FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Zytiga.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Zytiga.
English: What measures are being taken to ensure the safe and effective use of Zytiga?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zytiga?
English: The main measure of effectiveness was how long patients lived without their disease getting worse.
Croatian: Glavno mjerilo djelotvornosti bilo je razdoblje preživljenja bez pogoršanja bolesti.
English: What is Zytiga and what is it used for?
Croatian: Što je Zytiga i za što se koristi?
English: It is not intended to provide practical advice on how to use Zytiga.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Zytiga.
English: Zytiga must not be used in patients with severely reduced liver function.
Croatian: Lijek Zytiga ne smiju uzimati bolesnici sa znatno smanjenom jetrenom funkcijom.
English: Other important side effects include heart problems, liver problems, fractures and allergic alveolitis (a lung reaction causing cough and shortness of breath).
Croatian: Druge važne nuspojave uključuju probleme sa srcem, probleme s jetrom, prijelome i alergijski alveolitis (reakcija pluća koja uzrokuje kašalj i otežano disanje).
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).
Croatian: Zytiga je lijek koji se primjenjuje za liječenje raka prostate (muške spolne žlijezda) u odraslih muškaraca kada je rak metastazirao (proširio se na druge dijelove tijela).
English: If patients develop liver problems treatment should be stopped.
Croatian: Ako se u bolesnika pojave problemi s jetrom, liječenje treba prekinuti.
English: Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body.
Croatian: Abirateron to čini inhibirajući djelovanje enzima CYP17 koji je prisutan u testisima i drugdje u tijelu.
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.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Zytiga nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za njegovu primjenu u EU-u.
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.
Croatian: Agencija je napomenula da se lijek Zytiga u kombinaciji s prednizonom ili prednizolonom pokazao djelotvornim u usporavanju napretka bolesti ili povećanju preživljenja u usporedbi s placebom.
English: What are the risks associated with Zytiga?
Croatian: Koji su rizici povezani s lijekom Zytiga?
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).
Croatian: U trećem ispitivanju kojim je bilo obuhvaćeno 1 195 muškaraca s metastatskim rakom prostate, a čija se bolest pogoršala unatoč kirurškoj ili medicinskoj kastraciji i kemoterapiji docetakselom, glavno mjerilo djelotvornosti bilo je ukupno preživljenje (koliko su dugo bolesnici živjeli).
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;
Croatian: • ako je riječ o raku koji je nedavno dijagnosticiran, visokorizičan i još uvijek osjetljiv na hormone; Zytiga se tada primjenjuje u kombinaciji s terapijom deprivacije androgena;
English: • when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.
Croatian: • ako medicinska ili kirurška kastracija i kemoterapija koja sadržava docetaksel nisu djelovale ili više ne djeluju.
English: Zytiga is used together with the medicines prednisone or prednisolone in the following situations:
Croatian: Zytiga se primjenjuje u kombinaciji s prednizonom ili prednizolonom u sljedećim situacijama:
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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zytiga nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Zytiga was compared with placebo (a dummy treatment) in three main studies.
Croatian: Lijek Zytiga uspoređen je s placebom (prividnim liječenjem) u trima glavnim ispitivanjima.
English: Why is Zytiga approved?
Croatian: Zašto je lijek Zytiga odobren?
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);
Croatian: • ako medicinska kastracija (primjena lijekova kako bi se zaustavilo stvaranje muških hormona) u kombinaciji s terapijom deprivacije androgena nije djelovala ili više ne djeluje u muškaraca koji nemaju simptoma bolesti ili su ti simptomi blagi, a kojima još nije potrebna kemoterapija (lijekovi protiv raka);
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.
Croatian: Najčešće su nuspojave lijeka Zytiga (zabilježene u više od 1 na 10 bolesnika) infekcije mokraćnih putova, hipokalemija (niske razine kalija u krvi), visok krvni tlak, periferni edem (oticanje udova uslijed zadržavanja tekućine) i povišene razine jetrenih enzima.
English: The active substance in Zytiga, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone.
Croatian: Djelatna tvar lijeka Zytiga, abirateronacetat, u tijelu se pretvara u abirateron, koji zaustavlja stvaranje muškog spolnog hormona testosterona.
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.
Croatian: Drugim ispitivanjem bilo je obuhvaćeno 1 088 muškaraca s metastatskim rakom prostate koji nisu imali simptoma bolesti ili su simptomi bili blagi, a kod kojih kastracija nije djelovala ili je prestala djelovati.
English: One study involved 1,209 patients with newly diagnosed, high-risk, hormone-sensitive, metastatic prostate cancer.
Croatian: Jednim ispitivanjem bilo je obuhvaćeno 1 209 bolesnika s novodijagnosticiranim, visokorizičnim metastatskim rakom prostate osjetljivim na hormone.
English: For more information about treatment with Zytiga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Zytiga pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: For practical information about using Zytiga, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Zytiga bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How does Zytiga work?
Croatian: Kako djeluje Zytiga?
English: What benefits of Zytiga have been shown in studies?
Croatian: Koje su koristi lijeka Zytiga utvrđene u ispitivanjima?
English: In the studies, patients were also treated with prednisone or prednisolone.
Croatian: Tijekom tih ispitivanja bolesnici su liječeni i prednizonom ili prednizolonom.
English: For the full list of all side effects reported with Zytiga, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Zytiga potražite u uputi o lijeku.
English: Zytiga is well tolerated and its risks are considered manageable.
Croatian: Lijek Zytiga dobro se podnosi, a nuspojave se mogu kontrolirati.
English: Patients treated with Zytiga lived for just under 15 months from the start of treatment compared with just under 11 months for patients given placebo.
Croatian: Bolesnici liječeni lijekom Zytiga živjeli su samo nešto manje od 15 mjeseci nakon početka liječenja, dok su bolesnici koji su primali placebo živjeli nešto manje od 11 mjeseci.
English: How is Zytiga used?
Croatian: Kako se Zytiga koristi?
English: Patients treated with Zytiga lived for an average of around 16 months without their disease getting worse, compared with around 8 months in patients given placebo.
Croatian: Bolesnici koji su primali lijek Zytiga živjeli su u prosjeku oko 16 mjeseci bez pogoršanja bolesti, a oni koji su primali placebo oko 8 mjeseci.
English: Patients treated with Zytiga lived for an average of 33 months without their disease getting worse, compared with around 15 months for patients given placebo.
Croatian: Bolesnici liječeni lijekom Zytiga živjeli su u prosjeku 33 mjeseca bez pogoršanja bolesti, a bolesnici koji su primali placebo oko 15 mjeseci.
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.
Croatian: Primjenom lijeka Zytiga može se usporiti rast raka prostate jer se lijekom smanjuje stvaranje testosterona koji je raku potreban kako bi preživio i rastao.
English: Zytiga contains the active substance abiraterone acetate.
Croatian: Zytiga sadržava djelatnu tvar abirateronacetat.
English: Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction ………….
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koji od sljedećih znakova i simptoma koji mogu upućivati na ozbiljnu alergijsku reakciju ………….
English: Frequency ‘Not known': Kounis syndrome
Croatian: Učestalost „nepoznata”: Kounisov sindrom
English: There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8).
Croatian: Zabilježene su reakcije preosjetljivosti koje su se razvile u Kounisov sindrom (akutni alergijski spazam koronarne arterije koji može dovesti do infarkta miokarda, vidjeti dio 4.8).
English: Adopted at the 28-31 October 2019 PRAC
Croatian: Usvojeno na sjednici PRAC-a 28. - 31. listopada 2019.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/580133/2019
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/601855/2019
English: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions.
Croatian: Parenteralno primijenjeni pripravci željeza mogu uzrokovati reakcije preosjetljivosti, uključujući ozbiljne i potencijalno smrtonosne anafilaktičke/anafilaktoidne reakcije.
English: And chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
Croatian: I bol u prsnom košu, što može biti znak potencijalno ozbiljne alergijske reakcije poznate pod nazivom Kounisov sindrom.
English: Iron sucrose; iron carboxymaltose; iron isomaltoside; iron dextran; sodium ferric gluconate - Arteriospasm coronary (EPITT no 19408)
Croatian: Željezova saharoza; željezova karboksimaltoza; željezov izomaltozid; željezov dekstran; natrijev željezov(III) glukonat - spazam koronarne arterije (EPITT br. 19408)
English: Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.
Croatian: Reakcije preosjetljivosti zabilježene su i nakon što su primjene prethodnih doza parenteralnih kompleksa željeza prošle bez pojave reakcija.
English: Undesirable effetcs Cardiac disorders
Croatian: Srčani poremećaji
English: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom: Plendil
Croatian: Austrija, Belgija, Bugarska, Cipar, Češka Republika, Danska, Estonija, Finska, Grčka, Hrvatska, Island, Irska, Italija, Latvija, Litva, Luksemburg, Mađarska, Malta, Nizozemska, Norveška, Poljska, Portugal, Rumunjska, Slovačka, Španjolska, Švedska, Ujedinjeno Kraljevstvo: Plendil
English: France: Flodil
Croatian: Francuska: Flodil
English: Plendil with food and drink
Croatian: Plendil s hranom i pićem
English: The dose should be adjusted individually.
Croatian: Dozu treba prilagođavati individualno.
English: Your doctor will advise you how long to take your medicine.
Croatian: Vaš će Vam liječnik savjetovati koliko dugo trebate uzimati lijek.
English: Therefore, it is very important that you take the number of doses prescribed by your doctor.
Croatian: Stoga je vrlo važno da uzmete broj doza koji Vam je propisao Vaš liječnik.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Croatian: {Ime i adresa} {tel} {fax} {e-mail}
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Croatian: Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EEA) pod sljedećim nazivima:
English: Less than 0.5% of a dose is recovered unchanged in urine.
Croatian: Manje od 0,5% doze nađe se nepromijenjeno u urinu.
English: • Skin reactions due to increased sensitivity to sunlight
Croatian: • reakcije kože zbog pojačane osjetljivosti na sunčevu svjetlost
English: This belongs to a group of medicinces called calcium antagonists.
Croatian: Pripada skupini lijekova koje zovemo antagonisti kalcija.
English: Talk to your doctor before taking Plendil, especially if you have problems with your liver.
Croatian: Obratite se svom liječniku prije nego uzmete Plendil, osobito ako imate problema s jetrom.
English: If necessary another antihypertensive agent may be added.
Croatian: Ukoliko je potrebno može se dodati drugi antihipertenziv.
English: If you forget to take a tablet, leave out that dose completely.
Croatian: Ako ste zaboravili uzeti tabletu, u potpunosti izostavite tu dozu.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno u suradnji s referentnom državom članicom, sukladno postupcima navedenima u Poglavlju 4 Glave III Direktive 2001/83/EC.
English: Your doctor may lower the dose.
Croatian: Liječnik Vam može sniziti dozu.
English: If you take more Plendil than you should
Croatian: Ako uzmete više Plendila nego što ste trebali
English: What you need to know before you take Plendil
Croatian: Što morate znati prije nego počnete uzimati Plendil
English: Other medicines and Plendil
Croatian: Drugi lijekovi i Plendil
English: If necessary, your doctor may increase the dose or add another blood-pressure lowering medicine.
Croatian: Vaš liječnik po potrebi može povećati dozu ili dodati drugi lijek za snižavanje krvnog tlaka.
English: Do not use this medicine if you notice the packaging is torn or damaged.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje poderano ili oštećeno.
English: It does not negatively affect the heart function.
Croatian: Ne utječe negativno na rad srca.
English: • Certain flavonoids present in grapefruit juice
Croatian: • određeni flavonoidi prisutni u soku od grejpa
English: This leaflet was last revised in {MM/YYYY} {month YYYY}
Croatian: Ova uputa je zadnji put revidirana u {MM/GGGG} {mjesec GGGG}
English: Germany: Modip Italy: Feloday, Prevex Portugal: Preslow Sweden: Felodipin AstraZeneca
Croatian: Italija: Feloday, Prevex Portugal: Preslow Švedska: Felodipin AstraZeneca
English: Impotence/sexual dysfunction
Croatian: Impotencija/seksualna disfunkcija
English: The tablets should be taken in the morning and be swallowed with water.
Croatian: Tablete treba uzeti ujutro i progutati s vodom.
English: These effects are dose-dependent.
Croatian: Ti učinci ovise o dozi.
English: Management If justified: activated charcoal, gastric lavage if performed within one hour after ingestion.
Croatian: Ako je opravdano: aktivni ugljen, ispiranje želuca ako se obavi unutar jednog sata od ingestije.
English: Children The use of Plendil is not recommended in children.
Croatian: Uporaba Plendila u djece se ne preporučuje.
English: if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na felodipin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Plendil contains lactose that is a type of sugar.
Croatian: Plendil sadrži laktozu, koja je jedna vrsta šećera.
English: • Hypersensitivity and allergic reactions: The signs may include raised lumps on your skin (weals) or swelling of your face, lips, mouth, tongue or throat.
Croatian: • Preosjetljivost i alergijske reakcije: Znakovi mogu uključivati kvrge na koži (urtike) ili oticanje lica, usnica, usne šupljine, jezika ili grla.
English: Felodipine should not be given during pregnancy.
Croatian: Felodipin se ne smije primjenjivati tijekom trudnoće.
English: The half-life of felodipine in the elimination phase is approximately 25 hours and steady state is reached after 5 days.
Croatian: Eliminacija Poluvijek felodipina u eliminacijskoj fazi iznosi oko 25 sati, a stanje dinamičke ravnoteže postiže se nakon 5 dana.
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}> [To be completed nationally]
Croatian: DATUM REVIZIJE TEKSTA <{MM/GGGG}> <{DD/MM/GGGG}> <{DD mjesec GGGG}>
English: Take your next dose at the right time.
Croatian: Sljedeću dozu uzmite u za to predviđeno vrijeme.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: What Plendil is and what it is used for
Croatian: Što se nalazi u ovoj uputi: Što je Plendil i za što se koristi
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ovaj Sažetak opisa svojstava lijeka, označavanje i uputa o lijeku ishod su arbitražnog postupka na koji se odnosi ova Odluka Komisije EU.
English: Maximum blood plasma levels (tmax) are achieved with the prolonged-release form after 3 to 5 hours.
Croatian: Najviše razine u plazmi (tmax) postižu se s produljenim oslobađanjem nakon 3 do 5 sati.
English: • Cimetidine
Croatian: • cimetidin
English: Pharmacotherapeutic group: calcium channel blockers, dihydropyridine derivatives; ATC code: C08CA02
Croatian: Farmakoterapijska skupina: blokatori kalcijevih kanala, derivati dihidropiridina; ATK oznaka: C08CA02
English: Most of these reactions appear at start of treatment or after a dose increase.
Croatian: Većina ovih nuspojava javlja se na početku liječenja ili nakon povećanja doze.
English: How to take Plendil Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
English: Caution is recommended especially at the start of treatment.
Croatian: Poseban oprez potreban je na početku liječenja.
English: The study failed to demonstrate the efficacy of felodipine in lowering blood pressure in children aged 6-16 years (see section 4.2)
Croatian: Ispitivanje nije dokazalo djelotvornost felodipina u snižavanju krvnog tlaka u djece u dobi od 6 do 16 godina (vidjeti dio 4.2).
English: if you have acute myocardial infarction (heart attack).
Croatian: - ako imate akutni infarkt miokarda (srčani udar).
English: The plasma protein binding of felodipine is approximately 99%.
Croatian: Vezanje felodipina za proteine u plazmi je oko 99%.
English: Felodipine tablets should not be taken together with grapefruit juice.
Croatian: Felodipin tablete ne smiju se uzimati zajedno sa sokom od grejpa.
English: Felodipine is effective in all grades of hypertension.
Croatian: Felodipin je djelotvoran u svim stupnjevima hipertenzije.
English: The anomalies in the foetuses were induced when felodipine was administered during early foetal development (before day 15 of pregnancy).
Croatian: Anomalije u fetusa zabilježene su kad je felodipin primjenjivan tijekom ranog fetalnog razvoja (prije 15. dana trudnoće).
English: • Inflammation of small blood vessels of the skin
Croatian: • upala malih krvnih žila u koži
English: If severe hypotension occurs, symptomatic treatment should be instituted.
Croatian: U slučaju teške hipotenzije, treba započeti simptomatsko liječenje.
English: If you forget to take Plendil
Croatian: Ako ste zaboravili uzeti Plendil
English: Gingival hyperplasia, gingivitis
Croatian: Hiperplazija gingive, gingivitis
English: • barbiturates (medicine to treat anxiety, sleeping problems and epilepsy)
Croatian: • barbiturati (lijekovi za liječenje tjeskobe, problema sa spavanjem i epilepsije)
English: If you experience these symptoms, seek emergency care immediately.
Croatian: Ako osjetite ove simptome, odmah potražite pomoć liječnika.
English: If you have any further questions, ask your doctor.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku.
English: Some medicines/herbal remedies can affect treatment with Plendil.
Croatian: Neki lijekovi/biljni pripravci mogu utjecati na liječenje Plendilom.
English: The long-term efficacy of antihypertensive therapy as therapy in childhood to reduce cardiovascular morbidity and mortality in adulthood has also not been established.
Croatian: Dugotrajna djelotvornost antihipertenzijskog liječenja kao terapije u djetinjstvu s ciljem smanjenja kardiovaskularnog morbiditeta i mortaliteta u odrasloj dobi nije ustanovljena.
English: Plendil is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Croatian: Uporaba Plendila ne preporučuje se u majki koje doje pa će Vam Vaš liječnik propisati drugu terapiju ako želite dojiti.
English: What Plendil looks like and contents of the pack
Croatian: Kako Plendil izgleda i sadržaj pakiranja
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted> [To be completed nationally]
Croatian: <Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma> [Ispunjava država članica]
English: A total of 18,790 hypertensive patients (DBP 100-115 mmHg), aged 50-80 years were followed for a mean period of 3.8 years (range 3.3-4.9).
Croatian: Ukupno 18 790 bolesnika s hipertenzijom (dijastolički tlak 100 - 115 mmHg) u dobi od 50 do 80 godina praćeno je u prosječnom razdoblju od 3,8 godina (raspon 3,3 - 4,9).
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Hypertension
Croatian: 4.1 Terapijske indikacije Hipertenzija
English: Elderly population Initial treatment with lowest available dose should be considered.
Croatian: Treba razmotriti početno liječenje s najnižom mogućom dozom.
English: If you stop taking this medicine your condition may return.
Croatian: Ako prestanete uzimati Plendil Ako prestanete uzimati ovaj lijek, Vaša se bolest može vratiti.
English: The relevance of these findings for patients receiving felopidine is unknown.
Croatian: Relevantnost tih rezultata za bolesnike koji primaju felodipin nije poznata.