FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional adverse reactions were observed in adults treated with the aprepitant (125 mg/80 mg) regimen for chemotherapy induced nausea and vomiting (CINV) and at a greater incidence than with standard therapy: abdominal distension, abdominal pain, acne, anaemia, anxiety, AST increased, asthenia, blood alkaline phosphatase increased, blood sodium decreased, candidiasis, cardiovascular disorder, chest discomfort, cognitive disorder, conjunctivitis, cough, decreased appetite, disorientation, dizziness, duodenal ulcer perforation, dysgeusia, dyspepsia, dysuria, eructation, euphoric mood, faeces hard, fatigue, febrile neutropenia, flatulence, gait disturbance, gastroesophageal reflux disease, glucose urine present, hiccups, hot flush, hyperhidrosis, lethargy, malaise, muscle spasms, muscular weakness, nausea*, neutropenic colitis, neutrophil count decreased, oedema, oropharyngeal pain, palpitations, photosensitivity reaction, pollakiuria, polydipsia, postnasal drip, rash pruritic, red blood cells urine positive, seborrhoea, skin lesion, sneezing, somnolence, staphylococcal infection, stomatitis, throat irritation, tinnitus, urine output increased, vomiting*, weight decreased.
Maltese: Reazzjonijiet avversi addizzjonali ġew osservati f'adulti ttrattati b'kors ta' aprepitant (125 mg/80 mg) għad-dardir u rimettar ikkawżati mill-kimoterapija (CINV) u f'inċidenza akbar milli b'terapija standard: nefħa fl-addome, uġigħ addominali, akne, anemija, ansjetà, żieda fl-AST, astenja, żjieda f'alkaline phosphatase fid-demm, tnaqqis ta' sodium fid-demm, kandidajiżi, disturb kardjovaskulari, skumdita' fis-sider, disturbi kognitivi, konġuntivité, sogħla, tnaqqis fl-aptit, diżorjentament, sturdament, perforazzjoni ta' ulċera duwodenali, disgewżja, dispepsja, disurja, tifwiq, burdata ewforika, ippurgar iebes, għeja, newtropenja bid-deni, gass fl-istonku, disturb fil-mixi, marda ta' refluss gastroesofaġejali, preżenza ta' glucose fl-awrina, sulluzzu, fwawar, iperiderożi, letarġija, telqa tal-ġisem, spażmi fil-muskoli, dgħufija tal-muskoli, dardir*, kolite newtropenika, tnaqqis fl-għadd tannewtrofils, edima, uġigħ fil-ħalq u fil-farinġi, palpitazzjonijiet, reazzjoni ta' fotosensittività, pollakjurja, polidipsja, taqtir min-naħa ta' wara tal-imnieħer, raxx bil-ħakk, awrina pożittiva għal ċelluli ħomor tad-demm, ġilda żejtnija, leżjonijiet tal-ġilda, għatis, ħedla tan-ngħas, infezzjonijiet bi staphylococcus, stomatité, irritazzjoni fil-gerżuma, tinnitus, żjieda fit-tneħħija tal-awrina, rimettar*,
English: Concomitant administration of EMEND with herbal preparations containing St. John's Wort (Hypericum perforatum) is not recommended.
Maltese: John's wort (Hypericum perforatum) mhuwiex rakkomandat.
English: After reconstitution, 1 mL oral suspension contains 25 mg of aprepitant.
Maltese: Wara r-rikostituzzjoni, 1 mL ta' suspensjoni orali jkun fiha 25 mg ta' aprepitant.
English: Nervous system disorders dysarthria, hypoaesthesia, sensory disturbance uncommon
Maltese: Disturbi fis-sistema nervuża disartrija, ipoesteżija, disturbi tas-sensazzjoni mhux komuni
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 jkunu qegħdin taħt emodijaliżi, l- AUC0-∞ ta' aprepitant totali naqset b'42 % u Cmax naqset bi 32 %.
English: 1 hard capsule 6 x 1 hard capsule
Maltese: kapsula iebsa 1 6 x 1 kapsuli ibsin
English: Immune system disorders hypersensitivity reactions including anaphylactic reactions not known
Maltese: Disturbi fis-sistema immuni reazzjonijiet ta' sensittività eċċessiva inklużi reazzjonijiet anafilattiċi mhux magħruf
English: Methylprednisolone: Interaction studies with aprepitant 165 mg and methylprednisolone have not been conducted; however, the following study with the aprepitant 125 mg/80 mg regimen should be considered when using EMEND 165 mg with methylprednisolone.
Maltese: Ma sarux studji dwar interazzjoni bejn 165 mg ta' aprepitant u methylprednisolone; madakollu, l-istudju li ġej bi skeda ta' ghoti ta' aprepitant 125 mg/80 mg għandu jiġi kkunsidrat meta wieħed juża165 mg ta' EMEND ma' methylprednisolone.
English: Danmark MSD Danmark ApS Tlf: +45 44824000 dkmail@merck.com
Maltese: Tlf: +45 44824000 dkmail@merck.com
English: The reduction in risk for a vomiting episode over the 0 to 24 hour period with aprepitant 40 mg relative to ondansetron 4 mg was 53.3 % (95 % C.I.
Maltese: It-tnaqqis fir-riskju għal episodju ta' rimettar fuq perijodu ta' 0 sa 24 siegħa b'aprepitant 40 mg meta mqabbel ma' ondansetron 4 mg kien ta' 53.3 % (95 % C.I.: 35.3 sa 66.3) f'analiżi li ma tikkalkulax lillpazjenti waqt l-użu ta' salvataġġ.
English: How to give EMEND
Maltese: DATA TA' SKADENZA
English: In a study with 2 mg midazolam orally co-administered with 200 mg aprepitant in the fed state (standard light breakfast), the AUC0-∞ of midazolam, a sensitive CYP3A4 substrate, was increased 3.2-fold on Day 1.
Maltese: Fi studju b'2 mg ta' midazolam mogħti mill-ħalq flimkien ma' 200 mg ta' aprepitant fl-istat mitmugħ (kolazzjon standard ħafif), l-AUC0-∞ ta' midazolam, sustrat sensittiv ta' CYP3A4, żdiedet bi 3.2 drabi aktar fil-Jum 1.
English: For children aged 6 months to less than 12 years
Maltese: Għal tfal ta' età minn 6 xhur sa inqas minn 12-il sena
English: For aprepitant no clinical data on exposed pregnancies are available.
Maltese: Għal aprepitant m'hemmx dejta klinika disponibbli dwar tqaliet esposti.
English: The aprepitant regimen for children aged 6 months to less than 12 years (n=105) consisted of EMEND powder for oral suspension 3.0 mg/kg (up to 125 mg) orally on Day 1 and 2.0 mg/kg (up to 80 mg) orally on Days 2 and 3 in combination with ondansetron on Day 1.
Maltese: Ilkors terapewtiku ta' trattament b'aprepitant għal tfal ta' età minn 6 xhur sa inqas minn 12-il sena (n=105) kien jikkonsisti fi trab għal susupensjoni orali ta' EMEND 3.0 mg/kg (sa 125 mg) mill-ħalq f'Jum 1 u 2.0 mg/kg (sa 80 mg) mill-ħalq fil-Jiem 2 u 3 flimkien ma' ondansetron f'Jum 1.
English: The AUC of orally administrated midazolam increased by 1.2-fold when a single dose of 40 mg aprepitant was co-administered with a single oral dose of 2 mg midazolam; this effect was not considered clinically important.
Maltese: L-AUC ta' midazolam mogħti oralment żdiedet b'1.2 drabi meta doża waħda ta' 40 mg aprepitant ingħatat flimkien ma' doża waħda ta' 2 mg midazolam; dan l-effett ma tqisx klinikament importanti.
English: Of the paediatric patients, 29 % in the aprepitant regimen and 28 % in the control regimen used dexamethasone as part of the regimen in Cycle 1.
Maltese: Mill-pazjenti pedjatriċi, 29 % fil-kors terapewtiku ta' trattament b'aprepitant u 28 % fil-kors terapewtiku ta' trattament b'kontroll użaw dexamethasone bħala parti mill-kors terapewtiku ta' trattament f'Ċiklu 1.
English: EMEND 165 mg is given as part of combination therapy (see section 4.2).
Maltese: EMEND 165 mg jingħata bħala parti minn terapija mħallta (ara sezzjoni 4.2).
English: Please refer to the SmPC of co-administered 5-HT3 antagonist medicinal products.
Maltese: Jekk jogħġbok irreferi għall-SmPC tal-prodotti mediċinali antagonisti ta' 5-HT3 mogħtija flimkien miegħu.
English: Interaction studies with aprepitant 165 mg and midazolam have not been conducted; however, the following study with 200 mg of aprepitant should be considered when using EMEND 165 mg with medicinal products metabolised via CYP3A4.
Maltese: Ma sarux studji dwar interazzjoni bejn 165 mg ta' aprepitant u midazolam; madankollu, l-istudju li jmiss b'200 mg ta' aprepitant għandu jitqies meta wieħed juża 165 mg ta' EMEND ma' prodotti mediċinali mmetabolizzati permezz ta' CYP3A4.
English: Excipient with known effect Each capsule contains 40 mg of sucrose.
Maltese: Kull kapsula fiha 40 mg ta' sucrose.
English: - Use 5 mL oral dispenser if dose is more than 1 mL.
Maltese: - Uża d-dispenser orali ta' 5 mL jekk id-doża hija ta' aktar minn 1 mL.
English: Lactose (anhydrous) Red iron oxide (E 172) Sodium stearyl fumarate (E 485)
Maltese: Sodium stearyl fumarate (E 485)
English: In a juvenile toxicity study in dogs treated from post natal 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 it-tossiċità fil-frieħ fi klieb ittrattati minn jum 14 sa jum 42 wara t-twelid, deher tnaqqis fil-piż tat-testikoli u d-daqs taċ-ċelluli ta' Leydig fl-irġiel b'6 mg/kg/jum u żieda fil-piż tal-utru, ipertrofija tal-utru u taċ-ċerviċi, u edima fit-tessuti tal-vaġina dehru fin-nisa minn 4 mg/kg/jum.
English: Vascular disorders hot flush uncommon
Maltese: Disturbi vaskulari fwawar mhux komuni
English: Skin and subcutaneous tissue disorders pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis not known
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda ħakk, raxx, urtikarja, sindrome ta' StevensJohnson/nekroliżi tossika tal-epidermide mhux magħrufa
English: Paediatric population: In a study using a powder for oral suspension formulation, a single dose of 40 mg aprepitant administered to adolescent patients (aged 12 through 17 years) resulted in a mean AUC0-48hr of 6 µg/mL with a mean peak plasma concentration (Cmax) of 0.5 µg/mL occurring at approximately 4 hours.
Maltese: Fi studju bl-użu tal-formulazzjoni ta' trab għal suspensjoni orali, doża waħda ta' 40 mg aprepitant mogħtija lil pazjenti adolexxenti (ta' età minn 12 sa 17-il sena) wasslet għal AUC0-48hr medja ta' 6 µg/mL bl-ogħla konċentrazzjoni medja fil-plażma (Cmax) ta' 0.5 µg/mL li sseħħ wara madwar 4 sigħat.
English: EMEND, when given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 23 % on Day 4, 28 % on Day 8, and 15 % on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of EMEND and on Days 4, 8, and 15.
Maltese: Meta EMEND ngħata bħala 125 mg f'Jum 1 u 80 mg/kuljum f'Jiem 2 u 3, naqqas l-AUC ta' tolbutamide (sottostrat ta' CYP2C9) bi 23 % f'Jum 4, 28 % f'Jum 8, u 15 % f'Jum 15, meta doża waħda ta' 500 mg tolbutamide ingħatat oralment qabel l-għoti ta' kors ta' tlett ijiem ta' EMEND u filJiem 4, 8 u 15.
English: In 2 randomised, double-blind studies encompassing a total of 1,094 adult patients receiving chemotherapy that included cisplatin  70 mg/m2, aprepitant in combination with an ondansetron/dexamethasone regimen (see section 4.2) was compared with a standard regimen (placebo plus ondansetron 32 mg intravenously administered on Day 1 plus dexamethasone 20 mg orally on Day 1 and 8 mg orally twice daily on Days 2 to 4).
Maltese: F'żewġ studji randomised, double-blind li kienu jkopru total ta' 1,094 pazjent adult li kienu qed jirċievu kimoterapija li kienet tinkludi cisplatin ≥ 70 mg/m2, aprepitant flimkien ma' skeda ta' għoti ta' ondansetron/dexamethasone (ara sezzjoni 4.2) tqabbel ma' skeda ta' għoti standard (plaċebo flimkien ma' 32 mg ta' ondansetron ġol-vina li ngħata f'Jum 1 flimkien ma' 20 mg ta' dexamethasone mogħti mill-ħalq f'Jum 1 u 8 mg mogħti mill-ħalq darbtejn kuljum fil-Jiem 2 sa 4).
English: Capsule shell (80 mg) Gelatin
Maltese: Il-qoxra tal-kapsula (80 mg)
English: Methylprednisolone: The usual intravenously administered methylprednisolone dose should be reduced approximately 25 %, and the usual oral methylprednisolone dose should be reduced approximately 50 % when co-administered with EMEND 125 mg/80 mg regimen.
Maltese: Id-doża ta' methylprednisolone li ġeneralment tingħata ġol-vina għandha titnaqqas b'madwar 25 %, u d-doża ta' methylprednisolone li ġeneralment tingħata mill-ħalq għandha titnaqqas b'madwar 50 % meta tingħata flimkien ma' kors ta' EMEND 125 mg/80 mg.
English: The terminal half-life is approximately 9 hours after administration of a single 40 mg dose.
Maltese: Il-half-life terminali hija bejn wieħed u ieħor 9 sigħat wara l-għoti ta' doża waħda ta' 40 mg.
English: There were no margins to clinically relevant exposure.
Maltese: Din iż-żieda m'hiex meqjusa klinikament rilevanti.
English: Musculoskeletal and connective tissue disorders muscular weakness, muscle spasms rare
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi dgħufija fil-muskoli, spażmi fil-muskoli rari
English: During days 9 through 21 in this study, there was as much as a 64 % decrease in ethinyl estradiol trough concentrations and as much as a 60 % decrease in norethindrone trough concentrations.
Maltese: F'dan l-istudju matul il-jiem 9 sa 21, kien hemm sa 64 % tnaqqis filkonċentrazzjonijiet aktar baxxi ta' ethinyl estradiol u sa 60 % tnaqqis fil-konċentrazzjonijiet l-aktar baxxi ta' norethindrone.
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 definiti 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: Merck Sharp & Dohme Cyprus Limited Τηλ.
Maltese: Merck Sharp & Dohme Limited
English: Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4.
Maltese: Dexamethasone għandu jingħata 30 minuta qabel it-trattament kimoterapewtiku fl-1 Jum u filgħodu ta' Jiem 2 sa 4.
English: ENDPOINTS*
Maltese: SKOPIJIET*
English: Mild induction of glucuronidation is also seen with 80 mg oral aprepitant given for 7 days.
Maltese: Tidher ukoll induzzjoni ħafifa ta' glucoronidazzjoni permezz ta' 80mg 'aprepitant orali għal 7 ijiem.
English: EMEND (40 mg) should be used with caution in patients receiving concomitant administration of pimozide, terfenadine, astemizole, cisapride or ergot alkaloid derivatives.
Maltese: EMEND (40 mg) għandu jintuża b'attenzjoni f'pazjenti li qed jieħdu wkoll pimozide, terfenadine, astemizole, cisapride jew derivati ta' ergot alkaloid.
English: BLISTER TEXT
Maltese: SKOPIJIET FINALI
English: Pink to light pink powder.
Maltese: Trab roża sa roża ċar.
English: Complete response: No emesis and no use of rescue Difference (%) calculated as Aprepitant 40 mg minus Ondansetron 4 mg Difference (%) and 95 % C.I.
Maltese: Differenza (%) kkalkulata bħala Aprepitant 40 mg nieqes Ondansetron 4 mg #
English: It is anticipated that EMEND 165 mg would cause similar 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 to 8 days after first aprepitant dose has been observed.
Maltese: Huwa mistenni li 165 mg ta' EMEND jikkawża induzzjoni tixxiebah ta' CYP2C9, CYP3A4, u glukuronidazzjoni bħal dak ikkawżat bl-għoti tal-iskeda ta' għoti ta' aprepitant għal 3 ijiem mill-ħalq, fejn ġiet osservata induzzjoni temporanja bl-akbar effett minn 6 sa 8 ijiem wara l-ewwel doża ta' aprepitant.
English: In a clinical study, single doses of an oral contraceptive containing ethinyl estradiol and norethindrone were administered on Days 1 through 21 with EMEND, given as a regimen of 125 mg on Day 8 and 80 mg/day on Days 9 and 10 with ondansetron 32 mg intravenously on Day 8 and oral dexamethasone given as 12 mg on Day 8 and 8 mg/day on Days 9, 10, and 11.
Maltese: Fi studju kliniku, dożi individwali ta' kontraċettiv orali li fih ethinyl estradiol u norethindrone ngħataw fil-Jiem 1 sa 21 flimkien ma' EMEND, li ngħata bi skeda ta' 125 mg fil-Jum 8 u 80 mg/jum fil-Jiem 9 u 10 ma' 32 mg ta' ondansetron minn ġol-vini fil-Jum 8 u dexamethasone mill-ħalq mogħti bħala 12-il mg fil-Jum 8 u 8 mg/jum fil-Jiem 9, 10 u 11.
English: Data are lacking regarding effects of CYP2C8 and CYP2C19.
Maltese: Hemm nuqqas ta' dejta dwar l-effetti fuq CYP2C8 u CYP2C19.
English: When a single 375 mg dose of aprepitant was administered on Day 9 of a 14-day regimen of 600 mg/day of rifampicin, a strong CYP3A4 inducer, the AUC of aprepitant decreased 91 % and the mean terminal half-life decreased 68 %.
Maltese: Meta doża waħda ta' 375 mg ta' aprepitant ingħatat f'Jum 9 ta' kors ta' 14-il jum ta' 600 mg kuljum ta' rifampicin, li jinduċi b'mod qawwi CYP3A4, l-AUC ta' aprepitant naqset 91 % u l-half-life terminali medja naqset b'68 %.
English: Delayed phase: 25 to 120 hours following initiation of chemotherapy.
Maltese: Fażi ttardjata: 25 sa 120 siegħa mill-bidu tal-kimoterapija.
English: Metabolites are excreted in urine and via biliary excretion in faeces.
Maltese: Il-metaboliti jiġu eliminati fl-awrina u permezz ta' eliminazzjoni biljarja fl-ippurgar.
English: Excipient with known effect Each capsule contains 165 mg of sucrose.
Maltese: Kull kapsula fiha 165 mg ta' sucrose.
English: Different pack sizes including different strengths are available.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Hemm disponibbli daqsijiet differenti tal-pakkett.
English: 1-day regimen of fosaprepitant 150 mg in adults
Maltese: Skeda ta' għoti ta' 150 mg ta' fosaprepitant għal jum 1 fl-adulti
English: EMEND 40 mg should be used with caution in patients receiving pimozide, terfenadine, astemizole, cisapride, or ergot alkaloid derivatives.
Maltese: EMEND 40 mg għandu jintuża b'attenzjoni f'pazjenti li qegħdin jieħdu pimozide, terfenadine, astemizole, cisapride, jew derivati ta' ergot alkaloid.
English: In 2 multicentre, randomised, double-blind, active comparator-controlled, parallel-group phase III clinical studies in adults, aprepitant was compared with ondansetron for the prevention of PONV in 1,658 patients undergoing open abdominal surgery.
Maltese: III f'żewġ ċentri multipli fl-adulti, aprepitant tqabbel ma' ondansetron għall-prevenzjoni ta' PONV f'1,685 pazjent li saritilhom kirurġija addominali miftuħa.
English: • Discard any remaining suspension and waste material.
Maltese: • Armi kwalunkwe fdal ta' suspensjoni u skart.
English: EMEND 80 mg hard capsules Aprepitant
Maltese: EMEND 80 mg kapsuli iebsin Aprepitant
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: Ir-reazzjonijiet avversi l-aktar komuni rrappurtati b'inċidenza akbar f'pazjenti pedjatriċi trattati bilkors ta' aprepitant milli bil-kors ta' kontroll waqt li kienu qed jirċievu kimoterapija emetoġenika kontra l-kanċer kienu sulluzzu (3.3 % versus 0.0 %) u fwawar (1.1 % versus 0.0 %).
English: Fill the 5 mL oral dispenser with 4.6 mL of water from the mixing cup.
Maltese: Imla d-dispenser orali ta 5 mL b'4.6 mL ilma mit-tazza li tħallat fiha.
English: The AUC0-∞ of aprepitant following oral administration of 165 mg was equivalent to the AUC0-∞ of 150 mg fosaprepitant administered intravenously, while the Cmax was 2.4-fold lower.
Maltese: L-AUC0-∞ ta' aprepitant wara għoti ta' 165 mg mill-ħalq kien ekwivalenti għall-AUC0-∞ ta' 150 mg ta' fosaprepitant mogħti minn ġol-vina, filwaqt li s-Cmax kienet 2.4 drabi aktar baxxa.
English: Acute phase: 0 to 24 hours following initiation of chemotherapy.
Maltese: Fażi akuta: 0 sa 24 siegħa mill-bidu tal-kimoterapija.
English: Following oral administration of a single 125 mg dose of EMEND on Day 1 and 80 mg once daily on Days 2 and 3, the AUC0-24hr (mean±SD) was 19.6 ± 2.5 µg•h/mL and 21.2 ± 6.3 µg •h/mL on Days 1 and 3, respectively.
Maltese: Wara l-għoti mill-ħalq ta' doża waħda ta' 125 mg ta' EMEND f'Jum 1u 80 mg darba kuljum fil-Jiem 2 u 3, l-AUC0-24hr (medja±SD) kienet ta' 19.6 ± 2.5 µg•siegħa/mL u 21.2 ± 6.3 µg •siegħa/mL fil-Jiem 1 u 3, rispettivament.
English: Patients with rare hereditary problems of fructose or galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency, or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose jew galactose, assorbiment ħażin ta' glucose-galactose, defiċjenza ta' Lapp lactase, jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: Pack size of one carton contains one sachet, one 1 mL and one 5 mL oral dispenser (polypropylene with silicone o-ring), one cap and one mixing cup (polypropylene).
Maltese: Id-daqs tal-pakkett ta' kartuna waħda fih qartas wieħed, dispenser orali wieħed ta' 1 mL u wieħed ta' 5 mL (polypropylene b'o-ring tas-silicone), għatu wieħed u tazza waħda biex tħallat fiha (polypropylene).
English: EMEND 165 mg hard capsules aprepitant
Maltese: EMEND 165 mg kapsuli ibsin Aprepitant
English: If a corticosteroid, such as dexamethasone, is co-administered with EMEND, the dose of the corticosteroid should be administered at 50 % of the usual dose (see sections 4.5 and 5.1).
Maltese: Jekk kortikosterojd, bħal dexamethasone, jingħata flimkien ma' EMEND, id-doża tal-kortikosterojd li tingħata għandha tkun 50 % tad-doża tas-soltu (ara sezzjonijiet 4.5 u 5.1).
English: In patients with severe renal impairment, the AUC0- of total aprepitant (unbound and protein bound) decreased by 21 % and Cmax decreased by 32 %, relative to healthy subjects.
Maltese: F'pazjenti b'indeboliment renali serju, l-AUC0-∞ ta' aprepitant totali (dak mhux marbut u dak marbut mal-proteina) naqset b' 21 % u Cmax naqset bi 32 %, meta mqabbla ma' individwi b'saħħithom.
English: EMEND, when given as a regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3, increased the AUC of methylprednisolone, a CYP3A4 substrate, by 1.3-fold on Day 1 and by 2.5-fold on Day 3, when methylprednisolone was co-administered intravenously as 125 mg on Day 1 and orally as 40 mg on Days 2 and 3.
Maltese: EMEND, meta jingħata bħala skeda ta' 125 mg f'Jum 1 u 80 mg/jum fil-Jiem 2 u 3, żied l-AUC ta' methylprednisolone, li hu sustrat ta' CYP3A4, b'1.3 drabi aktar f'Jum 1 u b' 2.5 drabi aktar f'Jum 3, meta methylprednisolone ngħata flimkien miegħu, ġol-vina bħala 125 mg f'Jum 1 u mill-ħalq bħala 40 mg fil-Jiem 2 u 3.
English: Do not give EMEND 165 mg to children and adolescents under 18 years of age, because the 165 mg capsules have not been studied in this population.
Maltese: Tagħtix EMEND 165 mg lil tfal u adolexxenti taħt l-età ta' 18-il sena, minħabba li l-kapsuli ta' 165 mg ma ġewx studjati f'din il-popolazzjoni.
English: Your doctor will ask you to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron) for preventing nausea and vomiting the following three days.
Maltese: It-tabib tiegħek se jitolbok tkompli tieħu mediċini oħrajn inkluż kortikosterojd (bħal dexamethasone) u ‘antagonist ta' 5HT3' (bħal ondansetron) biex jilqgħu kontra ddardir u r-rimettar fit-tliet ijiem ta' wara.
English: calculated using stratified Miettinen-Nurminen method using CochranMantel-Haenszel weights
Maltese: Differenza (%) u 95 % C.I. ikkalkulata permezz tal-metodu stratifikat ta' Miettinen-Nurminen permezz talpiżijiet Cochran-Mantel-Haenszel
English: Co-administration with pimozide, terfenadine, astemizole or cisapride (see section 4.5).
Maltese: L-għoti flimkien ma' pimozide, terfenadine, astemizole jew cisapride (ara sezzjoni 4.5).
English: The geometric mean apparent volume of distribution at steady state (Vdss) is approximately 66 L in humans.
Maltese: Fil-bnedmin, il-medja ġeometrika tal-volum apparenti tad-distribuzzjoni fi stat fiss (Vdss) huwa bejn wieħed u ieħor 66 L.
English: % 95 % C.I.
Maltese: 45 % fl-ippurgar.
English: Ear and labyrinth disorders tinnitus rare
Maltese: Disturbi fil-widnejn u fissistema labirintika tinnite rari
English: EMEND 80 mg capsule
Maltese: 2 x 80 mg kapsula iebsa