natgillin/translations-raw huggingface dataset:
Daptomycin Hospira is not physically or chemically compatible with glucose-containing solutions.
Zdravilo Daptomicin Hospira fizikalno ali kemijsko ni združljivo z raztopinami, ki vsebujejo glukozo.
The key efficacy endpoint was the sponsor-defined clinical outcome at test-of-cure (TOC), which was defined by a blinded medical director.
Ključni cilj opazovanja za oceno učinkovitosti je bil klinični izid po definiciji naročnika glede na test ozdravitve (TOC-test-of-cure), ki ga je opredelil direktor medicinskega oddelka s slepim načinom ocenjevanja.
On the basis of reported adverse drug reactions, daptomycin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
Glede na neželene učinke, o katerih so poročali, je malo verjetno, da bi daptomicin vplival na sposobnost vožnje in upravljanja strojev.
No dose adjustment is necessary based on age alone.
Zgolj na osnovi starosti prilagajanje odmerka ni potrebno.
Dose Infusion Time
Odmerek Čas infundiranja
Single use 10 ml type I clear glass vials with gray rubber closure and aluminium cap.
10 ml viale za enkratno uporabo iz prozornega stekla tipa I s sivim gumijastim zamaškom in aluminijasto zaporko.
PP (per protocol) Population RIE
PP-populacija (populacija, ki so jo zdravili skladno s protokolom) RIE
2 (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP))
nenormalni izvidi preiskav delovanja jeter 2 (zvišane vrednosti alaninaminotransferaze (ALT), aspart-ataminotransferaze (AST) ali alkalne fosfataze (ALP))
Eosinophilic pneumonia
Eozinofilna pljučnica
If a focus of infection other than cSSTI or RIE is identified after initiation of daptomycin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Če po začetku zdravljenja z daptomicinom ugotovimo, da žarišče okužbe ni cSSTI oziroma RIE, je treba razmisliti o uvedbi zdravljenja z drugim antibiotikom, ki je dokazano učinkovit pri zdravljenju specifične okužbe (okužb), ki je prisotna.
60 minutes cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; (1) Minimum duration of Daptomycin Hospira for paediatric SAB should be in accordance with the perceived risk of complications in the individual patient.
24 ur v infuziji, ki traja 60 minut cSSTI = zapletene okužbe kože in mehkih tkiv, SAB = bakteriemija z bakterijo S. aureus (1) Minimalno trajanje zdravljenja z daptomicinom pri pediatričnih bolnikih mora biti v skladu z ocenjenim tveganjem za zaplete pri posameznem bolniku.
Your doctor will check the condition of your lungs and decide whether or not you should continue Daptomycin Hospira treatment.
Zdravnik bo preveril stanje vaših pljuč in se odločil, ali lahko nadaljujete zdravljenje z zdravilom Daptomicin Hospira ali ne.
If this applies to you, tell your doctor or nurse.
Če to velja za vas, obvestite svojega zdravnika ali medicinsko sestro.
Expelair, large bubbles, and any excess solution in order to obtain the required dose.
Iztisnite zrak, velike mehurčke in morebitno odvečno količino raztopine, da dobite zahtevani odmerek.
Simulation using a population pharmacokinetic model demonstrated that the AUCss (area under the concentration-time curve at steady state) of daptomycin in paediatric patients 1 to <2 years of age receiving12 mg/kg once daily would be comparable to that in adult patients receiving 6 mg/kg once daily.
Simulacija z uporabo populacijskega farmakokinetičnega modela je pokazala, da je AUCss (površina pod krivuljo koncentracije v odvisnosti od časa v stanju dinamičnega ravnovesja) za daptomicin pri pediatričnih bolnikih, starih od 1 do < 2 let, ki so prejemali 12 mg/kg enkrat dnevno, primerljiva s tistim pri odraslih bolnikih, ki so prejemali 6 mg/kg enkrat dnevno.
Daptomycin had no effect on the pharmacokinetics of warfarin or probenecid, nor did these medicinal products alter the pharmacokinetics of daptomycin.
Daptomicin ni vplival na farmakokinetične lastnosti varfarina in probenecida, navedeni zdravili pa nista vplivali na farmakokinetične lastnosti daptomicina.
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 (30-minute intravenous infusion) for patients with normal renal function.
Najnižjo koncentracijo z opaznim učinkom (LOEL - Lowest Observable Effect Level) za miopatijo so pri podganah in psih opazili pri stopnjah izpostavljenosti, ki so bile 0,8 do 2,3-kratniki terapevtskih koncentracij pri človeku pri odmerku 6 mg/kg (30-minutna intravenska infuzija) pri bolnikih z normalnim delovanjem ledvic.
The microbiological outcome at TOC for the daptomycin and SOC treatment arms for infections caused by MRSA and MSSA are presented in the table below (mMITT population).
Mikrobiološki izidi pri testu ozdravitve za skupini z daptomicinom in standardno oskrbo pri okužbah z MRSA in MSSA so prikazani v spodnji preglednici (populacija mMITT).
Caution is advised when administering daptomycin to patients who already have some degree of renal impairment (creatinine clearance <80 ml/min) before commencing therapy with Daptomycin Hospira.
Pri dajanju daptomicina bolnikom, ki že imajo določeno stopnjo okvare ledvic (očistek kreatinina < 80 ml/min) pred začetkom zdravljenja z zdravilom Daptomicin Hospira, je potrebna previdnost.
Therefore, until more experience is gained, breast-feeding should be discontinued when daptomycin is administered to nursing women.
Dokler ne bo na voljo več izkušenj zato velja, da je treba prenehati z dojenjem, če doječa mati prejema daptomicin.
Daptomycin Hospira vials are for single-use only.
Viale z zdravilom Daptomicin Hospira so samo za enkratno uporabo.
If not used immediately, in-use storage times are the responsibility of the user and would not normally be longer than 24 hours at 2°C-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Če zdravila ne uporabite takoj, je za čas shranjevanja med uporabo, ki normalno ne sme presegati 24 ur pri temperaturi 2 °C - 8 °C, odgovoren uporabnik, razen če je rekonstitucija/redčenje zdravila potekala v nadzorovanih in validiranih aseptičnih pogojih.
What Daptomycin Hospira is and what it is used for
Kaj je zdravilo Daptomicin Hospira in za kaj ga uporabljamo
There is insufficient evidence to be able to draw any conclusions regarding the possible clinical efficacy of daptomycin against infections due to enterococci, including Enterococcus faecalis and Enterococcus faecium.
Za sklepanje o morebitni klinični učinkovitosti daptomicina pri zdravljenju okužb z enterokoki, vključno z bakterijama Enterococcus faecalis in Enterococcus faecium, ni dovolj dokazov.
These could interfere with the effects of Daptomycin Hospira in the kidney.
Ta zdravila lahko vplivajo na učinke zdravila Daptomicin Hospira v ledvicah.
Anxiety, insomnia
tesnoba, nespečnost
It is recommended that other medicinal products associated with myopathy should if possible be temporarily discontinued during treatment with daptomycin unless the benefits of concomitant administration outweigh the risk.
Priporočamo, da med zdravljenjem z daptomicinom po možnosti začasno prekinete zdravljenje z drugimi zdravili, povezanimi z nastankom miopatij, razen v primeru, da koristi sočasne uporabe odtehtajo tveganja.
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 daptomicina.
Creatine phosphokinase and myopathy Increases in plasma creatine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/or weakness and cases of myositis, myoglobinaemia and rhabdomyolysis have been reported during therapy with daptomycin (see also sections 4.5, 4.8 and 5.3).
Kreatin-fosfokinaza in miopatija Med zdravljenjem z daptomicinom so poročali o zvišanju ravni kreatin-fosfokinaze v plazmi (CPK, izoencim MM), povezanem z bolečinami v mišicah in/ali mišično oslabelostjo, in primerih miozitisa, mioglobinemije in rabdomiolize (glejte tudi poglavja 4.5, 4.8 in 5.3).
What Daptomycin Hospira looks like and contents of the pack Daptomycin Hospira powder for solution for injection/infusion is supplied as a light yellow to light brown lyophilised cake or powder in a glass vial.
Izgled zdravila Daptomicin Hospira in vsebina pakiranja Zdravilo Daptomicin Hospira prašek za raztopino za injiciranje/infundiranje je na voljo kot svetlo rumena do svetlo rjava liofilizirana pogača ali prašek v stekleni viali.
Comments cSSTI without SAB
Opombe cSSTI brez SAB
To minimise this risk, physicians should be advised that for coagulation levels testing it is recommended to draw blood samples near the time of Daptomycin Hospira trough plasma concentration.
Za zmanjšanje tveganja za napačne rezultate je treba zdravnikom svetovati, naj vzorce krvi jemljejo približno v času, ko je koncentracija zdravila Daptomicin Hospira v plazmi najnižja.
Experience with the concomitant administration of daptomycin and warfarin is limited.
Izkušenj s sočasno uporabo daptomicina in varfarina je malo.
- Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.
- pri odraslih bolnikih z desnostranskim infekcijskim endokarditisom (RIE - Right-sided Infective Endocarditis) zaradi bakterije Staphylococcus aureus.
- Occasionally, patients receiving Daptomycin Hospira may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information).
- občasno se lahko pri bolnikih, ki prejemajo daptomicin, pojavijo občutljivost ali bolečine v mišicah ali mišična oslabelost (za več informacij glejte poglavje 4 v tem navodilu za uporabo).
What Daptomycin Hospira contains - The active substance is daptomycin.
Kaj vsebuje zdravilo Daptomicin Hospira - Učinkovina je daptomicin.
The pharmacokinetics of daptomycin in paediatric subjects was evaluated in 3 single-dose pharmacokinetic studies.
Farmakokinetiko daptomicina pri pediatričnih bolnikih so ocenili v 3 farmakokinetičnih študijah z enim odmerkom.
Please inform your doctor that you are on treatment with Daptomycin Hospira.
Zdravniku povejte, da se zdravite z zdravilom Daptomicin Hospira.
Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog.
Dajanje daptomicina je bilo pri podganah in psih povezano z minimalnimi do blagimi degenerativnimi/regenerativnimi spremembami skeletnih mišic.
However, daptomycin can cross the placenta in pregnant rats (see section 5.2).
Vendar pa daptomicin pri brejih podganah lahko prehaja skozi placento (glejte poglavje 5.2).
1 to <2 years (N=30)
1 do < 2 leti (N = 30)
The pharmacokinetics of daptomycin in patients with severe hepatic impairment (Child-Pugh C classification) have not been evaluated.
Farmakokinetike daptomicina pri bolnikih s hudo okvaro jeter (razred C po lestvici Child-Pugh) niso ovrednotili.
Hypertension, hypotension Uncommon: Flushes
hipertenzija, hipotenzija občasni:
The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) at 25°C must not exceed 12 hours (24 hours if refrigerated).
Skupni čas shranjevanja (rekonstituirana raztopina v viali in razredčena raztopina v infuzijski vrečki) pri 25 °C ne sme presegati 12 ur (ali 24 ur v primeru shranjevanja v hladilniku).
No clinical data on pregnancies are available for daptomycin.
Za daptomicin ni na voljo nobenih kliničnih podatkov o nosečnostih.
Anticoagulant activity in patients receiving daptomycin and warfarin should be monitored for the first several days after therapy with Daptomycin Hospira is initiated.
Pri bolnikih, ki prejemajo daptomicin in varfarin, je treba prvih nekaj dni po uvedbi zdravila Daptomicin Hospira spremljati njihovo antikoagulantno aktivnost.
Sodium hydroxide Citric acid
natrijev hidroksid citronska kislina
The polypropylene flip off cap should be removed to expose the central portion of the rubber stopper.
Snemljivo zaporko iz polipropilena morate odstraniti, da razkrijete osrednji del gumijastega zamaška.
Based on pharmacokinetic data and modelling, the daptomycin AUC during the first day after administration of a 6 mg/kg dose to adult patients on HD or CAPD was 2-fold higher than that observed in adult patients with normal renal function who received the same dose.
Glede na farmakokinetične podatke in modeliranje je bila vrednost AUC daptomicina prvi dan po uporabi odmerka 6 mg/kg pri odraslih bolnikih na HD ali CAPD dvakrat večja kot pri odraslih bolnikih z normalnim delovanjem ledvic, ki so prejeli enak odmerek.
- That daptomycin susceptibility testing needs Ca in the testing medium and testing methods with mediums providing consistent Ca concentrations are recommended.
- da mora biti pri testiranju občutljivosti za daptomicin v testnem mediju prisoten kalcij in da so priporočljive testne metode, ki zagotavljajo stalno koncentracijo kalcija v testnem mediju.
Deep-seated infections
Globoke okužbe
Population
ITT populacija
Daptomycin Hospira given as 2-minute intravenous injection (adult patients only)
Zdravilo Daptomicin Hospira za dajanje v obliki 2-minutne intravenske injekcije (samo odrasli bolniki)
The possibility of erroneous results may be minimised by drawing samples for PT or INR testing near the time of trough plasma concentrations of daptomycin (see section
Možnost napačnih rezultatov lahko zmanjšamo tako, da vzorce za določitev PČ ali INR odvzamemo približno v času, ko so koncentracije daptomicina v plazmi najnižje (glejte poglavje 4.4).
Release the syringe plunger and allow the syringe plunger to equalise the pressure before removing the syringe from the vial.
Sprostite bat injekcijske brizge in pustite, da bat injekcijske brizge izenači tlak, preden injekcijsko brizgo odstranite iz viale.
In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes.
Odrasli bolniki prejmete ta odmerek neposredno v krvni obtok (v veno), bodisi v obliki infuzije, ki traja okrog 30 minut, bodisi v obliki injekcije, ki traja približno 2 minuti.
The overall therapeutic response rate also was similar for the daptomycin and SOC treatment arms for infections caused by MRSA, MSSA and Streptococcus pyogenes (see table below; ME population); response rates were > 94% for both treatment arms across these common pathogens.
Tudi skupna stopnja terapevtskega odziva pri okužbah z bakterijami MRSA, MSSA in Streptococcus pyogenes je bila v skupini z daptomicinom podobna kot v skupini s standardno oskrbo (glejte preglednico spodaj, podatki populacije za mikrobiološko oceno primernih bolnikov): pri vseh običajnih patogenih je bila stopnja odziva v obeh študijskih skupinah > 94 %.
Following administration of a single 4 mg/kg or 6 mg/kg intravenous dose of daptomycin over a 30-minute period to adult subjects with various degrees of renal impairment, total daptomycin clearance (CL) decreased and systemic exposure (AUC) increased as renal function (creatinine clearance) decreased.
Po 30-minutnem dajanju enkratnega intravenskega odmerka 4 mg/kg ali 6 mg/kg daptomicina odraslim osebam z različnimi stopnjami okvare ledvic se je z zmanjševanjem delovanja ledvic (očistka kreatinina) celotni očistek daptomicina zmanjševal, sistemska izpostavljenost (AUC) pa povečevala.
In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes (see sections 4.2 and 5.2).
Pediatričnim bolnikom, mlajšim od 7 let, ki prejemajo odmerek 9-12 mg/kg, je treba daptomicin dati v 60 minutah (glejte poglavji 4.2 in 5.2).
Common:
občasni:
On the second day after administration of a 6 mg/kg dose to HD and CAPD adult patients the daptomycin AUC was approximately 1.3-fold higher than that observed after a second 6 mg/kg dose in adult patients with normal renal function.
Drugi dan po dajanju odmerka 6 mg/kg odraslim bolnikom na HD ali CAPD je bila njihova vrednost AUC daptomicina približno 1,3krat večja kot pri odraslih bolnikih z normalnim delovanjem ledvic po drugem odmerku 6 mg/kg.
No preservative or bacteriostatic agent is present in this product.
To zdravilo ne vsebuje konzervansov ali bakteriostatikov.
Sodium hydroxide (for pH adjustment) Citric acid (solubiliser/stabiliser)
6.1 Seznam pomožnih snovi natrijev hidroksid (za uravnavanje pH) citronska kislina (sredstvo za raztapljanje/stabilizator)
Gender No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
V farmakokinetiki daptomicina niso opazili nikakršnih klinično pomembnih razlik, povezanih s spolom.
The specific cell surface component directly targeted has not been identified.
Specifične strukture celične površine, na katero daptomicin neposredno deluje, niso ugotovili.
Replace needle with a new needle for the intravenous injection.
Injekcijsko iglo zamenjajte z novo iglo za intravensko injiciranje.
<Date of first authorisation: 22-March-2017> <Date of latest renewal: {DD month YYYY}>
Datum prve odobritve: 22. marec 2017
Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during co-administration with medicinal products that reduce renal filtration (e.g. NSAIDs and COX-2 inhibitors).
Daptomicin se primarno izloča z ledvično filtracijo, torej lahko sočasna uporaba zdravil, ki zavirajo ledvično filtracijo (npr. nesteroidna protivnetna zdravila in zaviralci COX-2), povzroči zvišanje njegovih ravni v plazmi.
Creatine phosphokinase (CPK) levels must be measured at baseline and at regular intervals (at least weekly) during treatment (see section 4.4).
Vrednost kreatin-fosfokinaze (CPK) je treba izmeriti pred začetkom zdravljenja in nato v rednih presledkih med zdravljenjem (vsaj enkrat na teden) (glejte poglavje 4.4).
Very rare serious side effects (may affect up to 1 in 10,000 people) A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)) has been reported, in some cases during administration of daptomycin.
Zelo redki resni neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) Poročali so o preobčutljivostni reakciji (resni alergijski reakciji, ki vključuje anafilaksijo, angioedem, z zdravilom povezan izpuščaj z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms)), v nekaterih primerih med dajanjem daptomicina.
Uncommon: Supraventricular tachycardia, extrasystole
supraventrikularna tahikardija, ekstrasistole
There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy (e.g. HMG-CoA reductase inhibitors).
Izkušnje glede sočasne uporabe daptomicina z drugimi zdravili, ki lahko povzročijo miopatijo (na primer z zaviralci reduktaze HMG-CoA), so omejene.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema pogosti:
What you need to know before you are given Daptomycin Hospira
Kaj morate vedeti, preden boste uporabili zdravilo Daptomicin Hospira
Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
Preden injekcijsko iglo izvlečete iz viale, potegnite bat povsem do konca tulca injekcijske brizge tako, da lahko iz obrnjene viale odstranite celotno raztopino.
The site of metabolism has not been identified.
Mesta presnove niso ugotovili.
7-11 years (N=19)
7-11 let (N = 19)
In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes.
Pediatričnim bolnikom, mlajšim od 7 let, ki prejemajo odmerek 9-12 mg/kg, je treba daptomicin dati v 60 minutah.
Dosage Regimen
Režim odmerjanja
Differences in Success n/N (%)
Razlike v spešnosti n/N (%)
Age Range 12-17 years (N=6) 7-11 years (N=2)
12-17 let (N = 6) 7-11 let (N = 2)
If you experience these symptoms, tell your doctor or nurse straight away.
Če opazite navedene simptome, takoj obvestite svojega zdravnika ali medicinsko sestro.
Obesity In obese subjects with Body Mass Index (BMI) >40 kg/m2 but with creatinine clearance >70 ml/min, the
Debelost Pri debelih preskušancih z indeksom telesne mase (ITM) > 40 kg/m2 in očistkom kreatinina >
For the 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C must not exceed 12 hours (or 48 hours at 2°C-8°C).
Pri 2-minutni intravenski injekciji čas shranjevanja rekonstituirane raztopine v viali (glejte poglavje 6.6) pri 25 °C ne sme presegati 12 ur (ali 48 ur pri 2 °C - 8 °C).
Daptomycin administered as a 2-minute intravenous injection also exhibited dose proportional pharmacokinetics in the approved therapeutic dose range of 4 to 6 mg/kg.
Tudi farmakokinetika daptomicina, danega v obliki 2-minutne intravenske injekcije, je v razponu odobrenih terapevtskih odmerkov od 4 do 6 mg/kg sorazmerna z odmerkom.
Renal impairment Daptomycin is eliminated primarily by the kidney.
Okvara ledvic Daptomicin se izloča primarno preko ledvic.
The dosage regimen for daptomycin in paediatric patients with renal impairment has not been established.
Režim odmerjanja daptomicina pri pediatričnih bolnikih z okvaro ledvic ni bil določen.
12-17 years (N=13)
12-17 let (N = 13)
After reconstitution: 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.
Po rekonstituciji: kemijsko in fizikalno stabilnost rekonstituirane raztopine v viali med uporabo so dokazali za 12 ur pri 25 °C in do 48 ur pri 2 °C - 8 °C.
Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy adult volunteers.
Farmakokinetika daptomicina je v odmerkih od 4 do 12 mg/kg, ki so jih zdravi odrasli prostovoljci prejemali v enkratnem dnevnem odmerku s 30-minutno intravensko infuzijo do 14 dni, v splošnem linearna in neodvisna od časa.
The success rates in RIE patients are shown in the table below.
Spodnja preglednica prikazuje stopnje uspešnosti pri bolnikih z RIE.
If you think you may be allergic, ask your doctor or nurse for advice.
Če menite, da bi lahko bili alergični, se posvetujte z zdravnikom ali medicinsko sestro.
Less frequently reported, but more serious, adverse reactions include hypersensitivity reactions, eosinophilic pneumonia (occasionally presenting as organising pneumonia), drug rash with eosinophilia and systemic symptoms (DRESS), angioedema and rhabdomyolysis.
Neželeni učinki, o katerih so poročali manj pogosto, a so resnejši, vključujejo preobčutljivostne reakcije, eozinofilno pljučnico (ki se občasno kaže kot organizirajoča pljučnica), z zdravilom povezan izpuščaj z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms), angioedem in rabdomiolizo.
The reconstituted solution should then be injected intravenously slowly over 2 minutes.
Rekonstituirano raztopino morate nato 2 minuti počasi intravensko injicirati.
Recurrence of eosinophilic pneumonia upon re-exposure has been reported.
Po ponovni izpostavljenosti zdravilu so poročali o ponovitvi eozinofilne pljučnice.
Paediatric patients 7 to 17 years old should receive daptomycin infused over 30 minutes.
Pediatričnim bolnikom, starim od 7 do 17 let, je treba daptomicin infundirati 30 minut.
Daptomycin is excreted primarily by the kidneys.
Daptomicin se izloča primarno preko ledvic.
The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes as directed in section 4.2.
Rekonstituirano in razredčeno raztopino morate nato intravensko infundirati 30 ali 60 minut, kot je navedeno v poglavju 4.2.
Daptomycin Hospira should not be used more frequently than once a day.
Zdravila Daptomycin Hospira se ne sme odmerjati več kot enkrat na dan.
Uncommon: Dyspepsia, glossitis
dispepsija, glositis