FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with Alzheimer's disease, inhibition of AChE in CSF by oral rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested.
Slovenian: Pri bolnikih z Alzheimerjevo boleznijo je bila stopnja inhibicije AChE v CSF s peroralnim rivastigminom odvisna od odmerka do največjega preizkušanega odmerka 6 mg, danega dvakrat na dan. Inhibicija aktivnosti butirilholinesteraze v CSF pri 14 bolnikih z Alzheimerjevo boleznijo, zdravljenih s peroralnim rivastigminom, je bila podobna kot inhibicija aktivnosti AChE.
English: Polyester film, fluoropolymer-coated
Slovenian: Opna za nadziranje sproščanja poliestrski film obložen s fluoro-polimerom.
English: 1 capsule contains 6.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Slovenian: 1 kapsula vsebuje 6,0 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
English: Prometax 1.5 mg hard capsules rivastigmine
Slovenian: Prometax 1,5 mg trde kapsule rivastigmin
English: Prometax 4.5 mg hard capsules
Slovenian: Prometax 4,5 mg trde kapsule
English: Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ENA 713 4,5 mg” on body.
Slovenian: Belkast do rahlo rumen prašek v kapsuli z rdečim pokrovčkom in rdečim telesom kapsule z belim napisom “ENA 713 4,5 mg”.
English: CARTON FOR UNIT PACK
Slovenian: ŠKATLICA ZA POSAMIČNO PAKIRANJE
English: 1 capsule contains 1.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
Slovenian: 1 kapsula vsebuje 1,5 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine.
Slovenian: Vsaka kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 4,5 mg rivastigmina.
English: - Prometax 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “ENA 713 4,5 mg” on the body.
Slovenian: Prometax 4,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in rdeče telo kapsule z belim napisom “ENA 713 4,5 mg”.
English: Prometax 6.0 mg hard capsules rivastigmine
Slovenian: Prometax 6,0 mg trde kapsule rivastigmin
English: Prometax 4.6 mg/24 h transdermal patch rivastigmine
Slovenian: Prometax 4,6 mg/24 h transdermalni obliž rivastigmin
English: • Uneven heartbeat and poor control of movements Other side effects seen with Prometax transdermal patches and which may occur with the hard capsules:
Slovenian: Drugi neželeni učinki, ki so jih opažali pri uporabi transdermalnih obližev Prometax in bi se lahko pojavili tudi pri uporabi trdih kapsul:
English: Prometax 3.0 mg hard capsules rivastigmine
Slovenian: Prometax 3,0 mg trde kapsule rivastigmin
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine.
Slovenian: Vsaka kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 3,0 mg rivastigmina.
English: Prometax 3.0 mg hard capsules
Slovenian: Prometax 3,0 mg trde kapsule
English: Prometax 9.5 mg/24 h transdermal patch rivastigmine
Slovenian: Prometax 9,5 mg/24 h transdermalni obliž rivastigmin
English: Gastrointestinal haemorrhage
Slovenian: peroralna raztopina
English: - Prometax 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “ENA 713 3 mg” on the body.
Slovenian: Prometax 3,0 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo oranžen pokrovček in oranžno telo kapsule z rdečim napisom “ENA 713 3 mg”.
English: • Changes in tests which show how well the liver is working
Slovenian: • spremembe v izvidih preiskav za oceno delovanja jeter
English: • Increased sweating
Slovenian: • povečano potenje
English: Prometax 4.5 mg hard capsules rivastigmine
Slovenian: Prometax 4,5 mg trde kapsule rivastigmin
English: Prometax 13.3 mg/24 h transdermal patch rivastigmine
Slovenian: Prometax 13,3 mg/24 h transdermalni obliž rivastigmin
English: 1 capsule contains 3.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Slovenian: 1 kapsula vsebuje 3,0 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
English: 1 capsule contains 4.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
Slovenian: 1 kapsula vsebuje 4,5 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
English: - Prometax 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “ENA 713 6 mg” on the body.
Slovenian: Prometax 6,0 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in oranžno telo kapsule z rdečim napisom “ENA 713 6 mg”.
English: Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine.
Slovenian: Vsak mililiter zdravila vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 2,0 mg rivastigmina.
English: Prometax might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
Slovenian: ki se uporabljajo za lajšanje želodčnih krčev (npr. diciklomin), za zdravljenje Parkinsonove bolezni (npr. amantadin) ali za preprečevanje potovalne slabosti (npr. difenhidramin, skopolamin ali meklizin) oziroma ta zdravila lahko vplivajo na rivastigmin.
English: Pancreatitis
Slovenian: Distonija
English: Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “ENA 713 6 mg” on body.
Slovenian: Belkast do rahlo rumen prašek v kapsuli z rdečim pokrovčkom in oranžnim telesom kapsule z rdečim napisom “ENA 713 6 mg”.
English: Skin irritation
Slovenian: Draženje kože
English: Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on body.
Slovenian: Belkast do rahlo rumen prašek v kapsuli z rumenim pokrovčkom in rumenim telesom kapsule z rdečim napisom “ENA 713 1,5 mg”.
English: • Carefully remove any existing patch before putting on a new one.
Slovenian: • Preden namestite nov obliž, previdno odstranite prešnjega.
English: Prometax 9.5 mg/24 h transdermal patch
Slovenian: Prometax 9,5 mg/24 h transdermalni obliž
English: Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “ENA 713 3 mg” on body.
Slovenian: Belkast do rahlo rumen prašek v kapsuli z oranžnim pokrovčkom in oranžnim telesom kapsule z rdečim napisom “ENA 713 3 mg”.
English: Prometax 4.6 mg/24 h transdermal patch
Slovenian: Prometax 4,6 mg/24 h transdermalni obliž
English: Headache, syncope, dizziness
Slovenian: • izpuščaj, srbenje
English: Prometax 13.3 mg/24 h transdermal patch
Slovenian: Prometax 13,3 mg/24 h transdermalni obliž
English: - if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.
Slovenian: Ne jemljite zdravila Prometax - če ste alergični na rivastigmin (zdravilno učinkovino v zdravilu Prometax) ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če opazite kožno reakcijo, ki se širi preko površine, ki jo pokriva transdermalni obliž, če je reakcija na tem mestu močneje izražena (če se pojavijo mehurčki, če je vnetje oziroma oteklina vse bolj izrazita) in če se ti znaki v 48 urah po odstranitvi transdermalnega obliža ne izboljšajo.
English: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain
Slovenian: Bolezni jeter, žolčnika in žolčevodov pogostnost neznana hepatitis
English: What Prometax looks like and contents of the pack - Prometax 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on the body.
Slovenian: Prometax 1,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rumen pokrovček in rumeno telo kapsule z rdečim napisom “ENA 713 1,5 mg”.
English: Application site skin reactions (e.g. application site erythema*, application site pruritus*, application site oedema*, application site dermatitis, application site irritation), asthenic conditions (e.g. fatigue, asthenia), pyrexia, weight decreased
Slovenian: Bolezni sečil pogosti urinska inkontinenca Splošne težave in spremembe na mestu aplikacije pogosti kožne reakcije na mestu aplikacije (npr. rdečina na mestu aplikacije*, srbenje na mestu aplikacije*, oteklina na mestu aplikacije*, dermatitis na mestu aplikacije, draženje na mestu aplikacije), astenična stanja (npr. utrujenost, astenija), zvišana telesna temperatura, zmanjšanje telesne mase redki padec *V 24-tedenski kontrolirani študiji pri japonskih bolnikih so o rdečini na mestu aplikacije, oteklini na mestu aplikacije in srbenju na mestu aplikacije poročali s pogostnostjo “zelo pogosto”.
English: EU/1/98/092/023-026 EU/1/98/092/035-038
Slovenian: EU/1/98/092/035-038
English: • Trembling
Slovenian: • zgaga
English: EU/1/98/092/027-030 EU/1/98/092/039-042
Slovenian: EU/1/98/092/039-042
English: • Uneven heartbeat and poor control of movements Other side effects seen with Prometax transdermal patches and which may occur with the oral solution:
Slovenian: Drugi neželeni učinki, ki so jih opažali pri uporabi transdermalnih obližev Prometax in bi se lahko pojavili tudi pri uporabi peroralne raztopine:
English: Syncope
Slovenian: ADASCog
English: EU/1/98/092/025 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/026 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/037 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/038 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
Slovenian: EU/1/98/092/025 60 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/026 90 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/037 60 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA) EU/1/98/092/038 90 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
English: EU/1/98/092/029 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/030 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/041 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/042 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
Slovenian: EU/1/98/092/029 60 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/030 90 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/041 60 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA) EU/1/98/092/042 90 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
English: Atrioventricular block, atrial fibrillation, tachycardia, sick sinus syndrome
Slovenian: Srčne bolezni pogosti bradikardija občasni atrijska fibrilacija občasni atrioventrikularni blok pogostnost neznana bolezen sinusnega vozla
English: Prometax 15 cm
Slovenian: 10 cm
English: Renal and hepatic impairment
Slovenian: Okvare ledvic in jeter
English: EU/1/98/092/023 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/024 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/035 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/036 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
Slovenian: EU/1/98/092/023 7 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/024 30 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/035 7 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA) EU/1/98/092/036 30 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
English: Restlessness
Slovenian: • omotičnost
English: How to remove your Prometax transdermal patch Gently pull at one edge of the patch to remove it slowly from the skin.
Slovenian: Nežno povlecite za en rob obliža in nato obliž počasi odstranite.
English: EU/1/98/092/027 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/028 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/039 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/040 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
Slovenian: EU/1/98/092/027 7 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/028 30 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/039 7 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA) EU/1/98/092/040 30 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
English: • Fainting
Slovenian: • hujšanje
English: EU/1/98/092/019 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/020 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/031 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/032 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
Slovenian: EU/1/98/092/019 7 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/020 30 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/031 7 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA) EU/1/98/092/032 30 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
English: Quinoline yellow WS dye (E104) Purified water
Slovenian: 6.1 Seznam pomožnih snovi natrijev benzoat citronska kislina natrijev citrat kinolinsko rumeno WS barvilo (E104) prečiščena voda
English: EU/1/98/092/021 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/022 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/033 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/034 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
Slovenian: EU/1/98/092/021 60 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/022 90 transdermalnih obližev (vrečka: papir/PET/alu/PAN) EU/1/98/092/033 60 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA) EU/1/98/092/034 90 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
English: EU/1/98/092/019-022 EU/1/98/092/031-034
Slovenian: EU/1/98/092/031-034
English: Unchanged rivastigmine is found in trace amounts in the urine; renal excretion of the metabolites is the major route of elimination after transdermal patch administration.
Slovenian: Poglavitna pot izločanja po aplikaciji s transdermalnim obližem je izločanje skozi ledvice.
English: Gastrointestinal disorders Very common
Slovenian: Preiskave pogosti hujšanje
English: How to store Prometax
Slovenian: Shranjevanje zdravila Prometax
English: Metabolism and nutrition disorders Very common
Slovenian: Presnovne in prehranske motnje pogosti zmanjšan apetit pogosti dehidracija
English: Management
Slovenian: Ukrepi
English: Take off your patch and tell your doctor straight away, if you notice any of the side effects above.
Slovenian: Če opazite katerega od zgoraj navedenih neželenih učinkov, takoj snemite obliž in obvestite svojega zdravnika.
English: Hepatitis Skin and subcutaneous tissue disorders Common
Slovenian: Žilne bolezni pogosti hipertenzija občasni hipotenzija
English: It is not for use in women and must not be given to women who are or who may be pregnant.
Slovenian: Ni namenjeno uporabi pri ženskah in se ne sme dajati ženskam, ki so ali bi lahko bile noseče.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zytiga on 5 September 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zytiga, veljavno po vsej Evropski uniji, izdala 5. septembra 2011.
English: What measures are being taken to ensure the safe and effective use of Zytiga?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zytiga?
English: Zytiga abiraterone acetate
Slovenian: Zytiga abirateron acetat
English: The recommended dose of Zytiga is 1,000 mg taken once a day at least two hours after eating and at least one hour before further food.
Slovenian: Priporočeni odmerek zdravila Zytiga je 1 000 mg enkrat na dan vsaj dve uri po obroku in najmanj eno uro pred naslednjim obrokom.
English: Other information about Zytiga
Slovenian: Druge informacije o zdravilu Zytiga
English: The full EPAR for Zytiga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zytiga je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Zytiga.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zytiga.
English: Treatment may be resumed at a reduced dose if liver function returns to normal.
Slovenian: Zdravljenje se lahko nadaljuje z zmanjšanim odmerkom, če se ponovno vzpostavi normalno delovanje jeter.
English: Zytiga is available as tablets (250 and 500 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Zytiga je na voljo v obliki tablet (250 in 500 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: The European Medicines Agency decided that Zytiga's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Zytiga večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: If patients develop liver problems treatment should be stopped.
Slovenian: Če se pri bolnikih pojavijo težave z jetri, je treba zdravljenje prekiniti.
English: Zytiga is a medicine used to treat cancer of the prostate (a gland of the male reproductive system) in adult men when the cancer is metastatic (has spread to other parts of the body).
Slovenian: Zytiga je zdravilo za zdravljenje raka prostate (žleze moškega reproduktivnega sistema) pri odraslih moških, pri katerih je rak metastaziral (se razširil v druge dele telesa).
English: What are the risks associated with Zytiga?
Slovenian: Kakšna tveganja so povezana z zdravilom Zytiga?
English: Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body.
Slovenian: Abirateron to doseže tako, da zavre encim, imenovan CYP17, ki se nahaja v modih, pa tudi drugod v telesu.
English: In the studies, patients were also treated with prednisone or prednisolone.
Slovenian: V študijah so bolniki prejemali tudi prednizon ali prednizolon.
English: • when the cancer is newly diagnosed, high risk and still sensitive to hormones; Zytiga is then used in combination with a treatment called androgen deprivation therapy;
Slovenian: • ob novo postavljeni diagnozi raka z visokim tveganjem in še vedno občutljivega na hormone se zdravilo Zytiga uporablja v kombinaciji z zdravljenjem, imenovanim terapija odtegnitve androgenov;
English: Because the cancer needs a supply of testosterone to survive and grow, by reducing the production of testosterone, Zytiga may slow the growth of the prostate cancer.
Slovenian: Ker rak za svoje preživetje in rast potrebuje prisotnost testosterona, lahko zdravilo Zytiga z zaviranjem proizvodnje testosterona upočasni rast raka prostate.
English: Zytiga is used together with the medicines prednisone or prednisolone in the following situations:
Slovenian: Zdravilo Zytiga se uporablja skupaj z zdraviloma prednizonom in prednizolonom v naslednjih primerih:
English: In a third study involving 1,195 men with metastatic prostate cancer whose disease had got worse despite surgical or medical castration treatment and chemotherapy with docetaxel, the main measure of effectiveness was overall survival (how long the patients lived).
Slovenian: V tretji študiji, v kateri je sodelovalo 1 195 moških z metastatskim rakom prostate, pri katerih se je bolezen poslabšala kljub kirurški ali medicinski kastraciji in kemoterapiji z docetakselom, je bilo glavno merilo učinkovitosti celokupno preživetje (kako dolgo so bolniki živeli).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zytiga have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Other important side effects include heart problems, liver problems, fractures and allergic alveolitis (a lung reaction causing cough and shortness of breath).
Slovenian: Drugi pomembni neželeni učinki vključujejo težave s srcem in jetri, zlome kosti in alergijski alveolitis (pljučna reakcija, ki se kaže kot kašelj in oteženo dihanje).
English: What benefits of Zytiga have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Zytiga izkazalo v študijah?
English: Zytiga was compared with placebo (a dummy treatment) in three main studies.
Slovenian: Zdravilo Zytiga so primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah.
English: What is Zytiga and what is it used for?
Slovenian: Kaj je zdravilo Zytiga in za kaj se uporablja?
English: The most common side effects with Zytiga (seen in more than 1 patient in 10) are urinary tract infection, hypokalaemia (low blood potassium levels), high blood pressure, peripheral oedema (swelling of the limbs due to fluid retention) and increases in liver enzymes.
Slovenian: Najpogostejši neželeni učinki zdravila Zytiga (opaženi pri več kot 1 bolniku od 10) so okužbe sečil, hipokaliemija (nizke ravni kalija v krvi), visok krvni tlak, periferni edem (otekanje okončin zaradi zadrževanja tekočine) in zvišane ravni jetrnih encimov.
English: Zytiga must not be used in patients with severely reduced liver function.
Slovenian: Zdravila Zytiga ne smejo uporabljati bolniki s hudo okvaro jeter.
English: It is not intended to provide practical advice on how to use Zytiga.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Zytiga approved?
Slovenian: Zakaj je bilo zdravilo Zytiga odobreno?
English: The Agency noted that Zytiga in combination with prednisone or prednisolone has been shown to either delay progression of the disease or improve survival compared with placebo.
Slovenian: Agencija je ugotovila, da zdravilo Zytiga v kombinaciji s prednizonom ali prednizolonom zavre napredovanje bolezni ali izboljša celokupno preživetje v primerjavi s placebom.
English: For more information about treatment with Zytiga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zytiga preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The second study involved 1,088 men with metastatic prostate cancer who had either no symptoms or only mild symptoms of the disease and for whom castration treatment had not worked or had stopped working.
Slovenian: Druga študija je vključevala 1 088 moških z metastatskim rakom prostate, ki bodisi niso imeli simptomov bodisi so ti bili blagi in pri katerih zdravljenje s kastracijo ni delovalo ali je prenehalo delovati.
English: • when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.
Slovenian: • ko medicinska ali kirurška kastracija in kemoterapija z docetakselom ni delovala ali je prenehala delovati.
English: • when medical castration (using medicines to stop the production of male hormones) with an androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines);
Slovenian: • ko medicinska kastracija (pri kateri se z zdravili zavre tvorjenje moških hormonov) s terapijo odtegnitve androgenov ni delovala ali je prenehala delovati pri moških brez simptomov ali z blagimi simptomi bolezni, ki še ne potrebujejo kemoterapije (zdravil za zdravljenje raka);
English: For practical information about using Zytiga, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Zytiga naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.