FrancophonIA/ELRC3.0 huggingface dataset:
English: In a mass balance study in male subjects using radiolabeled telavancin, 3 hydroxylated metabolites were identified with the predominant metabolite (THRX-651540) accounting for <10% of the radioactivity in urine and <2% of the radioactivity in plasma.
Croatian: U ispitivanju masene bilance na muškim ispitanicima pomoću radiooznačenog telavancina, utvrđena su 3 hidroksilirana metabolita s predominantim metabolitom (THRX-651540) koji je bio odgovoran za <10% radioaktivnosti u urinu i <2% radioaktivnosti u plazmi.
English: Despite in vitro susceptibility, there are insufficient clinical data to assess the potential for efficacy of telavancin in infections due to hGISA/GISA.
Croatian: Unatoč osjetljivosti in vitro, ne postoji dovoljno kliničkih podataka za ocjenjivanje potencijala djelotvornosti telavancina kod infekcija nastalih uslijed hGISA/GISA.
English: The excretion of telavancin in milk has not been studied in animals.
Croatian: Izlučivanje telavancina u mlijeko nije ispitivano na životinjama.
English: The dose given will depend on how much you weigh.
Croatian: Doza koju dobivate ovisi o vašoj tjelesnoj težini.
English: In mixed infections where Gram-negative and/or certain types of anaerobic bacteria are suspected, VIBATIV should be co-administered with appropriate antibacterial agent(s).
Croatian: Ako se sumnja na mješovite infekcije gram-negativnih i/ili određenih vrsta anaerobnih bakterija, VIBATIV se treba primjenjivati uz odgovarajuće antibakterijski(e) lijek(ove).
English: Not known: frequency cannot be estimated from the available data severe allergic reactions (anaphylaxis).
Croatian: Nepoznato: učestalost se ne može procijeniti na temelju dostupnih podataka teške alergijske reakcije (anafilaksija).
English: Since telavancin is primarily excreted unchanged by renal clearance and multiple CYP enzymes are able to metabolise telavancin, no relevant interactions are expected with inhibitors or inducers of the CYP450 system.
Croatian: Budući da se televancin primarno izlučuje nepromijenjen bubrežnim klirensom i da višestruki CYP enzimi mogu metabolizirati telavancin, ne očekuju se bitne interakcije s inhibitorima ili induktorima sustava CYP450.
English: if you experience skin reactions to the product.
Croatian: ako imate kožne reakcije na lijek.
English: S. aureus that exhibit high level resistance to glycopeptide antibacterial agents (GRSA) are not susceptible to telavancin.
Croatian: S. aureus koji pokazuju visoku razinu rezistencije na glikopeptidne antibakterijske tvari (GRSA) nisu osjetljivi na telavancin.
English: • Healthcare professionals should be aware that the administration of Vibativ may interfere with some coagulation laboratory tests and qualitative and quantitative urine protein tests.
Croatian: • zdravstveni radnici trebaju biti svjesni da primjena lijeka Vibativ može utjecati na određene laboratorijske pretrage koagulacije te kvalitativne i kvantitativne pretrage proteina u mokraći.
English: Blood samples for coagulation tests should be collected as closely as possible prior to a patient's next dose of telavancin or consideration given to using a test unaffected by telavancin.
Croatian: Uzorci krvi za pretrage koagulacije trebaju se uzeti što je moguće bliže prije nego što bolesnik primi sljedeću dozu telavancina li se treba obratiti pozornost na upotrebu testova na koje nije utjecao telavancin.
English: Do not use VIBATIV after the expiry date that is stated on the label and carton after EXP: The expiry date refers to the last day of that month.
Croatian: VIBATIV se ne smije upotrebiti nakon isteka roka valjanosti navedenog na na naljepnici i kutiji iza oznake „Rok valjanosti“: Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: Telavancin exhibited linear pharmacokinetics at doses up to 15 mg/kg administered as a daily 60 minute intravenous infusion for 7 days in healthy volunteers.
Croatian: Telavancin je pokazao linearnu farmakokinetiku u dozama do 15 mg/kg koje se primjenjuju kao dnevna 60 minutna intravenska infuzija tijekom 7 dana kod zdravih dobrovoljaca.
English: Changes in AUC only become clinically relevant in patients with moderate and severe renal impairment.
Croatian: Promjene u AUC postaju klinički važne samo kod bolesnika sa umjerenim i teškim oštećenjem bubrega.
English: An increase in the number of stillborn pups was observed in these pre- and post-natal studies (see section 4.3).
Croatian: Primijećen je i porast broja mrtvorođene štenadi u ovim pre- i postnatalnim istraživanjima (vidjeti dio 4.3).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: U svakoj su kategoriji nuspojave predstavljene redoslijedom prema sve manjoj ozbiljnosti.
English: The presence of hydroxypropylbetadex in the formulation at a ratio of 1:10 reduces the incidence and severity of the changes due to telavancin and attenuates the glycopeptides-like toxicity of telavancin.
Croatian: Prisutnost hidroksipropilbetadeksa u formulaciji pri omjeru 1:10 smanjuje incidenciju i težinu promjena do kojih dolazi uslijed telavancina i ublažava toksičnost telavancina nalik glikopeptidima.
English: Tell your doctor immediately if this is the case.
Croatian: Odmah o tome obavijestite liječnika.
English: Furthermore, no evidence of hypercoagulability has been seen, as healthy subjects receiving telavancin have normal levels of D-dimer and fibrin degradation products.
Croatian: Nadalje, nije zabilježena hiperkoagulabilnost jer su zdravi ispitanici koji su primali telavancin imali normalne razine D-dimera i produkata razgradnje fibrina.
English: In vitro experiments indicate that telavancin will not affect the clearance of medicinal products metabolised by CYP isoforms 1A2, 2C9, 2C19 and 2D6.
Croatian: In vitro eksperimenti pokazuju da telavancin neće imati utjecaj na klirens lijekova koje metabolizira CYP izooblika 1A2, 2C9, 2C19 i 2D6.
English: In healthy young adults, after infusion of radiolabeled telavancin, approximately 76% of the administered dose was recovered from urine and less than 1% of the dose was recovered from faeces (collected for up to 9 days), based on total radioactivity.
Croatian: Kod zdravih mlađih odraslih osoba, nakon infuzije radiooznačenog telavancina, približno 76% primijenjene doze pronađeno je u urinu, a manje od 1% doze pronađeno je u stolici (prikupljenoj tijekom 9 dana), od ukupne radioaktivnosti.
English: The elimination half-life in subjects with normal renal function is approximately 8 hours.
Croatian: Poluvrijeme eliminacije kod ispitanika s normalnom bubrežnom funkcijom je približno 8 sati.
English: Elderly patients should receive a telavancin dose in accordance with their bodyweight and renal function (see sections 4.3 and 5.2).
Croatian: Stariji bolesnici trebaju dobivati dozu telavancina u skladu s njihovom tjelesnom težinom i funkcijom bubrega (pogledajte dijelove 4.3 i 5.2)
English: Analysis of patient population pharmacokinetic data did not show a relevant effect of age on pharmacokinetics.
Croatian: Analiza farmakokinetičkih podataka populacije bolesnika nije pokazala na važan utjecaj dobi na farmakokinetiku.
English: The Marketing Authorisation Holder shall agree the format and content of the Healthcare Professional Guide with the National Competent Authority in the Member State.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dužan je uskladiti format i sadržaj Vodiča za zdravstvene djelatnike s ovlaštenim nacionalnim tijelom u državi članici.
English: A reconstituted concentrate of VIBATIV is a clear, colourless to pale pink solution.
Croatian: Rekonstituirani koncentrat lijeka VIBATIV je bistra, bezbojna do blijedo ružičasta otopina.
English: The potential risk for humans
Croatian: Potencijalni rizik za ljude nije poznat.
English: Renal excretion is the major route of elimination for telavancin in humans.
Croatian: Bubrežno izlučivanje najvažniji je put eliminacije telavancina kod ljudi.
English: The tubular injury was reversible, but not all animals had yet reached full recovery 4 weeks after the end of treatment.
Croatian: Tubularno oštećenje je bilo reverzibilno, ali nisu se sve životinje potpuno oporavile 4 tjedna nakon
English: Bolus injections must not be administered.
Croatian: Ne smiju se primjenjivati bolus injekcije.
English: Doses less than 150 mg or greater than 800 mg should be further diluted in a volume resulting in a final solution of 0.6 to 8 mg/ml.
Croatian: Doze manje od 150 mg ili veće od 800 mg moraju se dodatno razrijediti u volumenu koji daje završnu otopinu koncentracije od 0,6 do 8 mg/ml.
English: In the event of overdose, telavancin should be discontinued and supportive care is advised with maintenance of glomerular filtration and careful monitoring of renal function.
Croatian: U slučaju predoziranja mora se prekinuti davanje telavancina, a preporučuje se davanje potporne terapije uz održavanje glomerularne filtracije i pažljivo praćenje bubrežne funkcije.
English: VIBATIV contains telavancin as active substance, which is an antibiotic of the glycopeptide group.
Croatian: VIBATIV sadrži telavancin kao djelatnu tvar koji je antibiotik iz skupine glikopeptida.
English: VIBATIV may cause side effects, such as dizziness, sleepiness, confusion or blurred vision that can have an influence on the ability to drive or operate machinery.
Croatian: VIBATIV može prouzročiti nuspojave kao što su omaglica, pospanost, smetenost ili zamućeni vid koji mogu imati utjecaja na vašu sposobnost vožnje ili upravljanja strojevima.
English: In the liver, treatment for 13 weeks or longer resulted in reversible degeneration/necrosis of hepatocytes accompanied by elevations in serum AST and ALT in rats and dogs.
Croatian: U jetri, liječenje u trajanju od 13 tjedana ili dulje dovelo je do reverzibilne degeneracije/nekroze hepatocita praćenoj povećanjem AST i ALT u serumu kod štakora i pasa.
English: Patients with these conditions were not included in clinical trials of telavancin.
Croatian: Bolesnici s takvim stanjima nisu bili uključeni u klinička ispitivanja telavancina.
English: Mild to moderate degrees of hepatic impairment (Child-Pugh class B) (see section 5.2) did not result in a relevant change in pharmacokinetics of telavancin.
Croatian: Blago do umjereno oštećenje funkcije jetre (ChildPugh stadij B) (vidjeti dio 5.2) nije dovelo do značajne promjene farmakokinetike telavancina.
English: Renal function (serum creatinine and urinary output for oliguria/anuria) should be monitored daily for at least the first 3 to 5 days of therapy and every 48 to 72 hours thereafter in all patients receiving telavancin.
Croatian: Bubrežna funkcija (kreatinin u serumu i količina stvaranja urina zbog moguće oligurije/anurije) treba se svakodnevno nadzirati najmanje tijekom prvih 3 do 5 dana liječenja i zatim svakih 48 do 72 sata kod svih bolesnika koji primaju telavancin.
English: At a dose of 10 mg/kg for 3 consecutive days to healthy volunteers subjected to bronchoalveolar lavage, the concentration ratio in pulmonary epithelial lining fluid/plasma ranged from 0.050 and 0.121 over a period of 4 to 24 hours after start of infusion.
Croatian: U dozi od 10 mg/kg tijekom 3 uzastopna dana na zdravim ispitanicima koji su podvrgnuti bronhoalveolarnoj lavaži, omjer koncentracije u tekućini koja oblaže plućni epitel/plazmi bila je u rasponu od 0,050 i 0,121 tijekom razdoblja od 4 do 24 sata nakon početka infuzije.
English: In a second study, 6 weeks of dosing was associated with sloughed testicular germ cells in the epididymis, indicative of testicular injury, and effects upon sperm quality and quantity were observed.
Croatian: U drugom ispitivanju, 6 tjedana doziranja bilo je povezano sa smanjenjem zametnih stanica testisa u epididimisu, koji je naznaka oštećenja testisa, a opažen je i učinak na kvalitetu i količinu spermija.
English: The MAH shall agree the communication plan for the DHPC letter with the National Competent Authority in the Member States where the letter will be
Croatian: MAH mora dogovoriti komunikacijski plan za pismo liječnicima s nadležnim nacionalnim tijelom u državi članici u kojoj će se pismo distribuirati.
English: Although telavancin does not interfere with coagulation, it interfered with certain tests used to monitor coagulation (see below), when tests are conducted using samples drawn between 0 to 18 hours after telavancin administration to patients being treated once every 24 hours.
Croatian: Iako ne dolazi do interakcije telavancina s koagulacijom do interakcije dolazi s određenim pretragama koje se koriste za praćenje koagulacije (vidjeti u nastavku), kada se testovi provode na uzorcima uzetima u razdoblju između 0 do 18 sati nakon primjene telavancina bolesnicima koji se liječe jednom svaka 24 sata.
English: The tubular injury was characterised by degeneration and necrosis of proximal tubular cells, and was associated with increases in BUN and creatinine that reach a maximum of 2 times the control values at the highest doses.
Croatian: Tubularno oštećenje bilo je karakterizirano degeneracijom i nekrozom proksimalnih tubularnih stanica i povezano s rastom ureje u krvi i kreatinina koji maksimalno dostiže dvostruku kontrolnu vrijednost u najvišim dozama.
English: Vacuolisation is considered to represent a cytoprotective event and is expected to reverse with the same half-life as the turnover time of the proximal tubular cells.
Croatian: Smatra se da vakuolizacija predstavlja citoprotektivni događaj i očekuje se njezin oporavak u istom poluvijeku kao što je vrijeme oporavka proksimalnih tubularnih stanica.
English: Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with telavancin should be carefully evaluated and monitored (see section 4.8).
Croatian: Bolesnike kod kojih su se pojavili znakovi i simptomi oštećenog sluha ili poremećaja unutarnjega uha tijekom liječenja telavancinom mora se pažljivo procijeniti i nadzirati (vidjeti dio 4.8).
English: Therefore, the same dose of 10 mg/kg/24 hr can be used in patients with normal renal function or mild renal impairment.
Croatian: Stoga se ista doza od 10 mg/kg/24 h može primjenjivati kod bolesnika s normalnom bubrežnom funkcijom ili blagim oštećenjem bubrega.
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 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: If these symptoms occur you must inform your doctor or nurse immediately.
Croatian: Ako se pojavi bilo koji od ovih simptoma odmah obavijestite liječnika ili medicinsku sestru.
English: Telavancin interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods (e.g. pyrogallol red molybdate).
Croatian: Telavancin interferira s kvalitativnim pretragama proteina u mokraći pomoću trakica kao i s kvantitativnim metodama boja (npr. crveni pirogalol molibdat).
English: No clinically significant differences in pharmacokinetics of telavancin were observed between healthy elderly and healthy young subjects.
Croatian: Nisu uočene značajne razlike u farmakokinetici telavancina između zdravih starijih i zdravih mlađih osoba.
English: The telavancin medicinal product, which contains the excipient hydroxypropylbetadex (HP-β-CD), induced adverse effects in animal studies at plasma concentrations that were in the same range as clinical exposure levels and with possible relevance to clinical use.
Croatian: Lijek telavancin koji sadrži pomoćnu tvar hidroksipropilbetadeks (HP-β-CD), prouzročio je štetne učinke u ispitivanjima na životinjama pri koncentracijama u plazmi koje su bile u istom rasponu kao i kod kliničke izloženosti i s mogućim značajem za kliničku primjenu.
English: • That patients' renal function should be assessed and monitored and initial dose and dosage adjustments should be calculated based on the creatinine clearance.
Croatian: • da se funkcija bubrega kod bolesnika mora procijeniti i pratiti, a početna doza i prilagođavanje doze se trebaju izračunati na temelju klirensa kreatinina.
English: The studies did not provide any evidence for a genotoxic potential of telavancin.
Croatian: Ispitivanja nisu dala dokaze za genotoksični potencijal telavancina.
English: Telavancin exerts concentration-dependent bactericidal activity against susceptible Gram-positive bacteria.
Croatian: Telavancin pokazuje baktericidnu aktivnost koja ovisi o koncentraciji na osjetljive gram-pozitivne bakterije.
English: Telavancin was cleared by CVVH and the clearance of telavancin increased with increasing ultrafiltration rate.
Croatian: Telavancin je uklonjen postupkom CVVH i klirens telavancina povećan je uz povećanje stupnja ultrafiltriranja.
English: Telavancin demonstrated efficacy against MSSA and MRSA in two randomised controlled studies in patients with nosocomial pneumonia, including ventilator-associated pneumonia, involving 751 patients who received telavancin.
Croatian: Telavancin je pokazao djelotvornost na MSSA i MRSA u dvije randomizirane kontrolirane studije na bolesnicima s bolničkom pneumonijom uključujući i upalu pluća povezanu s mehaničkom ventilacijom, u koje je uključen 751 bolesnik koji je primao telavancin.
English: Systemic macrophage hypertrophy and hyperplasia occurred in rats and dogs, in many organ systems that normally contain macrophages.
Croatian: Kod štakora i pasa došlo je do sistemske hipertrofije makrofaga i hiperplazije na brojnim organskim sustavima koji uobičajeno sadrže makrofage.
English: Telavancin has no effect on platelet aggregation.
Croatian: Telavancin nema utjecaja na agregaciju trombocita.
English: Preparation of final diluted solution for infusion
Croatian: Priprema završne razrijeđene otopine za infuziju
English: Women of childbearing potential have to use effective contraception during treatment.
Croatian: Žene u reprodukcijskoj dobi moraju uzimati učinkovitu kontracepciju tijekom liječenja.
English: Reconstituted concentrate must be further diluted prior to administration.
Croatian: Rekonstituirani koncentrat mora se dodatno razrijediti prije primjene.
English: No data are available in subjects with severe hepatic impairment (Child-Pugh class C).
Croatian: Nema dostupnih podataka za osobe s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
English: It was demonstrated in a clinical study with intravenous midazolam that multiple doses of telavancin had no effect on the pharmacokinetics of midazolam, which is a sensitive substrate for CYP3A4.
Croatian: Kliničkim je ispitivanjima s intravenskim uzimanjem midazolama pokazano da višekratne doze telavancina ne utječu na farmakokinetiku midazolama koji je osjetljivi supstrat za CYP3A4.
English: Patients receiving telavancin in conjunction with or sequentially with other medicinal products with known ototoxic potential should be carefully monitored and the benefit of telavancin evaluated if hearing deteriorates.
Croatian: Bolesnike koji dobivaju telavancin zajedno s nekim drugim lijekom ili nakon lijeka koji ima poznati ototoksični potencijal treba pažljivo nadzirati i procijeniti korist telavancina ako se sluh pogoršava.
English: In embryo-fetal development studies malformations of digits and limbs were observed in rats, rabbits and minipigs.
Croatian: U ispitivanjima embrio-fetalnog razvoja primijećene su malformacije prstiju i udova u štakora, kunića i patuljastih svinja.
English: If this happens, the infusion of telavancin will be stopped and the doctor will check the functioning of your kidneys.
Croatian: Ako se to dogodi liječnik će prekinuti infuziju telavancina i provjeriti rad vaših bubrega.
English: In studies in healthy subjects, the pharmacokinetics of telavancin were not significantly altered by simultaneous administration of aztreonam or piperacillin-tazobactam.
Croatian: U ispitivanjima na zdravim ispitanicima farmakokinetika telavancina nije se značajno izmijenila uz istovremenu primjenu aztreonama ili piperacilin-tazobaktama.
English: Genotoxicity was addressed with a standard in vitro and in vivo test battery.
Croatian: Genotoksičnost je procijenjena sa standardnim in vitro i in vivo baterijama testova.
English: After 13 weeks of treatment, reversible seminiferous tubular degeneration was observed in the testis of rats.
Croatian: Nakon 13 tjedana tretmana primijećena je reverzibilna degeneracija sjemenih kanalića testisa štakora.
English: Rare: may affect up to 1 in 1,000 people deafness
Croatian: Rijetko: može se javiti u manje od 1 na 1000 osoba
English: As with other glycopeptides, ototoxicity (deafness and tinnitus) has been reported in patients treated with telavancin (see section 4.8).
Croatian: Kao i kod ostalih glikopeptida prijavljena je ototoksičnost (gluhoća i tinitus) kod bolesnika liječenih telavancinom (vidjeti dio 4.8).
English: Effects on the kidney occurred after a minimum of 4 weeks of dosing and were a combination of renal tubular injury and tubular epithelial vacuolisation.
Croatian: Učinci na bubrezima do kojih je došlo nakon najmanje 4 tjedna doziranja i predstavljali su kombinaciju bubrežnog tubularnog oštećenja i vakuolizacije tubularnog epitela.
English: Aseptic technique must be used to reconstitute VIBATIV.
Croatian: Za rekonstituciju lijeka VIBATIV mora se primijeniti aseptička tehnika.
English: If not used immediately, in use storage times are the responsibility of the user and should not be longer than
Croatian: Ako se ne upotrijebi odmah, vrijeme čuvanja odgovornost je korisnika i ono ne bi smjelo biti dulje od 24 sata na 2-8°C.
English: Male fertility was unaffected.
Croatian: Nije bilo utjecaja ne muški fertilitet.
English: if you are allergic (hypersensitive) to telavancin or any of the other ingredients of VIBATIV If you suffer from severe kidney problems, or receive haemodialysis
Croatian: ako ste alergični (preosjetljivi) na telavancin ili neki drugi sastojak lijeka VIBATIV (naveden u ako imate teške bubrežne probleme ili ste na hemodijalizi.
English: Vacuolisation was not associated with renal function impairment, but was not reversible after 4 weeks of recovery.
Croatian: Vakuolizacija nije bila povezana s oštećenjem bubrežne funkcije, ali nije bila reverzibilna nakon 4 tjedna oporavka.
English: The other ingredients are hydroxypropylbetadex, mannitol (E421), sodium hydroxide (E524) (for pH adjustment) and hydrochloric acid (E507) (for pH adjustment).
Croatian: Drugi sastojci su hidroksipropilbetadeks, manitol (E421), natrijev hidroksid (E524) (za podešavanje pH) i kloridna kiselina (E507) (za podešavanje pH).
English: In studies on fertility in male rats, decreases in sperm motility and epididymal sperm counts as well as an increase in the frequency of abnormal sperm were demonstrated after 10 weeks of intravenous administration of telavancin.
Croatian: U ispitivanjima fertiliteta muških štakora pokazalo se smanjenje pokretljivosti spermija i broja spermija u epididimisu kao i povećanje učestalosti abnormalnih spermija nakon 10 tjedana intravenske primjene telavancina.
English: However, no information is available on the use of haemodialysis to treat an overdose.
Croatian: Međutim, ne postoje dostupni podaci za primjenu hemodijalize za liječenje predoziranja.
English: A retrospective, chart review, post authorisation safety study (PASS) shall be conducted with the objective to further characterise the adverse drug reaction profile of telavancin when used in the clinical setting.
Croatian: Retrospektivni pregled ispitivanja sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (PASS) obavit će se s ciljem daljnje karakterizacije profila nuspojava telavancina koji se upotrebljava u bolnicama.
English: At higher doses or longer treatment durations, vacuolisation of the urothelium in the bladder also occurred.
Croatian: Kod viših doza ili duljeg trajanja tretmana došlo je također do vakuolizacije urotela u mokraćnom mjehuru.