natgillin/translations-raw huggingface dataset:
acute renal failure, renal failure, blood creatinine increased renal tubular acidosis, interstitial nephritis
intersticijski nefritis
Reproductive system and breast disorders Uncommon:
Občasni:
Uncommon: § See section 4.4.
Občasni: § glejte poglavje 4. 4.
* During post-marketing surveillance severe
spremenjene koncentracije zdravil
hepatic injury with fatal outcome has been reported (see section 4.4).
* V času spremljanja v obdobju trženja so poročali o hudi jetrni okvari s smrtnim izidom (glejte poglavje 4. 4).
During clinical trials, patients who received posaconazole doses up to 1,600 mg/ day experienced no different adverse reactions from those reported with patients at the lower doses.
Med kliničnimi preskušanji bolniki, ki so prejeli odmerke posakonazola do 1600 mg/ dan, so opazili neželene učinke, ki se niso razlikovali od tistih, prijavljenih pri bolnikih, ki so jemali manjše odmerke.
Antimycotics for systemic use-triazole derivatives, ATC code:
Antimikotiki za sistemsko zdravljenje – derivati triazola Oznaka ATC:
Mechanism of action Posaconazole inhibits the enzyme lanosterol 14α -demethylase (CYP51), which catalyses an essential step in ergosterol biosynthesis.
Mehanizem delovanja Posakonazol zavira encim lanosterol 14α- demetilazo (CYP51), ki katalizira nujno stopnjo v biosintezi ergosterola.
9 Microbiology Posaconazole has been shown in vitro to be active against the following microorganisms:
Mikrobiologija Pokazali so, da posakonazol in vitro deluje proti naslednjim mikroorganizmom:
Aspergillus species (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida species (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, and species of Fusarium, Rhizomucor, Mucor, and Rhizopus.
(Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi in vrste Fusarium, Rhizomucor, Mucor in Rhizopus.
Resistance Clinical isolates with decreased susceptibility to posaconazole have been identified.
Odpornost Našli so klinične izolate z zmanjšano občutljivostjo za posakonazol.
Combination with other antifungal agents The use of combination antifungal therapies should not decrease the efficacy of either posaconazole or the other therapies; however, there is currently no clinical evidence that combination therapy will provide an added benefit.
Kombinacije z drugimi antimikotiki Uporaba kombiniranih antimikotičnih terapij naj ne bi zmanjšala učinkovitosti posakonazola ali drugih terapij, vendar doslej ni kliničnih dokazov, da bo kombinirana terapija prinesla dodatno korist.
A correlation between total medicinal product exposure divided by MIC (AUC/ MIC) and clinical outcome was observed.
Opažali so korelacijo med količnikom celotne izpostavljenosti zdravilu deljeno z vrednostjo MIK (AUC/ MIK) in kliničnim izidom.
It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens and the effects of food on absorption).
Še posebej je pomembno, da skušate zagotoviti doseganje največje plazemske koncentracije pri bolnikih, okuženih z Aspergillusom (glejte poglavji 4. 2 in 5. 2 o priporočenih režimih odmerjanja in učinkih hrane na absorpcijo).
Clinical experience Invasive aspergillosis Oral posaconazole 800 mg/ day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a non-comparative salvage therapy trial.
Klinične izkušnje Invazivna aspergiloza Peroralni posakonazol 800 mg/ dan v deljenih odmerkih so ovrednotili za zdravljenje invazivne aspergiloze pri bolnikih z boleznijo, odporno na amfotericin B (vključno z liposomskimi oblikami) ali itrakonazol ter pri bolnikih, ki niso prenašali teh zdravil v neprimerjalnem preskušanju zadnje možnosti terapije.
Most of the cases of aspergillosis were considered to be refractory to prior therapy in both the posaconazole group (88%) and in the external control group (79%).
Večino primerov aspergiloze so ocenili za odporne na predhodno terapijo, tako v skupini za posakonazol (88%) kot v zunanji kontrolni skupini (79%).
As shown in Table 3, a successful response (complete or partial resolution) at the end of treatment was seen in 42% of posaconazole-treated patients compared to 26% of the external group.
Kot je prikazano v preglednici 3, je bil dober odziv (popolna ali delna ozdravitev) ob koncu zdravljenja opazen pri 42% bolnikov, zdravljenih s posakonazolom, v primerjavi s 26% bolnikov v zunanji skupini.
Overall efficacy of posaconazole at the end of treatment for invasive aspergillosis in comparison to an external control group Overall Response Success by Species All mycologically confirmed
Skupna učinkovitost posakonazola ob koncu zdravljenja invazivne aspergiloze v primerjavi z zunanjo kontrolno skupino
11 of 24 patients who had proven or probable fusariosis were successfully treated with posaconazole 800 mg/ day in divided doses for a median of 124 days and up to 212 days.
11 od 24 bolnikov, ki so dokazano ali verjetno imeli fusariozo, so uspešno pozdravili posakonazolom 800 mg/ dan v deljenih odmerkih, ki so jih dajali mediano vrednost časa 124 dni ter do 212 dni.
Chromoblastomycosis/ Mycetoma:
Kromoblastomikoza ali micetom:
9 of 11 patients were successfully treated with posaconazole 800 mg/ day in divided doses for a median of 268 days and up to 377 days.
9 od 11 bolnikov je bilo uspešno zdravljenih s posakonazolom 800 mg/ dan v deljenih odmerkih v času (mediana vrednost) 268 dni in do 377 dni.
Coccidioidomycosis:
Kokcidioidomikoza:
11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole 800 mg/ day in divided doses for a median of 296 days and up to 460 days.
11 od 16 bolnikov je bilo uspešno zdravljenih (ob koncu zdravljenja popolna ali delna odprava znakov in simptomov, prisotnih na začetku) s posakonazolom 800 mg/ dan v deljenih odmerkih v času (mediana vrednost) 296 dni in do 460 dni.
Treatment of azole-susceptible Oropharyngeal Candidiasis (OPC) A randomised, evaluator-blind, controlled study was completed in HIV-infected patients with azole- susceptible oropharyngeal candidiasis (most patients studied had C. albicans isolated at baseline).
Zdravljenje orofaringealne kandidiaze, občutljive na azole (OPC) Randomizirana, za ocenjevalce slepa kontrolirana študija je bila opravljena pri bolnikih, okuženih s HIV, ki so imeli na azole občutljivo orofaringealno kandidiazo (pri večini bolnikov v tej študiji so na začetku študije izolirali C. albicans).
Patients were treated with posaconazole or fluconazole oral suspension (both posaconazole and fluconazole were given as follows:
Bolnike so zdravili s posakonazolom ali s peroralno suspenzijo flukonazola (tako posakonazol kot flukonazol so odmerjali na naslednji način:
100 mg twice a day for 1 day followed by 100 mg once a day for 13 days).
100 mg dvakrat na dan 1 dan, potem pa 100 mg enkrat na dan 13 dni).
The primary efficacy endpoint was the incidence of proven/ probable IFIs at 16 weeks post-randomization as determined by an independent, blinded external expert panel.
Primarni končni rezultat učinkovitosti je bila incidenca dokazanih oziroma verjetnih IFI 16 tednov po
A key secondary endpoint was the incidence of proven/ probable IFIs during the on-treatment period (first dose to last dose of study medicinal product + 7 days).
Ključni sekundarni končni rezultat je bila incidenca dokazane oziroma verjetne IFI v obdobju na terapiji (od prvega odmerka do zadnjega odmerka proučevanega zdravila + 7 dni).
The majority (377/ 600, [63%]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/ 600, [32.5%]) GVHD at study start.
Večina (377/ 600, [63%]) v študijo vključenih bolnikov je imela na začetku študije akutno GVHD stadija 2 ali 3 ali kronično obsežno GVHD (195/ 600, [32, 5%]).
The primary efficacy endpoint was the incidence of proven/ probable IFIs as determined by an independent, blinded external expert panel during the on-treatment period.
Primarni končni rezultat učinkovitosti je bila incidenca dokazane oziroma verjetne IFI, kar je ugotavljala neodvisna komisija zunanjih strokovnjakov na slep način, v obdobju na terapiji.
A key secondary endpoint was the incidence of proven/ probable IFIs at 100 days post-randomization.
Ključni sekundarni končni rezultat je bila incidenca dokazane oziroma verjetne IFI 100 dni po randomizaciji.
New diagnosis of acute myelogenous leukemia was the most common underlying condition (435/ 602, [72%]).
Najpogostejša osnovna bolezen je bila novodiagnosticirana akutna mieloična levkemija (435/ 602, [72%]).
The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/ itraconazole.
Srednja dolžina zdravljenja je bila 29 dni za posakonazol in 25 dni za flukonazol oziroma itrakonazol.
11 In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
V obeh študijah profilaktične uporabe zdravila je bila aspergiloza najpogostejša okužba, ki se je pojavila kljub zdravljenju.
There were fewer breakthrough Aspergillus infections in patients receiving posaconazole prophylaxis when compared to control patients.
V primerjavi s kontrolno skupino je bilo pri bolnikih, ki so prejeli profilakso s posakonazolom, manj okužb z Aspergillus- om kljub zdravljenju.
Table 5.
12 Preglednica 5.
Results from clinical studies in prophylaxis of Invasive Fungal Infections.
Izsledki kliničnih študij profilakse invazivnih glivičnih okužb Kontrolna skupinaa
Study
Odstotek
Posaconazole
Posakonazol (%) bolnikov z
Controla
dokazanimi oziroma verjetnimi IFI Obdobje na terapijib
Proportion (%) of patients with proven/ probable IFIs On-treatment periodb 1899d 316e
1899 316e
7/ 304 (2) 7/ 291 (2)
7/ 304 7/ 291
25/ 298 (8) 22/ 288 (8)
(2) 25/ 298 (8) (2) 22/ 288 (8)
Fixed-time periodc 1899d 316 d
Določeno časovno obdobjec 1899d 316 d
FLU = fluconazole; ITZ = itraconazole; POS = posaconazole. a:
FLU = flukonazol; ITZ = itrakonazol; POS = posakonazol a:
In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316 it was the period from first dose to last dose of study medicinal product plus 7 days. c:
V študiji 1899 je šlo tu za obdobje od randomizacije do zadnjega odmerka proučevanega zdravila plus 7 dni, v študiji 316 pa je bilo to obdobje od prvega odmerka do zadnjega odmerka proučevanega zdravila plus 7 dni. c:
All treated
V študiji 1899 je bilo to obdobje od randomizacije do 100. dne po randomizaciji, v študiji 316 pa od začetka študije do 111. dne po začetku študije. d: vsi randomizirani e: vsi zdravljeni
Proportion (%) of patients with proven/ probable Aspergillosis On-treatment periodb 1899d 316e
Odstotek (%) bolnikov z dokazano oziroma verjetno aspergilozo Obdobje na terapijib 1899d 316e
Fixed-time periodc 1899d 316 d
Določeno časovno obdobjec 1899d 316 d FLU = flukonazol; ITZ = itrakonazol; POS a:
4/ 304 (1) 7/ 301 (2)
4/ 304 (1) 7/ 301 (2) = posakonazol
FLU/ ITZ (1899); FLU (316). b:
b:
FLU/ ITZ 67/ 298 (22%) p= 0.048].
V študiji 1899 so opazili bistveno zmanjšanje umrljivosti iz vseh vzrokov v prid posakonazolu [POS 49/ 304 (16%) v primerjavi s FLU/ ITZ 67/ 298 (22%) p= 0, 048].
Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomization, was significantly higher for posaconazole recipients; this survival benefit was demonstrated when the analysis considered all causes of death (P= 0.0354) as well as IFI-related deaths (P = 0.0209).
Ta koristen vpliv na stopnjo preživetja so pokazali, ko so v analizi upoštevali vse vzroke smrti (p= 0, 0354), pa tudi smrti, povezane z IFI (p = 0, 0209).
In Study 316, overall mortality was similar (POS, 25%; FLU, 28%); however, the proportion of IFI- related deaths was significantly lower in the POS group (4/ 301) compared with the FLU group (12/ 299; P= 0.0413).
V študiji 316 je bila skupna umrljivost podobna (POS, 25%; FLU, 28%), vendar je bil odstotek smrtnih primerov v povezavi z IFI bistveno manjši v skupini, ki je prejemala POS (4/ 301), kot pri skupini, ki je prejemala FLU (12/ 299; p= 0, 0413).
12 Use in paediatric patients Sixteen patients 8-17 years of age were treated with 800 mg/ day in a study for invasive fungal infections.
Uporaba pri pediatričnih bolnikih Šestnajst bolnikov, starih od 8 do 17 let, so zdravili z 800 mg/ dan v študiji uporabe zdravila pri invazivnih glivičnih okužbah.
Additionally, twelve patients 13-17 years of age received 600 mg/ day for prophylaxis of invasive fungal infections (Studies 316 and 1899).
13 Poleg tega je dvanajst bolnikov, starih od 13 do 17 let, prejemalo 600 mg/ dan za profilakso invazivnih glivičnih okužb (študiji 316 in 1899).
No clinically relevant changes in the mean QTc (Fridericia) interval from baseline were observed.
Ocena elektrokardiograma Od 173 zdravih prostovoljcev in prostovoljk, starih od 18 do 85 let, so pridobili večkratne, časovno usklajene EKG- je, zbrane v 12- urnem obdobju, in sicer pred in med uporabo posakonazola (400 mg dvakrat na dan, zaužitih z zelo mastno hrano) in pri tem niso opazili nobenih klinično pomembnih sprememb srednje vrednosti intervala QTc (Fridericia) glede na začetno vrednost.
Absorption Posaconazole is absorbed with a median tmax of 3 hours (fed patients).
Absorpcija Posakonazol se absorbira z mediano vrednostjo tmax 3 ure (nahranjeni bolniki).
In healthy volunteers under fasting conditions, dividing the total daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 58% over 48 hours.
Pri zdravih prostovoljcih na tešče so pokazali, da razdelitev celotnega dnevnega odmerka (800 mg) na 200 mg štirikrat na dan v primerjavi s 400 mg dvakrat na dan poveča izpostavljenost posakonazolu za 58% v času 48 ur.
Effect of food on oral absorption in healthy volunteers The AUC of posaconazole is about 2.6 times greater when administered with a non-fat meal or nutritional supplement (14 grams fat) and 4 times greater when administered with a high-fat meal (~ 50 grams fat) relative to the fasted state.
Vpliv hrane na peroralno absorpcijo pri zdravih prostovoljcih Vrednost AUC za posakonazol je približno 2, 6- krat večja pri uživanju z hrano brez maščob ali s prehranskim dodatkom (14 gramov maščobe) in 4- krat večja pri uživanju z hrano z veliko maščob (~ 50 gramov maščobe) kot pri uživanju zdravila na tešče.
Posaconazole should be administered with food or a nutritional supplement (see section 4.2).
Posakonazol naj bi bolniki jemali s hrano ali s prehranskim dodatkom (glejte poglavje 4. 2).
Distribution Posaconazole is slowly absorbed and slowly eliminated with a large apparent volume of distribution (1,774 litres) and is highly protein bound (> 98%), predominantly to serum albumin.
Porazdelitev Posakonazol se počasi absorbira in počasi izloča, z velikim navideznim porazdelitvenim volumnom (1774 litrov) in se v veliki meri veže na beljakovine (> 98%), predvsem na serumski albumin.
Metabolism Posaconazole does not have any major circulating metabolites and its concentrations are unlikely to be altered by inhibitors of CYP450 enzymes.
Presnova Posakonazol nima nobenega glavnega presnovka v krvi in malo je verjetno, da bi zaviralci encimov CYP450 vplivali na njegovo koncentracijo.
The excreted metabolites in urine and faeces account for approximately 17% of the administered radiolabelled dose.
Presnovki, izločeni v seč in blato, zajemajo približno 17% danega radioaktivno označenega odmerka.
Excretion Posaconazole is slowly eliminated with a mean half-life (t½) of 35 hours (range 20 to 66 hours).
Izločanje Posakonazol se izloča počasi, s srednjo razpolovno dobo (t½) 35 ur (razpon od 20 do 66 ur).
After administration of 14C-posaconazole, radioactivity was predominantly recovered in the faeces (77% of the radiolabelled dose) with the major component being parent compound (66% of the radiolabelled dose).
Po dajanju 14 C- posakonazola so radioaktivnost ugotovili predvsem v blatu (77% radioaktivno označenega odmerka), glavna komponenta pa je bila matična spojina (66% radioaktivno označenega odmerka).
Renal clearance is a minor elimination pathway, with 14% of the radiolabelled dose excreted in urine (< 0.2% of the radiolabelled dose is parent compound).
Ledvični očistek je bila manj pomembna pot izločanja, pri čemer se je 14% radioaktivno označenega odmerka izločilo s sečem (< 0, 2% radioaktivno označenega odmerka je bila matična spojina).
13 Following administration of 800 mg per day of posaconazole as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8 - 17 years of age (776 ng/ ml) were similar to concentrations from 194 patients 18 - 64 years of age (817 ng/ ml).
Farmakokinetika pri posebnih skupinah bolnikov Otroci (< 18 let) Po dajanju 800 mg posakonazola na dan v deljenih odmerkih za zdravljenje invazivnih glivičnih okužb, so bile srednje najmanjše plazemske koncentracije za 12 bolnikov, starih od 8 do 17 let (776 ng/ ml), podobne koncentracijam za 194 bolnikov, starih od 18 do 64 let (817 ng/ ml).
No pharmacokinetic data are available from paediatric patients less than 8 years of age.
Podobno je bila v študijah
Similarly, in the prophylaxis studies, the mean steady-state posaconazole average concentration (Cav) was comparable among ten adolescents (13-17 years of age) to Cav achieved in adults (≥ 18 years of age).
14 profilaktične uporabe zdravila srednja vrednost povprečne koncentracije posakonazola v stanju dinamičnega ravnovesja (Cav) pri desetih mladostnikih (starih od 13 do 17 let) podobna vrednosti Cav, doseženi pri odraslih (starih ≥ 18 let).
Elderly (≥ 65 years) An increase in Cmax (26%) and AUC (29%) was observed in elderly subjects (24 subjects ≥ 65 years of age) relative to younger subjects (24 subjects 18 - 45 years of age).
Starostniki (≥ 65 let) Pri starostnikih (24 preiskovancev, starih ≥ 65 let) so opažali povečanje Cmax (26%) in vrednosti AUC (29%) v primerjavi z mlajšimi preiskovanci (24 preiskovancev, starih od 18 do 45 let).
However, the safety profile of posaconazole between the Black and Caucasian subjects was similar.
Rasa Opažali so majhno zmanjšanje (16%) vrednosti AUC in Cmax za posakonazol pri preiskovancih črne rase v primerjavi z belimi preiskovanci, vendar je bil profil varnosti posakonazola pri črnih in pri belih preiskovancih podoben.
Renal impairment Following single-dose administration, there was no effect of mild and moderate renal impairment (n=18, Cl cr ≥ 20 ml/ min/ 1.73 m2) on posaconazole pharmacokinetics; therefore, no dose adjustment is required.
Ledvična okvara Po dajanju enkratnih odmerkov ni bilo nobenega vpliva blage in zmerne ledvične okvare (n=18 Cl kr ≥ 20 ml/ min/ 1, 73 m2) na farmakokinetiko posakonazola, zato ni potrebno nikakršno prilagajanje odmerka.
In subjects with severe renal impairment (n=6, Cl cr < 20 ml/min/1.73 m2), the AUC of posaconazole was highly variable [> 96% CV (coefficient of variance)] compared to other renal groups [< 40% CV].
Pri preiskovancih s hudo ledvično okvaro (n=6, Cl kr < 20 ml/ min/ 1, 73 m2) je bila vrednost AUC posakonazola močno spremenljiva [> 96% CV (koeficient variance)] v primerjavi z drugimi kategorijami ledvične funkcije [< 40% CV].
Hepatic impairment In a study with small number of subjects (n=12) who had hepatic impairment, there was an increase in exposure associated with prolongation of half-life in hepatic impaired patients (26.6, 35.3, and 46.1 hours for the mild, moderate and severe groups, respectively compared to 22.1 hours in subjects with normal hepatic function).
Jetrna okvara V študiji pri majhnem številu preiskovancev (n=12), ki so imeli jetrno okvaro, so ugotovili povečanje izpostavljenosti zdravilu, povezano s podaljšanjem razpolovne dobe pri bolnikih z jetrno okvaro (26, 6 ur za blago, 35, 3 ur za zmerno in 46, 1 ur za hudo jetrno okvaro, v primerjavi z 22, 1 ur pri preiskovancih z normalnim delovanjem jeter).
An approximately 2-fold increase in steady-state AUC is estimated in patients with severe hepatic impairment.
Pri bolnikih s hudo jetrno okvaro so ocenili, da pride do približno 2- kratnega povečanja vrednosti AUC v ravnovesnem stanju.
In twelve-month neurotoxicity studies in dogs and monkeys, no functional effects were observed on the central or peripheral nervous systems at systemic exposures greater than those achieved therapeutically.
V 12- mesečnih študijah nevrotoksičnosti pri psih in opicah niso opažali nobenih funkcionalnih učinkov na osrednje ali periferno živčevje pri sistemskih izpostavljenostih, večjih od tistih, ki jih dosežemo pri terapiji.
Pulmonary phospholipidosis resulting in dilatation and obstruction of the alveoli was observed in the 2-year study in rats.
V 2- letni študiji pri podganah so opažali pljučno fosfolipidozo, ki je povzročila dilatacijo in obstrukcijo alveolov.
14 No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at systemic exposures 4.6-fold greater than the exposures obtained at therapeutic doses in humans.
Ehokardiografija
Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 1.4-fold greater than that achieved therapeutically.
15 ni pokazala nobenih znakov srčne dekompenzacije v študiji farmakološke varnosti večkratnih odmerkov pri podganah pri sistemski izpostavljenosti, ki je bila 1, 4- krat večja od tiste, ki jo dosežemo pri terapiji.
Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 1.4-fold and 4.6-fold greater, respectively, than those achieved with therapeutic doses.
4, 6- krat večje od tistih, ki jih dosežemo pri terapevtskih odmerkih.
Reproduction, peri- and postnatal development studies were conducted in rats.
Pri podganah so bile opravljene študije razmnoževanja ter peri - in postnatalnega razvoja.
Polysorbate 80 Simeticone Sodium benzoate (E211) Sodium citrate dihydrate Citric acid monohydrate Glycerol Xanthan gum Liquid glucose Titanium dioxide (E171) Artificial cherry flavour containing benzyl alcohol and propylene glycol Purified water
polisorbat 80 simetikon natrijev benzoat (E211) natrijev citrat dihidrat citronska kislina monohidrat glicerol ksantanski gumi tekoča glukoza titanov dioksid (E171) umetna aroma češnje, ki vsebuje benzilalkohol in propilenglikol prečiščena voda
Unopened container:
Neodprt vsebnik:
After first opening the container:
Po prvem odprtju vsebnika:
4 weeks.
4 tedne.
105 ml of oral suspension in a 123 ml bottle (glass amber type IV) closed with a plastic child-resistant cap (polypropylene) and a measuring spoon (polystyrene) with 2 graduations:
105 ml peroralne suspenzije v 123 ml steklenički (rjavo steklo tipa IV), zaprti s plastično za otroke varno zaporko (iz polipropilena) in odmerno žličko (iz polistirena) z 2 oznakama:
2.5 ml and 5 ml.
2, 5 ml in 5 ml.
15 6.6 Special precautions for disposal
16 6. 6 Posebni varnostni ukrepi za odstranjevanje
16 ANNEX II
17 DODATEK II
17 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Schering-Plough S. A., 2, rue Louis Pasteur; 14200 Hérouville St Clair, France
Schering- Plough S. A., 2, rue Louis Pasteur; 14200 Hérouville St Clair, Francija
18 ANNEX III
19 DODATEK III
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE
BOTTLE (Outer Carton)
STEKLENIČKA (Škatla)
Noxafil 40 mg/ ml oral suspension posaconazole
Noxafil 40 mg/ ml peroralna suspenzija posakonazol
Oral use Shake well before use.
Peroralna uporaba Pred uporabo dobro pretresite.
EXP Any product remaining four weeks after opening the bottle should be discarded.
EXP Morebitno količino zdravila, ki preostane štiri tedne po odprtju stekleničke, zavrzite.