natgillin/translations-raw huggingface dataset:
Caution should be taken with concomitant use with other formulations of colistimethate sodium as there is little experience and there is a possibility of summative toxicity. 
Previdnost je potrebna v primeru sočasne uporabe z drugimi oblikami natrijevega kolistimetata, ker je izkušenj glede tega malo in obstaja možnost aditivne toksičnosti.
The dosage can be adjusted depending on the severity of the condition and clinical response. 
Odmerjanje je mogoče prilagoditi glede na izrazitost bolezni in klinični odziv.
The most commonly observed adverse effect of CMS administration was aseptic meningitis (see section 4.8). 
Najpogosteje opažen neželen učinek uporabe NKM v osrednjem živčevju je bil aseptični meningitis (glejte poglavje 4.8).
What you need to know before you <take> <use> [Product name] 
Kaj morate vedeti, preden boste <vzeli> <uporabili> [Ime zdravila]
fAUC/ MIC is considered to be correlated with clinical efficacy. 
Za fAUC/MIC velja, da korelirata s klinično učinkovitostjo.
[Product name] is indicated in adults and children including neonates for the treatment of serious infections due to selected aerobic Gram-negative pathogens in patients with limited treatment options (see sections 4.2, 4.4, 4.8 and 5.1). 
Zdravilo [Ime zdravila] je pri odraslih in otrocih, vključno z novorojenčki, indicirano za zdravljenje resnih okužb z izbranimi aerobnimi gramnegativnimi mikroorganizmi pri bolnikih, pri katerih so možnosti zdravljenja omejene (glejte poglavja 4.2, 4.4, 4.8 in 5.1).
The elimination of the active colistin is incompletely characterised. 
Izločanje aktivnega kolistina ni popolnoma opredeljeno.
The following regimes could be considered. 
V poštev pridejo naslednje sheme.
Discontinuation of therapy and the administration of specific treatment for Clostridium difficile should be considered. 
Prenehati je treba uporabljati to zdravilo in uvesti je treba specifično zdravljenje proti Clostridium difficile.
There are extremely limited data from population PK studies from very small numbers of patients on renal replacement therapy. 
Izredno malo je podatkov iz populacijskih farmakokinetičnih študij pri zelo majhnem številu bolnikov na ledvičnem nadomestnem zdravljenju.
Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose. 
Značilnost odpornih bakterij je sprememba fosfatnih skupin lipopolisaharidov, tako da jih nadomestita etanolamin ali aminoarabinoza.
Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin (see sections 4.5 and 4.8). 
Hipovolemični bolniki in bolniki, ki dobivajo druga potencialno nefrotoksična zdravila, imajo večje tveganje za nefrotoksičnost kolistina (glejte poglavji 4.5 in 4.8).
R>4 mg/L a Breakpoints apply to dosage of 2-3 MIU x 3. 
R > 4 mg/l a Mejne vrednosti veljajo za odmerjanje 2-3 Mi.e.
The volume of distribution is relevantly enlarged in critically ill subjects. 
Volumen porazdelitve je pri kritično bolnih bolnikih pomembno večji.
High serum concentrations of colistimethate sodium, which may be associated with overdosage or failure to reduce the dosage in patients with renal impairment, have been reported to lead to neurotoxic effects such as facial paraesthesia, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea. 
Opisano je, da visoka koncentracija natrijevega kolistimetata v serumu, ki je lahko posledica prevelikega odmerjanja ali uporabe nezmanjšanega odmerka pri bolnikih z okvaro ledvic, povzroči nevrotoksične učinke, npr. parestezije obraza, šibkost mišic, vrtoglavico, nejasen govor, vazomotorično nestabilnost,
For special precautions for disposal and handling of reconstituted solutions, see section 6.6. 
Za posebne previdnostne ukrepe pri odstranjevanju in ravnanju s pripravljenimi raztopinami glejte poglavje 6.6.
Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose. 
Naravno odporne gramnegativne bakterije, na primer Proteus mirabilis in Burkholderia cepacia, imajo lipidni fosfat v celoti nadomeščen z etanolaminom ali aminoarabinozo.
Dose adjustment is not considered necessary, however caution is advised in patients with renal impairment (see sections 4.4 and 5.2). 
Prilagoditev odmerka ni potrebna, priporočljiva pa je previdnost pri bolnikih z okvaro ledvic (glejte poglavji 4.4 in 5.2).
The dose of colistimethate sodium should be adjusted according to creatinine clearance (see section 4.2). 
Odmerek natrijevega kolistimetata je treba prilagoditi očistku kreatinina (glejte poglavje 4.2).
[Product name] is administered intravenously as a slow infusion over 30 - 60 minutes. 
Zdravilo [Ime zdravila] se daje s počasno intravensko infuzijo v 30 do 60 minutah.
Intrathecal and intraventricular administration 
Intratekalna in intraventrikularna uporaba
Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium. 
Polimiksini delujejo tako, da poškodujejo celično membrano; posledični fiziološki učinki so za bakterijo smrtni.
Dose adjustments in renal impairment are necessary, but pharmacokinetic data available for patients with impaired renal function is very limited. 
Bolnikom z okvaro ledvic je odmerek treba prilagoditi, toda farmakokinetičnih podatkov o bolnikih z okvarjenim delovanjem ledvic je zelo malo.
The usual dose for children less than 2 years old is 0.5-1 million units twice daily (maximum 2 million units per day). 
Običajen odmerek za otroke, mlajše od 2 let, je 0,5 do 1 milijona enot dvakrat na dan (največ 2 milijona enot na dan).
Intravenous colistimethate sodium does not cross the blood brain barrier to a clinically relevant extent. 
Intravensko uporabljeni natrijev kolistimetat ne prehaja skozi krvno-možgansko pregrado v klinično pomembni meri.
Polymyxins have been reported to have a concentration-dependent bactericidal effect on susceptible bacteria. 
Opisano je, da imajo polimiksini od koncentracije odvisen baktericiden učinek na občutljive bakterije.
Colistin clearance is decreased in renal impairment, possibly due to increased conversion of CMS. 
Očistek kolistina se pri okvari ledvic zmanjša, morda zaradi povečane pretvorbe v NKM.
The potential for drug-drug interactions should be borne in mind when [Product name] is coadministered with drugs known to inhibit or induce drug metabolising enzymes or drugs known to be substrates for renal carrier mechanisms. 
Možno medsebojno delovanje z zdravili je treba upoštevati, če je zdravilo [Ime zdravila] uporabljeno sočasno z zdravili, ki zavirajo ali inducirajo encime, vpletene v presnovo zdravil, ali z zdravili, ki so substrati ledvičnih prenašalnih mehanizmov.
Note: The existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the wording below: 
Opomba: Obstoječe navodilo za uporabo morate spremeniti (z vstavljanjem, nadomeščanjem ali izbrisanjem besedila) tako, da bo odražalo spodnje formulacije:
Note: The existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the wording below. 
Opomba: Obstoječe navodilo za uporabo morate spremeniti (z vstavljanjem, nadomeščanjem ali izbrisanjem besedila) tako, da bo odražalo spodnje formulacije.
How to <take><use> [Product name] 
Kako <jemati><uporabljati> zdravilo [Ime zdravila]
[Product name] is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis. 
Zdravilo [Ime zdravila] se daje v inhalaciji za zdravljenje kroničnih pljučnih okužb pri bolnikih s cistično fibrozo.
Colistimethate sodium is known to reduce the presynaptic release of acetyl-choline at the neuromuscular junction and should be used in patients with myasthenia gravis with the greatest caution and only if clearly needed. 
Znano je, da natrijev kolistimetat zmanjša predsinaptično sproščanje acetilholina na živčno-mišičnem stiku, zato ga je treba pri bolnikih z miastenijo gravis uporabljati le skrajno previdno in le če je nujno.
Twice daily dosing is recommended. 
Priporočeno je odmerjanje dvakrat na dan.
The benefit of prolonged treatment duration should be balanced against the potentially increased risk of renal toxicity. 
Koristi dolgotrajnega zdravljenja je treba pretehtati glede na možno večje tveganje nefrotoksičnosti.
The usual dose for adults, adolescents and children aged 2 years or older is 1-2 million units two to three times per day (maximum 6 million units per day). 
Običajen odmerek za odrasle, mladostnike in otroke, stare 2 leti ali več, je 1 do 2 milijona enot dva- do trikrat na dan (največ 6 milijonov enot na dan).
The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid (ECF). 
Volumen porazdelitve kolistina je pri zdravih osebah majhen in približno ustreza zunajcelični tekočini.
Half-life of colistin in healthy subjects and those with cystic fibrosis is reported to be around 3h and 4h, respectively, with a total clearance of around 3L/h. 
Razpolovni čas kolistina pri zdravih osebah je približno 3 ure in pri osebah s cistično fibrozo približno 4 ure, celotni očistek pa je približno 3 l/uro.
Modelling suggests that loading and maintenance doses of up to 12 MIU may be required in patients with good renal function in some cases. 
Modeliranje kaže, da sta lahko v nekaterih primerih pri bolnikih z dobrim delovanjem ledvic potrebna polnilni in vzdrževalni odmerek do 12 milijonov i.e.
Note: If present, any contraindication in myasthenia gravis should be deleted, to be replaced with a warning in section 4.4, as indicated below. 
Opomba: Če je navedena kakšna kontraindikacija pri miasteniji gravis, jo je treba odstraniti in nadomestiti z opozorilom v poglavju 4.4, kot je navedeno spodaj.
125.000 IU/day Intrathecally administered doses should not exceed those recommended for intraventricular use. 
Intratekalno uporabljeni odmerki ne smejo presegati odmerkov, priporočenih za intraventrikularno uporabo.
The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response. 
Pri določanju odmerka in trajanja zdravljenja je treba upoštevati izrazitost okužbe in klinični odziv.
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. 
Če je lokalna prevalenca odpornosti takšna, da je uporabnost tega zdravila vsaj pri nekaterih vrstah okužb vprašljiva, je treba poiskati nasvet strokovnjaka.
Note: If intrathecal administration is included in the SmPC of your product, the following should also be included: 
Opomba: Če je v povzetek glavnih značilnosti vašega zdravila vključena intratekalna uporaba, je treba vključiti tudi naslednje:
The information on the pharmacokinetics of colistimethate sodium (CMS) and colistin is limited. 
Informacij o farmakokinetiki natrijevega kolistimetata (NKM) in kolistina je malo.
Impaired renal function increases the possibility of apnoea and neuromuscular blockade following administration of colistimethate sodium. 
Okvarjeno delovanje ledvic poveča možnost za apnejo in živčno-mišično blokado po uporabi natrijevega kolistimetata.
[Product name] is given to you by your doctor as an infusion into a vein over 30 - 60 minutes. 
Zdravilo [Ime zdravila] vam bo dal zdravnik z infuzijo v veno; infundiranje bo trajalo od 30 do 60 minut.
Dose conversion table: 
Preglednica za pretvorbo odmerkov:
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents and may occur with colistimethate sodium. 
Z antibiotiki povezani kolitis in psevdomembranski kolitis sta opisana pri skoraj vseh protibakterijskih zdravilih in se lahko pojavita tudi z natrijevim kolistimetatom.
In the absence of meningeal inflammation, penetration into the cerebrospinal fluid (CSF) is minimal, but increases in the presence of meningeal inflammation. 
Če meninge niso vnete, je prodiranje v cerebrospinalno tekočino minimalno, v primeru vnetja mening pa se poveča.
In patients with very poor renal function (creatinine clearance <30 ml/min), the extent of conversion could be as high as 60 to 70%. 
Pri bolnikih z zelo slabim delovanjem ledvic (očistek kreatinina < 30 ml/min) lahko pretvorba doseže kar
4.5-5.5 MIU 
4,5-5,5 Mi.e.
3.5 MIU 
3,5 Mi.e.
[Product name] is indicated for the management in adult and paediatric of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (see section 5.1). 
Zdravilo [Ime zdravila] je indicirano za obvladanje kroničnih pljučnih okužb, ki jih povzroča Pseudomonas aeruginosa, pri odraslih in pediatričnih bolnikih s cistično fibrozo (glejte poglavje 5.1).
The dose is expressed in international units (IU) of colistimethate sodium (CMS). 
Odmerek je izražen v internacionalnih enotah (i.e.) natrijevega kolistimetata (NKM).
Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials, polymyxins. 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje infekcij, druge protimikrobne učinkovine,
The dose should be based on lean body weight. 
Odmerek mora temeljiti na pusti telesni masi.
Annex III Amendments to relevant sections of the summary of product characteristics and the package leaflets 
Spremembe relevantnih delov povzetka glavnih značilnosti zdravila in navodila za uporabo
Haemodialysis and continuous haemo(dia)filtration Colistin appears to be dialyzable through conventional haemodialysis and continuous venovenous haemo(dia)filtration (CVVHF, CVVHDF). 
Kot kaže, se kolistin dializira z običajno hemodializo in s stalno veno-vensko hemo(dia)filtracijo (CVVHF, CVVHDF).
Peak plasma concentrations of colistin have been shown to occur with a delay of up to 7 hours after administration of colistimethate sodium in critically ill patients. 
Največja koncentracija kolistina v plazmi se pri kritično bolnih bolnikih pojavi z zamudo do 7 ur po uporabi natrijevega kolistimetata.
Nephrotoxicity has been reported to be associated with cumulative dose and treatment duration in some studies. 
V nekaterih študijah je bilo opisano, da je nefrotoksičnost povezana s kumulativnim odmerkom in trajanjem zdravljenja.
Children ≤ 40kg 75.000-150.000 IU/kg/day divided into 3 doses. 
75.000-150.000 i.e./kg/dan, razdeljeno na 3 odmerke.
Further, the effect of immature renal and metabolic function on the conversion of colistimethate sodium to colistin is not known. 
Poleg tega ni znan vpliv nezrele ledvične in presnovne funkcije na pretvorbo natrijevega kolistimetata v kolistin.
Older people No dose adjustments in older patients with normal renal function are considered necessary. 
Starejše osebe Starejšim bolnikom z normalnim delovanjem ledvic odmerka ni treba prilagoditi.
Changes agreed by the CHMP to the product information of CMS-containing products for injection or infusion 
Spremembe, dogovorjene s CHMP za informacije o zdravilih za injiciranje ali infundiranje, ki vsebujejo NKM
Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group. 
Kolistin je cikličen polipeptiden antibiotik iz skupine polimiksinov.
In the EU, the dose of colistimethate sodium (CMS) must be prescribed and administered only as International Units (IU). 
V EU je dovoljeno odmerek natrijevega kolistimetata (NKM) predpisovati in uporabiti le izraženega v internacionalnih enotah (i.e.).
If present, any contraindication in myasthenia gravis should be deleted, to be replaced with a warning, as indicated below. 
Če je navedena kakšna kontraindikacije pri miasteniji gravis, jo je treba odstraniti in nadomestiti z opozorilom, kot je navedeno spodaj.
In patients who are critically ill, a loading dose of 9 MIU should be administered. 
Pri kritično bolnih bolnikih je treba uporabiti polnilni odmerek 9 milijonov i.e.
The mechanism of colistin clearance, including renal handling, is equally unknown. 
Prav tako ni znan mehanizem očistka kolistina, vključno z dogajanjem v ledvicah.
The data supporting the dose regimen in paediatric patients are very limited. 
Pediatrična populacija Podatkov v oporo shemi odmerjanja pri pediatričnih bolnikih je zelo malo.
In particular there are limited safety data for the use of high doses (> 6MIU/day) and the use of a loading dose, and for special populations (patients with renal impairment and the paediatric population). 
Mi.e./dan), uporabi polnilnega odmerka in o posebnih populacijah (bolniki z okvaro ledvic in pediatrična populacija).
Since the mechanism of action of the polymyxins is different from that of other antibacterial agents, resistance to colistin and polymyxin by the above mechanism alone would not be expected to result in resistance to other drug classes. 
Pričakovana je navzkrižna odpornost med kolistinom (polimiksin E) in polimiksinom B. Mehanizem delovanja polimiksinov se razlikuje od drugih protibakterijskih zdravil, zato ni pričakovati, da bi odpornost proti kolistinu in polimiksinu, ki je zgolj posledica omenjenega mehanizma, povzročila tudi odpornost proti drugim vrstam zdravil.
Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis (see section 4.4). 
Pri bolnikih z miastenijo gravis je potrebna previdnost v primeru sočasnega zdravljenja z natrijevim kolistimetatom in makrolidi, kot sta azitromicin in klaritromicin, ali fluorokinoloni, kot sta norfloksacin in ciprofloksacin (glejte poglavje 4.4).
Taking such medicines at the same time as [Product name] can increase the risk of damage to the kidneys. 
Jemanje takšnih zdravil hkrati z zdravilom [Ime zdravila] lahko poveča tveganje za neželene učinke na živčevju.
As the development of resistance to intravenous colistin has been reported in particular when it is used as a monotherapy, co- administration with other antibacterial should also be considered in order to prevent the emergence of resistance. 
Opisan je pojav odpornosti proti intravenskemu kolistinu, zlasti če je bil uporabljan kot monoterapija, zato pride v poštev tudi sočasna uporaba z drugim protibakterijskim zdravilom, da bi preprečili pojav odpornosti.
Concomitant use of intravenous colistimethate sodium with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution. 
Natrijev kolistimetat je treba zelo previdno uporabljati sočasno z drugimi potencialno nefrotoksičnimi ali nevrotoksičnimi zdravili.
Your doctor will monitor your kidney function regularly while you receive [Product name]. 
Zdravnik vam bo med zdravljenjem z zdravilom [Ime zdravila] redno kontroliral delovanje ledvic.
Data supporting the posology are very limited. 
Podatkov v podporo odmerjanju je zelo malo.
Older people Dose adjustment is not considered necessary 
Starejše osebe Prilagoditev odmerka ni potrebna.
They may range from mild to lifethreatening in severity. 
Segata lahko od blagih do smrtno nevarnih oblik.
Colistimethate sodium should be used with extreme caution in patients with porphyria. 
Pri bolnikih s porfirijo je treba natrijev kolistimetat uporabljati skrajno previdno.
It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium (see section 4.8). 
Na to diagnozo treba pomisliti pri vsakem bolniku, ki se mu med uporabo natrijevega kolistimetata ali po njej pojavi driska (glejte poglavje 4.8).
Due to the effects of colistin on the release of acetylcholine, non-depolarising muscle relaxants should be used with caution in patients receiving colistimethate sodium as their effects could be prolonged (see section 4.4). 
Zato je treba pri bolnikih, ki dobivajo natrijev kolistimetat, nedepolarizirajoče mišične relaksante uporabljati previdno, ker se njihovi učinki lahko podaljšajo (glejte poglavje 4.4).
Renal maturity should be taken into consideration when selecting the dose. 
Pri izbiri odmerka je treba upoštevati dozorelost ledvic.
Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation. 
Kolistin se v veliki meri reabsorbira v ledvičnih tubulih in se lahko odstrani neledvično ali se presnovi v ledvicah (s posledičnim možnim kopičenjem v ledvicah).
No specific dosing recommendation can be made in children for intrathecal and intraventricular routes of administration. 
Za intratekalno in intraventrikularno pot uporabe pri otrocih ni mogoče dati specifičnih priporočil za odmerjanje.
Changes agreed by the CHMP to the Product Information of CMS-containing products for solution for inhalation or nebulisation 
Spremembe, dogovorjene s CHMP za informacije o zdravilih za raztopino za inhaliranje ali za nebulizacijo, ki vsebujejo NKM
Consideration should be given to co-administering intravenous colistimethate sodium with another antibacterial agent whenever this is possible, taking into account the remaining susceptibilities of the pathogen(s) under treatment. 
Kadar koli je mogoče, naj bi intravenski natrijev kolistimetat uporabili skupaj z drugim protibakterijskim zdravilom, upoštevaje preostale občutljivosti patogena/patogenov, zaradi katerih je potrebno zdravljenje.
The use of doses >150.000 IU/kg/day has been reported in children with cystic fibrosis. 
Pri otrocih s cistično fibrozo je opisana uporaba odmerkov > 150.000 i.e./kg/dan.
Resistance 
Odpornost (rezistenca)
No dose recommendations have been established in children with impaired renal function. 
Za otroke z okvarjenim delovanjem ledvic ni oblikovanih priporočil za odmerjanje.
Monitoring should be performed for perioral paraesthesia and paraesthesia in the extremities, which are signs of overdose (see section 
Bolnika je treba kontrolirati glede perioralnih parestezij in parestezij v okončinah, ki so znak prevelikega odmerjanja (glejte poglavje 4.9).
Note: The wording of this section should be revised for all SmPCs for products for intravenous administration of CMS/colistin to include the following statements: 
Opomba: Besedilo tega poglavja je treba revidirati v povzetkih glavnih značilnosti vseh zdravil za intravensko uporabo NKM/kolistina, da bodo obsegala naslednje navedbe:
Note: The wording of this section should be revised for all SmPCs for products for intravenous administration of CMS/colistin to include the following warnings: 
Opomba: Besedilo tega poglavja je treba revidirati v povzetkih glavnih značilnosti vseh zdravil za intravensko uporabo NKM/kolistina, da bodo obsegala naslednja opozorila:
EUCAST Breakpoints 
Mejne vrednosti po EUCAST
It is estimated that approximately 30% of colistimethate sodium is converted to colistin in healthy subjects, its clearance is dependent on creatinine clearance and as renal function decreases, a greater portion of CMS is converted to colistin. 
Očistek je odvisen od očistka kreatinina in z zmanjševanjem delovanja ledvic se večji delež NKM pretvori v kolistin.
Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution. 
Natrijev kolistimetat v vodni raztopini hidrolizira v zdravilno učinkovino kolistin.
There are no data in patients with hepatic impairment. 
Okvara jeter Podatkov o bolnikih z okvaro jeter ni.
After infusion of colistimethate sodium the inactive pro-drug is converted to the active colistin. 
Po infundiranju natrijevega kolistimetata se neaktivno predzdravilo pretvori v aktivni kolistin.
Confusion and medication errors have occurred because of the different expressions of dose in terms of potency. 
Zaradi različnega izražanja odmerka glede na jakost so se pojavile zmeda in napake pri uporabi zdravila.
Having [Product name] as an infusion at the same time as receiving [Product name] as an inhalation can increase your risk of side effects. 
Če dobite zdravilo [Ime zdravila] v infuziji in hkrati tudi v inhalaciji, to lahko poveča tveganje za neželene učinke.