FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Bolesnike u kojih se jave klinički ili laboratorijski dokazi hemolize za vrijeme terapije mikafunginom treba pažljivo pratiti zbog mogućeg pogoršanja ovih stanja i procijeniti omjer rizika i koristi od nastavka terapije mikafunginom.
English: - The active substance is micafungin (as sodium).
Croatian: - Djelatna tvar je mikafungin (u obliku mikafunginnatrija).
English: • 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 benefit/risk of continuing micafungin therapy.
Croatian: • Bolesnike kod kojih se tijekom liječenja mikafunginom razvije klinički ili laboratorijski dokaz hemolize potrebno je pažljivo pratiti na pojavu dokaza pogoršanja ovih stanja te procijeniti omjer koristi i rizika nastavka njihova liječenja mikafunginom.
English: How to store Mycamine
Croatian: Kako čuvati Mycamine
English: 4 -10 mg/kg/day*
Croatian: 4-10 mg/kg/dan*
English: Mycamine 50 mg or 100 mg powder for solution for infusion is a white compact freeze-dried powder.
Croatian: Mycamine 50 mg ili 100 mg prašak za otopinu za infuziju bijeli je kompaktni prašak osušen smrzavanjem.
English: FAH recorded after treatment for 13 weeks or longer persisted after a 13-week withdrawal period and developed into hepatocellular tumours following a treatment free period which covered the life span of rats.
Croatian: Žarišta promijenjenih hepatocita zabilježena nakon liječenja u trajanju od 13 tjedana ili dulje bila su prisutna i nakon 13 tjedana bez uzimanja lijeka i razvila su se u hepatocelularne tumore nakon razdoblja bez liječenja koje je trajalo koliko i životni vijek štakora.
English: How to use Mycamine
Croatian: Kako primjenjivati Mycamine
English: - Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / µl) for 10 or more days.
Croatian: - liječenje invazivne kandidijaze. - profilaksa infekcije Candidom u bolesnika na alogenoj transplantaciji matičnih hematopoetskih stanica ili u bolesnika kod kojih se očekuje neutropenija (apsolutni broj neutrofila < 500 stanica / µl) tijekom 10 ili više dana.
English: An intact cell wall is necessary for the fungus to continue living and growing.
Croatian: Gljivici je potrebna cjelovita stanična stijenka za daljnji život i rast.
English: 5 ml approx. 5 ml (20 mg/ml)
Croatian: 5 ml približno 5 ml (20 mg/ml)
English: 1 MICs for C. tropicalis are 1-2 two-fold dilution steps higher than for C albicans and C. glabrata.
Croatian: 1 MIK vrijednosti dobivene metodom dvostrukog razrjeđenja su za C. tropicalis za 1-2 stupnja više nego za C. albicans i C. glabrata.
English: 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.
Croatian: Dokazana je kemijska i fizikalna stabilnost u primjeni do 48 sati, na temperaturi od 25°C, nakon rekonstitucije otopinom za infuziju natrijevog klorida od 9 mg/ml (0,9%) ili otopinom za infuziju glukoze od 50 mg/ml (5%).
English: Treatment of oesophageal candidiasis
Croatian: Liječenje ezofagealne kandidijaze
English: Co-administration of micafungin and amphotericin B desoxycholate should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.5).
Croatian: Interakcije s drugim lijekovima Mikafungin i amfotericin B dezoksikolat smiju se istodobno primjenjivati samo kad koristi jasno premašuju rizike, s time da treba pažljivo pratiti toksičnost amfotericin B dezoksikolata (vidjeti dio 4.5).
English: 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.
Croatian: Dokazana je kemijska i fizikalna stabilnost u primjeni 96 sati, na temperaturi od 25°C, zaštićeno od svjetlosti, nakon razrjeđivanja otopinom za infuziju natrijevog klorida od 9 mg/ml (0,9%) ili otopinom za infuziju glukoze od 50 mg/ml (5%).
English: Mycamine contains sodium
Croatian: Mycamine sadrži natrij
English: Do not use the diluted infusion solution if it is cloudy or precipitated.
Croatian: Nemojte primijeniti razrijeđenu otopinu za infuziju ako je zamućena ili sadrži talog.
English: Lactose monohydrate Citric acid anhydrous (to adjust the pH) Sodium hydroxide (to adjust the pH)
Croatian: 6.1 Popis pomoćnih tvari laktoza hidrat citratna kiselina, bezvodna (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
English: Oesophageal candidiasis: Micafungin should be administered for at least one week after resolution of clinical signs and symptoms.
Croatian: Ezofagealna kandidijaza: Mikafungin treba primjenjivati još najmanje jedan tjedan nakon nestanka kliničkih znakova i simptoma.
English: 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).
Croatian: Bolesnike koji primaju sirolimus, nifedipin ili itrakonazol u kombinaciji s mikafunginom treba nadzirati zbog toksičnosti sirolimusa, nifedipina ili itrakonazola te, ako je potrebno, sniziti doze sirolimusa, nifedipina ili itrakonazola (vidjeti dio 4.4).
English: Using aseptic techniques at room temperature, Mycamine is reconstituted and diluted as follows:
Croatian: Mycamine se rekonstituira i razrjeđuje pomoću aseptičkih tehnika na sobnoj temperaturi na sljedeći način:
English: 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).
Croatian: Bolesnike koji primaju sirolimus, nifedipin ili itrakonazol u kombinaciji s mikafunginom treba pratiti zbog toksičnosti sirolimusa, nifedipina ili itrakonazola i ako je potrebno smanjiti dozu sirolimusa, nifedipina ili itrakonazola (vidjeti dio 4.5).
English: Blood and lymphatic system disorders leukopenia, neutropenia, anaemia pancytopenia, thrombocytopenia, eosinophilia, hypoalbuminaemia haemolytic anaemia, haemolysis (see section disseminated intravascular coagulation
Croatian: Poremećaji krvi i limfnog sustava leukopenija, neutropenija, anemija pancitopenija, trombocitopenija, eozinofilija, hipoalbuminemija hemolitička anemija, hemoliza (vidjeti dio diseminirana intravaskularna koagulacija
English: 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
Croatian: Posavjetujte se s Vašim liječnikom ili ljekarnikom prije nego primijenite Mycamine - ako ste alergični na bilo koji lijek
English: Therefore, no dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Croatian: Stoga nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
English: Lactose monohydrate, citric acid anhydrous and sodium hydroxide.
Croatian: Laktoza hidrat, citratna kiselina bezvodna i natrijev hidroksid.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Izloženost (AUC)
English: 5 ml approx. 5 ml (10 mg/ml)
Croatian: 5 ml približno 5 ml (10 mg/ml)
English: Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections.
Croatian: 4.2 Doziranje i način primjene Liječenje Mycamineom treba započeti liječnik s iskustvom u liječenju gljivičnih infekcija.
English: Blood and lymphatic system disorders common thrombocytopenia
Croatian: Poremećaji krvi i limfnog sustava često trombocitopenija
English: Micafungin may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Croatian: Mikafungin može također uzrokovati tešku upalu/izbijanje promjena na koži i sluznicama (Stevens
English: Renal and urinary disorders blood creatinine increased, blood urea increased, renal failure aggravated renal impairment (see section 4.4), acute renal failure
Croatian: Poremećaji bubrega i mokraćnog sustava povišen kreatinin u krvi, povišena urea u krvi, pogoršanje zatajenja bubrega oštećenje funkcije bubrega (vidjeti dio 4.4), akutno zatajenje bubrega
English: Skin and subcutaneous tissue disorders rash urticaria, pruritus, erythema toxic skin eruption, erythema multiforme, StevensJohnson syndrome, toxic epidermal necrolysis (see section 4.4)
Croatian: Poremećaji kože i potkožnog tkiva osip urtikarija, svrbež, eritem toksične kožne erupcije, multiformni eritem, StevensJohnsonov sindrom,
English: Liver function should be carefully monitored during micafungin treatment.
Croatian: Tijekom liječenja mikafunginom potrebno je pažljivo pratiti funkciju jetre.
English: Astellas Ireland Co. Ltd Killorglin
Croatian: Ltd Killorglin
English: Prescriber checklist
Croatian: Kontrolna lista za propisivača
English: Renal impairment No dose adjustment is necessary in patients with renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: - The other ingredients are lactose monohydrate, citric acid anhydrous and sodium hydroxide.
Croatian: - Pomoćne tvari su laktoza hidrat, citratna kiselina bezvodna i natrijev hidroksid.
English: 10 ml Type I glass vial with an isobutylene-isoprene (PTFE-laminated) rubber stopper and a flip-off cap.
Croatian: I s izobutilen-izoprenskim (PTFE laminiranim) gumenim čepom i „flip-off“ poklopcem.
English: 1 vial contains 50 mg or 100 mg micafungin (as sodium).
Croatian: 1 bočica sadrži 50 mg ili 100 mg mikafungina (u obliku mikafunginnatrija).
English: 2 mg/kg/day*
Croatian: 2 mg/kg na dan*
English: 5 ml approx. 10 ml
Croatian: 5 ml približno 10 ml
English: 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.
Croatian: Izloženost lijeku u plazmi u procijenjenoj graničnoj koncentraciji za razvoj tumora u štakora (tj. dozi pri kojoj nisu otkrivena ni žarišta promijenjenih hepatocita ni tumori jetre)
English: Use in children > 4 months of age and adolescents < 16 years of age
Croatian: Primjena u djece u dobi od 4 mjeseca ili više i adolescenata mlađih od 16 godina
English: MIC breakpoint (mg/L)
Croatian: MIK granična vrijednost (mg/L) ≤S (osjetljivo)
English: - if you have kidney problems (e.g. kidney failure and abnormal kidney function test).
Croatian: - ako imate tegobe s bubrezima (npr. zatajenje bubrega i poremećene nalaze funkcije bubrega).
English: Adult Patients Overall Treatment Success Overall Treatment Success by Neutropenic Status Neutropenia at baseline No neutropenia at baseline 178 163 (91.6) 175 158 (90.3) Paediatric Patients Overall Treatment Success < 2 years old Premature Infants Neonates (0 days to < 4 weeks) 2 to 15 years old Adults and Children Combined, Overall Treatment Success by Candida Species Candida albicans Non-albicans species ¶: all C. tropicalis C. parapsilosis C. glabrata
Croatian: Ukupni uspjeh liječenja prema neutropenijskom statusu Neutropenija na početku 24 18 (75,0) Bez neutropenije na početku 178 163 (91,6) 175 158 (90,3) Pedijatrijski bolesnici
English: Tel: + 385 1 670 01 02
Croatian: Astellas d.o.o. Tel: + 385 1 670 01 02
English: 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).
Croatian: Na početku ispitivanja, udio pedijatrijskih bolesnika s neutropenijom bio je nekoliko puta viši nego u odraslih bolesnika (40,2% u djece i 7,3% u odraslih), kao i onih na alogenoj transplantaciji matičnih hematopoetskih stanica
English: 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.
Croatian: AST-a ili ukupnog bilirubina > 3 puta iznad gornje granice normale) u zdravih dobrovoljaca i u bolesnika.
English: At the recommended therapeutic dosage of Mycamine, these ratios are achievable for the wild-type distribution of Candida spp.
Croatian: Takvi se omjeri mogu postići za divlji oblik distribucije Candida spp. kod preporučenih doza za liječenje Mycamineom.
English: Therefore, please discard unused reconstituted concentrate immediately.
Croatian: Stoga odmah zbrinite pripremljeni koncentrat koji nije primijenjen.
English: - 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.
Croatian: - Uobičajena doza za liječenje invazivne infekcije Candidom je 100 mg na dan za bolesnike tjelesne težine 40 ili više kilograma i 2 mg/kg na dan za bolesnike tjelesne težine 40 ili manje kilograma.
English: A ratio of ~2400 and ~1300 was required for C. albicans and C. glabrata, respectively, in these models.
Croatian: Na tim se modelima pokazalo da je omjer potreban za C. albicans 2400, a za C. glabrata 1300.
English: Rare cases of haemolysis, including acute intravascular haemolysis or haemolytic anaemia, have been reported in patients treated with micafungin.
Croatian: U bolesnika liječenih mikafunginom zabilježeni su rijetki slučajevi hemolize, uključujući i akutnu intravaskularnu hemolizu ili hemolitičku anemiju.
English: - 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.
Croatian: - Uobičajena doza za sprječavanje invazivnih infekcija Candidom je 50 mg na dan za bolesnike tjelesne težine veće od 40 kg i 1 mg/kg na dan za bolesnike tjelesne težine od 40 ili manje kilograma.
English: Package leaflet: Information for the user Mycamine 50 mg powder for solution for infusion Mycamine 100 mg powder for solution for infusion micafungin
Croatian: Uputa o lijeku: Informacije za korisnika Mycamine 50 mg prašak za otopinu za infuziju Mycamine 100 mg prašak za otopinu za infuziju mikafungin
English: No impairment of male or female fertility was observed in the fertility and early embryonic development study in rats.
Croatian: U ispitivanjima utjecaja na plodnost i rani embrionalni razvoj u štakora nije bilo opaženo oštećenje plodnosti mužjaka ili ženki.
English: It is especially important to inform your doctor if you are using amphotericin B desoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant) or nifedipine (calcium channel blocker used to treat high blood pressure).
Croatian: (antimikotici), sirolimus (imunosupresiv) ili nifedipin (blokator kalcijevih kanala koji se koristi za liječenje visokog krvnog tlaka).
English: 100 mg/day*
Croatian: 100 mg na dan*
English: (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)
Croatian: neutropenija]), smanjen broj crvenih krvnih stanica (anemija) - sniženi kalij u krvi (hipokalemija), sniženi magnezij u krvi (hipomagnezemija), sniženi kalcij u krvi (hipokalcemija) - glavobolja - upala stijenke vene (na mjestu ubrizgavanja) - mučnina, povraćanje, proljev, bol u trbuhu - poremećeni nalazi jetrenih funkcija (povišena alkalna fosfataza, povišena aspartat aminotransferaza, povišena alanin aminotransferaza) - povećan žučni pigment u krvi (hiperbilirubinemija) - osip
English: Use in children ≥ 4 months of age up to adolescents < 16 years of age
Croatian: Primjena u djece u dobi od ≥ 4 mjeseca do adolescenata u dobi
English: Hepatobiliary disorders common hyperbilirubinaemia, hepatomegaly
Croatian: Poremećaji jetre i žuči često hiperbilirubinemija, hepatomegalija
English: 150 mg/day
Croatian: 150 mg na dan
English: The solution must not be used if it is cloudy or has precipitated.
Croatian: Otopina se ne smije primijeniti ako je zamućena ili se stvorio talog.
English: Vascular disorders common hypertension, hypotension
Croatian: Krvožilni poremećaji često hipertenzija, hipotenzija
English: 3 mg/kg/day
Croatian: 3 mg/kg na dan
English: Vascular disorders phlebitis hypotension, hypertension, flushing shock
Croatian: Krvožilni poremećaji flebitis hipotenzija, hipertenzija, crvenilo uz osjećaj vrućine šok
English: Hepatic effects:
Croatian: Pedijatrijski bolesnici:
English: Hepatobiliary disorders blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased (including hyperbilirubinaemia), liver function test abnormal hepatic failure (see section 4.4), gammaglutamyltransferase increased, jaundice, cholestasis, hepatomegaly, hepatitis hepatocellular damage including fatal cases (see section 4.4)
Croatian: poremećeni testovi jetrene funkcije zatajenje jetre (vidjeti dio 4.4), povišena gama-glutamil transferaza, žutica, kolestaza, hepatomegalija, hepatitis hepatocelularno oštećenje uključujući smrtne slučajeve
English: In the following table adverse reactions are listed by system organ class and MedDRA preferred term.
Croatian: U sljedećoj tablici nuspojave su navedene prema klasifikaciji organskih sustava i MedDRA
English: Renal and urinary disorders common acute renal failure, blood urea increased
Croatian: Poremećaji bubrega i mokraćnog sustava često akutno zatajenje bubrega, povišena urea u krvi
English: Hepatic impairment
Croatian: Jetrene nuspojave
English: Mycamine 50 mg powder for solution for infusion Mycamine 100 mg powder for solution for infusion
Croatian: Mycamine 50 mg prašak za otopinu za infuziju Mycamine 100 mg prašak za otopinu za infuziju
English: 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.
Croatian: U štakora je u ispitivanjima ponovljene doze koja su trajala 26 tjedana opažena vakuolizacija epitela bubrežne nakapnice, kao i vakuolizacija i zadebljanje (hiperplazija) epitela mokraćnog mjehura.
English: Immune system disorders anaphylactic / anaphylactoid reaction (see section 4.4), hypersensitivity anaphylactic and anaphylactoid shock (see section 4.4)
Croatian: anafilaktoidna reakcija (vidjeti dio 4.4), preosjetljivost anafilaktički /
English: Mycamine 100 mg powder for solution for infusion micafungin
Croatian: Mycamine 100 mg prašak za otopinu za infuziju mikafungin
English: decreased albumin in the blood (hypoalbuminaemia) - hypersensitivity - increased sweating - decreased sodium in the blood (hyponatraemia); increased potassium in the blood
Croatian: - sniženi natrij u krvi (hiponatremija), povišen kalij u krvi (hiperkalemija), sniženi fosfati u krvi
English: Mycamine 50 mg powder for solution for infusion micafungin
Croatian: Mycamine 50 mg prašak za otopinu za infuziju mikafungin
English: 50 mg/day
Croatian: 50 mg na dan
English: 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
Croatian: Manje često (mogu se javiti u do 1 na 100 ljudi) - poremećeni nalazi krvnih pretraga (snižen broj krvnih stanica [pancitopenija]), snižen broj krvnih pločica (trombocitopenija), povećanje broja određene vrste bijelih krvnih stanica koje se zovu eozinofili, snižen albumin u krvi (hipoalbuminemija) - preosjetljivost
English: Use in children and newborns < 4 months of age
Croatian: Primjena u djece (uključujući novorođenčad) u dobi ˂ 4 mjeseca Indikacija
English: - has history of haemolysis, haemolytic anaemia or renal impairment.
Croatian: - ako imate hemolitičku anemiju (anemija zbog raspada crvenih krvnih stanica) ili hemolizu
English: 150 1 x 100 + 1 x
Croatian: 150 1 x 100 + 1 x 50 5 ml približno 10 ml
English: 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.
Croatian: MIK vrijednosti dobivene metodom dvostrukog razrjeđenja su za C. krusei za 3 stupnja više nego za C. albicans, a za C.
English: Your doctor will determine how much Mycamine you will receive each day.
Croatian: Liječnik će odrediti koliko ćete
English: Haemolysis
Croatian: Dojenje
English: Chemical and physical in-use stability have been demonstrated for 96 hours at 25°C when protected from light and diluted as described above.
Croatian: Dokazana kemijska i fizikalna stabilnost pripremljenog lijeka je 96 sati na temperaturi od 25°C
English: Tel: +386 (0) 14011 400
Croatian: Astellas Pharma d.o.o. Tel: +386 (0) 14011 400
English: No dose adjustment is necessary for patients with renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega.
English: Not known (frequency cannot be estimated from the available data) - disorder of blood clotting system - (allergic) shock - damage to liver cells including death - kidney problems; acute kidney failure
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) - poremećaj sustava zgrušavanja krvi
English: Cardiac disorders common tachycardia
Croatian: Srčani poremećaji često tahikardija
English: General disorders and administration site conditions pyrexia, rigors injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema
Croatian: Opći poremećaji i reakcije na mjestu primjene vrućica, tresavica tromboza na mjestu primjene injekcije, upala na mjestu primjene infuzije, bol na mjestu primjene injekcije, periferni edemi
English: • Caution must be demonstrated if the patient: - has severe liver function impairment - has chronic liver diseases known to represent preneoplastic conditions (e.g. advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects) - is receiving a concomitant therapy including hepatotoxic and/or genotoxic properties
Croatian: - ima kroničnu bolest jetre koja predstavlja preneoplastično stanje (npr. uznapredovalu fibrozu jetre, cirozu, virusni hepatitis, neonatalnu bolest jetre ili prirođeni poremećaj enzima)
English: EUCAST breakpoints
Croatian: Granične vrijednosti EUCAST granične vrijednosti
English: Each vial contains: 100 mg micafungin (as sodium).
Croatian: Jedna bočica sadrži: 100 mg mikafungina (u obliku mikafunginnatrija).
English: However, once these results become available, antifungal therapy should be adjusted accordingly.
Croatian: antimikotičku terapiju treba prilagoditi sukladno tim nalazima.
English: (hyperkalaemia); decreased phosphates in the blood (hypophosphataemia); anorexia (eating disorder) - insomnia (difficulty in sleeping); anxiety; confusion - feeling lethargic (somnolence); trembling; dizziness; disturbed taste - increased heart rate; stronger heartbeat; irregular heartbeat - high or low blood pressure; skin flushing
Croatian: - osjećaj letargije (pospanost), drhtanje, omaglica, poremećen osjet okusa - povećana brzina rada srca, jače lupanje srca, nepravilan rad srca - visok ili nizak krvni tlak, crvenilo kože uz osjećaj vrućine