qanastek/EMEA-V3 huggingface dataset:
The drop will go in here. • Hold the container between your thumb and fingers with the open end pointing down. • Bring the container tip close to the eye.
Il- qatra se tmur hawn. • Żomm il- kontenitur wiċċu ’ l isfel bejn subgħajk il- kbir u s- swaba l- oħra. • Ġib it- tarf tal- kontenitur viċin tal- għajn.
Use the mirror if it helps. • Don’t touch your eye or eyelid, surrounding areas or other surfaces with the container tip.
Jekk jgħin, uża l- mera. • Tmissx għajnek jew il- kappell ta ’ l- għajn, il- postijiet tal- madwar jew xi superfiċji oħra bit- tarf tal- kontenitur.
It could infect the drops. • Gently squeeze the container to release one drop into the pocket between the eyelid and eye (picture 3). • If your doctor has told you to use drops in both eyes, repeat the steps for your other eye-using the same container. • Throw away the container and any left over solution at once. • Throw away any unused containers one week after opening the foil wrapper-even if the containers are still sealed.
Dan jista ’ jikkontamina il- qtar. • Għafas il- kontenitur bil- mod biex tinżel qatra waħda fl- ispazju bejn il- kappell t’ għajnek u l - għajn (stampa 3). • Jekk it- tabib tiegħek qallek biex tuża l- qtar f’ għajnejk it- tnejn, irrepeti il- proċedura għal l- għajn l- oħra - uża l- istess kontenitur. • Armi l- kontenitur u s- soluzzjoni li jifdal immedjatament. • Armi l- kontenituri mhux użati ġimgħa wara li tkun ftaħt il- pakkett tal- fojl - anki jekk il - kontenituri jkunu għadhom issiġillati.
If a drop misses your eye, try again.
Jekk qatra ma tidħolx f’ għajnejk, erġa ’ ipprova.
If you forget to use EMADINE use one drop as soon as you remember, and then go back to your normal routine.
Jekk tinsa tuża EMADINE, applika qatra waħda hekk kif tiftakar, u wara kompli bir- rutina tas- soltu.
You can carry on taking the drops, unless the effects are serious.
Jekk l- effetti ma jkunux serji tista ’ tkompli bil- qtar.
If you are worried, talk to your doctor or pharmacist.
Jekk inti inkwetat/ a, kellem lit- tabib jew lill - ispiżjar tiegħek.
Effects in the eye: corneal disorder, abnormal eye sensation, increased tear production, tired eyes
34 Effetti fl- għajn: disturb fil- korneja, sensazzjoni mhux normali fl- għajn, żjieda fil- produzzjoni ta ’ dmugħ, għeja fl- għajnejn
Not Known (frequency cannot be estimated from the available data)
Mhux magħruf (il- frekwenza ma tistax tiġi stmata mid- data disponibbli)
33 If any of these side effects gets serious or if you notice any side effects not listed, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Keep out of the reach and sight of children
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use EMADINE afer the expiry date which is stated on the bottle and box after “EXP”.
Tużax EMADINE wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kaxxa wara “ EXP ”.
You must throw away the container as soon as you have used it.
Għandek tarmi l- kontenitur eżatt wara li tużah.
Once the foil wrapper has been opened any unused containers must be thrown away one week after you first opened it.
Kif jinfetaħ il- pakkett tal- fojl għandek tarmi l - kontenituri mhux użati ġimgħa wara li tkun ftaħtu l- ewwel darba.
These measures will help protect the enviroment
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent.
The active substance is emedastine 0.5 mg/ml as difumarate.
Is- sustanza attiva hi emedastine 0. 5 mg/ ml bħala difumarate.
The other ingredients are: trometamol; sodium chloride; hypromellose; purified water.
Is- sustanzi l- oħra huma: trometamol; sodium chloride; hypromellose; ilma ppurifikat.
Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to keep acidity levels (pH levels) normal.
Xi kultant jiżdiedu ammonti żgħar ta ’ hydrochloric acid jew sodium hydroxide biex iżommu l- livelli ta ’ l- aċidità (livelli tal- pH) normali
What EMADINE looks like and the contents of the pack EMADINE is a liquid (a solution) supplied in single-dose plastic containers which contain 0.35 ml.
Id- Dehra ta ’ EMADINE u l- kontenuti tal- pakkett EMADINE huwa likwidu (soluzzjoni) disponibbli f’ kontenituri tal- plastik b’ doża waħda b’ volum ta ’ 0. 35 ml.
Five single-dose containers are provided in a pouch.
Ħames kontenituri b’ doża waħda huma pprovduti f’ pakkett tal- fojl.
EMADINE is supplied in packs containing 30 or 60 units.
EMADINE huwa disponibbli f’ pakketti li fihom 30 jew 60 kontenitur.
The marketing authorisation holder
35 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Laboratoires Alcon, 23 Rue Georges Ferrenbach F-68240 Kaysersberg, France
Laboratoires Alcon, 23 Rue Georges Ferrenbach F- 68240 Kaysersberg, Franza
34 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder..
36 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
35 Italia Alcon Italia S.p.A. + 39 02 81803.1
37 Italia Sverige Alcon Italia S. p. A.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet ta ’ CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Emend?
X’ inhu Emend?
Emend is a medicine containing the active substance aprepitant.
Emend huwa mediċina li fiha s- sustanza attiva aprepitant.
It is available as capsules (white and yellow:
Huwa disponibbli f’ kapsuli (bojod u sofor:
40 mg; white:
40 mg; bojod:
80 mg; white and pink:
80 mg; bojod u roża:
What is Emend used for?
Għal xiex jintuża Emend?
Emend is an anti-emetic (a medicine that prevents nausea [feeling sick] and vomiting).
Emend huwa antiemetiku (mediċina għall- prevenzjoni tan- nawżea [dardir] u remettar).
Emend 80 mg and 125 mg capsules are used with other medicines to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer) in adults.
Il- kapsuli ta ’ 80 mg u 125 mg ta ’ Emend jintużaw ma ’ mediċini oħra għall- prevenzjoni tan- nawżea u tar- remettar ikkawżati mill- kemjoterapija (mediċini użati għat- trattament tal- kanċer) f’ adulti.
Emend works with chemotherapy containing cisplatin (a strong trigger of nausea and vomiting) and with chemotherapy that is a moderate trigger of nausea and vomiting (such as cyclophosphamide, doxorubicin or epirubicin).
Emend jaħdem mal- kemjoterapija li fiha ċ- ċisplatin (emetoġena ħafna) u ma ’ kemjoterapija moderatament emetoġena (bħal ċiklofosfamide [cyclophosphamide], doxorubicin jew epirubicin.
Emend makes chemotherapy more tolerable for the patient.
Emend jagħmel il - kemjoterapija aktar tollerabbli għall- pazjent.
Emend 40 mg capsules are used to prevent postoperative nausea and vomiting (PONV) in adults.
Il- kapsuli ta ’ 40 mg ta ’ Emend jintużaw għall- prevenzjoni tan- nawżea u r- remettar postoperatorji (PONV) f’ adulti.
This is nausea and vomiting that a patient can experience after surgery.
Dawn huma nawżea u remettar li pazjent jista ’ jesperjenza wara operazzjonijiet kirurġiċi.
How is Emend used?
Kif jintuża Emend?
In chemotherapy, the usual dose of Emend is one 125 mg capsule by mouth one hour before the start of chemotherapy.
Matul il- kemjoterapija, id- doża tas- soltu ta ’ Emend hija kapsula waħda ta ’ 125 mg meħuda oralment siegħa qabel il- bidu tal- kemjoterapija.
After chemotherapy, one 80 mg capsule is taken each day for the next two days.
Wara l- kemjoterapija, tittieħed kapsula waħda ta ’ 80 mg kuljum għall- jumejn ta ’ wara.
It must be given with other medicines that also prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘ 5HT3 antagonist’ (such as ondansetron).
Emend għandu jingħata flimkien ma ’ mediċini oħra li jipprevjenu n- nawżea u r - remettar, inkluż kortikosterojde (bħal dexamethasone) u ‘ 5HT3 antagonisti ’ (bħal ondansetron).
In PONV, the usual dose is one 40 mg capsule given within the three hours before the patient is anaesthetised (‘ put to sleep ’).
F’ każ ta ’ PONV, id- doża tas- soltu hija kapsula waħda ta ’ 40 mg mogħtija fit- 3 sigħat qabel ma l - pazjent jiġi anestetizzat (‘ imraqqad ’).
Emend capsules should be swallowed whole, with or without food.
Il- kapsuli ta ’ Emend għandhom jinbelgħu sħaħ, fuq stonku vojt jew le.
How does Emend work?
Kif jaħdem Emend?
Emend is a neurokinin 1 (NK1) receptor antagonist.
Emend huwa antagonista tar- riċetturi tal- newrokinina 1 (neurokinin 1 receptor antagonist, NK1).
It stops a chemical in the body (substance P) from binding to the NK1 receptors.
Huwa jwaqqaf sustanza kimika (sustanza P) fil- ġisem milli tingħaqad mar- riċetturi NK1.
When substance P attaches to these receptors, it causes nausea and vomiting.
Meta sustanza P teħel ma ’ dawn ir- riċetturi, hija tikkawża nawżea u remettar.
By blocking the receptors, Emend can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.
Billi jimblokka lir- reċetturi, Emend jista ’ jipprevjeni n- nawżea u r- remettar, li spiss jiġru wara l- kemjoterapija jew bħala kumplikazzjoni ta ’ intervent kirurġiku.
How has Emend been studied?
Kif ġie studjat Emend?
In chemotherapy, three main studies have been carried out.
Waqt il- kemjoterapija twettqu tliet studji ewlenin.
The first two studies involved a total of 1,094 adults receiving chemotherapy including cisplatin, and the third involved 866 patients with breast cancer who were receiving cyclophosphamide, with or without doxorubicin or epirubicin.
L- ewwel żewġ studji involvew total ta ’ 1, 094 adult ittrattati bil- kemjoterapija li inkludiet ċisplatin u t- tielet wieħed involva 866 pazjent li jbatu minn kanċer tas- sider ittrattati biċ- ċiklofosfamide, b’ doxorubicin jew epirubicin jew mingħajrhom.
All three studies compared the effectiveness of Emend, taken in combination with dexamethasone and ondansetron, with that of the standard combination of dexamethasone and ondansetron.
It- tliet studji kollha qabblu l- effikaċja ta ’ Emend, meħud flimkien ma ’ dexamethasone u ondansetron, ma ’ dik tal- kombinazzjoni standard ta ’ dexamethasone u ondansetron.
The main measure of effectiveness was the number of patients who had nausea and vomiting in the five days after receiving chemotherapy.
Il- kejl ewlieni tal- effikaċja kien l - għadd ta ’ pazjenti li kellhom nawżea jew remettar fil- ħamest ijiem wara li kienu ġew ittrattati bil - kemjoterapija.
In PONV, two studies were carried out in a total of 1,727 patients, most of whom were women undergoing gynaecological operations.
Għal dak li għandu x’ jaqsam mal- PONV, twettqu żewġ studji li involvew 1, 727 pazjent, il - maġġoranza tagħhom kienu nisa sottoposti għal operazzjonijiet ġinekoloġiċi.
Two doses of Emend (40 and 125 mg) were compared with ondansetron given as an injection.
Tqabblu żewġ dożi ta ’ Emend (40 u 125 mg) ma ’ ondansetron mogħti permezz ta ’ injezzjoni.
The studies measured how many patients had a ‘ complete response’, which was defined as no vomiting and no need for any other medication to control nausea and vomiting in the 24 hours after the operation.
L- istudji kejlu l- għadd ta ’ pazjenti li kellhom ‘ risposta kompleta ’, definita bħala l- ebda każ ta ’ remettar u l- ebda bżonn ta ’ kwalunkwe mediċina oħra għall- kontroll tan- nawżea u tar- remettar fl- 24 siegħa wara l- operazzjoni.
What benefit has Emend shown during the studies?
X’ benefiċċji wera Emend matul l- istudji mwettqa?
In the chemotherapy studies, adding Emend to the standard combination was more effective than the standard combination alone.
Fl- istudji waqt il- kemjoterapija, irriżultat aktar effikaċi ż- żieda ta ’ Emend mal- kombinazzjoni standard minn din tal- aħħar waħedha.
Looking at the results of the two cisplatin studies taken together, 68% of the patients taking Emend had no nausea or vomiting over five days (352 out of 520), compared with 48% of the patients who did not take it (250 out of 523).
Meta jitqiesu r- riżultati taż- żewġ studji taċ- ċisplatin f’ daqqa, 68% tal - pazjenti ttrattati b’ Emend ma kellhom la nawżea u lanqas remettar fil- ħamest ijiem wara (352 minn 520), meta mqabbla ma ’ 48% tal- pazjenti li ma ġewx ittrattati bih (250 minn 523).
The effectiveness of Emend was also seen during a further five cycles of chemotherapy.
L- effikaċja ta ’ Emend ġiet osservata wkoll matul ħames ċikli oħra ta ’ kemjoterapija.
In the study of chemotherapy that is a moderate trigger of nausea and vomiting, 51% of the patients taking Emend had no nausea or vomiting (220 out of 433), compared with 43% of the patients who did not take it (180 out of 424).
Fl- istudji tal- kemjoterapija moderatament emetoġena, 51% tal- pazjenti ttrattati b’ Emend ma kellhom la nawżea u lanqas remettar (220 minn 433), meta mqabbla ma ’ 43% tal- pazjenti li ma ġewx ittrattati bih (180 minn 424).
In PONV, Emend was as effective as ondansetron.
Fil- każ ta ’ PONV, Emend kien aktar effikaċi minn ondansetron.
Looking at the results of both studies together, 55% of the patients taking Emend at a dose of 40 mg were ‘ complete responders’ (298 out of 541), compared with 49% of the patients who received ondansetron (258 out of 526).
Meta jitqiesu r- riżultati taż- żewġ studji f’ daqqa, 55% tal- pazjenti ttrattati b’ Emend f’ doża ta ’ 40 mg kellhom ‘ risposta kompleta ’ (298 minn 541), meta mqabbla ma ’ 49% tal- pazjenti ttrattati b’ ondansetron (258 minn 526).
What is the risk associated with Emend?
X’ inhu r- riskju assoċjat ma ’ Emend?
The most common side effect of Emend at all doses (seen in between 1 and 10 patients in 100) is increased liver enzymes.
L- effett sekondarju l- aktar komuni b’ Emend (li deher f’ bejn pazjent 1 u 10 minn kull 100) kien żieda tal- enzimi epatiċi.
At 80 mg and 125 mg, the other side effects seen in between 1 and 10 patients in 100 are headache, dizziness, hiccups, constipation, diarrhoea, dyspepsia (indigestion), eructation (burping), anorexia (loss of appetite), and asthenia (weakness) or fatigue (tiredness).
B’ doża ta ’ 80 mg u ta ’ 125 mg, l- effetti sekondarji l- oħra li dehru f’ bejn pazjent 1 u 10 minn kull 100 kienu wġigħ ta ’ ras, sturdament, sulluzzu, stitikezza, dijarrea, dispepsija (indiġestjoni), eruttazzjoni (tifwiq), anoressija (telf ta ’ aptit), u astenija (debbulizza) jew għeja.
For the full list of all side effects reported with Emend, see the Package Leaflet.
Għal lista sħiħa tal - effetti sekondarji kollha rrappurtati b’ Emend, ara l- Fuljett ta ’ Tagħrif.
Emend should not be used in people who may be hypersensitive (allergic) to aprepitant or any of the other ingredients.
Emend ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal aprepitant jew għal xi sustanza oħra tiegħu.
Emend should be used with caution when taking with some other medicines.
Emend b’ doża ta ’ 80 mg u 125 mg ma għandux jittieħed flimkien ma ’ dawn il- mediċini: • pimozide (użat għat- trattament ta ’ mard mentali); • terfenadine, astemizole (użati komunement għat- trattament tas- sintomi allerġiċi - dawn il- mediċini jistgħu jkunu disponibbli mingħajr riċetta); • cisapride (użat biex inaqqas ċerti problemi tal- istonku), Emend għandu jintuża b’ kawtela meta jittieħed ma ’ xi mediċini oħra.
Oral contraceptives may become less effective in patients taking Emend.
L- effikaċja tal- kontraċċettivi orali tista ’ tonqos f’ pazjenti ttrattati b’ Emend.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal aktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal - Prodott (parti wkoll mill- EPAR).
Why has Emend been approved?
Għaliex ġie approvat Emend?
The Committee for Medicinal Products for Human Use (CHMP) decided that Emend’ s benefits are greater than its risks for the prevention of PONV in adults, and of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy in adults.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Emend huma ogħla mir- riskji tiegħu għall- prevenzjoni ta ’ PONV f’ adulti, u tan- nawżea u remettar akuti u ttardjati assoċjati ma ’ kemjoterapija onkoloġika emetoġena ħafna abbażi ta ’ ċisplatin u kemjoterapija onkoloġika moderatament emetoġena f’ adulti.
The Committee recommended that Emend be given marketing authorisation.
Il- Kumitat irrakkomanda li Emend jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Emend:
Aktar tagħrif dwar Emend:
The European Commission granted a marketing authorisation valid throughout the European Union for Emend to Merck Sharp & Dohme Ltd on 11 November 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Emend lil Merck Sharp & Dohme Ltd fil- 11 ta ’ Novembru 2003.
The marketing authorisation was renewed on 11 November 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet mġedda fil- 11 ta ’ Novembru 2008.
The full EPAR for Emend is available here.
L- EPAR sħiħ dwar Emend jista ’ jiġi kkonsultat hawn.
2/ 3 This summary was last updated in 11-2008.
Dan is- sommarju kien aġġornat l- aħħar fi:
EMEND 40 mg hard capsules
EMEND kapsuli iebsin 40 mg
Each capsule contains 40 mg of aprepitant.
Kull kapsula fiha 40 mg ta 'aprepitant.
40 mg sucrose.
40 mg sucrose
Hard capsule
Kapsula iebsa
Capsules are opaque with a white body and mustard yellow cap with “ 464” and “ 40 mg” printed radially in black ink on the body.
Il- kapsuli huma opaki b' parti bajda u b' kappa safra kulur il- mustarda b '“ 464 ” u “ 40 mg ” stampati b' mod radjali b' linka sewda fuq il- parti l- bajda.
EMEND 40 mg is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.
EMEND 40 mg hu indikat għall- prevenzjoni ta 'nawseja u rimettar wara operazzjoni (PONV) fl- adulti.
Posology Clinical treatment guidelines should be considered as regards the need for prophylactic treatment against postoperative nausea and vomiting (PONV).
Pożoloġija Linji gwida għal trattament kliniku għandhom jiġu kkunsidrati fir- rigward ta 'trattament profilattiku għal nawseja u rimettar wara operazzjoni (PONV).
The recommended oral dosage of EMEND is a single 40 mg dose within 3 hours prior to induction of anesthesia.
Id- doża orali ta 'EMEND rakkomandata hi doża waħda ta' 40 mg fi żmien 3 sigħat qabel l- induzzjoni tal- loppju.
Elderly (≥ 65 years) No dose adjustment is necessary for the elderly (see section 5.2).
Anzjani (≥ 65 sena) L- ebda aġġustament fid- doża m' huwa meħtieġ għall- anzjani (ara sezzjoni 5. 2).
Gender No dosage adjustment is necessary based on gender (see section 5.2).
Sess M’ hemm bżonn ta ’ ebda aġġustament fid- doża abbażi tas- sess (ara sezzjoni 5. 2).
Renal impairment No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).
Indeboliment renali L- ebda aġġustament m' huwa meħtieġ għal pazjenti li għandhom indeboliment renali jew għal pazjenti li jinsabu fl- aħħar fażi tal- mard renali u li jkunu qegħdin jagħmlu ħemodijaliżi (ara sezzjoni 5. 2).
Hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment.
Indeboliment epatiku L- ebda aġġustament m' huwa meħtieġ għal pazjenti li għandhom indeboliment epatiku ħafif.
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Hemm data limitata dwar pazjenti b' indeboliment epatiku moderat u ma teżisti l- ebda data dwar pazjenti b' indeboliment epatiku serju (ara sezzjonijiet 4. 4 u 5. 2).
Children and adolescents EMEND is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
2 Tfal u adoloxxenti EMEND mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
2 Method of administration The hard capsule should be swallowed whole.
Metodu ta ’ għoti Il- kapsula iebsa għandha timbela sħiħa.
EMEND may be taken with or without food.
EMEND jista ’ jittieħed ma ’ l- ikel kif ukoll mhux ma ’ l- ikel.
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva jew għal sustanzi mhux attivi.
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Hemm data limitata f' pazjenti li għandhom indeboliment epatiku moderat u m' hemmx data f' pazjenti li għandhom indeboliment epatiku serju.
EMEND should be used with caution in these patients (see section 5.2).
EMEND għandu jintuża b' attenzjoni f' dawn il- pazjenti (ara sezzjoni 5. 2).
EMEND (40 mg) should be used with caution in patients receiving concomitant administration of pimozide, terfenadine, astemizole, cisapride or ergot alkaloid derivatives.
EMEND (40 mg) għandu jintuża b' attenzjoni f' pazjenti li qed jieħdu wkoll pimozide, terfenadine, astemizole, cisapride jew derivati ta 'ergot alkaloid.
Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by aprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious adverse reactions (see section 4.5).
L- impediment ta 'cytochrome P450 isoenżim 3A4 (CYP3A4) minħabba aprepitant jista' jirriżulta f' konċentrazzjonijiet ogħla fil- plażma ta 'dawn is - sustanzi attivi, li potenzjalment jistgħu jikkawżaw reazzjonijiet avversi (ara sezzjoni 4. 5).
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 (see section 4.5).
L- għoti fl- istess ħin 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- konċentrazzjoni ta 'aprepitant fil- plażma (ara sezzjoni 4. 5).
Concomitant administration of EMEND with herbal preparations containing St.
L- għoti ta 'EMEND flimkien ma' preparazzjonijiet erbali li fihom St.
John’ s Wort (Hypericum perforatum) is not recommended.
John’ s wort (Hypericum perforatum) m' huwiex rakkomandat.
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 (see section 4.5).
L- għoti fl- istess ħin ta 'EMEND ma' sustanzi attivi li jimpedixxu l- attività CYP3A4 (eż. ritonavir, ketoconazole, clarithromycin, telithromycin) għandu jsir b' mod kawt minħabba li meta jingħataw flimkien jirriżultaw f' konċentrazzjonijiet ogħla ta 'aprepitant fil- plażma (ara sezzjoni 4. 5).
EMEND contains sucrose.
EMEND fih sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fructose, nuqqas ta ’ assorbiment ta ’ glucose- galactose jew insuffiċjenza ta ’ sucrose- isomaltase m’ għandhomx jieħdu din il - mediċina.
For further information on interaction potential of aprepitant at higher and multiple doses, please refer to the Summary of Product Characteristics for EMEND 80 mg hard capsules and EMEND 125 mg hard capsules.
Għal aktar tagħrif fuq il- potenzjal ta ’ l- interazzjoni ta ’ aprepitant f’ dożi aktar għoljin u multipli, jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott għal EMEND 80 mg kapsuli iebsin u EMEND 125 mg kapsuli iebsin.
Aprepitant is a substrate and a dose-dependent inhibitor of CYP3A4.
Aprepitant huwa sottostrat u inibitur ta ’ CYP3A4 dipendenti fuq id- doża.
Aprepitant has been studied at higher doses.
Waqt it- trattament, id- doża waħda ta ’ 40 mg ta 'aprepitant rakkomandata għal PONV tirriżulta f’ inibizzjoni dgħajfa ta ’ CYP3A4 Aprepitant ġie studjat f' dożi aktar għoljin.
During treatment for chemotherapy induced nausea and vomiting (CINV), the 3-day 125 mg/ 80 mg regimen of aprepitant is a moderate inhibitor of CYP3A4.
Waqt trattament għan- nawseja u rimettar ikkaġunati mill - kimoterapija (CINV), il- kors ta ’ 125 mg/ 80 mg ta ’ apretitant għal 3 ijiem huwa inibitur moderat ta ’ CYP3A4.
The effects of induction by a single 40 mg dose of aprepitant have not been studied, but it is unlikely that a 40 mg single dose will cause any clinically relevant induction.
L- effetti ta ’ induzzjoni b’ doża waħda ta '40 mg ta ’ aprepitant ma ġewx studjati iżda huwa improbabbli li doża waħda ta ’ 40 mg tikkawża xi induzzjoni klinikament relevanti.
After the end of treatment with the 3-day CINV regimen, aprepitant causes a transient moderate induction of CYP2C9 and a transient mild induction of CYP3A4 and glucuronidation.
Wara t- tmiem tat- trattament bil - kors ta ’ 3 ijiem ta ’ CINV, aprepitant jikkaġuna induzzjoni moderata ta ’ CYP2C9 u induzzjoni ħafifa, li mhiex permanenti, ta ’ CYP3A4 u glukoronidazzjoni.
For further information on interaction potential of aprepitant at higher and multiple doses, please refer to the Summary of Product Characteristics for EMEND 80 mg hard capsules and EMEND 125 mg hard capsules.
Għal aktar tagħrif fuq il- potenzjal ta ’ interazzjoni ta ’ aprepitant f’ dożi aktar għoljin u multipli, jekk jogħġbok irreferi għas- Sommarju tal - Karatteristiċi tal- Prodott għal EMEND 80 mg kapsuli iebsin u EMEND 125 mg kapsuli iebsin.
Effect of CYP3A4 inhibition by aprepitant on the pharmacokinetics of other active substances As a weak inhibitor of CYP3A4, aprepitant (40 mg) can increase plasma concentrations of orally co-administered active substances that are metabolised through CYP3A4.
3 Effett ta 'inibizzjoni CYP3A4 b’ aprepitant fuq il- farmakokinetiċi ta' sustanzi attivi oħrajn Bħala inibitur dgħajjef ta ’ CYP3A4, aprepitant (40 mg) jista ’ jżid l- konċenterazzjonijiet fil- plażma ta ’ sustanzi attivi oħra mogħtija flimkien mill- ħalq li huma metabolizzati permezz ta ’ CYP3A4.
The area under the curve (AUC) of orally administered CYP3A4 substrates may increase up to approximately 1.5-fold after a single 40 mg dose of aprepitant; the effect of aprepitant on the plasma concentrations of intravenously administered CYP3A4 substrates is expected to be smaller.
L- erja taħt il- kurva (AUC) ta ’ sottostrati ta ’ CYP3A4 mogħtija mill- ħalq tista ’ tiżdied sa bejn wieħed u ieħor darba u nofs wara doża waħda ta ’ 40 mg aprepitant; l- effett ta ’ aprepitant fuq konċentrazzjonijiet tal - plażma ta ’ sottostrati ta ’ CYP3A4 mogħtija fil- vina huwa mistenni li jkun iċken.
3 EMEND 40 mg should be used with caution in patients receiving pimozide, terfenadine, astemizole, cisapride, or ergot alkaloid derivatives.
EMEND 40 mg għandu jintuża b’ attenzjoni f’ pazjenti li qegħdin jieħdu pimozide, terfenadine, astemizole, cisapride, jew derivati ta 'ergot alkaloid.
Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious reactions.
Inibizzjoni ta ’ CYP3A4 b' aprepitant tista ’ tirriżulta f’ konċentrazzjonijiet ogħla ta ’ dawn is- sustanzi attivi fil- plażma, li potenzjalment jistgħu jikkaġunaw reazzjonijiet serji.
Corticosteroids:
Kortikosterojdi:
Dexamethasone:
Dexamethasone:
A single 40 mg dose of aprepitant, when co-administered with a single oral dose of dexamethasone 20 mg, increased the AUC of dexamethasone by 1.45-fold.
Doża waħda ta ’ aprepitant 40 mg, meta mogħtija flimkien ma ’ doża orali waħda ta ’ dexamethasone 20 mg, żiedet l- AUC ta ’ dexamethasone b’ 1. 45 drabi.
No dose adjustment is recommended.
L- ebda aġġustament fid- doża m' huwa rakkomandat.
Methylprednisolone:
Methylprednisolone:
Although the concomitant administration of methylprednisolone with the single 40 mg dose of aprepitant has not been studied, a single 40 mg dose of aprepitant produces a weak inhibition of CYP3A4 and it is not expected to alter the plasma concentrations of methylprednisolone to a clinically significant degree.
Għalkemm l- għoti fl- istess ħin ta ’ methylprednisolone ma ’ doża waħda ta ’ 40mg ta ’ aprepitant ma ġiex studjat, doża waħda ta ’ 40 mg ta ’ aprepitant tikkawża inibizzjoni dgħajfa ta ’ CYP3A4 u m' hijiex mistennija li tibdel il- konċentrazzjonijiet fil- plażma ta ’ methylprednisolone fil - plażma sa xi grad klinikament sinifikattiv.
Therefore, no dose adjustment is recommended.
Għalhekk, l- ebda aġġustament fid- doża m' huwa rakkomandat.
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.
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.
The effect of a single 40 mg dose of aprepitant on oral contraceptives is unknown.
L- effett ta 'doża waħda ta' 40 mg aprepitant fuq kontraċettivi orali m' huwiex magħruf.
With higher dose and multiple doses of aprepitant, the efficacy of hormonal contraceptives may be reduced during and for 28 days after administration.
B’ dożi aktar għoljin u multipli ta ’ aprepitant, l- effikaċja tal- kontraċettivi ormonali tista ’ titnaqqas waqt u għal 28 jum wara li jingħata.
For the single 40 mg aprepitant dose, no special precautions are considered necessary.
Għal doża waħda ta ’ 40mg aprepitant, l- ebda prekawzjoni speċjali ma hija kkunsiderata meħtieġa.
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 dwar interazzjonijiet kliniċi, aprepitant ma kellux effetti klinikament importanti fuq il- farmakokinetiċi ta ’ ondansetron, granisetron, jew hydrodolasetron (il- metabolit attiv ta ’ dolasetron).
Aprepitant does not seem to interact with the P-glycoprotein transporter, as suggested by the lack of interaction of aprepitant with digoxin.
Aprepitant ma jidhirx li jinteraġġixxi mat- traportatur P- glycoprotein, kif issuġġerit min- nuqqas ta ’ interazzjoni ta ’ aprepitant ma ’ digoxin.
Effect of other active substances on the pharmacokinetics of aprepitant CYP3A4 inhibitors 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 'sustanzi attivi oħrajn fuq il- farmakokinetiċi ta' aprepitant Inibituri CYP3A4 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 l- kombinazzjoni tirriżulta f' konċentrazzjonijiet ogħla ta 'aprepitant fil- plażma.
CYP3A4 inducers 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.
Indutturi CYP3A4 L- għoti fl- istess ħin ta 'EMEND ma' sustanzi attivi li jinduċu b' mod qawwi l- attività ta ’ CYP3A4 (eż. rifampicin, phenytoin, carbamazepine, phenobarbital) għandu jiġi evitat billi l- kombinazzjoni tirriżulta fi tnaqqis fil- konċentrazzjonijiet ta 'aprepitant fil- plażma li jista ’ jirriżulta fi tnaqqis fl- effikaċja.
Concomitant administration of EMEND with herbal preparations containing St.
L - għoti ta 'EMEND flimkien ma' preparazzjonijiet erbali li fihom St.
Ketoconazole:
Ketoconazole:
When a single 125 mg dose of aprepitant was administered on Day 5 of a 10-day regimen of 400 mg/ day of ketoconazole, a strong CYP3A4 inhibitor, the AUC of aprepitant increased approximately 5-fold and the mean terminal half-life of aprepitant increased approximately 3-fold.
Meta doża waħda ta ’ 125 mg ta ’ aprepitant ingħatat f’ Jum 5 ta ’ kors ta ’ 10 tijiem ta ’ 400 mg kuljum ta ’ ketoconazole, impeditur qawwi ta ’ CYP3A4, l- AUC ta ’ aprepitant żdiedet bejn wieħed u ieħor b ’ ħames darbiet u l- half- life terminali medja żdiedet bejn wieħed u ieħor bi 3 darbiet.
Rifampicin:
4 Rifampicin:
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%.
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%.
In animal studies there was no indication of direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
4. 6 Tqala u treddigħ Fi studji li saru fuq l- annimali ma kien hemm l- ebda indikazzjoni ta ’ effetti ta ’ ħsara diretta jew indiretta fir- rigward tat- tqala, żvilupp tal- embriju/ fetu, it- twelid u l- iżvilupp ta ’ wara t- twelid (ara sezzjoni 5. 3).
The potential effects on reproduction of alterations in neurokinin regulation are unknown.
L- effetti potenzjali fuq ir- riproduzzjoni ta 'alterazzjonijiet fir - regolazzjoni ta' newrokinin m' humiex magħrufa.
EMEND should not be used during pregnancy unless clearly necessary.
EMEND m’ għandux jintuża waqt it- tqala sakemm ma jkunx hemm verament bżonn.
4 Aprepitant is excreted in the milk of lactating rats.
Aprepitant joħroġ fil- ħalib ta 'firien li jreddgħu.
It is not known whether aprepitant is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND.
M' huwiex magħruf jekk aprepitant joħroġx fil- ħalib uman; għalhekk, it- treddigħ m' huwiex rakkomandat waqt trattament b’ EMEND.
No studies on the effects of EMEND on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
However, when driving vehicles or operating machines, it should be taken into account that dizziness and fatigue have been reported after taking EMEND (see section 4.8).
Madankollu, meta ssuq vetturi jew tħaddem magni, għandu jiġi kkunsidrat li l- isturdament u għejja ġew irrapportati wara li jittieħed EMEND (ara sezzjoni 4. 8).
The safety profile of aprepitant was evaluated in approximately 4,900 individuals.
Il- profil tas- sigurtà ta 'aprepitant ġie evalwat f' madwar 4, 900 individwu.
Adverse reactions considered as drug-related by the investigator were reported in approximately 4% of patients treated with 40 mg aprepitant compared with approximately 6% of patients treated with 4 mg ondansetron IV.
Reazzjonijiet avversi li l- investigatur kkunsidra li huma relatati mal- mediċina ġew irraportati f' madwar 4% tal- pazjenti trattati b' 40 mg aprepitant meta mqabbla ma 'madwar 6% tal- pazjenti li kienu qed jiġu kkurati b’ 4 mg ondansetron IV.
In controlled clinical studies in patients receiving general anesthesia, 564 patients were administered 40 mg aprepitant orally and 538 patients were administered 4 mg ondansetron IV.
Fi studji kliniċi kkontrollati, li saru f' pazjenti li kienu qed jirċievu anestesija ġenerali, 564 pazjent ingħataw 40 mg aprepitant mill- ħalq u 538 pazjent ingħataw 4 mg ondansetron IV.
Most adverse reactions reported in these clinical studies were described as mild to moderate in intensity.
Il- biċċa l- kbira tar- reazzjonijiet avversi rrapportati f' dawn l- istudji kliniċi ġew deskritti bħala ta 'intensità ħafifa sa moderata.
The most common adverse reaction reported at a greater incidence in patients treated with aprepitant (1.1%) than with ondansetron (1.0%) was ALT increased.
Ir- reazzjoni avversa l- aktar komuni li kienet irrapportata aktar f' pazjenti ttrattati b' aprepitant (1. 1%) milli b' ondansetron (1. 0%) kienet żieda fl- ALT.
The following adverse reactions were observed in patients treated with aprepitant and at a greater incidence than with ondansetron:
Ir- reazzjonijiet avversi li ġejjin ġew osservati f' pazjenti ttrattati b' aprepitant u f' inċidenza akbar minn dik b' ondansetron:
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).
Il- frekwenzi huma definiti bħala: komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); mhux komuni (≥1/ 1, 000, < 1/ 100); rari (≥1/ 10, 000, < 1/ 1, 000) u rari ħafna (< 1/ 10, 000), mhux magħrufa (ma jistgħux jiġu stmati mit- tagħrif disponibbli).
System Organ Class
Sistema ta ’
Adverse reaction
Reazzjoni Avversa
ALT increased
ALT ogħla
Cardiac disorders Nervous system disorders Eye disorders Respiratory, thoracic and mediastinal disorders
Disturbi kardijaċi Disturbi tas- sistema nervuża Disturbi ta 'l- għajn Disturbi respiratorji, toraċiċi u medjastinali
Bradycardia dysarthria, hypoaesthesia, sensory disturbance miosis, visual acuity reduced dyspnoea, wheezing
bradikardja disartrija, ipoestrżja, disturbi fis- sensi mijożi, tnaqqis fl- akutezza tal- vista dispneja, tħarħir
uncommon uncommon uncommon uncommon
mhux komuni mhux komuni mhux komuni mhux komuni mhux komuni
abdominal pain upper, bowel sounds abnormal, dry mouth, nausea, stomach discomfort
uġigħ addominali fil- parti ta 'fuq, ħsejjes mhux normali fl- imsaren, ħalq niexef, nawseja, skumdità fl- istonku
Psychiatric disorders
Distrubi psikjattriċi
Insomnia
insomnja
In addition, two serious 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.
Barra minn hekk, ġew irrapportati żewġ każijiet avversi serji fi studji kliniċi dwar in- nawseja u r - rimettar ta 'wara l- operazzjoni (PONV) f' pazjenti li kienu qed jingħataw doża ogħla ta' aprepitant: każ wieħed ta 'stitikezza, u każ ieħor ta' sub- ileus.
Additional adverse reactions were observed in patients treated with the aprepitant (125 mg/ 80 mg) regimen for chemotherapy induced nausea and vomiting and at a greater incidence than with standard therapy: abdominal pain, acid reflux, acne, alkaline phosphatase increased, anaemia, anorexia, anxiety, AST increased, asthaenia/ fatigue, candidiasis, chest discomfort, cognitive disorder, conjunctivitis, constipation, cough, diarrhoea, disorientation, dizziness, dream abnormality, dysgeusia, dyspepsia, dysuria, enterocolitis, epigastric discomfort, eructation, euphoria, febrile neutropenia, flatulence, flushing, gastroesophageal reflux disease, headache, hiccups, hot flush, hyperglycaemia, hyperhidrosis, hyponatraemia, lethargy, microscopic haematuria, muscle cramp, myalgia, nausea*, obstipation, oedema, oily skin, perforating duodenal ulcer, pharyngitis, photosensitivity, pollakiuria,
5 Reazzjonijiet avversi addizzjonali ġew osservati f’ pazjenti ttrattati b’ kors ta ’ aprepitant (125 mg/ 80 mg) għad- dardir u rimettar ikkawżati mill- kimoterapija u f’ inċidenza akbar milli b’ terapija standard: uġigħ addominali, refluss ta ’ l- aċidu, akne, żieda fl- alkaline phosphatase, anemija, anoressja, ansjetà, żieda fl- AST, astenja/ għejja kbira, kandidajiżi, skumdita ’ fis- sider, disturbi kognitivi, konġuntivité, stitikezza, sogħla, dijarea, diżorjentament, sturdament, ħolm anormali, disgewżja, dispepsja, disurja, enterocolite, skumdita ’ epigastrika, tifwiq, ewforija, newtropenja bid- deni, uġigħ tal- gass fl- istonku, fwawar fil- wiċċ, marda ta ’ refluss gastroesofaġejali, uġigħ ta ’ ras, sulluzzu, fwawar, ipergliċemija, iperiderożi, iponatremija, letarġija, ematurja mikroskopika, bugħawwieġ muskolari, mijalġja, dardir *, stitikezza esaġerata, edema, ġilda żejtnija, ulċera duwodenali ipperforata, farinġité, fotosensibbilità, pollakjurja, polidipsja, polijurja,, taqtir min- naħa ta ’ wara ta ’ l- imnieħer, ħakk, raxx, leżjonijiet tal- ġilda, għatis, infezzjonijiet bi staphylococcus, stomatité, għatx, irritazzjoni fil- gerżuma, tinnitus, rimettar *, telf fil- piż, żieda fil- piż.
5 polydipsia, polyuria, postnasal drip, pruritus, rash, skin lesion, sneezing, staphylococcal infection, stomatitis, thirst, throat irritation, tinnitus, vomiting*, weight decreased, weight gain. *Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as reactions only thereafter.
* In- nawseja u r- rimettar kienu parametri ta ’ l- effikaċja fl- ewwel 5 tijiem wara t- trattament bil - kimoterapija u ġew irrapportati biss bħala esperjenzi avversi minn hemm ‘ il quddiem.
One case of Stevens-Johnson syndrome was reported as a serious adverse event in a patient receiving aprepitant with cancer chemotherapy.
Każ wieħed tas- sindromu Steven- Johnson ġie rrapportat bħala reazzjoni avversa serja f’ pazjent li ngħata aprepitant mal- kimoterapija tal- kanċer.
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.
Post-marketing experience During post-marketing experience the following side effects have been reported (frequency not known):
Esperjenza ta ’ wara t- tqegħid fis- suq Matul esperjenza ta ’ wara t- tqegħid fis- suq, ġew irrapportati l- effetti sekondarji li ġejjin (frekwenza mhux magħrufa):
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria Immune system disorders: hypersensitivity reactions including anaphylactic reactions
Disturbi tal- ġilda u tat- tessut ta ’ taħt il- ġilda: prurite, raxx, urtikarja Disturbi tas- sistema immuni: reazzjonijiet ta ’ ipersensittività inkluż reazzjonijiet anafilattiċi
No specific information is available on the treatment of overdose with EMEND.
L- ebda tagħrif speċifiku m' huwa disponibbli fuq it- trattament ta 'doża eċċessiva b' EMEND.
Drowsiness and headache were reported in one patient who ingested 1,440 mg of aprepitant.
Pazjent li bela '1, 440 mg ta' aprepitant ġie rrapportat li kellu ħedla u wġigħ ta 'ras.
In the event of overdose, EMEND should be discontinued and general supportive treatment and monitoring should be provided.
F’ każ ta ’ doża eċċessiva, EMEND għandu jitwaqqaf u għandu jiġi pprovdut trattament ġenerali ta ’ appoġġ u monitoraġġ.
Because of the antiemetic activity of aprepitant, drug-induced emesis may not be effective.
Minħabba l- attività antiemetika ta ’ aprepitant, rimettar imqanqal mill- mediċini jista ’ ma jkunx effettiv.
Aprepitant cannot be removed by haemodialysis.
Aprepitant ma jistax jiġi eliminat bil- ħemodijalisi.
Antiemetics and antinauseants, ATC code:
Anti- emetiċi u mediċini ta ’ kontra t- tqallih, Kodiċi ATC:
Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors.
Aprepitant huwa antagonist selettiv b’ affinità għolja għar- riċetturi tas- sustanza P newrokinina 1 (NK1) tal- bniedem.
In 2 multicenter, randomized, double-blind, active comparator-controlled, parallel-group phase III clinical studies, aprepitant was compared with ondansetron for the prevention of postoperative nausea and vomiting in 1,658 patients undergoing open abdominal surgery.
Fi studji kliniċi li saru b' mod każwali, double- blind, ikkontrollati, b' komparatur attiv fi grupp parallel ta ’ fażi III f' żewġ ċentri multipli, aprepitant tqabbel ma ’ ondansetron għall- prevenzjoni ta ’ nawseja u rimettar wara l- operazzjoni f’ 1, 685 pazjent li saritilhom kirurġija addominali miftuħa.
The majority of patients were women (> 90%), mainly undergoing gynaecological surgery.
Il- maġġoranza tal- pazjenti kienu nisa (> 90%), fil- parti l- kbira tagħhom kienu għaddejin minn kirurġija ġinekoloġika.
Patients were randomized to receive 40 mg aprepitant, 125 mg aprepitant, or 4 mg ondansetron.
Il- pazjenti ġew maqsumin sabiex b' mod każwali jingħataw 40 mg aprepitant, 125 mg 6 aprepitant, jew 4 mg ondansetron.
Aprepitant was given orally (PO) with 50 ml of water 1 to 3 hours before anesthesia.
Aprepitant ingħata oralment (PO) ma ’ 50 ml ilma, minn siegħa sa 3 sigħat qabel il- loppju.
Ondansetron was given intravenously immediately before induction of anesthesia.
Ondansetron ingħata mill- vina immedjatament qabel l- għoti tal- loppju.
The antiemetic activity of aprepitant was evaluated during the 0 to 48 hour period following the end of surgery.
L - attività anti- emetika ta ’ aprepitant ġiet evalwata waqt il- perijodu ta ’ 0 sa 48 siegħa wara tmiem il - kirurġija.
The results show that a higher percentage of post-surgical patients experienced complete response (no emesis and no use of rescue) with aprepitant 40 mg than with ondansetron 4 mg (lower bound of C. I. is 0.0 indicating borderline significance) as described in Table 1.
Ir- riżultati juru li perċentwal ogħla ta ’ pazjenti esperjenzaw rispons sħiħ (l- ebda rimettar u l- ebda użu ta ’ salvataġġ) wara l- kirurgija b’ 40 mg aprepitant milli b ’ 4 mg ondansetron (il- limitu t’ isfel tal- C. I. huwa 0. 0 li jindika li s- sinifikant tiegħu hi borderline) kif deskritt fit- Tabella 1.
6 Table 1 Percent of Post-Operative Patients Responding by Treatment Group Combined Results from 2 Phase III Trials
Tabella 1 Perċentwal ta 'Pazjenti Wara Operazzjoni li Jirrispondu skond il- Grupp ta' Trattament Riżultati kkombinati minn 2 Provi Kliniċi tat- Fażi III
Percentage Point Difference (%) § and 95% C. I. #
Id- Differenza f’ Punt Perċentwali (%) § u 95% C. I. #
(%) n/ m (%)%
(%) n/ m
(
(%)
95% C. I.
% 95% C. I.
Complete Response (0-24 hours) † †
Rispons sħiħ (0- 24 siegħa) †
(55.1)
(55. 1)
(49.0)
(49. 0)
(0.0, 11.8)
(0. 0, 11. 8)
Complete Response:
† Rispons sħiħ:
No emesis and no use of rescue § Difference (%) calculated as Aprepitant 40 mg minus Ondansetron 4 mg # Difference (%) and 95% C. I. calculated using stratified Miettinen-Nurminen method using Cochran-Mantel- Haenszel weights
L- ebda emesi u l- ebda użu ta 'salvataġġ § Differenza (%) kkalkulata bħala Aprepitant 40 mg nieqes Ondansetron 4 mg # Differenza (%) u 95% C. I. ikkalkulata permezz tal- metodu stratifikat ta' Miettinen- Nurminen permezz tal- piżijiet Cochran- Mantel- Haenszel
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.:
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 to 66.3) in an analysis that censors patients at the time of rescue use.
35. 3 sa 66. 3) (f' analiżi li tidentifika l - pazjenti waqt l- użu ta 'salvataġġ).
Aprepitant displays non-linear pharmacokinetics.
Aprepitant juri farmakokinetika mhux lineari.
Both clearance and absolute bioavailability decrease with increasing dose.
Kemm ir- rata ta 'eliminazzjoni kif ukoll il - bijodisponibilità assoluta jonqsu meta tiżdied d- doża.
Absorption The mean absolute oral bioavailability of aprepitant is 67% for the 80 mg capsule and 59% for the 125 mg capsule.
Assorbiment Il- biodisponibilità orali assoluta medja ta ’ aprepitant hija 67% għall- kapsula ta ’ 80 mg u 59% għall - kapsula ta ’ 125 mg.
The mean peak plasma concentration (Cmax) of aprepitant occurred at approximately 4 hours (tmax).
Il- konċentrazzjoni massima medja fil- plażma (Cmax) ta ’ aprepitant seħħet bejn wieħed u ieħor fir- 4 siegħa (tmax).
Following oral administration of a single 40 mg dose of EMEND in the fasted state, the AUC0-∞ (mean ± SD) was 8.0 ± 2.1 microgram x h/ ml and the Cmax was 0.7 ± 0.24 microgram/ ml.
Wara l- għoti ta ’ doża waħda orali ta ’ 40 mg ta 'EMEND fi stat ta ’ sawm, l- AUC0- ∞ (medja±SD) kienet 8. 0±2. 1 mikrogramma x sigħat/ ml u s- Cmax kien 0. 7±0. 24 mikrogrammi/ ml.
The median tmax was 3.0 hours.
It- tmax medjan kien 3. 0 sigħat.
Concomitant intake of a 40 mg dose with a standard breakfast decreased the aprepitant Cmax by 18% but did not affect AUC.
It- teħid fl- istess ħin ta ’ doża ta ’ 40 mg ma ’ kolazzjon standard naqqset is- Cmax ta 'aprepitant bi 18% iżda ma affettwatx l- AUC.
This is not considered to be clinically important.
Dan m' huwiex meqjus klinikament importanti.