FrancophonIA/ELRC3.0 huggingface dataset:
English: Yescarta is prepared using the patient's own white blood cells which are extracted from the blood and genetically modified in the laboratory.
Croatian: Yescarta se priprema upotrebom bijelih krvnih stanica samog bolesnika koje su dobivene iz krvi i genetski modificirane u laboratoriju.
English: As for all medicines, data on the use of Yescarta are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Yescarta kontinuirano se prate.
English: For more information about using Yescarta, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Yescarta pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: An overview of Yescarta and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Yescarta i zašto je odobren u EU-u
English: When Yescarta is given to the patient, the modified T cells attach to and kill cancer cells, thereby helping to clear the cancer from the body.
Croatian: Kada bolesnik primi lijek Yescarta, modificirane T-stanice povezuju se sa stanicama raka i uništavaju ih te na taj način pomažu pri uklanjanju raka iz tijela.
English: A main study showed that Yescarta is effective at clearing the cancer in many patients with DLBCL and PMBCL that was not responding to previous treatment or had returned.
Croatian: Glavno je istraživanje pokazalo da je lijek Yescarta djelotvoran u uklanjanju raka u mnogih bolesnika s DLBCL-om i PMBCL-om kod kojih bolest nije reagirala na terapiju ili se vratila.
English: A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).
Croatian: Lijek naziva tocilizumab i oprema za hitne slučajeve moraju biti dostupni u slučaju da bolesnik razvije potencijalno ozbiljnu nuspojavu koja se zove sindrom otpuštanja citokina (vidjeti odjeljak o rizicima u nastavku).
English: How is Yescarta used?
Croatian: Kako se Yescarta koristi?
English: Yescarta contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR).
Croatian: Yescarta sadržava bolesnikove T-stanice (vrsta bijele krvne stanice) koje su genetski modificirane u laboratoriju kako bi proizvele bjelančevinu naziva kimerični antigenski receptor (CAR).
English: CAR can attach to another protein on the surface of cancer cells called CD19.
Croatian: Bjelančevina CAR može se povezati s drugom bjelančevinom na površini stanica raka naziva CD19.
English: It is given as a single infusion (drip) into a vein and must only be given to the patient whose cells were used to make it. Before having Yescarta, the patient should have a short course of chemotherapy to clear away their existing white blood cells, and just before the infusion they are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.
Croatian: Prije uzimanja lijeka Yescarta bolesnik mora primiti kratku kemoterapiju kako bi se uklonile postojeće bijele krvne stanice, a netom prije infuzije daju mu se paracetamol i antihistaminik kako bi se smanjio rizik od reakcija na infuziju.
English: How does Yescarta work?
Croatian: Kako djeluje Yescarta?
English: What benefits of Yescarta have been shown in studies?
Croatian: Koje su koristi od lijeka Yescarta utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions with Yescarta, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Yescarta potražite u uputi o lijeku.
English: Name
Croatian: Doza
English: Two other studies have shown similar results.
Croatian: Druga dva ispitivanja pokazala su slične rezultate.
English: Do not increase or decrease the amount of medicine without your doctor's approval.
Croatian: Nemojte povećavati ili smanjivati količinu lijeka bez odobrenja Vašeg liječnika.
English: Different organs are affected at different ages.
Croatian: Različiti su organi zahvaćeni u različitoj dobi.
English: You should check with your doctor if you are not sure.
Croatian: Provjerite s Vašim liječnikom ukoliko niste sigurni.
English: Interactions with other medicines have not been studied.
Croatian: Interakcije s drugim lijekovima nisu bile proučavane.
English: Patients on dialysis or post-transplantation:
Croatian: Bolesnici na dijalizi ili nakon transplantacije:
English: If a dose of medicine is missed, it should be taken as soon as possible.
Croatian: Ako ste propustili dozu lijeka, trebate ju uzeti što je prije moguće.
English: It is important to take or give these supplements exactly as instructed.
Croatian: Važno je da uzimate ili dajete ove nadomjestke točno prema uputama.
English: Do not use after the expiry date which is stated on the label.
Croatian: Nemojte upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici.
English: Do not add to acidic drinks e.g. orange juice.
Croatian: Nemojte stavljati u kisela pića, npr. sok od naranče.
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Croatian: Molimo obavijestite svog liječnika ili ljekarnika ukoliko uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Starting doses should be 1/4 to 1/6 of the expected maintenance dose, increased gradually over 46 weeks to avoid intolerance.
Croatian: Početna doza treba biti 1/4 do 1/6 očekivane doze održavanja te je treba postupno povećavati kroz 46 tjedana kako bi se izbjegla intolerancija.
English: black ink on hard capsules containing E172
Croatian: crna tinta na tvrdim kapsulama koja sadrži E172
English: In order for CYSTAGON to work correctly, you must do the following: - Follow your doctor's directions exactly.
Croatian: Da bi CYSTAGON pravilno djelovao, morate slijediti sljedeće upute: - Točno slijedite upute Vašeg liječnika.
English: CYSTAGON should be taken 4 times a day, every 6 hours, preferably just after or with food.
Croatian: CYSTAGON treba uzimati 4 puta dnevno, svakih 6 sati, po mogućnosti neposredno nakon ili uz obroke.
English: No interaction studies have been performed
Croatian: Nisu provedene studije interakcija.
English: However if it is within two hours of the next dose, skip the missed dose and go back to the regular dosing schedule.
Croatian: Međutim ukoliko je približno dva sata do sljedeće doze, preskočite propuštenu dozu te se vratite svom uobičajenom režimu doziranja.
English: Very common: Anorexia
Croatian: Vrlo često: Anoreksija
English: However, growth velocity did not increase enough to allow patients to catch up the normal for their age.
Croatian: Međutim, brzina rasta nije se dovoljno ubrzala da bi dozvolila bolesnicima da sustignu normalne vrijednosti za svoju dob.
English: WHAT CYSTAGON IS AND WHAT IT IS USED FOR
Croatian: ŠTO JE CYSTAGON I ZA ŠTO SE KORISTI
English: You should not use CYSTAGON if you are pregnant.
Croatian: Ne smijete koristiti CYSTAGON ako ste trudni.
English: Experience suggests that foods such as milk, potatoes and other starch based products seem to be appropriate for mixing with the powder.
Croatian: Iskustvo sugerira da je hrana poput mlijeka, krumpira i drugih proizvoda bogatih škrobom čini se prikladna za miješanje s prahom lijeka.
English: Consult the doctor for complete directions.
Croatian: Posavjetujte se sa svojim liječnikom radi detaljnih uputa.
English: Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, uključujući teratogenost (vidjeti dio 5.3).
English: EXP {month/year}
Croatian: Rok valjanosti {mjesec/godina}
English: Using other medicines
Croatian: Primjena drugih lijekova
English: - If you are pregnant, this is particularly relevant during the first trimester - if you are breast-feeding.
Croatian: - ako ste trudni, ovo je osobito važno tijekom prvog tromjesečja - ako dojite.
English: The dose of CYSTAGON prescribed for you or your child will depend on your or your child's age and weight.
Croatian: Doza lijeka CYSTAGON propisana Vama ili Vašem djetetu ovisit će o dobi i tjelesnoj težini Vas ili Vašeg djeteta.
English: Since some of these side effects are serious, ask your or your child's doctor to explain their warning signs.
Croatian: Kako su neke od ovih nuspojava ozbiljnije, potražite svog liječnika ili liječnika Vašeg djeteta da Vam objasni znakove upozorenja.
English: However, acidic drinks, e.g. orange juice, should generally be avoided as the powder tends not to mix well and may precipitate out.
Croatian: Međutim, kisela pića, npr. sok od naranče, treba općenito izbjegavati jer se prah s njima ne pomiješa dobro već može ostati u talogu.
English: - Your or your child's medical treatment may include, in addition to CYSTAGON, one or more supplements to replace important electrolytes lost through the kidneys.
Croatian: - Liječenje Vas ili Vašeg djeteta može uključivati, uz CYSTAGON, jedan ili više nadomjestaka koji zamjenjuju važne elektrolite izgubljene bubrezima.
English: Your doctor could require a regular physical and X-ray examination for the skin and the bones to control the effects of the medicinal product.
Croatian: Vaš liječnik može zahtijevati redoviti fizikalni i rendgenski pregled kože i kostiju radi kontrole učinaka ovog lijeka.
English: Approximately 35% of patients can be expected to experience adverse reactions.
Croatian: Očekuje se da oko 35% bolesnika razvije nuspojave.
English: Patients on treatment maintained growth as compared to untreated patients.
Croatian: Liječeni bolesnici održali su rast usporediv s neliječenim bolesnicima.
English: The consequence of this for the clinical use of the drug is unknown.
Croatian: Posljedice ovoga, za kliničku upotrebu lijeka nisu poznate.
English: Intact CYSTAGON hard capsules should not be administered to children under the age of approximately 6 years due to risk of aspiration (see section 4.2).
Croatian: Neotvorene CYSTAGON tvrde kapsule ne treba davati djeci mlađoj od 6 godina zbog rizika aspiracije (vidjeti dio 4.2).
English: When these effects appear at the initiation of cysteamine therapy, temporary suspension and gradual reintroduction of treatment may be effective in improving tolerance.
Croatian: Kada se ove nuspojave pojave na početku terapije cisteaminom, privremena obustava i postupno ponovno uvođenje terapije može pomoći u poboljšanju tolerancije.
English: Make sure you know how you or your child reacts to this medicine before doing anything that could be dangerous if not alert.
Croatian: Provjerite kako Vi ili Vaše dijete reagirate na ovaj lijek prije nego što učinite bilo što, što bi moglo biti opasno ako Vam je smanjena pozornost.
English: Regular blood and urine tests to measure the levels of the body's important electrolytes are also necessary to help your or your child's doctor correctly adjust the doses of these supplements.
Croatian: Redovite pretrage krvi i mokraće radi mjerenja razine elektrolita važnih za tijelo također su nužne da bi pomogle Vašem liječniku ili liječniku Vašeg djeteta da prilagodi doze ovih nadomjestaka.
English: If any skin or bone abnormalities appear, please inform your doctor immediately.
Croatian: Ukoliko se pojave bilo kakve abnormalnosti kože ili kostiju, molimo Vas da odmah obavijestite svojeg liječnika.
English: The principal efficacy measurements were serum creatinine and calculated creatinine clearance and growth (height).
Croatian: Osnovne mjere djelotvornosti bile su kreatinin u serumu te izračunat klirens kreatinina i rast (visina).
English: The WBC levels should be measured 5 to 6 hours after dosing and should be checked frequently when initiating therapy (e.g. monthly) and every 3-4 months when on a stable dose.
Croatian: Razinu u leukocitima treba mjeriti 5 do 6 sati nakon uzimanja doze te ju treba pri uvođenju terapije često provjeravati (npr. svaki mjesec), a kada se postigne stabilna doza, treba provjeravati svaka 3-4 mjeseca.
English: The recommended dose is 1.30 g/m 2/day of the free base divided four times daily.
Croatian: Preporučena doza je 1,30 g/m2/dan slobodne baze podijeljene u četiri puta na dan.
English: Read all of this leaflet carefully before you start using this medicine.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati lijek.
English: Among cysteamine patients, glomerular function was maintained over time.
Croatian: Među bolesnicima koji su primali cisteamin, glomerularna funkcija je održana tijekom vremena.
English: Self examination of your or your child's skin is recommended.
Croatian: Preporuča se samopregled Vaše kože ili kože Vašeg djeteta.
English: Patients with hepatic insufficiency: Dose adjustment is not normally required; however, leucocyte cystine levels should be monitored.
Croatian: Bolesnici sa insuficijencijom jetre: Prilagodba doze obično nije potrebna; međutim, treba pratiti razinu cistina u leukocitima.
English: Date of latest renewal: 23 June 2007.
Croatian: Datum posljednje obnove: 23. lipanj 2007.
English: Do not use CYSTAGON - if you -or your child- are allergic (hypersensitive) to cysteamine bitartrate or penicillamine or any of the other ingredients of Cystagon.
Croatian: Nemojte primjenjivati CYSTAGON - ako ste Vi ili Vaše dijete alergični (preosjetljivi) na cisteaminditartrat ili penicilamin ili bilo koji drugi sastojak lijeka Cystagon.
English: It is important to take the dose as close to every 6 hours as possible.
Croatian: Važno je uzimati doze u razmacima od približno svakih 6 sati.
English: These mainly involve the gastrointestinal and central nervous systems.
Croatian: One uglavnom uključuju probavni i središnji živčani sustav.
English: - To avoid any risk of aspiration in the lungs, the capsules should not be given to children under the age of approximately 6 years.
Croatian: - Da bi se izbjegao rizik slučajnog udisanja u pluća, kapsule se ne smiju davati djeci mlađoj od približno 6 godina.
English: Like all medicines, CYSTAGON can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, CYSTAGON može uzrokovati nuspojave, iako se one neće pojaviti kod svih osoba.
English: In a pharmacokinetic study performed in 24 healthy volunteers for 24 hours, the mean estimate ( sd) for the terminal half-life of elimination was 4.8 ( 1.8) hours.
Croatian: U farmakokinetičkom ispitivanju provedenom na 24 zdrava dobrovoljca kroz 24 sata, procijenjena srednja vrijednost ( sd) poluvremena eliminacije bila je 4,8 ( 1,8) sati.
English: If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient must be advised of the possible teratogenic risk of cysteamine.
Croatian: Ukoliko se dijagnosticira trudnoća ili se ona planira, treba pažljivo razmotriti potrebu za liječenjem, a bolesnicu upoznati s mogućim teratogenim rizikom cisteamina.
English: A desiccant unit containing black activated carbon and silica gel granules is included in the bottle.
Croatian: Sredstvo za sušenje koje sadrži crni aktivni ugljen i granule silikagela umetnuto je u bočicu.
English: Uncommon: Nervousness, hallucination
Croatian: Manje često: Nervoza, halucinacija
English: In all studies, patient response was better when treatment was started at an early age with good renal function.
Croatian: U svim ispitivanjima, odgovor bolesnika bio je bolji kada se liječenje započelo u ranoj dobi uz dobru funkciju bubrega.
English: CYSTAGON may cause some people to become drowsy or less vigilant than they are normally.
Croatian: CYSTAGON može kod nekih ljudi dovesti do pospanosti ili slabije pažnje nego što je za njih normalno.
English: Self-examination of the skin by the patient or the parents should also be advised.
Croatian: Također treba bolesnicima ili roditeljima savjetovati samopregled kože.
English: Always use CYSTAGON exactly as your doctor or your child's doctor has told you.
Croatian: Uvijek primjenite CYSTAGON točno onako kako Vam je rekao Vaš liječnik ili liječnik Vašeg djeteta.
English: If several doses of the supplements are missed or weakness or drowsiness develops, call the doctor for instructions.
Croatian: Ukoliko propustite nekoliko doza ovih nadomjestaka ili dođe do slabosti i umora, nazovite svog liječnika radi uputa.
English: CYSTAGON is a medicine that reacts with cystine to decrease its level within the cells.
Croatian: CYSTAGON je lijek koji reagira s cistinom da bi smanjio njegovu razinu unutar stanica.
English: The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients).
Croatian: Sljedeće nuspojave zabilježene su kako slijedi: vrlo često (pojavljuju se kod najmanje 1 na 10 bolesnika), često (pojavljuju se kod najmanje 1 na 100 bolesnika), manje često (pojavljuju se kod najmanje 1 na 1000 bolesnika), rijetko (pojavljuju se kod najmanje 1 na 10 000 bolesnika), vrlo rijetko (pojavljuju se kod najmanje 1 na 100 000 bolesnika).
English: No carcinogenic studies have been conducted with CYSTAGON.
Croatian: Nisu provedena ispitivanja kancerogenosti sa CYSTAGONOM.
English: Date of first authorisation: 23 June 1997.
Croatian: Datum prvog odobrenja: 23. lipanj 1997.
English: CYSTAGON is prescribed to manage this rare inherited disorder.
Croatian: CYSTAGON se propisuje za liječenje ovog rijetkog nasljednog poremećaja.
English: Do not store above 25°C and keep the container tightly closed in order to protect from light and moisture.
Croatian: Nemojte čuvati na temperaturi iznad 25°C te spremnik čuvajte čvrsto zatvoren radi zaštite od svjetlosti i vlage.
English: When starting therapy, patients should not engage in potentially hazardous activities until the effects of the medicinal product on each individual are known.
Croatian: Pri započinjanju terapije, bolesnici se ne smiju upuštati u potencijalno opasne aktivnosti sve dok se ne vidi učinak ovog lijeka na svakog pojedinca.
English: - Hard capsules should not be given to children under approximately six years of age because they may not be able to swallow them and they may choke.
Croatian: - Tvrde kapsule ne smiju se davati djeci mlađoj od šest godina jer ih ona možda neće biti sposobna progutati te se mogu ugušiti.
English: In contrast to phosphocysteamine, CYSTAGON does not contain phosphate.
Croatian: Za razliku od fosfocisteamina, CYSTAGON ne sadrži fosfat.
English: The elimination of unchanged cysteamine in the urine has been shown to range between 0.3 % and 1.7% of the total daily dose in four patients; the bulk of cysteamine is excreted as sulphate.
Croatian: Pokazalo se da je eliminacija nepromijenjenog cisteamina urinom u rasponu od 0,3 % i 1,7% ukupne dnevne doze kod četiri bolesnika; većina cisteamina se izlučuje u obliku sulfata.
English: Therefore, CYSTAGON should not be used during pregnancy, particularly during the first trimester, unless clearly necessary.
Croatian: Stoga, se CYSTAGON ne smije primjenjivati tijekom trudnoće, osobito u prvom tromjesečju, ukoliko nije neophodno.
English: When starting therapy, you or your child should not engage in potentially hazardous activities until the effects of the drug are well known.
Croatian: Prilikom započinjanja terapije, Vi i Vaše dijete ne biste se trebali upuštati u potencijalno opasne aktivnosti sve dok nisu dobro poznati učinci lijeka.
English: Frequencies are defined as: very common (≥ 1/10), common (≥1/100 to 1/10) and uncommon (≥1/1,000 to 1/100).
Croatian: Učestalost je definirana prema sljedećim kategorijama: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10) te manje često (≥ 1/1000 i < 1/100).
English: Should overdosage occur, the respiratory and cardiovascular systems should be supported appropriately.
Croatian: Ukoliko dođe do predoziranja, treba dati suportivnu terapiju dišnog i kardiovaskularnog sustava.
English: Placebo treated patients, in contrast, experienced a gradual rise in serum creatinine.
Croatian: Suprotno toga, bolesnici koji su primali placebo doživjeli su postupni porast kreatinina u serumu.
English: Using CYSTAGON with food and drink
Croatian: Uzimanje hrane i pića s CYSTAGONom
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriouness
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Your or your child's doctor will arrange for the blood tests to be done.
Croatian: Vaš liječnik ili liječnik Vašeg djeteta organizirat će ove pretrage.
English: CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi syndrome as well as vitamin D and thyroid hormones.
Croatian: CYSTAGON se može primjenjivati zajedno s nadomjescima za elektrolite i minerale koji su potrebni za liječenje Fanconijevog sindroma kao i s vitaminom D i hormonima štitnjače.
English: Pharmacotherapeutic group: Alimentary tract and metabolism product, ATC code: A16AA04.
Croatian: Farmakoterapijska skupina: Lijekovi za probavni sustav i metabolizam, ATK oznaka: A16AA04.
English: Renal tubular function was not affected by treatment.
Croatian: Liječenje nije utjecalo na renalnu tubularnu funkciju.
English: Cystinosis is a metabolic disease called ‘nephropathic cystinosis' which is characterized by an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscle, pancreas, and brain.
Croatian: Cistinoza je metabolička bolest zvana 'nefropatska cistinoza' koju karakterizira abnormalno nakupljanje aminokiseline cistina u raznim tjelesnim organima poput bubrega, oka, mišića, gušterače i mozga.
English: Take special care with CYSTAGON - When your or your child's disorder has been confirmed by leucocyte cystine measurements, the therapy with CYSTAGON must be started as soon as possible.
Croatian: Budite posebno oprezni s CYSTAGONom - Kada je mjerenjem cistina u leukocitima kod Vas ili Vašeg djeteta potvrđen poremećaj, liječenje Cystagonom mora se započeti što je ranije moguće.
English: For children under approximately six years of age, the hard capsule may be opened and the contents sprinkled on food (e.g. milk, potatoes or starch based foods) or mixed in formula.
Croatian: Za djecu mlađu od šest godina starosti, tvrda se kapsula može otvoriti i sadržaj posuti po hrani (npr. mlijeku, krumpirima ili namirnicama na bazi škroba) ili pomiješati u formulu.
English: CYSTAGON is contraindicated in patients who have developed hypersensitivity to penicillamine.
Croatian: CYSTAGON je kontraindiciran kod bolesnika koji su razvili preosjetljivost na penicilamin.
English: Therefore, where cysteamine ophthalmic solution is used for that purpose, its usage should continue.
Croatian: Stoga, kada se za tu svrhu koristi oftalmološka otopina, njenu upotrebu treba nastaviti.
English: One patient subsequently died of acute cerebral ischemia with marked vasculopathy.
Croatian: Jedan je bolesnik posljedično umro od akutne cerebralne ishemije s izraženom vaskulopatijom.
English: Cysteamine mechanism of action by interfering with the cross-linking of collagen fibers has been postulated (see section 4.4).
Croatian: Pretpostavlja se da je mehanizam djelovanja cisteamina ometanje križnog povezivanja kolagenskih vlakana (vidjeti dio 4.4).
English: The mixed disulfide is then exported from the lysosomes by an intact lysine transport system.
Croatian: Miješani disulfid se zatim prenosi iz lizosoma putem neoštećenog transportnog sustava za lizin.
English: No information is available for patients with severe renal insufficiency.
Croatian: Nisu dostupni podaci za bolesnike s teškom insuficijencijom bubrega.
English: The maximum dose of CYSTAGON used in clinical trials was 1.95 g/m2/day.
Croatian: Maksimalna doza CYSTAGONA korištena u kliničkim ispitivanjima bila je 1,95 g/m2/dan.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Croatian: Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove (EMA) http://www.ema.europa.eu.