FrancophonIA/ELRC3.0 huggingface dataset:
English: Pulmonary phospholipidosis resulting in dilatation and obstruction of the alveoli was observed in the 2-year study in rats.
Croatian: Tijekom dvogodišnjeg ispitivanja u štakora opažena je plućna fosfolipidoza koja je dovela do dilatacije i opstrukcije alveola.
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.
Croatian: Nakon istodobne primjene oralne suspenzije posakonazola (400 mg dvaput na dan) s atazanavirom i ritonavirom (300/100 mg jedanput na dan) tijekom 7 dana, u zdravih se ispitanika Cmax atazavira povećao prosječno 1,5 puta, a AUC 2,5 puta (raspon od 0,9 do 4,1 puta).
English: Controla
Croatian: Pretrage
English: Patients, in particular those receiving posaconazole after HSCT, who have a low body weight (< 60 kg) are more likely to experience higher plasma concentrations of posaconazole and should be closely monitored for adverse events.
Croatian: Bolesnici, osobito oni koji primaju posakonazol nakon HSCT-a, a koji imaju nisku tjelesnu težinu (<60
English: Frequent monitoring for adverse reactions and toxicity related to calcium channel blockers is recommended during co-administration with posaconazole.
Croatian: Tijekom istodobne primjene s posakonazolom preporučuje se često nadzirati bolesnike zbog nuspojava i reakcija toksičnosti povezanih s primjenom blokatora kalcijevih kanala.
English: Co-administration with the HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin (see section 4.5).
Croatian: Istodobna primjena inhibitora HMG-CoA reduktaze simvastatina, lovastatina i atorvastatina (vidjeti dio
English: The tablet formulation was investigated in AML and MDS patients and those after HSCT with or at risk for Graft versus Host Disease (GvHD) only.
Croatian: Formulacija u obliku tablete ispitana je samo u bolesnika s akutnom mijeloičnom leukemijom (AML) ili mijelodisplastičnim sindromom (MDS) te u bolesnika nakon transplantacije hematopoetskih matičnih stanica (HSCT) s reakcijom presatka protiv primatelja (engl. graft versus host disease, GVHD) ili rizikom od njena nastanka.
English: See also below regarding the effect of posaconazole on rifabutin plasma levels.
Croatian: O učinku posakonazola na koncentraciju rifabutina u plazmi vidjeti u daljnjem tekstu.
English: 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%,
Croatian: 10 dana) s oralnom suspenzijom posakonazola (200 mg jedanput na dan prvog dana, 200 mg dvaput na dan drugog dana, a zatim 400 mg dvaput na dan sljedećih 8 dana) snizila je Cmax posakonazola za 21%, a
English: No dose adjustment is recommended for patients with mild to severe hepatic impairment but caution is advised due to the potential for higher plasma exposure.
Croatian: Ne preporučuje se prilagodba doze za bolesnike s blagim do teškim oštećenjem funkcije jetre,
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.
Croatian: Nakon toga potrebno je pažljivo pratiti razinu takrolimusa u krvi tijekom i po prestanku istodobnog liječenja posakonazolom te po potrebi prilagoditi dozu takrolimusa.
English: Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
Croatian: Udarna doza od 300 mg (tri tablete od 100 mg) dvaput na dan prvog dana, a nakon toga 300 mg (tri tablete od 100 mg) jedanput na dan.
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.
Croatian: Nakon jednokratne doze od 400 mg oralne suspenzije posakonazola u bolesnika s blagim (Child-Pugh stadij A), umjerenim (Child-Pugh stadij B) ili teškim oštećenjem funkcije jetre (Child-Pugh stadij C) (6
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain
Croatian: Ind. Zona Franca, Barcelona, 08040, Španjolska
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.
Croatian: na kraju liječenja opažen je u 42 % bolesnika liječenih posakonazolom u odnosu na 26 % ispitanika u vanjskoj kontrolnoj skupini.
English: Steady-state plasma concentrations are attained by Day 6 at the 300 mg dose (once daily after twice daily loading dose at Day 1).
Croatian: Stanje dinamičke ravnoteže postiže se do 6. dana kod primjene doze od 300 mg (jedanput na dan, nakon udarne doze primijenjene dvaput na dan 1. dana).
English: FLU = fluconazole; ITZ = itraconazole; POS = posaconazole.
Croatian: 1899d 316d FLU = flukonazol; ITZ = itrakonazol; POS = posakonazol a:
English: NAME OF THE MEDICINAL PRODUCT Posaconazole Accord 100 mg gastro-resistant tablets
Croatian: NAZIV LIJEKA Posakonazol Accord 100 mg želučanootporne tablete
English: Exposures after tablet administration are generally higher than, but overlapping with, exposures after administration of posaconazole oral suspension.
Croatian: Izloženost nakon primjene tablete općenito je veća od izloženosti nakon primjene oralne suspenzije posakonazola, iako se preklapaju.
English: Posaconazole Accord can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm: - any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraines.
Croatian: Posakonazol Accord može povećati količinu ovih lijekova u krvi, što može dovesti do jakog smanjenja krvotoka u prstima na rukama ili nogama i može izazvati njihova oštećenja. - „statini“ kao što je simvastatin, atorvastatin ili lovastatin koji se primjenjuju za liječenje visokog kolesterola.
English: Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients (see section 5.2).
Croatian: Nakon primjene tableta posakonazola u nekih bolesnika mogu se tijekom vremena povećati koncentracije posakonazola u plazmi (vidjeti dio 5.2).
English: Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy.
Croatian: Prije i tijekom terapije posakonazolom treba pratiti i po potrebi korigirati poremećaje ravnoteže elektrolita, osobito koncentracije kalija, magnezija ili kalcija.
English: Repeat dose administration of posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Croatian: Primjenom višestrukih doza oralne suspenzije posakonazola (400 mg dva puta na dan tijekom 16 dana) u zdravih se ispitanika Cmax sirolimusa (primijenjenog u jednokratnoj dozi od 2 mg) povećao za prosječno 6,7 puta, a AUC za prosječno 8,9 puta (raspon od 3,1 do 17,5 puta).
English: Cellulose, microcrystalline (E460) Silica, colloidal anhydrous Croscarmellose sodium
Croatian: celuloza, mikrokristalična (E460)
English: In another study in healthy volunteers, repeat dose administration of posaconazole oral suspension (200 mg twice daily for 7 days) increased the Cmax and AUC of intravenous midazolam (0.4 mg single dose) by an average of 1.3- and 4.6-fold (range 1.7 to 6.4-fold), respectively; Posaconazole oral suspension 400 mg twice daily for 7 days increased the intravenous midazolam Cmax and AUC by 1.6 and 6.2-fold (range 1.6 to 7.6-fold), respectively.
Croatian: U drugom ispitivanju u zdravih dobrovoljaca višestruka primjena doza oralne suspenzije posakonazola (200 mg dvaput na dan tijekom 7 dana) povećala je Cmax intravenski primijenjenog midazolama (u jednokratnoj dozi od 0,4 mg) za prosječno 1,3 puta, a AUC za prosječno 4,6 puta (raspon od 1,7 do 6,4 puta).
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.
Croatian: - kromoblastomikoze i micetoma u bolesnika koji ne reagiraju na liječenje itrakonazolom ili u bolesnika koji ne podnose itrakonazol; - kokcidioidomikoze u bolesnika koji ne reagiraju na liječenje amfotericinom B, itrakonazolom ili flukonazolom ili u bolesnika koji ne podnose ove lijekove;
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).
Croatian: - diltiazem, verapamil, nifedipin, nizoldipin ili druge blokatore kalcijevih kanala (primjenjuju se za liječenje povišenog krvnog tlaka),
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).
Croatian: 12 bolesnika u dobi 8-17 godina (776 ng/ml) bila je slična onoj u 194 bolesnika u dobi 18-64 godina
English: Cav quartile analyses of pivotal patient studies with posaconazole tablet and oral suspension Posaconazole tablet
Croatian: Tablica 3. Analize kvartila Cav-a u glavnim ispitivanjima s bolesnicima koji su uzimali tablete i oralnu suspenziju posakonazola
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.
Croatian: Nakon istodobne primjene oralne suspenzije posakonazola (400 mg dvaput na dan) i atazanavira (300 mg jedanput na dan) tijekom 7 dana, u zdravih se ispitanika Cmax atazavira povećao prosječno 2,6 puta, a AUC 3,7 puta (raspon od 1,2 do 26 puta).
English: Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
Croatian: Obavijestite liječnika, ljekarnika ili medicinsku sestru ako primijetite neku od sljedećih nuspojava: Često: mogu se javiti u do 1 na 10 osoba
English: Adverse reactions by body system and frequency* Blood and lymphatic system disorders Common:
Croatian: Tablica 2. Nuspojave prema klasifikaciji organskih sustava i učestalosti* Poremećaji krvi i limfnog sustava
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
Croatian: - niske razine kalija - vide se na krvnim pretragama - niske razine magnezija - vide se na krvnim pretragama - povišen krvni tlak - gubitak apetita, bol u želucu ili nadražen želudac, vjetrovi, suha usta, promjene osjeta okusa - žgaravica (žarenje u prsnom košu koje se diže do grla) - niske razine neutrofila, jedne vrste bijelih krvnih stanica (neutropenija) - zbog toga možete bili skloniji infekcijama i to se može vidjeti na krvnim pretragama
English: Posaconazole plasma concentrations following administration of posaconazole tablets are generally higher than those obtained with posaconazole oral suspension.
Croatian: Koncentracije posakonazola u plazmi nakon primjene tableta posakonazola općenito su više nego pri primjeni oralne suspenzije posakonazola.
English: Posaconazole therapy was given for a median duration of 28 days.
Croatian: Medijan trajanja terapije posakonazolom bio je 28 dana.
English: electrolyte imbalance, anorexia, decreased appetite, hypokalaemia, hypomagnesaemia
Croatian: poremećaj ravnoteže elektrolita, anoreksija, smanjen tek,
English: Hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.
Croatian: ALT-a, AST-a, alkalne fosfataze, ukupnog bilirubina i/ili klinički hepatitis).
English: There is insufficient data among different races with posaconazole tablets.
Croatian: Nema dovoljno podataka o primjeni tableta posakonazola u različitim rasama.
English: Posaconazole Accord can increase the amount of these medicines in the blood which may lead to a severe decrease in blood flow to your fingers or toes and could cause damage to them.
Croatian: Posakonazol Accord može povećati količinu ovih lijekova u krvi, što može dovesti do vrlo ozbiljnih promjena srčanog ritma.
English: See “Other medicines and Posaconazole Accord” below for more information including information on other medicines which may interact with Posaconazole Accord.
Croatian: Za informacije o drugim lijekovima koji mogu imati međusobno djelovanje s lijekom Posakonazol
English: - some medicines used to treat or prevent fits including; phenytoin, carbamazepine, phenobarbital or primidone).
Croatian: - neki lijekovi koji se primjenjuju u liječenju ili sprječavanju napadaja, uključujući fenitoin,
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Posaconazole Accord.
Croatian: Ako se nešto od gore navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku ili ljekarniku prije nego uzmete Posakonazol Accord.
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.
Croatian: Ispitivanju 1899 to je bilo razdoblje od randomizacije do 100 dana nakon randomizacije; u Ispitivanju
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.
Croatian: U 173 zdrava dobrovoljca muškog i ženskog spola u dobi od 18 do 85 godina prikupljeni su višekratni vremenski usklađeni nalazi EKG-a u razdoblju od 12 sati, i to prije i tijekom primjene oralne suspenzije posakonazola (400 mg dvaput na dan uz obroke bogate mastima).
English: Table 6.
Croatian: Svi liječeni Tablica 6.
English: Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections.
Croatian: U ispitivanju liječenja invazivnih gljivičnih infekcija 16 bolesnika u dobi od 8-17 godina liječeno je oralnom suspenzijom posakonazola u dozi od 800 mg na dan.
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).
Croatian: - ako imate poremećaj srčanog ritma; - ako imate bilo koji poremećaj razine kalija, magnezija ili kalcija u krvi
English: Epidemiological Cut-off (ECOFF) Values for Aspergillus spp.
Croatian: Epidemiološke granične vrijednosti (engl.
English: Hydroxypropyl cellulose (E463) Propyl gallate (E310)
Croatian: Jezgra tablete metakrilatna kiselina/etilakrilat kopolimer 1:1 trietilcitrat (E1505) ksilitol (E967) hidroksipropilceluloza (E463) propilgalat (E310)
English: Immune system disorders Uncommon:
Croatian: Poremećaji imunološkog sustava
English: oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation
Croatian: edem, bol, zimica, opća slabost, nelagoda u prsištu, nepodnošenje lijeka, osjećaj nervoze, upala sluznica
English: hepatic failure, hepatitis cholestatic, hepatosplenomegaly, liver tenderness, asterixis Skin and subcutaneous tissue disorders Common:
Croatian: atajenje jetre, kolestatski hepatitis, hepatosplenomegalija, osjetljivost jetre, asteriksis
English: Ear and labyrinth disorder Rare:
Croatian: Poremećaji reproduktivnog sustava i dojki Manje često:
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.
Croatian: Posakonazol Accord indiciran je i za profilaksu invazivnih gljivičnih infekcija u sljedećih bolesnika: - u bolesnika s akutnom mijeloičnom leukemijom (AML) ili mijelodisplastičnim sindromima
English: Gastrointestinal disorders Very Common:
Croatian: Poremećaji probavnog sustava Vrlo često:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 100 mg of posaconazole.
Croatian: Jedna želučanootporna tableta sadrži 100 mg posakonazola.
English: Therefore, reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
Croatian: uključujući vinkristin, azolne antimikotike, uključujući posakonazol, potrebno primjenjivati samo ako nema drugih opcija za antimikotičko liječenje.
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients.
Croatian: Nakon primjene tableta posakonazola u nekih bolesnika mogu se tijekom vremena povećati koncentracije posakonazola u plazmi.
English: Q2
Croatian: C.
English: hearing impairment
Croatian: oštećenje sluha
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)
Croatian: - nepravilan srčani ritam - vidi se na elektrokardiogramu (EKG-u), palpitacije, usporen ili ubrzan rad srca, povišen ili snižen krvni tlak - snižen krvni tlak - upala gušterače (pankreatitis) - to može uzrokovati jake bolove u trbuhu - prekid dotoka kisika u slezenu (infarkt slezene) - to može uzrokovati jake bolove u trbuhu - jake tegobe s bubrezima - znakovi uključuju povećanu ili smanjenu količinu mokraće koja je drugačije boje nego obično
English: Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during coadministration with posaconazole.
Croatian: Tijekom istodobne primjene s posakonazolom preporučuje se učestalo nadziranje bolesnika zbog mogućih nuspojava i reakcija toksičnosti povezanih s antiretrovirusnim lijekovima koji su supstrati enzima CYP3A4.
English: Gastro-resistant tablet
Croatian: Želučanootporna tableta
English: Q4 pCav: predicted Cav
Croatian: pCav: predviđeni Cav Cav = prosječna koncentracija kad se mjeri u stanju dinamičke ravnoteže
English: Q3
Croatian: Q1 Q2 Q3 Q4
English: Cardiac disorders Uncommon:
Croatian: Srčani poremećaji Manje često:
English: Fosamprenavir
Croatian: FARMACEUTSKI
English: Based on the available data in 16 of these paediatric patients, the safety profile appears to be similar to patients ≥ 18 years of age.
Croatian: pedijatrijskih bolesnika, čini se da je sigurnosni profil lijeka sličan onomu u bolesnika u dobi od
English: What Integrilin is and what it is used for
Croatian: Što je Integrilin i za što se koristi
English: In the absence of compatibility studies, INTEGRILIN must not be mixed with other medicinal products except those mentioned in 6.6.
Croatian: U nedostatku ispitivanja kompatibilnosti, INTEGRILIN se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: − Integrilin is not intended for use in children or adolescents less than 18 years of age.
Croatian: Integrilin nije namijenjen za primjenu u djece ili adolescenata mlađih od 18 godina.
English: Safety measures to prevent this from happening include blood tests and careful checking by the healthcare professionals taking care of you.
Croatian: Mjere sigurnosti koje se poduzimaju kako bi se ovo izbjeglo uključuju pretrage krvi i pažljiv nadzor zdravstvenog osoblja koje brine o Vama.
English: INTEGRILIN is not compatible with furosemide.
Croatian: INTEGRILIN nije kompatibilan s furosemidom.
English: Other medicines and Integrilin
Croatian: Drugi lijekovi i Integrilin
English: − sudden, severe allergic reaction.
Croatian: − iznenadna, teška alergijska reakcija.
English: − fatal bleeding.
Croatian: − fatalno krvarenje.
English: Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije.
English: > 110 mm Hg on antihypertensive therapy)
Croatian: > 110 mm Hg uz terapiju antihipertenzivima)
English: Particularly:
Croatian: Naročito:
English: − reduced blood flow to the brain.
Croatian: − smanjeni dotok krvi u mozak.
English: INTEGRILIN should not be used during pregnancy unless clearly necessary.
Croatian: INTEGRILIN ne treba primjenjivati tijekom trudnoće osim u slučaju jasne potrebe.
English: − if you have been treated with another medicineof the same type as Integrilin.
Croatian: − ako ste bili liječeni nekim drugim lijekom istog djelovanja kao Integrilin.