FrancophonIA/ELRC3.0 huggingface dataset:
English: What is the risk associated with Aloxi?
Croatian: Koji su rizici povezani s lijekom Aloxi?
English: The capsules are only used in adults for chemotherapy that is a moderate trigger of nausea and vomiting in adults.
Croatian: Kapsule se koriste samo u odraslih osoba za kemoterapiju koja je umjereni aktivator mučnine i povraćanja u odraslih osoba.
English: Why has Aloxi been approved?
Croatian: Zašto je Aloxi odobren?
English: A further study compared three doses of Aloxi capsules (250, 500 and 750 micrograms) with the solution for injection in 651 adults receiving chemotherapy that was a moderate trigger of nausea and vomiting.
Croatian: Daljnje ispitivanje usporedilo je doze kapsula lijeka Aloxi (250, 500 i 750 mikrograma) s otopinom za injekciju u 651 odrasle osobe koja je primala kemoterapiju koja je bila umjereni aktivator mučnine i povraćanja.
English: What is Aloxi?
Croatian: Što je Aloxi?
English: Aloxi solution for injection has been studied in three main studies involving 1,842 adults receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting.
Croatian: Otopina za injekciju Aloxi ispitan je u tri glavna ispitivanja koja su obuhvatila 1.842 odrasle osobe koje su primile kemoterapiju koja je bila snažni ili umjereni aktivator mučnine i povraćanja.
English: Aloxi solution for injection has also been investigated in one study involving 502 children receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting, where Aloxi was compared with ondansetron.
Croatian: Otopina za injekciju Aloxi ispitana je također u jednom ispitivanju koje je obuhvatilo 502 odrasle djece koja su primila kemoterapiju koja je bila snažni ili umjereni aktivator mučnine i povraćanja, u slučaju kada je Aloxi uspoređen s ondansetronom.
English: It may be made more effective by the addition of a corticosteroid (a type of medicine that can be used to prevent nausea and vomiting).
Croatian: Dodavanjem kortikosteroida l(tipa lijeka koji se može koristiti za sprječavanje mučnine i povraćanja), lijek se može učiniti djelotvornijim.
English: For the full list of all side effects and restrictions with Aloxi, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Aloxi potražite u uputi o lijeku.
English: In the study in children receiving chemotherapy that was a strong or moderate trigger of nausea and vomiting, 59% of the children receiving Aloxi solution for injection at a dose of 20 micrograms/kilogram did not vomit in the 24 hours after chemotherapy (98 out of 165), which was the same percentage as seen in patients receiving ondansetron (95 out of 162).
Croatian: U ispitivanju djece koja su primala kemoterapiju koja je bila snažan ili umjeren aktivator mučnine i povraćanja, 59% djece koja su primala otopinu za injekciju Aloxi u dozi od 20 mikrograma/kilogramu nije povraćalo unutar 24 sata nakon kemoterapije (98 od 165), što predstavlja isti postotak koji je uočen u bolesnika koji su primali ondansetron (95 od 162).
English: With chemotherapy that was a strong trigger of nausea and vomiting, 59% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (132 out of 223), compared with 57% of the patients receiving ondansetron (126 out of 221).
Croatian: U slučaju kemoterapije koja je bila snažni aktivator mučnine i povraćanja, 59% odraslih koji su primali lijek Aloxi nije povraćalo unutar 24 sata nakon kemoterapije (132 od 223) u usporedbi s 57% bolesnika koji su primali ondansetron (126 od 221).
English: With chemotherapy that was a moderate trigger of nausea and vomiting, 81% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (153 out of 189) compared with 69% of those receiving ondansetron (127 out of 185).
Croatian: U slučaju kemoterapije koja je bila umjereni aktivator mučnine i povraćanja, 81% odraslih osoba koje su primale lijek Aloxi nije povraćalo unutar 24 sata nakon kemoterapije (153 od 189) u usporedbi sa 69% onih koji su primali ondansetron (127 od 185).
English: What is Aloxi used for?
Croatian: Za što se Aloxi koristi?
English: What benefit has Aloxi shown during the studies?
Croatian: Koje su koristi lijeka Aloxi utvrđene u ispitivanjima?
English: How is Aloxi used?
Croatian: Kako se Aloxi koristi?
English: How does Aloxi work?
Croatian: Kako djeluje Aloxi?
English: How has Aloxi been studied?
Croatian: Kako je lijek Aloxi ispitivan?
English: A risk management plan has been developed to ensure that Fluenz is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Fluenz koristi što je sigurnije moguće.
English: Its use should be based on official recommendations.
Croatian: Primjena ovog lijeka treba se temeljiti na službenim preporukama.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fluenz on 27 January 2011.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Fluenz vrijedi na prostoru Europske unije od 27. siječnja 2011.
English: Other information about Fluenz
Croatian: Druge informacije o lijeku Fluenz
English: Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season.
Croatian: Svake godine Svjetska zdravstvene organizacija (WHO) izdaje preporuke o tome koji se sojevi gripe trebaju uključiti u cjepiva za nadolazeću sezonu gripe.
English: The viruses used in Fluenz are grown in hens' eggs.
Croatian: Virusi korišteni u lijeku Fluenz uzgajaju se u kokošjim jajima.
English: The full EPAR for Fluenz can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Fluenz može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Children who have not been previously vaccinated against seasonal flu should be given a second dose after at least four weeks.
Croatian: Djeca koja nisu prethodno cijepljena protiv sezonske influence trebaju primiti drugu dozu nakon najmanje četiri tjedna.
English: The flu strains were selected according to the influenza season.
Croatian: Sojevi gripe su odabrani u skladu sa sezonom gripe.
English: Fluenz contains strains of flu virus that have first been weakened so that they do not cause disease.
Croatian: Fluenz sadrži sojeve virusa gripe koji su prethodno oslabljeni kako ne bi uzrokovali bolest.
English: It must only be used as a nasal spray and must not be injected.
Croatian: Smije se koristiti samo kao sprej za nos, te se ne smije ubrizgavati.
English: It must also not be given to children who are receiving treatment with salicylates (painkillers such as aspirin).
Croatian: Ne smije se primjenjivati ni u djece koja primaju terapiju salicilatima (analgeticima poput aspirina).
English: What measures are being taken to ensure the safe and effective use of Fluenz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Fluenz?
English: Fluenz is given as a nasal spray using a single-use nasal applicator (0.1 ml sprayed into each nostril).
Croatian: Fluenz se koristi kao sprej za nos uz primjenu jednokratnog aplikatora za nos (0,1 ml uštrcano u svaku nosnicu).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fluenz.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Fluenz.
English: The main measure of effectiveness was the number of laboratory-confirmed cases of flu caused by the three strains during the given flu season, although one of the studies in adults measured the number of cases of feverish illness (as opposed to confirmed flu cases).
Croatian: Glavna mjera djelotvornosti bio je broj laboratorijski potvrđenih slučajeva gripe koje su uzrokovali tri soja tijekom određene sezone gripe, iako je jedno od ispitivanja provedeno u odraslih osoba zabilježilo niz slučajeva bolesti praćene groznicom (za razliku od potvrđenih slučajeva gripe).
English: It contains three live attenuated (weakened) influenza (flu) virus strains: A/California/7/2009 (H1N1)pdm09-like strain; A/Victoria/361/2011 (H3N2)-like strain; and B/Massachusetts/2/2012-like strain.
Croatian: Sadrži tri živa atenuirana (oslabljena) soja virusa influence (gripe): A/California/7/2009 (H1N1)pdm09kao soj; A/Victoria/361/2011 (H3N2)-kao soj; i B/Massachusetts/2/2012-kao soj.
English: It must also not be given to people with weakened immune systems due to conditions such as blood disorders, symptomatic HIV infection and cancer or as a result of certain medical treatments.
Croatian: Ne smije se primjenjivati u osoba s oslabljenim imunološkim sustavom zbog stanja, poput poremećaja krvi, infekcije simptomatične za HIV, raka ili određenih medicinskih stanja.
English: Fluenz must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins.
Croatian: Fluenz se ne smije koristiti u osoba koje su preosjetljive (alergične) na djelatne tvari ili na bilo koji drugi sastojak, na gentamicin (tip antibiotika) ili jaja ili proteine iz jaja.
English: Fluenz is a vaccine.
Croatian: Fluenz je cjepivo.
English: In the studies in children and adolescents, Fluenz reduced the number of flu cases caused by the three flu strains by between 62% and 100% compared with placebo and by between 35% and 53% compared with the comparator inactivated vaccine.
Croatian: U ispitivanjima provedenima u djece i adolescenata, Fluenz je smanjio broj slučajeva gripe uzrokovanih trima sojevima gripe od 62% do 100% u usporedbi s placebom, te između 35% i 53% u usporedbi s komparatorskim inaktiviranim cjepivom.
English: For more information about treatment with Fluenz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Fluenz pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: This is a summary of the European public assessment report (EPAR) for Fluenz.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Fluenz.
English: Fluenz is a vaccine which is available as a nasal spray to protect against influenza A (sub-types H1N1 and H3N2) and influenza B.
Croatian: Fluenz je cjepivo koje je dostupno kao sprej za nos za zaštitu protiv influence A (podtipovi H1N1 i H3N2) i influence B.
English: Fluenz will be updated with weakened virus strains type A-H1N1, type A-H3N2 and type B for each season, according to recommendations for the northern hemisphere from the WHO and from the European Union.
Croatian: Fluenz se obnavlja oslabljenim sojevima virusa tipa A-H1N1, tipa AH3N2 i tipa B za svaku sezonu, sukladno preporukama za sjevernu hemisferu izdanima od WHO i Europske unije.
English: The most common side effects with Fluenz (seen in more than 1 patient in 10) are reduced appetite, headache, blocked or runny nose and malaise (feeling unwell).
Croatian: Najčešće nuspojave od lijeka Fluenz (koje se mogu javiti u više od 1 na 10 osoba) su smanjeni apetit, glavobolja, začepljen nos ili curenje nosa i slabost (opće loše stanje).
English: The studies in adults showed that Fluenz may have some benefits compared with placebo but the results were inconsistent.
Croatian: Ispitivanja provedena u odraslih osoba dokazala su da lijek Fluenz može imati određene koristi u odnosu na placebo, no rezultati nisu bili konzistentni.
English: Nine main studies involving around 24,000 children and adolescents and four studies involving around 11,000 adults compared Fluenz with either placebo (a dummy vaccine) or another injectable flu vaccine containing inactivated (killed) viral material from the same three flu strains.
Croatian: Provedeno je devet glavnih ispitivanja koja su obuhvatilo otprilike 24.000 djece i adolescenata, te četiri ispitivanja koja su usporedila otprilike 11.000 odraslih osoba koje su uzimale Fluenz s placebom (lažnim liječenjem) ili drugim cjepivom protiv gripe koje je sadržavalo inaktiviran (ubijen) virusni materijal iz ista tri soja gripe.
English: These virus strains need to be included in Fluenz before it can be used.
Croatian: Ovi sojevi virusa moraju biti uključeni u lijek Fluenz prije primjene cjepiva.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fluenz, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Fluenz uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The CHMP noted that the studies showed convincingly that Fluenz was more effective than placebo and the comparator inactivated vaccine in children and adolescents, but not in adults.
Croatian: CHMP je zaključio da je ispitivanjima uvjerljivo dokazano da je lijek Fluenz bio djelotvorniji od placeba i komparatorskog inaktiviranog cjepiva u djece i adolescenata, no ne i u odraslih osoba.
English: Fluenz is used to prevent flu in children and adolescents from 24 months to less than 18 years old.
Croatian: Fluenz se koristi za profilaksu influence u djece u dobi od 24 mjeseca do mlađih od 18 godina.
English: The CHMP therefore decided that Fluenz's benefits are greater than its risks in children and adolescents from 24 months to less than 18 years old and recommended that it be given marketing authorisation in this patient group.
Croatian: Stoga, CHMP smatra da koristi od lijeka Fluenz nadmašuju s njim povezane rizike u djece i adolescenata u dobi od 24 mjeseca starosti do 18 godina te je preporučilo izdavanje odobrenja za stavljanje u promet u ovoj grupi bolesnika.
English: What is the risk associated with Fluenz?
Croatian: Koji su rizici povezani s lijekom Fluenz?
English: Why has Fluenz been approved?
Croatian: Zašto je Fluenz odobren?
English: Some studies also suggested that Fluenz was not as effective as the comparator inactivated vaccine in adults.
Croatian: Pojedina ispitivanja indiciraju da Fluenz nije bio podjednako učinkovit u odraslih osoba kao komparatorsko inaktivirano cjepivo.
English: What benefit has Fluenz shown during the studies?
Croatian: Koje koristi lijeka Fluenz su dokazane u ispitivanjima?
English: What is Fluenz?
Croatian: Što je Fluenz?
English: Fluenz influenza vaccine (live attenuated, nasal)
Croatian: EPAR, sažetak za javnost cjepivo protiv influence (živo, atenuirano, za nos)
English: For the full list of all side effects reported with Fluenz, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Fluenz potražite u uputi o lijeku.
English: How does Fluenz work?
Croatian: Kako Fluenz djeluje?
English: What is Fluenz used for?
Croatian: Za što se Fluenz koristi?
English: How is Fluenz used?
Croatian: Kako se Fluenz koristi?
English: How has Fluenz been studied?
Croatian: Kako se Fluenz ispitivao?
English: Your doctor will decide what to do if this happens to you.
Croatian: Vaš liječnik će odlučiti što učiniti ako se to Vama dogodi.
English: The physician educational programme should contain the following key elements:
Croatian: Edukacijski program liječnika mora sadržavati sljedeće ključne elemente:
English: Elderly population (≥65 years old)
Croatian: Starija populacija (≥65godina starosti)
English: Check with your doctor if you are not sure.
Croatian: Provjerite s liječnikom, ako niste sigurni.
English: This way, you will have to take fewer capsules at once.
Croatian: Na ovaj način morat ćete uzeti manji broj kapsula odjednom.
English: However, absolute numbers of cases are small.
Croatian: No, apsolutne brojke slučajeva su vrlo male.
English: - The other ingredients are:
Croatian: - Drugi sastoji su:
English: You may for example take one capsule in the morning and one in the evening.
Croatian: Primjerice, možete uzeti jednu kapsulu ujutro i jednu kapsulu uvečer.
English: The dose recommendations reflect the use in this population.
Croatian: Preporuke za doziranje odražavaju uporabu u ovoj populaciji.
English: Make sure you see your doctor for these regular examinations at least once a year.
Croatian: Obavite ove redovite preglede kod liječnika najmanje jednom godišnje.
English: If you take these medicines, take Orphacol at least 5 hours before or at least 5 hours after taking these other medicines.
Croatian: Ako uzimate ove lijekove, Orphacol uzmite najmanje 5 sati prije ili najmanje 5 sati nakon uzimanja ovih lijekova.
English: If your doctor has prescribed a dose which requires you to take more than one capsule per day, you and your doctor can decide how this will be taken during the day.
Croatian: Ako je Vaš liječnik propisao dozu koja zahtjeva da uzimate više od jedne kapsule dnevno, Vi i Vaš liječnik možete odlučiti o načinu uzimanja lijeka tijekom dana.
English: At each investigation, the need for dose adjustment should be considered.
Croatian: Pri svakom pregledu potrebno je razmotriti potrebu prilagođavanja doze.
English: Pack sizes: 30, 60, 120.
Croatian: Veličina pakiranja: 30, 60, 120.
English: Due to the rarity of the diseases, the information about the most serious and/or most frequently occurring adverse reactions is limited.
Croatian: Zbog rijetke učestalosti bolesti, informacije o najozbiljnijim i/ili najčešćim nuspojavama su ograničene.
English: There is a risk of permanently damaging your liver if you stop taking Orphacol.
Croatian: Postoji rizik od trajnog oštećenja jetre ako prestanete uzimati Orphacol.
English: PVC/PVDC-aluminium blister of 10 capsules.
Croatian: PVC/PVDC-aluminijski blister s 10 kapsula.
English: Please consult your doctor if you plan to become pregnant.
Croatian: Molimo savjetujte se sa svojim liječnikom ako planirate zatrudniti.
English: You should never stop taking Orphacol unless your doctor advises you to do so.
Croatian: Orphacol ne smijete nikada prestati uzimati, osim ako Vam to ne savjetuje liječnik.
English: Tell your doctor or pharmacist if you are taking, have recently taken any or might take other medicines.
Croatian: Obavijestite svojeg liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The dose should be adjusted accordingly, as described above.
Croatian: Doza se mora primjereno prilagoditi, kako je opisano ranije u tekstu.
English: Patients should be monitored as follows: 3-monthly during the first year, 6-monthly during the subsequent three years and annually thereafter (see below).
Croatian: Bolesnici se trebaju pratiti kako slijedi: svaka 3 mjeseca tijekom prve godine, svakih 6 mjeseci tijekom naredne tri godine, a nakon toga jednom godišnje (vidjeti dalje u tekstu).
English: The dose will then be further adjusted by your doctor depending on your body's response.
Croatian: Vaš liječnik može zatim dodatno prilagođavati dozu ovisno o odgovoru Vašeg tijela.
English: There is no experience in elderly patients.
Croatian: Nema iskustva primjene u starijih bolesnika.
English: Capsules must be swallowed whole with water.
Croatian: Kapsule se moraju progutati cijele s vodom.
English: Contents of the pack and other information What Orphacol contains
Croatian: Sadržaj pakiranja i druge informacije Što Orphacol sadrži
English: It is extremely important that pregnant women continue their therapy during pregnancy.
Croatian: Iznimno je važno da trudnice nastave svoju terapiju tijekom trudnoće.
English: What Orphacol is and what it is used for
Croatian: Što je Orphacol i za što se koristi
English: Other food such as fruit compote or yoghurt may be suitable for administration, but no data on the compatibility or palatability are available.
Croatian: Ostala hrana, poput voćnog kompota ili jogurta, može biti prikladna za primjenu, no nisu dostupni podaci o kompatibilnosti ili palatabilnosti.
English: Please tell your doctor if you are taking ciclosporin.
Croatian: Molimo obavijestite svojeg liječnika ako uzimate ciklosporin.
English: Taking Orphacol at regular times with a meal will help you remember to take this medicine, and may help your body to better take it up.
Croatian: Redovito uzimanje lijeka Orphacol uz obrok pomaže Vam da zapamtite uzeti ovaj lijek te može pomoći Vašem tijelu da ga lakše podnese.
English: If you become pregnant during treatment with Orphacol, your doctor will decide which treatment and dose is best in your situation.
Croatian: Ako zatrudnite tijekom liječenja lijekom Orphacol, Vaš će liječnik odlučiti koje je liječenje i doza najbolja za Vas.
English: Treatment should be stopped earlier if there are clear indicators of severe hepatic failure.
Croatian: Liječenje treba prekinuti ranije, ako postoje jasni indikatori teškog zatajenja jetre.
English: Other medicines and Orphacol
Croatian: Drugi lijekovi i Orphacol
English: Familial hypertriglyceridemia
Croatian: Obiteljska hipertrigliceridemija
English: In the case of an accidental overdose, treatment should be continued at the recommended dose after normalisation of clinical signs and/or biological abnormalities.
Croatian: U slučaju slučajnog predoziranja, liječenje se treba nastaviti u preporučenoj dozi nakon normalizacije kliničkih znakova i/ili bioloških abnormalnosti.
English: Alternative treatments should be used.
Croatian: Potrebna je primjena alternativnih metoda liječenja.
English: Medicines should not be disposed of via wasterwater or household waste.
Croatian: Lijekovi se ne smiju bacati u otpadne vode ili kućni otpad.
English: The frequency of these reactions is not known (cannot be estimated from the available data).
Croatian: Učestalost ovih nuspojava nije poznata (ne može se procijeniti na temelju dostupnih podataka).
English: Reduction of the dose led to resolution of the clinical signs and correction of abnormal laboratory parameters.
Croatian: Smanjenje doza rezultiralo je povlačenjem kliničkih znakova i ispravkom abnormalnih laboratorijskih parametara.
English: If you have taken more Orphacol than you should, contact your doctor as soon as possible.
Croatian: Ako ste uzeli više lijeka Orphacol nego što ste trebali, obratite se svom liječniku što je prije moguće.
English: If itching and/or diarrhoea last for more than three days, tell your doctor.
Croatian: Ako svrbež i/ili proljev traju dulje od tri dana, obratite se svom liječniku.
English: Episodes of symptomatic overdose have been reported, including accidental overdose.
Croatian: Prijavljene su epizode simptomatskog predoziranja, uključujući i slučajno predoziranje.
English: Always take Orphacol exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik.
English: Before treatment your doctor will make an assessment from your laboratory tests to determine the correct dose for you.
Croatian: Prije početka liječenja Vaš liječnik mora procijeniti Vaše laboratorijske nalaze kako bi utvrdio ispravnu dozu za Vas.
English: The available non-clinical data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Croatian: Dostupni neklinički podaci u literaturi ne upućuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti te reproduktivne toksičnosti.
English: They are contained in blisters of 10 capsules each.
Croatian: Lijek je sadržan u blisterima s po 10 kapsula u svakom.
English: In adults, the daily dose should not exceed 500 mg.
Croatian: Dnevna doza za odrasle osobe ne smije premašiti 500 mg.
English: It is very important to continue taking Orphacol during pregnancy.
Croatian: Izuzetno je važno da nastavite uzimati Orphacol tijekom trudnoće.