FrancophonIA/ELRC3.0 huggingface dataset:
English: The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use.
Croatian: Rekonstituiranu otopinu treba prije primjene pažljivo pregledati kako bi se osiguralo da je lijek otopljen i vizualno provjeriti da ne sadrži vidljive čestice.
English: Very rare serious side effects (may affect up to 1 in 10,000 people) A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)) has been reported, in some cases during administration of daptomycin.
Croatian: Vrlo rijetke ozbiljne nuspojave (mogu se javiti u manje od 1 na 10 000 osoba) Zabilježena je reakcija preosjetljivosti (ozbiljna alergijska reakcija, uključujući anafilaksiju, angioedem, osip uzrokovan lijekom uz eozinofiliju i sistemske simptome (DRESS)), u nekim slučajevima tijekom primjene daptomicina.
English: No dose adjustment is necessary when administering daptomycin to patients with mild or moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Croatian: Prilikom primjene daptomicina bolesnicima s blagim ili umjerenim oštećenjem jetre (Child-Pugh stadij B) dozu nije potrebno prilagođavati (vidjeti dio 5.2).
English: Based on pharmacokinetic data and modelling, the daptomycin AUC during the first day after administration of a 6 mg/kg dose to adult patients on HD or CAPD was 2-fold higher than that observed in adult patients with normal renal function who received the same dose.
Croatian: Temeljem farmakokinetičkih podataka i modela, tijekom prvog dana nakon primjene daptomicina u dozi od 6 mg/kg odraslim bolesnicima na hemodijalizi ili kontinuiranoj ambulantnoj peritonejskoj dijalizi, AUC daptomicina bio je 2 puta veći u usporedbi s odraslim bolesnicima s normalnom funkcijom bubrega koji su primili istu dozu.
English: After a single 4, 8, or 10 mg/kg dose of daptomycin, total clearance and elimination half-life of daptomycin in children 2-6 years of age were similar at different doses; total clearance was higher and elimination half-life was shorter than in adolescents.
Croatian: Nakon jednokratne daptomicina od 4, 8 ili 10 mg/kg, ukupni klirens i poluvijek eliminacije daptomicina u djece u dobi od 2 do 6 godina bili su slični pri različitim dozama; ukupni klirens bio je viši, a poluvijek eliminacije kraći nego u adolescenata.
English: To minimise foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution.
Croatian: IZBJEGAVAJTE snažno mućkanje ili protresanje bočice tijekom ili nakon rekonstitucije kako bi se minimaliziralo pjenjenje lijeka.
English: Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism.
Croatian: Citokrom P450 (CYP450) posreduje malo ili uopće ne posreduje u metabolizmu daptomicina.
English: Frequency not known: frequency cannot be estimated from the available data Antibacterial-associated colitis, including pseudomembranous colitis (severe or persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever), easy bruising, bleeding gums, or nosebleeds.
Croatian: Učestalost nepoznata: ne može se procijeniti iz dostupnih podataka Kolitis (upala debelog crijeva) povezan s primjenom antibakterijskih lijekova, uključujući pseudomembranozni kolitis (težak ili dugotrajan proljev koji sadrži krv i/ili sluz, povezan s bolovima u trbuhu ili vrućicom), lako stvaranje modrica, krvarenje desni ili krvarenje iz nosa.
English: In adults, daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes.
Croatian: U odraslih se daptomicin može primijeniti intravenski kao infuzija tijekom 30 minuta ili kao injekcija tijekom 2 minute.
English: - The other ingredientsaresodium hydroxideand citric acid.
Croatian: - Drugi sastojci su natrijev hidroksid i citratna kiselina.
English: In adults, daptomycin Hospira may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes.
Croatian: U odraslih se daptomicin Hospira može primijeniti intravenski kao infuzija tijekom 30 minuta ili kao injekcija tijekom 2 minute.
English: Clostridium difficile-associated diarrhoea
Croatian: Proljev povezan s bakterijom Clostridium difficile
English: Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours at 2°C - 8°C.
Croatian: Utvrđena kemijska i fizikalna stabilnost razrijeđene otopine u infuzijskim vrećicama iznosi 12 sati pri 25°C ili 24 sata pri 2°C - 8°C.
English: No clinical data on fertility are available for daptomycin.
Croatian: Nisu dostupni klinički podaci o utjecaju daptomicina na plodnost.
English: a 2-6 years (N=7)
Croatian: 2-6 godina (N=7)
English: Uncommon: Renal impairment, including renal failure and renal insufficiency, serum creatinine increased
Croatian: Oštećenje bubrega, uključujući zatajenje bubrega i bubrežnu insuficijenciju, povišena razina kreatinina u serumu
English: The response to treatment, renal function and creatine phosphokinase (CPK) levels should be closely monitored in all patients with any degree of renal impairment (see sections 4.4 and 5.2).
Croatian: U svih bolesnika s bilo kojim stupnjem oštećenja bubrega treba pozorno pratiti odgovor na liječenje, bubrežnu funkciju i razinu kreatin fosfokinaze (CPK) (vidjeti dijelove 4.4 i 5.2).
English: No preservative or bacteriostatic agent is present in this product.
Croatian: Lijek ne sadrži konzervanse niti bakteriostatike.
English: To prepare Daptomycin Hospira for intravenous infusion, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Daptomycin Hospira.
Croatian: Da biste pripremili lijek Daptomicin Hospira za intravensku infuziju, pratite upute u nastavku: Za rekonstituciju liofiliziranog lijeka Daptomicin Hospira potrebno je primijeniti aseptičku tehniku tijekom cijelog postupka.
English: Other side effects which may occur following daptomycin treatment are described below:
Croatian: Niže su navedene druge nuspojave koje se mogu javiti tijekom primjene lijeka Daptomicin Hospira:
English: To prepare Daptomycin Hospira for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Daptomycin Hospira.
Croatian: Da biste pripremili lijek Daptomicin Hospira za intravensku injekciju, pratite upute u nastavku: Za rekonstituciju liofiliziranog lijeka Daptomicin Hospira potrebno je primijeniti aseptičku tehniku tijekom cijelog postupka.
English: Expelair, large bubbles, and any excess solution in order to obtain the required dose.
Croatian: Zrak, velike mjehure i sav višak otopine treba izbaciti kako bi se dobila potrebna doza.
English: Tell your doctor or nurse straight away if you experience any of the following symptoms: - Chest pain or tightness, - Rash with blistering, sometimes affecting the mouth and genitals, - Swelling around throat, - Rapid or weak pulse, - Wheezing, - Fever, - Shivering or trembling, - Hot flushes, - Dizziness, - Fainting, - Metallic taste.
Croatian: Odmah obavijestite svojeg liječnika ili medicinsku sestru ako dobijete bilo koji od sljedećih simptoma: -bol ili stezanje u prsnom košu, -osip s pojavom mjehura, koji ponekada zahvaća usta i spolne organe, -oticanje grla, -ubrzan ili slab puls, -piskanje, -vrućicu, -drhtanje ili drhtavicu, -navale vrućine, -omaglicu, -nesvjesticu, -metalni okus u ustima.
English: Anaphylaxis/hypersensitivity reactions have been reported with daptomycin.
Croatian: Tijekom primjene daptomicina prijavljene su anafilaksija/reakcije preosjetljivosti.
English: After a single 4 mg/kg dose of daptomycin, total clearance of daptomycin in children 7-11 years of age with Gram-positive infection was higher than in adolescents, whereas elimination half-life was shorter.
Croatian: Nakon jednokratne doze daptomicina od 4 mg/kg, ukupni klirens daptomicina u djece u dobi od 7 do 11 godina s Grampozitivnom infekcijom bio je viši nego u adolescenata, dok je poluvijek eliminacije bio kraći.
English: After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C - 8°C.
Croatian: Nakon rekonstitucije: dokazana kemijska i fizikalna stabilnost pripremljene rekonstituirane otopine u bočici iznosi 12 sati pri 25°C te do 48 sati pri 2°C - 8°C.
English: Clostridium difficile-associated diarrhoea (CDAD) has been reported with daptomycin (see section 4.8).
Croatian: Tijekom primjene daptomicina prijavljen je proljev povezan s bakterijom Clostridium difficile (vidjeti dio 4.8).
English: Renal impairment Daptomycin is eliminated primarily by the kidney.
Croatian: Daptomicin se prvenstveno eliminira putem bubrega.
English: Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.
Croatian: Polako izvucite rekonstituiranu tekućinu (50 mg daptomicina/ml) iz bočice pomoću sterilne igle od 21 G ili manjeg promjera.
English: Serious side effects with frequency not known (frequency cannot be estimated from the available data) A rare but potentially serious lung disorder called eosinophilic pneumonia has been reported in patients given daptomycin, mostly after more than 2 weeks of treatment.
Croatian: U bolesnika koji su primili lijek Daptomicin Hospira zabilježen je rijetki, ali potencijalno ozbiljni plućni poremećaj koji se zove eozinofilna upala pluća, do koje je došlo najčešće nakon više od 2 tjedna liječenja.
English: Plasma exposures achieved with these doses were consistent with those achieved in the adult cSSTI study (following 4 mg/kg once daily in adults).
Croatian: Izloženost u plazmi postignuta uz ove doze bila je sukladna onoj postignutoj u ispitivanju kompliciranih infekcija kože i mekih tkiva u odraslih (nakon doze od 4 mg/kg jedanput na dan u odraslih).
English: How Daptomycin Hospira is given
Croatian: Kako se primjenjuje Daptomicin Hospira
English: Prothrombin time (PT) prolonged Not known*: Thrombocytopaenia
Croatian: Produljenje protrombinskog vremena (PV) Nepoznato Trombocitopenija
English: Daptomycin Hospira is administered intravenously in 0.9 % sodium chloride (see section 6.6).
Croatian: Daptomycin Hospira se primjenjuje intravenskom infuzijom u 0,9%-tnoj otopini natrijevog klorida (vidjeti dio 6.6).
English: Hold the vial by the vial neck, tilt the vial and swirl vial contents until the product is completely reconstituted.
Croatian: Uhvatite grlo bočice, nagnite je i kružeći lagano bočicom miješajte sadržaj bočice dok se lijek potpuno ne rekonstituira.
English: - Known or suspected RIE due to Staphylococcus aureus: daptomycin 6mg/kg is administered once every 24 hours.
Croatian: - Dokazani desnostrani infektivni endokarditis izazvan bakterijom Staphylococcus aureus ili sumnja na njega: 6 mg/kg daptomicina primjenjuje se jedanput svaka 24 sata.
English: These limitations of the patients population treated should be taken into account when deciding to use daptomycin.
Croatian: Pri donošenju odluke o primjeni daptomicina potrebno je uzeti u obzir i ta ograničenja dosad liječene populacije bolesnika.
English: Replace needle with a new needle for the intravenous injection.
Croatian: Zamijenite iglu novom iglom za intravensku injekciju.
English: - CPK should be measured more frequently (e.g. every 2-3 days at least during the first two weeks of treatment) in patients who are at higher risk of developing myopathy.
Croatian: - U bolesnika s povećanim rizikom od razvoja miopatije CPK treba češće kontrolirati (npr. svaka 23 dana tijekom najmanje prva dva tjedna terapije).
English: 350 mg presentation:
Croatian: Pakiranje od 350 mg:
English: Summary of Blinded Evaluator defined clinical outcome at TOC:
Croatian: Sažeti prikaz kliničkog ishoda prema slijepoj procjeni ocjenitelja pri utvrđivanju izlječenja:
English: The active substance in Daptomycin Hospira powder for solution for injection/infusion is daptomycin.
Croatian: Hospira prašku za otopinu za injekciju ili infuziju je daptomicin.
English: Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if stored under refrigeration (2°C-8°C).
Croatian: Dokazana kemijska i fizikalna stabilnost rekonstituirane otopine u bočici iznosi 12 sati pri 25°C i do 48 sati ako se čuva u hladnjaku (2°C - 8°C).
English: Daptomycin is excreted primarily by the kidneys.
Croatian: Daptomicin se prvenstveno izlučuje putem bubrega.
English: Release the syringe plunger and allow the syringe plunger to equalise the pressure before removing the syringe from the vial.
Croatian: Otpustite klip štrcaljke i omogućite mu da izjednači tlak prije nego izvučete štrcaljku iz bočice.
English: 500 mg presentation:
Croatian: Pakiranje od 500 mg:
English: See below for dose adjustments in patients with renal impairment.
Croatian: Za prilagođavanje doze bolesnicima s oštećenjem bubrega vidjeti niže.
English: Plasma exposures achieved with these doses were consistent with those achieved in the adult SAB study (following 6 mg/kg once daily in adults).
Croatian: Izloženost u plazmi postignuta uz ove doze bila je sukladna onoj postignutoj u ispitivanju bakterijemije izazvane bakterijom S. aureus u odraslih bolesnika (nakon doze od 6 mg/kg jedanput na dan u odraslih).
English: 1 to 6 years (N=19)*
Croatian: 7-11 godina (N=19) 1 do 6 godina (N=19)*
English: Replace needle with a new needle for the intravenous infusion.
Croatian: Zamijenite iglu novom iglom za intravensku infuziju.
English: Transfer the reconstituted solution into a sodium chloride 9 mg/ml (0.9%) infusion bag (typical volume 50 ml).
Croatian: 9. Prebacite rekonstituiranu otopinu u infuzijsku vrećicu s natrijevim kloridom 9 mg/ml (0,9%) (uobičajen volumen iznosi 50 ml).
English: Warnings and precautions Talk to your doctor or nurse before you are given Daptomycin Hospira.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego počnete primati Daptomicin Hospira.
English: 7-11 years (N=19)
Croatian: 7-11 godina (N=2)
English: Hypertension, hypotension Uncommon: Flushes
Croatian: Hipertenzija, hipotenzija
English: The reconstituted solution should then be injected intravenously slowly over 2 minutes as directed in section 4.2.
Croatian: 9. Rekonstituirana otopina zatim se treba primijeniti putem intravenske injekcije tijekom 2 minute, kao što je navedeno u dijelu 4.2.
English: Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe.
Croatian: Držeći bočicu preokrenutu, prilikom povlačenja otopine u štrcaljku vrh igle treba postaviti pri samom dnu otopine u bočici.
English: (2) The same dose adjustments, which are based on PK data in volunteers including PK modelling results, are recommended for adult patients on haemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).
Croatian: (2) Odraslim bolesnicima na hemodijalizi ili na kontinuiranoj ambulantnoj peritonejskoj dijalizi preporučuje se jednaka prilagodba doze, temeljeno na farmakokinetičkim podacima u skupini dobrovoljaca, uključujući i rezultate farmakokinetičkih modela.
English: • Age group 4 (n=45): 1 to < 2 years treated with daptomycin dosed at 10 mg/kg or SOC.
Croatian: • Dobna skupina 4 (n=45): 1 do <2 godine liječeni daptomicinom u dozi od 10 mg/kg ili standardom skrbi.
English: These could interfere with the effects of Daptomycin Hospira in the kidney.
Croatian: Oni mogu utjecati na djelovanje lijeka Daptomicin
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava Često:
English: In all populations the clinical success rates were comparable in the daptomycin versus the SOC treatment arm.
Croatian: U svim je populacijama stopa kliničkog uspjeha u skupini liječenoj daptomicinom bila usporediva s onom u skupini liječenoj standardnom skrbi.
English: Common: may affect up to 1 in 10 people - Fungal infections such as thrush, - Urinary tract infection, - Decreased number of red blood cells (anaemia), - Dizziness, anxiety, difficulty in sleeping, - Headache, - Fever, weakness (asthenia), - High or low blood pressure, - Constipation, abdominal pain, - Diarrhoea, feeling sick (nausea) or being sick (vomiting), - Flatulence, - Abdominal swelling or bloating, - Skin rash or itching, - Pain, itchiness or redness at the site of infusion, - Pain in arms or legs, - Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).
Croatian: Često: mogu se javiti u manje od 1 na 10 osoba - gljivične infekcije, npr. gljivična infekcija kandidom - infekcija mokraćnog sustava, - smanjen broj crvenih krvnih stanica (anemija), - omaglica, tjeskoba, otežano spavanje, - glavobolja, - vrućica, slabost (astenija), - povišen ili snižen krvni tlak, - zatvor, bol u trbuhu, - proljev, mučnina ili povraćanje, - vjetrovi, - rastezanje ili nadutost trbuha, - kožni osip ili svrbež, - bol, svrbež ili crvenilo na mjestu infuzije, - bolovi u rukama ili nogama, - nalazi krvnih pretraga koji pokazuju povišene razine jetrenih enzima ili kreatin fosfokinaze (CPK).
English: Drug/laboratory test interactions
Croatian: Utjecaj lijeka na rezultate laboratorijskih testova
English: The safety and efficacy of daptomycin was evaluated in paediatric patients aged 1 to 17 years (Study DAP-PEDS-07-03) with cSSTI caused by Gram positive pathogens.
Croatian: Sigurnost i djelotvornost daptomicina ocijenjene su u pedijatrijskih bolesnika u dobi od 1 do 17 godina (Ispitivanje DAP-PEDS-07-03) s kompliciranom infekcijom kože i mekog tkiva uzrokovanom grampozitivnim patogenima.
English: Fungal infections, urinary tract infection, candida infection, anaemia, anxiety, insomnia, dizziness, headache, hypertension, hypotension, gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension, liver function tests abnormal (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP)), rash, pruritus, limb pain, serum creatine phosphokinase (CPK) increased, infusion site reactions, pyrexia, asthenia.
Croatian: Najčešće zabilježene nuspojave (učestalost: često (≥ 1/100 i < 1/10)) su: gljivične infekcije, infekcija mokraćnog sustava, infekcija kandidom, anemija, anksioznost, nesanica, omaglica, glavobolja, hipertenzija, hipotenzija, gastrointestinalni i abdominalni bolovi, mučnina, povraćanje, konstipacija, proljev, flatulencija, napuhnutost i distenzija trbuha, abnormalne vrijednosti testova jetrene funkcije (povišenje alanin aminotransferaze (ALT), aspartat aminotransferaze (AST) ili alkalne fosfataze (ALP)), osip, pruritus, bolovi u ekstremitetima, povišenje razine kreatin fosfokinaze u serumu (CPK), reakcije na mjestu primjene infuzije, vrućica, astenija.
English: AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg) Pharmacokinetic parameter values estimated by noncompartmental analysis Individual values reported as only two patients in this age group provided pharmacokinetic samples to enable pharmacokinetic analysis; AUC, apparent t1/2 and CL/wt could be determined for only one of the two patients Pharmacokinetic analysis conducted on the pooled pharmacokinetic profile with mean concentrations across subjects at each time point
Croatian: Prijavljene pojedinačne vrijednosti jer su se farmakokinetički uzorci dobili od samo dva bolesnika u ovoj dobnoj skupini da bi se omogućila farmakokinetička analiza; AUC, prividni t1/2 i CL/wt mogli su se odrediti samo u jednog od ta dva bolesnika.
English: VIAL
Croatian: Vaginitis
English: Table 2 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric cSSTI Patients (1 to 17 Years of Age) in Study DAP-PEDS-07-03
Croatian: Tablica 2 Srednja vrijednost (standardna devijacija) farmakokinetike daptomicina u pedijatrijskih bolesnika (u dobi od 1 do 17 godina) s kompliciranom infekcijom kože i mekih tkiva u ispitivanju DAP-PEDS-07-03
English: Uncommon: Paraesthesia, taste disorder, tremor, eye irritation Not known*: Peripheral neuropathy**
Croatian: Parestezija, poremećaj osjeta okusa, tremor, iritacija oka
English: 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.
Croatian: Vaš liječnik će prije početka liječenja i često tijekom liječenja lijekom Daptomicin Hospira zatražiti krvne pretrage za praćenje zdravlja Vaših mišića.
English: However, some cases of marked rises in CPK levels and cases of rhabdomyolysis occurred in adult patients taking one of these medicinal products at the same time as daptomycin.
Croatian: Međutim, u odraslih bolesnika koji su uzimali jedan od tih lijekova istodobno s daptomicinom javilo se nekoliko slučajeva izraženih porasta razina CPK i nekoliko slučajeva rabdomiolize.
English: - That Daptomycin Hospira can interfere with coagulation tests (PT/INR) and this might lead to false results.
Croatian: U bolesnika s povećanim rizikom za razvoj miopatije potrebno je češće određivati vrijednosti CPK. - da lijek Daptomicin Hospira može interferirati s testovima koagulacije (PV/INR), što može dovesti do pogrešnih rezultata.
English: • Age group 1 (n=113): 12 to 17 years treated with daptomycin dosed at 5 mg/kg or standard-of-care comparator (SOC);
Croatian: • Dobna skupina 1 (n=113): 12 do 17 godina liječeni daptomicinom u dozi od 5 mg/kg ili standardom skrbi (engl. standard of care) kao komparatorom
English: - New or worsening fever, cough or difficulty breathing.
Croatian: - Ako Vam se pojave vrućica, kašalj ili otežano disanje, ili dođe do pogoršanja navedenih simptoma.
English: The reconstituted solution should then be injected intravenously slowly over 2 minutes.
Croatian: 9. Rekonstituirana se otopina zatim treba polagano primijeniti putem injekcije u venu tijekom 2 minute.
English: • Age group 3 (n=125): 2 to 6 years treated with daptomycin dosed at 9 mg/kg or SOC;
Croatian: • Dobna skupina 3 (n=125): 2 do 6 godina liječeni daptomicinom u dozi od 9 mg/kg ili standardom skrbi
English: Invert the vial in order to allow the solution to drain towards the stopper.
Croatian: Bočicu treba preokrenuti da bi se otopina mogla spustiti do čepa.
English: Paediatric patients (1 to 17 years of age) The recommended dosage regimens for paediatric patients based on age and indication are shown below.
Croatian: U nastavku je prikazan preporučeni režim doziranja u pedijatrijskih bolesnika na temelju dobi i indikacije.
English: A Phase 4 study (DAP-PEDS-07-03) was conducted to assess safety, efficacy, and pharmacokinetics of daptomycin in paediatric patients (1 to 17 years old, inclusive) with cSSTI caused by Gram-positive pathogens.
Croatian: Pedijatrijski bolesnici s kompliciranim infekcijama kože i mekih tkiva Ispitivanje faze 4 (DAP-PEDS-07-03) provedeno je radi procjene sigurnosti, djelotvornosti i farmakokinetike daptomicina u pedijatrijskih bolesnika (u dobi od 1 do uključivo 17 godina) s kompliciranim infekcijama kože i mekih tkiva uzrokovanima Gram-pozitivnim patogenima.
English: Table 3 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric SAB Patients (1 to 17 Years of Age) in Study DAP-PEDBAC-11-02
Croatian: Tablica 3 Srednja vrijednost (standardna devijacija) farmakokinetike daptomicina u pedijatrijskih bolesnika (u dobi od 1 do 17 godina) s bakterijemijom izazvanom bakterijom S. aureus u ispitivanju DAP-PEDBAC-11-02
English: Microbiological Success rate in Paedatric SAB n/N (%)
Croatian: Stopa mikrobiološkog uspjeha u pedijatrijskih bolesnika s bakterijemijom izazvanom bakterijom S. aureus n/N (%)
English: Methicillin-susceptible Staphylococcus aureus (MSSA) Methicillin-resistant Staphylococcus aureus (MRSA)
Croatian: Staphylococcus aureus otporan na meticilin (MRSA)