natgillin/translations-raw huggingface dataset:
Når aprepitant gives én gang dagligt i 14 dage som en 100 mg kapsel sammen med oral antikonception indeholdende 35 mikrogram etinyløstradiol og 1 mg norethindron nedsattes AUC for ethinyløstradiol med 43% og AUC for norethindron med 8%.
Aprepitant, when given once daily for 14 days as a 100 mg capsule with an oral contraceptive containing 35 μ g of ethinyl estradiol and 1 mg of norethindrone, decreased the AUC of ethinyl estradiol by 43%, and decreased the AUC of norethindrone by 8%.
EMEND blev samtidigt givet som 125 mg på dag 8 og som 80 mg / dag på dag 9 og 10 sammen med ondansetron 32 mg intravenøst på dag 8 og oral dexamethason givet som 12 mg på dag 8 og som 8 mg/ dag på dag 9, 10 og 11.
In another 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 intravenouslyon Day 8 and oral dexamethasone given as 12 mg on Day 8 and 8 mg/ day on Days 9, 10, and 11.
I dette studie var der fra dag 9 til og med dag 21 op til 64% fald i dalkoncentrationen for etinyløstradiol og et fald på op til 60% i dalkoncentrationen for norethindron.
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.
Andre lægemidlers virkning på aprepitants farmakokinetik Samtidig administration af EMEND og aktive substanser, som hæmmer CYP3A4- aktivitet (f. eks. ritonavir, ketoconazol, clarithromycin, telithromycin), bør kun ske med stor forsigtighed, idet kombinationen resulterer i forhøjede plasmakoncentrationer af aprepitant.
Effect of other agents on the pharmacokinetics of aprepitant Concomitant administration of EMEND with active substances that inhibit CYP3A4 activity (e. g., ritonavir, ketoconazole, clarithromycin, telithromycin) should be approached cautiously, as the combination results in increased plasma concentrations of aprepitant.
Samtidig administration af EMEND og aktive substanser, som er stærke inducere af CYP3A4- aktivitet (f. eks. rifampicin, fenytoin, carbamazepin, phenobarbital), bør undgås, idet kombinationen resulterer i reducerede plasmakoncentrationer af aprepitant.
Concomitant administration of EMEND with active substances that strongly induce CYP3A4 activity (e. g. rifampicin, phenytoin, carbamazepine, phenobarbital) should be avoided as the combination results in reductions of the plasma concentrations of aprepitant that may result in decreased efficacy of EMEND.
Dette kan nedsætte virkningen af EMEND.
Concomitant administration of EMEND herbal preparations containing St.
Ketoconazol:
15 Ketoconazole:
Når en enkelt 375 mg dosis aprepitant administreredes på dag 9 i et 14- dages behandlingsregime med 600 mg/ dag rifampicin, der er en stærk CYP3A4- inducer, faldt AUC for aprepitant med 91% og gennemsnitshalveringstiden faldt med 68%.
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%.
Risikoen for reproduktionstoxicitet på grund af aprepitant er ikke tilstrækkeligt belyst, idet der i dyreundersøgelser ikke er opnået resultater for eksponering over terapeutiske doser til mennesker med 125 mg/ 80 mg dosering.
The potential for reproductive toxicity of aprepitant has not been fully characterized, since exposure levels above the therapeutic exposure in humans at the 125 mg/ 80 mg dose were not attained in animal studies.
5. 3).
These studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Derfor bør man ikkeamme under behandlingmed EMEND.
It is not known whether aprepitant is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND.
13% af patienterne i standardbehandling hos patientgruppen som fik højemetogen kemoterapibehandling.
Adverse reactions considered as drug-related by the investigator were reported in approximately 17% of patients treated with the aprepitant regimen compared with approximately 13% of patients treated with standard therapy in patients receiving highly emetogenic chemotherapy.
0, 6% af patienterne i behandling med aprepitant sammenlignet med 0, 4% af patienterne i standardbehandling.
Aprepitant was discontinued due to adverse reactions in 0.6% of patients treated with the aprepitant regimen compared with 0.4% of patients treated with standard therapy.
20% af patienterne i standardbehandling.
In a clinical study of patients receiving moderately emetogenic chemotherapy, clinical adverse reactions were reported in approximately 21% of patients treated with the aprepitant regimen compared with approximately 20% of patients treated with standard therapy.
Aprepitantbehandling ophørte på grund af bivirkninger hos 1, 1% af patienterne i behandling med aprepitantregime sammenlignet med 0, 5% af patienterne i standardbehandling.
Aprepitant was discontinued due to adverse reactions in 1.1% of patients treated with the aprepitant regimen compared with 0.5% of patients treated with standard therapy.
Hikke (4, 6% mod 2, 9%), asteni/ træthed (2, 9% mod 1, 6%), forhøjet ALAT (2, 8% mod 1, 5%), konstipation (2, 2% mod 2, 0%), hovedpine (2, 2% mod 1, 8%) og anorexi (2, 0% mod 0, 5%).
The most common adverse reactions reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving highly emetogenic chemotherapy were: hiccups (4.6% versus 2.9%), asthenia/ fatigue (2.9% versus 1.6%), alanine aminotransferase (ALT) increased (2.8% versus 1.5%), constipation (2.2% versus 2.0%), headache (2.2% versus 1.8%), and anorexia (2.0% versus 0.5%).
Den mest almindelige bivirkning, som blev rapporteret med en højere incidens hos patienter, der var i aprepitantbehandling end i standardbehandling hos patienter, der var i behandling med moderat emetogen kemoterapibehandling var træthed (2, 5% mod 1, 6%).
The most common adverse reaction reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving moderately emetogenic chemotherapy was fatigue (2.5% versus 1.6%).
Følgende bivirkninger blev observeret hos patienter, der fik behandling med aprepitant og med en højere incidens end hos patienterne i standardbehandling:
The following adverse reactions were observed in patients treated with the aprepitant regimen and at a greater incidence than with standard therapy:
Meget almindelig (≥ 1/ 10) Almindelig (≥ 1/ 100 til < 1/ 10) Ikke almindelig (≥ 1/ 1. 000 til < 1/ 100) Sjælden (≥ 1/ 10. 000 til < 1/ 1. 000) Meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
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).
Stigning i ALAT og ASAT
ALT increased, AST increased
Øget
alkaline phosphatase increased, hyperglycaemia, microscopic haematuria, hyponatraemia, weight decreased
alkalisk
uncommon
fosfatase,
Cardiac disorders Blood and lymphatic system disorders
hyperglycæmi,
bradycardia febrile neutropenia, anaemia
Hjerte
Nervous system disorders
Ikke almindelig
headache, dizziness
16
common
Blod og lymfesystem Nervesystemet
dream abnormality, cognitive disorder
Hovedpine, svimmelhed.
uncommon
Ikke almindelig Almindelig
Eye disorders
Abnorme drømme, kognitiv forstyrrelse.
conjunctivitis
Øjne Øre og labyrint Luftveje, thorax og mediasti - num
Ear and labyrinth disorders Respiratory, thoracic and mediastinal disorders
Conjunctivitis Tinnitus Hikke
tinnitus hiccups
Ikke almindelig Ikke almindelig Almindelig
Uncommon common
Pharyngitis, nysen, hoste, næseflåd, halsirritation.
pharyngitis, sneezing, cough, postnasal drip, throat irritation
uncommon
uncommon
Konstipation, diarré, dyspepsi, opstød.
constipation, diarrhoea, dyspepsia, eructation
Perforerende dudenalulcus, kvalme *, opkast - ning *, syrereflux, smagsforstyrrelser, epigas - triske gener, obstipation, gastroesophageal re - fluxlidelse, mavesmerter, mundtørhed, enteroco - litis, flatulens, stomatitis.
perforating duodenal ulcer, nausea*, vomiting*, acid reflux, dysgeusia, epigastric discomfort, obstipation, gastroesophageal reflux disease, abdominal pain, dry mouth, enterocolitis, flatulence, stomatitis
Udslæt, akne, lysfølsomhed, øget svedtendens, fedtet hud, pruritus, hudlæsioner.
polyuria, dysuria, pollakiuria rash, acne, photosensitivity, hyperhidrosis, oily skin, pruritus, skin lesion
Muskelkramper, myalgi.
muscle cramp, myalgia
Anoreksi.
anorexia
Vægtøgning, polydipsi.
weight gain, polydipsia
Infektioner og parasitære sygdomme
Infection and infestations Vascular disorders General disorders and administration site conditions
Candidiasis, stafylokokinfektion.
candidiasis, staphylococcal infection flushing/ hot flush asthaenia/ fatigue
Ikke almindelig
Uncommon Uncommon common
Vaskulære sygdomme Almene symptomer og reaktioner på
oedema, chest discomfort, lethargy, thirst
Ikke almindelig Almindelig
uncommon
administrationsstedet Psykiske forstyrrelser
Psychiatric disorders
Desorientering, eufori, angst.
disorientation, euphoria, anxiety
Ikke almindelig Ikke almindelig
Uncommon
* Kvalme og opkastning var effektparametre de første 5 dage efter kemoterapibehandling og først derefter indberettet som bivirkninger.
*Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
Bivirkningsprofilerne for gentagne kemoterapibehandlinger (multi- cyclus) og op til 5 behandlinger var de samme som sås for kemoterapibehandling 1.
The adverse reactions profiles in the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy were generally similar to those observed in Cycle 1.
Smerter i øvre del af abdomen, anormale tarmlyde, dysartri, dyspnø, hypoæstesi, søvnløshed, myosis, kvalme, sensoriske forstyrrelser, mavegener, nedsat synsskarphed, hvæsende vejrtrækning.
Additional adverse reactions were observed in patients treated with aprepitant (40 mg) for postoperative nausea and vomiting and a greater incidence than with ondansetron: abdominal pain upper, bowel sounds abnormal, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, visual acuity reduced, wheezing.
Desuden er der rapporteret to alvorlige bivirkninger i kliniske undersøgelser vedrørende postoperativ kvalme og opkastning (PONV) hos patienter, der tog en højere dosis aprepitant:
In addition, two serious adverse reactions were reported in clinical studies in postoperative nausea and vomiting (PONV) in patients taking a higher dose of aprepitant: one case of constipation, and one case of sub-ileus.
Der er rapporteret om ét tilfælde af Stevens- Johnsons syndrom, som en alvorlig hændelse hos en patient, som fik aprepitant sammen med cancerkemoterapi.
One case of Stevens-Johnson syndrome was reported as a serious adverse event in a patient receiving aprepitant with cancer chemotherapy.
Der er hos en patient, som fik aprepitant i en non- CINV/ non- PONV undersøgelse, rapporteret om ét tilfælde af angioneurotisk ødem og urticaria som en alvorlig hændelse.
17 One case of angioedema and urticaria was reported as a serious adverse event in a patient receiving aprepitant in a non-CINV/ non-PONV study.
4. 2) sammenlignet med standardbehand - lingsregime (placebo plus ondansetron 32 mg intravenøst på dag 1 plus dexamethason 20 mg oralt på dag 1 og 8 mg oralt to gange dagligt på dag 2 til 4).
In 2 randomised, double-blind studies encompassing a total of 1,094 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).
Komplet respons (defineret som ingen emetiske episoder og ingen brug af erstatningsterapi) primært i cyklus 1.
Efficacy was based on evaluation of the following composite measure: complete response (defined as no emetic episodes and no use of rescue therapy) primarily during Cycle 1.
18 En opsummering af nøgleresultaterne for den kombinerede analyse kan ses i tabel 1.
A summary of the key study results from the combined analysis is shown in Table 1.
Tabel 1 Procent af patienter som responderer pr. behandlingsgruppe og fase - cyklus 1 Højemetogen kemoterapibehandling
18 Table 1 Percent of Patients Receiving Highly Emetogenic Chemotherapy Responding by Treatment Group and Phase — Cycle 1
Aprepitant SAMMENSATTE MÅL
Aprepitant Regimen
behandlingsregime (N=521)%
521) †%
Standardbehandling (N=524) †%%
(N= 524) †%
Forskelle * (95% CI)
(95% CI)
Komplet respons (ingen opkastning og ingen erstatningsterapi) Total (0- 120 timer) 0- 24 timer 25- 120 timer
Complete Response (no emesis and no
67, 7 86, 0 71, 5
rescue therapy)
INDIVIDUELLE MÅL
INDIVIDUAL MEASURES No Emesis (no emetic episodes regardless of use of rescue therapy)
Ingen opkastning (ingen opkastning uanset brug af erstatningsterapi) Total (0- 120 timer) 0- 24 timer 25- 120 timer
Overall (0-120 hours) 0-24 hours 25-120 hours
Ingen signifikant kvalme (maks.
No Significant Nausea (maximum VAS < 25 mm on a scale of 0-100 mm)
VAS < 25 mm på en skala fra 0- 100 mm) Total (0- 120 timer) 25- 120 timer
Overall (0-120 hours) 25-120 hours
* Konfidensintervallerne (CI) er ikke korrigeret for køn og samtidig kemoterapibehandling, som var inkluderet i den primære analyse af odds ratio og logistiske modeller. † En patient i aprepitantregimet havde kun data i den akutte fase og blev ekskluderet fra analyserne fra den totale og forsinkede fase; en patient i standardregimet havde kun data i den forsinkede fase og blev ekskluderet fra analyserne fra den totale og akutte fase.
* The confidence intervals were calculated with no adjustment for gender and concomitant chemotherapy, which were included in the primary analysis of odds ratios and logistic models. † One patient in the Aprepitant Regimen only had data in the acute phase and was excluded from the overall and delayed phase analyses; one patient in the Standard Regimen only had data in the delayed phase and was excluded from the overall and acute phase analyses.
Den anslåede tid indtil første opkastning i den kombinerede analyse er vist ved Kaplan- Meier plot i figur 1.
The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in Figure 1.
Figur 1 Procent af patienter som forbliver opkastningsfrie over tid - cyklus 1 Højemetogen kemoterapibehandling
Figure 1 Percent of Patients Receiving Highly Emetogenic Chemotherapy Who Remain Emesis Free Over Time – Cycle 1
19 Statistisk signifikante forskelle i virkning observeredes i hver af de to individuelle undersøgelser.
Statistically significant differences in efficacy were also observed in each of the 2 individual studies.
I samme to kliniske undersøgelser fortsatte 851 patienter i gentagne kemoterapibehandlinger (multi - cyclus) og op til 5 yderligere kemoterapibehandlinger.
In the same 2 clinical studies, 851 patients continued into the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy.
4. 2) sammenlignet med standardbehandlingsregime (placebo plus ondansetron 8 mg oralt (to gange på dag 1 og hver 12. time på dag 2 og 3) plus dexamethason 20 mg oralt på dag 1).
19 In a randomised, double-blind study in a total of 866 patients (864 females, 2 males) receiving chemotherapy that included cyclophosphamide 750-1500 mg/ m2; or cyclophosphamide 500- 1500 mg/ m2 and doxorubicin (< 60 mg/ m2) or epirubicin (< 100 mg/ m2), 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).
Komplet respons (defineret som ingen emetiske episoder og ingen brug af erstatningsterapi) primært i cyklus 1.
Efficacy was based on evaluation of the composite measure: complete response (defined as no emetic episodes and no use of rescue therapy) primarily during Cycle 1.
Tabel 2 Procent af patienter som responderer pr. behandlingsgruppe og fase - cyklus 1 Moderat emetogen kemoterapibehandling
Table 2 Percent of Patients Responding by Treatment Group and Phase — Cycle 1 Moderately Emetogenic Chemotherapy
behandlingsregime (N=433) †
Standard Therapy
Standardbehandling (N=424)
Differences*
Forskelle *
COMPOSITE MEASURES
%
(N= 433) †%
%
(N= 424)%%
Komplet respons (ingen opkastning og
Complete Response (no emesis and no rescue therapy)
Total (0- 120 timer) 0- 24 timer 25- 120 timer
Overall (0-120 hours) 0-24 hours 25-120 hours
INDIVIDUELLE MÅL Ingen opkastning (ingen opkastning uanset brug af erstatningsterapi) Total (0- 120 timer) 0- 24 timer 25- 120 timer
Overall (0-120 hours) 0-24 hours 25-120 hours
VAS < 25 mm på en skala fra 0- 100 mm) Total (0- 120 timer) 0- 24 timer 25- 120 timer
Overall (0-120 hours) 0-24 hours 25-120 hours
* Konfidensintervallerne (CI) er ikke korrigeret for køn (< 55år, ≥ 55 år) og investigatorgruppe, som var inkluderet i den primære analyse af odds ratio og logistiske modeller. † En patient i aprepitantregimet havde kun data i den akutte fase og blev ekskluderet fra analyserne fra den totale og forsinkede fase
* The confidence intervals were calculated with no adjustment for age category (< 55 years, ≥ 55 years) and investigator group, which were included in the primary analysis of odds ratios and logistic models. † One patient in the Aprepitant Regimen only had data in the acute phase and was excluded from the overall and delayed phase analyses.
20 Den anslåede tid indtil første opkastning i undersøgelsen er vist ved Kaplan- Meier plot i figur 2.
20 The estimated time to first emesis in the study is depicted by the Kaplan-Meier plot in Figure 2.
Figur 2 Procent af patienter som forbliver opkastningsfrie over tid - cyklus 1 Moderat emetogen kemoterapibehandling
Figure 2 Percent of Patients Receiving Moderately Emetogenic Chemotherapy Who Remain Emesis Free Over Time – Cycle 1
Aprepitant regime Standardbehandling (N=424) 90 Procent Patienter
Aprepitant Regimen (N=432) Standard Therapy (N=424) 90%
I samme kliniske undersøgelse fortsatte 744 patienter i gentagne kemoterapibehandlinger (multi - cyclus) og op til 3 yderligere kemoterapibehandlinger.
In the same clinical study, 744 patients continued into the Multiple-Cycle extension for up to 3 additional cycles of chemotherapy.
800 kilokalorier resulterede i en øgning på op til 40% i AUC for aprepitant.
Oral administration of the capsule with an approximately 800 Kcal standard breakfast resulted in an up to 40% increase in AUC of aprepitant.
For raske unge voksne var øgningen i AUC0- ∞ 26% højere end dosisproportionaliteten mellem 80 mg og 125 mg enkeltdoser administreret på fuld mave.
In healthy young adults, the increase in AUC0-∞ was 26% greater than dose proportional between 80 mg and 125 mg single doses administered in the fed state.
Efter oral administration af en enkelt 125 mg dosis af EMEND på dag 1 og 80 mg én gang dagligt på dag 2 og 3 var AUC0- 24 timer (middel ±SD) henholdsvis 19, 6±2, 5 mikrogram· t/ ml på dag 1 og 21, 2±6, 3 mikrogram· t/ ml på dag 3.
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 microgram x h/ ml and 21.2±6.3 microgram x h/ ml on Days 1 and 3, respectively.
Cmax var henholdsvis 1, 6±0, 36 mikrogram/ ml på dag 1 og 1, 4±0, 22 mikrogram/ ml på dag 3.
Cmax was 1.6±0.36 microgram/ ml and 1.4±0.22 microgram/ ml on Days 1 and 3, respectively.
21 Metabolisme Aprepitant metaboliseres i stort omfang.
21 Metabolism Aprepitant undergoes extensive metabolism.
Efter en enkelt intravenøs administreret 100 mg dosis af [14C] - fosaprepitant, der er et prodrug for aprepitant til raske personer genfandtes 57% af radioaktiviteten i urinen og 45% i fæces.
Following a single intravenously administered 100 mg dose of [14C]- fosaprepitant, a prodrug for aprepitant, to healthy subjects, 57% of the radioactivity was recovered in urine and 45% in faeces.
60 til 72 ml/ min i det terapeutiske dosisområde.
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.
9 til 13 timer.
The terminal half-life ranged from approximately 9 to 13 hours.
Mild leverinsufficiens (Child- Pugh klasse A) har ingen klinisk relevant indflydelse på farmakokinetikken for aprepitant.
Mild hepatic impairment (Child-Pugh class A) does not affect the pharmacokinetics of aprepitant to a clinically relevant extent.
Dosisjustering er ikke nødvendig til patienter med mild leverinsufficiens.
No dose adjustment is necessary for patients with mild hepatic impairment.
Konklusioner vedrørende indflydelse af moderat leverinsufficiens (Child- Pugh klasse B) på farmakokinetikken for aprepitant kan ikke udledes af de tilgængelige data.
Conclusions regarding the influence of moderate hepatic impairment (Child-Pugh class B) on aprepitant pharmacokinetics cannot be drawn from available data.
22 Relation mellem koncentration og effekt Ved brug af en høj- specifik NK1- receptortracer har positron emissionstomografi (PET) undersøgelser i raske unge mænd vist, at aprepitant penetrerer hjernebarrieren og sætter sig på NK1- receptorer på en dosis - og plasmakoncentrationsafhængig måde.
22 Relationship between concentration and effect 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 dose- and plasma- concentration-dependent manner.
Plasmakoncentrationer af aprepitant opnået efter 3 - dages behandlingsregime med EMEND anses for at optage mere end 95% af hjernens NK1- receptorer.
Aprepitant plasma concentrations achieved with the 3- day regimen of EMEND are predicted to provide greater than 95% occupancy of brain NK1 receptors.
Det bør imidlertid anføres, at systemisk eksponering til gnavere var den samme eller lavere end terapeutisk eksponering til mennesker ved 125 mg/ 80 mg dosering.
However, it should be noted that systemic exposure in rodents was similar or even lower than therapeutic exposure in humans at the 125 mg/ 80 mg dose.
Kapselskal Gelatine Natriumlaurilsulfat og silica, kolloid vandfri Titandioxid (E171)
Capsule shell Gelatin Sodium laurilsulfate and silica colloidal anhydrous may be used Titanium dioxide (E 171)
Forskellige pakkestørrelser med forskellige styrker er tilgængelige.
Different pack sizes including different strengths are available.
80 mg kapsel.
Aluminium blister containing one 80 mg capsule.
80 mg kapsler.
Aluminium blister containing two 80 mg capsules.
80 mg kapsel.
5 Aluminium blisters each containing one 80 mg capsule.
23 6. 6 Instruktioner vedrørende håndtering og destruktion
23 6.6 Special precautions for disposal
EMEND 125 mg hårde kapsler.
EMEND 125 mg hard capsules
Hver kapsel indeholder 125 mg aprepitant.
Each capsule contains 125 mg of aprepitant.
125 mg saccharose.
125 mg sucrose.
En liste over alle hjælpestoffer er anført under afsnit 6. 1.
For a full list of excipients, see section 6.1.
Kapslerne er ugennemsigtige med hvid kerne og lyserød kappe med "462" og "125 mg" præget med sort blæk på den ene halvdel af kapslen.
Capsules are opaque with a white body and pink cap with “ 462” and “ 125 mg” printed radially in black ink on the body.
EMEND 125 mg gives som en del af en kombinationsbehandling (se afsnit 4. 2).
EMEND 125 mg is given as part of combination therapy (see section 4.2).