FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported adverse reactions were nausea (2.8%), blood alkaline phosphatase increased (2.7%), phlebitis (2.5%, primarily in HIV infected patients with peripheral lines), vomiting (2.5%), and aspartate aminotransferase increased (2.3%).
Danish: De hyppigst indberettede bivirkninger var kvalme (2,8 %), forhøjet alkalisk fosfatase i blodet (2,7 %), flebit (2,5 %, hovedsageligt hos HIV-inficerede patienter med perifert venekateter), opkast (2,5 %) og forhøjet aspartataminotransferase (ASTA) (2,3 %).
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).
Danish: Patienter, som får sirolimus, nifedipin eller itraconazol i kombination med micafungin, bør monitoreres for sirolimus-, nifedipin- eller itraconazoltoksicitet, og dosis af sirolimus, nifedipin eller itraconazol skal om nødvendigt reduceres (se pkt.
English: To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended.
Danish: For at mindske risikoen for adaptiv regenerering og mulig dannelse af levertumorer anbefales der tidlig seponering ved signifikante og vedvarende forhøjede værdier af ALAT/ASAT.
English: - The usual dose to treat an invasive Candida infection is 4-10 mg/kg per day.
Danish: - Den normale dosis til behandling af en invasiv Candida-infektion er 4-10 mg/kg per dag.
English: Mycamine is supplied in a box containing 1 vial.
Danish: Mycamine leveres i pakninger med 1 hætteglas.
English: The plastic cap must be removed from the vial and the stopper disinfected with alcohol.
Danish: Platikhætten skal fjernes fra hætteglasset og proppen desinficeres med alkohol.
English: 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.
Danish: Af disse er M-1 (katekolform), M-2 (metoxyform af M-1) og M-5 (hydroxylering ved sidekæde) set i den systemiske cirkulation af micafungin.
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
Danish: Ikke kendte (kan ikke vurderes ud fra tilgængelige data) - forstyrrelser i blodets koagulation - (allergisk) shock - beskadigelse af leverceller, herunder dødelige tilfælde - nyreproblemer, akut nyresvigt
English: Patients should be closely monitored for worsening of renal function.
Danish: Patienten bør overvåges nøje, for at man kan følge en evt. forværring af nyrefunktionen.
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.
Danish: Hos rotter blev der observeret vakuolisering af epitellet i nyrebækkenet samt vakuolisering og fortykkelse (hyperplasi) af epitellet i urinblæren i et forsøg af 26 ugers varighed med gentagne doseringer.
English: However, if you are concerned that you may have been given too much Mycamine, speak to your doctor or another healthcare professional immediately.
Danish: Hvis De spekulerer på, om De har fået for meget Mycamine, skal De straks tale med lægen eller en anden sundhedsperson om det.
English: Therefore, unused reconstituted concentrate must be discarded immediately.
Danish: Derfor bør ubrugt rekonstitueret koncentrat straks kasseres.
English: Investigations blood lactate dehydrogenase increased
Danish: Undersøgelser forhøjet laktatdehydrogenase i blodet
English: - The active substance is micafungin (as sodium).
Danish: - Aktivt stof: Micafungin (som natriumsalt).
English: Pharmacokinetics are linear over the daily dose range of 12.5 mg to 200 mg and 3 mg/kg to 8 mg/kg.
Danish: Micafungins farmakokinetik er liniær over et dagligt dosisinterval på 12,5-200 mg og 3-8 mg/kg.
English: During administration of micafungin, anaphylactic/anaphylactoid reactions, including shock, may occur.
Danish: Under behandling med micafungin kan anafylaktiske/anafylaktoide reaktioner forekomme, herunder anafylaktisk shock.
English: Use in children and newborns < 4 months of age
Danish: Anvendelse til spædbørn og nyfødte < 4 måneder
English: In order to protect the infusion bottle / bag containing the diluted infusion solution from light it should be inserted into a closable opaque bag.
Danish: For at beskytte infusionsflasken/posen med den fortyndede infusionsvæske mod lys bør den anbringes i en uigennemsigtig pose, der kan lukkes.
English: Hypersensitivity to the active substance, to other echinocandins or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, andre echinocandiner eller over for et eller flere af hjælpestofferne anført i pkt.
English: Micafungin treatment should be conducted on a careful risk/benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/or genotoxic properties.
Danish: Micafunginbehandling bør først gives efter nøje vurdering af risk/benefit-forholdet, især af patienter med svært nedsat leverfunktion eller kroniske leversygdomme med præneoplastiske tilstande, som f.eks. fremskreden leverfibrose, cirrose, viral hepatit, neonatal leversygdom eller medfødte enzymdefekter eller hos patienter, som samtidig får behandling, som har hepatotoksiske og/eller genotoksiske egenskaber.
English: Therefore, please discard unused reconstituted concentrate immediately.
Danish: Kassér derfor ubrugt rekonstitueret koncentrat med det samme.
English: (breakdown of red blood cells).
Danish: eller hæmolyse (nedbrydning af røde blodlegemer).
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).
Danish: Patienter med nedsat leverfunktion: I et studie foretaget på patienter med moderat nedsat leverfunktion (Child-Pugh-score 7-9) adskilte farmakokinetikken for micafungin sig ikke signifikant fra den hos raske forsøgspersoner (n=8).
English: Metabolism and nutritional disorders hypokalaemia, hypomagnesaemia, hypocalcaemia hyponatraemia, hyperkalaemia, hypophosphataemia, anorexia
Danish: Metabolisme og ernæring hypokaliæmi, hypomagnesæmi, hypokalcæmi hyponatremi, hyperkaliæmi, hypofosfatæmi, anoreksi
English: - The usual dose to prevent invasive Candida infections is 2 mg/kg per day.
Danish: - Den normale dosis til forbyggelse af invasiv Candida-infektioner er 2 mg/kg per dag.
English: 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.
Danish: 5 ml natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning eller glucose 50 mg/ml (5 %) infusionsvæske, opløsning (udtaget fra 100 ml flaske/pose) bør aseptisk og langsomt injiceres i hvert hætteglas langs siden af indervæggen.
English: Mycamine 50 mg or 100 mg powder for solution for infusion is a white compact freeze-dried powder.
Danish: Mycamine 50 mg eller 100 mg pulver til infusionsvæske, opløsning er et hvidt, kompakt frysetørret pulver.
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.
Danish: • Patienter, som udvikler kliniske symptomer eller har laboratorieprøver, som viser hæmolyse under behandling med micafungin, bør overvåges nøje, for at man kan følge en mulig forværring af disse tilstande, og vurdere benefit/risk-forholdet med henblik på at fortsætte behandlingen.
English: Vascular disorders common hypertension, hypotension
Danish: Vaskulære sygdomme almindelig hypertension, hypotension
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.
Danish: Hos voksne hunde sås atrofi af sædkanaler med vakuolisering af sædkanalernes epitel og reduktion af sædceller i bitestiklerne efter længere tids behandling (39 uger), men ikke efter 13 ugers behandling.
English: General disorders and administration site conditions pyrexia, rigors injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema
Danish: Almene symptomer og reaktioner på administrationsstedet pyreksi, rigor trombose på injektionsstedet, inflammation på injektionsstedet, smerte på injektionsstedet, perifert ødem
English: PK/PD relationship
Danish: Farmakokinetiske/farmakodynamiske (PK/PD) forhold
English: Micafungin may cause kidney problems, renal failure, and abnormal renal function test.
Danish: Micafungin kan forårsage nyreproblemer, nyresvigt og unormale nyrefunktionsværdier.
English: The overall incidence of hepatic adverse reactions in the patients treated with micafungin in clinical studies was 8.6% (260/3028).
Danish: I de kliniske studier var den totale incidens af hepatiske bivirkninger 8,6 % (260/3028) hos patienter, som blev behandlet med micafungin.
English: The vial should be rotated gently.
Danish: Hætteglasset skal roteres forsigtigt.
English: Your doctor monitors your response and condition to determine what dose of Mycamine is needed.
Danish: Lægen vil vurdere, hvordan De reagerer på behandlingen, og bedømme Deres tilstand for at afgøre, hvilken dosering af Mycamine der er nødvendig.
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).
Danish: Samtidig administration af micafungin og amphotericin B-desoxycholat bør kun anvendes, når fordelene klart opvejer risikoen og under omhyggelig monitorering af toksiciteten af amphotericin Bdesoxycholat (se pkt.
English: This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Skin and subcutaneous tissue disorders rash urticaria, pruritus, erythema toxic skin eruption, erythema multiforme, StevensJohnson syndrome, toxic epidermal necrolysis (see section 4.4)
Danish: Hud og subkutane væv udslæt urticaria, pruritus, erytem toksisk hududslæt, erythema multiforme, StevensJohnsons syndrom, toksisk epidermal nekrolyse (se pkt.
English: Renal and urinary disorders common acute renal failure, blood urea increased
Danish: Nyrer og urinveje almindelig akut nyresvigt, forhøjet urinstof i blodet
English: Lactose monohydrate Citric acid anhydrous (to adjust the pH) Sodium hydroxide (to adjust the pH)
Danish: Lactosemonohydrat Citronsyre, vandfri (til pH-justering) Natriumhydroxid (til pH-justering)
English: - if you have kidney problems (e.g. kidney failure and abnormal kidney function test).
Danish: - hvis De har nyreproblemer (f.eks. nyresvigt og unormal nyrefunktionstest).
English: How to use Mycamine
Danish: Sådan skal De bruge Mycamine
English: Mycamine vial to be used (mg/vial)
Danish: Mycamine hætteglas der skal bruges (mg/hætteglas)
English: The nature and incidence of adverse events were similar between treatment groups.
Danish: Typen og forekomsten af bivirkningerne var ens for de to behandlingsgrupper.
English: Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light and diluted as described above.
Danish: Kemisk og fysisk stabilitet under brug er vist for 96 timer ved 25°C, ved beskyttelse mod lys, og ved fortynding som beskrevet ovenfor.
English: Do not use the diluted infusion solution if it is cloudy or precipitated.
Danish: Brug ikke den fortyndede infusionsvæske, hvis den er uklar eller har bundfald.
English: - The other ingredients are lactose monohydrate, citric acid anhydrous and sodium hydroxide.
Danish: - Øvrige indholdsstoffer: Lactosemonohydrat, vandfri citronsyre og natriumhydroxid.
English: The vial is for single use only.
Danish: Hætteglasset er kun til éngangsbrug.
English: 3 mg/kg/day
Danish: 3 mg/kg/dag
English: What you need to know before you use Mycamine Do not use Mycamine
Danish: Det skal De vide, før De begynder at bruge Mycamine Sådan skal De bruge Mycamine Bivirkninger
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.
Danish: Patienter, som udvikler kliniske symptomer eller har laboratorieprøver, som viser hæmolyse under behandling med micafungin, bør overvåges nøje, for at man kan følge en mulig forværring af disse tilstande, og vurdere risk/benefitforholdet med henblik på at fortsætte behandlingen.
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.
Danish: Der er vist kemisk og fysisk stabilitet i op til 48 timer ved 25°C efter rekonstitution med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske eller glucose 50 mg/ml (5 %) infusionsvæske.
English: Following intravenous administration concentrations of micafungin show a biexponential decline.
Danish: Efter intravenøs indgift mindskes koncentrationer af micafungin bieksponentielt.
English: Rare (may affect up to 1 in 1,000 people) - anaemia due to breakdown of red blood cells (haemolytic anaemia), breakdown of red blood cells (haemolysis)
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer) - anæmi pga. nedbrydning af røde blodlegemer (hæmolytisk anæmi), nedbrydning af røde blodlegemer (hæmolyse)
English: In rats, long-term treatment with micafungin led to liver damage and subsequent liver tumours.
Danish: Hos rotter fører langvarig behandling med micafungin til leverskade og efterfølgende svulster i leveren (levertumorer).
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.
Danish: - Profylakse mod Candida-infektion hos patienter, der gennemgår allogen hæmatopoietisk stamcelletransplantation eller patienter, der forventes at få neutropeni (absolut neutrofiltal < 500
English: 100 mg/day*
Danish: 100 mg/dag*
English: Overall Treatment Success in the Per Protocol Set, Invasive Candidiasis Study Micafungin
Danish: Total behandlingssucces i per-protokol-sæt, forsøg med invasiv candidiasis Micafungin Liposomalt Amphotericin B
English: The development of foci of altered hepatocytes (FAH) and hepatocellular tumours after a treatment period of 3 months or longer were observed in rats.
Danish: Hos rotter blev der observeret udvikling af foci med forandrede hepatocytter (FAH) og hepatocellulære tumorer efter en behandlingsperiode på 3 måneder eller længere.
English: No dose adjustment is necessary for patients with renal impairment.
Danish: Dosisjustering er ikke nødvendig for patienter med nedsat nyrefunktion.
English: Use in children > 4 months of age and adolescents < 16 years of age
Danish: Anvendelse til børn > 4 måneder og unge < 16 år
English: An intact cell wall is necessary for the fungus to continue living and growing.
Danish: En intakt cellevæg er nødvendig, for at svampe kan fortsætte med at leve og gro. Mycamine skader svampenes cellevægge, så svampe ikke kan vokse og leve.
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.
Danish: Der er vist kemisk og fysisk stabilitet i 96 timer ved 25°C, hvis opløsningen beskyttes mod lys, og hvis den er fortyndet med natriumchlorid 9 mg/ml (0,9 %) til infusionsvæske, opløsning eller glucose 50 mg/ml (5 %) til infusionsvæske, opløsning.
English: Cases of serious hepatic dysfunction occurred uncommonly (see section 4.4).
Danish: Tilfælde af svært nedsat leverfunktion var ikke almindelige (se pkt.
English: Powder for solution for infusion White compact powder
Danish: Pulver til infusionsvæske, opløsning Hvidt kompakt pulver
English: - if you are allergic to micafungin, other echinocandins (Ecalta or Cancidas) or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal De vide, før De begynder at bruge Mycamine Brug ikke Mycamine hvis De er allergisk over for micafungin, andre echinocandiner (Ecalta eller Cancidas) eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: For reconstitution instructions see section 6.6.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN 16.
English: Gastrointestinal disorders nausea, vomiting, diarrhoea, abdominal pain dyspepsia, constipation
Danish: Mavetarmkanalen kvalme, opkastning, diarré, abdominalsmerter dyspepsi, obstipation
English: No dose adjustment is necessary in patients with mild or moderate hepatic impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion (se pkt.
English: If you miss a dose of Mycamine
Danish: Hvis De har brugt for meget Mycamine
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.
Danish: - Den normale dosis til forebyggelse af invasive Candida-infektioner er 50 mg per dag for patienter, der vejer mere end 40 kg, og 1 mg/kg per dag for patienter, der vejer 40 kg eller mindre.
English: What Mycamine looks like and contents of the pack
Danish: Mycamines udseende og pakningsstørrelse
English: However, if you are concerned that you may have missed a dose, speak to your doctor or another healthcare professional immediately.
Danish: Hvis De spekulerer på, om De mangler en dosis Mycamine, skal De straks tale med lægen eller en anden sundhedsperson om det.
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.
Danish: Den totale clearance var 0,15-0,3 ml/min/kg hos raske personer og hos voksne patienter.
English: It interferes with the production of a part of the fungal cell wall.
Danish: Det påvirker svampenes evne til at danne cellevægge.
English: Hepatic effects:
Danish: Hepatiske bivirkninger
English: The infusion bottle/bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming.
Danish: Infusionsflasken/posen bør vendes forsigtigt for at fordele den fortyndede opløsning, men for at undgå skumdannelse må den IKKE rystes.
English: Vascular disorders phlebitis hypotension, hypertension, flushing shock
Danish: Vaskulære sygdomme flebit hypotension, hypertension, rødmen shock
English: 4 -10 mg/kg/day*
Danish: 4-10 mg/kg/dag*
English: Uncommon (may affect up to 1 in 100 people) - abnormal blood tests (decreased blood cells [pancytopenia]); decreased blood platelets
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) - unormale blodprøver (nedsat antal blodlegemer (pancytopeni), nedsat antal blodplader
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
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer) - unormale blodprøver (nedsat antal hvide blodlegemer (leukopeni, neutropeni), nedsat antal røde blodlegemer (anæmi) - nedsat kaliumindhold i blodet (hypokalæmi), nedsat magnesiumindhold i blodet
English: The infusion bottle/bag containing the diluted infusion solution should be inserted into a closable opaque bag for protection from light.
Danish: Infusionsflasken/posen med den fortyndede opløsning skal anbringes i en uigennemsigtig pose for at beskytte mod lys.
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.
Danish: Candida albicans Non-albicans species ¶: alle C. tropicalis C. parapsilosis C. glabrata C. krusei † Raten for micafungin minus raten for liposomalt amphotericin B og dobbeltsidet 95 % konfidensinterval, som viser forskellen i total succesrate er baseret på tilnærmelse til normalfordeling.
English: Hepatobiliary disorders common hyperbilirubinaemia, hepatomegaly
Danish: Lever og galdeveje almindelig hyperbilirubinæmi, hepatomegali
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.
Danish: - Den normale dosis til behandling af en invasiv Candida-infektion er 100 mg per dag for patienter, der vejer 40 kg eller mere, og 2 mg/kg per dag for patienter, der vejer 40 kg eller mindre.
English: Using aseptic techniques at room temperature, Mycamine is reconstituted and diluted as follows:
Danish: Mycamine rekonstitueres og fortyndes under anvendelse af aseptisk teknik og ved stuetemperatur på følgende måde:
English: Cardiac disorders common tachycardia
Danish: Hjerte almindelig takykardi
English: Lactose monohydrate, citric acid anhydrous and sodium hydroxide.
Danish: Lactosemonohydrat, citronsyre (vandfrit) og natriumhydroxid.
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).
Danish: Det samme gjaldt for allogen SCT (henholdsvis 29,4 % og 13,4 %) og hæmatologisk malignitet (henholdsvis 29,1 % og 8,7 %,).
English: The incidence of some adverse reactions was higher in paediatric patients than in adult patients (see section 4.8).
Danish: Visse bivirkninger var hyppigere hos børn end hos voksne (se pkt.
English: The safety and efficacy in children (including neonates) less than 4 months of age of doses of 4 and 10 mg/kg for the treatment of invasive candidiasis with CNS involvement has not been adequately established.
Danish: Sikkerheden og virkningen af doser på 4 og 10 mg/kg til behandling af invasiv candidiasis med involvering af CNS er ikke tilstrækkeligt klarlagt hos spædbørn (herunder nyfødte) under 4 måneder.
English: Use in children ≥ 4 months of age up to adolescents < 16 years of age
Danish: Brug hos børn ≥ 4 måneder og unge < 16 år
English: Renal impairment No dose adjustment is necessary in patients with renal impairment (see section 5.2).
Danish: Nedsat nyrefunktion Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: Package leaflet: Information for the user Mycamine 50 mg powder for solution for infusion Mycamine 100 mg powder for solution for infusion micafungin
Danish: Indlægsseddel: information til brugeren Mycamine 50 mg pulver til infusionsvæske, opløsning Mycamine 100 mg pulver til infusionsvæske, opløsning micafungin