natgillin/translations-raw huggingface dataset:
Non-nucleoside reverse transcriptase inhibitors (NNRTI) (CYP3A4 substrates, inhibitors or CYP450 inducers):
50 Zaviralci nenukleozidne reverzne transkriptaze (NNRTI – » Non- nucleoside reverse transcriptase inhibitors «) (substrati, zaviralci CYP3A4 ali induktorji CYP450):
Patients should be carefully monitored for any occurrence of drug toxicity and/ or lack of efficacy during the coadministration of voriconazole and NNRTIs.
Med sočasno uporabo vorikonazola in NNRTI bolnike natančno nadzorovati glede toksičnih učinkov zdravila in/ ali nezadostne učinkovitosti.
It may cause transient and reversible changes to vision, including blurring, altered/ enhanced visual perception
Lahko povzroči prehodne in reverzibilne spremembe vida, vključno z zamegljenim vidom, spremenjenim/ okrepljenim vidnim zaznavanjem in/ ali fotofobijo.
Undesirable effects reported in subjects receiving voriconazole
Ker je bila večina študij odprtega tipa, spodnja preglednica navaja neželene učinke vseh vzročnosti, če je mogoče, da bi bili vzročno povezani.
In the table below, since the majority of the studies were of an open nature all causality adverse events, by system organ class and frequency (very common ≥ 1/ 10, common ≥ 1/ 100 and < 1/ 10, uncommon ≥ 1/ 1000 and < 1/ 100, rare, ≥ 1/ 10 000 and < 1/ 1000 and very rare, < 1/ 10 000) if possibly causally related are listed.
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti (zelo pogosti ≥1/ 10, pogosti ≥1/ 100 in < 1/ 10, občasni ≥1/ 1. 000 in < 1/ 100, redki ≥1/ 10. 000 in < 1/ 1. 000 ter zelo redki < 1/ 10. 000).
Undesirable effects reported in subjects receiving voriconazole:
51 Neželeni učinki, opisani pri bolnikih, ki so prejemali vorikonazol
Headache Dizziness, confusional state, tremor, agitation, paraesthesia Brain oedema, ataxia, diplopia, vertigo, hypoaesthesia Convulsion, encephalopathy, Guillain-Barre syndrome, extrapyramidal symptoms, somnolence during infusion
Glavobol Omotica, stanje zmedenosti, tremor, agitiracija, parestezija Možganski edem, ataksija, diplopija, vrtoglavica, hipestezija Konvulzije, encefalopatija, Guillain- Barrejev sindrom, ekstrapiramidni simptomi, zaspanost med infundiranjem
52 Eye disorders Visual disturbances (including blurred vision (see Section Very common 4.4), chromotopsia and photophobia) Uncommon
Očesne bolezni Zelo pogosti Občasni
Papilloedema (se Section 4.4), optic nerve disorder (including optic neuritis, see Section 4.4), nystagmus, scleritis, blepharitis
Motnje vida Edem papile vidnega živca, obolenje vidnega živca, nistagmus, skleritis, blefaritis
Retinal haemorrhage, optic atrophy, oculogyration, corneal opacity
Mrežnična krvavitev, atrofija vidnega živca, okulogirna kriza, zamotnitev roženice
Ear and labyrinth disorders Rare Hypoacusis, tinnitus
Ušesne bolezni, vključno z
Acute respiratory distress syndrome, pulmonary oedema, respiratory distress, chest pain
Akutni sindrom dihalne stiske, pljučni edem, dihalna stiska, bolečine v prsih
Gastrointestinal disorders Very common Uncommon
Zelo pogosti Občasni
Abdominal pain, nausea, vomiting, diarrhoea Pancreatitis, peritonitis, duodenitis, gingivitis, glossitis, swollen tongue, dyspepsia, constipation
Bolečine v trebuhu, navzea, bruhanje, diareja Pankreatitis, peritonitis, duodenitis, gingivitis, glositis, otekel jezik, dispepsija, zaprtje
Dysgeusia
Motnje okušanja
Renal and urinary disorders Common Uncommon Rare
Bolezni sečil Pogosti Občasni Redki
Renal failure acute, haematuria Nephritis, proteinuria Renal tubular necrosis
Akutna odpoved ledvic, hematurija Nefritis, proteinurija Ledvična tubulna nekroza
Skin and subcutaneous tissue disorders Very common Common
Bolezni kože in podkožja
53 Vascular disorders Common Rare
Žilne bolezni
Hepato-biliary disorders Common Uncommon
Bolezni jeter, žolčnika Pogosti Občasni Redki
There was evidence of attenuation with repeated doses of voriconazole.
53 odmerki vorikonazola.
54 dose adjustment, including discontinuation of therapy.
Večina nenormalnih testov jetrne funkcije je izginila med zdravljenjem brez prilagoditve odmerka, ali pa po prilagoditvi odmerka, vključno s prekinitvijo zdravljenja.
Infusion-Related Reactions During infusion of the intravenous formulation of voriconazole in healthy subjects, anaphylactoid-type reactions, including flushing, fever, sweating, tachycardia, chest tightness, dyspnoea, faintness, nausea, pruritus and rash have occurred.
Z infundiranjem povezane reakcije Med infundiranjem intravenskega pripravka vorikonazola zdravim preiskovancem so se pojavile anafilaktoidne reakcije, vključno z zardevanjem, zvišano telesno temperaturo, znojenjem, tahikardijo, tiščanjem v prsih, dispnejo, omedlevico, navzeo, srbenjem in izpuščajem.
Symptoms appeared immediately upon initiating the infusion (see also section 4.4).
Simptomi so se pojavili takoj po začetku infundiranja (glejte tudi poglavje 4. 4).
In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse events (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis (1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
Pri 22 bolnikih, mlajših od dveh let, ki so dobivali vorikonazol v programu sočutne uporabe, so poročali o naslednjih neželenih učinkih (za katere povezava z vorikonzolom ni bila izključena): fotosenzitivnostna kožna reakcija (1), aritmija (1), pankreatitis (1), zvišanje ravni bilirubina v krvi (1), zvišanje ravni jetrnih encimov (1), izpuščaj (1) in edem papile vidnega živca (1).
55 Microbiology Clinical efficacy (with partial or complete response, see below under Clinical Experience) has been demonstrated for Aspergillus spp. including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans and Fusarium spp.
Klinična učinkovitost (z delnim ali popolnim odzivom, glejte "Klinične izkušnje", spodaj) je bila dokazana za Aspergillus spp., vključno z A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, za Candida spp., vključno s C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis in omejenim številom C. dubliniensis, C. inconspicua, in C. guilliermondii, za Scedosporium spp., vključno s S. apiospermum in S. prolificans ter za Fusarium spp.
Other treated fungal infections (with often partial or complete response, see below under Clinical Experience) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp. including T. beigelii infections.
Med drugimi zdravljenimi glivičnimi okužbami (pogosto z delnim ali popolnim odzivom, glejte "Klinične izkušnje", spodaj) so bili posamezni primeri Alternarie spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp., vključno s P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis ter Trichosporon spp., vključno z okužbami s T. beigelii.
However, elevated minimum inhibitory concentrations did not always correlate with clinical failure and clinical success has been observed in patients infected with organisms resistant to other azoles.
Korelacija delovanja in vitro s
Correlation of in vitro activity with clinical outcome is difficult owing to the complexity of the patients studied in clinical trials; breakpoints for voriconazole remain to be established.
55 kliničnim izidom je težavno zaradi zapletenosti primerov, proučevanih v kliničnih preskušanjih; prelomno točko za vorikonazol bo treba še ugotoviti.
Clinical Experience Succesful outcome in this section is defined as complete or partial response.
Uspešen izid je v tem delu opredeljen kot popoln ali delen odziv.
56 age) with documented candidaemia were included in the study, of whom 248 were treated with voriconazole.
Študija je zajela 370 nenevtropeničnih bolnikov (starejših od 12 let) s potrjeno kandidemijo; 248 teh bolnikov je dobivalo terapijo z vorikonazolom.
Timepoint
časovna točka
Serious refractory Candida infections The study comprised 55 patients with serious refractory systemic Candida infections (including candidaemia, disseminated and other invasive candidiasis) where prior antifungal treatment, particularly with fluconazole, had been ineffective.
56 Hude refraktarne okužbe s Candido Študija je zajela 55 bolnikov s hudimi refraktarnimi sistemskimi okužbami s Candido (vključno s kandidemijo, diseminirano kandidiazo in drugimi invazivnimi oblikami kandidiaze), pri katerih prejšnje antimikotično zdravljenje, zlasti s flukonazolom, ni bilo učinkovito.
In fluconazole-resistant non albicans species, a successful outcome was seen in 3/ 3 C. krusei (complete responses) and 6/ 8 C. glabrata (5 complete, 1 partial response) infections.
Pri ne- albicans vrstah, odpornih proti flukonazolu, so uspešen odziv ugotovili pri 3/ 3 okužbah s C. krusei (popolni odzivi) in 6/ 8 okužbah s C. glabrata (5 popolnih, 1 delen odziv).
Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial response) of 7 patients with S. prolificans infection.
Uspešen odziv na zdravljenje z vorikonazolom so ugotovili pri 16 (6 popolnih, 10 delnih odzivov) od 28 bolnikov, okuženih s S. apiospermum, in pri 2 (oba delna odziva) od 7 bolnikov, okuženih s S. prolificans.
Duration of treatment In clinical trials, 561 patients received voriconazole therapy for greater than 12 weeks, with 136 patients receiving voriconazole for over 6 months.
V kliničnih preskušanjih je 561 bolnikov dobivalo vorikonazol več kot 12 tednov, 136 pa več kot 6 mesecev.
57 Experience in paediatric patients Sixty one paediatric patients aged 9 months up to 15 years who had definite or probable invasive fungal infections, were treated with voriconazole.
Z vorikonazolom je bilo zdravljenih 61 pediatričnih bolnikov, starih od 9 mesecev do 15 let, ki so imeli potrjeno ali verjetno invazivno glivično okužbo.
Clinical Studies Examining QT Interval A placebo-controlled, randomized, single-dose, crossover study to evaluate the effect on the QT interval of healthy volunteers was conducted with three oral doses of voriconazole and ketoconazole.
S placebom kontrolirana, randomizirana, navzkrižna študija z enkratnim odmerkom, ki je ocenjevala vpliv treh peroralnih odmerkov vorikonazola in ketokonazola na interval Q- T, je bila izvedena pri zdravih prostovoljcih.
During oral administration of 200 mg or 300 mg twice daily for 14 days in patients at risk of aspergillosis (mainly patients with malignant neoplasms of lymphatic or haematopoietic tissue), the observed pharmacokinetic characteristics of rapid and consistent absorption, accumulation and non- linear pharmacokinetics were in agreement with those observed in healthy subjects.
57 z aspergilozo (v glavnem bolnikih z malignimi novotvorbami limfatičnega ali hematopoetskega tkiva), so se opazovane farmakokinetične značilnosti, hitra in konstantna absorpcija, kopičenje in nelinearna farmakokinetika, ujemale s tistimi, opazovanimi pri zdravih osebah.
58 The inter-individual variability of voriconazole pharmacokinetics is high.
Interindividualna variabilnost farmakokinetike vorikonazola je velika.
This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole
Ta presnovek deluje minimalno antimikotično in ne prispeva k celotni učinkovitosti vorikonazola.
Pharmacokinetic-Pharmacodynamic relationships In 10 therapeutic studies, the median for the average and maximum plasma concentrations in individual subjects across the studies was 2425 ng/ ml (inter-quartile range 1193 to 4380 ng/ ml) and 3742 ng/ ml (inter-quartile range 2027 to 6302 ng/ ml), respectively.
V 10 terapevtskih študijah je bila mediana povprečne koncentracije v plazmi pri posameznih preiskovancih v vseh raziskavah 2425 ng/ ml (interkvartilni obseg od 1193 do 4380 ng/ ml), mediana največje koncentracije v plazmi pa 3742 ng/ ml (interkvartilni obseg od 2027 do 6302 ng/ ml).
59 In the therapeutic studies no dosage adjustment was made on the basis of age.
V terapevtskih študijah odmerjanja niso prilagajali glede na starost.
The majority of patients received more than one dose level with a maximum duration of dosing of 30 days.
(Študija je proučevala posamična intravenska odmerka 3 in 4 mg/ kg dvakrat na dan, multiple intravenske odmerke 3, 4, 6 in 8 mg/ kg dvakrat na dan in peroralno suspenzijo v multiplih odmerkih 4 in 6 mg/ kg dvakrat na dan.) Večina bolnikov je dobila več kot eno raven odmerka, najdaljša uporaba pa je bila 30 dni.
A comparison of the paediatric and adult population pharmacokinetic data indicated that in order to obtain comparable exposures to those obtained in adults following intravenous maintenance doses of 4 mg/ kg twice daily, intravenous maintenance doses of 7 mg/ kg twice daily are required in paediatric patients.
Primerjava farmakokinetičnih podatkov pediatrične in odrasle populacije kaže, da je treba pri pediatričnih bolnikih za doseganje primerljive izpostavljenosti, kot je pri odraslih dosežena z intravenskim vzdrževalnim odmerkom 4 mg/ kg dvakrat na dan, uporabiti intravenski vzdrževalni odmerek 7 mg/ kg dvakrat na dan.
The higher intravenous maintenance dose in paediatric patients relative to adults reflects the higher elimination capacity in paediatric patients due to a greater liver mass to body mass ratio.
Intravenski vzdrževalni odmerek pri pediatričnih bolnikih je v primerjavi z odraslimi večji zaradi večje eliminacijske sposobnosti pediatričnih bolnikov, ta pa je posledica višjega razmerja med maso jeter in telesno maso.
In order to obtain comparable exposures to those obtained in adults following intravenous maintenance doses of 3 mg/ kg twice daily, intravenous maintenance doses of 4 mg/ kg twice daily are required in paediatric patients.
Da bi pri pediatričnih bolnikih dosegli primerljivo (mediano) izpostavljenost kot pri odraslih po vzdrževalnem odmerku 3 mg/ kg i. v. dvakrat na dan, potrebujejo pediatrični bolniki intravenski vzdrževalni odmerek 4 mg/ kg dvakrat na dan.
Based on the population pharmacokinetic analysis, no loading dose or dosage adjustment according to age is warranted in patients aged 2 to < 12 years old.
Na podlagi populacijske farmakokinetične analize pri bolnikih, starih od 2 do < 12 let, polnilnega odmerka ali odmerka ni treba prilagajati glede na starost.
Renal impairment In patients with moderate to severe renal dysfunction (serum creatinine levels > 2.5 mg / dl), accumulation of the intravenous vehicle, SBECD, occurs.
Ledvična okvara Pri bolnikih z zmerno do hudo prizadetim delovanjem ledvic (koncentracija kreatinina v serumu > 2, 5 mg/ dl) se pojavi kopičenje intravenskega vehikla SBECD.
Hepatic impairment After an oral single dose (200 mg), AUC was 233% higher in subjects with mild to moderate hepatic cirrhosis (Child-Pugh A and B) compared with subjects with normal hepatic function.
59 Jetrna okvara Po enkratnem peroralnem odmerku (200 mg) je bila AUC pri osebah z blago do zmerno cirozo jeter (Child- Pugh A in B) 233% večja kot pri tistih z normalnim delovanjem jeter.
The effects on parturition are probably mediated by species-specific mechanisms, involving reduction of oestradiol levels, and are consistent with those observed with other azole antifungal agents.
Učinki na porod se verjetno posredujejo z za živalsko vrsto specifični mehanizmi, ki obsegajo zmanjšanje koncentracije estradiola in se skladajo z mehanizmi, ugotovljenimi pri drugih azolskih antimikotikih.
60 Preclinical data on the intravenous vehicle, SBECD indicated that the main effects were vacuolation of urinary tract epithelium and activation of macrophages in the liver and lungs in the repeated-dose toxicity studies.
Predklinični podatki o intravenskem vehiklu SBECD so pokazali, da sta v študijah toksičnosti ponavljajočih se odmerkov glavna učinka vakuolizacija epitelija v sečilih in aktiviranje makrofagov v jetrih in pljučih.
Sulphobutylether beta cyclodextrin sodium (SBECD)
Sulfobutileter betaciklodekstrin natrij (SBECD)
Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to initiation of voriconazole therapy (see section 4.2 and section 4.4).
Motnje elektrolitov, kot so hipokaliemija, hipomagneziemija in hipokalciemija, morajo biti korigirane pred začetkom zdravljenja z vorikonazolom (glejte poglavji 4. 2 in 4. 4).
Total parenteral nutrition:
60 Popolna parenteralna prehrana:
Total parenteral nutrition (TPN) need not be discontinued when prescribed with VFEND, but does need to be infused through a separate line.
Pri predpisanem zdravilu VFEND ni potrebno prekiniti dajanja popolne parenteralne prehrane (TPN – total parenteral nutrition), vendar mora biti le- ta infundirana skozi ločeno linijo.
If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for VFEND.
Pri infuziji skozi multi- lumni kateter je treba pri dajanju TPN uporabiti drugo odprtino kot za zdravilo VFEND.
VFEND must not be diluted with 4.2% Sodium Bicarbonate Infusion.
Zdravila VFEND se ne sme razredčiti z infuzijo 4, 2% natrijevega bikarbonata.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6. 6.
VFEND powder for solution for infusion:
VFEND prašek za raztopino za infundiranje:
Therefore, from a microbiological point of view, once reconstituted, the product must be used immediately.
Z mikrobiološkega stališča je zato treba zdravilo uporabiti takoj po pripravi.
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°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika, vendar čas običajno ne sme presegati 24 ur pri temperaturi med 2 °C in 8 °C, razen če ni priprava opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
Reconstituted concentrate:
Pripravljeni koncentrat:
Store at 2°C-8°C for up to 24 hours (in a refrigerator).
Shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku) do 24 ur.
61 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Packs of 1 single use 30 ml clear Type I glass vials with rubber stoppers and aluminium caps with plastic seals.
Pakiranje z eno 30- ml vialo za enkratno uporabo, izdelano iz stekla tipa I, z gumijastim zamaškom in aluminijasto zaporko s plastičnim pečatom.
The powder is reconstituted with 19 ml of Water for Injections to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ ml of voriconazole.
Prašek se pripravi z 19 ml vode za injekcije, tako da nastane 20 ml ekstraktibilne prostornina bistrega koncentrata, ki vsebuje 10 mg/ ml vorikonazola.
It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact amount (19.0 ml) of Water for Injections is dispensed.
Priporočljiva je uporaba standardne 20- ml (neavtomatične) brizge, da se zagotovi aplikacija natančne količine (19, 0 ml) vode za injekcije.
This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.
Uporabiti se sme samo bistro raztopino brez delcev.
For administration, the required volume of the reconstituted concentrate is added to a recommended compatible infusion solution (detailed below) to obtain a final voriconazole solution containing 0.5-5 mg/ ml.
Za aplikacijo se potrebno prostornino pripravljenega koncentrata doda priporočeni združljivi raztopini za infundiranje (navedene so spodaj), da nastane končna raztopina zdravila VFEND, ki vsebuje 0, 5– 5 mg/ ml.
Required Volumes of 10 mg/ ml VFEND Concentrate
61 Potrebne prostornine za 10 mg/ ml VFEND koncentrata
Volume of VFEND Concentrate (10 mg/ ml) required for:
Prostornina VFEND koncentrata (10 mg/ ml) potrebna za:
Body Weight (kg) 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
(kg) 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
3 mg/ kg dose (number of vials) - - - - 9.0 ml (1) 10.5 ml (1) 12.0 ml (1) 13.5 ml (1) 15.0 ml (1) 16.5 ml (1) 18.0 ml (1) 19.5 ml (1) 21.0 ml (2) 22.5 ml (2) 24.0 ml (2) 25.5 ml (2) 27.0 ml (2) 28.5 ml (2) 30.0 ml (2)
(število vial) - - - - 9, 0 ml (1) 10, 5 ml (1) 12, 0 ml (1) 13, 5 ml (1) 15, 0 ml (1) 16, 5 ml (1) 18, 0 ml (1) 19, 5 ml (1) 21, 0 ml (2) 22, 5 ml (2) 24, 0 ml (2) 25, 5 ml (2) 27, 0 ml (2) 28, 5 ml (2) 30, 0 ml (2)
4 mg/ kg dose (number of vials) 4.0 ml (1) 6.0 ml (1) 8.0 ml (1) 10.0 ml (1) 12.0 ml (1) 14.0 ml (1) 16.0 ml (1) 18.0 ml (1) 20.0 ml (1) 22.0 ml (2) 24.0 ml (2) 26.0 ml (2) 28.0 ml (2) 30.0 ml (2) 32.0 ml (2) 34.0 ml (2) 36.0 ml (2) 38.0 ml (2) 40.0 ml (2)
(število vial) (število vial) 4, 0 ml (1) - 6, 0 ml (1) - 8, 0 ml (1) - 10, 0 ml (1) - 12, 0 ml (1) 18, 0 ml (1) 14, 0 ml (1) 21, 0 ml (2) 16, 0 ml (1) 24, 0 ml (2) 18, 0 ml (1) 27, 0 ml (2) 20, 0 ml (1) 30, 0 ml (2) 22, 0 ml (2) 33, 0 ml (2) 24, 0 ml (2) 36, 0 ml (2) 26, 0 ml (2) 39, 0 ml (2) 28, 0 ml (2) 42, 0 ml (3) 30, 0 ml (2) 45, 0 ml (3) 32, 0 ml (2) 48, 0 ml (3) 34, 0 ml (2) 51, 0 ml (3) 36, 0 ml (2) 54, 0 ml (3) 38, 0 ml (2) 57, 0 ml (3) 40, 0 ml (2) 60, 0 ml (3)
7 mg/ kg dose (number of vials) 7.0 ml (1) 10.5 ml (1) 14.0 ml (1) 17.5 ml (1) 21.0 ml (2) 24.5 ml (2) 28.0 ml (2) 31.5 ml (2) 35.0 ml (2) - - - - - - - - - -
(število vial) 7, 0 ml (1) 10, 5 ml (1) 14, 0 ml (1) 17, 5 ml (1) 21, 0 ml (2) 24, 5 ml (2) 28, 0 ml (2) 31, 5 ml (2) 35, 0 ml (2) - - - - - - - - - -
Voriconazole is a single dose unpreserved sterile lyophile.
Vorikonazol je en odmerek sterilnega liofilizata brez konzervansov.
Therefore, from a microbiological point of view, the reconstituted solution must be used immediately.
Z mikrobiološkega stališča je zato treba zdravilo uporabiti takoj po rekonstituciji.
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 has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, so čas shranjevanja in pogoji pred uporabo odgovornost uporabnika, vendar običajno ne sme presegati 24 ur pri temperaturi med 2 °C in 8 °C, razen če ni rekonstitucija opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
62 The reconstituted solution can be diluted with:
Pripravljeno (rekonstituirano) raztopino je mogoče razredčiti z:
9 mg/ ml (0.9%) Sodium Chloride for Infusion Lactated Ringer’ s Intravenous Infusion 5% Glucose and Lactated Ringer’ s Intravenous Infusion 5% Glucose and 0.45% Sodium Chloride Intravenous Infusion 5% Glucose Intravenous Infusion 5% Glucose in 20 mEq Potassium Chloride Intravenous Infusion 0.45% Sodium Chloride Intravenous Infusion 5% Glucose and 0.9% Sodium Chloride Intravenous Infusion
Natrijevim kloridom 9 mg/ ml (0, 9%) za infundiranje Ringerjevim laktatom za intravensko infundiranje 5% glukozo in Ringerjevim laktatom za intravensko infundiranje 5% glukozo in 0, 45% natrijevim kloridom za intravensko infundiranje 5% glukozo za intravensko infundiranje 5% glukozo v 20 mEq raztopini kalijevega klorida za intravensko infundiranje 0, 45% natrijevim kloridom za intravensko infundiranje 5% glukozo in natrijevim kloridom 9 mg/ ml (0, 9%) za intravensko infundiranje