FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Croatian: Bolesnici s postojećom disfunkcijom jetre, uključujući kronični aktivni hepatitis, imaju povećanu učestalost poremećaja jetrene funkcije tijekom kombinirane antiretrovirusne terapije te se moraju nadzirati u skladu s uobičajenom praksom.
English: Taking Triumeq at the time of becoming pregnant or during the first twelve weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
Croatian: Ako uzimate lijek Triumeq u vrijeme začeća ili tijekom prvih dvanaest tjedana trudnoće, povećava se rizik od urođene mane pod nazivom defekt neuralne cijevi, kao što je spina bifida (rascjep kralježnice).
English: Your methadone dose may need to be changed.
Croatian: Možda će biti potrebno promijeniti dozu metadona.
English: These hypersensitivity reactions have been seen more frequently in people taking medicines that contain abacavir.
Croatian: Te reakcije preosjetljivosti češće su primijećene u osoba liječenih lijekovima koji sadrže abakavir.
English: Separate preparations of dolutegravir, abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated.
Croatian: Postoje odvojeni pripravci dolutegravira, abakavira ili lamivudina za slučajeve kada je indiciran prekid primjene ili prilagodba doze jedne od djelatnih tvari.
English: Triumeq contains dolutegravir, abacavir and lamivudine, therefore any interactions identified for these individually are relevant to Triumeq.
Croatian: Triumeq sadrži dolutegravir, abakavir i lamivudin, stoga su sve interakcije utvrđene za svaku od tih djelatnih tvari pojedinačno relevantne i za Triumeq.
English: The absolute bioavailability of oral abacavir and lamivudine in adults is about 83% and 80-85% respectively.
Croatian: Apsolutna bioraspoloživost peroralno primijenjenog abakavira u odraslih osoba iznosi 83%, a lamivudina 80-85%.
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Croatian: Preporučuje se da žene s HIV infekcijom ni pod kojim uvjetom ne doje svoju dojenčad kako bi se izbjegao prijenos HIV-a.
English: Since Triumeq contains abacavir some patients taking Triumeq may develop a hypersensitivity reaction (serious allergic reaction).
Croatian: Budući da Triumeq sadrži abakavir, u nekih bolesnika koji uzimaju Triumeq može se razviti reakcija preosjetljivosti (ozbiljna alergijska reakcija).
English: Triumeq is a fixed-dose tablet and should not be prescribed for patients requiring dose adjustments.
Croatian: Triumeq je tableta s fiksnom kombinacijom doza pa se ne smije propisivati bolesnicima kojima je potrebna prilagodba doze.
English: This variant arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Croatian: Ta se varijanta pojavljuje i in vitro i u bolesnika s HIV-1 infekcijom liječenih antiretrovirusnom terapijom koja sadrži lamivudin.
English: If you get any symptoms of infection and inflammation or if you notice any of the symptoms above: → Tell your doctor immediately.
Croatian: Ako dobijete bilo koji simptom infekcije i upale ili ako primijetite neki od gore navedenih simptoma:
English: Some people taking Triumeq or other combination treatments for HIV are more at risk of serious side effects than others.
Croatian: U nekih osoba koje uzimaju Triumeq ili druge kombinirane terapije za HIV postoji povećan rizik od ozbiljnih nuspojava u odnosu na druge osobe.
English: There is no specific treatment for an overdose of Triumeq.
Croatian: Nema specifičnog liječenja za predoziranje lijekom Triumeq.
English: In addition, ribavirin had no apparent effect on dolutegravir activity.
Croatian: Osim toga, ribavirin nije primjetno utjecao na djelovanje dolutegravira.
English: Data from clinical trials showed limited numbers of myocardial infarction and could not exclude a small increase in risk.
Croatian: Podaci iz kliničkih ispitivanja ukazali su na ograničen broj slučajeva infarkta miokarda te nisu mogli isključiti malo povećanje rizika.
English: In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting.
Croatian: In vitro lamivudin inhibira unutarstaničnu fosforilaciju kladribina, što za posljedicu može imati rizik od gubitka djelotvornosti kladribina u slučaju kombinirane primjene u kliničkom okruženju.
English: Trimethoprim: AUC ↔
Croatian: trimetoprim: AUC ↔
English: M184V is associated with about a 2-fold increase in abacavir resistance but does not confer clinical resistance for abacavir.
Croatian: M184V se povezuje s približno dvostrukim povećanjem rezistencije na abakavir, ali ne uzrokuje kliničku rezistenciju na abakavir.
English: If you take too many tablets of Triumeq, contact your doctor or pharmacist for advice.
Croatian: Ako uzmete previše Triumeq tableta, obratite se liječniku ili ljekarniku za savjet.
English: African-American/African Heritage/Other Age (years)
Croatian: Afroamerikanci/afričko podrijetlo/ostalo
English: • trimethoprim/sulfamethoxazole, an antibiotic to treat bacterial infections
Croatian: • trimetoprim/sulfametoksazol, antibiotik za liječenje bakterijskih infekcija
English: Isolates resistant to abacavir may also show reduced sensitivity to lamivudine.
Croatian: Izolati rezistentni na abakavir mogu pokazivati i smanjenu osjetljivost na lamivudin.
English: Abacavir increases the rate at which methadone is removed from the body.
Croatian: Abakavir povećava brzinu kojom se metadon uklanja iz tijela.
English: Dolutegravir was not carcinogenic in long term studies in the mouse and rat.
Croatian: Dolutegravir nije bio kancerogen u dugoročnim istraživanjima na miševima i štakorima.
English: CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Triumeq if:
Croatian: ODMAH SE OBRATITE SVOM LIJEČNIKU za savjet o tome morate li prestati uzimati Triumeq:
English: Clinical status including liver aminotransferases and bilirubin should be monitored.
Croatian: Potrebno je pratiti klinički status, uključujući jetrene aminotransferaze i bilirubin.
English: • supplements or multivitamins containing calcium, iron or magnesium.
Croatian: • nadomjeske ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij.
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir (a component of Triumeq) at the time of conception compared with mothers exposed to non-dolutegravir containing regimens (0.1%).
Croatian: Preliminarni podaci iz ispitivanja s ciljem praćenja upućuju na porast incidencije defekata neuralne cijevi (0,9 %) u majki izloženih dolutegraviru (sastavnica lijeka Triumeq) u vrijeme začeća u odnosu na majke koje su bile izložene režimima koji ne sadržavaju dolutegravir (0,1 %).
English: No clinical data are available in patients with moderate or severe hepatic impairment, therefore the use of Triumeq is not recommended unless judged necessary.
Croatian: Nema kliničkih podataka za bolesnike s umjerenim ili teškim oštećenjem jetre, stoga se primjena lijeka Triumeq ne preporučuje osim ako se procijeni da je neophodna.
English: Key elements included in the educational material to increase understanding and awareness of ABC HSR and expand on the information already included in the SmPC:
Croatian: Ključni elementi uključeni u edukacijske materijale radi poboljšanja razumljivosti, povećanja svijesti o reakcijama preosjetljivosti na abakavir i proširenja informacija već uključenih u Sažetak opisa svojstava lijeka:
English: Abacavir and its metabolites are excreted into the milk of lactating rats.
Croatian: Abakavir i njegovi metaboliti se izlučuju u mlijeko štakorica.
English: Dolutegravir is primarily metabolized via UGT1A1 with a minor CYP3A component (9.7% of total dose administered in a human mass balance study).
Croatian: Dolutegravir se prvenstveno metabolizira putem UGT1A1, a manjim dijelom posredstvom CYP3A (9,7% ukupne doze primijenjene u ispitivanju masene bilance u ljudi).
English: Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
Croatian: U toj se dobnoj skupini preporučuje poseban oprez zbog mogućih promjena povezanih s dobi, poput smanjene bubrežne funkcije i promjena u hematološkim parametrima.
English: Trimethoprim (an inhibitor of these drug transporters) has been shown to increase lamivudine plasma concentrations, however the resulting increase was not clinically significant (see Table 1).
Croatian: Pokazalo se da trimetoprim (inhibitor tih prijenosnika lijekova) povećava plazmatske koncentracije lamivudina, ali to povećanje nije bilo klinički značajno (vidjeti Tablicu 1).
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66% of the administered dose.
Croatian: Glavni metabolički putovi u čovjeka odvijaju se posredstvom alkohol dehidrogenaze i glukuronidacijom, pri čemu nastaju 5'-karboksilna kiselina i 5'-glukuronid, koji čine oko 66% primijenjene doze.
English: These findings should be considered for any child exposed in utero to nucleoside and nucleotide analogues, who presents with severe clinical findings of unknown aetiology, particularly neurologic findings.
Croatian: Ovi nalazi bi se trebali razmotriti za svako dijete koje je bilo izloženo nukleozidnim i nukleotidnim analozima in utero, a kod kojeg su prisutni teški klinički nalazi nepoznate etiologije, posebice neurološki nalazi.
English: Week 48 outcomes (including outcomes by key baseline covariates) are shown in Table 3.
Croatian: Ishodi nakon 48 tjedana (uključujući ishode prema ključnim kovarijantama s početka ispitivanja) prikazani su u Tablici 3.
English: In vitro, abacavir was an inhibitor of MATE1; the clinical consequences are not known.
Croatian: In vitro je abakavir bio inhibitor prijenosnika MATE1; kliničke posljedice nisu poznate.
English: Of these four, two subjects had a unique R263K integrase substitution, with a maximum fold change of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum fold change of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase experienced or infected with integrase resistant virus by transmission.
Croatian: Od ta četiri ispitanika, dva su imala jedinstvenu supstituciju R263K na integrazi uz najvišu vrijednost promjene 1,93, jedan je imao polimorfnu supstituciju V151V/I na integrazi uz najvišu vrijednost promjene 0,92, a jedan je ispitanik imao otprije postojeće mutacije integraze te se pretpostavlja da je prethodno primao inhibitore integraze ili da je prijenosom bio zaražen virusom rezistentnim na inhibitore integraze.
English: Dolutegravir has a <10-fold change against 94% of the 705 clinical isolates.
Croatian: Vrijednost promjene osjetljivosti za dolutegravir iznosila je <10 puta u 94% od 705 kliničkih izolata.
English: Two mutations conferred a 7 to 8-fold change in abacavir susceptibility and combinations of three mutations were required to confer more than an 8-fold change in susceptibility.
Croatian: Dvije mutacije dovele su do promjene osjetljivosti na abakavir za 7-8 puta, dok je za promjenu osjetljivosti za više od 8 puta bila je potrebna kombinacija triju mutacija.
English: Abacavir demonstrated toxicity to the developing embryo and foetus in rats, but not in rabbits.
Croatian: Abakavir je bio toksičan za razvoj embrija i fetusa u štakora, ali ne i u kunića.
English: Dolutegravir has not been studied in patients on dialysis, though differences in exposure are not expected.
Croatian: Dolutegravir nije ispitivan u bolesnika na dijalizi, ali se ne očekuju razlike u izloženosti.
English: No relevant effects were seen on the QTc interval, with doses of dolutegravir exceeding the clinical dose by approximately 3-fold.
Croatian: Nisu primijećeni značajni učinci na QTc interval pri primjeni doza dolutegravira približno trostruko većih od kliničkih doza.
English: In lactating rats that received a single oral dose of 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood.
Croatian: U štakorica u laktaciji koje su primile jednu oralnu dozu od 50 mg/kg 10 dana postpartalno, dolutegravir je pronađen u mlijeku u koncentracijama koje su obično bile veće od onih u krvi.
English: Triumeq should not be administered to adults or adolescents who weigh less than 40 kg because it is a fixed-dose tablet that cannot be dose reduced.
Croatian: Triumeq se ne smije primjenjivati u odraslih i adolescenata tjelesne težine manje od 40 kg jer je kombinacija doza u tableti fiksna i ne može se smanjiti.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - COMPONENT OF MULTIPACK)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU UNUTARNJA KUTIJA (BEZ PLAVOG OKVIRA - SASTAVNI DIO VIŠESTRUKOG PAKIRANJA)
English: (organic cation transporter inhibition)
Croatian: (inhibicija prijenosnika organskih kationa)
English: DTG/ABC/3TC FDC - abacavir/dolutegravir/lamivudine fixed-dose combination ATV+RTV+TDF/FTC FDC -atazanavir plus ritonavir plus tenofovir disproxil/emtricitabine fixeddose combination
Croatian: DTG/ABC/3TC - dolutegravir/abakavir/lamivudin ATV+RTV+TDF/FTC -atazanavir plus ritonavir plus tenofovirdizoproksil/emtricitabin
English: Children and adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet once a day.
Croatian: Djeca i adolescenti u dobi između 12 i 17 godina i tjelesne težine najmanje 40 kg mogu uzimati dozu namijenjenu odraslim osobama - jednu tabletu jedanput na dan.
English: Abacavir:
Croatian: abakavir:
English: It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen.
Croatian: Nije poznato je li sve ili samo dio toga posljedica neapsorpcije djelatne tvari ili izlučivanja glukuronidacijskog konjugata u žuči, koji se u lumenu crijeva može dalje razgraditi i činiti ishodišni spoj.
English: The metabolites and unchanged abacavir account for about 83% of the administered abacavir dose in the urine.
Croatian: Metaboliti i nepromijenjeni abakavir čine približno 83% primijenjene doze abakavira u mokraći.
English: Symptoms can occur at any time during treatment with ABC, but usually occur within the first 6 weeks of therapy.
Croatian: Simptomi se mogu se javiti u bilo kojem trenutku tijekom liječenja abakavirom, ali obično se jave tijekom prvih 6 tjedana terapije.
English: It is important to read the information in this section under the heading ‘Other possible side effects of combination therapy for HIV'.
Croatian: Važno je da pročitate informacije u odlomku pod naslovom 'Druge moguće nuspojave na kombiniranu terapiju za HIV', koji se nalazi u ovome dijelu.
English: More than 1000 outcomes from second and third trimester exposure to dolutegravir in pregnant women indicate no evidence of increased risk of malformative and foeto/neonatal negative effects.
Croatian: Više od 1000 ishoda izloženosti trudnica u drugom i trećem tromjesečju ne pokazuje povećan rizik od malformacijskih i fetalnih/neonatalnih negativnih učinaka.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Croatian: Relevantni primjeri su retinitis izazvan citomegalovirusom, generalizirane i/ili žarišne mikobakterijske infekcije i pneumonija čiji je uzročnik Pneumocystis jirovecii (koja se često naziva
English: The effect of a high fat meal on the Triumeq tablet was evaluated in a subgroup of subjects in this study (n=12).
Croatian: Učinak obroka s visokim udjelom masnoća na Triumeq tabletu ocijenjen je u podskupini bolesnika unutar navedenog ispitivanja (n=12).
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. metformin) (see Table 1).
Croatian: In vivo dolutegravir može povećati plazmatske koncentracije lijekova čije izlučivanje ovisi o OCT2 ili MATE-1 (npr. metformin) (vidjeti Tablicu 1).
English: Please refer to section 4.4 for further details on patient management in the event of a suspected HSR to Triumeq.
Croatian: Vidjeti dio 4.4 za dodatne informacije o zbrinjavanju bolesnika u slučaju sumnje na reakciju preosjetljivosti na Triumeq.
English: In patients with mild hepatic impairment (Child-Pugh score 5-6) close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
Croatian: Bolesnike s blagim oštećenjem jetrene funkcije (Child-Pugh skor 5-6) potrebno je pažljivo pratiti, uključujući praćenje razine abakavira u plazmi, ako je moguće (vidjeti dijelove 4.4 i 5.2).
English: Hypersensitivity reactions can start at any time during treatment with Triumeq, but are more likely during the first 6 weeks of treatment.
Croatian: Reakcije preosjetljivosti mogu se javiti u bilo kojem trenutku tijekom liječenja lijekom Triumeq, ali je njihova pojava vjerojatnija tijekom prvih 6 tjedana liječenja.
English: Available toxicological data in animals have shown excretion of dolutegravir in milk.
Croatian: Dostupni toksikološki podaci prikupljeni u životinja pokazali su da se dolutegravir izlučuje u mlijeko.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, bisphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Croatian: Iako se etiologija smatra višeuzročnom (uključujući primjenu kortikosteroida, bisfosfonata, konzumiranje alkohola, tešku imunosupresiju, veći indeks tjelesne mase), slučajevi osteonekroze prijavljeni su osobito u bolesnika s uznapredovalom HIV bolešću i/ili u bolesnika dugotrajno izloženih kombiniranoj antiretrovirusnoj terapiji.
English: Resistance in vitro and in vivo: (abacavir and lamivudine) Abacavir-resistant isolates of HIV-1 have been selected in vitro and in vivo and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115F).
Croatian: Rezistencija in vitro i in vivo: (abakavir and lamivudin) Izolati HIV-1 rezistentni na abakavir izdvojeni su in vitro i in vivo, a povezuju se sa specifičnim genotipskim promjenama regije kodona reverzne transkriptaze (RT) (kodoni M184V, K65R, L74V i Y115).
English: Main demographics and outcomes are summarised in Table 5.
Croatian: Glavne demografske značajke i ishodi sažeto su prikazani u Tablici 5.
English: Methadone/Abacavir (40 to 90mg once daily for 14 days/600mg single dose, then 600mg twice daily for 14 days)
Croatian: Opioidi metadon/abakavir (40 do 90 mg jedanput na dan tijekom 14 dana/600 mg u jednokratnoj dozi, a zatim 600 mg dvaput na dan tijekom 14 dana)
English: In a Phase I/II 48 week multicentre, open-label study (P1093/ING112578), the pharmacokinetic parameters, safety, tolerability and efficacy of dolutegravir was evaluated in combination regimens in HIV-1 infected infants, children and adolescents.
Croatian: U 48-tjednom multicentričnom, otvorenom ispitivanju faze I/II (P1093/ING112578) farmakokinetički parametri, sigurnost, podnošljivost i djelotvornost dolutegravira ocijenjena je u kombiniranim režimima liječenja u dojenčadi, djece i adolescenata s HIV-1 infekcijom.
English: Some lateonset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Croatian: Rijetko su prijavljeni i neki neurološki poremećaji s kasnim nastupom (hipertonija, konvulzije, neuobičajeno ponašanje).
English: The median time from first starting ART was around 4.5 years.
Croatian: Medijan vremena od početka antiretrovirusne terapije iznosio je 4,5 godine.
English: Combination therapy such as Triumeq may cause other conditions to develop during HIV treatment.
Croatian: Kombinirana terapija, poput one lijekom Triumeq, može uzrokovati razvoj drugih stanja tijekom liječenja HIV infekcije.
English: Although abacavir and lamivudine are substrates of BCRP and P-gp in vitro, given the high absolute bioavailability of abacavir and lamivudine, (see section 5.2), inhibitors of these efflux transporters are unlikely to result in a clinically relevant impact on abacavir or lamivudine concentrations.
Croatian: Iako su abakavir i lamivudin supstrati za BCRP i P-gp in vitro, s obzirom na visoku apsolutnu bioraspoloživost abakavira i lamivudina (vidjeti dio 5.2) nije vjerojatno da će inhibitori tih efluksnih prijenosnika imati klinički značajnog učinka na koncentracije abakavira ili lamivudina.
English: WOCBP who are taking Triumeq should use effective contraception throughout treatment.
Croatian: Žene reproduktivne dobi koje uzimaju lijek Triumeq trebaju koristiti učinkovitu kontracepciju tijekom cijelog liječenja.
English: For the comparators typical resistance was detected with TDF/FTC/EFV (SINGLE; six with NNRTI associated resistance and one with major NRTI resistance) and with 2 NRTIs + raltegravir (SPRING2; four with major NRTI resistance and one with raltegravir resistance), while no de novo resistance was detected in patients treated with 2 NRTIs + DRV/RTV (FLAMINGO).
Croatian: Za usporedne je lijekove tipična rezistencija primijećena kod primjene kombinacije TDF/FTC/EFV (SINGLE; šest s rezistencijom na NNRTI i jedan sa značajnom rezistencijom na NRTI) te kod kombinacije 2 NRTI-ja + raltegravir (SPRING-2; četiri sa značajnom rezistencijom na NRTI i jedan s rezistencijom na raltegravir), dok de novo rezistencija nije otkrivena u bolesnika liječenih kombinacijom 2 NRTI-ja + DRV/RTV (FLAMINGO).
English: If you could get pregnant while receiving Triumeq, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Croatian: Ako biste mogli zatrudnjeti dok primate lijek Triumeq, morate primjenjivati pouzdanu metodu barijerne kontracepcije (na primjer kondom) uz druge metode kontracepcije, uključujući oralne
English: Both the time to viral suppression and change from baseline analyses were pre-specified and adjusted for multiplicity.
Croatian: I analiza vremena do virusne progresije i analiza promjene od početne vrijednosti bile su unaprijed određene i prilagođene za multiplicitet.
English: Sulfamethoxazole: AUC ↔
Croatian: sulfametoksazol: AUC ↔
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase class, or to the NRTI class was seen (n=876, follow-up of 48-96 weeks).
Croatian: U prethodno neliječenih bolesnika koji su u ispitivanjima faze IIb i faze III primali dolutegravir + 2 nukleozidna inhibitora reverzne transkriptaze (NRTI) nije primijećen razvoj rezistencije na skupinu inhibitora integraze niti na skupinu NRTI-ja (n=876, praćenje u trajanju od 48-96 tjedana).
English: If you have stopped taking Triumeq for any reason - especially because you think you are having side effects, or because you have other illness:
Croatian: Ako ste iz bilo kojeg razloga prestali uzimati Triumeq - osobito ako ste to učinili zato što mislite da imate nuspojave ili zato što imate druge bolesti: