FrancophonIA/ELRC3.0 huggingface dataset:
English: Venclyxto 50 mg film-coated tablets Each film-coated tablet contains 50 mg of venetoclax.
Croatian: Venclyxto 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg venetoklaksa.
English: • Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg venetoclax.
Croatian: • Venclyxto 10 mg filmom obložene tablete: jedna filmom obložena tableta sadrži 10 mg venetoklaksa.
English: LIST OF EXCIPIENTS
Croatian: Ocjena ispitivača
English: • Venclyxto 10 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Croatian: • Venclyxto 10 mg filmom obložene tablete: žuti željezov oksid (E172), poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 3350 (E1521), talk (E553b).
English: The safety and efficacy of venetoclax in 107 patients with previously treated CLL with 17p deletion were evaluated in a single arm, open-label, multi-center study (M13-982).
Croatian: 17p ocjenjivale su se u otvorenom, multicentričnom ispitivanju s jednom skupinom (M13-982).
English: Gastric acid reducing agents
Croatian: Lijekovi koji smanjuju želučanu kiselinu
English: Venclyxto 100 mg film-coated tablets Each film-coated tablet contains 100 mg of venetoclax.
Croatian: Venclyxto 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg venetoklaksa.
English: Venclyxto 100 mg film-coated tablets:
Croatian: Venclyxto 100 mg filmom obložene tablete:
English: Venclyxto 50 mg film-coated tablets:
Croatian: Venclyxto 50 mg filmom obložene tablete:
English: The estimated PFS rate at 6 months post treatment was 92%.
Croatian: Procijenjena stopa PFS-a 6 mjeseci nakon liječenja iznosila je
English: Venclyxto 10 mg film-coated tablets Each film-coated tablet contains 10 mg of venetoclax.
Croatian: Venclyxto 10 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 10 mg venetoklaksa.
English: Venclyxto 10 mg film-coated tablets:
Croatian: Venclyxto 10 mg filmom obložene tablete:
English: Venclyxto 10 mg tablets venetoclax
Croatian: Venclyxto 10 mg tablete venetoklaks
English: Venclyxto 100 mg film-coated tablet
Croatian: Venclyxto 100 mg filmom obložena tableta
English: Constipation
Croatian: Cijepljenje
English: Colloidal anhydrous silica (E551) Polysorbate 80 (E433)
Croatian: Jezgra tablete kopovidon (K 28) silicijev dioksid, koloidni, bezvodni (E551) polisorbat 80 (E433) natrijev stearilfumarat kalcijev hidrogenfosfat, bezvodni (E341 (ii))
English: Venclyxto 10 mg film-coated tablets
Croatian: Venclyxto 10 mg filmom obložena tableta
English: Venclyxto 10 mg film-coated tablets venetoclax
Croatian: Venclyxto 10 mg filmom obložene tablete venetoklaks
English: • constipation
Croatian: • smetenost
English: Venclyxto 100 mg tablets venetoclax
Croatian: Venclyxto 100 mg tablete venetoklaks
English: Venclyxto 50 mg film-coated tablets
Croatian: Venclyxto 50 mg filmom obložena tableta
English: Hepatic impairment
Croatian: Progresija bolesti
English: Venclyxto 100 mg film-coated tablets venetoclax
Croatian: Venclyxto 100 mg filmom obložene tablete venetoklaks
English: If a patient misses a dose of venetoclax within 8 hours of the time it is usually taken, the patient should take the missed dose as soon as possible on the same day.
Croatian: 8 sati, treba uzeti propuštenu dozu što je prije moguće istoga dana.
English: Venclyxto 50 mg film-coated tablets venetoclax
Croatian: Venclyxto 50 mg filmom obložene tablete venetoklaks
English: • diarrhoea
Croatian: • nedostatak zraka
English: EXPIRY DATE
Croatian: Završni datum prikupljanja podataka
English: Ltd
Croatian: KG
English: At baseline, 46.6% of patients had one or more nodes ≥5 cm, and
Croatian: Na početku je ispitivanja 46,6% bolesnika imalo jedan ili više čvorova ≥ 5 cm, dok ih je 67,6% imalo apsolutni broj limfocita ≥ 25 x 109/l.
English: Tumour lysis syndrome Hyperuricaemia
Croatian: Opis odabranih nuspojava Sindrom lize tumora
English: • higher level of urea
Croatian: • povišene vrijednosti ureje
English: Eighteen patients in the venetoclax + rituximab arm and 3 patients in the bendamustine + rituximab arm had negative bone marrow and lymph nodes <2 cm. bMinimal residual disease was evaluated using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry.
Croatian: bMinimalna rezidualna bolest (MRD) ocjenjivala se lančanom reakcijom polimerazom uz primjenu oligonukleotida specifičnih za alel (engl. allele-specific oligonucleotide polymerase chain reaction,
English: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171)
Croatian: Film ovojnica željezov oksid, žuti (E172) željezov oksid, crveni (E172) željezov oksid, crni (E172) poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol 3350 (E1521) talk (E553b)
English: 8 (8 x 1) vials
Croatian: 8 ( 8 x 1 ) bočica
English: [The below wording should replace the previous wording] Titration on a weekly basis is recommended in case higher doses are required.
Croatian: [Prethodni tekst mora se zamijeniti sljedećim tekstom] U slučaju da su potrebne više doze preporučuje se tjedna titracija.
English: Note: These amendments are to be incorporated to the valid summary of product characteristics, labelling and package leaflet which are the final versions achieved during the Coordination group procedure.
Croatian: Napomena: Ove izmjene potrebno je unijeti u važeći sažetak opisa svojstava lijeka, označavanje i uputu o lijeku koji su konačne verzije postignute tijekom postupka Koordinacijske skupine.
English: Some patients may benefit from higher daily doses up to a maximum of 60 mg/30 mg oxycodone.
Croatian: Nekim bolesnicima mogu koristiti više dnevne doze do najviše 60 mg/30 mg oksikodona.
English: The mean daily dose in the pivotal study was 20mg/10mg oxycodone hydrochloride/naloxone hydrochloride.
Croatian: Srednja vrijednost dnevne doze u glavnom ispitivanju bila je 20 mg/10 mg oksikodonklorida/naloksonklorida.
English: Annex III Amendments to the summary of product characteristics
Croatian: Dodatak III Izmjene sažetka opisa svojstava lijeka
English: • Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Croatian: • Bioekvivalencija u odnosu na referentni lijek odobren u EU-u dokazana je na temelju relevantnih podataka, sukladno zahtjevima iz članka 10.
English: For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holder(s)
Croatian: Kako bi se ukinula privremena obustava odobrenja za stavljanje lijeka u promet iz Priloga I.B, nadležna će tijela osigurati da je nositelj odobrenja za stavljanje lijeka u promet ispunio sljedeće uvjete:
English: 24 months.
Croatian: 24 mjeseci.
English: Date of first authorisation: 5 September 2017
Croatian: Datum prvog odobrenja: 5. rujna 2017.
English: This medicine has been prescribed for you only.
Croatian: Ovaj je lijek propisan samo vama.
English: These findings were not reversible.
Croatian: Ti nalazi nisu bili reverzibilni.
English: Do not stop your treatment without the advice of your doctor even if you feel better because Wilson's disease is a life-long condition.
Croatian: Nemojte prekidati liječenje bez savjeta liječnika, čak i ako se osjećate bolje jer Wilsonova bolest traje cijeli život.
English: Not known (frequency cannot be estimated from available data)
Croatian: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka)
English: This leaflet was last revised in.
Croatian: Ova uputa zadnji je put revidirana u
English: Your symptoms may initially get worse after starting the treatment.
Croatian: Vaši se simptomi prvo mogu pogoršati nakon početka liječenja.
English: EU/1/17/1199/001 72 film-coated tablets EU/1/17/1199/002 96 film-coated tablets
Croatian: EU/1/17/1199/001 72 filmom obložene tablete EU/1/17/1199/002 96 filmom obloženih tableta
English: Do not throw away any medicines via wastewater or household waste.
Croatian: Nikada nemojte lijekove bacati u otpadne vode niti u kućni otpad.
English: You and your doctor should fully discuss the potential benefits of treatment whilst considering any possible risks that there may be.
Croatian: Vi i Vaš liječnik trebate detaljno razmotriti moguće koristi liječenja, ali istovremeno uzeti u obzir moguće rizike.
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); not known (cannot be estimated from the available data).
Croatian: Učestalost se određuje kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
English: OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets.
Croatian: OPA/Al/PVC-Al blisteri, svaki blister sadrži 8 filmom obloženih tableta.
English: However it was not possible to determine if the reaction was due to trientine or to previous penicillamine treatment.
Croatian: Međutim, nije bilo moguće utvrditi je li reakcija uzrokovana trientinom ili prethodnim liječenjem penicilaminom.
English: Children ≥ 5 years
Croatian: Djeca ≥ 5 godina
English: Your doctor will tell you how many tablets you should take and how often in the day.
Croatian: Liječnik će vam reći koliko tableta trebate uzeti i koliko često tijekom dana.
English: If this happens, you must tell your doctor.
Croatian: Ako se to dogodi, obavijestite svog liječnika.
English: This means that the small amounts of copper from food and drink build up to excessive levels and can lead to liver damage and problems in the nervous system.
Croatian: To znači da se male količine bakra iz hrane i vode nakupljaju do prekomjerne razine i mogu dovesti do oštećenja jetre i problema u živčanom sustavu.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Cuprior.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Cuprior.
English: In particular, you must tell your doctor if you are already taking iron supplements or if you take indigestion remedies (medicines that reduce discomfort after eating).
Croatian: Posebice morate reći liječniku ako već uzimate nadomjestke željeza ili lijekove za probavu (lijekovi koji smanjuju nelagodu nakon jela).
English: There are only limited data on concomitant use available and no specific dose recommendations can be made.
Croatian: O istodobnoj uporabi dostupni su samo ograničeni podatci te preporuka specifične doze nije moguća.
English: Although there is no evidence that calcium or magnesium antacids alter the efficacy of trientine, it is good practice to separate their administration.
Croatian: Iako nema dokaza da antacidi kalcija ili magnezija mijenjaju djelotvornost trientina, dobra je praksa odvojiti njihovu primjenu.
English: The overall pharmacokinetic profiles were similar between males and females, although males had higher levels of trientine.
Croatian: Ukupni farmakokinetički profili bili su slični u žena i muškaraca, iako su muškarci imali više razine trientina.
English: The dose that you will take is usually lower than for an adult and depends on your age and body weight.
Croatian: Doza koju ćete uzeti obično je manja od doze za odrasle i ovisi o vašoj dobi i tjelesnoj težini.
English: However, no food interaction studies have been performed and so the extent of the food effect on systemic trientine exposure is unknown.
Croatian: Međutim, nisu provedena ispitivanja interakcija s hranom, tako da je opseg učinka hrane na sistemsku izloženost trientinu nepoznat.
English: What Cuprior contains
Croatian: Što Cuprior sadrži
English: Repeat dose toxicity
Croatian: Toksičnost ponovljene doze
English: Common (may affect up to 1 in 10 people)
Croatian: Česte (mogu se pojaviti u do 1 na 10 osoba)
English: Once you have started the treatment, your doctor may adjust the dose based on the response to treatment.
Croatian: Nakon što započnete liječenje, liječnik vam može prilagoditi dozu na temelju odgovora na liječenje.
English: Trientine and its metabolites are rapidly excreted in the urine, although low levels of trientine could still be detected in the plasma after 20 hours.
Croatian: Trientin i njegovi metaboliti brzo se izlučuju u urin, iako se niske razine trientina u plazmi mogu uočiti i nakon 20 sati.
English: The film-coated tablets should be swallowed with water.
Croatian: Filmom obložene tablete treba progutati s vodom.
English: The trientine plasma concentration then declined in a multiphasic manner, initially rapidly, followed by a slower elimination phase.
Croatian: Koncentracija trientina u plazmi zatim se smanjila u više faza, na početku brzo, nakon čega je slijedila faza sporije eliminacije.
English: Cuprior should only be used in pregnancy after careful consideration of the benefits compared with the risks of treatment in the individual patient.
Croatian: Cuprior se u trudnoći smije primjenjivati samo nakon pažljivog razmatranja koristi u odnosu na rizike liječenja u pojedine bolesnice.
English: When your baby is born, the copper level in the baby's blood will also be monitored.
Croatian: Nakon što rodite dijete, također će se pratiti razina bakra u djetetovoj krvi.
English: If you take these medicines you may need to take Cuprior at a different time in the day because otherwise Cuprior may not be as effective.
Croatian: Ako uzimate te lijekove, možda ćete Cuprior trebati uzimati u drugo doba dana jer u suprotnom Cuprior neće biti jednako djelotvoran.
English: The most reliable index for monitoring therapy is the determination of serum free copper which is calculated using the difference between the total copper and the ceruloplasmin-bound copper (normal level of free copper in the serum is usually 100 to 150 microgram/L).
Croatian: Najpouzdaniji pokazatelj za praćenje liječenja je određivanje slobodnog bakra u serumu čija se razina izračunava pomoću razlike ukupnog bakra i bakra vezanog za ceruloplazmin (normalna razina slobodnog bakra u serumu obično je 100 do 150 mikrograma/l).
English: No dose adjustment is required in elderly patients.
Croatian: Prilagodba doze nije potrebna u starijih bolesnika.
English: What Cuprior is and what it is used for 2.
Croatian: Što je Cuprior i za što se koristi 2.
English: Children aged < 5 years
Croatian: Djeca < 5 godina
English: The aim of maintenance treatment is to maintain free copper levels in the serum within acceptable limits.
Croatian: Cilj liječenja održavanja je održati razine slobodnog bakra u serumu u prihvatljivim granicama.
English: Cuprior is available in packs containing 72 or 96 film-coated tablets.
Croatian: Cuprior je dostupan u pakiranjima koja sadrže 72 ili 96 filmom obloženih tableta.
English: Close monitoring is required to optimise the dose or to adapt treatment if necessary.
Croatian: Potrebno je pažljivo praćenje radi optimizacije doze ili prilagodbe liječenja ako je potrebno.
English: Overtreatment carries the risk of copper deficiency.
Croatian: Prekomjerno liječenje dovodi do rizika od nedostatka bakra.
English: This medicine may also reduce the level of iron in your blood and your doctor may prescribe iron supplements (see section “Other medicines and Cuprior” below).
Croatian: Ovaj lijek može smanjiti i razinu željeza u krvi te vam liječnik može propisati nadomjestak željeza (vidjeti dio „Drugi lijekovi i Cuprior” u nastavku).
English: Trientine is acetylated in two majors metabolites, N(1)-acetyltriethylenetetramine (MAT) and N(1),N(10)-diacetyltriethylenetetramine (DAT).
Croatian: Trientin se acetilira u dva glavna metabolita, N(1)-acetiltrietilentetramin (MAT) i N(1),N(10)diacetiltrietilentetramin (DAT).
English: The pharmacokinetic profile of Cuprior has been evaluated after a single oral dose of 450, 600 mg and 750 mg trientine in healthy male and female subjects.
Croatian: Farmakokinetički profil lijeka Cuprior procijenjen je nakon jedne oralne doze od 450, 600 mg i 750 mg trientina u zdravih ispitanika i ispitanica.
English: The measurement of copper excretion in the urine may be performed during therapy.
Croatian: Mjerenje izlučivanja bakra u urinu može se provesti tijekom liječenja.
English: In vivo, trientine was however negative in the mouse micronucleus test.
Croatian: Međutim, in vivo, trientin je bio negativan u mikronukleus testu u miševa.
English: Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.
Croatian: Cuprior je indiciran za liječenje Wilsonove bolesti u odraslih, adolescenata i djece ≥ 5 godina koji ne podnose liječenje D-penicilaminom.
English: This daily total will be divided into 2 to 4 smaller doses to be taken during the day.
Croatian: Ta se ukupna dnevna doza treba podijeliti u 2 do 4 manje doze koje se uzimaju tijekom dana.
English: Factors which need to be born in mind include the risks associated with the disease itself, the risk of those alternative treatments which are available and the possible teratogenic effects of trientine (see section 5.3).
Croatian: Čimbenici koje treba uzeti u obzir uključuju rizike povezane sa samom bolesti, rizike dostupnog zamjenskog liječenja i moguće teratogene učinke trientina (vidjeti dio 5.3).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Croatian: PODATCI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER
English: Linearity/non-linearity Plasma exposures in humans have shown a linear relationship with oral doses of trientine.
Croatian: Linearnost/nelinearnost Plazmatska izloženost u ljudi pokazala je linearnu povezanost s oralnim dozama trientina.
English: Since iron and trientine may inhibit absorption of each other, iron supplements should be taken after at least two hours have elapsed from the administration of trientine.
Croatian: Budući da željezo i trientin mogu međusobno inhibirati apsorpciju, nadomjestak željeza treba uzimati najmanje dva sata nakon primjene trientina.
English: Wilson's disease is an inherited condition in which the body cannot transport copper around the body in the normal way or remove copper in the normal way as a secretion from the liver into the gut.
Croatian: Wilsonova bolest nasljedni je poremećaj u kojem tijelo ne može na normalan način prenositi bakar ili ga uklanjati iz tijela normalnim putem, odnosno sekrecijom iz jetre u crijeva.
English: What Cuprior is and what it is used for
Croatian: Što je Cuprior i za što se koristi
English: Plasma levels of trientine rose rapidly following administration with the median peak level reached after 1.25 to 2 hours.
Croatian: Razine trientina u plazmi brzo su se povećale nakon primjene, pri čemu je medijan vršne razine dosegnut nakon 1,25 do 2 sata.
English: Fertility It is unknown whether trientine has an effect on human fertility.
Croatian: Plodnost Nije poznato ima li trientin utjecaja na plodnost ljudi.
English: MAT may also participate to the overall clinical activity of Cuprior, however the extent of MAT to the overall effect of Cuprior on copper levels remains to be determined.
Croatian: MAT može također sudjelovati i u ukupnom kliničkom djelovanju lijeka Cuprior, međutim doprinos MAT-a u ukupnom učinku lijeka Cuprior na razine bakra još treba utvrditi.
English: The pregnancy should be closely monitored in order to detect possible foetal abnormality and to assess maternal serum copper levels throughout the pregnancy.
Croatian: Trudnoću treba pažljivo pratiti da bi se otkrile moguće abnormalnosti fetusa i procijenile razine bakra u serumu majke tijekom trudnoće.
English: The microscopic changes in lung were considered indicative of a persistent inflammatory reaction or persistent toxic effect on alveolar cells.
Croatian: Mikroskopske promjene na plućima smatraju se pokazateljima trajne upalne reakcije ili trajnog toksičnog učinka na alveolarne stanice.
English: Distribution Little is known on the distribution of trientine in organs and tissues.
Croatian: O distribuciji trientina u organe i tkiva malo se zna.
English: What you need to know before you take Cuprior
Croatian: Što morate znati prije nego počnete uzimati Cuprior
English: Cuprior is given to adults, adolescents and children aged 5 years and over who cannot tolerate another medicine that is used to treat this disease, called penicillamine.
Croatian: Cuprior se daje odraslima, adolescentima i djeci u dobi od 5 godina i starijoj koji ne podnose drugi lijek za liječenje te bolesti koji se naziva penicilamin.
English: This medicine is not recommended for children aged below 5 years of age.
Croatian: Ne preporučuje se uporaba lijeka u djece mlađe od 5 godina.
English: In patients who were previously treated with D-penicillamine, lupus-like reactions have been reported during subsequent treatment with trientine, however it is not possible to determine if there is a causal relationship with trientine.
Croatian: U bolesnika koji su prethodno liječeni D-penicilaminom prijavljene su nuspojave slične lupusu tijekom kasnijeg liječenja trientinom, međutim nije moguće utvrditi postoji li uzročna veza s trientinom.
English: No specific dose adjustment is required in these patients (see section 4.4).
Croatian: Nije potrebna posebna prilagodba doze u tih bolesnika (vidjeti dio 4.4).
English: Cuprior has no or negligible influence on the ability to drive and use machines.
Croatian: Cuprior ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: It is very important to continue treatment to reduce copper during pregnancy.
Croatian: Nastavak liječenja vrlo je važan radi smanjenja bakra u tijelu tijekom trudnoće.
English: Trientine is a copper-chelating agent whose principal mechanism of action is to eliminate absorbed copper from the body by forming a stable complex that is then eliminated through urinary excretion.
Croatian: Trientin je sredstvo za kelaciju bakra, a njegov je glavni mehanizam djelovanja eliminacija apsorbiranog bakra iz tijela formiranjem stabilnog kompleksa koji se tada eliminira izlučivanjem putem urina.
English: Cuprior is a medicine used to treat Wilson's disease that contains the active substance trientine.
Croatian: Cuprior je lijek koji se koristi za liječenje Wilsonove bolesti i sadrži djelatnu tvar trientin.
English: Since chelation therapy leads to an increase in urinary copper levels, this may/will not give an accurate reflection of the excess copper load in the body but may be a useful measure of treatment compliance.
Croatian: Budući da kelacijska terapija dovodi do povećanja razine bakra u urinu, to može, ali i ne mora točno odraziti višak količine bakra u tijelu, no može biti korisna mjera za suradljivost u liječenju.
English: The recommended doses of Cuprior are expressed as mg of trientine base (i.e. not in mg of the trientine tetrahydrochloride salt).
Croatian: Preporučene doze lijeka Cuprior izražene su u mg baze trientina (tj. ne u miligramima soli trientintetraklorida).
English: If you are pregnant and taking Cuprior, you will be monitored throughout your pregnancy for any effects on the baby or changes in your copper levels.
Croatian: Ako ste trudni i uzimate Cuprior, kontrolirat će Vas tijekom trudnoće radi mogućeg utjecaja lijeka na dijete ili promjene razine bakra.
English: Preclinical data obtained with trientine have shown adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use as follows:
Croatian: Neklinički podaci dobiveni za trientin pokazali su nuspojave koje nisu opažene u kliničkim ispitivanjima, ali su zapažene u životinja pri razinama izloženosti sličnima kliničkim razinama izloženosti, a njihova moguća važnost za kliničku primjenu uključuje sljedeće: