natgillin/translations-raw huggingface dataset:
The expiry date refers to the last day of that month. • Store powder and solvent below 25°C • Store powder and solvent protected from light • Do not freeze, to prevent damage to the solvent vial • It is recommended that the product be used immediately following reconstitution.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca. • Prašek in topilo shranjujte pri temperaturi do 25 °C. • Prašek in topilo shranjujte zaščiteno pred svetlobo. • Ne zamrzujte, da boste preprečili poškodbo viale s topilom. • Priporočljivo je, da zdravilo uporabite takoj po pripravi.
It should not be longer than 24 hours at 2°C – 8°C, unless reconstitution has taken place in controlled and validated bacteria-free conditions.
Če ni uporabljeno takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas ne sme biti daljši od 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bila raztopina pripravljena v nadzorovanih in preverjenih pogojih brez bakterij.
What NovoSeven contains • The active substance is recombinant coagulation factor VIIa (activated eptacog alfa). • The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium hydroxide.
Kaj vsebuje zdravilo NovoSeven • Zdravilna učinkovina je rekombinantni koagulacijski faktor VIIa (aktivirani eptakog alfa). • Pomožne snovi v prašku so natrijev klorid, kalcijev klorid dihidrat, glicilglicin, polisorbat 80, manitol, saharoza, metionin, klorovodikova kislina, natrijev hidroksid.
1 mg/ vial (corresponding to 50 KIU/ vial), 2 mg/ vial
1 mg/ vialo (ustreza 50 k. i. e. / vialo), 2 mg/ vialo (ustreza 100 k. i. e. / vialo) ali 5 mg/ vialo (ustreza 250 k. i. e. / vialo).
After reconstitution 1 ml of the solution contains 1 mg eptacog alfa (activated).
98 Po pripravi vsebuje 1 ml raztopine 1 mg aktiviranega eptakoga alfa.
What NovoSeven looks like and contents of the pack The powder vial contains white powder and the solvent contains a clear colourless solution.
Izgled zdravila NovoSeven in vsebina pakiranja Viala s praškom vsebuje bel prašek, viala s topilom pa bistro in brezbarvno raztopino.
Do not use the reconstituted solution if particle formation or discolouration is noticed.
Pripravljene raztopine ne uporabite, če se v njej pojavijo delci ali če opazite, da je obarvana.
Each NovoSeven pack contains: • 1 vial with white powder for solution for injection • 1 vial with solvent for reconstitution
Vsako pakiranje NovoSeven vsebuje: • 1 vialo z belim praškom za raztopino za injiciranje, • 1 vialo s topilom za pripravo.
1 mg (50 KIU), 2 mg (100 KIU) and 5 mg (250 KIU).
1 mg (50 k. i. e.), 2 mg (100 k. i. e.) in 5 mg (250 k. i. e.).
99 NOVOSEVEN USER INSTRUCTIONS
99 NAVODILA ZA UPORABO NOVOSEVEN
Solvent vial Plastic cap
Viala s praškom Viala s topilom
Rubber stopper
plastičen pokrovček gumijasti zamašek
A Remove the protective paper from the vial adapter without taking it out of the protective cap.
A Odstranite zaščitni papir iz nastavka za vialo, brez da bi ga vzeli iz zaščitnega pokrovčka.
B Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (ml equals cc on the syringe).
B Potegnite bat nazaj, tako da potegnete v brizgo natanko toliko zraka, kolikor je topila v viali s topilom (mililitri ustrezajo oznaki cc na brizgi).
C Screw the syringe tightly onto the vial adapter on the solvent vial.
C Brizgo trdno privijte v nastavek za vialo na viali s topilom.
D Hold the syringe with the solvent vial upside down.
D Obrnite na glavo brizgo skupaj z vialo s topilom.
E Remove the empty solvent vial.
E Odstranite prazno vialo s topilom.
F Attach the syringe with vial adapter or transfer needle to the powder vial.
F Namestite brizgo z nastavkom za vialo ali iglo na vialo s praškom.
If you notice either, do not use it.
Če opazite eno ali drugo, raztopine ne
101 G
101 uporabite.
Although NovoSeven will be stable for 24 hours after it has been mixed, you should use it at once to avoid infection.
Čeprav je NovoSeven stabilen 24 ur po pripravi, ga uporabite takoj, da boste preprečili možnost okužbe.
I If you use a vial adapter, unscrew the vial adapter with the empty vial.
I Če uporabljate nastavek za vialo, odvijte nastavek za vialo in prazno vialo.
102 J Safely dispose of the syringe, vials, any unused product and other waste materials as instructed by your health care professional.
J Varno zavrzite brizgo, obe viali, morebitno neuporabljeno zdravilo in ostali odpadni material, tako kot vas je o tem poučilo vaše zdravstveno osebje.
Noxafil is an oral suspension that contains the active substance posaconazole (40 mg/ ml).
Zdravilo Noxafil je peroralna suspenzija, ki vsebuje zdravilno učinkovino posakonazol (40 mg/ ml).
Noxafil is an antifungal medicine.
Zdravilo Noxafil je sredstvo proti glivičnim okužbam.
It is used to treat patients with the following diseases, when they cannot tolerate other antifungal medicines (amphotericin B, itraconazole or fluconazole) or have not improved after at least 7 days of treatment with other antifungal medicines: • invasive aspergillosis (a type of fungal infection due to Aspergillus), • fusariosis (another type of fungal infection due to Fusarium), • chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters), • coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
Uporablja se za zdravljenje bolnikov z naslednjimi boleznimi, kadar ne prenašajo drugih antimikotikov (amfotericina B, itrakonazola ali flukonazola) ali kadar se stanje pri njih ni izboljšalo po vsaj 7 dneh zdravljenja z drugimi antimikotiki: • invazivna aspergiloza (vrsta glivične okužbe, ki jo povzroča Aspergillus), • fuzarioza (vrsta glivične okužbe, ki jo povzroča Fusarium), • kromoblastomikoza in micetom (dolgotrajni glivični okužbi kože in podkožnega tkiva, ki ju navadno povzročajo glivične spore, ki okužijo rane, ki jih povzročijo trni ali trske), • kokcidioidomikoza (glivična okužba pljuč, ki jo povzroča vdihavanje spor).
Noxafil is also used to treat patients with oropharyngeal candidiasis or ‘ thrush’, a fungal infection of the mouth and throat due to Candida.
Zdravilo Noxafil se uporablja tudi za zdravljenje bolnikov z orofaringealno kandidiozo, glivično okužbo ust in žrela, ki jo povzroča Candida.
Noxafil is used if the disease is severe, or if the patient is immunocompromised (with a weakened immune system).
Zdravilo Noxafil se uporablja, če je bolezen huda ali če je bolnik imunokompromitiran (ima oslabljen imunski sistem).
Noxafil can be used to prevent invasive fungal infections in patients whose immune system is weakened.
Zdravilo Noxafil se lahko uporablja za preprečevanje invazivne glivične okužbe pri bolnikih z oslabljenim imunskim sistemom.
This can be either because they have cancer in the blood or bone marrow and have received chemotherapy, or because they have had a haematopoietic stem cell transplant (a transplant of cells that make blood cells) and are receiving high doses of immunosuppressant medicines.
To je lahko posledica krvnega raka ali raka kostnega mozga in kemoterapije ali presaditve hematopoetskih matičnih celic (presaditev celic, ki proizvajajo krvne celice) in prejemanja velikih odmerkov imunosupresivnih zdravil.
Noxafil treatment should be started by a doctor who has experience in the management of fungal infections or of treating patients at high risk of invasive fungal infections.
Zdravljenje z zdravilom Noxafil mora začeti zdravnik, ki ima izkušnje pri obravnavi glivičnih okužb ali pri zdravljenju bolnikov z velikim tveganjem za invazivne glivične okužbe.
In the treatment of fungal infections except candidiasis, Noxafil is given at a dose of 400 mg (10 ml) twice a day, or 200 mg (5 ml) four times a day in patients who cannot tolerate a meal.
Za zdravljenje glivičnih okužb, razen kandidoze, se zdravilo Noxafil daje v odmerku 400 mg (10 ml) dvakrat dnevno ali 200 mg (5 ml) štirikrat dnevno pri bolnikih, ki ne prenesejo obroka.
The duration of treatment depends on the severity of the disease and the patient’ s response.
Trajanje zdravljenja je odvisno od resnosti bolezni in bolnikovega odziva.
For candidiasis, Noxafil is given as 200 mg (5 ml) on the first day followed by 100 mg (2.5 ml) once a day for the following 13 days.
Pri kandidiozi je prvi dan odmerek zdravila Noxafil 200 mg (5 ml), potem pa 100 mg (2, 5 ml) na dan naslednjih 13 dni.
In the prevention of invasive fungal infections, Noxafil is given as 200 mg (5 ml) three times a day.
Pri preprečevanju invazivnih glivičnih okužb je odmerek zdravila Noxafil 200 mg (5 ml) trikrat dnevno.
The duration of treatment depends on the patient’ s condition.
Trajanje zdravljenja je odvisno od bolnikovega stanja.
The oral suspension must be shaken well before use.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako zdravilo Noxafil deluje?
The active substance in Noxafil, posaconazole, is an antifungal medicine that belongs to the triazoles group.
Zdravilna učinkovina zdravila Noxafil, posakonazol, je antimikotik, ki spada v skupino triazolov.
Without ergosterol, the fungus is killed or prevented from spreading.
Brez ergosterola glivica umre, oziroma se ne more širiti.
The list of fungi against which Noxafil is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Seznam glivic, proti katerim deluje zdravilo Noxafil, je naveden v Povzetku glavnih značilnosti zdravila (tudi del EPAR).
Noxafil was studied in 238 patients with invasive fungal infections that did not respond to standard antifungal treatment.
Zdravilo Noxafil so raziskovali pri 238 bolnikih z invazivnimi glivičnimi okužbami, ki se niso odzivale na standardno antimikotično zdravljenje.
The results obtained with Noxafil were compared with the records of 218 patients who were treated with other antifungal medicines.
Rezultate, ki so jih dobili z zdravilom Noxafil, so primerjali s poročili 218 bolnikov, ki so se zdravili z drugimi antimikotiki.
Noxafil has also been studied in 350 HIV-infected patients with oropharyngeal candidiasis, where its effectiveness was compared with that of fluconazole.
Zdravilo Noxafil so preučevali pri 350 bolnikih, okuženih z virusom HIV, ki so imeli orofaringealno kandidozo in primerjali njegovo učinkovitost s flukonazolom.
In the prevention of invasive fungal infections, the effectiveness of Noxafil has been studied in 600 stem cell transplant patients with fluconazole as a comparator and 602 patients with blood or bone marrow cancer, comparing it to fluconazole or itraconazole.
Glede preprečevanja invazivnih glivičnih okužb so učinkovitost zdravila Noxafil preučevali pri 600 bolnikih, ki so imeli presaditev matičnih celic, pri katerih so ga primerjali s flukonazolom, in 602 bolnikih s krvnim rakom ali rakom kostnega mozga, pri katerih so ga primerjali s flukonazolom in itrakonazolom.
The effectiveness was measured by looking at how many patients developed an invasive fungal infection, either proven or probable, during the studies.
Učinkovitost so merili z opazovanjem, pri koliko bolnikih se je med študijo razvila invazivna glivična okužba, dokazana ali verjetna.
What benefit has Noxafil shown during the studies?
Kakšne koristi je zdravilo Noxafil izkazalo med raziskavami?
In invasive aspergillosis, a successful response at the end of treatment was seen in 42% of the patients taking Noxafil, compared with 26% of the comparison group.
Pri invazivni aspergilozi so uspešen odziv na koncu zdravljenja ugotovili pri 42% bolnikov, ki so prejemali zdravilo Noxafil, v primerjavi s 26% bolnikov v primerjalni skupini.
Noxafil also successfully treated 11 of 24 patients who had proven or probable fusariosis, 9 of 11 patients with chromoblastomycosis or mycetoma, and 11 of 16 patients with coccidioidomycosis.
Zdravilo Noxafil je prav tako uspešno pozdravilo 11 od 24 bolnikov, ki so imeli dokazano ali verjetno fuzariozo, 9 od 11 bolnikov s kromoblastomikozo ali micetomom in 11 od 16 bolnikov s kokcidioidomikozo.
In oropharyngeal candidiasis, Noxafil was as effective as fluconazole.
Pri orofaringealni kandidozi je bilo zdravilo Noxafil enako učinkovito kot flukonazol.
After 14 days of treatment, both medicines had been successful in curing or improving about 92% of patients.
Po 14 dneh zdravljenja sta bili obe zdravili uspešni pri ozdravljenju ali izboljšanju stanja 92% bolnikov.
In the prevention studies, Noxafil was as effective as fluconazole in stem cell transplant patients, with 5% of patients developing an infection in the Noxafil group, and 9% in the comparator group.
V raziskavah glede preprečevanja je bilo zdravilo Noxafil pri bolnikih s presaditvijo matičnih celic enako uspešno kot flukonazol – v skupini, ki je prejemala zdravilo Noxafil je okužbo razvilo 5% bolnikov, v primerjalni skupini pa 9%.
The medicine was more effective than fluconazole or itraconazole in cancer patients, with 2% of patients developing an infection in the Noxafil group, and 8% in the comparator group.
Pri rakavih bolnikih je bilo zdravilo Noxafil učinkovitejše kot flukonazol ali itrakonazol – v skupini, ki je prejemala zdravilo Noxafil, sta okužbo razvila 2% bolnikov, v primerjalni skupini pa 8%.
The most commonly reported side effects are nausea (feeling sick, 6%) and headache (6%).
Najpogostejša neželena učinka, o katerih so poročali, sta navzeja (slabost, 6%) in glavobol (6%).
Other common side effects (seen in between 1 and 10 patients in 100) are neutropenia (low white blood cell count), electrolyte imbalance, anorexia (lack of appetite), dizziness, paresthesia (pins and needles), somnolence (sleepiness), vomiting, abdominal (tummy) pain, diarrhoea, dyspepsia (indigestion), dry mouth, flatulence (gas), signs of liver damage in the blood, rash, asthenia (weakness), fatigue (tiredness) and pyrexia (fever).
Drugi pogosti neželeni učinki (o katerih so poročali pri 1 do 10 izmed 100 bolnikov) so nevtropenija (majhno število belih krvnih celic), neravnovesje elektrolitov, anoreksija (pomanjkanje apetita), omotica, parestezija (mravljinčenje), somnolenca (zaspanost), bruhanje, abdominalna bolečine (bolečina v trebuhu), driska, dispepsija (prebavne motnje), suha usta, flatulenca (vetrovi), znaki jetrne okvare v krvi, izpuščaj, astenija (šibkost), utrujenost in pireksija (povečana telesna temperatura).
For the full list of all side effects reported with Noxafil, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Noxafil najdete v Navodilih za uporabo.
Noxafil should not be used in people who may be hypersensitive (allergic) to posaconazole or any of the other ingredients.
Zdravilo Noxafil se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) posakonazol ali katero koli drugo sestavino.
Noxafil should not be used in patients who are taking any of the following drugs: • Ergotamine or dihydroergotamine (used to treat migraine), • Terfenadine, astemizole (used for allergy), • Cisapride (used for stomach problems), • Pimozide (used for treating mental illness), • Quinidine (used for irregular heart beat), • Halofantrine (used to treat malaria), • Simvastatin, lovastatin or atorvastatin (used to lower cholesterol).
Zdravilo Noxafil se ne sme uporabljati pri bolnikih, ki jemljejo katero koli od naslednjih zdravil: • ergotamin ali dihidroergotamin (ki se uporablja za zdravljenje migren), • terfenadin, astemizol (ki se uporablja za zdravljenje alergij), • cisaprid (ki se uporablja za zdravljenje želodčnih težav), • pimozid (ki se uporablja za zdravljenje duševnih bolezni), • kinidin (ki se uporablja za zdravljenje motenj srčnega ritma), • halofantrin (ki se uporablja za zdravljenje malarije), • simvastatin, lovastatin or atorvastatin (ki se uporabljajo za zniževanje holesterola).
See the Package Leaflet for full details.
Celoten seznam omejitev najdete v Navodilih za uporabo.
The Committee for Medicinal products for Human Use (CHMP) concluded that, although the main study lacked a control group, the effectiveness of Noxafil in fungal infections refractory to other antifungal medicines had been shown.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da je bila učinkovitost zdravila Noxafil proti glivičnim okužbam, ki so odporne na druge antimikotike, dokazana kljub odsotnosti kontrolne skupine v glavni raziskavi.
The Committee decided that Noxafil’ s benefits are greater than its risks for treatment of invasive aspergillosis, fusariosis, coccidioidomycosis, chromoblastomycosis and mycetoma in patients who cannot tolerate other antifungal drugs or have not improved after at least 7 days of treatment.
Odbor je odločil, da so koristi zdravila Noxafil večje od z njim povezanih tveganj pri zdravljenju invazivne aspergiloze, fuzarioze, kokcidioidomikoze, kromoblastomikoze in micetoma pri bolnikih, ki ne prenašajo drugih antimikotikov, ali pri katerih se stanje po 7 dneh zdravljenja ni izboljšalo.
It also decided that Noxafil’ s effectiveness had been shown as first-line therapy in oropharyngeal candidiasis and in the prophylaxis of invasive fungal infections in patients receiving chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS), and haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease.
Prav tako je odločil, da je bila dokazana učinkovitost zdravila Noxafil kot zdravljenja prve izbire pri orofaringealni kandidozi in pri preprečevanju invazivnih glivičnih okužb pri bolnikih na kemoterapiji zaradi akutne mieloblastne levkemije (AML) ali mielodisplastičnih sindromov (MDS) in bolnikih, ki so jim presadili hematopoetske matične celice (HSCT) in jih zdravijo z imunosupresivnimi zdravili, da telo ne bi zavrnilo vsadka.
They recommended that Noxafil be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Noxafil.
Other information about Noxafil:
Druge informacije o zdravilu Noxafil:
The European Commission granted a marketing authorisation valid throughout the European Union, for Noxafil to SP Europe on 25 October 2005.
Evropska komisija je dovoljenje za promet z zdravilom Noxafil, veljavno po vsej Evropski uniji, odobrila družbi SP Europe dne 25. oktobra 2005.
The full EPAR for Noxafil is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Noxafil je na voljo tukaj.
Noxafil 40 mg/ ml oral suspension
Noxafil 40 mg/ ml peroralna suspenzija
Noxafil is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):
Noxafil je indiciran za uporabo pri zdravljenju naslednjih glivičnih okužb pri odraslih (glejte poglavje 5. 1):
- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or
- invazivne aspergiloze, pri bolnikih z okužbo, ki je odporna na amfotericin B ali itrakonazol, ter
itraconazole or in patients who are intolerant of these medicinal products;
pri bolnikih, ki ne prenašajo teh zdravil;
- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are
- fusarioze, pri bolnikih z okužbo, ki je odporna na amfotericin B, ter pri bolnikih, ki ne prenašajo
- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole
- kromoblastomikoze in micetoma, pri bolnikih z okužbo, ki je odporna na itrakonazol ter pri
or in patients who are intolerant of itraconazole;
bolnikih, ki ne prenašajo itrakonazola;
- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or
- kokcidioidomikoze, pri bolnikih z okužbo, ki je odporna na amfotericin B, itrakonazol ali
fluconazole or in patients who are intolerant of these medicinal products;
flukonazol ter pri bolnikih, ki ne prenašajo teh zdravil;
- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are
- orofaringealna kandidoza: kot terapija prve izbire pri bolnikih s hudo okužbo ali pri tistih z
immunocompromised, in whom response to topical therapy is expected to be poor.
imunskim pomanjkanjem, pri katerih pričakujemo, da bo odziv na topikalno terapijo slab.
Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Odpornost na zdravilo je opredeljena kot napredovanje okužbe ali odsotnost izboljšanja po najmanj 7- dnevni predhodni učinkoviti antimikotični terapiji s terapevtskimi odmerki.
Noxafil is also indicated for prophylaxis of invasive fungal infections in the following patients:
Noxafil je indiciran tudi za profilakso invazivnih glivičnih okužb pri naslednjih bolnikih:
- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML)
- pri bolnikih, ki prejemajo kemoterapijo za doseganje remisije zaradi akutne mieloične levkemije
or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
ali mielodisplastičnih sindromov (MDS) in pri katerih pričakujemo, da bodo imeli zaradi tega dolgotrajnejšo nevtropenijo ter obstaja pri njih veliko tveganje za nastanek invazivnih glivičnih okužb;
- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose
- pri prejemnikih transplantata krvotvornih matičnih celic (HSCT), ki so na visokoodmerni
immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
imunosupresivni terapiji zaradi reakcije presadka proti gostitelju in pri katerih obstaja veliko tveganje za nastanek invazivnih glivičnih okužb.
2 Table 1.
2 Preglednica 1.
Refractory Invasive Fungal 400 mg (10 ml) twice a day.
400 mg (10 ml) dvakrat na dan.
administered at a dose of 200 mg (5 ml) four times a day.
Pri bolnikih, ki ne morejo jesti hrane ali uživati prehranskih dodatkov, je treba zdravilo Noxafil dajati v odmerku 200 mg (5 ml) štirikrat na dan.
Oropharyngeal Candidiasis
Orofaringealna kandidioza Profilaksa invazivnih glivičnih okužb
Loading dose of 200 mg (5 ml) once a day on the first day, then 100 mg (2.5 ml) once a day for 13 days.
Polnilni odmerek 200 mg (5 ml) enkrat na dan prvi dan, potem pa 100 mg (2, 5 ml) enkrat na dan še 13 dni.
Each dose of Noxafil should be administered with a meal, or with a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure.
Bolniki, ki ne prenašajo hrane, pa naj zdravilo zaužijejo s prehranskim dodatkom, da bi povečali peroralno absorpcijo in zagotovili zadostno izpostavljenost zdravilu.
200 mg (5 ml) three times a day.
200 mg (5 ml) trikrat na dan.
For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Noxafil should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
Pri bolnikih z akutno mieloično levkemijo ali mielodisplastičnimi sindromi je treba profilakso z zdravilom Noxafil začeti več dni pred pričakovanim nastopom nevtropenije in naj traja še 7 dni po zvišanju števila nevtrofilcev nad 500 celic/ mm3.
An effect of renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended (see section 5.2).
Vpliva ledvične okvare na farmakokinetiko posakonazola ni pričakovati, zato ni priporočil za prilagajanje odmerkov (glejte poglavje 5. 2).
There are limited pharmacokinetic data in patients with hepatic impairment; therefore, no recommendation for dose adjustment can be made.
Farmakokinetični podatki za bolnike z jetrno okvaro so skopi, zato ni mogoče dati priporočil za prilagajanje odmerka.