natgillin/translations-raw huggingface dataset:
EMEND should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 (see section 4.5).
38 Zdravilo EMEND je treba uporabljati previdno pri bolnikih, ki sočasno jemljejo peroralne zdravilne učinkovine, ki se primarno presnavljajo s CYP3A4 (glejte poglavje 4. 5).
Co-administration of EMEND with ergot alkaloid derivatives, which are CYP3A4 substrates, may result in elevated plasma concentrations of these active substances.
Pri sočasni uporabi zdravila EMEND z alkaloidi rženega rožička (ergot alkaloidi), ki so substrat za CYP3A4, se lahko zviša plazemska raven teh zdravilnih učinkovin.
John’ s Wort (Hypericum perforatum) is not recommended.
Sočasna uporaba zdravila EMEND in zeliščnih pripravkov, ki vsebujejo in šentjanževko (Hypericum perforatum,) ni priporočljiva.
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.
Učinek aprepitanta preko inhibicije CYP3A4 na farmakokinetiko drugih zdravilnih učinkovinKot zmerni zaviralec CYP3A4 lahko aprepitant (125 mg/ 80 mg) zviša plazemske koncentracije sočasno uporabljenih peroralnih zdravilnih učinkovin, ki se presnavljajo s CYP3A4.
Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious or life-threatening reactions.
Aprepitant zavira CYP3A4, zaradi česar bi se lahko zvišale plazemske koncentracije teh zdravilnih učinkovin, kar bi lahko povzročilo resne ali življenje ogrožajoče reakcije.
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.
Indukcija Kot zmeren induktor CYP2C9 in blag induktor CYP3A4 in glukuronidacije, lahko aprepitant zniža plazemske koncentracije substratov, ki se izločajo po teh poteh.
The effect is maintained for a few days, thereafter slowly declines and is clinically insignificant by two weeks after end of EMEND treatment.
39 Učinek traja nekaj dni, potem pa počasi upada in je klinično nesignifikanten v dveh tednih po koncu zdravljenja z zdravilom EMEND.
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.
V tretji študiji z intravenskim in s peroralnim odmerjanjem midazolama so EMEND dajali po shemi 125 mg prvi dan ter 80 mg/ dan drugi in tretji dan, skupaj z ondansentronom 32 mg prvi dan in deksametazonom 12 mg prvi dan ter 8 mg drugi do četrti dan.
Intravenous 2 mg midazolam was given 1 hour after oral administration of a single dose of EMEND 125 mg.
40 125 mg peroralnega odmerka zdravila EMEND.
4.6 Pregnancy and lactation
41 4. 6 Nosečnost in dojenje
The most common adverse reactions reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving highly emetogenic chemotherapy were: hiccups (4.6% versus 2.9%), asthenia/ fatigue (2.9% versus 1.6%), alanine aminotransferase (ALT) increased (2.8% versus 1.5%), constipation (2.2% versus 2.0%), headache (2.2% versus 1.8%), and anorexia (2.0% versus 0.5%).
Najpogostejši neželeni učinki, o katerih so pri zdravljenju z aprepitantom pri bolnikih, ki so dobivali zelo emetogeno kemoterapijo, poročali pogosteje kot pri običajni terapiji, so bili: kolcanje (4, 6% versus 2, 9%), astenija/ utrujenost (2, 9% versus 1, 6%), zvišanje alanin- aminotransferaze (ALT) (2, 8% versus 1, 5%), zaprtje (2, 2% versus2, 0%), glavobol (2, 2% versus 1, 8%) ter anoreksija (2, 0% versus 0, 5%).
tinnitus hiccups
tinitus
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.
Poročali so o enem primeru angioedema in urtikarije kot o resnem neželenem dogodku, vendar pa ne v študiji CINV/ PONV.
4.9 Overdose
43 4. 9 Preveliko odmerjanje
46 A summary of the key study results from the combined analysis is shown in Table 1.
Povzetek ključnih rezultatov kombinirane analize je prikazan v Preglednici 1.
Table 1 Percent of Patients Receiving Highly Emetogenic Chemotherapy Responding by Treatment Group and Phase — Cycle 1
Preglednica 1 Odstotek bolnikov, ki so prejemali zelo emetogeno kemoterapijo, z odzivom po zdravljenih skupinah in fazi – 1. ciklus
47 In the same 2 clinical studies, 851 patients continued into the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy.
851 bolnikov iz teh dveh študij je zdravljenje nadaljevalo v podaljšku z več ciklusi, in sicer so prejeli do 5 dodatnih ciklusov kemoterapije.
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).
V randomizirani, dvojno slepi študiji, ki je skupaj zajela 866 bolnikov (864 žensk, 2 moška), ki so dobivali kemoterapijo s ciklofosfamidom 750– 1500 mg/ m2 ali ciklofosfamidom 500– 1500 mg/ m2 in doksorubicinom (≤60 mg/ m2) ali epirubicinom (≤100 mg/ m2), so primerjali aprepitant v kombinaciji z ondansetronom in deksametazonom (glejte 4. 2) ter standardno terapijo (placebo in ondansetron 8 mg peroralno (dvakrat 1. dan ter na 12 ur 2. in 3. dan) ter deksametazon 20 mg peroralno 1. dan).
Complete Response (no emesis and no rescue therapy)
45 Popoln odziv (brez bruhanja in brez rešilnega zdravljenja)
48 The estimated time to first emesis in the study is depicted by the Kaplan-Meier plot in Figure 2.
Oceno časa do prvega bruhanja v kombinirani analizi prikazuje Kaplan- Meierjeva krivulja na sliki 2.
The geometric mean apparent volume of distribution at steady state (Vdss) is approximately 66 l in humans.
Geometrični srednji navidezni volumen porazdelitve v stanju dinamičnega ravnovesja( Vdss) je pri ljudeh približno 66 l.
49 Metabolism Aprepitant undergoes extensive metabolism.
Presnova Aprepitant se v veliki meri presnavlja.
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.
Pri zdravih mladih preiskovancih je, 72 ur po eni intravenski infuziji 100 mg odmerka [14C] fosaprepitanta, predzdravila aprepitanta, približno 19% radioaktivnosti v plazmi prispeval aprepitant, kar kaže na znatno prisotnost presnovkov v plazmi.
In patients with severe renal impairment, the AUC0-∞ of total aprepitant (unbound and protein bound) decreased by 21% and Cmax decreased by 32%, relative to healthy subjects.
47 Pri bolnikih s hudo okvaro ledvic je bil AUC0– ∞ celokupnega aprepitanta (nevezanega in vezanega na beljakovine) za 21% manjši, Cmax pa je bila za 32% nižja kot pri zdravih preiskovancih.
No dose adjustment for EMEND is necessary for patients with renal impairmentor for patients with ESRD undergoing haemodialysis.
Pri bolnikih z okvaro ledvic in pri bolnikih s končno odpovedjo ledvic, ki se zdravijo s hemodializo, odmerka ni treba prilagoditi.
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.
Razmerje med koncentracijo in učinkom (PK/ PD) S študijami pozitronske emisijske tomografije (PET) pri mladih odraslih moških so z uporabo visoko specifičnega označevalca receptorjev NK1 ugotovili, da aprepitant prodre v možgane in zasede receptorje NK1, pri čemer je stopnja zasedenosti odvisna od odmerka in plazemske koncentracije.
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)
Ovojnica kapsule (125 mg) želatina uporabljata se lahko natrijev lavrilsulfat in brezvodni, koloidni silicijev dioksid titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
Capsule shell (80 mg) Gelatin Sodium laurilsulfate and silica colloidal anhydrous may be used Titanium dioxide (E 171)
Ovojnica kapsule (80 mg) želatina uporabljata se lahko natrijev lavrilsulfat in brezvodni, koloidni silicijev dioksid
Printing ink Shellac Potassium hydroxide Black iron oxide (E 172)
Črnilo za tisk šelak kalijev hidroksid 48 črni železov oksid (E172)
51 Different pack sizes including different strengths are available.
Na voljo so različna pakiranja, ki vsebujejo različne jakosti zdravila.
52 ANNEX II
49 DODATEK II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK (IMETNIKI) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Box 581, 2031 BN 2003 PC Haarlem Netherlands
Box 581, 2031 BN 2003 PC Haarlem Nizozemska
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.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3. 0, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
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.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 2. 0 načrta za obvladovanje tveganja (RMP) v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnih dopolnitvah RMP, s katerim soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja)
At the request of the EMEA
na zahtevo Evropske agencije za zdravila (EMEA).
54 ANNEX III
51 DODATEK III
55 A.
52 A.
56 PARTICULARS TO APPEAR ON OUTER PACKAGING
53 PODATKI NA ZUNANJI OVOJNINI
EU/1/03/262/007 1 hard capsule EU/1/03/262/008 5 x 1 hard capsule
EU/ 1/ 03/ 262/ 007 1 trda kapsula EU/ 1/ 03/ 262/ 008 5 x 1 trda kapsula
59 PARTICULARS TO APPEAR ON OUTER PACKAGING
56 PODATKI NA ZUNANJI OVOJNINI
1 hard capsule 2-day treatment pack containing:
1 trda kapsula Ovojnina za 2- dnevno zdravljenje vsebuje:
2 x 80 mg hard capsule 5 x 1 hard capsule
2 x 80 mg trda kapsula 5 x 1 trda kapsula
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 trda kapsula EU/ 1/ 03/ 262/ 002 2 x 1 trda kapsula EU/ 1/ 03/ 262/ 003 5 x 1 trda kapsula
61 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (INCLUDING 2 HARD CAPSULES 80 MG)
58 PODATKI NA PRIMARNI OVOJNINI (Z DVEMA 80 mg TRDIMA KAPSULAMA)
IMMEDIATE PACKAGING – TRIFOLD – 2-day treatment pack
PRIMARNA OVOJNINA – pakiranje za 2- dnevno zdravljenje
2-day treatment pack containing:
Pakiranje za 2- dnevno zdravljenje vsebuje:
Please read enclosed leaflet before use.
Pred uporabo natančno preberite priloženo navodilo za uporabo.
See enclosed leaflet for additional information about how to take EMEND.
Za dodatne informacije o načinu jemanja zdravila EMEND glejte priloženo navodilo za uporabo.
Your doctor has prescribed EMEND, an anti-emetic, to help prevent nausea and vomiting associated with chemotherapy.
Vaš zdravnik vam je predpisal EMEND, antiemetik, za preprečevanje navzee (siljenja na bruhanje) in bruhanja zaradi zdravljenja s kemoterapijo.
Start of Therapy WHEN:
Začetek zdravljenja KDAJ:
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.
Ker se v dneh po kemoterapiji lahko pojavi navzea (siljenje na bruhanje) in bruhanje je pomembno, da zdravilo EMEND jemljete dva dni zapored, kot vam je predpisal zdravnik.
62 6.
59 6.
63 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
60 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
EU/1/03/262/004 1 hard capsule EU/1/03/262/005 5 x 1 hard capsule
EU/ 1/ 03/ 262/ 004 1 trda kapsula EU/ 1/ 03/ 262/ 005 5 x 1 trda kapsula
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
63 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
64 PODATKI NA ZUNANJI OVOJNINI
OUTER PACKAGING – TRIFOLD PACK (CARTON) – 3-day treatment pack
ZUNANJA OVOJNINA – ŠKATLA – pakiranje za 3- dnevno zdravljenje
3-day treatment pack containing:
Pakiranje za 3- dnevno zdravljenje vsebuje:
1 x 125 mg hard capsule and 2 x 80 mg hard capsule
1 x 125 mg trda kapsula 2 x 80 mg trda kapsula
69 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (INCLUDING 1 HARD CAPSULE 125 MG AND 2 HARD CAPUSULES 80 MG)
66 PODATKI NA PRIMARNI OVOJNINI (Z ENO 125 mg TRDO KAPSULO IN DVEMA 80 mg TRDIMA KAPSULAMA)
IMMEDIATE PACKAGING – TRIFOLD – 3-day treatment pack
PRIMARNA OVOJNINA – pakiranje za 3- dnevno zdravljenje
See leaflet for further information.
Za nadaljnje informacije glejte Navodilo za uporabo
70 Start of Therapy WHEN:
Začetek zdravljenja KDAJ:
EMEND 125 mg capsule WHEN:
EMEND 125 mg kapsula 67 KDAJ:
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.
Ker se v dneh po kemoterapiji lahko pojavi navzea (siljenje na bruhanje) in bruhanje je pomembno, da zdravilo EMEND jemljete tri dni zapored, kot vam je predpisal zdravnik.
14.
68 14.
72 B.
69 B.
INFORMATION FOR THE USER
70 NAVODILO ZA UPORABO
EMEND 40 mg hard capsules aprepitant
EMEND 40 mg trde kapsule aprepitant
Read all of this leaflet carefully before taking this medicine. • Keep this leaflet.
Pred začetkom jemanja natančno preberite navodilo!
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.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
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.
- Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni
What EMEND is and what it is used for 2.
Kaj je zdravilo EMEND in za kaj ga uporabljamo 2.
Before you take EMEND 3.
Kaj morate vedeti, preden boste vzeli zdravilo EMEND 3.
How to take EMEND 4.
Kako jemati zdravilo EMEND 4.
How to store EMEND 6.
Shranjevanje zdravila EMEND 6.
WHAT EMEND IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO EMEND IN ZA KAJ GA UPORABLJAMO
EMEND is used to prevent nausea and vomiting after surgery.
Zdravilo EMEND uporabljamo za preprečevanje navzee (siljenja na bruhanje) in bruhanja po operaciji.
EMEND is a neurokinin 1 (NK1) receptor antagonist.
Zdravilo EMEND je antagonist nevrokinin 1 (NK1) receptorjev.
It stops a chemical in the body (substance P) from binding to the NK1 receptors.
Prepreči vezavo kemične substance (substance P) v telesu na NK1 receptorje.
When substance P attaches to these receptors, it causes nausea and vomiting.
Vezava substance P na te receptorje povzroči siljenje na bruhanje in bruhanje.
By blocking the receptors, EMEND can prevent nausea and vomiting, which often happens as a complication of surgery.
Z blokado receptorjev lahko zdravilo EMEND prepreči siljenje na bruhanje in bruhanje, kar je pogost zaplet operacije.
BEFORE YOU TAKE EMEND
Ne jemljite zdravila EMEND:
Do not take EMEND • If you are allergic (hypersensitive) to aprepitant or any of the other ingredients of EMEND.
- če ste alergični na (preobčutljivi za) aprepitant ali katerokoli sestavino zdravila EMEND.
Take special care with EMEND • if you have liver disease
Bodite posebno pozorni pri uporabi zdravila EMEND
EMEND is not for use in children and adolescents under 18 years.
Zdravilo EMEND se ne uporablja pri otrocih in mladostnikih mlajših od 18 let.
EMEND can affect other medicines.
Zdravilo EMEND lahko vpliva na druga zdravila.
EMEND should be used with caution when taken with some medicines.
Pri sočasnem jemanju z drugimi zdravili je treba zdravilo EMEND uporabljati previdno.
Pregnancy and breast-feeding You should not use EMEND during pregnancy unless clearly necessary.
Nosečnost in dojenje Zdravila EMEND med nosečnostjo ne jemljite, razen če je to izrecno potrebno.
It is important that you tell your doctor if you are pregnant or are planning to become pregnant before taking EMEND.
Pomembno je, da preden vzamete zdravilo EMEND poveste zdravniku, če ste noseči ali če nameravate zanositi.
It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND.
Ni znano, ali se zdravilo EMEND izloča v materino mleko, zato se dojenje v času jemanja zdravila EMEND ne priporoča.
It is important that you tell your doctor if you are breast- feeding or are planning to breast-feed before taking EMEND.
Pomembno je, da preden vzamete zdravilo EMEND poveste zdravniku, če dojite ali nameravate dojiti.
74 Driving and using machines It should be taken into account that some people feel dizzy and sleepy after taking EMEND.
71 Upoštevati je treba, da nekateri ljudje po zaužitju zdravila EMEND postanejo omotični in zaspani.
If you feel dizzy or sleepy, you should avoid driving or operating machines after taking EMEND.
Če ste po zaužitju zdravila EMEND omotični ali zaspani, se izogibajte vožnji ali upravljanju strojev.
(See POSSIBLE SIDE EFFECTS).
(Glejte MOŽNI NEŽELENI UČINKI).
Important information about some of the ingredients of EMEND EMEND contains sucrose.
Pomembne informacije o nekaterih sestavinah zdravila EMEND Zdravilo EMEND vsebuje saharozo.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ste preobčutljivi za katerega od sladkorjev, se pred začetkom jemanja zdravila pogovorite z zdravnikom.
HOW TO TAKE EMEND
KAKO JEMATI ZDRAVILO EMEND
Always take EMEND exactly as your doctor has instructed you.
Pri jemanju zdravila EMEND natančno upoštevajte zdravnikova navodila.
The recommended oral dose of EMEND is one 40 mg capsule within 3 hours prior to the start of anesthesia.
Priporočeni peroralni odmerek zdravila EMEND je ena 40 mg kapsula, ki jo morate zaužiti do 3 ure pred začetkom anestezije.
EMEND should be swallowed whole with some liquid.
Kapsulo zdravila EMEND morate pogoltniti celo, z nekaj tekočine.
Like all medicines, EMEND can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo EMEND neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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).
zelo pogosti (se pojavijo pri več kot 1 od 10 uporabnikov) pogosti (se pojavijo pri 1 do 10 od 100 uporabnikov) občasni (se pojavijo pri 1 do 10 od 1. 000 uporabnikov) redki (se pojavijo pri 1 do 10 od 10. 000 uporabnikov) zelo redki (se pojavijo pri manj kot 1 od 10. 000 uporabnikov) neznani (pogostnosti ni mogoče oceniti iz podatkov, ki so na voljo)
Common side effects: increased liver enzymes.
Pogosti neželeni učinki: povečanje vrednosti jetrnih encimov.
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.
Občasni neželeni učinki: nenormalni črevesni zvoki, zmanjšana občutljivost ali senzitivnost (še posebej v koži), zoženje zenice, zmanjšanje ostrine vida (izguba vida), težave pri govoru, suha usta, nespečnost, siljenje na bruhanje, čutilne motnje, zasoplost, počasen srčni utrip, neugodje v želodcu, bolečine v zgornjem predelu trebuha in piskajoče dihanje.
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).
Poročali so tudi o posameznih primerih Stevens- Johnsonovega sindroma (redka huda kožna reakcija), angioedema (otekanje obraza, ustnic, ust, jezika ali žrela, kar lahko povzroči težave pri požiranju ali dihanju), huda zaprtja, nepravilnega delovanja tankega črevesja (subileus) ter urtikarije (koprivnice).
Allergic reactions, which may be serious, and may include hives, rash and itching and cause difficulty in breathing or swallowing.
V obdobju trženja zdravila so poročali o naslednjih neželenih učinkih (pogostnost je neznana): alergijske reakcije, ki so lahko resne in lahko vključujejo koprivnico, izpuščaj in srbenje ter težave z dihanjem in požiranjem.
If you have an allergic reaction, stop taking EMEND and call your doctor right away.
Če imate alergijsko reakcijo, prenehajte z jemanjem zdravila EMEND in takoj pokličite vašega zdravnika.
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.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE EMEND
SHRANJEVANJE ZDRAVILA EMEND
Keep out of the reach and sight of children.
72 Zdravilo shranjujte nedosegljivo otrokom!
Do not use EMEND after the expiry date which is stated on the carton.
Zdravila EMEND ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do.
Do not remove the capsule from its blister until you are ready to take it.
Kapsule ne jemljite iz pretisnega omota, dokler je ne nameravate vzeti.
Medicines should not be disposed of via wastewater or house hold waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
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).
Pomožne snovi so: saharoza, mikrokristalna celuloza (E460), hidroksipropilceluloza (E463), natrijev lavrilsulfat, želatina, titanov dioksid (E171), šelak, kalijev hidroksid, črni železov oksid (E172) in rumeni železov oksid (E172).
The capsule shell may also contain sodium laurilsulfate and silica colloidal anhydrous.
Ovojnica kapsule lahko vsebuje natrijev lavrilsulfat in brezvodni koloidni silicijev dioksid.
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.
- ena 40 mg kapsula v aluminijastem pretisnem omotu;