FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Croatian: Klinička dijagnoza suspektne preosjetljivosti na abakavir ostaje temelj za donošenje kliničkih odluka.
English: Not everyone responds to treatment with Triumeq in the same way.
Croatian: Ne odgovaraju svi jednako na liječenje lijekom Triumeq.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Croatian: HIV infekcija širi se spolnim odnosom s nekime tko je već zaražen ili prijenosom zaražene krvi (primjerice, dijeljenjem injekcijskih igala).
English: Don't stop taking Triumeq unless your doctor advises you to do so.
Croatian: Nemojte prestati uzimati Triumeq, osim ako Vam to ne savjetuje liječnik.
English: This reaction can be life-threatening if treatment with Triumeq is continued.
Croatian: Ova reakcija može biti opasna po život ako se liječenje lijekom Triumeq nastavi.
English: 1) you get a skin rash OR
Croatian: 1) ako dobijete kožni osip ILI
English: Other possible side effects of combination therapy for HIV
Croatian: Druge moguće nuspojave na kombiniranu terapiju za HIV
English: Talk to your doctor before you start taking it again.
Croatian: Obratite se svom liječniku prije nego što ga počnete ponovno uzimati.
English: The proportion with a positive HCV serology was 7%.
Croatian: Udio bolesnika s pozitivnim serološkim nalazom na HCV iznosio je 7%.
English: Four subjects had virologic failure none of which had INI resistance at the time of virologic failure.
Croatian: U četiri ispitanika zabilježen je virološki neuspjeh, ali nijedan od njih nije imao rezistenciju na inhibitore integraze u trenutku virološkog neuspjeha.
English: At 96 weeks, the response was 80% vs 72%, respectively.
Croatian: Nakon 96 tjedana odgovor je postiglo 80% naspram 72% bolesnika.
English: Abacavir and lamivudine are potent selective inhibitors of HIV-1 and HIV-2.
Croatian: Abakavir i lamivudin su snažni selektivni inhibitori HIV-1 i HIV-2.
English: Do not discontinue Triumeq without consulting your doctor, as this may harm you and your unborn child.
Croatian: Nemojte prekidati primjenu lijeka Triumeq bez savjetovanja s liječnikom jer možete naštetiti sebi i svojem nerođenom djetetu.
English: Interaction not studied (Inhibition of alcohol dehydrogenase)
Croatian: Interakcija nije ispitivana (inhibicija alkoholdehidrogenaze).
English: The safety and efficacy of Triumeq in children less than 12 years of age has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Triumeq u djece mlađe od 12 godina nisu još ustanovljene.
English: Symptoms usually include fever, plus some of the following:
Croatian: Simptomi obično uključuju vrućicu praćenu nekim od sljedećih simptoma:
English: What you need to know before you take Triumeq
Croatian: Što morate znati prije nego počnete uzimati Triumeq
English: No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Croatian: Ne može se izvući zaključak o teratogenom potencijalu abakavira zbog te embriofetalne toksičnosti.
English: A small amount of the ingredients in Triumeq can also pass into your breast milk.
Croatian: Mala količina sastojaka lijeka Triumeq također može prijeći u majčino mlijeko.
English: Antihistamines (histamine H2 receptor antagonists) Ranitidine
Croatian: Antihistaminici (antagonisti histaminskog H2-receptora)
English: Effect of nevirapine on dolutegravir exposure is likely similar to or less than that of efavirenz.
Croatian: Učinak nevirapina na izloženost dolutegraviru vjerojatno je sličan ili manji od učinka efavirenza.
English: There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2).
Croatian: Nema dokaza koji bi ukazivali na to da je starijim bolesnicima potrebna drugačija doza od one koja se daje mlađim odraslim bolesnicima (vidjeti dio 5.2).
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Croatian: Ovi nalazi ne utječu na trenutno važeće nacionalne preporuke za primjenu antiretrovirusne terapije u trudnica radi sprječavanja vertikalnog prijenosa HIV-a.
English: It is recommended women who are HIV-positive do not breast-feed because HIV infection can be passed on to the baby in breast milk.
Croatian: Preporučuje se da žene koje su pozitivne na HIV ne doje jer se HIV infekcija može majčinim mlijekom prenijeti na dijete.
English: Resistance in vivo: (dolutegravir)
Croatian: Rezistencija in vivo: (dolutegravir)
English: You should also never again take medicines containing dolutegravir.
Croatian: Nikada više ne smijete uzimati niti lijekove koji sadrže dolutegravir.
English: Insufficient data to recommend dosage adjustment.
Croatian: Nema dovoljno podataka da bi se dale preporuke za prilagođavanje doze.
English: erythema multiform1, Stevens-Johnson syndrome1, toxic epidermal necrolysis1
Croatian: multiformni eritem1, Stevens-Johnsonov sindrom1, toksična epidermalna nekroliza1
English: See sections 4.4 and 4.8.
Croatian: Vidjeti dijelove 4.4 i
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Croatian: U slučaju istodobne antiretrovirusne terapije za hepatitis B ili C, pročitajte odgovarajuće informacije o lijeku i za te lijekove.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe Triumeq are provided with a health care professional information pack containing the following:
Croatian: Nositelj odobrenja mora se pobrinuti da svi liječnici za koje se očekuje da će propisivati Triumeq dobiju paket s informacijama za zdravstvene radnike, koji sadrži sljedeće:
English: * Adjusted for baseline stratification factors.
Croatian: * Prilagođeno za početne faktore stratifikacije.
English: pancreatitis1
Croatian: pankreatitis1
English: → Don't drive or operate machinery unless you are sure your alertness has not been affected.
Croatian: Nemojte upravljati vozilima niti raditi sa strojevima ako niste sigurni da lijek nije utjecao na Vašu sposobnost reagiranja.
English: Based on the above patients are advised to contact their physician immediately to determine whether they should stop taking abacavir if:
Croatian: S obzirom na navedeno, bolesnicima se savjetuje da se odmah obrate svom liječniku kako bi se utvrdilo moraju li prestati uzimati abakavir:
English: Oral use Triumeq can be taken with or without food (see section 5.2).
Croatian: Triumeq se može uzimati s hranom ili bez nje (vidjeti dio 5.2).
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „EXP“.
English: After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation.
Croatian: Nakon početka liječenja imunosni sustav jača i počinje se boriti s infekcijom , što može uzrokovati simptome infekcije ili upale.
English: You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you don't have this gene).
Croatian: Vjerojatnost da će se ta reakcija razviti veća je ako imate gen koji se zove HLA-B*5701 (međutim, reakciju možete dobiti čak i ako nemate taj gen).
English: rash, pruritus, alopecia1
Croatian: osip, pruritus, alopecija1
English: Your doctor may decide to adjust your dose or that you need extra checkups.
Croatian: Liječnik će možda odlučiti prilagoditi dozu lijeka ili dogovoriti dodatne kontrolne preglede.
English: The mean half-life of abacavir is about 1.5 hours.
Croatian: Srednja vrijednost poluvijeka abakavira iznosi približno 1,5 sati.
English: No additional types of adverse reactions have been observed beyond those characterised for the adult population.
Croatian: Nisu primijećene dodatne vrste nuspojava u odnosu na one zabilježene u odrasloj populaciji.
English: • other medicines containing lamivudine, used to treat HIV infection or hepatitis B infection
Croatian: • druge lijekove koji sadrže lamivudin, a koriste se za liječenje HIV infekcije ili infekcije hepatitisom B
English: In such cases medicinal products containing abacavir should be permanently discontinued.
Croatian: U takvim slučajevima treba trajno obustaviti primjenu lijekova koji sadrže abakavir.
English: If the patient misses a dose of Triumeq, the patient should take it as soon as possible, providing the next dose is not due within 4 hours.
Croatian: Ako bolesnik propusti dozu lijeka Triumeq, bolesnik ju mora uzeti što je prije moguće, pod uvjetom da je do sljedeće doze preostalo još najmanje 4 sata.
English: Anyone taking Triumeq could develop a hypersensitivity reaction, which could be life threatening if they continue to take Triumeq.
Croatian: Svatko tko uzima Triumeq može razviti reakciju preosjetljivosti, koja može biti opasna po život ako osoba nastavi uzimati Triumeq.
English: Following discontinuation of abacavir, the symptoms of the reaction should be treated according to local standard of care.
Croatian: Nakon prekida terapije abakavirom, simptome reakcije preosjetljivosti treba liječiti u skladu s lokalnim standardima liječenja.
English: • liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine).
Croatian: • zatajenje jetre (znakovi mogu uključivati žutu boju kože i bjeloočnica ili neuobičajeno tamnu mokraću)
English: → If you think this applies to you, tell your doctor.
Croatian: Ako mislite da se ovo odnosi na Vas, obavijestite svog liječnika.
English: • aches and pains (especially in the hip, knee or shoulder)
Croatian: • bolove i probadanja u zglobovima (osobito u kuku, koljenu ili ramenu)
English: The effect of prolonged daily treatment with high doses of dolutegravir has been evaluated in repeat oral dose toxicity studies in rats (up to 26 weeks) and in monkeys (up to 38 weeks).
Croatian: Učinak dugotrajnog svakodnevnog liječenja visokim dozama dolutegravira ocijenjen je u ispitivanjima toksičnosti ponovljenih peroralnih doza u štakora (do 26 tjedana) i majmuna (do 38 tjedana).
English: In subtype C (n=2) and A/G (n=2) isolates the integrase substitution R263K was selected in one isolate, and G118R in two isolates.
Croatian: U izolatima podvrste C (n=2) i A/G (n=2), supstitucija R263 na integrazi izdvojena je u jednom izolatu, a supstitucija G118R u dvama izolatima.
English: Triumeq should only be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus.
Croatian: Lijek Triumeq se smije primjenjivati tijekom drugog i trećeg tromjesečja trudnoće samo kada očekivana korist nadmašuje potencijalni rizik za fetus.
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Croatian: U nekih osoba koje uzimaju kombiniranu terapiju za HIV može se razviti bolest koja se zove osteonekroza.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare
Croatian: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko
English: If your doctor advises that you can start taking Triumeq again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
Croatian: Ako Vam liječnik kaže da možete ponovno početi uzimati Triumeq, možda će Vas zamoliti da prve doze uzmete na mjestu na kojem Vam se u slučaju potrebe odmah može pružiti liječnička pomoć.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Croatian: • kožni osip, kod kojeg mogu nastati mjehurići na koži koji izgledaju poput malenih meta (tamne mrlje u sredini, okružene svjetlijim područjem s tamnim prstenom uz rub) (multiformni eritem)
English: Triumeq can also affect how some other medicines work.
Croatian: I Triumeq može utjecati na način djelovanja nekih drugih lijekova.
English: Triumeq is used to treat HIV (human immunodeficiency virus) infection in adults and children over 12 years old who weigh at least 40 kg.
Croatian: Triumeq se koristi za liječenje infekcije HIV-om (virusom humane imunodeficijencije) u odraslih osoba i djece starije od 12 godina koja imaju najmanje 40 kg.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Croatian: Primijećeno poluvrijeme eliminacije lamivudina iznosi 5 do 7 sati.
English: Abacavir: AUC ↑ 41% Ethanol: AUC ↔
Croatian: abakavir: AUC ↑ 41% etanol: AUC ↔
English: → Tell your doctor or pharmacist if you are taking any of these.
Croatian: → Obavijestite svog liječnika ili ljekarnika ako uzimate neki od tih lijekova.
English: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Croatian: Nukleozidni i nukleotidni analozi mogu u različitom stupnju utjecati na mitohondrijsku funkciju što je najizraženije prilikom primjene stavudina, didanozina i zidovudina.
English: Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in rabbits at relatively low systemic exposures, comparable to those achieved in humans.
Croatian: Lamivudin nije bio teratogen u istraživanjima na životinjama, ali bilo je znakova koji su ukazivali na porast rane smrtnosti embrija u kunića pri relativno niskim razinama sistemske izloženosti, usporedivima s onima koje se postižu u ljudi.
English: → Talk to your doctor about the risks and benefits of taking Triumeq.
Croatian: Razgovarajte sa svojim liječnikom o rizicima i koristima liječenja lijekom Triumeq.
English: Lamivudine has not shown any genotoxic activity in the in vivo studies.
Croatian: Lamivudin nije pokazao genotoksičnu aktivnost u ispitivanjima in vivo.
English: Almost all patients developing hypersensitivity reactions will have fever and/or rash (usually maculopapular or urticarial) as part of the syndrome, however reactions have occurred without rash or fever.
Croatian: Gotovo svi bolesnici u kojih se razviju reakcije preosjetljivosti imat će vrućicu i/ili osip (obično makulopapularni ili urtikarijski) kao dio sindroma, međutim reakcije su se javljale i bez osipa ili vrućice.
English: Important information about the contents of Triumeq tablets.
Croatian: Važne informacije o nekim sastojcima Triumeq tableta
English: In long-term oral carcinogenicity studies in rats and mice, lamivudine did not show any carcinogenic potential.
Croatian: U dugoročnim ispitivanjima kancerogenosti oralnih doza u štakora i miševa, lamivudin nije pokazao nikakav kancerogeni potencijal.
English: If you are hypersensitive to Triumeq, return all your unused Triumeq tablets for safe disposal.
Croatian: Ako ste preosjetljivi na Triumeq, vratite sve neupotrijebljene Triumeq tablete radi sigurnog zbrinjavanja.
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Croatian: Farmakoterapijska skupina: Antivirotici za sustavnu primjenu, antivirotici za liječenje HIV infekcije, kombinacije.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Croatian: Bolesnike treba uputiti da potraže savjet liječnika ako osjete bolove i probadanja u zglobovima, zglobnu ukočenost ili teškoće pri kretnjama.
English: However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Croatian: Međutim, glavno antivirusno djelovanje ostvaruju ubacivanjem monofosfatnog oblika u lanac virusne DNK, što dovodi do prekida tog lanca.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Croatian: Na temelju više od 200 parova majka/dijete liječenih zbog HIV infekcije, serumske koncentracije lamivudina u dojenčadi čije su majke liječene zbog HIV infekcije su vrlo niske (< 4% serumskih koncentracija u majke) i progresivno se smanjuju do nemjerljivih razina nakon što dojenče navrši 24
English: Overall treatment differences at Week 96 are applicable to patients with high and low Baseline viral loads.
Croatian: Ukupne razlike između liječenja u 96. tjednu odnose se na bolesnike s visokim i niskim virusnim opterećenjem na početku ispitivanja.
English: Fifty-three percent of total oral dose is excreted unchanged in the faeces.
Croatian: Pedeset i tri posto ukupne peroralne doze izlučuje se u nepromijenjenu obliku u fecesu.
English: When prescribing Triumeq, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Croatian: potrebno je poduzeti mjere kako bi se pokušalo minimizirati sve faktore rizika na koje se može utjecati (npr. pušenje, hipertenziju i hiperlipidemiju).
English: The frequency of this is unknown (see section 4.4).
Croatian: Učestalost toga nije poznata (vidjeti dio 4.4).
English: The majority of these tumours occurred at the highest abacavir dose of 330 mg/kg/day in mice and 600 mg/kg/day in rats.
Croatian: Većina tih tumora nastala je pri najvećoj dozi abakavira od 330 mg/kg/dan u miševa i 600 mg/kg/dan u štakora.
English: Resistance in vitro: (dolutegravir)
Croatian: Rezistencija in vitro: (dolutegravir)
English: Notes: DRV+RTV = darunavir + ritonavir, DTG = dolutegravir.
Croatian: Napomene: DRV+RTV =darunavir + ritonavir, DTG = dolutegravir.
English: • joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you're taking Triumeq.
Croatian: • bol u zglobovima, ukočenost te tegobe s kostima Morate znati na koje važne znakove i simptome treba pripaziti dok uzimate Triumeq.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Pojave li se u tih bolesnika znakovi pogoršanja jetrene bolesti, mora se razmotriti privremen ili trajan prekid liječenja.
English: Mitochondrial dysfunction following exposure in utero
Croatian: Mitohondrijska disfunkcija nakon izloženosti in utero
English: Oral contraceptives Ethinyl estradiol (EE) and Norgestromin (NGMN)/Dolutegravir
Croatian: Oralni kontraceptivi etinilestradiol (EE) i norelgestromin (NGMN)/dolutegravir
English: • if you are allergic (hypersensitive) to dolutegravir, abacavir (or any other medicine containing abacavir), or lamivudine, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični (preosjetljivi) na dolutegravir, abakavir (ili bilo koji drugi lijek koji sadrži abakavir), lamivudin ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.)
English: When you're being treated for HIV, it can be hard to tell whether a symptom is a side effect of Triumeq or other medicines you are taking, or an effect of the HIV disease itself.
Croatian: Kada se liječite zbog HIV-a, može biti teško raspoznati je li simptom nuspojava lijek Triumeq, drugi lijekovi koje uzimate ili učinak same HIV infekcije.
English: Abacavir and lamivudine may inhibit cellular DNA replication and abacavir has been shown to be carcinogenic in animal models (see section 5.3).
Croatian: Abakavir i lamivudin mogu inhibirati replikaciju stanične DNK, a abakavir se pokazao kancerogenim u životinjskim modelima (vidjeti dio 5.3).
English: Due to the potential risk of neural tube defects with dolutegravir, Triumeq should not be used during the first trimester unless there is no alternative.
Croatian: Zbog mogućeg rizika od defekata neuralne cijevi, lijek Triumeq se ne smije primjenjivati tijekom prvog tromjesečja, osim ako nema drugog izbora.
English: Fosamprenavir/ritonavir decreases dolutegravir concentrations, but based on limited data, did not result in decreased efficacy in Phase III studies.
Croatian: Fosamprenavir/ritonavir smanjuje koncentracije dolutegravira, ali temeljem ograničenih podataka iz ispitivanja faze III to nije smanjilo djelotvornost.
English: There is no evidence from clinical studies that abacavir is hepatotoxic.
Croatian: Nema dokaza iz kliničkih ispitivanja da je abakavir hepatotoksičan.
English: Adults and adolescents (weighing at least 40kg) The recommended dose of Triumeq in adults and adolescents is one tablet once daily.
Croatian: Odrasli i adolescenti (tjelesne težine najmanje 40 kg) Preporučena doza lijeka Triumeq u odraslih i adolescenata je jedna tableta jedanput na dan.
English: • development of 1 or more symptom from at least 2 of the following groups:
Croatian: 2) ako primijetite jedan ili više simptoma iz najmanje DVIJU od sljedećih skupina
English: When using the lab-strain HIVIII during passage over 112 days, mutations selected appeared slowly, with substitutions at positions S153Y and F. These mutations were not selected in patients treated with dolutegravir in the clinical studies.
Croatian: Pri korištenju laboratorijskog soja HIVIII za vrijeme pasaže tijekom 112 dana, odabrane mutacije pojavljivale su se polako, sa supstitucijama na položajima S153Y i F. Spomenute mutacije nisu izdvojene u bolesnika koji su liječeni dolutegravirom u kliničkim ispitivanjima.
English: In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY.
Croatian: U slučaju pojave bilo kojeg simptoma koji upućuje na reakcije preosjetljivosti, ODMAH se javite svom liječniku.
English: People with advanced HIV infection or AIDS have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Croatian: Osobe s uznapredovalom HIV infekcijom ili AIDS-om imaju oslabljen imunološki sustav te su sklonije razvoju ozbiljnih infekcija (oportunističke infekcije).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 2nd September 2014 Date of latest renewal:
Croatian: Datum prvog odobrenja: 2. rujna 2014.
English: Possible interaction given common pathway of elimination via alcohol dehydrogenase (abacavircomponent).
Croatian: Moguća je interakcija zbog zajedničkog puta eliminacije posredstvom alkohol-dehidrogenaze (abakavir).
English: anorexia1
Croatian: anoreksija1
English: The film-coated tablets are provided in bottles containing 30 tablets.
Croatian: Filmom obložene tablete dolaze u bocama koje sadrže 30 tableta.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
Croatian: • lijekovi (obično u tekućem obliku) koji sadrže sorbitol i druge šećerne alkohole (poput ksilitola, manitola, laktitola ili maltitola), ako se uzimaju redovito
English: The concentration of active substance necessary to effect viral replication by 50% (IC50 - half maximal inhibitory concentration) varied according to virus and host cell type.
Croatian: Koncentracija djelatne tvari potrebna da bi se virusna replikacija smanjila za 50% (IC50 - pola maksimalne inhibicijske koncentracije) varirala je ovisno o vrsti virusa i stanice domaćina.
English: SIDE 2 You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Triumeq.
Croatian: Morate se odmah javiti svom liječniku ako mislite da imate reakciju preosjetljivosti na Triumeq.
English: If possible, show them the Triumeq pack.
Croatian: pokažite im pakiranje lijeka Triumeq.
English: Using strain NL432 mutations E92Q (fold change 3) and G193E (fold change 3) were selected.
Croatian: Kada se koristio soj NL432, odabrane su mutacije E92Q (vrijednost promjene 3) i G193E (vrijednost promjene 3).
English: Reference should be made to treatment guidelines.
Croatian: Potrebno je slijediti smjernice za liječenje.