natgillin/translations-raw huggingface dataset:
Following intravenous administration concentrations of micafungin show a biexponential decline.
Po intravenski aplikaciji padajo koncentracije mikafungina bieksponentno.
Micafungin treatment was associated with significant impairment of liver function (increase of ALT, AST or total bilirubin > 3 times ULN) in both healthy volunteers and patients.
ALT, AST ali celotni bilirubin > 3-kratnik ULN) tako pri zdravih prostovoljcih kot tudi pri bolnikih.
Investigations blood lactate dehydrogenase increased
Preiskave povečana koncentracija laktatdehidrogenaze v krvi
Lactose monohydrate, citric acid anhydrous and sodium hydroxide.
Laktoza monohidrat, brezvodna citronska kislina in natrijev hidroksid.
Patients receiving sirolimus, nifedipine or itraconazole in combination with micafungin should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see section 4.5).
Bolnike, ki prejemajo sirolimus, nifedipin ali itrakonazol v kombinaciji z mikafunginom, je potrebno spremljati zaradi možnosti pojava toksičnosti sirolimusa, nifedipina ali itrakonazola in po potrebi zmanjšati odmerke sirolinusa, nifedipina ali itrakonusa (glejte poglavje 4.5).
4 -10 mg/kg/day*
4 -10 mg/kg/dan*
The potential risk of developing liver tumours in humans is not known, and your doctor will assess the benefits and risks of Mycamine treatment before starting your medicine.
Vaš zdravnik bo ocenil koristi in tveganja pri zdravljenju z zdravilom Mycamine pred začetkom zdravljenja.
The mean period of treatment was 19 days for micafungin and 18 days for fluconazole in the adult population (N=798) and 23 days for both treatment arms in the paediatric population (N=84).
Srednja vrednost trajanja zdravljenja pri odrasli populaciji (N = 798) je bila 19 dni za mikafungin in 18 dni za flukonazol, pri obeh skupinah otrok (N = 84) pa 23 dni.
• Patients should be carefully monitored for liver damage and for worsening of renal function.
Bolnike je treba pozorno spremljati zaradi poškodb jeter in poslabšanja v delovanju ledvic.
Do not use the diluted infusion solution if it is cloudy or precipitated.
Razredčene raztopine za infundiranje ne uporabite, če je motna ali je v njej oborina.
Since this may be of clinical significance this coadministration should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.4).
Ker je to lahko klinično pomembno, je sočasno dajanje dovoljeno le, ko koristi jasno odtehtajo tveganja, in ob natančnem spremljanju toksičnosti amfotericina
As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded.
Kot pri vseh antimikrobnih učinkovinah so poročali o primerih zmanjšane občutljivosti in rezistence.
Prophylaxis of Candida infections: Micafungin should be administered for at least one week after neutrophil recovery.
Preprečevanje okužb s kandido: bolniki morajo mikafungin prejemati še vsaj 1 teden po tem, ko je število nevtrofilcev v območju normalnih vrednosti.
Patients who develop clinical or laboratory evidence of haemolysis during micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing micafungin therapy.
Bolnike, pri katerih se med zdravljenjem z mikafunginom pojavijo klinični ali laboratorijski znaki hemolize, je treba skrbno spremljati glede znakov poslabšanja tega stanja ter oceniti razmerje med koristjo in tveganjem nadaljevanja zdravljenja z mikafunginom.
Candidaemia and Invasive Candidiasis: Micafungin (100 mg/day or 2 mg/kg/day) was as effective as and better tolerated than liposomal amphotericin B (3 mg/kg) as first-line treatment of candidaemia and invasive candidiasis in a randomised, double-blind, multinational non-inferiority study.
Kandidemija in invazivna kandidoza: V randomizirani, dvojno slepi, mednarodni študiji enakovrednosti mikafungina in amfotericina kot zdravil prvega izbora pri zdravljenju kandidemije in invazivne kandidoze je bil mikafungin (100 mg/dan ali 2 mg/kg/dan) enako učinkovit in so ga bolniki bolje prenašali kot amfotericin B v obliki liposomov (3 mg/kg).
One abortion occurred in rabbits at 32 mg/kg/day.
Pri zajcih je prišlo pri odmerku 32 mg/kg/dan do enega splava.
1,3-β-D-glucan is not present in mammalian cells.
Celice sesalcev ne vsebujejo 1,3-β-D-glukana.
MICs for C. krusei are approximately 3 two-fold dilution steps higher than those for C. albicans and, similarly, those for C. guilliermondii are approximately 8 two-fold dilutions higher.
Razlika ni bila statistično značilna in ni znano, ali je klinično pomembna.MIC za C. krusei je za približno 3 dvakratna redčenja večja kot za C. albicans in podobno je MIC za C. guilliermondii večja za približno 8 dvakratnih redčenj.
Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways.
Mikafungin ima majhen potencial za interakcije z zdravili, ki se presnavljajo s pomočjo encimov
Breakthrough Aspergillus infections were observed in 1 versus 7 patients, and proven or probable breakthrough Candida infections were observed in 4 versus 2 patients in the micafungin and fluconazole groups, respectively.
V skupini, ki je prejemala mikafungin in v skupini, ki je prejemala flukonazol so izbruhe okužb z Aspergillus opazili pri 1 v primerjavi z 7 bolniki in dokazanega ali verjetnega izbruha okužbe s kandido pri 4 v primerjavi z 2 bolnikoma.
Endocrine disorders hyperhidrosis
Bolezni endokrinega sistema hiperhidroza
If patients develop a rash they should be monitored closely and micafungin discontinued if lesions progress.
Če se pri bolniku pojavi izpuščaj, ga je potrebno skrbno spremljati in v primeru širjenja izpuščaja prekiniti zdravljenje z mikafunginom.
Patients receiving sirolimus, nifedipine or itraconazole in combination with micafungin should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see section 4.4).
Bolnike, ki prejemajo sirolimus, nifedipin ali itrakonazol v kombinaciji z mikafunginom, je treba spremljati zaradi možnosti pojava toksičnosti sirolimusa, nifedipina ali itrakonazola ter po potrebi zmanjšati njihove odmerke (glejte poglavje 4.4).
Lactose monohydrate Citric acid anhydrous (to adjust the pH) Sodium hydroxide (to adjust the pH)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat brezvodna citronska kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH)
However, patients should be informed that dizziness has been reported during treatment with micafungin (see section
Vseeno je treba bolnike opozoriti, da so med uporabo mikafungina poročali o pojavu omotičnost (glejte poglavje 4.8).
Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Razredčena raztopina za infundiranje Kemična in fizikalna stabilnost med uporabo sta dokazani za 96 ur pri temperaturi 25 °C in zaščiti pred svetlobo, če je koncentrat razredčen z 9 mg/ml (0,9 %) raztopino natrijevega klorida za infundiranje ali 50 mg/ml (5 %) raztopino glukoze za infundiranje.
Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Kemična in fizikalna stabilnost med uporabo sta dokazani do 48 ur pri temperaturi 25 °C, če je koncentrat pripravljen z 9 mg/ml (0,9 %) raztopino natrijevega klorida za infundiranje ali 50 mg/ml (5 %) raztopino glukoze za infundiranje.
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Liver function should be carefully monitored during micafungin treatment.
Med zdravljenjem z mikafunginom je treba pozorno spremljati delovanje jeter.
Micafungin has been shown to be metabolised to several compounds; of these M-1 (catechol form), M-2 (methoxy form of M-1) and M-5 (hydroxylation at the side chain) of micafungin have been detected in systemic circulation.
Mikafungin se presnavlja v več spojin; v sistemskem krvnem obtoku so zaznali prisotnost M-1 (v obliki katehola),
In the following table adverse reactions are listed by system organ class and MedDRA preferred term.
V spodnji preglednici so glede na organski sistem in priporočeno terminologijo MedDRA navedeni neželeni učinki.
No micafungin dose adjustments are necessary when these medicines are administered concomitantly.
Pri sočasni uporabi s temi zdravili niso potrebne prilagoditve odmerka mikafungina.
5 ml approx. 5 ml (10 mg/ml)
5 ml približno 5 ml (10 mg/ml) 0,5 mg/ml
Oesophageal candidiasis: Micafungin should be administered for at least one week after resolution of clinical signs and symptoms.
Kandidoza požiralnika: bolniki morajo mikafungin prejemati še vsaj 1 teden po tem, ko so klinični znaki in simptomi že izginili.
Mycamine contains sodium
Zdravilo Mycamine vsebuje natrij
Blood and lymphatic system disorders common thrombocytopenia
Bolezni krvi in limfatičnega sistema pogosti trombocitopenija
Micafungin haemolysed rabbit blood in vitro.
In vitro je mikafungin hemoliziral kri kuncev.
• To prevent infection with Candida in patients who are having a bone-marrow transplant or who are expected to have a neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.
• Za preprečevanje okužbe s kandido pri bolnikih, ki so jim presadili kostni mozeg ali pri bolnikih, pri katerih se pričakuje nevtropenija (nizka koncentracija nevtrofilcev v krvi;
Vascular disorders common hypertension, hypotension
Žilne bolezni pogosti hipertenzija, hipotenzija
100 mg/day*
100 mg/dan*
5 ml approx. 5 ml (20 mg/ml)
5 ml približno 5 ml (20 mg/ml) 1,0 mg/ml
Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections.
4.2 Odmerjanje in način uporabe Zdravljenje z zdravilom Mycamine mora uvesti zdravnik, ki ima izkušnje z obvladovanjem glivičnih okužb.
Use in children and newborns < 4 months of age
Uporaba pri otrocih (vključno z novorojenčki) < 4 mesece
Renal impairment No dose adjustment is necessary in patients with renal impairment (see section 5.2).
Okvara ledvic Pri bolnikih z motnjami v delovanju ledvic prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
In juvenile dogs, 39 weeks treatment did not induce lesions in the testis and epididymides in a dose dependent manner at the end of treatment but after a treatment free period of 13 weeks a dose dependent increase in these lesions were noted in the treated recovery groups.
Pri mladih psih 39 tednov trajajoče zdravljenje ni povzročilo lezij na modih in obmodkih na način, ki bi bil odvisen od odmerka na koncu zdravljenja, po koncu 13
Paediatric patients: In paediatric patients AUC values were dose proportional over the dose range of 0.5-4 mg/kg.
Otroci: Pri otrocih so bile površine pod krivuljo koncentracije v odvisnosti od časa (AUC) v območju odmerkov 0,5 mg/kg do 4 mg/kg sorazmerne z odmerkom.
Therefore, no dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Zato pri bolnikih z blagimi do zmernimi motnjami v delovanju jeter prilagoditev odmerka ni potrebna.
Contents of the pack and other information
Shranjevanje zdravila Mycamine Vsebina pakiranja in dodatne informacije
At the time of entering the study, the proportion of paediatric patients with neutropenia was several-fold higher than in adult patients (40.2% and 7.3% of children and adults, respectively), as well as allogeneic HSCT (29.4% and 13.4%, respectively) and haematological malignancy (29.1% and 8.7%, respectively).
Enako velja za alogensko HSCT (29,4 % pri otrocih in 13,4 % pri odraslih) in hematološko malignost (29,1 % pri otrocih in 8,7 % pri odraslih).
Mycamine 50 mg or 100 mg powder for solution for infusion is a white compact freeze-dried powder.
Zdravilo Mycamine 50 mg ali 100 mg prašek za raztopino za infundiranje je bel kompakten prašek, pridobljen z zamrzovalnim sušenjem.
Use in children ≥ 4 months of age up to adolescents < 16 years of age
Uporaba pri otrocih ≥ 4 mesece in mladostnikih < 16 let Indikacija
Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall.
Aseptično je treba izvleči 5 mililitrov 9 mg/ml (0,9 %) raztopine natrijevega klorida za infundiranje ali 50 mg/ml (5 %) raztopine glukoze za infundiranje (iz 100 ml steklenice/vrečke)
Unopened vials
Koncentrat v viali
Mycamine causes defects in the fungal cell wall, making the fungus unable to live and grow.
Zdravilo Mycamine celično steno gliv okvari in jim tako onemogoči življenje in rast.
- The active substance is micafungin (as sodium).
Učinkovina je mikafungin (v obliki natrijeve soli).
The solution must not be used if it is cloudy or has precipitated.
Raztopina se ne sme uporabiti, če je motna ali se je pojavila oborina.
1 vial contains 50 mg or 100 mg micafungin (as sodium).
1 viala vsebuje 50 mg ali 100 mg mikafungina (v obliki natrijeve soli).
No impairment of male or female fertility was observed in the fertility and early embryonic development study in rats.
V študijah plodnosti in zgodnjega razvoja zarodka pri podganah niso opazili poslabšanja plodnosti samcev ali samic.
2 mg/kg/day*
2 mg/kg/dan*
3 mg/kg/day
3 mg/kg/dan
The vial should be rotated gently.
Vialo vrtite previdno.
No dose adjustment of micafungin is required based on gender or race.
Zaradi spola ali rase prilagoditev odmerka mikafungina ni potrebna.
Serious reactions (e.g. anaphylactoid reaction 0.2%, 6/3028) were uncommonly reported during therapy with micafungin and only in patients with serious underlying conditions (e.g. advanced AIDS, malignancies) requiring multiple co-medications.
so v času zdravljenja z mikafunginom poročali le občasno in samo pri bolnikih z resnimi sočasno prisotnimi boleznimi (npr. napredovali AIDS, maligna obolenja), ki so zahtevale sočasno zdravljenje z več zdravili.
Diluted infusion solution
diseminirana znotrajžilna koagulacija
Rare cases of haemolysis, including acute intravascular haemolysis or haemolytic anaemia, have been reported in patients treated with micafungin.
Pri bolnikih, ki se zdravijo z mikafunginom, so v redkih primerih poročali o pojavu hemolize, vključno z akutno intravaskularno hemolizo ali hemolitično anemijo.
- The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing more than 40 kg and 1 mg/kg per day for patients weighing 40 kg or less.
- Običajni odmerek za preprečevanje invazivnih okužb s kandido je 50 mg na dan za bolnike s telesno maso nad 40 kg in 1 mg/kg na dan za bolnike s telesno maso 40 kg ali manj.
Respiratory, thoracic and mediastinal disorders dyspnoea
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja
Cardiac disorders common tachycardia
Srčne bolezni pogosti tahikardija
Immune system disorders anaphylactic / anaphylactoid reaction (see section 4.4), hypersensitivity anaphylactic and anaphylactoid shock (see section 4.4)
Bolezni imunskega sistema anafilaktična/ anafilaktoidna reakcija (glejte poglavje 4.4),
Blood and lymphatic system disorders leukopenia, neutropenia, anaemia pancytopenia, thrombocytopenia, eosinophilia, hypoalbuminaemia haemolytic anaemia, haemolysis (see section disseminated intravascular coagulation
Bolezni krvi in limfatičnega sistema levkopenija, nevtropenija, anemija pancitopenija, trombocitopenija, eozinofilija, hipoalbuminemija hemolitična anemija, hemoliza (glejte poglavje 4.4)
No dose adjustment is necessary in patients with mild or moderate hepatic impairment (see section 5.2).
Pri bolnikih z blagimi do zmernimi motnjami v delovanju jeter prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
As Mycamine is given intravenously (into a vein), no restrictions on food or drink are required.
Za zdravilo Mycamine ni omejitev glede hrane in pijače, ker se uporablja intravensko (daje v veno).
The infusion bottle/bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming.
Infuzijsko steklenico/vrečko je treba previdno obrniti, da se razredčena raztopina dispergira.
Psychiatric disorders insomnia, anxiety, confusion
- nespečnost (težave s spanjem), tesnoba, zmedenost
The plasma exposure at the assumed threshold for tumour development in rats (i.e. the dose where no FAH and liver tumours were detected) was in the same range as the clinical exposure.
odmerek pri katerem FAH in tumorji jeter niso bili zaznani) je bila v istem obsegu kot izpostavitev v klinični uporabi.
Nervous system disorders headache somnolence, tremor, dizziness, dysgeusia
Bolezni živčevja glavobol zaspanost, tremor,
Therefore, please discard unused reconstituted concentrate immediately.
Zato ves neuporabljen koncentrat zavrzite.
(hypomagnesaemia); decreased calcium in the blood (hypocalcaemia) - headache - inflammation of the vein wall (at injection-site) - nausea (feeling sick); vomiting (being sick); diarrhoea; abdominal pain - abnormal liver function tests (increased alkaline phosphatase; increased aspartate aminotransferase, increased alanine aminotransferase) - increased bile pigment in the blood (hyperbilirubinaemia) - rash - fever - rigors (shivering)
- slabost, bruhanje, driska, bolečina v trebuhu - nenormalne preiskave jetrnega delovanja (povečana vrednost alkalne fosfataze, povečana vrednost aspartat-aminotransferaze, povečana vrednost alanin-aminotransferaze) - povečana vrednost žolčnega pigmenta v krvi (hiperbilirubinemija) - izpuščaj - povečana telesna temperatura
How to store Mycamine
Shranjevanje zdravila Mycamine
General disorders and administration site conditions pyrexia, rigors injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema
Splošne težave in spremembe na mestu aplikacije pireksija, mrzlica tromboza na mestu injiciranja, vnetje na mestu infundiranja,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ŠKATLA
Mycamine is effective in treating systemic infections (those that have penetrated within the body).
Zdravilo Mycamine učinkovito zdravi sistemske okužbe (okužba, ki je zajela večji del organizma), tako da ovira nastajanje dela celične stene gliv.
Hepatobiliary disorders common hyperbilirubinaemia, hepatomegaly
Bolezni jeter, žolčnika in žolčevodov pogosti hiperbilirubinemija, hepatomegalija
Micafungin was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests, including an in vitro study on unscheduled DNA synthesis using rat hepatocytes.
Pri standardnih in vitro in in vivo testih, vključno z in vitro študijo na neurejeni sintezi DNA z uporabo hepatocitov podgan, mikafungin ni pokazal mutagenih ali klastogenih učinkov.
In rats, vacuolation of the renal pelvic epithelium as well as vacuolation and thickening (hyperplasia) of the bladder epithelium were observed in 26-week repeat dose studies.
V 26-tedenski študiji ponavljajočih odmerkov so pri podganah opazili vakuolizacijo epitelija v ledvičnem mehu ter vakuolizacijo in zadebelitev (hiperplazijo) epitelija v mehurju.
In dog, liver effects consisted of increased weight and centrilobular hypertrophy, no degenerative changes of hepatocytes were observed.
Pri psih so učinki vključevali povečanje njihove mase in centrolobularno hipertrofijo.
- The dose to treat a Candida infection of the oesophagus is 150 mg for patients weighing more than 40 kg and 3 mg/kg per day for patients weighing 40 kg or less.
- Odmerek za zdravljenja okužbe požiralnika s kandido je 150 mg za bolnike s telesno maso nad 40 kg in 3 mg/kg za bolnike s telesno maso 40 kg ali manj.
- The usual dose to treat an invasive Candida infection is 100 mg per day for patients weighing 40 kg or more and 2 mg/kg per day for patients weighing 40 kg or less.
- Običajni odmerek za zdravljenje invazivne okužbe s kandido je 100 mg na dan za bolnike s telesno maso 40 kg ali več in 2 mg/kg za bolnike s telesno maso 40 kg ali manj.
Renal and urinary disorders common acute renal failure, blood urea increased
Bolezni sečil pogosti akutna ledvična odpoved, povečana vrednost sečnine v krvi
Mycamine 50 mg powder for solution for infusion Mycamine 100 mg powder for solution for infusion
Mycamine 50 mg prašek za raztopino za infundiranje Mycamine 100 mg prašek za raztopino za infundiranje
aggravated kidney failure - increase in an enzyme called lactate dehydrogenase - clotting in vein at injection-site; inflammation at injection-site; pain at injection-site; collection of fluid in your body
- strjevanje krvi v veni na mestu injiciranja, vnetje na mestu injiciranja, bolečina na mestu injiciranja, kopičenje tekočine v telesu
Your doctor monitors your response and condition to determine what dose of Mycamine is needed.
Če ste dobili večji odmerek zdravila Mycamine, kot bi smeli Zdravnik spremlja vaš odziv in vašo bolezen ter glede na to določi, kolikšen odmerek zdravila Mycamine potrebujete.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ
Talk to your doctor or pharmacist before using Mycamine - if you are allergic to any medicine - if you have haemolytic anaemia (anaemia due to breakdown of red blood cells) or haemolysis
Pred začetkom uporabe zdravila Mycamine se posvetujte z zdravnikom ali farmacevtom: - če ste alergični na katero koli zdravilo.
Common (may affect up to 1 in 10 people) - abnormal blood tests (decreased white blood cells [leucopenia; neutropenia]); decreased red blood cells (anaemia) - decreased potassium in the blood (hypokalaemia); decreased magnesium in the blood
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - nenormalne krvne preiskave (zmanjšano število krvničk [pancitopenija]), zmanjšano število trombocitov (trombocitopenija), povečano število nekaterih vrst belih krvničk, imenovanih eozinofilci, zmanjšana vrednost albumina v krvi (hipoalbuminemija)
decreased albumin in the blood (hypoalbuminaemia) - hypersensitivity - increased sweating - decreased sodium in the blood (hyponatraemia); increased potassium in the blood
zmanjšano število rdečih krvničk (anemija) - zmanjšana količina kalija v krvi (hipokaliemija), zmanjšana količina magnezija v krvi
Skin and subcutaneous tissue disorders rash urticaria, pruritus, erythema toxic skin eruption, erythema multiforme, StevensJohnson syndrome, toxic epidermal necrolysis (see section 4.4)
multiformni eritem, Stevens-Johnsonov sindrom, toksična epidermalna nekroliza (glejte poglavje 4.4)
150 1 x 100 + 1 x
1 x 100 + 1 x 50 5 ml približno 10 ml
An intact cell wall is necessary for the fungus to continue living and growing.
Glive za življenje in rast potrebujejo nepoškodovano celično steno.
Experience with Mycamine in patients less than 2 years of age is limited.
mlajših od dveh let, je malo.
Mycamine 100 mg powder for solution for infusion micafungin
Mycamine 100 mg prašek za raztopino za infundiranje mikafungin
Chemical and physical in-use stability have been demonstrated for 96 hours at 25°C when protected from light and diluted as described above.
Kemična in fizikalna stabilnost med uporabo sta dokazani za 96 ur pri temperaturi 25 °C,
Mycamine 50 mg powder for solution for infusion micafungin
Mycamine 50 mg prašek za raztopino za infundiranje mikafungin
In adult dogs, atrophy of seminiferous tubules with vacuolation of the seminiferous epithelium and decreased sperm in the epididymides were noted after prolonged treatment (39 weeks) but not after 13 weeks of treatment.
Pri dolgotrajnem zdravljenju (39 tednov), toda ne po 13. tednih, so pri odraslih psih opazili atrofijo seminifernih tubulov z vakuolacijo seminifernega epitelija in zmanjšanje števila spermijev v obmodku.
Uncommon (may affect up to 1 in 100 people) - abnormal blood tests (decreased blood cells [pancytopenia]); decreased blood platelets
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - nenormalne krvne preiskave (zmanjšano število belih krvničk [levkopenija, nevtropenija]),