natgillin/translations-raw huggingface dataset:
Patients were randomised in a 2:1 ratio into the following age groups and given age-dependent doses once daily for up to 42 days, as follows:
Bolnike so v razmerju 2:1 randomizirali v naslednje starostne skupine in so jim do 42 dni dajali od starosti odvisne odmerke enkrat na dan, in sicer:
In very rare cases (reported in less than 1 in every 10,000 patients), muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.
V zelo redkih primerih (o katerih so poročali pri manj kot 1 od 10.000 bolnikov) so lahko mišične težave resne, vključno z razgradnjo mišic (rabdomiolizo), ki lahko privede do okvare ledvic.
On this basis, it is recommended that adult patients on HD or CAPD receive daptomycin once every 48 hours at the dose recommended for the type of infection being treated (see section 4.2).
Na osnovi teh podatkov je priporočljivo, da odrasli bolniki na HD ali CAPD prejemajo daptomicin vsakih 48 ur v odmerku, ki ga priporočajo za zadevno vrsto okužbe (glejte poglavje 4.2).
This leaflet was last revised in MM/YYYY
Navodilo je bilo nazadnje revidirano dne MM/LLLL.
- It cannot be ruled out that those patients with CPK greater than 5 times upper limit of normal at baseline may be at increased risk of further increases during daptomycin therapy.
• Ne moremo izključiti možnosti, da pri tistih bolnikih, ki imajo raven CPK ob izhodišču več kot 5krat višjo od zgornje meje normale, obstaja večje tveganje za dodatno zvišanje med zdravljenjem z daptomicinom.
The most frequently reported side effects are described below:
Neželeni učinki, o katerih so najpogosteje poročali, so opisani spodaj:
The majority of cases occurred after more than 2 weeks of treatment with daptomycin and improved when daptomycin was discontinued and steroid therapy was initiated.
Večina primerov se je pojavila po več kot 2 tednih zdravljenja z daptomicinom, stanje pa se je izboljšalo po prekinitvi zdravljenja z daptomicinom in uvedbi zdravljenja s steroidi.
If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.
Če opazite pridvignjene ali s tekočino napolnjene kožne izpuščaje na večji površini telesa, takoj obvestite zdravnika ali medicinsko sestro.
Inactive metabolites were detected in urine, as determined by the difference in total radioactive concentrations and microbiologically active concentrations.
V urinu so odkrili neaktivne presnovke, ki so jih določili kot razliko med skupnimi radioaktivnimi koncentracijami in mikrobiološko aktivno koncentracijo.
Daptomycin should not be used more frequently than once a day.
Daptomicina ne smemo uporabljati pogosteje kot enkrat na dan.
It is particularly important that you mention the following: - Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis).
Posebno pomembno je, da omenite naslednja zdravila: - zdravila, ki jih imenujemo statini ali fibrati (za zniževanje holesterola), ali ciklosporin (zdravilo, ki ga uporabljamo pri presaditvah za preprečevanje zavrnitve presadka in pri drugih boleznih, na primer pri revmatoidnem artritisu ali atopijskem dermatitisu).
When clinical information on the patients was available to make a judgement, approximately 50% of the cases occurred in patients with pre-existing renal impairment, or in those receiving concomitant medicinal products known to cause rhabdomyolysis.
Kjer so bile za presojo na voljo klinične informacije o bolnikih, je bilo moč ugotoviti, da se je približno 50 % primerov pojavilo pri bolnikih z obstoječo okvaro ledvic ali pri tistih, ki so sočasno prejemali zdravila, za katera je znano, da povzročajo rabdomiolizo.
The mechanism of action involves binding (in the presence of calcium ions) to bacterial membranes of both growing and stationary phase cells causing depolarisation and leading to a rapid inhibition of protein, DNA, and RNA synthesis.
Mehanizem delovanja vključuje vezavo (ob prisotnosti kalcijevih ionov) na bakterijske membrane celic v fazi rasti in celic v fazi mirovanja, kar povzroča depolarizacijo in vodi do hitrega zaviranja sinteze beljakovin, DNA in RNA.
Reversal of both the microscopic and functional effects was complete within 6 months post-dose.
Mikroskopski in funkcionalni učinki so bili popolnoma reverzibilni v 6 mesecih po končanem odmerjanju.
Daptomycin Hospira is not usually given to pregnant women.
Daptomicina običajno ne dajemo nosečnicam.
Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance
zmanjšan apetit, hiperglikemija, neravnovesje elektrolitov
The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is mainly based on pharmacokinetic modelling data.
Varnosti in učinkovitosti prilagajanja odmernega intervala niso ovrednotili v nadzorovanih kliničnih preskušanjih, priporočila pa temeljijo na farmakokinetičnih študijah in rezultatih modeliranja.
The safety data for the administration of daptomycin via 2-minute intravenous injection are derived from two pharmacokinetic studies in healthy adult volunteers.
Podatki o varnosti dajanja daptomicina z 2-minutno intravensko injekcijo izhajajo iz dveh farmakokinetičnih študij pri zdravih odraslih prostovoljcih.
In healthy adult volunteers and adult patients treated with daptomycin, protein binding averaged about 90% including subjects with renal impairment.
Pri zdravih odraslih prostovoljcih in odraslih bolnikih, ki so jih zdravili z daptomicinom, je vezava na beljakovine znašala povprečno okrog 90 %, vključno s preskušanci z okvaro ledvic.
7 to 11 years
Od 7 do 11 let
- Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
- zdravila proti bolečinam, ki jih imenujemo nesteroidna protivnetna zdravila (NSAID - Non-Steroidal Anti-Inflammatory Drug) ali zaviralci COX-2 (npr. celekoksib).
Do not breast-feed if you are receiving Daptomycin Hospira, because it may pass into your breast milk and could affect the baby.
Če prejemate daptomicin, ne smete dojiti, saj zdravilo lahko prehaja v vaše mleko in vpliva na dojenčka.
Severe renal impairment may in itself also pre-dispose to elevations in daptomycin levels which may increase the risk of development of myopathy (see above).
Huda okvara ledvic lahko sama po sebi povzroči povišanja ravni daptomicina, kar lahko poveča tveganje za nastanek miopatij (glejte zgoraj).
Of these 19 patients 11 were infected with methicillin-susceptible and 8 with methicillin-resistant Staphylococcus aureus.
Izmed teh 19 bolnikov jih je bilo 11 okuženih z za meticilin občutljivim sevom Staphylococcus aureus, 8 pa z na meticilin odpornim sevom Staphylococcus aureus.
Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Daptomycin Hospira.
Zdravnik bo opravil krvne preiskave za spremljanje zdravstvenega stanja vaših mišic, in sicer pred začetkom zdravljenja ter nato pogosto med zdravljenjem z zdravilom Daptomicin Hospira.
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 izloči iz telesa s hemodializo (približno 15 % danega odmerka se odstrani v 4 urah) ali s peritonealno dializo (približno 11 % danega odmerka se odstrani v 48 urah).
It has been demonstrated in clinical studies that daptomycin is not effective in the treatment of pneumonia.
V kliničnih študijah so dokazali, da daptomicin ni učinkovit pri zdravljenju pljučnice.
Clinical data on the use of daptomycin to treat RIE due to Staphylococcus aureus are limited to 19 adult patients (see “Information from clinical trials” in section 5.1).
Klinični podatki o uporabi daptomicina za zdravljenje RIE zaradi bakterije Staphylococcus aureus so omejeni na 19 odraslih bolnikov (glejte informacije iz kliničnih preskušanj v poglavju 5.1).
However, when compared with the same doses given as intravenous infusions over 30 minutes there were no clinically important differences in the pharmacokinetics and safety profile of daptomycin (see sections 4.8 and 5.2).
Kljub temu v primerjavi z enakimi odmerki, ki so jih dali v obliki 30-minutne intravenske infuzije, ni bilo klinično pomembnih razlik v farmakokinetičnih lastnostih daptomicina in njegovem varnostnem profilu (glejte poglavji 4.8 in 5.2).
Daptomycin is active against Gram positive bacteria only (see section 5.1).
Daptomicin deluje samo proti gram pozitivnim bakterijam (glejte poglavje 5.1).
Your doctor may decide not to give you Daptomycin Hospira or to stop the other medicine for a while.
Zdravnik se bo morda odločil, da vam ne bo predpisal zdravila Daptomicin Hospira ali da bo za nekaj časa prekinil zdravljenje z drugim zdravilom.
In contrast to adult dogs, juvenile dogs appeared to be more sensitive to peripheral nerve lesions as compared to skeletal myopathy.
V nasprotju z odraslimi psi je bilo videti, da so mladi psi dovzetnejši za lezije perifernih živcev kot za skeletno miopatijo.
1 to < 2 years
1 do < 2 leti
In paediatric studies, 372 patients received daptomycin, of whom 61 received a single dose and 311 received a therapeutic regimen for cSSTI or SAB (daily doses ranged from 4 mg/kg to 12 mg/kg).
V pediatričnih študijah je daptomicin prejemalo 372 bolnikov; 61 od teh jih je prejelo en sam odmerek, 311 pa jih je prejemalo terapevtsko shemo za cSSTI ali SAB (dnevni odmerki so segali od 4 mg/kg do 12 mg/kg).
As the pharmacokinetics (see section 5.2) is comparable, the safety margins for both methods of administration are very similar.
Farmakokinetika je pri obeh načinih uporabe primerljiva (glejte poglavje 5.2), zato je tudi varno območje zelo podobno.
Rates (95% CI)
stopnje (95 % IZ)
In addition, regular monitoring of renal function is advised during concomitant administration of potentially nephrotoxic agents, regardless of the patient's pre-existing renal function (see section 4.5).
Poleg tega je redno spremljanje delovanja ledvic priporočljivo tudi pri sočasnem dajanju potencialno nefrotoksičnih zdravil, ne glede na bolnikovo predhodno delovanje ledvic (glejte tudi poglavje 4.5).
Indicationfor use Creatinine clearance Dose recommendation
Indikacija za uporabo Očistek kreatinina
Subjects achieving clinical success (Clinical Response of “Cure” or “Improved”) and microbiological success (pathogen-level response of “Eradicated” or “Presumed Eradicated”) are classified as overall therapeutic success.
Bolniki, pri katerih pride do kliničnega uspeha (klinični odziv je “ozdravitev” ali “izboljšanje”) in do mikrobiološkega uspeha (odziv s stopnjo prisotnosti patogenov “izkoreninjen” ali “domnevno izkoreninjen”), so opredeljeni kot skupni terapevtski uspeh.
Interaction studies for daptomycin were performed with aztreonam, tobramycin, warfarin and probenecid.
Študije medsebojnega delovanja za daptomicin so izvedli z aztreonamom, tobramicinom, varfarinom in probenecidom.
Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients and 156 were healthy volunteers.
V okviru teh preskušanj je 1.221 preskušancev, med katerimi je bilo 1.108 bolnikov in 113 zdravih prostovoljcev, prejemalo dnevni odmerek 4 mg/kg; 460 preskušancev, med katerimi je bilo 304 bolnikov in 156 zdravih prostovoljcev, pa je prejemalo dnevni odmerek 6 mg/kg.
In a separate study, no metabolites were observed in plasma, and minor amounts of three oxidative metabolites and one unidentified compound were detected in urine.
V ločeni študiji niso opazili nobenih presnovkov v plazmi, v urinu pa so odkrili manjše količine treh oksidativnih presnovkov in ene neznane spojine.
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.
Učinke na periferne živce so opazili pri odmerkih, ki so bili večji od tistih, povezanih z učinki na skeletne mišice pri podganah in psih, povezani pa so bili predvsem z vrednostjo Cmax v plazmi.
To minimise foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution.
Da zmanjšate penjenje, se IZOGIBAJTE močnemu stresanju viale med rekonstitucijo ali po njej.
- The dosage card should contain the appropriate algorithms for calculating the Daptomycin Hospira dose for reconstitution, to help minimise the risk of medication errors (high osmolarity, overdose).
- kartica za odmerjanje mora vsebovati ustrezne algoritme za izračunavanje odmerka zdravila Daptomicin Hospira za rekonstitucijo, kar pripomore k zmanjšanju tveganja za napake pri odmerjanju (visoka osmolarnost ali preveliko odmerjanje).
There was no histopathological correlation in the peripheral and central nervous system tissue, or in the skeletal muscle, at any dose level, and the mechanism and clinical relevance for the adverse clinical signs are therefore unknown.
Pri nobeni ravni odmerka niso opazili histopatološke korelacije v tkivih perifernega in centralnega živčevja ali v skeletnih mišicah, zato mehanizem in klinični pomen teh neželenih kliničnih znakov nista znana.
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), večji odmerki pa so bili povezani z zvišanjem vrednosti CPK.
Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness.
Takoj obvestite zdravnika, če se vam pojavijo nepojasnjene bolečine v mišicah, občutljivost mišic ali mišična oslabelost.
Patients at higher risk of developing myopathy should have more frequent CPK measurements.
Pri bolnikih s povečanim tveganjem za nastanek miopatij je treba vrednosti CPK meriti pogosteje.
4 mg/kg every 48 hours
4 mg/kg vsakih 48 ur
Tell your doctor straight away if you develop any of the following symptoms: - Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including Daptomycin Hospira.
Takoj obvestite zdravnika, če se vam pojavi kateri koli od naslednjih simptomov: - pri bolnikih, ki so jih zdravili s skoraj vsemi antibiotiki, vključno z daptomicinom, so opazili resne akutne alergijske reakcije.
The symptoms generally go away within a few days of stopping Daptomycin Hospira.
Simptomi običajno izzvenijo v nekaj dneh po prenehanju uporabe zdravila Daptomicin Hospira.
Tissue distribution studies in rats showed that daptomycin appears to only minimally penetrate the blood-brain barrier and the placental barrier following single and multiple doses.
Študije o porazdelitvi v tkivih na podganah so pokazale, da naj bi daptomicin le minimalno prehajal skozi krvno-možgansko pregrado in skozi placento po enkratnem in večkratnih odmerkih.
It is possible that the risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Daptomycin Hospira.
Tveganje za pojav neželenih učinkov, ki vplivajo na mišice, je lahko večje, če med zdravljenjem z daptomicinom jemljete katerokoli od teh zdravil (in nekatera druga zdravila, ki lahko vplivajo na mišice).
- If any of these applies to you, tell your doctor or nurse before you are given Daptomycin Hospira.
Če karkoli od navedenega velja za vas, se posvetujte z zdravnikom ali medicinsko sestro, preden vam dajo zdravilo Daptomicin Hospira.
Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Daptomicin je ciklični lipopeptid naravnega izvora, ki deluje samo proti po Gramu pozitivnim bakterijam.
Enterococcal infections
Enterokokne okužbe
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.
Mejni vrednosti minimalnih inhibitornih koncentracij (MIK), ki jih je ugotovil Evropski odbor za testiranje občutljivosti za protimikrobna zdravila (EUCAST - European Committee on Antimicrobial Susceptibility Testing) za stafilokoke in streptokoke (razen za bakterijo S. pneumoniae), sta ≤ 1 mg/l za občutljive in > 1 mg/l za odporne bakterije.
There were no differences in Cmax.
Razlik v vrednosti Cmax.
Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry (perform the same for the sodium chloride solution vial, if applicable).
Obrišite vrh gumijastega zamaška z alkoholnim zložencem ali uporabite drugo antiseptično raztopino in pustite, da se posuši (enako naredite z vialo z raztopino natrijevega klorida, če je to primerno).
The laboratory susceptibility testing leaflet should contain the following key messages: - That susceptibility testing minimises the risk of treatment failure by identifying strains with potential resistance to daptomycin.
Letak za laboratorije s pojasnili glede testiranja na občutljivost mora vsebovati naslednja ključna sporočila: - da testiranje občutljivost zmanjša tveganje za neuspešno zdravljenje, saj pokaže, kateri sevi so potencialno odporni proti daptomicinu.
It may be necessary for your doctor to monitor your blood clotting times.
Zdravnik bo morda moral večkrat določati čas strjevanja vaše krvi.
The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.
Povsem rekonstituirano zdravilo je videti bistro in ima lahko ob robu viale nekaj majhnih mehurčkov ali pene.
Daptomycin is reversibly bound to human plasma proteins in a concentration independent manner.
Daptomicin se reverzibilno veže na humane plazemske beljakovine na način, ki ni odvisen od koncentracije.
- Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting.
- peroralne antikoagulante (na primer varfarin), to so zdravila, ki preprečujejo strjevanje krvi.
The recommended doses should be used in elderly patients except those with severe renal impairment (see above and section 4.4).
Pri starejših bolnikih, razen pri tistih s hudo okvaro ledvic, je treba uporabljati priporočene odmerke (glejte zgoraj in poglavje 4.4).
If you are receiving dialysis, and your next dose of Daptomycin Hospira is due on a dialysis day, you will be usually given Daptomycin Hospira after the dialysis session.
Če ste na dializi in je vaš naslednji odmerek daptomicina predviden na dan dialize, boste daptomicin običajno prejeli po končani dializi.
In a randomised controlled open-label study in 235 adult 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 daptomycin met the criteria for RIE.
V randomizirani nadzorovani odprti študiji z 235 odraslimi bolniki, ki so imeli bakteriemijo s Staphylococcus aureus (tj. vsaj eno hemokulturo, pozitivno na Staphylococcus aureus pred prvim odmerkom), je 19 od 120 bolnikov, ki so jih zdravili z daptomicinom, izpolnjevalo merila za RIE.
The dose will depend on how much you weigh and the type of infection being treated.
Odmerek zdravila bo odvisen od vaše telesne mase in vrste okužbe, ki vam jo zdravijo.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
Patients who develop these signs and symptoms while receiving daptomycin should undergo prompt medical evaluation, including, if appropriate, bronchoalveolar lavage, to exclude other causes (e.g. bacterial infection, fungal infection, parasites, other medicinal products).
Pri bolnikih, pri katerih se v času jemanja daptomicina pojavijo ti znaki in simptomi, je treba takoj opraviti zdravniški pregled in po potrebi bronhoalveolarno lavažo, da lahko izključimo druge vzroke bolezni (na primer bakterijsko okužbo, glivično okužbo, parazite, druga zdravila).
The findings of in vitro and some in vivo studies designed to investigate the mechanism of daptomycin myotoxicity indicate that the plasma membrane of differentiated spontaneously contracting muscle cells is the target of toxicity.
Ugotovitve študij in vitro in nekaterih študij in vivo, ki so jih zasnovali za preučevanje mehanizma toksičnosti daptomicina na mišice, kažejo, da je tarča toksičnosti plazemska membrana diferenciranih celic skeletnih mišic, ki se spontano krčijo.
Your doctor may need to change the dose of Daptomycin Hospira (see section 3 of this leaflet).
Zdravnik bo morda moral spremeniti odmerek zdravila Daptomicin Hospira (glejte poglavje 3 tega navodila).
The interaction between daptomycin and tobramycin with an approved dose of daptomycin is unknown.
Medsebojno delovanje daptomicina in tobramicina pri odobrenem odmerku daptomicina ni znano.
There is a possibility that your blood levels of Daptomycin Hospira could be higher than those found in persons of average weight and you may need careful monitoring in case of side effects.
Obstaja možnost, da bo raven daptomicina v vaši krvi višja kot pri osebah z normalno telesno maso in morda vas bo treba pozorno spremljati glede pojava neželenih učinkov.
In neonatal dogs, daptomycin caused marked clinical signs of twitching, muscle rigidity in the limbs, and impaired use of limbs, which resulted in decreases in body weight and overall body condition at doses ≥50 mg/kg/day and necessitated early discontinuation of treatment in these dose groups.
Pri novoskotenih pasjih mladičih je daptomicin povzročil izrazite klinične znake trzanja, mišične okorelosti v okončinah in težav pri premikanju okončin, kar je povzročilo zmanjšanje telesne mase in splošne telesne kondicije pri odmerkih ≥ 50 mg/kg/dan in zaradi česar je bilo treba v teh odmernih skupinah predčasno prekiniti zdravljenje.
Excretion of daptomycin into milk of lactating animals has not been studied.
Izločanja daptomicina v mleko doječih živali niso raziskovali.
Long-term carcinogenicity studies in rodents were not conducted.
Dolgotrajnih študij kancerogenosti pri glodalcih niso izvedli.
These transaminase increases were likely to be related to the skeletal muscle effects.
Ta zvečanja vrednosti aminotransferaz so verjetno povezana z učinki na skeletne mišice.
Reproductive toxicity testing showed no evidence of effects on fertility, embryofoetal, or postnatal development.
Testiranje vpliva na sposobnost razmnoževanja ni pokazalo nobenih učinkov na plodnost, razvoj zarodka/plodu ali postnatalni razvoj.
How to store Daptomycin Hospira Contents of the pack and other information
Shranjevanje zdravila Daptomicin Hospira Vsebina pakiranja in dodatne informacije
This dose is given directly into the blood stream (into a vein), as an infusion lasting about 30-60 minutes.
Ta odmerek se aplicira v krvni obtok (v veno) kot infuzija, ki traja okrog 30-60 minut.
If co-administration cannot be avoided, CPK levels should be measured more frequently than once weekly and patients should be closely monitored for any signs or symptoms that might represent myopathy (see sections 4.4, 4.8 and
Če se sočasnemu dajanju zdravil ni moč izogniti, je treba ravni CPK meriti pogosteje kot enkrat tedensko, bolnike pa je treba skrbno spremljati glede kakršnihkoli znakov ali simptomov, ki bi lahko predstavljali miopatijo (glejte poglavja 4.4, 4.8 in 5.3).
In some cases of myopathy involving raised CPK and muscle symptoms, the patients also presented with elevated transaminases.
V nekaterih primerih miopatije z zvečano vrednostjo CPK in mišičnimi simptomi so imeli bolniki tudi zvečane vrednosti aminotransferaz.