FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric patients: In paediatric patients AUC values were dose proportional over the dose range of 0.5-4 mg/kg.
Maltese: F'pazjenti pedjatriċi, il-valuri AUC kienu proporzjonali mad-doża fuq il-medda tad-doża ta' 0.5-4 mg/kg.
English: 5 ml approx. 5 ml (10 mg/ml)
Maltese: 5 ml madwar 5 ml (10 mg/ml)
English: Children (including neonates) and adolescents < 16 years of age: - Treatment of invasive candidiasis.
Maltese: Tfal (li jinkludu trabi għadhom jitwieldu) u adoloxxenti < 16-il sena: - Trattament ta' kandidjasi invażiva.
English: The incidence of some adverse reactions was higher in paediatric patients than in adult patients (see section 4.8).
Maltese: L-inċidenza ta' xi reazzjonijiet avversi kienu ogħla f'pazjenti pedjatriċi milli f'pazjenti adulti (ara sezzjoni 4.8).
English: PK/PD bridging study demonstrated dose-dependent penetration of micafungin into CNS with the minimum AUC of 170 µg*hr/L required to achieve maximum eradication of fungal burden in the CNS tissues.
Maltese: Studju bridging dwar il-PK/PD wera penetrazzjoni li tiddependi mid-doża ta' micafungin fis-CNS, billivell minimu tal-AUC ta' 170 µg*hr/L meħtieġ biex tinkiseb l-eradikazzjoni massima tal-ammont fungali fit-tessuti tas-CNS.
English: - 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.
Maltese: - Id-doża biex tiġi ttrattata infezzjoni Candida ta' l-esofagu hija ta' 150 mg għal pazjenti li jiżnu aktar minn 40 kg u 3 mg/kg kuljum għal pazjenti li jiżnu 40 kg jew anqas.
English: 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.
Maltese: It-tneħħija totali kienet ta' 0.15-0.3 ml/min/kg f'suġġetti b'saħħithom u pazjenti adulti u hija indipendenti mid-doża wara għoti wieħed u ripetut.
English: Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
Maltese: micafungin (22%, 21% u 18% rispettivament).
English: Micafungin haemolysed rabbit blood in vitro.
Maltese: Micafungin emolizza d-demm tal-fenek f'testijiet in vitro.
English: - The usual dose to prevent invasive Candida infections is 2 mg/kg per day.
Maltese: - Id-doża tas-soltu għall-prevenzjoni ta' infezzjonijiet b'Candida invażiva hija ta' 2 mg/kg kuljum.
English: Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event.
Maltese: Għadd żgħir ta' pazjenti (1.1%; 0.4% serji) waqqfu t-trattament minħabba każ epatiku.
English: 50 mg
Maltese: 50 mg 100 mg
English: 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.
Maltese: Eliminazzjoni u eskrezzjoni Il-medja tal-half-life terminali hija madwar 10-17-il siegħa u tibqa' konsistenti tul dożi sa 8 mg/kg u wara għoti wieħed u ripetut.
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)
Maltese: - dardir (tħossok ma tiflaħx); remettar (tħossok ma tiflaħx); dijarea, uġigħ addominali - riżultati anormali ta' testijiet tal-funzjoni tal-fwied (żieda fl-alkaline phosphatase; żieda fl aspartate aminotransferase, żieda fl-alanine aminotransferase)
English: Patients with hepatic impairment: In a study performed in patients with moderate hepatic impairment (Child-Pugh score 7-9), (n=8), the pharmacokinetics of micafungin did not significantly differ from those in healthy subjects (n=8).
Maltese: (punteġġ Child-Pugh 7-9), (n=8), il-farmakokinetiċi ta' micafungin b'mod sinifikanti ma kinux wisq differenti minn dawk ta' suġġetti b'saħħithom (n=8).
English: Blood and lymphatic system disorders common thrombocytopenia
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni tromboċitopenija
English: MIC breakpoint (mg/L)
Maltese: Punti ta' riferiment Punti mill- MIC EUCAST
English: ≤S (Susceptible)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA
English: Unchanged micafungin is the principal circulating compound in systemic circulation.
Maltese: Micafungin mhux mibdul huwa l-kompost prinċipali li jiċċirkola f'ċirkulazzjoni sistemika.
English: 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).
Maltese: Fl-istudju kliniku irriżulta b'suċċess li kien hemm numru kemmxejn inqas għal C. tropicalis milli għall C. albicans kemm fid- dożi (100 u 150 mg kuljum).
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.
Maltese: Fil-firien, vakulazzjoni ta' l-epitelju pelviku renali kif ukoll vakulazzjoni u tħaxxin (iperplasja) ta' lepitelju tal-bużżieqa ta' l-awrina kienu osservati fi studji ta' 26 ġimgħa b'dożi ripetuti.
English: 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%]).
Maltese: Grad endoskopu ta' 0 (kura endoskopika) fi tmiem it-trattament ġie osservat għal 87.7% (228/260) u 88.0%
English: Mycamine 50 mg powder for solution for infusion Mycamine 100 mg powder for solution for infusion
Maltese: Mycamine 50 mg trab għal soluzzjoni għall-infużjoni Mycamine 100 mg trab għal soluzzjoni għall-infużjoni
English: During treatment your liver functions will be monitored more closely.
Maltese: Waqt it-trattament il-funzjoni tal-fwied tiegħek ser jiġi monitorat aktar mill-qrib.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Maltese: ħażna effettivi qabel l-użu huma fir-responsabbiltà ta' l-utent u normalment ma jkunx aktar minn 24 siegħa f'temperatura ta' 2 sa 8°C, sakemm ir-rikostituzzjoni u d-dilwizzjoni ma jkunux saru f'kundizzjonijiet asettiċi kkontrollati u validati.
English: Neutropenia persisted for a median of 13 days.
Maltese: In-newtropenja ippersistiet għal medja ta' 13-il jum.
English: • The decision to use Mycamine should take into account a potential risk for the development of liver tumours.
Maltese: • Id-deċiżjoni li jintuża Mycamine għanda titqies bir- riskju potenzjali għall-iżvilupp ta 'tumuri filfwied.
English: 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.
Maltese: Fil-klieb adulti, atrofija tat-tubi seminiferi b'vakulazzjoni ta' l epitilu seminiferu u anqas sperma fl-epididimidi ġew innotati wara trattament fit-tul (39 ġimgħa), imma mhux wara 13-il ġimgħa ta' trattament.
English: There is no evidence of systemic accumulation with repeated administration and steady-state is generally reached within 4 to 5 days.
Maltese: M'hemmx evidenza ta' akkumulazzjoni sistemika u stat fiss ġeneralment jintlaħaq fi żmien 4
English: Efficacy findings were consistent, independent of the infective Candida species, primary site of infection and neutropenic status (see Table).
Maltese: Ir-riżultati dwar l-effikaċja kienu konsistenti, indipendentement mill-ispeċijiet ta' Candida infettiva, is-sit prinċipali ta' infezzjoni u stat newtropeniku (ara Tabella).
English: These data indicate that elimination of micafungin is primarily non-renal.
Maltese: Din id-dejta tindika li t tneħħija ta' micafungin hija primarjament mhux renali.
English: If central nervous system (CNS) infection is suspected, a higher dosage (e.g. 10 mg/kg) should be used due to the dose-dependent penetration of micafungin into the CNS (see section 5.2).
Maltese: Jekk ikun hemm suspett ta' infezzjoni tassistema nervuża ċentrali (CNS), dożaġġ ogħla (eż. 10 mg/kg) għandu jintuża minħabba l-penetrazzjoni li tiddependi mid-doża ta' micafungin fis-CNS (ara sezzjoni 5.2).
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.
Maltese: Stabbiltà kimika u fiżika waqt l-użu kienet murija għal 96 siegħa f'temperatura ta' 25°C meta kienet protetta mid-dawl meta dilwita b'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) jew soluzzjoni għall-infużjoni ta' glucose 50 mg/ml (5%).
English: Date of first authorisation: 25 April 2008 Date of latest renewal: 19 February 2018
Maltese: Data ta' l-aħħar tiġdid: 19 ta' Frar 2018
English: Micafungin exhibits fungicidal activity against most Candida species and prominently inhibits actively growing hyphae of Aspergillus species.
Maltese: Micafungin juri attività fungiċida kontra l-maġġoranza ta' l-ispeċi Candida u jimpedixxi b'mod prominenti t-tkabbir attiv ta' hyphae ta' l-ispeċi Aspergillus.
English: 1 vial contains 50 mg or 100 mg micafungin (as sodium).
Maltese: Kunjett wieħed fih 50 mg jew 100 mg micafungin (bħala sodium).
English: Symptoms such as rash and rigors have been reported in clinical studies.
Maltese: Sintomi bħal raxx u tertir ġew irrappurtati fi studji kliniċi.
English: Astellas Pharma Kft. Tel: +36 1577 8200
Maltese: Tel: +36 1577 8200
English: Oesophageal Candidiasis: In a randomised, double-blind study of micafungin versus fluconazole in the first-line treatment of oesophageal candidiasis, 518 patients received at least a single dose of study drug.
Maltese: Fi studju randomised u double-blind ta' micafungin kontra fluconazole bħala lewwel trattament preferenzjali ta' kandidjasi esofagali, 518-il pazjent irċevew mill-anqas doża waħda tal-mediċina studjata.
English: C. krusei † Micafungin rate minus the liposomal amphotericin B rate, and 2-sided 95% confidence interval for the difference in overall success rate based on large sample normal approximation.
Maltese: kunfidenza ta' 95% b'żewġ naħat għad-differenza fir-rata globali ta' suċċess ibbażata fuq approssimazzjoni normali ta' kampjun kbir.
English: In animals models of candidiasis, a correlation was observed between exposure of micafungin divided by MIC (AUC/MIC) and efficacy defined as the ratio required to prevent progressive fungal growth.
Maltese: F'mudelli tal-annimali 'fuq il-kandidjasi, ġiet osservata korrelazzjoni bejn l-espożizzjoni ta' micafungin diviż bil MIC (AUC / MIC) u l-effikaċja definita bħala l-proporzjon meħtieġ biex jinkiseb l-inqas effett statiku.
English: 10 ml Type I glass vial with an isobutylene-isoprene (PTFE-laminated) rubber stopper and a flip-off cap.
Maltese: Kunjett ta' 10 ml magħmul minn ħġieġ ta' Tip I b'tapp tal-lastku isobutylene-isoprene (laminat bitPTFE) u għatu li jinqala bis-suba'.
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.
Maltese: • Pazjenti li jiżviluppaw evidenza klinika jew tal-laboratorju ta' emolisi matul it-terapija b'micafungin għandhom jiġu mmonitorjati mill-qrib għal evidenza ta' deterjorament ta' dawn il-kundizzjonijiet, u jiġu evalwati għall-benefiċċju/riskju li jkomplu t-terapija b'micafungin.
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
Maltese: Candida albicans Speċijiet mhux albicans ¶: kollha 151 133 (88.1) 140 123 (87.9) C. tropicalis C. parapsilosis C. glabrata C. krusei †
English: Liver function should be carefully monitored during micafungin treatment.
Maltese: Il-funzjoni tal-fwied għandha tiġi monitorata b'attenzjoni waqt it-trattament b'micafungin.
English: 2 mg/kg/day *Micafungin dosed at 4 mg/kg in children less than 4 months approximates drug exposures achieved in adults receiving 100 mg/day for the treatment of invasive candidiasis.
Maltese: * Micafungin f'doża ta' 4 mg/kg fi tfal li jiżnu inqas minn 4 xhur joqrob għall-esponimenti li nkisbu f'adulti li kienu qed jirċievu 100 mg/jum għall-kura ta' kandidjasite invażiva.
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.
Maltese: Stabbiltà kimika u fiżika waqt l-użu kienet murija sa 48 siegħa f'temperatura ta' 25°C meta rikostitwit b' soluzzjoni għall-infużjoni 9 mg/ml (0.9%) ta' sodium chloride jew soluzzjoni għall-infużjoni
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Maltese: Rapurtar ta' rejazjonijiet avversi wara l-awtorizzazjoni ta' prodott mediċinali hija importanti.
English: 5 ml approx. 10 ml
Maltese: 5 ml madwar 10 ml
English: Hepatic adverse reactions
Maltese: Reazzjonijiet epatiċi avversi
English: Mycamine 50 mg or 100 mg powder for solution for infusion is a white compact freeze-dried powder.
Maltese: Mycamine 50 mg jew100 mg trab għal soluzzjoni għal infużjoni huwa trab abjad kompatt ixxottat bilfriża.
English: A ratio of ~2400 and ~1300 was required for C. albicans and C. glabrata, respectively, in these models.
Maltese: Proporzjon ta madwar 2400 u madwar 1300 kienu meħtieġa għall C. albicans u
English: 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.
Maltese: Micafungin ma kienx mutaġeniku jew klastoġeniku meta kien evalwat f'batterija standard ta' testijiet in vitro u in vivo li jinkludi studju in vitro fuq sintesi mhux skedata tad-DNA li uża epatoċiti ta' firien.
English: 1 mg/kg/day *If the patient's response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weighing ≤ 40 kg. Use in children (including neonates) < 4 months of age Indication
Maltese: 1 mg/kg/kuljum *Kemm-il darba r-rispons tal-pazjent ma jkunx adegwat, eż. persistenza tal-kulturi jew jekk il-kundizzjoni klinika ma titjiebx, id-doża tista' tiżdied għal 200 mg/kuljum f'pazjenti li jiżnu > 40 kg jew 4 mg/kg/kuljum f'pazjenti li jiżnu ≤ 40 kg.
English: Use in adults, adolescents ≥ 16 years of age and elderly
Maltese: Użu fl-adulti, adoloxxenti ≥ 16-il sena u anzjani
English: It interferes with the production of a part of the fungal cell wall.
Maltese: Huwa jinterferixxi mal-produzzjoni ta' parti mir-riti taċ-ċelluli fungali.
English: - Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.
Maltese: - Trattament ta' kandidjasi esofagali f'pazjenti li għalihom hija xierqa terapija intravenuża.
English: EXP:
Maltese: Anzjani:
English: In some patients more severe hepatic dysfunction, hepatitis, or hepatic failure including fatal cases have been reported.
Maltese: F'xi pazjenti problemi aktar severi fil-funzjoni epatika, epatite, jew insuffiċjenza epatika li jinkludu każijiet fatali li ġew irrapportati.
English: Additionally, paediatric patients < 1 year of age experienced about two times more often an increase in ALT, AST and AP than older paediatric patients (see section 4.4).
Maltese: Barraminhekk, pazjenti pedjatriċi < 1 sena esperjenzaw bi frekwenza ta' darbtejn aktar ta' spiss żieda fl-ALT, AST u AP minn pazjenti pedjatriċi akbar (ara sezzjoni 4.4).
English: Patients should be closely monitored for worsening of renal function.
Maltese: Il-pazjenti għandhom jiġu mmonitorati mill-qrib għal aggravar tal-funzjoni renali.
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).
Maltese: Hu aktar u aktar importanti li tavża lit-tabib tiegħek jekk qed tuża amphotericin B desoxycholate jew itraconazole (antibijotiċi antifungali), sirolimus (immunosuppressant) jew nifedipine (calcium channel blocker) li jintużaw għal kura ta' pressjoni tad-demm għolja).
English: Each vial contains: 100 mg micafungin (as sodium).
Maltese: Kull kunjett fih: 100 mg micafungin (bħala sodium).
English: 50 mg/day
Maltese: 50 mg/kuljum
English: DO NOT SHAKE.
Maltese: ansjetà, konfużjoni
English: Patients with renal impairment: Severe renal impairment (Glomerular Filtration Rate [GFR] < 30 ml/min) did not significantly affect the pharmacokinetics of micafungin.
Maltese: [GFR] < 30 ml/min) ma affettwax il-farmakokinetiċi ta' micafungin b'mod sinifikanti.
English: Renal impairment No dose adjustment is necessary in patients with renal impairment (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża għal pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: Each vial contains: 50 mg micafungin (as sodium).
Maltese: Kull kunjett fih: 50 mg micafungin (bħala sodium).
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.
Maltese: - Id-doża li s-soltu tingħata għall-prevenzjoni ta' infezzjonijiet invażivi ta' Candida hija 50 mg kuljum għal pazjenti li jiżnu aktar minn 40 kg u 1 mg/kg kuljum għal pazjenti li jiżnu 40 kg jew inqas.
English: In plasma, metabolites M-1 and M-2 were detected only at trace concentrations and metabolite M-5, the more abundant metabolite, accounted for a total of 6.5% relative to parent compound.
Maltese: M-1 u M-2 instabu biss f'konċentrazzjonijiet ta' traċċa u l-metabolit
English: Each vial contains 50 mg micafungin (as sodium).
Maltese: Kull kunjett fih 50 mg micafungin (bħala sodium).
English: Blood and lymphatic system disorders leukopenia, neutropenia, anaemia pancytopenia, thrombocytopenia, eosinophilia, hypoalbuminaemia haemolytic anaemia, haemolysis (see section disseminated intravascular coagulation
Maltese: Disturbi tad-demm u tas-sistema limfatika lewkopenja, newtropenja, anemija panċitopenija, tromboċitopenija,
English: Skin and subcutaneous tissue disorders rash urticaria, pruritus, erythema toxic skin eruption, erythema multiforme, StevensJohnson syndrome, toxic epidermal necrolysis (see section 4.4)
Maltese: Eruzzjoni tossika talġilda, eritema multiforme, sindromu StevensJohnson,
English: The toxicology of micafungin following repeated intravenous dosing in rats and/or dogs showed adverse responses in liver, urinary tract, red blood cells, and male reproductive organs.
Maltese: It-tossikoloġija ta' micafungin wara dożi intravenużi ripetuti fil-firien u/jew fil-klieb wriet risponsi avversi fil-fwied, passaġġ urinarju, ċelluli tad-demm ħomor, u l-organi ta' riproduzzjoni tar-raġel.
English: 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).
Maltese: Profilassi: Micafungin kien aktar effettiv minn fluconazole sabiex jipprevjeni infezzjonijiet fungali invażivi f'popolazzjoni ta' pazjenti li jinsabu f'riskju għoli li jiżviluppaw infezzjoni fungali sistemiċi
English: Package leaflet: Information for the user Mycamine 50 mg powder for solution for infusion Mycamine 100 mg powder for solution for infusion micafungin
Maltese: Mycamine 50 mg trab għal soluzzjoni għall-infużjoni Mycamine 100 mg trab għal soluzzjoni għall-infużjoni micafungin
English: Each vial contains 100 mg micafungin (as sodium).
Maltese: Kull kunjett fih 100 mg micafungin (bħala sodium).
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.
Maltese: - Id-doża li s-soltu tingħata biex tiġi ttrattata infezzjoni ta' Candida invażiva hija ta' 100 mg kuljum għal pazjenti li jiżnu 40 kg jew aktar u 2 mg/kg kuljum għal pazjenti li jiżnu 40 kg jew anqas.
English: How to store Mycamine
Maltese: X'fih Mycamine
English: The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies.
Maltese: Ir-raġuni l aktar plawsibbli għal din id-differenza kienet id-differenza fil-kundizzjonijiet fl-isfond meta mqabbla ma' adulti jew pazjenti pedjatriċi akbar osservati fi studji kliniċi.
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).
Maltese: La darba dan jista' għandu sinjifikanza klinika din il ko-amministrazzjoni tista' tiġi użata biss meta il-benefiċċji huma aktar mir-riskji, b'moniteraġġ millqrib tat-tossiċi ta' amphotericin B desoxycholate (ara sezzjoni 4.4).
English: EXP
Maltese: Volum
English: Volume of sodium chloride (0.9%) or glucose (5%) to be added per vial
Maltese: Volum ta' (0.9%) sodium chloride jew (5% glucose) li jrid jiġi magħdud f'kull kunjett
English: See section 4.
Maltese: sa 5 ijiem.
English: After reconstitution each ml contains 20 mg micafungin (as sodium).
Maltese: Wara r-rikostituzzjoni kull ml fih 20 mg micafungin (bħala sodium).
English: 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.
Maltese: Ma saru ebda studji karċinoġeniċi standard iżda l-iżvilupp ta' FAH kien analizzat fil-firien nisa sa perijodu ta' 20 xahar u 18-il xahar wara il-waqfien ta' trattament li dam sejjer għal 3 u 6 xhur rispettivament.
English: Hepatic effects:
Maltese: Kategorija farmakoterapewtika:
English: Mycamine is indicated for:
Maltese: Kandidjasi esofagali:
English: Using aseptic techniques at room temperature, Mycamine is reconstituted and diluted as follows:
Maltese: Billi jintużaw metodi asettiċi f'temperatura tal-kamra, Mycamine jiġi rikostitwit u dilwit kif ġej:
English: • To treat adults, adolescents and children including neonates who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body).
Maltese: • Biex jiġu ttrattati adulti, adoloxxenti u tfal li jinkludu trabi tat-twelid li għandhom infezzjoni fungali serja msejħa kandidjasi invażiva (infezzjoni li ppenetrat il-ġisem).
English: Preparation of the solution for infusion
Maltese: Preparazzjoni tas-soluzzjoni għal infużjoni
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
Maltese: - tnaqqis tas-sodium fid-demm (iponatremja); żieda fil-potassium fid-demm (iperkalemja) - tnaqqis fl-ammont ta' fosfati fid-demm (ipofosfatemja); anoreksja (disturb marbut ma' l-ikel)