natgillin/translations-raw huggingface dataset:
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).
Warnings and precautions Talk to your doctor or hospital pharmacist or nurse before using Vancomycin if: - You suffered a previous allergic reaction to teicoplanin because this could mean you are also allergic to vancomycin.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila se posvetujte z bolnišničnim zdravnikom, farmacevtom ali medicinsko sestro, če: - ste že imeli alergijske reakcije na teikoplanin, saj bi lahko bili alergični tudi na vankomicin.
Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”.
Vankomicin je antibiotik, ki pripada skupini antibiotikov, imenovanih glikopeptidi.
The frequency of infusion-related reactions (hypotension, flushing, erythema, urticaria and pruritus) increases with the concomitant administration of anaesthetic agents (see section 4.5).
Pogostnost reakcij, povezanih z infuzijo (hipotenzija, rdečina, eritem, koprivnica in srbečica), se poveča s hkratnim prejemom anestetikov (glejte poglavje 4.5).
Decrease in blood pressure
Žilne bolezni: Pogosto znižanje krvnega tlaka
Orally administered Vancomycin capsules are not effective for other types of infections.
Kapsule vankomicina, ki jih uporabimo peroralno, niso učinkovite za druge vrste okužb.
Below 12 years, age-appropriate formulation should be used.
Za otroke, mlajše od 12 let, je treba uporabiti primerno farmacevtsko obliko.
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.
Če so prisotni simptomi ali znaki SJS (denimo progresivni kožni izpuščaj, pogosto z mehurji ali poškodbami sluznice), takoj prekinemo zdravljenje z vankomicinom in se posvetujemo s specialistom dermatologom.
Posology and method of administration.
Odmerjanje in način uporabe.
In some cases, your doctor may decide to give a higher daily dose of up to 500 mg every 6 hours.
Zdravnik se v nekaterih primerih lahko odloči, da vam predpiše večji dnevni odmerek, do 500 mg na vsakih 6 ur.
Intravenous vancomycin should be infused slowly.
Vankomicin v intravenski infuziji moramo dajati počasi.
The dose given to you will depend on: - your age, - your weight, - the infection you have, - how well your kidneys are working,
Odmerek, ki ga boste dobili, je odvisen od: - vaše starosti - vaše telesne mase - vrste okužbe - zdravstvenega stanja ledvic
In patients with severe renal failure, it is preferable to prolong the interval of administration rather than administer lower daily doses.
Pri bolnikih s hudo ledvično okvaro je primerneje podaljšati intervale med posameznimi odmerki kot aplicirati manjše dnevne odmerke.
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.
Običajni začetni odmerek za odrasle bolnike je 15 do 20 mg/kg, ki se ga pri pacientih z očistkom kreatinina med 20 in 49 ml/min lahko da na vsakih 24 ur.
After parenteral administration it is excreted almost completely as microbiologically active substance (approx. 75-90% within 24 hours) through glomerular filtration via the kidneys.
Po parenteralni uporabi se z glomerulno filtracijo skozi ledvice skoraj popolnoma izloči kot mikrobiološko aktivna snov (približno 75-90 % v 24 urah).
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.
Pri prostovoljcih, ki so vzeli 7 odmerkov po 250 mg vsakih 8 ur, so koncentracije vankomicina v večini vzorcev blata presegla 100 mg/kg.
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).
Zaradi zelo majhne sistemske absorpcije prilagajanje odmerka ni potrebno, razen če lahko pride do bistvene peroralne absorpcije v primeru vnetnih črevesnih bolezni in psevdomembranskega kolitisa, ki je posledica okužbe s Clostridium difficile (glejte poglavje 4.4).
Hospital-acquired pneumonia, including ventilator-associated pneumonia
Bolnišnična pljučnica, tudi ventilatorska pljučnica
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).
Naravno zmanjšanje glomerulne filtracije s starostjo lahko privede do dviga koncentracije vankomicina v serumu, če odmerka ne prilagodimo (glejte poglavje 4.2).
Vancomycin capsules are not appropriate for children under 12 years or for adolescents unable to swallow them.
Kapsule vankomicina niso primerne za otroke, stare manj kot 12 let, ali mladostnike, ki jih ne morejo pogoltniti.
For the intraperitoneal treatment of peritoneal dialysis-associated peritonitis (PDP) in children with residual renal function, intermittent therapy should only be indicated provided that vancomycin serum levels can be monitored in a timely manner.
Za intraperitonealno zdravljenje peritonitisa, povezanega s peritonealno dializo, pri otrocih z rezidualno ledvično funkcijo, se sme intermitentno terapijo uporabiti le pod pogojem, da je ravni vankomicina v serumu mogoče pravočasno preverjati.
Gram-negative bacteria are resistant.
Po Gramu negativne bakterije so odporne.
[The below should be introduced in section 4.2 for all vancomycin products powder for concentrate]
[Spodnje besedilo je treba vstaviti v poglavje 4.2 za vsa zdravila z vankomicinom v obliki praška za koncentrat]
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.
Pri hudo bolnih pacientih je lahko začetni odmerek 25-30 mg/kg telesne mase, da hitreje dosežemo tarčno koncentracijo vankomicina v serumu.
There is no cross-resistance between vancomycin and other classes of antibiotics.
Med vankomicinom in drugimi vrstami antibiotikov ni navzkrižne odpornosti.
Vancomycin capsules are not appropriate for the treatment of children under the age of 12 years or for adolescents unable to swallow them.
Kapsule vankomicina niso primerne za zdravljenje otrok, mlajših od 12 let, ali za mladostnike, ki jih ne morejo pogoltniti.
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.
Vankomicin je treba infundirati počasi v razredčeni raztopini (2,5 do 5,0 mg/ml) pri hitrosti največ 10 mg/min in najmanj 60 minut, da bi preprečili reakcije, povezane s hitro infuzijo.
What you need to know before you take [product name] Do not take Vancomycin
Kaj morate vedeti, preden boste vzeli zdravilo [Ime zdravila] Ne uporabljajte zdravila [Ime zdravila]
For establishing the dosing regimen for neonates, the advice of a physician experienced in the management of neonates should be sought.
Pi določanju odmerka za novorojenčke naj svetuje zdravnik z izkušnjami pri zdravljenju novorojenčkov.
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.
Če bolnik prejema vankomicin daljše časovno obdobje ali hkrati z drugimi zdravili, ki lahko povzročijo nevtropenijo ali agranulocitozo, moramo v rednih intervalih spremljati število levkocitov.