FrancophonIA/ELRC3.0 huggingface dataset:
English: Dialysis is unlikely to be an efficient method of medicinal product removal due to high protein binding.
Slovenian: Zaradi obsežne vezave na beljakovine ni verjetno, da bi bilo zdravilo
English: NAME OF THE MEDICINAL PRODUCT Onsenal 400 mg capsules Celecoxib
Slovenian: Onsenal 400 mg kapsule celekoksib
English: Helicobacter infection, herpes zoster, erysipelas, wound infection, gingival infection, labrynthitis, bacterial infection Lipoma
Slovenian: okužba ušesa, glivična okužba okužba s Helicobactrom, herpes zoster, šen, okužba rane, okužbe dlesni, labirintitis, bakterijska okužba lipom motnja spanja cerebralni infarkt delci v steklovini, veznična krvavitev hipakuza nestabilna angina pektoris, insuficienca aortne zaklopke, ateroskleroza koronarnih arterij, sinusna bradikardija, prekatna hipertrofija globoka venska tromboza, hematomi disfonija hemoroidalna krvavitev, pogosto iztrebljanje, razjeda v ustih, stomatitis alergijski dermatitis in vezivnega tkiva ganglion
English: Celecoxib exhibits dose- and time-independent pharmacokinetics in the therapeutic dose range.
Slovenian: Farmakokinetika celekoksiba v terapevtskem odmernem območju ni odvisna od odmerka in časa.
English: Foot fracture, lower limb fracture, epicondylitis, tendon rupture,
Slovenian: Poškodbe, zastrupitve in zapleti pri postopkih zlom stopala, zlom spodnje okončine, epikondilitis, pretrganje tetive, zlom
English: Pfizer Polska Sp. z o.o Tel.:+48 22 335 61 00
Slovenian: Pfizer Hellas A.E. Τηλ: +30 210 6785 800
English: If you are quite unwell, you will be given a higher dose of 9 million units once at the start of treatment.
Slovenian: Če ste zelo bolni, boste dobili večji odmerek 9 milijonov enot enkrat na začetku zdravljenja.
English: Susceptible (S) Resistant (R) a
Slovenian: Občutljive (O) Rezistentne (R) a
English: The following conversion table is prepared for information and the values must be considered nominal and approximate only.
Slovenian: Naslednja preglednica za pretvorbo je informativna in vrednosti je treba obravnavati kot nominalne in le približne.
English: Therapeutic guidelines should be adhered to.
Slovenian: Upoštevati je treba terapevtske smernice.
English: For inhalation use.
Slovenian: Za inhalacijsko uporabo.
English: ATC Code: J01XB01
Slovenian: Oznaka ATC: J01XB01 Mehanizem delovanja
English: The most appropriate time interval to the first maintenance dose has not been established.
Slovenian: Najustreznejši časovni presledek za prvi vzdrževalni odmerek še ni ugotovljen.
English: Section 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: Poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Protein binding is moderate and decreases at higher concentrations.
Slovenian: Vezava na beljakovine je zmerna in se pri višjih koncentracijah zmanjša.
English: Your doctor may decide to adjust the dose depending on your circumstances.
Slovenian: Zdravnik lahko prilagodi odmerek glede na vaše okoliščine.
English: In some cases, your doctor may decide to give a higher daily dose of up to 12 million units.
Slovenian: V nekaterih primerih se zdravnik lahko odloči za uporabo večjega dnevnega odmerka, do 12 milijonov enot.
English: Clinical experience with such doses is however extremely limited, and safety has not been established.
Slovenian: A kliničnih izkušenj s takšnimi odmerki je izredno malo in varnost ni ugotovljena.
English: - medicines which can affect your nervous system.
Slovenian: - zdravila, ki lahko vplivajo na živčevje.
English: S≤4
Slovenian: O ≤ 4
English: [Product name] is used when other antibiotics are not suitable.
Slovenian: Zdravilo [Ime zdravila] se uporablja, kadar drugi antibiotiki niso primerni.
English: Firm dose recommendations cannot be made.
Slovenian: Trdnih priporočil za odmerjanje ni mogoče dati.
English: Based on limited data, the following dose is recommended in adults:
Slovenian: Na podlagi maloštevilnih podatkov je za odrasle priporočen naslednji odmerek:
English: There are indications that pharmacokinetics in critically ill patients differ from those in patients with less severe physiological derangement and from those in healthy volunteers.
Slovenian: Kot kaže, se farmakokinetika pri kritično bolnih bolnikih razlikuje od tiste pri bolnikih z manj hudimi fiziološkimi motnjami in od tiste pri zdravih prostovoljcih.
English: A loading dose (9 MIU) may be needed.
Slovenian: Potreben je lahko polnilni odmerek (9 Mi.e.
English: [Product name] can increase the effects of these medicines.
Slovenian: Zdravilo [Ime zdravila] lahko poveča učinke teh zdravil.
English: ≈ mass of CMS (mg)*
Slovenian: NKM (mg)*
English: S≤2
Slovenian: O ≤ 2
English: Higher doses have occasionally been given in cystic fibrosis.
Slovenian: Večje odmerke so občasno uporabljali pri cistični fibrozi.
English: [Information on suitable nebuliser(s) and output characteristics may be included]
Slovenian: [Vključite lahko informacije o primernem nebulizatorju/nebulizatorjih in njihovih izhodnih karakteristikah]
English: For children with a body weight above 40 kg, use of the dosing recommendation for adults should be considered.
Slovenian: Pri otrocih s telesno maso nad 40 kg pride v poštev uporaba priporočil za odmerjanje pri odraslih.
English: The following dose adjustments are suggested as guidance.
Slovenian: Naslednje prilagoditve odmerka so mišljene kot vodilo.
English: In case of an allergic reaction, treatment with colistimethate sodium must be discontinued and appropriate measures implemented.
Slovenian: V primeru alergijske reakcije je treba zdravljenje z natrijevim kolistimetatom prekiniti in ustrezno ukrepati.
English: The recommended doses in all subpopulations are equally based on limited data (clinical and pharmacokinetic/ pharmacodynamics data).
Slovenian: Priporočeni odmerki v vseh podpopulacijah prav tako temeljijo na maloštevilnih podatkih (kliničnih in farmakokinetičnih/farmakodinamičnih).
English: The product label states the number of IU per vial.
Slovenian: Označevanje zdravila navaja število i.e. na vialo.
English: Recommended dose range:
Slovenian: Priporočeni razpon odmerkov:
English: No in vivo interaction studies have been performed.
Slovenian: Študij medsebojnega delovanja in vivo niso izvedli.
English: Renal function monitoring should be performed at the start of treatment and regularly during treatment in all patients.
Slovenian: Vsem bolnikom je treba delovanje ledvic kontrolirati na začetku zdravljenja in redno med zdravljenjem.
English: There are no data regarding the use or magnitude of a loading dose in critically ill children.
Slovenian: Podatkov o uporabi ali velikosti polnilnega odmerka pri kritično bolnih otrocih ni.
English: In critically ill patients, half-life has been reported to be prolonged to around 9-18h.
Slovenian: Opisano je, da se pri kritično bolnih bolnikih razpolovni čas podaljša na približno 9 do 18 ur.
English: Colistimethate sodium should only be used when other, more commonly prescribed antibiotics are not effective or not appropriate.
Slovenian: Natrijev kolistimetat se sme uporabiti le, če drugi, pogosteje predpisovani antibiotiki niso učinkoviti ali niso primerni.
English: The following data are based on studies using HPLC to determine CMS/colistin plasma concentrations.
Slovenian: Naslednji podatki temeljijo na študijah z uporabo HLPC za določanje koncentracije NKM/kolistina v plazmi.
English: The use of intrathecal or intraventricular administration of colistimethate sodium in the treatment of meningitis was not systematically investigated in clinical trials and is supported by case reports only.
Slovenian: Intratekalna ali intraventrikularna uporaba natrijevega kolistimetata pri zdravljenju meningitisa ni sistematično raziskana v kliničnih preskušanjih in jo podpirajo le poročila o posameznih primerih.
English: Note: The wording of this section should be replaced with the following wording:
Slovenian: Opomba: Besedilo v tem poglavju je treba nadomestiti z naslednjim besedilom:
English: Dose reductions are recommended for patients with creatinine clearance < 50 ml/min: Twice daily dosing is recommended.
Slovenian: Odmerek je priporočljivo zmanjšati bolnikom z očistkom kreatinina < 50 ml/min: Priporočeno je odmerjanje dvakrat na dan.
English: In healthy subjects, 60% to 70% of CMS is excreted unchanged in the urine within 24 hours.
Slovenian: do 70 % NKM izloči nespremenjenega v urinu v 24 urah.
English: 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.
Slovenian: Preglednica za pretvorbo iz i.e. NKM v mg NKM ter v mg aktivnosti kolistinove baze (AKB) je vključena na koncu tega poglavja.
English: No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
Slovenian: Dnevi brez HD: 2,25 Mi.e./dan (2,2-2,3 Mi.e./dan).
English: The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients (see section 4.4):
Slovenian: Naslednja priporočila za odmerjanje temeljijo na maloštevilnih populacijskih farmakokinetičnih podatkih pri kritično bolnih bolnikih (glejte poglavje 4.4):
English: [Product name] is given by injection to treat some types of serious infections caused by certain bacteria.
Slovenian: Zdravilo [Ime zdravila] se daje v injekciji za zdravljenje nekaterih vrst resnih okužb, ki jih povzročajo določene bakterije.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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).
English: * Nominal potency of the drug substance = 12.500 IU/mg
Slovenian: * Nominalna jakost snovi zdravila = 12.500 i.e./mg
English: 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.
Slovenian: 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.
English: Three times daily dosing is recommended.
Slovenian: Priporočeno je odmerjanje trikrat na dan.
English: Medicinal products that inhibit peristalsis should not be given.
Slovenian: Ne sme se uporabiti zdravil, ki zavirajo peristaltiko.
English: Children and adults with kidney problems, including those on dialysis, are usually given lower doses.
Slovenian: Otroci in tisti odrasli, ki imajo težave z ledvicami (vključno z bolniki na dializi), po navadi dobijo manjše odmerke.
English: The loading dose applies to patients with normal and impaired renal functions including those on renal replacement therapy.
Slovenian: Polnilni odmerek velja za bolnike z normalnim in okvarjenim delovanjem ledvic, vključno z bolniki na ledvičnem nadomestnem zdravljenju.
English: CMS is eliminated predominantly by the kidneys via glomerular filtration.
Slovenian: NKM se izloča predvsem skozi ledvice z glomerularno filtracijo.
English: If other treatments are being taken, they should be taken in the order recommended by the physician.
Slovenian: V primeru uporabe drugih zdravil je treba ta zdravila vzeti v zaporedju, ki ga svetuje zdravnik.
English: In premature and new-born babies, special care should be taken when using [Product name] as the kidneys are not yet fully developed.
Slovenian: Pri nedonošenčkih in novorojenčkih je treba zdravilo [Ime zdravila] uporabljati posebej previdno, ker njihove ledvice še niso povsem razvite.
English: The usual daily dose in adults is 9 million units, divided into two or three doses.
Slovenian: Običajen dnevni odmerek za odrasle je 9 milijonov enot, razdeljen na dva ali tri odmerke.
English: A tabulated presentation of the posology could be considered acceptable.
Slovenian: Prikaz odmerjanja v preglednici lahko velja za sprejemljivega.
English: ≈ mg CBA
Slovenian: ≈ mg AKB
English: 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.
Slovenian: 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.
English: Other medicines and [Product name] - medicines which can affect how your kidneys function.
Slovenian: Druga zdravila in zdravilo [Ime zdravila] - zdravila, ki lahko vplivajo na delovanje ledvic.
English: HD days: 3 MIU/day on haemodialysis days, to be given after the HD session.
Slovenian: Dnevi HD: 3 Mi.e./dan na dneve hemodialize; zdravilo je treba dati po koncu HD.
English: Relevant clinical guidance on treatment regimens, including duration of treatment, periodicity and coadministration of other antibacterial agents should be adhered to.
Slovenian: Upoštevati je treba relevantne klinične smernice o shemah zdravljenja, vključno s trajanjem zdravljenja, periodičnostjo in sočasno uporabo drugih proti bakterijskih zdravil.
English: Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer membrane.
Slovenian: Polimiksini so selektivni za aerobne gramnegativne bakterije, ki imajo hidrofobno zunanjo membrano.
English: The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity (mg CBA).
Slovenian: V ZDA in drugod po svetu odmerek izražajo v miligramih aktivnosti kolistinove baze (mg AKB).
English: If you have a general anaesthetic, let your anaesthetist know that you are having [Product name]
Slovenian: Če boste dobili splošno anestezijo, morate anesteziologa obvestiti, da jemljete zdravilo [Ime zdravila].
English: There are limited clinical data on the efficacy and safety of intravenous colistimethate sodium.
Slovenian: Kliničnih podatkov o učinkovitosti in varnosti intravenskega natrijevega kolistimetata je malo.
English: CVVHF/ CVVHDF As in patients with normal renal function.
Slovenian: CVVHF/ CVVHDF Kot pri bolnikih z normalnim delovanjem ledvic.
English: Talk to your doctor, pharmacist or nurse before using [Product name] - If you have or have had kidney problems.
Slovenian: Pred uporabo zdravila [Ime zdravila] se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro - če imate ali ste imeli težave z ledvicami.
English: 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.
Slovenian: Previdnost je potrebna v primeru sočasne uporabe z drugimi oblikami natrijevega kolistimetata, ker je izkušenj glede tega malo in obstaja možnost aditivne toksičnosti.
English: The dosage can be adjusted depending on the severity of the condition and clinical response.
Slovenian: Odmerjanje je mogoče prilagoditi glede na izrazitost bolezni in klinični odziv.
English: The most commonly observed adverse effect of CMS administration was aseptic meningitis (see section 4.8).
Slovenian: Najpogosteje opažen neželen učinek uporabe NKM v osrednjem živčevju je bil aseptični meningitis (glejte poglavje 4.8).
English: What you need to know before you <take> <use> [Product name]
Slovenian: Kaj morate vedeti, preden boste <vzeli> <uporabili> [Ime zdravila]
English: fAUC/ MIC is considered to be correlated with clinical efficacy.
Slovenian: Za fAUC/MIC velja, da korelirata s klinično učinkovitostjo.
English: [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).
Slovenian: 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).
English: The elimination of the active colistin is incompletely characterised.
Slovenian: Izločanje aktivnega kolistina ni popolnoma opredeljeno.
English: The following regimes could be considered.
Slovenian: V poštev pridejo naslednje sheme.
English: Discontinuation of therapy and the administration of specific treatment for Clostridium difficile should be considered.
Slovenian: Prenehati je treba uporabljati to zdravilo in uvesti je treba specifično zdravljenje proti Clostridium difficile.
English: There are extremely limited data from population PK studies from very small numbers of patients on renal replacement therapy.
Slovenian: Izredno malo je podatkov iz populacijskih farmakokinetičnih študij pri zelo majhnem številu bolnikov na ledvičnem nadomestnem zdravljenju.
English: Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose.
Slovenian: Značilnost odpornih bakterij je sprememba fosfatnih skupin lipopolisaharidov, tako da jih nadomestita etanolamin ali aminoarabinoza.
English: 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).
Slovenian: Hipovolemični bolniki in bolniki, ki dobivajo druga potencialno nefrotoksična zdravila, imajo večje tveganje za nefrotoksičnost kolistina (glejte poglavji 4.5 in 4.8).
English: R>4 mg/L a Breakpoints apply to dosage of 2-3 MIU x 3.
Slovenian: R > 4 mg/l a Mejne vrednosti veljajo za odmerjanje 2-3 Mi.e.
English: The volume of distribution is relevantly enlarged in critically ill subjects.
Slovenian: Volumen porazdelitve je pri kritično bolnih bolnikih pomembno večji.
English: 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.
Slovenian: 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,
English: For special precautions for disposal and handling of reconstituted solutions, see section 6.6.
Slovenian: Za posebne previdnostne ukrepe pri odstranjevanju in ravnanju s pripravljenimi raztopinami glejte poglavje 6.6.
English: Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.
Slovenian: Naravno odporne gramnegativne bakterije, na primer Proteus mirabilis in Burkholderia cepacia, imajo lipidni fosfat v celoti nadomeščen z etanolaminom ali aminoarabinozo.
English: Dose adjustment is not considered necessary, however caution is advised in patients with renal impairment (see sections 4.4 and 5.2).
Slovenian: Prilagoditev odmerka ni potrebna, priporočljiva pa je previdnost pri bolnikih z okvaro ledvic (glejte poglavji 4.4 in 5.2).
English: The dose of colistimethate sodium should be adjusted according to creatinine clearance (see section 4.2).
Slovenian: Odmerek natrijevega kolistimetata je treba prilagoditi očistku kreatinina (glejte poglavje 4.2).
English: [Product name] is administered intravenously as a slow infusion over 30 - 60 minutes.
Slovenian: Zdravilo [Ime zdravila] se daje s počasno intravensko infuzijo v 30 do 60 minutah.
English: Intrathecal and intraventricular administration
Slovenian: Intratekalna in intraventrikularna uporaba
English: Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium.
Slovenian: Polimiksini delujejo tako, da poškodujejo celično membrano; posledični fiziološki učinki so za bakterijo smrtni.
English: Dose adjustments in renal impairment are necessary, but pharmacokinetic data available for patients with impaired renal function is very limited.
Slovenian: Bolnikom z okvaro ledvic je odmerek treba prilagoditi, toda farmakokinetičnih podatkov o bolnikih z okvarjenim delovanjem ledvic je zelo malo.
English: The usual dose for children less than 2 years old is 0.5-1 million units twice daily (maximum 2 million units per day).
Slovenian: Običajen odmerek za otroke, mlajše od 2 let, je 0,5 do 1 milijona enot dvakrat na dan (največ 2 milijona enot na dan).
English: Intravenous colistimethate sodium does not cross the blood brain barrier to a clinically relevant extent.
Slovenian: Intravensko uporabljeni natrijev kolistimetat ne prehaja skozi krvno-možgansko pregrado v klinično pomembni meri.
English: Polymyxins have been reported to have a concentration-dependent bactericidal effect on susceptible bacteria.
Slovenian: Opisano je, da imajo polimiksini od koncentracije odvisen baktericiden učinek na občutljive bakterije.
English: Colistin clearance is decreased in renal impairment, possibly due to increased conversion of CMS.
Slovenian: Očistek kolistina se pri okvari ledvic zmanjša, morda zaradi povečane pretvorbe v NKM.
English: 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.
Slovenian: 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.
English: Note: The existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the wording below:
Slovenian: Opomba: Obstoječe navodilo za uporabo morate spremeniti (z vstavljanjem, nadomeščanjem ali izbrisanjem besedila) tako, da bo odražalo spodnje formulacije:
English: Note: The existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the wording below.
Slovenian: Opomba: Obstoječe navodilo za uporabo morate spremeniti (z vstavljanjem, nadomeščanjem ali izbrisanjem besedila) tako, da bo odražalo spodnje formulacije.
English: How to <take><use> [Product name]
Slovenian: Kako <jemati><uporabljati> zdravilo [Ime zdravila]
English: [Product name] is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis.
Slovenian: Zdravilo [Ime zdravila] se daje v inhalaciji za zdravljenje kroničnih pljučnih okužb pri bolnikih s cistično fibrozo.
English: 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.
Slovenian: 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.
English: Twice daily dosing is recommended.
Slovenian: Priporočeno je odmerjanje dvakrat na dan.
English: The benefit of prolonged treatment duration should be balanced against the potentially increased risk of renal toxicity.
Slovenian: Koristi dolgotrajnega zdravljenja je treba pretehtati glede na možno večje tveganje nefrotoksičnosti.