FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Tivicay, dolutegravir, is an integrase inhibitor.
Croatian: Djelatna tvar u lijeku Tivicay, dolutegravir, je inhibitor integraze.
English: Supportive data from an ongoing study in children and adolescents indicated that adolescents could be given the adult dose of Tivicay.
Croatian: Potkrepljujući podaci iz ispitivanja koje se trenutačno provodi na djeci i adolescentima upućivali su na to da se adolescentima može dati doza lijeka Tivicay za odrasle.
English: The Committee concluded that the medicine had demonstrated its effectiveness in both untreated and previously treated patients, including those with resistance to integrase inhibitors.
Croatian: Odbor je zaključio da je lijek dokazao svoju djelotvornost kako u slučaju neliječenih tako i u slučaju liječenih bolesnika, uključujući bolesnika otpornih na inhibitore integraze.
English: For more information about treatment with Tivicay, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Tivicay pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Tivicay is an antiviral medicine containing the active substance dolutegravir.
Croatian: Tivicay je protuvirusni lijek koji sadrži djelatnu tvar dolutegravir.
English: Why is Tivicay approved?
Croatian: Zašto je lijek Tivicay odobren?
English: • In patients whose virus is not resistant to integrase inhibitors, the usual dose is one 50-mg tablet a day; however, when given with certain medicines that decrease the effectiveness of Tivicay the dose is increased to one 50 mg tablet twice a day.
Croatian: • U bolesnika čiji virus nije otporan na inhibitore integraze, uobičajena doza iznosi jednu tabletu od 50 mg na dan; no ako se primjenjuje s određenim lijekovima koji smanjuju djelotvornost lijeka Tivicay, doza se povećava na jednu tabletu od 50 mg dva puta na dan.
English: Response rate at 48 weeks was 71% in patients given treatment based on Tivicay, and 64% in those given treatment based on raltegravir.
Croatian: Stopa odgovora u 48. tjednu iznosila je 71 % u bolesnika koji su primili liječenje temeljeno na lijeku Tivicay, i 64 % u bolesnika koji su primili liječenje temeljeno na raltegraviru.
English: Patients were treated with a combination of HIV medicines that included either Tivicay or raltegravir.
Croatian: Bolesnici su liječeni kombinacijom lijekova protiv HIV-a koja je uključivala Tivicay ili raltegravir.
English: • The second study involved 833 patients given either a combination of Tivicay with two NRTIs or a different three-drug combination (Atripla) that did not include an integrase inhibitor.
Croatian: • Drugo ispitivanje obuhvatilo je 833 bolesnika koji su primili kombinaciju lijeka Tivicay s dva NRTI-a ili kombinaciju tri različita lijeka (Atripla) koja nije uključivala inhibitor integraze.
English: • The second study in previously treated patients involved 183 patients with infection resistant to previous treatment that had involved an integrase inhibitor (i.e. their infection was resistant to several classes of medicine, including previous integrase inhibitors): adding Tivicay twice daily to other treatment resulted in a response rate of 69% after 24 weeks of therapy.
Croatian: • Drugo ispitivanje u prethodno liječenih bolesnika obuhvatilo je 183 bolesnika s infekcijom otpornom na prethodno liječenje koje je uključivalo inhibitor integraze (primjerice njihova infekcija bila je otporna na nekoliko klasa lijeka, uključujući prethodne inhibitore integraze): dodavanje lijeka Tivicay dva puta dnevno u drugo liječenje rezultiralo je stopom odgovora od 69 % nakon 24 tjedna terapije.
English: • In the first of these, involving 822 patients, Tivicay once daily was compared with raltegravir (another integrase inhibitor), both given in combination with two other HIV medicines of a different class (known as nucleoside reverse transcriptase inhibitors or NRTIs): 88% (361 of 411 patients) given Tivicay and 85% (351 of 411) given raltegravir responded after 48 weeks of treatment.
Croatian: • U prvom od ova dva ispitivanja, koje je obuhvatilo 822 bolesnika, jedna doza lijeka Tivicay jednom dnevno uspoređena je s raltegravirom (drugim inhibitorom integraze), oba su primijenjena u kombinaciji s dva druga lijeka protiv HIV-a iz dvije različite klase (poznatima pod nazivom nenukleozidni inhibitori reverzne transkriptaze ili NRTI-ovi): 88 % (361 od 411 bolesnika) bolesnika koji su primili lijek Tivicay i 85 % (351 od 411) bolesnika koji su primili raltegravir odgovorilo je nakon 48 tjedana liječenja.
English: Tivicay can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
Croatian: Tivicay se izdaje samo na recept, a liječenje treba nadzirati liječnik iskusan u liječenju infekcija HIVom.
English: For practical information about using Tivicay, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Tivicay bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Two studies involved patients who had not previously been treated for HIV:
Croatian: Dva su ispitivanja obuhvatila bolesnike koji prethodno nisu primili terapiju protiv HIV-a:
English: What benefits of Tivicay have been shown in studies?
Croatian: Koje su koristi lijeka Tivicay utvrđene u ispitivanjima?
English: How does Tivicay work?
Croatian: Kako djeluje Tivicay?
English: How is Tivicay used?
Croatian: Kako se Tivicay koristi?
English: For the full list of all side effects reported with Tivicay, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Tivicay potražite u uputi o lijeku.
English: • The dose is one 50-mg tablet twice a day in patients whose virus is known or suspected to be resistant to integrase inhibitors; in these patients, giving Tivicay with medicines that decrease its effectiveness should be avoided.
Croatian: • U bolesnika, u kojih je poznato ili se sumnja da je virus otporan na inhibitore integraze, doza iznosi jednu tabletu od 50 mg dva puta na dan; u ovih se bolesnika mora izbjegavati primjena lijeka Tivicay s lijekovima koji smanjuju njegovu djelotvornost.
English: Strength Pharmaceuti cal Form
Croatian: Jačina Farmaceutski oblik
English: 1 bottle + 1 cap adapter
Croatian: 1 boca + 1 nastavak za bocu s čepom za ponovno zatvaranje
English: EU (MA) Number (Invented) name
Croatian: Broj (EU)
English: Oral liquid Oral or gastroenteral use bottle (glass) 25 ml
Croatian: 1,1 g/ml oralna tekućina Kroz usta ili želučanocrijevno boca (staklo) 25 ml
English: Zyllt with food and drink Zyllt may be taken with or without food.
Croatian: Zyllt s hranom i pićem Zyllt se može uzimati s obrokom ili bez obroka.
English: If you take more Zyllt than you should
Croatian: Ako uzmete više Zyllta nego što ste trebali
English: Other medicines and Zyllt
Croatian: Drugi lijekovi i Zyllt
English: What Zyllt is and what it is used for
Croatian: Što je Zyllt i za što se koristi
English: • if you have had an allergy or reaction to any medicine used to treat your disease.
Croatian: - Ako ste imali alergiju ili reakciju na bilo koji lijek koji ste koristili za liječenje Vaše bolesti.
English: You should take Zyllt for as long as your doctor continues to prescribe it.
Croatian: Zyllt trebate uzimati sve dok Vam ga liječnik propisuje.
English: Some other medicines may influence the use of Zyllt or vice versa.
Croatian: Neki lijekovi mogu utjecati na djelovanje Zyllta i obratno.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Zyllt contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Croatian: Zyllt sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
English: Their frequency is defined using the following conventions: common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Njihova je učestalost definirana na sljedeći način: česte (≥1/100, <1/10); manje česte (≥1/1000, <1/100); rijetke (≥1/10 000, <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Excipients with known effect: Each film-coated tablet contains 108.125 mg lactose.
Croatian: Pomoćne tvari s poznatim učinkom: Jedna filmom obložena tableta sadrži 108,125 mg laktoze.
English: • If you suffer from severe liver disease.
Croatian: - ako patite od teške bolesti jetre.
English: • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
Croatian: - Ako ste imali krvni ugrušak u arteriji u mozgu (ishemijski moždani udar) koji se pojavio unutar posljednjih sedam dana.
English: Date of first authorisation: 28/9/2009 Date of latest renewal: 14 May 2014
Croatian: Datum posljednje obnove odobrenja: 14. svibnja 2014.
English: 7 film-coated tablets: EU/1/09/553/001 14 film-coated tablets: EU/1/09/553/002 28 film-coated tablets: EU/1/09/553/003 30 film-coated tablets: EU/1/09/553/004 50 film-coated tablets: EU/1/09/553/005 56 film-coated tablets: EU/1/09/553/006 60 film-coated tablets: EU/1/09/553/007 84 film-coated tablets: EU/1/09/553/008 90 film-coated tablets: EU/1/09/553/009 100 film-coated tablets: EU/1/09/553/010
Croatian: 7 filmom obloženih tableta: EU/1/09/553/001 14 filmom obloženih tableta: EU/1/09/553/002 28 filmom obloženih tableta: EU/1/09/553/003 30 filmom obloženih tableta: EU/1/09/553/004 50 filmom obloženih tableta: EU/1/09/553/005 56 filmom obloženih tableta: EU/1/09/553/006 60 filmom obloženih tableta: EU/1/09/553/007 84 filmom obložene tablete: EU/1/09/553/008 90 filmom obloženih tableta: EU/1/09/553/009 100 filmom obloženih tableta: EU/1/09/553/010
English: The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Croatian: Poluvijek eliminacije glavnog cirkulirajućeg (neaktivnog) metabolita iznosio je 8 sati nakon jednokratne i ponovljene primjene.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Zyllt and acetylsalicylic acid for this condition.
Croatian: Trebalo Vam je biti rečeno da su za ovo stanje 'oralni antikoagulansi' učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene Zyllta i acetilsalicilatne kiseline.
English: As a precautionary measure, breast-feeding should not be continued during treatment with Zyllt.
Croatian: Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja Zylltom.
English: Then, the recommended dose is one 75 mg tablet of Zyllt per day as described above.
Croatian: Nakon toga, preporučena doza Zyllta je jedna tableta od 75 mg dnevno, kao što je opisano iznad.
English: Your doctor should have prescribed Zyllt plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Croatian: Liječnik Vam treba propisati Zyllt i acetilsalicilatnu kiselinu ako ne možete uzimati oralne antikoagulanse te nemate rizik od velikog krvarenja.
English: If you become pregnant while taking Zyllt, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Croatian: Ako zatrudnite za vrijeme uzimanja Zyllta, odmah se posavjetujte s liječnikom, jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Croatian: 7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 60 filmom obloženih tableta 84 filmom obložene tablete 90 filmom obloženih tableta 100 filmom obloženih tableta
English: What Zyllt contains - The active substance is clopidogrel.
Croatian: Što Zyllt sadrži - Djelatna tvar je klopidogrel.
English: Film coating Hypromellose (E464) Titanium dioxide (E171) Red iron oxide (E172) Talc
Croatian: Film ovojnica: hipromeloza (E464) titanijev dioksid (E171) željezov oksid, crveni (E172) talk propilenglikol
English: - You have an irregular heartbeat, a condition called ‘atrial fibrillation', and you cannot take medicines known as ‘oral anticoagulants' (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing.
Croatian: - imate nepravilne otkucaje srca, stanje koje se zove 'fibrilacija atrija', a ne možete uzimati lijekove poznate kao 'oralni antikoagulansi' (antagonisti vitamina K), koji sprječavaju stvaranje novih ugrušaka te rast postojećih ugrušaka.
English: If you forget to take a dose of Zyllt, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Croatian: Ako zaboravite uzeti jednu dozu Zyllta, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
English: What you need to know before you take Zyllt
Croatian: Što morate znati prije nego počnete uzimati Zyllt
English: Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Croatian: Rezultati kliničkih ispitivanja podupiru trajanje liječenja do 12 mjeseci, a najveći učinak zabilježen je u trećem mjesecu liječenja (vidjeti dio 5.1).
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Zyllt in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Croatian: Ako ste imali jaku bol u prsištu (nestabilna angina ili srčani udar), liječnik Vam može propisati Zyllt u kombinaciji s acetilsalicilatnom kiselinom, tvari prisutnom u mnogim lijekovima za ublažavanje boli i snižavanje temperature.
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Croatian: U studijama CURE, CLARITY, ACTIVE-A i jednoj od kohortnih studija (Trenk), nije uočena povećana stopa događaja slučajeva temeljena na metabolizatorskom statusu.
English: The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Zyllt per day to be taken orally with or without food, and at the same time each day.
Croatian: Preporučena doza, uključujući za bolesnike sa stanjem zvanim "fibrilacija atrija" (nepravilni otkucaji srca), je jedna tableta Zyllta od 75 mg dnevno koja se uzima kroz usta, s obrokom ili bez obroka, i u isto vrijeme svaki dan.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Zyllt.
Croatian: Ako ste trudni ili sumnjate na trudnoću, obavjestite svog liječnika ili ljekarnika prije nego što uzmete Zyllt.
English: • You should tell your doctor if a surgery (including dental) is planned.
Croatian: Dok uzimate Zyllt: - Obavijestite svog liječnika ako planirate kirurški zahvat (uključujući stomatološke zahvate).
English: Driving and using machines Zyllt is unlikely to affect your ability to drive or to use machines.
Croatian: Upravljanje vozilima i strojevima Zyllt ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: Boxes of 7, 14, 28, 30, 50, 56, 60, 84, 90 and 100 film-coated tablets in blisters are available.
Croatian: Kutije sadrže 7, 14, 28, 30, 50, 56, 60, 84, 90 i 100 filmom obloženih tableta u blister pakiranjima.
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Croatian: Apsorpcija Nakon jednokratne i ponovljene oralne doze od 75 mg dnevno, klopidogrel se brzo apsorbira.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Zyllt (4 tablets of 75 mg) once at the start of treatment.
Croatian: Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg Zyllta (4 tablete od po 75 mg).
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Croatian: Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio 2. 'Upozorenja i mjere opreza').
English: If you stop taking Zyllt
Croatian: Ako prestanete uzimati Zyllt
English: - The other ingredients are lactose (see section 2 ‘Zyllt contains lactose'), microcrystalline cellulose, pregelatinised maize starch, macrogol 6000 and hydrogenated castor oil in the tablet core and hypromellose (E464), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the film-coating.
Croatian: - Drugi sastojci su laktoza (vidjeti dio 2 'Zyllt sadrži laktozu'), mikrokristalična celuloza, prethodno geliran škrob, makrogol 6000 i hidrogenirano ricinusovo ulje u jezgri tablete, te hipromeloza (E464), titanijev dioksid (E171), crveni željezov oksid (E172), talk i propilenglikol u film ovojnici tablete (vidjeti dio 2.).
English: You have been prescribed Zyllt to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Croatian: Zyllt Vam je propisan za sprječavanje stvaranja krvnih ugrušaka i smanjivanje opasnosti od ovih ozbiljnih događaja jer: - imate otvrdnuće arterija (koje se još zove ateroskleroza) te - ste već imali srčani udar, moždani udar ili imate stanje koje se zove bolest perifernih arterija, - ste imali teški oblik boli u prsištu, poznat pod nazivom 'nestabilna angina' ili 'infarkt miokarda' (srčani udar).
English: A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non- fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Croatian: Fibrinolitike je primalo 99,7% bolesnika (fibrin-specifični: 68,7%, fibrin-nespecifični: 31,1%), 89,5% heparin, 78,7% beta blokatore, 54,7% ACE inhibitore i 63%
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Croatian: Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku hidrogensulfata).
English: • if you have kidney or liver disease
Croatian: - Ako imate bolest bubrega ili jetre.
English: You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
Croatian: Liječnik će Vam propisati i acetilsalicilatnu kiselinu (tvar koju sadržavaju mnogi lijekovi za ublažavanje boli i snižavanje povišene temperature, kao i oni za sprječavanje stvaranja krvnih ugrušaka).
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘POSSIBLE SIDE EFFECTS').
Croatian: Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio 4. 'Moguće nuspojave').
English: If you forget to take Zyllt
Croatian: Ako ste zaboravili uzeti Zyllt
English: Zyllt is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Croatian: Zyllt uzimaju odrasli za sprječavanje stvaranja krvnih ugrušaka (tromba) u otvrdnutim krvnim žilama (arterijama), a taj poremećaj zove se aterotromboza i može dovesti do aterotrombotičkih događaja (kao što su moždani udar, srčani udar ili smrt).
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS').
Croatian: - Također, odmah obavijestite svog liječnika ukoliko se pojavi medicinsko stanje (koje se naziva "trombotična trombocitopenična purpura" ili "TTP") sa simptomima koji uključuju vrućicu i potkožne modrice koji se mogu pojaviti kao crvene točkice, sa ili bez neobjašnjivog teškog umora, zbunjenosti i žute boje kože ili očiju (žutica) (vidjeti dio 4. 'Moguće nuspojave').
English: Zyllt contains lactose.
Croatian: Zyllt sadrži laktozu.
English: Zyllt contains lactose
Croatian: Zyllt sadrži laktozu
English: - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Croatian: Akutni infarkt miokarda s elevacijom ST-segmenta, u kombinaciji s ASK u medicinski tretiranih bolesnika pogodnih za liječenje trombolitičkom terapijom.
English: Równoległa 5, 02-235 Warszawa, Poland KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
Croatian: Równoległa 5, 02-235 Warszawa, Poljska KRKA - FARMA d.o.o., V.
English: In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Croatian: Bolesnici s akutnim koronarnim sindromom: - Akutni koronarni sindrom bez elevacije ST-segmenta (nestabilna angina ili non-Q infarkt miokarda), liječenje klopidogrelom treba započeti s jednokratnom udarnom dozom od 300 mg, a zatim nastaviti sa 75 mg jedanput dnevno (uz acetilsalicilatnu kiselinu (ASK) 75 mg do 325 mg dnevno).
English: How to take Zyllt
Croatian: Kako uzimati Zyllt
English: Zyllt 75 mg film-coated tablets clopidogrel
Croatian: Zyllt 75 mg filmom obložene tablete klopidogrel
English: Zyllt 75 mg film-coated tablets
Croatian: Zyllt 75 mg filmom obložene tablete
English: Cellulose, microcrystalline Pregelatinised maize starch Macrogol 6000
Croatian: Jezgra tablete: laktoza celuloza, mikrokristalična škrob, prethodno geliran makrogol 6000 ricinusovo ulje, hidrogenirano