FrancophonIA/ELRC3.0 huggingface dataset:
English: These medicines include: - vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer) - ciclosporin (used during or after transplant surgery) - tacrolimus and sirolimus (used during or after transplant surgery) - rifabutin (used to treat certain infections) - medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir,
Slovenian: - vinkristin, vinblastin in drugi alkaloidi vinke (uporabljajo se za zdravljenje raka), - ciklosporin (uporablja se med ali po presaditvah), - takrolimus in sirolimus (uporabljata se med ali po presaditvah),
English: There is no paediatric experience with posaconazole tablets.
Slovenian: Pediatrična populacija Izkušenj s tabletami posakonazolapri pediatričnih bolnikih ni.
English: If you are not sure, talk to your doctor or pharmacist before taking Posaconazole Accord.
Slovenian: Če ste negotovi, se posvetujtezzdravnikom ali farmacevtom, preden vzamete zdraviloPosakonazol Accord.
English: NAME OF THE MEDICINAL PRODUCT Posaconazole Accord 100 mg gastro-resistant tablets
Slovenian: IME ZDRAVILA PosakonazolAccord 100 mg gastrorezistentne tablete
English: Controla
Slovenian: Kontrolnaskupinaa
English: Posaconazole Accord can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them: - infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped; - infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped; - infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped; - infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped.
Slovenian: - okužb,kijihpovzročajogliveiz družine Aspergillus in ki se niso izboljšale med zdravljenjem sprotiglivnima zdraviloma amfotericin B ali itrakonazol, ali če je bilo treba ti dve zdraviliukiniti; - okužb,kijihpovzročajogliveiz družine Fusariumin ki se niso izboljšale med zdravljenjem zamfotericinom B, ali če je bilo treba amfotericin B ukiniti;
English: Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients.
Slovenian: Plazemskekoncentracijeposakonazola se lahko po uporabi tablet pri nekaterih bolnikih sčasomapovečajo.
English: Tell your doctor or pharmacist or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment: - nausea or vomit (feeling or being sick), diarrhoea - signs of liver problems - these include yellowing of your skin or whites of the eyes, unusually dark urine or pale faeces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests - allergic reaction.
Slovenian: - znakitežav z jetri;mednjimi so porumenelost kože ali očesnih beločnic, nenavadno temen urinalisvetloblato,slabost v želodcubrezrazloga,težave z želodcem,izguba apetita ali nenavadnautrujenost ali šibkost, zvišanje jetrnih encimov (pokaže se na preiskavah krvi) - alergijska reakcija
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER
Slovenian: PERFORIRAN PRETISNI OMOT ZA ENKRATNI ODMEREK
English: Co-administration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes (see sections 4.4 and 4.5).
Slovenian: pimozidom,halofantrinomalikinidinom,kerlahkopovečaplazemske koncentracije tehzdravil,karpalahkopovzroči podaljšanje intervala QTc in redko tudi torsades de pointes(glejte poglavji 4.4 in 4.5).
English: Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during coadministration with posaconazole.
Slovenian: Medsočasno uporabo posakonazola jepriporočljivo pogosto spremljanje glede neželenih učinkov intoksičnosti, povezanih s protiretrovirusnimi zdravili, ki so substrati CYP3A4.
English: Uncommon: the following may affect up to 1 in 100 people - anaemia - signs include headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests - low level of platelets (thrombocytopenia) shown in blood tests - this may lead to bleeding - low level of “leukocytes” a type of white blood cell (leukopenia) shown in blood tests - this can make you more likely to get infections - high level of “eosinophils” a type of white blood cell (eosinophilia) - this can happen if you have inflammation - inflammation of the blood vessels - heart rhythm problems - fits (convulsions) - nerve damage (neuropathy) - abnormal heart rhythm - shown up on a heart trace (ECG), palpitations, slow or fast heartbeat,
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 oseb - anemija - med znaki so glavoboli, utrujenost ali omotičnost, kratka sapa ali bledica ter nizka koncentracija hemoglobina, ki se pokaže na preiskavah krvi - nizko število trombocitov (trombocitopenija), ki se pokaže na preiskavah krvi - povzroči lahko krvavitve - nizko število levkocitov - belih krvnih celic (levkopenija) - pokaže se na preiskavah krvi;
English: The external control group included 86 patients treated with available therapy (as above) mostly at the same time and at the same sites as the patients treated with posaconazole.
Slovenian: (kot navedeno zgoraj), večinoma ob istem času in na istih mestih kot bolniki, zdravljeni s posakonazolom.
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26-fold respectively.
Slovenian: Po 7-dnevni sočasni uporabi peroralne suspenzijeposakonazola (400 mg dvakrat na dan) z atazanavirjem (300 mg enkrat na dan)se je pri zdravihpreiskovancihCmaxatazanavirja povečala v povprečjuza 2,6-krat, njegova AUC paza 3,7-krat
English: which are given with ritonavir) - midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants) - diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure) - digoxin (used to treat heart failure) - Glipizide or other “sulfonylureas” (used to treat high blood sugar).
Slovenian: - diltiazem, verapamil, nifedipin, nizoldipin in drugi zaviralci kalcijevih kanalčkov (uporabljajo se za zdravljenje visokega krvnega tlaka),
English: After a single oral dose of 400 mg posaconazole oral suspension to patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment (six per group), the mean AUC was 1.3 to 1.6-fold higher compared to that for matched control subjects with normal hepatic function.
Slovenian: Po enkratnem peroralnem odmerku 400 mg peroralne suspenzije posakonazola pri bolnikih z blago(razred A po Child-Pughu), zmerno (razred B po Child-Pughu) ali hudo okvaro jeter (razred C
English: Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial (Study 0041).
Slovenian: V neprimerjalnem preskušanju (študija 0041) zadnje možnosti zdravljenja so za zdravljenje invazivneaspergilozepribolnikih z okužbo,odpornonaamfotericin B (vključno z liposomskimioblikami)aliitrakonazol, oziroma pri bolnikih, ki niso prenašali teh zdravil, ovrednotili peroralno suspenzijoposakonazola800 mg/dan v deljenih odmerkih.
English: Co-administration of posaconazole and ergot alkaloids is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba posakonazola in alkaloidov ergot je kontraindicirana
English: Neuronal phospholipidosis occurred in dogs dosed for ≥ 3 months at lower systemic exposures than those obtained at therapeutic doses in humans.
Slovenian: Pri psih, ki so ≥ 3 mesece dobivali odmerke zdravila za manjšo sistemsko izpostavljenost od tiste,
English: Posaconazole Accord 100 mg gastro-resistant tablets posaconazole
Slovenian: Posakonazol Accord 100 mg gastrorezistentne tablete
English: Based on average Cmin concentrations, a predicted average concentration (Cav) could be calculated for 186 subjects dosed with 300 mg. PK analysis in patients of Cav found that 81% of the subjects treated with the 300 mg once daily dose attained steady state predicted Cav between 500-2,500 ng/mL.
Slovenian: preiskovancev, zdravljenih z odmerkom 300 mg enkrat na dan, doseglo predvideno Cav v stanjudinamičnega ravnovesja od 500 do 2.500 ng/ml.
English: The effect of co-administration with posaconazole on plasma levels of CYP3A4 substrates may also be variable within a patient.
Slovenian: Učinek sočasne uporabe posakonazola na plazemske koncentracije substratov CYP3A4selahkorazlikujetudipriposameznembolniku.
English: Thereafter blood levels of tacrolimus should be monitored carefully during co-administration, and upon discontinuation of posaconazole, and the dose of tacrolimus should be adjusted as necessary.
Slovenian: Potem je treba natančno spremljati koncentracijotakrolimusa v krvi, in sicer med sočasno uporabo in po prenehanju zdravljenja s posakonazolom; odmerek takrolimusa jetrebaprilagoditi,kotjepotrebno.
English: Terfenadine, astemizole, cisapride, pimozide, halofantrine and quinidine (CYP3A4 substrates) Co-administration of posaconazole and terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine is contraindicated.
Slovenian: Terfenadin, astemizol, cisaprid, pimozid, halofantrin in kinidin (substrati CYP3A4)
English: Posaconazole Accord contain sodium
Slovenian: Zdravilo Posakonazol Accord vsebuje natrij
English: Therefore, trough concentrations that fall in the upper part of the usual therapeutic range should be targeted and careful attention should be paid to clinical signs and symptoms, laboratory parameters and tissue biopsies.
Slovenian: Zaradi tega lahko najnižja koncentracija sirolimusa, ki je še v običajnemterapevtskemrazponu,dejansko pomeni koncentracijo, nižjo odterapevtske.Zatomora biti ciljna najnižja koncentracija sirolimusa v zgornjem delu običajnega terapevtskega razpona inposebnopozornostjetrebanamenitikliničnimznakominsimptomom,laboratorijskimparametromin tkivnim biopsijam.
English: It is, therefore, suggested to closely monitor for breakthrough fungal infections in patients weighing more than 120 kg.
Slovenian: Zato je bolnike, ki tehtajo več kot120 kg, priporočljivo skrbno spremljati glede prebijajočih glivnih okužb.
English: In a study in healthy volunteers posaconazole oral suspension (200 mg once daily for 10 days) increased the exposure (AUC) of intravenous midazolam (0.05 mg/kg) by 83%.
Slovenian: V študiji pri zdravih prostovoljcih je peroralna suspenzija posakonazola (200 mg enkrat na dan10 dni)
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir and ritonavir (300/100 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 1.5-fold and 2.5-fold (range 0.9 to 4.1-fold), respectively.
Slovenian: mgdvakrat na dan) z atazanavirjem in ritonavirjem(300/100 mg enkrat na dan) se je pri zdravihpreiskovancihCmaxatazanavirja povečala v povprečjuza 1,5-krat, njegova AUC paza 2,5-krat (razponod 0,9-krat do 4,1-krat).
English: 9 of 11 patients were successfully treated with posaconazole oral suspension 800 mg/day in divided doses for a median of 268 days and up to 377 days.
Slovenian: 9 od 11 bolnikov so uspešno zdravili s peroralno suspenzijo posakonazola 800 mg/dan v deljenihodmerkih.
English: Discontinuation of Posaconazole Accord should be considered if clinical signs and symptoms are consistent with development of liver disease.
Slovenian: Spremljanje bolnika mora vključevatilaboratorijskoocenodelovanjajeter(šeposebejjetrnetesteindoločanjebilirubina).Če klinični znaki in simptomi kažejo na razvoj jetrne bolezni, je treba po potrebi prekiniti zdravljenje z zdravilom Posakonazol Accord.
English: Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient outweighs the risk.
Slovenian: %.Sočasni uporabi posakonazola in efavirenza se je treba izogibati, razen če korist za bolnika odtehta tveganje.
English: Thereafter blood levels of ciclosporin should be monitored carefully during co-administration, and upon discontinuation of posaconazole treatment, and the dose of ciclosporin should be adjusted as necessary.
Slovenian: Potem je treba natančno spremljati koncentracije ciklosporina v krvi, in sicer med sočasno uporabo in po prenehanju zdravljenja s posakonazolom;
English: When initiating posaconazole treatment in patients already receiving tacrolimus, the dose of tacrolimus should be reduced (e.g. to about one third of the current dose).
Slovenian: Ob uvedbi zdravljenja s posakonazolomjetrebabolnikom,kižeprejemajotakrolimus,odmerektakrolimusazmanjšati(npr.napribližn otretjinotrenutnega odmerka).
English: What Posaconazole Accord contains The active substance is posaconazole.
Slovenian: Zdravilo Posakonazol Accord vsebuje učinkovino posakonazol.
English: oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation
Slovenian: edemi, bolečine, mrzlica, splošno slabo počutje, nelagodje v prsnem košu, neprenašanje zdravila, občutek živčnosti,
English: Posaconazole therapy was given for a median duration of 28 days.
Slovenian: Srednji čas zdravljenje s posakonazolom je bil 28 dni.
English: 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.
Slovenian: 7-dnevnem predhodnem zdravljenju s terapevtskimi odmerki učinkovitega antimikotičnega zdravila.
English: Posaconazole may substantially increase plasma levels of HMG-CoA reductase inhibitors that are metabolised by CYP3A4.
Slovenian: Posakonazollahkobistveno povečaplazemskokoncentracijozaviralcevreduktazeHMG-CoA, ki sepresnovijo s CYP3A4.
English: Sirolimus concentrations should be measured upon initiation, during co-administration, and at discontinuation of posaconazole treatment, with sirolimus doses adjusted accordingly.
Slovenian: Koncentracijo sirolimusa je treba izmeriti ob uvedbi zdravljenja, med sočasno uporabo in tudi ob ukinitvi zdravljenja s posakonazolom in po potrebi ustrezno prilagoditi odmerke sirolimusa.Zavedatise je treba, da se med sočasno uporabo sirolimusa in posakonazola spremeni razmerje med najnižjo koncentracijo sirolimusa in njegovo AUC.
English: Exposures after tablet administration are generally higher than, but overlapping with, exposures after administration of posaconazole oral suspension.
Slovenian: Izpostavljenost je po uporabi tablet na splošno večja kot po uporabi peroralne suspenzije posakonazola, vendar pa se ena in druga prekrivata.
English: Summary of the safety profile
Slovenian: Povzetek varnostnega profila Tablete posakonazola
English: The most frequently reported serious related adverse reactions included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.
Slovenian: Med najpogosteje poročanimi resnimi, z zdravilom povezanimi neželenimi učinki so bili navzea, bruhanje, driska,
English: Summary of posaconazole tablet bridging study
Slovenian: Povzetek premostitvene študije s tabletami posakonazola
English: Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole oral suspension (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years.
Slovenian: Ocena elektrokardiograma 173 zdravim prostovoljcem in prostovoljkam, starim od 18 do 85 let, so v 12-urnem obdobju posneli več časovno usklajenih EKG, in sicer pred in med uporabo peroralne suspenzije posakonazola (400 mg dvakrat na dan, zaužite z zelo mastno hrano).
English: it was the period from first dose to last dose of study medicinal product plus 7 days.
Slovenian: v študiji316pa je bilo to obdobje od prvega odmerka do zadnjega odmerka preučevanega zdravila plus
English: hepatocellular damage, hepatitis, jaundice, hepatomegaly, cholestasis, hepatic toxicity, hepatic function abnormal
Slovenian: holestaza, hepatotoksičnost, nenormalno delovanje jeter
English: renal tubular acidosis, interstitial nephritis Reproductive system and breast disorders Uncommon:
Slovenian: ledvična tubularna acidoza, intersticijski nefritis
English: Cav = the average concentration when measured at steady state *20 patients received 200 mg once daily (Day 1 200 mg twice daily)
Slovenian: *20 bolnikov je prejemalo 200 mg enkrat na dan (200 mg dvakrat na dan1.dan)
English: If you become pregnant while you are taking Posaconazole Accord, contact your doctor straight away.
Slovenian: Če med jemanjem zdravila Posakonazol Accord zanosite, se nemudoma posvetujte z zdravnikom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 100 mg of posaconazole.
Slovenian: Ena gastrorezistentna tableta vsebuje 100 mg posakonazola.
English: What Posaconazole Accord is and what it is used for
Slovenian: Kaj je zdravilo Posakonazol Accord in za kaj ga uporabljamo
English: Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Slovenian: Zdravilo Posakonazol Accord je indicirano tudi za profilakso invazivnih glivnih okužb pri: - bolnikih, ki prejemajo kemoterapijo za doseganje remisije akutne mieloične levkemije (AML)
English: Gastrointestinal dysfunction
Slovenian: Profilaksainvazivnihglivniho kužb
English: vomiting, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence, constipation, anorectal discomfort
Slovenian: bruhanje, bolečine v trebuhu, driska, dispepsija, suha usta,
English: Posaconazole Accord should be administered with caution to patients with pro-arrhythmic conditions such as: - Congenital or acquired QTc prolongation - Cardiomyopathy, especially in the presence of cardiac failure - Sinus bradycardia - Existing symptomatic arrhythmias - Concomitant use with medicinal products known to prolong the QTc interval (other than those mentioned in section 4.3).
Slovenian: - obstoječe simptomatske aritmije, - sočasna uporaba z zdravili, za katera je znano, da podaljšajo interval QTc (razen tistih, ki so omenjena v poglavju 4.3).
English: Posaconazole Accord contains a medicine called posaconazole.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Posakonazol Accord
English: altered medicine levels, blood phosphorus decreased, chest x-ray abnormal * Based on adverse reactions observed with the oral suspension, gastro-resistant tablets, and concentrate for solution for infusion.
Slovenian: * Na podlagi neželenih učinkov, opaženih s peroralno suspenzijo, gastrorezistentnimi tabletami in koncentratom za raztopino za infundiranje.
English: This finding was not seen in monkeys dosed for one year.
Slovenian: dosežene med uporabo terapevtskih odmerkov pri človeku, se je pojavila fosfolipidoza nevronov.Tega niso opazili pri opicah, ki so zdravilo dobivale eno leto.
English: Do not breast-feed while taking Posaconazole Accord.
Slovenian: Med jemanjem zdravila Posakonazol Accord ne dojite.
English: - if you have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval - if you have a weakness of the heart muscle or heart failure - if you have a very slow heartbeat - if you have heart rhythm disturbance - if you have any problem with potassium, magnesium or calcium levels in your blood - if you are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).
Slovenian: - srčno popuščanje ali srčni infarkt, ki lahko povzroči zastoj srca in smrt; motnje srčnega ritma z nenadno smrtjo - krvni strdki v nogah (globoka venska tromboza) - med znaki so močne bolečine ali oteklost nog
English: Posaconazole oral suspension External control group
Slovenian: Zunanja kontrolna skupina
English: Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections.
Slovenian: Šestnajst bolnikov, starih od 8 do 17 let, so v študiji invazivnih glivnih okužb zdravili s peroralno suspenzijo posakonazola v odmerku mg/dan.Napodlagirazpoložljivihpodatkovza16odtehpediatričnih bolnikov je varnostniprofilzdravila videti podoben kot pri bolnikih,starih ≥18 let.
English: Breast-feeding
Slovenian: nizoldipin)
English: There is insufficient data among different races with posaconazole tablets.
Slovenian: O uporabi tablet posakonazola pri različnih rasah ni dovolj podatkov.
English: Posaconazole plasma concentrations following administration of posaconazole tablets are generally higher than those obtained with posaconazole oral suspension.
Slovenian: Koncentracije posakonazola vplazmi so po uporabi tablet običajno večje kot po uporabi peroralnesuspenzije.
English: high or low blood pressure - low blood pressure - inflammation of the pancreas (pancreatitis) - this may cause severe stomach pain - oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain - severe kidney problems - signs include passing more or less urine, that is a different colour than usual - high blood levels of creatinine - shown in blood tests - cough, hiccups - nose bleeds - severe sharp chest pain when breathing in (pleurritic pain) - swelling of lymph glands (lymphadenopathy) - reduced feeling of sensitivity especially on the skin - tremor - high or low blood sugar levels - blurred vision, sensitivity to light - hair loss (alopecia) - mouth ulcers - shivering, feeling generally unwell - pain, back or neck pain, pain in arms or legs - water retention (oedema) - menstrual problems (abnormal vaginal bleeding)
Slovenian: - hude težave z ledvicami - med znaki so izločanje več ali manj urina, ki je drugačne barve kot po navadi - visoka koncentracija kreatinina v krvi - pokaže se na preiskavah krvi - kašelj, kolcanje - krvavitve iz nosu
English: Common: the following may affect up to 1 in 10 people - a change in the salt level in your blood shown in blood tests - signs include feeling confused or weak - abnormal skin sensations, such as numbness, tingling, itching, creeping, pricking or burning - headache - low potassium levels - shown up in blood tests - low magnesium levels - shown up in blood tests - high blood pressure - loss of appetite, stomach pain or upset stomach, passing wind, dry mouth, changes in your taste - heartburn (a burning sensation in the chest rising up to the throat) - low levels of “neutrophils” a type of white blood cell (neutropenia) -this can make you more likely to get infections and be shown up in blood tests - fever - feeling weak, dizzy, tired or sleepy - rash - itching - constipation - rectal discomfort
Slovenian: - glavobol - nizka koncentracija kalija - pokaže se na preiskavah krvi - nizka koncentracija magnezija - pokaže se na preiskavah krvi - visok krvni tlak - izguba apetita, bolečine v želodcu ali razdražen želodec, vetrovi, suha usta, spremembe okusa