FrancophonIA/ELRC3.0 huggingface dataset:
English: The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Slovenian: Razširjenost odpornosti lahko pri izbranih vrstah geografsko in časovno variira in lokalne informacije o odpornosti so zaželene, še posebno kadar gre za zdravljenje hudih okužb.
English: A course of treatment usually lasts for 1 to 2 weeks for skin infections.
Slovenian: Postopek zdravljenja pri okužbah kože običajno traja 1 do 2 tedna.
English: This mode of administration was only studied in healthy subjects.
Slovenian: Ta način uporabe zdravila so proučevali samo pri zdravih osebah.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati je treba uradne smernice za ustrezno uporabo protimikrobnih zdravil.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
Slovenian: Ker o teh učinkih spontano poroča populacija neznane velikosti, ni mogoče zanesljivo določiti njihove pogostnosti, zato je ta opredeljena kot ''neznana''.
English: Detailed instructions for use and handling are given at the end of the leaflet.
Slovenian: Podrobna navodila za uporabo in ravnanje z zdravilom so navedena na koncu navodila za uporabo.
English: Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Slovenian: Daptomicin je antibiotik, ki lahko zaustavi rast določenih bakterij.
English: - Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy.
Slovenian: • Bolnike je treba med zdravljenjem redno pregledovati glede kakršnihkoli znakov ali simptomov, ki bi lahko predstavljali miopatijo.
English: From a microbiological point of view, the product should be used immediately after reconstitution (see section 6.3).
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji (glejte poglavje 6.3).
English: In the event of overdose, supportive care is advised.
Slovenian: V primeru prevelikega odmerjanja svetujemo podporno oskrbo.
English: The differences noted are most likely due to the normal reduction in renal function observed in the geriatric population.
Slovenian: Ugotovljene razlike so najverjetneje posledica normalnega zmanjšanja delovanja ledvic, ki so ga opazili pri starejši populaciji.
English: The primary objective of Study DAP-PEDS-07-03 was to assess the safety of treatment.
Slovenian: Primarni cilj študije DAP-PEDS-07-03 je bil oceniti varnost zdravljenja.
English: The results can suggest poor blood clotting when, in fact, there is no problem.
Slovenian: Izvidi lahko pokažejo slabo strjevanje krvi, čeprav s tem dejansko nimate težav.
English: - Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake "EXP".
English: - Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements.
Slovenian: - kakršno koli nenavadno mravljinčenje ali odrevenelost v dlaneh in stopalih, izguba občutka ali težave z gibanjem.
English: This results in bacterial cell death with negligible cell lysis.
Slovenian: Rezultat tega je smrt bakterijskih celic z zanemarljivo citolizo.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden prejmete to zdravilo.
English: This medicinal product must not be mixed with other medicinal products except those mentioned above.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena zgoraj.
English: Adults (18 years of age and above)
Slovenian: Odrasli (stari 18 let ali več)
English: People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Slovenian: Osebam, ki so starejše od 65 let, lahko dajemo enake odmerke kot drugim odraslim, če njihove ledvice delujejo dobro.
English: Children and adolescents (1 to 17 years of age)
Slovenian: Otroci in mladostniki (stari od 1 do 17 let)
English: In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.
Slovenian: Pri odraslih mora biti uporaba pri bakteriemiji povezana z RIE ali cSSTI, pri pediatričnih bolnikih pa mora biti uporaba pri bakteriemiji povezana z cSSTI.
English: 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).
Slovenian: Natančna pojavnost eozinofilne pljučnice zaradi daptomicina sicer ni znana, vendar je stopnja spontanega poročanja zaenkrat zelo nizka (< 1/10.000).
English: No patients 1 to <2 years of age were enrolled in the study.
Slovenian: V študijo niso bili vključeni bolniki, stari od 1 do < 2 let.
English: Peripheral nerve changes were characterised by minimal to slight axonal degeneration and were frequently accompanied by functional changes.
Slovenian: Za spremembe perifernih živcev je bila značilna minimalna do blaga degeneracija aksonov in so jih pogosto spremljale funkcionalne spremembe.
English: Daptomycin Hospira will usually be given to you by a doctor or a nurse.
Slovenian: Zdravilo Daptomicin Hospira vam bo običajno dal zdravnik ali medicinska sestra.
English: For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji ter po rekonstituciji in redčenju zdravila glejte poglavje 6.3.
English: Daptomycin Hospira should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal.
Slovenian: Zdravljenje z daptomicinom je treba v prisotnosti nepojasnjenih mišičnih simptomov prekiniti, če raven CPK doseže več kot 5kratno zgornjo mejo normale.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Slovenian: Če med zdravljenjem pride do superinfekcije, je treba ustrezno ukrepati.
English: The highest measured concentration of daptomycin in the breast milk was 0.045 mcg/ml, which is a low concentration.
Slovenian: Najvišja koncentracija daptomicina, ki so jo izmerili v mleku, je bila 0,045 μg/ml, kar je nizka koncentracija.
English: However, renal function should be assessed and the dose should be reduced if there is evidence of severe renal impairment.
Slovenian: Kljub temu pa je treba oceniti delovanje ledvic in odmerek zmanjšati, če obstajajo dokazi za hudo okvaro ledvic.
English: There was no relevant difference in local tolerability or in the nature and frequency of adverse reactions.
Slovenian: Pomembnih razlik v lokalnem prenašanju ali naravi in pogostnosti neželenih učinkov ni bilo.
English: CARTON FOR 1 VIAL CARTON FOR 5 VIALS
Slovenian: ŠKATLA ZA 1 VIALO ŠKATLA ZA 5 VIAL
English: If your kidneys do not work well, you may receive Daptomycin Hospira less often, e.g. once every other day.
Slovenian: Če vaše ledvice ne delujejo dobro, boste daptomicin prejemali manj pogosto, na primer vsak drugi dan.
English: The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data):
Slovenian: Med zdravljenjem ali spremljanjem bolnikov so o naslednjih neželenih učinkih poročali z navedbo pogostnosti, ki je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Gram negative organisms * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Slovenian: Naravno odporni organizmi po Gramu negativni organizmi * označuje vrsto, za katero velja, da so aktivnost proti njej zadovoljivo dokazali v kliničnih študijah.
English: *Mean (Standard Deviation) calculated for patients 2 to 6 years of age, since no patients 1 to <2 years of age were enrolled in the study.
Slovenian: *Srednja vrednost (standardna deviacija), izračunana za bolnike, stare od 2 do 6 let, saj v to študijo niso bili vključeni bolniki, stari od 1 do < 2 let.
English: The results of these studies show that exposures (AUC) in paediatric patients across all doses are generally lower than those in adults at comparable doses.
Slovenian: Rezultati teh študij kažejo, da je pri pediatričnih bolnikih izpostavljenost (AUC) pri vseh odmerkih na splošno manjša kot pri odraslih med uporabo primerljivih odmerkov.
English: Daptomycin Hospira may interfere with laboratory tests that measure how well your blood is clotting.
Slovenian: Daptomicin lahko vpliva na laboratorijske preiskave, s katerimi izmerijo, kako dobro se strjuje vaša kri.
English: Dose adjustments in adult patients with renal impairment by indication and creatinine clearance
Slovenian: Prilagajanje odmerkov pri odraslih bolnikih z okvaro ledvic glede na indikacijo in očistek kreatinina
English: Daptomycin should be discontinued immediately and treatment with systemic steroids should be initiated when appropriate.
Slovenian: Zdravljenje z daptomicinom je treba takoj prekiniti in uvesti zdravljenje s sistemskimi steroidi, kadar je to primerno.
English: The dose for children and adolescents (1 to 17 years of age) will depend on the age of patient and the type of infection being treated.
Slovenian: Višina odmerkov za otroke in mladostnike (v starosti od 1 do 17 let) je odvisna od starosti bolnika in vrste zdravljene okužbe.
English: The majority of transaminase elevations were of Grade 1-3 toxicity and resolved upon discontinuation of treatment.
Slovenian: Večina zvečanj vrednosti aminotransferaz je bila toksičnosti stopnje 1-3 in je izzvenela po prekinitvi zdravljenja.
English: Preparation of the solution for infusion requires an additional dilution step as detailed below.
Slovenian: Za pripravo raztopine za infundiranje so potrebni dodatni koraki za razredčenje, kot je opisano spodaj.
English: Regular monitoring of renal function is advised (see section 5.2).
Slovenian: Priporočljivo je redno spremljanje delovanja ledvic (glejte poglavje 5.2).
English: 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.
Slovenian: Rezultati študij in vitro s človeškimi hepatociti kažejo, da daptomicin niti ne zavira niti ne inducira delovanja naslednjih izooblik človeškega citokroma P450: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 in 3A4.
English: No fibrosis or rhabdomyolysis was observed.
Slovenian: Fibroze ali rabdomiolize niso opažali.
English: The mechanism(s) of daptomycin resistance is (are) not fully understood.
Slovenian: Mehanizem (mehanizmi) odpornosti proti daptomicinu ni(so) v celoti pojasnjen(i).
English: These may be signs of a rare but serious lung disorder called eosinophilic pneumonia.
Slovenian: To so lahko znaki redke, a resne pljučne bolezni, ki jo imenujemo eozinofilna pljučnica.
English: Table 1 Adverse reactions from clinical studies and post-marketing reports
Slovenian: Preglednica 1 Neželeni učinki iz kliničnih študij in poročil v obdobju trženja zdravila
English: Therefore it is important that your doctor takes into account that you are receiving Daptomycin Hospira.
Slovenian: Zato je pomembno, da vaš zdravnik upošteva, da prejemate daptomicin.
English: Daptomycin Hospira should not be used during pregnancy unless clearly necessary i.e., only if the expected benefit outweighs the possible risk.
Slovenian: Daptomicina ne smemo uporabljati med nosečnostjo, razen če je to očitno potrebno, tj. samo, če pričakovana korist odtehta možno tveganje.
English: After cleaning, do not touch the rubber stopper or allow it to touch any other surface.
Slovenian: Po čiščenju se gumijastega zamaška ne dotikajte več in pazite, da ne pride v stik s kakršnokoli drugo površino.
English: It is also used to treat infections in the blood when associated with skin infection.
Slovenian: Uporablja se tudi za zdravljenje okužb krvi, kadar so povezane z okužbo kože.
English: Other side effects which may occur following daptomycin treatment are described below:
Slovenian: Drugi neželeni učinki, ki se lahko pojavijo pri zdravljenju z daptomicinom, so opisani spodaj:
English: Depending on the study duration, all muscle effects, including microscopic changes, were fully reversible within 1-3 months following cessation of dosing.
Slovenian: Glede na trajanje študije so bili vsi učinki na mišice, vključno z mikroskopskimi spremembami, popolnoma reverzibilni v 13 mesecih po prekinitvi odmerjanja.
English: Manufacturer Hospira UK Limited Horizon
Slovenian: Izdelovalec Hospira UK Limited Horizon
English: Commonly Susceptible Species
Slovenian: Vrste, ki so običajno občutljive
English: - Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
Slovenian: • Pri vsakem bolniku, pri katerem se pojavijo nepojasnjene bolečine v mišicah, občutljivost, oslabelost ali krči, je treba ravni CPK spremljati na vsaka 2 dni.
English: The same dose is recommended in people aged over 65 years provided their kidneys are working well.
Slovenian: Enak odmerek priporočamo tudi za osebe, starejše od 65 let, pod pogojem, da njihove ledvice dobro delujejo.
English: The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection.
Slovenian: Običajni odmerek za odrasle je 4 mg na vsak kilogram (kg) telesne mase enkrat dnevno za okužbe kože oziroma 6 mg na vsak kg telesne mase enkrat dnevno za okužbe srca ali okužbe krvi, ki so povezane z okužbo kože ali srca.
English: Uncommon: Fatigue, pain * Based on post-marketing reports.
Slovenian: utrujenost, bolečine * Na osnovi poročil v obdobju trženja zdravila.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Other antibacterials, ATC code: J01XX09
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, druga zdravila za zdravljenje bakterijskih infekcij, oznaka ATC: J01XX09
English: This should be taken into account when initiating daptomycin therapy and, if daptomycin is given, these patients should be monitored more frequently than once weekly.
Slovenian: To je treba upoštevati pri uvedbi zdravljenja z daptomicinom in v primeru uporabe daptomicina te bolnike spremljati pogosteje kot enkrat tedensko.
English: In clinical studies, 2,011 adult subjects received daptomycin.
Slovenian: V kliničnih študijah je daptomicin prejemalo 2.011 odraslih preskušancev.
English: No functional or pathological changes in smooth or cardiac muscle were observed.
Slovenian: V gladkih mišicah ali srčni mišici niso opazili nobenih funkcionalnih ali patoloških sprememb.
English: Daptomycin Hospira 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.
Slovenian: Daptomicina ne smemo dajati otrokom, ki so stari manj kot 1 leto, saj so rezultati študij na živalih pokazali, da se pri tej starostni skupini lahko pojavijo hudi neželeni učinki.
English: Clinical efficacy in paediatric patients
Slovenian: Klinična učinkovitost pri pediatričnih bolnikih
English: In two adult clinical trials in complicated skin and soft tissues infections, 36% of patients treated with daptomycin met the criteria for systemic inflammatory response syndrome (SIRS).
Slovenian: V dveh kliničnih preskušanjih pri odraslih z zapletenimi okužbami kože in mehkih tkiv je 36 % bolnikov, ki so jih zdravili z daptomicinom, izpolnjevalo merila za sindrom sistemskega vnetnega odziva (SIRS - Systemic Inflammatory Response Syndrome).
English: This finding was not associated with an effect on muscle contraction.
Slovenian: Ta ugotovitev ni bila povezana z vplivom na krčenje mišic.
English: 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.
Slovenian: V študiji masnega ravnovesja z uporabo radioaktivno označenega materiala se je glede na celotno radioaktivnost z urinom izločilo 78 % danega odmerka, medtem ko je izločanje nespremenjenega daptomicina z urinom znašalo približno 50 % odmerka.
English: 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:
Slovenian: 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:
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: This leaflet was last revised in MM/YYYY
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL.
English: - 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.
Slovenian: • 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.
English: The most frequently reported side effects are described below:
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so opisani spodaj:
English: 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.
Slovenian: 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.
English: If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.
Slovenian: Če opazite pridvignjene ali s tekočino napolnjene kožne izpuščaje na večji površini telesa, takoj obvestite zdravnika ali medicinsko sestro.
English: Inactive metabolites were detected in urine, as determined by the difference in total radioactive concentrations and microbiologically active concentrations.
Slovenian: V urinu so odkrili neaktivne presnovke, ki so jih določili kot razliko med skupnimi radioaktivnimi koncentracijami in mikrobiološko aktivno koncentracijo.
English: Daptomycin should not be used more frequently than once a day.
Slovenian: Daptomicina ne smemo uporabljati pogosteje kot enkrat na dan.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Reversal of both the microscopic and functional effects was complete within 6 months post-dose.
Slovenian: Mikroskopski in funkcionalni učinki so bili popolnoma reverzibilni v 6 mesecih po končanem odmerjanju.
English: Daptomycin Hospira is not usually given to pregnant women.
Slovenian: Daptomicina običajno ne dajemo nosečnicam.
English: Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance
Slovenian: zmanjšan apetit, hiperglikemija, neravnovesje elektrolitov
English: 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.
Slovenian: Varnosti in učinkovitosti prilagajanja odmernega intervala niso ovrednotili v nadzorovanih kliničnih preskušanjih, priporočila pa temeljijo na farmakokinetičnih študijah in rezultatih modeliranja.
English: The safety data for the administration of daptomycin via 2-minute intravenous injection are derived from two pharmacokinetic studies in healthy adult volunteers.
Slovenian: Podatki o varnosti dajanja daptomicina z 2-minutno intravensko injekcijo izhajajo iz dveh farmakokinetičnih študij pri zdravih odraslih prostovoljcih.
English: In healthy adult volunteers and adult patients treated with daptomycin, protein binding averaged about 90% including subjects with renal impairment.
Slovenian: 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.
English: 7 to 11 years
Slovenian: Od 7 do 11 let
English: - Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
Slovenian: - zdravila proti bolečinam, ki jih imenujemo nesteroidna protivnetna zdravila (NSAID - Non-Steroidal Anti-Inflammatory Drug) ali zaviralci COX-2 (npr. celekoksib).
English: Do not breast-feed if you are receiving Daptomycin Hospira, because it may pass into your breast milk and could affect the baby.
Slovenian: Če prejemate daptomicin, ne smete dojiti, saj zdravilo lahko prehaja v vaše mleko in vpliva na dojenčka.
English: 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).
Slovenian: Huda okvara ledvic lahko sama po sebi povzroči povišanja ravni daptomicina, kar lahko poveča tveganje za nastanek miopatij (glejte zgoraj).