FrancophonIA/ELRC3.0 huggingface dataset:
English: Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 and Fks2 genes coding for a major subunit of glucan synthase.
Slovenian: Zmanjšana občutljivost ehinokandinov je povezana z mutacijami gena Fks1 in Fks2, ki kodirata veliko podenoto glukansintaze.
English: Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall.
Slovenian: Mikafungin nekompetitivno zavre sintezo 1,3-β-D-glukana, ki je bistvena sestavina celične stene gliv.
English: • To treat adults, adolescents and children including neonates who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body).
Slovenian: • Za zdravljenje odraslih, mladostnikov in otrok (vključno z novorojenčki) z resno glivično okužbo, imenovano invazivna kandidoza (okužba, ki je zajela večji del organizma).
English: Mycamine may cause the following other side effects:
Slovenian: Zdravilo Mycamine lahko povzroči naslednje neželene učinke:
English: Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure.
Slovenian: Sočasno dajanje mikafungina in amfotericina B deoksikolata je bilo povezano s 30 % porastom izpostavljenosti amfotericinu B deoksikolatu.
English: Pharmacokinetics are linear over the daily dose range of 12.5 mg to 200 mg and 3 mg/kg to 8 mg/kg.
Slovenian: Farmakokinetika je v območjih dnevnih odmerkov od 12,5 mg do 200 mg in od 3 mg/kg do 8 mg/kg linearna.
English: In rats, long-term treatment with micafungin led to liver damage and subsequent liver tumours.
Slovenian: Pri podganah je dolgotrajno zdravljenje z mikafunginom povzročilo poškodbe jeter in posledične jetrne tumorje.
English: Therefore, unused reconstituted concentrate must be discarded immediately.
Slovenian: Zato je treba neporabljen koncentrat takoj zavreči.
English: Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
Slovenian: Izpostavljenost (AUC oz. površina pod krivuljo koncentracije v odvisnosti od časa) itrakonazolu, sirolimusu in nifedipinu je bila ob prisotnosti mikafungina nekoliko povečana (22 %, 21 % oz. 18 %).
English: - Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.
Slovenian: - Zdravljenje kandidoze požiralnika pri bolnikih, za katere je intravensko zdravljenje primerno.
English: The MAH shall ensure that prior to prescribing of the product prescribers will receive the prescriber checklist.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo zdravniki, ki predpisujejo zdravilo, še pred začetkom predpisovanja prejeli Kontrolni seznam.
English: - Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / µl) for 10 or more days.
Slovenian: - Preprečevanje glivičnih okužb s kandido pri bolnikih, po alogenski presaditvi hematopoetskih matičnih celic, ali bolnikih, pri katerih je treba pričakovati nevtropenijo (absolutno število nevtrofilcev < 500 celic/µl) 10 dni ali več.
English: Drug interaction studies in healthy human subjects were conducted to evaluate the potential for interaction between micafungin and mycophenolate mofetil, ciclosporin, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole, voriconazole and amphotericin B. In these studies, no evidence of altered pharmacokinetics of micafungin was observed.
Slovenian: Pri zdravih preiskovancih so izvedli študije medsebojnega delovanja, da bi ocenili možnost medsebojnega delovanja med mikafunginom in mofetilmikofenolatom, ciklosporinom, takrolimusom, prednizolonom, sirolimusom, nifedipinom, flukonazolom, ritonavirjem, rifampicinom, itrakonazolom, vorikonazolom in amfotericinom B. V teh študijah niso opazili sprememb v farmakokinetiki mikafungina.
English: Micafungin is highly protein-bound and not dialysable.
Slovenian: Mikafungin se v veliki meri veže na beljakovine in se ga z dializo ne da odstraniti.
English: The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies.
Slovenian: Najverjetnejši vzrok za to razliko v kliničnih študijah so bile drugačne sočasno prisotne bolezni v primerjavi z odraslimi bolniki in starejšimi otroci.
English: Patients with renal impairment: Severe renal impairment (Glomerular Filtration Rate [GFR] < 30 ml/min) did not significantly affect the pharmacokinetics of micafungin.
Slovenian: Bolniki z motnjami v delovanju ledvic: Hude motnje v delovanju ledvic (hitrost glomerularne filtracije [GFR] < 30 ml/min) niso pomembno vplivale na farmakokinetiko mikafungina.
English: Mechanism(s) of resistance
Slovenian: Mehanizem(i) rezistence
English: How to use Mycamine
Slovenian: Kako uporabljati zdravilo Mycamine
English: During administration of micafungin, anaphylactic/anaphylactoid reactions, including shock, may occur.
Slovenian: V času zdravljenja z mikafunginom se lahko pojavijo anafilaktične/anafilaktoidne reakcije, vključno s šokom.
English: Overall Treatment Success in the Per Protocol Set, Invasive Candidiasis Study Micafungin
Slovenian: Skupna uspešnost zdravljenja pri posameznem protokolu, študija invazivne kandidoze
English: Oesophageal Candidiasis: In a randomised, double-blind study of micafungin versus fluconazole in the first-line treatment of oesophageal candidiasis, 518 patients received at least a single dose of study drug.
Slovenian: Kandidoza požiralnika: V randomizirani, dvojno slepi študiji, ki je primerjala mikafungin s flukonazolom kot zdravilo prvega izbora pri zdravljenju kandidoze požiralnika, je 518 bolnikov prejelo vsaj enkratni odmerek preiskovanega zdravila.
English: Elderly: When administered as a single 1-hour infusion of 50 mg the pharmacokinetics of micafungin in the elderly (aged 66-78 years) were similar to those in young (20-24 years) subjects.
Slovenian: Starejši bolniki: Po enkratni aplikaciji odmerka 50 mg v obliki enourne infuzije je bila pri starejših bolnikih (starost 66-78 let) farmakokinetika mikafungina podobna kot pri mlajših (20-24 let) preiskovancih.
English: Adults, adolescents ≥ 16 years of age and elderly: - Treatment of invasive candidiasis.
Slovenian: Odrasle, mladostnike, stare 16 let ali več, in starejše: - Zdravljenje invazivne kandidoze.
English: The dose regimen of micafungin depends on the body weight of the patient as given in the following tables:
Slovenian: Režim odmerjanja mikafungina je odvisen od telesne mase bolnika in je predstavljen v spodnjih tabelah:
English: No adverse reactions associated with this high dose were noted.
Slovenian: Neželenih učinkov, povezanih s tako velikim odmerkom, niso opazili.
English: However, if you are concerned that you may have been given too much Mycamine, speak to your doctor or another healthcare professional immediately.
Slovenian: A če vas skrbi, da ste dobili preveč zdravila Mycamine, se takoj posvetujte z zdravnikom ali drugim zdravstvenim delavcem.
English: 2 mg/kg/day *Micafungin dosed at 4 mg/kg in children less than 4 months approximates drug exposures achieved in adults receiving 100 mg/day for the treatment of invasive candidiasis.
Slovenian: 2 mg/kg/dan *Odmerek mikafungina 4 mg/kg pri otrocih, mlajših od 4 mesecev, doseže podobno izpostavljenost zdravilu, kot je bila dosežena pri odraslih, ki so prejemali 100 mg/dan za zdravljenje invazivne kandidoze.
English: Injection-site reactions None of the injection-site adverse reactions were treatment limiting.
Slovenian: Noben neželen učinek na mestu injiciranja ni omejeval zdravljenja.
English: Paediatric patients < 1 year of age might be more prone to liver injury (see section 4.8).
Slovenian: Otroci, stari eno leto ali manj, utegnejo biti bolj nagnjeni k poškodbam jeter (glejte poglavje 4.8).
English: There is no experience with overdoses of micafungin.
Slovenian: Ni izkušenj s prevelikim odmerjanjem mikafungina.
English: Male rats treated intravenously for 9 weeks showed vacuolation of the epididymal ductal epithelial cells, increased epididymis weights and reduced number of sperm cells (by 15%), however, in studies of 13 and 26 weeks duration these changes did not occur.
Slovenian: Pri samcih podgan so po 9 tednih intravenske uporabe opazili vakuolizacijo epitelijskih celic v duktusu nadmodka, povečanje mase nadmodka in zmanjšano število spermijev (za 15 %), vendar pa se v študijah, ki so trajale od 13 do 26 tednov, te spremembe niso pojavile.
English: Additionally, paediatric patients < 1 year of age experienced about two times more often an increase in ALT, AST and AP than older paediatric patients (see section 4.4).
Slovenian: Poleg tega se je pri otrocih, starih eno leto ali manj, približno dvakrat pogosteje pojavilo povišanje ALT, AST in AP kot pri starejših otrocih (glejte poglavje 4.4).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: The nature and incidence of adverse events were similar between treatment groups.
Slovenian: Značaj in incidenca neželenih učinkov sta bila pri skupinah podobna.
English: 10 ml Type I glass vial with an isobutylene-isoprene (PTFE-laminated) rubber stopper and a flip-off cap.
Slovenian: 10-ml steklena viala (iz stekla tipa I) z izobutilen-izoprenskim (PTFE-laminiranim) gumijastim zamaškom in snemljivo zaporko.
English: EUCAST breakpoints
Slovenian: Mejne vrednosti EUCAST
English: The incidence of some adverse reactions was higher in paediatric patients than in adult patients (see section 4.8).
Slovenian: Pediatrična populacija Incidenca nekaterih neželenih učinkov je bila pri otrocih večja kot pri odraslih (glejte poglavje 4.8).
English: Your doctor monitors your response and condition to determine what Mycamine treatment is needed.
Slovenian: Zdravnik spremlja vaš odziv in vašo bolezen in glede na to določi, kakšno zdravljenje z zdravilom Mycamine je potrebno.
English: Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Slovenian: Poročali so o pojavu eksfoliativnih kožnih reakcij, kot npr. Stevens-Johnsonovega sindroma in toksične epidermalne nekrolize.
English: Mycamine vial to be used (mg/vial)
Slovenian: Viala zdravila Mycamine, ki jo je treba uporabiti (mg/vialo)
English: In animals models of candidiasis, a correlation was observed between exposure of micafungin divided by MIC (AUC/MIC) and efficacy defined as the ratio required to prevent progressive fungal growth.
Slovenian: Pri živalskih modelih s kandidozo je bila opažena korelacija med izpostavljenostjo mikafunginu, deljeno z minimalno inhibitorno koncentracijo (AUC/MIC), in učinkovitostjo, izražena kot razmerje,
English: Micafungin demonstrated a smaller mean peak decrease in estimated glomerular filtration rate during treatment (p<0.001) and a lower incidence of infusion-related reactions (p=0.001) than liposomal amphotericin B.
Slovenian: Pri mikafunginu so v času zdravljenja opazili manjše povprečne vrednosti največjega zmanjšanja ocenjene hitrosti glomerularne filtracije (p < 0,001) in manjšo incidenco z infundiranjem povezanih reakcij kot pri amfotericinu B v obliki liposomov (p = 0,001).
English: The incidence of some adverse reactions (listed in the table below) was higher in paediatric patients than in adult patients.
Slovenian: Incidenca nekaterih neželenih učinkov (v spodnji tabeli) je bila pri otrocih večja kot pri odraslih.
English: 1 MICs for C. tropicalis are 1-2 two-fold dilution steps higher than for C albicans and C. glabrata.
Slovenian: nezadostni podatki 1 MIC za C. tropicalis je za 1 do 2 dvakratni redčenji večja kot za C. albicans in C. glabrata.
English: The diluted infusion solution should be used immediately.
Slovenian: Razredčeno raztopino za infundiranje je treba uporabiti takoj.
English: • The decision to use Mycamine should take into account a potential risk for the development of liver tumours.
Slovenian: Kontrolni seznam Pri odločitvi o uporabi zdravila Mycamine je treba upoštevati morebitno tveganje za razvoj tumorjev jeter.
English: In rats, signs of haemolytic anaemia were observed after repeated bolus injection of micafungin.
Slovenian: Pri podganah so znake hemolitične anemije opazili po večkratnih bolusnih injiciranjih mikafungina.
English: PK/PD bridging study demonstrated dose-dependent penetration of micafungin into CNS with the minimum AUC of 170 µg*hr/L required to achieve maximum eradication of fungal burden in the CNS tissues.
Slovenian: Farmakokinetično/farmakodinamična (FK/FD) premostitvena študija je dokazala od odmerka odvisno penetracijo mikafungina v centralni živčni sistem z minimalnim AUC 170 µg*h/L, ki je potreben za dosego maksimalne odstranitve glivičnega bremena v tkivih centralnega živčnega sistema.
English: The majority of hepatic adverse reactions were mild and moderate.
Slovenian: Večina neželenih učinkov na jetra je bila blagih ali zmernih.
English: If central nervous system (CNS) infection is suspected, a higher dosage (e.g. 10 mg/kg) should be used due to the dose-dependent penetration of micafungin into the CNS (see section 5.2).
Slovenian: Če obstaja sum okužbe centralnega živčnega sistema (CŽS), je treba zaradi od odmerka odvisne penetracije mikafungina v CŽS (glejte poglavje 5.2) uporabiti višje odmerke (na primer 10 mg/kg).
English: In animal studies micafungin crossed the placental barrier and reproductive toxicity was seen (see section 5.3).
Slovenian: Mikafungin je v študijah na živalih prešel skozi placentarno bariero, opazili pa so tudi vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Micafungin treatment should be conducted on a careful risk/benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/or genotoxic properties.
Slovenian: Zdravljenje z mikafunginom mora biti osnovano na temeljiti oceni razmerja med tveganjem in koristjo, še posebej pri bolnikih s hudimi motnjami v delovanju jeter, ali kronično boleznijo jeter, za katero je bilo ugotovljeno, da predstavlja preneoplastično stanje, kot je napredovala jetrna fibroza, ciroza, virusni hepatitis, neonatalna jetrna bolezen ali prirojeni encimski defekt, ali bolnikih deležnih sočasnega zdravljenja s hepatotoksičnimi in/ali genotoksičnimi lastnostmi.
English: - if you have kidney problems (e.g. kidney failure and abnormal kidney function test).
Slovenian: - če imate težave z ledvicami (na primer ledvično odpoved in nenormalne rezultate preiskav delovanja ledvic).
English: Mycamine is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Slovenian: Zdravilo Mycamine spada v skupino antimikotikov, ker se uporablja za zdravljenje okužb, ki jih povzročajo glive.
English: In plasma, metabolites M-1 and M-2 were detected only at trace concentrations and metabolite M-5, the more abundant metabolite, accounted for a total of 6.5% relative to parent compound.
Slovenian: V plazmi so presnovka M-1 in M-2 zaznali le v sledovih, presnovek M-5, ki je prevladujoč presnovek, pa je predstavljal skupno 6,5 % glede na nespremenjeno učinkovino.
English: The safety and efficacy in children (including neonates) less than 4 months of age of doses of 4 and 10 mg/kg for the treatment of invasive candidiasis with CNS involvement has not been adequately established.
Slovenian: Varnost in učinkovitost pri otrocih (vključno z novorojenčki), starimi manj kot 4 mesece, zdravljenih za invazivno kandidozo, ki vključuje okužbo CŽS, v odmerkih 4 in 10 mg/kg, ni bila ustrezno ugotovljena.
English: In some patients more severe hepatic dysfunction, hepatitis, or hepatic failure including fatal cases have been reported.
Slovenian: Poročali so, da so pri nekaterih bolnikih opazili hujše motnje v delovanju jeter, hepatitis ali odpoved jeter, vključno s smrtnimi primeri.
English: Hepatic effects:
Slovenian: Učinki na jetra:
English: The median treatment duration was 14 days and the median average daily dose was 150 mg for micafungin (N=260) and 200 mg for fluconazole (N=258).
Slovenian: mediana povprečnega dnevnega odmerka pa je bila 150 mg za mikafungin (N = 260) in 200 mg za flukonazol (N = 258).
English: Micafungin may cause kidney problems, renal failure, and abnormal renal function test.
Slovenian: Mikafungin lahko povzroči težave z ledvicami, ledvično odpoved in nenormalne izvide ledvičnega delovanja.
English: Patients with hepatic impairment: In a study performed in patients with moderate hepatic impairment (Child-Pugh score 7-9), (n=8), the pharmacokinetics of micafungin did not significantly differ from those in healthy subjects (n=8).
Slovenian: Bolniki z motnjami v delovanju jeter: V študiji, opravljeni pri bolnikih z zmerno motnjo v delovanju jeter (stopnja po Child-Pughu 7-9) (n = 8), se farmakokinetika mikafungina ni pomembno razlikovala od farmakokinetike pri zdravih preizkušancih (n = 8).
English: In a study performed in patients with severe hepatic impairment (ChildPugh score 10-12) (n=8), lower plasma concentrations of micafungin and higher plasma concentrations of the hydroxide metabolite (M-5) were seen compared to healthy subjects (n=8).
Slovenian: V študiji, opravljeni pri bolnikih s hudo motnjo v delovanju jeter (stopnja po Child-Pughu 10-12) (n = 8), so v primerjavi z zdravimi preizkušanci opažali nižje plazemske koncentracije mikafungina in višje plazemske koncentracije hidroksidnega presnovka (M-5) (n = 8).
English: Liposomal Amphotericin B
Slovenian: Mikafungin Amfotericin B v obliki liposomov
English: To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended.
Slovenian: Za zmanjšanje tveganja adaptivne regeneracije in morebiten posledičen nastanek jetrnih tumorjev na najmanjšo možno mero, je v primeru značilnega in trajnega povišanja ALT/AST priporočljiva predčasna prekinitev terapije.
English: There was a fixed daily dose of 50 mg (1.0 mg/kg) for micafungin and 400 mg (8 mg/kg) for fluconazole.
Slovenian: Za mikafungin je bil fiksni dnevni odmerek 50 mg (1,0 mg/kg), za flukonazol pa 400 mg (8 mg/kg).
English: It is especially important to inform your doctor if you are using amphotericin B desoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant) or nifedipine (calcium channel blocker used to treat high blood pressure).
Slovenian: Zelo pomembno je, da obvestite svojega zdravnika, če uporabljate amfotericin B dezoksiholat ali itrakonazol (protiglivični antibiotik), sirolimus (zdravila za zmanjšanje imunskega odziva)
English: Mycamine contains no preservatives.
Slovenian: Zdravilo Mycamine ne vsebuje konzervansov.
English: FAH recorded after treatment for 13 weeks or longer persisted after a 13-week withdrawal period and developed into hepatocellular tumours following a treatment free period which covered the life span of rats.
Slovenian: FAH, ki so jih zabeležili po 13 ali več tednov trajajočem zdravljenju, so bili po 13 tedenskem obdobju po prekinitvi terapije še vedno prisotni in so se po obdobju brez zdravljenja, ki je zajemala celo življenje podgan, razvili v hepatocelične tumorje.
English: The most frequently reported adverse reactions were nausea (2.8%), blood alkaline phosphatase increased (2.7%), phlebitis (2.5%, primarily in HIV infected patients with peripheral lines), vomiting (2.5%), and aspartate aminotransferase increased (2.3%).
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali, so bili: navzea (2,8 %), povišanje vrednosti alkalne fosfataze v krvi (2,7 %), flebitis (2,5 %, predvsem pri bolnikih, okuženimi s HIV, ki imajo intravenski kateter), bruhanje (2,5 %) in povečanje vrednosti aspartat-aminotransferaze (2,3 %).
English: Micafungin is unlikely to have an effect on driving or using machines.
Slovenian: Ni verjetno, da bi mikafungin vplival na sposobnost upravljanja vozil ali strojev.
English: § The paediatric population was not sized to test for non-inferiority.
Slovenian: § Populacija otrok ni ustrezne velikosti za testiranje enakovrednosti zdravljenj.
English: If you use Mycamine you should not breast-feed.
Slovenian: Če dobivate zdravilo Mycamine, ne smete dojiti.
English: No dose adjustment is necessary for the elderly.
Slovenian: Pri starejših bolnikih prilagoditev odmerka ni potrebna.
English: Repeated daily doses up to 8 mg/kg (maximum total dose 896 mg) in adult patients have been administered in clinical trials with no reported dose-limiting toxicity.
Slovenian: V kliničnih študijah so odrasli bolniki prejemali ponavljajoče dnevne odmerke do 8 mg/kg (največji celokupni odmerek 896 mg), pri čemer se niso pojavili toksični učinki, ki bi omejevali velikost odmerka.
English: Mycamine is used to treat fungal infections caused by fungal or yeast cells called Candida.
Slovenian: Zdravilo Mycamine se uporablja za zdravljenje glivičnih okužb, ki jih povzročajo glive ali kvasovke, imenovane kandida.
English: In repeat dose studies in dogs, haemolytic anaemia was not observed.
Slovenian: Pri študijah ponovljajočih odmerkov pri psih hemolitične anemije niso opazili.
English: Most frequent reactions were increase in AP (2.7%), AST (2.3%), ALT (2.0%), blood bilirubin (1.6%) and liver function test abnormal (1.5%).
Slovenian: Najpogostejše reakcije so bile povečane vrednosti alkalne fosfataze (2,7 %), aspartataminotransferaze (2,3 %), alanin-aminotransferaze (2,0 %), bilirubina v krvi (1,6 %) in nenormalne vrednosti testov jetrne funkcije (1,5 %).
English: ≥ 1/10,000 to
Slovenian: ≥ 1/10.000 do
English: What Mycamine looks like and contents of the pack
Slovenian: Izgled zdravila Mycamine in vsebina pakiranja
English: ‡ Adjusted for neutropenic status; primary endpoint.
Slovenian: ‡ Prilagojeno glede na stanje nevtropenije; primarni opazovani dogodek.
English: The infusion bottle/bag containing the diluted infusion solution should be inserted into a closable opaque bag for protection from light.
Slovenian: Infuzijsko steklenico/vrečko, ki vsebuje razredčeno raztopino za infundiranje, je treba za zaščito pred svetlobo vložiti v neprosojno vrečko, ki jo je mogoče zapreti.
English: Treatment of invasive candidiasis
Slovenian: Zdravljenje invazivne kandidoze
English: The toxicology of micafungin following repeated intravenous dosing in rats and/or dogs showed adverse responses in liver, urinary tract, red blood cells, and male reproductive organs.
Slovenian: Študije toksičnosti ponavljajočih intravenskih odmerjanj mikafungina pri podganah in/ali psih so pokazale neželene učinke v jetrih, sečilih, eritrocitih in moških reproduktivnih organih.
English: Hypersensitivity to the active substance, to other echinocandins or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, druge ehinokandine ali katerokoli pomožno snov, navedeno v poglavju
English: Powder for solution for infusion White compact powder
Slovenian: prašek za raztopino za infundiranje bel kompakten prašek
English: 1 mg/kg/day *If the patient's response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients ≤ 40 kg.
Slovenian: * Če je odziv bolnika nezadosten, npr. ponavljajoči se pozitivni rezultati kulture ali če se klinično stanje ne izboljša, se lahko odmerek pri bolnikih s telesno maso > 40 kg poveča na 200 mg/dan, pri bolnikih s telesno maso ≤ 40 kg pa na 4 mg/kg/dan.