natgillin/translations-raw huggingface dataset:
For example, patients with any degree of renal impairment (creatinine clearance <80 ml/min; see also section 4.2), including those on haemodialysis or CAPD, and patients taking other medicinal products known to be associated with myopathy (e.g. HMG-CoA reductase inhibitors, fibrates and ciclosporin).
V to skupino sodijo na primer bolniki s kakršnokoli stopnjo okvare ledvic (z očistkom kreatinina < 80 ml/min; glejte tudi poglavje 4.2), vključno s tistimi na hemodializi ali CAPD, ter bolniki, ki jemljejo druga zdravila, za katera je znano, da so povezana z nastankom miopatij (npr. zaviralci reduktaze HMG-CoA, fibrati in ciklosporin).
Steady-state concentrations are achieved by the third daily dose.
Koncentracije v stanju dinamičnega ravnovesja dosežemo s tretjim dnevnim odmerkom.
Adverse reactions (i.e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported at similar frequencies for daptomycin and comparator regimens.
O neželenih učinkih (tj. tistih učinkih, za katere raziskovalec meni, da so mogoče, verjetno ali zagotovo povezani z zdravilom) daptomicina in primerjalnih shem zdravljenja so poročali s podobno pogostnostjo.
6 mg/kg every 48 hours cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; RIE = right-sided infective endocarditis (1) The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is based on pharmacokinetic (PK) studies and modelling results (see sections 4.4 and 5.2).
6 mg/kg vsakih 48 ur cSSTI = zapletene okužbe kože in mehkih tkiv, SAB = bakteriemija z bakterijo S. aureus (1) Varnost in učinkovitost prilagajanja intervalov med odmerki nista bili ovrednoteni v kontroliranih kliničnih preskušanjih in priporočila temeljijo na farmakokinetičnih študijah in rezultatih modeliranja (glejte poglavji 4.4 in 5.2).
Patients with deep-seated infections should receive any required surgical interventions (e.g. debridement, removal of prosthetic devices, valve replacement surgery) without delay.
Bolnike z globokimi okužbami je treba brez odlašanja ustrezno kirurško oskrbeti (npr. odstraniti odmrlo tkivo, odstraniti protetične pripomočke ali operativno zamenjati zaklopke).
At lower dose levels (25 mg/kg/day), mild and reversible clinical signs of twitching and one incidence of muscle rigidity were observed without any effects on body weight.
Pri manjših odmerkih (25 mg/kg/dan) so opažali blage in reverzibilne klinične znake trzanja in en primer mišične okorelosti brez kakršnegakoli vpliva na telesno maso.
12 to 17 years
Od 12 do 17 let
Daptomycin exhibits rapid, concentration dependent bactericidal activity against Gram positive organisms in vitro and in in vivo animal models.
Daptomicin ima hiter, od koncentracije odvisen baktericiden učinek proti po Gramu pozitivnim organizmom in vitro in na živalskih modelih in vivo.
In some instances treatment failure has been associated with the selection of organisms with reduced susceptibility or frank resistance to daptomycin (see section 5.1).
V nekaterih primerih je bil neuspeh zdravljenja povezan z organizmi, ki so postali manj občutljivi za daptomicin ali odkrito odporni proti njemu (glejte poglavje 5.1).
The following have been shown to be compatible when added to Daptomycin Hospira containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.
Za naslednje učinkovine so dokazali, da so združljive in jih lahko dodajamo v raztopine za infundiranje, ki vsebujejo zdravilo Daptomicin Hospira: aztreonam, ceftazidim, ceftriakson, gentamicin, flukonazol, levofloksacin, dopamin, heparin in lidokain.
The dosage card should contain the following key messages: - That there is a risk of severe skeletal muscle toxicity and so measuring the CPK at treatment initiation and at regular intervals is important.
Kartica za odmerjanje daptomicina mora vsebovati naslednja ključna sporočila: - da obstaja tveganje za hudo toksično delovanje na skeletne mišice, zato je pomembno meriti vrednosti kreatin-fosfokinaze (CPK - Creatine Phosphokinase) pred začetkom zdravljenja in nato v rednih intervalih.
ITT (intention to treat) Population RIE
ITT-populacija (populacija, ki so jo nameravali zdraviti) RIE
Clinically evaluable (CE)
Klinično ocenljivi (CEclinically evaluable)
In addition, dose regimens of daptomycin that might be appropriate for the treatment of enterococcal infections, with or without bacteraemia, have not been identified.
Poleg tega niso določili shem odmerjanja daptomicina, ki bi lahko bile primerne za zdravljenje enterokoknih okužb z bakteriemijo ali brez nje.
If an allergic reaction to daptomycin occurs, discontinue use and institute appropriate therapy.
Če pride do alergijske reakcije na daptomicin, je treba prekiniti uporabo zdravila in uvesti ustrezno zdravljenje.
Therefore, caution is advised when daptomycin is co-administered with any other medicinal product known to reduce renal filtration.
Zaradi tega je priporočljiva previdnost pri sočasni uporabi daptomicina in kateregakoli drugega zdravila, za katerega je znano, da zmanjšuje ledvično filtracijo.
Modified intent-to-treat (MITT) Microbiologically modified intent-to-treat (mMITT)
Modificirana z-namenomzdravljenja (MITT - modified intent-to-treat)
Due to limited clinical experience (see table and footnotes below) daptomycin should only be used in adult patients with any degree of renal impairment (CrCl <80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk.
Zaradi omejenega obsega kliničnih izkušenj (glejte spodnjo preglednico in opombe pod črto) lahko pri odraslih bolnikih z okvaro ledvic katerekoli stopnje (z očistkom kreatinina < 80 ml/min) daptomicin uporabljamo le, če pričakovana klinična korist odtehta morebitno tveganje.
Reconstituted solutions of Daptomycin Hospira range in colour from yellow to light brown.
Rekonstituirane raztopine zdravila Daptomicin Hospira so v barvnem razponu od rumene do svetlo rjave barve.
- Daptomycin Hospira should not be administered to patients who are taking other medicinal products associated with myopathy unless it is considered that the benefit to the patient outweighs the risk.
• Daptomicina ne smemo dajati bolnikom, ki jemljejo druga zdravila, povezana z nastankom miopatij, razen če menimo, da korist za bolnika odtehta tveganje.
In animal models AUC/MIC and Cmax/MIC correlate with efficacy and predicted bacterial kill in vivo at single doses equivalent to human adult doses of 4 mg/kg and 6 mg/kg once daily.
Na živalskih modelih razmerji vrednosti AUC/MIK in Cmax/MIK korelirata z učinkovitostjo in pričakovanim uničenjem bakterij in vivo pri enkratnih odmerkih, ki ustrezajo odmerkoma pri odraslem človeku 4 mg/kg in 6 mg/kg enkrat dnevno.
Uncommon: Renal impairment, including renal failure and renal insufficiency, serum creatinine increased
okvara ledvic, vključno z odpovedjo in insuficienco ledvic, zvišane vrednosti kreatinina v serumu
It is also used to treat infections in the blood caused by the same type of bacteria when associated with heart infection.
Uporablja se tudi za zdravljenje okužb krvi, ki jih povzroča ista vrsta bakterij, kadar so povezane z okužbo srca.
Anaphylaxis/hypersensitivity reactions
Anafilaktične/preobčutljivostne reakcije
Animal studies showed that daptomycin is not absorbed to any significant extent after oral administration.
Študije na živalih so pokazale, da se daptomicin po peroralnem dajanju ne absorbira v pomembnem obsegu.
It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Malo verjetno je, da bi daptomicin zaviral ali induciral presnovo zdravil, ki se presnavljajo preko sistema citokroma P450.
2 to 6 years
Od 2 do 6 let
Studies of daptomycin with anticoagulants other than warfarin have not been conducted.
Študij z daptomicinom in drugimi antikoagulanti, razen varfarinom, niso opravili.
The symptoms can include difficulty breathing, new or worsening cough, or new or worsening fever.
Simptomi lahko vključujejo težko dihanje ter pojav ali poslabšanje kašlja in zvišane telesne temperature.
If unexplained abnormalities of PT/INR are observed in patients taking daptomycin, consideration should be given to a possible in vitro interaction with the laboratory test.
Če pri bolnikih, ki jih zdravimo z daptomicinom, opazimo nepojasnjene nepravilnosti v PČ/INR, moramo pomisliti na možnost interakcije in vitro z laboratorijsko preiskavo.
A total of 389 subjects were treated in the study, including 256 subjects who received daptomycin and 133 subjects who received standard-of-care.
Skupno so v študiji zdravili 389 preiskovancev, med katerimi jih je 256 prejemalo daptomicin, 133 pa standardno oskrbo.
Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Daptomycin Hospira.
Glede na to, kakšno vrsto okužb(e) imate, vam bo zdravnik med zdravljenjem z zdravilom Daptomicin Hospira morda predpisal tudi druge antibiotike.
In addition, there is a potential for a pharmacodynamic interaction to occur during co-administration due to additive renal effects.
Poleg tega obstaja možnost, da pri sočasni uporabi zaradi dodatnega delovanja na ledvice pride do farmakodinamične interakcije.
- That Daptomycin Hospira can interfere with coagulation tests (PT/INR) and this might lead to false results.
- da zdravilo Daptomicin Hospira lahko moti koagulacijske teste za določanje protrombinskega časa/mednarodno umerjenega razmerja (PČ/INR), kar ima lahko za posledico napačne rezultate.
After infusion of 14C-daptomycin in healthy adults, the plasma radioactivity was similar to the concentration determined by microbiological assay.
Po infundiranju 14C-daptomicina zdravim odraslim osebam je bila koncentracija radioaktivno označenega daptomicina v plazmi podobna koncentraciji, ugotovljeni v mikrobiološkem preskusu.
In most reported cases associated with daptomycin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
V večini primerov, o katerih so poročali in ki so bili povezani z daptomicinom, se je pri bolnikih pojavila zvišana telesna temperatura, dispneja s hipoksično respiratorno insuficienco in difuzni pljučni infiltrati ali organizirajoča pljučnica.
Among these failures six patients treated with daptomycin 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 neuspešno zdravljenimi bolniki je bilo šest bolnikov, ki so jih zdravili z daptomicinom, in en bolnik, ki so ga zdravili z vankomicinom, okuženih z bakterijo Staphylococcus aureus, kjer je prišlo do povečevanja MIK daptomicina v času zdravljenja ali po njem (glejte ''Mehanizmi odpornosti'' zgoraj).
Secondary objectives included: Clinical outcome based on the blinded Evaluator's assessment of clinical response (success [cure, improved], failure, or non-evaluable) at the TOC Visit; and Microbiological response (success, failure, or non-evaluable) based on evaluation of Baseline infecting pathogen at TOC.
Med sekundarnimi cilji sta bila klinični izid po presoji ocenjevalca kliničnega odgovora, s slepim načinom ocenjevanja (uspeh [ozdravitev, izboljšanje], neuspeh ali neocenljivo) pri pregledu za test ozdravitve (TOC) ter mikrobiološki odgovor (uspeh, neuspeh ali neocenljivo) na podlagi ovrednotenja izhodiščnega infekcijskega patogena pri pregledu za test ozdravitve.
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, ledvični očistek pa 4 do 7 ml/h/kg.
Patients who develop signs or symptoms that might represent a peripheral neuropathy during therapy with daptomycin should be investigated and consideration should be given to discontinuation of daptomycin (see sections 4.8 and 5.3).
Bolnike, pri katerih se med zdravljenjem z daptomicinom pojavijo znaki ali simptomi, ki bi lahko predstavljali periferno nevropatijo, je treba pregledati in razmisliti o prekinitvi uporabe daptomicina (glejte poglavji 4.8 in 5.3).
Adults - cSSTI without concurrent SAB: daptomycin 4mg/kg is administered once every 24hours for 7-14 days or until the infection is resolved (see section 5.1).
Odrasli bolniki - cSSTI brez sočasne SAB: daptomicin dajemo v odmerku 4 mg/kg vsakih 24 ur 7-14 dni oziroma dokler okužba ni odpravljena (glejte poglavje 5.1).
Daptomycin Hospira is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a type of bacteria called Staphylococcus aureus.
Pri odraslih se zdravilo Daptomicin Hospira uporablja tudi za zdravljenje okužb tkiv, ki tvorijo notranjo plast srca (vključno s srčnimi zaklopkami), kadar take okužbe povzroča vrsta bakterije z imenom Staphyloccocus aureus.
Daptomycin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Daptomicin lahko dajemo takim bolnikom le, če pričakovana klinična korist odtehta morebitno tveganje.
The volume of distribution at steady state of daptomycin in healthy adult subjects was approximately 0.1 l/kg and was independent of dose.
Volumen porazdelitve daptomicina v stanju dinamičnega ravnovesja je pri zdravih odraslih osebah znašal približno 0,1 l/kg in ni bil odvisen od odmerka.
Most patients who failed due to persisting or relapsing Staphylococcus aureus infection had deep-seated infection and did not receive necessary surgical intervention.
Večina bolnikov, pri katerih zdravljenje ni bilo uspešno zaradi trdovratne ali ponovne okužbe z bakterijo Staphylococcus aureus, je imela globoko okužbo, potrebnega kirurškega posega pa pri njih niso opravili.
There is limited information on the safety and efficacy of daptomycin in the very obese and so caution is recommended.
Podatki o varnosti in učinkovitosti daptomicina pri zelo debelih bolnikih so omejeni, zato priporočamo previdnost.
During post-marketing surveillance, cases of interference between daptomycin and particular reagents used in some assays of prothrombin time/international normalised ratio (PT/INR) have been reported.
Med spremljanjem v obdobju trženja zdravila so poročali o primerih interference med daptomicinom in določenimi reagenti, ki jih uporabljamo v nekaterih preskusih za določanje protrombinskega časa/mednarodno umerjenega razmerja (PČ/INR).
In in vitro studies, daptomycin was not metabolised by human liver microsomes.
V študijah in vitro se daptomicin ni presnavljal preko človeških jetrnih mikrosomov.
Patients were enrolled in a stepwise approach into well-defined age groups and given age-dependent doses once daily for up to 14 days, as follows:
Bolnike so stopenjsko vključevali v natančno opredeljene starostne skupine in jim zdravilo odmerjali glede na starost največ 14 dni kot sledi:
Any unused portion remaining in the vial should be discarded.
Neuporabljeno količino zdravila, ki ostane v viali, zavrzite.
In clinical studies, marked increases in plasma CPK to >5x Upper Limit of Normal (ULN) without muscle symptoms occurred more commonly in daptomycin -treated patients (1.9%) than in those that received comparators (0.5%).
V kliničnih študijah je pri bolnikih, ki so jih zdravili z daptomicinom, prišlo do izrazitega zvišanja ravni CPK v plazmi na > 5kratno zgornjo mejo normale (ZMN) brez mišičnih simptomov bolj pogosto (1,9 %) kot pri tistih bolnikih, ki so prejemali primerjalna zdravila (0,5 %).
Whenever possible, Daptomycin Hospira should be administered following the completion of dialysis on dialysis days (see section 5.2).
Če je le mogoče, je treba zdravilo Daptomycin Hospira dati na dializne dni po dokončani dializi (glejte poglavje 5.2).
Powder for solution for injection/infusion 1 vial
prašek za raztopino za injiciranje/infundiranje 1 viala
Your doctor will make sure you have a blood test and will advise whether or not to continue with Daptomycin Hospira.
Zdravnik bo poskrbel, da boste opravili krvno preiskavo in vam svetoval, ali nadaljevati z uporabo zdravila Daptomicin Hospira ali ne.
In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).
Pri mešanih okužbah, kjer obstaja sum na prisotnost gram negativnih in/ali določenih tipov anaerobnih bakterij, je treba daptomicin dajati skupaj z enim ali več ustreznimi protimikrobnimi zdravili.
Failure of treatment due to persisting or relapsing Staphylococcus aureus infections was observed in 19/120 (15.8%) patients treated with daptomycin, 9/53 (16.7%) patients treated with vancomycin and 2/62 (3.2%) patients treated with an anti-staphylococcal semi-synthetic penicillin.
Neuspeh zdravljenja zaradi trdovratne ali ponovne okužbe z bakterijo Staphylococcus aureus so opažali pri 19 od 120 bolnikov (15,8 %), ki so jih zdravili z daptomicinom, 9 od 53 bolnikov (16,7 %), ki so jih zdravili z vankomicinom, ter 2 od 62 bolnikov (3,2 %), ki so jih zdravili z antistafilokoknim polsintetičnim penicilinom.
Rare: may affect up to 1 in 1,000 people - Yellowing of the skin and eyes, - Prothrombin time prolonged.
Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov - rumeno obarvanje kože in oči - podaljšan protrombinski čas
Following administration of multiple doses, daptomycin exposure was similar across different age groups after dose adjustment based on body weight and age.
Po uporabi več odmerkov je bila izpostavljenost daptomicinu v različnih starostnih skupinah (po prilagoditvi odmerka glede na telesno maso in starost) podobna.
Secondary objectives included an assessment of efficacy of age-dependent doses of intravenous daptomycin in comparison with standard-of-care therapy.
Sekundarni cilji so vključevali oceno učinkovitosti posameznih na starost prilagojenih odmerkov intravensko apliciranega daptomicina v primerjavi z uveljavljenim načinom zdravljenja (s standardno oskrbo).
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.
Poročali o sevih z zmanjšano občutljivostjo za daptomicin, posebno med zdravljenjem bolnikov z okužbami, ki jih je težko zdraviti, in/ali po dolgotrajnejšem dajanju zdravila.
What Daptomycin Hospira is and what it is used for What you need to know before you are given Daptomycin Hospira How Daptomycin Hospira is given Possible side effects
Kaj je zdravilo Daptomicin Hospira in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Daptomicin Hospira Kako uporabljati zdravilo Daptomicin Hospira Možni neželeni učinki
Clinical studies in patients employed infusion of daptomycin over at least 30 minutes.
V kliničnih študijah so bolnikom dajali infuzijo daptomicina vsaj 30 minut.
A study in dogs demonstrated that skeletal myopathy was reduced upon once daily administration as compared to fractionated dosing at same total daily dose, suggesting that myopathic effects in animals were primarily related to time between doses.
V študiji na psih so dokazali zmanjšanje skeletne miopatije pri odmerjanju enkrat dnevno v primerjavi s frakcioniranim odmerjanjem enakega dnevnega odmerka, kar kaže, da so bile miopatske spremembe pri živalih odvisne predvsem od intervalov med odmerjanji.
Daptomycin Hospira given as 30 or 60-minute intravenous infusion
Zdravilo Daptomicin Hospira za dajanje v obliki 30- ali 60-minutne intravenske infuzije
Daptomycin Hospira is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin.
Zdravilo Daptomicin Hospira uporabljamo pri odraslih in otrocih ter mladostnikih (starih od 1 do 17 let) za zdravljenje okužb kože in podkožnih tkiv.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe/use Daptomycin Hospira are provided with: - Summary of Product Characteristics - Dosage card
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravniki, ki bodo predvidoma predpisovali/uporabljali zdravilo Daptomicin Hospira, prejeli: - povzetek glavnih značilnosti zdravila, - kartico za odmerjanje daptomicina.
The primary objective of Study DAP-PEDBAC-11-02 was to assess the safety of intravenous daptomycin versus SOC antibiotics.
Primarni cilj študije DAP-PEDBAC-11-02 je bil oceniti varnost intravenskega daptomicina v primerjavi z antibiotiki, ki se uporabljajo za standardno oskrbo.
The reconstituted solution should be checked carefullyto ensure that the product is in solution and visually inspected for the absence of particulates prior to use.
Rekonstituirano raztopino morate pazljivo preveriti in se prepričati, da je zdravilo v raztopini, ter jo pred uporabo vizualno pregledati, da v njej ni trdnih delcev.
The most serious side effects are described below:
Spodaj so navedeni najbolj resni neželeni učinki:
UNIQUE IDENTIFIER -2D BARCODE
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
Daptomycin Hospira is available in packs containing 1 vial or 5 vials.
Zdravilo Daptomicin Hospira je na voljo v pakiranjih po 1 ali 5 vial.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Kadar je lokalna razširjenost odpornosti takšna, da je koristnost zdravila pri vsaj nekaterih vrstah okužb vprašljiva, je treba po potrebi pridobiti mnenje strokovnjaka.
The safety and efficacy of daptomycin in children and adolescents aged below 18 years with RIE due to Staphylococcus aureus have not been established.
Varnost in učinkovitost daptomicina pri otrocih in mladostnikih do 18. leta starosti z RIE zaradi bakterije Staphylococcus aureus nista bili dokazani.
If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Daptomicin Hospira: če ste alergični na daptomicin, natrijev hidroksid ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
1 to 6 years (N=19)*
1 do 6 let (N = 19)*
Paediatric patients below the age of one year should not be given daptomycin due to the risk of potential effects on muscular, neuromuscular and/or nervous systems (either peripheral and/or central) that were observed in neonatal dogs (see section 5.3).
Pediatrični bolniki, ki so stari manj kot eno leto, daptomicina ne smejo prejemati zaradi tveganja za morebitne učinke na mišični, živčno-mišični in/ali živčni sistem (periferni in/ali centralni), kar so opažali pri novoskotenih pasjih mladičih (glejte poglavje 5.3).
About 5% of the administered radiolabel was excreted in the faeces.
Približno 5 % danega radioaktivno označenega zdravila se je izločilo z blatom.
Driving and using machines Daptomycin Hospira has no known effects on the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Daptomicin nima znanega vpliva na sposobnost vožnje in upravljanja strojev.
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 z bakterijo Staphylococcus aureus, Enterococcus faecalis ali Enterococcus faecium, med drugim tudi pri bolnikih z bakteriemijo, neuspeh pa je bil povezan z organizmi, ki so med zdravljenjem postali manj občutljivi za daptomicin ali očitno odporni proti njemu.
Daptomycin pharmacokinetics in patients in this study are summarised in Table 2.
Farmakokinetika daptomicina pri bolnikih v tej študiji je povzeta v preglednici 2.