FrancophonIA/ELRC3.0 huggingface dataset:
English: Vancomycin should be infused slowly (see sections 4.2 and 4.4).
Croatian: Vankomicin je potrebno primijeniti sporo infuzijom (vidjeti dijelove 4.2 i 4.4).
English: *The appropriate timing and amount of subsequent doses largely depends on the modality of RRT and should be based on serum vancomycin levels obtained prior to dosing and on residual renal function.
Croatian: Redoziranje temeljeno na razini* * Odgovarajuće vrijeme i količina daljnjih doza u velikoj mjeri ovise o modalitetu BNT-a i trebaju se temeljiti na razinama serumskog vankomicina dobivenima prije doziranja i rezidualnoj funkciji bubrega.
English: Intravenous administration of vancomycin is not effective for the treatment of Clostridium difficile infection.
Croatian: Intravenska primjena vankomicina nije učinkovita u liječenju infekcije s Clostridium difficile.
English: Drug interactions with anaesthetic agents
Croatian: Interakcije s anesteticima
English: Acquired resistance to glycopeptides is most common in enterococci and is based on acquisition of various van gene complexes which modifies the D-alanyl-D-alanine target to D-alanyl-D-lactate or Dalanyl-D-serine which bind vancomycin poorly.
Croatian: Stečena rezistencija na glikopeptide najčešća je kod enterokoka i temelji se na usvajanju različitih kompleksa van gena koji modificiraju D-alanil-D-alaninski dio u D-alanil-D-laktatni ili D-alanil-Dserinski koji slabo vežu vankomicin.
English: Vancomycin powder is made into a <solution for infusion> <or> <oral solution>.
Croatian: Od vankomicin praška se priprema <otopinu za infuziju> <ili> <otopina za oralnu upotrebu>.
English: In obese patients, the initial dose should be individually adapted according to total body weight as in non-obese patients.
Croatian: Kod pretilih bolesnika potrebno je prilagoditi početnu dozu individualno prema ukupnoj tjelesnoj težini kao kod bolesnika koji nisu pretili.
English: Rare side effects (may affect up to 1 in 1,000 people): - Decrease in white blood cells, red blood cells and platelets (blood cells responsible for blood clotting)
Croatian: Rijetke nuspojave (mogu se javiti u do1 na 1000 osoba): - Smanjenje broja bijelih krvnih stanica, crvenih krvnih stanica i trombocita (krvne stanice odgovorne za zgrušavanje krvi)
English: The adverse reactions listed below are defined using the following MedDRA convention and system organ class database:
Croatian: Nuspojave navedene u nastavku prikazane su prema MedDRA klasifikaciji organskih sustava i učestalosti:
English: The reduced susceptibility or resistance to vancomycin in Staphylococcus is not well understood.
Croatian: Smanjena osjetljivost ili rezistencija na vankomicin kod stafilokoka nije sasvim razjašnjena.
English: Pseudomembranous enterocolitis
Croatian: Pseudomembranozni enterokolitis
English: System organ class Frequency
Croatian: Klasifikacija organskih sustava
English: Vancomycin capsules are not appropriate for the treatment of children under the age of 12 years or for adolescents unable to swallow them.
Croatian: Kapsule vankomicina nisu prikladne za liječenje djece mlađe od 12 godina i adolescenata koji ih ne mogu progutati.
English: In patients on intermittent haemodialysis, vancomycin levels should be usually obtained before the start of the haemodialysis session.
Croatian: U bolesnika na intermitentnoj hemodijalizi razine vankomicina je obično potrebno postići prije početka epizode hemodijalize.
English: Vancomycin should not be administered intramuscularly due to the risk of necrosis at the site of administration.
Croatian: Vankomicin se ne smije davati intramuskularno zbog rizika od nekroze na mjestu primjene.
English: Van genes have rarely been found in Staphylococcus aureus, where changes in cell wall structure result in “intermediate” susceptibility, which is most commonly heterogeneous.
Croatian: Van geni su rijetko nađeni u vrsti Staphylococcus aureus, gdje promjene u strukturi stanične stijenke rezultiraju „srednjom” osjetljivošću koja je najčešće heterogena.
English: Also, methicillinresistant staphylococcus strains (MRSA) with reduced susceptibility for vancomycin were reported.
Croatian: Prijavljeni su također i sojevi stafilokoka rezistentni na meticilin (MRSA) sa smanjenom osjetljivošću na vankomicin.
English: Plasma clearance is about 0.058 L/kg/h and kidney clearance about 0.048 L/kg/h.
Croatian: Klirens plazme je oko 0,058 L/kg/h, a klirens bubrega oko 0,048 L/kg/h.
English: Ototoxicity, which may be transitory or permanent (see section 4.8) has been reported in patients with prior deafness, who have received excessive intravenous doses, or who receive concomitant treatment with another ototoxic active substance such as an aminoglycoside.
Croatian: Ototoksičnost, koja može biti prolazna ili trajna (vidjeti dio 4.8), je uočena u bolesnika s prethodnom gluhoćom koji su primili prekomjerne intravenske doze ili su istodobno liječeni drugim ototoksičnim lijekovima, kao što su aminoglikozidi.
English: The combination of vancomycin with an aminoglycoside antibiotic has a synergistic effect against many strains of Staphylococcus aureus, non-enterococcal group D-streptococci, enterococci and streptococci of the Viridans group.
Croatian: Kombinacija vankomicina s aminoglikozidnim antibioticima ima sinergistički učinak protiv mnogih sojeva Staphylococcus aureus, ne-enterokokne skupine D-streptokoka, enterokoka i streptokoka iz skupine Viridans.
English: Nephrotoxicity has been described in children, usually in association with other nephrotoxic agents such as aminoglycosides.
Croatian: Nefrotoksičnost je opisana u djece, obično kod istodobne primjene s drugim nefrotoksičnim lijekovima kao što su aminoglikozidi.
English: Adequate replacement of fluid and electrolytes should be ensured.
Croatian: Potrebno je osigurati primjerenu nadoknadu tekućine i elektrolita.
English: Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”.
Croatian: Vankomicin je antibiotik koji pripada skupini glikopeptidnih antibiotika.
English: Treatment duration with vancomycin may need to be tailored to the clinical course of individual patients.
Croatian: Trajanje liječenja vankomicinom može biti potrebno potrebno prilagoditi kliničkom tijeku u pojedinih bolesnika.
English: Patients aged 12 years and older
Croatian: Bolesnici u dobi od 12 godina naviše
English: Similarly, concomitant use with nephrotoxic agents such as aminoglycoside antibiotics, NSAIDs (e.g., ibuprofen for closure of patent ductus arteriosus) or amphotericin B is associated with an increased risk of nephrotoxicity (see section 4.5) and therefore more frequent monitoring of vancomycin serum levels and renal function is indicated.
Croatian: Također, istodobna primjena s nefrotoksičnim agensima, kao što su aminoglikozidni antibiotici, NSAIL-i (npr. ibuprofen za zatvaranje ductusa arteriosusa) ili amfotericin B je povezana s povećanim rizikom od nefrotoksičnosti (vidjeti dio 4.5), stoga je potrebno učestalo praćenje serumske razine vankomicina i funkcije bubrega.
English: Vancomycin should be used with caution in patients with allergic reactions to teicoplanin, since cross hypersensitivity, including fatal anaphylactic shock, may occur.
Croatian: Vankomicin je potrebno koristiti s oprezom u bolesnika s alergijskim reakcijama na teikoplanin jer se može pojaviti križna preosjetljivost, uključujući anafilaktički šok koji može uzrokovati smrt.
English: Continuous infusion: loading dose of 30 mg/kg followed by a maintenance dose of 1.5 mg/kg/bag in all exchanges.
Croatian: Kontinuirana infuzija: udarna doza od 30 mg/kg nakon čega slijedi doza održavanja od 1,5 mg/kg/vrećica u svim izmjenama.
English: In case of severe persistent diarrhoea the possibility of pseudomembranous enterocolitis that might be life-threatening has to be taken into account (see section 4.8).
Croatian: U slučaju teške perzistentne dijareje potrebno je uzeti u obzir mogući nastanak po život opasnog pseudomembranoznog enterokolitisa (vidjeti dio 4.8).
English: In patients with impaired renal function the terminal elimination half- life of vancomycin is prolonged and the total body clearance is reduced.
Croatian: U bolesnika s oslabljenom funkcijom bubrega terminalni poluvijek eliminacije vankomicina je produljen, a ukupni klirens smanjen.
English: In adult and paediatric patients with renal impairment, consideration should be given to an initial starting dose followed by serum vancomycin trough levels rather than to a scheduled dosing regimen, particularly in patients with severe renal impairment or those who undergo renal replacement therapy (RRT) due to the many varying factors that may affect vancomycin levels in them.
Croatian: U odraslih i pedijatrijskih bolesnika s oštećenjem funkcije bubrega potrebno je razmotriti početnu dozu prateći najniže koncentracije vankomicina u serumu, a ne slijediti raspored režima doziranja, osobito u bolesnika s teškim oštećenjem funkcije bubrega ili onih koji su podvrgnuti bubrežnoj nadomjesnoj terapiji (BNT) s obzirom na mnoge faktore koji mogu utjecati na razinu vankomicina u takvih bolesnika.
English: Vancomycin should be used with particular care in premature neonates and young infants, because of their renal immaturity and the possible increase in the serum concentration of vancomycin.
Croatian: Vankomicin je potrebno koristiti s posebnim oprezom u nedonoščadi i male djece zbog nerazvijenosti njihovih bubrega i mogućeg povećanja serumske koncentracije vankomicina.
English: The usual infusion dose is 10 to 15 mg for each kg of body weight.
Croatian: Uobičajena doza infuzije je 10 do 15 mg na svaki kilogram tjelesne težine.
English: Vancomycin is a tricyclic glycopeptide antibiotic that inhibits the synthesis of the cell wall in sensitive bacteria by binding with high affinity to the D-alanyl-D-alanine terminus of cell wall precursor units.
Croatian: Vankomicin je triciklički glikopeptidni antibiotik koji inhibira sintezu stanične stijenke u osjetljivim bakterijama vezivanjem visokim afinitetom na D-alanil-D-alaninski kraj prekursorskih jedinica stanične stijenke.
English: In patients with multiple recurrences, consideration may be given to treat the current episode of CDI with vancomycin, 125 mg four times daily for 10 days followed by either tapering the dose, i.e., gradually decreasing it until 125 mg per day or a pulse regimen, i.e., 125-500 mg/day every 2-3 days for at least 3 weeks.
Croatian: U bolesnika s višestrukim recidivima može se uzeti u obzir liječenje trenutne epizode infekcije vankomicinom, 125 mg četiri puta dnevno tijekom 10 dana nakon čega slijedi smanjivanje doze, odnosno postupno snižavanje do 125 mg dnevno ili pulsni režim, odnosno 125 - 500 mg/dan svakih 2 - 3 dana tijekom najmanje 3 tjedna.
English: An oral dose is excreted almost exclusively in the faeces.
Croatian: Peroralna doza se izlučuje gotovo isključivo stolicom.
English: In patients with severe renal impairment (creatinine clearance below 20 ml/min) or those on renal replacement therapy, the appropriate timing and amount of subsequent doses largely depend on the modality of RRT and should be based on serum vancomycin trough levels and on residual renal function (see section 4.4).
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina ispod 20 ml/min) ili onih na bubrežnoj nadomjesnoj terapiji odgovarajuće vrijeme i količina naknadnih doza u velikoj mjeri ovise o modalitetu BNT-a i moraju se temeljiti na najnižim serumskim koncentracijama vankomicina i na rezidualnoj funkciji bubrega (vidjeti dio 4.4).
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg liječnika, ljekarnika ili medicinsku sestru.
English: [For parenteral formulations authorised for oral use:] If given for treatment of gastric disorders (so called Pseudomembranous colitis), the medicinal product must be administrated as a solution for oral use (you will take the medicine by mouth).
Croatian: [Za parenteralne formulacije odobrene za peroralnu primjenu:] Ako je namijenjen za liječenje bolesti progavnog trakta (tzv. pseudomembranozni kolitis), lijek mora biti primijenjen kao otopina za oralnu uporabu (uzet ćete lijek kroz usta).
English: Cardiac disorders Very rare
Croatian: Srčani poremećaji: Vrlo rijetko
English: Oral administration [This section must include instructions for preparation and administration of the oral solution.
Croatian: [Ovaj dio mora sadržavati upute za pripremu i primjenu peroralne otopine.
English: Resistant > 2 mg/L 1 The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility.
Croatian: 1 Granične vrijednosti se temelje na epidemiološkim cut-off vrijednostima (ECOFF), koje razlikuju izolate divljeg tipa od onih sa smanjenom osjetljivošću.
English: The frequency and severity of thrombophlebitis can be minimized by administering the medicinal product slowly as a dilute solution (see section 4.2) and by changing the sites of infusion regularly.
Croatian: Učestalost i težina tromboflebitisa može se minimizirati sporom primjenom lijeka u obliku razrijeđene otopine (vidjeti dio 4.2) i redovitim mijenjanjem mjesta primjene.
English: Children Vancomycin will be used with particular care in premature infants and young infants, because their kidneys are not fully developed and they may accumulare vancomycin in the blood.
Croatian: Vankomicin je potrebno koristiti s posebnom pažnjom u nedonoščadi i male djece jer njihovi bubrezi nisu u potpunosti razvijeni pa može doći do nakupljanja vankomicina u krvi.
English: The usual infusion dose is 15 to 20 mg for each kg of body weight.
Croatian: Uobičajena doza za infuziju je 15 do 20 mg na svaki kilogram tjelesne težine.
English: Plasma concentrations during multiple dose administration are similar to those after the administration of a single dose.
Croatian: Koncentracije u plazmi tijekom višekratnog doziranja su slične onima nakon primjene jednokratne doze.
English: Anti-diarrhoeic medicinal products must not be given.
Croatian: Antidijaroici se ne smiju primjenjivati.
English: Necrosis may occur after intramuscular injection.
Croatian: Nakon intramuskularne injekcije može se pojaviti nekroza.
English: Vancomycin is used in adults and adolescents from 12 years of age for the treatment of infections of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the Clostridium difficile bacterium.
Croatian: Vankomicin se koristi u odraslih i adolescenata u dobi od 12 godina naviše za liječenje infekcija sluznice tankog i debelog crijeva s oštećenjem sluznice (pseudomembranozni kolitis) koje uzrokuje bakterija Clostridium difficile.
English: As vancomycin in combination with a cephalosporin may also have an antagonistic effect against some Staphylococcus epidermidis strains and in combination with rifampicin against some Staphylococcus aureus strains, preceding synergism testing is useful.
Croatian: S obzirom da vankomicin u kombinaciji s cefalosporinima također može imati antagonistički učinak protiv nekih sojeva Staphylococcus epidermidis i u kombinaciji s rifampicinom protiv nekih sojeva Staphylococcus aureus, korisno je napraviti prethodno testiranje sinergizma.
English: Vertigo, tinnitus, dizziness
Croatian: Vrtoglavica, tinitus, omaglica
English: Alternative aetiologies should always be sought and Clostridium difficile enterocolitis be proven.
Croatian: Potrebno je uvijek tražiti drugu etiologiju i dokazati enterokolitis povezan s Clostridium difficile.
English: Due to ototoxicity of vancomycin therapy-adjuvant monitoring of the plasma concentrations is indicated in such cases.
Croatian: Zbog ototoksičnosti vankomicina potrebno je u takvim slučajevima uz liječenje pratiti koncentracije u plazmi.
English: Intermittent therapy: initial dose of 30 mg/kg in the long-dwell, followed by 15 mg/kg every 3-5 days during the long-dwell (the second dose should be time-based on a blood level obtained 2-4 days after the initial dose, see section 4.4).
Croatian: Intermitentna terapija: početna doza od 30 mg/kg u dugom vremenu zadržavanja dijalizne otopine u trbušnoj šupljini nakon čega slijedi 15 mg/kg svakih 3 - 5 dana, tijekom dugog vremena zadržavanja dijalizne otopine u trbušnoj šupljini (druga doza trebabiti vremenski utemeljena na razini u krvi dobivenoj 2 - 4 dana nakon početne doze, vidjeti dio 4.4).
English: Drug fever, shivering, Pain and muscle spasm of the chest and back muscles
Croatian: Vrućica uzrokovana lijekom, drhtanje, bol i spazam prsnih i leđnih mišića
English: Regular monitoring of the blood levels of vancomycin is indicated in high dose therapy and longer-term use, particularly in patients with renal dysfunction or impaired faculty of hearing as well as in concurrent administration of nephrotoxic or ototoxic substances, respectively (see section 4.2).
Croatian: Redovito praćenje razine vankomicina u krvi je indicirano u terapiji visokim dozama i dugotrajnom primjenom, osobito u bolesnika s bubrežnom disfunkcijom ili ostećenjem funkcije sluha, kao i kod istodobne primjene nefrotoksičnih, odnosno ototoksičnih tvari (vidjeti dio 4.2).
English: Hypersensitivity to the active substance or to any of the excipients (see section 4.4).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari (vidjeti dio 4.4).
English: - Necrotizing
Croatian: Nekrotizirajuće
English: The drug is bactericidal for dividing microorganisms.
Croatian: Baktericidan je za mikroorganizme koji se dijele.
English: - Inflammation of the bowel which causes abdominal pain and diarrhea, which may contain blood
Croatian: - Srčani zastoj - Upala crijeva koja uzrokuje bol u trbuhu i proljev koji može sadržavati krv
English: Intermittent therapy: the recommended dose is 15-30 mg/kg in the long-dwell, every 5-7 days.
Croatian: Intermitentna terapija: preporučena doza iznosi 15 - 30 mg/kg u dugom vremenu zadržavanja dijalizne otopine u trbušnoj šupljini (engl. long-dwell) svakih 5 - 7 dana.
English: Vomiting, Diarrhoea
Croatian: Povraćanje, proljev
English: Administration site related reactions
Croatian: Reakcije na mjestu primjene
English: Continuous infusion: loading dose of 1000 mg/L per litter of dialysate followed by 25 mg/L (after 3-6 h of loading dose) in all exchanges.
Croatian: Kontinuirana infuzija: udarna doza od 1000 mg/L po litri dijalizata nakon čega slijedi 25 mg/L (nakon 3 - 6 sati od udarne doze) u svim izmjenama.
English: In the case of patients with normal renal function, intravenous infusion of multiple doses of 1g vancomycin (15 mg/kg) for 60 minutes produces approximate average plasma concentrations of 50-60 mg/L, 20-25 mg/L and 5-10 mg/L, immediately, 2 hours and 11 hours after completing the infusion, respectively.
Croatian: Kod bolesnika s normalnom funkcijom bubrega, intravenska infuzija višekratnih doza od 1 g vankomicina (15 mg/kg) tijekom 60 minuta postiže približne prosječne koncentracije u plazmi od 5060 mg/L odmah, 20 - 25 mg/L 2 sata nakon završetka infuzije i 5 - 10 mg/L 11 sati nakon primjene infuzije.
English: The combination of vancomycin with a cephalosporin has a synergistic effect against some oxacillin-resistant Staphylococcus epidermidis strains, and the combination of vancomycin with rifampicin has a synergistic effect against Staphylococcus epidermidis and a partial synergistic effect against some Staphylococcus aureus strains.
Croatian: Kombinacija vankomicina s cefalosporinima ima sinergistički učinak protiv nekih sojeva Staphylococcus epidermidis rezistentnih na oksacilin, a kombinacija vankomicina s rifampicinom ima sinergistički učinak protiv Staphylococcus epidermidis i djelomični sinergistički učinak protiv nekih sojeva Staphylococcus aureus.
English: No blood concentrations were detected and urinary recovery did not exceed
Croatian: Nije detektirana koncentracija u krvi, a dio izdvojen urinom nije prelazio 0,76 %.
English: Therefore, the side effects and frequencies which are reported for vancomycin given as infusion are included.
Croatian: Nuspojave i učestalosti koje su prijavljene za vankomicin primijenjen infuzijom su stoga također navedene.
English: [For all vancomycin 250 mg capsule] [The following wording to be reflected in this section] Each capsule contains 250mg vancomycin hydrochloride equivalent to 250,000IU vancomycin.
Croatian: [Za sve kapsule vankomicina 250 mg] [Navod u ovom dijelu treba odražavati sljedeći tekst] Jedna kapsula sadrži 250 mg vankomicinklorida što odgovara 250 000 IU vankomicina.
English: Renal dysfunction delays the excretion of vancomycin.
Croatian: Bubrežna disfunkcija odgađa izlučivanje vankomicina.
English: However, absorption may occur after oral administration in patients with (pseudomembranous) colitis.
Croatian: Međutim, može doći do apsorpcije nakon peroralne primjene u bolesnika s (pseudomembranoznim) kolitisom.
English: When vancomycin is administered parenterally, the most common adverse reactions are phlebitis, pseudo-allergic reactions and flushing of the upper body (“red-neck syndrome”) in connection with too rapid intravenous infusion of vancomycin.
Croatian: Kada se vankomicin primjenjuje parenteralno, najčešće nuspojave uključuju flebitis, pseudo-alergijske reakcije i naleti crvenila kože gornjeg dijela tijela („sindrom crvenog vrata“) povezane s prebrzom intravenskom infuzijom vankomicina.
English: Vancomycin should be administered orally for this indication.
Croatian: Vankomicin je za ovu indikaciju potrebno primijeniti kroz usta.
English: [For parenteral formulations authorised for perioperative antibacterial prophylaxis, include the wording as follows:]
Croatian: [Za parenteralne formulacije odobrene za perioperativnu antibakterijsku profilaksu unesite tekst kako slijedi:]
English: Vancomycin capsules are indicated in patients 12 years and older for the treatment of Clostridium difficile infection (CDI) (see sections 4.2, 4.4 and 5.1).
Croatian: Kapsule vankomicina indicirane su u bolesnika u dobi od 12 godina naviše za liječenje infekcije s Clostridium difficile (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered.
Croatian: Potrebno je izbjegavati antipropulzive i preispitati uporabu inhibitora protonske pumpe.
English: [For parenteral formulations authorised for intraperitoneal use:] - In patients receiving peritoneal dialysis, vancomycin is used in adults and children for the treatment of infections related to peritoneal dialysis.
Croatian: [Za parenteralne formulacije odobrene za intraperitonealnu primjenu:] - U bolesnika na peritonealnoj dijalizi vankomicin se primjenjuje u odraslih i djece za liječenje infekcija povezanih s peritonealnom dijalizom.
English: The most common adverse reactions are phlebitis, pseudo-allergic reactions and flushing of the upper body (“red-neck syndrome”) in connection with too rapid intravenous infusion of vancomycin.
Croatian: Najčešće nuspojave su flebitis, pseudoalergijske reakcije i naleti crvenila kože u gornjem dijelu tijela („sindrom crvenog vrata”), povezane s brzom primjenom vankomicina u venu.
English: Oral vancomycin use increases the chance of vancomycin-resistant Enterococci populations in the gastrointestinal tract.
Croatian: Peroralna primjena vankomicina povećava vjerojatnost nastanka populacije enterokoka rezistentnih na vankomicin u probavnom traktu.
English: [The below should be introduced in section 4.2 for all vancomycin products powder for concentrate]
Croatian: [Niže navedeno se treba unijeti u dio 4.2 za sve vankomicin praške za koncentrat] Praćenje serumske koncentracije vankomicina
English: *Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours **Longer courses of oral suppression treatment with suitable antibiotics should be considered for prosthetic joint infections ***Duration and need for combination therapy is based on valve-type and organism
Croatian: * Nastavite sve dok daljnji debridman ne bude neophodan, dok se ne zabilježi kliničko poboljšanje u bolesnika i dok bolesnik ne bude afebrilan 48 do 72 sata ** U slučaju infekcija umjetnih zglobova treba razmotriti dulja razdoblja oralne supresivne terapije odgovarajućim antibioticima.