FrancophonIA/ELRC3.0 huggingface dataset:
English: In Table 3 a comparison is shown of exposure (Cav) after administration of posaconazole tablet and posaconazole oral suspension at therapeutic doses in patients depicted as quartile analysis.
Slovenian: Preglednica 3 prikazuje primerjavo izpostavljenosti (Cav) po uporabi tablet posakonazola in peroralnesuspenzije posakonazola v terapevtskih odmerkih pri bolnikih, predstavljeno z analizo kvartilov.
English: Quartile pCav Range (ng/mL)
Slovenian: Razpon pCav(ng/
English: During clinical trials, patients who received posaconazole oral suspension doses up to 1,600 mg/day experienced no different adverse reactions from those reported with patients at the lower doses.
Slovenian: Med kliničnimi preskušanji niso bili neželeni učinki pri bolnikih, ki so dobili peroralno suspenzijo posakonazola v odmerkih do 1.600 mg/dan, nič drugačni odneželenihučinkov, o katerih so poročalipri bolnikih, ki so dobivali manjše odmerke.
English: 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 oral suspension 800 mg/day in divided doses for a median of 296 days and up to 460 days.
Slovenian: 11 od 16 bolnikov so uspešno zdravili (ob koncu zdravljenja popolno ali delno izginotje izhodiščnih znakov in simptomov) s peroralno suspenzijo posakonazola 800 mg/dan v deljenihodmerkih.Srednjavrednosttrajanjazdravljenjajebila296 dni,zdravljenjepajelahkotrajalodo460 dni.
English: Adrenal suppressive effects were observed in toxicity studies in rats and dogs at exposures equal to or greater than those obtained at therapeutic doses in humans.
Slovenian: V študijah toksičnosti na podganah in psih so opažali supresivne učinke na nadledvično žlezo pri izpostavljenostih, ki so bile enake ali večje od izpostavljenosti, dosežene s terapevtskimi odmerki pri človeku.
English: Treatment with these HMG-CoA reductase inhibitors should be discontinued during treatment with posaconazole as increased levels have been associated with rhabdomyolysis (see section 4.3).
Slovenian: Med zdravljenjem s posakonazolom je treba zdravljenje z zaviralci reduktaze HMG-CoA prekiniti, ker so bile povečane koncentracije povezane z rabdomiolizo (glejtepoglavje 4.3).
English: Following administration of 800 mg per day of posaconazole oral suspension 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).
Slovenian: Po uporabi peroralne suspenzije posakonazola 800 mg na dan v deljenih odmerkih za zdravljenje invazivnihglivnih okužb je bila povprečna najmanjša plazemska koncentracija pri 12 bolnikih, starih od 8 do 17 let (776 ng/ml), podobna kot pri 194 bolnikih, starih od 18 do 64 let (817 ng/ml).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Posakonazol Accord Vsebina pakiranja in dodatne informacije
English: Posaconazole was not genotoxic in in vitro and in vivo studies.
Slovenian: Posakonazol v študijah invitro in invivo ni bil genotoksičen.
English: In subjects with severe renal impairment (n=6, Clcr< 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].
Slovenian: Pri preiskovancih s hudo okvaro ledvic (n = 6,očistek kreatinina<20 ml/min/1,73 m2)jebilaAUCposakonazolamočnospremenljiva[koeficientvariacije(KV)> 96 %] v primerjavi z drugimi kategorijami delovanja ledvic [KV< 40 %].
English: hyperglycaemia, hypoglycaemia
Slovenian: hiperglikemija, hipoglikemija
English: You may feel dizzy, sleepy, or have blurred vision while taking Posaconazole Accord, which may affect your ability to drive or use tools or machines.
Slovenian: Med jemanjem zdravila Posakonazol Accord ste lahko omotični, zaspani ali imate zamegljen vid, kar lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
English: c: In 1899, this was the period from randomization to 100 days post-randomization; in 316 it was the period from the baseline day to 111 days post-baseline.
Slovenian: Vštudiji 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.
English: Posaconazole is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4 (see section 4.5).
Slovenian: Posakonazol je zaviralec CYP3A4, zato ga je le v posebnih primerih dovoljeno uporabljati sočasno z drugimi zdravili, ki se presnovijo s CYP3A4 (glejte poglavje 4.5).
English: EUCAST ECOFF values: - Aspergillus flavus: 0.5 mg/L - Aspergillus fumigatus: 0.25 mg/L - Aspergillus nidulans: 0.5 mg/L - Aspergillus niger: 0.5 mg/L - Aspergillus terreus: 0.25 mg/L
Slovenian: EUCAST ECOFF vrednosti: - Aspergillusflavus: 0,5 mg/l - Aspergillus fumigatus: 0,25 mg/l
English: In addition, posaconazole oral suspension (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 8-10 hours during co-administration.
Slovenian: Poleg tega jeperoralna suspenzija posakonazola (200 mg ali 400 mg) med sočasno uporabo podaljšala povprečni terminalnirazpolovničasmidazolama s približno 3 do 4ure na 8 do 10 ur.
English: What Posaconazole Accord looks like and contents of the pack Posaconazole Accord gastro-resistant tablets are yellow coated, capsule shaped tablet of approximate 17.5 mm length and 6.7 mm width, debossed with “100P” on one side and plain on the other side, packaged in a blister or in perforated unit dose blister in cartons of 24 or 96 tablets.
Slovenian: Izgled zdravila Posakonazol Accord in vsebina pakiranja Posakonazol Accord gastrorezistentne tablete so rumene obložene tablete v obliki kapsule, dolge približno 17,5 mm in široke približno 6,7 mm, z vtisnjeno oznako "100P" na eni strani in brez oznake na drugi strani; pakirane so v pretisnih omotih ali v perforiranih pretisnih omotih za enkratni odmerek v škatlah, ki vsebujejo po 24 ali 96 tablet.
English: Calcium channel blockers metabolised through CYP3A4 (e.g. diltiazem, verapamil, nifedipine, nisoldipine)
Slovenian: Zaviralci kalcijevih kanalčkov, ki se presnovijo s CYP3A4 (npr. diltiazem, verapamil, nifedipin,
English: Plasma exposure
Slovenian: Plazemska izpostavljenost
English: haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Slovenian: hemolitično-uremični sindrom, trombotična trombocitopenična purpura, pancitopenija, koagulopatija,
English: Children (< 18 years)
Slovenian: Farmakokinetika pri posebnih skupinah bolnikov Otroci (< 18let)
English: However, as posaconazole is not significantly renally eliminated, an effect of severe renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended.
Slovenian: Ker pa seposakonazol skozi ledvice ne izloča v pomembni meri, ni pričakovati, da bi huda okvara ledvicvplivalanafarmakokinetikoposakonazola;prilagajanje odmerka tako ni potrebno.
English: Reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options (see section 4.5).
Slovenian: Azolski antimikotiki, vključno sposakonazolom, naj bodo rezerviraniza bolnike, ki prejemajoalkaloid vinke, vključno z vinkristinom, in ki nimajo alternativnih možnosti protiglivnega zdravljenja (glejte poglavje 4.5).
English: Hepatic toxicity
Slovenian: Jetrna toksičnost
English: Proportion (%) of patients with proven/probable IFIs On-treatment periodb d
Slovenian: Vrednost p Odstotek (%) bolnikov z dokazanimi oziroma verjetnimi invazivnimi glivnimi okužbami Obdobjezdravljenjab
English: Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Slovenian: Zdravilo Posakonazol Accord je indicirano za zdravljenje naslednjih glivnih okužb pri odraslih (glejte poglavje 5.1): - invazivne aspergiloze pri bolnikih z okužbo, odporno na amfotericin B ali itrakonazol,terpri bolnikih, ki ne prenašajo teh zdravil, - fuzarioze pri bolnikih z okužbo, odporno na amfotericin B,terpri bolnikih, ki ne prenašajoamfotericina B, - kromoblastomikoze in micetoma pri bolnikih z okužbo, odporno na itrakonazol,terpri bolnikih,ki ne prenašajo itrakonazola, - kokcidioidomikozepribolnikih z okužbo,odpornonaamfotericinB,itrakonazolaliflukonazol,terpri bolnikih, ki ne prenašajo teh zdravil.
English: As observed with other azole antifungal agents, effects related to inhibition of steroid hormone synthesis were seen in repeated-dose toxicity studies with posaconazole.
Slovenian: Kot so opažali tudi pri drugih azolskih antimikotikih, so v študijah toksičnosti ponavljajočih se odmerkov posakonazola opazili učinke, povezane z zaviranjem sinteze steroidnih hormonov.
English: Study 5615 was conducted in a similar patient population to that previously studied in the pivotal posaconazole oral suspension clinical program.
Slovenian: varnosti in prenašanja tablet posakonazola.Študijo 5615 so izvedli pri podobni populaciji bolnikov, kot je bila pred tem preučena v ključnem kliničnem programu s peroralno suspenzijo posakonazola.
English: World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona,
Slovenian: World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, Španija
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Slovenian: Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, če opazite katerega od naslednjih neželenih učinkov:
English: Adverse reactions by body system and frequency* Blood and lymphatic system disorders Common:
Slovenian: Neželeni učinki, razvrščeni po organskih sistemih in pogostnosti* Bolezni krvi in limfatičnega sistema
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.1-fold greater than that achieved therapeutically.
Slovenian: Vfarmakološki študiji varnosti ponavljajočih se odmerkov ehokardiografija pri podganah ni pokazala znakov srčne dekompenzacije pri sistemski izpostavljenosti, ki je bila 2,1-krat večja od terapevtskodosežene.
English: What Posaconazole Accord is and what it is used for What you need to know before you take Posaconazole Accord How to take Posaconazole Accord Possible side effects
Slovenian: Kaj je zdravilo Posakonazol Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Posakonazol Accord Kako jemati zdravilo Posakonazol Accord
English: This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as: - patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS) - patients having “high- dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).
Slovenian: To zdravilo se lahko uporabi tudi za preprečevanje glivnih okužb pri odraslih, ki imajo veliko tveganje za takšne okužbe, na primer: - pri bolnikih z oslabljenim imunskim sistemom zaradi kemoterapije, potrebne za zdravljenje akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS);
English: Other medicines and Posaconazole Accord
Slovenian: Druga zdravila in zdravilo Posakonazol Accord
English: A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomization.
Slovenian: Ključni sekundarni opazovani dogodek je bila pojavnostdokazanih oziromaverjetnih invazivnih glivnih okužb 100 dni po randomizaciji.
English: Study 5615 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole tablet.
Slovenian: Študija 5615 je bila neprimerjalna, multicentrična študija za oceno farmakokinetičnih lastnosti,
English: Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (3.4 times the 300 mg tablet based on steady-state plasma concentrations in patients) or female rats at a dose up to 45 mg/kg (2.6 times the 300 mg tablet based on steady-state plasma concentrations in patients).
Slovenian: Posakonazol ni vplival na plodnost podganjih samcev v odmerkih do 180 mg/kg (3,4kratnikvprimerjavi z uporabo 300-mg tablet na podlagi plazemske koncentracije v stanju dinamičnegaravnovesja pri bolnikih) alipodganjih samic vodmerkudo 45 mg/kg (2,6-kratnikv primerjavi zuporabo 300-mg tablet na podlagi plazemske koncentracije v stanju dinamičnega ravnovesja pribolnikih).
English: fluconazole, itraconazole or voriconazole.
Slovenian: flukonazol,itrakonazolalivorikonazol.
English: Posaconazole is not removed by haemodialysis.
Slovenian: Posakonazol se ne odstranjuje s hemodializo.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Accord Healthcare S.L.U.
English: If you develop severe diarrhoea or vomiting (being sick) while taking Posaconazole Accord, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly.
Slovenian: Če se med jemanjem zdravila Posakonazol Accord pojavita huda driska ali bruhanje (slabost), se takoj posvetujte zzdravnikom, farmacevtom ali medicinsko sestro, kajti lahko preprečita pravilno delovanje zdravila.
English: Twenty patients received 200 mg daily dose and 210 patients received 300 mg daily dose (following twice daily dosing on Day 1 in each cohort).
Slovenian: Dvajset bolnikov je prejemalo dnevni odmerek 200 mg, 210 bolnikov pa dnevni odmerek 300 mg (po uporabi dvakrat na dan 1. dan v obeh skupinah).
English: gastrointestinal haemorrhage, ileus
Slovenian: krvavitev v prebavilih, ileus
English: In rabbits, posaconazole was embryotoxic at exposures greater than those obtained at therapeutic doses.
Slovenian: Pri kuncih je bil posakonazol embriotoksičen pri izpostavljenostih, večjih od izpostavljenosti, doseženih s terapevtskimi odmerki.
English: Accidental overdose was noted in one patient who took posaconazole oral suspension 1,200 mg twice a day for 3 days.
Slovenian: Nenamerno preveliko odmerjanje je bilo zabeleženo pri enem bolniku, ki je 3dni jemal peroralno suspenzijo posakonazola v odmerku 1.200 mg dvakrat nadan.
English: The usual dose is 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day, thereafter.
Slovenian: Običajen odmerek je 300 mg (tri 100-mg tablete) dvakrat na dan prvi dan, nato pa 300 mg (tri 100-mg tablete) enkrat na dan.
English: Two different dosing groups were evaluated: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Part IA) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Part 1B and Part 2).
Slovenian: Ocenili so skupini z dvema različnima odmerjanjema: 200 mg dvakrat na dan 1. dan in nato 200 mg enkrat nadan (del IA) in 300 mg dvakrat na dan 1. dan in nato 300 mg enkrat na dan (del IB in del 2).
English: HMG-CoA reductase inhibitors metabolised through CYP3A4 (e.g. simvastatin, lovastatin, and atorvastatin)
Slovenian: Zaviralci reduktaze HMG-CoA, ki se presnovijo s CYP3A4 (npr. simvastatin, lovastatininatorvastatin)
English: Co-administration with the HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin (see section 4.5).
Slovenian: Sočasna uporaba z zaviralci reduktaze HMG-CoA simvastatinom, lovastatinom in atorvastatinom(glejte poglavje 4.5).
English: The tablet and oral suspension are not to be used interchangeably due to the differences between these two formulations in frequency of dosing, administration with food and plasma drug concentration achieved.
Slovenian: Medsebojna nezamenljivost tablet Posakonazol Accord in peroralne suspenzije posakonazola Tablet in peroralne suspenzije se ne sme uporabljati medsebojno zamenljivo zaradi razlik med oblikama v pogostnosti odmerjanja, razlik pri uporabi s hrano in razlik v doseganju plazemskih koncentracij zdravila.
English: Certain medicines may increase the risk of side effects of Posaconazole Accord by increasing the amount of Posaconazole Accord in the blood.
Slovenian: Določena zdravila lahko povečajo tveganje za pojav neželenih učinkov zdravila Posakonazol Accord, ker povečajo količino zdravila Posakonazol Accord v krvi.
English: One subject (<1%) had a predicted Cav below 500 ng/mL and 19% of the subjects had a predicted Cav above 2,500 ng/mL.
Slovenian: En preiskovanec (< 1 %) je imel predvideno Cav pod500ng/mlin19 %
English: - Do not crush, chew, break or dissolve the tablet.
Slovenian: - Tablete ne smete zdrobiti, žvečiti, prelomiti ali raztopiti.
English: Do not take Posaconazole Accord if any of the above apply to you.
Slovenian: Ne vzemite zdravila Posakonazol Accord, če kaj od naštetega velja za vas.
English: As shown in Table 4, 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.
Slovenian: Kot prikazuje preglednica 4, je bil uspešen odziv (popolno ali delno izginotje) ob koncu zdravljenja opazen pri 42 % bolnikov, zdravljenih s posakonazolom, in pri 26 % bolnikov iz zunanje skupine.Vendar to ni bila prospektvina, randomizirana in kontrolirana študija, zato je treba vse primerjave z zunanjo kontrolno skupino previdno obravnavati.
English: Do not take Posaconazole Accord - if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Posakonazol Accord Ne jemljite zdravila Posakonazol Accord: - če ste alergični na posakonazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: back pain, neck pain, musculoskeletal pain, pain in extremity
Slovenian: bolečine v hrbtu, bolečine v vratu, mišično-skeletna bolečina, bolečine v okončinah
English: Polyvinyl alcohol-part hydrolyzed Titanium dioxide (E171) Macrogol
Slovenian: Obloga tablete polivinilalkohol, delno hidroliziran titanov dioksid (E171) makrogol smukec (E553b) rumeni železov oksid (E172)
English: FLU = fluconazole; ITZ = itraconazole; POS = posaconazole.
Slovenian: FLU = flukonazol; ITZ = itrakonazol; POS =posakonazol a:
English: hypertension
Slovenian: hipertenzija
English: Posaconazole may increase the plasma concentration of ergot alkaloids (ergotamine and dihydroergotamine), which may lead to ergotism.
Slovenian: Posakonazol lahko poveča plazemsko koncentracijo alkaloidov ergot (ergotamina indihidroergotamina)
English: As HIV protease inhibitors are CYP3A4 substrates, it is expected that posaconazole will increase plasma levels of these antiretroviral agents.
Slovenian: Zaviralci proteazeHIVsosubstratiCYP3A4,zato se pričakuje, da bo posakonazol povečal plazemskokoncentracijo teh protiretrovirusnih zdravil.
English: Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with neurotoxicity and other serious adverse reactions, including seizures, peripheral neuropathy, syndrome of inappropriate antidiuretic hormone secretion, and paralytic ileus.
Slovenian: Sočasna uporaba azolskih antimikotikov,vključno s posakonazolom,invinkristinajebilapovezana znevrotoksičnostjo in drugimi resnimi neželenimi učinki, vključno z epileptičnimi napadi, periferno nevropatijo, sindromomneustreznega izločanja antidiuretskega hormona in paralitičnim ileusom.
English: Posaconazole is also available as 40 mg/mL oral suspension and 300 mg concentrate for solution for infusion.
Slovenian: Posakonazolje na voljo tudi kot peroralna suspenzija 40 mg/mlin300mgkoncentratzaraztopinozainfundiranje.
English: Each tablet contains 100 mg of posaconazole.
Slovenian: Ena tableta vsebuje 100 mg posakonazola.
English: tongue oedema, face oedema
Slovenian: edem jezika, edem obraza
English: How to take Posaconazole Accord
Slovenian: Kako jemati zdravilo Posakonazol Accord
English: Rarely, more severe hepatic reactions with fatal outcomes have been reported.
Slovenian: O hujših učinkih na jetra s smrtnim izidom so poročali redko.
English: 24x1 gastro-resistant tablet 96x1 gastro-resistant tablet
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 24 gastrorezistentnih tablet 96 gastrorezistentnih tablet 24 x 1 gastrorezistentna tableta 96 x 1 gastrorezistentna tableta
English: Concomitant use of posaconazole and rifabutin and similar inducers (e.g. rifampicin) should be avoided unless the benefit to the patient outweighs the risk.
Slovenian: Sočasni uporabi posakonazola in rifabutina ter podobnih induktorjev (npr. rifampicina) se je treba izogibati, razen če korist za bolnika odtehta tveganje.
English: breast pain
Slovenian: bolečine v dojkah
English: cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope
Slovenian: cerebrovaskularni inzult, encefalopatija, periferna nevropatija, sinkopa
English: Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy.
Slovenian: Bolnika je treba spremljati, da bi ugotovili morebitne motnje ravnovesja elektrolitov, zlasti motnje koncentracije kalija, magnezija ali kalcija, in jih po potrebi odpraviti pred ali med zdravljenjem s posakonazolom.
English: Posaconazole increased Cmax and AUC of tacrolimus (0.05 mg/kg body weight single dose) by 121% and 358%, respectively.
Slovenian: Posakonazolje povečal Cmaxtakrolimusa(enkratni odmerek0,05 mg/kg telesne mase) za121 %innjegovo
English: As observed with other azole antifungal agents, these effects on reproduction were considered to be due to a treatment-related effect on steroidogenesis.
Slovenian: Tako kot pri drugih azolskih antimikotikih so ti učinki na razmnoževanje štelizaposledico z zdravljenjempovezanegaučinkanasteroidogenezo.
English: Serial PK samples were collected on Day 1 and at steady-state on Day 8 for all Part 1 subjects and a subset of Part 2 subjects.
Slovenian: Zaporedne farmakokinetične vzorce so vzeli 1.dan in v stanju dinamičnega ravnovesja 8. dan, in sicer vsem preiskovancem iz dela 1 in podskupini preiskovancev iz dela 2.
English: Posaconazole oral suspension
Slovenian: Peroralna suspenzija posakonazola
English: Summary of posaconazole oral suspension studies
Slovenian: Povzetek študij s peroralno suspenzijo posakonazola
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA
English: Efavirenz (400 mg once a day) decreased the Cmax and AUC of posaconazole by 45% and 50%, respectively.
Slovenian: Efavirenz(400 mg enkrat na dan) je zmanjšalCmaxposakonazola za 45 %, njegovo AUC paza 50
English: Stevens Johnson syndrome, vesicular rash Musculoskeletal and connective tissue disorders Uncommon:
Slovenian: Stevens-Johnsonov sindrom, vezikularen izpuščaj Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: Concomitant use of posaconazole and phenytoin and similar inducers (e.g. carbamazepine, phenobarbital, primidone) should be avoided unless the benefit to the patient outweighs the risk.
Slovenian: 50 %.Sočasni uporabi posakonazola in fenitoina ter podobnih induktorjev (npr. karbamazepina, fenobarbitala, primidona) se je treba izogibati, razen če korist za bolnika odtehta tveganje.