FrancophonIA/ELRC3.0 huggingface dataset:
English: Eye disorders very common conjunctival hyperaemia, ocular pruritus, growth of eyelashes common superficial punctate keratitis, corneal erosion, ocular burning, ocular irritation, allergic conjunctivitis, blepharitis, worsening of visual acuity, asthenopia, conjunctival oedema, foreign body sensation, ocular dryness, eye pain, photophobia, tearing, eye discharge, visual disturbance/blurred vision, increased iris pigmentation, eyelash darkening, eyelid erythema, eyelid pruritus uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction, periorbital erythema, eyelid oedema not known periorbital and lid changes including deepening of the eyelid sulcus ocular discomfort
Croatian: Poremećaji oka vrlo često hiperemija konjunktive, svrbež oka, rast trepavica često površinski točkasti keratitis, erozija rožnice, pečenje oka, iritacija oka, alergijski konjunktivitis, blefaritis, pogoršanje oštrine vida, astenopija, edem konjunktive, osjećaj stranog tijela, suhoća oka, bol u oku, fotofobija, suzenje, iscjedak iz oka, smetnje vida/zamućen pogled, povećana pigmentacija šarenice, tamnjenje trepavica, eritem vjeđe, svrbež vjeđe manje često retinalno krvarenje, uveitis, cistoidni makularni edem, iritis, blefarospazam, retrakcija vjeđe, periorbitalni eritem, edem vjeđe nepoznato promjene na periorbitalnom području i vjeđama uključujući produbljenje brazde vjeđe, osjećaj nelagode u oku
English: How to use LUMIGAN 0.3 mg/ml
Croatian: Kako primjenjivati LUMIGAN 0,3 mg/ml
English: Eye disorders very common ocular pruritus, growth of eyelashes common corneal erosion, ocular burning, allergic conjunctivitis, blepharitis, worsening of visual acuity, asthenopia, conjunctival oedema, foreign body sensation, ocular dryness, eye pain, photophobia, tearing, eye discharge, visual disturbance/blurred vision, increased iris pigmentation, eyelash darkening uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction, periorbital erythema
Croatian: Poremećaji oka vrlo često svrbež oka, rast trepavica često erozija rožnice, pečenje oka, alergijski konjunktivitis, blefaritis, pogoršanje oštrine vida, astenopija, edem konjunktive, osjećaj stranog tijela, suhoća oka, bol u oku, fotofobija, suzenje, iscjedak iz oka, smetnje vida/zamućen vid, povećana pigmentacija šarenice, tamnjenje trepavica manje često retinalno krvarenje, uveitis, cistoidni makularni edem, iritis, blefarospazam, retrakcija vjeđe, periorbitalni eritem
English: • ocular pruritus in up to 14% of patients in the first year with the incidence of new reports decreasing to 3% at 2 years and 0% at 3 years.
Croatian: • svrbež očiju i do 14% u prvoj godini primjene s padom incidencije na 3% u drugoj i 0 % u trećoj godini primjene.
English: Eye disorders very common conjunctival hyperaemia common punctate keratitis, eye irritation, eye pruritus, growth of eyelashes, eye pain, erythema of eyelid, eyelid pruritus uncommon asthenopia, blurred vision, conjunctival disorder, conjunctival oedema, iris hyperpigmentation, madarosis, eyelid oedema not known blepharal pigmentation, macular oedema, periorbital and lid changes including deepening of the eyelid sulcus, dry eye, eye discharge, eye oedema, foreign body sensation in eyes, lacrimation increased, ocular discomfort, photophobia
Croatian: Poremećaji oka vrlo često hiperemija konjunktive često točkasti keratitis, iritacija oka, svrbež oka, rast trepavica, bol u oku, eritem vjeđe, svrbež vjeđe manje često astenopija, zamagljen vid, poremećaj konjunktive, edem konjunktive, hiperpigmentacija šarenice, madaroza, edem vjeđe nepoznato pigmentacija vjeđa, makularni edem, promjene na periorbitalnom području i vjeđama uključujući produbljenje brazde vjeđe, suho oko, iscjedak iz oka, edem oka, osjećaj stranog tijela u oku, pojačano suzenje, osjećaj nelagode u oku, fotofobija
English: LUMIGAN 0.3 mg/mL, eye drops, solution, in single-dose container Bimatoprost
Croatian: LUMIGAN 0,3 mg/ml kapi za oko, otopina u jednodoznom spremniku bimatoprost
English: How to use LUMIGAN 0.1 mg/ml
Croatian: Kako primjenjivati LUMIGAN 0,1 mg/ml
English: BOTTLE
Croatian: Nuspojava
English: How to store LUMIGAN 0.3 mg/ml
Croatian: Kako čuvati LUMIGAN 0,3 mg/ml
English: In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/ml eye drops, solution.
Croatian: U kliničkim ispitivanjima, s LUMIGAN 0,3 mg/ml kapima za oko liječeno je više od 1800 bolesnika.
English: • Tired eye
Croatian: • Svrbež oka
English: • Nausea
Croatian: • Mučnina
English: Wait 15 minutes after using the drops before you put your lenses back in. A preservative in LUMIGAN called benzalkonium chloride may cause eye irritation and can discolour soft contact lenses.
Croatian: Konzervans koji LUMIGAN sadrži, koji se naziva benzalkonijev klorid, može izazvati iritaciju oka i promijeniti boju vaših mekanih kontaktnih leća.
English: Nervous system disorders uncommon dizziness
Croatian: Poremećaji živčanog sustava manje često omaglica
English: • Iris inflammation
Croatian: • Krvarenje mrežnice
English: • Sticky eyes
Croatian: • Ljepljive oči
English: • Dryness
Croatian: • Pečenje
English: EU/1/02/205/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/205/001-002
English: LIST OF EXCIPIENTS
Croatian: Okularna primjena
English: How to store LUMIGAN 0.1 mg/ml
Croatian: Kako čuvati LUMIGAN 0,1 mg/ml
English: What LUMIGAN 0.3 mg/mL single-dose is and what it is used for
Croatian: Što je jednodozni LUMIGAN 0,3 mg/ml i za što se koristi
English: What you need to know before you use LUMIGAN 0.3 mg/mL single-dose
Croatian: Što morate znati prije nego počnete primjenjivati jednodozni LUMIGAN 0,3 mg/ml
English: • Eyelid shrinking, moving away from surface of the eye
Croatian: • Sužavanje kapka,odvajanje očnog kapka od površine oka
English: Eye drops, solution 30 x 0.4 ml
Croatian: 30 x 0,4 ml
English: Eye drops, solution 5 x 0.4 ml
Croatian: 5 x 0,4 ml
English: • Dizziness
Croatian: • Suzenje
English: • A feeling that something is in your eye
Croatian: • Osjećaj stranog tijela u oku
English: Do not use LUMIGAN 0.3 mg/ml: - if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte primjenjivati LUMIGAN 0,3 mg/ml: - ako ste alergični na bimatoprost ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste ranije morali prekinuti s korištenjem kapi za oči zbog nuspojava uzrokovanih konzervansom benzalkonijevim kloridom.
English: Skin and subcutaneous tissue disorders uncommon hirsutism
Croatian: Poremećaji kože i potkožnog tkiva manje često hirzutizam
English: Eye disorders very common conjunctival hyperaemia common punctate keratitis, eye irritation, foreign body sensation, dry eye, eye pain, eye pruritus, growth of eyelashes, eyelid erythema uncommon asthenopia, conjunctival oedema, photophobia, lacrimation increased, iris hyperpigmentation, blurred vision, eyelid pruritus, eyelid oedema not known eye discharge, ocular discomfort
Croatian: Poremećaji oka vrlo često hiperemija konjunktive često točkasti keratitis, iritacija oka, osjećaj stranog tijela, suho oko, bol u oku, svrbež oka, rast trepavica, eritem vjeđe manje često astenopija, konjunktivalni edem, fotofobija, pojačano suzenje, hiperpigmentacija šarenice, zamućen vid, svrbež vjeđe, edem vjeđe nepoznato iscjedak iz oka, osjećaj nelagode u oku
English: Sími: +354 550 3300
Croatian: Actavis Pharmaceuticals Iceland ehf. Sími: +354 550 3300
English: Frequency
Croatian: Serija
English: Very common side effects These may affect one or more users in 10 Affecting the eye
Croatian: Mogu se javiti kod jednog ili više od jednog na 10 korisnika.
English: Ocular
Croatian: Oči
English: • Eyelid twitching
Croatian: • Ispadanje trepavica
English: Affecting the eye
Croatian: Za oko
English: • Increasing tears
Croatian: • Pojačano suzenje
English: • Swelling of the eye
Croatian: • Oticanje oka
English: One ml of solution contains 0.1 mg bimatoprost
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml otopine sadrži 0,1 mg bimatoprosta
English: POUCH CONTAINING 10 SINGLE-DOSE CONTAINERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VREĆICA KOJA SADRŽI 10 JEDNODOZNIH SPREMNIKA
English: LUMIGAN 0.3 mg/mL single-dose
Croatian: 16. PODACI NA BRAILLEOVOM PISMU LUMIGAN 0,3 mg/ml jednodozni
English: One ml of solution contains 0.3 mg bimatoprost
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml otopine sadrži 0,3 mg bimatoprosta
English: Neither naevi nor freckles of the iris appear to be affected by the treatment.
Croatian: Ovaj lijek ne utječe na nevuse i na pjege šarenice.
English: LUMIGAN 0.3 mg/mL eye drops, solution, in single-dose container
Croatian: NAZIV LIJEKA LUMIGAN 0,3 mg/ml kapi za oko, otopina u jednodoznom spremniku
English: Eye disorders common corneal erosion, ocular burning, allergic conjunctivitis, blepharitis, worsening of visual acuity, eye discharge, visual disturbance, eyelash darkening uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction not known periorbital and lid changes including deepening of the eyelid sulcus
Croatian: manje često retinalno krvarenje, uveitis, cistoidni makularni edem, iritis, blefarospazam, retrakcija vjeđe nepoznato promjene na periorbitalnom području i vjeđama uključujući produbljenje brazde vjeđe
English: LUMIGAN 0.3 mg/ml
Croatian: 16. PODACI NA BRAILLEOVOM PISMU LUMIGAN 0,3 mg/ml
English: Annex I List of medicinal products and presentations
Croatian: Popis lijekova i prikazi
English: United Kingdom
Croatian: Ujedinjena Kraljevina
English: CR8 2AD,
Croatian: Prilog I.
English: Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Croatian: Ponedjeljak Utorak Srijeda Četvrtak Petak
English: There is no specific antidote.
Croatian: Ne postoji specifični antidot.
English: Your doctor may want to change the dose of these medicines.
Croatian: Liječnik će možda htjeti promijeniti dozu tih lijekova.
English: Date of first authorisation: 05 September 2011
Croatian: Datum prvog odobrenja: 05. rujna 2011.
English: Not known (frequency cannot be estimated from the available data):
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):
English: Date of latest renewal: 26 May 2016
Croatian: Datum posljednje obnove odobrenja: 26. svibnja 2016.
English: All changes showed complete or partial reversibility.
Croatian: Sve su promjene bile potpuno ili djelomično reverzibilne.
English: Potential risks
Croatian: Mogući rizici
English: Liver function also should be assessed.
Croatian: Treba procijeniti i funkciju jetre.
English: There are no clinical data available to confirm transporter based interaction.
Croatian: Nema dostupnih kliničkih podataka koji potvrđuju interakcije temeljene na transporteru.
English: Not reached (11.66; NE)
Croatian: nije dostignuto (11,66; NP)
English: - Do not throw away any medicines via wastewater or household waste.
Croatian: - Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: What ZYTIGA is and what it is used for
Croatian: Što je ZYTIGA i za što se koristi
English: Fill in your weekdays
Croatian: Ispunite dane u tjednu
English: It is not known whether abiraterone or its metabolites are present in semen.
Croatian: Nije poznato jesu li abirateron ili njegovi metaboliti prisutni u spermi.
English: (25.95; NE)
Croatian: (25,95; NP)
English: This medicine is not for use in children and adolescents.
Croatian: Ovaj lijek nije namijenjen za primjenu u djece i adolescenata.
English: This medicinal product should be prescribed by an appropriate healthcare professional.
Croatian: Ovaj lijek mora biti propisan od strane odgovarajućeg zdravstvenog radnika.
English: Taking this medicine - Take this medicine by mouth.
Croatian: Kako uzimati ovaj lijek - Ovaj lijek uzmite kroz usta.
English: Contraception in males and females
Croatian: Kontracepcija u muškaraca i žena
English: Mineralocorticoid reactions generally were able to be successfully managed medically.
Croatian: Mineralokortikoidne reakcije općenito su se mogle uspješno liječiti.
English: - The amount of prednisone or prednisolone you take may need to change if you have a medical emergency.
Croatian: - Količina prednizona ili prednizolona koju uzimate možda će se morati promijeniti ako nastupi neko hitno medicinsko stanje.
English: - This medicine may cause harm to the unborn child if it is taken by women who are pregnant.
Croatian: - Ovaj lijek može naštetiti nerođenom djetetu ako ga uzimaju trudnice.
English: C-abiraterone in human plasma is 99.8%.
Croatian: C-abiraterona na proteine plazme u ljudi iznosi 99,8%.
English: Treatment continued until disease progression, withdrawal of consent, the occurrence of unacceptable toxicity, or death.
Croatian: Liječenje se nastavilo do progresije bolesti, povlačenja pristanka, pojave neprihvatljive toksičnosti ili smrti.
English: Injury, poisoning and procedural complications common: fractures**
Croatian: Ozljede, trovanja i proceduralne komplikacije često: frakture**
English: The safety of re-treatment in such patients is unknown.
Croatian: Nije poznata sigurnost ponovne primjene lijeka u tih bolesnika.
English: The radiographic progression and death are considered in defining the rPFS event.
Croatian: Radiografska progresija i smrt uzeti su u obzir pri definiranju rPFS događaja.
English: Also, some medicines may increase or decrease the effects of ZYTIGA.
Croatian: Osim toga, neki lijekovi mogu pojačati ili smanjiti djelovanje lijeka ZYTIGA.
English: It is used to treat prostate cancer in adult men that has spread to other parts of the body.
Croatian: Koristi se za liječenje karcinoma prostate u odraslih muškaraca koji se proširio u druge dijelove tijela.
English: The majority of circulating radioactivity (approximately 92%) is found in the form of metabolites of abiraterone.
Croatian: Većina radioaktivnosti u cirkulaciji (oko 92%) nalazi se u obliku metabolita abiraterona.
English: 120 tablets
Croatian: 120 tableta
English: Start date:
Croatian: Početni datum:
English: When you are taking this medicine, your doctor will check your blood periodically to look for any effects on your liver.
Croatian: Dok uzimate ovaj lijek, liječnik će periodično zatražiti da obavite krvne pretrage kako bi se uočili učinci na jetru.
English: The median age of enrolled patients was 69 years (range 39-95).
Croatian: Medijan dobi uključenih bolesnika bio je 69 godina (raspon 39-95).
English: ZYTIGA with food - This medicine must not be taken with food (see section 3, “Taking this medicine”).
Croatian: ZYTIGA s hranom - Ovaj lijek se ne smije uzimati s hranom (pogledajte dio 3, “Kako uzimati ovaj lijek”).
English: Your doctor will tell you if you need to change the amount of prednisone or prednisolone you take.
Croatian: Liječnik će Vam reći ako budete trebali promijeniti količinu prednizona ili prednizolona koju uzimate.
English: Cardiovascular reactions
Croatian: Kardiovaskularne reakcije
English: Caution is advised in these patients.
Croatian: U tih se bolesnika savjetuje oprez.
English: - Women who are pregnant or who may be pregnant should wear gloves if they need to touch or handle ZYTIGA.
Croatian: - Žene koje su trudne ili bi mogle biti trudne moraju nositi rukavice ako trebaju dodirivati ili rukovati lijekom ZYTIGA.
English: Aside from reproductive organ changes seen in all animal toxicology studies, non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Croatian: Osim promjena na spolnim organima opaženima u toksikološkim istraživanjima na životinjama, neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
English: This may lead to side effects or to ZYTIGA not working as well as it should.
Croatian: To može dovesti do nuspojava ili do toga da ZYTIGA ne djeluje kako bi trebala.
English: These may be signs that the level of potassium in your blood is low.
Croatian: To mogu biti znakovi niske razine kalija u krvi.
English: Based on its mechanism of action, this medicinal product may harm a developing foetus; therefore, women who are pregnant or may be pregnant should not handle it without protection, e.g., gloves.
Croatian: S obzirom na mehanizam djelovanja, ovaj lijek može naštetiti razvoju fetusa; stoga žene koje su trudne ili bi mogle biti trudne ne smiju rukovati lijekom bez zaštite, npr. rukavica.
English: Tell your doctor if you are taking any of the medicines listed above.
Croatian: Obavijestite svog liječnika ako uzimate bilo koji od lijekova navednih iznad.
English: Do not take this medicine if any of the above apply to you.
Croatian: Nemojte uzimati ovaj lijek ako se nešto od navedenog odnosi na Vas.
English: 33.02 (29.57, NE)
Croatian: 33,02 (29,57, NP)
English: 34.73 (33.05, NE)
Croatian: 34,73 (33,05, NP)
English: Use with Spironolactone
Croatian: Primjena sa spironolaktonom
English: The planned final analysis for OS was conducted after 741 deaths were observed (median follow up of 49 months).
Croatian: Planirana završna analiza za ukupno preživljenje provedena je nakon što je zabilježena 741 smrt (medijan praćenja od 49 mjeseci).
English: Scientific conclusions
Croatian: ZNANSTVENI ZAKLJUČCI
English: - You need to take prednisone or prednisolone every day while you are taking ZYTIGA.
Croatian: - Morate uzimati prednizon ili prednizolon svakog dana dok uzimate lijek ZYTIGA.
English: Patients with active or symptomatic viral hepatitis were excluded from clinical trials; thus, there are no data to support the use of ZYTIGA in this population.
Croatian: Bolesnici s aktivnim ili simptomatskim virusnim hepatitisom su bili isključeni iz kliničkih ispitivanja; stoga, nema podataka koji bi opravdali primjenu lijeka ZYTIGA u toj populaciji.
English: In all animal toxicity studies, circulating testosterone levels were significantly reduced.
Croatian: U svim istraživanjima toksičnosti na životinjama koncentracija testosterona u cirkulaciji bila je znatno snižena.
English: A higher incidence of hypertension and hypokalemia was observed in the hormone sensitive population (study 3011).
Croatian: Viša incidencija hipertenzije i hipokalemije bila je zabilježena u hormon osjetljivoj populaciji (ispitivanje 3011).
English: The apparent volume of distribution is approximately 5,630 l, suggesting that abiraterone extensively distributes to peripheral tissues.
Croatian: Prividni volumen distribucije je približno 5,630 l, što ukazuje da se abirateron u velikoj mjeri raspodjeljuje u periferna tkiva.
English: Each pack contains one bottle.
Croatian: Svako pakiranje sadrži jednu bocu.
English: ZYTIGA contains lactose and sodium - ZYTIGA contains lactose (a type of sugar).
Croatian: ZYTIGA sadrži laktozu i natrij - ZYTIGA sadrži laktozu (vrstu šećera).
English: However, subject data continued to be collected through the date of the second interim analysis of Overall survival (OS).
Croatian: Međutim, podaci iz ispitivanja nastavili su se prikupljati do druge interim analize ukupnog preživljenja (engl. overall survival).
English: Study treatments were discontinued at the time of unequivocal clinical progression.
Croatian: Liječenja iz ispitivanja prekinuta su u trenutku nedvosmislene kliničke progresije.
English: All treatment-related hormonal changes reversed or were shown to be resolving after a 4-week recovery period.
Croatian: Sve su se hormonske promjene povezane s liječenjem povukle ili se vidjelo poboljšanje nakon 4-tjednog razdoblja oporavka.
English: Analysis of rPFS utilised centrally-reviewed radiographic assessment of progression.
Croatian: U analizi rPFS korišten je centralni pregled radiografske procjene progresije.
English: - If you are having sex with a pregnant woman, use a condom to protect the unborn child.
Croatian: - Ako imate spolni odnos s trudnicom, koristite kondom kako biste zaštitili nerođeno dijete.
English: Interactions with other medicinal products
Croatian: Interakcije s drugim lijekovima
English: Heart attack, changes in ECG - electrocardiogram (QT prolongation).
Croatian: Srčani udar, promjene u EKG-u - elektrokardiogramu (produljenje QT intervala).
English: - Women who are or may potentially be pregnant (see section 4.6).
Croatian: - Žene koje su trudne ili bi mogle biti trudne (vidjeti dio 4.6).
English: Treatments could also be discontinued at the time of confirmed radiographic progression at the discretion of the investigator.
Croatian: Liječenja su također mogla biti prekinuta radi potvrđene radiografske progresije po odluci ispitivača.
English: - Keep this medicine out of the sight and reach of children.
Croatian: - Lijek čuvajte izvan pogleda i dohvata djece.
English: Hypertension, hypokalaemia and fluid retention should be corrected and controlled.
Croatian: Hipertenziju, hipokalemiju i retenciju tekućine treba korigirati i kontrolirati.
English: Recommended monitoring
Croatian: Preporučeno praćenje
English: Figure 7: Overall survival by subgroup: hazard ratio and 95% confidence interval
Croatian: Slika 7: Ukupno preživljenje po podskupinama: omjer hazarda i 95%-tni interval pouzdanosti
English: ZYTIGA has no or negligible influence on the ability to drive and use machines.
Croatian: ZYTIGA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: - The tablets are provided in a plastic bottle with a child-resistant closure.
Croatian: - Tablete su dostupne u plastičnim bocama sa sigurnosnim zatvaračem za djecu.
English: The investigator radiographic review of rPFS performed as a follow up sensitivity analysis is presented in Table 5 and Figure 4.
Croatian: Radiografski pregled ispitivača rPFS proveden kao nastavna analiza osjetljivosti, prikazan je u Tablici 5 i na Slici 4.
English: • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Croatian: • liječenje mCRPC-a u odraslih muškaraca čija je bolest napredovala tijekom ili nakon kemoterapijskog protokola temeljenog na docetakselu.
English: The active substance, abiraterone, shows an environmental risk for the aquatic environment, especially to fish.
Croatian: Djelatna tvar, abirateron, predstavlja rizik za vodeni okoliš, posebno za ribu.
English: A planned interim analysis (IA) for OS was conducted after 333 deaths were observed.
Croatian: Planirana interim analiza (IA) ukupnog preživljenja (engl. overall survival, OS) provedena je nakon zabilježene 333 smrti.
English: Changes in PSA serum concentration independently do not always predict clinical benefit.
Croatian: Promjene koncentracije PSA u serumu ne pretkazuju uvijek kliničku korist.
English: The Eastern Cooperative Oncology Group (ECOG) performance status was 0 for 76% of patients, and 1 for 24% of patients in both arms.
Croatian: Eastern Cooperative Oncology Group, ECOG) bilo je 0 za 76% bolesnika i 1 za 24% bolesnika u obje skupine.
English: Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death.
Croatian: Rijetko, može se pojaviti zatajenje funkcije jetre (nazvano akutno zatajenje jetre) koje može dovesti do smrti.
English: What ZYTIGA is and what it is used for What you need to know before you take ZYTIGA How to take ZYTIGA
Croatian: Što je ZYTIGA i za što se koristi Što morate znati prije nego počnete uzimati lijek ZYTIGA
English: Do not break the tablets.
Croatian: Nemojte lomiti tablete.
English: Hazard ratio <1 favors AA-P.
Croatian: Omjer hazarda <1 u korist AA-P.
English: Abiraterone affected fertility in male and female rats, but these effects were fully reversible (see section 5.3).
Croatian: Abirateron je utjecao na plodnost u mužjaka i ženki štakora, ali taj je učinak bio potpuno reverzibilan (vidjeti dio 5.3).
English: Effects on the external genitalia were observed though abiraterone acetate was not teratogenic.
Croatian: Uočeni su učinci na vanjske spolne organe, premda abirateronacetat nije bio teratogen.
English: The tablets should be swallowed whole with water (see section 4.2).
Croatian: Tablete je potrebno progutati cijele s vodom (vidjeti dio 4.2).