FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not keep any unused solution.
Slovenian: Neporabljeno raztopino zavrzite.
English: LUMIGAN 0.1 mg/ml, eye drops, solution Bimatoprost
Slovenian: LUMIGAN 0,1 mg/ml, kapljice za oko, raztopina bimatoprost
English: Cystoid macular oedema has been uncommonly reported (≥1/1,000 to <1/100) following treatment with bimatoprost 0.3 mg/ml eye drops.
Slovenian: Občasno (≥1/1.000 do <1/100) so poročali o cistoidnem makularnem edemu kot posledici zdravljenja z bimatoprostom 0,3 mg/ml kapljicami za oko.
English: How to use LUMIGAN 0.3 mg/ml
Slovenian: Kako uporabljati zdravilo LUMIGAN 0,3 mg/ml
English: • Swollen eyelids
Slovenian: • izpadanje trepalnic.
English: • Dryness
Slovenian: • draženje,
English: If you get any of the side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng/mL) following ocular dosing with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation).
Slovenian: Ker je sistemska koncentracija bimatoprosta pri lokalni uporabi bimatoprosta, 0,3 mg/ml kapljic za oko, raztopine, na očeh izjemno nizka (manj kot 0,2 ng/ml), interakcij pri ljudeh ni pričakovati.
English: • growth of eyelashes in up to 45% in the first year with the incidence of new reports decreasing to 7% at 2 years and 2% at 3 years
Slovenian: • rast trepalnic pri do 45 % bolnikov v prvem letu, z upadom števila novih poročil na 7 % pri 2 letih in 2 % pri 3 letih,
English: Nervous system disorders common headache uncommon dizziness
Slovenian: Bolezni živčevja pogosti glavobol občasni omotica
English: Medicinal product subject to medical prescription
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
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
Slovenian: Očesne bolezni zelo pogosti hiperemija veznice pogosti točkasti keratitis, draženje očesa, očesni pruritus, rast trepalnic, bolečine v očeh, eritem veke, pruritus veke občasni astenopija, zamegljen vid, konjunktivna motnja, konjunktivni edem, hiperpigmentacija irisa, madaroza, edem vek neznana pogostnost pigmentacija veke, makularni edem, periorbitalne spremembe in spremembe očesnih vek, vključno s poglobitvijo sulkusa očesne veke, suhe oči, izcedek iz oči, očesni edem, občutek tujka v očeh, povečano solzenje, neprijeten občutek v očesu, fotofobija
English: How to use LUMIGAN 0.1 mg/ml
Slovenian: Kako uporabljati zdravilo LUMIGAN 0,1 mg/ml
English: Warnings and precautions Talk to you doctor or pharmacist before you use LUMIGAN 0.3 mg/mL single-dose.
Slovenian: Pred začetkom uporabe zdravila LUMIGAN 0,1 mg/ml se posvetujte z zdravnikom ali farmacevtom.
English: Skin and subcutaneous tissue disorders common eyelid pruritus
Slovenian: Bolezni kože in podkožja pogosti pruritus vek
English: Most were ocular, mild and none was serious.
Slovenian: Večinoma so se pojavljali na očesu, bili so blagi in niso bili resni.
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
Slovenian: Očesne bolezni zelo pogosti očesni pruritus, rast trepalnic pogosti erozija roženice, pekoče oči, alergijski konjunktivitis, blefaritis, slabšanje ostrine vida, astenopija, konjunktivni edem, občutek tujka v očesu, suhe oči, bolečine v očeh, fotofobija, solzenje, očesni izcedek, motnje vida/zamegljen vid, povečana pigmentacija irisa, temnenje trepalnic občasni retinalne krvavitve, uveitis, cistoidni makularni edem, iritis, blefarospazem, retrakcija vek, periorbitalni eritem
English: Neither naevi nor freckles of the iris appears to be affected by the treatment.
Slovenian: Kaže, da zdravljenje ne vpliva na znamenja in pege irisa.
English: • Headache
Slovenian: • omotica
English: • Slight redness (up to 44% of people)
Slovenian: • rahla rdečina (do 44 % ljudi),
English: LUMIGAN 0.3 mg/ml, eye drops, solution Bimatoprost
Slovenian: LUMIGAN 0,3 mg/ml, kapljice za oko, raztopina bimatoprost
English: • Slight redness (up to 24% of people)
Slovenian: • rahla rdečina (do 24 % ljudi).
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
Slovenian: Očesne bolezni zelo pogosti hiperemija veznice, očesni pruritus, rast trepalnic pogosti površinski točkasti keratitis, erozija roženice, pekoče oči, draženje očesa, alergijski konjunktivitis, blefaritis, slabšanje ostrine vida, astenopija, konjunktivni edem, občutek tujka v očesu, suhe oči, bolečine v očeh, fotofobija, solzenje, očesni izcedek, motnje vida/zamegljen vid, povečana pigmentacija irisa, temnenje trepalnic, eritem vek, pruritus vek občasni retinalne krvavitve, uveitis, cistoidni makularni edem, iritis, blefarospazem, retrakcija vek, periorbitalni eritem, edem vek neznana pogostnost periorbitalne spremembe in spremembe očesne veke, vključno s poglobitvijo sulkusa očesne veke, neprijeten občutek v očesu
English: How to store LUMIGAN 0.3 mg/mL single-dose Contents of the pack and other information
Slovenian: Shranjevanje zdravila LUMIGAN 0,3 mg/ml (enoodmerna oblika) Vsebina pakiranja in dodatne informacije
English: LUMIGAN 0.3 mg/mL eye drops, solution, in single-dose container
Slovenian: LUMIGAN 0,3 mg/ml kapljice za oko, raztopina, v enoodmernem vsebniku
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.
Slovenian: Konzervans v zdravilu LUMIGAN, imenovan benzalkonijev klorid, lahko povzroči draženje oči in spremeni barvo mehkih kontaktnih leč.
English: There have been a limited number of spontaneous reports of bradycardia or hypotension with bimatoprost 0.3 mg/ml eye drops, solution.
Slovenian: Pri bimatoprostu 0,3 mg/ml kapljicah za oko, raztopini, obstaja omejeno število spontanih poročil o bradikardiji ali hipotenziji.
English: Neither naevi nor freckles of the iris appear to be affected by the treatment.
Slovenian: Zdravljenje kot kaže ne vpliva na znamenja in pege irisa.
English: • Dizziness
Slovenian: • srbenje.
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
Slovenian: Očesne bolezni pogosti erozija roženice, pekoče oči, alergijski konjunktivitis, blefaritis, slabšanje ostrine vida, očesni izcedek, motnje vida, temnenje trepalnic občasni retinalna krvavitev, uveitis, cistoidni makularni edem, iritis, blefarospazem, retrakcija vek neznana pogostnost periorbitalne spremembe in spremembe vek, vključno s poglobitvijo sulkusa očesne veke, neprijeten občutek v očesu
English: The following adverse reactions were reported during clinical trials with LUMIGAN 0.1 mg/ml eye drops, solution or in the post-marketing period.
Slovenian: Med kliničnimi preskušanji z zdravilom LUMIGAN 0,1 mg/ml kapljice za oko, raztopina, ali po prihodu zdravila na trg so poročali o naslednjih neželenih učinkih.
English: OTHER
Slovenian: Oči
English: The following adverse reactions were reported during clinical trials with LUMIGAN 0.3 mg/ml eye drops, solution or in the post-marketing period.
Slovenian: V kliničnih preskušanjih z zdravilom LUMIGAN 0,3 mg/ml kapljice za oko, raztopina, ali po prihodu zdravila na trg so poročali o naslednjih neželenih učinkih.
English: • Itchy and swollen eyelids
Slovenian: • srbeče in otečene veke,
English: • Headaches
Slovenian: • glavobol,
English: One ml of solution contains 0.3 mg bimatoprost
Slovenian: En ml raztopine vsebuje 0,3 mg bimatoprosta (Bimatoprost).
English: LUMIGAN 0.1 mg/ml eye drops, solution
Slovenian: LUMIGAN 0,1 mg/ml kapljice za oko, raztopina
English: What LUMIGAN 0.3 mg/ml looks like and contents of the pack LUMIGAN is a colourless clear eye drop solution in a pack containing either 1 plastic bottle or 3 plastic bottles each with a screw cap. Each bottle is approximately half full and contains 3 millilitres of solution.
Slovenian: Zdravilo LUMIGAN je brezbarvna, čista raztopina za oko v pakiranju, ki vsebuje 1 ali 3 plastenke z navojno zaporko.
English: In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/ml eye drops, solution.
Slovenian: V kliničnih študijah je bilo z z zdravilom LUMIGAN 0,3 mg/ml kapljice za oko, raztopina, zdravljenih prek 1800 bolnikov.
English: If you forget to use LUMIGAN, use a single drop as soon as you remember, and then go back to your regular routine.
Slovenian: Če ste pozabili uporabiti zdravilo LUMIGAN 0,1 mg/ml Če ste pozabili uporabiti zdravilo LUMIGAN, si vkapajte eno kapljico takoj, ko se spomnite in nadaljujte zdravljenje v običajnih razmikih.
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
Slovenian: Očesne bolezni zelo pogosti hiperemija veznice pogosti točkasti keratitis, draženje očesa, občutek tujka v očesu, suhe oči, bolečine v očeh, očesni pruritus, rast trepalnic, eritem vek občasni astenopija, edem veznice, fotofobija, povečano solzenje, povečana pigmentacija irisa, zamegljen vid, pruritus vek, edem vek neznana pogostnost izcedek iz oči, neprijeten občutek v očesu
English: Uncommon side effects
Slovenian: Občasni neželeni učinki
English: LUMIGAN 0.3 mg/ml eye drops, solution
Slovenian: LUMIGAN 0,3 mg/ml kapljice za oko, raztopina
English: How to use LUMIGAN 0.3 mg/mL single-dose
Slovenian: Kako uporabljati zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika)
English: There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with bimatoprost 0.3 mg/ml eye drops, solution.
Slovenian: Pri uporabi bimatoprosta 0,3 mg/ml kapljic za oko, raztopine, so redko spontano poročali o reaktivaciji predhodnih infiltratov roženice ali očesnih okužbah.
English: There have been a limited number of spontaneous reports of bradycardia or hypotension with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation).
Slovenian: Pri bimatoprostu 0,3 mg/ml kapljicah za oko, raztopini (večodmerna oblika), obstaja omejeno število spontanih poročil o bradikardiji ali hipotenziji.
English: • Shortness of breath
Slovenian: • potemnitev vek,
English: Nervous system disorders uncommon dizziness
Slovenian: Bolezni živčevja občasni omotica
English: Your sight may become blurred for a short time just after using LUMIGAN 0.3 mg/mL single-dose.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Takoj po uporabi zdravila LUMIGAN 0,3 mg/ml (enoodmerna oblika) je lahko vid za kratek čas zamegljen.
English: How to store LUMIGAN 0.3 mg/ml
Slovenian: Shranjevanje zdravila LUMIGAN 0,3 mg/ml
English: How to store LUMIGAN 0.1 mg/ml
Slovenian: Shranjevanje zdravila LUMIGAN 0,1 mg/ml
English: How to store LUMIGAN 0.3 mg/mL single-dose
Slovenian: Shranjevanje zdravila LUMIGAN 0,3 mg/ml (enoodmerna oblika)
English: • Sticky eyes
Slovenian: • srbenje oči,
English: Annex I List of medicinal products and presentations
Slovenian: Priloga I Seznam zdravil in oblik
English: - if you are a woman, especially if pregnant.
Slovenian: - Če ste ženska, še posebej, če ste noseči.
English: Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Slovenian: Ponedeljek Torek Sreda Četrtek Petek Sobota Nedelja peroralna uporaba
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Slovenian: CHMP se strinja z znanstvenimi zaključki PRAC.
English: There is no specific antidote.
Slovenian: Specifičnega antidota ni.
English: The safety of re-treatment in such patients is unknown.
Slovenian: Varnost ponovnega zdravljenja pri takih bolnikih ni znana.
English: • Risk Management Plan (RMP)
Slovenian: ● Načrt za obvladovanje tveganja (RMP)
English: Recommended monitoring
Slovenian: Priporočeno spremljanje
English: - if you have severe liver damage.
Slovenian: - Če imate hude težave z jetri.
English: All changes showed complete or partial reversibility.
Slovenian: Vse spremembe so bile v celoti ali deloma reverzibilne.
English: Your doctor may want to change the dose of these medicines.
Slovenian: Zdravnik vam bo morda spremenil odmerke teh zdravil.
English: Fill in your weekdays
Slovenian: Izpolnite dneve v tednu
English: This medicine is not for use in children and adolescents.
Slovenian: To zdravilo ni namenjeno za uporabo pri otrocih in mladostnikih.
English: Liver function also should be assessed.
Slovenian: Preveriti je treba tudi jetrno funkcijo.
English: Potential risks
Slovenian: Morebitno tveganje
English: “AA250” written on one side.
Slovenian: z oznako "AA250" na eni strani.
English: No dose adjustment can be predicted.
Slovenian: Prilagoditve odmerkov se ne da napovedati.
English: Not reached (11.66; NE)
Slovenian: ni doseženo (11,66; NE)
English: Also, some medicines may increase or decrease the effects of ZYTIGA.
Slovenian: Nekatera zdravila pa lahko povečajo ali zmanjšajo učinek zdravila ZYTIGA.
English: Contraception in males and females
Slovenian: Kontracepcija pri moških in ženskah
English: - in combination with Ra-223 (which is used to treat prostate cancer).
Slovenian: - Skupaj z Ra-223 (uporablja se za zdravljenje raka prostate).
English: Date of latest renewal: 26 May 2016
Slovenian: Datum prve odobritve: 05. september 2011 Datum zadnjega podaljšanja: 26. maj 2016
English: The median age of enrolled patients was 69 years (range 39-95).
Slovenian: Mediana starost vključenih bolnikov je bila 69 let (razpon 39-95).
English: Do not take ZYTIGA - if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila ZYTIGA - Če ste alergični na abirateronacetat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V posameznih kategorijah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: - Do not take ZYTIGA with food.
Slovenian: - Zdravila ZYTIGA ne jemljite skupaj s hrano.
English: However, subject data continued to be collected through the date of the second interim analysis of Overall survival (OS).
Slovenian: Podatke o preiskovancih so še naprej zbirali do datuma druge vmesne analize celokupnega preživetja.
English: Not reached (NE; NE)
Slovenian: ni doseženo (NE; NE)
English: A higher incidence of hypertension and hypokalemia was observed in the hormone sensitive population (study 3011).
Slovenian: Večjo incidenco hipertenzije in hipokaliemije so opažali pri populaciji hormonsko občutljivih bolnikov (študija 3011).
English: It is used to treat prostate cancer in adult men that has spread to other parts of the body.
Slovenian: Uporabljamo ga pri odraslih moških za zdravljenje raka prostate, ki se je že razširil na druge dele telesa.
English: These may be signs that the level of potassium in your blood is low.
Slovenian: Ti znaki lahko pomenijo, da je koncentracija kalija v vaši krvi prenizka.
English: The ECOG performance status was 0 or 1 for 97% of patients.
Slovenian: Ocena stanja zmogljivosti po lestvici ECOG je bila 0 ali 1 za 97% bolnikov.
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.
Slovenian: Bolniki z aktivnim ali simptomatskim virusnim hepatitisom niso bili vključeni v klinična preskušanja, zato ni podatkov, ki bi podpirali uporabo zdravila ZYTIGA pri tej populaciji.
English: When you are taking this medicine, your doctor will check your blood periodically to look for any effects on your liver.
Slovenian: V času jemanja zdravila vam bo zdravnik redno pregledoval kri, da bo lahko spremljal učinke na jetra.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ZYTIGA in all subsets of the paediatric population in advanced prostate cancer.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom ZYTIGA za vse podskupine pediatrične populacije za napredovalega raka prostate.
English: C-abiraterone in human plasma is 99.8%.
Slovenian: C-abirateron veže na beljakovine v plazmi v 99,8%.
English: The apparent volume of distribution is approximately 5,630 l, suggesting that abiraterone extensively distributes to peripheral tissues.
Slovenian: Navidezni volumen porazdelitve znaša približno 5.630 l, kar kaže na to, da se abirateron obsežno porazdeli v periferna tkiva.
English: 120 tablets
Slovenian: 120 tablet
English: What ZYTIGA is and what it is used for
Slovenian: Kaj je zdravilo ZYTIGA in za kaj ga uporabljamo
English: It is not known whether abiraterone or its metabolites are present in semen.
Slovenian: Ni znano, ali so abirateron oziroma njegovi presnovki prisotni v spermi.
English: ZYTIGA must not be given in combination with Ra-223 due to a possible increase in the risk of bone fracture or death.
Slovenian: Zdravila ZYTIGA se ne sme dajati v kombinaciji z Ra-223 zaradi možnega povečanja tveganja za zlome kosti ali smrti.
English: Therefore, in all studies it was recommended that patients be maintained on their study treatments until discontinuation criteria were met as specified below for each study.
Slovenian: Zato so v vseh študijah priporočali, da bolnik prejema študijsko zdravljenje, dokler ne izpolni za vsako študijo v nadaljevanju opisanih prekinitvenih kriterijev.
English: The active substance, abiraterone, shows an environmental risk for the aquatic environment, especially to fish.
Slovenian: Učinkovina abirateron predstavlja tveganje za vodno okolje, posebej za ribe.
English: There are no clinical data available to confirm transporter based interaction.
Slovenian: Kliničnih podatkov, ki bi potrdili medsebojno delovanje na osnovi prenašalca, ni.
English: Changes in PSA serum concentration independently do not always predict clinical benefit.
Slovenian: Spremembe koncentracije PSA v serumu vsaka zase ne napovedujejo vedno kliničnih koristi za bolnika.
English: Use with Spironolactone
Slovenian: Sočasna uporaba s spironolaktonom
English: In two instances marked increases in liver function tests occurred (see section 4.4).
Slovenian: V dveh primerih je prišlo do izrazitega zvišanja vrednosti testov jetrne funkcije (glejte poglavje 4.4).
English: This may lead to side effects or to ZYTIGA not working as well as it should.
Slovenian: To lahko vodi v pojav neželenih učinkov ali pa zdravilo ZYTIGA ne deluje tako učinkovito kot bi moralo.
English: - Women who are or may potentially be pregnant (see section 4.6).
Slovenian: - Ženske, ki so noseče oziroma bi lahko bile noseče (glejte poglavje 4.6).
English: Driving and using machines This medicine is not likely to affect your being able to drive and use any tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bo zdravilo vplivalo na vašo sposobnost vožnje in uporabe orodij in strojev.
English: What you need to know before you take ZYTIGA
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo ZYTIGA
English: No patient died of hepatotoxicity in Study 3011.
Slovenian: Noben bolnik pa v študiji 3011 ni umrl zaradi hepatotoksičnosti.
English: - Do not throw away any medicines via wastewater or household waste.
Slovenian: - Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: - Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: A planned interim analysis (IA) for OS was conducted after 333 deaths were observed.
Slovenian: Načrtovana vmesna analiza (IA) celokupnega preživetja (OS-overall survival) je bila izvedena po smrti 333 bolnikov.
English: Your doctor will tell you if you need to change the amount of prednisone or prednisolone you take.
Slovenian: Zdravnik vam bo povedal, če boste morali spremeniti odmerek prednizona ali prednizolona.
English: Do not break the tablets.
Slovenian: Tablet ne smete zdrobiti.
English: If hepatotoxicity recurs at the reduced dose of 500 mg daily, treatment should be discontinued.
Slovenian: Če se hepatotoksičnost ponovno pojavi pri jemanju zmanjšanega odmerka 500 mg na dan, je treba zdravljenje prekiniti.
English: - Do not break the tablets.
Slovenian: - Tablet ne smete zdrobiti.
English: In all animal toxicity studies, circulating testosterone levels were significantly reduced.
Slovenian: V vseh študijah toksičnosti na živalih so opažali bistveno znižanje koncentracij testosterona v obtoku.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
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.
Slovenian: Razen sprememb, ki so jih v vseh raziskavah toksičnosti na živalih opažali na reproduktivnih organih, neklinični podatki na podlagi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: The use of ZYTIGA in combination with a glucocorticoid could increase this effect.
Slovenian: Jemanje zdravila ZYTIGA v kombinaciji z glukokortikoidi lahko ta učinek poveča.
English: Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death.
Slovenian: Redko lahko pride do odpovedi delovanja jeter (imenujemo jo akutna odpoved jeter), ki lahko povzroči smrt.
English: ZYTIGA has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo ZYTIGA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The primary efficacy endpoint was overall survival.
Slovenian: Primarni cilj opazovanja je bilo celokupno preživetje.