natgillin/translations-raw huggingface dataset:
Mycamine should be administered once daily by slow intravenous (into a vein) infusion.
Mycamine je treba uporabiti enkrat na dan s počasnim intravenskim infundiranjem (dajanjem v veno).
The plastic cap must be removed from the vial and the stopper disinfected with alcohol.
Plastično zaporko je treba sneti z viale in zamašek dezinficirati z alkoholom.
Your doctor has prescribed Mycamine for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2):
Zdravnik vam je zdravilo Mycamine predpisal v naslednjih okoliščinah, kadar na razpolago ni drugega primernega zdravljenja proti glivam (glejte 2. poglavje):
Consequently, the occurrence of these adverse responses may be expected in human clinical use of micafungin.
Posledično se lahko pojavnost teh neželenih učinkov pričakuje pri klinični uporabi mikafungina pri človeku.
- if you are allergic to micafungin, other echinocandins (Ecalta or Cancidas) or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na mikafungin, druge ehinokandine (Ecalta ali Cancidas) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Pharmacotherapeutic group: Antimycotics for systemic use, other antimycotics for systemic use, ATC code: J02AX05
Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, drugi antimikotiki za sistemsko zdravljenje, oznaka ATC: J02AX05
In a second 26-week study hyperplasia of transitional cells in the urinary bladder occurred with a much lower incidence.
V drugi 26-tedenski študiji pa se je hiperplazija prehodnih celic v sečnem mehurju pojavila z veliko manjšo incidenco.
The reconstituted concentrate and the diluted infusion solution should be used immediately, because it does not contain any preservatives to prevent bacterial contamination.
Koncentrat in razredčeno raztopino za infundiranje je treba uporabiti takoj, saj ne vsebuje konservansov, ki preprečujejo onesnaženje z bakterijami.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Other medicines and Mycamine
Druga zdravila in zdravilo Mycamine
The vial is wrapped with an UV-protective film.
Viala je prevlečena z UV-zaščitnim slojem.
The relevance of the hepatocarcinogenic potential of micafungin for the human therapeutic use is not known.
Pomembnost hepatokarcinogenega potenciala mikafungina pri zdravljenju ljudi ni znana.
Other breakthrough infections were caused by Fusarium (1 and 2 patients, respectively) and Zygomycetes (1 and 0 patients, respectively).
Druge prebojne okužbe so povzročili Fusarium (1 oz. 2 bolnika) in Zygomycetes (1 oz. nič bolnikov).
The MAH should agree the final content, format and distribution modalities of the Prescriber checklist with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Imetnik dovoljenja za promet z zdravilom se bo z nacionalnim pristojnim organom v vsaki državi članici dogovoril o končni vsebini, obliki in načinu razdeljevanja Kontrolnega seznama ter zagotovil, da bo gradivo vsebovalo ključne elemente, kot je opisano v nadaljevanju.
Animal studies have shown excretion of micafungin in breast milk.
Študije na živalih so pokazale izločanje mikafungina v materino mleko.
Micafungin exhibits fungicidal activity against most Candida species and prominently inhibits actively growing hyphae of Aspergillus species.
Mikafungin kaže fungicidno delovanje proti večini vrst kandida in izrazito zavira aktivno rastoče hife vrste Aspergillus.
Although the concentrate will foam, every effort should be made to minimise the amount of foam generated.
Koncentrat se bo sicer penil, vendar si je treba prizadevati, da bi količino pene karseda omejili.
This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in section 6.6.
Zdravila ne smemo mešati ali infundirati skupaj z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
Volume of sodium chloride (0.9%) or glucose (5%) to be added per vial
Volumen natrijevega klorida (0,9 %) ali glukoze (5 %), ki se ga doda na vialo
However, once these results become available, antifungal therapy should be adjusted accordingly.
Ko pa so rezultati na voljo, je treba temu ustrezno prilagoditi tudi antimikotično terapijo.
Invasive candidiasis: The treatment duration of Candida infection should be a minimum of 14 days.
Invazivna kandidoza: zdravljenje okužbe s kandido mora trajati najmanj 14 dni.
The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.
Zdravljenje z antimikotiki je treba nadaljevati še vsaj 1 teden po dveh zaporednih negativnih rezultatih krvnih kultur in po tem, ko so klinični znaki in simptomi okužbe že izginili.
There is no evidence of systemic accumulation with repeated administration and steady-state is generally reached within 4 to 5 days.
Ni dokazov, da bi se pri ponavljajočih odmerkih zdravilo sistemsko akumuliralo, stanje dinamičnega ravnovesja pa je običajno doseženo po 4 do 5 dneh.
The duration of micafungin dosing in these rat studies (6 months) exceeds the usual duration of micafungin dosing in patients (see section 5.1).
Trajanje odmerjanja mikafungina v teh študijah pri podganah (6 mesecev) presega običajno trajanje odmerjanja mikafungina pri bolnikih (glejte poglavje 5.1).
The assumed threshold for tumour development in rats is approximately in the range of clinical exposure.
Domneven prag za razvoj tumorjev pri podganah je približno v območju klinične izpostavitve.
Only a trained healthcare professional who has read the complete directions properly can prepare this medicine for use.
To zdravilo lahko za uporabo pripravi samo usposobljen zdravstveni strokovnjak, ki je ustrezno prebral celotna navodila za uporabo.
Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery.
Obvestite zdravnika, če imate katerekoli učinke, ki lahko povzročajo težave pri upravljanju vozil in strojev.
Following a single intravenous dose of 14C-micafungin (25 mg) to healthy volunteers, 11.6% of the radioactivity was recovered in the urine and 71.0% in the faeces over 28 days.
Po aplikaciji enkratnega intravenskega odmerka 14C-mikafungina (25 mg) zdravim prostovoljcem so v 28 dneh 11,6 % radioaktivnosti zaznali v seču in 71,0 % v blatu.
The majority were of mild to moderate intensity and not treatment limiting.
Večinoma so bili blagi do zmerni in niso omejevali zdravljenja.
Mean weight-adjusted clearance in children less than 4 months of age is approximately 2.6-fold greater than older children (12-16 years) and 2.3-fold greater than in adults.
Srednja vrednost masi prilagojenega očistka pri otrocih, mlajših od 4 mesecev, je približno 2,6-krat večja kot pri starejših otrocih (12-16 let) in 2,3-krat večja kot pri odraslih.
In both studies increased incidences/numbers of hepatocellular tumours were observed after the 18 and 20 month treatment free period in the high dose group of 32 mg/kg/day as well as in a lower dose group (although not statistically significant).
V obeh študijah je bila opažena povečana incidenca/število hepatoceličnih tumorjev, ki so jih opazili po 18 in 20 mesečnih obdobjih brez zdravljenja v skupini z velikim odmerkom (32 mg/kg/dan) kot tudi v skupini z manjšim odmerkom (čeprav ni bila statistično pomembna).
Treatment success was defined as the absence of a proven, probable, or suspected systemic fungal infection through the end of therapy and absence of a proven or probable systemic fungal infection through the end of study.
Uspešnost zdravljenja je bila opredeljena kot odsotnost dokazane ali verjetne sistemske glivične okužbe oz. odsotnost suma nanjo v obdobju do konca zdravljenja ter odsotnost dokazane ali verjetne sistemske glivične okužbe na koncu študije.
If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered.
Če se tovrstne reakcije pojavijo, je treba infundiranje mikafungina prekiniti in uvesti ustrezno zdravljenje.
Astellas Ireland Co., Ltd. Killorglin, County Kerry Ireland
Astellas Ireland Co., Ltd. Killorglin, Country Kerry Irska
The rate of treatment success was statistically significantly higher for micafungin than fluconazole (1.6% versus 2.4% breakthrough infections).
Stopnja uspešnosti zdravljenja je bila pri mikafunginu značilno večja kot pri flukonazolu (1,6 % v primerjavi z 2,4 % izbruhom okužb).
This medicinal product does not require any special storage conditions.
Zdravilo ne zahteva posebnih pogojev za shranjevanje.
This means there is insufficient evidence to indicate whether the wild-type population of these pathogens can be considered susceptible to micafungin.
To pomeni, da nimamo dovolj dokazov o tem, ali so nemutirane populacije naštetih patogenov občutljive za mikafungin.
A sufficient number of vials of Mycamine must be reconstituted to obtain the required dose in mg (see table below).
Pripraviti je treba zadostno število vial zdravila Mycamine, da dobimo potrebni odmerek v miligramih (glejte spodnjo tabelo).
Mycamine is supplied in a box containing 1 vial.
Zdravilo Mycamine je na voljo v škatlicah, ki vsebujejo 1 vialo.
No standard carcinogenicity studies have been conducted but the development of FAH was assessed in female rats after up to 20 and 18 months after cessation of a 3 and 6 month treatment, respectively.
Standardne študije karcinogenosti niso bile izvedene, vendar pa je bil razvoj FAH ocenjen pri samicah podgan po preteku 20 oz. 18 mesecev po prekinitvi 3 oz. 6 mesečnega zdravljenja.
Micafungin may have the potential to affect male fertility in humans.
Obstaja možnost, da mikafungin vpliva na moško plodnost pri človeku.
However some people may feel dizzy when taking this medicine and if this happens to you, do not drive or use any tools or machines.
Vseeno se pri nekaterih bolnikih lahko pojavi omotica in če se pojavi pri vas, ne vozite in ne upravljajte orodja oz.
Unchanged micafungin is the principal circulating compound in systemic circulation.
Nespremenjeni mikafungin je glavna oblika učinkovine v sistemskem krvnem obtoku.
Gender/Race: Gender and race (Caucasian, Black and Oriental) did not significantly influence the pharmacokinetic parameters of micafungin.
Spol/rasa: Spol in rasa (bela, črna in rumena) nimata pomembnega vpliva na farmakokinetične parametre mikafungina.
Older children (12-16 years) had mean clearance values similar to those determined in adult patients.
Pri starejših otrocih (12-16 let) so bile srednje vrednosti očistka podobne kot pri odraslih bolnikih.
More rapid infusions may result in more frequent histamine mediated reactions.
Hitrejše infundiranje lahko povzroči pogostejše reakcije, v katerih ima glavno vlogo histamin.
Exposure to these metabolites is low and metabolites do not contribute to the overall efficacy of micafungin.
Izpostavljenost omenjenim presnovkom je majhna in le-ti ne prispevajo k skupni učinkovitosti mikafungina.
Micafungin has no or negligible influence on the ability to drive or use machines.
Mikafungin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
These data are insufficient to support a dosing recommendation in patients with severe hepatic impairment.
Ti podatki pa niso zadostni, da bi upravičili priporočilo za prilagoditev odmerka pri bolnikih s hudo motnjo v delovanju jeter.
The overall incidence of hepatic adverse reactions in the patients treated with micafungin in clinical studies was 8.6% (260/3028).
Celokupna incidenca neželenih učinkov na jetra je bila v kliničnih študijah pri bolnikih, ki so se zdravili z mikafunginom, 8,6 % (260/3028).
Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below.
Zdravila Mycamine se ne sme mešati ali infundirati skupaj z drugimi zdravili razen s tistimi, ki so navedena spodaj.
What Mycamine is and what it is used for
Kaj je zdravilo Mycamine in za kaj ga uporabljamo
In the clinical study, successful outcome was numerically slightly lower for C. tropicalis than for C. albicans at both dosages (100 and 150 mg daily).
klinični študiji je bil uspešen izid številčno nekoliko manjši za C. tropicalis v primerjavi s C. albicans ob obeh odmerkih (100 in 150 mg na dan).
What you need to know before you use Mycamine Do not use Mycamine
Kaj morate vedeti, preden boste uporabili zdravilo Mycamine Ne uporabljajte zdravila Mycamine
An endoscopic grade of 0 (endoscopic cure) at the end of treatment was observed for 87.7% (228/260) and 88.0% (227/258) of patients in the micafungin and fluconazole groups, respectively (95% CI for difference: [-5.9%, 5.3%]).
Endoskopska stopnja 0 (endoskopska ozdravitev) na koncu zdravljenja je bila ugotovljena pri 87,7 % (228/260) in 88,0 % (227/258) bolnikov v skupinah, ki sta prejemali mikafungin oziroma flukonazol (95-odstotni IZ za razliko: [-5,9 %, 5,3 %]).
Please tell your doctor if you have severe liver problems (e.g. liver failure or hepatitis) or have had abnormal liver function tests.
Povejte svojemu zdravniku, če imate hude težave z jetri (npr. jetrno odpoved ali hepatitis) ali ste kdaj imeli nenormalne teste delovanja jeter.
These data indicate that elimination of micafungin is primarily non-renal.
Ti podatki kažejo, da eliminacija mikafungina v veliki meri ne poteka preko ledvic.
Population PK modeling demonstrated that a dose of 10 mg/kg in children less than 4 month of age would be sufficient to achieve the target exposure for the treatment of CNS Candida infections.
FK model populacije je pokazal, da bi bil odmerek 10 mg/kg pri otrocih, mlajših od 4 mesecev, zadosten za dosego ciljne izpostavljenosti, potrebne za zdravljenje okužbe s kandido v CŽS.
There are currently insufficient data available for the use of micafungin in patients with severe hepatic impairment and its use is not recommended in these patients (see sections 4.4 and 5.2).
Trenutno ni zadostnih podatkov o uporabi mikafungina pri bolnikih s hudimi motnjami v delovanju jeter, zato uporaba zdravila pri teh bolnikih ni priporočljiva (glejte poglavji 4.4 in 5.2).
Even though micafungin is a substrate for CYP3A in vitro, hydroxylation by CYP3A is not a major pathway for micafungin metabolism in vivo.
Čeprav je mikafungin in vitro substrat CYP3A, pa hidroksilacija s CYP3A ni glavna pot presnove mikafungina in vivo.
Do not use Mycamine after the expiry date which is stated on the vial and on the carton.
Zdravila Mycamine ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli.
Efficacy findings were consistent, independent of the infective Candida species, primary site of infection and neutropenic status (see Table).
Podatki o učinkovitosti so bili skladni, ne glede na vrsto gliv kandida, ki je povzročila okužbo, primarno mesto okužbe in stanje nevtropenije (glejte tabelo).
Contents of the pack and other information What Mycamine contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Mycamine
In repeated dose toxicity studies in rat signs of hepatotoxicity consisted of increased liver enzymes and degenerative changes of hepatocytes which were accompanied by signs of compensatory regeneration.
Pri študijah toksičnosti ponavljajočih odmerkov pri podganah so se znaki hepatotoksičnosti pokazali kot povečana vrednost jetrnih encimov in kot degenerativne spremembe hepatocitov, ki so jih spremljali znaki kompenzatorne regeneracije.
What Mycamine is and what it is used for What you need to know before you use Mycamine How to use Mycamine
Kaj je zdravilo Mycamine in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Mycamine Kako uporabljati zdravilo Mycamine
Clearance was influenced by weight, with mean values of weight-adjusted clearance 1.35 times higher in the younger children (4 months to 5 years) and 1.14 times higher in paediatric patients aged 6 to 11 years.
Masa je vplivala na očistek; srednja vrednost masi prilagojenega očistka je bila 1,35 krat večja pri mlajših otrocih (4 mesece do 5 let starosti) in 1,14 krat večja pri pediatričnih bolnikih, starih od 6 do 11 let.
Micafungin and liposomal amphotericin B were received for a median duration of 15 days (range, 4 to 42 days in adults; 12 to 42 days in children).
Mediana trajanja zdravljenja z mikafunginom in liposomskim amfotericinom B je bila 15 dni (interval, 4 do 42 dni pri odraslih, 12 do 42 dni pri otrocih).
After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.
Po pripravi raztopine in redčenju je treba raztopino dati v obliki intravenske infuzije v približno eni uri.
If you miss a dose of Mycamine
Če ste izpustili odmerek zdravila Mycamine
It is not known whether micafungin is excreted in human breast milk.
Ni znano, ali se mikafungin izloča v materino mleko.
The unopened vial does not require any special storage conditions.
Zdravilo v neodprti viali ne zahteva posebnih pogojev za shranjevanje.
The development of foci of altered hepatocytes (FAH) and hepatocellular tumours in rats was dependent on both dose and duration of micafungin treatment.
Razvoj žarišč spremenjenih hepatocitov (FAH) in hepatocelični tumorji pri podganah sta bila odvisna od odmerka in trajanja zdravljenja z mikafunginom.
Most patients (97%, N=882) had neutropenia at baseline (< 200 neutrophils/µL).
Večina bolnikov (97 %; N=882) je imela na izhodišču nevtropenijo (< 200 nevtrofilcev/µL).
In one spontaneous case, it was reported a dosage of 16 mg/kg/day was administered in a newborn patient.
V enem spontanem poročilu so poročali, da je bil pri novorojenčku apliciran odmerek 16 mg/kg/dan.
The mean terminal half-life is approximately 10-17 hours and stays consistent across doses up to 8 mg/kg and after single and repeated administration.
Povprečna končna biološka razpolovna doba je približno 10-17 ur in je nespremenjena pri odmerkih do 8 mg/kg, po enkratni in ponavljajočih aplikacijah.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Mycamine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mycamine therapy to the mother.
Odločitev o nadaljevanju/prekinitvi dojenja ali nadaljevanju/prekinitvi zdravljenja z zdravilom Mycamine mora temeljiti na oceni koristi dojenja za otroka in koristi zdravljenja z zdravilom Mycamine za mater.
Prophylaxis: Micafungin was more effective than fluconazole in preventing invasive fungal infections in a population of patients at high risk of developing a systemic fungal infection (patients undergoing haematopoietic stem cell transplantation [HSCT] in a randomised, double-blind, multicentre study).
Profilaksa: Mikafungin je bil v primerjavi s flukonazolom učinkovitejši pri preprečevanju invazivnih glivičnih okužb pri populaciji bolnikov z velikim tveganjem za razvoj sistemske glivične okužbe (bolnikih, ki so jim presadili hematopoetske matične celice [HSCT] v randomizirani dvojno slepi multicentrični študiji).
At the recommended therapeutic dosage of Mycamine, these ratios are achievable for the wild-type distribution of Candida spp.
Ob priporočenem terapevtskem odmerku zdravila Mycamine, je takšno razmerje doseženo pri večini nemutiranih Candida spp.
Mycamine should therefore only be used if other antifungals are not appropriate.
Zdravilo Mycamine naj se uporabi le, če uporaba drugih antimikotikov ni primerna.
The decision to use Mycamine should take into account a potential risk for the development of liver tumours (see section 4.4).
Zdravnik mora pri odločitvi o uporabi zdravila Mycamine upoštevati morebitno tveganje za razvoj tumorjev jeter (glejte poglavje 4.4).
During treatment your liver functions will be monitored more closely.
Zdravnik bo delovanje vaših jeter med zdravljenjem spremljal pozorneje.
Body weight > 40 kg Body weight ≤ 40 kg
Telesna masa ≤ 40 kg
Cardiac disorders tachycardia, palpitations, bradycardia
Srčne bolezni tahikardija, palpitacije, bradikardija
Prolongation of infusion time reducing the plasma concentration peak appeared to reduce these effects.
S podaljšanjem časa infundiranja se zmanjša največja plazemska koncentracija, kar vodi do zmanjšanja teh učinkov.
Total clearance was 0.15-0.3 ml/min/kg in healthy subjects and adult patients and is independent of dose after single and repeated administration.
Celokupni očistek je pri zdravih preiskovancih in odraslih bolnikih 0,15-0,3 ml/min/kg in je po enkratni in ponavljajočih aplikacijah neodvisen od odmerka.
Testicular toxicity was observed in animal studies (see section 5.3).
V študijah na živalih so opazili toksični učinek na testise (glejte poglavje 5.3).
Micafungin may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Mikafungin lahko prav tako povzroči hudo vnetje/izpuščaje na koži in sluznici (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza).
Patients should be closely monitored for worsening of renal function.
Bolnike je treba skrbno spremljati glede poslabšanja ledvičnega delovanja.
All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken.
Iz vsake viale je treba potegniti ves koncentrat in ga vbrizgati v infuzijsko steklenico/vrečko, iz katere je bila originalno vzeta raztopina.
From a microbiological point of view, the reconstituted and diluted solutions should be used immediately.
Z mikrobiološkega stališča je koncentrat in razredčeno raztopino treba uporabiti takoj.
Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 and Fks2 genes coding for a major subunit of glucan synthase.
Zmanjšana občutljivost ehinokandinov je povezana z mutacijami gena Fks1 in Fks2, ki kodirata veliko podenoto glukansintaze.
Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall.
Mikafungin nekompetitivno zavre sintezo 1,3-β-D-glukana, ki je bistvena sestavina celične stene gliv.
• To treat adults, adolescents and children including neonates who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body).
• Za zdravljenje odraslih, mladostnikov in otrok (vključno z novorojenčki) z resno glivično okužbo, imenovano invazivna kandidoza (okužba, ki je zajela večji del organizma).
Mycamine may cause the following other side effects:
Zdravilo Mycamine lahko povzroči naslednje neželene učinke:
Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure.
Sočasno dajanje mikafungina in amfotericina B deoksikolata je bilo povezano s 30 % porastom izpostavljenosti amfotericinu B deoksikolatu.
Pharmacokinetics are linear over the daily dose range of 12.5 mg to 200 mg and 3 mg/kg to 8 mg/kg.
Farmakokinetika je v območjih dnevnih odmerkov od 12,5 mg do 200 mg in od 3 mg/kg do 8 mg/kg linearna.
In rats, long-term treatment with micafungin led to liver damage and subsequent liver tumours.
Pri podganah je dolgotrajno zdravljenje z mikafunginom povzročilo poškodbe jeter in posledične jetrne tumorje.
Therefore, unused reconstituted concentrate must be discarded immediately.
Zato je treba neporabljen koncentrat takoj zavreči.
Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
Izpostavljenost (AUC oz. površina pod krivuljo koncentracije v odvisnosti od časa) itrakonazolu, sirolimusu in nifedipinu je bila ob prisotnosti mikafungina nekoliko povečana (22 %, 21 % oz. 18 %).
- Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.
- Zdravljenje kandidoze požiralnika pri bolnikih, za katere je intravensko zdravljenje primerno.