FrancophonIA/ELRC3.0 huggingface dataset:
English: These hepatic reactions were observed during or immediately after treatment, and in most cases were reversible after discontinuation of telithromycin.
Croatian: Te su jetrene reakcije opažene tijekom ili neposredno nakon liječenja i u većini slučajeva su bile reverzibilne nakon obustave primjene telitromicina.
English: Its principal circulating metabolite represents approximately 13% of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Croatian: Njegov glavni cirkulirajući metabolit predstavlja oko 13% AUC-a telitromicina i ima malu antimikrobnu aktivnost u usporedbi s ishodišnim lijekom.
English: The same precautions should also apply to the other benzodiazepines which are metabolised by CYP3A4, (especially triazolam but also to a lesser extent alprazolam).
Croatian: Iste mjere opreza treba primijeniti i za ostale benzodiazepine koji se metaboliziraju pomoću CYP3A4 (posebice triazolam, a u manjoj mjeri i alprazolam).
English: You may experience this within a few hours of taking your daily dose of Ketek the first or second time.
Croatian: Ovo možete iskusiti unutar nekoliko sati od prvog ili drugog uzimanja dnevne doze lijeka Ketek.
English: After oral administration, two-thirds of the dose is eliminated as metabolites and one-third unchanged.
Croatian: Nakon peroralne primjene dvije trećine doze eliminira se u obliku metabolita, a jedna trećina u nepromijenjenom obliku.
English: Do not take a double dose to make up
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Previous history of hepatitis and/or jaundice associated with the use of telithromycin.
Croatian: Prethodna pojava hepatitisa i/ili žutice povezana s primjenom telitromicina.
English: Most of them are mild and transient, but very rare cases of serious adverse liver reactions and liver failure, including fatal cases, have been reported.
Croatian: One su većinom blage i prolazne, no prijavljeni su i vrlo rijetki slučajevi ozbiljnih jetrenih nuspojava i zatajenja jetre, uključujući i one sa smrtnim ishodom.
English: Patients should be informed that these adverse reactions may occur as early as after the first dose of medicinal product.
Croatian: Bolesnicima treba napomenuti da se te nuspojave mogu pojaviti već nakon prve doze lijeka.
English: If any of these apply to you, or if you are not sure, tell your doctor before taking Ketek.
Croatian: Ako se nešto od navedenog odnosi na Vas, ili niste sigurni, obavijestite svog liječnika prije nego
English: Ranitidine (taken 1 hour before Ketek) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
Croatian: Ranitidin (uzet 1 sat prije lijeka Ketek) i antacidi koji sadrže aluminijev i magnezijev hidroksid nemaju klinički relevantan značajan utjecaj na farmakokinetiku telitromicina.
English: In clinical trials the effect on QTc was small (mean of approximately 1 msec).
Croatian: U kliničkim je ispitivanjima učinak na QTc-interval bio malen (prosječno produljenje od približno 1 ms).
English: Rapid distribution of telithromycin into tissues results in significantly higher telithromycin concentrations in most target tissues than in plasma.
Croatian: Brza raspodjela telitromicina u tkiva rezultira značajno većim koncentracijama u većini ciljnih tkiva nego u plazmi.
English: Ageusia, anosmia, tremors, convulsions
Croatian: Ageuzija, anosmija, tremori, konvulzije
English: • Effect of Ketek on other medicinal products
Croatian: • Učinak lijeka Ketek na druge lijekove
English: Common (≥1/100 to
Croatian: Često (≥ 1/100 i
English: • a medicine called protease inhibitor (anti-HIV treatment)
Croatian: • lijek koji se zove inhibitor proteaze (za liječenje HIV infekcije)
English: B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
Croatian: B-dul Theodor Pallady nr. 50, sector 3, Bukurešt, cod 032266, Rumunjska
English: The effect of ritonavir on telithromycin has not been studied and could lead to larger increase in telithromycin exposure.
Croatian: Učinak ritonavira na telitromicin nije ispitivan, a mogao bi uzrokovati veći porast izloženosti telitromicinu.
English: Blood electrolytes (especially potassium) must be controlled.
Croatian: Moraju se kontrolirati razine elektrolita u krvi (posebice kalija).
English: Ketek is an antibiotic of the type macrolides.
Croatian: Ketek je antibiotik iz skupine makrolida.
English: When prescribing Ketek, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).
Croatian: Kada se propisuje Ketek, treba uzeti u obzir službene smjernice za primjerenu primjenu antibiotika i lokalnu prevalenciju rezistencije (vidjeti također dio 4.4 i 5.1).
English: At high doses embryotoxicity was apparent and an increase in incomplete ossification and in skeletal anomalies was seen.
Croatian: Pri visokim je dozama zabilježena embriotoksičnost kao i porast nepotpune osifikacije i anomalije skeleta.
English: Repeated dose toxicity studies of 1, 3 and 6 month duration with telithromycin conducted in rat, dog and monkey showed that the liver was the principal target for toxicity with elevations of liver enzymes, and histological evidence of damage.
Croatian: Ispitivanja toksičnosti ponovljenih doza telitromicina u trajanju od 1, 3 i 6 mjeseci provedena na štakorima, psima i majmunima pokazala su da je jetra glavni ciljni organ za toksičnost, što se očituje povišenjem vrijednosti jetrenih enzima i histološkim dokazima oštećenja.
English: Hypokalaemia and quinidine had additive/supraadditive effects in vitro while potentiation was evident with sotalol.
Croatian: Hipokalijemija i kinidin imaju aditivne/supraaditivne učinke in vitro, dok je kod sotalola opažena potencijacija.
English: Reproduction toxicity studies showed reduced gamete maturation in rat and adverse effects on fertilization.
Croatian: Ispitivanja reproduktivne toksičnosti pokazala su smanjeno sazrijevanje gameta u štakora kao i štetne učinke na oplodnju.
English: If you accidentally take several tablets too many, contact your doctor or pharmacist.
Croatian: Ako slučajno uzmete nekoliko tableta previše, obratite se svom liječniku ili ljekarniku.
English: These changes in the pharmacokinetics of telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well tolerated range.
Croatian: Ove promjene u farmakokinetici telitromicina ne zahtijevaju prilagodbu doze jer izloženost telitromicinu ostaje u granicama dobre podnošljivosti.
English: In subjects over 65 (median 75 years), the maximum plasma concentration and AUC of telithromycin were increased approximately 2-fold compared with those achieved in young healthy adults.
Croatian: U ispitanika starijih od 65 godina (medijan 75 godina), maksimalna koncentracija u plazmi i AUC telitromicina bili su približno dvostruko veći u odnosu na vrijednosti u mladih zdravih odraslih osoba.
English: Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the
Croatian: Preosjetljivost na djelatnu tvar, na bilo koji makrolidni antibiotik ili na bilo koju od pomoćnih tvari
English: When metoprolol (a CYP2D6 substrate) was coadministered with Ketek, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
Croatian: Kada se metoprolol (supstrat CYP2D6) primjenjivao istodobno s lijekom Ketek, Cmax i AUC metropolola povećali su se za oko 38%, no nije bilo učinka na poluvrijeme eliminacije metoprolola.
English: Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Croatian: Telitromicin se izlučuje u mlijeko životinja u laktaciji, u koncentracijama oko 5 puta većima od onih u plazmi majke.
English: L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the treatment of pneumonia caused by legionella is limited.
Croatian: L. pneumophila je vrlo osjetljiva na telitromicin in vitro, no kliničko iskustvo u liječenju pneumonija uzrokovanih legionelom je ograničeno.
English: • terfenadine or astemizole (allergic problems)
Croatian: • terfenadin ili astemizol (za alergijske tegobe)
English: Telithromycin inhibits protein synthesis by interacting with domains II and V of the 23S ribosomal RNA of the 50S ribosome subunit.
Croatian: Telitromicin inhibira sintezu proteina interakcijom s domenama II i V na 23S RNK-komponenti ribosomske podjedinice 50S.
English: S.C. Zentiva S.A. B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
Croatian: S.C. Zentiva S.A. B-dul Theodor Pallady nr. 50, sector 3, Bukurešt, cod 032266, Rumunjska
English: Very common side effects (may affect more than 1 in 10 people) - diarrhoea, usually mild and temporary.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - proljev, obično blag i prolazan.
English: The main circulating compound in plasma is telithromycin.
Croatian: Glavni cirkulirajući spoj u plazmi je telitromicin.
English: If you are breast-feeding do not take Ketek.
Croatian: Ako dojite, nemojte uzimati Ketek.
English: The mean maximum white blood cell concentration of telithromycin was 83±25 mg/l.
Croatian: Prosječna maksimalna koncentracija telitromicina u bijelim krvnim stanicama bila je 83 ± 25 mg/l.
English: Experience of treatment of infections caused by penicillin/or erythromycin resistant S. pneumoniae is limited, but so far, clinical efficacy and eradication rates have been similar compared with the treatment of susceptible S. pneumoniae.
Croatian: Iskustvo u liječenju infekcija uzrokovanih S. pneumoniae rezistentnim na penicilin ili eritromicin je ograničeno, ali su do sada klinička djelotvornost i stope eradikacije bile slične u usporedbi s rezultatima liječenja osjetljivog S. pneumoniae.
English: The recommended dose is 800 mg once a day i.e. two 400 mg tablets once a day.
Croatian: Preporučena doza je 800 mg jedanput na dan, tj. dvije tablete od 400 mg jedanput na dan.
English: If you notice any of the following, stop taking Ketek and tell your doctor immediately: - Allergic or skin reactions such as face swelling, general allergic reactions including allergic shock, or serious skin conditions associated with red spots, blisters (frequency not known).
Croatian: Ako primijetite bilo što od navedenog, prestanite uzimati Ketek i odmah obavijestite svog liječnika: - alergijske ili kožne reakcije poput oticanja lica, opće alergijske reakcije uključujući alergijski šok ili ozbiljne promjene na koži praćene crvenim mrljama i mjehurićima (učestalost nije
English: In case the combination is considered necessary, the dose of the calcium channel blocker should be reduced and close clinical monitoring of efficacy and safety in the patient should be exercised.
Croatian: Ako se takva kombinacija smatra neophodnom, potrebno je smanjiti dozu blokatora kalcijevih kanala te pažljivo klinički pratiti djelotvornost i sigurnost primjene lijeka u bolesnika.
English: Although Ketek has no clinically relevant pharmacokinetic or pharmacodynamic interaction with warfarin after single dose administration, more frequent monitoring of prothrombin time/INR (International Normalised Ratio) values should be considered during concomitant treatment.
Croatian: Iako nema klinički značajne farmakokinetičke ni farmakodinamičke interakcije između lijeka Ketek i varfarina nakon primjene jedne doze, treba razmotriti češće kontrole vrijednosti protrombinskog vremena/INR-a (međunarodnog normaliziranog omjera) tijekom njihove istodobne primjene.
English: QT interval prolongation
Croatian: Produljenje QT-intervala
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 2001
Croatian: Datum prvog odobrenja: 9. srpnja 2001.
English: The recommended dose of Ketek for adults and children of 12 years and older is two tablets of 400 mg once daily (800 mg once daily).
Croatian: Preporučena doza lijeka Ketek za odrasle i djecu u dobi od 12 ili više godina su dvije tablete od 400 mg jedanput na dan (800 mg jedanput na dan).
English: The usual duration of treatment is 5 days for infections of the throat, infections of the sinuses, chest infections in patients with long standing breathing difficulties and 7 to 10 days for pneumonia.
Croatian: Liječenje obično traje 5 dana kod infekcija grla, infekcija sinusa i infekcija dišnog sustava u bolesnika koji imaju dugotrajne poteškoće s disanjem, a 7 do 10 dana u slučaju upale pluća.
English: The increase exposure to metoprolol may be of clinical importance in patients with heart failure treated with metoprolol.
Croatian: Povećana izloženost metoprololu može biti od kliničkog značaja u bolesnika sa zatajenjem srca koji se liječe metoprololom.
English: No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, however the experience in patients with impaired hepatic function is limited.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim, umjerenim ili teškim oštećenjem jetre, no iskustvo u bolesnika s oštećenjem funkcije jetre je ograničeno.
English: Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9,
Croatian: Telitromicin je inhibitor CYP3A4 i CYP2D6, ali nema učinka ili mu je učinak slab prema CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 i 2E1.
English: Calcium channel blockers that are metabolized by CYP3A4
Croatian: Blokatori kalcijevih kanala koji se metaboliziraju putem CYP3A4
English: Intravenous dosage of midazolam should be adjusted as necessary and monitoring of the patient should be undertaken.
Croatian: Po potrebi treba prilagoditi intravensku dozu midazolama i nadzirati bolesnika.
English: After oral administration of radiolabelled telithromycin, 76% of the radioactivity was recovered from faeces, and 17% from the urine.
Croatian: Nakon peroralne primjene radioaktivno obilježenog telitromicina 76% radioaktivnosti je ustanovljeno u fecesu, a 17% u mokraći.
English: - hallucination (seeing or hearing things that are not there)
Croatian: - halucinacije (kada vidite, osjećate ili čujete stvari koje nisu prisutne) - gubitak osjeta okusa i mirisa
English: • Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).
Croatian: • tonzilitis/faringitis uzrokovan bakterijom Streptococcus pyogenes, kao alternativa u slučaju kad nije prikladna primjena beta-laktamskih antibiotika u zemljama/područjima sa značajnom prevalencijom S. pyogenes rezistentnog na makrolide, kada je rezistencija posredovana genima ermTR ili mefA (vidjeti dio 4.4 i 5.1).
English: In similarity to some macrolides, telithromycin caused a prolongation of QTc interval in dogs and on action potential duration in rabbit Purkinje fibers in vitro.
Croatian: Slično nekim makrolidima, telitromicin je uzrokovao produljenje QTc-intervala kod pasa kao i produljenje trajanja akcijskog potencijala u Purkinjeovim vlaknima kunića in vitro.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2
English: History of congenital or a family history of long QT syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.
Croatian: Prirođeni sindrom produljenog QT-intervala u osobnoj ili obiteljskoj anamnezi (ako se ne isključi EKG-om) i bolesnici s poznatim stečenim produljenjem QT-intervala.
English: Slight reductions in fertility indices were seen in rats at parentally toxic doses higher than 150 mg/kg.
Croatian: U štakora je opaženo malo smanjenje indeksa plodnosti pri dozama toksičnima za roditelje višima od 150 mg/kg.
English: Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma
Croatian: Ostali metaboliti prisutni su u plazmi, mokraći i fecesu i čine manje od 3% AUC-a u plazmi.
English: For those benzodiazepines which are not metabolised by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Ketek is unlikely.
Croatian: Za benzodiazepine koji se ne metaboliziraju pomoću CYP3A4 (temazepam, nitrazepam, lorazepam) nije vjerojatna interakcija s Ketekom.
English: Visual disturbances included blurred vision, difficulty focusing, and diplopia.
Croatian: Smetnje vida obuhvaćale su zamagljen vid, otežano fokusiranje i diplopiju.
English: The combination is contraindicated (see section 4.3).
Croatian: Ova je kombinacija kontraindicirana (vidjeti dio 4.3).
English: Ketek may produce a similar interaction with lovastatin and atorvastatin which are also mainly metabolised by CYP3A4.
Croatian: Ketek može proizvesti sličnu interakciju s lovastatinom i atorvastatinomom, koji se također uglavnom metaboliziraju putem CYP3A4.
English: Caution should be taken when S. aureus is the suspected pathogen and there is a likelihood of erythromycin resistance based on local epidemiology.
Croatian: Potreban je oprez pri sumnji da je uzročnik S. aureus, a prema lokalnim epidemiološkim podacima postoji vjerojatnost rezistencije na eritromicin.
English: In these patients, co-administration of Ketek and metoprolol, a CYP2D6 substrate, should be considered with caution.
Croatian: U tih bolesnika istodobnu primjenu lijeka Ketek i metoprolola, supstrata CYP2D6, treba razmatrati uz oprez.
English: • When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):
Croatian: • infekcije uzrokovane sojevima s poznatom ili suspektnom rezistencijom na beta-laktame i/ili makrolide (na temelju anamneze bolesnika ili nacionalnih i/ili regionalnih podataka o rezistenciji) koji su obuhvaćeni antibakterijskim spektrom telitromicina (vidjeti dio 4.4 i 5.1):
English: In haemodialysed patients, the posology should be adjusted so that Ketek 800 mg is given after the dialysis session (see also section 5.2).
Croatian: U bolesnika na hemodijalizi doziranje treba prilagoditi na način da se Ketek u dozi od 800 mg primijeni nakon dijalize (vidjeti također dio 5.2).
English: Plasma exposures based on free fraction of active substance, at the no observed adverse effect levels ranged from 1.6 to 13 times the expected clinical exposure.
Croatian: Izloženost u plazmi, s obzirom na slobodnu frakciju djelatne tvari, pri kojoj nisu zabilježeni štetni učinci bila je od 1,6 do 13 puta veća od očekivane izloženosti u kliničkoj primjeni.
English: If you have kidney problems (severe renal insufficiency) you should take alternating daily doses of 800 mg (two tablets of 400 mg) and 400 mg (one tablet of 400 mg), starting with the 800 mg dose.
Croatian: Ako imate probleme s bubrezima (teško oštećenje funkcije bubrega) trebate naizmjence uzimati dnevnu dozu od 800 mg (dvije tablete od 400 mg) i 400 mg (jednu tabletu od 400 mg), a liječenje počinjete s dozom od 800 mg.
English: Transient loss of consciousness, paraesthesia
Croatian: prolazan gubitak svijesti, parestezija parosmija
English: - if you have kidney problems (severely impaired renal function) and/or liver problems (severely impaired hepatic function), do not take Ketek while taking other medicines containing any of the following active substances:
Croatian: - ako imate probleme s bubrezima (teško oštećenje funkcije bubrega) i/ili probleme s jetrom (teško oštećenje funkcije jetre), nemojte uzimati Ketek dok uzimate druge lijekove koji sadrže neku od sljedećih djelatnih tvari:
English: Ventricular arrhythmias (including ventricular tachycardia, torsade de pointes) have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose (see
Croatian: Ventrikularne artimije (uključujući ventrikularnu tahikardiju, torsades de pointes) prijavljene su u bolesnika liječenih telitromicinom i ponekad su se pojavile unutar nekoliko sati od prve doze (vidjeti
English: Concomitant treatment with these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore encompass a risk of treatment failure (see section 4.5).
Croatian: Istodobna primjena tih lijekova vjerojatno će rezultirati supterapijskim koncentracijama telitromicina te stoga nosi rizik od neuspjeha liječenja (vidjeti dio 4.5).
English: Studies in rats and rabbits were inconclusive with respect to potential for teratogenicity; there was equivocal evidence of adverse effects on foetal development at high doses.
Croatian: Istraživanja na štakorima i kunićima nisu pružila nedvojben odgovor o mogućoj teratogenosti, a dokazi o štetnim učincima na razvoj fetusa pri visokim dozama
English: Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that maximum plasma concentrations of telithromycin were increased respectively by 1.22 and 1.51 fold and AUC by respectively 1.54 fold and 2.0 fold.
Croatian: Ispitivanja interakcija s itrakonazolom i ketokonazolom, dvama inhibitorima CYP3A4, pokazala su da su kod istodobne primjene maksimalne koncentracije telitromicina u plazmi porasle 1,22 odnosno 1,51 puta, a njegov AUC 1,54 odnosno 2,0 puta.
English: The effect of dialysis on the elimination of telithromycin has not been assessed.
Croatian: Učinak dijalize na eliminaciju telitromicina još nije ocijenjen.
English: Ketek is not recommended as first choice in patients with severe renal impairment (creatinine clearance <30 ml/min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
Croatian: Ketek se ne preporučuje kao prvi izbor u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) niti u bolesnika koji imaju teško oštećenje bubrega i istodobno oštećenje jetre jer ne postoji prikladan oblik doziranja lijeka (600 mg).
English: The pharmacokinetics of telithromycin is similar between males and females.
Croatian: -Spol Farmakokinetika telitromicina podjednaka je u muškaraca i žena.
English: Exposure to telithromycin in vitro did select for pneumococcal mutants with increased MICs of telithromycin, generally resulting in MIC values of ≤1 mg/l.
Croatian: S izloženošću telitromicinu in vitro izdvojili su se pneumokokni mutanti s povećanim MIK-ovima telitromicina, što je u pravilu rezultiralo vrijednostima MIK-a od ≤ 1 mg/l.
English: Ketek is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4.
Croatian: Ketek je inhibitor CYP3A4 i samo se u posebnim okolnostima smije primjenjivati tijekom liječenja drugim lijekovima koji se metaboliziraju putem CYP3A4.
English: There were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical program and no subgroups at risk were identified.
Croatian: U kliničkom programu nisu prijavljeni torsade de pointes niti druge ozbiljne ventrikularne aritmije ili povezani slučajevi sinkope, a nisu utvrđene ni rizične podskupine.
English: Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
Croatian: Bolesnicima treba savjetovati da prekinu liječenje i obrate se liječniku ako se razviju znakovi i simptomi jetrene bolesti, kao što su anoreksija, žutica, tamna mokraća, svrbež ili osjetljivost
English: Hence, telithromycin should be used with caution (see also sections 4.4 and 5.2).
Croatian: Stoga telitromicin u tih bolesnika treba primjenjivati uz oprez (vidjeti također dio 4.4 i 5.2).
English: • ketoconazole or fluconazole (anti-fungal treatment)
Croatian: • ketokonazol ili flukonazol (za liječenje gljivičnih infekcija)