natgillin/translations-raw huggingface dataset:
The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to Common = ≥ 1/ 100 ,< 1/10; Uncommon = > 1/1 ,000, < 1/100; Rare = > 1/10,000, < 1/ 1,000, Very rare = ≤ 1/10 ,000:
O naslednjih neželenih učinkih so poročali med terapijo in kontrolnimi pregledi z navedbo pogostnosti, ki ustreza dogovoru: pogosti ≥ 1/ 100, < 1/ 10; občasni ≥ 1/ 1. 000, < 1/ 100; redki ≥ 1/ 10. 000, < 1/ 1000; zelo redki < 1/ 10. 000:
6 Infections and Infestations Common:
6 V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Urinary tract infection
Infekcijske in parazitske bolezni Pogoste: glivične okužbe Občasne: okužbe urinarnega trakta
Thrombocythaemia, anaemia, eosinophilia
Bolezni krvi in limfatičnega sistema Občasne: trombocitemija, anemija, eozinofilija
Anorexia, hyperglycaemia
Presnovne in prehranske motnje Občasne: anoreksija, hiperglikemija
Anxiety, insomnia
Psihiatrične motnje Občasne: strah, nespečnost
Dizziness, paraesthesiae, taste disorder
Bolezni živčevja Pogoste: glavobol Občasne: vrtoglavica, parestezije, motnje okusa
Supraventricular tachycardia, extrasystole
Srčne bolezni Občasne: supraventrikularna tahikardija, ekstrasistole
Flushes, hypertension, hypotension
Žilne bolezni Občasne: navali rdečice, hipertenzija, hipotenzija
Constipation, abdominal pain, dyspepsia, glossitis
Bolezni prebavil Pogoste: slabost, bruhanje, driska Občasne: zaprtje, abdominalne bolečine, dispepsija, glositis
Jaundice
Bolezni jeter, žolčnika in žolčevodov Občasne: zlatenica
Pruritis, urticaria
Bolezni kože in podkožja Pogoste: izpuščaj Občasne: pruritis, urtikarija
Myositis, muscle weakness, muscle pain, arthralgia
Bolezni mišično- skeletnega sistema, vezivnega tkiva in kosti Občasne: miozitis, mišična slabost, bolečine v mišicah, artralgija
Renal insufficiency, including renal impairment and renal failure
Bolezni sečil Občasne: ledvična insuficienca, vključno z okvaro ledvic in ledvično odpovedjo
Vaginitis
Motnje reprodukcije in dojk Občasne: vaginitis
Pyrexia, weakness, fatigue, pain
Splošne težave in spremembe na mestu aplikacije Pogoste: reakcije na mestu infundiranja Občasne: zvišana telesna temperatura, slabotnost, utrujenost, bolečine
Liver function tests abnormal (increased AST, ALT and alkaline phosphatase), increased CPK Uncommon:
Občasne:
Electrolyte imbalance, increased serum creatinine, increased myoglobin, Lactic dehydrogenase (LDH) increased
Porušeno elektrolitsko ravnovesje, povišan serumski kreatinin, povišan mioglobin, povišana laktat dehidrogenaza (LDH)
7 Post-Marketing Adverse reactions that have been reported Post-Marketing that are not listed above are:
Postmarketinško obdobje Neželeni učinki, o katerih so poročali v postmarketinškem obdobju:
Immune system disorders Hypersensitivity, manifested by isolated spontaneous reports including, but not limited to; pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling.
7 Bolezni imunskega sistema Preobčutljivosti, ki so bile opisane v posameznih poročanjih, so med drugim vključevale: pulmonalne eozinofilije, vezikulobulozne izpuščaje s prizadetostjo mukozne membrane in občutkom orofaringealne otekline.
Anaphylaxis Infusion reactions including the following symptoms: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste.
Anafilaksija Reakcije na infundiranje, vključno z naslednjimi simptomi: tahikardija, sopenje, zvišana telesna temperatura, okorelost, rdečica vsega telesa, vrtoglavica, sinkopa in kovinski okus.
Musculoskeletal, connective tissue and bone disorders Rhabdomyolysis When clinical information on the patients was available to make a judgement, approximately 50% of the cases occurred in patients with pre-existing renal insufficiency, or in those receiving concomitant medications known to cause rhabdomyolysis.
Bolezni mišično- skeletnega sistema in vezivnega tkiva Rabdomioliza Kjer so bile na voljo klinične informacije o bolnikih, je bilo moč ugotoviti, da se je približno 50% primerov zgodilo pri bolnikih z obstoječo ledvičo insuficienco ali pa pri tistih, ki so sočasno prejemali zdravila, za katera je znano, da povzročajo rabdomiolizo.
Nervous system disorders Peripheral neuropathy
Bolezni živčevja Periferna nevropatija
Investigations In some cases of myopathy involving raised CPK and muscle symptoms, the patients also presented with elevated transaminases.
Preiskave Pri nekaterih bolnikih z miopatijo z zvišano CPK in mišičnimi simptomi so zabeležili tudi zvišane vrednosti aminotransferaz.
The majority of transaminase elevations were of Grade 1-3 toxicity and resolved upon discontinuation of treatment.
Največkrat so bile vrednosti aminotransferaz zvišane v toksičnem razredu 1- 3 in so se po prekinitvi zdravljenja znižale.
In the event of overdose, supportive care is advised.
V primeru prevelikega odmerjanje svetujemo podporno nego.
Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
Daptomicin se počasi očisti iz telesa s hemodializo (približno 15% danega odmerka se očisti v 4 urah) ali s peritonealno dializo (približno 11% danega odmerka se očisti v 48 urah).
Antibacterials for systemic use, Other antibacterials, ATC code:
Zdravila za sistemsko zdravljenje bakterijskih infekcij, Druga zdravila za zdravljenje bakterijskih infekcij, oznaka ATC:
Mode of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Način delovanja Daptomicin je ciklični lipopeptid naravnega izvora, ki deluje samo proti po Gramu pozitivnim bakterijam.
PK/ PD relationship Daptomycin exhibits rapid, concentration dependent bactericidal activity against sensitive Gram positive organisms in vitro.
Farmakokinetično/ farmakodinamično razmerje Daptomicin ima hiter, od koncentracije odvisen baktericiden učinek proti občutljivim po Gramu pozitivnim organizmom in vitro.
In animal models AUC/ MIC and Cmax/ MIC correlate with efficacy and predicted bacterial kill in vivo at single doses equivalent to human doses of 4 mg/ kg and 6 mg/ kg once daily.
Na živalskih modelih razmerji AUC/ MIK in Cmax/ MIK korelirata z učinkovitostjo in napovedano povzročitvijo smrti bakterij in vivo pri enkratnih odmerkih, ki ustrezajo odmerku za ljudi 4 mg/ kg in 6 mg/ kg enkrat dnevno.
8 Mechanisms of resistance Strains with decreased susceptibility to daptomycin have been reported especially during the treatment of patients with difficult-to-treat infections and/ or following administration for prolonged periods.
Mehanizmi rezistence Posebno pri zdravljenju bolnikov s hudimi okužbami, ki jih je težko zdraviti, in/ ali po dolgotrajnejšem zdravljenju so poročali o sevih z zmanjšano občutljivostjo za daptomicin.
In particular, there have been reports of treatment failures in patients infected with Staphylococcus aureus, Enterococcus faecalis or Enterococcus faecium, including bacteraemic patients, that have been associated with the selection of organisms with reduced susceptibility or frank resistance to daptomycin during therapy.
O neuspehu zdravljenja so poročali predvsem pri bolnikih, ki so bili okuženi s Staphylococcus aureus, z Enterococcus faecalis ali z Enterococcus faecium, med drugim pri bolnikih, ki so imeli med zdravljenjem bakteriemijo v
The mechanism of resistance to daptomycin has not yet been identified.
Mehanizma rezistence na daptomicin še niso odkrili.
Breakpoints Minimum inhibitory concentration (MIC) breakpoint established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for Staphylococci and Streptococci (except S. pneumoniae) are Susceptible ≤ 1 mg/ l and Resistant > 1 mg/ l.
Koncentracije za dosego želenega protibakterijskega delovanja Minimalna inhibitorna koncentracija (MIK) za dosego želenega protibakterijskega delovanja, ki jo je za stafilokoke in streptokoke (razen S. pneumoniae) določil Evropski odbor za testiranje protimikrobne občutljivosti (EUCAST), je za občutljive ≤ 1 mg/ l in za odporne > 1 mg/ l.
Susceptibility The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Občutljivost Prevalenca občutljivosti lahko geografsko in časovno variira za izbrane vrste in lokalne informacije o rezistenci so zaželene, še posebno kadar gre za zdravljenje hudih okužb.
Commonly Susceptible Species Staphylococcus aureus * Staphylococcus haemolyticus Coagulase negative staphylococci Streptococcus agalactiae* Streptococcus dysgalactiae subsp equisimilis* Streptococcus pyogenes* Group G streptococci Clostridium perfringens Peptostreptococcus spp Inherently resistant organisms Gram negative organisms * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Splošno občutljive vrste Staphylococcus aureus * Staphylococcus haemolyticus koagulaza negativni stafilokoki Streptococcus agalactiae * Streptococcus dysgalactiae subsp equisimilis * Streptococcus pyogenes * streptokoki skupine G Clostridium perfringens Peptostreptococcus spp Po naravi odporni organizmi po Gramu negativni organizmi * zaznamuje vrste, za katere velja, da je bilo delovanje proti njim zadovoljivo prikazano v kliničnih študijah
Information from clinical trials In two clinical trials in complicated skin and soft tissues infections, 36% of patients treated with Cubicin met the criteria for systemic inflammatory response syndrome (SIRS).
Informacije iz kliničnih preskušanj V dveh kliničnih preskušanjih pri zapletenih okužbah kože in mehkih tkiv je 36% bolnikov, zdravljenih z zdravilom Cubicin, ustrezalo kriterijem za sindrom sistemskega vnetnega odziva (SIRS).
The most common type of infection treated was wound infection (38% of patients), while 21% had major abscesses.
Najbolj pogost tip zdravljene okužbe je bila okužba rane (38% bolnikov), medtem ko je imelo 21% bolnikov manjše abscese.
These limitations of the patients population treated should be taken into account when deciding to use Cubicin.
Kadar se odločate za uporabo zdravila Cubicin, bi morali upoštevati navedene omejitve za skupine bolnikov, ki jih zdravite.
In a randomised controlled open-label study in 235 patients with Staphylococcus aureus bacteraemia (i. e, at least one positive blood culture of Staphylococcus aureus prior to receiving the first dose) 19 of 120 patients treated with Cubicin met the criteria for RIE.
V randomizirani kontrolirani odprti študiji z 235 bolniki, ki so imeli bakteriemijo s Staphylococcus aureus (to pomeni, da so imeli pred prvim odmerkom vsaj eno hemokulturo pozitivno na Staphylococcus aureus), je 19 od 120 bolnikov ustrezalo kriterijem za infektivni endokarditis desne strani.
The success rates in RIE patients are shown in the table below.
Deleži odzivov pri bolnikih z infektivnim endokarditisom desne strani so prikazani v spodnji preglednici.
9 Differences in Population
primerjalno skupine bolnikov
Comparator
zdravilo
Success
razlike v odzivih
Rates (95% CI)
deleži (95% IZ)
RIE PP (per protocol) Population
infektivni endokarditis desne strani PP populacija (bolniki, zdravljeni v skladu s protokolom)
RIE
infektivni endokarditis desne strani
Failure of treatment due to persisting or relapsing Staphylococcus aureus infections was observed in 19/ 120 (15.8%) patients treated with Cubicin, 9/ 53 (16.7%) patients treated with vancomycin and 2/ 62 (3.2%) patients treated with an anti-staphylococcal semi-synthetic penicillin.
9 Neuspeh zdravljenja zaradi persistentne ali ponovne okužbe z bakterijo Staphylococcus aureus so opažali pri 19 od 120 bolnikov (15, 8%), zdravljenih z zdravilom Cubicin, pri 9 od 53 bolnikov (16, 7%), zdravljenih z vankomicinom, in pri 2 od 62 bolnikov (3, 2%), zdravljenih z antistafilokoknim polsintetičnim penicilinom.
Among these failures six patients treated with Cubicin and one patient treated with vancomycin were infected with Staphylococcus aureus that developed increasing MICs of daptomycin on or following therapy (see “ Mechanisms of resistance” above).
Med temi bolniki je bilo šest bolnikov, zdravljenih z zdravilom Cubicin, in en bolnik, zdravljen z vankomicinom, okuženih s sevom Staphylococcus aureus, pri katerem je prišlo do zviševanja MIK daptomicina v času zdravljenja ali po njem (glejte zgoraj odstavek “ Mehanizmi rezistence ”).
Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/ kg administered as a single daily dose for up to 14 days in healthy volunteers.
Farmakokinetika daptomicina je pri odmerkih od 4 do 12 mg/ kg, danih zdravim prostovoljcem v enkratnem dnevnem odmerku do 14 dni, običajno linearna in neodvisna od časa.
Distribution The steady state volume of distribution of daptomycin was approximately 0.1 l/ kg in healthy adult volunteers, consistent with distribution primarily within the extracellular space.
Porazdelitev Volumen porazdelitve daptomicina v stanju dinamičnega ravnovesja je pri zdravem odraslem prostovoljcu znašal približno 0, 1 l/ kg, kar ustreza prvenstveno porazdelitvi znotraj zunajceličnega prostora.
Tissue distribution studies in animals have shown that daptomycin preferentially distributes into highly vascularised tissues and to a lesser degree penetrates the blood-brain barrier and the placental barrier following single and multiple doses.
Študije o porazdelitvi v tkivih pri živalih so pokazale, da se daptomicin, po enkratnem in večkratnih odmerkih, prednostno porazdeli v bogato vaskulariziranih tkivih in v manjši meri prehaja krvno- možgansko bariero in placentarno bariero.
In healthy volunteers and patients treated with daptomycin, protein binding averaged about 90% including subjects with renal insufficiency.
Pri zdravih prostovoljcih in bolnikih zdravljenih z daptomicinom je vezava na proteine znašala povprečno okrog 90%, vključno z osebami z ledvično insuficienco.
Metabolism In vitro studies have demonstrated that there is no or limited liver microsomal mediated metabolism of daptomycin in humans and that CYP450 involvement in daptomycin metabolism is minimal.
Presnova In vitro študije so pokazale, da pri ljudeh ni jetrnega mikrosomalnega metabolizma daptomicina oziroma je prisoten v zelo omejenem obsegu, in da je vpliv CYP450 na metabolizem daptomicina minimalen.
Analysis of plasma samples from subjects who received a 6 mg/ kg dose of daptomycin did not show any trace of metabolism, suggesting little to no systemic metabolism.
Analiza vzorcev plazme oseb, ki so prejele odmerek daptomicina 6 mg/ kg, niso pokazale nobenih sledi presnove, kar kaže na malo ali nič sistemskega metabolizma.
Furthermore, no metabolites have been observed in plasma following administration of radiolabeled drug to humans based on total radiolabel and microbiologically active concentrations.
Poleg tega po dajanju radioaktivno označenega zdravila pri ljudeh v plazmi niso opazili nobenih metabolitov na osnovi celotne količine radioaktivnega označevalca in mikrobiološko aktivnih koncentracij.
Of the four minor metabolites detected in urine, two are Phase I oxidative metabolites present in low concentrations.
Od štirih manjših metabolitov, ki so jih našli v urinu, sta dva oksidacijska metabolita iz faze I, prisotna v nizkih koncentracijah.
Elimination Daptomycin is excreted primarily by the kidneys.
Izločanje Daptomicin se večinoma izloča preko ledvic.
Concomitant administration of probenecid and daptomycin has no effect on daptomycin pharmacokinetics in humans suggesting minimal to no active tubular secretion of daptomycin.
Sočasno dajanje probenecida in daptomicina nima vpliva na farmakokinetiko daptomicina pri ljudeh, kar kaže na minimalno ali neobstoječo aktivno tubularno sekrecijo daptamicina.
10 Following intravenous administration, plasma clearance of daptomycin is approximately 7 to 9 ml/ h/ kg and its renal clearance is 4 to 7 ml/ h/ kg.
Po intravenskemu dajanju znaša plazemski očistek daptomicina približno 7 do 9 ml/ h/ kg in ledvični očistek 4 do 7 ml/ h/ kg.
In a mass balance study using radiolabelled material, 78% of the administered dose was recovered from the urine based on total radioactivity, whilst urinary recovery of unchanged daptomycin was approximately 50% of the dose.
V študiji snovne bilance z uporabo radioaktivno označenega materiala je bilo mogoče zaslediti v urinu 78% danega odmerka na podlagi celotne radioaktivnosti, medtem ko je znašalo izločanje nespremenjenega daptomicina z urinom približno 50% odmerka.
About 5% of the administered radiolabel was excreted in the faeces.
Okrog 5% danega radioaktivnega označevalca se je izločilo z blatom.
Special populations
10 Posebne skupine bolnikov
Elderly No dose adjustment is necessary based on age alone.
Starejši Samo na osnovi starosti prilagajanje odmerka ni potrebno.
However, renal function should be assessed and the dose should be reduced if there is evidence of severe renal insufficiency.
Vseeno pa je potrebno oceniti ledvično funkcijo in odmerek zmanjšati, če obstajajo dokazi za hudo ledvično insuficienco.
Children and adolescents (< 18 years of age) Pharmacokinetic profiles were obtained following single intravenous administration of daptomycin 4 mg/ kg in paediatric patients with proven or suspected Gram-positive infection, divided into three age groups (2-6 years, 7-11 years and 12-17 years).
2- 6 let, 7- 11 let in 12- 17 let.
The pharmacokinetics of daptomycin following a single 4 mg/ kg dose in adolescents aged 12-17 years are generally similar to those of healthy adult subjects with normal renal function with trends towards lower AUC and Cmax in adolescents.
Pri mladostnikih, starih 12- 17 let, so farmakokinetične lastnosti daptomicina po enkratnem odmerku 4 mg/ kg v glavnem enake kot pri zdravih odraslih z normalnim delovanjem ledvic, s tem da pri mladostnikih AUC in Cmax kažeta trend zniževanja.
In the younger age groups (2-6 years and 7-11 years), exposure (Cmax and AUC) and elimination half-life for the same mg/ kg dose were reduced compared with adolescents.
Pri mlajših starostnih skupinah (2- 6 let in 7- 11 let) sta pri enakem odmerku v mg/ kg izpostavljenost zdravilu (Cmax in AUC) ter razpolovni čas izločanja nižja v primerjavi z mladostniki.
Obesity Relative to non-obese subjects daptomycin systemic exposure measured by AUC is increased by about 28% in moderately obese subjects (Body Mass Index of 25-40 kg/ m2) and by 42% in extremely obese subjects (Body Mass Index of > 40 kg/ m2).
Debelost V primerjavi z osebami, ki niso debele je sistemska izpostavljenost daptomicinu, merjena v obliki AUC, večja za okrog 28% pri srednje debelih osebah (indeks telesne mase 25- 40 kg/ m2) in za 42% pri izredno debelih osebah (indeks telesne mase > 40 kg/ m2).
Gender No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
Spol V farmakokinetiki daptomicina niso opazili nikakršnih klinično pomembnih razlik, povezanih s spolom.
Renal insufficiency Following administration of a single 4 mg/ kg or 6 mg/ kg dose of daptomycin to subjects with various degrees of renal insufficiency, daptomycin clearance (CL) was reduced and systemic exposure (AUC) was increased.
Ledvična insuficienca Pri dajanju enkratnih odmerkov daptomicina 4 mg/ kg ali 6 mg/ kg osebam z različnimi stopnjami ledvične insuficience je bil njihov očistek daptomicina (CL) manjši, sistemska izpostavljenost (AUC) pa večja.
In subjects with severe renal insufficiency (CLcr < 30 ml/ min) and end-stage renal disease, exposure (AUC) and elimination half life were increased between 2-3-fold relative to healthy subjects.
Pri osebah s hudo ledvično insuficienco (CLcr < 30 ml/ min) in končno ledvično odpovedjo sta bila izpostavljenost (AUC) in razpolovni čas izločanja 2- 3- krat večja v primerjavi z zdravimi osebami.
See section 4.2 regarding the need for dose adjustment.
Glejte poglavje 4. 2 glede potrebe po prilagajanju odmerka.
Hepatic insufficiency The pharmacokinetics of daptomycin is not altered in subjects with moderate hepatic insufficiency (Child-Pugh B classification of hepatic insufficiency) compared with healthy volunteers matched for gender, age and weight following a single 4 mg/ kg dose.
Jetrna insuficienca Farmakokinetika daptomicina pri osebah z zmerno jetrno insuficienco (klasifikacija jetrne insuficience Child Pugh B) pri dajanju enkratnih odmerkov 4 mg/ kg ni spremenjena v primerjavi z zdravimi prostovoljci, primerljivimi glede na spol, starost in težo.
No dosage adjustment is necessary when administering daptomycin in patients with moderate hepatic insufficiency.
Pri dajanju daptomicina bolnikom z zmerno jetrno insuficienco prilagajanje odmerka ni potrebno.
The pharmacokinetics of daptomycin in patients with severe hepatic insufficiency (Child-Pugh C classification) have not been evaluated.
Farmakokinetika daptomicina pri bolnikih s hudo jetrno insuficienco (klasifikacija Child Pugh C) še ni bila ocenjena.
In studies of clinically-relevant duration (14-28 days), daptomycin administration was associated with minimal to mild degenerative/ regenerative changes in skeletal muscle in the rat and dog.
V študijah s klinično relevantnim trajanjem (14- 28 dni) je bilo dajanje daptomicina povezano z minimalnimi do blagimi degenerativnimi/ regenerativnim spremembami skeletnih mišic pri podganah in psih.
Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK.
Mikroskopskih sprememb v skeletnih mišicah je bilo zelo malo (prizadetih je bilo približno 0, 05% mišičnih vlaken), višji odmerki pa so bili povezani z zvišanjem CPK.
11 The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/ kg for patients with normal renal function.
Do najnižje koncentracije z opaznim učinkom (the lowest observable effect level - LOEL) za miopatijo je pri podganah in psih prišlo pri izpostavljenostih, ki so bile 0, 8 do 2, 3- kratniki terapevtskih koncentracij pri človeku pri odmerjanju 6 mg/ kg za bolnike z normalnim delovanjem ledvic.
Effects on peripheral nerves were observed at higher doses than those associated with skeletal muscle effects in adult rats and dogs, and were primarily related to plasma Cmax.
11 Učinke na periferne živce so opazili pri odmerkih, ki so bili višji od tistih, povezanih z vplivi na skeletne mišice pri podganah in psih, in so se nanašali predvsem na Cmax v plazmi.
Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 6 mg/ kg once daily in patients with normal renal function.
Glede učinkov na periferne živce je določanje še varnih odmerkov temeljilo na primerjavi med 8- kratno (pri podganah) oziroma 6- kratno (pri psih) vrednostjo Cmax pri odmerku brez opaženih učinkov (No Observed Effect Level - NOEL) in med Cmax pri odmerjanju 6 mg/ kg enkrat dnevno pri bolnikih z normalnim delovanjem ledvic.
Reproductive toxicity testing showed no evidence of effects on fertility, embryofetal, or postnatal development.
Testiranje reproduktivne toksičnosti ni pokazalo nikakršnih dokazov o vplivih na plodnost, razvoj zarodka/ plodu ali postnatalni razvoj.
However, daptomycin can cross the placenta in pregnant rats (see section 5.2).
Vendar pa daptomicin lahko prehaja skozi placento pri brejih podganah (glejte poglavje 5. 2).
Sodium hydroxide.
natrijev hidroksid
Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C - 8°C.
Kemijska in fizikalna stabilnost pripravljene rekonstituirane raztopine v viali je bila dokazana za 12 ur pri 25 °C in do 48 ur pri 2 °C do 8 °C.
Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours at 2°C - 8°C.
Kemijska in fizikalna stabilnost razredčene raztopine v infuzijskih vrečkah je dokazana za 12 ur pri 25 °C ali 24 ur pri 2 °C - 8 °C.