natgillin/translations-raw huggingface dataset:
Note: The wording of this section should be replaced with the following wording:
Opomba: Besedilo v tem poglavju je treba nadomestiti z naslednjim besedilom:
Dose reductions are recommended for patients with creatinine clearance < 50 ml/min: Twice daily dosing is recommended.
Odmerek je priporočljivo zmanjšati bolnikom z očistkom kreatinina < 50 ml/min: Priporočeno je odmerjanje dvakrat na dan.
In healthy subjects, 60% to 70% of CMS is excreted unchanged in the urine within 24 hours.
do 70 % NKM izloči nespremenjenega v urinu v 24 urah.
A conversion table from CMS in IU to mg of CMS as well as to mg of colistin base activity (CBA) is included at the end of this section.
Preglednica za pretvorbo iz i.e. NKM v mg NKM ter v mg aktivnosti kolistinove baze (AKB) je vključena na koncu tega poglavja.
No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
Dnevi brez HD: 2,25 Mi.e./dan (2,2-2,3 Mi.e./dan).
The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients (see section 4.4):
Naslednja priporočila za odmerjanje temeljijo na maloštevilnih populacijskih farmakokinetičnih podatkih pri kritično bolnih bolnikih (glejte poglavje 4.4):
[Product name] is given by injection to treat some types of serious infections caused by certain bacteria.
Zdravilo [Ime zdravila] se daje v injekciji za zdravljenje nekaterih vrst resnih okužb, ki jih povzročajo določene bakterije.
Note: The following intrathecal and intraventricular administration posology recommendations should be included in the SmPC as the current pharmaceutical formulation of all products included in this procedure is suitable for these routes of administration (based on the pH, absence of preservatives and antioxidant and volume for injection).
Opomba: V povzetek glavnih značilnosti zdravila je treba vključiti naslednja priporočila za intratekalno in intraventrikularno uporabo, ker je trenutno farmacevtska oblika vseh zdravil, vključenih v ta postopek, primerna za takšno pot uporabe (glede na pH, odsotnost konzervansov in antioksidanta ter količino za injiciranje).
Colistimethate sodium or colistin did not induce the activity of any P 450 (CYP) enzyme tested (CYP1A2, 2B6, 2C8, 2C9, 2C19 and 3A4/5) in in vitro studies in human hepatocytes.
Natrijev kolistimetat v študijah in vitro na človeških hepatocitih ni induciral aktivnosti nobenega od testiranih encimov P 450 (CYP) (CYP1A2, 2B6, 2C8, 2C9, 2C19 in 3A4/5).
* Nominal potency of the drug substance = 12.500 IU/mg
* Nominalna jakost snovi zdravila = 12.500 i.e./mg
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Občutljivost Prevalenca pridobljene odpornosti se lahko pri določenih vrstah spreminja geografsko in s časom, zato je zaželeno, da dobite lokalne podatke o odpornosti mikroorganizmov, še posebej pri zdravljenju hudih okužb.
Three times daily dosing is recommended.
Priporočeno je odmerjanje trikrat na dan.
Medicinal products that inhibit peristalsis should not be given.
Ne sme se uporabiti zdravil, ki zavirajo peristaltiko.
Children and adults with kidney problems, including those on dialysis, are usually given lower doses.
Otroci in tisti odrasli, ki imajo težave z ledvicami (vključno z bolniki na dializi), po navadi dobijo manjše odmerke.
The loading dose applies to patients with normal and impaired renal functions including those on renal replacement therapy.
Polnilni odmerek velja za bolnike z normalnim in okvarjenim delovanjem ledvic, vključno z bolniki na ledvičnem nadomestnem zdravljenju.
CMS is eliminated predominantly by the kidneys via glomerular filtration.
NKM se izloča predvsem skozi ledvice z glomerularno filtracijo.
If other treatments are being taken, they should be taken in the order recommended by the physician.
V primeru uporabe drugih zdravil je treba ta zdravila vzeti v zaporedju, ki ga svetuje zdravnik.
In premature and new-born babies, special care should be taken when using [Product name] as the kidneys are not yet fully developed.
Pri nedonošenčkih in novorojenčkih je treba zdravilo [Ime zdravila] uporabljati posebej previdno, ker njihove ledvice še niso povsem razvite.
The usual daily dose in adults is 9 million units, divided into two or three doses.
Običajen dnevni odmerek za odrasle je 9 milijonov enot, razdeljen na dva ali tri odmerke.
A tabulated presentation of the posology could be considered acceptable.
Prikaz odmerjanja v preglednici lahko velja za sprejemljivega.
≈ mg CBA
≈ mg AKB
The usual daily dose in children weighing up to 40 kg is 75.000 to 150.000 units per kilogram body weight, divided into three doses.
Običajen dnevni odmerek za otroke, ki tehtajo do 40 kg, je 75.000 do 150.000 enot na kilogram telesne mase, razdeljen v tri odmerke.
Other medicines and [Product name] - medicines which can affect how your kidneys function.
Druga zdravila in zdravilo [Ime zdravila] - zdravila, ki lahko vplivajo na delovanje ledvic.
HD days: 3 MIU/day on haemodialysis days, to be given after the HD session.
Dnevi HD: 3 Mi.e./dan na dneve hemodialize; zdravilo je treba dati po koncu HD.
Relevant clinical guidance on treatment regimens, including duration of treatment, periodicity and coadministration of other antibacterial agents should be adhered to.
Upoštevati je treba relevantne klinične smernice o shemah zdravljenja, vključno s trajanjem zdravljenja, periodičnostjo in sočasno uporabo drugih proti bakterijskih zdravil.
Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer membrane.
Polimiksini so selektivni za aerobne gramnegativne bakterije, ki imajo hidrofobno zunanjo membrano.
The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity (mg CBA).
V ZDA in drugod po svetu odmerek izražajo v miligramih aktivnosti kolistinove baze (mg AKB).
If you have a general anaesthetic, let your anaesthetist know that you are having [Product name]
Če boste dobili splošno anestezijo, morate anesteziologa obvestiti, da jemljete zdravilo [Ime zdravila].
There are limited clinical data on the efficacy and safety of intravenous colistimethate sodium.
Kliničnih podatkov o učinkovitosti in varnosti intravenskega natrijevega kolistimetata je malo.
CVVHF/ CVVHDF As in patients with normal renal function.
CVVHF/ CVVHDF Kot pri bolnikih z normalnim delovanjem ledvic.
Talk to your doctor, pharmacist or nurse before using [Product name] - If you have or have had kidney problems.
Pred uporabo zdravila [Ime zdravila] se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro - če imate ali ste imeli težave z ledvicami.
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.