natgillin/translations-raw huggingface dataset:
Your doctor may need to change the dose of Cubicin (see section 3 of this leaflet).
Zdravnik bo morda moral prilagoditi odmerek zdravila Cubicin (glejte poglavje 3 tega navodila).
In vitro studies with human hepatocytes indicate that daptomycin does not inhibit or induce the activities of the following human cytochrome P450 isoforms: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A4.
Rezultati in vitro študij s človeškimi hepatociti kažejo, da daptomicin niti ne zavira niti ne inducira delovanja naslednjih človeških izooblik citokroma P450: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 in 3A4.
Therefore caution should be exercised if Cubicin is given to such patients.
Zaradi tega je potrebna velika previdnost, če se zdravilo Cubicin daje tem bolnikom.
In the event of overdose, supportive care is advised.
V primeru prevelikega odmerjanje svetujemo podporno oskrbo.
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.
Varnost in učinkovitost prilagajanja intervalov odmerjanja nista bili ovrednoteni v kontroliranih kliničnih študijah, priporočila temeljijo predvsem na podatkih farmakokinetičnih modelov.
For Reconstitution:
Za rekonstitucijo:
In clinical studies, 2,011 adult subjects received Cubicin.
V kliničnih študijah je zdravilo Cubicin prejemalo več kot 2.011 odraslih preiskovancev .
If this happens tell your doctor.
Če se to pojavi, obvestite zdravnika.
After cleaning, do not touch the rubber stopper or allow it to touch any other surface.
Po čiščenju se gumijastega zamaška ne dotikajte več in pazite, da ne pride v stik s katero koli drugo površino.
Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution.
Nazadnje je treba vialo nekaj minut nežno obračati/vrteti, kolikor je potrebno, da dobimo bistro rekonstituirano raztopino.
As the pharmacokinetics (see section 5.2) is comparable, the safety margins for both methods of administration are very similar.
Ker je farmakokinetika pri obeh načinih vnosa medsebojno primerljiva (glejte poglavje 5.2), je tudi varno območje odmerjanja zelo podobno.
While the exact incidence of eosinophilic pneumonia associated with daptomycin is unknown, to date the reporting rate of spontaneous reports is very low (< 1/10,000).
Natančna incidenca eozinofilne pljučnice zaradi daptomicina sicer ni znana, spontana poročila pa so zaenkrat zelo redka (< 1/10.000).
These may be signs of a rare but serious lung disorder called eosinophilic pneumonia.
To so lahko znaki redke, a resne bolezni pljuč, ki jo imenujemo eozinofilna pljučnica.
Your doctor may decide not to give you Cubicin or to stop the other medicine for a while.
Zdravnik se bo morda odločil, da vam ne bo predpisal zdravila Cubicin ali pa bo zdravljenje za nekaj časa prekinil.
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 oseb prejemalo dnevni odmerek 4 mg/kg, od teh je bilo 1.108 bolnikov, 113 pa zdravih prostovoljcev; 460 oseb je prejemalo dnevni odmerek 6 mg/kg, od teh so bili 304 bolniki, 156 pa je bilo zdravih prostovoljcev.
Pharmacotherapeutic group: Antibacterials for systemic use, Other antibacterials, ATC code: J01XX09
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, Druga zdravila za zdravljenje bakterijskih infekcij, oznaka ATC: J01XX09
Other medicines and Cubicin Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Cubicin Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
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 krvno-možgansko bariero in placentarno bariero po enkratnem in večkratnih odmerkih.
Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Cubicin.
Zdravnik bo naročil preiskave krvi za spremljanje stanja vaših mišic, in sicer pred začetkom zdravljenja in nato pogosto med zdravljenjem z zdravilom Cubicin.
In two adult clinical trials in complicated skin and soft tissues infections, 36% of patients treated with Cubicin met the criteria for systemic inflammatory response syndrome (SIRS).
V dveh kliničnih preskušanjih pri odraslih z zapletenimi okužbami kože in mehkih tkiv je 36 % bolnikov, zdravljenih z zdravilom Cubicin, ustrezalo kriterijem za sindrom sistemskega vnetnega odziva (SIRS).
• 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 izhodiščno vrednost CPK več kot 5-krat višjo od zgornje meje normale, obstaja večje tveganje za dodatno zvišanje med zdravljenjem z daptomicinom.
What you need to know before you are given Cubicin
Kaj morate vedeti, preden boste prejeli zdravilo Cubicin
Gram negative organisms * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Po naravi odporni organizmi gramnegativni organizmi * zaznamuje vrste, za katere velja, da je bilo delovanje proti njim zadovoljivo prikazano v kliničnih študijah
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, zdravljenih z daptomicinom, je vezava na proteine znašala povprečno okrog 90 %, vključno z osebami z okvaro ledvic.
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.
Če se sočasnemu dajanju zdravil ni moč izogniti, je treba bolj pogosto kot enkrat tedensko kontrolirati ravni CPK, bolnike pa je treba skrbno pregledovati, da opazimo kakršne koli znake ali simptome, ki bi lahko predstavljali miopatijo.
Cubicin should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.
Zdravila Cubicin se ne sme uporabljati pri otrocih, ki so stari manj kot 1 leto, ker rezultati študij na živalih kažejo na možnost hudih neželenih učinkov v tej starostni skupini.
Cubicin is not physically or chemically compatible with glucose-containing solutions.
Zdravilo Cubicin fizikalno ali kemijsko ni kompatibilno z raztopinami, ki vsebujejo glukozo.
In a mass balance study using radiolabelled material, 78% of the administered dose was recovered from the urine based on total radioactivity, whilst urinary recovery of unchanged daptomycin was approximately 50% of the dose.
V študiji snovne bilance z uporabo radioaktivno označenega materiala je bilo mogoče zaslediti v urinu 78 % danega odmerka na podlagi celotne radioaktivnosti, medtem ko je znašalo izločanje nespremenjenega daptomicina z urinom približno 50 % odmerka.
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 Cubicin and comparator regimens.
O neželenih učinkih (to pomeni tiste učinke, za katere raziskovalec meni, da so mogoče, verjetno ali definitivno povezani z zdravilom) so poročali s podobno pogostnostjo za zdravilo Cubicin in za primerjalne sheme zdravljenja.
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 Cubicin.
Možno je, da se bo pojavilo več neželenih učinkov na mišice, kadar se ta zdravila (in še nekatera druga, ki vplivajo na mišice) jemljejo v času zdravljenja z zdravilom Cubicin.
Reproductive toxicity testing showed no evidence of effects on fertility, embryofoetal, or postnatal development.
Testiranje reproduktivne toksičnosti ni pokazalo nikakršnih dokazov o vplivih na plodnost, razvoj zarodka/plodu ali postnatalni razvoj.
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 dvignjene ali s tekočino napolnjene mehurčke na koži po večjem delu telesa, takoj povejte zdravniku ali medicinski sestri.
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 resen zaplet, vključno z razpadanjem mišic (rabdomiolizo), ki lahko privede do okvare ledvic.
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 na voljo klinične informacije o bolnikih, je bilo moč ugotoviti, da se je približno 50 % primerov zgodilo pri bolnikih z obstoječo okvaro ledvic ali pa pri tistih, ki so sočasno prejemali zdravila, za katera je znano, da povzročajo rabdomiolizo.
The highest measured concentration of daptomycin in the breast milk was 0.045 mcg/ml, which is a low concentration.
Najvišja koncentracija daptomicina, ki so jo izmerili v mleku, je bila 0,045 mikrogramov/ml, kar je nizka koncentracija učinkovine v mleku.
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 se uporablja pri presaditvah za preprečevanje zavrnitve presadka in pri drugih boleznih, na primer pri revmatoidnem artritisu ali pri atopijskem dermatitisu).
No functional or pathological changes in smooth or cardiac muscle were observed.
V gladkih mišicah ali srčni mišici niso opažali nobenih funkcionalnih ali patoloških sprememb.
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 Cubicin.
Takoj obvestite zdravnika, če pride do katerega od naslednjih simptomov: - pri zdravljenju bolnikov s skoraj vsemi antibiotiki, vključno z zdravilom Cubicin, so opažali resne akutne alergijske reakcije.
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 povišanje ravni daptomicina, kar lahko poveča tveganje za nastanek miopatije (glejte zgoraj).
The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.
Vialo je treba nežno vrteti, da se zagotovi popolna navlažitev celotnega zdravila, in jo nato pustiti stati 10 minut.
Patients were randomized 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:
Cubicin should not be used during pregnancy unless clearly necessary i.e., only if the expected benefit outweighs the possible risk.
Zdravila Cubicin ne smete uporabljati pri nosečnicah, razen če je nujno potrebno, to pomeni, samo če je pričakovana korist večja od možnega tveganja.
Indication for use Creatinine clearance Dose recommendation
Indikacija za uporabo Očistek kreatinina
The symptoms generally go away within a few days of stopping Cubicin.
Navadno simptomi izginejo nekaj dni po prenehanju uporabe zdravila Cubicin.
Instructions for use and handling
Navodilo za uporabo in ravnanje
AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg)
AUC0-24h (g×h/ml) Cmax (g/ml) Navidezni t1/2 (h) Očistek/t.m.
If you are receiving dialysis, and your next dose of Cubicin is due on a dialysis day, you will be usually given Cubicin after the dialysis session.
Če ste na dializi in je vaš naslednji odmerek zdravila Cubicin predviden na dializni dan, boste običajno prejeli zdravilo Cubicin po končani dializi.
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, tako rastočih celic kot tudi celic v stacionarni fazi, kar povzroča depolarizacijo in vodi do hitrega zaviranja sinteze proteinov, DNK in RNK.
The mechanism(s) of daptomycin resistance is (are) not fully understood.
Mehanizem (mehanizmi) rezistence na daptomicin ni v celoti pojasnjen (niso v celoti pojasnjeni).
Do not breast-feed if you are receiving Cubicin, because it may pass into your breast milk and could affect the baby.
Če prejemate zdravilo Cubicin, ne smete dojiti, ker bi zdravilo lahko prehajalo v mleko in vplivalo na dojenčka.
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 višji od tistih, povezanih z vplivi na skeletne mišice pri podganah in psih, in so se nanašali predvsem na Cmax v plazmi.
Steady-state concentrations are achieved by the third daily dose.
Koncentracije v stanju dinamičnega ravnovesja so dosežene s tretjim dnevnim odmerkom.
Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog.
Aplikacija daptomicina je bila povezana z minimalnimi do blagimi degenerativnimi/regenerativnim spremembami skeletnih mišic pri podganah in psih.
Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
Daptomicin se počasi očisti iz telesa s hemodializo (približno 15 % danega odmerka se očisti v 4 urah) ali s peritonealno dializo (približno 11 % danega odmerka se očisti v 48 urah).
Important: Please refer to the Summary of Product Characteristics before prescribing.
Pomembno: Pred predpisovanjem zdravila, prosimo, glejte Povzetek glavnih značilnosti zdravila.
Reversal of both the microscopic and functional effects was complete within 6 months post-dose.
Tako mikroskopski kot tudi funkcionalni učinki so popolnoma izginili 6 mesecev po končanem odmerjanju.
- If you are very overweight.
- če imate izrazito zvečano telesno maso.
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 aplikacije daptomicina z 2-minutno intravensko injekcijo izhajajo iz dveh farmakokinetičnih študij z zdravimi odraslimi prostovoljci.
Cubicin should be discontinued immediately and treatment with systemic steroids should be initiated when appropriate.
Zdravilo Cubicin je treba takoj ukiniti in uvesti zdravljenje s sistemskimi steroidi, če je to za bolnika primerno.
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 opažali presnovkov v plazmi, v urinu pa so ugotovili manjše količine treh oksidativnih presnovkov in ene neprepoznane spojine.
To minimise this risk, physicians should be advised that for coagulation levels testing it is recommended to draw blood samples near the time of Cubicin trough plasma concentration.
Za zmanjševanje tega tveganja je treba zdravnikom svetovati, da je vzorce krvi priporočljivo odvzeti približno v času, ko je koncentracija zdravila Cubicin v plazmi najnižja,
People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Pri osebah, starih več kot 65 let, se sme uporabljati enake odmerke kot pri ostalih odraslih osebah, če njihove ledvice delujejo normalno.
Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK.
Mikroskopskih sprememb v skeletnih mišicah je bilo zelo malo (prizadetih je bilo približno 0,05 % mišičnih vlaken), višji odmerki pa so bili povezani z zvišanjem CPK.
• Cubicin 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.
• Zdravila Cubicin ne smemo dajati bolnikom, ki jemljejo druga zdravila, povezana z nastankom miopatij, razen če menimo, da je korist za bolnika večja od tveganja.
Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Mehanizem delovanja Daptomicin je ciklični lipopeptid naravnega izvora, ki deluje samo proti grampozitivnim bakterijam.
These transaminase increases were likely to be related to the skeletal muscle effects.
Ta dvig vrednosti aminotransferaz je najverjetneje povezan z učinki na skeletno mišičje.
- Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
- zdravila proti bolečinam, ki se imenujejo nesteroidna protivnetna zdravila (NSAID) ali zaviralci COX-2 (npr. celekoksib).
It has been demonstrated in clinical studies that Cubicin is not effective in the treatment of pneumonia.
V kliničnih študijah je bilo nazorno prikazano, da zdravilo Cubicin za zdravljenje pljučnice ni učinkovito.
Therefore it is important that your doctor takes into account that you are receiving Cubicin.
Zato mora zdravnik upoštevati, da prejemate zdravilo Cubicin.
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 se zdravijo z daptomicinom, opazite nepojasnjene nepravilnosti PT/INR, je treba pomisliti na možnost in vitro interakcije z laboratorijskim testom.
The dose will depend on how much you weigh and the type of infection being treated.
Odmerek zdravila je odvisen od vaše telesne mase in vrste okužbe, ki jo je treba zdraviti.
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 podlagi teh podatkov je priporočeno, da odrasli bolniki na hemodializi ali kontinuirani ambulantni peritonealni dializi prejemajo daptomicin vsakih 48 ur v odmerku, ki je priporočen za dano vrsto okužbe (glejte poglavje 4.2).
The recommended dosage regimens for paediatric patients based on age and indication are shown below.
Spodaj so navedeni priporočeni režimi odmerjanja za pediatrične bolnike glede na starost in indikacijo.
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 kazalo, da so mladi psi dovzetnejši za lezije perifernih živcev kot za skeletno miopatijo.
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 also section 4.5).
Poleg tega se pri sočasnem dajanju potencialno nefrotoksičnih sredstev svetuje redno kontroliranje ledvične funkcije, ne glede na bolnikovo obstoječo ledvično funkcijo (glejte tudi poglavje 4.5).
These could interfere with the effects of Cubicin in the kidney.
Ta zdravila lahko vplivajo na učinke zdravila Cubicin v ledvicah.
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 na meticilin občutljivim sevom Staphylococcus aureus (MSSA), 8 pa z na meticilin odpornim sevom Staphylococcus aureus (MRSA).
The majority of transaminase elevations were of Grade 1-3 toxicity and resolved upon discontinuation of treatment.
Največkrat so bile vrednosti aminotransferaz zvišane v toksičnem razredu 1-3 in so se po prekinitvi zdravljenja znižale.
The following have been shown to be compatible when added to Cubicin containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.
Za sledeče snovi se je pokazalo, da so kompatibilne, kadar jih dodajajo v raztopine za infundiranje, ki vsebujejo zdravilo Cubicin: aztreonam, ceftazidim, ceftriakson, gentamicin, flukonazol, levofloksacin, dopamin, heparin in lidokain.
The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper.
Snemno zaporko iz polipropilena je treba odstraniti, tako da se pokaže osrednji del gumijastega zamaška.
About 5% of the administered radiolabel was excreted in the faeces.
Okrog 5 % danega radioaktivnega označevalca se je izločilo z blatom.
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 signifikantni meri.
Patients who develop these signs and symptoms while receiving Cubicin should undergo prompt medical evaluation, including, if appropriate, bronchoalveolar lavage, to exclude other causes (e.g. bacterial infection, fungal infection, parasites, other medicinal products).
Bolnike, pri katerih v času jemanja zdravila Cubicin pride do navedenih znakov in simptomov, je treba takoj preiskati in jim, če je treba, izvesti bronhoalveolarno lavažo, da bi lahko izključili druge vzroke bolezni (na primer bakterijsko okužbo, glivno okužbo, parazite ali druga zdravila).
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 nižjih ravneh odmerjanja (25 mg/kg/dan) so opažali blage in reverzibilne klinične znake trzanja mišic in en primer mišične okorelosti brez kakršnega koli vpliva na telesno maso.
- The dosage card should contain the appropriate algorithms for calculating the Cubicin 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 Cubicin za rekonstitucijo, kar pomaga zmanjševati tveganje za napake pri uporabi zdravila (za previsoko osmolarnost ali preveliko odmerjanje).
Rates (95% CI)
deleži (95 % IZ)
In addition, there is a potential for a pharmacodynamic interaction to occur during coadministration due to additive renal effects.
Poleg tega obstaja možnost, da pri sočasni uporabi, zaradi dodatnih učinkov na ledvice, pride do farmakodinamične interakcije.
Depending on the study duration, all muscle effects, including microscopic changes, were fully reversible within 1-3 months following cessation of dosing.
Vsi učinki na mišice, vključno z mikroskopskimi spremembami, so bili popolnoma reverzibilni v 1 do 3 mesecih po prekinitvi odmerjanja v odvisnosti od trajanja študije.
Your doctor will make sure you have a blood test and will advise whether or not to continue with Cubicin.
Zdravnik bo poskrbel, da boste opravili krvne preiskave in vam svetoval, ali nadaljevati z uporabo zdravila Cubicin ali ne.