natgillin/translations-raw huggingface dataset:
The unbound fraction of caspofungin in plasma varies from 3.5 % in healthy volunteers to 7.6 % in patients with invasive candidiasis.
Delež nevezanega kaspofungina v plazmi je od 3,5 % pri zdravih prostovoljcih do 7,6 % pri bolnikih z invazivno kandidiazo.
In elderly patients (65 years of age or more), the area under the curve (AUC) is increased by approximately 30 %.
Pri starejših bolnikih (starih 65 let ali več) se je površina pod krivuljo (AUC) povečala za približno 30 %.
There are no clinical data for caspofungin to assess its impact on fertility.
Za kaspofungin ni nobenih kliničnih podatkov, da bi lahko ocenili njegov vpliv na plodnost.
Standardised techniques for susceptibility testing have been established for yeasts by EUCAST.
Standardizirane tehnike za preizkušanje občutljivosti je za kvasovke določil EUCAST.
• serious fungal infections in your tissues or organs (called ‘invasive candidiasis').
• resnih glivnih okužb v vaših tkivih ali organih (imenovanih "invazivna kandidaza").
If you are pregnant or breast-feeding ,think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite to zdravilo.
If this occurs, Caspofungin should be discontinued and appropriate treatment administered.
Če se ta pojavi, je treba Kaspofungin Accord ukiniti in uporabiti ustrezno zdravljenje.
Caspofungin is extensively bound to albumin.
Kaspofungin se močno veže na albumin.
Beta (1,3)-D-glucan is not present in mammalian cells.
Beta (1,3)-Dglukan ni prisoten v celicah sesalcev.
Efficacy was a secondary endpoint in this study.
Sekundarni opazovani dogodek v študiji je bila učinkovitost.
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.
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The elimination of caspofungin from plasma is slow with a clearance of 10-12 mL/min.
Izločanje kaspofungina iz plazme je počasno, očistek znaša 10-12 ml/min.
Other side effects in adults include
Ostali neželeni učinki pri odraslih so
The distribution into tissues peaked at 1.5 to 2 days after dosing when 92 % of the dose was distributed into tissues.
Porazdelitev v tkiva je dosegla največjo vrednost 1,5 do 2 dni po odmerku, ko je bilo v tkiva porazdeljenih 92 % odmerka.
This belongs to a group of medicines called anti-fungals.
Spada v skupino zdravil, imenovanih antimikotiki.
Animal studies have shown developmental toxicity (see section 5.3).
Študije na živalih so pokazale toksični vpliv na razvoj (glejte poglavje 5.3).
However, available data suggest that caspofungin continues to be well tolerated with longer courses of therapy (up to 162 days in adult patients and up to 87 days in paediatric patients).
Vendar pa razpoložljivi podatki kažejo, da bolniki kaspofungin dobro prenašajo tudi pri dolgotrajnejši terapiji (do 162 dni pri odraslih bolnikih in do 87 dni pri pediatričnih bolnikih).
Excretion is slow and the terminal half-life of radioactivity was 12 to 15 days.
Terminalni razpolovni čas radioaktivnosti je bil 12 do 15 dni.
Available pharmacodynamic/ toxicological data in animals have shown excretion of caspofungin in milk.
Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje kaspofungina v mleko.
As this was a primary therapy study, patients who were refractory to prior antifungal agents were also excluded.
Ker je bila to študija primarnega zdravljenja, so izključili tudi bolnike, ki se bili že prej nedovzetni za antimikotična zdravila.
If you are worried that you may have been given too much Caspofungin Accord, tell your doctor or nurse straight away.
Če pa vas skrbi, da ste morda dobili prevelik odmerek zdravila Kaspofungin Accord, se takoj pogovorite z zdravnikom ali medicinsko sestro.
Caspofungin resistance in Candida has been observed but the incidence may differ by species or region.
Rezistenca proti kaspofunginu pri Candidi so opazili, vendar se pojavnost rezistence lahko razlikuje glede na vrsto ali območje.
Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Prosimo, obvestite zdravnika, medicinsko sestro ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The following adverse reactions were reported:
Poročali so o naslednjih neželenih učinkih:
• cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.
• kašelj, resne težave pri dihanju - če ste odrasli in imate invazivno aspergilozo, imate lahko resne težave z dihanjem, ki lahko povzročijo zastoj dihanja.
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).
Pričakovati je večjo izpostavitev kot pri bolnikih z zmerno jetrno okvaro, zato je treba pri njih kaspofungin previdno uporabljati (glejte poglavji 4.2 in 5.2).
It is likely that only a small fraction of the caspofungin taken up into tissues later returns to plasma as parent compound.
Verjetno je, da se samo majhen delež kaspofungina, ki se porazdeli v tkiva, pozneje vrne v plazmo v obliki nespremenjene učinkovine.
There is no information to suggest that Caspofungin Accord affects your ability to drive or operate machinery.
Ni podatkov, ki bi kazali, da zdravilo Kaspofungin Accord vpliva na sposobnost vožnje ali upravljanja s stroji.
Overall, the available pharmacokinetic, efficacy, and safety data are limited in patients 3 to 10 months of age.
V celoti je podatkov o farmakokinetiki, učinkovitosti in varnosti, ki so na voljo pri bolnikih, starih od 3 do 10 mesecev, malo.
This infection is caused by a mould called Aspergillus.
Te okužbe povzroča plesen, imenovana Aspergilus.
• 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.
• glivnih okužb v vašem nosu, obnosnih votlinah ali pljučih (imenovanih "invazivna aspergiloza"), če druga protiglivna zdravljenja niso bila učinkovita ali so povzročala neželene učinke.
Women receiving caspofungin should not breast-feed.
Ženske, ki dobivajo kaspofungin, ne smejo dojiti.
Caspofungin Accord is used to treat the following infections in children, adolescents and adults:
Za kaj se uporablja zdravilo Kaspofungin Accord Zdravilo Kaspofungin Accord se uporablja za zdravljenje naslednjih okužb pri otrocih, mladostnikih in odraslih:
* 10.5 mL should be used for reconstitution of all vials.
*Za rekonstitucijo vseh vial je treba uporabiti 10,5 ml vehikla.
In general, treatment should continue for at least 7 days after resolution of symptoms.
Na splošno naj zdravljenje traja vsaj še 7 dni po prenehanju simptomov.
• phenytoin or carbamazepine (used for the treatment of seizures)
• fenitoin ali karbamezapin (ki se uporabljata za zdravljenje napadov krčev)
Duration of empirical therapy should be based on the patient's clinical response.
Trajanje empiričnega zdravljenja mora temeljiti na kliničnem odzivu bolnika.
Also some other medicines can affect the way Caspofungin Accord works.
Prav tako lahko nekatera druga zdravila vplivajo na delovanje zdravila Kaspofungin Accord.
An increase in the incidence of cervical ribs was also noted.
Opazili so tudi večjo pojavnost vratnih reber.
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).
Pri pediatričnih bolnikih (starih od 12 mesecev do 17 let) je treba odmerjanje določiti glede na bolnikovo telesno površino (glejte Navodila za uporabo pri pediatričnih bolnikih, Mostellerjeva1 formula).
In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6 or 3A4.
Študije in vitro kažejo, da kaspofungin ne zavira citokrom P450 encimov 1A2, 2A6, 2C9, 2C19, 2D6 ali 3A4.
It is unknown whether caspofungin is excreted in human milk.
Ni znano, ali se kaspofungin izloča v materino mleko.
Reconstituted concentrate: should be used immediately.
Pripravljeni koncentrat je treba uporabiti takoj.
A favourable response required both symptom resolution and microbiological clearance of the Candida infection.
Za oceno ugodnega odziva sta bila potrebna tako izginitev simptomov kot mikrobiološko izginotje okužbe s Candido.
The mechanism of resistance identified is FKS1 and/or FKS2 (for C. glabrata) gene mutations.
Ugotovili so, da rezistenco omogočijo mutacije na genih FKS1 in/ali FKS2 (pri C. glabrata).
Store in a refrigerator (2C to 8C).
Shranjujte v hladilniku (2 ˚C do 8 ˚C).
Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.
Klinične in laboratorijske nepravilnosti, o katerih so poročali, so bile pri vseh odraslih, zdravljenih s kaspofunginom (skupno 1.780), ponavadi blage in so le redko vodile v prekinitev zdravljenja.
The most frequent diagnoses were bloodstream infections (candidaemia) (77 %, n=186) and Candida peritonitis (8 %, n=19); patients with Candida endocarditis, osteomyelitis, or meningitis were excluded from this study.
Najpogostejši diagnozi sta bili okužba krvi (kandidemija) (77 %, n = 186) in kandidiazni peritonitis (8 %, n = 19); bolniki s kandidiaznim endokarditisom, osteomielitisom ali meningitisom so bili iz študije izključeni.
The average exposure in an adult patient weighing 80 kg was predicted to be about 23 % lower than in an adult patient weighing 60 kg (see section 4.2).
Predvidoma je povprečna izpostavitev pri odraslem bolniku, ki tehta 80 kg, približno 23 % manjša kot pri odraslem bolniku, ki tehta 60 kg (glejte poglavje 4.2).
No dosage adjustment is necessary based on gender or race (see section 5.2).
Odmerjanja ni treba prilagoditi glede na spol ali raso (glejte poglavje 5.2).
Inadvertent administration of up to 400 mg of caspofungin in one day has been reported.
Poročali so o nenamernem zaužitju do 400 mg kaspofungina v enem dnevu.
• suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic.
• verjetnih glivnih okužb, če imate zvišano telesno temperaturo in nizko število belih krvnih celic, ki se ne izboljšata po zdravljenju z antibiotiki.
The plasma concentrations decrease with increasing weight.
Plazemske koncentracije se z naraščanjem telesne mase zmanjšajo.
For patients receiving both therapies, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are mandatory.
Pri bolnikih, ki dobivajo obe zdravili, sta nujno potrebna običajno spremljanje koncentracije takrolimusa v krvi in ustrezna prilagoditev odmerkov takrolimusa.
An independent expert panel determined that 41 % (26/63) of patients receiving at least one dose of caspofungin had a favourable response.
Neodvisni strokovni odbor je ugotovil, da je do ugodnega odziva prišlo pri 41 % (26/63) bolnikih, ki so dobili vsaj en odmerek kaspofungina.
Caution should apply in patients with history of allergic skin reaction (see section 4.8).
Previdnost je potrebna pri bolnikih z alergijskimi kožnimi reakcijami v anamnezi (glejte poglavje 4.8).
The safety and efficacy of caspofungin was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicentre clinical trials.
Varnost in učinkovitost kaspofungina so pri pediatričnih bolnikih, starih od 3 mesece do 17 let, ocenili v dveh prospektivnih, multicentričnih kliničnih preskušanjih.
• dexamethasone (a steroid)
• deksametazon (steroid)
The mean duration of intravenous therapy was 11.9 days, with a range of 1 to 28 days.
Intravensko zdravljenje je v povprečju trajalo 11,9 dneva, z razponom od 1 do 28 dni.
The efficacy of caspofungin against these fungal pathogens has not been established.
Učinkovitost kaspofungina proti tem glivnim patogenom ni bila ugotovljena.
All adolescents received doses >50 mg daily, and, in fact, 6 of 8 received the maximum dose of 70 mg/day.
Vsi mladostniki so dobivali odmerke >50 mg na dan in 6 od 8 jih je dobivalo največji odmerek, 70 mg/dan.
Duration of treatment of invasive candidiasis should be based upon the patient's clinical and microbiological response.
Trajanje zdravljenja invazivne kandidiaze mora temeljiti na bolnikovem kliničnem in mikrobiološkem odzivu.
Mix gently until a clear solution is obtained.
Nežno mešajte, dokler ne dobite bistre raztopine.
DOSE*
ODMEREK*
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.
Raztopino za infundiranje pripravite tako, da ustrezno količino pripravljenega koncentrata (kot je prikazano v spodnji preglednici) aseptično dodate v 250 ml infuzijsko vrečko ali steklenico.
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.
Bolnike s potrjeno glivno okužbo je treba zdraviti najmanj 14 dni, zdravljenje pa se mora nadaljevati vsaj še 7 dni po tem, ko nevtropenija in klinični simptomi izginejo.
• Treatment of invasive candidiasis in adult or paediatric patients.
• Zdravljenje invazivne kandidiaze pri odraslih ali pediatričnih bolnikih.
After reconstitution and dilution, the solution should be administered by slow intravenous infusion over approximately 1 hour.
Po rekonstituciji in redčenju je treba raztopino aplicirati v počasni, približno enourni intravenski infuziji.
Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicinal product (see section 2).
Bolniki z redko dedno intoleranco za fruktozo ali s pomanjkanjem saharaze - izomaltaze ne smejo uporabljati tega zdravila (glejte poglavje 2).
Your doctor will decide how much Caspofungin Accord you need and for how long each day.
Zdravnik se bo odločil, koliko zdravila Kaspofungin Accord boste prejeli dnevno in trajanje zdravljenja.
Further metabolism involves peptide hydrolysis and N-acetylation.
V nadaljnji presnovi pride do peptidne hidrolize in N-acetilacije.
• 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
• zvišan krvni tlak in spremembe nekaterih laboratorijskih izvidov krvi (vključno z ledvičnimi elektroliti in s testi strjevanja krvi), zvišane koncentracije zdravil, ki jih uporabljate in oslabijo imunski sistem
In patients who were treated empirically or who had invasive candidiasis, a similar modest effect of age was seen in older patients relative to younger patients.
Pri bolnikih, ki so se zdravili empirično, ali so imeli invazivno kandidiazo je bil pri starejših bolnikih v primerjavi z mlajšimi bolniki opazen podoben zmeren vpliv starosti.
Increased caspofungin exposure was seen in adult patients with renal impairment and mild liver impairment, in female subjects, and in the elderly.
Večjo izpostavitev kaspofunginu so opazili pri odraslih bolnikih z ledvično okvaro in blago jetrno okvaro, pri ženskah in pri starejših.
Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.
Pri bolnikih z invazivno aspergilozo so poročali tudi o pljučnem edemu, sindromu dihalne stiske pri odraslih (ARDS) in rentgensko vidnih infiltratih.
This finding may indicate that paediatric patients will have similar reductions with inducers as seen in adults.
To lahko kaže, da induktorji pri pediatričnih bolnikih povzročijo podobno zmanjšanje, kot je bilo ugotovljeno pri odraslih.
• Changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood cells and white blood cells)
• spremembe nekaterih laboratorijskih izvidov krvi (vključno z motnjami strjevanja krvi, trombocitov, rdečih krvnih celic in belih krvnih celic)
** If 70 mg vial is not available, the 70 mg dose can be prepared from two 50 mg vials
**Če 70 ml viala ni na voljo, lahko 70 ml odmerek pripravite iz dveh 50 ml vial.
• Loss of appetite, increase in amount of body fluid, imbalance of salt in the body, high sugar level in the blood, low calcium level in the blood, increase calcium level in the blood, low magnesium level in the blood, increase in acid level in the blood
• izguba apetita, povečanje količine telesne tekočine, porušeno ravnotežje soli v telesu, visoke vrednosti sladkorja v krvi, nizke vrednosti kalcija v krvi, zvišane vrednosti kalcija v krvi, nizke vrednosti magnezija v krvi, zvišanje vrednosti kisline v krvi
Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
Obvestite zdravnika, medicinsko sestro ali farmacevta, če jemljete katero od naslednjih zdravil:
To reconstitute the powder, bring the vial to room temperature and aseptically add 10.5 mL of water for injection.
Za pripravo koncentrata prenesite vialo na sobno temperaturo in vanjo aseptično dodajte 10,5 ml vode za injekcije.
Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea lozoyensis.
Kaspofunginijev acetat je polsintetična lipopeptidna (ehinokandin) spojina, sintetizirana iz fermentacijskega produkta Glarea-e lozoyensis.
• you are already taking cyclosporin (used to help prevent organ transplant rejection or to suppress your immune system) - as your doctor may need to run extra blood tests during your treatment.
• če že jemljete ciklosporin (ki se uporablja za preprečevanje reakcije zavrnitve presajenega organa ali za zaviranje vašega imunskega sistema) - zdravnik se bo med zdravljenjem morda odločil za dodatne preiskave krvi.
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 %.
V dveh kliničnih študijah pri zdravih odraslih preiskovancih je ciklosporin A (en odmerek 4 mg/kg ali dva odmerka 3 mg/kg v 12-urnem razmiku) povečal AUC kaspofungina za približno 35 %.
The study excluded patients with suspected Candida endocarditis, meningitis, or osteomyelitis.
Iz študije so izključili bolnike s sumom na kandidiazni endokarditis, meningitis ali osteomielitis.
Stringent definitions, modelled after the Mycoses Study Group Criteria, were used for diagnosis of invasive aspergillosis and for response to therapy (favourable response required clinically significant improvement in radiographs as well as in signs and symptoms).
Za diagnozo invazivne aspergiloze in odziv na zdravljenje so uporabili stroge definicije, oblikovane po merilih Mycoses Study Group (za ugoden odziv je bilo potrebno klinično pomembno izboljšanje tako radiogramov kot tudi znakov in simptomov).
The second study was a prospective, open-label, non-comparative study estimating the safety and efficacy of caspofungin in paediatric patients (ages 6 months to 17 years) with invasive candidiasis, esophageal candidiasis, and invasive aspergillosis (as salvage therapy).
Druga študija je bila prospektivna, odprta, neprimerjalna študija varnosti in učinkovitosti kaspofungina pri pediatričnih bolnikih (starih od 6 mesecev do 17 let) z invazivno kandidiazo, ezofagealno kandidiazo in invazivno aspergilozo (kot rešilno zdravljenje).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER
VSEBINA IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT DRUGI PODATKI
PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
PRIPRAVA RAZTOPINE ZA INFUNDIRANJE ZA ODRASLE
Caspofungin Accord may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Zdravilo Kaspofungin Accord lahko povzroči tudi resne kožne neželene učinke, kot npr. StevensJohnsonov sindrom (SJS) in toksično epidermalno nekrolizo (TEN).
There are no or limited data from the use of caspofungin in pregnant women.
Podatkov o uporabi kaspofungina pri nosečnicah ni oziroma so omejeni.
• Caspofungin Accord has not been studied in pregnant women.
• Uporabe zdravila Kaspofungin Accord pri nosečnicah niso preučevali.
Caspofungin is not a substrate for P-glycoprotein and is a poor substrate for cytochrome P450 enzymes.
Kaspofungin ni substrat za P-glikoprotein in je šibek substrat za encime sistema citokrom P450.
Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see below “Instructions of how to reconstitute and dilute Caspofungin Accord”).
Zdravilo lahko pripravi le usposobljeni zdravstveni delavec, ki je prebral celotno navodilo (v nadaljevanju glejte "Navodilo za pripravo in razredčevanje zdravila Kaspofungin Accord").
If you have been given more Caspofungin Accord than you should
Če ste uporabili večji odmerek zdravila Kaspofungin Accord, kot bi smeli
However, in adult patients with invasive candidiasis, oesophageal candidiasis, or invasive aspergillosis who received multiple daily doses of caspofungin 50 mg, there was no significant effect of mild to advanced renal impairment on caspofungin concentrations.
Vendar pa pri odraslih bolnikih z invazivno kandidiazo, ezofagealno kandidiazo ali z invazivno aspergilozo, ki so dobivali kaspofungin 50 mg v večkratnih dnevnih odmerkih, blaga do napredovala ledvična okvara ni pomembno vplivala na koncentracijo kaspofungina.
The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.
Dnevni vzdrževalni odmerek ne sme preseči 70 mg, ne glede na izračunani odmerek za bolnika.
• The active substance is caspofungin.
• Zdravilna učinkovina je kaspofungin.
The incidence of resistance to caspofungin by various clinical isolates of Aspergillus is rare.
Pojavnost rezistence na kaspofungin pri različnih kliničnih izolatih vrste Candida in Aspergillus je redka.
Caspofungin acetate inhibits the synthesis of beta (1,3)-D-glucan, an essential component of the cell wall of many filamentous fungi and yeast.
Kaspofunginijev acetat zavira sintezo beta (1,3)-Dglukana, ki je bistvena sestavina celične stene številnih filamentoznih gliv in kvasovk.
What Caspofungin Accord is and what it is used for
Kaj je zdravilo Kaspofungin Accord in za kaj ga uporabljamo
For those patients who received more than 7 days of therapy with caspofungin, 50 % (26/52) had a favourable response.
Med bolniki, ki so se s kaspofunginom zdravili več kot 7 dni, se jih je na zdravljenje ugodno odzvalo 50 % (26/52).
This medicinal product contains sucrose.
To zdravilo vsebuje saharozo.
In adult patients with moderate liver impairment or in higher weight patients, a dosage adjustment may be necessary (see below).
Pri odraslih bolnikih z zmerno jetrno okvaro ali večjo telesno maso je lahko potrebna prilagoditev odmerka (glejte nadaljevanje).
In this group of patients, the safety of caspofungin at this higher dose appeared generally similar to patients receiving the 50-mg daily dose of caspofungin.
Kaže, da je v tej skupini bolnikov varnost kaspofungina pri višjem odmerku na splošno podobna kot pri bolnikih, ki so prejemali 50 mg odmerek kaspofungina na dan.
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