FrancophonIA/ELRC3.0 huggingface dataset:
English: Information on the use and licensing of aniseed medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o primjeni i davanju odobrenja za lijekove koji sadrže anišev plod u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of aniseed.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske primjene aniševog ploda.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing aniseed.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjene zahtjeva za davanje odobrenja za biljne lijekove koji sadrže anišev plod.
English: Detailed instructions on how to take aniseed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu uzimanja lijekova koji sadrže anišev plod i o tome tko ih smije uzimati navedene su u uputi o lijeku koja je priložena uz lijek.
English: In its assessment, the HMPC considered laboratory studies which showed aniseed preparations to have a relaxant effect on muscles of the gut and airways.
Croatian: Prilikom svoje ocjene HMPC je razmotrio ispitivanja provedena u laboratoriju koja su pokazala da pripravci aniševog ploda imaju učinak opuštanja mišića crijeva i dišnih putova.
English: What are the risks associated with aniseed medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže anišev plod?
English: Allergic reactions to aniseed that affect the skin or airways may occur.
Croatian: Moguće su alergijske reakcije na anišev plod koje zahvaćaju kožu ili dišne putove.
English: The HMPC concluded that, on the basis of its long-standing use, these aniseed medicines can be used for treating symptoms of mild indigestion complaints including bloating and flatulence.
Croatian: Na temelju dugotrajne primjene, HMPC je zaključio da se ovi lijekovi koji sadrže anišev plod mogu koristiti za liječenje simptoma blagih probavnih tegoba, uključujući nadutost i flatulenciju.
English: For more information about treatment with aniseed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Za više informacija o liječenju lijekovima koji sadrže anišev plod pročitajte uputu o lijeku priloženu uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: How are aniseed medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže anišev plod?
English: For practical information about using aniseed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o primjeni lijekova koji sadrže anišev plod bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: What evidence supports the use of aniseed medicines?
Croatian: Kojim se dokazima potkrjepljuje primjena lijekova koji sadrže anišev plod?
English: Date of first authorisation: 11 November 2003 Date of latest renewal: 22 September 2008
Croatian: Datum prvog odobrenja: 11. studenog 2003. Datum posljednje obnove odobrenja: 22. rujna 2008.
English: Do not remove all capsules at one time.
Croatian: Nemojte izvaditi sve kapsule odjednom.
English: The median tmax was 3.0 hours.
Croatian: Medijan tmax bio je 3,0 sata.
English: To remove, push capsules through from this side.
Croatian: Da biste izvadili kapsulu, pritisnite je s ove strane.
English: This is normal and the medicine is okay to use.
Croatian: Ovo je normalno i lijek se smije koristiti.
English: 25-120 hours
Croatian: 25-120 sati
English: However, the data from this small study do not support a conclusion on the optimal dosing regimen.
Croatian: Međutim, podaci iz ovog malog ispitivanja ne podupiru zaključak o optimalnom režimu doziranja.
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: When to take
Croatian: Kada uzeti
English: Statistically significant differences in efficacy were also observed in each of the 2 individual studies.
Croatian: Statistički značajne razlike u djelotvornosti zabilježene su i u svakom od ova dva ispitivanja zasebno.
English: Relationship between concentration and effect
Croatian: Odnos između koncentracije i učinka lijeka
English: Other medicines and EMEND
Croatian: Drugi lijekovi i EMEND
English: The storage details, should you need them, are as follows:
Croatian: Informacije o čuvanju, u slučaju da vam zatrebaju, su sljedeće:
English: **N: Number of patients included in the primary analysis of complete response.
Croatian: **N: Broj bolesnika uključenih u primarnu analizu potpunog odgovora.
English: Do not take more capsules than the doctor recommends.
Croatian: Nemojte uzeti više kapsula nego što je preporučio liječnik.
English: Unopened sachet: 2 years
Croatian: Neotvorena vrećica: 2 godine
English: Differences*
Croatian: Razlike*
English: Complete response (0-24 hours)
Croatian: Potpuni odgovor (0-24 sata)
English: EMEND is taken just once a day for 3 consecutive days.
Croatian: EMEND se uzima samo jednom dnevno 3 dana zaredom.
English: Do not remove the capsule from its blister until you are ready to take it.
Croatian: Nemojte vaditi kapsulu iz blistera dok niste spremni progutati je.
English: Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Croatian: Drugi farmaceutski oblici/jačine mogu biti primjereniji za primjenu u ove populacije.
English: What EMEND is and what it is used for
Croatian: Što je EMEND i za što se koristi
English: The majority of adults were women (> 90 %), mainly undergoing gynaecological surgery.
Croatian: Većinu odraslih činile su žene (> 90%) koje su imale ginekološku operaciju.
English: Make sure no air is in the oral dispenser (if air is present, remove).
Croatian: Pazite da u oralnom dozatoru nema zraka (ako je prisutan, uklonite ga).
English: - If there is any foam, wait for the foam to disappear before going on to Step 9.
Croatian: Ako primijetite pjenu, pričekajte da pjena nestane prije nego što krenete na korak br.9.
English: EMEND oral suspension
Croatian: EMEND oralna suspenzija
English: 0-24 hours
Croatian: 0-24 sata
English: Emend will generally be stored by healthcare professionals.
Croatian: EMEND će u pravilu čuvati zdravstveni radnici.
English: For children aged 6 months to less than 12 years
Croatian: Za djecu u dobi od 6 mjeseci do manje od 12 godina
English: WHEN and HOW to take EMEND
Croatian: KADA i KAKO uzimati EMEND
English: Aprepitant has been studied at higher doses.
Croatian: Aprepitant je ispitivan u višim dozama.
English: If you forget to give EMEND
Croatian: Ako ste zaboravili dati EMEND
English: Adolescents (aged 12 through 17 years)
Croatian: Adolescenti (u dobi od 12 do 17 godina)
English: - Place the tip of the oral dispenser in the child's mouth along in the inner cheek on either the right or left side.
Croatian: - Postavite vršak oralnog dozatora u usta djeteta uz unutarnju stranu desnog ili lijevog obraza.
English: Use this medicine within 2 days of getting the medicine from the healthcare provider.
Croatian: Primijenite ovaj lijek u roku od 2 dana nakon što od zdravstvenog radnika dobijete ovaj lijek.
English: * - Acute phase
Croatian: * - akutna faza
English: * - Delayed phase
Croatian: * - kasna faza
English: It is very important that this medicine is given exactly as directed below.
Croatian: Jako je važno davati ovaj lijek točno prema sljedećim uputama.
English: For information regarding pregnancy, breast-feeding and contraception, ask your doctor for advice.
Croatian: Za informacije u vezi s trudnoćom, dojenjem i kontracepcijom, obratite se liječniku za savjet.
English: • Once mixed, measure the recommended volume (dose) of suspension with the oral dispenser.
Croatian: • Nakon miješanja, izmjerite preporučeni volumen (dozu) suspenzije pomoću oralnog dozatora.
English: If you are the parent of a child taking EMEND, please read this information carefully.
Croatian: Ako ste roditelj djeteta koje uzima EMEND, molimo da pažljivo pročitate ove informacije.
English: Aprepitant is excreted in the milk of lactating rats.
Croatian: Aprepitant se izlučuje u mlijeko štakorica.
English: Day 2 and Day 3: - If the child will not have chemotherapy - give this medicine in the morning.
Croatian: 2. i 3. dan: - Ako dijete ne prima kemoterapiju - dajte mu lijek ujutro.
English: Different pack sizes are available:
Croatian: Dostupne su različite veličine pakiranja:
English: Complete response
Croatian: Potpuni odgovor
English: This leaflet has been written for the parent or carer who will give this medicine to the child- please read this information carefully.
Croatian: Ova je uputa napisana za roditelja ili njegovatelja koji će davati ovaj lijek djetetu - molimo da pažljivo pročitate ove informacije.
English: Instructions for healthcare professionals on the preparation of the oral suspension
Croatian: Upute za zdravstvene radnike za pripremu oralne suspenzije
English: Mix the EMEND suspension gently by swirling 20 times; then gently invert the mixing cup 5 times.
Croatian: Promiješajte EMEND suspenziju polaganim kružnim pokretima 20 puta, potom pažljivo preokrenite čašu za miješanje 5 puta.
English: Also, some other medicines can affect the way this medicine works.
Croatian: Također, neki drugi lijekovi mogu utjecati na djelovanje ovog lijeka.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja nuspojava definirana je kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) te nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The safety profile of aprepitant was evaluated in approximately 6,500 adults in more than 50 studies and 184 children and adolescents in 2 pivotal paediatric clinical trials.
Croatian: Sigurnost primjene aprepitanta ispitana je u približno 6500 odraslih u više od 50 ispitivanja i 184 djece i adolescenata u 2 pivotalna pedijatrijska klinička ispitivanja.
English: INDIVIDUAL MEASURES
Croatian: POJEDINAČNE MJERE
English: Pharmacotherapeutic group: Antiemetics and antinauseants, ATC code: A04AD12
Croatian: Farmakoterapijska skupina: Antiemetici i lijekovi za suzbijanje mučnine, ATK oznaka: A04AD12
English: Fill the mixing cup with room temperature drinking water.
Croatian: Napunite čašu za miješanje vodom za piće sobne temperature.
English: • For more details on preparation and administration of the suspension, see the package leaflet and the instructions for preparation of the oral suspension for healthcare professionals.
Croatian: • Za detaljniji opis pripreme i primjene suspenzije, vidjeti uputu o lijeku i upute za pripremu oralne suspenzije za zdravstvene radnike
English: WHEN:
Croatian: KADA:
English: Ondansetron was given intravenously immediately before induction of anaesthesia.
Croatian: Ondanzetron se davao intravenski neposredno prije uvođenja u anesteziju.
English: Summary of the safety profile The safety profile of aprepitant was evaluated in approximately 6,500 adults.
Croatian: Sažetak sigurnosnog profila Sigurnost primjene aprepitanta ispitana je u približno 6500 odraslih.
English: The efficacy of the aprepitant regimen was evaluated in a single cycle (Cycle 1).
Croatian: Djelotvornost aprepitanta bila je procijenjena u jednom ciklusu (1. ciklusu).
English: - It is common to have medicine leftover in the cup.
Croatian: - Uobičajeno je da u čaši za miješanje ostane malo lijeka.
English: For each dose of EMEND, you will get a pre-filled oral dispenser that contains the child's prescribed dose.
Croatian: Za svaku dozu lijeka EMEND dobiti ćete napunjeni oralni dozator koji sadrži propisanu dozu za dijete.
English: Most adverse reactions reported in these clinical studies were described as mild to moderate in intensity.
Croatian: Većina nuspojava zabilježenih u ovim kliničkim ispitivanjima bila je blagog do umjerenog intenziteta.
English: Start on the day after your chemotherapy.
Croatian: Počnite dan nakon kemoterapije.
English: There were no treatment-related effects on mating, fertility or embryonic/foetal survival, and no pathological changes in the reproductive organs.
Croatian: Nije bilo učinaka povezanih s liječenjem na parenje, plodnost ili embriofetalno preživljenje, kao ni patoloških promjena na reproduktivnim organima.
English: Healthcare professionals: See the instructions for preparation of the oral suspension for healthcare professionals at the end of this package leaflet.
Croatian: Zdravstveni radnici: Pogledajte upute za pripremu oralne suspenzije za zdravstvene radnike na kraju ove upute o lijeku.
English: Additionally, concomitant administration with irinotecan should be approached with particular caution as the combination might result in increased toxicity.
Croatian: Nadalje, posebnu pozornost treba obratiti pri istodobnoj primjeni s irinotekanom jer ta kombinacija može uzrokovati pojačano toksično djelovanje irinotekana.
English: Patients had the opportunity to receive open-label aprepitant in subsequent cycles (Optional Cycles 2-6); however efficacy was not assessed in these optional cycles.
Croatian: Bolesnici su imali priliku na otvoren način primati aprepitant u daljnjim ciklusima (od 2. do 6. ciklusa po izboru); međutim, djelotvornost nije bila procijenjena u tim ciklusima u kojima se aprepitant uzimao po izboru.
English: Swallow the capsule whole with some liquid.
Croatian: Kapsulu treba progutati cijelu uz nešto tekućine.
English: For information regarding birth control, see ‘Other medicines and EMEND'.
Croatian: Za informacije o kontracepciji vidjeti "Drugi lijekovi i EMEND".
English: To prevent foaming, do not shake the mixing cup.
Croatian: Kako biste spriječili stvaranje pjene nemojte mućkati sadržaj čaše za miješanje.
English: OUTER PACKAGING - STANDARD PACK (CARTON)
Croatian: VANJSKO PAKIRANJE - STANDARDNO PAKIRANJE (KUTIJA)
English: What EMEND looks like and contents of the pack The powder for oral suspension is a pink to light pink powder in a single-use sachet.
Croatian: Kako EMEND izgleda i sadržaj pakiranja Pražak za oralnu suspenziju je ružičasti do svijetloružičasti prašak u vrećici za jednokratnu primjenu.
English: If the child feels dizzy or sleepy, they should not ride a bicycle or use any tools or machines.
Croatian: Ako dijete osjeća omaglicu ili pospanost, ne smije voziti bicikl niti rukovati nikakvim alatima ili strojevima.
English: Pre-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti jednokratnih i ponovljenih doza, genotoksičnosti, kancerogenosti te reproduktivne i razvojne toksičnosti.
English: No dose reduction was required for paediatric patients receiving the control regimen.
Croatian: Sniženje doze nije bilo potrebno u pedijatrijskih bolesnika koji su primali kontrolni režim.
English: HOW:
Croatian: KAKO:
English: Pink to light pink powder.
Croatian: Ružičasti to svijetloružičasti prašak.
English: If no chemotherapy is given on Days 2 and 3, EMEND should be administered in the morning.
Croatian: Ako se kemoterapija ne daje 2. i 3. dana, EMEND treba primijeniti ujutro.
English: The frequency categories given in the table are based on the studies in adults; the observed frequencies in the paediatric studies were similar or lower, unless shown in the table.
Croatian: Kategorije učestalosti prikazane u tablici temelje se na ispitivanjima u odraslih; opažene učestalosti u pedijatrijskim ispitivanjima bile su slične ili manje, osim ako su prikazane u tablici.
English: It should be noted that systemic exposure in adult male rats was lower than the therapeutic exposure in humans at 40 mg. Consequently, no adequate assessment of potential effects on male fertility in rats can be made.
Croatian: Treba istaknuti da je sistemska izloženost u odraslih mužjaka štakora bila niža od terapijske izloženosti u ljudi pri dozi od 40 mg te se stoga ne može izvesti odgovarajuća procjena mogućeg djelovanja na plodnost mužjaka štakora.
English: If you have taken too many capsules, contact your doctor immediately.
Croatian: Ako ste uzeli previše kapsula, odmah se javite liječniku.
English: For details on preparation and administration of the suspension, see section 6.6.
Croatian: Za detaljni opis pripreme i primjene suspenzije vidjeti dio 6.6.
English: Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Croatian: Neiskorišteni lijek ili otpadni materijal treba zbrinuti sukladno lokalnim propisima.
English: Different pack sizes including different strengths are available.
Croatian: Dostupne su različite veličine pakiranja s različitim jačinama lijeka.
English: The recommended dose of EMEND powder for oral suspension is based on weight, as specified in the table below.
Croatian: Preporučena doza EMEND praška za oralnu suspenziju temelji se na tjelesnoj težini, kako je prikazano u tablici niže.
English: The results were evaluated for each individual study and for the 2 studies combined.
Croatian: Analizirani su rezultati svakoga ispitivanja zasebno, a potom i udruženo za oba ispitivanja.
English: The benefit of aprepitant combination therapy in the full study population was mainly driven by the results observed in patients with poor control with the standard regimen such as in women, even though the results were numerically better regardless of age, tumour type or gender.
Croatian: Korist kombinacijskog liječenja aprepitantom u cijeloj ispitivanoj populaciji većinom proizlazi iz rezultata u bolesnika koji su imali slabu kontrolu simptoma uz standardnu terapiju, kao što su žene, iako su rezultati bili numerički bolji bez obzira na dob, vrstu tumora ili spol.
English: If you take more EMEND than you should
Croatian: Ako uzmete više lijeka EMEND nego što ste trebali
English: No new safety concerns were identified.
Croatian: Nisu bili utvrđeni novi razlozi za zabrinutost u pogledu sigurnosti lijeka.
English: Concomitant intake of a 40 mg dose with a standard breakfast decreased the aprepitant Cmax by 18 % but did not affect AUC.
Croatian: Uzimanje doze od 40 mg istodobno sa standardnim doručkom smanjilo je Cmax aprepitanta za 18%, ali nije utjecalo na AUC.
English: For short term treatment according to recommended dose regimen these findings are considered unlikely to be clinically relevant.
Croatian: Za kratkotrajno liječenje u skladu s režimom u preporučenim dozama, smatra se da ovi nalazi najvjerojatnije nemaju kliničku važnost.
English: EMEND 80 mg hard capsules are taken just once a day for 2 consecutive days.
Croatian: EMEND 80 mg tvrde kapsule uzimaju se samo jedanput na dan 2 dana zaredom.
English: When you have finished do not throw away any medicines via wastewater or household waste.
Croatian: Kada završite, nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: EMEND or placebo and ondansetron were administered 1 hour and 30 minutes prior to initiation of chemotherapy, respectively.
Croatian: EMEND ili placebo i ondanzetron bili su primijenjeni 1 sat odnosno 30 minuta prije početka kemoterapije.
English: The safety and exploratory efficacy of aprepitant were evaluated in a Phase I clinical study (n=50) using a 40 mg powder for oral suspension.
Croatian: Sigurnost i eksplorativna djelotvornost aprepitanta bile su procijenjene u ispitivanju faze I (n=50) primjenom 40 mg praška za oralnu suspenziju.
English: - This medicine has been prescribed for you or the child only.
Croatian: - Ovaj je lijek propisan samo Vama ili djetetu.
English: - Slowly push the plunger all the way down to give all the medicine in the oral dispenser.
Croatian: - Polako pritisnite klip do kraja kako biste dali sav lijek koji je sadržan u oralnom dozatoru.
English: This medicine can affect other medicines.
Croatian: Ovaj lijek može utjecati na djelovanje drugih lijekova.
English: Complete response to the aprepitant regimen and standard therapy, respectively, was reached in 209/324 (65 %) and 161/320 (50 %) in women and 83/101 (82 %) and 68/87 (78 %) of men.
Croatian: Potpuni odgovor na režim liječenja aprepitantom postiglo je 209/324 (65%) žena i 83/101 (82%) muškaraca, a standardnom terapijom 161/320 (50%) žena i 68/87 (78%) muškaraca.
English: The color of the medicine in the oral dispenser may be different shades of pink (light pink to dark pink).
Croatian: Boja lijeka u oralnom dozatoru može varirati u nekoliko nijansi ružičaste (svijetloružičasta do tamnoružičasta).
English: Aprepitant 40 mg orally (N=541)
Croatian: Aprepitant 40 mg peroralno (N= 541)
English: Intravenous dexamethasone was permitted as part of the antiemetic regimen for paediatric patients in both age groups, at the discretion of the physician.
Croatian: Bila je dopuštena primjena intravenskog deksametazona u sklopu antiemetičkog režima liječenja u pedijatrijskih bolesnika u obje dobne skupine, prema procjeni liječnika.
English: The percentage of subjects reporting no vomiting over the first 24 hours following surgery was similar for subjects receiving aprepitant versus ondansetron.
Croatian: Postotak ispitanika koji su prijavili da nisu povraćali tijekom prva 24 sata nakon kirurškog zahvata bio je sličan u onih koji su primali aprepitant i onih koji su primali ondanzetron.
English: If you or the child has taken too many capsules, contact your doctor immediately.
Croatian: Ako ste Vi ili dijete uzeli previše kapsula, odmah se javite liječniku.
English: EMEND capsules contain sucrose.
Croatian: EMEND kapsule sadrže saharozu.
English: Talk to the doctor, pharmacist or nurse if the child is taking any of the following medicines: - medicines that affect the immune system - such as cyclosporine, tacrolimus, sirolimus,
Croatian: Obavijestite liječnika, ljekarnika ili medicinsku sestru ako dijete prima bilo koji od sljedećih lijekova: - lijekove koji utječu na imunološki sustav - kao što su ciklosporin, takrolimus, sirolimus,
English: Recommended dose of EMEND oral suspension in paediatric patients aged 6 months to less than 12 years
Croatian: Preporučena doza EMEND oralne suspenzije u pedijatrijskih bolesnika u dobi od 6 mjeseci do manje od 12 godina
English: If you give the child more than you should, contact the doctor straight away.
Croatian: Ako date djetetu više lijeka nego što ste trebali, odmah se javite liječniku.
English: The mean absolute oral bioavailability of aprepitant is 67 % for the 80 mg capsule and 59 % for the 125 mg capsule.
Croatian: Srednja apsolutna oralna bioraspoloživost aprepitanta je 67% za kapsule od 80 mg te 59% za kapsule od 125 mg.
English: Do not give EMEND powder for oral suspension to children under 6 months of age or who weigh less than 6 kg, or to adolescents between 12 and 18 years, because the powder for oral suspension has not been studied in this population.
Croatian: Nemojte davati EMEND prašak za oralnu suspenziju djeci mlađoj od 6 mjeseci ili čija je tjelesna težina manja od 6 kg niti u adolescenata u dobi između 12 i 18 godina zato što prašak za oralnu suspenziju nije ispitan u toj populaciji.
English: If the child misses a dose of this medicine, talk to the doctor.
Croatian: Ako dijete propusti dozu ovog lijeka, obratite se liječniku.
English: No dose adjustment for EMEND is necessary in elderly patients.
Croatian: Nije potrebno prilagođavati dozu lijeka EMEND u starijih bolesnika.