FrancophonIA/ELRC3.0 huggingface dataset:
English: STELARA 45 mg solution for injection in pre-filled syringe Solution for injection.
Croatian: STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki.
English: Sucrose
Croatian: PedsQL
English: This stops air bubbles forming in the syringe (see Figure 4)
Croatian: Na taj način se sprječava stvaranje mjehurića u štrcaljki
English: Single dose versus multiple doses
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials-discard 52 mL, for 3 vials- discard 78 mL, for 4 vials- discard 104 mL)
Croatian: Izvucite i uklonite volumen 9 mg/ml (0,9%-tne) otopine natrijevog klorida iz infuzijske vrećice od 250 ml, jednak volumenu STELARE koji će se dodati (uklonite 26 ml otopine natrijevog klorida za svaku bočicu STELARE koju trebate, za 2 bočice- uklonite 52 ml, za 3 bočice bacite 78 ml, za 4 bočice- uklonite 104 ml).
English: The tablets must never be swallowed but should be placed under the tongue and allowed to dissolve, which usually takes five to 10 minutes.
Croatian: Tablete se ne smiju nikada progutati već ih treba staviti pod jezik kako bi se omogućila njihova razgradnja, što obično traje 5 do 10 minuta.
English: Suboxone is used in adults and children over 15 years of age, who are also receiving medical, social and psychological support.
Croatian: Suboxone se koristi u odraslih osoba i djece starije od 15 godina koji također primaju medicinsku, socijalnu i psihološku podršku.
English: The doctor may increase the dose depending on the patient's response but the daily dose should not be higher than 24 mg buprenorphine.
Croatian: Liječnik može povećati dozu ovisno o odgovoru bolesnika, no dnevna doza ne smije premašiti 24 mg buprenorfina.
English: Other information about Suboxone
Croatian: Ostale informacije o lijeku Suboxone
English: Once the patient has been stabilised, the maintenance dose may be reduced gradually and eventually treatment may be stopped.
Croatian: Nakon što je bolesnik stabiliziran, doza održavanja može se postupno smanjivati te se terapija može naposljetku prekinuti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Suboxone on 26 September 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Suboxone na snazi u Europskoj uniji od 26. rujna 2006.
English: What measures are being taken to ensure the safe and effective use of Suboxone?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Suboxone?
English: Suboxone buprenorphine / naloxone
Croatian: Suboxone buprenorfin / nalokson
English: Sublingual tablets containing buprenorphine alone have been available in the EU since the mid-1990's for the treatment of opioid addiction.
Croatian: Sublingvalne tablete koje sadrže samo buprenorfin dostupne su u EU-u od sredine 1990.-ih godina za liječenje ovisnosti o opioidima.
English: The CHMP noted that the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential misuse of the medicine.
Croatian: CHMP je zaključio da je kombinacija opioidnog analoga s opioidnim antagonistom ustaljena strategija za smanjivanje potencijalne zlouporabe lijeka.
English: Patients also used a specially designed questionnaire to record their cravings, and the change in the questionnaire score before and at the end of the study was measured.
Croatian: Bolesnici su također koristili posebno osmišljene upitnike kako bi zabilježili svoju žudnju, te su utvrđene promjene rezultata upitnika prije i nakon ispitivanja.
English: Suboxone must not be used in patients with severe respiratory insufficiency (difficulty breathing) or severe liver problems.
Croatian: Suboxone se ne smije koristiti u bolesnika s ozbiljnom respiratornom insuficijencijom (poteškoćama s disanjem) ili ozbiljnim jetrenim problemima.
English: The recommended starting dose is one or two tablets of Suboxone 2 mg/0.5 mg.
Croatian: Preporučena početna doza je jedna do dvije tablete lijeka Suboxone od 2 mg/0,5 mg.
English: This document is a summary of the European public assessment report (EPAR) for Suboxone.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Suboxone.
English: It is recommended that the patient's liver be checked before starting treatment with Suboxone and should also be monitored regularly during treatment.
Croatian: Preporučuje se da se jetra bolesnika pregleda prije početka terapije lijekom Suboxone te se treba redovito kontrolirati tijekom terapije.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Suboxone.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Suboxone.
English: The most common side effects with Suboxone (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache and withdrawal syndrome.
Croatian: Najčešće nuspojave lijeka Suboxone (uočene u više od 1 bolesnika na 10) su insomnija (poteškoće sa spavanjem), zatvor, mučnina (povraćanje), znojenje, glavobolja i sindrom ustezanja.
English: A risk management plan has been developed to ensure that Suboxone is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Suboxone.
English: The craving score, which was between 62.4 and 65.6 before treatment, decreased at the end of the study to 29.8 with Suboxone, compared with 55.1 with placebo.
Croatian: Rezultat žudnje, koji je bio između 62,4 i 65,6 prije terapije, smanjio se u trenutku završetka ispitivanja na 29,8 uz primjenu lijeka Suboxone, a na 55,1 uz primjenu placeba.
English: The addition of naloxone helps prevent the misuse of the medicine.
Croatian: Dodavanje naloksona pomaže pri sprječavanju zlouporabe lijeka.
English: In patients who have mild to moderately reduced liver function lower starting doses are recommended.
Croatian: U bolesnika koji imaju blago do umjereno smanjenu funkciju jetre preporučuje se primjena slabijih početnih doza.
English: The way Suboxone is used depends on the patient's status: type of addiction, state of withdrawal, and whether the patient is already using another substitution treatment such as methadone before starting Suboxone.
Croatian: Način primjene lijeka Suboxone ovisi o statusu bolesnika: tipu ovisnosti, stanju ustezanja, te je li bolesnik već koristio druge zamjenske terapije poput metadona prije početka terapije lijekom Suboxone.
English: The effectiveness of Suboxone treatment depends on the patient also receiving other medical, social and psychological support.
Croatian: Djelovanje terapije lijekom Suboxone ovisi i o tome prima li bolesnik drugu medicinsku, socijalnu i psihološku pomoć.
English: It must also not be used in patients with acute alcohol intoxication (excessive alcohol consumption), delirium tremens (a condition caused by alcohol withdrawal) or together with medicines known as opioid antagonists used for the treatment of alcohol or opioid dependence.
Croatian: Ne smije se koristiti ni u bolesnika s akutnom intoksikacijom alkoholom (prekomjernom konzumacijom alkohola), u stanju delirium tremens (koje je uzrokovano ustezanjem od alkohola) ili zajedno s lijekovima koji su poznati kao opioidni antagonisti koji se koriste za liječenje ovisnosti o alkoholu ili opioidima.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Suboxone, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Suboxone nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Croatian: Suboxone se koristi za liječenje ovisnosti o opioidima (narkoticima) poput heroina ili morfina u ovisnika o drogama koji su pristali na liječenje od ovisnosti.
English: What is the risk associated with Suboxone?
Croatian: Koji su rizici povezani s lijekom Suboxone?
English: Suboxone was as effective as buprenorphine on its own and more effective than placebo: 17.8% of the patients who received Suboxone had a urine sample that tested negative at the end of the study, compared with 5.8% of the patients receiving placebo.
Croatian: Suboxone je bio jednako djelotvoran kao i monoterapija buprenorfinom, a djelotvorniji od placeba: 17,8 % bolesnika koji su primali lijek Suboxone imalo je negativan nalaz urina na kraju ispitivanja, u usporedbi s 5,8 % bolesnika koji su primali placebo.
English: This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.
Croatian: To znači da se lijek primjenjuje pod strožim uvjetima od normalnih jer se može zlouporabiti ili uzrokovati ovisnost.
English: Suboxone must be used under the supervision of a doctor who has experience in the management of opioid addiction.
Croatian: Suboxone se smije primjenjivati samo pod nadzorom liječnika koji je iskusan u liječenju ovisnosti o opioidima.
English: Suboxone contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug), and naloxone, an opioid antagonists (it counteracts the effects of opioid drugs).
Croatian: Suboxone sadrži dvije djelatne tvari: buprenorfin, djelomično opioidni agonist (djeluje poput opioida) i nalokson, opioidni antagonist (poništava djelovanje opioida).
English: Suboxone is a medicine that contains two active substances, buprenorphine and naloxone.
Croatian: Suboxone je lijek koji sadrži dvije djelatne tvari, buprenorfin i nalokson.
English: This is because, when injected, naloxone counteracts the effects of opioids, causing the patient to experience acute withdrawal symptoms.
Croatian: Razlog tomu je činjenica da prilikom ubrizgavanja nalokson suzbija djelovanje opioida te uzrokuje akutne simptome ustezanja kod bolesnika.
English: It is available as sublingual tablets containing 2 mg buprenorphine and 0.5 mg naloxone, 8 mg buprenorphine and 2 mg naloxone, or 16 mg buprenorphine and 4 mg naloxone.
Croatian: Dostupan je u obliku sublingvalnih tableta koje sadrže 2 mg buprenofrina i 0,5 mg naloksona, 8 mg buprenorfina i 2 mg naloksona ili 16 mg buprenorfina i 4 mg naloksona. „Sublingvalno” znači da se tableta stavlja pod jezik gdje se razgrađuje.
English: One main study compared Suboxone with buprenorphine on its own or with placebo (a dummy treatment) in 326 heroin-dependent patients for four weeks, and measured the percentage of patients who had no trace of opioids in their urine at the end of the study.
Croatian: U jednom glavnom ispitivanju Suboxone je uspoređen s monoterapijom buprenorfinom i s placebom (prividnim liječenjem) u 326 bolesnika ovisnih o heroinu tijekom razdoblja od četiri tjedna te je utvrđen postotak bolesnika koji po završetku ispitivanja nisu imali tragove opioida u urinu.
English: However, buprenorphine tablets have been misused by drug addicts who dissolve the tablets and inject themselves with the resulting solution.
Croatian: No, ovisnici o drogama zloupotrebljavali su tablete koje sadrže buprenorfin otapajući ih i ubrizgavajući si nastalu otopinu.
English: The full EPAR for Suboxone can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports For more information about treatment with Suboxone, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Cjeloviti EPAR za lijek Suboxone nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The Committee decided that Suboxone's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Suboxone nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Why has Suboxone been approved?
Croatian: Zašto je lijek Suboxone odobren?
English: What is Suboxone?
Croatian: Što je Suboxone?
English: For the full list of all side effects reported with Suboxone, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Suboxone potražite u uputi o lijeku.
English: What benefit has Suboxone shown during the studies?
Croatian: Koje su koristi lijeka Suboxone utvrđene u ispitivanjima?
English: What is Suboxone used for?
Croatian: Za što se Suboxone koristi?
English: How is Suboxone used?
Croatian: Kako se Suboxone koristi?
English: How has Suboxone been studied?
Croatian: Kako je Suboxone ispitivan?
English: How does Suboxone work?
Croatian: Kako djeluje Suboxone?
English: * Antigenic mass ELISA units.
Croatian: * Antigena masa ELISA jedinice.
English: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Croatian: - Leptospira. interrogans serogrupa Canicola serovar Portland-vere (soj Ca-12-000)
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Croatian: - Leptospira. interrogans serogrupa Icterohaemorrhagiae serovar Copenhageni (soj Ic-02-001)
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Croatian: - Leptopsira. interrogans serogrupa Australis serovar Bratislava (soj As-05-073)
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Croatian: - Leptospira. kirschneri serogrupa Grippotyphosa serovar Dadas (soj Gr-01-005)
English: EMEA Number
Croatian: EU broj
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant in the Member States
Croatian: Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, podnositelj(a) zahtjeva u državama članicama
English: United Kingdom TEVA Pharma B.V. Computerweg 10,
Croatian: Velika Britanija TEVA Pharma B.V.
English: Netherlands
Croatian: The Netherlands
English: Belgium TEVA Pharma B.V. Computerweg 10,
Croatian: Computerweg 10,
English: Ocular use vial (glass)
Croatian: U oko bočica (staklo)
English: Luxturna (voretigene neparvovec)
Croatian: Luxturna (voretigen neparvovek)
English: The improvement in patients' vision was maintained for at least three years.
Croatian: Poboljšanje vida bolesnika zadržalo se u razdoblju od najmanje tri godine.
English: The type of virus used in this medicine (adeno-associated virus) does not cause disease in humans.
Croatian: Vrsta virusa koja je upotrijebljena u ovom lijeku (adeno-pridruženi virus) ne uzrokuje bolest u ljudi.
English: An information package for patients and their carers will also be provided.
Croatian: Isto tako, osigurat će se informativni paket za bolesnike i njihove njegovatelje.
English: Patients were considered to have passed the test if they completed the route within 3 minutes and bumped into no more than 3 obstacles.
Croatian: Smatralo se da su bolesnici prošli na testu ako su prešli rutu u roku od tri minute i ako se nisu sudarili s više od tri prepreke.
English: This was considered an important clinical benefit, taking into account the lack of authorised treatments for this progressive, degenerative condition.
Croatian: To se smatralo važnom kliničkom koristi, uzimajući u obzir nedostatak odobrenih načina liječenja tog progresivnog, degenerativnog stanja.
English: Luxturna will only be available from centres where the educational programme is in place.
Croatian: Lijek Luxturna bit će dostupan samo u centrima gdje postoji edukacijski program.
English: What is Luxturna and what is it used for?
Croatian: Što je Luxturna i za što se primjenjuje?
English: The second eye should be treated at least 6 days after the first.
Croatian: Postupak treba primijeniti na drugo oko u razmaku od barem šest dana od primjene na prvom oku.
English: Further information on Luxturna can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/luxturna.
Croatian: Više informacija o lijeku Luxturna nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/luxturna.
English: What measures are being taken to ensure the safe and effective use of Luxturna?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Luxturna?
English: Inherited retinal dystrophy is rare, and Luxturna was designated an ‘orphan medicine' (a medicine used in rare diseases) for two forms of the disease on various dates (retinitis pigmentosa: 28 July 2015; Leber's congenital amaurosis: 2 April 2012).
Croatian: Nasljedna retinalna distrofija rijetka je bolest, a lijek Luxturna dobio je status „lijeka za rijetku bolest” za dva oblika bolesti na različite datume (za pigmentozni retinitis: 28. srpnja 2015.; za Leberovu kongenitalnu amaurozu: 2. travnja 2012.).
English: Patients should start receiving immunosuppressant medicines (medicines that reduce the activity of the immune system, the body's natural defences) 3 days before Luxturna is injected into the first eye, to lower the risk of the medicine being rejected by the body, and this treatment should continue for 14 days after injection.
Croatian: Bolesnici trebaju započeti primati imunosupresivne lijekove (lijekove koji smanjuju aktivnost imunosnog sustava, prirodne obrane tijela) tri dana prije ubrizgavanja lijeka Luxturna u prvo oko, kako bi se smanjio rizik da će tijelo odbaciti lijek, a s tim postupkom treba nastaviti tijekom 14 dana nakon davanja injekcije.
English: Additionally, 13 of the 21 patients (62%) treated with Luxturna passed the mobility test at the lowest light level of 1 lux (similar to conditions of a poorly lit pavement at night), while none of the patients not given the medicine were able to do so.
Croatian: Nadalje, 13 od 21 bolesnika (62 %) liječenih lijekom Luxturna prošlo je na testu mobilnosti pri najnižoj razini osvjetljenja od 1 luksa (što je slično uvjetima slabo osvjetljenog pločnika noću), dok nijedan bolesnik koji nije primao lijek to nije mogao napraviti.
English: Side effects reported with Luxturna are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Luxturna pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/medicines/human/orphandesignations.
Croatian: Više informacija o statusu lijeka za rijetku bolest nalazi se na internetskim stranicama Europske agencije za lijekove ema.europa.eu/medicines/human/orphandesignations.
English: In addition, the company will have to follow-up all patients who received Luxturna in the main studies for 15 years, in order to characterise the long-term effectiveness and safety of the medicine, and establish a registry to collect long-term safety data in patients treated with Luxturna.
Croatian: Osim toga, tvrtka će morati nastaviti pratiti sve bolesnike koji su primili lijek Luxturna u okviru glavnih ispitivanja tijekom 15 godina kako bi se odredila dugoročna učinkovitost i sigurnost primjene lijeka te uspostavio registar za prikupljanje podataka o dugoročnoj sigurnosti primjene u bolesnika liječenih lijekom Luxturna.
English: This helps the cells in the retina to function better, slowing down the progression of the disease.
Croatian: Time se stanicama u mrežnici pomaže da bolje funkcioniraju te se usporava napredovanje bolesti.
English: Other information about Luxturna
Croatian: Ostale informacije o lijeku Luxturna
English: Luxturna must not be used in patients with eye infection or inflammation.
Croatian: Lijek Luxturna ne smije se primjenjivati u bolesnika s infekcijom ili upalom oka.
English: As for all medicines, data on the use of Luxturna are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Luxturna kontinuirano se prate.
English: The company that markets Luxturna will set up an educational programme and prepare educational material aimed at doctors and pharmacists expected to use and handle Luxturna, in order to ensure the correct use of the medicine and minimise the risks associated with the medicine and its administration.
Croatian: Tvrtka koja stavlja lijek Luxturna u promet uspostavit će edukacijski program i pripremiti materijal za obuku namijenjen liječnicima i ljekarnicima od kojih se očekuje da će upotrebljavati i rukovati lijekom Luxturna kako bi se osigurala ispravna uporaba lijeka i smanjili rizici povezni s primjenom i davanjem lijeka.
English: What are the risks associated with Luxturna?
Croatian: Koji su rizici povezani s lijekom Luxturna?
English: The main measure of effectiveness was how well patients performed in a mobility test, where they were required to navigate a route with turns and obstacles under various light settings.
Croatian: Glavna mjera učinkovitosti bila je uspješnost bolesnika na testu mobilnosti gdje se od njih tražilo da se kreću određenom rutom na kojoj je bilo zavoja i prepreka, pri različitim razinama osvjetljenja okoline.
English: Therefore, the European Medicines Agency decided that Luxturna's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Luxturna nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: An overview of Luxturna and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Luxturna i zašto je odobren u EU-u
English: RPE65 is responsible for the production of an enzyme called all-trans retinyl isomerase, which is necessary for the normal functioning of retinal cells.
Croatian: Gen RPE65 odgovoran je za proizvodnju enzima sav-trans-retinil izomeraze, koji je neophodan za normalno funkcioniranje stanica mrežnice.
English: Why is Luxturna authorised in the EU?
Croatian: Zašto je lijek Luxturna odobren u EU-u?
English: After one year of treatment, patients treated with Luxturna improved their scores by 1.8 points, while patients who were not given Luxturna improved their scores by 0.2 points, meaning that patients treated with Luxturna were able to move better along the route.
Croatian: Nakon godinu dana liječenja, bolesnici koji su primali lijek Luxturna poboljšali su svoj rezultat za 1,8 bodova, dok su bolesnici koji nisu primali lijek Luxturna poboljšali svoj rezultat za 0,2 boda.
English: Luxturna is a medicine that is used to treat adults and children with loss of vision due to inherited retinal dystrophy, a rare genetic disorder of the retina (the light sensitive membrane at the back of the eye).
Croatian: Luxturna je lijek koji se primjenjuje za liječenje odraslih osoba i djece s gubitkom vida uzrokovanim nasljednom retinalnom distrofijom, rijetkim genetskim poremećajem mrežnice (opne osjetljive na svjetlost koja se nalazi u stražnjem dijelu oka).
English: Luxturna contains the active substance voretigene neparvovec and is a type of advanced therapy medicine called a ‘gene therapy product'.
Croatian: Lijek Luxturna sadržava djelatnu tvar voretigen neparvovek i vrsta je lijeka za naprednu terapiju koji se naziva „lijek za gensku terapiju”.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luxturna 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 Luxturna nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.