natgillin/translations-raw huggingface dataset:
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.
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.
As observed with other azole antifungal agents, effects related to inhibition of steroid hormone synthesis were seen in repeated-dose toxicity studies with posaconazole.
Kot so opažali tudi pri drugih azolskih antimikotikih, so v študijah toksičnosti ponavljajočih se odmerkov posakonazola opazili učinke, povezane z zaviranjem sinteze steroidnih hormonov.
Study 5615 was conducted in a similar patient population to that previously studied in the pivotal posaconazole oral suspension clinical program.
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.
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona,
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, Španija
Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, če opazite katerega od naslednjih neželenih učinkov:
Adverse reactions by body system and frequency* Blood and lymphatic system disorders Common:
Neželeni učinki, razvrščeni po organskih sistemih in pogostnosti* Bolezni krvi in limfatičnega sistema
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.
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.
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
Kaj je zdravilo Posakonazol Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Posakonazol Accord Kako jemati zdravilo Posakonazol Accord
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).
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);
Other medicines and Posaconazole Accord
Druga zdravila in zdravilo Posakonazol Accord
A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomization.
Ključni sekundarni opazovani dogodek je bila pojavnostdokazanih oziromaverjetnih invazivnih glivnih okužb 100 dni po randomizaciji.
Study 5615 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole tablet.
Študija 5615 je bila neprimerjalna, multicentrična študija za oceno farmakokinetičnih lastnosti,
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).
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).
fluconazole, itraconazole or voriconazole.
flukonazol,itrakonazolalivorikonazol.
Posaconazole is not removed by haemodialysis.
Posakonazol se ne odstranjuje s hemodializo.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Accord Healthcare S.L.U.
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.
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.
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).
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).
gastrointestinal haemorrhage, ileus
krvavitev v prebavilih, ileus
In rabbits, posaconazole was embryotoxic at exposures greater than those obtained at therapeutic doses.
Pri kuncih je bil posakonazol embriotoksičen pri izpostavljenostih, večjih od izpostavljenosti, doseženih s terapevtskimi odmerki.
Accidental overdose was noted in one patient who took posaconazole oral suspension 1,200 mg twice a day for 3 days.
Nenamerno preveliko odmerjanje je bilo zabeleženo pri enem bolniku, ki je 3dni jemal peroralno suspenzijo posakonazola v odmerku 1.200 mg dvakrat nadan.
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.
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.
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).
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).
HMG-CoA reductase inhibitors metabolised through CYP3A4 (e.g. simvastatin, lovastatin, and atorvastatin)
Zaviralci reduktaze HMG-CoA, ki se presnovijo s CYP3A4 (npr. simvastatin, lovastatininatorvastatin)
Co-administration with the HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin (see section 4.5).
Sočasna uporaba z zaviralci reduktaze HMG-CoA simvastatinom, lovastatinom in atorvastatinom(glejte poglavje 4.5).
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.
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.
Certain medicines may increase the risk of side effects of Posaconazole Accord by increasing the amount of Posaconazole Accord in the blood.
Določena zdravila lahko povečajo tveganje za pojav neželenih učinkov zdravila Posakonazol Accord, ker povečajo količino zdravila Posakonazol Accord v krvi.
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.
En preiskovanec (< 1 %) je imel predvideno Cav pod500ng/mlin19 %
- Do not crush, chew, break or dissolve the tablet.
- Tablete ne smete zdrobiti, žvečiti, prelomiti ali raztopiti.
Do not take Posaconazole Accord if any of the above apply to you.
Ne vzemite zdravila Posakonazol Accord, če kaj od naštetega velja za vas.
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.
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.
Do not take Posaconazole Accord - if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
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).
back pain, neck pain, musculoskeletal pain, pain in extremity
bolečine v hrbtu, bolečine v vratu, mišično-skeletna bolečina, bolečine v okončinah
Polyvinyl alcohol-part hydrolyzed Titanium dioxide (E171) Macrogol
Obloga tablete polivinilalkohol, delno hidroliziran titanov dioksid (E171) makrogol smukec (E553b) rumeni železov oksid (E172)
FLU = fluconazole; ITZ = itraconazole; POS = posaconazole.
FLU = flukonazol; ITZ = itrakonazol; POS =posakonazol a:
Posaconazole may increase the plasma concentration of ergot alkaloids (ergotamine and dihydroergotamine), which may lead to ergotism.
Posakonazol lahko poveča plazemsko koncentracijo alkaloidov ergot (ergotamina indihidroergotamina)
As HIV protease inhibitors are CYP3A4 substrates, it is expected that posaconazole will increase plasma levels of these antiretroviral agents.
Zaviralci proteazeHIVsosubstratiCYP3A4,zato se pričakuje, da bo posakonazol povečal plazemskokoncentracijo teh protiretrovirusnih zdravil.
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.
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.
Posaconazole is also available as 40 mg/mL oral suspension and 300 mg concentrate for solution for infusion.
Posakonazolje na voljo tudi kot peroralna suspenzija 40 mg/mlin300mgkoncentratzaraztopinozainfundiranje.
Each tablet contains 100 mg of posaconazole.
Ena tableta vsebuje 100 mg posakonazola.
tongue oedema, face oedema
edem jezika, edem obraza
How to take Posaconazole Accord
Kako jemati zdravilo Posakonazol Accord
Rarely, more severe hepatic reactions with fatal outcomes have been reported.
O hujših učinkih na jetra s smrtnim izidom so poročali redko.
24x1 gastro-resistant tablet 96x1 gastro-resistant tablet
FARMACEVTSKA OBLIKA IN VSEBINA 24 gastrorezistentnih tablet 96 gastrorezistentnih tablet 24 x 1 gastrorezistentna tableta 96 x 1 gastrorezistentna tableta
Concomitant use of posaconazole and rifabutin and similar inducers (e.g. rifampicin) should be avoided unless the benefit to the patient outweighs the risk.
Sočasni uporabi posakonazola in rifabutina ter podobnih induktorjev (npr. rifampicina) se je treba izogibati, razen če korist za bolnika odtehta tveganje.
breast pain
bolečine v dojkah
cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope
cerebrovaskularni inzult, encefalopatija, periferna nevropatija, sinkopa
Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy.
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.
Posaconazole increased Cmax and AUC of tacrolimus (0.05 mg/kg body weight single dose) by 121% and 358%, respectively.
Posakonazolje povečal Cmaxtakrolimusa(enkratni odmerek0,05 mg/kg telesne mase) za121 %innjegovo
As observed with other azole antifungal agents, these effects on reproduction were considered to be due to a treatment-related effect on steroidogenesis.
Tako kot pri drugih azolskih antimikotikih so ti učinki na razmnoževanje štelizaposledico z zdravljenjempovezanegaučinkanasteroidogenezo.
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.
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.
Posaconazole oral suspension
Peroralna suspenzija posakonazola
Summary of posaconazole oral suspension studies
Povzetek študij s peroralno suspenzijo posakonazola
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
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA
Efavirenz (400 mg once a day) decreased the Cmax and AUC of posaconazole by 45% and 50%, respectively.
Efavirenz(400 mg enkrat na dan) je zmanjšalCmaxposakonazola za 45 %, njegovo AUC paza 50
Stevens Johnson syndrome, vesicular rash Musculoskeletal and connective tissue disorders Uncommon:
Stevens-Johnsonov sindrom, vezikularen izpuščaj Bolezni mišično-skeletnega sistema in vezivnega tkiva
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.
50 %.Sočasni uporabi posakonazola in fenitoina ter podobnih induktorjev (npr. karbamazepina, fenobarbitala, primidona) se je treba izogibati, razen če korist za bolnika odtehta tveganje.
Maximum duration of exposure to the tablet formulation was shorter than with the oral suspension.
Najdaljša izpostavljenost zdravilu v obliki tablet je bila krajša kot izpostavljenost zdravilu v obliki peroralne suspenzije.
Monitoring of hepatic function
Spremljanje delovanja jeter
Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the 1st day, 200 mg twice daily on the 2nd day, then 400 mg twice daily x 8 Days) by 21% and 23%,
10dni)sta se Cmaxin AUC posakonazola vobliki peroralne suspenzije (200 mg enkrat nadan prvi dan,200 mg dvakrat na dan drugi dan, nato 400 mg dvakrat na dan 8 dni) zmanjšali za 21 % oz. 23 %.
The safety of posaconazole oral suspension has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Varnost peroralne suspenzije posakonazola so ocenili pri > 2.400 bolnikih in zdravih prostovoljcih,
Dose adjustment of benzodiazepines metabolised by CYP3A4 should be considered (see section 4.5).
Razmisliti je treba o prilagoditvi odmerka benzodiazepinov, ki se presnavljajo s CYP3A4 (glejtepoglavje 4.5).
11 of 24 patients who had proven or probable fusariosis were successfully treated with posaconazole oral suspension 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 fuzariozo, so uspešno zdravili s peroralno suspenzijo posakonazola 800 mg/dan v deljenih odmerkih.
Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole tablets when given as antifungal prophylaxis.
Bolnike so vključili v neprimerjalno preskušanje farmakokinetike in varnosti tablet posakonazola, uporabljenih za antimikotično profilakso.
If concomitant administration is required, close monitoring for breakthrough fungal infections is recommended.
Če je potrebna sočasna uporaba, je bolnike priporočljivoskrbnospremljatigledeprebijajočih glivnih okužb.
Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Študija316 je bila randomizirano, dvojno slepo preskušanje s peroralno suspenzijo posakonazola (200 mgtrikratnadan) v primerjavi s kapsulamiflukonazola(400mgenkratnadan)pribolnikihpoalogenski transplantaciji hematopoetskih matičnih celic z reakcijo presadka proti gostitelju (GVHD -graftversus-host disease).
pancreatitis, abdominal distension, enteritis, epigastric discomfort, eructation, gastrooesophageal reflux disease, oedema mouth
pankreatitis, abdominalna distenzija, enteritis, nelagodje v epigastriju, spahovanje, gastroezofagealna refluksna bolezen, edem v ustih
Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients (see section 5.2).
Koncentracije posakonazola vplazmi se lahko po uporabi tablet pri nekaterih bolnikihsčasoma povečajo (glejte poglavje 5.2).
Following single-dose administration of posaconazole oral suspension, 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.
Poenkratnemodmerkuperoralnesuspenzijeposakonazolablagainzmernaokvaraledvic(n= 18,očistekkreatinina≥20 ml/min/1,73 m2)nistavplivalinafarmakokinetikoposakonazola,zatoprilagoditev odmerka ni potrebna.
Patients were immunocompromised with underlying conditions including haematological malignancy, neutropenia post-chemotherapy, GVHD, and post HSCT.
Bolniki so imeli oslabljen imunski sistem in osnovne bolezni, med njimi hematološke malignome, nevtropenijo po kemoterapiji, GVHD ali so bili po presaditvi hematopoetskih matičnih celic (HSCT).
b: In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316
V študiji 1899 je bilo to obdobje od randomizacije do zadnjega odmerka preučevanega zdravila plus 7dni,
Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), and efavirenz
Rifamicinski antibiotiki (rifampicin, rifabutin), določeni antikonvulzivi (fenitoin,
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 opazovani dogodek učinkovitosti je bila pojavnostdokazanihoziromaverjetnihinvazivnihglivnih okužb, kijihjeugotavljala neodvisna skupina zunanjih strokovnjakov na slep način medobdobjem zdravljenja.
Study 1899 was a randomised, evaluator-blinded study of posaconazole oral suspension (200 mg three times a day) versus fluconazole suspension (400 mg once daily) or itraconazole oral solution (200 mg twice a day) in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukaemia or myelodysplastic syndromes.
Študija 1899 je bila randomizirana, za ocenjevalce slepa študija, ki je primerjala uporabo peroralne suspenzije posakonazola (200 mg trikrat na dan) in suspenzije flukonazola (400 mgenkratnadan)aliperoralne raztopine itrakonazola (200 mg dvakrat na dan) pri bolnikih z nevtropenijo, ki so prejemalicitotoksično kemoterapijo zaradi akutne mieloične levkemije ali mielodisplastičnih sindromov.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Posaconazole Accord.
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden začnete jemati zdravilo Posakonazol Accord.
Posaconazole is highly protein bound (> 98%), predominantly to serum albumin.
Posakonazolje v velikimerivezannabeljakovine(>98%),predvsemnaserumskialbumin.
Cav quartile analyses of pivotal patient studies with posaconazole tablet and oral suspension Posaconazole tablet
Preglednica 3.Analiza kvartilov Cav ključnih študij pri bolnikih z uporabo tablet in peroralne suspenzije posakonazola
A. fumigatus
A. fumigatus A. flavus
hypersensitivity reaction
preobčutljivostna reakcija
If posaconazole is used concomitantly with CYP3A4 substrates that are administered orally, and for which an increase in plasma concentrations may be associated with unacceptable adverse reactions, plasma concentrations of the CYP3A4 substrate and/or adverse reactions should be closely monitored and the dose adjusted as needed.
Med sočasno uporabo posakonazola in peroralnih substratov CYP3A4, pri katerih lahko povečanje plazemske koncentracije spremljajo nesprejemljivi neželeni učinki, je treba skrbno spremljati plazemske koncentracije substrata
convulsions, neuropathy, hypoaesthesia, tremor, aphasia, insomnia
konvulzije, nevropatija, hipestezija, tremor, afazija,
Plasma exposure resulting from the tablet formulation was higher than observed with the oral suspension.
Plazemska izpostavljenost zdravilu iz tablet je bila večja od tiste, ki so jo opazili pri peroralni suspenziji.
Do not take Posaconazole Accord if you are taking any of the following: - terfenadine (used to treat allergies) - astemizole (used to treat allergies) - cisapride (used to treat stomach problems) - pimozide (used to treat symptoms of Tourette's and mental illness) - halofantrine (used to treat malaria) - quinidine (used to treat abnormal heart rhythms).
- terfenadin (za zdravljenje alergij) - astemizol (za zdravljenje alergij) - cisaprid (za zdravljenje težav z želodcem) - pimozid (za zdravljenje simptomov Tourettovega sindroma in duševnih bolezni) - halofantrin (za zdravljenje malarije)
Caution should be used when prescribing Posaconazole Accord to patients with hypersensitivity to other azoles.
Pripredpisovanju zdravila Posakonazol Accord bolnikom, preobčutljivim na druge azole, je potrebna previdnost.
Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1st line therapy
Rezistentne invazivne glivne okužbe/bolniki z rezistentno glivnookužbo,kineprenašajo zdravljenja 1. izbora
- inability to sleep (insomnia) - being completely or partially unable to talk - swelling of the mouth - abnormal dreams, or difficulty sleeping - problems with co-ordination or balance - mucosal inflammation - stuffy nose - difficulty breathing - chest discomfort - feeling bloated - mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain - belching - feeling jittery
- zastajanje vode (edemi) - težave z menstruacijo (nenormalna krvavitev iz nožnice) - nezmožnost zaspati (nespečnost) - popolna ali delna nezmožnost govorjenja - otekanje vustih - nenormalne sanje, težave s spanjem - težave z usklajenostjo gibov (koordinacijo) ali ravnotežjem - vnetje sluznice - zamašen nos - težko dihanje - nelagodje v prsnem košu - občutek napihnjenosti