natgillin/translations-raw huggingface dataset:
The second study was a prospective, open-label, non-comparative study estimating the safety and efficacy of caspofungin in paediatric patients (ages 6 months to 17 years) with invasive candidiasis, esophageal candidiasis, and invasive aspergillosis (as salvage therapy).
Druga raziskava je bila prospektivna, odprta, neprimerjalna raziskava varnosti in učinkovitosti kaspofungina pri pediatričnih bolnikih (starih od 6 mesecev do 17 let) z invazivno kandidiazo, ezofagealno kandidiazo in invazivno aspergilozo (kot rešilno zdravljenje).
Forty-nine patients were enrolled and received CANCIDAS at 50 mg/ m2 IV once daily following a 70-mg/ m2 loading dose on Day 1 (not to exceed 70 mg daily), of whom 48 were included in the MITT analysis.
Dobili so zdravilo CANCIDAS, in sicer uvajalni odmerek 70 mg/ m2 1. dan (a ne več kot 70 mg na dan) in nato 50 mg/ m2 intravensko enkrat na dan; 48 bolnikov je bilo vključenih v analizo MZNZ.
The favorable response rate, by indication, at the end of caspofungin therapy was as follows in the MITT
Ugodni delež odziva po indikaciji je bil na koncu zdravljenja s kaspofunginom v analizi MZNZ naslednji:
81% (30/ 37) in invasive candidiasis, 50% (5/ 10) in invasive aspergillosis, and 100% (1/ 1) in esophageal candidiasis.
81% (30/ 37) pri invazivni kandidiazi, 50% (5/ 10) pri invazivni aspergilozi in 100% (1/ 1) pri ezofagealni kandidiazi.
Distribution Caspofungin is extensively bound to albumin.
Porazdelitev Kaspofungin se močno veže na albumin.
The unbound fraction of caspofungin in plasma varies from 3.5% in healthy volunteers to 7.6% in patients with invasive candidiasis.
Delež nevezanega kaspofungina v plazmi sega od 3, 5% pri zdravih prostovoljcih do 7, 6% pri bolnikih z invazivno kandidiazo.
The distribution into tissues peaked at 1.5 to 2 days after dosing when 92% of the dose was distributed into tissues.
Porazdelitev v tkiva je dosegla največjo vrednost 1, 5 do 2 dni po odmerku, ko je bilo v tkiva porazdeljenih 92% odmerka.
Metabolism Caspofungin undergoes spontaneous degradation to an open ring compound.
Presnova Kaspofungin se spontano razgradi v spojino z odprtim obročem.
Further metabolism involves peptide hydrolysis and N-acetylation.
V nadaljnji presnovi pride do peptidne hidrolize in N- acetilacije.
In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6 or 3A4.
Raziskave in vitro kažejo, da kaspofungin ne zavira citokrom P450 encimov 1A2, 2A6, 2C9, 2C19, 2D6 ali 3A4.
In clinical studies, caspofungin did not induce or inhibit the CYP3A4 metabolism of other medicinal products.
V kliničnih raziskavah kaspofungin ni induciral ali zaviral presnove drugih zdravil z encimom CYP3A4.
Elimination and excretion The elimination of caspofungin from plasma is slow with a clearance of 10-12 ml/ min.
Izločanje Izločanje kaspofungina iz plazme je počasno, očistek znaša 10- 12 ml/ min.
Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour intravenous infusions.
Po eni 1- urni intravenski infuziji se plazemske koncentracije kaspofungina zmanjšujejo večfazno.
Distribution, rather than excretion or biotransformation, is the dominant mechanism influencing plasma clearance.
Glavni dejavnik, ki vpliva na plazemski očistek, je porazdelitev, ne pa izločanje ali biotransformacija.
Approximately 75% of a radioactive dose was recovered during 27 days:
Približno 75% radioaktivnega odmerka se je izločilo v 27 dneh:
41% in urine and 34% in faeces.
41% v urinu in 34% v blatu.
There is little excretion or biotransformation of caspofungin during the first 30 hours after administration.
Izločanje je počasno.
A small amount of caspofungin is excreted unchanged in urine (approximately 1.4% of dose).
Majhna količina kaspofungina se izloči nespremenjena z urinom (približno 1, 4% odmerka).
Caspofungin displays moderate non-linear pharmacokinetics with increased accumulation as the dose is increased, and a dose dependency in the time to reach steady state upon multiple-dose administration.
Po večkratnih odmerkih je čas do stanja dinamičnega ravnovesja odvisen od odmerka.
Special populations Increased caspofungin exposure was seen in adult patients with renal impairment and mild liver impairment, in female subjects, and in the elderly.
10 Posebne skupine bolnikov Večjo izpostavitev kaspofunginu so opazili pri odraslih bolnikih z ledvično okvaro in blago jetrno okvaro, pri ženskah in pri starejših.
Weight was found to influence caspofungin pharmacokinetics in the population pharmacokinetic analysis in adult candidiasis patients.
V populacijski farmakokinetični analizi pri odraslih bolnikih s kandidiazo so ugotovili, da telesna masa vpliva na farmakokinetiko kaspofungina.
The average exposure in an adult patient weighing 80 kg was predicted to be about 23% lower than in an adult patient weighing 60 kg (see section 4.2).
Predvidoma je povprečna izpostavitev pri odraslem bolniku, ki tehta 80 kg, okrog 23% manjša kot pri odraslem bolniku, ki tehta 60 kg (glejte poglavje 4. 2).
In adult patients with mild and moderate hepatic impairment, the AUC is increased about 20 and 75%, respectively.
Pri odraslih bolnikih z blago jetrno okvaro se AUC poveča za okrog 20%, pri odraslih bolnikih z zmerno jetrno okvaro pa za okrog 75%.
There is no clinical experience in adult patients with severe hepatic insufficiency and in paediatric patients with any degree of hepatic insufficiency.
Kliničnih izkušenj pri odraslih bolnikih s hudo jetrno okvaro in pri pediatričnih bolnikih ne glede na stopnjo jetrne okvare nimamo.
10 hepatic impairment has been shown to provide an AUC similar to that obtained in adult subjects with normal hepatic function receiving the standard regimen (see section 4.2).
V raziskavi z večkratnimi odmerki je bila AUC pri odraslih bolnikih z zmerno jetrno okvaro po zmanjšanju dnevnega odmerka na 35 mg podobna kot AUC pri odraslih preiskovancih z normalnim delovanjem jeter, ki so dobivali običajen odmerek (glejte poglavje 4. 2).
In a clinical study of single 70 mg doses, caspofungin pharmacokinetics were similar in adult volunteers with mild renal insufficiency (creatinine clearance 50 to 80 ml/ min) and control subjects.
V klinični raziskavi enkratnih 70 mg odmerkov je bila farmakokinetika kaspofungina pri odraslih prostovoljcih z blago okvaro ledvic (kreatininski očistek 50 do 80 ml/ min) podobna kot pri kontrolnih preiskovancih.
Moderate (creatinine clearance 31 to 49 ml/ min), advanced (creatinine clearance 5 to 30 ml/ min), and end-stage (creatinine clearance < 10 ml/ min and dialysis dependent) renal insufficiency moderately increased caspofungin plasma concentrations after single-dose administration (range:
Zaradi zmerne (kreatininski očistek 31 do 49 ml/ min), napredovale (kreatininski očistek 5 do 30 ml/ min) in dokončne ledvične odpovedi (kreatininski očistek < 10 ml/ min) se je plazemska koncentracija kaspofungina po enem odmerku zmerno povečala (razpon: za 30 do 49% AUC).
However, in adult patients with invasive candidiasis, oesophageal candidiasis, or invasive aspergillosis who received multiple daily doses of CANCIDAS 50 mg, there was no significant effect of mild to advanced renal impairment on caspofungin concentrations.
Vendar pa pri odraslih bolnikih z invazivno kandidiazo, kandidiazo požiralnika ali z invazivno aspergilozo, ki so dobivali CANCIDAS 50 mg v večkratnih dnevnih odmerkih, blaga do napredovala ledvična okvara ni pomembno vplivala na koncentracijo kaspofungina.
No dosage adjustment is necessary for patients with renal insufficiency.
Pri bolnikih z okvaro ledvic odmerka ni treba prilagoditi.
Caspofungin plasma concentrations were on average 17-38% higher in women than in men.
Plazemske koncentracije kaspofungina so bile pri ženskah povprečno za 17- 38% večje kot pri moških.
A modest increase in AUC (28%) and C24h (32%) was observed in elderly male subjects compared with young male subjects.
Pri starejših moških preiskovancih so ugotovili zmerno povečanje AUC (28%) in C24h (32%) v primerjavi z mladimi moškimi.
In patients who were treated empirically or who had invasive candidiasis, a similar modest effect of age was seen in older patients relative to younger patients.
Med empirično zdravljenimi bolniki in bolniki z invazivno kandidiazo je bil pri starejših bolnikih v primerjavi z mlajšimi bolniki opazen podoben zmeren vpliv starosti.
Patient pharmacokinetic data indicated that no clinically significant differences in the pharmacokinetics of caspofungin were seen among Caucasians, Blacks, Hispanics, and Mestizos.
Farmakokinetični podatki pri bolnikih so pokazali, da ni bilo klinično pomembnih razlik v farmakokinetiki kaspofungina pri belcih, črncih, Latinoameričanih ter mešancih belih in indijanskih staršev.
In adolescents (ages 12 to 17 years) receiving caspofungin at 50 mg/ m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24hr was generally comparable to that seen in adults receiving caspofungin at 50 mg daily.
Pri mladostnikih (starih od 12 do 17 let), ki so dobivali kaspofungin v odmerku 50 mg/ m2 na dan (največ 70 mg na dan) je bila AUC0- 24h kaspofungina v plazmi na splošno primerljiva kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan.
All adolescents received doses > 50 mg daily, and, in fact, 6 of 8 received the maximum dose of 70 mg/ day.
Vsi mladostniki so dobivali odmerke > 50 mg na dan in 6 od 8 jih je dobivalo največji odmerek, 70 mg/ dan.
The caspofungin plasma concentrations in these adolescents were reduced relative to adults receiving 70 mg daily, the dose most often administered to adolescents.
Koncentracija kaspofungina v plazmi je bila pri teh mladostnikih nižja glede na odrasle, ki so dobivali 70 mg na dan, tj. odmerek, ki so ga najpogosteje dobili mladostniki.
In children (ages 2 to 11 years) receiving caspofungin at 50 mg/ m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg/ day.
Pri otrocih (starih od 2 do 11 let), ki so dobivali kaspofungin v odmerku 50 mg/ m2 na dan (največ 70 mg na dan), je bila AUC0- 24h kaspofungina v plazmi po več odmerkih primerljiva kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan.
In young children and toddlers (ages 12 to 23 months) receiving caspofungin at 50 mg/ m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg daily and to that in older children (2 to 11 years of age) receiving the 50 mg/ m2 daily dose.
Pri malih otrocih (starih od 12 do 23 mesecev), ki so dobivali kaspofungin v odmerku 50 mg/ m2 na dan (največ 70 mg na dan), je bila AUC0- 24h kaspofungina v plazmi po več odmerkih primerljiva kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan in kot pri starejših otrocih (starih od 2 do 11 let), ki so dobivali dnevni odmerek 50 mg/ m2.
Overall, the available pharmacokinetic, efficacy, and safety data are limited in patients 3 to 10 months of age.
11 V celoti so podatki o farmakokinetiki, učinkovitosti in varnosti, ki so na voljo, omejeni na bolnike, stare od 3 do 10 mesecev.
Pharmacokinetic data from one 10-month old child receiving the 50 mg/ m2 daily dose indicated an AUC0-24hr within the same range as that observed in older children and adults at the 50 mg/ m2 and the 50 mg dose, respectively, while in one 6-month old child receiving the 50 mg/ m2 dose, the AUC0-24hr was somewhat higher.
Farmakokinetični podatki so pri enem 10- mesečnem otroku, ki je dobival 50 mg/ m2 na dan, pokazali AUC0- 24h v enakem območju, kot je bila pri starejših otrocih med uporabo 50 mg/ m2 in odraslih med uporabo 50- mg odmerka, pri enem 6- mesečnem otroku, ki je dobival 50 mg/ m2, pa je bila AUC0- 24h nekoliko večja.
In neonates and infants (< 3 months) receiving caspofungin at 25 mg/ m2 daily (corresponding mean daily dose of 2.1 mg/ kg), caspofungin peak concentration (C1 hr) and caspofungin trough concentration (C24 hr) after multiple doses were comparable to that seen in adults receiving caspofungin at 50 mg daily.
Pri novorojenčkih in dojenčkih (starih < 3 mesece), ki so dobivali kaspofungin v odmerku 25 mg/ m2 (kar ustreza povprečnemu dnevnemu odmerku 2, 1 mg/ kg), sta bili največja koncentracija kaspofungina (C1 h) in koncentracija kaspofungina tik pred naslednjim odmerkom (C24 h) po večkratnih odmerkih podobni kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan.
On Day 1, C1 hr was comparable and C24 hr modestly elevated (36%) in these neonates and infants relative to adults.
Prvi dan je bila C1 h pri teh novorojenčkih in dojenčkih primerljiva, C24 h pa zmerno večja (36%) v primerjavi z odraslimi.
However, variability was seen in both C1 hr (Day 4 geometric mean 11.73 µg/ ml, range 2.63 to 22.05 µg/ ml) and C24 hr (Day 4 geometric mean 3.55 µg/ ml, range 0.13 to 7.17 µg/ ml).
Vendar pa je bila variabilnost opazna tako pri C1 h (geometrična sredina 4. dan 11, 73 µg/ ml, razpon od 2, 63 do 22, 05 µg/ ml) kot pri C24 h (geometrična sredina 4. dan 3, 55 µg/ ml, razpon od 0, 13 do 7, 17 µg/ ml).
AUC0-24hr measurements were not performed in this study due to the sparse plasma sampling.
Meritev AUC0- 24h v tej raziskavi niso naredili zaradi pičlega vzorčenja plazme.
Of note, the efficacy and safety of CANCIDAS have not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age.
Opozoriti je treba, da učinkovitost in varnost zdravila CANCIDAS nista ustrezno raziskani v prospektivnih kliničnih preskušanjih pri novorojenčkih in dojenčkih, mlajših od 3 mesecev.
Repeated dose toxicity studies in rats and monkeys using doses up to 7-8 mg/ kg given intravenously showed injection site reactions in rats and monkeys, signs of histamine release in rats, and evidence of adverse effects directed at the liver in monkeys.
Raziskave toksičnosti po ponavljajočih odmerkih pri podganah in opicah z odmerki do 7- 8 mg/ kg intravensko so pokazale reakcije na mestu vbrizganja pri podganah in opicah, znake sproščanja histamina pri podganah in znake neželenih učinkov na jetra pri opicah.
Developmental toxicity studies in rats showed that caspofungin caused decreases in foetal body weights and an increase in the incidence of incomplete ossification of vertebra, sternebra, and skull bone at doses of 5 mg/ kg that were coupled to adverse maternal effects such as signs of histamine release in pregnant rats.
Raziskave toksičnega vpliva na razvoj pri podganah so pokazale, da kaspofungin povzroči zmanjšanje telesne teže ploda in povečanje pojavnosti nepopolnega zakostenevanja vretenc, prsnice in lobanjskih kosti pri odmerkih 5 mg/ kg, kar je povezano z neželenimi učinki pri materi, kot so znaki sproščanja histamina pri brejih podganah.
No long-term studies in animals have been performed to evaluate the carcinogenic potential.
Dolgoročnih raziskav pri živalih za oceno kancerogenega potenciala ni.
Sucrose Mannitol Glacial acetic acid Sodium hydroxide (to adjust the pH)
saharoza manitol koncentrirana ocetna kislina (ledocet) natrijev hidroksid (za uravnavanje pH)
Do not mix with diluents containing glucose, as CANCIDAS is not stable in diluents containing glucose.
Ne mešajte s tekočinami, ki vsebujejo glukozo, ker CANCIDAS v njih ni stabilen.
Do not mix or co-infuse CANCIDAS with other medicinal products, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products.
Zdravila CANCIDAS ne mešajte in ne infundirajte sočasno z drugimi zdravili, ker ni podatkov o kompatibilnosti zdravila CANCIDAS z drugimi učinkovinami, aditivi ali zdravili za intravensko uporabo.
Stability data have shown that the concentrate for solution for infusion can be stored for up to 24 hours when the vial is stored at 25°C or less and reconstituted with water for injections.
Stabilnostni podatki kažejo, da koncentrat za pripravo raztopine za infundiranje, ki smo ga pripravili z vodo za injekcije, lahko shranjujemo 24 ur pri temperaturi 25 °C ali manj.
Dilute patient infusion solution: should be used immediately.
Razredčeno raztopino za infundiranje je treba uporabiti takoj.
Stability data have shown that the product can be used within 24 hours when stored at 25°C or less, or within 48 hours when the intravenous infusion bag (bottle) is stored refrigerated (2 to 8°C) and diluted with sodium chloride solution 9 mg/ ml (0.9%), 4.5 mg/ ml (0.45%), or 2.25 mg/ ml (0.225%) for infusion, or lactated Ringer’ s solution.
Stabilnostni podatki kažejo, da raztopino, ki smo jo pripravili z raztopino natrijevega klorida za infundiranje 9 mg/ ml (0, 9%), 4, 5 mg/ ml (0, 45%) ali 2, 25 mg/ ml (0, 225%) ali raztopino Ringerjevega laktata, lahko uporabimo v
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution have taken place in controlled validated aseptic conditions.
Normalno naj ta čas ne bi bil daljši od 24 ur, če raztopino shranjujemo pri temperaturi med 2 in 8 °C, razen če sta priprava in razredčenje potekala v kontroliranih, validiranih aseptičnih pogojih.
Unopened vials: store in a refrigerator (2°C - 8°C).
Neodprte viale: shranjujte v hladilniku (2°C - 8 °C).
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega ali razredčenega zdravila glejte poglavje 6. 3.
10 ml Type I glass vials with a grey butyl stopper and a plastic cap with a red aluminium band for single use only.
10 ml steklena viala tipa I s sivim zamaškom iz butilne gume in plastično zaporko z rdečim aluminijastim obročkom, samo za enkratno uporabo.
Supplied in packs of 1 vial.
Na voljo so škatlice z eno vialo.
Reconstitution of CANCIDAS DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in diluents containing glucose.
Priprava zdravila CANCIDAS ZA PRIPRAVO NE UPORABLJAJTE TEKOČIN, KI VSEBUJEJO GLUKOZO, ker CANCIDAS v njih ni stabilen.
DO NOT MIX OR CO-INFUSE CANCIDAS WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products.
Zdravila CANCIDAS NE MEŠAJTE IN GA NE INFUNDIRAJTE SKUPAJ S KATERIMKOLI DRUGIM ZDRAVILOM, ker ni podatkov o kompatibilnosti zdravila CANCIDAS in drugih učinkovin, aditivov in zdravil za intravensko uporabo.
Step 1 Reconstitution of conventional vials To reconstitute the powder, bring the vial to room temperature and aseptically add 10.5 ml of water for injections.
1. korak priprava koncentrata Za pripravo koncentrata prenesite vialo na sobno temperaturo in vanjo aseptično dodajte 10, 5 ml vode za injekcije.
The concentrations of the reconstituted vials will be 5.2 mg/ ml.
Koncentracija pripravljenega koncentrata bo 5, 2 mg/ ml.
This reconstituted solution may be stored for up to 24 hours at or below 25°C.
Tako pripravljeno raztopino lahko hranite 24 ur pri temperaturi 25 °C ali manj.
Step 2 Addition of Reconstituted CANCIDAS to patient infusion solution Diluents for the final solution for infusion are: sodium chloride solution for injection, or lactated Ringer’ s solution.
2. korak priprava končne raztopine za infundiranje Tekočini za pripravo končne raztopine za infundiranje sta raztopina natrijevega klorida za injiciranje ali raztopina Ringerjevega laktata.
Reduced volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses.
Če je to iz zdravstvenih razlogov potrebno, lahko za 50 mg ali 35 mg dnevne odmerke pripravite manjšo prostornino infuzije - 100 ml.
This infusion solution must be used within 24 hours if stored at or below 25°C, or within 48 hours if stored refrigerated at 2 to 8°C.
Raztopino za infundiranje je treba uporabiti v 24 urah, če jo shranjujete pri temperaturi 25 °C ali manj, oziroma v 48 urah, če jo shranjujete v hladilniku pri temperaturi med 2 in 8 °C.
Chemical and physical in-use stability of the diluted solution in sterile lactated Ringer’ s solution and sodium chloride solution 9 mg/ ml (0.9%), 4.5 mg/ ml (0.45%), and 2.25 mg/ ml (0.225%) for infusion has been demonstrated for 24 hours at 25°C and for 48 hours at 2 to 8°C.
Kemijska in fizikalna stabilnost pripravljene raztopine v sterilni raztopini Ringerjevega laktata ali raztopini natrijevega klorida za infundiranje 9 mg/ ml (0, 9%), 4, 5 mg/ ml (0, 45%) ali 2, 25 mg/ ml (0, 225%) pri temperaturi 25 °C je bila dokazana za obdobje 24 ur po pripravi, pri temperaturi med 2 in 8 °C (hladilnik) pa za obdobje 48 ur po pripravi.
From a microbiological point of view, the solution must be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Normalno naj ta čas ne bi bil daljši od 24 ur, če
13 PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
PRIPRAVA RAZTOPINE ZA INFUNDIRANJE ZA ODRASLE
DOSE*
Prostornina
Volume of recon- stituted CANCIDAS for transfer to intravenous bag or bottle
Standardna priprava (koncentrat zdravila
Standard preparation (reconstituted CANCIDAS added to 250 ml) final concentration
CANCIDAS, ki ga je treba vbrizgati v infuzijsko vrečko ali steklenico
Reduced volume infusion (reconstituted CANCIDAS added to 100 ml) final concentration
CANCIDAS + 100 ml) končna koncentracija
50 mg 50 mg at reduced
50 mg 50 mg / zmanjšana
volume 35 mg for moderate
prostornina infuzije 35 mg pri zmerni
hepatic insufficiency (from one 50 mg vial) 35 mg for moderate hepatic insufficiency
okvari jeter (iz ene 50 ml viale) 35 mg pri zmerni okvari jeter (iz ene
(from one 50 mg vial) at reduced volume
50 ml viale) / zmanjšana prostornina infuzije
* 10.5 ml should be used for reconstitution of all vials.
* Za pripravo koncentrata je treba vedno uporabiti 10, 5 ml topila.
Calculation of Body Surface Area (BSA) for paediatric dosing Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula:
Izračun telesne površine za pediatrično odmerjanje Pred pripravo infuzije izračunajte bolnikovo telesno površino po naslednji formuli (Mostellerjeva formula):
(Mosteller Formula)
Višina( cm) xTeža( kg) Telesna površina (m2) = 3600
Preparation of the 70 mg/ m2 infusion for paediatric patients > 3 months of age (using a 50-mg vial) 1.
Priprava infuzije 70 mg/ m2 za pediatrične bolnike, stare > 3 mesece (z uporabo 50- mg viale) 1.
BSA (m2) X 70 mg/ m2 = Loading Dose The maximum loading dose on Day 1 should not exceed 70 mg regardless of the patient's calculated dose.
Telesna površina (m2) X 70 mg/ m2 = uvajalni odmerek Največji uvajalni odmerek 1. dan ne sme preseči 70 mg, ne glede na izračunani odmerek za bolnika.
Aseptically add 10.5 ml of 0.9% Sodium Chloride Injection, Sterile Water for Injection or Bacteriostatic Water for Injection with methylparaben and propylparaben. a This reconstituted solution may be stored for up to one hour at ≤ 25°C (≤ 77°F). b This will give a final caspofungin concentration in the vial of 5.2 mg/ ml.
Aseptično dodajte 10, 5 ml 0, 9% raztopine natrijevega klorida za injekcije, sterilne vode za injekcije ali bakteriostatične vode za injekcije z metilparabenom in propilparabenom. a Pripravljeno raztopino lahko shranite do 1 uro pri temperaturi ≤ 25 °C. b Končna koncentracija kaspofungina v viali bo tako 5, 2 mg/ ml.
Remove the volume of drug equal to the calculated loading dose (Step 1) from the vial.
Potegnite iz viale količino zdravila, ki ustreza izračunanemu uvajalnemu odmerku (1. korak).
Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection.
Aseptično prenesite to količino (ml) c pripravljene raztopine CANCIDAS v intravensko vrečko (ali steklenico), ki vsebuje 250 ml 0, 9%, 0, 45% ali 0, 225% raztopine natrijevega klorida za injekcije ali raztopine Ringerjevega laktata.