FrancophonIA/ELRC3.0 huggingface dataset:
English: 6 mg/kg every 48 hours cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; RIE = right-sided infective endocarditis (1) The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is based on pharmacokinetic (PK) studies and modelling results (see sections 4.4 and 5.2).
Croatian: 6 mg/kg svakih 48 sati cSSTI = komplicirane infekcije kože i mekih tkiva; SAB = bakterijemija izazvana bakterijom S. aureus (1) Sigurnost i djelotvornost prilagođavanja intervala doziranja nisu procijenjene u kontroliranim kliničkim ispitivanjima, a preporuka se temelji na rezultatima farmakokinetičkih ispitivanja i rezultatima farmakokinetičkih modela (vidjeti dijelove 4.4 i 5.2).
English: Daptomycin should not be used more frequently than once a day.
Croatian: Daptomicin se ne smije primjenjivati češće od jedanput na dan.
English: In animal models AUC/MIC and Cmax/MIC correlate with efficacy and predicted bacterial kill in vivo at single doses equivalent to human adult doses of 4 mg/kg and 6 mg/kg once daily.
Croatian: U životinjskih modela omjeri AUC/MIK i Cmax/MIK koreliraju s djelotvornošću i očekivanom smrću bakterija in vivo pri jednokratnim dozama koje odgovaraju dozama za odrasle od 4 mg/kg i 6 mg/kg jedanput na dan u ljudi.
English: Summary of overall therapeutic response by type of baseline pathogen (ME population):
Croatian: Sažetak ukupnog terapijskog odgovora prema tipu početnog patogena (mikrobiološki ocjenjiva populacija):
English: Paediatric patients below the age of one year should not be given daptomycin due to the risk of potential effects on muscular, neuromuscular and/or nervous systems (either peripheral and/or central) that were observed in neonatal dogs (see section 5.3).
Croatian: Pedijatrijskim bolesnicima mlađima od jedne godine ne smije se davati daptomicin zbog rizika od potencijalnih učinaka na mišićni, neuromišićni i/ili živčani sustav (periferni i/ili središnji) koji su zamijećeni u novookoćene štenadi (vidjeti dio 5.3).
English: - If any of these applies to you, tell your doctor or nurse before you are given Daptomycin Hospira.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika ili medicinsku sestru prije nego primite lijek Daptomicin Hospira.
English: In some instances treatment failure has been associated with the selection of organisms with reduced susceptibility or frank resistance to daptomycin (see section 5.1).
Croatian: U nekim je slučajevima neuspješno liječenje bilo povezano s pojavom mikroorganizama smanjene osjetljivosti ili sa evidentnom rezistencijom na daptomicin (vidjeti dio 5.1).
English: Reversal of both the microscopic and functional effects was complete within 6 months post-dose.
Croatian: Mikroskopski i funkcionalni učinci potpuno su nestali unutar 6 mjeseci nakon prestanka doziranja.
English: Interaction studies for daptomycin were performed with aztreonam, tobramycin, warfarin and probenecid.
Croatian: Provedena su ispitivanja interakcije daptomicina s aztreonamom, tobramicinom, varfarinom i probenecidom.
English: An updated RMP should be submitted: - At the request of the European Medicines Agency; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Rare: may affect up to 1 in 1,000 people - Yellowing of the skin and eyes, - Prothrombin time prolonged.
Croatian: Rijetko: mogu se javiti u manje od 1 na 1000 osoba - žuta boja kože i očiju, - produljeno protrombinsko vrijeme.
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.
Croatian: U bolesnika kod kojih su bili dostupni klinički podaci za prosudbu, u otprilike 50% slučajeva rabdomioliza se javila u bolesnika s ranije prisutnim oštećenjem bubrega ili u onih koji su istodobno primali lijekove za koje je poznato da izazivaju rabdomiolizu.
English: It is also used to treat infections in the blood caused by the same type of bacteria when associated with heart infection.
Croatian: Također se primjenjuje za liječenje infekcija u krvi izazvanih istom vrstom bakterije, kada su udružene s infekcijom srca.
English: In contrast to adult dogs, juvenile dogs appeared to be more sensitive to peripheral nerve lesions as compared to skeletal myopathy.
Croatian: Za razliku od odraslih pasa, čini se da su mladi psi osjetljiviji na pojavu lezija u perifernim živcima, nego na pojavu miopatije skeletnih mišića.
English: Juvenile dogs developed peripheral and spinal nerve lesions at doses lower than those associated with skeletal muscle toxicity.
Croatian: U mladih su se pasa lezije na perifernim i spinalnim živcima razvile pri dozama nižim od onih povezanih s toksičnim učincima na skeletne mišiće.
English: A study in dogs demonstrated that skeletal myopathy was reduced upon once daily administration as compared to fractionated dosing at same total daily dose, suggesting that myopathic effects in animals were primarily related to time between doses.
Croatian: Ispitivanje na psima pokazalo je da se miopatija skeletnih mišića ublažila nakon primjene jedanput na dan, u usporedbi s podijeljenim doziranjem jednake ukupne dnevne doze, što pokazuje da su učinci vezani uz miopatiju u životinja bili prvenstveno povezani s vremenskim razmacima između doza.
English: The duration of Daptomycin Hospira may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.
Croatian: Možda će biti potrebno liječenje lijekom Daptomycin Hospira u trajanju duljem od 14 dana u skladu s procijenjenim rizikom od komplikacija za svakog pojedinog bolesnika.
English: Of these 19 patients 11 were infected with methicillin-susceptible and 8 with methicillin-resistant Staphylococcus aureus.
Croatian: Od tih 19 bolesnika, 11 je imalo infekciju izazvanu bakterijom Staphylococcus aureus osjetljivim na meticilin, a njih 8 imalo je infekciju izazvanu Staphylococcus aureus rezistentnim na meticilin.
English: 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.
Croatian: Ako ste na dijalizi, a sljedeću dozu lijeka Daptomicin Hospira trebate primiti na dan dijalize, lijek Daptomicin Hospira obično ćete primiti nakon završetka dijalize.
English: 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).
Croatian: Obrišite vrh gumenog čepa vatom natopljenom alkoholom ili drugom antiseptičkom otopinom i pustite da se osuši (ako je to primjenjivo u danom slučaju, učinite to isto s bočicom koja sadrži otopinu natrijevog klorida).
English: Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during co-administration with medicinal products that reduce renal filtration (e.g. NSAIDs and COX-2 inhibitors).
Croatian: Daptomicin se primarno uklanja bubrežnom filtracijom tako da njegove razine u plazmi mogu porasti pri istodobnoj primjeni s lijekovima koji smanjuju bubrežnu filtraciju (npr. nesteroidni protuupalni lijekovi i inhibitori COX-2).
English: Daptomycin
Croatian: Daptomicin
English: Failure of treatment due to persisting or relapsing Staphylococcus aureus infections was observed in 19/120 (15.8%) patients treated with daptomycin, 9/53 (16.7%) patients treated with vancomycin and 2/62 (3.2%) patients treated with an anti-staphylococcal semi-synthetic penicillin.
Croatian: Neuspjeh u liječenju zbog ustrajnih i/ili ponavljajućih infekcija izazvanih bakterijom Staphylococcus aureus uočen je u 19/120 (15,8%) bolesnika liječenih daptomicinom, u 9/53 (16,7%) bolesnika liječenih vankomicinom i u 2/62 (3,2%) bolesnika liječena polusintetskim anti-stafilokoknim penicilinom.
English: 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).
Croatian: U pedijatrijskim ispitivanjima, od 372 bolesnika koji su primali daptomicin, njih 61 primilo je jednu dozu, a 311 primalo je terapijski režim za kompliciranu infekciju kože i mekih tkiva ili bakterijemiju izazvanu bakterijom S. aureus (dnevne doze bile su u rasponu od 4 mg/kg do 12 mg/kg).
English: Therefore caution should be exercised if Daptomycin Hospira is given to such patients.
Croatian: Stoga je nužan oprez pri davanju daptomicina tim bolesnicima.
English: Daptomycin Hospira should not be used more frequently than once a day.
Croatian: Daptomycin Hospira se ne smije primjenjivati češće od jedanput na dan.
English: The majority of transaminase elevations were of Grade 1-3 toxicity and resolved upon discontinuation of treatment.
Croatian: Većina slučajeva u kojima je zabilježeno povišenje transaminaza bilo je između 1. i 3. stupnja toksičnosti te se povišenje enzima povuklo nakon prestanka primjene lijeka.
English: If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primati lijek Daptomicin Hospira: ako ste alergični na daptomicin ili na natrijev hidroksid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: In in vitro studies, daptomycin was not metabolised by human liver microsomes.
Croatian: U in vitro ispitivanjima daptomicin se nije metabolizirao putem mikrosoma ljudske jetre.
English: Therefore, caution is advised when daptomycin is co-administered with any other medicinal product known to reduce renal filtration.
Croatian: Stoga se savjetuje oprez pri istodobnoj primjeni daptomicina s bilo kojim lijekom za koji je poznato da smanjuje bubrežnu filtraciju.
English: Among these failures six patients treated with daptomycin and one patient treated with vancomycin were infected with Staphylococcus aureus that developed increasing MICs of daptomycin on or following therapy (see “Mechanisms of resistance” above).
Croatian: Od tih neuspjelih slučajeva, šest bolesnika liječenih daptomicinom i jedan bolesnik liječen vankomicinom imali su infekcije izazvane bakterijom Staphylococcus aureus kod kojih su se tijekom ili nakon terapije povećali MIK-ovi za daptomicin (vidjeti "Mehanizmi rezistencije" gore).
English: The volume of distribution at steady state of daptomycin in healthy adult subjects was approximately 0.1 l/kg and was independent of dose.
Croatian: Volumen distribucije daptomicina u stanju dinamičke ravnoteže bio je u zdravih odraslih dobrovoljaca otprilike 0,1 l/kg te je bio neovisan o dozi.
English: For example, patients with any degree of renal impairment (creatinine clearance <80 ml/min; see also section 4.2), including those on haemodialysis or CAPD, and patients taking other medicinal products known to be associated with myopathy (e.g. HMG-CoA reductase inhibitors, fibrates and ciclosporin).
Croatian: Među te bolesnike ubrajaju se oni s bilo kojim stupnjem oštećenja bubrega (klirens kreatinina < 80 ml/min; vidjeti također dio 4.2), uključujući one na hemodijalizi ili kontinuiranoj ambulantnoj peritonejskoj dijalizi (CAPD), kao i bolesnici koji uzimaju druge lijekove za koje se zna da su povezani s miopatijom (npr. inhibitori HMG-CoA reduktaze, fibrati i ciklosporin).
English: Tell a doctor or a nurse straight away if you experience symptoms suggestive of allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever (see section 4 of this leaflet for more information).
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako Vam se pojave simptomi koji upućuju na alergijsku reakciju, poput piskanja, otežanog disanja, oticanje lica, vrata ili grla, osipa i koprivnjače, vrućice (za više podataka vidjeti dio 4 ove upute).
English: Therefore it is important that your doctor takes into account that you are receiving Daptomycin Hospira.
Croatian: Stoga je važno da liječnik zna da primate lijek Daptomicin Hospira.
English: False prolongation of prothrombin time (PT) and elevation of international normalised ratio (INR) have been observed when certain recombinant thromboplastin reagents are utilised for the assay (see section
Croatian: Lažno produljenje protrombinskog vremena (PV) i povećanje internacionalnog normaliziranog omjera (INR) zabilježeni su kada se određeni rekombinantni tromboplastinski reagensi koriste u testu (vidjeti također dio 4.5).
English: Daptomycin Hospira is therefore not indicated for the treatment of pneumonia.
Croatian: Stoga lijek Daptomicin Hospira nije indiciran za liječenje pneumonije.
English: Single use 10 ml type I clear glass vials with gray rubber closure and aluminium cap.
Croatian: Prozirne staklene bočice (staklo tip I) od 10 ml, za jednokratnu upotrebu, sa sivim gumenim čepom i aluminijskom kapicom.
English: 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.
Croatian: Ako se u bolesnika koji primaju daptomicin uoče neobjašnjivi poremećaji vrijednosti PV/INR, potrebno je razmotriti moguću in vitro interakciju u laboratorijskoj pretrazi.
English: In the paediatric SAB study, the mean duration of IV Daptomycin Hospira was 12 days, with a range of 1 to 44 days.
Croatian: U pedijatrijskom SAB ispitivanju, srednja vrijednost trajanja liječenja lijekom Daptomycin Hospira primjenjenog intravenski, iznosila je 12 dana, s rasponom od 1 do 44 dana.
English: Deep-seated infections
Croatian: Duboko smještene infekcije
English: The key efficacy endpoint was the sponsor-defined clinical outcome at test-of-cure (TOC), which was defined by a blinded medical director.
Croatian: Ključna mjera ishoda djelotvornosti bio je klinički ishod prema definiciji naručitelja ispitivanja kod utvrđivanja izlječenja (engl. test-of-cure, TOC), koji je definirao medicinski direktor koji nije bio upoznat s informacijama o ispitanicima.
English: Failures with daptomycin in the treatment of enterococcal infections that were mostly accompanied by bacteraemia have been reported.
Croatian: Zabilježeni su neuspjesi s daptomicinom u liječenju enterokoknih infekcija koje su većinom bile praćene bakterijemijom.
English: Creatine phosphokinase and myopathy Increases in plasma creatine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/or weakness and cases of myositis, myoglobinaemia and rhabdomyolysis have been reported during therapy with daptomycin (see also sections 4.5, 4.8 and 5.3).
Croatian: Kreatin fosfokinaza i miopatija Tijekom terapije daptomicinom zabilježeni su porasti razina kreatin fosfokinaze (CPK; MM izoenzim) u plazmi, povezani s bolovima i/ili slabošću mišića, kao i slučajevi miozitisa, mioglobinemije i rabdomiolize (vidjeti također dijelove 4.5, 4.8 i 5.3).
English: The site of metabolism has not been identified.
Croatian: Metabolički put nije utvrđen.
English: In a single human case study, daptomycin was intravenously administered daily for 28 days to a nursing mother at a dose of 500 mg/day, and samples of the patient's breast milk were collected over a 24-hour period on day 27.
Croatian: Tijekom ispitivanja pojedinačnog slučaja daptomicin je primjenjivan intravenski svaki dan tijekom 28 dana u dozi od 500 mg/dan majci koja je dojila, a 27. dana prikupljeni su uzorci izdojenog mlijeka bolesnice tijekom razdoblja od 24 sata.
English: Following intravenous administration, plasma clearance of daptomycin is approximately 7 to 9 ml/h/kg and its renal clearance is 4 to 7 ml/h/kg.
Croatian: Nakon intravenske primjene, klirens daptomicina iz plazme iznosi otprilike 7 do 9 ml/h/kg, a bubrežni klirens iznosi 4 do 7 ml/h/kg.
English: Experience with the concomitant administration of daptomycin and warfarin is limited.
Croatian: Ograničena su iskustva s istodobnom primjenom daptomicina i varfarina.
English: Powder for solution for injection/infusion 1 vial
Croatian: Prašak za otopinu za injekciju/infuziju 1 bočica
English: This results in bacterial cell death with negligible cell lysis.
Croatian: Ishod je smrt bakterijske stanice uz zanemarivu lizu stanice.
English: Eosinophilic pneumonia has been reported in patients receiving daptomycin (see section 4.8).
Croatian: Eozinofilna pneumonija prijavljena je u bolesnika koji su dobivali daptomicin (vidjeti dio 4.8).
English: The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/kg (30-minute intravenous infusion) for patients with normal renal function.
Croatian: Lowest Observable Effect Level, LOEL) za miopatiju se u štakora i pasa javila pri razinama izloženosti od 0,8 do 2,3 puta većim od terapijskih razina u ljudi uz 6 mg/kg (30-minutna intravenska infuzija) u bolesnika s urednom funkcijom bubrega.
English: Anticoagulant activity in patients receiving daptomycin and warfarin should be monitored for the first several days after therapy with Daptomycin Hospira is initiated.
Croatian: U bolesnika koji primaju daptomicin i varfarin potrebno je pratiti antikoagulantnu aktivnost tijekom prvih nekoliko dana nakon uvođenja terapije lijekom Daptomicin Hospira.
English: Please inform your doctor that you are on treatment with Daptomycin Hospira.
Croatian: Obavijestite svog liječnika da se liječite lijekom Daptomicin Hospira.
English: Relative to non-obese subjects daptomycin systemic exposure measured by AUC was about 28% higher in moderately obese subjects (Body Mass Index of 25-40 kg/m2) and 42% higher in extremely obese subjects
Croatian: U usporedbi s ispitanicima koji nisu bili pretili, sustavna izloženost daptomicinu mjerena pomoću AUC bila je za oko 28% veća u umjereno pretilih ispitanika (indeks tjelesne mase 25-40 kg/m2) a 42%
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Croatian: Po potrebi, kada je lokalna prevalencija rezistencije takva da je opravdanost primjene lijeka barem u nekim vrstama infekcija upitna, potrebno je zatražiti stručni savjet.
English: If you experience these symptoms, tell your doctor or nurse straight away.
Croatian: Ukoliko Vam se pojave ovi simptomi, odmah obavijestite svog liječnika ili medicinsku sestru.
English: The most common type of infection treated was wound infection (38% of patients), while 21% had major abscesses.
Croatian: (38% bolesnika), dok je 21% imalo velike apscese.
English: 1 to <2 years (N=30)
Croatian: 1 do <2 godina (N=30)
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.
Croatian: U ispitivanju masene ravnoteže pomoću radioaktivno obilježenog materijala, temeljeno na ukupnoj radioaktivnosti, 78% primijenjene doze nađeno je u mokraći, dok je otprilike 50% doze nađeno u mokraći u obliku nepromijenjenog daptomicina.
English: This dose is given directly into the blood stream (into a vein), as an infusion lasting about 30-60 minutes.
Croatian: Ova doza se daje izravno u krvotok (u venu) u obliku infuzije u trajanju od 30 do 60 minuta.
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.
Croatian: - U bolesnika s početnom vrijednošću CPK 5 puta većom od gornje granice normale ne može se isključiti povećan rizik od daljnjih porasta tijekom terapije daptomicinom.
English: Limb pain, serum creatine phosphokinase (CPK) increased
Croatian: Bolovi u ekstremitetima, povišenje razine kreatin fosfokinaze u serumu (CPK)
English: Other medicines and Daptomycin Hospira Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The microbiological outcome at TOC for the daptomycin and SOC treatment arms for infections caused by MRSA and MSSA are presented in the table below (mMITT population).
Croatian: Mikrobiološki ishod kod utvrđivanja izlječenja infekcija uzrokovanih MRSA ili MSSA u skupinama liječenima daptomicinom i standardnom skrbi prikazan je u tablici niže (mMITT populacija).
English: Concomitant administration of probenecid and daptomycin has no effect on daptomycin pharmacokinetics in humans suggesting minimal to no active tubular secretion of daptomycin.
Croatian: Istodobna primjena probenecida i daptomicina ne utječe na farmakokinetiku daptomicina u ljudi, što ukazuje da je aktivna tubularna sekrecija daptomicina minimalna ili je uopće nema.
English: Recurrence of eosinophilic pneumonia upon re-exposure has been reported.
Croatian: Nakon ponovnog uvođenja lijeka prijavljena je ponovna pojava eozinofilne pneumonije.
English: Therefore, until more experience is gained, breast-feeding should be discontinued when daptomycin is administered to nursing women.
Croatian: Stoga, dok se ne bude raspolagalo većim brojem podataka, treba prekinuti dojenje ukoliko se daptomicin primjenjuje u dojilja.
English: Following administration of a single 4 mg/kg intravenous dose of daptomycin over a 30-minute period, the mean total clearance of daptomycin was approximately 35% lower and the mean AUC0-∞ was approximately 58% higher in elderly subjects (≥ 75 years of age) compared with those in healthy young subjects (18 to 30 years of age).
Croatian: Nakon jednokratne primjene daptomicina u dozi od 4 mg/kg intravenski tijekom 30 minuta prosječni ukupni klirens daptomicina bio je otprilike 35% manji, a prosječni AUC0-∞ bio je otprilike 58% veći u starijih ispitanika (≥ 75 godina starosti) u usporedbi sa skupinom mladih zdravih ispitanika (18 do 30 godina starosti).
English: Less frequently reported, but more serious, adverse reactions include hypersensitivity reactions, eosinophilic pneumonia (occasionally presenting as organising pneumonia), drug rash with eosinophilia and systemic symptoms (DRESS), angioedema and rhabdomyolysis.
Croatian: Manje učestale, ali ozbiljnije nuspojave, uključuju reakcije preosjetljivosti, eozinofilnu pneumoniju (koja se povremeno manifestira kao organizirana pneumonija), osip uzrokovan lijekom uz eozinofiliju i sistemske simptome (DRESS), angioedem i rabdomiolizu.
English: Your doctor will check the condition of your lungs and decide whether or not you should continue Daptomycin Hospira treatment.
Croatian: Liječnik će Vam pregledati pluća te će odlučiti trebate li nastaviti liječenje lijekom Daptomicin Hospira ili ne.
English: Daptomycin Hospira vials are for single-use only.
Croatian: Bočice lijeka Daptomicin Hospira isključivo su za jednokratnu uporabu.
English: What Daptomycin Hospira is and what it is used for
Croatian: Hospira i za što se koristi
English: Simulation using a population pharmacokinetic model demonstrated that the AUCss (area under the concentration-time curve at steady state) of daptomycin in paediatric patients 1 to <2 years of age receiving12 mg/kg once daily would be comparable to that in adult patients receiving 6 mg/kg once daily.
Croatian: Simulacija korištenjem modela populacijske farmakokinetike pokazala je da bi AUCss (površina ispod krivulje u stanju mirovanja) daptomicina u pedijatrijskih bolesnika u dobi od 1 do <2 godine koji su primali 12 mg/kg na dan bio usporediv s onim primijećenim u odraslih bolesnika koja su primali 6 mg/kg na dan.