 hours, ≥97 % at 48 hours, and between 41 % and 75 % at 120 hours, following dosing.
Maltese: Studji tal-immaġini permezz ta' tomografija b'emissjonijiet positron (PET - Positron emission tomography), bl-użu ta' trejser speċifiku ħafna għar-riċettur-NK1, f'irġiel għadhom żgħar f'saħħithom li ngħataw doża waħda ta' 150 mg fosaprepitant ġol-vini (N=8) urew li l-okkupanza tar-riċetturi NK1 tal-moħħ hija ta' ≥100 % f'Tmax, u wara 24 siegħa, ≥97 % wara 48 siegħa, u bejn 41 % u 75 % wara 120 siegħa, wara d-dożaġġ.
English: The total exposure of CYP3A4 substrates may increase up to 2-fold on Days 1 and 2 after coadministration with a single 150 mg fosaprepitant dose.
Maltese: L-esponiment totali ta' sottostrati ta' CYP3A4 jista' jiżdied b'madwar darbtejn aktar fil-Jiem 1 u 2 wara l-għoti flimkien ma' doża singola ta' 150 mg fosaprepitant.
English: Infusion of 100 mg fosaprepitant over 15 minutes with diltiazem 120 mg 3 times daily, resulted in a 1.5-fold increase of aprepitant AUC.
Maltese: Infużjoni ta' 100 mg fosaprepitant fuq 15-il minuta b'diltiazem 120 mg 3 darbiet kuljum, irriżultat f'żieda ta' 1.5 drabi tal-AUC ta' aprepitant.
English: In humans, fosaprepitant administered intravenously was rapidly converted to aprepitant within 30 minutes following the end of infusion.
Maltese: Fil-bnedmin, fosaprepitant amministrat fil-vina kien mibdul rapidament għal aprepitant fi żmien 30 minuta wara tmiem linfużjoni.
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.
Maltese: Indeboliment renali: Doża waħda ta' 240 mg ta' aprepitant orali ngħatat lil pazjenti b'indeboliment renali sever (CrCl< 30 ml/min) u lil pazjenti b'mard renali ta' stadju finali (ESRD) li jeħtieġu emodijaliżi.
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.
Maltese: Ir-reġimen ta' aprepitant kien jikkonsisti f'għoti ta' aprepitant 125 mg fil-Jum 1 u 80 mg/jum fil-Jiem 2 u 3 flimkien ma' ondansetron 32 mg IV fil-Jum 1 u dexamethasone 12-il mg fil-Jum 1 u 8 mg kuljum filJiem 2 sa 4.
English: 8 mg orally 8 mg orally twice daily
Maltese: 12-il mg mill-ħalq 8 mg millħalq
English: Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant, which corresponds to 130.5 mg of aprepitant.
Maltese: Kull kunjett fih fosaprepitant dimeglumine ekwivalenti għal 150 mg fosaprepitant, li jikkorrispondi għal 130.5 mg ta' aprepitant.
English: Cmax (ng/mL)
Maltese: (ng/mL)
English: The recommended dose is 150 mg administered as an infusion over 20-30 minutes on Day 1, initiated approximately 30 minutes prior to chemotherapy (see section 6.6).
Maltese: Id-doża rakkomandata hija ta' 150 mg mogħtija bħala infużjoni fuq perjodu ta' bejn 20 u 30 minuta fil-Jum 1, mibdija madwar 30 minuta qabel il-kimoterapija (ara sezzjoni 6.6).
English: IVEMEND 150 mg powder for solution for infusion Fosaprepitant
Maltese: IVEMEND 150 mg trab għal soluzzjoni għall-infużjoni fosaprepitant
English: 12 - 17 years old 150 mg 30400
Maltese: 150 mg 30400
English: Safety data following the administration of the 3-day IV/oral/oral regimen were also included.
Maltese: Dejta dwar sigurtà wara l-għoti tal-iskeda IV/orali/orali ta' 3 ijiem ġiet inkluża wkoll.
English: Fosaprepitant 150 mg, given as a single dose, is a weak inhibitor of CYP3A4.
Maltese: Fosaprepitant 150 mg, mogħti bħala doża singola, huwa impeditur dgħajjef ta' CYP3A4.