qanastek/EMEA-V3 huggingface dataset:
(see section 4.5).
L - inibizzjoni ta 'cytochrome P450 isoenżim 3A4 (CYP3A4) minħabba aprepitant tista' tirriżulta f' konċentrazzjonijiet ogħla fil- plażma ta 'dawn is- sustanzi attivi, li potenzjalment jistgħu jikkawżaw reazzjonijiet serji jew li jipperikolaw il- ħajja (ara sezzjoni 4. 5).
4.5 Interaction with other medicinal products and other forms of interaction
43 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
After the end of treatment, EMEND causes a transient moderate induction of CYP2C9 and a transient mild induction of CYP3A4 and glucuronidation.
Wara t- tmiem tat- trattament, EMEND jikkawża induzzjoni moderata li mhiex permanenti ta ’ CYP2C9 u induzzjoni ħafifa, li mhiex permanenti ta ’ CYP3A4 u glukorinidazzjoni.
Effect of CYP3A4 inhibition by aprepitant on the pharmacokinetics of other active substances As a moderate inhibitor of CYP3A4, aprepitant (125 mg/ 80 mg) can increase plasma concentrations of co-administered active substances that are metabolised through CYP3A4.
L- effett ta ’ inibizzjoni CYP3A4 b’ aprepitant fuq il- farmakokinetiċi ta 'sustanzi attivi oħrajn Bħala inibitur moderat ta ’ CYP3A4, aprepitant (125 mg/ 80 mg) jista ’ jżid l- konċenterazzjonijiet fil - plażma ta ’ sustanzi attivi oħra mogħtija flimkien, mill- ħalq li huma metabolizzati permezz ta ’ CYP3A4.
Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious or life-threatening reactions.
Inibizzjoni ta ’ CYP3A4 permezz ta ’ 'aprepitant tista ’ tirriżulta f’ konċentrazzjonijiet ogħla ta' dawn is- sustanzi attivi fil- plażma, li jistgħu jikkawżaw reazzjonijiet li jheddu l- ħajja.
41 Induction As a moderate inducer of CYP2C9 and a mild inducer of CYP3A4 and glucuronidation, aprepitant can decrease plasma concentrations of substrates eliminated by these routes.
Induzzjoni Bħala induttur moderat ta 'CYP2C9 u induttur ħafif tas- CYP3A4 u glucoronidazzjoni, aprepitant jista' jnaqqas il- konċentrazzjonijiet tal- plażma ta 'sottostrati eliminati b' dawn il- modi.
The effect is maintained for a few days, thereafter slowly declines and is clinically insignificant by two weeks after end of EMEND treatment.
L- effett jibqa 'għal ftit jiem, imbagħad jibda jnaqqas bil- mod u jsir klinikament insinjifikanti fi żmiem ġimagħtejn minn tmiem it- trattament b' EMEND.
EMEND, when given as a regimen of 125 mg with dexamethasone co-administered orally as 20 mg on Day 1, and EMEND when given as 80 mg/ day with dexamethasone co- administered orally as 8 mg on Days 2 through 5, increased the AUC of dexamethasone, a CYP3A4 substrate, 2.2-fold on Days 1 and 5.
EMEND, meta mogħti bħala kors ta '125 mg flimkien ma' dexamethasone orali f' doża ta '20 mg f' Jum 1, u EMEND meta mogħti bħala 80 mg kuljum day flimkien ma' 8 mg dexamethasone orali fil- Jiem 2 sa 5, żied l- AUC ta 'dexamethasone, sottostrat ta' CYP3A4, bi 2. 2 drabi fil- Jiem 1 u 5.
During continuous treatment with methylprednisolone, the AUC of methylprednisolone may decrease at later time points within 2 weeks following initiation of dosing with EMEND, due to the inducing effect of aprepitant on CYP3A4.
Waqt trattament kontinwu b' methylprednisolone, l- AUC ta 'methylprednisolone tista' tonqos aktar tardfi żmien ġimagħtejn minn wara l- bidu tad- dożaġġ b' EMEND, minħabba l- effett induttiv ta 'aprepitant fuq CYP3A4.
In pharmacokinetic studies, EMEND, when given as a regimen of 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, did not influence the pharmacokinetics of docetaxel administered intravenously on Day 1 or vinorelbine administered intravenously on Day 1 or Day 8.
Fi studji farmakokinetiċi, EMEND, meta mogħti bħala reġimen ta ’ 125 mg f’ Jum 1 u 80 mg/ kuljum f’ Jiem 2 u 3, ma nfluwenzax il- farmakokinetiċi ta ’ docetaxel mogħti fil- vina 44 (b' mod intravenuż) f’ Jum 1 jew ta ’ vinorelbine mogħti ġol- vina f’ Jum 1 u Jum 8.
42 In a third study with intravenous and oral administration of midazolam, EMEND was given as 125 mg on Day 1 and 80 mg/ day on Days 2 and 3, together with ondansetron 32 mg Day 1, dexamethasone 12 mg Day 1 and 8 mg Days 2-4.
Fit- tielet stħarriġ fejn midazolam ingħata mil- vina u mill- ħalq / kuljum fil- Jiem 2 u 3, flimkien ma ’ 32 mg ondansetron f’ Jum 1, 12 mg dexamethasone f’ Jum 1 u 8 mg fil- Jiem 2- 4.
EMEND, ondansetron and dexamethasone) decreased the AUC of oral midazolam 16% on Day 6, 9% on Day 8, 7% on Day 15 and 17% on Day 22.
Din it- taħlita (jiġifieri EMEND, ondansetron u dexamethasone) naqqset l- AUC ta ’ midazolam mill- ħalq b’ 16% f’ Jum 6, b’ 9% f’ Jum 8, b’ 7% f’ Jum15 u bi 17% f’ Jum 22.
Intravenous 2 mg midazolam was given 1 hour after oral administration of a single dose of EMEND 125 mg.
2 mg midazolam ġol- vini ingħataw siegħa wara ta 'doża waħda orali ta' 125 mg EMEND.
The plasma AUC of midazolam was increased by 1.5-fold.
L- AUC ta 'midazolam żdiedet b' darba u nofs.
In patients on chronic warfarin therapy, the prothrombin time (INR) should be monitored closely during treatment with EMEND and for 2 weeks following each 3-day course of EMEND for chemotherapy induced nausea and vomiting (see section 4.4).
F' pazjenti li qegħdin fuq terapija kronika tal- warfarina, il- prothrombin time (INR) għandu jiġi sorveljat mill- qrib waqt it- trattament b' EMEND u għal ġimagħtejn wara kull kors ta 'tlett ijiem ta' EMEND għal nawseja u rimettar ikkawżati mill- l- kimoterapija (ara sezzjoni 4. 4).
When a single 125 mg dose of EMEND was administered on Day 1 and 80 mg/ day on Days 2 and 3 to healthy subjects who were stabilised on chronic warfarin therapy, there was no effect of EMEND on the plasma AUC of R(+) or S(-) warfarin determined on Day 3; however, there was a 34% decrease in S(-) warfarin (a CYP2C9 substrate) trough concentration accompanied by a 14% decrease in INR 5 days after completion of dosing with EMEND.
Meta doża waħda ta '125 mg ta' EMEND ingħatat f' Jum 1 u 80 mg/ kuljum fil- Jiem 2 u 3 f' individwi b' saħħithom li kienu stabbilizzati fuq terapija ta 'warfarina kronika, ma kien hemm l- ebda effett ta' EMEND fuq l - AUC fil - plażma ta 'warfarin R( +) jew S (-) stabbilita fil- Jum 3; madankollu, kien hemm tnaqqis ta' 34% fil - konċentrazzjoni l- aktar baxxa ta 'warfarin S (-) (sottostrat ta' CYP2C9) li kien akkumpanjat bi tnaqqis ta '14% f' INR 5 ijiem wara t- tmiem tad- dożaġġ b' EMEND.
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.
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 fil- Jiem 4, 8 u 15.
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.
F’ dan l- istudju matul il- jiem 9 sa 21, kien hemm s sa 64% tnaqqis fil -
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.
45 konċentrazzjonijiet aktar baxxi h ta ’ ethinyl estradiol u sa 60% tnaqqis fil- konċentrazzjonijiet l- aktar baxxi ta ’ norethindrone.
In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
Antagonisti ta '5- HT3 Fi studji ta ’ interazzjonijiet kliniċi, aprepitant ma kellux effetti klinikament importanti fuq il- farmakokinetiċi ta ’ ondansetron, granisetron, jew hydrodolasetron (il- metabolit attiv ta ’ dolasetron).
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.
Effett ta 'mediċini oħra fuq il- farmakokinetiċi ta' aprepitant L- għoti fl- istess ħin ta 'EMEND ma' sustanzi attivi li jimpedixxu l- attività ta 'CYP3A4 (eż. ritonavir, ketoconazole, clarithromycin, telithromycin) għandu jsir b' kawtela billi flimkien jirriżultaw f' konċentrazzjonijiet ogħla ta' aprepitant fil- plażma.
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.
L- għoti fl- istess ħin ta 'ta' EMEND ma 'sustanzi attivi li jinduċu b' mod qawwi l- attività ta' CYP3A4 (eż. rifampicin, phenytoin, carbamazepine, phenobarbital) għandu jiġi evitat billi flimkien jirriżultaw fi tnaqqis fil- konċentrazzjonijiet ta 'aprepitant fil- plażma li jistgħu jirriżultaw fi tnaqqis fl- effikaċja ta ’ EMEND.
43 Ketoconazole:
Ketoconazole:
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.
Il- potenzjal ta 'aprepitant għal tossiċità fis- sistema riproduttiva għadu ma ġiex ikkaratterizzat kompletament, minħabba li l- livelli ta' esponiment ogħla mil- livell ta 'esponiment terapewtikua fil- bniedem fid- doża ta' 125 mg/ 80 mg ma ntlaħqux fl- istudji bl- annimali.
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.
Aprepitant twaqqaf minħabba reazzjonijiet avversi f' 0. 6% ta 'pazjenti ttrattati bil- kors ta' aprepitant meta mqabbel ma '0. 4% ta' pazjenti ttrattati bit- terapija standard.
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.
Fi studju kliniku ta 'pazjenti li kienu qed jirċievu kimoterapija 46 moderatament emetoġenika, ġew irrapportati reazzjonijiet klinikament avversi kliniċi f' madwar 21% tal- pazjenti ttrattati bil- kors ta' aprepitant meta mqabbla ma 'madwar 20% tal- pazjenti ttrattati bit - terapija standard.
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.
Aprepitant twaqqaf minħabba reazzjonijiet avversi f' 1. 1% ta 'pazjenti ttrattati bil - kors ta' aprepitant meta mqabbel ma '0. 5% ta' pazjenti ttrattati bit- terapija standard.
uncommon uncommon
mhux komuni mhux komuni
Gastrointestinal disorders
Disturbi fil- kliewi u fis- sistema polijurja, disurja, pollakjurja urinarja
Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n - anoreksja nutrizzjoni żieda fil- piż, polidipsja 47
Infection and infestations Vascular disorders General disorders and administration site conditions
mhux komuni Infezzjonijiet u infestazzjonijiet Disturbi vaskulari Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
candidiasis, staphylococcal infection flushing/ hot flush asthaenia/ fatigue
kandidajiżi, infezzjoni ta 'l- istaphylococcus fwawar astenja/ għejja
uncommon uncommon common
mhux komuni mhux komuni komuni
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.
Reazzjonijiet avversi addizzjonali ġew osservati f' pazjenti ttrattati b' aprepitant (40 mg) għal nawseja u remettar ta 'wara l- operazzjoni u f' inċidenza akbar milli b' ondansetron: uġigħ fil- parti ta' fuq ta 'l - addome, ħsejjes anormali fil- musrana, disartrija, dispneja a, ipoestesja, i insomnja, mijożi, nawseja, disturbi fis- seni, skonfort fl- istonku, tnaqqis fl- akutezza tal- vista, tħarħir.
45 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.
Każ ta ’ anġjoedema u urtikarja ġie rrapportat bħala reazzjoni avversa serja f’ pazjent li ngħata aprepitant fi stħarriġ non- CINV/ non- PONV.
Antiemetics and antinauseants, ATC code:
Anti- emetiċi u antinawsjanti, Kodiċi ATC:
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).
48 F' żewġ studji b' mod każwali u double- blind li kienu jkopru total ta '1, 094 pazjent li kienu qed jirċievu l- kimoterapija li kienet tinkludi cisplatin ≥ 70 mg/ m2, aprepitant flimkien ma' kors ta 'ondansetron/ dexamethasone (ara sezzjoni 4. 2) ġie mqabbel ma' kors standard (plaċebo flimkien ma '32 mg ondansetron ġol- vina li ngħata f' Jum 1 flimkien ma' dexamethasone 20 mg mogħti mill- ħalq f' Jum 1 u 8 mg mogħtija darbtejn kuljum fil- Jiem 2 sa 4).
46 A summary of the key study results from the combined analysis is shown in Table 1.
Sommarju tar- riżultati ewlenin ta 'l- istudju mill- analiżi kombinata hija murija fit- Tabella 1.
Table 1 Percent of Patients Receiving Highly Emetogenic Chemotherapy Responding by Treatment Group and Phase — Cycle 1
Tabella 1 Perċentwal ta 'Pazjenti li Kienu qed Jirċievu Kimoterapija Ferm Emetoġenika li Jirrispondu skond il- Grupp u Fażi ta' Trattament — Ċiklu 1
* 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.
* L- intervalli ta 'kunfidenza ġew ikkalkulati mingħajr ebda aġġustament għall- ġeneru tal - persuna u għal kimoterapija li kienet qed tingħata fl- istess ħin li kienu inklużi fl- analiżi primarja ta ’ l- odds ratios u mudelli loġistiċi.
The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in Figure 1.
49 Il- ħin stmat għall- ewwel emesi fl- analiżi kkombinata hu muri bil- Kaplan- Meier plot f' Figura 1.
Aprepitant Regimen (N=520) Standard Therapy (N=523)
Regimen ta ’ Aprepitant (N=520) Terapija Standard (N=523)
47 In the same 2 clinical studies, 851 patients continued into the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy.
Fl- istess 2 studji kliniċi, 851 pazjenti komplew fl- estensjoni taċ- Ċiklu- Multiplu għal sa 5 ċikli ta ’ kimoterapija addizzjonali.
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).
Fi stħarriġ double- blind, b' mod każwali, f’ total ta ’ 866 pazjent (864 mara, 2 irġiel) li kienu qed jingħataw il- kimoterapija li nkludiet cyclophosphamide 750- 1500 mg/ m2; jew cyclophosphamide 500 - 1500 mg/ m2 u doxorubicin (60 mg/ m2) jew epirubicin (100 mg/ m2), aprepitant flimkien ma ’ kors ta ’ ondansetron/ dexamethasone (ara sezzjoni 4. 2) tqabbel ma ’ terapija standard (plaċebo u 8 mg ondansetronoralment (darbtejn f’ Jum 1, u kull 12- il siegħa f’ Jiem 2 u 3) flimkien ma ’ 20 mg dexamethasone oralment f’ Jum 1).
Table 2 Percent of Patients Responding by Treatment Group and Phase — Cycle 1 Moderately Emetogenic Chemotherapy
50 Tabella 2 Perċentwal ta 'Pazjenti li Jirrispondu skond il- Grupp u Fażi ta' Trattament — Ċiklu 1 Kimoterapija Moderatament Emetoġenika
INDIVIDUAL MEASURES No Emesis (no emetic episodes regardless of use of rescue therapy)
MIŻURI INDIVIDWALI L- ebda emesi (l- ebda każ ta 'emesi minkejja l- użu ta ’ terapija ta' salvataġġ)
* 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.
* L- intervalli ta 'kunfidenza ġew ikkalkulati bla ebda aġġustament għall- kategorija t' età (< 55 sena, ≥ 55 sena) u għall- grupp ta ’ l- investigatur, li kienu inklużi fl- analiżi primarja ta ’ l - odds ratios u mudelli loġistiċi.
48 The estimated time to first emesis in the study is depicted by the Kaplan-Meier plot in Figure 2.
Il- ħin stmat għall- ewwel emesi fl- analiżi hu muri bil- Kaplan- Meier plot f' Figura 2.
In the same clinical study, 744 patients continued into the Multiple-Cycle extension for up to 3 additional cycles of chemotherapy.
51 Fl- istess studju kliniku, 744 pazjent komplew fl- estensjoni taċ- Ċiklu- Multiplu għal sa 3 ċikli ta ’ kimoterapija addizzjonali.
The efficacy of the aprepitant regimen was apparently maintained during all cycles.
Apparentament, l- effikaċja tal - kors inżammet matul iċ- ċikli kollha.
Both clearance and absolute bioavailability decrease with increasing dose.
Kemm ir- rata ta 'eliminazzjoni kif ukoll il - bijodisponibilità assoluta onqsu meta tiżdied d- doża.
49 Metabolism Aprepitant undergoes extensive metabolism.
Metaboliżmu Aprepitant jgħaddi minn metaboliżmu estensiv.
In healthy young adults, aprepitant accounts for approximately 19% of the radioactivity in plasma over 72 hours following a single intravenous administration 100-mg dose of [14C]-fosaprepitant, a prodrug for aprepitant, indicating a substantial presence of metabolites in the plasma.
F' adulti żgħar b' saħħithom aprepitant huwa responsabbli għal bejn wieħed u ieħor 19% tar- radjoattività fil- plażma fuq perijodu ta ’ 72 siegħa wara l- għoti mill- vina ta ’ doża waħda ta ’ 100 mg ta ’ [14C] - fosaprepitant, promediċina għal aprepitant, li tindika l- preżenza sostanzjali ta ’ metaboliti fil- plażma.
The metabolism of aprepitant occurs largely via oxidation at the morpholine ring and its side chains and the resultant metabolites were only weakly active.
Il- metaboliżmu ta ’ aprepitant iseħħ fil- parti l- kbira permezz ta ’ ossidazzjoni fiċ - ċirku morpholine u l - s- side chains tiegħu u l- metaboliti li rriżultaw kienu biss ta ’ attività dgħajfa.
Metabolites are excreted in urine and via biliary excretion in faeces.
Il- metaboliti jiġueliminati fl- awrina u permezz ta ’ eliminazzjoni biljarja fl- ippurgar.
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.
Wara l- għoti mill- vina ta ’ doża waħda ta ’ 100 mg ta ’ [14C] - fosaprepitant, promediċina għal aprepitant f’ individwi b’ saħħithom, 57% tar- radjoattività ġiet irkuprata fl- awrina u 45% fl- ippurgar.
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.
Ir- rata ta 'l- eliminazzjoni ta ’ aprepitant fil plażma hija dipendenti fuq id- doża, tonqos maż- żieda fid - doża u tvarja minn bejn wieħed u ieħor 60 sa 72ml/ min fil- limiti tad- doża terapewtika.
Gender:
52 Ġeneru:
No dose adjustment for EMEND is necessary for patients with renal impairmentor for patients with ESRD undergoing haemodialysis.
L- ebda aġġustament fid- doża ta ’ EMEND ma huwa meħtieġ f’ pazjenti b’ indeboliment renali u f’ pazjenti b’ ESRD li tkun qed issirilhom ħemodijaliżi.
50 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.
Relazzjoni bejn il- konċentrazzjoni u l- effett (PK/ PD) Bl- użu ta ’ traċċatur speċifiku ħafna għar- riċettur NK1, studji positron emission tomography (PET) f’ irġiel għadhom żgħar u b’ saħħithom urew li aprepitant jippenetra fil- moħħ u jokkupa r- riċetturi- NK1 b' mod li jiddipendi fuq id- doża u l- konċentrazzjoni fil- plażma.
Pre-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Data ta ’ qabel il- provi kliniċi, ibbażata fuq studji konvenzjonali dwar tossiċita ’ kkawżata minn doża waħda jew dożi multipli ma turi l- ebda riskju specjali għall- bniedem, ta ’ tossicità, ġenotossiċità, potenzjal karċinoġeniku u tossiċità għar- riproduzzjoni fuq doża waħda jew ripetuta.
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.
Madankollu, għandu jiġi nnotat li espożizzjoni sistematika f' annimali gerriema kienet simili jew saħansita inqas minn espożizzjoni terapewtika fil- bnedmin fid- doża ta '125 mg/ 80 mg.
In particular, although no adverse effects were noted in reproduction studies at human exposure levels, the animal exposures are not sufficient to make an adequate risk assessment in man.
B' mod partikolari, għalkemm l - ebda effetti avversi ma ġew innotati fl- istudju dwar ir - riproduzzjoni f' livelli ta 'espożizzjoni għall - bniedem, l- espożizzjonijiet għall- annimali m' humiex biżżejjed sabiex issir stima adegwata dwar ir - riskju fil- bniedem.
Capsule shell (125 mg) Gelatin Sodium laurilsulfate and silica colloidal anhydrous may be used Titanium dioxide (E 171) Red iron oxide (E 172) Yellow iron oxide (E 172)
Kontenut tal- kapsula sucrosemicrocrystalline cellulose (E 460) hydroxypropyl cellulose (E 463) sodium laurilsulfate 53 Il- qoxra tal- kapsula (125 mg) Gelatin jistgħu jintużaw sodium laurilsulfate u silica colloidal anhydrous titanium dioxide (E 171) red iron oxide (E 172) yellow iron oxide (E 172)
Capsule shell (80 mg) Gelatin Sodium laurilsulfate and silica colloidal anhydrous may be used Titanium dioxide (E 171)
Il- qoxra tal- kapsula (80 mg) Gelatin jistgħu jintużaw sodium laurilsulfate u silica colloidal anhydrous titanium dioxide (E 171)
51 Different pack sizes including different strengths are available.
Daqsijiet differenti tal- pakketti li jinkludu qawwiet differenti huma disponibbli.
Aluminium blister containing one 125 mg capsule and two 80 mg capsules.
Folja ta 'l- aluminju li fiha kapsula waħda ta' 125 mg u żewġ kapsuli ta '80 mg.
52 ANNEX II
55 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Box 581, 2031 BN 2003 PC Haarlem Netherlands
Box 581, 2031 BN 2003 PC Haarlem L- Olanda
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Il- MAH għandu jaċċerta ruħu li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżoni 3. 0 li hemm f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni Għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qegħda taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management plan
Pjan ta ’ Ġestjoni tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Il- MAH jintrabat sabiex iwettaq l- istudji u attivitajiet oħra ta ’ farmakoviġilanza kif hemm fid- dettal fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni tat- 30 Mejju 2007 tal- Pjan ta ’ l- Immaniġġar tar- Riskju (RMP) li hemm f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni Għall- Awtorizzazzjoni Għat- Tqegħid fis- Suq u kwalunkwe aġġornament sussegwenti ta ’ l- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP dwar is- Sistemi ta ’ Ġestjoni tar- Riskju għall- prodotti mediċinali għall- użu mill- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess ħin mar- Rapport Perjodiku dwar is- Sigurtà Aġġornat (PSUR).
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Minbarra hekk, RMP aġġornat għandu jkun sottomess • Meta tasal informazzjoni li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni kurrenti dwar is- Sigurtà, Pjan ta ’ Farmakoviġilanza jew attivitajiet sabiex ikun imnaqqas għall- minimu r- riskju. • Fi żmien 60 jum minn meta jintlaħaq avveniment importanti (farmakoviġilanza jew tnaqqis tar - riskju għall- minimu) • Fuq talba ta ’ l- EMEA
54 ANNEX III
57 ANNESS III
56 PARTICULARS TO APPEAR ON OUTER PACKAGING
59 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER PACKAGING – STANDARD PACK (CARTON)
PAKKETT TA 'BARRA – PAKKETT STANDARD (KARTUNA)
EMEND 40 mg hard capsules Aprepitant
EMEND kapsuli iebsin 40 mg Aprepitant
Each hard capsule contains 40 mg of aprepitant.
Kull kapsula iebsa fiha 40 mg ta 'aprepitant.
Oral use.
Orali.
Store in the original package in order to protect from moisture.
Żommhom fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Hertford Road, Hoddesdon Hertfordshire EN 11 9BU Ir- Renju Unit
EU/1/03/262/007 1 hard capsule EU/1/03/262/008 5 x 1 hard capsule
EU/ 1/ 03/ 262/ 007 1 kapsula iebsa EU/ 1/ 03/ 262/ 008 5 x 1 kapsula iebsa
58 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
61 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
BLISTER TEXT
TEST FUQ IL- FOLJA
59 PARTICULARS TO APPEAR ON OUTER PACKAGING
62 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
EMEND 80 mg hard capsules Aprepitant
EMEND 80 mg kapsuli iebsin Aprepitant
Each hard capsule contains 80 mg of aprepitant.
Kull kapsula iebsa fiha 80 mg ta 'aprepitant.
1 hard capsule 2-day treatment pack containing:
2 x 80 mg kapsula iebsa 5 x 1 kapsula iebsa
EU/1/03/262/001 1 hard capsule EU/1/03/262/002 2 x 1 hard capsule EU/1/03/262/003 5 x 1 hard capsule
EU/ 1/ 03/ 262/ 001 1 kapsula iebsa EU/ 1/ 03/ 262/ 002 2 x 1 kapsula iebsa EU/ 1/ 03/ 262/ 003 5 x 1 kapsula iebsa
61 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (INCLUDING 2 HARD CAPSULES 80 MG)
64 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (LI JINKLUDI 2 KAPSULI IEBSIN TA '80 MG)
IMMEDIATE PACKAGING – TRIFOLD – 2-day treatment pack
PAKKETT LI JMISS MAL- PRODOTT – TA 'BI TLIETA – Pakkett ta' trattament ta 'jumejn
2-day treatment pack containing:
Pakkett ta 'trattament ta' jumejn li fih:
2 x 80 mg hard capsule
2 x 80 mg kapsula iebsa
Please read enclosed leaflet before use.
Aqra l- fuljett ta 'tagħrif qabel l- użu.
See enclosed leaflet for additional information about how to take EMEND.
Ara l- fuljett mehmuż għal aktar informazzjoni dwar kif tieħu EMEND.
WHEN and HOW to take EMEND
META u KIF għandek tieħu EMEND
Your doctor has prescribed EMEND, an anti-emetic, to help prevent nausea and vomiting associated with chemotherapy.
It- tabib tiegħek ippreskriva EMEND, mediċina anti- emetika, sabiex jiġu evitati n- nawseja u r- rimettar assoċjati mal- kimoterapija.
HOW:
KIF:
EMEND 80 mg hard capsules are taken just once a day for 2 consecutive days.
Il- kapsuli iebsin EMEND 80 mg għandhom jittieħdu darba kuljum għal jumejn fuq xulxin.
EMEND capsules can be taken with or without food.
Il- kapsuli EMEND jistgħu jittieħdu ma 'l- ikel jew fuq stonku vojt.
Do not remove all capsules at one time.
Toħroġx il- kapsuli kollha f' darba.
To remove, push capsules through from this side.
Sabiex toħroġhom, imbotta l- kapsuli minn din in- naħa.
Start of Therapy WHEN:
Bidu tat- Terapija META:
Take one EMEND 80 mg capsule each morning.
Ħu kapsula waħda ta 'EMEND 80 mg darba kull filgħodu.
Start on the day after your chemotherapy.
Ibda ħudhom mill- ġurnata ta 'wara l - kemjoterapija.
EMEND 80 mg capsule
65 Kapsula EMEND ta '80 mg
As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 2 consecutive days as prescribed by your doctor.
Billi jista 'jkun hemm nawsea u rimettar fil- jiem ta' wara l- kemjoterapija tiegħek, huwa importanti li tieħu EMEND għal jumejn wara xulxin kif preskritt mit- tabib tiegħek.
63 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
67 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
EMEND 125 mg hard capsules Aprepitant
EMEND 125 mg kapsuli iebsin Aprepitant
Each hard capsule contains 125 mg of aprepitant.
Kull kapsula iebsa fiha 125 mg ta 'aprepitant.
EU/1/03/262/004 1 hard capsule EU/1/03/262/005 5 x 1 hard capsule
EU/ 1/ 03/ 262/ 004 1 kapsula iebsa EU/ 1/ 03/ 262/ 005 5 x 1 kapsula iebsa
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER PACKAGING – TRIFOLD PACK (CARTON) – 3-day treatment pack
PAKKETT TA 'BARRA – PAKKETT TA' BI TLIETA (KARTUNA) – Pakkett ta 'trattament ta' tlett ijiem
EMEND 125 mg hard capsule EMEND 80 mg hard capsules Aprepitant
EMEND 125 mg kapsuli iebsin EMEND 80 mg kapsuli iebsin Aprepitant
Each 125 mg hard capsule contains 125 mg of aprepitant.
Kull kapsula iebsa ta '125 mg fiha 125 mg ta' aprepitant.
Each 80 mg hard capsule contains 80 mg of aprepitant.
Kull kapsula iebsa ta '80 mg fiha 80 mg ta' aprepitant
1 x 125 mg hard capsule and 2 x 80 mg hard capsule
Pakkett ta 'trattament ta' tlett ijiem li fih: kapsula iebsa ta '1 x 125 mg u kapsula iebsa ta' 2 x 80 mg
69 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (INCLUDING 1 HARD CAPSULE 125 MG AND 2 HARD CAPUSULES 80 MG)
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (LI JINKLUDI KAPSULA IEBSA WAĦDA TA '125 MG U 2 KAPSULI IEBSIN TA' 80 MG)
IMMEDIATE PACKAGING – TRIFOLD – 3-day treatment pack
PAKKETT LI JMISS MAL- PRODOTT – TA 'BI TLIETA – Pakkett ta' trattament ta 'tlett ijiem
Each 80 mg hard capsule contains 80 mg of aprepitant.
Kull kapsula iebsa ta '80 mg fiha 80 mg ta' aprepitant.
See leaflet for further information.
Ara l- fuljett għal iktar informazzjoni
Oral use.
Użu Orali.
EMEND is taken just once a day for 3 consecutive days.
EMEND għandu jittieħed darba kuljum għal tlett ijiem konsekuttivi.
EMEND capsules can be taken with or without food.
Il- kapsuli ta 'EMEND jistgħu jittieħdu ma' l- ikel jew fuq stonku vojt.
70 Start of Therapy WHEN:
74 Bidu tat- Terapija META:
Take one EMEND 125 mg capsule by mouth 1-hour BEFORE you start your chemotherapy treatment.
Ħu kapsula waħda ta 'EMEND 125 mg minn ħalqek siegħa QABEL ma tibda t- terapija tal - kimoterapija tiegħek.
EMEND 125 mg capsule WHEN:
Kapsula EMEND ta '125 mg META:
Take one EMEND 80 mg capsule each morning on the next two days.
Ħu kapsula waħda ta 'EMEND 80 mg kull filgħodu fil- jumejn ta' wara.
EMEND 80 mg capsule
Kapsula ta 'EMEND ta' 80 mg
As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 3 consecutive days as prescribed by your doctor.
Billi jista 'jkun hemm nawseja u rimettar fil- jiem ta' wara l- kimoterapija tiegħek, huwa importanti li tieħu EMEND għal tlett ijiem wara xulxin kif preskritt mit- tabib tiegħek.
73 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF FULJETT TA ’ TAGĦRIF:
EMEND 40 mg hard capsules aprepitant
EMEND kapsuli iebsin 40 mg aprepitant
Read all of this leaflet carefully before taking this medicine. • Keep this leaflet.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina • Żomm dan il- fuljett.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet preskritta lilek.
Do not pass it on to others.
TAGĦTIHIEX lil ħaddieħor.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What EMEND is and what it is used for 2.
X’ inhu EMEND u għalxiex jintuża 2.
Before you take EMEND 3.
Qabel ma tieħu EMEND 3.
How to take EMEND 4.
Kif għandek tieħu EMEND 4.
How to store EMEND 6.
Kif taħżen EMEND 6.
WHAT EMEND IS AND WHAT IT IS USED FOR
X’ INHU EMEND U GĦALXIEX JINTUŻA
EMEND is used to prevent nausea and vomiting after surgery.
EMEND jintuża biex jimpedixxi nawsja u rimettar ikkawżati wara kirurġija.
EMEND is a neurokinin 1 (NK1) receptor antagonist.
EMEND huwa neurokinin 1 (NK1) receptor antagonist.
It stops a chemical in the body (substance P) from binding to the NK1 receptors.
Iwaqqaf sustanza kimika fil- ġisem (sustanza P) milli teħel mar- riċetturi NK1.
When substance P attaches to these receptors, it causes nausea and vomiting.
Meta sustanza P teħel ma ’ dawn ir- riċetturi, tikkawża nawsja u rimettar.
By blocking the receptors, EMEND can prevent nausea and vomiting, which often happens as a complication of surgery.
Billi jimblokka r- riċetturi, EMEND jista ’ jimpedixxi nawsja u rimettar, li spiss iseħħu bħala kumplikazzjoni tal- kirurġija.
BEFORE YOU TAKE EMEND
QABEL MA TIEĦU EMEND
Do not take EMEND • If you are allergic (hypersensitive) to aprepitant or any of the other ingredients of EMEND.
Tieħux EMEND • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal aprepitant jew sustanzi oħra ta ’ EMEND.
Take special care with EMEND • if you have liver disease
Oqgħod attent ħafna b’ EMEND • jekk għandek mard tal- fwied
EMEND is not for use in children and adolescents under 18 years.
EMEND ma għandux jintuża minn tfal u adoloxxenti taħt it- 18- il sena.
EMEND can affect other medicines.
EMEND jista ’ jaffettwa mediċini oħra.
EMEND should be used with caution when taken with some medicines.
EMEND għandu jintuża b’ kawtela meta jittieħed ma ’ mediċini oħra.
Pregnancy and breast-feeding You should not use EMEND during pregnancy unless clearly necessary.
Tqala u treddigħ M' għandekx tieħu EMEND waqt it- tqala ħlief meta jkun tassew meħtieġ.
It is important that you tell your doctor if you are pregnant or are planning to become pregnant before taking EMEND.
Huwa importanti li tgħarraf lit- tabib tiegħek jekk inti tqila, jew jekk qed tippjana li tinqabad tqila, qabel ma tibda tieħu EMEND.
It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND.
M' huwiex magħruf jekk EMEND joħroġx fil- ħalib uman; għalhekk, it- treddigħ m' huwiex rakkomandat waqt trattament b’ EMEND.
It is important that you tell your doctor if you are breast- feeding or are planning to breast-feed before taking EMEND.
Huwa importanti li tgħarraf lit- tabib tiegħek jekk inti qed tredda ', jew jekk qed tippjana li tredda', qabel ma tibda tieħu EMEND.
74 Driving and using machines It should be taken into account that some people feel dizzy and sleepy after taking EMEND.
78 Sewqan u tħaddim ta 'magni Għandu jiġi kkunsidrat li xi persuni jistordu jew jitħedlu wara li jieħdu EMEND.
If you feel dizzy or sleepy, you should avoid driving or operating machines after taking EMEND.
Jekk inti tħossok stordut/ a, għandek tevita li ssuq jew tħaddem magni wara li tieħu EMEND.
(See POSSIBLE SIDE EFFECTS).
(Ara EFFETTI SEKONDARJI LI JISTA ’ JKOLLU).
Important information about some of the ingredients of EMEND EMEND contains sucrose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'EMEND EMEND fih sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li għandek xi intolleranza għal xi tipi ta 'zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
HOW TO TAKE EMEND
Kif għandek tieħu EMEND
Always take EMEND exactly as your doctor has instructed you.
Dejjem għandek tieħu EMEND skond il- parir tat- tabib.
The recommended oral dose of EMEND is one 40 mg capsule within 3 hours prior to the start of anesthesia.
Id- doża rakkomandata ta 'EMEND hi kapsula waħda ta' 40 mg fi żmien 3 sigħat qabel il- bidu ta ’ l - anestesija.
EMEND should be swallowed whole with some liquid.
EMEND għandu jinbela 'sħiħ ma ’ xi likwidu.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek
Like all medicines, EMEND can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, EMEND jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Il- frekwenza ta ’ effetti sekondarji possibbli elenkati taħt hija definita permezz tal- konvenzjoni li ġejja: komuni ħafna (taffettwa aktar minn utent 1 minn kull 10) komuni (taffettwa 1 sa 10 utent minn kull 100) mhux komuni (taffettwa 1 sa 10 utent minn kull 1, 000) rari (taffettwa 1 sa 10 utent minn kull 10, 000) rari ħafna (taffettwa inqas minn utent 1 minn kull 10, 000) mhux magħrufa (il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli).
Common side effects: increased liver enzymes.
Effetti sekondarji komuni: żieda fl- enżimi tal- fwied.
Uncommon side effects: bowel sounds abnormal, decreased feeling or sensitivity (especially in skin), decrease in pupil size, decrease in sharpness of vision (vision loss), difficulty in speaking, dry mouth, inability to sleep, nausea, sensory disturbance, shortness of breath, slow heartbeat, stomach discomfort, upper stomach pain, and whistling sound while breathing.
Effetti sekondarji oħra mhux komuni: ħsejjes mhux normali ta 'l- imsaren, nuqqas ta' ħass jew sensittività (speċjalment fuq il- ġilda), tnaqqis fil- mimmi ta 'l- għajn, tnaqqis fl- akutezza tal- viżta (telf tal- viżta), diffikultà biex wieħed jitkellem, ħalq niexef, nuqqas ta' rqad, nawsea, disturb sensorjali, nifs qasir, qalb tħabbat fil- mod, skumdità fl- istonku, uġigħ fil- parti ta 'fuq ta' l- istonku, u ħoss ta 'tisfir mat - teħid tan- nifs.
Single cases of the following have been reported:
Ġew irraportati każijiet iżolati ta 'dawn li ġejjin:
Stevens-Johnson syndrome (rare severe skin reaction), angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing), serious constipation, small bowel not working properly (sub-ileus), and urticaria (hives).
Sindromu ta 'Stevens - Johnson (reazzjoni severa rari fuq il- ġilda), anġjodema (nefħa fil- wiċċ, fix- xofftejn, fil- ħalq, fl- ilsien u fil- griżmejn li tista' tikkaġuna diffikultà biex wieħed jibla 'jew jieħu n- nifs), stitikezza serja, il- musrana ż- żgħira ma taħdimx tajjeb (sub- ileus), u urtikarja (infafet).
During post-marketing experience the following side effects have been reported (frequency not known):
Matul esperjenza ta ’ wara t- tqegħid fis- suq, ġew irrapportati l- effetti sekondarji li ġejjin (frekwenza mhux magħrufa):
Allergic reactions, which may be serious, and may include hives, rash and itching and cause difficulty in breathing or swallowing.
Reazzjonijiet allerġiċi, li jistgħu jkunu serji, u li jistgħu jinkludu ħorriqija, raxx u ħakk u jikkawżaw diffikultà fit- teħid tan- nifs u biex wieħed jibla ’.
If you have an allergic reaction, stop taking EMEND and call your doctor right away.
Jekk għandek reazzjoni allerġika, waqqaf EMEND u sejjaħ lit- tabib tiegħek minnufih.
If any of the side effects gets serious, or if you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmija f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE EMEND
KIF TAĦŻEN EMEND
Do not use EMEND after the expiry date which is stated on the carton.
Tużax EMEND wara d- data ta ’ skadenza li tidher fuq il- kartuna wara JIS.
Store in the original package in order to protect from moisture.
Żomm fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Do not remove the capsule from its blister until you are ready to take it.
Tneħħix il- kapsula mill- folja tagħha għajr meta tkun lest/ a biex teħodha.
Medicines should not be disposed of via wastewater or house hold waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What EMEND contains The active substance is aprepitant.
X' fih EMEND Is- sustanza attiva hi aprepitant.
The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, black iron oxide (E 172), and yellow iron oxide (E 172).
Is- sustanzi l- oħra huma: sukrożju, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), xellak, potassium hydroxide, black iron oxide (E 172), u yellow iron oxide (E 172).
The capsule shell may also contain sodium laurilsulfate and silica colloidal anhydrous.
Il- qoxra tal- kapsula jista 'jkun fiha wkoll sodium laurilsulfate u silica colloidal anhydrous.
What EMEND looks like and contents of the pack The 40 mg hard capsule is opaque with a white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink on the body.
Id- dehra ta 'EMEND u d- daqs tal- pakkett Il- kapsuli ta' 40 mg huma opaki b' għamla bajda u b' kappa safra kulur il- mustarda b '“ 464 ” u “ 40 mg ” stampati b' mod radjali b' linka sewda fuq il- korp.
EMEND 40 mg hard capsules are supplied in the following pack sizes: • Aluminium blister containing one 40 mg capsule • 5 Aluminium blisters each containing one 40 mg capsule
EMEND kapsuli iebsin 40 mg huma fornuti f' pakketti bid- daqsijiet li ġejjin: • Folja ta ’ l- aluminju li fiha kapsula waħda ta 'EMEND 40 mg • 5 folji ta ’ l- aluminju li kull waħda fiha kapsula waħda ta' EMEND 40 mg
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha huma għal skop kummerċjali.
Marketing Authorisation Holder Merck Sharp & Dohme Ltd.
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq Merck Sharp & Dohme Ltd.
Hertford Road, Hoddesdon UK - Hertfordshire EN11 9BU United Kingdom
Hertford Road, Hoddesdon Hertfordshire EN 11 9BU Ir- Renju Unit
Manufacturer Merck Sharp & Dohme B.
Manifattur Merck Sharp & Dohme Ltd.
Waarderweg 39, Postbus 581 NL-2003 PC Haarlem The Netherlands
Waarderweg 39, Postbus 581 NL- 2003 PC Haarlem L- Olanda
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Succursale belge/Belgisch bijhuis Tél/Tel: +32 (0) 800 38693 MSDBelgium_info@merck .com
Succursale belge/ Belgisch bijhuis Tél/ Tel: +32 (0) 2 373 42 11 MSDBelgium_ info@ merck. com
Succursale belge Tél: +32 (0) 800 38693 MSDBelgium_info@merck.com
Succursale belge Tél: +32 (0) 2 373 42 11 MSDBelgium_ info@ merck. com
Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0) 1 2998771 medinfo_ ireland@ merck. com
Ísland Icepharma hf.Simi: +354 540 8000 ISmail@merck.com
Simi: +354 520 8600 ISmail@ merck. com
Tel: +371 67364 224 msd_lv@merck .com.
Tel: +371 7364 224 msd_ lv@ merck. com.
78 PACKAGE LEAFLET:
82 FULJETT TA ’ TAGĦRIF:
EMEND 80 mg hard capsules aprepitant
EMEND kapsuli iebsin 80 mg aprepitant
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
EMEND is used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment).
EMEND jintuża f’ kombinazzjoni ma ’ mediċini oħrajn biex jimpedixxi nawsja u rimettar ikkawżati minn trattament kemjoterapewtiku (kura kontra l- kanċer).
By blocking the receptors, EMEND can prevent nausea and vomiting, which often happens during and after chemotherapy.
Billi jimblokka r- riċetturi, EMEND jista ’ jimpedixxi nawsja u rimettar, li spiss iseħħu bħala kumplikazzjoni tal- kirurġija.
Do not take EMEND • If you are allergic (hypersensitive) to aprepitant or any of the other ingredients of EMEND.
Tieħux EMEND • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal aprepitant jew sustanzi oħra
• With medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating gastrointestinal motility disorders).
• Ma ’ mediċini li fihom pimozide (użati għat- trattament ta ’ mard psikjattriku), terfenadine u astemizole (użati għal hay fever u kundizzjonijiet allerġiċi oħra), cisapride (użat għat- trattament ta ’ mard gastrointestinali).
Tell your doctor if you are taking these medicines since your treatment must be modified before you start taking EMEND.
Għid lit- tabib tiegħek jekk tkun qed tieħu dawn il- prodotti minħabba li t- trattament tiegħek jeħtieġ jiġi mmodifikat qabel tibda tieħu EMEND
EMEND can affect other medicines both during and after treatment with EMEND.
EMEND jista ’ jaffettwa mediċini oħra.
EMEND should be used with caution when taken with many other medicines.
EMEND għandu jintuża b’ kawtela meta jittieħed ma ’ mediċini oħra.
79 Pregnancy and breast-feeding You should not use EMEND during pregnancy unless clearly necessary.
Tqala u treddigħ M' għandekx tieħu EMEND waqt it- tqala għajr jekk mhux tassew meħtieġ.
Birth control medicines (oral contraceptives) may not work adequately; another form of contraception should be used during treatment with EMEND and for up to 2 months after using EMEND.
83 Mediċini li jikkontrollaw it- twelid (kontraċettivi orali) jistgħu ma jaħdmux adegwatament; għandha tintuża għamla oħra ta 'kontraċezzjoni waqt it- trattament b' EMEND u sa xahrejn wara t- teħid ta' EMEND.
It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND.
M' huwiex magħruf jekk jinħariġx EMEND fil- ħalib uman; għalhekk, it- treddigħ m' huwiex rakkomandat waqt trattament b’ EMEND.