FrancophonIA/ELRC3.0 huggingface dataset:
English: An additional gamma-phase also occurs with a half-life of 45 hours.
Croatian: Naknadno nastupa gama faza s poluvremenom od 45 sati.
English: Beta (1,3)-D-glucan is not present in mammalian cells.
Croatian: Beta (1,3)-D-glukan ne nalazi se u stanicama sisavaca.
English: • serious fungal infections in your tissues or organs (called ‘invasive candidiasis').
Croatian: • ozbiljne gljivične infekcije u tkivima ili organima (nazvane „invazivna kandidijaza“).
English: The distribution into tissues peaked at 1.5 to 2 days after dosing when 92 % of the dose was distributed into tissues.
Croatian: Distribucija u tkiva dostiže vrhunac 1,5 do 2 dana nakon primjene kada 92% doze bude raspodijeljeno u tkiva.
English: These occurrences did not result in clinically important adverse reactions.
Croatian: Takvi događaji nisu izazvali klinički važne nuspojave.
English: • Itching at the injection site.
Croatian: • Svrbež na mjestu injekcije.
English: Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.
Croatian: Vi ili Vaše dijete počnete primati ovaj lijek jer sadrži Vama važne podatke.
English: The mechanism of resistance identified is FKS1 and/or FKS2 (for C. glabrata) gene mutations.
Croatian: Mehanizam rezistencije identificiran je kao mutacije gena FKS1 i/ili FKS2 (za C. glabrata).
English: Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicinal product (see section 2).
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze ili nedostatkom saharoza-izomaltaze ne smiju uzimati ovaj lijek (vidjeti dio 2).
English: Your doctor will decide how much Caspofungin Accord you need and for how long each day.
Croatian: Liječnik će odlučiti koliko lijeka Caspofungin Accord trebate primiti i koliko dugo svaki dan.
English: • Caspofungin Accord has not been studied in pregnant women.
Croatian: • Caspofungin Accord nije ispitan u trudnica.
English: As with any prescription medicine, some side effects may be serious.
Croatian: Kao i sa svakim lijekom koji se izdaje na recept, neke nuspojave mogu biti ozbiljne.
English: Further metabolism involves peptide hydrolysis and N-acetylation.
Croatian: Daljnji metabolizam uključuje hidrolizu peptidnih veza i N-acetilaciju.
English: In elderly patients (65 years of age or more), the area under the curve (AUC) is increased by approximately 30 %.
Croatian: U starijih je bolesnika (u dobi od 65 ili više godina) površina ispod krivulje (AUC) povećana za otprilike 30%.
English: Tell your doctor or nurse straight away if you notice any of the following side effects - you may need urgent medical treatment:
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ukoliko primijetite neku od sljedećih nuspojava - možda ćete trebati hitnu medicinsku pomoć:
English: If this occurs, Caspofungin should be discontinued and appropriate treatment administered.
Croatian: Ako se ona pojavi, mora se prekinuti primjena kaspofungina i primijeniti odgovarajuće liječenje.
English: An independent expert panel determined that 41 % (26/63) of patients receiving at least one dose of caspofungin had a favourable response.
Croatian: Skupina neovisnih stručnjaka utvrdila je da je 41% (26/63) bolesnika, koji su primili barem jednu dozu kaspofungina imalo povoljan odgovor.
English: There are no clinical data for caspofungin to assess its impact on fertility.
Croatian: Nema kliničkih podataka za kaspofungin koji bi procijenili njegov utjecaj na plodnost.
English: This belongs to a group of medicines called anti-fungals.
Croatian: On pripada skupini lijekova koji se zovu antimikotici.
English: The mean duration of therapy was 33.7 days, with a range of 1 to 162 days.
Croatian: Liječenje je prosječno trajalo 33,7 dana, u rasponu od 1 do 162 dana.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution have taken place in controlled validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika te ne bi trebali biti dulji od 24 sata pri temperaturi od 2°C do 8°C, osim ako su rekonstitucija i razrjeđivanje provedeni u kontroliranim i validiranim aseptičkim uvjetima.
English: This infection is caused by a mould called Aspergillus.
Croatian: Ovu infekciju uzrokuje plijesan pod nazivom Aspergilus.
English: • some HIV medicines such as efavirenz or nevirapine
Croatian: • neki lijekovi za liječenje HIV infekcije kao što su efavirenz ili nevirapin
English: Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour intravenous infusions.
Croatian: Koncentracija kaspofungina u plazmi opada na polifazni način nakon primjene jedne intravenske infuzije u trajanju od 1 sat.
English: Patients who met the entry criteria and received one or more doses of caspofungin study therapy were included in the efficacy analysis.
Croatian: Bolesnici koji su zadovoljili kriterije uključenja i primili jednu ili više doza ispitivane terapije kaspofunginom bili su uključeni u analizu djelotvornosti.
English: Instructions of how to reconstitute and dilute Caspofungin Accord:
Croatian: Upute kako rekonstituirati i razrijediti Caspofungin Accord:
English: It is likely that only a small fraction of the caspofungin taken up into tissues later returns to plasma as parent compound.
Croatian: Vjerojatno se samo mali dio kaspofungina koji su preuzela tkiva kasnije vraća u plazmu u izvornom obliku.
English: • difficulty breathing with wheezing or a rash that gets worse - you may be having an allergic reaction to the medicine.
Croatian: • otežano disanje uz piskanje pri disanju ili osip koji se pogoršava - možda imate alergijsku reakciju na ovaj lijek.
English: The unbound fraction of caspofungin in plasma varies from 3.5 % in healthy volunteers to 7.6 % in patients with invasive candidiasis.
Croatian: Nevezana frakcija kaspofungina u plazmi varira od 3,5% u zdravih ispitanika do 7,6% u bolesnika s invazivnom kandidijazom.
English: If you weigh more than 80 kg, you may need a different dose.
Croatian: Ako je Vaša tjelesna težina veća od 80 kg, doza će se morati prilagoditi.
English: In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6 or 3A4.
Croatian: In vitro ispitivanja pokazuju da kaspofungin ne inhibira enzime citokroma P450 1A2, 2A6, 2C9, 2C19, 2D6 ili 3A4.
English: Caspofungin Accord contains a medicine called caspofungin.
Croatian: Caspofungin Accord sadrži lijek koji se zove kaspofungin.
English: • Loss of kidney function, sudden loss of kidney function
Croatian: • Gubitak funkcije bubrega, iznenadni gubitak funkcije bubrega
English: Approximately 75 % of a radioactive dose was recovered during 27 days: 41 % in urine and 34 % in faeces.
Croatian: Oko 75% radioaktivne doze otkriveno je u razdoblju od 27 dana, i to 41% u mokraći, a 34% u stolici.
English: • fungal infections in your nose, nasal sinuses or lungs (called ‘invasive aspergillosis') if other anti-fungal treatments have not worked or have caused side effects.
Croatian: • gljivične infekcije nosa, nosnih sinusa ili pluća (nazvane „invazivna aspergiloza“) ukoliko drugi antimikotici nisu pomogli ili su uzrokovali pojavu nuspojava.
English: DOSE*
Croatian: DOZA*
English: The following adverse reactions were reported:
Croatian: Prijavljene su sljedeće nuspojave:
English: Caspofungin should be given as a single daily infusion.
Croatian: Kaspofungin treba primjenjivati kao infuziju jedanput na dan.
English: The mean duration of intravenous therapy was 11.9 days, with a range of 1 to 28 days.
Croatian: Intravenska terapija prosječno je trajala 11,9 dana u rasponu od 1 do 28 dana.
English: Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Nervous system disorders headache
Croatian: Poremećaji živčanog sustava glavobolja
English: For those patients who received more than 7 days of therapy with caspofungin, 50 % (26/52) had a favourable response.
Croatian: Od bolesnika koji su primali terapiju kaspofunginom dulje od 7 dana, 50% (26/52) imalo je povoljan odgovor.
English: How to store Caspofungin Accord Contents of the pack and other information
Croatian: Kako čuvati Caspofungin Accord Sadržaj pakiranja i druge informacije
English: The efficacy of caspofungin against these fungal pathogens has not been established.
Croatian: Nije bila utvrđena djelotvornost kaspofungina na te gljivične patogene.
English: All adolescents received doses >50 mg daily, and, in fact, 6 of 8 received the maximum dose of 70 mg/day.
Croatian: Svi su adolescenti primali doze >50 mg na dan, a njih 6 od 8 je, u načelu, primalo maksimalnu dozu od 70 mg/dan.
English: There is no information to suggest that Caspofungin Accord affects your ability to drive or operate machinery.
Croatian: Nema podataka koji ukazuju na to da Caspofungin Accord utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Of these, 37 had invasive candidiasis, 10 had invasive aspergillosis, and 1 patient had esophageal candidiasis.
Croatian: Od njih je 37 bolesnika imalo invazivnu kandidijazu, 10 je imalo invazivnu aspergilozu, a 1 je bolesnik imao kandidijazu jednjaka.
English: After two weeks' administration rifampicin had limited effect on AUC, but trough levels were 30 % lower than in adult subjects who received caspofungin alone.
Croatian: Nakon dvotjedne primjene rifampicin je imao ograničeni utjecaj na AUC, ali vrijednosti najniže koncentracije bile su 30% niže nego u odraslih ispitanika koji su primali samo kaspofungin.
English: The elimination of caspofungin from plasma is slow with a clearance of 10-12 mL/min.
Croatian: Eliminacija kaspofungina iz plazme je spora, klirens iznosi 10-12 ml/min.
English: • suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic.
Croatian: • stanja u kojima postoji sumnja na gljivičnu infekciju, ako imate vrućicu i smanjeni broj bijelih krvnih stanica, koja nisu poboljšana nakon terapije antibioticima.
English: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom
Croatian: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Ujedinjeno Kraljevstvo
English: In paediatric patients (12 months to 17 years of age), dosing should be based on the patient's body surface area (see Instructions for Use in Paediatric Patients, Mosteller1 Formula).
Croatian: U pedijatrijskih bolesnika (u dobi od 12 mjeseci do 17 godina) doza se određuje na temelju površine tijela bolesnika (vidjeti Upute za primjenu u pedijatrijskih bolesnika, Mostellerova1 formula).
English: • phenytoin or carbamazepine (used for the treatment of seizures)
Croatian: • fenitoin ili karbamazepin (koriste se za liječenje epileptičkih napadaja)
English: AUC0-24 hr measurements were not performed in this study due to the sparse plasma sampling.
Croatian: AUC0-24 h u ovom ispitivanju nije mjerena zbog nedovoljnog uzorkovanja plazme.
English: In general, treatment should continue for at least 7 days after resolution of symptoms.
Croatian: Liječenje općenito mora trajati još najmanje 7 dana nakon nestanka simptoma.
English: Your doctor will determine the duration of your treatment and how much Caspofungin Accord you will be given each day.
Croatian: Liječnik će odrediti trajanje liječenja i koliko ćete lijeka Caspofungin Accord primiti svakog dana.
English: The safety and efficacy of caspofungin was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicentre clinical trials.
Croatian: Djelotvornost i sigurnost primjene kaspofungina procjenjivala se u pedijatrijskih bolesnika u dobi od 3 mjeseca do 17 godina u dva prospektivna, multicentrična klinička ispitivanja.
English: Patients were to be treated until up to 72 hours after resolution of neutropaenia, with a maximum duration of 28 days.
Croatian: Bolesnici su trebali biti liječeni do 72 sata nakon prestanka neutropenije, uz maksimalno trajanje terapije od 28 dana.
English: A higher exposure than in moderate hepatic impairment is expected and caspofungin should be used with caution in these patients (see sections 4.2 and 5.2).
Croatian: Očekuje se veća izloženost nego u slučaju umjerenog oštećenja jetre pa se kaspofungin u takvih bolesnika mora primjenjivati s oprezom (vidjeti dijelove 4.2 i 5.2).
English: Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections.
Croatian: Liječenje kaspofunginom mora započeti liječnik s iskustvom u liječenju invazivnih gljivičnih infekcija.
English: For caspofungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Croatian: Kaspofungin, nije imao utjecaja na plodnost u ispitivanjima provedenim na mužjacima i ženkama štakora (vidjeti dio 5.3).
English: Supplied in packs of 1 vial.
Croatian: Dostupno u pakiranju s 1 bočicom.
English: Preparation notes:
Croatian: Napomene za pripremu:
English: No dosage adjustment is necessary based on gender or race (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu zbog spola ili rase (vidjeti dio 5.2).
English: Although the doses of prior antifungal therapies in 5 patients enrolled as refractory were lower than those often administered for invasive aspergillosis, the favourable response rate during therapy with caspofungin was similar in these patients to that seen in the remaining refractory patients (2/5 versus 17/48, respectively).
Croatian: Premda su doze prethodno primijenjenih antimikotika u 5 bolesnika s infekcijom otpornom na liječenje bile niže od onih često primjenjivanih za invazivnu aspergilozu, stopa povoljnih odgovora tijekom liječenja kaspofunginom u tih bolesnika bila je slična onoj u preostalih bolesnika s infekcijom otpornom na liječenje (2/5 naspram 17/48).
English: Caspofungin Accord may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Croatian: Caspofungin Accord također može uzrokovati ozbiljne kožne nuspojave kao što su Stevens-Johnsonov sindrom (SJS) i toksična epidermalna nekroliza (TEN).
English: There is limited treatment experience in patients 65 years of age and older (see section 5.2).
Croatian: Iskustvo s liječenjem bolesnika u dobi od 65 godina i starijih je ograničeno (vidjeti dio 5.2).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: Data in patients with non-blood sites of infection were more limited.
Croatian: Podaci prikupljeni u bolesnika s infekcijama koje nisu zahvaćale krv su ograničeni.
English: Among patients with extrapulmonary disease, 2 of 8 patients who also had definite, probable, or possible CNS involvement had a favourable response.
Croatian: Među bolesnicima s ekstrapulmonarnom bolesti, 2 od 8 bolesnika u kojih je postojala sigurna, vjerojatna ili moguća zahvaćenost središnjeg živčanog sustava imalo je povoljan odgovor.
English: Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.
Croatian: Klinički i laboratorijski poremećaji prijavljeni u svih odraslih bolesnika liječenih kaspofunginom (ukupno 1780) bili su tipično blagi i rijetko su dovodili do prekida terapije.
English: However, patients found to have a documented fungal infection could be treated longer.
Croatian: Međutim, bolesnici s utvrđenom gljivičnom infekcijom mogli su biti liječeni i dulje.
English: Patients found to have a fungal infection should be treated for a minimum of 14 days and treatment should continue for at least 7 days after both neutropaenia and clinical symptoms are resolved.
Croatian: Bolesnici u kojih je pronađena gljivična infekcija moraju se liječiti najmanje 14 dana, a liječenje se mora nastaviti najmanje 7 dana nakon prestanka i neutropenije i kliničkih simptoma.
English: • Itching, rash, skin redness or sweating more than usual
Croatian: • Svrbež, osip, crvenilo kože ili znojenje više nego uobičajeno
English: Available pharmacodynamic/ toxicological data in animals have shown excretion of caspofungin in milk.
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se kaspofungin izlučuje u mlijeko.
English: Caspofungin did not increase the plasma levels of cyclosporin.
Croatian: Kaspofungin nije povisio razinu ciklosporina u plazmi.
English: In two clinical studies performed in healthy adult subjects, cyclosporin A (one 4 mg/kg dose or two 3 mg/kg doses 12 hours apart) increased the AUC of caspofungin by approximately 35 %.
Croatian: U dva klinička ispitivanja provedena u zdravih odraslih ispitanika ciklosporin A (jedna doza od 4 mg/kg ili dvije od 3 mg/kg u razmaku od 12 sati) povećao je AUC kaspofungina za otprilike 35%.
English: Duration of empirical therapy should be based on the patient's clinical response.
Croatian: Trajanje empirijskog liječenja mora se temeljiti na kliničkom odgovoru bolesnika.
English: Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea lozoyensis.
Croatian: Kaspofungin acetat je polusintetski lipopeptidni (ehinokandin) spoj koji se sintetizira iz fermentacijskog produkta Glarea lozoyensis.
English: Distribution plays the prominent role in caspofungin plasma pharmacokinetics and is the rate-controlling step in both the alpha- and beta-disposition phases.
Croatian: Distribucija igra značajnu ulogu u farmakokinetici kaspofungina u plazmi i ona je korak koji regulira brzinu alfa i beta faze raspoloživosti lijeka.
English: • Changes in some laboratory blood tests.
Croatian: Promjene nekih krvnih laboratorijskih testova
English: There is little excretion or biotransformation of caspofungin during the first 30 hours after administration.
Croatian: Izlučivanje i biotransformacija kaspofungina tijekom prvih 30 sati nakon primjene je izrazito malo.
English: These data suggest that caspofungin can be used in patients receiving cyclosporin when the potential benefit outweighs the potential risk.
Croatian: Takvi podaci pokazuju da se kaspofungin i ciklosporin istodobno mogu davati bolesnicima u kojih očekivana korist nadmašuje mogući rizik.
English: Caspofungin has also been evaluated at 150 mg daily (for up to 51 days) in 100 adult patients (see section 5.1).
Croatian: Kaspofungin je ispitivan i u dozi od 150 mg dnevno (u trajanju do 51 dana) u 100 odraslih bolesnika (vidjeti dio 5.1).
English: Caution should apply in patients with history of allergic skin reaction (see section 4.8).
Croatian: Potreban je oprez u bolesnika s alergijskom kožnom reakcijom u anamnezi (vidjeti dio 4.8).
English: ** If 70 mg vial is not available, the 70 mg dose can be prepared from two 50 mg vials
Croatian: **Ako bočica od 70 mg nije na raspolaganju, doza od 70 mg može se pripremiti iz dvije bočice od 50 mg
English: • Increased blood pressure and alterations in some laboratory blood tests (including kidney electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the immune system
Croatian: • Povišene vrijednosti krvnog tlaka i promjene nekih laboratorijskih krvnih testova (uključujući bubrežne elektrolite i testove zgrušavanja), povišene razine lijekova koje uzimate koji slabe imunološki sustav
English: Duration of treatment of invasive aspergillosis is determined on a case by case basis and should be based upon the severity of the patient's underlying disease, recovery from immunosuppression, and clinical response.
Croatian: Trajanje liječenja invazivne aspergiloze određuje se za svakog bolesnika posebno i mora se temeljiti na težini osnovne bolesti, oporavku od imunosupresije i kliničkom odgovoru.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial .
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici
English: • Diarrhoea, nausea or vomiting
Croatian: • Proljev, mučnina ili povraćanje
English: Also some other medicines can affect the way Caspofungin Accord works.
Croatian: Također, drugi lijekovi mogu utjecati na djelovanje lijeka Caspofungin Accord .
English: The plasma concentrations decrease with increasing weight.
Croatian: S porastom tjelesne težine smanjuje se njegova koncentracija u plazmi.
English: Caspofungin is not dialysable, thus supplementary dosing is not required following haemodialysis.
Croatian: Kaspofungin se ne može ukloniti dijalizom pa stoga nije potrebna primjena dodatne doze nakon hemodijalize.
English: Two intermediate products, formed during the degradation of caspofungin to this open ring compound, form covalent adducts to plasma proteins resulting in a low-level, irreversible binding to plasma proteins.
Croatian: Dva intermedijarna spoja, koji nastaju tijekom razgradnje kaspofungina na taj spoj s otvorenim prstenom, spajaju se kovalentnom vezom za proteine plazme, posljedica čega je slabo ireverzibilno vezanje za proteine plazme.
English: The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 mL infusion bag or bottle.
Croatian: Otopina za infuziju priprema se dodavanjem odgovarajuće količine rekonstituiranog koncentrata (kako je prikazano u donjoj tablici) u aseptičkim uvjetima u infuzijsku vrećicu ili bocu od 250 ml.
English: Talk to your doctor, nurse or pharmacist before you are given Caspofungin Accord if:
Croatian: Obratite se svom liječniku, medicinskoj sestri ili ljekarniku prije nego primite Caspofungin Accord :
English: • The active substance is caspofungin.
Croatian: • Djelatna tvar je kaspofungin.
English: Concomitant use of caspofungin with cyclosporin has been evaluated in healthy adult volunteers and in adult patients.
Croatian: Istodobna primjena kaspofungina i ciklosporina bila je ispitana u odraslih zdravih dobrovoljaca i u odraslih bolesnika.
English: • The other ingredients are sucrose, mannitol, succinic acid and sodium hydroxide (please see section 2.
Croatian: • Drugi sastojci su saharoza, manitol, sukcinatna kiselina i natrijev hidroksid (vidjeti dio 2.
English: For patients receiving both therapies, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are mandatory.
Croatian: U bolesnika koji primaju oba lijeka obavezno je standardno praćenje koncentracije takrolimusa u krvi i prilagođavanje doze na odgovarajući način.
English: There are no or limited data from the use of caspofungin in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni kaspofungina u trudnica ograničeni.
English: The incidence of resistance to caspofungin by various clinical isolates of Aspergillus is rare.
Croatian: Incidencija rezistencije različitih kliničkih izolata roda Aspergillus na kaspofungin je rijetka.
English: The interaction of higher doses of caspofungin with other medicinal products has not been formally studied.
Croatian: Interakcije između kaspofungina primijenjenog u većim dozama i drugih lijekova nisu službeno ispitivane.
English: Stability data have shown that the concentrate for solution for infusion can be stored for up to 24 hours when the vial is stored at 25°C or less and reconstituted with water for injections.
Croatian: Podaci o stabilnosti pokazali su da se koncentrat za otopinu za infuziju može čuvati najdulje 24 sata kad se bočica čuva pri temperaturi od 25°C ili nižoj i kad je rekonstituiran s vodom za injekciju.