FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies have shown that CYP1A1, 1A2, 2B6, 2C18, 2C19, 2D6, 2E1, 2J2, 3A4, 3A5 and 4F12 are able to metabolise telavancin, resulting in hydroxylation at the 7, 8 and 9 position of the 2-(decylamino) ethyl side chain of telavancin.
Slovenian: In vitro študije so pokazale, da so CYP1A1, 1A2, 2B6, 2C18, 2C19, 2D6, 2E1, 2J2, 3A4, 3A5 in 4F12 zmožni presnavljati telavancin, kar vodi do hidroksilacije na 7., 8. in 9. mestu 2-(decikloamino) etilne
English: Women of childbearing potential have to use effective contraception during treatment.
Slovenian: Ženske v rodni dobi morajo v času zdravljenja uporabljati učinkovito kontracepcijo.
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.
Slovenian: Prisotnost hidroksipropilbetadeksa v pripravku v razmerju 1:10 zmanjša pojavnost in resnost sprememb zaradi telavancina in zmanjša glikopeptidom podobno toksičnost telavancina.
English: The studies did not provide any evidence for a genotoxic potential of telavancin.
Slovenian: Študije niso ponudile kakršnihkoli dokazov o genotoksičnem potencialu telavancina.
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.
Slovenian: Pri zdravih mladih odraslih osebah se je po infuziji radioaktivno označenega telavancina približno 76 % danega odmerka izločilo z urinom in manj kot 1 % odmerka z blatom (zbranih v do 9 dneh), glede na celotno radioaktivnost.
English: Furthermore, no evidence of hypercoagulability has been seen, as healthy subjects receiving telavancin have normal levels of D-dimer and fibrin degradation products.
Slovenian: Poleg tega ni dokaza za zmožnost hiperkoagulacije, saj so imele zdrave osebe, ki so prejemale telavancin običajne ravni D-dimera in produktov razgradnje fibrina.
English: Telavancin has been shown to affect sperm quantity and quality of male rats (see section 5.3) although no effect on fertility, mating, or early embryogenesis has been reported.
Slovenian: Telavancin dokazano vpliva na število in kakovost spermijev pri podganah (glejte poglavje 5.3), čeprav niso poročali o učinku na plodnost, parjenje ali zgodnjo embriogenezo.
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.
Slovenian: Telavancin je pokazal linearno farmakokinetiko pri odmerkih do 15 mg/kg danih kot dnevna 60minutna intravenska infuzija zdravim prostovoljcem v 7-dnevnem obdobju.
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.
Slovenian: V primeru prekomernega odmerjanja je treba prekiniti zdravljenje s telavancinom; priporočena je podporna nega z vzdrževanjem glomerularne filtracije in pozornim nadzorom ledvične funkcije.
English: The tubular injury was reversible, but not all animals had yet reached full recovery 4 weeks after the end of treatment.
Slovenian: Tubularna poškodba je bila reverzibilna vendar pa niso vse živali dosegle popolnega okrevanja v 4 tednih po
English: if you experience skin reactions to the product.
Slovenian: Če imate kožne reakcije na zdravilo.
English: What VIBATIV is and what it is used for
Slovenian: Kaj je zdravilo VIBATIV in za kaj ga uporabljamo
English: Telavancin must not be given to pregnant women.
Slovenian: Telavancina nosečnice ne smejo dobivati.
English: Therefore, the same dose of 10 mg/kg/24 hr can be used in patients with normal renal function or mild renal impairment.
Slovenian: Zato je mogoče uporabiti enak odmerek 10 mg/kg/24 ur pri bolnikih z normalno ledvično funkcijo ali z blago ledvično okvaro.
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.
Slovenian: Telavancin je dokazal učinkovitost proti MSSA in MRSA v dveh randomiziranih kontroliranih študijah pri bolnikih z bolnišnično pljučnico, vključno z ventilatorsko pljučnico, ki sta vključevali 751 bolnikov, ki so prejemali telavancin.
English: In vitro studies showed that telavancin retained full activity in the presence of pulmonary surfactant.
Slovenian: In vitro študije so pokazale, da je telavancin zadržal polno aktivnost v prisotnosti pljučnega
English: If not used immediately, in use storage times are the responsibility of the user and should not be longer than
Slovenian: Če ga ne porabite takoj, je za čas shranjevanja do uporabe odgovoren uporabnik, čas shranjevanja pa ne sme biti daljši od 24 ur pri
English: Your doctor will decide how long you should be treated.
Slovenian: Vaš zdravnik se bo odločil, koliko časa bo trajalo zdravljenje.
English: Important information about some of the ingredients of VIBATIV This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila VIBATIV To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar pomeni, da je v bistvu »brez
English: Bolus injections must not be administered.
Slovenian: Bolusni odmerki se ne smejo injicirati.
English: For routine monitoring of renal function it is recommended to use serum creatinine concentration or estimated creatinine clearance.
Slovenian: Za rutinski nadzor ledvične funkcije je priporočljiva uporaba koncentracije kreatinina v serumu ali ocenjenega očistka kreatinina.
English: • That there is a potential risk of teratogenicity and Vibativ is contraindicated during pregnancy.
Slovenian: • Obstaja možno tveganje za teratogenost, zato je zdravilo Vibativ v času nosečnosti kontraindicirano.
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.
Slovenian: Klinična študija z intravenoznim midazolamom je pokazala, da telavancin v več odmerkih ni imel vpliva na farmakokinetiko midazolama, ki je občutljiv substrat za CYP3A4.
English: Acute renal failure (see section 4.4).
Slovenian: Akutna ledvična odpoved (glejte poglavje 4.4).
English: Vacuolisation is considered to be a cytoprotective event, which is not associated with functional impairment.
Slovenian: Vakuolizacijo se razume kot citoprotektiven učinek, ki ni povezan s funkcionalnim poslabšanjem.
English: To ensure a comparable exposure in patients with moderate renal impairment, the dose should be lowered to 7.5 mg/kg/24 hr.
Slovenian: Za zagotovitev primerljive izpostavljenosti pri bolnikih z zmerno ledvično okvaro je potrebno odmerek znižati na 7,5 mg/kg/24 ur.
English: Your doctor may decide to reduce the dose of VIBATIV and monitor you more closely during treatment.
Slovenian: Vaš zdravnik se bo morda odločil za zmanjšanje odmerka zdravila VIBATIV in vas bo med zdravljenjem podrobneje opazoval.
English: S. aureus that exhibit high level resistance to glycopeptide antibacterial agents (GRSA) are not susceptible to telavancin.
Slovenian: S. aureus, ki kaže visoko raven odpornosti na glikopeptidne antibiotike (GRSA), ni občutljiv na telavancin.
English: if you develop diarrhoea during or shortly after your treatment, tell your doctor immediately.
Slovenian: Če med zdravljenjem ali kmalu po zdravljenju dobite drisko, o tem nemudoma obvestite zdravnika.
English: Telavancin is active against Gram-positive bacteria only (see section 5.1 for information on the antimicrobial spectrum).
Slovenian: Telavancin deluje izključno proti grampozitivnim bakterijam (glejte poglavje 5.1 za podatke o antibakterijskem spektru).
English: Elderly patients should receive a telavancin dose in accordance with their bodyweight and renal function (see sections 4.3 and 5.2).
Slovenian: Starejši bolniki prejmejo odmerek telavancina glede na njihovo telesno maso in ledvično funkcijo (glejte poglavji 4.3 in 5.2).
English: At higher doses or longer treatment durations, vacuolisation of the urothelium in the bladder also occurred.
Slovenian: Pri višjem odmerku in daljšem zdravljenju, se je prav tako pojavila vakuolizacija urotelija v mehurju.
English: Vacuolisation was not associated with renal function impairment, but was not reversible after 4 weeks of recovery.
Slovenian: Vakuolizacija ni bila povezana z okvaro ledvične funkcije, vendar ni bila odpravljena po 4 tednih okrevanja.
English: Renal excretion is the major route of elimination for telavancin in humans.
Slovenian: Izločanje preko ledvic je glavni način izločanja telavancina pri ljudeh.
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.
Slovenian: Blage do zmerne stopnje okvare jeter (Child-Pugh razred B) (glejte poglavje 5.2) niso pomembno spremenile farmakokinetike telavancina.
English: Telavancin is not to be used in children or adolescents under 18 years of age.
Slovenian: Telavancina ne smete uporabljati pri otrocih in mladostnikih, ki so mlajši od 18 let.
English: Patients with these conditions were not included in clinical trials of telavancin.
Slovenian: Bolniki s temi obolenji niso bili vključeni v klinična preskušanja telavancina.
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.
Slovenian: Pri odmerku 10 mg/kg v 3 zaporednih dneh zdravim prostovoljcem, pri katerih so delali bronhoalveolarno izpiranje, je bilo razmerje koncentracije med tekočino v pljučnem epitelnem sloju in plazmo od 0,050 do 0,121 v času od 4 do 24 ur po začetku infundiranja.
English: The excretion of telavancin in milk has not been studied in animals.
Slovenian: Izločanje telavancina v mleku pri živalih ni preučeno.
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.
Slovenian: Vakuolizacija naj bi predstavljala dogodek celične zaščite in naj bi bila odpravljena z enako razpolovno dobo kot je čas nadomestitve proksimalnih tubularnih celic.
English: • That the benefit risk balance for the Complicated Skin and Soft Tissue Infections indication was assessed as negative by the Committee for Medicinal Products for Human Use (CHMP), therefore Vibativ should not be used in this or other indications not approved.
Slovenian: • Odbor za zdravila za uporabo v humani medicini (CHMP) je ocenil razmerje med koristmi in tveganji za indikacijo zapletenih okužb kože in mehkega tkiva kot negativno, zato se zdravilo Vibativ ne sme uporabljati za to in za druge neodobrene indikacije.
English: Dosage regimen
Slovenian: Režim odmerjanja
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
Slovenian: če ste alergični (preobčutljivi) na telavancin ali katerokoli sestavino zdravila VIBATIV če imate hude težave z ledvicami ali če ste na hemodializi
English: • The role and use of the Prescriber Checklist sticker included in the product package to document the established pregnancy status prior to dosing.
Slovenian: • Vlogo in uporabo kontrolnega seznama za predpisovalce zdravila, ki je vključen v pakiranje za evidentiranje ugotovljene nosečnosti pred dajanjem zdravila.
English: Telavancin inhibits cell wall biosynthesis by binding to late-stage peptidoglycan precursors, including lipid II, which prevents polymerisation of the precursor into peptidoglycan and subsequent cross-linking events.
Slovenian: Telavancin zavira biosintezo celične stene z vezavo na prekurzorje peptidoglikana pozne faze, vključno z lipidom II, ki preprečuje polimerizacijo prekurzorja v peptidoglikan in poznejše povezovalne dogodke.
English: Powder for concentrate for solution for infusion A white to pale pink, whole or fragmented cake
Slovenian: prašek za koncentrat za raztopino za infundiranje Bela do bledo roza pogača, cela ali zdrobljena
English: 4.7 Effects on ability to drive and use machines Dizziness, somnolence, confusion and blurred vision may occur and VIBATIV may have an influence on the ability to drive and use machines (see section 4.8).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Pojavijo se lahko omotica, somnolenca, zmedenost in zamegljen vid in zdravilo VIBATIV lahko vpliva na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
English: Genotoxicity was addressed with a standard in vitro and in vivo test battery.
Slovenian: Genotoksičnost so ugotavljali z običajno in vitro in in vivo testno baterijo.
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.
Slovenian: Značilnost tubularne poškodbe je degeneracija in nekroza proksimalnih tubularnih celic in je bila povezana s povišanjem BUN-ja in kreatinina, ki je dosegel dvakratni maksimum kontrolnih vrednosti najvišjega odmerka.
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).
Slovenian: Bolnike, ki med zdravljenjem s telavancinom razvijejo znake in simptome okvare sluha ali bolezni notranjega ušesa, je treba pozorno oceniti in nadzorovati (glejte poglavje 4.8).
English: • That patients' renal function should be assessed and monitored and initial dose and dosage adjustments should be calculated based on the creatinine clearance.
Slovenian: • Oceniti in spremljati je treba delovanje ledvic, začetni odmerek in prilagoditve odmerka pa je treba izračunati na podlagi očistka kreatinina.
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.
Slovenian: V jetrih je zdravljenje, dolgo 13 tednov ali dlje, vodilo do reverzibilne degeneracije/nekroze hepatocitov, skupaj s povišanjem seruma AST in ALT pri podganah in psih.
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.
Slovenian: V drugi študiji je bilo 6-tedensko dajanje odmerka povezano z odmrlimi bakterijskimi celicami v obmodku, kar je kazalo na testikularno poškodbo in ugotovljeni so bili učinki na kakovost in količino spermijev.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Slovenian: Če imate še kakšna dodatna vprašanja v zvezi z uporabo tega izdelka, vprašajte svojega zdravnika ali
English: Male fertility was unaffected.
Slovenian: Fertilnost samcev ni bila prizadeta.
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.
Slovenian: Bolnike, ki prejemajo telavancin v povezavi z drugimi zdravili oz. po drugih zdravilih z znanim ototoksičnim potencialom, je potrebno skrbno spremljati, korist telavancina pa oceniti, če se sluh poslabša.
English: • That Vibativ has a risk of nephrotoxicity including increased risk of mortality in patients with pre existing acute renal failure and is therefore contraindicated in patients with pre-existing acute renal failure and in patients with creatinine clearance < 30ml/min, including patients undergoing haemodialysis.
Slovenian: • Pri zdravilu Vibativ obstaja tveganje za nefrotoksičnost, vključno s povečanim tveganjem smrtnosti pri bolnikih s predobstoječo akutno ledvično odpovedjo in je zato kontraindicirano pri bolnikih s predhodno akutno ledvično odpovedjo ter pri bolnikih z očistkom kreatinina < 30 ml/min, vključno z bolniki na hemodializi.
English: Telavancin also binds to bacterial membranes and causes depolarisation of membrane potential and an increase in membrane permeability that results in inhibition of protein,
Slovenian: Telavancin se prav tako veže na bakterijske membrane in povzroča depolarizacijo potenciala membrane in povečanje prepustnosti membrane, kar zavira protein, RNK in
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.
Slovenian: Učinki na ledvice so se pojavili po najmanj 4 tednih dajanja odmerka in so bili kombinacija ledvične tubularne poškodbe in tubularne epitelialne vakuolizacije.
English: In healthy young adults, three hydroxylated metabolites were identified after infusion of telavancin.
Slovenian: Pri zdravih mladih odraslih osebah so bili po infuziji telavancina identificirani trihidroksilirane metabolite.
English: What VIBATIV looks like and contents of the pack
Slovenian: Izgled zdravila VIBATIV in vsebina pakiranja
English: However, no information is available on the use of haemodialysis to treat an overdose.
Slovenian: Vendar pa podatki o uporabi hemodialize za zdravljenje prekomernega odmerjanja niso na voljo.
English: 10 mg/kg every 24 hours 7.5 mg/kg every 24 hours *As calculated using the Cockcroft-Gault formula
Slovenian: 7,5 mg/kg vsakih 24 ur *Kot je bilo izračunano z uporabo formule Cockcroft-Gault.
English: However, the clearance of telavancin by CVVH has not been evaluated in a clinical study; thus, the clinical significance of this finding and use of CVVH to treat an overdose
Slovenian: Vendar pa očistek telavancina z venovensko hemofiltracijo (CVVH) ni bil ocenjen v klinični študiji; zato klinični pomen te ugotovitve in uporabe venovenske hemofiltracije (CVVH) za zdravljenje prekomernega odmerjanja ni znan.
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.
Slovenian: Zdravilo VIBATIV lahko povzroči neželene učinke, kot so omotica, zaspanost, zmedenost ali zamegljen vid, ki imajo lahko vpliv na sposobnost vožnje in upravljanje strojev.
English: VIBATIV contains telavancin as active substance, which is an antibiotic of the glycopeptide group.
Slovenian: Zdravilo VIBATIV vsebuje telavancin kot učinkovino, ki je antibiotik iz skupine glikopeptidov.
English: In phase 3 clinical trials involving 1680 patients (751 and 929, NP and cSSTI, respectively) who received telavancin at a daily dose of 10 mg/kg, adverse reactions were reported in 47.3% of patients.
Slovenian: V kliničnih preskušanjih 3. faze, ki so vključevala 1680 bolnikov (751 z bolnišnično pljučnico in 929 s cSSTI), ki so prejemali telavancin v dnevnem odmerku 10 mg/kg, so poročali o neželenih učinkih pri 47,3 % bolnikov.
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.
Slovenian: Ledvično funkcijo (kreatinin v serumu in izločanje z urinom za oligourijo/anurijo) je potrebno vsakodnevno spremljati pri vseh bolnikih, ki prejemajo telavancin, vsaj prve 3 do 5 dni zdravljenja, zatem pa na vsakih 48 do 72 ur.
English: Mixing is continued until the content of the vial is completely dissolved and is free of particulate
Slovenian: Mešanje poteka tako dolgo, dokler se vsebina viale popolnoma ne raztopi in pri pregledu s prostim
English: The effect of renal impairment on the pharmacokinetics of telavancin has been evaluated in 2 clinical pharmacology studies in healthy subjects with normal renal function and subjects with mild to severe renal impairment.
Slovenian: Vpliv ledvične okvare na farmakokinetiko telavancina je bil ocenjen v 2 kliničnih farmakoloških študijah na zdravih osebah z normalno ledvično funkcijo ter osebah z blago do hujšo ledvično okvaro.
English: A reconstituted concentrate of VIBATIV is a clear, colourless to pale pink solution.
Slovenian: Rekonstituirani koncentrat zdravila VIBATIV je čista, brezbarvna do svetlo roza raztopina.
English: In studies in healthy subjects, the pharmacokinetics of telavancin were not significantly altered by simultaneous administration of aztreonam or piperacillin-tazobactam.
Slovenian: Pri študijah z zdravimi ljudmi se farmakokinetika telavancina ni bistveno spremenila pri istočasnemu jemanju aztreonama ali piperacilin-tazobaktama.
English: Based on their pharmacokinetic properties, no interaction is expected with other beta-lactams, clindamycin, metronidazole, or
Slovenian: Na osnovi njihovih farmakokinetičnih značilnosti ni pričakovati interakcije z ostalimi betalaktami, klindamicinom, metronidazolom ali fluorokinoloni.
English: If renal function markedly decreases during treatment, the benefit of continuing telavancin should be assessed.
Slovenian: Če se med zdravljenjem ledvična funkcija izrazito zmanjša, je treba oceniti korist v primeru nadaljevanja zdravljenja s
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Vibativ are provided with a healthcare professional educational pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom vsem zdravnikom, za katere pričakuje, da bodo predpisovali ali uporabljali zdravilo Vibativ, zagotovi izobraževalni paket za zdravstvene delavce, ki vsebuje
English: Tell your doctor immediately if this is the case.
Slovenian: To takoj povejte svojemu zdravniku.
English: 6.6 Special precautions for disposal and other handling The powder must be reconstituted and the resulting concentrate must then be immediately diluted further prior to use.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Prašek je potrebno rekonstituirati, dobljeni koncentrat pa je potrebno pred nadaljnjo uporabo takoj razredčiti.
English: Aseptic technique must be used to reconstitute VIBATIV.
Slovenian: Za rekonstituiranje zdravila VIBATIV uporabljajte aseptično tehniko.
English: In embryo-fetal development studies malformations of digits and limbs were observed in rats, rabbits and minipigs.
Slovenian: V študijah embrio-fetalnega razvoja je bila pri podganah, zajcih in morskih prašičkih ugotovljena spačenost prstov in udov.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with telavancin in one or more subsets of the paediatric population in nosocomial pneumonia.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij s telavancinom za vse skupine pediatrične populacije z bolnišnično pljučnico.
English: a ESRD= End-stage renal disease maintained on haemodialysis b Baseline mean creatinine clearance as calculated by Cockcroft-Gault equation
Slovenian: a ESRD= ledvična bolezen v zadnjem stadiju, zdravljena s hemodializo b Izhodiščna vrednost za srednji očistek kreatinina, izračunano po enačbi Cockcroft-Gault
English: The MAH shall continue to monitor the activity of telavancin and the microbiological resistance as compared to other agents, through the longitudinal resistance surveillance program.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo še naprej spremljal delovanje telavancina in mikrobiološko odpornost v primerjavi z drugimi učinkovinami prek programa namenskega spremljanja odpornosti.
English: Telavancin was cleared by CVVH and the clearance of telavancin increased with increasing ultrafiltration rate.
Slovenian: Telavancin se je očistil z venovensko hemofiltracijo (CVVH), očistek telavancina pa se je povečal s povišanjem hitrosti ultrafiltracije.
English: No data are available in subjects with severe hepatic impairment (Child-Pugh class C).
Slovenian: Podatki o bolnikih s hudo okvaro jeter (Child-Pugh razred C) niso na voljo.