natgillin/translations-raw huggingface dataset:
Systemic exposures to dalbavancin are dose proportional following single doses over a range of 140 to 1120 mg, indicating linear pharmacokinetics of dalbavancin.
Sistemska izpostavljenost dalbavancinu je sorazmerna z odmerki po enkratnih odmerkih v razponu od 140 do 1120 mg, kar kaže na linearno farmakokinetiko dalbavancina.
It is not known if dalbavancin is an inhibitor of transporters.
Ni znano, ali je dalbavancin inhibitor prenašalcev.
Frequency categories are derived according to the following conventions: very common (≥ 1/10), common
Kategorije pogostnosti so izpeljane na podlagi naslednje konvencije: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do
However, dalbavancin is excreted in the milk of lactating rats and may be excreted in human breast milk.
Se pa dalbavancin izloča v mleko pri podganah in bi se lahko izločal v materino mleko pri človeku.
Xydalba is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimise the risk of infusion-related reactions.
Zdravilo Xydalba se uporablja z intravenskim infundiranjem, ki traja skupaj 30 minut, da se zmanjša tveganje za z infuzijo povezano reakcijo.
is mediated by VanA, a genotype that results in modification of the target peptide in nascent cell wall.
genotipom, ki povzroči spremembo ciljnega peptida v nastajajoči celični steni.
Antibacterial activity against other relevant pathogens
Protibakterijsko delovanje na druge patogene organizme
Ototoxicity has been associated with glycopeptide use (vancomycin and teicoplanin); patients who are receiving concomitant therapy with an ototoxic medicinal product, such as an aminoglycoside, may be at increased risk.
Ototoksičnost se povezuje z uporabo glikopeptidov (vankomicin in teikoplanin); pri bolnikih, ki imajo spremljevalno zdravljenje z ototoksičnim zdravilom, kakršen je recimo aminoglikozid, je tveganje lahko zvečano.
The clinical significance of the decrease in mean plasma CLT, and the associated increase in AUC0-∞ noted in these pharmacokinetic studies of dalbavancin in subjects with severe renal impairment has not been established.
Klinične pomembnosti zmanjšanja plazemskega CLT in povezanega povečanja AUC0-∞, zabeleženega v teh farmakokinetičnih študijah dalbavancina pri osebah s hudo okvaro ledvic, niso ugotovili.
What Xydalba is and what it is used for What you need to know before you are given Xydalba How you will be given Xydalba Possible side effects
Kaj je zdravilo Xydalba in za kaj ga uporabljamo Kaj morate vedeti, preden prejmete zdravilo Xydalba Kako boste prejeli zdravilo Xydalba
Other medicines and Xydalba
Druga zdravila in zdravilo Xydalba
Do not use this medicine after the expiry date which is stated on the vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali poleg oznake EXP (uporabno do).
Methicillin resistance has no impact on dalbavancin activity.
Odpornost na meticilin nima vpliva na aktivnost dalbavancina.
No dose adjustment is recommended based on gender.
Prilagoditve odmerjanja glede na spol niso potrebne.
In mixed infections in which Gram-negative bacteria are suspected patients should also be treated with an appropriate antibacterial agent(s) against Gram-negative bacteria (see section 5.1).
Pri mešanih okužbah, kjer obstaja sum na Gram-negativne bakterije, se morajo bolniki zdraviti tudi z ustreznim protibakterijskim zdravilom oz. zdravili, proti Gram-negativnim bakterijam (glejte poglavje 5.1).
Bactericidal activity against staphylococci in vitro is time-dependent at serum concentrations of dalbavancin similar to those obtained at the recommended dose in humans.
Baktericidna aktivnost dalbavancina proti stafilokokom in vitro je časovno odvisna pri serumskih koncentracijah dalbavancina, podobnih tistim, ki jih dobimo pri priporočenih odmerkih za ljudi.
The safety and efficacy of dalbavancin in children aged from birth to < 18 years has not yet been established.
Varnost in učinkovitost dalbavancina pri otrocih v starosti od rojstva do < 18 let še nista ugotovljeni.
Dalbavancin is not well absorbed orally; however, an impact on the gastrointestinal flora or mouth flora of a breast-feeding infant cannot be excluded.
Dalbavancin se po peroralni uporabi ne absorbira dobro, vendar pa vpliv na gastrointestinalno ali ustno floro pri dojenem otroku ni izključen.
The mean AUC for subjects with creatinine clearance < 30 ml/min was approximately 2 - fold higher.
Povprečni AUC za osebe s kreatininskim očistkom < 30 ml/min je bil približno dvakrat večji.
There is no experience with dalbavancin in the treatment of severely immunocompromised patients.
Izkušenj z dalbavancinom pri zdravljenju bolnikov s hudo oslabljenim imunskim sistemom ni.
Elderly No dose adjustment is necessary (see section 5.2).
Starostniki Prilagoditev odmerka ni potrebna (glej poglavje 5.2).
Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
Zdravilo Xydalba je indicirano za zdravljenje akutnih bakterijskih okužb kože in kožnih struktur (ABSSSI - acute bacterial skin and skin structure infections) pri odraslih (glejte poglavji 4.4 in 5.1).
Xydalba is used to treat adults with infections of the skin or in the layers of flesh below the skin.
Zdravilo Xydalba se uporablja za zdravljenje odraslih z okužbami kože ali plasti pod kožo.
Xydalba contains sodium
Xydalba vsebuje natrij
Cross-resistance between dalbavancin and other classes of antibiotics was not seen in in vitro studies.
Navzkrižna odpornost med dalbavancinom in drugimi skupinami antibiotikov med in vitro študijami ni bila opažena.
Clinical drug-drug interaction studies with dalbavancin have not been conducted.
Klinične študije interakcij zdravilo-zdravilo z dalbavancinom niso bile izvedene.
Xydalba must not be mixed with other medicinal products or intravenous solutions.
Zdravila Xydalba ne smete mešati z drugimi zdravili ali intravenskimi raztopinami.
Sodium chloride solutions may cause precipitation and must not be used for reconstitution or dilution (see section 6.6).
Raztopine natrijevega klorida lahko povzročijo nastajanje usedlin, zato se jih ne sme uporabiti za rekonstituiranje ali redčenje (glejte poglavje 6.6).
Resistance to dalbavancin in Staphylococcus spp.
Odpornost na dalbavancin pri Staphylococcus spp.
Metabolites have not been observed in significant amounts in human plasma.
Večjih količin presnovkov v humani plazmi niso opazili.
• Viridans group streptococci (Streptococcus anginosus group only): Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l.
• streptokoki skupine Viridans (samo skupina Streptococcus anginosus): občutljivi ≤ 0,125 mg/l; odporni > 0,125 mg/l.
Clinically significant gender-related differences in dalbavancin pharmacokinetics have not been observed in healthy subjects or in patients with infections.
Klinično pomembnih razlik, povezanih s spolom, pri farmakokinetiki dalbavancina niso zaznali niti pri zdravih osebah niti pri bolnikih z okužbami.
The metabolic pathways responsible for producing these metabolites have not been identified; however, due to the relatively minor contribution of metabolism to the overall elimination of dalbavancin, drug-drug interactions via inhibition or induction of metabolism of dalbavancin are not anticipated.
Presnovnih poti, odgovornih za nastanek teh presnovkov, niso identificirali; vseeno pa, zaradi razmeroma majhnega prispevka presnove pri celotnem izločanju dalbavancina, interakcij zdravilo-zdravilo prek inhibicije ali indukcije presnove dalbavancina ne gre pričakovati.
Following a single intravenous dose of 1,000 mg in healthy volunteers AUC in skin blister fluid amounted (bound and unbound dalbavancin) to approximately 60 % of the plasma AUC at day 7 post-dose.
1000 mg pri zdravih prostovoljcih je AUC v tekočini v kožnih mehurčkih narasla (vezan in nevezan dalbavancin) na približno 60 % AUC v plazmi 7. dan po odmerku.
Dose-dependent toxicity included serum chemistry and histological evidence of renal and hepatic injury, reduced red blood cell parameters and injection site irritation.
Od odmerka odvisna toksičnost je vključevala biokemične preiskave seruma in histološke dokaze poškodb ledvic in jeter, zmanjšanja parametrov rdečih krvničk in draženja na mestu injiciranja.
In Phase 3 studies, patients have been administered single doses of up to 1,500 mg.
V študijah 3.faze so bolniki prejemali enkratne odmerke do 1500 mg.
Intravenous infusions with these types of antibiotics can cause flushing of the upper body, hives, itching and/or rashes.
Intravenske infuzije tega tipa antibiotikov lahko povzročijo rdečico zgornjega dela telesa, koprivnico, srbenje in/ali izpuščaje.
Discard any portion of the reconstituted solution that remains unused.
Zavrzite morebitne ostanke rekonstituirane raztopine, ki ni bila uporabljena.
What you need to know before you are given Xydalba
Kaj morate vedeti, preden prejmete zdravilo Xydalba
Based on in vitro studies the activity of dalbavancin is not affected by other classes of vancomycin resistance genes.
Na podlagi in vitro študij na delovanje dalbavancina ne vplivajo ostale vrste genov, odpornih na vankomicin.
Following administration of a single 1,000 mg dose in healthy subjects, an average of 19 % to 33 % of the administered dalbavancin dose was excreted in urine as dalbavancin and 8 % to 12 % as the metabolite hydroxy-dalbavancin.
Po dajanju enega odmerka 1000 mg pri zdravih osebah se je v povprečju od 19 % do 33 % uporabljenega odmerka izločilo z urinom kot dalbavancin in 8 % do 12 % kot presnovek hidroksi-dalbavancin.
In rats, at exposures approximately 3 times above clinical exposure, there was reduced fertility and an increased incidence of embryo-lethality, reductions in foetal weight and skeletal ossification and increased neonatal mortality.
Pri podganah je, pri 3-krat večji izpostavljenosti od klinične izpostavljenosti, prišlo do zmanjšane plodnosti in povečane incidence smrtnosti zarodka, zmanjšanja mase ploda, zapoznele osifikacije skeleta in povečane neonatalne umrljivosti.
2 1,000 mg on Day 1 + 500 mg on Day 8; Study DUR001-303 subjects with evaluable PK sample.
2 1000 mg 1. dan + 500 mg 8. dan; študija DUR001-303 oseb z ovrednotenim PK vzorcem.
Caution should be exercised when prescribing dalbavancin to patients with moderate or severe hepatic impairment (Child-Pugh B & C) as no data are available to determine appropriate dosing (see sections 5.2).
Previdnost je potrebna pri predpisovanju dalbavancina bolnikom z zmerno ali hudo okvaro delovanja jeter (Child-Pugh B & C), ker ni ustreznih podatkov za določitev primernega odmerjanja
Increase in blood levels of gamma-glutamyl transferase (an enzyme produced by the liver and other body tissues)
• zvišane vrednosti gama-glutamil transferaze v krvi (encim, ki nastane v jetrih in drugih telesnih tkivih);
Dalbavancin is not metabolised by CYP enzymes in vitro, therefore co-administered CYP inducers or inhibitors are unlikely to influence the pharmacokinetics of dalbavancin.
Dalbavancin se ne presnavlja z encimi CYP in vitro, zato sočasni CYP induktorji ali inhibitorji malo verjetno vplivajo na farmakokinetiko dalbavancina.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Čas običajno ne sme presegati 24 ur pri temperaturah od 2 do 8 °C, razen če je bila rekonstitucija/redčenje opravljena v nadzorovanih in validiranih aseptičnih pogojih.
Potential for other medicinal products to affect the pharmacokinetics of dalbavancin.
Potencialni vpliv drugih zdravil na farmakokinetiko dalbavancina
Psychiatric disorders insomnia
Psihiatrične motnje insomnija
Reproductive system and breast disorders vulvovaginal pruritus
Bolezni reproduktivnega sistema in dojk vulvovaginalni pruritus
Hydroxy-dalbavancin and mannosyl aglycone show significantly less antibacterial activity compared to dalbavancin.
Hidroksi-dalbavancin in manosil aglikon v primerjavi z dalbavancinom izkazujeta občutno manjše protibakterijsko delovanje.
The vial contains white to off-white to pale yellow powder.
Viala vsebuje bel do umazano bel do bledo rumen prašek.
The pharmacokinetics of dalbavancin were evaluated in 28 subjects with varying degrees of renal impairment and in 15 matched control subjects with normal renal function.
Farmakokinetika dalbavancina je bila ocenjena pri 28 osebah z različno stopnjo okvare delovanja ledvic in pri 15 osebah v kontrolni skupini z normalnim delovanjem ledvic.
Dalbavancin is reversibly bound to human plasma proteins, primarily to albumin.
Dalbavancin je reverzibilno vezan na proteine humane plazme,
: Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l,
: občutljivi ≤ 0,125 mg/l; odporni > 0,125 mg/l,
• Abnormal liver function test
• neobičajni rezultati jetrnih testov;
If a common intravenous line is being used to administer other medicinal products in addition to Xydalba, the line should be flushed before and after each Xydalba infusion with 5% glucose solution for infusion.
Če uporabite isto linijo za intravensko dajanje zdravila Xydalba in drugih zdravil, linijo pred in po vsaki infuziji zdravila Xydalba sperite s 5 % raztopino glukoze za infundiranje.
It is unknown whether dalbavancin is excreted in human milk.
Ni znano, ali se dalbavancin izloča v mleko pri človeku.
• The other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid and/or sodium hydroxide (for pH adjustment only).
• Druge sestavine zdravila so manitol (E421), laktoza monohidrat, klorovodikova kislina in/ali natrijev hidroksid (samo za uravnavanje pH).
Results from an in vitro receptor screening study do not indicate a likely interaction with other therapeutic targets or a potential for clinically relevant pharmacodynamic interactions (see section 5.1).
Rezultati in vitro receptorske presejalne študije ne kažejo verjetnega medsebojnega delovanja z drugimi terapevtskimi tarčami ali potenciala za klinično pomembne farmakodinamične interakcije
If you miss a dose of Xydalba
Če ste izpustili odmerek zdravila Xydalba
Single-dose regimen3
Režim z enim odmerkom3
Apparent terminal t½ was similar for dalbavancin doses of 1,000 mg and 15 mg/kg, with mean values of 227 and 202 hours, respectively.
Navidezni končni t½ je bil podoben tako pri 1000-mg odmerkih dalbavancina kot pri odmerkih 15 mg/kg s povprečno vrednostjo 227 ur oziroma 202 uri.
Diarrhoea during or after treatment If you develop diarrhoea during or after your treatment, tell your doctor at once.
Če se driska pojavi med zdravljenjem ali po njem, to takoj povejte zdravniku.
The safety and efficacy of Xydalba in children aged from birth to < 18 years have not yet been established.
Varnost in učinkovitost zdravila Xydalba pri otrocih od rojstva do <18 let, še nista ugotovljeni.
Xydalba contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group.
Zdravilo Xydalba vsebuje učinkovino dalbavancin, ki je antibiotik iz skupine glikopeptidov.
It is not known if dalbavancin is a substrate for hepatic uptake and efflux transporters.
Ni znano, ali je dalbavancin substrat za prenašalce jetrnega privzema in efluksa.
Dose adjustments are not required for patients with mild or moderate renal impairment (creatinine clearance ≥ 30 to 79 ml/min).
Pri bolnikih z blago ali zmerno okvaro delovanja ledvic prilagoditve odmerka niso potrebne (kreatininski očistek ≥ 30 do 79 ml/min).
For example: 25 ml of the concentrate contains 500 mg dalbavancin.
Na primer: 25 ml koncentrata vsebuje 500 mg dalbavancina.
Blood and lymphatic system disorders anaemia, thrombocytosis, eosinophilia, leucopenia, neutropenia
Bolezni krvi in limfatičnega sistema anemija, trombocitoza, eozinofilija, levkopenija, nevtropenija
Following a single dose of 500 mg or 1,000 mg dalbavancin, the mean plasma clearance (CLT) was reduced 11 %, 35 %, and 47 % in subjects with mild (CLCR 50 - 79 ml/min), moderate (CLCR 30 - 49 ml/min), and severe (CLCR < 30 ml/min) renal impairment, respectively, compared to subjects with normal renal function.
V primerjavi z osebami z normalnim delovanjem ledvic je bil po enkratnem odmerku 500 mg ali 1000 mg dalbavancina plazemski očistek (CLT) zmanjšan za 11 %, 35 % oz. 47 %pri osebah z blago (CLCR 50 - 79 ml/min), zmerno (CLCR 30 - 49 ml/min) oziroma s hudo okvaro ledvic (CLCR < 30 ml/min).
Dalbavancin is a bactericidal lipoglycopeptide.
Mehanizem delovanja Dalbavancin je baktericiden lipoglikopeptid.
Based on simulations, dose adjustment is needed for patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regular haemodialysis (see sections 4.2 and 5.2).
Na podlagi simulacij je prilagoditev odmerjanja potrebna pri bolnikih s kronično okvaro delovanja ledvic, katerih kreatininski očistek je manjši od 30 ml/min in ki redno ne prejemajo hemodialize (glejte poglavji 4.2 in 5.2).
The solution for infusion must be clear, colourless to yellow solution with no visible particles.
Raztopina za infundiranje mora biti bistra, brezbarvna do rumena raztopina brez vidnih delcev.
Dalbavancin MICs are higher for vancomycin-intermediate staphylococci (VISA) than for fully vancomycin susceptible strains.
Minimalne inhibitorne koncentracije (MIK) dalbavancina so višje za stafilokoke, ki so dovzetni za visoke koncentracije vankomicina (VISA-vancomycin-intermediate staphylococci), kot za v celoti občutljive seve na vankomicin.
The metabolites hydroxy-dalbavancin and mannosyl aglycone have been detected in urine (< 25 % of administered dose).
V urinu so zaznali presnovka hidroksidalbavancin in manosil aglikon (< 25 % predpisanega odmerka).
and Enterococcus spp.
in Enterococcus spp.
• Beta-haemolytic streptococci of Groups A, B, C, G: Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l,
• beta-hemolitični streptokoki skupin A, B, C, G: občutljivi ≤ 0,125 mg/l;
General disorders and administration site conditions infusion-related reactions
Splošne težave in spremembe na mestu aplikacije z infuzijo povezana reakcija
Infections and infestations vulvovaginal mycotic infection, urinary tract infection, fungal infection, Clostridioides (formerly Clostridium) difficile colitis, oral candidiasis
Infekcijske in parazitske bolezni vulvovaginalna glivična okužba, okužba sečil, glivična okužba, kolitis zaradi razrasta Clostridioides (prej Clostridium) difficile, oralna kandidiaza
In the major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only.
(ABSSSI) so bile vrste zdravljenih okužb omejene samo na celulitis/šen, abscese in okužbe ran.
Xydalba must be reconstituted and then further diluted prior to administration by intravenous infusion over a 30 - minute period.
Zdravilo Xydalba mora biti rekonstituirano in potem še razredčeno pred dajanjem intravenske infuzije, ki traja 30 minut.
In Phase 2 / 3 clinical studies, 2,473 patients received dalbavancin administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg.
V fazi 2/3 kliničnih študij je 2473 bolnikov prejelo dalbavancin z enkratnim infundiranjem 1500 mg ali infundiranjem 1000 mg, ki mu je po enem tednu sledilo še 500 mg.
Two-dose regimen2
Režim z dvema odmerkoma2
The prepared Xydalba solution for infusion must not be used if there are any particles or the solution is cloudy.
Pripravljene raztopine za infundiranje Xydalba ne smete uporabiti, če so v njej kakršni koli delci ali pa je raztopina motna.
Xydalba is given in a single dose of 1,500 mg or in two doses a week apart: 1,000 mg on Day 1 and 500 mg on Day 8.
Zdravilo Xydalba boste prejeli v enkratnem odmerku 1500 mg ali v dveh odmerkih s tednom dni razmika: 1000 mg prvi dan in 500 mg osmi dan.
Xydalba powder for concentrate for solution for infusion is provided in a 48 ml glass vial with a green flip off seal.
Xydalba prašek za koncentrat za raztopino za infundiranje je na voljo 48-ml stekleni viali z zeleno snemljivo zaporko.
Xydalba may cause dizziness.
Zdravilo Xydalba lahko povzroči omotico.
Rapid intravenous infusions of glycopeptide antibacterial agents can cause reactions that resemble “Red-Man Syndrome”, including flushing of the upper body, urticaria, pruritus, and/or rash.
Hitre intravenske infuzije glikopeptidnih protibakterijskih zdravil lahko povzročijo reakcijo, ki je podobna “sindromu rdečeličneža”, z rdečico na zgornjem delu telesa, z urtikarijo, pruritusom in/ali izpuščajem.
A total of 10 paediatric patients with ages 12 to 16 years who had resolving infections were given single doses of either dalbavancin 1,000 mg (body weight ≥ 60 kg) or dalbavancin 15 mg/kg (body weight < 60 kg).
Skupaj 10 otrok v starosti od 12 do 16 let s trajajočimi okužbami je prejelo enkratni odmerek dalbavancina 1000 mg (telesna masa ≥ 60 kg) ali 15 mg/kg dalbavancin, če je bila telesna masa
Dose adjustments are not required for patients receiving regularly scheduled haemodialysis (3 times/week), and dalbavancin may be administered without regard to the timing of haemodialysis.
Pri bolnikih, ki redno prejemajo hemodializo (3-krat tedensko), prilagoditve odmerka niso potrebne, dalbavancin se lahko uporablja ne glede na čas hemodialize.
In patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regularly scheduled haemodialysis, the recommended dose is reduced to either 1,000 mg administered as a single infusion or 750 mg followed one week later by 375 mg (see section 5.2).
Pri bolnikih s kronično okvaro delovanja ledvic, katerih kreatininski očistek je < 30 ml/min in ki ne prejemajo redno hemodialize, je priporočeni odmerek dalbavancina zmanjšan na 1000 mg z enkratnim infundiranjem ali 750 mg, ki mu sledi 375 mg v naslednjem tednu (glej poglavje 5.2).
After dilution the solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin
Razredčena raztopina za infundiranje mora imeti končno koncentracijo od 1 do 5 mg/ml dalbavancina
Recommended dose and duration of treatment for adults The recommended dose of dalbavancin in adult patients with ABSSSI is 1,500 mg administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg (see sections 5.1 and 5.2).
Priporočeni odmerek in trajanje zdravljenja pri odraslih Priporočeni odmerek dalbavancina pri odraslih bolnikih z ABSSSI je 1500 mg z enkratnim infundiranjem 1500 mg ali 1000 mg prvi teden, naslednji teden pa 500 mg (glej poglavji 5.1 in 5.2).
Dalbavancin was not mutagenic or clastogenic in a battery of in vitro and in vivo genotoxicity tests.
Dalbavancin v bateriji in vitro in in vivo genotoksičnih testov ni bil mutagen niti klastogen.
Estimated pharmacokinetic parameters of dalbavancin following the two-dose regimen and the single-dose regimen, respectively, are shown in Table 2 below.
Ocenjeni farmakokinetični parametri dalbavancina po uporabi režima z dvema odmerkoma oziroma režima z enkratnim odmerkom so prikazani v spodnji preglednici 2.
What Xydalba looks like and contents of the pack
Izgled zdravila Xydalba in vsebina pakiranja
Immune system disorders anaphylactoid reaction
Bolezni imunskega sistema anafilaktoidna reakcija
Sodium chloride containing solutions can cause precipitation and should NOT be used for reconstitution or dilution.
Raztopine, ki vsebujejo natrijev klorid, lahko povzročijo nastajanje usedlin in jih NE smete uporabljati za rekonstitucijo ali redčenje.
Potential for dalbavancin to affect the pharmacokinetics of other medicinal products.
Potencialni vpliv dalbavancina na farmakokinetiko drugih zdravil
No specific information is available on the treatment of overdose with dalbavancin, as dose-limiting toxicity has not been observed in clinical studies.
Posebnih podatkov o prevelikem odmerjanju dalbavancina ni, ker v kliničnih študijah niso opazovali toksičnih učinkov, ki bi omejevali odmerek.