FrancophonIA/ELRC3.0 huggingface dataset:
English: Protection lasts for one year for both serotype 1 and 8.
Croatian: Zaštita za oba serotipa traje jednu godinu.
English: How does Zulvac BTV work?
Croatian: Kako djeluje Zulvac BTV?
English: Laboratory studies were conducted with the individual serotypes 1 and 8 in cattle which showed that protection starts 15 days after completion on the initial vaccination course of two injections for serotype 1 and 25 days after completion of the initial vaccination course for serotype 8.
Croatian: Laboratorijskim ispitivanjima provedenima na pojedinačnim serotipovima 1, 4 i 8 u goveda pokazalo se da se zaštita od bolesti stvara 15 dana nakon završetka početne terapije dvjema injekcijama za serotip 1 te 25 dana nakon završetka početne terapije injekcijama za serotip 8.
English: What benefits of Zulvac BTV have been shown in studies?
Croatian: Koje su koristi od VMP-a Zulvac BTV utvrđene u ispitivanjima?
English: Target species
Croatian: Ciljana vrsta životinja
English: Children and Adult
Croatian: Djeca i odrasli
English: There is no evidence of development of tolerance.
Croatian: Nema dokaza razvoja tolerancije.
English: You will therefore need regular blood tests to determine the correct daily dose.
Croatian: Trebati ćete stoga redovite pretrage krvi da se odredi ispravna dnevna doza.
English: An updated RMP should be submitted:
Croatian: Nadopunjen RMP treba dostaviti :
English: Do not take a double dose to make up for forgotten doses.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Your doctor may adapt the dose depending on your laboratory values.
Croatian: Vaš liječnik može prilagoditi dozu ovisno o Vašim laboratorijskim vrijednostima.
English: However, Cystadane should not be used during pregnancy unless clearly necessary.
Croatian: Ipak, Cystadane ne treba primjenjivati tijekom trudnoće, osim ukoliko nije neophodno.
English: After the first opening of the bottle, the medicine should be used within 3 months.
Croatian: Nakon prvog otvaranja boce, lijek treba upotrijebiti unutar 3 mjeseca.
English: Your doctor will decide if you can use this medicine during pregnancy and breast-feeding.
Croatian: Liječnik će odlučiti možete li ovaj lijek koristiti tijekom trudnoće i dojenja.
English: Do not stop the treatment without consulting your doctor.
Croatian: Nemojte prestati s liječenjm bez savjetovanja sa svojim liječnikom.
English: There are also links to other websites about rare diseases and treatments.
Croatian: Tamo se također nalaze poveznice na druge internetske stranice o rijetkim bolestima i liječenju istih.
English: To measure the dose:
Croatian: Da bi se izmjerila doza:
English: If you forget to take a dose take it as soon as you remember it and continue the next dose as planned.
Croatian: Ako zaboravite uzeti dozu, uzmite ju čim se sjetite i nastavite sa sljedećom dozom prema uobičajenom rasporedu.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće javiti u svakoga.
English: What Cystadane is and what it is used for
Croatian: Što je Cystadane i za što se koristi
English: • 5,10-methylene-tetrahydrofolate reductase (MTHFR),
Croatian: • 5,10-metilen-tetrahidrofolat reduktazi (MTHFR),
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), very rare (< 1/10,000).
Croatian: Učestalosti su prikazane kao vrlo česta (≥ 1/10), česta (≥ 1/100 i < 1/10), manje česta (≥ 1/1000 i < 1/100), rijetka (≥ 1/10 000 i < 1/1000), vrlo rijetka (< 1/10 000).
English: Talk to your doctor or pharmacist before taking Cystadane.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Cystadane.
English: Other medicines and Cystadane
Croatian: Drugi lijekovi i Cystadane
English: A standard battery of genotoxicity test reveals no specific hazard for humans.
Croatian: Niz standardnih ispitivanja genotoksičnosti nije pokazao specifičan rizik za ljude.
English: Uncommon: agitation, irritability
Croatian: Manje često: agitacija, razdražljivost
English: Date of first authorisation: 15 February 2007 Date of latest renewal: 21 November 2016
Croatian: Datum posljednje obnove: 21. studeni 2016.
English: Methionine is present in regular food protein (e.g. meat, fish, milk, cheese, eggs).
Croatian: Metionin je prisutan u bjelančevinama hrane (npr. mesu, ribi, mlijeku, siru, jajima).
English: If methionine increases particularly above the first safety threshold of 700 µmol/L, patient should be monitored more frequently and compliance with diet should be checked.
Croatian: Ako se koncentracija metionina poveća osobito iznad prvog sigurnosnog praga od 700 µmol/l, bolesnika treba pratiti češće i provjeravati pridržavanje režima prehrane.
English: The aim of treatment is to keep plasma levels of total homocysteine below 15 µM or as low as possible.
Croatian: Cilj liječenja je održavati razinu ukupnog homocisteina u plazmi ispod 15 µM ili što je moguće nižu.
English: Betaine anhydrous was rapidly distributed into a relatively large volume (V/F = 1.3 l/kg).
Croatian: Bezvodni betain se brzo distirbuirao u relativno veliki volumen (V/F = 1,3 l/kg).
English: Oral powder.
Croatian: Oralni prašak.
English: For specific recommendations, see section 4.4.
Croatian: Za posebna upozorenja, vidjeti dio 4.4.
English: What Cystadane is and what it is used for What do you need to know before you take Cystadane How to take Cystadane
Croatian: Što je Cystadane i za što se koristi Što morate znati prije nego počnete uzimati Cystadane Kako uzimati Cystadane
English: Do not take Cystadane If you are allergic to betaine anhydrous.
Croatian: Nemojte uzimati Cystadane Ako ste alergični na bezvodni betain.
English: Adjunctive treatment of homocystinuria, involving deficiencies or defects in:
Croatian: Kao dodatak u liječenju homocistinurije, uključujući nedostatke ili poremećaje u:
English: It is recommended to measure plasma methionine level at start of treatment and about annually or biannually thereafter.
Croatian: Preporučuje se mjeriti razinu metionina u plazmi na početku liječenja i zatim otprilike jednom godišnje ili jednom u dvije godine.
English: In paediatric patients less than 10 years of age, the usual effective dose regimen is 100 mg/kg/day given in 2 doses daily; increasing the frequency above twice daily and/or the dose above 150 mg/kg/day does not improve the homocysteine-lowering effect.
Croatian: U pedijatrijskih bolesnika mlađih od 10 godina, uobičajeni učinkovit režim doziranja je 100 mg/kg/dan podijeljeno u dvije doze dnevno; doziranje češće od dva puta dnevno i/ili povećanje doze iznad 150 mg/kg/dan ne poboljšava učinak smanjnja homocisteina.
English: The available clinical data do not allow correlating posology and clinical efficacy.
Croatian: Dostupni klinički podaci ne dopuštaju korelaciju doziranja i kliničke djelotvornosti.
English: Uncommon: anorexia
Croatian: Manje često: anoreksija
English: After a repeated dose regimen of 100 mg/kg/day for 5 days, the absorption kinetics did not change.
Croatian: Nakon ponavljenog režima doziranja od 100 mg/kg/dan tijekom 5 dana, kinetika apsorpcije se nije promijenila.
English: In a few cases, increased plasma methionine levels were associated with cerebral oedema (see sections 4.4 and 4.8).
Croatian: U nekoliko je slučajeva povećana razina metionina u plazmi bila povezana s edemom mozga (vidjeti dijelove 4.4 i 4.8).
English: Complete recovery was seen after treatment discontinuation (see section 4.4).
Croatian: Nakon prekida liječenja došlo je do potpunog oporavka (vidjeti dio 4.4).
English: Very common: blood methionine increased*
Croatian: Vrlo često: povećana razina metionina u krvi*
English: After a repeated dose regiment of 100 mg/kg/day for 5 days, the distribution half life was prolonged significantly (up to 36 h), indicating saturable transport and redistribution processes.
Croatian: Nakon ponovljenog režima doziranja od 100 mg/kg/dan kroz 5 dana, poluvijek distribucije se značajno produžio (do 36 sati), što upućuje na zasićenje transportnih i redistribucijskih procesa.
English: The steady-state response usually occurs within a month.
Croatian: Stanje dinamičke ravnoteže se uobičajeno postiže unutar mjesec dana.
English: Unopened bottle: 3 years After the first opening: 3 months.
Croatian: Neotvorena boca: 3 godine Nakon prvog otvaranja: 3 mjeseca.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja lijeka nakon prvog otvaranja vidjeti u dijelu 6.3
English: The most commonly side effect when taking Cystadane which may affect more than 1 in 10 people (frequency very common) is elevated levels of methionine in the blood.
Croatian: Najčešća nuspojava tijekom uzimanja Cystadanea, koja se javlja u više od 1 na 10 osoba (učestalost je vrlo često), je povišena razina metionina u krvi.
English: In some patients doses above 200 mg/ kg/day were needed to reach therapeutic goals.
Croatian: Nekim su bolesnicima potrebne doze veće od 200 mg/kg na dan kako bi se postigli terapijski ciljevi.
English: It is converted into homocysteine which is then normally converted into cysteine during digestion.
Croatian: Metionin se pretvara u homocistein koji se zatim tijekom probave normalno pretvara u cistein.
English: 5 How to store Cystadane Contents of the pack and other information
Croatian: Kako čuvati Cystadane Sadržaj pakiranja i druge informacije
English: BOTTLE LABEL
Croatian: NALJEPNICA BOCE
English: • cystathionine beta-synthase (CBS),
Croatian: • cistationin beta sintazi (CBS),
English: What you need to know before you take Cystadane
Croatian: Što morate znati prije nego počnete uzimati Cystadane
English: Fertility No data is available.
Croatian: Plodnost Nema dostupnih podataka.
English: Each bottle contains 180 g of powder.
Croatian: Svaka boca sadržava 180 g praška.
English: Complete recovery was seen after treatment discontinuation: - The plasma methionine concentrations should be kept below 1000 µM.
Croatian: Nakon prekida liječenja uočen je potpuni oporavak: - Koncentracije metionina u plazmi treba održavati ispod 1000 µM.
English: The extent of this effect was dependent on the absolute degree of hyperhomocysteinemia, being higher in severe hyperhomocysteinemia.
Croatian: Opseg učinak je bio ovisan o apsolutnom stupnju hiperhomocisteinemije, a koji je veći teške hiperhomocisteinemije.
English: Hypersensitivity to the active substance.
Croatian: Preosjetljivost na djelatnu tvar.
English: • take the correct measuring spoon:
Croatian: • uzmite odgovarajuću mjernu žličicu:
English: • cobalamin cofactor metabolism (cbl).
Croatian: • metabolizmu kofaktora kobalamina (cbl).
English: Animal reproduction studies have not been conducted.
Croatian: Nisu provedena ispitivanja utjecaja na reprodukciju u životinja.
English: As a result, plasma levels of homocysteine should decrease in these patients, to 20-30 % of pre-treatment levels.
Croatian: Rezulatat je snižavanje razine homocisteina u plazmi u tih bolesnika na 20-30% vrijednosti prije liječenja.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC code: A16AA06.
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, ATK oznaka: A16AA06.
English: (age between 21 to 49 years), after a single oral dose of betaine anhydrous (50 mg/kg), absorption was rapid (tmax = 0.9 ± 0.3 hours and a Cmax = 0.9 ± 0.2 mM).
Croatian: U zdravih odraslih dobrovoljaca (dob od 21 do 49 godina), nakon jednokratne oralne doze bezvodnog betaina (50 mg/kg), apsorpcija je bila brza (tmax = 0,9 ± 0,3 sati i Cmax = 0,9 ± 0,2 mM).
English: Other uncommon side effects (may affect up to 1 in 100 people) may include decreased appetite (anorexia), agitation, irritability, hair loss, hives, skin odour abnormal, lack of control over passing urine (urinary incontinence).
Croatian: Druge manje česte nuspojave (mogu se javiti u do 1 na 100 ljudi) mogu uključivati smanjeni apetit (anoreksiju), uznemirenost, razdražljivost, ispadanje kose, koprivnjaču, promjenu mirisa kože, nemogućnost kontrole mokrenja (urinarnu inkontinenciju).
English: Your treatment with Cystadane may need to be interrupted.
Croatian: Možda će trebati prekinuti Vaše liječenje Cystadaneom.
English: Each carton contains one bottle and three measuring spoons.
Croatian: Svaka kutija sadržava jednu bocu i tri mjerne žličice.
English: The pharmacokinetic data of homocystinuric patients on long-term betaine anhydrous supplementation are very similar to those of healthy volunteers.
Croatian: Farmakokinetički podaci bolesnika s homocistinurijom koji dugotrajno primaju bezvodni betain kao dodatak, vrlo su slični podacima dobivenim na zdravim dobrovoljcima.
English: It is presented in bottles with child resistant closures.
Croatian: Dostupan je u bocama sa zatvaračem sigurnim za djecu.
English: If you are treated with Cystadane and with an amino-acid mixture and if you need to take other medicines at the same time, leave 30 minutes between the intake (see “section “Other medicines and Cystadane”).
Croatian: Ako se liječite Cystadaneom i mješavinom aminokiselina te istodobno trebate uzeti i druge lijekove, napravite pauzu od 30 minuta između primjene Cystadanea i drugih lijekova (pogledajte dio
English: In general, adverse reactions seen with betaine anhydrous therapy appeared to be not serious and are mainly related to the gastrointestinal system.
Croatian: Općenito, nuspojave koje se javljaju tijekom terapije bezvodnim betainom nisu ozbiljne i uglavnom su vezane za gastrointestinalni sustav.
English: 180 g of oral powder.
Croatian: 180 g oralnog praška.
English: In order to reduce methionine levels, modification of diet as well as dose reduction of Cystadane or temporal interruption of Cystadane treatment should be considered.
Croatian: Kako bi se smanjile razine metionina, treba razmotriti promjenu režima prehrane te smanjenje doze Cystadanea ili privremeni prekid liječenja Cystadaneom.
English: Methionine level can be related to swelling in the brain (cerebral swelling), which may affect up to 1 in 100 people (frequency uncommon).
Croatian: Razina metionina može biti povezana s oticanjem mozga (cerebralnim edemom), što se može javiti u do 1 na 100 ljudi (učestalost manje često).
English: Cystadane 1 g oral powder
Croatian: Cystadane 1 g oralni prašak
English: It is not known whether betaine anhydrous is excreted in human milk (although its metabolic precursor, choline, occurs at high levels in human milk).
Croatian: Nije poznato izlučuje li se bezvodni betain u majčino mlijeko (iako se njegov metabolički prekursor kolin pojavljuje u visokim koncentracijama u majčinom mlijeku).
English: Experience with betaine anhydrous therapy in patients with renal insufficiency or non-alcoholic hepatic steatosis has demonstrated no need to adapt the dose regimen of Cystadane.
Croatian: Iskustvo s terapijom bezvodnim betainom u bolesnika s bubrežnom insuficijencijom ili s nealkoholnom steatozom jetre nije pokazalo potrebu za prilagodbom režima doziranja Cystadanea.
English: Caution should be exercised with up-titrating doses for patients with CBS deficiency due to the risk for hypermethioninaemia.
Croatian: Treba biti oprezan pri titraciji na višu dozu u bolesnika s nedostatkom CBS-a zbog rizika od hipermetioninemije.
English: At high doses, a CNS depressant effect and irritation of the gastrointestinal tract was seen in rats.
Croatian: Pri visokim dozama, zabilježena je depresija središnjeg živčanog sustava i iritacija gastrointestinalnog trakta u štakora.
English: Monitoring betaine plasma concentrations does not help to define the efficacy of treatment, since these concentrations do not directly correspond to the flux through the cytosolic betaine homocysteine methyl transferase pathway.
Croatian: Djelotvornost liječenja ne može se utvrditi praćenjem koncentracije betaina u plazmi, budući da te koncentracije ne odgovaraju direktno prijelazu kroz metabolički put citosolne betain homocistein metil transferaze.
English: Methionine levels should be closely monitored in these patients.
Croatian: U tih bolesnika treba pomno pratiti razine metionina.
English: The recommended total daily dose is 100 mg/kg/day given in 2 doses daily.
Croatian: Preporučena ukupna dnevna doza je 100 mg/kg na dan koja se daje u dvije doze dnevno.
English: Driving and using machines Cystadane has no or negligible influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Cystadane ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In observational studies, clinical improvement (cardiovascular and neurodevelopmental) was reported by the treating physician in about 75% of patients taking betaine anhydrous.
Croatian: U opservacijskim ispitivanjima liječenici su zabilježili kliničko poboljšanje (na kardiovaskularni sustav i na razvoj živčanog sustava) u oko 75% bolesnika koji su uzimali bezvodni betain.
English: If you stop taking Cystadane
Croatian: Ako prestanete uzimati Cystadane
English: It is likely that due to the multiple nature of therapy (dietary, pharmaceutical, supportive) in these patients, there may be an element of overestimation in the clinical effects of betaine anhydrous treatment.
Croatian: Vjerojatno je da je kao posljedica višestruke terapije (prehranom, lijekovima i dodacima) u tih bolesnika moglo doći i do precijenjivanja kliničkog učinka bezvodnog betaina.
English: In most cases, adding betaine anhydrous resulted in a further reduction in plasma homocysteine level.
Croatian: U većini je slučajeva dodavanje bezvodnog betaina rezultiralo daljnjim smanjenjem razine homocisteina u plazmi.
English: Do not use this medicine after the expiry date which is stated on the bottle label and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake ”Rok valjanosti”.
English: Cystadane has no or negligible influence on the ability to drive and use machines.
Croatian: Cystadane ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The most commonly reported adverse reaction during treatment is blood methionine increased.
Croatian: Najčešće zabilježena nuspojava tijekom liječenja je povećana razina metionina u krvi.
English: Late detection of homocystinuria in symptomatic state is responsible for residual morbidity due to irreversible damage to connective tissue (ophtalmological, skeletal) that cannot be corrected by further therapy.
Croatian: Kasno dijagnosticiranje homocistinurije u simptomatskom stadiju odgovorno je za rezidualni morbiditet uslijed ireverzibilnog oštećenja vezivnog tkiva (oftalmološkog, skeletnog), što se ne može ispraviti daljnjom terapijom.
English: To minimise the risk of potential drug interactions, it is advisable to leave 30 minutes between the intake of betaine anhydrous and amino acids mixtures and/or medicinal products containing vigabatrin and GABA analogues (see section 4.5).
Croatian: Da bi se smanjio rizik od potencijalnih interakcija lijekova, preporučuje se napraviti pauzu od 30 minuta od unosa bezvodnog betaina i mješavine aminokiselina i/ili lijekova koji sadrže vigabatrin i analoge GABA-e (vidjeti dio 4.5).
English: It is recommended that a heaped measuring spoon is removed from the bottle and a flat surface e.g. base of a knife is drawn across the top of the measure.
Croatian: Preporučuje se napunjenu mjernu žličicu izvaditi iz boce i predmetom ravne površine, na primjer s nožem, poravnati razinu praška s rubom žličice.
English: No case of overdose has been reported.
Croatian: Slučajevi predoziranja nisu zabilježeni.
English: The powder should be mixed with water, juice, milk, formula or food until completely dissolved and ingested immediately after mixing.
Croatian: Prašak treba pomiješati s vodom, sokom, mlijekom, adaptiranim mlijekom ili hranom dok se potpuno ne rastopi i odmah progutati.
English: If you experience morning headaches with vomiting and/or visual changes, contact immediately your doctor (they could be signs of a swelling in the brain).
Croatian: Ako Vam se pojave jutarnje glavobolje s povraćanjem i/ili poremećaj vida, odmah obavijestite svog liječnika (navedene nuspojave mogu biti znakovi oticanja mozga).
English: Medicinal product subject to restricted medical prescription (see annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2)
English: The use of Cystadane together with other treatments such as vitamin B6, vitamin B12, folate and a specific diet aims to reduce the elevated homocysteine levels in your body.
Croatian: Primjena Cystadanea zajedno s drugim pripravcima kao što su vitamin B6, vitamin B12, folatna kiselina, uz specifičan režim prehrane, ima za cilj sniziti povišenu razinu homocisteina u Vašem tijelu.
English: • take the correct number of spoonfuls of powder from the bottle
Croatian: • uzmite odgovarajući broj vrhom punih žlica praška iz boce
English: Cystadane contains betaine anhydrous which is intended to be an adjunctive treatment of homocystinuria, an inherited (genetic) disease where the amino acid methionine cannot be broken down completely by the body.
Croatian: Cystadane sadrži bezvodni betain, koji se koristi kao dodatno liječenje homocistinurije, nasljedne (genetske) bolesti u kojoj se u organizmu aminokiselina metionin ne može do kraja razgraditi.
English: If you forget to take Cystadane
Croatian: Ako ste zaboravili uzeti Cystadane
English: The bottle should be lightly shaken before opening.
Croatian: Bocu treba lagano protresti prije otvaranja.
English: Uncommon cases of severe cerebral oedema associated with hypermethioninemia were reported with betaine anhydrous therapy in patients with CBS deficiency (see section 4.8).
Croatian: Manje česti slučajevi teškog cerebralnog edema povezanog s hipermetioninemijom prijavljeni su s terapijom bezvodnim betainom u bolesnika s nedostatkom CBS-a (vidjeti dio 4.8).
English: With a slow elimination rate (mean half life = 14 h, mean total body clearance, CL/F, = 84 ml/h/kg),
Croatian: Sa sporom stopom eliminacije (srednji poluvijek = 14 h, srednja vrijednost ukupnog tjelesnog klirensa, CL/F, = 84 ml/h/kg), klirens putem bubrega je zanemariv (5% od ukupnog tjelesnog klirensa),
English: You should take Cystadane orally (by mouth).
Croatian: Cystadane treba primijeniti kroz usta.
English: Because of lack of data, caution should be exercised when prescribing Cystadane to breast-feeding women.
Croatian: S obzirom na nedostatak podataka, potreban je oprez kada se Cystadane propisuje dojiljama.
English: The use of this medicine will be supervised by a doctor experienced in the treatment of patients with homocystinuria.
Croatian: Primjenu ovog lijeka će nadzirati liječnik iskusan u liječenju bolesnika s homocistinurijom.
English: 180 g of oral powder and three measuring spoons.
Croatian: 180 g oralnog praška i tri mjerne žličice.
English: However, the dose should be individually titrated according to plasma levels of homocysteine and methionine.
Croatian: Međutim, dozu treba posebno titrirati u pojedinog bolesnika u skladu s razinama homocisteina i metionina u plazmi.
English: What Cystadane contains - The active substance is betaine anhydrous.
Croatian: Što Cystadane sadrži - Djelatna tvar je bezvodni betain.
English: Based on in vitro data, betaine anhydrous might interact with amino acids mixtures and medicinal products containing vigabatrin and GABA analogues.
Croatian: Na temelju in vitro podataka, bezvodni betain može ući u interakciju s mješavinama aminokiselina i lijekovima koji sadrže vigabatrin i analoge GABA-e.
English: This will give the following doses: small measure 100 mg, middle size measure 150 mg and large measure 1 g of betaine anhydrous.
Croatian: Tako će se odrediti sljedeće doze: mala mjerica 100 mg, srednja mjerica 150 mg i velika mjerica 1 g bezvodnog betaina.