FrancophonIA/ELRC3.0 huggingface dataset:
English: Vancomycin concentration generally increases proportionally with increasing dose.
Croatian: Koncentracija vankomicina uglavnom se povećava proporcionalno s povećanjem doze.
English: Spectrum of antibacterial activity
Croatian: Spektar antibakterijske aktivnosti
English: Below 12 years, age-appropriate formulation should be used.
Croatian: Za djecu mlađu od 12 godina potrebno je koristiti formulaciju prikladnu za navedenu dob.
English: Intravenous infusion means that the medicinal product flows from an infusion bottle or bag through a tube to one of your blood vessels and into your body.
Croatian: Intravenska infuzija znači da lijek protječe iz infuzijske boce ili vrećice kroz cijev u jednu od Vaših krvnih žila i u Vaše tijelo.
English: Experience with other antibiotics suggests that deafness may be progressive despite cessation of treatment.
Croatian: Iskustva s drugim antibioticima sugeriraju da gubitak sluha može biti progresivan unatoč prestanku liječenja.
English: In addition, appropriate information should be given under Method of administration and in section 6.6.]
Croatian: Osim toga, odgovarajuće informacije je potrebno navesti pod Način primjene u dijelu 6.6]
English: Note: The existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the wording below.
Croatian: Napomena: Postojeća uputa o lijeku bit će izmijenjena (umetanje, zamjena ili brisanje teksta prema potrebi) kako bi se umetnuo dolje navedeni tekst.
English: Half-life varies between 3.5 and 10 h and is longer than in adults, reflecting the usual lower values for clearance in the neonate.
Croatian: Poluvijek varira između 3,5 i 10 sati i dulje je nego u odraslih, odražavajući uobičajene niže vrijednosti klirensa u novorođenčadi.
English: Gram-negative bacteria are resistant.
Croatian: Gram-negativne bakterije su rezistentne.
English: How to take [product name]
Croatian: Kako uzimati (ime lijeka)
English: Misuse of antibiotics increases resistance.
Croatian: Pogrešna primjena antibiotika povećava otpornost.
English: The reactions abate when administration is stopped, generally between 20 minutes and 2 hours.
Croatian: Reakcije se smiruju nakon prestanka primjene, obično između 20 minuta i 2 sata.
English: The emergence of resistance towards vancomycin differs from one hospital to another and a local microbiological laboratory should therefore be contacted for relevant local information.
Croatian: Pojava rezistencije na vankomicin se razlikuje od bolnice do bolnice, stoga je potrebno kontaktirati lokalni mikrobiološki laboratorij za relevantne informacije.
English: This phenomenon is called resistance: some antibiotic treatments become ineffective.
Croatian: Ovaj fenomen se naziva rezistencija (otpornost): neki antibiotici postaju neučinkoviti.
English: Infective endocarditis
Croatian: Infektivni endokarditis
English: Concurrent or sequential use of other ototoxic substances should be avoided.
Croatian: Potrebno je izbjegavati istodobno ili sekvencijalno korištenje drugih ototoksičnih tvari.
English: In any case, the duration of treatment should be tailored to the type and severity of infection and the individual clinical response.
Croatian: U svakom slučaju, trajanje liječenja je potrebno prilagoditi vrsti i težini infekcije i individualnom kliničkom odgovoru.
English: Mechanism of resistance
Croatian: Mehanizam rezistencije
English: Model-based methods may be useful in the prediction of individual dose requirements to reach an adequate AUC.
Croatian: Metode temeljene na modelu mogu biti korisne u predviđanju individualno potrebnih doza kako bi se dostigao odgovarajući AUC.
English: Re-dose based on levels*
Croatian: Prilagodba doziranja temeljeno na razini*
English: Antibiotics are used to cure bacterial infections.
Croatian: Antibiotici se koriste za liječenje bakterijskih infekcija.
English: However, the safety of increased vancomycin dosing has not been properly assessed and higher doses than 60 mg/kg/day cannot be generally recommended.
Croatian: Međutim, sigurnost povećanog doziranja vankomicinom nije odgovarajuće utvrđena, stoga se doze veće od 60 mg/kg/dan ne mogu generalno preporučivati.
English: Subsequent dose adjustments should be based on serum concentrations to achieve targeted therapeutic concentrations.
Croatian: Daljnje prilagodbe doze je potrebno temeljiti na koncentracijama u serumu kako bi se postigle ciljane terapijske koncentracije.
English: Capsules
Croatian: Kapsule
English: Monitoring of vestibular and auditory function in the elderly should be carried out during and after treatment.
Croatian: Praćenje vestibularne i slušne funkcije u starijih osoba potrebno je provoditi tijekom i nakon liječenja.
English: 7 to 14 days
Croatian: 7 do 14 dana
English: Superinfection
Croatian: Superinfekcije
English: What you need to know before you take [product name] Do not take Vancomycin
Croatian: Što morate znati prije nego počnete uzimati (ime lijeka) Nemojte uzimati Vankomicin:
English: There is no cross-resistance between vancomycin and other classes of antibiotics.
Croatian: Ne postoji križna rezistencija između vankomicina i drugih skupina antibiotika.
English: The current intravenous dosing recommendations for the paediatric population, in particular for children below 12 years of age, may lead to sub-therapeutic vancomycin levels in a substantial number of children.
Croatian: Trenutne preporuke intravenskog doziranja za pedijatrijsku populaciju, osobito za djecu ispod 12 godina starosti, mogu dovesti do subterapijske razine vankomicina kod značajnog broja djece.
English: PMA (weeks) Dose (mg/kg) Interval of administration (h)
Croatian: PMD (tjedni) Doza (mg/kg) Interval primjene (sati)
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Croatian: Ove izmjene odgovarajućih dijelova informacija o lijeku ishod su arbitražnog postupka.
English: The volume of distribution is about 60 L/1.73 m2 body surface.
Croatian: Volumen distribucije je oko 60 L/1,73 m2 površine tijela.
English: Vancomycin can cause allergic reactions, although serious allergic reactions (anaphylactic shock) are rare.
Croatian: Vankomicin može uzrokovati alergijske reakcije, iako su ozbiljne alergijske reakcije (anafilaktički šok) rijetke.
English: During anaesthesia, doses must be well diluted and administered slowly with close cardiac monitoring.
Croatian: Tijekom anestezije doze moraju biti dobro razrijeđene i moraju se davati sporo, uz praćenje rada srca.
English: The initial dose should be based on total body weight.
Croatian: Početnu dozu je potrebno temeljiti na ukupnoj tjelesnoj težini.
English: Renal insufficiency manifested primarily by increased serum creatinine and serum urea
Croatian: Bubrežna insuficijencija primarno manifestirana povećanim serumskim kreatininom i serumskom urejom
English: This may be reduced by administering vancomycin by infusion over at least 60 minutes, before anaesthetic induction.
Croatian: Ovo se može reducirati primjenom infuzije vankomicina tijekom najmanje 60 minuta, prije početka anestezije.
English: Dose adjustments in adult patients could be based on glomerular filtration rate estimated (eGFR) by the following formula:
Croatian: Prilagodba doze u odraslih bolesnika se može temeljiti na glomerularnoj filtraciji (eGFR) određenoj sljedećom formulom:
English: Decrease in blood pressure
Croatian: Pad krvnog tlaka
English: The dose given to you will depend on: - your age, - your weight, - the infection you have, - how well your kidneys are working,
Croatian: Primijenjena doza ovisi o: - Vašim godinama, - Vašoj tjelesnoj težini, - infekcijama od kojih bolujete, - funkciji bubrega,
English: There is very little metabolism of the drug.
Croatian: Metabolizam lijeka je vrlo mali.
English: The maximum daily dose should not exceed 2 g.
Croatian: Najveća dnevna doza ne smije prelaziti 2 g.
English: For information about the preparation of the solution, please see section 6.6.
Croatian: Za informacije o pripremi otopine vidjeti dio 6.6.
English: Men: [Weight (kg) x 140 - age (years)]/ 72 x serum creatinine (mg/dl) Women: 0.85 x value calculated by the above formula.
Croatian: Muškarci: [težina (kg) x 140 - dob (godine)] / 72 x serumski kreatinin (mg/dl) Žene: 0,85 x vrijednost izračunata gornjom formulom.
English: The rational use of vancomycin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient.
Croatian: Kod racionalnog korištenja vankomicina potrebno je uzeti u obzir spektar bakterijskog djelovanja, sigurnosni profil i prikladnost standardne antibakterijske terapije za liječenje pojedinog bolesnika.
English: In contrast, high concentrations of vancomycin are found in the faeces (>3100 mg/kg with doses of 2 g/day).
Croatian: Suprotno tome, visoke koncentracije vankomicina pronađene su u stolici (> 3100 mg/kg s dozama od 2 g/dan).
English: Vancomycin is primarily cleared by glomerular filtration.
Croatian: Vankomicin se primarno eliminira glomerularnom filtracijom.
English: The elderly, pregnant women and patients with a kidney disorder, including those on dialysis, may need a different dose.
Croatian: Za starije osobe, trudnice i bolesnike s poremećajem rada bubrega, uključujući i one na dijalizi, možda će biti potrebna drugačija doza.
English: Gram positive anaerobes
Croatian: Gram-pozitivni anaerobi
English: Vancomycin works by eliminating certain bacteria that cause infections.
Croatian: Vankomicin djeluje tako što uništava određene bakterije koje uzrokuju infekcije.
English: Acute tubular necrosis
Croatian: Akutna tubularna nekroza
English: Vancomycin displays concentration-independent activity with the area under the concentration curve (AUC) divided by the minimum inhibitory concentration (MIC) of the target organism as the primary predictive parameter for efficacy.
Croatian: Vankomicin pokazuje aktivnost neovisnu o koncentraciji s površinom ispod krivulje koncentracije (AUC) podijeljenom s minimalnom inhibitornom koncentracijom (MIK) ciljnog organizma kao primarnim prediktivnim parametrom učinkovitosti.
English: Stevens-Johnson syndrome (SJS) has been reported with the use of vancomycin (see section 4.8).
Croatian: Stevens-Johnsonov sindrom (SJS) je prijavljen s primjenom vankomicina (vidjeti dio 4.8).
English: Intraperitoneal antibiotics should be added to the dialysate using sterile technique.
Croatian: Intraperitonealne antibiotike je potrebno dodati dijalizatu korištenjem sterilne tehnike.
English: Specimens for bacterial cultures should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to vancomycin.
Croatian: Potrebno je uzeti uzoraka za bakterijske kulture kako bi se mogli izolirati i identificirati uzročnici i odrediti njihova osjetljivost na vankomicin.
English: Vancomycin will be given into your vein for at least 60 minutes.
Croatian: Vankomicin će se davati u venu tijekom najmanje 60 minuta.
English: Complicated skin and soft tissue infections -Non necrotizing
Croatian: Komplicirane infekcije kože i mekog tkiva Ne-nekrotizirajuće
English: If superinfection occurs during therapy, appropriate measures should be taken.
Croatian: Ako dođe do superinfekcije tijekom terapije, potrebno je poduzeti odgovarajuće mjere.
English: After parenteral administration it is excreted almost completely as microbiologically active substance (approx. 75-90% within 24 hours) through glomerular filtration via the kidneys.
Croatian: Nakon parenteralne primjene izlučuje se gotovo u potpunosti kao mikrobiološki aktivna tvar (pribl. 75 - 90 % u 24 sata) glomerularnom filtracijom putem bubrega.
English: The elderly are particularly susceptible to auditory damage.
Croatian: Starije osobe su posebno podložne oštećenju funkcije sluha.
English: Pharmacokinetic/ Pharmacodynamic relationship
Croatian: Farmakokinetički/farmakodinamički odnos
English: The frequency of therapeutic drug monitoring (TDM) needs to be individualized based on the clinical situation and response to treatment, ranging from daily sampling that may be required in some hemodynamically unstable patients to at least once weekly in stable patients showing a treatment response.
Croatian: Učestalost terapijskog praćenja koncentracije lijeka (engl. therapeutic drug monitoring, TDM) je potrebno individualizirati na temelju kliničke situacije i odgovora na liječenje, u rasponu od dnevnog uzorkovanja koje može biti potrebno u nekih hemodinamski nestabilnih bolesnika do barem jednom u tjednu u stabilnih bolesnika koji pokazuju odgovor na liječenje.
English: The model-based approach can be used both in calculating the personalized starting dose and for dose adjustments based on TDM results (see section 5.1).
Croatian: Pristup temeljen na modelu može se koristiti u izračunu personalizirane početne doze i za prilagodbe doza na temelju rezultata TDM-a (vidjeti dio 5.1).
English: Where appropriate, vancomycin should be administered in combination with other antibacterial agents.
Croatian: Kada je prikladno, vankomicin treba primjenjivati u kombinaciji s drugim antibakterijskim lijekovima.
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Croatian: Prevalencija stečene rezistencije za određene vrste može se razlikovati geografski i vremenski, stoga su poželjni lokalni podaci o rezistenciji, posebice kod liječenja teških infekcija.
English: If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na vankomicin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The elimination half-life of vancomycin is 4 to 6 hours in patients with normal renal function and 2.2-3 hours in children.
Croatian: Vrijeme poluživota izlučivanja vankomicina je 4 do 6 sati u bolesnika s normalnom funkcijom bubrega i 2,2 - 3 sata u djece.
English: Therapeutic trough (minimum) vancomycin blood levels should normally be 10-20 mg/l, depending on the site of infection and susceptibility of the pathogen.
Croatian: Najniža (minimalna) terapijski razina vankomicina u krvi obično treba iznositi 10 - 20 mg/l, ovisno o mjestu infekcije i osjetljivosti patogena.
English: You will be given Vancomycin by medical staff while you are in hospital.
Croatian: Medicinsko osoblje će primjenjivati vankomicin za vrijeme Vašeg boravka u bolnici.
English: For establishing the dosing regimen for neonates, the advice of a physician experienced in the management of neonates should be sought.
Croatian: Za utvrđivanje režima doziranja u novorođenčadi, potrebno je potražiti savjet liječnika koji ima iskustva u liječenju novorođenčadi.
English: Orally administered Vancomycin capsules are not effective for other types of infections.
Croatian: Peroralno primijenjene kapsule vankomicina nisu učinkovite za druge vrste infekcija.
English: If vancomycin is administered during a peritoneal dialysis intraperitoneally, approximately 30-65% reach the systemic cycle during the first 6 hours.
Croatian: Ako se vankomicin primjenjuje u trbušnu šupljinu tijekom peritonealne dijalize, približno 30 - 65 % će dospjeti u sistemsku cirkulaciju tijekom prvih 6 sati.
English: The risk of toxicity is increased by high blood concentrations or prolonged therapy.
Croatian: Rizik od toksičnosti povećava se s visokim koncentracijama u krvi ili produljenim liječenjem.
English: In case of hypersensitivity reactions, treatment with vancomycin must be discontinued immediately and the adequate emergency measures must be initiated.
Croatian: U slučaju reakcija preosjetljivosti liječenje vankomicinom je potrebno odmah prekinuti i potrebno je poduzeti odgovarajuće hitne mjere.
English: Patients whose fluid intake must be limited can also receive a solution of 500 mg/50 ml or 1000 mg/100 ml, although the risk of infusion-related undesirable effects can be increased with these higher concentrations.
Croatian: Bolesnici čiji unos tekućine mora biti ograničen mogu također primiti otopinu od 500 mg/50 ml ili 1000 mg/100 ml, premda se s tim većim koncentracijama može povećati rizik od pojave nuspojava povezanih s infuzijom.
English: On basis of in vitro, animal and limited human data, an AUC/MIC ratio of 400 has been established as a PK/PD target to achieve clinical effectiveness with vancomycin.
Croatian: Na temelju in vitro podataka, u životinja i ograničenih podataka u ljudi, AUC/MIK omjer = 400 je utvrđen kao PK/PD cilj kako bi se postigla klinička učinkovitost vankomicina.
English: This dose can be increased to 500 mg every 6 hours for 10 days in case of severe or complicated disease.
Croatian: Ova doza se može povećati na 500 mg svakih 6 sati tijekom 10 dana u slučaju teške ili komplicirane bolesti.
English: The usual duration of the therapy is 10 days but it may be different depending on the individual response to treatment for every patient.
Croatian: Uobičajeno trajanje terapije je 10 dana, ali može biti različito ovisno o odgovoru pojedinačnog bolesnika na liječenje.
English: Subsequently, optimal dose should be calculated in line with dosing recommendations provided in section 4.2.
Croatian: Posljedično je potrebno izračunati optimalnu dozu u skladu s preporukama za doziranje navedenima u dijelu 4.2 Doziranje i način primjene.
English: Reversible neutropenia usually starting one week or more after onset of intravenous therapy or after total dose of more than 25 g.
Croatian: Reverzibilna neutropenija obično počinje jedan tjedan ili više nakon početka intravenske terapije ili nakon ukupne doze veće od 25 g.
English: In these subpopulations vancomycin serum concentration were found higher than expected in male healthy adults (see section 4.2).
Croatian: U toj subpopulaciji pronađene su serumske koncentracije vankomicina više od očekivanih u zdravih muških odraslih osoba (vidjeti dio 4.2).
English: Gram positive aerobic species Erysipelothrix rhusiopathiae, Heterofermentative Lactobacillus, Leuconostoc spp
Croatian: Gram-pozitivne aerobne vrste Erysipelothrix rhusiopathiae, Heterofermentative Lactobacillus, Leuconostoc spp
English: In non-inflamed meninges, vancomycin passes the blood-brain barrier only to a low extent.
Croatian: Kod neupaljenih moždanih ovojnica, vankomicin prolazi krvno-moždanu barijeru samo u maloj mjeri.
English: In some countries, increasing cases of resistance are observed particularly in enterococci; multi-resistant strains of Enterococcus faecium are especially alarming.
Croatian: U nekim zemljama opaženo je povećanje broja slučajeva rezistencije posebno kod enterokoka; multirezistentni sojevi Enterococcus faecium su posebno alarmantni.
English: In the critically ill patient with renal insufficiency, the initial loading dose (25 to 30 mg/kg) should not be reduced.
Croatian: U kritičnih bolesnika s bubrežnom insuficijencijom, početna udarna doza (25 do 30 mg/kg) se ne smije smanjivati.
English: All patients receiving vancomycin should have periodic haematologic studies, urine analysis, liver and renal function tests.
Croatian: Svi bolesnici koji primaju vankomicin trebaju periodično obavljati hematološke pretrage, analizu urina i ispitivanje funkcije jetre i bubrega.
English: During the treatment, you might have blood tests, be asked to provide urine samples and possibly have hearing tests to look for signs of possible side effects.
Croatian: Tijekom liječenja možda ćete morati napraviti krvne pretrage i biti zamoljeni za davanje uzorka mokraće i moguće ispitivanje funkcije sluha kako bi se utvrdili znakovi mogućih nuspojava.
English: Vancomycin should also be avoided in patients with previous hearing loss.
Croatian: Vankomicin također treba izbjegavati u bolesnika s prethodnim gubitkom sluha.
English: Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Croatian: Moguće su ozbiljne reakcije preosjetljivosti koje ponekad mogu uzrokovati smrt (vidjeti dijelove 4.3 i 4.8).
English: During multiple dosing of 250 mg every 8 hours for 7 doses, faecal concentrations of vancomycin, in volunteers, exceeded 100 mg/kg in the majority of samples.
Croatian: Tijekom višekratnog doziranja od 250 mg svakih 8 sati za 7 doza koncentracije vankomicina u fecesu dobrovoljaca premašile su 100 mg/kg u većini uzoraka.
English: If a bullous disorder is suspected, the drug should be discontinued and specialised dermatological assessment should be carried out.
Croatian: Ako se sumnja na bulozni poremećaj, potrebno je prekinuti liječenje i provesti specijalističku dermatološku procjenu.
English: In the first 24 hours, approximately 80 % of an administered dose of vancomycin is excreted in the urine through glomerular filtration.
Croatian: Tijekom prva 24 sata približno 80 % primijenjene doze vankomicina izlučuje se putem mokraće glomerularnom filtracijom.
English: Position changes should be delayed until the infusion is completed to allow for postural adjustment (see section 4.5).
Croatian: Promjene položaja je potrebno odgoditi sve dok infuzija nije gotova, nakon čega je moguća posturalna prilagodba (vidjeti dio 4.5).
English: If symptoms or signs of SJS (e.g. progressive skin rash often with blisters or mucosal lesions) are present, vancomycin treatment should be discontinued immediately and specialised dermatological assessment be sought.
Croatian: Ako su prisutni simptomi ili znakovi SJS-a (npr. progresivni kožni osip, često s mjehurima ili oštećenjem sluznice), liječenje vankomicinom je potrebno odmah prekinuti i provesti specijalističku dermatološku procjenu.
English: Orientative dosing recommendations for the paediatric population are shown in table below that follow the same principles as in adult patients.
Croatian: U sljedećoj tablici prikazane su preporuke orijentacijskih doza za pedijatrijsku populaciju koje slijede iste principe kao kod odraslih bolesnika.
English: Linerarity/non-linearity
Croatian: Linearnost/nelinearnost
English: Depending on the clinical situation, consideration could be given to withhold the next dose while awaiting the results of vancomycin levels.
Croatian: Ovisno o kliničkoj situaciji, može se uzeti u obzir uskraćivanje sljedeće doze dok se čekaju rezultati razine vankomicina.
English: Intravenous vancomycin is usually administered as an intermittent infusion and the dosing recommendations presented in this section for the intravenous route correspond to this type of administration.
Croatian: Intravenski se vankomicin obično primjenjuje kao intermitentna infuzija i preporuke za doziranje opisane u ovom dijelu za intravensku primjenu odgovaraju ovoj vrsti primjene.
English: When using for the treatment of infections related to peritoneal dialysis, your doctor will decide exactly how much vancomycin you need.
Croatian: Za liječenje infekcija vezanih uz peritonealnu dijalizu Vaš liječnik će odlučiti koliko točno vankomicina
English: The natural decrement of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted (see section 4.2).
Croatian: Prirodno smanjenje glomerularne filtracije s povećanjem starosne dobi može dovesti do povišenih koncentracija vankomicina u serumu ako doza nije prilagođena (vidjeti dio 4.2).
English: The efficacy and safety of vancomycin has not been established for the intrathecal, intralumbar and intraventricular routes of administration.
Croatian: Učinkovitost i sigurnost vankomicina nije utvrđena za intratekalni, intralumbalni i intraventrikularni put primjene.
English: At serum concentrations of vancomycin of 10 mg/l to 100 mg/l, the binding of the drug to plasma proteins is approximately 30-55%, measured by ultra-filtration.
Croatian: Pri serumskim koncentracijama vankomicina od 10 mg/l do 100 mg/l vezanje lijeka na proteine plazme je približno 30 - 55 %, mjereno ultrafiltracijom.