natgillin/translations-raw huggingface dataset:
Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist. 
Za otroke so morda primernejše druge oblike tega zdravila; posvetujte se z zdravnikom ali farmacevtom.
The length of treatment depends on the infection you have and may last a number of weeks. 
Trajanje zdravljenja je odvisno od vrste okužbe, ki jo imate, in lahko traja več tednov.
Biliary excretion is insignificant (less than 5% of a dose). 
Izločanje z žolčem je zanemarljivo (manj kot 5 % odmerka).
Your doctor, or nurse, will always give vancomycin into your blood and not in the muscle. 
Zdravnik ali sestra vam bosta vankomicin vedno dala v kri, ne v mišico.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. 
Nasvet strokovnjaka je nujno potreben, če je lokalna prevalenca odpornosti tolikšna, da je koristnost uporabe učinkovine pri vsaj nekaterih vrstah okužb vprašljiva.
Adults and children 
Odrasli in otroci
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. 
Intravenska infuzija pomeni, da zdravilo teče iz steklenice ali vrečke po cevki v eno vaših krvnih žil in v vaše telo.
Suggested treatment duration is shown in table below. 
Trajanje zdravljenja je prikazano v spodnji preglednici.
Vancomycin concentration generally increases proportionally with increasing dose. 
Koncentracija vankomicina običajno narašča sorazmerno s povečanjem odmerka.
Subsequently, optimal dose should be calculated in line with dosing recommendations provided in section 4.2. 
Posledično je treba izračunati optimalni odmerek v skladu s priporočili za odmerjanje zdravila, navedenimi v poglavju 4.2.
In any case, the duration of treatment should be tailored to the type and severity of infection and the individual clinical response. 
V vsakem primeru je treba trajanje zdravljenja prilagoditi vrsti in resnosti okužbe in kliničnemu odzivu posameznika.
Despite antibiotics, some bacteria may survive or grow. 
Navkljub jemanju antibiotikov lahko nekatere bakterije preživijo ali se namnožijo.
They are ineffective against viral infections. 
Pri virusnih okužbah so neučinkoviti.
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). 
Pogostosti pojavljanja so: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do 1/1.000), zelo redki (<1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Whenever possible the antibacterial suspected to have caused CDI should be discontinued. 
Kadarkoli je mogoče, je uporabo antibiotika, za katerega se sumi, da je povzročil CDI, treba prekiniti.
Contents of the pack and other information Other sources of information 
Vsebina pakiranja in dodatne informacije Drugi viri informacij
The volume of distribution is about 60 L/1.73 m2 body surface. 
Volumen porazdelitve je približno 60 l/1,73 m2 telesne površine.
Acute bacterial meningitis (For parenteral formulations authorised for Acute bacterial meningitis) 
Akutni bakterijski meningitis (za parenteralna zdravila, odobrena za akutni bakterijski meningitis)
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. 
Med zdravljenjem boste morda imeli krvne preiskave, lahko vas prosijo, da prinesete vzorce urina in morda boste opravili preizkuse sluha, da bi ugotovili morebitne neželene učinke.
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. 
Pojav odpornosti na vankomicin se razlikuje od bolnišnice do bolnišnice, zato se je treba obrniti na krajevni mikrobiološki laboratorij za relevantne informacije.
7 to 14 days 
7 do 14 dni
In the first 24 hours, approximately 80 % of an administered dose of vancomycin is excreted in the urine through glomerular filtration. 
V prvih 24 urah se približno 80 % odmerka vankomicina izloči z urinom skozi glomerulno filtracijo.
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. 
Razpolovni čas je med 3,5 do 10 ur in je daljši kot pri odraslih, kar se običajno odraža v nižjih vrednostih očistka pri novorojenčkih.
Infective endocarditis 
Infekcijski endokarditis
5 - After completion of treatment, return all unused drugs to your chemist's shop to ensure they will be disposed of correctly. 
5 - po končanem zdravljenju vsa neuporabljena zdravila vrnite v lekarno, ker jih bodo primerno zavrgli.
Gram positive anaerobes 
Po Gramu pozitivni anaerobi
In anephric patients, the mean half-life is 7.5 days. 
Pri ledvičnih bolnikih je povprečni razpolovni čas 7,5 dni.
The elderly are particularly susceptible to auditory damage. 
Starejši so še posebej dovzetni za poškodbe sluha.
You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate: - dosage - schedules - duration of treatment 
K odpornosti bakterij lahko prispevate in s tem podaljšate čas svojega zdravljenja zaradi zmanjšanja učinkovitosti antibiotikov, če ne upoštevate: - odmerka - razporeda jemanja zdravila - trajanja zdravljenja
Superinfection 
Superokužba
3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness. 
3 - ne začnite ponovno jemati antibiotikov, če vam jih ne predpiše zdravnik, tudi če želite zdraviti podobno bolezen
Specimens for bacterial cultures should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to vancomycin. 
Treba je pridobiti vzorce bakterijskih kultur, da bi izolirali in določili mikroorganizme povzročitelje ter opredelili njihovo občutljivost na vankomicin.
Experience with other antibiotics suggests that deafness may be progressive despite cessation of treatment. 
Izkušnje z drugimi antibiotiki kažejo, da se lahko sluh še naprej slabša kljub prekinitvi terapije.
The elderly, pregnant women and patients with a kidney disorder, including those on dialysis, may need a different dose. 
Starejši, nosečnice in bolniki z motnjo v delovanju ledvic, tudi tisti na dializi, bodo morda potrebovali drugačne odmerke.
This information only provides approximate guidance on the chance whether micro-organisms are susceptible to vancomycin. 
Ti podatki so le približno vodilo o tem, ali so mikroorganizmi občutljivi na vankomicin.
The adverse reactions listed below are defined using the following MedDRA convention and system organ class database: 
Spodaj navedeni neželeni učinki so opredeljeni v skladu z naslednjo konvencijo MedDRA in bazo podatkov razredov organskih sistemov.
However, the safety of increased vancomycin dosing has not been properly assessed and higher doses than 60 mg/kg/day cannot be generally recommended. 
Vendar pa primerna ocena o varnosti pri večjem odmerjanju še ni bila opravljena, zato odmerkov, večjih od 60 mg/kg/dan, ni mogoče splošno priporočiti.
Vancomycin can cause allergic reactions, although serious allergic reactions (anaphylactic shock) are rare. 
Vankomicin lahko povzroči alergijske reakcije, čeprav so hude alergijske reakcije (anafilaktični šok) redke.
Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8). 
Hude in včasih usodne preobčutljivostne reakcije so mogoče (glejte poglavji 4.3 in 4.8).
If vancomycin is administered during a peritoneal dialysis intraperitoneally, approximately 30-65% reach the systemic cycle during the first 6 hours. 
Če vankomicin apliciranmo intraperitonealno med peritonealno dializo, ga približno 30-65 % doseže sistemski obtok v prvih 6 urah.
In case of hypersensitivity reactions, treatment with vancomycin must be discontinued immediately and the adequate emergency measures must be initiated. 
V primeru preobčutljivostnih reakcij moramo zdravljenje z vankomicinom takoj prekiniti in začeti ustrezne nujne ukrepe.
This dose can be increased to 500 mg every 6 hours for 10 days in case of severe or complicated disease. 
Odmerek lahko povečamo na 500 mg na vsakih 6 ur za 10 dni v primeru hude bolezni ali zapletov.
Concurrent or sequential use of other ototoxic substances should be avoided. 
Izogibati se moramo hkratni in zaporedni uporabi ototoksičnih snovi.
Oral administration [This section must include instructions for preparation and administration of the oral solution. 
Peroralna uporaba [To poglavje mora vsebovati navodila za pripravo in dajanje oralne raztopine.
This may be reduced by administering vancomycin by infusion over at least 60 minutes, before anaesthetic induction. 
To lahko omilimo z infundiranjem vankomicina vsaj 60 minut pred anestezijo.
Antibiotics are used to cure bacterial infections. 
Antibiotike uporabljamo za zdravljenje bakterijskih okužb.
Vancomycin will be given into your vein for at least 60 minutes. 
Vankomicin bo počasi tekel v vašo žilo najmanj 60 minut.
Consideration should be given to official guidance on the appropriate use of antibacterial agents. 
Potrebno je upoštevati uradne smernice o primerni uporabi antibakterijskih sredstev.
Men: [Weight (kg) x 140 - age (years)]/ 72 x serum creatinine (mg/dl) Women: 0.85 x value calculated by the above formula. 
Moški: [masa (kg) x 140 - starost (leta)]/ 72 x serumski kreatinin (mg/dl) Ženske: 0,85 x vrednost, izračunana po zgornji formuli.
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. 
Ni primeren za uporabo kot edino sredstvo za zdravljenje nekaterih vrst okužbe, razen če je patogen že dokumentiran in je znano, da je občutljiv oziroma obstaja velika verjetnost za to, da je vankomicin primeren za zdravljenje okužbe s tem patogenom.
The initial dose should be based on total body weight. 
Prvi odmerek mora temeljiti na skupni telesni masi.
In contrast, high concentrations of vancomycin are found in the faeces (>3100 mg/kg with doses of 2 g/day). 
Po drugi strani so velike koncentracije vankomicina našli v blatu (>3100 mg/kg pri odmerku 2 g/dan).
Vancomycin works by eliminating certain bacteria that cause infections. 
Vankomicin učinkuje tako, da uniči nekatere bakterije, ki povzročajo okužbe.
The maximum daily dose should not exceed 2 g. If you suffered other episodes (infection of the mucosa) before you may need different dose and different duration of the therapy. 
Največji dnevni odmerek ne sme preseči 2 g. Če ste pred tem imeli druga bolezenska stanja (vnetje sluznice), boste morda potrebovali drugačen odmerek in se bo trajanje terapije spremenilo.
Adequate replacement of fluid and electrolytes should be instituted. 
Potrebno je nadomestiti ustrezno količino tekočin in elektrolitov.
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). 
Tak pristop lahko uporabimo tako za izračun personaliziranega začetnega odmerka kot za nadaljnje prilagojene odmerke na podlagi rezultatov TDM (glejte poglavje 5.1).
Infusion-related reactions 
Reakcije, povezane z infuzijo
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). 
Treba je ustrezno presoditi o hkratni uporabi zdravil, ki lahko zmanjšajo očistek vankomicina in/ali povečajo njegove neželene učinke (glejte poglavje 4.4).
If superinfection occurs during therapy, appropriate measures should be taken. 
Če do superokužbe pride med terapijo, je treba sprejeti ustrezne ukrepe.
Monitoring of vestibular and auditory function in the elderly should be carried out during and after treatment. 
Vestibularno in slušno funkcijo je treba pri starejših spremljati med zdravljenjem in po njem.
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. 
Na podlagi podatkov in vitro ter podatkov pri živalih in omejenih podatkov pri ljudeh je vrednost razmerja AUC/MIK 400 določena kot ciljna vrednost FK/PD za doseganje klinične učinkovitosti vankomicina.
The reactions abate when administration is stopped, generally between 20 minutes and 2 hours. 
Reakcije se zmanjšajo po prenehanju dajanja zdravila, običajno po 20 minutah do 2 urah.
Treatment of Clostridium difficile infection (CDI): 
Zdravljenje okužb s Clostridium difficile (CDI, Clostridium difficile infection):
All patients receiving vancomycin should have periodic haematologic studies, urine analysis, liver and renal function tests. 
Vsi bolniki, ki prejemajo vankomicin, morajo redno hoditi na hematološke preiskave, analizo urina, ter preiskave jetne in ledvične funkcije.
Where appropriate, vancomycin should be administered in combination with other antibacterial agents. 
Kjer je primerno, vankomicin uporabljamo v kombinaciji z drugimi antibiotiki.
Subsequent dose adjustments should be based on serum concentrations to achieve targeted therapeutic concentrations. 
Naslednje odmerke je treba prilagoditi glede na koncentracije v serumu, da dosežemo tarčno terapevtsko koncentracijo.
These amendments to the relevant sections of the Product Information are the outcome of the referral procedure. 
Te spremembe delov povzetka glavnih značilnosti zdravila in navodil za uporabo so rezultat napotitvenega postopka.
How to take [product name] 
Kako jemati zdravilo [ime izdelka]
Therefore adverse events following intake of capsules are unlikely. 
Zato so neželeni dogodki po jemanju kapsul malo verjetni.
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. 
Intravensko vankomicin običajno uporabimo kot intermitentno infuzijo, zato priporočila za odmerjanje, opisana v tem poglavju za intravensko uporabo, ustrezajo tej vrsti uporabe.
Dose adjustments in adult patients could be based on glomerular filtration rate estimated (eGFR) by the following formula: 
Pri odraslih bolnikih lahko odmerek prilagodimo glede na oceno hitrosti glomerulne filtracije (eGFR, estimated glomerular filtration rate) po naslednji formuli:
In the critically ill patient with renal insufficiency, the initial loading dose (25 to 30 mg/kg) should not be reduced. 
Pri hudo bolnih ljudeh z renalno insuficienco začetnega odmerka (25 do 30 mg/kg) ne smemo zmanjšati.
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. 
Vankomicin moramo uporabljati razumno glede na njegov protibakterijski spekter delovanja, varnostni profil in primernost standardne protibakterijske terapije za zdravljenje posameznih bolnikov.
Vancomycin is primarily cleared by glomerular filtration. 
Vankomicin se večinoma izloča skozi glomerulno filtracijo.
As a consequence, prudent use of oral vancomycin is advised. 
Posledično se svetuje razsodna peroralna uporaba vankomicina.
Therapeutic trough (minimum) vancomycin blood levels should normally be 10-20 mg/l, depending on the site of infection and susceptibility of the pathogen. 
Najnižja terapevtska raven vankomicina v krvi je običajno 10-20 mg/l, odvisno od mesta okužbe in občutljivosti patogena.
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. 
Prilagoditev odmerka pri otrocih, starih 1 leto in več, lahko temelji na ocenjeni hitrosti glomerulne filtracije (eGFR) po revidirani Schwartzevi formuli: eGFR (ml/min/1,73m2 ) = (višina cm x 0,413)/ serumski kreatinin (mg/dl) eGFR (ml/min/1,73m2)= (višina cm x 36,2/serumski kreatinin (µmol/l) Za novorojenčke in otroke, mlajše kot 1 leto, prosite za pomoč strokovnjaka, saj zanje ne moremo uporabiti Schwartzeve formule.
The risk of toxicity is increased by high blood concentrations or prolonged therapy. 
Tveganje za toksične učinke se znatno poveča ob visokih koncentracijah zdravila v krvi ali ob dolgotrajnem zdravljenju.
What you need to know before you use Vancomycin Do not use Vancomycin 
Kaj morate vedeti, preden boste vzeli zdravilo Vankomicin Ne jemljite zdravila Vankomicin
4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness. 
4 - antibiotikov, ki vam jih je predpisal zdravnik, nikoli ne dajte drugi osebi; morda niso primerni za bolezen te osebe
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. 
Trenutna priporočila za intravensko uporabo pri pediatrični populaciji, posebej za otroke mlajše od 12 let, bi lahko pri precejšnjem številu otrok vodila v koncentracije vankomicina, ki so nižje od terapevtskih.
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. 
Bolniki z omejenim vnosom tekočin lahko dobijo raztopino 500 mg/50 ml ali 1000 mg/100 ml, čeprav je verjetnost za neželene učinke pri višjih koncentracijah večja.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 
neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Van genes have rarely been found in Staphylococcus aureus, where changes in cell wall structure result in “intermediate” susceptibility, which is most commonly heterogeneous. 
Gene van so redko našli pri vrsti Staphylococcus aureus, kjer so spremembe v strukturi celične stene vzrok »srednje« občutljivosti, ki je najpogosteje heterogena.
Deafness may be preceded by tinnitus. 
Pred gluhostjo lahko pride do tinitusa.
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. 
Pogostnost in resnost tromboflebitisa lahko minimiziramo s počasnim dajanjem zdravila v obliki razredčene raztopine (glejte poglavje 4.2) in z rednim menjavanjem mesta dajanja infuzije.
Vancomycin PK has shown wide inter-individual variability in preterm and term neonates. 
FK vankomicina kaže široko interindividualno variabilnost pri nedonošenčkih in novorojenčkih.
An oral dose is excreted almost exclusively in the faeces. 
Oralni odmerek se izloči skoraj izključno v blatu.
Misuse of antibiotics increases resistance. 
Nepravilna uporaba antibotikov povečuje odpornost bakterij.
Complicated skin and soft tissue infections -Non necrotizing 
Zapletene okužbe kože in mehkih tkiv -ne-nekrotizirajoče
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. 
Testiranje na kolonizacijo ali toksin Clostridium difficile ni priporočljivo za otroke, mlajše od 1 leta, zaradi visoke stopnje asimptomatske kolonizacije, razen če je prisotna huda driska s faktorji tveganja za zastoj, kot so Hirschsprungova bolezen, operirana atrezija anusa ali druge hude motnje motilitete.
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. 
Vankomicina ima od koncentracije neodvisno aktivnost, vrednost površine pod krivuljo koncentracije (AUC), deljena z minimalno inhibitorno koncentracijo (MIK) tarčnega organizma, je primarni parameter za določanje njegove učinkovitosti.
This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics. 
To je morda znak vnetja črevesja (psevdomembranski kolitis), do katerega lahko pride po zdravljenju z antibiotiki.
How to use [product name] 
Kako uporabljati zdravilo [Ime zdravila]
Description of selected adverse drug reactions 
Opis izbranih neželenih učinkov zdravila
Reversible neutropenia usually starting one week or more after onset of intravenous therapy or after total dose of more than 25 g. 
Reverzibilna nevtropenija se običajno začne teden ali več po začetku intravenske terapije, ali ko skupni odmerek preseže 25 g.
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. 
Čeprav se vankomicin ne izloči učinkovito s hemodializo ali peritonealno dializo, so poročali o povečanem očistku vankomicina s hemoperfuzijo in hemofiltracijo.
Monitoring of vancomycin serum concentrations 
Spremljanje koncentracije vankomicina v serumu
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. 
1 Vrednosti MIK za S. aureus z vankomicinom 2 mg/l so na meji distribucije divjega tipa in lahko pride do zmanjšanega kliničnega odziva.
Position changes should be delayed until the infusion is completed to allow for postural adjustment (see section 4.5). 
S spremembo položaja počakamo do konca infuzije, da omogočimo posturalno prilagoditev (glejte poglavje 4.5).
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) 
Novorojenčki (od rojstva do starosti 27 dni) in nedonošenčki (od rojstva do pričakovanega roka rojstva plus 27 dni)
Inherently resistant All Gram negative bacteria 
Naravno odporne Vse po Gramu negativne baktrerije
To reduce the risk of ototoxicity, blood levels should be determined periodically and periodic testing of auditory function is recommended. 
Da bi zmanjšali nevarnost za oglušitev, je treba redno spremljati krvne vrednosti in preverjati slušno funkcijo.
Vancomycin should be infused slowly (see sections 4.2 and 4.4). 
Vankomicin moramo infundirati počasi (glejte poglavji 4.2 in 4.4).
Vancomycin has a spectrum of antibacterial activity limited to Gram-positive organisms. 
Vankomicin ima spekter protibakterijskega delovanja omejen proti po Gramu pozitivnim bakterijam.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
Preglednica neželenih učinkov V vsaki skupini pogostnosti pojavljanja so neželeni učinki razvrščeni po padajoči resnosti.
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. 
Pri bolnikih s prekomerno telesno maso se porazdelitev vankomicina lahko spremeni zaradi povečanega volumna porazdelitve, ledvičnega očistka in možnih sprememb pri vezavi na plazemske beljakovine.
If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6). 
Če ste alergični na vankomicin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).