FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, since certain other combination treatments could be more effective, the use of Trizivir should only be considered under special circumstances such as co-infection with tuberculosis (as other HIV treatments can interact with the medicines being taken by the patient).
Croatian: Načelno, budući da bi određene druge kombinacijske terapije mogle biti djelotvornije, primjena lijeka Trizivir treba se razmotriti samo u posebnim uvjetima poput istovremene infekcije tuberkulozom (budući da druge terapije protiv HIV-a mogu biti u interakciji s lijekovima koje uzima bolesnik).
English: They all work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Croatian: Sve tri djeluju na sličan način blokirajući djelovanje reverzne transkriptaze, enzima koji HIV proizvodi, a koji mu omogućuje da zarazi stanice i proizvodi više virusa.
English: Trizivir reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Trizivir smanjuje količinu HIV-a u krvi i održava ga u malim koncentracijama.
English: Hypersensitivity reactions (allergic reactions) occur in patients taking Trizivir, usually within the first six weeks of treatment, and can be life-threatening.
Croatian: Reakcije preosjetljivosti (alergijske reakcije) pojavljuju se u bolesnika koji uzimaju lijek Trizivir obično u roku od šest tjedana od liječenja i mogu biti opasne po život.
English: The risk of hypersensitivity is higher in patients who have the HLA-B (type 5701) gene.
Croatian: Rizik od preosjetljivosti veći je u bolesnika koji imaju gen HLA-B (tip 5701).
English: The European Commission granted a marketing authorisation valid throughout the EU for Trizivir on 28 December 2000.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Trizivir na snazi u Europskoj uniji od 28. prosinca 2000.
English: In addition, the company that markets Trizivir provides educational materials for doctors about hypersensitivity reactions with the medicine, including the need to test patients for the HLA-B (type 5701) gene and to remind patients to contact their doctor immediately if they develop symptoms suggestive of hypersensitivity.
Croatian: Nadalje, tvrtka koja stavlja u promet lijek Trizivir dostavit će edukacijske materijale liječnicima o reakcijama preosjetljivosti na lijek, uključujući potrebu za testiranje bolesnika na gen HLA-B (tip 5701) i podsjetnik bolesnicima da se odmah obrate svom liječniku ako se pojave simptomi koji ukazuju na preosjetljivost.
English: Because it contains zidovudine, Trizivir must not be used by patients with low neutrophil counts (low levels of a type of white blood cell) or anaemia (low red blood cell counts).
Croatian: Budući da sadrži zidovudin, Trizivir se ne smije koristiti u bolesnika s niskim brojem neutrofila (niskom razinom jedne vste bijelih krvnih stanica) ili anemijom (niskom brojem crvenih krvnih stanica).
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 Trizivir.
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 Trizivir.
English: Treatment with Trizivir should be stopped promptly if the patient has a hypersensitivity reaction.
Croatian: Liječenje lijekom Trizivir treba odmah prekinuti ako bolesnik ima reakciju preosjetljivosti.
English: For more information about treatment with Trizivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Trizivir pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate tablets.
Croatian: Tvrtka je također ispitala način na koji se kombinirane tablete apsorbiraju u tijelu u usporedbi s tabletama koje se uzimaju posebno.
English: This document is a summary of the European Public Assessment Report (EPAR) for Trizivir.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Trizivir.
English: Before prescribing Trizivir, doctors should consider the expected improved ability of the patient to stick to their treatment, the expected effectiveness of the medicine, and the risks associated with the active substances.
Croatian: Prije propisivanja lijeka Trizivir, liječnici trebaju razmotriti očekivanu povećanu sposobnost bolesnika da se pridržavaju terapije, očekivanu djelotvornost lijeka i rizike povezane s djelatnim tvarima.
English: Before starting treatment with abacavir, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)'.
Croatian: Prije početka liječenja abakavirom svi se bolesnici trebaju testirati kako bi se utvrdilo imaju li gen „HLA-B (tip 5701)”.
English: It also noted that the benefit of Trizivir has mainly been shown in patients who have had little or no previous HIV treatment and who do not have advanced disease.
Croatian: Također je zaključio da je korist od lijeka Trizivir uglavnom dokazana u bolesnika koji su prethodno malo primali ili uopće nisu primali terapiju protiv HIV-a te u kojih bolest nije uznapredovala.
English: Patients will also receive an alert card summarising key safety information on hypersensitivity reactions with this medicine.
Croatian: Bolesnici će također primiti karticu upozorenja koja sadrži sažetak ključnih informacija za sigurnu primjenu vezanih uz reakcije preosjetljivosti na ovaj lijek.
English: Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain (stomach ache), headache, signs of liver damage in the blood, myalgia (muscle pain), dyspnoea (difficulty breathing), cough, lethargy
Croatian: Simptomi gotovo uvijek uključuju vrućicu ili osip, no vrlo često uključuju i mučninu, povraćanje, proljev, abdominalnu bol (bol u trbuhu), glavobolju, znakove oštećenja jetre, mijalgiju (mišićnu bol), dispneju (otežano disanje), kašalj, letargiju (pomanjkanje energije) i iscrpljenost (osjećaj slabosti).
English: The combination tablet was absorbed in the body in the same way as the separate tablets.
Croatian: Kombinirana tableta apsorbira se u tijelu na isti način kao i tablete koje se uzimaju posebno.
English: A risk management plan has been developed to ensure that Trizivir is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Trizivir.
English: In the studies carried out for the development of Ziagen, the combination of the three active substances was shown to be at least as effective as the comparator combinations in keeping viral loads low.
Croatian: U ispitivanjima provedenima za potrebe razvoja lijeka Ziagen utvrđeno je da je kombinacija triju djelatnih tvari barem jednako djelotvorna kao i usporedne kombinacije s obzirom na održavanje niske razine virusnog opterećenja.
English: Patients with this gene are at an increased risk of having an allergic reaction to abacavir so they should not take Trizivir.
Croatian: Bolesnici s tim genom izloženi su povećanom riziku od alergijske reakcije na abakavir pa ne bi smjeli uzimati lijek Trizivir.
English: Treatment with Trizivir should be started by a doctor who has experience in the management of HIV infection.
Croatian: Liječenje lijekom Trizivir mora započeti liječnik s iskustvom u liječenju infekcija HIV-om.
English: If patients need to stop taking abacavir, lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing abacavir, lamivudine or zidovudine separately.
Croatian: Ako bolesnici trebaju prekinuti terapiju abakavirom, lamivudinom ili zidovudinom ili trebaju uzimati druge doze jer imaju problema s bubrezima, jetrom ili krvlju, trebaju zasebno uzimati lijekove koji sadrže abakavir, lamivudin ili zidovudin.
English: The company presented the results of studies with abacavir, lamivudine and zidovudine taken together, which were carried out during the development of Ziagen.
Croatian: Tvrtka je dostavila rezultate ispitivanja abakavira, lamivudina i zidovudina koji su uzimani zajedno, a koja su provedena tijekom razvoja lijeka Ziagen.
English: Trizivir abacavir, lamivudine and zidovudine
Croatian: Trizivir abakavir, lamivudin i zidovudin
English: Other information about Trizivir:
Croatian: Ostale informacije o lijeku Trizivir
English: Trizivir is used to treat adults who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Trizivir se koristi za liječenje bolesnika zaraženih virusom humane imunodeficijencije (HIV), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trizivir, 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 lijek Trizivir nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Trizivir is a medicine that contains three active substances: abacavir, lamivudine and zidovudine.
Croatian: Trizivir je lijek koji sadrži tri djelatne tvari: abakavir, lamivudin i zidovudin.
English: The Committee decided that Trizivir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi lijeka Trizivir nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The most common effects with Trizivir (seen in more than 1 patient in 10) are headache and nausea (feeling sick).
Croatian: Najčešće su nuspojave lijeka Trizivir (koje se mogu javiti u više od 1 na 10 osoba) glavobolja i mučnina (osjećaj slabosti).
English: What is Trizivir?
Croatian: Što je Trizivir?
English: It is used to replace treatment with the three active substances (abacavir, lamivudine and zidovudine) taken separately at doses similar to those in Trizivir.
Croatian: Koristi se kao zamjena za terapiju s tri djelatne tvari (abakavirom, lamivudinom i zidovudinom) koje se uzimaju zasebno u dozama sličnima onima koje sadrži lijek Trizivir.
English: What is the risk associated with Trizivir?
Croatian: Koji su rizici povezani s lijekom Trizivir?
English: All three active substances in Trizivir, abacavir, lamivudine, and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Croatian: Sve tri djelatne tvari lijeka Trizivir, tj. abakavir, lamivudin i zidovudin, nukleozidni su inhibitori reverzne transkriptaze (NRTI-ovi).
English: Trizivir must not be used in patients who have kidney failure.
Croatian: Trizivir se ne smije primjenjivati u bolesnika sa zatajenjem bubrega.
English: Why has Trizivir been approved?
Croatian: Zašto je lijek Trizivir odobren?
English: For the full list of all side effects reported with Trizivir, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Trizivir potražite u uputi o lijeku.
English: What is Trizivir used for?
Croatian: Za što se Trizivir koristi?
English: How is Trizivir used?
Croatian: Kako se Trizivir koristi?
English: What benefit has Trizivir shown during the studies?
Croatian: Koje su koristi lijeka Trizivir utvrđene u ispitivanjima?
English: How has Trizivir been studied?
Croatian: Kako je Trizivir ispitivan?
English: For more information, see the package leaflet.
Croatian: Dodatne informacije potražite u uputi o lijeku.
English: How does Trizivir work?
Croatian: Kako djeluje Trizivir?
English: Repeatability was 97%.
Croatian: Ponovljivost je bila 97 %.
English: Frequency not known (cannot be estimated from the available data):
Croatian: Učestalost nepoznata (ne može se procijeniti iz dostupnih podataka):
English: If this happens, do not drive or use machines.
Croatian: Ako se to dogodi, nemojte upravljati vozilima ili strojevima.
English: To ensure that the test results are reliable, you need to follow the rules below:
Croatian: Kako bi se osiguralo da su rezultati testa pouzdani, morate se pridržavati pravila u nastavku:
English: Read all of this leaflet carefully before you take this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite ovaj lijek jer sadrži Vama važne podatke.
English: Package leaflet: Information for the patient/user
Croatian: Uputa o lijeku: Informacije za bolesnika/korisnika
English: It is a test that helps your doctor to diagnose this condition.
Croatian: To je test koji Vašem liječniku pomaže dijagnosticirati to stanje.
English: Agreement between the result of the first test and the second test was observed in 31 cases (91.2%).
Croatian: Slaganje rezultata prvog i drugog testa opaženo je u 31 slučaju (91,2 %).
English: No specific recommendations after overdose are given.
Croatian: Nisu dane nikakve specifične preporuke nakon predoziranja.
English: Store in the original package, in order to protect from light and moisture.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti i vlage.
English: If occurring, such changes would be timely limited and not last long.
Croatian: Takve promjene, ako se dogode, vremenski su ograničene i ne traju dugo.
English: During the test, the patient needs to stay fasted until the end of the blood sampling.
Croatian: Tijekom testa bolesnik mora ostati natašte do kraja uzimanja uzoraka krvi.
English: If you are a woman able to have children, you must use effective contraceptive methods to ensure you are not pregnant at the time of the test.
Croatian: Ako ste žena koja može zatrudnjeti, morate primjenjivati učinkovite metode kontracepcije kako bi se zajamčilo da nećete biti trudni u vrijeme provedbe testa.
English: It is unknown whether such potential interactions may also affect QTc (see above).
Croatian: Nije poznato mogu li takve potencijalne interakcije utjecati i na QTc (vidjeti iznad).
English: The number of test sachets needed is based on body weight.
Croatian: Broj potrebnih testnih vrećica temelji se na tjelesnoj težini.
English: The dose is calculated based on the patient´s body weight.
Croatian: Doza se izračunava na temelju tjelesne težine bolesnika.
English: Overall, the adverse reactions reported were mostly of mild intensity and short duration without a specific treatment need.
Croatian: Ukupno gledano, prijavljene nuspojave bile su uglavnom blagog intenziteta i kratkog trajanja bez potrebe za određenim liječenjem.
English: It is unknown whether this may affect QTc.
Croatian: Nije poznato može li to utjecati na QTc.
English: No studies to assess carcinogenicity and effects on reproduction and development have been conducted.
Croatian: Nisu provedena ispitivanja za procjenu kancerogenosti i učinaka na reprodukciju i razvoj.
English: • Physical exercise - avoid strenuous physical activity 24 hours before the test.
Croatian: • tjelesna aktivnost - izbjegavajte napornu tjelesnu aktivnost 24 sata prije testa
English: This medicinal product is for diagnostic use only.
Croatian: Ovaj se lijek koristi samo u dijagnostičke svrhe.
English: Repeatability was tested in a subset of 34 subjects who underwent two MAC tests.
Croatian: Ponovljivost je testirana na podskupini od 34 ispitanika na kojima su provedena dva MAC testa.
English: Stir the suspension gently for 2 minutes (a small amount of undissolved particles will remain giving a slightly turbid suspension).
Croatian: Pažljivo miješajte suspenziju 2 minute (ostat će mala količina neotopljenih čestica, zbog čega će suspenzija biti malo zamućena).
English: • Fasting - you must not eat for at least 8 hours before the test, and during the test.
Croatian: • morate biti natašte - ne smijete jesti najmanje 8 sati prije testa te tijekom testa
English: Step 1 Weigh the patient.
Croatian: 1. korak Vaganje bolesnika.
English: Reconstituted suspension
Croatian: Rekonstituirana suspenzija
English: Plasma protein binding decreases with increasing concentrations from 78% at 0.1 µM to 62% at 10 µM.
Croatian: Vezivanje za proteine plazme smanjuje se s povećanjem koncentracije sa 78 % pri 0,1 µM na 62 % pri 10 µM.
English: These side effects are mostly mild, do not last long, and usually go away quickly without treatment.
Croatian: Te su nuspojave većinom blage, ne traju dugo i obično brzo prođu bez liječenja.
English: Reconstituted suspension:
Croatian: Rekonstituirana suspenzija:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before this medicine is given to you.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svojem liječniku ili medicinskoj sestri za savjet prije nego primite ovaj lijek.
English: Results
Croatian: Rezultati
English: You have to drink the complete test dose within 30 seconds.
Croatian: Cijelu testnu dozu morate popiti unutar 30 sekundi.
English: Transfer the measured amount to a drinking glass.
Croatian: Izmjerenu količinu prebacite u čašu.
English: Only limited pharmacokinetic data are available in the elderly.
Croatian: Za starije osobe dostupni su samo ograničeni farmakokinetički podatci.
English: The median age was 41 years (range: 18 - 66 years) and body mass index 27.5 kg/m2 (range: 16 - 40 kg/m2).
Croatian: Medijan dobi bio je 41 godina (raspon: 18 - 66 godina), a indeks tjelesne mase 27,5 kg/m2 (raspon: 16 - 40 kg/m2).
English: In the event of an overdose, symptomatic and supportive measures should be employed.
Croatian: U slučaju predoziranja potrebno je primijeniti mjere simptomatskog i potpornog liječenja.
English: The shelf life of a sachet is 4 years.
Croatian: Rok valjanosti vrećice je 4 godine.
English: The description in this leaflet is for your information on the testing procedure.
Croatian: Opis u ovim uputama za Vašu je informaciju o postupku testiranja.
English: In such a situation, a repetition of the test may be required.
Croatian: U takvoj situaciji može biti potrebno ponoviti test.
English: Each cardboard box contains 1 sachet.
Croatian: Jedna kartonska kutija sadrži 1 vrećicu.
English: In the age group 60 years up to 65 years, the limited data available do not indicate the need for a separate cut-off point.
Croatian: U dobnoj skupini od 60 do 65 godina dostupni su ograničeni podatci koji ne upućuju na potrebu za posebnom graničnom vrijednošću.
English: A decision must be made whether to discontinue breast-feeding or to abstain from macimorelin, taking into account the benefit of breast-feeding for the child and the benefit of the test for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili se suzdržati od primjene macimorelina uzimajući u obzir korist dojenja za dijete i korist testa za ženu.
English: One hundred and fifty-seven (157) subjects underwent at least one of the two tests in this study, 59% were male, 41% female and 86% of white origin.
Croatian: Stotinu pedeset i sedam (157) ispitanika podvrgnuto je najmanje jednom od dva testa u ovom ispitivanju, 59 % bili su muškarci, 41 % žene i 86 % ispitanika bili su bijelci.
English: This is not a treatment for patients who do not have enough growth hormone.
Croatian: Ovo nije terapija za bolesnike koji nemaju dovoljno hormona rasta.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dostavit će prvo periodičko izvješće o neškodljivosti za ovaj lijek unutar 6 mjeseci nakon dobivanja odobrenja.
English: Add required volume of water in a graduated glass or transparent plastic container.
Croatian: Dodajte potreban volumen vode u graduiranu staklenu ili prozirnu plastičnu posudu.
English: The suspension should be stirred until it is slightly turbid without particles at the bottom of the container.
Croatian: Suspenziju je potrebno miješati sve dok ne postane malo zamućena bez čestica na dnu posude.
English: Assessment of fasted condition and lack of prior strenuous physical exercise
Croatian: Procjena stanja natašte i nepostojanja prethodne naporne tjelesne aktivnosti
English: Have the patient drink the entire content of the drinking glass within 30 seconds.
Croatian: Bolesnik mora popiti cijeli sadržaj čaše unutar 30 sekundi.
English: The efficacy of macimorelin in patients aged over 65 years has not been established.
Croatian: Djelotvornost macimorelina u bolesnika starijih od 65 godina nije utvrđena.
English: Any suspension that remains must not be stored and must be discarded.
Croatian: Preostala suspenzija ne smije se pohraniti; mora se baciti.
English: Prepare plasma or serum samples and send to a laboratory for growth hormone determination.
Croatian: Pripremite uzorke plazme ili seruma i pošaljite ih u laboratorij radi određivanja hormona rasta.
English: Macimorelin Aeterna Zentaris must not be used in children and adolescents aged below 18 years, because the safety and effectiveness in these groups have not yet been established.
Croatian: Macimorelin Aeterna Zentaris ne smije se primjenjivati u djece i adolescenata u dobi mlađoj od 18 godina, jer sigurnost primjene i učinkovitost još nisu utvrđene u tim skupinama.
English: No drug-drug interaction studies have been performed in humans.
Croatian: Nisu provedena ispitivanja interakcija lijekova u ljudi.
English: Talk to your doctor or nurse if:
Croatian: Obratite se liječniku ili medicinskoj sestri:
English: Point estimates for sensitivity ranged from 0.87 to 0.90 for the MAC and from 0.97 to 1.0 for the ITT, depending on the inclusion or exclusion of data from not matched Group A subjects, respectively.
Croatian: Točkovne procjene osjetljivosti bile su u rasponu od 0,87 do 0,90 za MAC i od 0,97 do 1,0 za ITT, ovisno o uključivanju odnosno isključivanju podataka za nepodudarne ispitanike iz skupine A.
English: Studies in animals are insufficient with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama s obzirom na reproduktivnu toksičnost nedostatna su (vidjeti dio 5.3).
English: • The active substance is macimorelin.
Croatian: • Djelatna tvar je macimorelin.
English: Information about lactose and sodium
Croatian: Informacije o laktozi i natriju
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should take this medicinal product only if the expected benefit of the test clearly outweighs the potential risk associated with an intake of maximum 1,691.8 mg lactose per sachet.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze smiju uzimati ovaj lijek samo ako očekivana korist testa jasno nadmašuje potencijalni rizik povezan s unosom najviše 1691,8 mg laktoze po vrećici.
English: White to off-white granules.
Croatian: Bijele do bjelkaste granule.
English: Other medicines and Macimorelin Aeterna Zentaris Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Macimorelin Aeterna Zentaris Obavijestite svojeg liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1337/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/1/18/1337/001
English: In case you should have heart rhythm disturbances, an ECG monitoring will be performed.
Croatian: U slučaju da Vam se pojave poremećaji srčanog ritma, provodit će se praćenje