FrancophonIA/ELRC3.0 huggingface dataset:
English: It contains the active substance pegaspargase.
Croatian: Sadržava djelatnu tvar pegaspargazu.
English: Oncaspar is normally given every 14 days by injection into a muscle or by infusion (drip) into a vein, with the dose depending on age and body surface area.
Croatian: Oncaspar se u pravilu primjenjuje svakih 14 dana injekcijom u mišić ili infuzijom (dripom) u venu, a doza ovisi o dobi i površini tijela bolesnika.
English: Side effects reported with Oncaspar are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Oncaspar pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Oncaspar
Croatian: Ostale informacije o lijeku Oncaspar
English: Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.
Croatian: S druge strane, normalne stanice mogu proizvesti svoj vlastiti asparagin te na njih lijek slabije djeluje.
English: As for its risks, the side effects of Oncaspar are similar to those of other asparaginase medicines and are considered manageable
Croatian: Što se tiče rizika, nuspojave lijeka Oncaspar slične su onima drugih lijekova koji sadržavaju asparaginazu te se smatra da ih je moguće kontrolirati.
English: As for all medicines, data on the use of Oncaspar are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Oncaspar kontinuirano se prate.
English: The European Medicines Agency therefore decided that Oncaspar's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Oncaspar nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The active substance (pegaspargase) contains the enzyme asparaginase which works by breaking up and reducing the blood levels of the amino acid asparagine.
Croatian: Djelatna tvar pegaspargaza sadržava enzim asparaginazu koji djeluje na način da razgrađuje i snižava razine asparaginske aminokiseline u krvi.
English: The most common side effects with Oncaspar (which may affect more than 1 in 10 people) include signs of liver problems (raised levels of liver enzymes and bilirubin in the blood), reduced blood clotting, high levels of fats in the blood, high levels of blood glucose and low levels of white blood cells accompanied by fever.
Croatian: Najčešće nuspojave lijeka Oncaspar (koje se mogu javiti u više od 1 u 10 osoba) uključuju znakove jetrenih problema (povišene razine jetrenih enzima i bilirubina u krvi), otežano zgrušavanje krvi, visoke razine krvnih masnoća, visoke razine glukoze u krvi i niske razine bijelih krvnih stanica popraćene vrućicom.
English: What is Oncaspar and what is it used for?
Croatian: Što je Oncaspar i za što se primjenjuje?
English: Oncaspar is a cancer medicine used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts.
Croatian: Oncaspar je lijek protiv raka koji se primjenjuje u odraslih i djece za liječenje akutne limfoblastične leukemije (ALL), raka bijelih krvnih stanica naziva limfoblasti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oncaspar have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Oncaspar nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: In a study in 118 children newly diagnosed with ALL, 75% of those treated with Oncaspar (in combination with other medicines) were free of the cancer after 7 years, without having relapse or a new cancer during that period.
Croatian: U ispitivanju na 118-ero djece s novodijagnosticiranim ALL-om, 75 % one liječene lijekom Oncaspar (u kombinaciji s drugim lijekovima) nakon sedam godina nije imalo simptome raka, nije bilo relapsa bolesti ni pojave drugog oblika raka u tom razdoblju.
English: Oncaspar also comes with the advantage of requiring fewer injections as the medicine stays longer in the body than some other asparaginases.
Croatian: Druga je prednost lijeka Oncaspar manji broj potrebnih injekcija jer se lijek u organizmu zadržava duže od nekih drugih vrsta asparaginaze.
English: An overview of Oncaspar and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Oncaspar i zašto je odobren u EU-u
English: In another study of 76 children whose cancer returned after earlier treatment, around 40% of Oncaspar-treated patients (some of whom were allergic to other asparaginase treatments) were cleared of the cancer, compared with 47% of patients treated with an asparaginase comparator.
Croatian: U drugom ispitivanju na 76-ero djece čiji se rak ponovo razvio nakon prethodne terapije, oko 40 % bolesnika liječenih lijekom Oncaspar (pri čemu su neki bili alergični na druge terapije asparaginazom) nije imalo simptome raka, u usporedbi s 47 % bolesnika liječenih usporednim lijekom s asparaginazom.
English: What are the risks associated with Oncaspar?
Croatian: Koji su rizici povezani s lijekom Oncaspar?
English: Oncaspar must not be used in patients with severe liver disease, patients who have ever had pancreatitis (including pancreatitis caused by previous asparaginase treatments) or patients who have had severe bleeding or serious blood clots following asparaginase treatment.
Croatian: Oncaspar se ne smije primjenjivati u bolesnika s ozbiljnim oštećenjem jetre, bolesnika koji su preboljeli pankreatitis (uključujući pankreatitis uzrokovan ranijim terapijama asparaginazom) ni u bolesnika koji su nakon terapije asparaginazom dobili teško krvarenje ili ozbiljne ugruške u krvi.
English: Studies showed Oncaspar to be effective in patients with ALL, including patients who were allergic to asparaginase.
Croatian: Ispitivanja su pokazala da je Oncaspar učinkovit u bolesnika s ALL-om, uključujući bolesnike alergične na asparaginazu.
English: For more information about using Oncaspar, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Oncaspar pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Why is Oncaspar authorised in the EU?
Croatian: Zašto je lijek Oncaspar odobren u EU-u?
English: The cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die.
Croatian: Ta je aminokiselina potreba stanicama raka za rast i umnožavanje te smanjenje njezine količine u krvi uzrokuje odumiranje tih stanica.
English: How does Oncaspar work?
Croatian: Kako djeluje Oncaspar?
English: What benefits of Oncaspar have been shown in studies?
Croatian: Koje su koristi od lijeka Oncaspar utvrđene u ispitivanjima?
English: For the full list of side effects of Oncaspar, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Oncaspar potražite u uputi o lijeku.
English: As the company had submitted the additional information requested, the ‘exceptional circumstances' ended on 21 September 2009.
Croatian: Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” prestale su 21. rujna 2009.
English: These amino acids are normally found in proteins in foods and drinks.
Croatian: Ove amino kiseline se normalno nalaze u proteinima u hrani i pićima.
English: This is a programme through which doctors can request a medicine for one of their patients before the medicine is fully authorised.
Croatian: Ovo je program putem kojeg liječnici mogu zatražiti lijek za jednog od svojih bolesnika prije nego što se lijek u potpunosti odobri.
English: The capsules are usually swallowed whole, but they may be opened and their contents mixed into a small amount of water or formula just before swallowing.
Croatian: Kapsule se najčešće gutaju cijele, no mogu se otvoriti, a njihov se sadržaj miješa u malim količinama s vodom ili formulom netom prije gutanja.
English: The largest study of Orfadin was carried out in 257 patients in 87 different hospitals in 25 countries, as part of a ‘compassionate-use' programme.
Croatian: Najveće ispitivanje lijeka Orfadin provedeno je na 257 bolesnika u 87 različitih bolnica u 25 država kao dio programa „liječenja donacijom“.
English: With additional Orfadin treatment, the survival rate increases to 82%.
Croatian: Uz dodatnu terapiju lijekom Orfadin, stopa preživljenja povećava se na 82%.
English: Orfadin nitisinone
Croatian: Orfadin nitizinon
English: It is available as capsules (2 mg, 5 mg, 10 mg and 20 mg) and as a suspension (4 mg/ml) to be taken by mouth.
Croatian: Lijek je dostupan kao kapsule (2 mg, 5 mg, 10 mg i 20 mg) i kao suspenzija (4 mg/ml) koja se uzima perioralno.
English: The recommended starting dose is 1 mg per kilogram body weight per day, divided into two doses.
Croatian: Preporučena početna doza iznosi 1 mg po kilogramu tjelesne težine podijeljeno u dvije doze.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orfadin on 21 February 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Orfadin na snazi u Europskoj uniji od 21. veljače 2005.
English: Other information about Orfadin
Croatian: Ostale informacije o lijeku Orfadin
English: Orfadin was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of the approval.
Croatian: Orfadin je prvobitno odobren u „iznimnim okolnostima” zbog toga što su, iz znanstvenih razloga, u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
English: For example, a baby less than two months old with HT-1 would normally have only a 28% chance of surviving for five years using a modified diet alone.
Croatian: Primjerice, novorođenče mlađe od dva mjeseca s HT-1 normalno ima samo 28% izgleda za preživljenje tijekom pet godina primjene samo prilagođene prehrane.
English: Thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), granulocytopenia (low levels of granulocytes, a type of white blood cell), conjunctivitis (inflammation of the membrane that lines the eyelid), corneal opacity (clouding of the cornea, the transparent layer in front of the pupil), keratitis (inflammation of the cornea), photophobia (increased sensitivity of the eyes to light) and eye pain are also common (seen in between 1 and 10 patients in 100).
Croatian: Trombocitopenija (mali broj trombocita u krvi), leukopenija (mali broj bijelih krvnih stanica), granulocitopenija (mali broj granulocita, tipa bijelih krvnih stanica), konjuktivitis (upala membrane očnih kapaka), zamućenje rožnice (zamućenost rožnice, prozirnog sloja ispred šarenice), keratitis (upala mrežnice), fotofobija (povećana osjetljivost oka na svjetlo) i bol oka su također česte nuspojave (uočene u 1 do 10 bolesnika na 100).
English: The sooner treatment is started, the better the chances of survival.
Croatian: Što se prije terapija započne, to su bolju izgledi za preživljenje.
English: Orfadin is intended for long-term use.
Croatian: Orfadin je namijenjen za dugoročnu primjenu.
English: Treatment should be started as early as possible and the dose of Orfadin adjusted according to the patient's response and body weight.
Croatian: Terapiju treba započeti što je ranije moguće, a dozu lijeka Orfadin treba prilagoditi u skladu s odgovorom bolesnika i tjelesnom težinom.
English: The main benefit of Orfadin is to greatly extend life expectancy.
Croatian: Glavna korist lijeka Orfadin jest da uvelike produljuje očekivani životni vijek.
English: What measures are being taken to ensure the safe and effective use of Orfadin?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Orfadin?
English: The oral suspension is for children who have difficulty swallowing capsules.
Croatian: Oralna suspenzija je predviđena za primjenu u djece koja imaju poteškoće s gutanjem kapsula.
English: This is a rare disease in which the body is unable to completely break down the amino acid tyrosine, and harmful substances are formed, causing serious liver problems and liver cancer.
Croatian: Ovo je rijetka bolest uslijed koje tijelo ne može u potpunosti razgraditi amino kiselinu tirozin, te se stvaraju štetne tvari, što uzrokuje ozbiljno oštećenje jetre i rak jetre.
English: Treatment with Orfadin leads to high levels of tyrosine in the blood (due to the medicine's mode of action); this side effect is seen in more than 1 patient in 10.
Croatian: Terapija lijekom Orfadin rezultira visokim koncentracijama tirozina u krvi (uslijed načina djelovanja lijeka); ova nuspojava je uočena u više od 1 na 10 bolesnika.
English: Because the number of patients with HT-1 is low, the disease is considered ‘rare', and Orfadin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 December 2000.
Croatian: Budući da je broj bolesnika s HT-1 mali, dotična se bolest smatra „rijetkom” te se Orfadin označava kao lijek za liječenje rijetkih bolesti od dana 29. prosinca 2000.
English: Orfadin is used to treat hereditary tyrosinaemia type 1 (HT-1).
Croatian: Orfadin se koristi za liječenje nasljedne tirozinemije tipa 1 (HT-1).
English: Patients with HT-1 lack one of these enzymes, so tyrosine is not properly eliminated but is transformed into harmful substances.
Croatian: Bolesnicima s HT-1 nedostaje jedan od ovih enzima, tako da se tirozin ne izbacuje ispravno iz njihovog tijela, već se transformira u štetne tvari.
English: A risk management plan has been developed to ensure that Orfadin is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Orfadin.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Orfadin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Orfadin dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
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 Orfadin.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Orfadin.
English: The CHMP noted that Orfadin seems to be an effective treatment for HT-1, particularly if it is started early, before the patient's liver is too damaged.
Croatian: CHMP je zaključio da se lijek Orfadin čini djelotvornim za liječenje HT-1, a posebice ako se terapija započne u ranoj fazi prije oštećenja jetre bolesnika.
English: Orfadin also provides a better outcome for patients than that reported in the literature in patients eating a modified diet alone.
Croatian: Orfadin također rezultira boljim ishodima za bolesnika u odnosu na one prijavljene u literaturi u slučaju bolesnika koji su jeli samo prilagođenu prehranu.
English: However, as tyrosine remains in the body during Orfadin treatment, patients need to eat a special diet low in tyrosine.
Croatian: No, budući da tirozin ostaje u tijelu tijekom terapije Orfadinom, bolesnici trebaju primjenjivati posebnu prehranu koja je siromašna tirozinom.
English: This is a summary of the European public assessment report (EPAR) for Orfadin.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Orfadin.
English: What is the risk associated with Orfadin?
Croatian: Koji su rizici povezani s lijekom Orfadin?
English: The study looked at the effect of Orfadin on survival, and compared this with reports published in medical journals describing survival in patients with HT-1 who were only receiving a modified diet.
Croatian: Ovo je ispitivanje istražilo djelovanje lijeka Orfadin na preživljenje i usporedilo je to s izvještajima objavljenima u medicinskim časopisima koji opisuju preživljenje u bolesnika s HT-1 koji su primali samo prilagođenu prehranu.
English: The full EPAR for Orfadin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Orfadin nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Many of these side effects can be the result of high tyrosine levels caused by patients not eating the right foods.
Croatian: Mnoge od navedenih nuspojava mogu rezultirati visokim koncentracijama tirozina što može biti rezultat nepravilne prehrane bolesnika.
English: The diet also needs to be low in phenylalanine, as this is converted into tyrosine in the body.
Croatian: Prehrana također treba biti siromašna fenilalaninom, budući da se isti pretvara u tirozin u tijelu.
English: Treatment with Orfadin should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
Croatian: Liječenje lijekom Orfadin mora započeti i nadzirati liječnik iskusan u liječenju bolesnika s HT-1.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Orfadin, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Orfadin nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For more information about treatment with Orfadin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Mekinist pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: Therefore, the CHMP decided that Orfadin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Orfadin nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Orfadin is a medicine that contains the active substance nitisinone.
Croatian: Orfadin je lijek koji sadrži djelatnu tvar nitizinon.
English: Why has Orfadin been approved?
Croatian: Zašto je lijek Orfadin odobren?
English: Orfadin is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Croatian: Orfadin se koristi zajedno s prehranom koja ograničava unos amino kiselina naziva tirozin i fenilalanin.
English: What benefit has Orfadin shown during the studies?
Croatian: Koje su koristi lijeka Orfadin dokazane u ispitivanjima?
English: The active substance in Orfadin, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Croatian: Djelatna tvar lijeka Orfadin, nitizinon, inhibira enzim koji pretvara tirozin u štetne tvari.
English: What is Orfadin?
Croatian: Što je Orfadin?
English: Tyrosine is broken down in the body by a number of enzymes.
Croatian: Niz enzima razgrađuju tirozin u tijelu.
English: For the full list of all side effects and restrictions with Orfadin, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Orfadin potražite u uputi o lijeku.
English: What is Orfadin used for?
Croatian: Za što se Orfadin koristi?
English: How does Orfadin work?
Croatian: Kako djeluje Orfadin?
English: How is Orfadin used?
Croatian: Kako se Orfadin koristi?
English: How has Orfadin been studied?
Croatian: Kako je Orfadin ispitivan?
English: Date of first authorisation: 12/09/2013.
Croatian: Datum prvog odobrenja: 12/09/2013.
English: ATC vet code: QD11AH90.
Croatian: ATCvet kod: QD11AH90.
English: Date of last renewal: 26/07/2018.
Croatian: Datum posljednjeg produljenja: 26/07/2018.
English: These tablets can be administered with or without food.
Croatian: Ove tablete se mogu primijeniti sa ili bez hrane.
English: Wash hands after administration.
Croatian: Operite ruke nakon primjene.
English: The tablets can be divided into equal halves.
Croatian: Tablete se mogu razdijeliti u jednake polovine.
English: Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALY
Croatian: Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALIJA
English: Neither of these clinical pathology changes appeared clinically significant.
Croatian: Niti jedna od ovih kliničkih patoloških promjena nema klinički značaj.
English: Anaemia and lymphoma have been reported very rarely in spontaneous reports.
Croatian: Anemija i limfom zabilježeni su vrlo rijetko u spontanim izvješćima.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 (E1521)
Croatian: Laktoza monohidrat Hipromeloza (E464) Titanijev dioksid (E171) Makrogol 400 (E1521)
English: The absolute bioavailability of oclacitinib maleate was 89%.
Croatian: Apsolutna bioraspoloživost oklacitinib maleata je bila 89%.
English: One major oxidative metabolite was identified in plasma and urine.
Croatian: Jedan od glavnih oksidativnih metabolita je identificiran u plazmi i u mokraći.
English: Dogs receiving Apoquel tablets should therefore be monitored for the development of infections and neoplasia.
Croatian: Pse koji primaju Apoquel tablete treba promatrati zbog razvoja infekcija i neoplazija.
English: Do not use in dogs less than 12 months of age or less than 3 kg bodyweight.
Croatian: Ne primjenjivati kod pasa mlađih od 12 mjeseci ili lakših od 3 kg.
English: It can inhibit the function of a variety of cytokines dependent on JAK enzyme activity.
Croatian: Može inhibirati funkciju raznih citokina ovisno o aktivnosti JAK enzima.
English: Oclacitinib is a Janus kinase (JAK) inhibitor.
Croatian: Oklacitinib je inhibitor Janus kinaze (JAK).
English: Regarding susceptibility to infection and neoplastic conditions, see section 4.5.
Croatian: Informacije vezane uz podložnost prema infekcijama i neoplastičnim stanjima vidi u odjeljku 4.5.
English: Therefore, the risk of metabolic drug-drug interactions due to oclacitinib inhibition is very low.
Croatian: Zbog toga je rizik metaboličke interakcije lijeka sa lijekom radi inhibicije oklacitiniba vrlo nizak.
English: For oclacitinib, the target cytokines are those that are proinflammatory or have a role in allergic responses/pruritis.
Croatian: Za oclacitinib, ciljni citokini su oni koji su proinflamatorni ili imaju ulogu u alergijskoj reakciji/pruritusu.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation, or in breeding male dogs, therefore its use is not recommended during pregnancy, lactation or in dogs intended for breeding.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije, ili kod muških rasplodnih pasa, stoga nije preporučena primjena za vrijeme graviditeta i laktacije, ili kod muških rasplodnih pasa.
English: There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically.
Croatian: Ne postoji specifični antidot u slučajevima predoziranja, pse treba liječiti simptomatski.
English: However, oclacitinib may also exert effects on other cytokines (for example, those involved in host defence or haematopoiesis) with the potential for unwanted effects.
Croatian: Međutim, oklacitinib može proširiti učinke na druge citokine (npr. onih vezanih za obranu domaćina ili hematopoezu) uz potencijalnu mogućnost neželjenih učinaka.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the blister or bottle after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na blisteru ili bočici poslije EXP.