natgillin/translations-raw huggingface dataset:
Hvis de ikke anvendes straks, er opbevaringstid og opbevaringsbetingelser før anvendelsen brugerens ansvar og bør ikke overstige 24 timer ved 2 - 8°C, medmindre rekonstitution og fortynding sker under kontrollerede og validerede aseptiske forhold.
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.
Dosering af micafungin afhænger af patientens vægt, som vist i følgende tabeller:
The dose regimen of micafungin depends on the body weight of the patient as given in the following tables:
Elimination og udskillelse
Elimination and excretion
I systemisk cirkulation er micafungin ekstensivt plasmabundet (> 99 %) primært til albumin.
In systemic circulation, micafungin is highly bound to plasma protein (> 99%), primarily to albumin.
Størstedelen var af mild til moderat grad og begrænsede ikke behandlingen.
The majority were of mild to moderate intensity and not treatment limiting.
Den potentielle risiko for udvikling af levertumorer hos mennesker kendes ikke, og Deres læge vil vurdere fordele og ulemper ved behandling med Mycamine, inden De starter med medicinen.
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.
De fleste patienter (97 %, N=882) havde neutropeni ved baseline (< 200 neutrofile/μL).
Most patients (97%, N=882) had neutropenia at baseline (< 200 neutrophils/µL).
Micafungin hæmolyserede kaninblod in vitro.
Micafungin haemolysed rabbit blood in vitro.
Andre påviste infektioner var forårsaget af Fusarium (henholdsvis 1 og 2 patienter) og Zygomycetes (henholdsvis 1 og 0 patienter).
Other breakthrough infections were caused by Fusarium (1 and 2 patients, respectively) and Zygomycetes (1 and 0 patients, respectively).
Nogle mennesker kan føle svimmelhed, når de tager medicinen, og hvis det sker for Dem, må De ikke køre eller betjene maskiner.
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.
Hvis sådanne reaktioner forekommer, bør infusionen af micafungin afbrydes og passende behandling igangsættes.
If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered.
Farmakoterapeutisk klassifikation: Antimykotika til systemisk brug, andre antimykotika til systemisk brug, ATC-kode: J02AX05.
Pharmacotherapeutic group: Antimycotics for systemic use, other antimycotics for systemic use, ATC code: J02AX05
• Beslutningen om at anvende Mycamine skal tage højde for en potentiel risiko for udvikling af levertumorer.
• The decision to use Mycamine should take into account a potential risk for the development of liver tumours.
Mycamine indeholder det aktive stof micafungin.
Mycamine contains the active substance micafungin.
Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De bruger dette lægemiddel.
If you are pregnant of breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Behandlingssucces blev defineret som ingen påvist, mulig eller mistænkt systemisk svampeinfektion ved slutningen af behandlingen og ingen påvist, mulig eller mistænkt systemisk svampeinfektion ved slutningen af studiet.
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.
En forlængelse af infusionstiden reducerer den maksimale plasmakoncentration, og så ud til at reducere disse effekter.
Prolongation of infusion time reducing the plasma concentration peak appeared to reduce these effects.
Behandlingen kan startes, før dyrkningsresultaterne og andre laboratorietests foreligger.
Therapy may be instituted before the results of the cultures and other laboratory studies are known.
§ Børnepopulation er ikke beregnet til at blive undersøgt for non-inferioritet.
§ The paediatric population was not sized to test for non-inferiority.
Virkningerne var konsistente, uafhængigt af Candida-arten, det primære infektionsområde og den neutropene status (se tabel).
Efficacy findings were consistent, independent of the infective Candida species, primary site of infection and neutropenic status (see Table).
Astellas Ireland Co., Ltd. Killorglin, County Kerry Irland
Astellas Ireland Co., Ltd. Killorglin, County Kerry Ireland
Mycamine bør indgives 1 gang om dagen ved langsom intravenøs (ind i en vene) infusion.
Mycamine should be administered once daily by slow intravenous (into a vein) infusion.
Den gennemsnitlige terminale halveringstid er ca. 10-17 timer og er konstant i doser op til 8 mg/kg og efter enkelt og gentagen administration.
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.
I dyremodeller af candidiasis blev det observeret, at der er en korrelation mellem eksponeringen for micafungin divideret med MIC (AUC/MIC) og virkningen defineret som den ratio, som er nødvendig for at hindre progressiv svampevækst.
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.
En ratio på ~2400 og ~1300 var nødvendig for henholdsvis C. albicans og C. glabrata i disse modeller.
A ratio of ~2400 and ~1300 was required for C. albicans and C. glabrata, respectively, in these models.
Køn/race: Køn og race (hvid, sort og orientalsk) påvirkede ikke de farmakokinetiske parametre for micafungin signifikant.
Gender/Race: Gender and race (Caucasian, Black and Oriental) did not significantly influence the pharmacokinetic parameters of micafungin.
1,3-β-D-glucan findes ikke i pattedyrs celler.
1,3-β-D-glucan is not present in mammalian cells.
De uåbnede hætteglas kræver ingen særlige opbevaringsbetingelser.
The unopened vial does not require any special storage conditions.
Micafungin er stærkt proteinbundet og kan ikke dialyseres.
Micafungin is highly protein-bound and not dialysable.
I reproduktions- og udviklingstoksicitetsstudier blev der observeret reduceret fødselsvægt hos hundehvalpe.
In reproductive and developmental toxicity studies, reduced birth weight of the pups was noted.
Selvom micafungin er et substrat for CYP3A in vitro, er hydroxylering af CYP3A ikke en større metaboliseringsbane for micafungin in vivo.
Even though micafungin is a substrate for CYP3A in vitro, hydroxylation by CYP3A is not a major pathway for micafungin metabolism in vivo.
Micafungin og liposomalt amphotericin B blev taget i gennemsnitligt 15 dage (4 til 42 dage hos voksne, og 12 til 42 dage hos børn).
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).
Det rekonstituerede koncentrat og den fortyndede infusionsvæske bør anvendes straks, da det ikke indeholder konserveringsmiddel til at forhindre forurening med bakterier.
The reconstituted concentrate and the diluted infusion solution should be used immediately, because it does not contain any preservatives to prevent bacterial contamination.
Informer Deres læge, hvis De mærker eventuelle bivirkninger, som kan give problemer med at køre eller betjene maskiner.
Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery.
Gentagne daglige doser på op til 8 mg/kg (maksimal total dosis 896 mg) er blevet administreret til voksne patienter i kliniske forsøg uden rapportering af dosisbegrænsende toksicitet.
Repeated daily doses up to 8 mg/kg (maximum total dose 896 mg) in adult patients have been administered in clinical trials with no reported dose-limiting toxicity.
Koncentratet bør benyttes straks.
The concentrate should be used immediately.
Officielle/nationale vejledninger vedrørende rigtig brug af antimykotika bør tages med i vurderingen.
Consideration should be given to official/national guidance on the appropriate use of antifungal agents.
Invasiv candidiasis: Behandlingsvarigheden af Candida-infektion bør være på mindst 14 dage.
Invasive candidiasis: The treatment duration of Candida infection should be a minimum of 14 days.
Relevansen af det carcinogene potentiale i leveren for micafungin ved terapeutisk brug hos mennesker kendes ikke.
The relevance of the hepatocarcinogenic potential of micafungin for the human therapeutic use is not known.
Ved gentagne doseringsstudier på hunde blev der ikke observeret hæmolytisk anæmi.
In repeat dose studies in dogs, haemolytic anaemia was not observed.
Alt rekonstitueret koncentrat bør udtages fra hvert hætteglas og returneres til den infusionsflaske/pose, hvorfra det oprindeligt blev udtaget.
All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken.
I et spontant tilfælde blev der indberettet administration af en dosis på 16 mg/kg/dag til et nyfødt barn.
In one spontaneous case, it was reported a dosage of 16 mg/kg/day was administered in a newborn patient.
Prøver til svampekulturer og andre relevante laboratorietests (inklusive histopatologi) bør tages før behandling for at isolere og identificere de(n) sygdomsfremkaldende organisme(r).
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s).
Patienter bør imidlertid informeres om, at svimmelhed er rapporteret under behandling med micafungin (se pkt.
However, patients should be informed that dizziness has been reported during treatment with micafungin (see section
Hos kaniner forekom der en abort ved 32 mg/kg/dag.
One abortion occurred in rabbits at 32 mg/kg/day.
Mycamine må ikke blandes med eller indgives sammen med andre lægemidler end de nedenfor nævnte.
Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below.
I det kliniske studie var vellykket resultat numerisk en anelse lavere for C. tropicalis end for C. albicans ved begge doser (100 og 150 mg daglig).
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).
Mycamine bør ikke bruges under graviditet, medmindre det er strengt nødvendigt.
Mycamine should not be used during pregnancy unless clearly necessary.
Eksponering (AUC) for itraconazol, sirolimus og nifedipin viste en let øgning i forbindelse med micafungin (henholdsvis 22 %, 21 % og 18 %).
Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
Mycamine er effektivt til at behandle systemiske infektioner (infektioner, der har spredt sig i hele kroppen).
Mycamine is effective in treating systemic infections (those that have penetrated within the body).
Ikke anvendt lægemiddel samt affald heraf skal destrueres i henhold til lokale retningslinjer.
Any unused product or waste material should be disposed of in accordance with local requirements.
Behandlingssucces var signifikant højere for micafungin end for fluconazol (1,6 % versus 2,4 % påviste infektioner).
The rate of treatment success was statistically significantly higher for micafungin than fluconazole (1.6% versus 2.4% breakthrough infections).
Et tilstrækkeligt antal hætteglas med Mycamine skal rekonstitueres for at kunne få den tilstrækkelige dosis i mg (se nedenstående tabel).
A sufficient number of vials of Mycamine must be reconstituted to obtain the required dose in mg (see table below).
Hvis De får et allergisk anfald eller en alvorlig hudreaktion (f.eks. blæredannelse og afskalning af huden), skal De straks fortælle det til lægen eller sundhedspersonalet.
If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor or nurse immediately
Micafungin har et lavt interaktionspotentiale med lægemidler, som omdannes via CYP3A- medierede nedbrydningsveje.
Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways.
Der blev ikke indberettet bivirkninger i forbindelse med denne høje dosis.
No adverse reactions associated with this high dose were noted.
Infektionsbehandlingen bør fortsætte i mindst en uge, efter at to på hinanden følgende negative blodprøver er taget, og efter at kliniske symptomer fra infektionen er ophørt.
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.
Vægt havde betydning for clearance, idet gennemsnitsværdien af vægt-justeret clearance var 1,35 gange højere hos yngre børn (4 måneder-5 år) og 1,14 gange højere hos pædiatriske patienter i alderen 6-11 år.
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.
Den gennemsnitlige vægtjusterede clearance hos børn under 4 måneder er ca. 2,6 gange højere end hos ældre børn (12-16 år) og 2,3 gange højere end hos voksne.
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.
Dosisjustering af micafungin er ikke nødvendig ved samtidig administration af disse lægemidler.
No micafungin dose adjustments are necessary when these medicines are administered concomitantly.
Micafungin udviser fungicid effekt på de fleste Candida-arter og hæmmer kraftigt aktivt voksende hyfer af Aspergillus-arter.
Micafungin exhibits fungicidal activity against most Candida species and prominently inhibits actively growing hyphae of Aspergillus species.
Efter rekonstitution og fortynding skal opløsningen administreres ved intravenøs infusion over ca. 1 time.
After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.
- Behandling af candidiasis i øsofagus hos patienter, hvor intravenøs behandling er passende.
- Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.
Behandling af invasiv candidiasis
Treatment of invasive candidiasis
Behandling med Mycamine bør initieres af en læge med erfaring i behandling af systemiske svampeinfektioner.
Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections.
Micafungin kan muligvis påvirke fertiliteten hos mænd.
Micafungin may have the potential to affect male fertility in humans.
Påviste Aspergillus-infektioner blev observeret hos 1 versus 7 patienter og påvist, eller mulig udvikling af Candida-infektioner blev observeret i henholdsvis 4 versus 2 patienter i micafungin- og fluconazol-grupperne.
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.
Reduceret følsomhed over for echinocandiner har været associeret med mutationer i Fks1og Fks2-generne, som koder for en større subunit i glukansyntase.
Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 and Fks2 genes coding for a major subunit of glucan synthase.
• Til behandling af voksne og unge ≥ 16 år, som har en svampeinfektion i spiserøret (øsofagus), hvor en behandling givet ind i en vene (intravenøs) er egnet.
• To treat adults and adolescents ≥ 16 years of age who have a fungal infection in the gullet (oesophagus) where treatment into a vein (intravenous) is appropriate.
• Til at forhindre Candida infektion hos patienter, der skal gennemgå en knoglemarvstransplantation eller som forventes at have neutropeni (lave niveauer af neutrofiler, en type hvide blodlegemer) i 10 dage eller mere.
• 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.
Candidæmi og invasiv Candidiasis: Micafungin (100 mg/dag eller 2 mg/kg/dag) var lige så effektivt og bedre tolereret end liposomalt amphotericin B (3 mg/kg) som førstevalgsbehandling af candidæmi og invasiv candidiasis i et randomiseret, dobbeltblindt, multinationalt non-inferioritetsstudie.
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.
Børn: Hos pædiatriske patienter var AUC proportional med dosis over et interval på 0,5-4 mg/kg.
Paediatric patients: In paediatric patients AUC values were dose proportional over the dose range of 0.5-4 mg/kg.
Profylakse: Micafungin var mere effektiv end fluconazol til at forhindre invasive svampeinfektioner i en patientgruppe med højere risiko for at udvikle en systemisk svampeinfektion (patienter der gennemgår en hæmatopoetisk stamcelletransplantation [HSCT] i et randomiseret, dobbeltblindt multicenterstudie).
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).
Efter indgift af enkelt intravenøs dosis af 14C-micafungin (25 mg) til raske personer genfindes 11,6 % i urinen og 71,0 % i fæces efter 28 dage.
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.
Hvis De ønsker yderligere oplysninger om Mycamine, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Leverfunktionen bør overvåges nøje under behandlingen med micafungin.
Liver function should be carefully monitored during micafungin treatment.
En endoskopisk grad på 0 (endoskopisk heling) ved slutningen af behandlingen blev observeret hos 87,7 % (228/260) og 88,0 % (227/258) af patienterne i henholdsvis micafungin- og fluconazolgrupperne (95 % KI for forskellen: [-5,9 %; 5,3 %]).
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%]).
Der er ikke udført standard carcinogenicitetsstudier, men udviklingen af FAH blev vurderet hos hunrotter efter 20 og 18 måneder efter afsluttet behandling, der havde varet henholdsvis 3 og 6 måneder.
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.
Candidiasis i øsofagus: I et randomiseret, dobbeltblindt studie med micafungin versus fluconazol som førstevalgsbehandling af candidiasis i øsofagus, modtog 518 patienter mindst én enkeltdosis forsøgsmedicin.
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.
Micafunginbehandling var forbundet med signifikant forværring af leverfunktion (forhøjet ALAT, ASAT eller total-bilirubin > 3 gange ULN) både hos raske frivillige og hos patienter.
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.
10 ml type I-hætteglas med isobutylen-isopren (PTFE-lamineret) prop med "flip-off cap".
10 ml Type I glass vial with an isobutylene-isoprene (PTFE-laminated) rubber stopper and a flip-off cap.
Sjældne tilfælde af hæmolyse, inklusive akut intravaskulær hæmolyse eller hæmolytisk anæmi, er blevet indberettet for patienter, som blev behandlet med micafungin.
Rare cases of haemolysis, including acute intravascular haemolysis or haemolytic anaemia, have been reported in patients treated with micafungin.
Micafungin hæmmer ikke-kompetitivt syntesen af 1,3-β-D-glucan, der er en essentiel komponent i svampens cellevæg.
Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall.
Ældre børn (12-16 år) havde gennemsnitsclearanceværdier svarende til de værdier, man fandt hos voksne.
Older children (12-16 years) had mean clearance values similar to those determined in adult patients.
Udviklingen af foci med ændrede hepatocytter (FAH) og hepatocellulære tumorer i rotter var afhængige af både dosis og af varigheden af micafunginbehandlingen.
The development of foci of altered hepatocytes (FAH) and hepatocellular tumours in rats was dependent on both dose and duration of micafungin treatment.
Det vides ikke, om micafungin udskilles i human mælk.
It is not known whether micafungin is excreted in human breast milk.
Det endokrine system hyperhidrose
Endocrine disorders hyperhidrosis
Varigheden af micafungindoseringen i disse rottestudier (6 måneder) overskred den normale varighed for micafungindosering hos patienter (se pkt.
The duration of micafungin dosing in these rat studies (6 months) exceeds the usual duration of micafungin dosing in patients (see section 5.1).
Samtidig administration af micafungin og amphotericin B-desoxycholat var forbundet med en 30 % øgning i amphotericin B-deoxycholat eksponeringen.
Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure.
Micafungin viste en mindre middelværdisreduktion i den estimerede glomerulære filtrationshastighed under behandlingen (P<0,001) og en lavere forekomst af infusionsrelaterede reaktioner (P=0,001) sammenlignet med liposomalt amphotericin B.
Micafungin demonstrated a smaller mean peak decrease in estimated glomerular filtration rate during treatment (p<0.001) and a lower incidence of infusion-related reactions (p=0.001) than liposomal amphotericin B.
Størstedelen af disse bivirkninger var lette eller moderate.
The majority of hepatic adverse reactions were mild and moderate.
Det kan derfor forventes, at disse bivirkninger kan forekomme hos mennesker ved klinisk brug af micafungin.
Consequently, the occurrence of these adverse responses may be expected in human clinical use of micafungin.
Micafungin var ikke mutagent eller klastogent i et arsenal af standardundersøgelser omfattende både in vitro og in vivo tests, herunder et in vitro studie ”Unscheduled DNA Synthesis” med hepatocytter fra rotter.
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.
Disse data er utilstrækkelige til at kunne anbefale en dosis i patienter med svært nedsat leverfunktion.
These data are insufficient to support a dosing recommendation in patients with severe hepatic impairment.
Ældre: Når micafungin indgives som en enkelt 1-times infusion på 50 mg, svarer farmakokinetikken hos ældre (66-78 år) til, hvad man finder hos yngre voksne (20-24 år).
Elderly: When administered as a single 1-hour infusion of 50 mg the pharmacokinetics of micafungin in the elderly (aged 66-78 years) were similar to those in young (20-24 years) subjects.