natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD to Merck Sharpe and Dohme Limited on 24 October 2001.
Evropska komisija je dovoljenje za promet z zdravilom Caspofungin MSD, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharpe and Dohme Limited dne 24. oktobra 2001.
The marketing authorisation was renewed on 24 October 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 24. oktobra 2006.
The full EPAR for Cancidas is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cancidas je na voljo tukaj.
Powder for concentrate for solution for infusion
Prašek za koncentrat za raztopino za infundiranje
vial (glass)
Intravenska viala (steklena) uporaba
Each vial contains 50 mg caspofungin (as acetate).
Ena viala vsebuje 50 mg kaspofungina (v obliki acetata).
Each 50mg vial contains 35.7 mg of sucrose.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
White to off-white compact, lyophilised powder.
Bel do sivobel kompakten, liofiliziran prašek.
• Treatment of invasive candidiasis in adult or paediatric patients. • 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 kandidiaze pri odraslih ali pediatričnih bolnikih. • 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.
Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. • Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.
Nedovzetnost pomeni, da po najmanj 7 dneh prejemanja terapevtskih odmerkov učinkovitega protiglivičnega zdravila okužba še vedno napreduje ali se stanje ne izboljša. • Empirično zdravljenje domnevnih glivičnih okužb (npr. s Candido ali Aspergillusom) pri febrilnih, nevtropeničnih odraslih ali pediatričnih bolnikih.
CANCIDAS should be initiated by a physician experienced in the management of invasive fungal infections.
Zdravljenje z zdravilom CANCIDAS mora uvesti zdravnik z izkušnjami pri zdravljenju invazivnih glivičnih okužb.
After reconstitution and dilution, the solution should be administered by slow intravenous infusion over approximately 1 hour.
Po pripravi in razredčenju je treba raztopino dati v počasni, približno enourni intravenski infuziji.
Do not mix or co-infuse CANCIDAS with other medicines, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products.
Zdravila CANCIDAS ne mešajte in ne infundirajte sočasno z drugimi zdravili, ker ni podatkov o kompatibilnosti zdravila CANCIDAS in drugih učinkovin, aditivov ali zdravil za intravensko uporabo.
DO NOT USE DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in diluents containing glucose.
NE UPORABLJAJTE RAZTOPIN, KI VSEBUJEJO GLUKOZO, ker CANCIDAS v njih ni stabilen.
For reconstitution directions see section 6.6.
Navodila za pripravo so v poglavju 6. 6.
CANCIDAS should be given as a single daily infusion.
Zdravilo CANCIDAS se daje v obliki infuzije enkrat na dan.
Dosage in adult patients A single 70 mg loading dose should be administered on Day-1, followed by 50 mg daily thereafter.
Odmerjanje pri odraslih bolnikih Prvi dan je potreben en uvajalni odmerek 70 mg, ki mu nato sledijo odmerki 50 mg dnevno.
In patients weighing more than 80 kg, after the initial 70 mg loading dose, CANCIDAS 70 mg daily is recommended (see section 5.2).
Pri bolnikih, težjih od 80 kg, po začetnem uvajalnem odmerku 70 mg priporočamo CANCIDAS v odmerku 70 mg dnevno (glejte poglavje 5. 2).
Doses higher than 70 mg daily have not been adequately studied.
Odmerki, večji od 70 mg na dan, niso ustrezno raziskani.
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).
2 Dosage in paediatric patients (12 months to 17 years) 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, Mosteller 1 Formula).
2 Odmerjanje pri pediatričnih bolnikih (starih od 12 mesecev do 17 let) 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, Mostellerjeva 1 formula).
For all indications, a single 70-mg/ m2 loading dose (not to exceed an actual dose of 70 mg) should be administered on Day 1, followed by 50 mg/ m2 daily thereafter (not to exceed an actual dose of 70 mg daily).
Za vse indikacije je treba 1. dan uporabiti en uvajalni odmerek 70 mg/ m2 (vendar absolutni odmerek ne sme preseči 70 mg), čemur sledi uporaba 50 mg/ m2 (pri čemer absolutni odmerek ne sme preseči 70 mg na dan).
If the 50- mg/ m2 daily dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg/ m2 daily (not to exceed an actual daily dose of 70 mg).
Če bolnik dnevni odmerek 50 mg/ m2 dobro prenaša, vendar ta odmerek ne prinese ustreznega kliničnega odziva, je mogoče dnevni odmerek povečati na 70 mg/ m2 na dan (pri čemer absolutni dnevni odmerek ne sme preseči 70 mg).
The efficacy and safety of CANCIDAS have not been sufficiently studied in clinical trials involving neonates and infants below 12 months of age.
Učinkovitost in varnost zdravila CANCIDAS nista dovolj raziskani v kliničnih preskušanjih, ki bi zajela novorojenčke in dojenčke, mlajše od 12 mesecev.
Limited data suggest that CANCIDAS at 25 mg/ m2 daily in neonates and infants (less than 3 months of age) and 50 mg/ m2 daily in young children (3 to 11 months of age) can be considered (see section 5.2).
Nekateri podatki nakazujejo, da pride pri novorojenčkih in dojenčkih (starih manj kot 3 mesece) v poštev zdravljenje z zdravilom CANCIDAS v odmerku 25 mg/ m2 na dan, pri majhnih otrocih (starih od 3 do 11 mesecev) pa v odmerku 50 mg/ m2 na dan (glejte poglavje 5. 2).
Duration of treatment Duration of empirical therapy should be based on the patient’ s clinical response.
Trajanje zdravljenja Trajanje empiričnega zdravljenja mora temeljiti na kliničnem odzivu bolnika.
Therapy should be continued until up to 72 hours after resolution of neutropaenia (ANC≥ 500).
Zdravljenje se mora nadaljevati še 72 ur po koncu nevtropenije (absolutno število nevtrofilcev ≥ 500).
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 glivično okužbo je treba zdraviti najmanj 14 dni, zdravljenje pa se mora nadaljevati vsaj še 7 dni po koncu nevtropenije in kliničnih simptomov.
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.
After signs and symptoms of invasive candidiasis have improved and cultures have become negative, a switch to oral antifungal therapy may be considered.
Ko se znaki in simptomi invazivne kandidiaze izboljšajo in kulture postanejo negativne, je mogoče razmisliti o prehodu na peroralno antimikotično zdravljenje.
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.
Temelji naj na resnosti bolnikove osnovne bolezni, okrevanju od imunosupresije in kliničnem odzivu.
Dosage in elderly patients In elderly patients (65 years of age or more), the area under the curve (AUC) is increased by approximately 30%.
Odmerjanje pri starejših bolnikih Pri starejših bolnikih (starih 65 let ali več) se je površina pod krivuljo (AUC) povečala za približno 30%.
However, no systematic dosage adjustment is required.
Vendar pa sistematično prilagajanje odmerka ni potrebno.
There is limited treatment experience in patients 65 years of age and older.
Izkušnje z zdravljenjem bolnikov, starih 65 let ali več, so omejene.
Dosage in patients with renal impairment No dosage adjustment is necessary based on renal impairment (see section 5.2).
Odmerjanje pri bolnikih z okvaro ledvic Prilagajanje odmerka glede na ledvično okvaro ni potrebno (glejte poglavje 5. 2).
Dosage in patients with hepatic insufficiency For adult patients with mild hepatic insufficiency (Child-Pugh score 5 to 6), no dosage adjustment is needed.
Odmerjanje pri bolnikih z insuficienco jeter Pri odraslih bolnikih z blago jetrno okvaro (stopnja Child- Pugh 5 do 6 točk) prilagoditev odmerka ni potrebna.
For adult patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), CANCIDAS 35 mg daily is recommended based upon pharmacokinetic data.
Pri odraslih bolnikih z zmerno jetrno okvaro (stopnja Child- Pugh 7 do 9 točk) priporočamo CANCIDAS v odmerku 35 mg dnevno, glede na farmakokinetične podatke.
An initial 70 mg loading dose should be administered on Day-1.
Prvi dan je treba dati uvodni 70 mg uvajalni odmerek.
(see section 4.4).
Kliničnih izkušenj pri odraslih bolnikih s hudo jetrno okvaro (stopnja Child- Pugh nad 9 točk) in pri pediatričnih bolnikih ne glede na stopnjo okvare jeter nimamo (glejte poglavje 4. 4).
Co-administration with inducers of metabolic enzymes Limited data suggest that an increase in the daily dose of CANCIDAS to 70 mg, following the 70 mg loading dose, should be considered when co-administering CANCIDAS in adult patients with certain inducers of metabolic enzymes (see section 4.5).
Sočasna uporaba z induktorji presnovnih encimovNekateri podatki nakazujejo, da je treba pri odraslih bolnikih v primeru sočasne uporabe zdravila CANCIDAS z določenimi induktorji presnovnih encimov razmisliti o povečanju dnevnega odmerka zdravila CANCIDAS na 70 mg (po 70- mg uvajalnem odmerku) (glejte poglavje 4. 5).
When CANCIDAS is co-administered to paediatric patients (12 months to 17 years of age) with these same inducers of metabolic enzymes (see section 4.5), a CANCIDAS dose of 70-mg/ m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
Če je zdravilo CANCIDAS uporabljeno pri pediatričnih bolnikih (starih od 12 mesecev do 17 let) sočasno s temi induktorji presnovnih encimov (glejte poglavje 4. 5), je treba razmisliti o uporabi zdravila CANCIDAS v odmerku 70 mg/ m2 na dan (pri čemer pa absolutni dnevni odmerek ne sme preseči 70 mg).
3 4.3 Contraindications
3 4. 3 Kontraindikacije
Limited data suggest that less common non-Candida yeasts and non-Aspergillus moulds are not covered by caspofungin.
Nekaj podatkov kaže, da kaspofungin morda ne deluje proti manj običajnim vrstam gliv, vendar ne iz vrst Candida ali Aspergillus.
The efficacy of caspofungin against these fungal pathogens has not been established.
Učinkovitost kaspofungina proti tem glivičnim patogenom ni bila ugotovljena.
Concomitant use of CANCIDAS with cyclosporin has been evaluated in healthy adult volunteers and in adult patients.
Sočasno zdravljenje z zdravilom CANCIDAS in ciklosporinom so preučevali tako pri zdravih odraslih prostovoljcih kot pri odraslih bolnikih.
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.
In a retrospective study of 40 patients treated during marketed use with CANCIDAS and cyclosporin for 1 to 290 days (median 17.5 days), no serious hepatic adverse events were noted.
V retrospektivni raziskavi 40 bolnikov, ki so med trženjem zdravila dobili CANCIDAS in ciklosporin 1- 290 dni (povprečno 17, 5 dni), niso opazili resnih neželenih učinkov na jetra.
These data suggest that CANCIDAS can be used in patients receiving cyclosporin when the potential benefit outweighs the potential risk.
Ti podatki kažejo, da se CANCIDAS lahko uporablja pri bolnikih, ki prejemajo ciklosporin, če pričakovana korist odtehta morebitno tveganje.
Close monitoring of liver enzymes should be considered if CANCIDAS and cyclosporin are used concomitantly.
Pri sočasni uporabi zdravila CANCIDAS in ciklosporina je treba razmisliti o skrbnem spremljanju jetrnih encimov.
In adult patients with mild and moderate hepatic impairment, the AUC is increased about 20 and 75%, respectively.
Pri odraslih bolnikih z blago jetrno okvaro se je AUC povečal za 20%, pri odraslih bolnikih z zmerno jetrno okvaro pa za 75%.
There is no clinical experience in adults with severe hepatic insufficiency or in paediatric patients with any degree of hepatic insufficiency.
Kliničnih izkušenj pri odraslih bolnikih s hudo jetrno okvaro in pri pediatričnih bolnikih ne glede na stopnjo okvare jeter nimamo.
A higher exposure than in moderate hepatic insufficiency is expected and CANCIDAS should be used with caution in these patients (see sections 4.2 and 5.2).
Pričakovati je, da imajo večjo izpostavitev kot bolniki z zmerno jetrno okvaro, zato moramo pri njih CANCIDAS previdno uporabljati (glejte poglavji 4. 2 in 5. 2).
Patients with rare hereditary problems of fructose intolerance or sucrase– isomaltase insufficiency should not take this medicinal product.
Bolniki z redko dedno intoleranco za fruktozo ali pomanjkanjem saharaze – izomaltaze ne smejo jemati tega zdravila.
Studies in vitro show that caspofungin acetate is not an inhibitor of any enzyme in the cytochrome P450 (CYP) system.
Raziskave in vitro kažejo, da kaspofunginijev acetat ne zavira nobenega od encimov sistema citokrom P450 (CYP).
In clinical studies, caspofungin did not induce the CYP3A4 metabolism of other substances.
V kliničnih raziskavah kaspofungin ni induciral presnove drugih snovi z encimom CYP3A4.
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.
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 raziskavah pokazale interakcije kaspofungina z drugimi zdravili (glejte nadaljevanje).
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 raziskavah 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%.
CANCIDAS did not increase the plasma levels of cyclosporin.
CANCIDAS ni povečal plazemskih koncentracij ciklosporina.
There were transient increases in liver ALT and AST of less than or equal to 3-fold the upper limit of normal (ULN) when CANCIDAS and cyclosporin were co-administered, that resolved with discontinuation of the medicinal products.
Pri sočasnem dajanju zdravila CANCIDAS in ciklosporina je prišlo do prehodnega povečanja jetrne ALT in AST, ki je bilo manjše ali enako trikratni zgornji meji normalne vrednosti in ki se je po ukinitvi zdravil normaliziralo.
In a retrospective study of 40 patients treated during marketed use with CANCIDAS and cyclosporin for 1 to 290 days (median 17.5 days), no serious hepatic adverse events were noted (see section 4.4).
V retrospektivni raziskavi 40 bolnikov, ki so se med trženjem zdravila zdravili z zdravilom CANCIDAS in ciklosporinom 1- 290 dni (povprečno 17, 5 dni), niso opazili resnih neželenih učinkov na jetra (glejte poglavje 4. 4).
Close monitoring of liver enzymes should be considered if the two medicinal products are used concomitantly.
Pri sočasni uporabi teh dveh zdravil je treba razmisliti o skrbnem spremljanju jetrnih encimov.
CANCIDAS reduced the trough concentration of tacrolimus by 26% in healthy adult volunteers.
Zdravilo CANCIDAS je pri zdravih odraslih prostovoljcih zmanjšalo koncentracijo takrolimusa, izmerjeno tik pred naslednjim odmerkom, za 26%.
For patients receiving both therapies, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are mandatory.
Pri bolnikih, ki dobivajo obe zdravili, je nujno potrebno običajno spremljanje koncentracije takrolimusa v krvi in ustrezno prilagajanje odmerkov takrolimusa.
4 rifampicin or mycophenolate mofetil.
4 Klinične raziskave pri zdravih odraslih prostovoljcih kažejo, da itrakonazol, amfotericin B, mikofenolat, nelfinavir in takrolimus farmakokinetike zdravila CANCIDAS ne spremenijo v klinično pomembni meri.
Rifampicin caused a 60% increase in AUC and 170% increase in trough concentration of caspofungin on the first day of co-administration when both medicinal products were initiated together in healthy adult volunteers.
Rifampicin je prvi dan sočasnega zdravljenja s kaspofunginom povzročil 60% povečanje AUC kaspofungina in 170% povečanje koncentracije kaspofungina, izmerjene tik pred naslednjim odmerkom, če je bilo zdravljenje z obema zdraviloma uvedeno hkrati pri zdravih odraslih prostovoljcih.
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.
Limited data from population pharmacokinetics studies indicate that concomitant use of CANCIDAS with the inducers efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, or carbamazepine may result in a decrease in caspofungin AUC.
Omejeni podatki iz populacijskih farmakokinetičnih raziskav kažejo, da lahko sočasna uporaba zdravila CANCIDAS z induktorji efavirenzom, nevirapinom, rifampicinom, deksametazonom, fenitoinom ali karbamazepinom povzroči zmanjšanje AUC kaspofungina.
When co-administering inducers of metabolic enzymes, an increase in the daily dose of CANCIDAS to 70 mg, following the 70 mg loading dose, should be considered in adult patients (see section 4.2).
Pri sočasnem zdravljenju z induktorji presnovnih encimov moramo razmisliti o povečanju dnevnega odmerka zdravila CANCIDAS na 70 mg, po 70 mg uvajalnem odmerku pri odraslih bolnikih (glejte poglavje 4. 2).
In paediatric patients, results from regression analyses of pharmacokinetic data suggest that co-administration of dexamethasone with CANCIDAS may result in clinically meaningful reductions in caspofungin trough concentrations.
Rezultati regresijske analize farmakokinetičnih podatkov pri pediatričnih bolnikih kažejo, da lahko sočasna uporaba deksametazona in zdravila CANCIDAS klinično pomembno zmanjša koncentracijo kaspofungina, izmerjeno tik pred naslednjim odmerkom.
This finding may indicate that paediatric patients will have similar reductions with inducers as seen in adults.
To morda kaže, da induktorji pri pediatričnih bolnikih povzročijo podobno zmanjšanje, kot je ugotovljeno pri odraslih.
When CANCIDAS is co-administered to paediatric patients (12 months to 17 years of age) with inducers of drug clearance, such as rifampicin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a CANCIDAS dose of 70-mg/ m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
Če je zdravilo CANCIDAS uporabljeno pri pediatričnih bolnikih (starih od 12 mesecev do 17 let) sočasno z induktorji očistka zdravila, kakršni so rifampicin, efavirenz, nevirapin, fenitoin, deksametazon ali karbamazepin, je treba razmisliti o uporabi zdravila CANCIDAS v odmerku 70 mg/ m2 na dan (pri čemer pa absolutni dnevni odmerek ne sme preseči 70 mg).
For CANCIDAS, no clinical data on exposed pregnancies are available.
Kliničnih podatkov o uporabi zdravila CANCIDAS med nosečnostjo ni.
Caspofungin should not be used during pregnancy unless clearly necessary.
Kaspofungina se v nosečnosti ne sme uporabljati, razen če je to nujno potrebno.
There are no adequate data from the use of caspofungin in pregnant women.
O uporabi kaspofungina pri nosečnicah ni zadostnih podatkov.
Developmental studies in animals have shown adverse effects (see section 5.3).
Razvojne raziskave pri živalih so pokazale neželene učinke (glejte poglavje 5. 3).
Caspofungin has been shown to cross the placental barrier in animal studies.
V raziskavah na živalih je kaspofungin prehajal skozi posteljico.
The potential risk to the human foetus is unknown.
Možno tveganje za človeški plod ni znano.
Caspofungin is excreted in milk of lactating animals.
Kaspofungin se izloča v mleku doječih živali.
It is not known whether it is excreted in human milk.
Ni znano, ali se izloča v materino mleko.
Adult patients In clinical studies, 1440 adult individuals received single or multiple doses of CANCIDAS:
Odrasli bolniki V kliničnih raziskavah je 1440 odraslih oseb dobilo posamične ali večkratne odmerke zdravila CANCIDAS:
564 febrile neutropaenic patients (empirical therapy study), 125 patients with invasive candidiasis, 72 patients with invasive aspergillosis, 285 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies.
564 bolnikov z febrilno nevtropenijo (raziskava empiričnega zdravljenja), 125 bolnikov z invazivno kandidiazo, 72 bolnikov z invazivno aspergilozo, 285 bolnikov z lokaliziranimi okužbami s Candido in 394 oseb vključenih v raziskave I. faze.
In the empirical therapy study patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation (including 39 allogeneic transplantations).
Bolniki v raziskavi empiričnega zdravljenja so dobivali kemoterapijo zaradi malignoma ali so prestali presaditev hematopoetskih matičnih celic (vključno z 39 alogenskimi presaditvami).
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 raziskavah bolnikov 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
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 raziskavi 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.
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.
5 Reported clinical and laboratory abnormalities among all adult patients treated with CANCIDAS (total 989) were typically mild and rarely led to discontinuation.
Klinične in laboratorijske nepravilnosti, o katerih so poročali, so bile pri vseh odraslih bolnikih, zdravljenih z zdravilom CANCIDAS (skupno 989), ponavadi blage in so le redko vodile v prekinitev zdravljenja.
The following adverse reactions were reported:
Opisani so bili naslednji neželeni učinki: