FrancophonIA/ELRC3.0 huggingface dataset:
English: Supplemental doses may be needed for patients on Automated Peritoneal Dialysis (APD) because rapid exchanges in APD may lead to inadequate time to achieve therapeutic levels when vancomycin is given via intraperitoneal intermittently.
Croatian: Dodatne doze mogu biti potrebne za bolesnike na automatiziranoj peritonealnoj dijalizi (APD), budući da brza izmjena u APD-u može dovesti do neadekvatnog vremena za postizanje terapijskih razina kada se vankomicin daje intermitentnom intraperitonealnom primjenom.
English: This information only provides approximate guidance on the chance whether micro-organisms are susceptible to vancomycin.
Croatian: Ovi podaci daju samo približne smjernice o vjerojatnosti da su mikroorganizmi osjetljivi na vankomicin.
English: Exfoliative dermatitis, Stevens-Johnson syndrome, Lyell's syndrome, Linear IgA bullous dermatosis
Croatian: Eksfolijativni dermatitis, Stevens-Johnsonov sindrom, Lyellov sindrom, linearna IgA bulozna dermatoza
English: In some cases, your doctor may decide to give a higher daily dose of up to 500 mg every 6 hours.
Croatian: U nekim slučajevima Vaš liječnik može odlučiti primijeniti veću dnevnu dozu do 500 mg svakih 6 sati.
English: One possible way of dosing vancomycin in neonates is illustrated in the following table: (see section 4.4)
Croatian: Jedan od mogućih načina doziranja vankomicina u novorođenčadi je prikazan u sljedećoj tablici: (vidjeti dio 4.4)
English: In seriously ill patients, a loading dose of 25-30 mg/kg of body weight can be used to facilitate rapid attainment of target trough serum vancomycin concentration.
Croatian: U ozbiljno oboljelih bolesnika može se upotrijebiti udarna doza od 25-30 mg/kg tjelesne težine kako bi se olakšalo brzo postizanje najniže ciljane koncentracije vankomicina u serumu.
English: - Infections of bone and joints.
Croatian: Infekcije kostiju i zglobova
English: Deafness may be preceded by tinnitus.
Croatian: Tinitus može prethoditi gluhoći.
English: Development of Drug-Resistant Bacteria
Croatian: Razvoj rezistentnih bakterija
English: Dose adjustments in paediatric patients aged 1 year and older could be based on glomerular filtration rate estimated (eGFR) by the revised Schwartz formula: eGFR (mL/min/1.73m2 ) = (height cm x 0.413)/ serum creatinine (mg/dl) eGFR (mL/min/1.73m2)= (height cm x 36.2/serum creatinine (µmol/L) For neonates and infants below 1 year of age, expert advice should be sought as the revised Schwartz formula is not applicable to them.
Croatian: Prilagodba doze kod pedijatrijskih bolesnika u dobi od 1 i više godina može se temeljiti na glomerularnoj filtraciji (eGFR) određenoj revidiranom Schwartzovom formulom: eGFR (mL/min/1,73 m2) = (visina cm x 0,413 ) / serumski kreatinin (mg/dl) eGFR (mL/min/1,73 m2) = (visina cm x 36,2) / serumski kreatinin (µmol/L) Za novorođenčad i dojenčad mlađu od jedne godine potrebno je potražiti stručni savjet, budući da revidirana Schwartzova formula nije primjenjiva na njih.
English: Neonates, infants and children less than 12 years old The recommended dose is 10 mg for each kg of body weight.
Croatian: Novorođenčad, dojenčad i djeca mlađa od 12 godina Preporučena doza je 10 mg na svaki kilogram tjelesne težine.
English: In patients with normal renal function, the serum concentration of vancomycin should be monitored on the second day of treatment immediately prior to the next dose.
Croatian: U bolesnika s normalnom funkcijom bubrega koncentraciju vankomicina u serumu je potrebno pratiti drugi dan liječenja, neposredno prije sljedeće doze.
English: Vancomycin PK has shown wide inter-individual variability in preterm and term neonates.
Croatian: PK vankomicina pokazuje široku interindividualnu varijabilnost u nedonoščadi i novorođenčadi rođene u terminu.
English: Lower maintenance doses may be required due to the age-related reduction in renal function.
Croatian: Donja doza održavanja može biti potrebna zbog smanjenja funkcije bubrega povezane s dobi.
English: Use in the elderly
Croatian: Primjena u starijih osoba
English: [This section should read as follows:]
Croatian: [Ovaj dio treba glasiti:]
English: To reduce the risk of ototoxicity, blood levels should be determined periodically and periodic testing of auditory function is recommended.
Croatian: Kako bi se smanjio rizik od ototoksičnosti, potrebno je periodično ispitivati razinu vankomicina u krvi, a također se preporučuje periodično ispitivanje funkcije sluha.
English: Vancomycin shall only be administered as slow intravenous infusion of at least one hour duration or at a maximum rate of 10 mg/min (whichever is longer) which is sufficiently diluted (at least 100 ml per 500 mg or at least 200 ml per 1000 mg) (see section 4.4).
Croatian: Vankomicin će se primijeniti samo kao spora intravenska infuzija u trajanju od najmanje jednog sata ili najveće brzine od 10 mg/min (ono što je duže) koja je dovoljno razrijeđena (najmanje 100 ml na 500 mg ili najmanje 200 ml na 1000 mg ) (vidjeti dio 4.4).
English: Anaesthetic induced myocardial depression may be enhanced by vancomycin.
Croatian: Miokardijalna depresija izazvana anestetikom se može pojačati uporabom vankomicina.
English: Prolonged use of vancomycin may result in the overgrowth of non-susceptible organisms.
Croatian: Dugotrajno korištenje vankomicina može rezultirati prekomjernim rastom neosjetljivih mikroorganizama.
English: Vancomycin has a spectrum of antibacterial activity limited to Gram-positive organisms.
Croatian: Spektar antibakterijskog djelovanja vankomicina ograničen je na gram-pozitivne mikroorganizme.
English: Vancomycin is poorly dialyzable by intermittent hemodialysis.
Croatian: Vankomicin se slabo dijalizira intermitentnom hemodijalizom.
English: aureus with vancomycin MIC values of 2 mg/L are on the border of the wild type distribution and there may be an impaired clinical response.
Croatian: 1S. aureus s vrijednostima MIK-a za vankomicin koji iznosi 2 mg/L su na granici distribucije divljeg tipa i može doći do smanjenog kliničkog odgovora.
English: Intravenous vancomycin should be infused slowly.
Croatian: Intravenski vankomicin je potrebno primijeniti sporo infuzijom.
English: [The below wording should be introduced in this section for all vancomycin containing products] Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: [Tekst u nastavku treba unijeti u ovome dijelu za sve lijekove koji sadrže vankomicin] Potrebno je uzeti u obzir službene smjernice vezane uz primjerenu uporabu antibakterijskih lijekova.
English: Tinnitus, possibly preceding onset of deafness, should be regarded as an indication to discontinue treatment.
Croatian: Tinitus, koji može prethoditi početku gluhoće, potrebno je smatrati znakom za prekid liječenja.
English: The plasma levels obtained after multiple doses are similar to those achieved after a single dose.
Croatian: Razine u plazmi dobivene nakon višekratnih doza su slične onima koje se postižu nakon jednokratne doze.
English: Trough values of 15-20 mg/l are usually recommended by clinical laboratories to better cover susceptible-classified pathogens with MIC ≥1 mg/L (see sections 4.4 and 5.1).
Croatian: Najniže vrijednosti od 15 - 20 mg/l obično preporučuju klinički laboratoriji kako bi bolje pokrili osjetljivo-klasificirane patogene s MIK ≥1 mg/L (vidjeti dijelove 4.4 i
English: Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, redness on the upper part of the body, rash or itching.
Croatian: Odmah obavijestite Vašeg liječnika u slučaju iznenadnog zviždanja pri disanju, otežanog disanja, crvenila kože na gornjem dijelu tijela, osipa ili svrbeža.
English: The recommended dose is 15 to 20 mg/kg of body weight every 8 to 12 h (not to exceed 2 g per dose).
Croatian: Preporučena doza iznosi 15 do 20 mg/kg tjelesne težine svakih 8 do 12 sati (ne smije prijeći 2 g po dozi).
English: Vancomycin distribution may be altered in overweight patients due to increases in volume of distribution, in renal clearance and possible changes in plasma protein binding.
Croatian: Distribucija vankomicina može biti promijenjena u bolesnika s prekomjernom tjelesnom težinom zbog povećanja volumena distribucije, bubrežnog klirensa i mogućih promjena u vezanju na proteine plazme.
English: Hypersensitivity reactions, anaphylactic reactions Ear and labyrinth disorders:
Croatian: Reakcije preosjetljivosti, anafilaktičke reakcije Poremećaji uha i labirinta:
English: Although the vancomycin is not eliminated efficiently by haemodialysis or peritoneal dialysis, there have been reports of an increase in vancomycin clearance with haemoperfusion and haemofiltration.
Croatian: Iako se vankomicin ne eliminira učinkovito hemodijalizom ili peritonealnom dijalizom, bilo je prijava o povećanom klirensu vankomicina hemoperfuzijom i hemofiltracijom.
English: Term neonates (from birth to 27 days of post-natal age) and preterm neonates (from birth to the expected date of delivery plus 27 days)
Croatian: Novorođenčad rođena u terminu (od rođenja do 27 dana postnatalne dobi) i nedonoščad (od rođenja do očekivanog datuma rođenja plus 27 dana)
English: In patients receiving vancomycin over a longer-term period or concurrently with other medications which may cause neutropenia or agranulocytosis, the leukocyte count should be monitored at regular intervals.
Croatian: U bolesnika koji primaju vankomicin tijekom duljeg razdoblja ili istodobno s drugim lijekovima koji mogu uzrokovati neutropeniju ili agranulocitozu potrebno je redovito pratiti broj leukocita.
English: Testing for Clostridium difficile colonization or toxin is not recommended in children younger than 1 year due to high rate of asymptomatic colonisation unless severe diarrhoea is present in infants with risk factors for stasis such as Hirschsprung disease, operated anal atresia or other severe motility disorders.
Croatian: Testiranje kolonizacije Clostridium difficile ili toksina se ne preporučuje u djece mlađe od 1 godine zbog visoke stope asimptomatske kolonizacije, osim ako je prisutna teška dijareja u dojenčadi s faktorima rizika za stazu poput Hirschsprungove bolesti, operirane analne atrezije ili drugih teških poremećaja motiliteta.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Potrebno je uzeti u obzir službene smjernice vezane uz primjerenu uporabu antibakterijskih lijekova.
English: Eosinophilia and systemic symptoms (DRESS syndrome), AGEP (Acute Generalized Exanthematous Pustulosis) Renal and urinary disorders: Common
Croatian: Eozinofilija i sistemski simptomi (DRESS sindrom), AGEP (Akutna generalizirana egzantematozna pustuloza) Poremećaji bubrega i mokraćnog sustava: Često
English: In some cases, your doctor may decide to give an initial dose of up to 30 mg for each kg of body weight.
Croatian: U nekim slučajevima Vaš liječnik može odlučiti primijeniti početnu dozu do 30 mg na svaki kilogram tjelesne težine.
English: Very rare side effects (may affect up to 1 in 10,000 people):
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba):
English: Due to the very low systemic absorption, dose adjustment is unlikely, unless substantial oral absorption may occur in case of inflammatory intestinal disorders or Clostridium difficile-induced pseudomembranous colitis (see section 4.4).
Croatian: Zbog vrlo niske sistemske apsorpcije malo je vjerojatno da će prilagodba doze biti potrebna, osim ako se postigne značajna oralna apsorpcija u slučaju upalnih crijevnih bolesti i pseudomembranoznog kolitisa uzrokovanog s Clostridium difficile (vidjeti dio 4.4).
English: Very rare side effects (may affect up to 1 in 10,000 people): - Sudden onset of severe allergic skin reaction with skin flaking blistering or peeling skin.
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba): - Iznenadna pojava teške alergijske reakcije kože s prhutanjem, stvaranjem mjehura i ljuštenjem kože.
English: To achieve this target when MICs are ≥ 1.0 mg/l, dosing in the upper range and high trough serum concentrations (15-20 mg/l) are required (see section 4.2).
Croatian: Da bi se postigao ovaj odnos kada su MIK-ovi ≥ 1,0 mg/l, potrebno je doziranje u gornjem rasponu i visoke najniže koncentracije u serumu (15-20 mg/l) (vidjeti dio 4.2).
English: As a consequence, prudent use of oral vancomycin is advised.
Croatian: Kao posljedica toga preporučuje se racionalna uporaba peroralnog vankomicina.
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia
Croatian: Bolnički stečena pneumonija, uključujući pneumoniju povezanu s respiratorom
English: However, use of high-flux membranes and continuous renal replacement therapy (CRRT) increases vancomycin clearance and generally requires replacement dosing (usually after the haemodialysis session in case of intermittent haemodialysis).
Croatian: Međutim, korištenje membrana s visokim protokom i kontinuirane bubrežne nadomjesne terapije (KBNT) povećava klirens vankomicina i općenito zahtijeva nadomjesno doziranje (obično nakon obavljene hemodijalize u slučaju intermitentne hemodijalize).
English: PMA: post-menstrual age [(time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (post-natal age)].
Croatian: PMD: postmenstrualna dob [( vrijeme između prvog dana posljednje menstruacije i porođaja (gestacijska dob) plus vrijeme proteklo od porođaja (postnatalna dob)].
English: Adequate replacement of fluid and electrolytes should be instituted.
Croatian: Potrebno je uspostaviti odgovarajuću nadoknadu tekućine i elektrolita.
English: Reversible neutropenia, agranulocytosis, eosinophilia, thrombocytopenia, pancytopenia.
Croatian: Reverzibilna neutropenija, agranulocitoza, eozinofilija, trombocitopenija, pancitopenija.
English: Synergism
Croatian: Sinergizam
English: Adults and adolescents aged 12 to less than 18 years old
Croatian: Odrasli i adolescenti u dobi od 12 do 18 godina
English: Treatment of Clostridium difficile infection (CDI):
Croatian: Liječenje infekcije s Clostridium difficile:
English: The blood concentrations of vancomycin should therefore be monitored carefully in these children.
Croatian: Koncentracije vankomicina u krvi stoga treba pomno pratiti u ovakve djece.
English: This may be associated with a high fever and joint pains
Croatian: Može biti povezano s visokom temperaturom i bolovima u zglobovima.
English: Anaerobic species Clostridium innocuum
Croatian: Anaerobne vrste Clostridium innocuum
English: In patients with mild or moderate renal failure, the starting dose must not be reduced.
Croatian: U bolesnika s blagim ili umjerenim zatajenjem bubrega, početna se doza ne smije smanjivati.
English: Appropriate consideration should be given to the concomitant administration of medicinal products that may reduce vancomycin clearance and/or potentiate its undesirable effects (see section 4.4).
Croatian: Potrebno je odgovarajuće razmotriti istodobnu primjenu lijekova koji mogu smanjiti klirens vankomicina i/ili potencirati njegove nuspojave (vidjeti dio 4.4).
English: The usual starting dose for adult patients is 15 to 20 mg/kg that could be administered every 24 hours in patients with creatinine clearance between 20 to 49 ml/min.
Croatian: Uobičajena početna doza za odrasle bolesnike je 15 do 20 mg/kg i može se primjenjivati svaka 24 sata u bolesnika s klirensom kreatinina između 20 i 49 ml/min.
English: Vancomycin capsules are not appropriate for children under 12 years or for adolescents unable to swallow them.
Croatian: Kapsule vankomicina nisu prikladne za djecu mlađu od 12 godina i adolescente koji ih ne mogu progutati.
English: Vancomycin should be infused slowly in a dilute solution (2.5 to 5.0 mg/ml) at a rate no greater than 10 mg/min and over a period not less than 60 minutes to avoid rapid infusion-related reactions.
Croatian: Vankomicin je potrebno sporo primijeniti u venu u razrijeđenoj otopini (2,5 do 5,0 mg/ml) pri brzini koja ne prelazi 10 mg/min i u trajanju od najmanje 60 minuta kako bi se izbjegle reakcije povezane s brzom infuzijom.
English: Rapid bolus administration (i.e. over several minutes) may be associated with exaggerated hypotension (including shock and, rarely, cardiac arrest), histamine like responses and maculopapular or erythematous rash (“red man's syndrome” or “red neck syndrome”).
Croatian: Brza primjena bolusa (odnosno primjena kroz nekoliko minuta) može biti povezana s jakom hipotenzijom (uključujući šok i rijetko srčani zastoj), reakcije nalik histaminskim i makulopapularni ili eritemski osip („sindrom crvenog čovjeka” ili „sindrom crvenog vrata”).
English: Vancomycin is not usually absorbed into the blood after oral administration.
Croatian: Vankomicin se obično ne apsorbira u krv nakon peroralne primjene.
English: In addition, it impairs the permeability of the bacterial cell membrane and RNA synthesis.
Croatian: Osim toga, ometa propusnost bakterijske stanične membrane i sintezu RNK.
English: Similarly, concomitant use with other medicines such as aminoglycoside antibiotics, nonsteroidal anti-inflammatory agents (NSAIDs, e.g., ibuprofen) or amphotericin B (medicine for fungal infection) can increase the risk of kidney damage and therefore more frequent blood and renal test may be necessary.
Croatian: Slično tome, istodobna primjena s drugim lijekovima, kao što su aminoglikozidni antibiotici, nesteroidni protuupalni lijekovi (NSAIL, npr. ibuprofen) ili amfotericin B (lijek za gljivične infekcije) može povećati rizik od oštećenja bubrega i stoga će možda biti potrebne češće pretrage krvi i bubrega.
English: The recommended vancomycin dose is 125 mg every 6 hours for 10 days for the first episode of nonsevere CDI.
Croatian: Preporučena doza vankomicina je 125 mg svakih 6 sati tijekom 10 dana za prve epizode ne-teške infekcije s Clostridium difficile.
English: In infants and older children, the volume of distribution ranges between 0.26-1.05 L/kg while clearance varies between 0.33-1.87 ml/kg/min.
Croatian: U dojenčadi i starije djece volumen distribucije je u rasponu od 0,26 do 1,05 L/kg, dok klirens varira između 0,33 - 1,87 ml/kg/min.
English: The duration of the therapy may be different depending on the individual response to treatment for every patient.
Croatian: Trajanje terapije može biti različito ovisno o individualnom odgovoru bolesnika na liječenje.
English: Significantly increased doses may be required to achieve therapeutic serum concentrations in pregnant women (see Section 4.6).
Croatian: Može biti potrebno značajno povećanje doze kako bi se postigla terapijska serumska koncentracija u trudnica (vidjeti dio 4.6).
English: 24 hourly
Croatian: 24-satna
English: These patients may be at risk for the development of adverse reactions, especially if there is a concomitant renal impairment.
Croatian: Ovi bolesnici mogu biti izloženi riziku od razvoja nuspojava, osobito ako istodobno imaju poremećaj funkcije bubrega.
English: In neonates, after intravenous administration, vancomycin volume of distribution varies between 0.38 and 0.97 L/kg, similar to adult values, while clearance varies between 0.63 and 1.4 ml/kg/min.
Croatian: U novorođenčadi, nakon intravenske primjene, volumen distribucije vankomicina varira između 0,38 i 0,97 L/kg, slično vrijednostima u odraslih osoba, a klirens varira između 0,63 i 1,4 ml/kg/min.
English: Drug interactions with anti-motility agents and proton pump inhibitors
Croatian: Interakcije s antipropulzivima i inhibitorima protonske pumpe
English: It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with vancomycin.
Croatian: Vankomicin nije pogodan za korištenje kao samostalan lijek za liječenje nekih vrsta infekcija, osim ako je patogen već dokumentiran i zna se da je osjetljiv ili postoji izrazita sumnja na određeni patogen koji će biti pogodan za liječenje vankomicinom.
English: The frequency of infusion-related reactions (hypotension, flushing, erythema, urticaria and pruritus) increases with the concomitant administration of anaesthetic agents (see section 4.5).
Croatian: Učestalost reakcija na infuziju (hipotenzija, naleti crvenila, eritem, urtikarija i svrbež) se povećava s istodobnom primjenom anestetika (vidjeti dio 4.5).
English: Renal function must be taken into consideration for subsequent doses and interval of administration.
Croatian: Potrebno je uzeti u obzir funkciju bubrega za daljnje doze i interval primjene.
English: If you have an inflammatory disorder of the digestive tract (you may be at risk of side effects, especially if you also have a kidney disorder).
Croatian: Ako bolujete od upalnog poremećaja probavnog trakta (možete imati rizik pojave nuspojava, osobito ako imate i poremećaj funkcije bubrega).
English: Vancomycin is administered intravenously for the treatment of systemic infections.
Croatian: Vankomicin se primjenjuje intravenski za liječenje sistemskih infekcija.
English: No dose adjustment is needed in patients with hepatic insufficiency.
Croatian: Nije potrebno prilagođavanje doze u bolesnika s insuficijencijom jetre.
English: If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg liječnika, bolničkog ljekarnika ili medicinsku sestru.
English: Streptococcus groups A, B, C and G
Croatian: Streptokoki skupine A, B, C i G ≤ 2 mg/L
English: The greater the renal impairment, the greater the risk of developing the adverse reactions associated with the parenteral administration of vancomycin.
Croatian: Što je veće oštećenje bubrega, to je veći rizik od razvoja nuspojava povezanih s parenteralnom primjenom vankomicina.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Croatian: Granične vrijednosti minimalne inhibitorne koncentracije (MIK) koje je odredio Europsko povjerenstvo za ispitivanje antimikrobne osjetljivosti (EUCAST) su sljedeće:
English: Continuous vancomycin infusion may be considered, e.g., in patients with unstable vancomycin clearance.
Croatian: Kontinuirana infuzija vankomicina se može uzeti u obzir, primjerice, u bolesnika s nestabilnim klirensom vankomicina.
English: Resistant
Croatian: Rezistentni
English: Vancomycin should be used with care in patients with renal insufficiency, including anuria, as the possibility of developing toxic effects is much higher in the presence of prolonged high blood concentrations.
Croatian: Vankomicin je potrebno koristiti s oprezom u bolesnika s bubrežnom insuficijencijom, uključujući anuriju jer je mogućnost razvoja toksičnih učinaka puno veća u prisustvu dugotrajno visokih koncentracija u krvi.
English: Blood and the lymphatic system disorders: Rare
Croatian: Poremećaji krvi i limfnog sustava: Rijetko
English: Minimum inhibitory concentration breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Croatian: Granične vrijednosti minimalne inhibitorne koncentracije koje je odredio Europsko povjerenstvo za ispitivanje antimikrobne osjetljivosti (EUCAST) su sljedeće:
English: Concomitant administration of vancomycin and anaesthetic agents has been associated with skin redness (erythema) and allergic reactions in children.
Croatian: Istodobna primjena vankomicina i anestetika je povezana s crvenilom kože (eritem) i alergijskim reakcijama u djece.
English: Vancomycin diffuses readily across the placenta and is distributed into cord blood.
Croatian: Vankomicin lako prolazi kroz placentu i distribuira se u krv pupčane vrpce.
English: In patients with severe renal failure, it is preferable to prolong the interval of administration rather than administer lower daily doses.
Croatian: U bolesnika s teškim zatajenjem bubrega poželjno je produljiti interval primjene, a ne primjenjivati niže dnevne doze.
English: Inherently resistant All Gram negative bacteria
Croatian: Vrste koje su urođeno rezistentne Sve gram-negativne bakterije