FrancophonIA/ELRC3.0 huggingface dataset:
English: This will cover information on the risk of kidney disease in adults and adolescents and the measures to reduce this risk, including appropriate screening and monitoring of patients.
Croatian: On će sadržavati informacije o riziku od bolesti bubrega u odraslih osoba i adolescenata i o mjerama za smanjenje tog rizika, koje uključuju odgovarajuće pretrage i praćenje bolesnika.
English: This is a summary of the European public assessment report (EPAR) for Stribild.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Stribild.
English: In patients taking some of the components of Stribild, certain rare but serious side effects have been seen including lactic acidosis (excess lactic acid in the blood) and severe kidney problems that may also affect bones.
Croatian: U bolesnika koji uzimaju neke od komponenata lijeka Stribild uočene su rijetke ali ozbiljne nuspojave, koje uključuju laktacidozu (višak mliječne kiseline u krvi) i teška oštećenja bubrega koja mogu utjecati i na kosti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stribild on 24/05/2013
Croatian: Europska komisija dala je odobrenje za stavljanje lijeka Stribild u promet koje vrijedi na prostoru Europske unije od 24. svibnja 2013.
English: Stribild must not be used with several other medicines as it may interact with them, thereby reducing the effectiveness of treatment or increasing the risk of side effects.
Croatian: Lijek Stribild ne smije se primjenjivati s nekoliko drugih lijekova zbog moguće interakcije s njima, što umanjuje djelotvornost liječenja ili povećava rizik od nuspojava.
English: What are the risks associated with Stribild?
Croatian: Koji su rizici povezani s lijekom Stribild?
English: It is used to treat patients from 12 years of age and weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Namijenjen je liječenju bolesnika u dobi od 12 godine i starijih, tjelesne težine od najmanje 35 kg, koji su zaraženi virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji je uzrok sindroma stečene imunološke deficijencije (AIDS).
English: A third study involving 50 adolescents aged 12 to 18 years who had not been previously treated for HIV-1 showed that Stribild was also effective in reducing viral load in this age group; 88% (44 of 50 patients) responded to treatment after 24 weeks, and the response persisted after 48 weeks.
Croatian: Treće ispitivanje, koje je uključivalo 50 adolescenata u dobi od 12 do 18 godina koji nisu prethodno liječeni od infekcije virusom HIV-1, pokazalo je da je Stribild djelotvoran u smanjivanju virusnog opterećenja i u ovoj dobnoj skupini: 88 % bolesnika (44 od 50) odgovorilo je na liječenje nakon 24 tjedna, a odgovor se održao nakon 48 tjedana.
English: Why is Stribild approved?
Croatian: Zašto je lijek Stribild odobren?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stribild have also 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 Stribild nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Stribild is available as tablets (150 mg elvitegravir/150 mg cobicistat /200 mg emtricitabine/245 mg tenofovir disoproxil).
Croatian: Lijek Stribild dostupan je u obliku tableta (150 mg elvitegravira, 150 mg kobicistata, 200 mg emtricitabina i 245 mg tenofovirdizoproksila).
English: Stribild elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil
Croatian: Stribild elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksil
English: It is not intended to provide practical advice on how to use Stribild.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Stribild.
English: In particular, the Agency concluded that the benefits of Stribild in reducing HIV viral load had been clearly shown in studies, and noted that it has the advantage of being taken once per day.
Croatian: Konkretno, Agencija je zaključila da su koristi od lijeka Stribild u smanjivanju opterećenja virusom HIV-a jasno utvrđena u ispitivanjima te je primijetila prednost uzimanja lijeka jedanput dnevno.
English: The European Medicines Agency decided that Stribild'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 od lijeka Stribild nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: The Agency also noted the risk of side effects affecting the kidneys, and recommended that kidney function should be carefully assessed before patients start taking Stribild and should be monitored during treatment.
Croatian: Agencija je također primijetila rizik od nuspojava koje pogađaju bubrege te je preporučila pažljivu procjenu bubrežne funkcije bolesnika prije početka liječenja lijekom Stribild i praćenje tijekom liječenja.
English: Elvitegravir is a type of antiviral agent called an ‘integrase inhibitor'.
Croatian: Elvitegravir je vrsta antivirusnog lijeka naziva „inhibitor integraze”.
English: The most common side effects with Stribild are nausea (feeling sick) and diarrhoea, which can affect more than 1 in 10 people.
Croatian: Najčešće nuspojave lijeka Stribild su mučnina i proljev, koje se mogu javiti u više od 1 na 10 osoba.
English: The company that markets Stribild will ensure that all doctors who are expected to prescribe Stribild are provided with educational materials containing important safety information.
Croatian: Tvrtka koja stavlja na tržište lijek Stribild osigurat će edukacijski materijal s važnim informacijama o sigurnoj primjeni svim liječnicima za koje se očekuje da će propisivati lijek Stribild.
English: Stribild can only be obtained with a prescription and treatment should only be started by a doctor who is experienced in managing HIV infection.
Croatian: Stribild se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: Cobicistat enhances the effects of elvitegravir, by prolonging the time for which elvitegravir continues to work.
Croatian: Kobicistat pojačava učinak elvitegravira time što produljuje njegovo vrijeme djelovanja.
English: For more information about treatment with Stribild, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Stribild pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Tenofovir and emtricitabine are closely related types of antiviral agent called reverse transcriptase inhibitors.
Croatian: Tenofovir i emtricitabin blisko su povezane vrste antivirusnih lijekova naziva inhibitori reverzne transkriptaze.
English: They block the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows the virus to replicate itself in the body.
Croatian: Oni inhibiraju djelovanje reverzne transkriptaze, enzima kojeg stvara HIV-1, a koji virusu omogućuje umnožavanje u tijelu.
English: After 48 weeks, around 88% of patients treated with Stribild (305 out of 348) responded to treatment compared with around 84% of patients treated with the comparator medicine (296 out of 352).
Croatian: Nakon 48 tjedana, otprilike 88 % bolesnika liječenih lijekom Stribild (305 od 348) odgovorilo je na liječenje, u usporedbi s otprilike 84 % bolesnika liječenih usporednim lijekom (296 od 352).
English: It blocks an HIV-1 enzyme called integrase, which is involved in thevirus's replication, thereby reducing the virus's ability to replicate normally and slowing down its spread.
Croatian: On inhibira enzim virusa HIV-1 naziva integraza, koji je povezan s replikacijom virusa, čime smanjuje mogućnost uobičajenog umnožavanja virusa i usporava njegovo širenje.
English: After 48 weeks, around 90% of patients treated with Stribild (316 out of 353) responded to treatment compared with around 87% of patients treated with the comparator treatment (308 out of
Croatian: Nakon 48 tjedana, otprilike 90 % bolesnika liječenih lijekom Stribild (316 od 353) odgovorilo je na liječenje, u usporedbi s otprilike 87 % bolesnika koji su primali usporedno liječenje (308 od 355).
English: For practical information about using Stribild, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Stribild bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How is Stribild used?
Croatian: Kako se Stribild koristi?
English: In the first study, involving 715 patients, Stribild was compared with the combination of ritonavir, atazanavir plus a medicine containing emtricitabine and tenofovir disoproxil (which are also contained in Stribild).
Croatian: U prvom ispitivanju, koje je uključivalo 715 bolesnika, lijek Stribild uspoređen je s kombinacijom ritonavira, atazanavira i lijeka koji je sadržavao emtricitabin i tenofovirdizoproksil (koji su također sadržani u lijeku Stribild).
English: Stribild was investigated in two main studies involving 1,422 adult patients with HIV-1 who had not been treated before, where Stribild was compared with other HIV medicines.
Croatian: Lijek Stribild istraživan je u dvama glavnim ispitivanjima koja su uključivala 1 422 odraslih bolesnika s virusom HIV-1 koji nisu prethodno liječeni.
English: What benefits of Stribild have been shown in studies?
Croatian: Koje su koristi lijeka Stribild utvrđene u ispitivanjima?
English: In the second study, involving 707 patients, Stribild was compared with a medicine containing efavirenz, emtricitabine and tenofovir disoproxil.
Croatian: U drugom ispitivanju, koje je uključivalo 707 bolesnika, lijek Stribild uspoređen je s lijekom koji je sadržavao efavirenz, emtricitabin i tenofovirdizoproksil.
English: Stribild must not be used in patients who have previously stopped treatment with tenofovir disoproxil due to kidney toxicity.
Croatian: Lijek Stribild ne smije se primjenjivati u bolesnika koji su zbog bubrežne toksičnosti prethodno prekinuli liječenje tenofovirdizoproksilom.
English: Stribild is a medicine that contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Croatian: Stribild je lijek koji sadržava djelatne tvari elvitegravir, kobicistat, emtricitabin i tenofovirdizoproksil.
English: How does Stribild work?
Croatian: Kako djeluje Stribild?
English: Tenofovir disoproxil is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Croatian: tenofovira, što znači da se u tijelu pretvara u djelatnu tvar tenofovir.
English: By blocking reverse transcriptase as well as integrase, Stribild reduces the amount of HIV-1 in the blood and keeps it at a low level.
Croatian: Stribild smanjuje količinu virusa HIV-1 u krvi te je održava na niskoj razini.
English: Patients whose viral load was reduced to less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Croatian: Smatralo se da su na liječenje odgovorili bolesnici u kojih je nakon 48 tjedana liječenja virusno opterećenje smanjeno na manje od 50 HIV-1 RNK kopija/ml.
English: For the full list of all side effects reported with Stribild, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Stribild potražite u uputi o lijeku.
English: It is used only in patients who have not received HIV medicines before or whose disease is not expected to be resistant to any of the antiviral agents in Stribild; it should only be used in patients under 18 years if other HIV medicines not including tenofovir disoproxil cannot be used because of side effects.
Croatian: Lijek se smije primjenjivati u bolesnika mlađih od 18 godina samo ako se drugi lijekovi za liječenje HIV-a koji ne sadržavaju tenofovirdizoproksil ne mogu primijeniti zbog nuspojava.
English: Strength Pharmaceutical form
Croatian: (Zaštićeno) ime Jačina Farmaceutski oblik
English: Route of administration
Croatian: Put primjene Unutarnje pakiranje Sadržaj
English: Date of first authorisation: 26th July 2017
Croatian: Datum prvog odobrenja: 26. srpnja 2017.
English: Take the medicine pack with you so that you can show the doctor what you have taken.
Croatian: Ponesite pakiranje lijeka sa sobom kako biste mogli pokazati liječniku što ste uzeli.
English: Then take the next dose at your usual time.
Croatian: Zatim uzmite sljedeću dozu u uobičajeno vrijeme.
English: This allows the infection to be eliminated from the body.
Croatian: Time omogućuje uklanjanje infekcije iz tijela.
English: f. VOYAGE-1 and VOYAGE-2 were Asian regional studies.
Croatian: f. VOYAGE-1 i VOYAGE-2 bila su azijska regionalna ispitivanja.
English: 8017 JV Zwolle NETHERLANDS
Croatian: 8017 JV Zwolle NIZOZEMSKA
English: Do not take Maviret if any of the above apply to you.
Croatian: Nemojte uzeti Maviret ako se bilo što od gore navedenoga odnosi na Vas.
English: A risk to the suckling child cannot be excluded.
Croatian: Ne može se isključiti rizik za dojeno dijete.
English: Do not take a double dose (two doses too close together).
Croatian: Nemojte uzeti dvostruku dozu (dvije doze u prekratkom vremenskom razdoblju).
English: DORA (Part 1)
Croatian: DORA (1. dio)
English: 6a NA = not available
Croatian: 6a ND = nije dostupno
English: The final study report shall be submitted by:
Croatian: Završno izvješće iz ispitivanja treba predati do:
English: • Take the tablets with food.
Croatian: • Tablete uzmite s hranom.
English: Major route of elimination
Croatian: Glavni put eliminacije
English: Patients should be instructed not to take a double dose.
Croatian: Bolesnicima treba napomenuti da ne smiju uzeti dvostruku dozu.
English: Caution is recommended.
Croatian: Preporučuje se oprez.
English: Effect of meal (relative to fasting)b
Croatian: Učinak hrane (u odnosu na primjenu natašte)b
English: It is important not to miss a dose of this medicine.
Croatian: Važno je da ne propustite uzeti nijednu dozu ovog lijeka.
English: Number of clinical isolates
Croatian: Broj kliničkih izolata
English: What Maviret is and what it is used for
Croatian: Što je Maviret i za što se koristi
English: Medicinal product by therapeutic areas/possible mechanism of interaction
Croatian: Lijekovi prema terapijskim područjima/ mogući mehanizam interakcije
English: Your doctor will tell you how long you need to take Maviret for.
Croatian: Liječnik će Vam reći koliko dugo trebate uzimati Maviret.
English: d. Oxidative metabolites or their byproducts accounted for 26% of radioactive dose.
Croatian: Oksidacijski metaboliti ili njihovi nusproizvodi činili su 26% radioaktivne doze.
English: • you should take Maviret and for how long
Croatian: • utvrdio trebate li uzimati Maviret i koliko dugo
English: Other medicines and Maviret
Croatian: Drugi lijekovi i Maviret
English: Do not give this medicine to children under 12 years of age.
Croatian: Ovaj lijek ne smije se davati djeci mlađoj od 12 godina.
English: If you take more Maviret than you should
Croatian: Ako uzmete više lijeka Maviret nego što ste trebali
English: GT3b is a subtype reported in a relatively small number of HCV infected patients in China and a few countries in South and Southeast Asia, but rarely outside of this region.
Croatian: Genotip 3b je podtip prijavljen u relativno malom broju bolesnika s HCV infekcijom u Kini i u nekoliko država u južnoj i jugoistočnoj Aziji, ali rijetko izvan ove regije.
English: Co-administration with darunavir is not recommended.
Croatian: Istodobna primjena s darunavirom se ne preporučuje.
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Da biste poslušali ili zatražili primjerak ove upute na <Brailleovu pismu>, u <velikom fontu> ili u obliku <audio zapisa>, obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet.
English: Take all 3 tablets in 1 blister once daily with food
Croatian: Uzmite sve 3 tablete iz 1 blistera zajedno, jedanput na dan s hranom
English: The effects of Maviret during pregnancy are not known.
Croatian: Učinci lijeka Maviret tijekom trudnoće nisu poznati.
English: The presence of HIV-1 coinfection did not impact efficacy.
Croatian: Prisutnost istodobne HIV-1 infekcije virusom nije utjecala na djelotvornost.
English: Contents of the pack and other information What Maviret contains
Croatian: Sadržaj pakiranja i druge informacije Što Maviret sadrži
English: What Maviret looks like and contents of the pack
Croatian: Kako Maviret izgleda i sadržaj pakiranja
English: The risk of failure was, as expected, highest for those exposed to both classes.
Croatian: U skladu s očekivanjima, rizik od neuspjeha bio je najveći u bolesnika koji su bili izloženi lijekovima iz obje skupine.
English: If you accidentally take more than the recommended dose, contact your doctor or go to the nearest hospital straight away.
Croatian: Ako slučajno uzmete veću dozu od preporučene, obratite se svom liječniku ili odmah otiđite u najbližu bolnicu.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, as the use of Maviret in pregnancy is not recommended.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek, jer se primjena lijeka Maviret u trudnoći ne preporučuje.
English: This may make Maviret work less well.
Croatian: Zbog toga Maviret možda neće djelovati dovoljno dobro.
English: Maviret is not recommended for use in patients requiring stable ciclosporin doses > 100 mg per day.
Croatian: Primjena lijeka Maviret ne preporučuje se u bolesnika kojima trebaju stabilne doze ciklosporina > 100 mg na dan.
English: Non-interventional post-authorisation safety study (PASS):
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS):
English: If you forget to take Maviret
Croatian: Ako ste zaboravili uzeti Maviret
English: This is not an exclusive list.
Croatian: Ovaj popis nije konačan.
English: • ethinyl oestradiol-containing medicines (such as contraception medicines, including vaginal rings and tablets)
Croatian: • lijekove koji sadrže etinilestradiol (kao što su kontracepcijski lijekovi, uključujući vaginalne prstene i tablete)
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Maviret therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Maviret, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: ↔ ↔ ↔ No dose adjustment is required.
Croatian: ↔ ↔ ↔ Nije potrebno prilagođavati dozu.
English: The response rates observed for patients ≥ 65 years of age were similar to that of patients < 65 years of age, across treatment groups.
Croatian: Stope odgovora primijećene u bolesnika u dobi od ≥ 65 godina bile su slične onima u bolesnika u dobi od < 65 godina u svim liječenim skupinama.
English: Caution and therapeutic concentration monitoring of digoxin is recommended.
Croatian: Preporučuje se oprez i praćenje terapijskih koncentracija digoksina.
English: Nervous system disorders Very common headache
Croatian: Poremećaji živčanog sustava Vrlo često glavobolja
English: The safety and efficacy of Maviret in children aged less than 12 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Maviret u djece mlađe od 12 godina nisu još ustanovljene.
English: • Do not chew, crush or break the tablets as it may affect the amount of Maviret in your blood.
Croatian: • Nemojte žvakati, drobiti ni lomiti tablete jer to može utjecati na količinu lijeka Maviret u krvi.
English: Direct hyperbilirubinemia was reported in 0.3% of subjects.
Croatian: Direktna hiperbilirubinemija prijavljena je u 0,3% ispitanika.
English: Metabolism secondary none
Croatian: Metabolizam sekundaran nema
English: • atorvastatin or simvastatin (to lower blood cholesterol)
Croatian: • atorvastatin ili simvastatin (za snižavanje razine kolesterola u krvi)
English: Hepatitis B Virus reactivation
Croatian: Reaktivacija virusa hepatitisa B
English: to prevent blood clots *Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Croatian: za sprječavanje krvnih ugrušaka *Liječnik će Vam možda trebati povećati učestalost krvnih pretraga kako bi utvrdio koliko Vam se dobro krv zgrušava.
English: 8 weeks
Croatian: 8 tjedana
English: Table 3: Interactions between Maviret and other medicinal products
Croatian: Tablica 3: Interakcije između lijeka Maviret i drugih lijekova
English: No clinically significant interactions are expected with tenofovir disoproxil fumarate.
Croatian: Ne očekuju se klinički značajne interakcije s tenofovirdizoproksilfumaratom.
English: Contraceptive medicines that contain ethinylestradiol must not be used in combination with Maviret.
Croatian: Kontraceptivi koji sadrže etinilestradiol ne smiju se koristiti u kombinaciji s lijekom Maviret.
English: Talk to your doctor if you have the following because your doctor may want to check you more closely:
Croatian: Obratite se svom liječniku ako imate nešto od navedenoga u nastavku, jer će Vas možda htjeti pomnije pratiti:
English: Co-administration is not recommended with several medicinal products as detailed in section 4.5.
Croatian: Ne preporučuje se istodobna primjena s nekolicinom lijekova, kako je detaljno navedeno u dijelu 4.5.
English: SOF+DCV 12 weeks N=115
Croatian: SOF + DKV, 12 tjedana N=115
English: • you are allergic to glecaprevir, pibrentasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Croatian: • ako ste alergični na glekaprevir, pibrentasvir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: How to take Maviret
Croatian: Kako uzimati Maviret
English: If you do miss a dose, work out how long it is since you should have last taken Maviret:
Croatian: Ako ipak propustite dozu, izračunajte koliko je vremena prošlo otkad ste trebali uzeti Maviret:
English: Clinical comments
Croatian: Klinički komentari
English: No glecaprevir metabolites were observed in plasma.
Croatian: U plazmi nisu primijećeni metaboliti glekaprevira.
English: As a precautionary measure, Maviret use is not recommended in pregnancy.
Croatian: Kao mjera opreza, ne preporučuje se primjena lijeka Maviret u trudnoći.
English: The proportion of subjects treated with Maviret who permanently discontinued treatment due to adverse reactions was 0.1%.
Croatian: Udio ispitanika liječenih lijekom Maviret koji su trajno prekinuli liječenje zbog nuspojava iznosio je 0,1%.
English: The most commonly reported adverse reactions (incidence ≥ 10%) were headache and fatigue.
Croatian: Najčešće prijavljene nuspojave (incidencija ≥ 10%) bile su glavobolja i umor.
English: There were no virologic failures.
Croatian: Nije bilo viroloških neuspjeha.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Maviret, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Croatian: Kako bi se ocijenila ponovna pojava hepatocelularnog karcinoma povezana s lijekom Maviret, nositelj odobrenja će provesti i podnijeti rezultate prospektivnog ispitivanja sigurnosti primjene lijeka, koristeći podatke prikupljene u kohorti dobro definirane skupine bolesnika na temelju dogovorenog protokola ispitivanja.
English: NA = not available
Croatian: ND = nije dostupno Rezistencija