FrancophonIA/ELRC3.0 huggingface dataset:
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced BMD (rats and dogs).
Croatian: Toksičnost za kosti dijagnosticirana je kao osteomalacija (u majmuna) i sniženi BMD (u štakora i pasa).
English: renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)
Croatian: zatajenje bubrega (akutno i kronično), akutna tubularna nekroza, nefritis (uključujući akutni intersticijski nefritis)
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Croatian: Tenofovir se prvenstveno izlučuje preko bubrega filtracijom i aktivnim tubularnim transportnim sustavom, pri čemu se oko 70-80% doze izlučuje u nepromijenjenom obliku u urinu nakon intravenske primjene.
English: - At the request of the European Medicines Agency; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Ažurirani RMP treba dostaviti: - na zahtjev Europske agencije za lijekove; - prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: The film-coated tablet can be disintegrated in approximately 100 mL of water, orange juice or grape juice and taken immediately.
Croatian: Filmom obložena tableta može se smrviti u približno 100 mL vode, soka od naranče ili soka od grožđa i odmah uzeti.
English: for blisters:
Croatian: za blister:
English: Excipient(s) with known effect Each film-coated tablet contains 80 mg lactose monohydrate.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna filmom obložena tableta sadrži 80 mg laktoze hidrata.
English: Following intravenous administration the volume of distribution of emtricitabine and tenofovir was approximately 1.4 L/kg and 800 mL/kg, respectively.
Croatian: Nakon intravenske primjene volumen distribucije emtricitabina i tenofovira bio je približno 1,4 l/kg odnosno 800 mL/kg.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
Croatian: In vitro vezanje emtricitabina na humane plazmatske proteine bilo je < 4% i nije ovisilo o koncentraciji u rasponu od 0,02 do 200 µg/mL.
English: Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Croatian: Anemija je bila česta, a promjena boje kože (povećana pigmentacija) vrlo česta kad se emtricitabin primjenjivao u pedijatrijskih bolesnika.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, 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 smatra da je etiologija multifaktorska (uključujući primjenu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, veći indeks tjelesne mase), zabilježeni su slučajevi osteonekroze osobito u bolesnika s uznapredovalom HIV-bolešću i/ili dugotrajnom izloženošću CART-u.
English: Talk to your doctor if you are over 65.
Croatian: Ako ste stariji od 65 godina, razgovarajte s liječnikom.
English: Oral carcinogenicity studies in rats and mice only revealed a low incidence of duodenal tumours at an extremely high dose in mice.
Croatian: Ispitivanja kancerogenosti peroralne primjene u štakora i miševa pokazala su tek nisku incidenciju duodenalnih tumora, pri izuzetno visokoj dozi u miševa.
English: In infants and children older than 4 months, the majority of patients taking emtricitabine achieved or maintained complete suppression of plasma HIV 1 RNA through 48 weeks (89% achieved ≤ 400 copies/mL and 77% achieved ≤ 50 copies/mL).
Croatian: U dojenčadi i djece starije od 4 mjeseca, većina bolesnika koji su primali emtricitabin postigla je ili održala potpunu supresiju plazmatske HIV-1 RNK tijekom 48 tjedana (89% postiglo je ≤ 400 kopija/mL, a 77% postiglo je ≤ 50 kopija/mL).
English: 3, nephrogenic diabetes insipidus
Croatian: 3, nefrogeni dijabetes insipidus
English: The difference in the proportion of patients who maintained < 400 copies/mL at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil treatment group.
Croatian: Razlika u udjelu bolesnika koji su održali < 400 kopija/mL u 48. tjednu uglavnom je posljedica većeg broja odustajanja u skupini koja je dobivala tenofovirdizoproksil.
English: - Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
Croatian: Koristite kondome kako biste smanjili dodir sa sjemenom, vaginalnom tekućinom ili krvlju.
English: The potential risks and benefits associated with co-administration should be considered, particularly in patients at increased risk of renal dysfunction.
Croatian: Potrebno je razmotriti moguće rizike i koristi povezane s istovremenom primjenom, osobito u bolesnika s povećanim rizikom od poremećaja funkcije bubrega.
English: Look out for any symptoms of infection or other symptoms such as: - muscle weakness - weakness beginning in the hands and feet and moving up towards the trunk of the body - palpitations, tremor or hyperactivity
Croatian: Pazite na sve simptome infekcije ili druge simptome kao što su: - mišićna slabost - slabost koja počinje u šakama i stopalima i napreduje prema trupu - osjećaj lupanja srca, nevoljno drhtanje ili hiperaktivnost
English: 3 and +196 cells/mm
Croatian: 3 odnosno +196 stanica/mm
English: 28 film-coated tablets 84 film-coated tablets for bottle:
Croatian: 28 filmom obloženih tableta 84 filmom obložene tablete za bocu:
English: Involved in Transactional Sex Last 6 Month, N (%) Known HIV+ Partner Last 6 Months, N (%) Syphilis Seroreactivity, N (%) Serum Herpes Simplex Virus Type 2 Infection, N (%) Urine Leukocyte Esterase Positive, N (%)
Croatian: Bavili se transakcijskim seksom u zadnjih 6 mjeseci, N (%) Poznati HIV+ partner u zadnjih 6 mjeseci, N (%) Seroreaktivnost na sifilis, N (%) Infekcija virusom herpes simplex tipa 2 u serumu, N (%) Pozitivna leukocitna esteraza u mokraći, N (%)
English: Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.” and once daily as “q.d.”).
Croatian: Interakcije između emtricitabin/tenofovirdizoproksila ili pojednačnih komponenti i drugih lijekova navedene su u sljedećoj Tablici 2 (povećanje je označeno kao „↑”, smanjenje kao „↓”, bez promjene kao „↔”, dvaput na dan kao „b.i.d.” i jedanput na dan kao „q.d.”).
English: Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection.
Croatian: - Autoimuni poremećaji, kod kojih imunološki sustav napada zdravo tkivo u organizmu, također se mogu pojaviti nakon što počnete uzimati lijekove za liječenje infekcije virusom HIV-a.
English: ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR = Time to Loss of Virologic Response a: Van Elteren Test
Croatian: ** p-vrijednost se temeljila na Cochran-Mantel-Haenszelovu testu uslojenom prema početnom broju CD4 stanica TLOVR = vrijeme do gubitka virološkog odgovora (engl.
English: Table 2: Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products
Croatian: Tablica 2: Interakcije između emtricitabina/tenofovirdizoproksila ili njegovih pojedinačnih komponenti i drugih lijekova
English: Before and during treatment, your doctor may order blood tests to measure kidney function.
Croatian: Prije početka i tijekom liječenja, liječnik će možda zatražiti krvne pretrage kako bi se izmjerila funkcija bubrega.
English: Film coating: hypromellose 5 cP, titanum dioxide (E171), macrogol, indigo carmine aluminium lake (E132).
Croatian: Film ovojnica: hipromeloza 5 cP, titanijev dioksid (E171), makrogol, boja Indigo carmine aluminium lake (E132).
English: The most frequent adverse reaction reported in the emtricitabine/tenofovir disoproxil group in the iPrEx study was headache (1%).
Croatian: Najčešća nuspojava prijavljena u skupini koja je primala emtricitabin/tenofovirdizoproksil u ispitivanju iPrEx bila je glavobolja (1%).
English: If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of therapy with Emtricitabine/Tenofovir disoproxil Krka to you and your child.
Croatian: Ako ostanete trudni ili planirate trudnoću, posavjetujte se s liječnikom o potencijalnim koristima i rizicima liječenja lijekom Emtricitabine/Tenofovir disoproxil Krka po Vas i dijete.
English: Emtricitabine/Tenofovir disoproxil Krka is available in carton boxes of 28 and 84 film-coated tablets in blisters.
Croatian: Emtricitabine/Tenofovir disoproxil Krka je dostupan u kartonskim kutijama s 28 i 84 filmom obložene tablete u blisterima.
English: 28 film-coated tablets: EU/1/16/1151/001 84 film-coated tablets: EU/1/16/1151/003
Croatian: 28 filmom obloženih tableta: EU/1/16/1151/001 84 filmom obložene tablete: EU/1/16/1151/003
English: The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV-1 RNA concentrations < 400 copies/mL over 48 weeks.
Croatian: Primarna mjera ishoda djelotvornosti u ovom ispitivanju bila je postizanje i održavanje potvrđene HIV-1 RNK koncentracije < 400 kopija/mL tijekom 48 tjedana.
English: Pack sizes: 28 and 84 film-coated tablets.
Croatian: Veličine pakiranja: 28 i 84 filmom obložene tablete.
English: In general, emtricitabine pharmacokinetics in HBV infected subjects were similar to those in healthy subjects and in HIV infected patients.
Croatian: Općenito je farmakokinetika emtricitabina u osoba zaraženih virusom HBV-a bila slična farmakokinetici u zdravih ispitanika i u HIV-om zaraženih bolesnika.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Croatian: U nekih bolesnika s uznapredovalom infekcijom virusa HIV-a (SIDA) i oportunističkim infekcijama u povijesti bolesti (infekcije koje nastaju u osoba sa slabim imunloškim sustavom) mogu se pojaviti znakovi i simptomi upale od prethodnih infekcija ubrzo nakon početka liječenja lijekovima protiv HIV-a.
English: NC = not calculated.
Croatian: NP = nije primjenjivo.
English: Physicians should refer to current HIV treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Croatian: Liječnici se trebaju pridržavati trenutno važećih smjernica za liječenje infekcije HIV-om u bolesnika istovremeno zaraženih virusom hepatitisa B (HBV) ili virusom hepatitisa C (HCV).
English: Patients infected with HBV who discontinue Emtricitabine/Tenofovir disoproxil Krka should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Croatian: Bolesnike zaražene HBV-om koji prestanu uzimati lijek Emtricitabine/Tenofovir disoproxil Krka treba pažljivo pratiti uz kliničku i laboratorijsku kontrolu tijekom najmanje nekoliko mjeseci nakon prestanka liječenja.
English: In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/mL.
Croatian: In vitro proteinsko vezanje tenofovira na proteine plazme ili seruma bilo je manje od 0,7 odnosno 7,2%, u rasponu koncentracija tenofovira od 0,01 do 25 µg/mL.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Croatian: Dostupne su sljedeće veličine pakiranja: vanjska kutija sadrži 1 bocu s 30 filmom obloženih tableta i 90 (3 boce od 30) filmom obloženih tableta.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Emtricitabine/Tenofovir disoproxil Krka are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će da svi liječnici za koje se očekuje da će propisivati/primjenjivati Emtricitabine/Tenofovir disoproxil Krka dobiju edukacijski paket za liječnike koji sadrži sažetak opisa svojstava lijeka i odgovarajuće edukacijske brošure, kako je detaljno opisano niže:
English: → If you notice any of the side effects listed above or if any of the side effects get serious, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju od gore navedenih nuspojava ili ako neka nuspojava postane ozbiljna, obratite se svom liječniku ili ljekarniku.
English: If you are a woman who could get pregnant during treatment with Emtricitabine/Tenofovir disoproxil Krka, you must use an effective method of contraception to avoid becoming pregnant.
Croatian: Ako ste žena koja bi tijekom liječenja lijekom Emtricitabine/Tenofovir disoproxil Krka mogla zanijeti, morate koristiti neku učinkovitu metodu kontracepcije kako biste spriječili trudnoću.
English: Individuals over the age of 65 years are more likely to have decreased renal function, therefore caution should be exercised when administering Emtricitabine/Tenofovir disoproxil Krka to older people.
Croatian: U osoba starijih od 65 godina veća je vjerojatnost da imaju smanjenu funkciju bubrega, pa je stoga potrebno primijeniti oprez kad se Emtricitabine/Tenofovir disoproxil Krka primjenjuje u starijih osoba.
English: Both of these active substances are antiretroviral medicines which are used to treat HIV infection.
Croatian: Obje su djelatne tvari antiretrovirusni lijekovi koji se upotrebljavaju za liječenje infekcije virusom HIV-a.
English: Tenofovir disoproxil 245 mg (n = 1584)
Croatian: Tenofovirdizoproksil 245 mg (n = 1584)
English: Film-coated tablet for blisters:
Croatian: Filmom obložena tableta za blistere:
English: Therefore, the same problems may be seen if Emtricitabine/Tenofovir disoproxil Krka is administered with a third nucleoside analogue.
Croatian: Stoga se mogu uočavati isti problemi ako se Emtricitabine/Tenofovir disoproxil Krka daje s nekim trećim analogom nukleozida.
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 mL/min/1.73 m2.
Croatian: Sedmero bolesnika imalo je procijenjenu brzinu glomerularne filtracije između 70 i 90 mL/min/1,73 m2.
English: Emtricitabine/Tenofovir disoproxil Krka is also used to reduce the risk of getting HIV-1 infection in adults, and adolescents aged 12 years to less than 18 years who weigh at least 35 kg, when taken daily, together with safer sex practices:
Croatian: - Emtricitabine/Tenofovir disoproxil Krka se također primjenjuje za smanjenje rizika od dobivanja infekcije virusom HIV-1 u odraslih, te adolescenata u dobi od 12 godina do manje od 18 godina, tjelesne težine najmanje 35 kg, kad se uzima svakodnevno, zajedno s provođenjem mjera sigurnijih spolnih odnosa:
English: 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Croatian: 30 filmom obloženih tableta 90 (3 boce od 30) filmom obloženih tableta
English: Therefore the use of Emtricitabine/Tenofovir disoproxil Krka may be considered during pregnancy, if necessary.
Croatian: Stoga se može razmotriti primjena lijeka Emtricitabine/Tenofovir disoproxil Krka tijekom trudnoće ako je neophodno.
English: OUTER CARTON/for blisters and bottle
Croatian: KUTIJA/za blistere i boce
English: If you have taken Emtricitabine/Tenofovir disoproxil Krka during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste lijek Emtricitabine/Tenofovir disoproxil Krka uzimali tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj Vašega djeteta.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in a periand postnatal toxicity study at maternally toxic doses.
Croatian: Ipak, tenofovirdizoproksil je smanjio indeks preživljenja i težinu mladunčadi u perinatalnom i postnatalnom ispitivanju toksičnosti pri dozama toksičnim za majku.
English: In addition to the adverse reactions reported in adults, anaemia (9.5%) and skin discolouration (31.8%) occurred more frequently in clinical trials in paediatric patients than in adults (see section 4.8, Tabulated summary of adverse reactions).
Croatian: Uz nuspojave zabilježene u odraslih, anemija (9,5%) i promjena boje kože (31,8%) pojavile su se češće u kliničkim ispitivanjima u pedijatrijskih bolesnika nego u odraslih (vidjeti dio 4.8, Tablični prikaz nuspojava).
English: Limited data from clinical studies support once daily dosing in HIV-1 uninfected individuals with CrCl 60-80 mL/min.
Croatian: Ograničeni podaci iz kliničkih ispitivanja govore u prilog doziranju jedanput na dan u osoba koje nisu zaražene virusom HIV-1 i imaju CrCl 60-80 mL/min.
English: Emtricitabine/Tenofovir disoproxil Krka contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Emtricitabine/Tenofovir disoproxil Krka sadrži laktozu Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.
Croatian: Ako ste žena zaražena virusom HIV-a, preporučuje se da ne dojite kako bi se izbjegla mogućnost da virus u majčinom mlijeku prijeđe na dojenče.
English: Patients with hepatitis B or C virus infection
Croatian: Bolesnici s infekcijom virusom hepatitisa B ili C
English: Emtricitabine/Tenofovir disoproxil Krka is available also in bottles of 30 tablets, with a child-resistant tamper evident plastic closure with integrated a silica gel desiccant, which helps to protect your tablets.
Croatian: Emtricitabine/Tenofovir disoproxil Krka je dostupan također u bocama s 30 tableta, sa sigurnosnom zaštitom za djecu s plastičnim zatvaračem koji sadrži sredstvo za sušenje, a koje pomaže zaštititi tablete.
English: Use is not recommended in HIV-1 uninfected individuals with CrCl < 60 mL/min as it has not been studied in this population (see sections 4.4 and 5.2).
Croatian: Primjena se ne preporučuje u osoba koje nisu zaražene virusom HIV-1 i imaju CrCl < 60 mL/min jer nije ispitana u ovoj populaciji (vidjeti dijelove 4.4 i 5.2).
English: Didanosine/Emtricitabine
Croatian: Didanozin/Emtricitabin
English: At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/mL) and CD4 counts (233 and 241 cells/mm
Croatian: Na početku su randomizirane skupine imale sličan medijan plazmatske HIV-1 RNK (5,02 i 5,00 log10 kopija/mL) i broj CD4 stanica (233 i 241 stanica/mm
English: The predominant circulating metabolite of sofosbuvir.
Croatian: Glavni metabolit sofosbuvira u cirkulaciji.
English: The mean changes in CD4 cell count from baseline were +185 cells/mm
Croatian: Srednje promjene broja CD4 stanica od početne vrijednosti bile su +185 stanica/mm
English: The systemic clearance of emtricitabine averaged 307 mL/min.
Croatian: Sistemski klirens emtricitabina u prosjeku je iznosio 307 mL/min.
English: The effects of tenofovir disoproxilassociated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section 5.1).
Croatian: Učinci promjena BMD-a povezanih s tenofovirdizoproksilom na dugoročno zdravlje kostiju i rizik od budućih prijeloma trenutačno nisu poznati (vidjeti dio 5.1).
English: Substudy participants received active adherence monitoring, e.g. unannounced home visits and pill counts, and counselling to improve compliance with study drug.
Croatian: U ispitanika u podispitivanju aktivno je praćeno pridržavanje terapije, npr. putem nenajavljenih kućnih posjeta i brojenja tableta i savjetovanja radi poboljšanja suradljivosti u uzimanju ispitivanog lijeka.
English: No dose adjustment of norgestimate/ethinyl oestradiol is required.
Croatian: Nije potrebna prilagodba doziranja norgestimata/etinilestradiola.
English: In addition, the clinical response to treatment should be closely monitored in patients receiving Emtricitabine/Tenofovir disoproxil Krka at a prolonged dosing interval.
Croatian: Osim toga, klinički odgovor na liječenje treba pažljivo pratiti u bolesnika koji primaju Emtricitabine/Tenofovir disoproxil Krka u produljenom intervalu doziranja.
English: Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Croatian: Emtricitabin se prvenstveno izlučuje preko bubrega pri čemu se čitava doza izolira iz urina (oko 86%) i stolice (oko 14%).
English: A multidisciplinary approach is recommended to weigh the benefit/risk balance of the use of emtricitabine/tenofovir for the treatment of HIV-1 infection or for pre-exposure prophylaxis, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation on a case by case basis.
Croatian: Preporučuje se multidisciplinarni pristup kako bi se odredio omjer koristi i rizika primjene emtricitabina/tenofovira za liječenje infekcije virusom HIV-1 ili za predekspozicijsku profilaksu, odlučilo o prikladnom praćenju tijekom liječenja (uključujući odluku o prekidu liječenja) i razmotrila potreba za dodatnim liječenjem od slučaja do slučaja.
English: Emtricitabine and tenofovir pharmacokinetics are similar in male and female patients.
Croatian: Farmakokinetike emtricitabina i tenofovira slične su u bolesnika muškog i ženskog spola.
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV-1 infected patients when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Croatian: Postoje izvješća o visokoj stopi virološkog neuspjeha i pojavi rezistencije u početnom stadiju u bolesnika zaraženih virusom HIV-1 kada se tenofovirdizoproksil kombinirao s lamivudinom i abakavirom, kao i s lamivudinom i didanozinom u režimu liječenja jedanput na dan.
English: Dose interval adjustments are recommended for HIV-1 infected patients with creatinine clearance 30-49 mL/min (see section 4.2).
Croatian: Preporučuje se prilagođavanje intervala doziranja u bolesnika zaraženih virusom HIV-1 s klirensom kreatinina između 30 i 49 mL/min (vidjeti dio 4.2).
English: Race, N (%)
Croatian: Spol, N (%) Muški Ženski
English: There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Croatian: Postoje izvješća o poremećaju funkcije mitohondrija u HIV-negativne dojenčadi koja je bila in utero i/ili postnatalno izložena analozima nukleozida; ova izvješća su se pretežno odnosila na liječenje režimima koji su sadržavali zidovudin.