FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 1-day IV fosaprepitant setting, simulated median AUC0-24hr of aprepitant with median peak plasma concentration (Cmax) on Day 1 and the median concentrations at the end of Day 1, Day 2 and Day 3 in paediatric patients (6 months to < 12 years old) and observed mean AUC0-24hr with median peak plasma concentration (Cmax) on Day 1 and mean concentrations at the end of Day 1, Day 2 and Day 3 in paediatric patients (12 to 17 years old) are shown in Table 10.
Maltese: Fl-ambjent ta' jum 1 ta' fosaprepitant IV, medjan simulat tal-AUC0-24hr ta' aprepitant mal-medjan talogħla konċentrazzjoni fil-plażma (Cmax) f'Jum 1 u l-medjan tal-konċentrazzjonijiet fi tmiem Jum 1, Jum 2, u Jum 3 f'pazjenti pedjatriċi (6 xhur sa < 12-il sena) u medja osservata tal-AUC0-24hr malmedjan tal-ogħla konċentrazzjoni fil-plażma (Cmax) f'Jum 1 u l-medjan tal-konċentrazzjonijiet fi tmiem Jum 1, Jum 2, u Jum 3 f'pazjenti pedjatriċi (12 sa 17-il sena) qed jintwerew f'Tabella 10.
English: 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 %).
Maltese: L-aktar reazzjonijiet avversi komuni rappurtati b'inċidenza akbar f'pazjenti pedjatriċi ttrattati bliskeda ta' aprepitant milli bl-iskeda ta' kontroll waqt li kienu qed jirċievu kimoterapija emetoġenika għall-kanċer kienu sulluzzu (3.3 % versus 0.0 %) u fwawar (1.1 % versus 0.0 %).
English: It is anticipated that IVEMEND would cause less or no greater induction of CYP2C9, CYP3A4, and glucuronidation than that caused by the administration of the 3-day oral aprepitant regimen, for which a transient induction with its maximum effect 6-8 days after first aprepitant dose has been observed.
Maltese: Huwa mistenni li IVEMEND jikkawża anqas induzzjoni jew ma jikkawżax induzzjoni akbar ta' CYP2C9, CYP3A4, u glukuronidazzjoni minn dik ikkawżata permezz tal-għoti tar-reġimen ta' 3 ijiem ta' aprepitanti mill-ħalq, li fih kienet osservata induzzjoni temporanja bl-effett massimu tagħha jseħħ minn 6-8 ijiem wara l-ewwel doża ta' aprepitant.
English: In a toxicity study in juvenile dogs treated with fosaprepitant from postnatal day 14 to day 42, a decreased testicular weight and Leydig cell size were seen in the males at 6 mg/kg/day and increased uterine weight, hypertrophy of the uterus and cervix, and oedema of vaginal tissues were seen in females from 4 mg/kg/day.
Maltese: Fi studju dwar l-effetti tossiċi fi klieb ta' età żgħira ttrattati b'fosaprepitant minn jum 14 sa jum 42 wara t-twelid, deher tnaqqis fil-piż tat-testikoli u fid-daqs taċ-ċellula ta' Leydig fl-irġiel b'6 mg/kg/jum kif ukoll żieda fil-piż tal-utru, ipertrofija tal-utru u taċ-ċerviċi, u edima tat-tessuti tal vaġina fin-nisa minn 4 mg/kg/jum.
English: There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh class C).
Maltese: Ma hemm l-ebda tagħrif kliniku jew farmakokinetiku f'pazjenti b'indeboliment epatiku sever (Child-Pugh klassi C).
English: Vascular disorders hot flush/flushing uncommon
Maltese: Disturbi vaskulari fwawar sħan/fwawar mhux komuni
English: Paediatrics
Maltese: FARMAĊEWTIKU
English: Nervous system disorders headache common dizziness, somnolence uncommon cognitive disorder, lethargy, dysgeusia rare
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras komuni sturdament, ħedla ta' ngħas mhux komuni disturb konoxxittiv, letarġija, disgewżja rari
English: Caution is advised when warfarin, acenocoumarol, tolbutamide, phenytoin or other active substances that are known to be metabolised by CYP2C9 are administered with IVEMEND.
Maltese: Hija rrikmandata l-kawtela meta warfarin, acenocoumarol, tolbutamide, phenytoin jew sustanzi attivi oħrajn li huma magħrufa li huma metabolizzati permezz ta' CYP2C9 jingħataw ma' IVEMEND.
English: Other medicines and IVEMEND
Maltese: Mediċini oħra u IVEMEND
English: Fosaprepitant must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride.
Maltese: Fosaprepitant ma għandux jintuża fl-istess ħin ma' pimozide, terfenadine, astemizole, jew cisapride.
English: The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of fosaprepitant.
Maltese: L-effikaċja ta' kontraċettivi ormonali tista' tkun imnaqqsa waqt u għal 28 jum wara lamministrazzjoni ta' fosaprepitant.
English: The safety and efficacy of IVEMEND in infants below 6 months of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' IVEMEND fi trabi taħt l-età ta' 6 xhur ma' ġewx determinati.
English: • with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems).
Maltese: • ma' mediċini li fihom pimozide (użat biex jittratta mard psikjatriku), terfenadine u astemizole (użati għall-hayfever jew kundizzjonijiet allerġiċi oħra), cisapride (użat biex jittratta problemi diġestivi).
English: 5-HT3 antagonist
Maltese: Antagonist ta' 5-HT3
English: Following a single intravenous 150-mg dose of fosaprepitant administered as a 20-minute infusion to healthy adult volunteers, the mean AUC0-∞ of aprepitant was 35.0 µg•hr/ml and the mean maximal aprepitant concentration was 4.01 µg/ml.
Maltese: Għoti ta' aprepitant wara li jingħata fosaprepitant Wara doża waħda fil-vina ta' 150 mg fosaprepitant amministrata bħala infużjoni ta' 20 minuta lil voluntiera adulti f'saħħithom l-AUC0-∞ medja ta' aprepitant kienet 35.0 μg•siegħa/ml u lkonċentrazzjoni medja massima ta' aprepitant kienet 4.01 μg/ml.
English: Interaction studies with fosaprepitant 150 mg and chemotherapeutic medicinal products have not been conducted; however, based on studies with oral aprepitant and docetaxel and vinorelbine, IVEMEND 150 mg is not expected to have a clinically relevant interaction with intravenously administered docetaxel and vinorelbine.
Maltese: Ma sarux studji ta' interazzjoni b'fosaprepitant 150 mg u prodotti mediċinali kimoterapewtiċi; madankollu, fuq bażi ta' studji b'aprepitant mill-ħalq u docetaxel u vinorelbine, IVEMEND 150 mg mhuwiex mistenni li jkollu interazzjoni klinika rilevanti ma' docetaxel u vinorelbine mogħtija minn ġol-vini.
English: In patients on chronic warfarin therapy, the prothrombin time (INR) should be monitored closely during treatment with and for 14 days following the use of IVEMEND for the prevention of chemotherapy induced nausea and vomiting (see section 4.4).
Maltese: F'pazjenti fuq terapija kronika b'warfarin, il-prothrombin time (INR) għandu jiġi sorveljat bir-reqqa waqt il-kura b'IVEMEND u għal 14-il jum wara l-użu tiegħu għal prevenzjoni ta' nawsja u rimettar ikkawżati minn kimoterapija (ara sezzjoni 4.4).
English: Table 2: Recommended dosing for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy regimen in adults
Maltese: Tabella 2: Għoti ta' dożi rrakkomandat għall-prevenzjoni ta' nawsja u rimettar assoċjati ma' skeda ta' kimoterapija moderatament emetoġenika fl-adulti
English: • Volume to administer (ml) equals the recommended dose (mg)
Maltese: • Volum li għandu jingħata (ml) huwa daqs id-doża rrakkomandata (mg)
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 4 jew 48 siegħa wara d-doża ma kellha lebda effett sinjifikanti fuq il-farmakokinetika ta' aprepitant; inqas minn 0.2 % tad-doża kienet irkuprata fid-dialysate.
English: In an active-controlled clinical study in adult patients receiving HEC, safety was evaluated for 1,143 patients receiving the 1-day regimen of IVEMEND 150 mg compared to 1,169 patients receiving the 3-day regimen of aprepitant.
Maltese: Fi studju kliniku kkontrollat b'mod attiv f'pazjenti adulti li kienu qed jirċievu HEC, is-sigurtà ġiet evalwata għal 1,143 pazjent li kienu qed jirċievu r-reġimen ta' jum wieħed ta' 150 mg IVEMEND mqabbla ma' 1,169 pazjent li kienu qed jirċievu r-reġimen ta' 3 ijiem ta' aprepitant.
English: ENDPOINTS*
Maltese: SKOPIJIET FINALI*
English: - Infusion site reactions (ISR) at or near the infusion site.
Maltese: - Reazzjonijiet fil-post tal-infużjoni (ISR, infusion site reactions) fil-post jew qrib il-post talinfużjoni.
English: , Mg including Hartman's and lactated Ringer's solutions.
Maltese: IVEMEND mhuwiex kompatibbli ma' xi soluzzjonijiet li fihom cations divalenti (eż., Ca2+, Mg2+), inkluż soluzzjonijiet Hartman u lactated ringer.
English: The geometric mean plasma clearance of aprepitant following a 150 mg intravenous dose of fosaprepitant was approximately 73 ml/min.
Maltese: It-tneħħija ġeometrika medja ta' apepitant mill-plażma wara għoti ta' doża ta' 150 mg fosaprepitant minn ġolvini kienet ta' madwar 73 ml/min.
English: Infusion site reactions (ISRs) have been reported with the use of IVEMEND (see section 4.4).
Maltese: Reazzjonijiet fil-post tal-infużjoni (ISRs, infusion site reactions) ġew irrappurtati bl-użu ta' IVEMEND (ara sezzjoni (4.4).
English: Inject 5 ml sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial.
Maltese: Injetta 5 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %) għal injezzjoni fil-kunjett.
English: Interaction studies with fosaprepitant 150 mg and diltiazem have not been conducted; however, the following study with 100 mg of fosaprepitant should be considered when using IVEMEND 150 mg with diltiazem.
Maltese: Ma sarux studji dwar interazzjonijiet b'fosaprepitant 150 mg u diltiazem; madankollu, l-istudju li ġej b'100 mg ta' fospaprepitant għandu jiġi kkunsidrat meta wieħed juża IVEMEND 150 mg ma' diltiazem.
English: There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Maltese: Hemm dejta limitata f'pazjenti b'indeboliment epatiku moderat u l-ebda dejta f'pazjenti b'indeboliment epatiku sever.
English: * For paediatric patients 12 years and older, administer IVEMEND intravenously over 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy.
Maltese: * Għal pazjenti pedjatriċi ta' 12-il sena u aktar, agħti IVEMEND minn ġol-vini fuq perjodu ta' 30 minuta, u lesti l-infużjoni madwar 30 minuta qabel il-kimoterapija.
English: In patients with mild to moderate hypertension, infusion of 100 mg of fosaprepitant over 15 minutes with diltiazem 120 mg 3 times daily, resulted in a 1.4-fold increase in diltiazem AUC and a small but clinically meaningful decrease in blood pressure, but did not result in a clinically meaningful change in heart rate, or PR interval.
Maltese: F'pazjenti bi pressjoni għolja minn ħafifa sa moderata, infużjoni ta' 100 mg ta' fosaprepitant fuq 15-il minuta ma' diltiazem 120 mg 3 darbiet kuljum, wasslet għal żieda ta' 1.4 drabi fl-AUC ta' diltiazem u tnaqqis żgħir iżda klinikament sinjifikanti fil-pressjoni, iżda ma wasslitx għal bidla klinikament sinjifikanti fir-rata tal-qalb, jew fl-interval PR.
English: • Volume to administer (ml) = recommended dose (mg/kg) x weight (kg) o Note: Do not exceed maximum doses (see section 4.2).
Maltese: • Volum li għandu jingħata (ml) = id-doża rrakkomandata (mg/kg) x piż (kg) o Nota:
English: Maximum dose 80 mg
Maltese: 80 mg
English: The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these medicinal products with IVEMEND.
Maltese: L-effetti potenzjali ta' żieda fil-konċentrazzjonijiet fil-plażma ta' midazolam jew ta' benzodiazepines oħra metabolizzati permezz ta' CYP3A4 (alprazolam, triazolam) għandhom jiġu ikkunsidrati meta dawn il-prodotti mediċinali jingħataw flimkien ma' IVEMEND.
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 kienu osservati f'pazjenti adulti ttrattati b'aprepitant għal dardir u rimettar wara operazzjoni (PONV) u f'inċidenza akbar milli b'ondansetron: uġigħ fin-naħa ta' fuq taladdome, ħsejjes tal-imsaren anormali, stitikezza*, diżartrija, qtugħ ta' nifs, ipoestesija, nuqqas ta' rqad, mijożi, dardir, disturb sensorili, dwejjaq fl-istonku, sub-ileus*, tnaqqis tal-akutezza viżwali, tħarħir.
English: *Nausea and vomiting were efficacy parameters in the first 5-days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
Maltese: *Id-dardir u r-rimettar kienu parametri tal-effikaċja fl-ewwel 5 ijiem ta' trattament ta' wara l-kimoterapija u ġew irrappurtati bħala reazzjonijiet avversi biss wara.
English: The solution for infusion is given to you by a health care professional, such as a doctor or nurse, via an intravenous infusion (a drip) approximately 30 minutes before you start the chemotherapy treatment in adults or 60 - 90 minutes before you start the chemotherapy treatment in children and adolescents.
Maltese: Is-soluzzjoni għal infużjoni tingħatalek minn professjonist fil-qasam mediku, bħal tabib jew infermier, permezz ta' infużjoni ġol-vina (dripp) madwar 30 minuta qabel tibda t-trattament tal-kimoterapija fl-adulti jew 60 - 90 minuta qabel tibda t-trattament talkimoterapija fit-tfal u fl-adolexxenti.
English: Tel: +48 22 549 51 00 msdpolska@merck.com
Maltese: MSD Polska Sp. z o.o. Tel: +48 22 549 51 00 msdpolska@merck.com
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' sensittività għad-dawl, iperidrosi, saborrea, ferita fil-ġilda, raxx bil-ħakk, sidrome ta' Stevens-Johnson/nekroliżi tossika tal-epidermide rari ħakk, urtikarja mhux magħruf
English: Effect of fosaprepitant on the pharmacokinetics of other active substances CYP3A4 inhibition
Maltese: Amministrazzjoni konkomitanti ta' fosaprepitant ma' sustanzi attivi li jimpedixxu l-attività ta' CYP3A4
English: Withdraw the entire volume from the vial and transfer it into an infusion bag containing 145 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection to yield a total volume of 150 ml and final concentration of 1 mg/ml.
Maltese: Iġbed il-volum sħiħ minn ġol-kunjett u ittrasferixxih għal ġo borża tal-infużjoni li jkun fiha 145 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %) għall-injezzjoni biex tagħti volum totali ta' 150 ml u konċentrazzjoni finali ta' 1 mg/ml.
English: It belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists".
Maltese: Huwa jagħmel parti minn grupp ta' mediċini msejħa "antagonisti tar-riċettur ta' neurokinin 1 (NK1)".
English: Metabolism and nutrition disorders decreased appetite common polydipsia rare
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni tnaqqis fl-aptit komuni
English: : 800 00 673 (+357 22866700) cyprus_info@merck.com
Maltese: Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com
English: Blood and lymphatic system disorders febrile neutropenia, anaemia uncommon
Maltese: Disturbi tad-demm u tas-sistema limfatika newtropenija bid-deni, anemija mhux komuni
English: In the performed safety pharmacology and repeated dose toxicity studies with dogs, fosaprepitant Cmax and aprepitant AUC values were up to 3 times and 40 times, respectively, higher than clinical values.
Maltese: Fl-istudji mwettqa dwar il-farmakoloġija tassigurtà u tat-tossiċità b'dożi ripetuti fuq il-klieb, Cmax ta' fosaprepitant u l-valuri AUC ta' aprepitant kienu sa 3 darbiet u 40 darba, rispettivament, ogħla mill-valuri kliniċi.
English: The pharmacokinetics of aprepitant is non-linear across the clinical dose range.
Maltese: Il-farmakokinetika ta' aprepitant m'hijiex linejari matul il-medda ta' doża klinika.
English: Paediatric patients 6 months to less than 12 years and not less than 6 kg
Maltese: Pazjenti pedjatriċi minn 6 xhur sa 12-il sena u mhux anqas minn 6 kg
English: Conclusions regarding the influence of moderate hepatic impairment (Child-Pugh class B) on aprepitant pharmacokinetics cannot be drawn from available data.
Maltese: Minn dejta disponibbli ma jistgħux jinġibdu konklużjonijiet rigward linfluwenza ta' indeboliment epatiku moderat (Child-Pugh klassi B) fuq il-farmakokinetika ta' aprepitant.
English: Hypersensitivity to the active substance or to polysorbate 80 or any of the other excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal polysorbate 80 jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Table 8: Percent of adult patients receiving Moderately Emetogenic Chemotherapy responding by treatment group and phase
Maltese: Tabella 8: Perċentwal ta' pazjenti adulti li kienu qed jirċievu Kimoterapija Emetoġenika b'Mod Moderat li rrispondew skont il-grupp ta' trattament u l-fażi
English: Furthermore, fosaprepitant underwent rapid and nearly complete conversion to aprepitant in S9 preparations from other human tissues including kidney, lung and ileum.
Maltese: Barra dan, fosaprepitant sarlu tibdil rapidu u kważi komplut għal aprepitant fi preparazzjonijiet S9 minn tessuti tal-bniedem oħra inklużi kliewi, pulmun u iljum.
English: Paediatric population: As part of a 3-day IV/IV/IV regimen, simulated median AUC0-24hr of aprepitant with median peak plasma concentration (Cmax) on Day 1 and the median concentrations at the end of Day 1, Day 2 and Day 3 in paediatric patients (6 months to 17 years old) are shown in Table 9.
Maltese: Bħala parti mill-iskeda IV/IV/IV ta' 3 ijiem, medjan simulat tal-AUC0-24hr ta' aprepitant mal-medjan tal-ogħla konċentrazzjoni fil-plażma (Cmax) f'Jum 1 u l-medjan talkonċentrazzjonijiet fi tmiem Jum 1, Jum 2, u Jum 3 f'pazjenti pedjatriċi (6 xhur sa 17-il sena) qed jintwerew f'Tabella 9.
English: The fosaprepitant regimen consisted of fosaprepitant 150 mg on Day 1 in combination with ondansetron 32 mg IV 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.
Maltese: Ir-reġimen ta' fosaprepitant kien jikkonsisti f'għoti ta' fosaprepitant 150 mg fil-Jum 1 flimkien ma' ondansetron 32 mg IV fil-Jum 1 u dexamethasone 12-il mg fil-Jum 1, 8 mg fil-Jum 2, u 8 mg darbtejn kuljum fil-Jiem 3 u 4.
English: In laboratory animals, fosaprepitant in non-commercial formulations caused vascular toxicity and hemolysis at concentrations below 1 mg/ml and higher, dependent on the formulation.
Maltese: F'annimali tal-laboratorju, fosaprepitant f'formulazzjonijiet mhux kummerċjali kkawża tossiċità vaskulari u emolisi f'konċentrazzjonijiet taħt il-1 mg/ml u ogħla, skont il-formulazzjoni.
English: IVEMEND 150 mg powder for solution for infusion fosaprepitant
Maltese: IVEMEND 150 mg trab għal soulzzjoni għall-infużjoni Fosaprepitant
English: IVEMEND 150 mg powder for solution for infusion.
Maltese: IVEMEND 150 mg trab għal soluzzjoni għall-infużjoni.
English: If a corticosteroid, such as dexamethasone, is coadministered, administer 50% of the recommended corticosteroid dose on days 1 through 4
Maltese: Jekk kortikosterojd, bħal dexamethasone, jingħata flimkien miegħu, agħti 50% tad-doża rrakkomandata tal-kortikosterojd fil-jiem 1 sa 4
English: Tabulated list of adverse reactions - fosaprepitant The following are adverse reactions reported in adult patients receiving fosaprepitant in clinical studies or postmarketing that have not been reported with aprepitant as described above.
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella - fosaprepitant Dawn li ġejjin huma reazzjonijiet avversi rrappurtati f'pazjenti adulti li kienu qed jirċievu fosaprepitant fi studji kliniċi jew wara t-tqegħid fis-suq u li ma kinux irrapurtati b'aprepitant kif deskritt hawn fuq.
English: As a weak inhibitor of CYP3A4, the fosaprepitant 150 mg single dose can cause a transient increase in plasma concentrations of co-administered active substances that are metabolised through CYP3A4.
Maltese: Bħala inibitur dgħajjef ta' CYP3A4, fosaprepitant 150 mg f'doża singola jista' jikkawża żieda temporanja fil-konċentrazzjonijiet tal-plażma ta' sustanzi attivi oħra amministrati flimkien li huma metabolizzati permezz ta' CYP3A4.
English: The terminal half-life of aprepitant following a 150 mg intravenous dose of fosaprepitant was approximately 11 hours.
Maltese: Il-half-life terminali ta' aprepitant wara għoti ta' 150 mg fosaprepitant mill-vina kienet madwar 11-il siegħa.
English: No hemolysis was found with the commercial formulation up to a fosaprepitant concentration of 1 mg/ml in human whole blood and washed human erythrocytes.
Maltese: Ma nstabet l-ebda emolisi bil-formulazzjoni kummerċjali sa konċentrazzjoni ta' fosaprepitant ta' 1 mg/ml f'demm sħiħ uman u f'eritroċiti umani maħsulin.
English: 5 mg/kg intravenously
Maltese: 5 mg/kg minn ġol-vini
English: Metabolites are excreted in urine and via biliary excretion in faeces.
Maltese: Il-metaboliti huma eliminati fl-awrina u permezz ta' eliminazzjoni biljari fl-ippurgar.
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 addizzjonali kkontrollat b'mod attiv f'1,169 pazjent adult li kienu qed jirċievu aprepitant u HEC, il-profil tar-reazzjonijiet avversi kien ġeneralment jixbah lil dak li deher fl-istudji oħra ta' HEC b'aprepitant.
English: It is anticipated that fosaprepitant would cause less or no greater induction of CYP2C9, CYP3A4 and glucuronidation than that caused by the administration of oral aprepitant.
Maltese: Huwa mistenni li fosaprepitant jikkawża anqas induzzjoni jew ma jikkawżax induzzjoni akbar ta' CYP2C9, CYP3A4 u glukuronidazzjoni minn dik ikkawżata minn għoti ta' aprepitant mill-ħalq.
English: 150 mg intravenously none none none
Maltese: 150 mg għal ġol-vini xejn xejn xejn
English: Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, and protease inhibitors) should be approached cautiously, as the combination is expected to result in several-fold increased plasma concentrations of aprepitant (see section 4.4).
Maltese: (eż. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, u inibituri tal-protease) għandha ssir b'kawtela, peress li t-taħlita hija mistennija li twassal għal żieda ta' ħafna drabi fil-konċentrazzjonijiet ta' aprepitant fil-plażma (ara s-sezzjoni 4.4).
English: The dose of dexamethasone accounts for active substance interactions.
Maltese: Id-doża ta' dexamethasone tagħmel tajjeb għall-interazzjonijiet tas-sustanza attiva.
English: Each vial contains 150 mg of fosaprepitant.
Maltese: Kull kunjett fih 150 mg ta' fosaprepitant.
English: Additionally, in a placebo-controlled clinical trial in adult patients receiving MEC, safety was evaluated for 504 patients receiving a single dose of IVEMEND 150 mg compared to 497 patients receiving the control regimen.
Maltese: Barra dan, fi prova klinika kkontrollata bi plaċebo f'pazjenti adulti li kienu qed jirċievu MEC, is-sigurtà ġiet stmata f'504 pazjenti li kienu qed jirċievu doża waħda ta' IVEMEND 150 mg meta mqabbla ma' 497 pazjent li kienu qed jirċievu l-iskeda ta' kontroll.
English: Fosaprepitant 150 mg is a weak CYP3A4 inhibitor as a single dose on Day 1 with no evidence of inhibition or induction of CYP3A4 observed on Day 4.
Maltese: Fosaprepitant 150 mg huwa impeditur dgħajjef ta' CYP3A4 meta mogħti bħala doża singola fil-Jum 1iżda l-ebda evidenza ta' impediment jew induzzjoni ta' CYP3A4 ma huma osservati fil-Jum 4.