natgillin/translations-raw huggingface dataset:
Invasive Aspergillosis in Adult Patients: Sixty-nine adult patients (age 18-80) with invasive aspergillosis were enrolled in an open-label, non-comparative study to evaluate the safety, tolerability, and efficacy of caspofungin. 
Invazivna aspergiloza pri odraslih bolnikih: 69 odraslih bolnikov (starih 18-80 let) z invazivno aspergilozo je sodelovalo v odprti, neprimerjalni študiji za oceno varnosti, prenašanja in učinkovitosti kaspofungina.
Caution is advised when treating this age group. 
Pri zdravljenju bolnikov iz te starostne skupine je potrebna previdnost.
• Changes in some laboratory blood tests. 
• spremembe nekaterih laboratorijskih izvidov krvi
What you need to know before you are given Caspofungin Accord 
Kaj morate vedeti, preden boste dobili zdravilo Kaspofungin Accord
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ POGLEDA IN DOSEGA OTROK
Concomitant use of caspofungin with cyclosporin has been evaluated in healthy adult volunteers and in adult patients. 
Sočasno zdravljenje s kaspofunginom in ciklosporinom so preučevali tako pri zdravih odraslih prostovoljcih kot pri odraslih bolnikih.
The proportion of patients with a serious drug-related adverse reaction or a drug-related adverse reaction leading to caspofungin discontinuation was comparable in the 2 treatment groups. 
Delež bolnikov z zdravilom povezanimi resnimi neželenimi učinki ali z zdravilom povezanimi neželenimi učinki, zaradi katerih je bil kaspofungin ukinjen, je bil primerljiv v obeh skupinah.
Both 70 mg and 50 mg vials are available. 
Na voljo so tako 70 mg kot 50 mg viale.
• Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. 
• Zdravljenje invazivne aspergiloze pri odraslih ali pediatričnih bolnikih, ki so nedovzetni za zdravljenje z amfotericinom B, lipidnimi pripravki amfotericina B in/ali itrakonazolom ali teh zdravil ne prenašajo.
• difficulty breathing with wheezing or a rash that gets worse - you may be having an allergic reaction to the medicine. 
• težave pri dihanju s piskanjem ali poslabšanje obstoječega izpuščaja - morda imate alergijsko reakcijo na zdravilo,
Caspofungin should be given as a single daily infusion. 
Kaspofungin se daje v obliki infuzije enkrat na dan.
• Decreased blood albumin (a type of protein) in your blood, decreased potassium or low potassium levels in the blood 
• zmanjšana vrednost albumina (vrsta beljakovine) v vaši krvi, zmanjšana vrednost kalija ali nizka vrednost kalija v krvi
Patients who develop abnormal liver function tests during caspofungin therapy should be monitored for evidence of worsening hepatic function and the risk/benefit of continuing caspofungin therapy should be re-evaluated. 
Bolnike, pri katerih so se med zdravljenjem s kaspofunginom pojavili nenormalni izvidi jetrnih testov, je treba spremljati glede znakov poslabšanja delovanja jeter in pri njih ponovno oceniti razmerje med tveganjem in koristjo nadaljevanja zdravljenja s kaspofunginom.
Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections. 
Zdravljenje s kaspofunginom mora uvesti zdravnik z izkušnjami pri zdravljenju invazivnih glivnih okužb.
Repeated dose toxicity studies in rats and monkeys using doses up to 7-8 mg/kg given intravenously showed injection site reactions in rats and monkeys, signs of histamine release in rats, and evidence of adverse effects directed at the liver in monkeys. 
Študije toksičnosti po ponavljajočih odmerkih pri podganah in opicah z odmerki do 7-8 mg/kg intravensko so pokazale reakcije na mestu vbrizganja pri podganah in opicah, znake sproščanja histamina pri podganah in znake neželenih učinkov na jetra pri opicah.
Candida species (Candida albicans [N = 1,032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis [N = 215], Candida rugosa [N = 1], and Candida tropicalis [N = 258]), including isolates with multiple resistance transport mutations and those with acquired or intrinsic resistance to fluconazole, amphotericin B, and 5-flucytosine. 
In vitro je kaspofungin učinkovit tudi proti Candida sp. (Candida albicans n = 1.032, Candida dubliniensis n = 100, Candida glabrata n = 151, Candida guilliermondii n = 67, Candida kefyr n = 62, Candida krusei n = 147, Candida lipolytica n = 20, Candida lusitaniae n = 80, Candida parapsilosis n = 215, Candida rugosa n = 1 in Candida tropicalis n = 258, vključno z izolati s prenosnimi mutacijami, ki so odgovorne za rezistenco na številne antibiotike, in tistimi s pridobljeno ali intrinzično rezistenco na flukonazol, amfotericin B in 5flucitozin.
Hypersensitivity reactions (anaphylaxis and possibly histamine-mediated adverse reactions) have been reported (see section 4.4). 
Poročali so o preobčutljivostnih reakcijah (anafilaksiji in verjetno histaminsko posredovanih neželenih učinkih) (glejte poglavje 4.4).
Caspofungin did not increase the plasma levels of cyclosporin. 
Kaspofungin ni povečal plazemskih koncentracij ciklosporina.
In this study, the caspofungin dose was administered over 2 hours (instead of the routine 1-hour administration). 
V tej študiji so bolnikom dajali odmerek kaspofungina dve uri (namesto običajnega enournega dajanja).
There is limited treatment experience in patients 65 years of age and older (see section 5.2). 
Izkušenj z zdravljenjem bolnikov, starih 65 let ali več, je malo (glejte poglavje 5.2).
The most common drug-related clinical adverse experiences reported in paediatric patients treated with caspofungin were pyrexia (11.7%), rash (4.7%) and headache (2.9%). 
Najpogostejši klinični neželeni učinki, povezani z zdravilom, o katerih so poročali pri pediatričnih bolnikih, zdravljenih s kaspofunginom, so bili zvišana telesna temperatura (11,7 %), izpuščaj (4,7 %) in glavobol (2,9 %).
The caspofungin plasma concentrations in these adolescents were reduced relative to adults receiving 70 mg daily, the dose most often administered to adolescents. 
Koncentracija kaspofungina v plazmi je bila pri teh mladostnikih nižja kot pri odraslih, ki so dobivali 70 mg na dan, tj. odmerek, ki so ga najpogosteje dobili mladostniki.
Patients in the non-comparative Aspergillus study often had serious predisposing medical conditions (e.g., bone marrow or peripheral stem cell transplants, haematologic malignancy, solid tumours or organ transplants) requiring multiple concomitant medications. 
Bolniki v neprimerjalni študiji Aspergillusa so pogosto imeli resna predisponirajoča zdravstvena stanja (npr. presaditev kostnega mozga ali perifernih matičnih celic, hematološke malignome, solidne tumorje ali presajene organe), zaradi katerih so morali sočasno dobivati več zdravil.
Blood and lymphatic system disorders eosinophil count increased 
Bolezni krvi in limfatičnega sistema povečano število eozinofilcev
Isolates of Candida with reduced susceptibility to caspofungin have been identified in a small number of patients during treatment (MICs for caspofungin >2 mg/L (4- to 30-fold MIC increases) have been reported using standardized MIC testing techniques approved by the CLSI). 
Pri manjšem številu bolnikov so med zdravljenjem odkrili izolate vrste Candida z zmanjšano občutljivostjo na kaspofungin (poročali so o MIC za kaspofungin > 2 mg/l (4-do 30-kratno povečanje MIC), pri čemer so uporabili standardizirane tehnike za testiranje MIC, odobrene s strani CLSI).
Caspofungin has also been evaluated at 150 mg daily (for up to 51 days) in 100 adult patients (see section 5.1). 
Ovrednotili so tudi odmerke po 150 mg kaspofungina na dan (v času do 51 dni) pri 100 odraslih bolnikih (glejte poglavje 5.1).
For adult patients with mild hepaticimpairment (Child-Pugh score 5 to 6), no dosage adjustment is needed. 
Pri odraslih bolnikih z blago jetrno okvaro (stopnja Child-Pugh 5 do 6 točk) prilagoditev odmerka ni potrebna.
The following adverse reactions were reportedduring clinical studies and/or post-marketing use: 
Seznam neželenih učinkov v preglednici V kliničnih študijah in/ali v obdobju trženja so poročali o naslednjih neželenih učinkih:
This infection is caused by fungal (yeast) cells called Candida. 
Te okužbe povzročajo glive (kvasovke), imenovane Candida.
After two weeks' administration rifampicin had limited effect on AUC, but trough levels were 30 % lower than in adult subjects who received caspofungin alone. 
Po dveh tednih zdravljenja je imel rifampicin omejen učinek na AUC, koncentracije, izmerjene tik pred naslednjim odmerkom, pa so bile 30 % manjše kot pri odraslih preiskovancih, ki so dobivali samo kaspofungin.
In the studies involving patients with documented Candida infections, the majority of the patients with invasive Candida infections had serious underlying medical conditions (e.g., haematologic or other malignancy, recent major surgery, HIV) requiring multiple concomitant medications. 
V študijah pri bolnikih s potrjenimi okužbami s Candido je imela večina bolnikov z invazivnimi okužbami s Candido resne osnovne bolezni (npr. hematološki ali kakšen drug malignom, nedavni večji kirurški poseg, HIV), zaradi katerih so morali sočasno dobivati več zdravil.
Nervous system disorders headache 
Bolezni živčevja glavobol
For reconstitution directions see section 6.6. 
Za navodila glede rekonstitucije glejte poglavje 6.6.
The safety and efficacy of caspofungin have not been sufficiently studied in clinical trials involving neonates and infants below 12 months of age. 
Varnost in učinkovitost kaspofungina nista bili dovolj raziskani v kliničnih preskušanjih, ki bi vključevala novorojenčke in dojenčke, mlajše od 12 mesecev.
Renal impairment: In a clinical study of single 70 mg doses, caspofungin pharmacokinetics were similar in adult volunteers with mild renal impairment (creatinine clearance 50 to 80 mL/min) and control subjects. 
Okvara ledvic: V klinični študiji enkratnih 70 mg odmerkov je bila farmakokinetika kaspofungina pri odraslih prostovoljcih z blago ledvično okvaro (kreatininski očistek 50 do 80 ml/min) podobna kot pri kontrolnih preiskovancih.
However, variability was seen in both C1 hr (Day 4 geometric mean 11.73 µg/mL, range 2.63 to 22.05 µg/mL) and C24 hr (Day 4 geometric mean 3.55 µg/mL, range 0.13 to 7.17 µg/mL). 
Vendar pa je bila variabilnost opazna tako pri C1 h (geometrična sredina 4. dan 11,73 µg/ml, razpon od 2,63 do 22,05 µg/ml) kot pri C24 h (geometrična sredina 4. dan 3,55 µg/ml, razpon od 0,13 do 7,17 µg/ml).
In the empirical therapy study patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation (including 39 allogeneic transplantations). 
Bolniki v študiji empiričnega zdravljenja so dobivali kemoterapijo zaradi malignoma ali so prestali presaditev hematopoetskih matičnih celic (vključno z 39 alogenskimi presaditvami).
Patients had to be either refractory to (disease progression or failure to improve with other antifungal therapies given for at least 7 days) (84 % of the enrolled patients) or intolerant of (16 % of enrolled patients) other standard antifungal therapies. 
Bolniki so morali biti nedovzetni za druga standardna protiglivna zdravila (napredovanje bolezni ali nespremenjeno stanje ob vsaj 7 dnevnem prejemanju drugih protiglivnih zdravil) (84 % vključenih bolnikov) ali jih niso smeli prenašati (16 % vključenih bolnikov).
• Loss of kidney function, sudden loss of kidney function 
• prenehanje delovanja ledvic, nenadno prenehanje delovanja ledvic
Among patients with extrapulmonary disease, 2 of 8 patients who also had definite, probable, or possible CNS involvement had a favourable response. 
Med bolniki z zunaj-pljučno boleznijo sta se na zdravljenje ugodno odzvala 2 bolnika od 8 z gotovo, verjetno ali možno okužbo osrednjega živčevja.
BSA (m2) X 50 mg/m2 = Daily Maintenance Dose 
Telesna površina (m2) X 50 mg/m2 = dnevni vzdrževalni odmerek
Equilibrate the refrigerated vial of Caspofungin Accord to room temperature. 
Pustite, da se ohlajena viala z zdravilom Kaspofungin Accord ogreje na sobno temperaturo.
Supplied in packs of 1 vial. 
Zdravilo je na voljo v pakiranjih po 1 vialo.
Talk to your doctor, nurse or pharmacist before you are given Caspofungin Accord if: 
Posvetujte se z zdravnikom, medicinsko sestro ali farmacevtom, preden dobite zdravilo Kaspofungin Accord:
Studies in vitro and in vivo demonstrate that exposure of Aspergillus to caspofungin results in lysis and death of hyphal apical tips and branch points where cell growth and division occur. 
Študije in vitro in in vivo so pokazale, da pri izpostavitvi glive Aspergillus kaspofunginu pride do lize in odmrtja apikalnih vršičkov in mest vejanja hif, kjer se odvijata celična rast in delitev.
Elderly: A modest increase in AUC (28 %) and C24h (32 %) was observed in elderly male subjects compared with young male subjects. 
Starejši bolniki: Pri starejših moških preiskovancih so ugotovili zmerno povečanje AUC (28 %) in C24h (32 %) v primerjavi z mladimi moškimi.
Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], and Aspergillus candidus [N = 3]). 
In vitro je kaspofungin učinkovit proti Aspergillus sp. (Aspergillus fumigatus n = 75, Aspergillus flavus n = 111, Aspergillus niger n = 31, Aspergillus nidulans n = 8, Aspergillus terreus n = 52
Other local reactions included erythema, pain/tenderness, itching, discharge, and a burning sensation. 
Druge lokalne reakcije so vključevale eritem, bolečino/občutljivost, srbenje, izcedek in pekoč občutek.
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after reconstitution and dilution. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Intravenska uporaba po predhodni pripravi in razredčenju.
If the drug was well tolerated but the patient's fever persisted and clinical condition deteriorated after 5 days of therapy, the dosage of study drug could be increased to 70 mg/day of caspofungin (13.3 % of patients treated) or to 5.0 mg/kg/day of liposomal amphotericin B (14.3 % of patients treated). 
Če je bolnik zdravilo dobro prenašal, a je imel po 5 dneh zdravljenja še vedno zvišano telesno temperaturo, klinično stanje pa se je slabšalo, je bilo mogoče odmerek študijskega zdravila zvečati na 70 mg kaspofungina/dan (13,3 % zdravljenih bolnikov) oz. na 5,0 mg liposomskega amfotericina B/kg/dan (14,3 % zdravljenih bolnikov).
• Sensation of fast or irregular heart beats, rapid heart beat, irregular heart beat, abnormal heart rhythm, heart failure 
• občutek hitrega ali nepravilnega utripanja srca, pospešen srčni utrip, nepravilen srčni utrip, nenormalni srčni ritem, srčno popuščanje
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). 
Čeprav so bili pri 5 bolnikih, ki so bili v študijo vključeni kot nedovzetni, odmerki prejšnjih protiglivnih zdravil manjši, kot se običajno uporabljajo pri invazivni aspergilozi, je bil delež ugodnega odziva na zdravljenje s kaspofunginom pri njih (2/5) podoben deležu pri ostalih neodzivnih bolnikih (17/48).
In lieu of breakpoints, Candida isolates that are susceptible to anidulafungin as well as micafungin should be considered susceptible to caspofungin. 
Namesto mejnih vrednosti je treba upoštevati, da so izolati vrste Candida, ki so občutljivi za anidulafungin kot tudi za mikafungin, občutljivi za kaspofungin.
What Caspofungin Accord is and what it is used for What you need to know before you are given Caspofungin Accord How to use Caspofungin Accord 
Kaj je zdravilo Kaspofungin Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Kaspofungin Accord Kako uporabljati zdravilo Kaspofungin Accord Možni neželeni učinki
Do not use if the solution is cloudy or has precipitated. 
Raztopine ne uporabite, če je motna ali če se je pojavila oborina.
Limited data from population pharmacokinetics studies indicate that concomitant use of caspofungin with the inducers efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, or carbamazepine may result in a decrease in caspofungin AUC. 
Malo podatkov iz populacijskih farmakokinetičnih študij kaže, da lahko sočasna uporaba kaspofungina z induktorji efavirenzom, nevirapinom, rifampicinom, deksametazonom, fenitoinom ali karbamazepinom povzroči zmanjšanje AUC kaspofungina.
Some healthy adult volunteers who received two 3 mg/kg doses of cyclosporin with caspofungin showed transient increases in alanine transaminase (ALT) and aspartate transaminase (AST) of less than or equal to 3-fold the upper limit of normal (ULN) that resolved with discontinuation of the treatment. 
Pri nekaterih zdravih odraslih prostovoljcih, ki so sočasno dobili dva odmerka ciklosporina 3 mg/kg ter kaspofungin, je prišlo do prehodnega povečanja alanin transaminaze (ALT) in aspartat transaminaze (AST), ki je bilo manjše ali enako 3-kratni zgornji meji normalne vrednosti in ki se je normaliziralo po prekinitvi zdravljenja.
Possibly histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm have been reported and may require discontinuation and/or administration of appropriate treatment. 
Poročali so o verjetno histaminsko posredovanih neželenih učinkih, ki so vključevali izpuščaj, otekanje obraza, angioedem, pruritus, občutek toplote ali bronhospazem in ki lahko zahtevajo ukinitev kaspofungina in/ali ustrezno zdravljenje.
If any of the above applies to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Caspofungin Accord. 
Če kaj od zgoraj naštetega velja za vas (ali pa niste prepričani), se pogovorite z zdravnikom, medicinsko sestro ali farmacevtom, preden dobite zdravilo Kaspofungin Accord.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. 
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
There is no clinical experience in adult patients with severe hepatic impairment (Child-Pugh score greater than 9) and in paediatric patients with any degree of hepatic impairment (see section 4.4). 
Kliničnih izkušenj pri odraslih bolnikih s hudo jetrno okvaro (stopnja Child-Pugh nad 9 točk) in pri pediatričnih bolnikih s katero koli stopnjo jetrne okvare nimamo (glejte poglavje 4.4).
Data from 5 clinical studies completed in 171 paediatric patients suggest that the overall incidence of clinical adverse experiences (26.3%; 95% CI -19.9, 33.6) is not worse than reported for adults treated with caspofungin (43.1%; 95% CI -40.0, 46.2). 
Podatki iz 5 kliničnih študij pri 171 pediatričnih bolnikih kažejo, da skupna pojavnost kliničnih neželenih učinkov (26,3 %; 95 % IZ -19,9; 33,6) ni večja kot pri odraslih, zdravljenih s kaspofunginom (43,1 %; 95 % IZ -40,0; 46,2).
564 febrile neutropaenic patients (empirical therapy study), 382 patients with invasive candidiasis, 228 patients with invasive aspergillosis, 297 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies. 
V kliničnih študijah je 1.865 odraslih oseb dobilo enkratne ali večkratne odmerke kaspofungina: 564 bolnikov s febrilno nevtropenijo (študija empiričnega zdravljenja), 382 bolnikov z invazivno kandidiazo, 228 bolnikov z invazivno aspergilozo, 297 bolnikov z lokaliziranimi okužbami s Candido in 394 oseb vključenih v študije I. faze.
Caspofungin did not influence the pharmacokinetics of amphotericin B, itraconazole, rifampicin or mycophenolate mofetil. 
Kaspofungin ni vplival na farmakokinetiko amfotericina B, itrakonazola, rifampicina ali mofetilmikofenolata.
Most patients had underlying conditions (haematologic malignancy [N = 24], allogeneic bone marrow transplant or stem cell transplant [N = 18], organ transplant [N = 8], solid tumour [N = 3], or other conditions [N = 10]). 
Večina bolnikov je imela neko osnovno bolezen/stanje (maligno hematološko bolezen n = 24, stanje po alogenski presaditvi kostnega mozga ali matičnih celic n = 18, stanje po presaditvi organa n = 8, solidni tumor n = 3 ali drugo bolezen/stanje n = 10).
However, caspofungin has been shown to interact with other medicinal products in pharmacological and clinical studies (see below). 
Vendar pa so se v farmakoloških in kliničnih študijah pokazale interakcije kaspofungina z drugimi zdravili (glejte nadaljevanje).
How to store Caspofungin Accord Contents of the pack and other information 
Shranjevanje zdravila Kaspofungin Accord Vsebina pakiranja in dodatne informacije
Susceptibility testing was performed according to a modification of both the Clinical and Laboratory Standards Institute (CLSI, formerly known as the National Committee for Clinical Laboratory Standards [NCCLS]) method M38-A2 (for Aspergillus species) and method M27-A3 (for Candida species). 
Testiranje občutljivosti je bilo izvedeno po modifikaciji metode M38-A2 (za Aspergillus sp.) kot tudi metode M27-A3 (za Candida sp.) Inštituta za klinične in laboratorijske standarde (CLSI, prej znanega pod imenom Nacionalni odbor za klinične laboratorijske standarde [National Committee for Clinical Laboratory Standard - NCCLS]).
Developmental toxicity studies in rats showed that caspofungin caused decreases in foetal body weights and an increase in the incidence of incomplete ossification of vertebra, sternebra, and skull bone at doses of 5 mg/kg that were coupled to adverse maternal effects such as signs of histamine release in pregnant rats. 
Študije toksičnega vpliva na razvoj pri podganah so pokazale, da kaspofungin povzroči zmanjšanje telesne mase ploda in povečanje pojavnosti nepopolnega zakostenevanja vretenc, prsnice in lobanjskih kosti pri odmerkih 5 mg/kg, kar je povezano z neželenimi učinki pri materi, kot so znaki sproščanja histamina pri brejih podganah.
Caspofungin Accord makes fungal cells fragile and stops the fungus from growing properly. 
Zdravilo Kaspofungin Accord povzroča krhkost glivnih celic in ustavi pravilno rast gliv.
• rash, itching, feeling warm, swelling of your face, lips or throat or difficulty breathing - you may be having a histamine reaction to the medicine. 
• izpuščaj, srbenje, občutek vročine, otekanje obraza, ustnic ali žrela ali težave pri dihanju morda imate histaminsko reakcijo na zdravilo,
Caspofungin is not dialysable, thus supplementary dosing is not required following haemodialysis. 
Kaspofungin se ne dializira, zato po hemodializi ni potreben nadomestni odmerek.