FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid (ECF).
Slovenian: Volumen porazdelitve kolistina je pri zdravih osebah majhen in približno ustreza zunajcelični tekočini.
English: 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.
Slovenian: 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.
English: Modelling suggests that loading and maintenance doses of up to 12 MIU may be required in patients with good renal function in some cases.
Slovenian: Modeliranje kaže, da sta lahko v nekaterih primerih pri bolnikih z dobrim delovanjem ledvic potrebna polnilni in vzdrževalni odmerek do 12 milijonov i.e.
English: Creatinine clearance (ml/min)
Slovenian: (ml/min)
English: Note: If present, any contraindication in myasthenia gravis should be deleted, to be replaced with a warning in section 4.4, as indicated below.
Slovenian: 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.
English: 125.000 IU/day Intrathecally administered doses should not exceed those recommended for intraventricular use.
Slovenian: Intratekalno uporabljeni odmerki ne smejo presegati odmerkov, priporočenih za intraventrikularno uporabo.
English: Commonly susceptible species Acinetobacter baumannii
Slovenian: Acinetobacter baumannii
English: The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response.
Slovenian: Pri določanju odmerka in trajanja zdravljenja je treba upoštevati izrazitost okužbe in klinični odziv.
English: 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.
Slovenian: Če je lokalna prevalenca odpornosti takšna, da je uporabnost tega zdravila vsaj pri nekaterih vrstah okužb vprašljiva, je treba poiskati nasvet strokovnjaka.
English: Note: If intrathecal administration is included in the SmPC of your product, the following should also be included:
Slovenian: Opomba: Če je v povzetek glavnih značilnosti vašega zdravila vključena intratekalna uporaba, je treba vključiti tudi naslednje:
English: The information on the pharmacokinetics of colistimethate sodium (CMS) and colistin is limited.
Slovenian: Informacij o farmakokinetiki natrijevega kolistimetata (NKM) in kolistina je malo.
English: Impaired renal function increases the possibility of apnoea and neuromuscular blockade following administration of colistimethate sodium.
Slovenian: Okvarjeno delovanje ledvic poveča možnost za apnejo in živčno-mišično blokado po uporabi natrijevega kolistimetata.
English: [Product name] is given to you by your doctor as an infusion into a vein over 30 - 60 minutes.
Slovenian: Zdravilo [Ime zdravila] vam bo dal zdravnik z infuzijo v veno; infundiranje bo trajalo od 30 do 60 minut.
English: Dose conversion table:
Slovenian: Preglednica za pretvorbo odmerkov:
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents and may occur with colistimethate sodium.
Slovenian: Z antibiotiki povezani kolitis in psevdomembranski kolitis sta opisana pri skoraj vseh protibakterijskih zdravilih in se lahko pojavita tudi z natrijevim kolistimetatom.
English: In the absence of meningeal inflammation, penetration into the cerebrospinal fluid (CSF) is minimal, but increases in the presence of meningeal inflammation.
Slovenian: Če meninge niso vnete, je prodiranje v cerebrospinalno tekočino minimalno, v primeru vnetja mening pa se poveča.
English: In patients with very poor renal function (creatinine clearance <30 ml/min), the extent of conversion could be as high as 60 to 70%.
Slovenian: Pri bolnikih z zelo slabim delovanjem ledvic (očistek kreatinina < 30 ml/min) lahko pretvorba doseže kar
English: 4.5-5.5 MIU
Slovenian: 4,5-5,5 Mi.e.
English: 3.5 MIU
Slovenian: 3,5 Mi.e.
English: [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).
Slovenian: 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).
English: The dose is expressed in international units (IU) of colistimethate sodium (CMS).
Slovenian: Odmerek je izražen v internacionalnih enotah (i.e.) natrijevega kolistimetata (NKM).
English: Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials, polymyxins.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje infekcij, druge protimikrobne učinkovine,
English: The dose should be based on lean body weight.
Slovenian: Odmerek mora temeljiti na pusti telesni masi.
English: Annex III Amendments to relevant sections of the summary of product characteristics and the package leaflets
Slovenian: Spremembe relevantnih delov povzetka glavnih značilnosti zdravila in navodila za uporabo
English: Haemodialysis and continuous haemo(dia)filtration Colistin appears to be dialyzable through conventional haemodialysis and continuous venovenous haemo(dia)filtration (CVVHF, CVVHDF).
Slovenian: Kot kaže, se kolistin dializira z običajno hemodializo in s stalno veno-vensko hemo(dia)filtracijo (CVVHF, CVVHDF).
English: 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.
Slovenian: Največja koncentracija kolistina v plazmi se pri kritično bolnih bolnikih pojavi z zamudo do 7 ur po uporabi natrijevega kolistimetata.
English: Nephrotoxicity has been reported to be associated with cumulative dose and treatment duration in some studies.
Slovenian: V nekaterih študijah je bilo opisano, da je nefrotoksičnost povezana s kumulativnim odmerkom in trajanjem zdravljenja.
English: Children ≤ 40kg 75.000-150.000 IU/kg/day divided into 3 doses.
Slovenian: 75.000-150.000 i.e./kg/dan, razdeljeno na 3 odmerke.
English: Further, the effect of immature renal and metabolic function on the conversion of colistimethate sodium to colistin is not known.
Slovenian: Poleg tega ni znan vpliv nezrele ledvične in presnovne funkcije na pretvorbo natrijevega kolistimetata v kolistin.
English: Older people No dose adjustments in older patients with normal renal function are considered necessary.
Slovenian: Starejše osebe Starejšim bolnikom z normalnim delovanjem ledvic odmerka ni treba prilagoditi.
English: Changes agreed by the CHMP to the product information of CMS-containing products for injection or infusion
Slovenian: Spremembe, dogovorjene s CHMP za informacije o zdravilih za injiciranje ali infundiranje, ki vsebujejo NKM
English: Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group.
Slovenian: Kolistin je cikličen polipeptiden antibiotik iz skupine polimiksinov.
English: In the EU, the dose of colistimethate sodium (CMS) must be prescribed and administered only as International Units (IU).
Slovenian: V EU je dovoljeno odmerek natrijevega kolistimetata (NKM) predpisovati in uporabiti le izraženega v internacionalnih enotah (i.e.).
English: If present, any contraindication in myasthenia gravis should be deleted, to be replaced with a warning, as indicated below.
Slovenian: Če je navedena kakšna kontraindikacije pri miasteniji gravis, jo je treba odstraniti in nadomestiti z opozorilom, kot je navedeno spodaj.
English: In patients who are critically ill, a loading dose of 9 MIU should be administered.
Slovenian: Pri kritično bolnih bolnikih je treba uporabiti polnilni odmerek 9 milijonov i.e.
English: The mechanism of colistin clearance, including renal handling, is equally unknown.
Slovenian: Prav tako ni znan mehanizem očistka kolistina, vključno z dogajanjem v ledvicah.
English: The data supporting the dose regimen in paediatric patients are very limited.
Slovenian: Pediatrična populacija Podatkov v oporo shemi odmerjanja pri pediatričnih bolnikih je zelo malo.
English: 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).
Slovenian: Mi.e./dan), uporabi polnilnega odmerka in o posebnih populacijah (bolniki z okvaro ledvic in pediatrična populacija).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Taking such medicines at the same time as [Product name] can increase the risk of damage to the kidneys.
Slovenian: Jemanje takšnih zdravil hkrati z zdravilom [Ime zdravila] lahko poveča tveganje za neželene učinke na živčevju.
English: 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.
Slovenian: 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.
English: Concomitant use of intravenous colistimethate sodium with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.
Slovenian: Natrijev kolistimetat je treba zelo previdno uporabljati sočasno z drugimi potencialno nefrotoksičnimi ali nevrotoksičnimi zdravili.
English: Your doctor will monitor your kidney function regularly while you receive [Product name].
Slovenian: Zdravnik vam bo med zdravljenjem z zdravilom [Ime zdravila] redno kontroliral delovanje ledvic.
English: Data supporting the posology are very limited.
Slovenian: Podatkov v podporo odmerjanju je zelo malo.
English: Older people Dose adjustment is not considered necessary
Slovenian: Starejše osebe Prilagoditev odmerka ni potrebna.
English: They may range from mild to lifethreatening in severity.
Slovenian: Segata lahko od blagih do smrtno nevarnih oblik.
English: Colistimethate sodium should be used with extreme caution in patients with porphyria.
Slovenian: Pri bolnikih s porfirijo je treba natrijev kolistimetat uporabljati skrajno previdno.
English: It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium (see section 4.8).
Slovenian: Na to diagnozo treba pomisliti pri vsakem bolniku, ki se mu med uporabo natrijevega kolistimetata ali po njej pojavi driska (glejte poglavje 4.8).
English: 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).
Slovenian: Zato je treba pri bolnikih, ki dobivajo natrijev kolistimetat, nedepolarizirajoče mišične relaksante uporabljati previdno, ker se njihovi učinki lahko podaljšajo (glejte poglavje 4.4).
English: Renal maturity should be taken into consideration when selecting the dose.
Slovenian: Pri izbiri odmerka je treba upoštevati dozorelost ledvic.
English: Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation.
Slovenian: 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).
English: No specific dosing recommendation can be made in children for intrathecal and intraventricular routes of administration.
Slovenian: Za intratekalno in intraventrikularno pot uporabe pri otrocih ni mogoče dati specifičnih priporočil za odmerjanje.
English: Changes agreed by the CHMP to the Product Information of CMS-containing products for solution for inhalation or nebulisation
Slovenian: Spremembe, dogovorjene s CHMP za informacije o zdravilih za raztopino za inhaliranje ali za nebulizacijo, ki vsebujejo NKM
English: 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.
Slovenian: 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.
English: The use of doses >150.000 IU/kg/day has been reported in children with cystic fibrosis.
Slovenian: Pri otrocih s cistično fibrozo je opisana uporaba odmerkov > 150.000 i.e./kg/dan.
English: Resistance
Slovenian: Odpornost (rezistenca)
English: No dose recommendations have been established in children with impaired renal function.
Slovenian: Za otroke z okvarjenim delovanjem ledvic ni oblikovanih priporočil za odmerjanje.
English: Monitoring should be performed for perioral paraesthesia and paraesthesia in the extremities, which are signs of overdose (see section
Slovenian: Bolnika je treba kontrolirati glede perioralnih parestezij in parestezij v okončinah, ki so znak prevelikega odmerjanja (glejte poglavje 4.9).
English: 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:
Slovenian: Opomba: Besedilo tega poglavja je treba revidirati v povzetkih glavnih značilnosti vseh zdravil za intravensko uporabo NKM/kolistina, da bodo obsegala naslednje navedbe:
English: 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:
Slovenian: Opomba: Besedilo tega poglavja je treba revidirati v povzetkih glavnih značilnosti vseh zdravil za intravensko uporabo NKM/kolistina, da bodo obsegala naslednja opozorila:
English: EUCAST Breakpoints
Slovenian: Mejne vrednosti po EUCAST
English: 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.
Slovenian: Očistek je odvisen od očistka kreatinina in z zmanjševanjem delovanja ledvic se večji delež NKM pretvori v kolistin.
English: Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution.
Slovenian: Natrijev kolistimetat v vodni raztopini hidrolizira v zdravilno učinkovino kolistin.
English: There are no data in patients with hepatic impairment.
Slovenian: Okvara jeter Podatkov o bolnikih z okvaro jeter ni.
English: After infusion of colistimethate sodium the inactive pro-drug is converted to the active colistin.
Slovenian: Po infundiranju natrijevega kolistimetata se neaktivno predzdravilo pretvori v aktivni kolistin.
English: Confusion and medication errors have occurred because of the different expressions of dose in terms of potency.
Slovenian: Zaradi različnega izražanja odmerka glede na jakost so se pojavile zmeda in napake pri uporabi zdravila.
English: Having [Product name] as an infusion at the same time as receiving [Product name] as an inhalation can increase your risk of side effects.
Slovenian: Če dobite zdravilo [Ime zdravila] v infuziji in hkrati tudi v inhalaciji, to lahko poveča tveganje za neželene učinke.
English: It is recommended that colistimethate sodium (CMS) should be administered under the supervision of physicians with appropriate experience in its use.
Slovenian: Opomba: Besedilo v tem poglavju je treba nadomestiti z naslednjim besedilom: Priporočljivo je, da uporaba natrijevega kolistimetata (NKM) poteka pod nadzorom zdravnikov, ki imajo ustrezne izkušnje z njegovo uporabo.
English: Burkholderia cepacia and related species Proteus spp
Slovenian: Achromobacter xylosoxidans (prej Alcaligenes xylosoxidans) Inherentno odporni organizmi Burkholderia cepacia in sorodne vrste Proteus spp
English: Hepatic impairment Dose adjustment is not considered necessary
Slovenian: Prilagoditev odmerka ni potrebna.
English: Caution is advised when administering colistimethate sodium to infants < 1 year of age as renal function is not fully mature in this age group.
Slovenian: Pri dojenčkih, mlajših od 1 let, je treba natrijev kolistimetat uporabljati previdno, ker delovanje ledvic v tej starostni skupini še ni povsem dozorelo.
English: For dose preparation, particularly where combination of multiple vials is needed, reconstitution of the required dose must be performed using strict aseptic technique (see section 6.6).
Slovenian: Za pripravo odmerka je treba uporabiti strogo aseptičen postopek, še zlasti kadar je potrebno uporabiti več vial (glejte poglavje
English: Maintenance dose 9MIU/day in 2-3 divided doses
Slovenian: Odrasli in mladostniki Vzdrževalni odmerek 9 milijonov i.e./dan v 2 do 3 deljenih odmerkih
English: Species for which acquired resistance may be a problem
Slovenian: Vrste, pri katerih je lahko problem pridobljena odpornost Stenotrophomonas maltophilia
English: Do not <take><use> [Product name] If you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins.
Slovenian: - Če ste alergični (preobčutljivi) na natrijev kolistimetat, kolistin ali druge polimiksine.
English: If you also take other inhaled medicines, your doctor will tell you which order to taken them in.
Slovenian: vam bo zdravnik povedal, v kakšnem zaporedju jih uporabite.
English: The mechanism of conversion of colistimethate sodium to the active substance, colistin, is not characterised.
Slovenian: Mehanizem pretvorbe natrijevega kolistimetata v zdravilno učinkovino kolistin ni razjasnjen.
English: CMS conversion table
Slovenian: Preglednica za pretvorbo NKM Jakost
English: 5.5-7.5 MIU
Slovenian: Dnevni odmerek 5,5-7,5 Mi.e.
English: - If you suffer from myasthenia gravis - If you suffer from porphyria
Slovenian: - če imate porfirijo.
English: Adults and adolescents
Slovenian: Otroci, mlajši od 2 let
English: Both CMS and colistin display linear PK in the clinically relevant dose range.
Slovenian: V klinično pomembnem razponu odmerkov imata tako NKM kot kolistin linearno farmakokinetiko.
English: Taking such medicines at the same time as [Product name] can increase the risk of side effects in your nervous system - medicines called muscle relaxants, often used during general anaesthesia.
Slovenian: - zdravila, imenovana mišični relaksanti, ki se pogosto uporabljajo med splošno anestezijo.
English: [Product name] is used when these infections are cause by specific bacteria called Pseudomonas aeruginosa.
Slovenian: Zdravilo [Ime zdravila] se uporablja, če te okužbe povzročajo posebne bakterije, imenovane
English: If you suffer from myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking [Product name] further increases the risk of muscle weakness and breathing difficulties.
Slovenian: Če imate miastenijo gravis in jemljete tudi druge antibiotike, imenovane makrolidi (na primer azitromicin,
English: Respiratory arrest has been reported following intramuscular administration of colistimethate sodium.
Slovenian: Po intramuskularni uporabi natrijevega kolistimetata je bil opisan zastoj dihanja.
English: MIU = million IU
Slovenian: 1-2 Mi.e.
English: IU
Slovenian: ≈ masa
English: Children < 2 years 0.5-1 MIU twice daily (max 2 MIU/ day)
Slovenian: dvakrat na dan (največ 2 Mi.e./dan)
English: Caution is advised when administering colistimethate sodium in these patients.
Slovenian: Pri teh bolnikih je treba natrijev kolistimetat uporabljati previdno.
English: • Balance of water and salts in your body.
Slovenian: • Ravnovesje vode in soli v telesu.
English: The following measures will be taken where necessary:
Slovenian: Če bo treba, bo uporabil naslednje ukrepe:
English: These parameters should be carefully monitored during treatment.
Slovenian: Te parametre je treba med zdravljenjem skrbno kontrolirati.
English: If this happens to you, tell your doctor or nurse straight away.
Slovenian: Če se vam to zgodi, morate takoj povedati zdravniku ali medicinski sestri.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko pozneje posodobijo pristojni organi države članice v sodelovanju z referenčno državo članico, kot je primerno, v skladu s postopki določenimi v Poglavju 4 Naslova III Direktive 2001/83/EC.
English: Your doctor will monitor your heart and your unborn baby.
Slovenian: Zdravnik vam bo kontroliral srce in bo nadzoroval vašega nerojenega otroka.
English: You will receive <invented name> for a maximum of 48 hours.
Slovenian: Zdravilo <izmišljeno ime> boste prejemali največ 48 ur.
English: This short term delay may be used to implement other measures known to improve perinatal health.
Slovenian: Ta kratkotrajni odlog je mogoče izkoristiti za uporabo drugih ukrepov, ki izboljšajo perinatalno zdravje.
English: <invented name> is contra-indicated in the following conditions:
Slovenian: Zdravilo <izmišljeno ime> je kontraindicirano v naslednjih primerih:
English: Your doctor may also take blood tests to monitor for changes in your blood (see section 3).
Slovenian: Zdravnik lahko opravi tudi preiskave krvi za spremljanje sprememb v krvi (glejte poglavje 3).
English: *Hypotension (see section 4.4) *Peripheral vasodilatation.
Slovenian: *hipotenzija (glejte poglavje 4.4) *periferna vazodilatacija
English: This includes herbal medicines.
Slovenian: To velja tudi za zeliščna zdravila.
English: If you have ever experienced miscarriage in the first two trimesters of your pregnancy.
Slovenian: če ste kdaj imeli spontan splav v prvih dveh trimesečjih nosečnosti.
English: <invented name> can have an effect on the way some medicines work, and some medicines can effect how <invented name> works.
Slovenian: Zdravilo <izmišljeno ime> lahko vpliva na delovanje nekaterih zdravil in nekatera zdravila lahko vplivajo na delovanje zdravila <izmišljeno ime>.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure.
Slovenian: Ta Povzetek glavnih značilnosti zdravila, Označevanje in Navodilo za uporabo so rezultat napotitvenega postopka.