FrancophonIA/ELRC3.0 huggingface dataset:
English: Atripla contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Croatian: Atripla sadržava tri djelatne tvari: efavirenz, nenukleozidni inhibitor reverzne transkriptaze (NNRTI); emtricitabin, nukleozidni inhibitor reverzne transkriptaze; i tenofirdizoproksil, odnosno „prolijek” za tenofovir, što znači da se pretvara u djelatnu tvar tenofovir u tijelu.
English: It must also not be used in patients who have had arrhythmia (abnormal heartbeat) and patients with abnormal levels of electrolytes in the blood (for example, potassium or magnesium).
Croatian: Isto tako, ne smije se primjenjivati u bolesnika koji su imali aritmiju (abnormalne otkucaje srca) ni u bolesnika s abnormalnim razinama elektrolita u krvi (npr. kalija ili magnezija).
English: The main measure of effectiveness was the proportion of patients whose viral loads were below 200 copies/ml after 48 weeks.
Croatian: Glavno mjerilo učinkovitosti bilo je udio bolesnika u kojih je nakon 48 tjedana virusno opterećenje iznosilo manje od 200 kopija/ml.
English: Atripla must not be started in patients with HIV that is resistant to any of the three active substances in Atripla.
Croatian: Terapija lijekom Atripla ne smije se započeti u bolesnika s HIV-om otpornim na bilo koju od triju djelatnih tvari u lijeku Atripla.
English: Atripla can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Croatian: Atripla se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: How is Atripla used?
Croatian: Kako se Atripla koristi?
English: The Agency decided that Atripla's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi od lijeka Atripla nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The study showed that switching to Atripla was as effective as remaining on the previous treatment combination.
Croatian: Ispitivanje je pokazalo da je prijelaz na lijek Atripla jednako učinkovit kao i nastavak liječenja prijašnjom kombiniranom terapijom.
English: What benefits of Atripla have been shown in studies?
Croatian: Koje su koristi od lijeka Atripla utvrđene u ispitivanjima?
English: Based on the data available it could only recommend Atripla as a convenient ‘once-a-day tablet' treatment for maintaining viral loads in patients whose viral loads have already been reduced with other HIV treatment.
Croatian: Na temelju raspoloživih podataka, Agencija može preporučiti samo praktičnu terapiju lijekom Atripla u obliku jedne tablete jednom dnevno za održavanje virusnog opterećenja u bolesnika čije je virusno opterećenje već smanjeno zbog uzimanja nekog drugog lijeka za liječenje infekcije HIVom.
English: The study compared the effectiveness of switching to Atripla tablets with that of continuing the successful HIV treatment combination.
Croatian: U tom ispitivanju uspoređivala se učinkovitost prebacivanja na tablete lijeka Atripla s nastavkom uspješnog liječenja kombiniranom terapijom protiv HIV-a.
English: It is only used in patients whose levels of HIV in the blood (viral loads) have been below 50 copies/ml for more than three months on their current HIV treatment combination.
Croatian: Primjenjuje se samo u bolesnika kojima uz njihovu postojeću kombiniranu terapiju protiv HIV-a, razina HIV-a u krvi (virusno opterećenje) iznosi manje od 50 kopija/ml dulje od tri mjeseca.
English: • St John's wort (a herbal preparation used to treat depression);
Croatian: • gospinu travu (biljni pripravak za liječenje depresije)
English: See the package leaflet for further details and for the full list of restrictions.
Croatian: Više pojedinosti i potpuni popis ograničenja potražite u uputi o lijeku.
English: How does Atripla work?
Croatian: Kako djeluje Atripla?
English: For the full list of side effects reported with Atripla, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Atripla potražite u uputi o lijeku.
English: 13 December 2019 EMA/189409/2019
Croatian: 13. prosinac 2019. EMA/189409/2019
English: A letter with this information will be sent to healthcare professionals.
Croatian: Zdravstvenim radnicima bit će upućeno pismo s tim informacijama.
English: Trisenox has been authorised in the European Union since November 2016.
Croatian: Lijek Trisenox odobren je u Europskoj uniji od studenoga 2016.
English: More information on Trisenox can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/trisenox
Croatian: Više informacija o lijeku Trisenox dostupno je na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/trisenox
English: Information for healthcare professionals
Croatian: Informacije za liječnike
English: Whereas underdosing may result in an inadequate effect overdose can result in serious and potentially fatal complications such as bleeding, severe infections and cardiac arrest.
Croatian: Dok primjena premale doze može rezultirati neodgovarajućim učinkom, predoziranje može prouzročiti ozbiljne i potencijalno smrtonosne komplikacije kao što su krvarenje, teške infekcije i srčani arest.
English: Ampoule of 10 ml
Croatian: Ampula od 10 ml
English: • To help differentiate between the two presentations, the packages have distinctive features shown below.
Croatian: • Kao pomoć u razlikovanju dviju koncentracija, pakiranja imaju različita obilježja kao što je prikazano u nastavku.
English: Both should be diluted with 100-250 ml of either glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection
Croatian: Obje jačine treba razrijediti pomoću 100-250 ml otopine glukoze 50 mg/ml (5 %) za injekciju ili otopine natrijeva klorida 9 mg/ml (0,9 %) za injekciju
English: Front of the carton
Croatian: Prednja strana kutije
English: The Agency is concerned that the coexistence of the two strengths may result in healthcare professionals inadvertently giving their patients too much (overdose) or not enough (underdose) of the active substance.
Croatian: Agencija je zabrinuta da bi istodobno postojanje dviju koncentracija moglo dovesti do toga da zdravstveni radnici daju svojim pacijentima previše (preveliku dozu) ili nedovoljno (premalu dozu) djelatne tvari.
English: Trisenox is a medicine used to treat adults with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic translocation (when there is a swap of genes between two chromosomes).
Croatian: Trisenox je lijek koji se koristi za liječenje odraslih osoba s akutnom promijelocitnom leukemijom (APL), rijetkim oblikom leukemije (raka bijelih krvnih stanica) izazvane translokacijom gena (kada dođe do zamjene gena između dvaju kromosoma).
English: After dilution Trisenox is given by an infusion (drip) into a vein over 1 to 2 hours.
Croatian: Nakon razrjeđivanja Trisenox se daje infuzijom (drip) u venu u trajanju od 1 do 2 sata.
English: Vial of 6 ml
Croatian: Bočica od 6 ml
English: Total content
Croatian: Ukupni sadržaj
English: • To avoid any mix-ups while both presentations coexist, healthcare professionals must carefully check the concentration of the available presentation when calculating the volume of Trisenox to withdraw for dilution and infusion to ensure that the patient receives the correct dose of arsenic trioxide.
Croatian: • Kako bi se spriječila svaka mogućnost zabune dok su dostupne obje koncentracije, zdravstveni radnici moraju pažljivo provjeriti koncentraciju navedenu na pakiranju kada izračunavaju volumen lijeka Trisenox koji treba izvući za razrjeđivanje i infuziju kako bi bili sigurni da će bolesnik primiti pravilnu dozu arsenova trioksida.
English: EMA is therefore alerting healthcare professionals using Trisenox of the risk of dosing errors and is reminding them to check the strength of the available presentation and follow the instructions for use carefully.
Croatian: EMA stoga upozorava zdravstvene radnike koji primjenjuju lijek Trisenox na rizik od pogrešaka pri doziranju i podsjeća ih da provjere jačinu lijeka koji im je na raspolaganju i pažljivo prate upute za uporabu.
English: EMA issues alert on the risk of dosing errors with the cancer medicine Trisenox
Croatian: EMA objavljuje upozorenje o riziku od pogreške pri doziranju lijeka protiv raka Trisenox
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein, and contains the active ingredient arsenic trioxide.
Croatian: Dostupan je kao koncentrat od kojeg se pripremi otopina za infuziju (drip) u venu i sadrži djelatni sastojak arsenov trioksid.
English: Label of the immediate container
Croatian: Naljepnica na unutarnjem pakiranju
English: The new presentation will replace the existing one, which contains 1 mg/ml in each ampoule.
Croatian: Nova koncentracija zamijenit će postojeću koja sadrži 1 mg/ml u jednoj ampuli.
English: • Both formulations will coexist until stocks of the one containing 1 mg/ml have all been used.
Croatian: • Obje formulacije će biti dostupne sve dok se zalihe one od 1 mg/ml ne upotrijebe u cijelosti.
English: The European Medicines Agency (EMA) has recommended the approval of a new presentation of the injectable cancer medicine Trisenox (arsenic trioxide) that contains 2 mg/ml of the active substance in each vial.
Croatian: Europska agencija za lijekove (EMA) preporučila je davanje odobrenja za novu koncentraciju lijeka protiv raka za primjenu infuzijom Trisenox (arsenov trioksid) koja sadrži 2 mg/ml djelatne tvari u jednoj bočici.
English: • A new presentation of Trisenox (vial containing 2 mg/ml arsenic trioxide) will be introduced to replace the existing presentation (ampoule containing 1 mg/ml arsenic trioxide).
Croatian: • Uvođenjem nove koncentracije i spremnika za lijek Trisenox (bočica koja sadrži 2 mg/ml arsenova trioksida) zamijenit će se postojeća koncentracija i spremnik (ampula koja sadrži 1 mg/ml arsenova trioksida).
English: Presentation
Croatian: Primjena
English: In addition, the new vial contains a total volume of 6 ml (and a total content of 12 mg arsenic trioxide) whereas the existing ampoule contains 10 ml (and a total content of 10 mg).
Croatian: Nadalje, nova bočica ima ukupni volumen od 6 ml (i sadrži ukupno 12 mg arsenova trioksida) dok je postojeća ampula volumena od 10 ml (i sadrži ukupno 10 mg).
English: In addition, the new presentation contains a total volume of 6 ml (and a total content of 12 mg) whereas the existing presentation contains 10 ml (and a total content of 10 mg).
Croatian: Nadalje, novi spremnik ima ukupni volumen od 6 ml (i sadrži ukupno 12 mg arsenova trioksida) dok je postojeći spremnik volumena od 10 ml (i sadrži ukupno 10 mg).
English: The two strengths will temporarily coexist until the one containing 1 mg/ml has all been used.
Croatian: Privremeno će na tržištu biti dostupne obje koncentracije, sve dok se ona od 1 mg/ml u cijelosti ne potroši.
English: PC: {number} SN: {number} NN: {number}
Croatian: < PC: {broj} SN: {broj} NN: {broj}
English: However, a return to higher doses is not recommended.
Croatian: Međutim, povratak na više doze se ne preporučuje.
English: Sexual dysfunction (not specified)*
Croatian: Seksualna disfunkcija (nije specificirano)*
English: • have HIV (human immunodeficiency virus) or have ever had any other problems with your immune system.
Croatian: • imate HIV (virus humane imunodeficijencije) ili ste bilo kada imali bilo kakav drugi problem s imunološkim sustavom.
English: Of these, sixty-three were sustained responders.
Croatian: Šezdeset i troje njih imalo je trajan odgovor.
English: Paediatric population: Growth and development:
Croatian: Pedijatrijska populacija: Rast i razvoj:
English: Your physician will prescribe the pack size which is best for you.
Croatian: Liječnik će propisati veličinu pakovanja koja je najbolja za Vas.
English: For additional details see section 4.5.
Croatian: Za dodatne pojedinosti pogledajte dio 4.5.
English: Do not use this medicine without advice of your doctor or pharmacist if you notice any change in the appearance of the hard capsules.
Croatian: Nemojte koristiti ovaj lijek bez savjetovanja s liječnikom ili ljekarnikom ako primijetite bilo kakve promjene u izgledu tvrdih kapsula.
English: - Aluminium
Croatian: − aluminij
English: Talk to your doctor if you or the child you are caring for:
Croatian: Razgovarajte s liječnikom ako ste Vi ili dijete o kojem skrbite:
English: However, absolute bioavailability is approximately 45%-65%, which appears to be due to first pass metabolism.
Croatian: Međutim, apsolutna bioraspoloživost iznosi oko 45-65 %, što je, čini se, posljedica metabolizma prvog prolaza.
English: • Genotype 2 or 3: The recommended duration of treatment is 24 weeks.
Croatian: • Genotipovi 2 ili 3: Preporučeno trajanje liječenja je 24 tjedna.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što počnete uzimati lijek jer sadrži Vama važne podatke.
English: • Inability to achieve full adult height may occur in some children and adolescents
Croatian: • nemogućnost postizanja pune visine odrasle osobe može se pojaviti u neke djece i adolescenata.
English: Some children did not reach their projected height within 1-12 years after completing treatment.
Croatian: Neka djeca nisu dostigla svoju planiranu visinu unutar 1-12 godina nakon završetka liječenja.
English: Based on the results of clinical trials, it is recommended that patients be treated for at least six months.
Croatian: Na temelju rezultata kliničkih ispitivanja preporučuje se bolesnike liječiti najmanje šest mjeseci.
English: Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Croatian: Stoga ćete redovito obavljati krvne pretrage kako bi se potvrdilo da se HIV infekcija ne pogoršava.
English: Date of first authorisation: 10 June 2010 Date of latest renewal: 11 February 2015
Croatian: Datum posljednje obnove odobrenja: 11 veljača 2015
English: Duration of treatment - Retreatment
Croatian: Trajanje liječenja - ponovno liječenje
English: • had a previous heart condition or have heart disease.
Croatian: • ranije imali srčanih tegoba ili imate srčanu bolest
English: • Men:
Croatian: • Muškarci:
English: - Depending upon the results of these tests, your doctor may change/adjust the number of hard capsules you or the child you are caring for take, prescribe a different pack size of this medicine, and/or change the length of time to take this treatment.
Croatian: - Ovisno o rezultatima tih pretraga, Vaš liječnik može izmijeniti/prilagoditi broj tvrdih kapsula koje uzimate ili uzima dijete o kojem skrbite, propisati drugačiju veličinu pakiranja ovog lijeka i/ili izmijeniti trajanje uzimanja ovog liječenja.
English: Elderly patients (≥ 65 years of age)
Croatian: Stariji bolesnici (≥65 godina)
English: Depending on the genotype of the hepatitis C virus that you have, your doctor may choose to treat you with a combination of this medicine with other medicines.
Croatian: Ovisno o genotipu virusa hepatitisa C koji imate, Vaš liječnik može odlučiti da Vas liječi kombinacijom ovog lijeka i drugih lijekova.
English: Like all medicines, this medicine used in combination with other medicines can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek korišten u kombinaciji s drugim lijekovima može uzrokovati nuspojave, iako se neće javiti u svakoga.
English: With zidovudine or stavudine, it is not certain if this medicine will change the way these medicines work.
Croatian: Kod primjene sa zidovudinom ili stavudinom nije sigurno hoće li ovaj lijek promijeniti njihovo djelovanje.
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards
Croatian: Ako imate tu reakciju, temeljito isperite usta nakon toga.
English: If an entire day has gone by, check with your doctor.
Croatian: Ako je prošao cijeli dan, provjerite s liječnikom što da učinite.
English: < 12 g/dL despite 4 weeks at reduced dose
Croatian: < 12 g/dl unatoč 4 tjedna liječenja sniženom dozom
English: No histopathological effects on bone were observed.
Croatian: Nisu opaženi histopatološki učinci na kost.
English: Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Croatian: Kad god je to moguće, dijete treba liječiti nakon pubertetskog zamaha rasta kako bi se smanjio rizik od inhibicije rasta.
English: Overall Population*
Croatian: Ukupna populacija*
English: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
Croatian: Biopsije jetre učinjene su prije i nakon liječenja u Ispitivanju 1, a nalazi su bili dostupni za 210 od 412 ispitanika (51 %).
English: - Blood tests will be done regularly to help your doctor to know if this treatment is working.
Croatian: - Krvne pretrage provodit će se redovito kako bi Vaš liječnik znao djeluje li ovo liječenje.
English: For laboratory monitoring of pregnancy, please refer to Laboratory tests.
Croatian: Za laboratorijski nadzor trudnoće pogledajte dio Laboratorijske pretrage.
English: The selection of formulation is based on individual characteristics of the patient.
Croatian: Odabir formulacija temelji se na pojedinačnim značajkama bolesnika.
English: Ninety-four of 107 children enrolled in the 5 year long-term follow-up trial.
Croatian: Devedeset i četvero djece od 107 djece upisano je u petogodišnje dugotrajno praćenje.
English: Seek medical help immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Croatian: Odmah potražite liječničku pomoć ako razvijete simptome teške alergijske reakcije (kao što je otežano disanje, piskanje pri disanju ili koprivnjača) dok uzimate ovo liječenje.
English: If you take more Ribavirin Mylan than you should Tell your doctor or pharmacist as soon as possible.
Croatian: Ako uzmete više lijeka Ribavirin Mylan nego što ste trebali Što prije obavijestite svog liječnika ili ljekarnika.
English: This Leaflet was Last Approved In.
Croatian: Ova uputa je zadnji puta revidirana u.
English: Blisters - No special storage conditions.
Croatian: Blisteri − nema posebnih uvjeta čuvanja.
English: Do not use this medicine after the expiry date which is stated on the bottle or blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici ili blisteru nakon EXP.
English: Sustained virologic response
Croatian: Trajan virološki odgovor
English: In this subgroup, there was a 56 % (463/823) sustained virological response rate.
Croatian: U toj je podskupini stopa trajnog virološkog odgovora iznosila 56 % (463/823).
English: The high sustained response rate in this subgroup of patients was identified in an interim analysis (n=49) and prospectively confirmed (n=48).
Croatian: Visoka stopa trajnog odgovora u ovoj podskupini bolesnika utvrđena je preliminarnom analizom (n = 49) te je prospektivno potvrđena (n = 48).
English: Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Croatian: Bolesnike se mora pomno nadzirati kako bi se uočili znakovi ili simptomi psihijatrijskih poremećaja.
English: Gwent, NP22 3AA United Kingom
Croatian: Gwent, NP22 3AA Ujedinjeno Kraljevstvo
English: Ribavirin capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Croatian: Ribavirin kapsule primjenjuju se peroralno svakoga dana, u dvije odvojene doze (ujutro i navečer), uz obrok.
English: The overall sustained response rate after a 24-week treatment duration was 50%.
Croatian: Ukupna stopa trajnog odgovora nakon liječenja u trajanju od 24 tjedna iznosila je 50 %.
English: Haemoglobin in patients with No Cardiac Disease
Croatian: Hemoglobin u bolesnika bez srčanih bolesti
English: Routine monthly pregnancy tests must be performed during this time.
Croatian: Tijekom tog vremena moraju se provoditi redoviti mjesečni testovi na trudnoću.
English: This type of transporter is present on virtually all cell types and may account for the high volume of distribution of ribavirin.
Croatian: Ovaj tip prijenosnika prisutan je na gotovo svim tipovima stanica i može biti odgovoran za velik volumen distribucije ribavirina.
English: Although data are limited, no evidence of long-term effects on sexual maturation was noted in the 5 year observational follow-up study.
Croatian: Premda su podaci ograničeni, nisu zabilježeni dokazi o dugotrajnim učincima na spolno sazrijevanje u petogodišnjem kontrolnom ispitivanju koje je služilo za promatranje.
English: Homicidal ideation*, mania*, mental status change
Croatian: homicidalne misli*, manija*, promjena mentalnog statusa
English: In this subgroup, there was a 92% (89/97) sustained virological response rate.
Croatian: U toj je podskupini stopa trajnog virusnog odgovora iznosila 92 % (89/97).
English: Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Croatian: Svakom bolesniku koji se požali na slabljenje ili gubitak vida odmah se mora učiniti temeljit očni pregled.
English: • Increased hormone related to your thyroid (TSH) in children and adolescents
Croatian: • povećanje hormona povezanog sa štitnjačom (TSH) u djece i adolescenata.
English: If the child/adolescent weighs (kg)
Croatian: Ako je tjelesna težina djeteta/ adolescenta (kg)
English: Standard blood tests will be taken to check your blood, kidney and liver function.
Croatian: Provest će se standardne pretrage krvi kako bi se provjerila Vaša krv te funkcija bubrega i jetre.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENA IDENTIFIKACIJSKA OZNAKA - PODACI RAZUMLJIVI ČOVJEKU
English: You or your female partner must use an effective contraceptive during the time you are taking ribavirin and for 7 months after stopping treatment.
Croatian: Vi ili Vaša partnerica morate koristiti učinkovitu kontracepciju za vrijeme Vašeg liječenja ribavirinom i tijekom sedam mjeseci nakon prestanka liječenja.
English: - History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months (see section 4.4).
Croatian: - Teška srčana bolest u anamnezi, uključujući nestabilnu ili nekontroliranu srčanu bolest u prethodnih 6 mjeseci (vidjeti dio 4.4).
English: Contains lactose.
Croatian: Sadrži laktozu
English: Growth rate decrease (height and/or weight decrease for age)
Croatian: smanjenje brzine rasta (smanjenje tjelesne visine i/ili težine za dob)
English: Dose modifications were required in 30% of patients, most commonly for anaemia and neutropenia.
Croatian: Prilagodbe doze bile su potrebne u 30 % bolesnika, najčešće zbog anemije i neutropenije.
English: Male: impotence, prostatitis, erectile dysfunction.
Croatian: Muškarci: impotencija, prostatitis, erektilna disfunkcija.
English: No ribavirin effects were observed regarding neurobehavioural or reproductive development.
Croatian: Nije bilo zabilježenih učinaka ribavirina na neurološki ili reproduktivni razvoj.
English: This should be discussed with your doctor (see section “Do not take Ribavirin Mylan”).
Croatian: O ovome morate razgovarati sa svojim liječnikom (pogledajte dio „Nemojte uzimati Ribavirin Mylan”).
English: > 4 mg/dL (adults)
Croatian: > 4 mg/dl (odrasli)
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Croatian: Ograničeni prethodni podaci ukazuju na to da bi liječenje u trajanju od 48 tjedana moglo biti povezano s višom stopom trajnog odgovora (11/11) i nižim rizikom od relapsa (0/11 u usporedbi sa 7/96 nakon 24 tjedna liječenja).