FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 Includes other less common species or species unknown
Slovenian: 1Vključuje druge manj pogoste vrste ali neznane vrste
English: ● At the request of the European Medicines Agency;
Slovenian: • na zahtevoEvropskeagencijezazdravila;
English: a: FLU/ITZ (1899); FLU (316).
Slovenian: FLU/ITZ (1899); FLU (316).
English: The length of treatment may depend on the type of infection that you have and may be individually adapted for you by your doctor.
Slovenian: Trajanje zdravljenja je lahko odvisno od vrste okužbe, ki jo imate, in ga lahko zdravnik individualno prilagodi za vas.
English: These findings are not necessarily indicative of a potential for functional changes in humans.
Slovenian: Ti izsledki ne pomenijo nujno možnosti za funkcionalne spremembe pri človeku.
English: Carcinogenicity studies did not reveal special hazards for humans.
Slovenian: Študije kancerogenosti ne kažejo posebnega tveganja za človeka.
English: 08039 Barcelona, Spain
Slovenian: 08039 Barcelona, Španija
English: The reason for this time-dependency is not completely understood.
Slovenian: Razlog za časovno odvisnost pojava ni popolnoma jasen.
English: - Tablets may be taken with or without food.
Slovenian: - Tablete lahko vzamete s hrano ali brez nje.
English: Taking this medicine - Swallow the tablet whole with some water.
Slovenian: Jemanje tega zdravila - Tableto zaužijte celo z nekaj vode.
English: The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Slovenian: Glavni mehanizem odpornosti je pridobitev substitucij v tarčni beljakovini, CYP51.
English: Safety data mainly derive from studies with the oral suspension.
Slovenian: Podatki o varnosti izvirajo predvsem iz študij s peroralno suspenzijo.
English: It is used to prevent and treat many different fungal infections.
Slovenian: Uporablja se za preprečevanje in zdravljenje številnih različnih vrst glivnih okužb.
English: menstrual disorder
Slovenian: menstrualne motnje
English: A higher incidence of adverse reactions cannot be ruled out.
Slovenian: Večje pogostnosti neželenih učinkov ni mogoče izključiti.
English: psychotic disorder, depression
Slovenian: psihotična motnja, depresija
English: - Do not take a double dose to make up for a forgotten dose.
Slovenian: - Ne vzemite dvojnega odmerka, da bi nadomestili izpuščeni odmerek.
English: Children Posaconazole Accord should not be used in children (17 years of age and younger).
Slovenian: Otroci Zdravila Posakonazol Accord se ne sme uporabljati pri otrocih (starih 17 let ali manj).
English: Recommended dose is shown in Table 1.
Slovenian: Priporočeno odmerjanje je podano v Preglednici 1.
English: Some azoles have been associated with prolongation of the QTc interval.
Slovenian: Nekateri azoli so povezani s podaljšanjem intervala QTc.
English: Q4 pCav: predicted Cav
Slovenian: pCav: predvidena Cav
English: No adverse reactions were noted by the investigator.
Slovenian: Raziskovalec ni zabeležil nobenih neželenih učinkov.
English: You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno nanacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna spremembaposledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik(farmakovigilančnialipovezan z zmanjševanjem tveganja).
English: The ECOFF values for posaconazole, which distinguish the wild type population from isolates with acquired resistance, have been determined by EUCAST methodology.
Slovenian: ECOFF vrednosti za posakonazol, ki razlikujejo populacijo divjega tipa od izolatov s pridobljenoodpornostjo, so bile določene po metodologiji EUCAST.
English: This is because small amounts may pass into breast milk.
Slovenian: To zdravilo lahko namreč v majhni meri prehaja v materino mleko.
English: If this happens, do not drive or use any tools or machines and contact your doctor.
Slovenian: Če se to zgodi, ne upravljajte vozil in strojev ter se posvetujte z zdravnikom.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known.
Slovenian: V okviru organskih sistemov so neželeni učinki navedeni z naslednjimi kategorijami pogostnosti: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost.
English: Dose and duration of therapy (See section 5.2)
Slovenian: Odmerek in trajanje zdravljenja (glejte poglavje 5.2)
English: Epidemiological Cut-off (ECOFF) Values for Aspergillus spp.
Slovenian: Epidemiološke mejne vrednosti (ECOFF) za Aspergillus spp.
English: Prophylaxis in AML and HSCT Study 5615
Slovenian: Profilaksapri AML in HSCT Študija 5615
English: Invasive aspergillosis
Slovenian: Invazivna aspergiloza
English: There are currently insufficient data to set clinical breakpoints for other Candida species.
Slovenian: Trenutno ni dovolj podatkov za določitev kliničnih mejnih vrednosti za druge vrste Candide.
English: This belongs to a group of medicines called “antifungals”.
Slovenian: Ta učinkovina spada v skupino zdravil, imenovanih "antimikotiki" (protiglivna zdravila).
English: Dose adjustment of calcium channel blockers may be required.
Slovenian: Morda bo potrebna prilagoditev odmerkazaviralcev kalcijevih kanalčkov.
English: The tablets should be swallowed whole with water and should not be crushed, chewed, or broken.
Slovenian: Tablete je treba pogoltniti cele, z nekaj vode in se jih ne sme drobiti, žvečiti ali lomiti.
English: Recommended dose according to indication.
Slovenian: Priporočeno odmerjanje glede na indikacijo
English: The pharmacokinetics and safety data from Study 5615 were bridged to the existing data (including efficacy data) with the oral suspension.
Slovenian: Spodatki o farmakokinetiki in varnosti iz študije 5615 je bila opravljena premostitev na obstoječe podatke (vključno s podatki o učinkovitosti), pridobljene s peroralno suspenzijo.
English: § See section 4.4.
Slovenian: § Glejte poglavje 4.4.
English: Budapest, 1045, Hungary
Slovenian: Budimpešta, 1045, Madžarska
English: Budapest, 1045, HUNGARY
Slovenian: Budimpešta, 1045, MADŽARSKA
English: Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Slovenian: Skupni odziv Uspešnost po vrstah Vse mikološko potrjene Aspergillusspp.1
English: - if you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.
Slovenian: - če se pojavita huda driska ali bruhanje, kajti lahko zmanjšata učinkovitost tega zdravila.
English: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF United Kingdom
Slovenian: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF
English: - efavirenz and fosamprenavir used to treat HIV infection.
Slovenian: - efavirenz in fosamprenavir, ki se uporabljata za zdravljenje okužbe s HIV.
English: Other medicines
Slovenian: Druga zdravila
English: Therefore, follow the specific dosage recommendations for each formulation.
Slovenian: Za vsako obliko je treba upoštevati posebna priporočila za odmerjanje.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalnicenter za poročanje, ki je naveden v Prilogi V.
English: Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy.
Slovenian: Zvišanevrednostitestov delovanja jeter so bile običajno reverzibilne po prenehanju zdravljenja, v nekaterih primerih pa so se normalizirale že brez prekinitve zdravljenja.
English: EUCAST MIC breakpoints for posaconazole [susceptible (S); resistant (R)]:
Slovenian: Mejne vrednosti EUCAST MIC za posakonazol [občutljivi (S - susceptible); odporni (R - resistant)]:
English: d: All randomized e: All treated
Slovenian: Vsi randomizirani e:
English: Clinical outcomes were compared with those in an external control group derived from a retrospective review of medical records.
Slovenian: Klinične izide so primerjali z izidi zunanje kontrolneskupine, ki so jih dobili na osnovi retrospektivnega pregleda zdravstvene dokumentacije.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Vplivi drugih zdravil na posakonazol
English: 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%).
Slovenian: Večina primerov aspergiloze je veljala za odporne na predhodno zdravljenje tako v skupini, ki je prejemala posakonazol(88 %), kot v zunanji kontrolni skupini (79 %).
English: Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. That expiry date refers to the last day of that month.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden napretisnem omotu ali škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dannavedenega meseca.
English: was comparable among ten adolescents (13-17 years of age) to Cav achieved in adults (≥ 18 years of age).
Slovenian: (Cav) pri desetih mladostnikih (starih od 13 do 17 let) primerljiva Cav, doseženi pri odraslih(starih
English: 319 Pinner Road North Harrow Middlesex
Slovenian: 319 Pinner Road North Harrow
English: The excreted metabolites in urine and faeces account for approximately 17% of the administered radiolabelled dose.
Slovenian: V urinu in blatu izločeni presnovki zajemajo približno 17 % uporabljenega radioaktivno označenega odmerka.
English: Similar recommendations apply to posaconazole tablets; however, a specific study has not been conducted with the posaconazole tablets.
Slovenian: Podobna priporočila veljajo za posakonazol v tabletah, vendar pa specifične študije s tabletami posakonazola niso bile izvedene.
English: Vincristine toxicity
Slovenian: Toksičnost vinkristina
English: See Section 4 for more information
Slovenian: Za več informacij glejte poglavje 4.
English: Posaconazole Accord may be taken with or without food (see section 5.2).
Slovenian: Zdravilo Posakonazol Accord je mogoče jemati s hrano ali brez nje (glejte poglavje 5.2).
English: Unbound concentrations were not determined and it cannot be excluded that there is a larger increase in unbound posaconazole exposure than the observed 60% increase in total AUC.
Slovenian: Koncentracije nevezanega posakonazola niso bile določene in ni mogoče izključiti možnosti, da pride do večjega povečanja izpostavljenosti nevezanemu posakonazolu od opaženega 60 % povečanjacelokupneAUC.
English: Duration of therapy is based on recovery from neutropenia or immunosuppression.
Slovenian: Trajanje zdravljenja je odvisno od okrevanja po nevtropeniji ali imunosupresiji.
English: 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.
Slovenian: Uporaba kombiniranih antimikotičnih zdravljenj naj ne bi zmanjšala učinkovitosti posakonazola ali drugih zdravil, vendar doslej ni kliničnih dokazov, da kombinirano zdravljenje dodatno koristi.
English: 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).
Slovenian: Ledvični očistek je manjpomembna pot izločanja; v urinu se izloči 14 % radioaktivno označenega odmerka (<0,2 % radioaktivno označenega odmerka predstavlja matična spojina).
English: The excretion of posaconazole in human breast milk has not been investigated.
Slovenian: Izločanje posakonazola v materino mleko pri človeku ni raziskano.
English: 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).
Slovenian: Ključni sekundarni opazovani dogodek je bila pojavnost dokazanih oziroma verjetnih invazivnih glivnih okužb med obdobjem zdravljenja (odprvega odmerka do zadnjega odmerka proučevanega zdravila + 7 dni).
English: Combination with other antifungal agents
Slovenian: Kombinacije z drugimi antimikotiki
English: Midazolam and other benzodiazepines
Slovenian: Midazolam in drugi benzodiazepini
English: Safety and efficacy in paediatric patients below the age of 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila pri pediatričnih bolnikih, mlajših od 18 let,nista ugotovljeni.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni, da je »brez natrija«.
English: Posaconazole is excreted into the milk of lactating rats (see section 5.3).
Slovenian: Posakonazol se izloča v mleko doječih podgan (glejte poglavje 5.3).
English: Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group
Slovenian: Skupna učinkovitost peroralne suspenzije posakonazola ob koncu zdravljenja invazivneaspergiloze v primerjavi z zunanjokontrolnoskupino Peroralna suspenzija posakonazola
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv nasposobnost razmnoževanja (glejte poglavje 5.3).
English: diplopia, scotoma
Slovenian: diplopija, skotom
English: New diagnosis of acute myelogenous leukaemia was the most common underlying condition (435/602, [72%]).
Slovenian: Najpogostejša osnovna bolezen je bila na novo diagnosticirana akutna mieloična levkemija (435/602, [72 %]).
English: Do not switch between taking Posaconazole Accord tablets and posaconazole oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.
Slovenian: Ne preidite na jemanje tablet Posakonazol Accord, če jemljete peroralno suspenzijo posakonazola, in obratno, ne da bi se posvetovali z zdravnikom ali farmacevtom, saj lahko pride do pomanjkanja učinkovitosti ali povečanega tveganja za neželene učinke.
English: The following medicines may decrease the effectiveness of Posaconazole Accord by decreasing the amount of Posaconazole Accord in the blood: - rifabutin and rifampicin (used to treat certain infections).
Slovenian: Naslednja zdravila lahko zmanjšajo učinkovitost zdravila Posakonazol Accord, ker zmanjšajo njegovo količino v krvi: - rifabutin in rifampicin (uporabljata se za zdravljenje določenih okužb).
English: The microbiological data suggest that posaconazole is active against Rhizomucor, Mucor, and Rhizopus; however the clinical data are currently too limited to assess the efficacy of posaconazole against these causative agents.
Slovenian: Mikrobiološki podatki kažejo, da jeposakonazolučinkovitprotivrstam Rhizomucor, Mucor in Rhizopus;vendar je kliničnih podatkovtrenutno premalo, da bi lahko ocenili učinkovitost posakonazola proti tem povzročiteljem okužb.
English: The majority (377/600, [63%]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/600, [32.5%])
Slovenian: Večina (377/600, [63 %]) vštudijo vključenih bolnikov je imela na začetku študije akutno GVHD stadija 2 ali 3 ali kronično obsežno GVHD (195/600, [32,5 %]).
English: Prophylaxis in GVHD Study 316
Slovenian: Profilaksapri GVHD Študija 316
English: Effects of posaconazole on other medicinal products
Slovenian: Vplivi posakonazola na druga zdravila
English: 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).
Slovenian: V študiji 316 je bila celokupna umrljivost podobna (POS 25 %, FLU 28%),vendar je bil odstotek zinvazivno glivno okužbo povezanih smrti v skupini s POS značilno manjši (4/301) kot v skupini sFLU (12/299, p = 0,0413).
English: If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine.
Slovenian: Če ste ženska v rodni dobi, morate med jemanjem tega zdravila uporabljati učinkovito kontracepcijo.
English: Reproduction, peri- and postnatal development studies were conducted in rats.
Slovenian: Pri podganah so bile opravljene študije razmnoževanja ter peri-in post-natalnega razvoja.
English: See “Other medicines and Posaconazole Accord” below for more information including information on other medicines which may interact with Posaconazole Accord.
Slovenian: Glejte "Druga zdravila in zdravilo Posakonazol Accord" (spodaj) za več informacij, vključno z informacijami o drugih zdravilih, ki lahko medsebojno delujejo z zdravilom Posakonazol Accord.
English: No data are available for the tablet formulation.
Slovenian: Podatkov za zdravilo v obliki tablet ni na voljo.
English: No pharmacokinetic data are available from paediatric patients less than 8 years of age.
Slovenian: Farmakokinetičnih podatkov za pediatrične bolnike, mlajše od 8let, ni na voljo.
English: Five of these patients had chromoblastomycosis due to Fonsecaea pedrosoi and 4 had mycetoma, mostly due to Madurella species.
Slovenian: Pet od teh bolnikov je imelo kromoblastomikozo zaradi okužbe sFonsecaea pedrosoi, 4 pasoimelimicetom, večinoma zaradi okužbe zMadurella spp.
English: Endocrine disorders Rare:
Slovenian: Bolezni endokrinega sistema Redki:
English: pulmonary hypertension, interstitial pneumonia, pneumonitis
Slovenian: pljučna hipertenzija, intersticijska pljučnica, pnevmonitis
English: The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical trials.
Slovenian: Varnost tablet posakonazola so ocenili pri 336 bolnikih in zdravih prostovoljcih, vključenih v klinična preskušanja.
English: For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole Accord 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.
Slovenian: Pri bolnikih z akutno mieloično levkemijo ali mielodisplastičnimi sindromi je treba profilakso z zdravilom Posakonazol Accord začeti več dni pred pričakovanim pojavom nevtropenije in naj traja še 7 dni po zvečanjuštevila nevtrofilcev nad 500 celic/mm3.
English: Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed).
Slovenian: Zdravniku morate zato povedati za vsa zdravila, ki jih jemljete (tako za zdravila, ki ste jih dobili na recept, kot za takšna, ki ste jih dobili brez recepta).
English: Posaconazole must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Slovenian: Posakonazola sene sme uporabljatipri nosečnicah, razen če korist za mater očitno odtehta možno tveganje za plod.
English: Among eighteen patients who were intolerant or had infections refractory to amphotericin B or itraconazole, seven patients were classed as responders.
Slovenian: Med osemnajstimi bolniki, ki niso prenašaliamfotericina B ali itrakonazola ali ki so imeli okužbe, odporne na amfotericin B ali itrakonazol, so jih sedem uvrstili med odzivne na zdravljenje.
English: Prophylaxis of Invasive Fungal Infections (IFIs) (Studies 316 and 1899) Two randomised, controlled prophylaxis studies were conducted among patients at high risk for developing invasive fungal infections.
Slovenian: Profilaksa invazivnih glivnih okužb (študiji 316 in 1899) Opravljeni sta bili dve randomizirani, kontrolirani študiji profilakse pri bolnikih z velikim tveganjem za pojav invazivnih glivnih okužb.
English: You may need to have blood tests while you are taking this medicine.
Slovenian: Morda vam bodo morali med jemanjem tega zdravilaopravljati preiskave krvi.
English: There is insufficient information on the use of posaconazole in pregnant women.
Slovenian: O uporabi posakonazola pri nosečnicah ni dovolj podatkov.
English: Triplex (PVC/PE/PVdC) white opaque-aluminium blister or perforated unit dose blister in cartons of 24 or 96 tablets.
Slovenian: Bel neprozoren-aluminijev pretisni omot tripleks (PVC/PE/PVdC) ali perforiran pretisni omot v škatlah, ki vsebujejo po 24 ali 96 tablet.
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain
Slovenian: Laboratori Fundació Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Španija
English: Most of the vinca alkaloids (e.g., vincristine and vinblastine) are substrates of CYP3A4.
Slovenian: Večina alkaloidov vinke (npr. vinkristin in vinblastin) je substratov CYP3A4.
English: Clinical isolates with decreased susceptibility to posaconazole have been identified.
Slovenian: Našli so klinične izolate z zmanjšano občutljivostjo za posakonazol.
English: The effect of posaconazole on CYP3A4 substrates in patients might be somewhat lower than that observed in healthy volunteers, and is expected to be variable between patients due to the variable posaconazole exposure in patients.
Slovenian: Učinek posakonazola na substrate CYP3A4 je lahkopri bolnikih nekoliko manjši kot pri zdravih prostovoljcih in mogoče je pričakovati, da se od bolnika do bolnika razlikuje zaradi različne stopnje izpostavljenosti posakonazolu.
English: The subject population included: 1) patients with AML or MDS who had recently received chemotherapy and had developed or were anticipated to develop significant neutropenia, or 2) patients who had undergone a HSCT and were receiving immunosuppressive therapy for prevention or treatment of GVHD.
Slovenian: Populacija preiskovancev je vključevala: 1) bolnike z AML ali MDS, ki so nedavno prejemali kemoterapijo in se jim je pojavila, ali je bilo pričakovano, da se jim bo pojavila pomembna nevtropenija, oziroma 2) bolnike, ki so imeli opravljeno presaditev hematopoetskih matičnih celic (HSCT) in so prejemali imunosupresivno zdravljenje za preprečevanje ali zdravljenje GVHD.
English: It is recommended to exercise caution due to the potential for higher plasma exposure.
Slovenian: Priporočljiva je previdnostzaradi možne večje plazemske izpostavljenosti.
English: TreatmentInvasive Aspergillosis Study 0041
Slovenian: Zdravljenjeinvazivnaasp ergiloza Študija 0041
English: Results from clinical studies in prophylaxis of Invasive Fungal Infections Study
Slovenian: Preglednica 5.Izsledki kliničnih študij profilakse invazivnih glivnih okužb Študija
English: If you are already taking rifabutin, you will need a blood test and you will need to look out for some possible side effects of rifabutin.
Slovenian: boste morali opraviti preiskavo krvi in biti pozorni na nekatere možne neželene učinke rifabutina.
English: liver function tests raised (ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, GGT increased)
Slovenian: zvišane vrednosti jetrnih testov (zvišanje ALT, zvišanje AST, zvišanje bilirubina, zvišanje alkalne fosfataze, zvišanje GGT)