natgillin/translations-raw huggingface dataset:
Paediatric patients The incidence of some adverse reactions (listed in the table below) was higher in paediatric patients than in adult patients.
Otroci Incidenca nekaterih neželenih učinkov (v spodnji tabeli) je bila pri otrocih večja kot pri odraslih.
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).
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).
At the time of entering the study, the proportion of paediatric patients with neutropenia was several-fold higher than in adult patients (40.2% and 7.3% of children and adults, respectively), as well as allogeneic HSCT (29.4% and 13.4%, respectively) and haematological malignancy (29.1% and 8.7%, respectively).
V času vključevanja v študijo je bil odstotek otrok z nevtropenijo veliko večji kot pri odraslih bolnikih (40, 2% pri otrocih in 7, 3% pri odraslih).
Blood and lymphatic system disorders common
Enako velja za alogensko HSCT (29, 4% pri otrocih in 13, 4% pri odraslih) in hematološko malignost (29, 1% pri otrocih in 8, 7% pri odraslih).
Cardiac disorders
Bolezni krvi in limfatičnega sistema trombocitopenija Pogosti
Vascular disorders common
Srčne bolezni tahikardija pogosti
hypertension, hypotension
Žilne bolezni hipertenzija, hipotenzija pogosti
Hepatobiliary disorders
Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija, hepatomegalija pogosti
7 Renal and urinary disorders common
7 Bolezni sečil akutna ledvična odpoved, povečana vrednost sečnine v krvi pogosti
acute renal failure, blood urea increased
4. 9 Preveliko odmerjanje
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.
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.
One case of mis-dosage of 7.8 mg/kg/day for 7 days was reported in a newborn patient.
Pri enem novorojenčku so poročali o primeru napačnega odmerka 7, 8 mg/ kg/ dan, ki ga je prejemal 7 dni.
Other antimycotics for systemic use, ATC code:
Farmakoterapevtska skupina: drugi antimikotiki za sistemsko uporabo, oznaka ATC:
Mode of action Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall.
Mehanizem delovanja Mikafungin nekompetitivno zavre sintezo 1, 3- β- D- glukana, ki je bistvena sestavina celične stene gliv.
1,3-β-D-glucan is not present in mammalian cells.
Celice sesalcev ne vsebujejo 1, 3- β- D- glukana.
PK/PD relationship An additive or synergistic pharmacodynamic interaction of micafungin and amphotericin B was found in a mouse model of pulmonary aspergillosis (immunosuppression with hydrocortisone, intranasal infection with Aspergillus fumigatus).
Razmerje FK/ FD Aditivna ali sinergistična farmakodinamična interakcija mikafungina in amfotericina B je bila ugotovljena pri mišjem modelu pljučne aspergiloze (imunosupresija s hidrokortizonom, intranazalna okužba z Aspergillus fumigatus).
Mechanism(s) of resistance As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded.
Navzkrižne rezistence z drugimi ehinokandini ni mogoče izključiti.
Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 gene coding for a major subunit of glucan synthase.
Zmanjšana občutljivost ehinokandinov je povezana z mutacijami gena Fks1, ki kodira veliko podenoto glukansintaze.
Breakpoints Susceptibility testing was performed with modifications according to the Clinical and Laboratory Standards Institute (CLSI) methods M27-A2 (Candida species) and M38-A (Aspergillus species), respectively.
Mejne vrednosti Testiranje občutljivosti je bilo narejeno, s prilagoditvami, v skladu s CLSI (Clinical Laboratory Standards Institute), z metodama M27- A2 (za vrsto Candida) in M38- A (za vrsto Aspergillus).
To date, standardised techniques for susceptibility testing for 1,3-β-D-glucan synthesis inhibitors have not been established and results of susceptibility testing do not necessarily correlate with clinical outcome.
Za zdaj ni na voljo standardiziranih postopkov za testiranje občutljivosti na zaviralce sinteze 1, 3- β- D- glukana in ni nujno, da rezultati testiranja občutljivosti korelirajo s kliničnim izidom.
Although no MIC breakpoints for echinocandins have been established, a MIC of < 2 mg/l encompasses > 99% of all clinical isolates of Candida spp. without bisecting any species group and represents a concentration that is easily maintained throughout the dosing interval.
Čeprav niso ugotovili nobenih mejnih vrednosti MIC za ehinokandine, MIC ≤ 2 mg/ l učinkuje pri > 99% vseh kliničnih izolatov Candida spp. ne glede na sev in predstavlja koncentracijo, ki se v režimu odmerjanja zlahka vzdržuje.
Infections due to Candida spp. in this MIC range are likely to respond to therapy.
Verjetno je, da se bodo okužbe s Candida spp. v tem razponu MIC odzvale na zdravljenje.
The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Prevalenca rezistence je lahko različna glede na geografsko območje in izbrani sev v različnem časovnem obdobju, zato so potrebni lokalni podatki o rezistenci, predvsem ob zdravljenju hudih okužb.
This information is only a guide to the probabilities of whether micro-organisms will be susceptible to micafungin or not.
Ti podatki so samo vodilo za ugotavljanje verjetnosti, ali bodo mikroorganizmi občutljivi za mikafungin ali ne.
Where applicable the information on the European range of acquired resistance for the individual micro-organisms is indicated in brackets.
Kjer so evropski podatki o razponu pridobljene rezistence za posamezni mikroorganizem dostopni, so navedeni v oklepajih.
Commonly susceptible species [MIC ranges in Europe, mg/l]
Pogosto občutljivi sevi [razpon MIC v Evropi, mg/ l] Candida albicans [0, 007– 0, 25] Candida glabrata [0, 007– 0, 12] Candida tropicalis [0, 007– 0, 12]
8 Candida albicans [0.007 - 0.25] Candida glabrata [0.007 - 0.12] Candida tropicalis [0.007 - 0.12] Candida krusei [0.015 - 0.12] Candida kefyr [0.03 - 0.06] Candida parapsilosis [0.12 - 2] Candida guilliermondii [0.5] Candida lusitaniae [0.12 - 0.25] Candida spp.
8 Candida krusei [0, 015– 0, 12] Candida kefyr [0, 03– 0, 06] Candida parapsilosis [0, 12– 2] Candida guilliermondii [0, 5] Candida lusitaniae [0, 12– 0, 25] Candida spp.
C. famata, C. dubliniensis, C. lipolytica, C. pelliculosa, C. rugosa, C. stellatoidea and C. zeylanoides)
[0, 015– 0, 5] (vključno s C. famata, C. dubliniensis, C. lipolytica, C. pelliculosa, C. rugosa, C. stellatoidea and C. zeylanoides)
Histoplasma capsulatum, Blastomyces dermatitidis, Coccidioides immitis)
Micelijska oblika dimorfnih gliv (na primer Histoplasma capsulatum, Blastomyces dermatitidis, Coccidioides immitis)
Species for which acquired resistance may be a problem None
Vrste, pri katerih bi pridobljena rezistenca lahko predstavljala težavo Jih ni.
Inherently resistant organisms Cryptococcus spp.
Inherentno rezistentni organizmi Cryptococcus spp.
Information from clinical studies Candidaemia and Invasive Candidiasis:
Podatki iz kliničnih študij Kandidemija in invazivna kandidoza:
Micafungin (100 mg/day or 2 mg/kg/day) was as effective as and better tolerated than liposomal amphotericin B (3 mg/kg) as first-line treatment of candidaemia and invasive candidiasis in a randomised, double-blind, multinational non-inferiority study.
V randomizirani, dvojno slepi, mednarodni študiji enakovrednosti mikafungina in amfotericina kot zdravil prvega izbora pri zdravljenju kandidemije in invazivne kandidoze je bil mikafungin (100 mg/ dan ali 2 mg/ kg/ dan) enako učinkovit in so ga bolniki bolje prenašali kot amfotericin B v obliki liposomov (3 mg/ kg).
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.
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).
Liposomal
Amfotericin B v obliki liposomov
% Difference
% razlike [95% interval zaupanja]
Adult Patie nts
Odrasli bolniki
Overall Treatment Success
Skupna uspešnost zdravljenja Skupna uspešnost zdravljenja glede
181 (89.6) 190
202 181 (89, 6) 190 na stanje nevtropenije
Overall Treatment Success by Neutropenic Status
Skupna uspešnost zdravljenja
Neutropenia at baseline
9 [- 17, 3; 11, 9] §
24
24 (77, 4) 6 (66, 7)
No neutropenia at baseline
Prezgodaj rojeni dojenčki
178
10
163 (91.6) 175
7 (70, 0)
Overall Treatment Success < 2 years old Premature Infants Neonates (0 days to < 4 weeks)
Novorojenčki (0 dni do < 4 tedne)
48 26 10 7
7
35 (72.9) 21 (80.8) 7 (70.0) 7 (100)
7 (100)
50 31 9 5
5
91 (89.2) 133 (88.1) 54 (91.5) 41 (85.4) 19 (82.6) 8 (88.9)
Drugi sevi (ne albicans) ¶ skupaj
89 (90.8) 123 (87.9) 49 (96.1) 35 (79.5) 14 (82.4) 6 (85.7)
123 (87, 9) 49 (96, 1)
† Micafungin rate minus the liposomal amphotericin B rate, and 2-sided 95% confidence interval for the difference in overall success rate based on large sample normal approximation. ‡ Adjusted for neutropenic status; primary endpoint. § The paediatric population was not sized to test for non-inferiority. ¶ Clinical efficacy was also observed (< 5 patients) in the following Candida species:
† Odstotek pri mikafunginu minus odstotek pri amfotericinu B v obliki liposomov ter dvostranski 95% interval zaupanja za razliko v skupni uspešnosti zdravljenja, ki temelji na normalni aproksimaciji velikemu vzorcu. ‡ Prilagojeno glede na stanje nevtropenije; primarni opazovani dogodek. § Populacija otrok ni ustrezne velikosti za testiranje enakovrednosti zdravljenj. ¶ Klinično učinkovitost so opazili (< 5 bolnikov) tudi pri naslednjih sevih Candide:
C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua and C. dubliniensis.
C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua in C. dubliniensis.
Oesophageal Candidiasis:
Kandidoza požiralnika:
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.
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.
An endoscopic grade of 0 (endoscopic cure) at the end of treatment was observed for 87.7% (228/260) and 88.0% (227/258) of patients in the micafungin and fluconazole groups, respectively (95% CI for difference:
Endoskopska stopnja 0 (endoskopska ozdravitev) na koncu zdravljenja je bila ugotovljena pri 87, 7% (228/ 260) in 88, 0% (227/ 258) bolnikov v skupinah, ki sta prejemali mikafungin oziroma flukonazol (95- odstotni IZ za razliko:
[-5.9%, 5.3%]).
[– 5, 9%, 5, 3%]).
The lower limit of the 95% CI was above the predefined non-inferiority margin of -10%, proving non-inferiority.
Spodnja meja 95- odstotnega IZ je bila nad predhodno opredeljeno mejo enakovrednosti – 10%, kar je dokazalo enakovrednost.
Micafungin was more effective than fluconazole in preventing invasive fungal infections in a population of patients at high risk of developing a systemic fungal infection (patients undergoing haematopoietic stem cell transplantation [HSCT] in a randomised, double-blind, multicentre study).
Mikafungin je bil v primerjavi s flukonazolom učinkovitejši pri preprečevanju invazivnih glivičnih okužb pri populaciji bolnikov z velikim tveganjem za razvoj sistemske glivične okužbe (bolnikih, ki so jim presadili hematopoetske matične celice [HSCT] v randomizirani dvojno slepi multicentrični študiji).
Most patients (97%, N=882) had neutropenia at baseline (< 200 neutrophils/µL).
Večina bolnikov (97%; N=882) je imela na izhodišču nevtropenijo (< 200 nevtrofilcev/ µL).
There was a fixed daily dose of 50 mg (1.0 mg/kg) for micafungin and 400 mg (8 mg/kg) for fluconazole.
Za mikafungin je bil fiksni dnevni odmerek 50 mg (1, 0 mg/ kg), za flukonazol pa 400 mg (8 mg/ kg).
The rate of treatment success was statistically significantly higher for micafungin than fluconazole (1.6% versus 2.4% breakthrough infections).
Stopnja uspešnosti zdravljenja je bila pri mikafunginu značilno večja kot pri flukonazolu (1, 6% v primerjavi z 2, 4% izbruhom okužb).
Other breakthrough infections were caused by Fusarium (1 and 2 patients, respectively) and Zygomycetes (1 and 0 patients, respectively).
2 bolnika) in Zygomycetes (1 oz. nič bolnikov).
Absorption Micafungin is an intravenously administered medication.
Absorpcija Mikafungin je zdravilo, ki se aplicira intravensko.
Pharmacokinetics are linear over the daily dose range of 12.5 mg to 200 mg and 3 mg/kg to 8 mg/kg.
Farmakokinetika je v območjih dnevnih odmerkov od 12, 5 mg do 200 mg in od 3 mg/ kg do 8 mg/ kg linearna.
The drug is rapidly distributed into tissues.
Porazdelitev
10 In systemic circulation, micafungin is highly bound to plasma protein (> 99%), primarily to albumin.
Zdravilo se hitro porazdeli v tkiva.
Binding to albumin is independent of micafungin concentration (10-100 µg/ml).
Vezava na albumin je neodvisna od koncentracije mikafungina (10– 100 µg/ ml).
The volume of distribution at steady state (Vss) was approximately 18-19 litres.
Volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je približno 18– 19 litrov.
Metabolism Unchanged micafungin is the principal circulating compound in systemic circulation.
Presnova Nespremenjeni mikafungin je glavna oblika učinkovine v sistemskem krvnem obtoku.
Micafungin has been shown to be metabolised to several compounds; of these M-1 (catechol form), M-2 (methoxy form of M-1) and M-5 (hydroxylation at the side chain) of micafungin have been detected in systemic circulation.
Mikafungin se presnavlja v več spojin; v sistemskem krvnem obtoku so zaznali prisotnost M- 1 (v obliki katehola), M- 2 (metoksi oblika M- 1) in M- 5 (hidroksilacija stranske verige).
Exposure to these metabolites is low and metabolites do not contribute to the overall efficacy of micafungin.
Izpostavljenost omenjenim presnovkom je majhna in le- ti ne prispevajo k skupni učinkovitosti mikafungina.
Elimination and excretion The mean terminal half-life is approximately 10-17 hours and stays consistent across doses up to 8 mg/kg and after single and repeated administration.
Eliminacija in izločanje Povprečna končna biološka razpolovna doba je približno 10– 17 ur in je nespremenjena pri odmerkih do 8 mg/ kg, po enkratni in ponavljajočih aplikacijah.
Total clearance was 0.15-0.3 ml/min/kg in healthy subjects and adult patients and is independent of dose after single and repeated administration.
Celokupni očistek je pri zdravih preiskovancih in odraslih bolnikih 0, 15– 0, 3 ml/ min/ kg in je po enkratni in ponavljajočih aplikacijah neodvisen od odmerka.
Following a single intravenous dose of 14C-micafungin (25 mg) to healthy volunteers, 11.6% of the radioactivity was recovered in the urine and 71.0% in the faeces over 28 days.
Po aplikaciji enkratnega intravenskega odmerka 14C- mikafungina (25 mg) zdravim prostovoljcem so v 28 dneh 11, 6% radioaktivnosti zaznali v seču in 71, 0% v blatu.
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.
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.
Special populations Paediatric patients:
Posebne skupine bolnikov Otroci:
In paediatric patients AUC values were dose proportional over the dose range of 0.5-4 mg/kg.
Pri otrocih so bile površine pod krivuljo koncentracije v odvisnosti od časa (AUC) v območju odmerkov 0, 5 mg/ kg do 4 mg/ kg sorazmerne z odmerkom.
Clearance was influenced by age, with mean values of clearance in younger children (2-11 years) being approximately 1.3 -fold greater than those in older children (12-17 years).
Starost vpliva na očistek; srednja vrednost očistka pri mlajših otrocih (2– 11 let) je bila približno 1, 3- krat večja kot pri starejših otrocih (12– 17 let).
Older children had mean clearance values similar to those determined in adult patients.
Pri starejših otrocih so bile srednje vrednosti očistka podobne kot pri odraslih bolnikih.
Mean clearance in premature infants (gestational age approximately 26 weeks) is approximately 5-fold greater than in adults.
Srednja vrednost očistka pri nedonošenčkih (gestacijska starost približno 26 tednov) je približno 5- krat večja kot pri odraslih.
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.
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.
Patients with hepatic impairment:
Bolniki z motnjami v delovanju jeter:
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).
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).
The pharmacokinetics of micafungin has not been studied in patients with severe hepatic insufficiency.
Pri bolnikih s hudimi motnjami v delovanju jeter farmakokinetike mikafungina niso preučevali.
Patients with renal impairment:
Bolniki z motnjami v delovanju ledvic:
Severe renal impairment (Glomerular Filtration Rate [GFR] < 30 ml/min) did not significantly affect the pharmacokinetics of micafungin.
Hude motnje v delovanju ledvic (hitrost glomerularne filtracije [GFR] < 30 ml/ min) niso pomembno vplivale na farmakokinetiko mikafungina.
Gender/Race:
Spol/ rasa:
Gender and race (Caucasian, Black and Oriental) did not significantly influence the pharmacokinetic parameters of micafungin.
Spol in rasa (bela, črna in rumena) nimata pomembnega vpliva na farmakokinetične parametre mikafungina.
In both studies
Standardne študije karcinogenosti niso bile izvedene, vendar pa je bil razvoj FAH ocenjen pri samicah
11 increased incidences/numbers of hepatocellular tumours were observed after the 18 and 20 month treatment free period in the high dose group of 32 mg/kg/day as well as in a lower dose group (although not statistically significant).
V obeh študijah je bila opažena povečana incidenca/ število hepatoceličnih tumorjev, ki so jih opazili po 18 in 20 mesečnih obdobjih brez zdravljenja v skupini z velikim odmerkom (32 mg/ kg/ dan) kot tudi v skupini z manjšim odmerkom (čeprav ni bila statistično pomembna).
The plasma exposure at the assumed threshold for tumour development in rats (i.e. the dose where no FAH and liver tumours were detected) was in the same range as the clinical exposure.
Plazemska izpostavitev pri domnevnem pragu za razvoj tumorjev pri podganah (t. j. odmerek pri katerem FAH in tumorji jeter niso bili zaznani) je bila v istem obsegu kot izpostavitev v klinični uporabi.
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.
Študije toksičnosti ponavljajočih intravenskih odmerjanj mikafungina pri podganah in/ ali psih so pokazale neželene učinke v jetrih, sečilih, eritrocitih in moških reproduktivnih organih.
In repe ated dose toxicity studies in rat signs of hepatotoxicity consisted of increased liver enzymes and degenerative changes of hepatocytes which were accompanied by signs of compensatory regeneration.
Pri študijah toksičnosti ponavljajočih odmerkov pri podganah so se znaki hepatotoksičnosti pokazali kot povečana vrednost jetrnih encimov in kot degenerativne spremembe hepatocitov, ki so jih spremljali znaki kompenzatorne regeneracije.
In dog, liver effects consisted of increased weight and centrilobular hypertrophy, no degenerative changes of hepatocytes were observed.
Opazili niso nobenih degenerativnih sprememb hepatocitov.
In rats, vacuolation of the renal pelvic epithelium as well as vacuolation and thickening (hyperplasia) of the bladder epithelium were observed in 26-week repeat dose studies.
V 26- tedenski študiji ponavljajočih odmerkov so pri podganah opazili vakuolizacijo epitelija v ledvičnem mehu ter vakuolizacijo in zadebelitev (hiperplazijo) epitelija v mehurju.
In a second 26-week study hyperplasia of transitional cells in the urinary bladder occurred with a much lower incidence.
V drugi 26- tedenski študiji pa se je hiperplazija prehodnih celic v sečnem mehurju pojavila z veliko manjšo incidenco.
These findings showed reversibility over a follow-up period of 18 months.
Te ugotovitve so pokazale reverzibilnost med 18- mesečnim sledenjem.
The duration of micafungin dosing in these rat studies (6 months) exceeds the usual duration of micafungin dosing in patients (see section 5.1).
Trajanje odmerjanja mikafungina v teh študijah pri podganah (6 mesecev) presega običajno trajanje odmerjanja mikafungina pri bolnikih (glejte poglavje 5. 1).
One abortion occurred in rabbits at 32 mg/kg/day.
Pri zajcih je prišlo pri odmerku 32 mg/ kg/ dan do enega splava.
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.
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.
Lactose monohydrate Citric acid anhydrous (to adjust the pH) Sodium hydroxide (to adjust the pH)
laktoza monohidrat brezvodna citronska kislina (za prilagoditev pH)
12 6.2 Incompatibilities
12 natrijev hidroksid (za prilagoditev pH)
This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in section 6.6.
Zdravila se ne sme mešati ali infundirati skupaj z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6. 6.
Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Kemična in fizikalna stabilnost med uporabo sta dokazani do 48 ur pri temperaturi 25 °C, če je koncentrat pripravljen z 9 mg/ ml (0, 9%) raztopino natrijevega klorida za infundiranje ali 50 mg/ ml (5%) raztopino glukoze za infundiranje.
Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Kemična in fizikalna stabilnost med uporabo sta dokazani za 96 ur pri temperaturi 25 °C in zaščiti pred svetlobo, če je koncentrat razredčen z 9 mg/ ml (0, 9%) raztopino natrijevega klorida za infundiranje ali 50 mg/ ml (5%) raztopino glukoze za infundiranje.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Za pogoje shranjevanja koncentrata in razredčene raztopine zdravila glejte poglavje 6. 3.