FrancophonIA/ELRC3.0 huggingface dataset:
English: What Noxafil looks like and contents of the pack Noxafil concentrate for solution for infusion is a clear, colourless to yellow liquid.
Danish: Noxafil koncentrat til infusionsvæske, opløsning er en klar, farveløs til gul væske.
English: rash, pruritis
Danish: udslæt, pruritis
English: • bleeding into your stomach or gut - signs include vomiting blood or passing blood in your stool
Danish: • blødning i maven eller tarmen - tegn på dette kan omfatte opkastning af blod eller blod i afføringen
English: • are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).
Danish: • tager vincristin, vinblastin og andre “vinkaalkaloider” (medicin til behandling af kræft).
English: hepatic failure, hepatitis cholestatic, hepatosplenomegaly, liver tenderness, asterixis
Danish: nedsat leverfunktion, kolestatisk hepatitis, hepatosplenomegali, leverømhed, asterixis
English: Please return the bottle containing any leftover suspension to your pharmacist.
Danish: Aflever flasken med medicinresten på apoteket.
English: • Administer via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow intravenous infusion over approximately 90 minutes.
Danish: • Administrer Noxafil via en infusionsslange med et centralt venekateter (CVK) eller et perifert anlagt centralt venekateter (PICC-line) som en langsom intravenøs infusion over ca. 90 minutter.
English: • vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)
Danish: • vincristin, vinblastin og andre ”vinkaalkaloider” (anvendes til behandling af kræft)
English: hypertension hypotension, thrombophlebitis, vasculitis
Danish: hypotension, tromboflebitis, vaskulitis
English: Ciprofloxacin
Danish: Ciprofloxacin Daptomycin
English: • infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;
Danish: • infektioner fremkaldt af svampe, som medfører tilstande kaldet ”chromoblastomykose” og/eller ”mycetoma”, hvis infektionen ikke er behandlet tilstrækkeligt med itraconazol, eller hvis du var nødt til at stoppe behandlingen med dette middel.
English: • high blood pressure in the blood vessels in the lungs (pulmonary hypertension) this can cause serious damage to your lungs and heart
Danish: • højt blodtryk i blodkarrene i lungerne (pulmonal hypertension).
English: Hepatic reactions (e.g. elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.
Danish: Der er rapporteret hepatiske reaktioner (f.eks. forhøjelser af ALAT, ASAT, alkalisk fosfatase og total bilirubin og/eller klinisk hepatitis) under behandling med posaconazol.
English: Efavirenz (400 mg once a day) decreased the Cmax and AUC of posaconazole by 45 % and 50 %, respectively.
Danish: Efavirenz (400 mg en gang dagligt) nedsatte Cmax og AUC for posaconazol med henholdsvis 45 % og 50 %.
English: • Equilibrate the refrigerated vial of Noxafil to room temperature.
Danish: • Lad det afkølede hætteglas med Noxafil opnå stuetemperatur.
English: thrombocytopenia, leukopenia, anaemia, eosinophilia, lymphadenopathy, splenic infarction
Danish: trombocytopeni, leukopeni, anæmi, eosinofili, lymfadenopati, miltinfarkt
English: • mucosal inflammation
Danish: • slimhindebetændelse
English: Noxafil contains sodium
Danish: Noxafil indeholder natrium
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 1.4-fold and 4.6-fold greater, respectively, than those achieved with the human therapeutic doses.
Danish: Forhøjet systolisk og arterielt blodtryk (op til 29 mmHg) blev målt hos rotter og aber ved systemisk eksponering, der var henholdsvis 1,4 gange og 4,6 gange større end den, der blev opnået med terapeutiske doser hos mennesker.
English: 200 mg (5 mL) three times a day.
Danish: 200 mg (5 ml) tre gange dagligt.
English: Thereafter blood levels of ciclosporin should be monitored carefully during co-administration, and upon discontinuation of posaconazole treatment, and the dose of ciclosporin should be adjusted as necessary.
Danish: Niveauet af ciclosporin i blodet bør derefter følges omhyggeligt under samtidig administration og efter afbrydelse af behandling med posaconazol, og dosis af ciclosporin bør om nødvendigt justeres.
English: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.
Danish: - Patienter, der får kemoterapi til remissionsinduktion for akut myeloid leukæmi (AML) eller myelodysplastiske syndromer (MDS), der forventes at resultere i langvarig neutropeni og som har høj risiko for at udvikle invasive svampeinfektioner; - Modtagere af hematopoietisk stamcelletransplantation (HSCT), der gennemgår en høj-dosis immunsuppressiv behandling for graft versus host-sygdom og som har høj risiko for at udvikle invasive svampeinfektioner.
English: Reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options (see section 4.5).
Danish: Azolantimykotika, inklusive posaconazol, bør kun anvendes til patienter, der får vinkaalkaloider, inklusive vincristin, og som ikke har andre muligheder for behandling med antimykotika (se pkt.
English: Following administration of 800 mg per day of posaconazole oral suspension as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 817 years of age (776 ng/mL) were similar to concentrations from 194 patients 18 - 64 years of age
Danish: Efter administration af 800 mg posaconazol oral suspension dagligt fordelt på flere doser til behandling af invasive svampeinfektioner svarede de gennemsnitlige dalplasmakoncentrationer fra 12 patienter i alderen 8-17 år (776 ng/ml) til koncentrationerne fra 194 patienter i alderen 18-64 år (817 ng/ml).
English: Excipients: Betadex Sulfobutyl Ether Sodium (SBECD), disodium edetate, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
Danish: Hjælpestoffer: Sulfobutylether beta cyclodextrinnatrium (SBECD), dinatriumedetat, saltsyre og natriumhydroxid (til pH-justering), vand til injektionsvæsker.
English: In another study in healthy volunteers, repeat dose administration of posaconazole oral suspension (200 mg twice daily for 7 days) increased the Cmax and AUC of intravenous midazolam (0.4 mg single dose) by an average of 1.3- and 4.6-fold (range 1.7 to 6.4-fold), respectively; Posaconazole oral suspension 400 mg twice daily for 7 days increased the intravenous midazolam Cmax and AUC by 1.6 and 6.2-fold (range 1.6 to 7.6-fold), respectively.
Danish: I et andet studie med raske frivillige øgede gentagen administration af posaconazol oral suspension (200 mg to gange dagligt i 7 dage) Cmax og AUC for intravenøst midazolam (0,4 mg enkeltdosis) med et gennemsnit på henholdsvis 1,3 og 4,6 gange (interval 1,7 til 6,4 gange); posaconazol oral suspension 400 mg to gange dagligt i 7 dage øgede intravenøst midazolam Cmax og AUC med henholdsvis 1,6 og 6,2 gange (interval 1,6 til 7,6 gange).
English: Psychiatric disorders Uncommon:
Danish: Psykiske forstyrrelser Ikke almindelig Sjælden:
English: Paediatric population There is no paediatric experience for posaconazole tablets.
Danish: Pædiatrisk population Der foreligger ingen erfaring med posaconazol tabletter til børn.
English: If you think that you may have taken too much Noxafil, talk to a doctor or go to the hospital straight away.
Danish: Hvis du har taget for meget Noxafil Kontakt straks lægen eller tag på hospitalet, hvis du tror, at du har taget for meget Noxafil.
English: • severe sharp chest pain when breathing in (pleurritic pain)
Danish: • meget stærke brystsmerter ved indånding (pleurasmerter)
English: Noxafil can increase the amount of these medicines in the blood which may lead to a severe decrease in blood flow to your fingers or toes and could cause damage to them.
Danish: Dette kan føre til en alvorlig nedsættelse af blodgennemstrømningen til dine fingre eller tæer, og dette kan beskadige dem.
English: Hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.
Danish: Der er rapporteret hepatiske reaktioner (f.eks. lette til moderate forhøjelser af ALAT, ASAT, alkalisk fosfatase og total bilirubin og/eller klinisk hepatitis) under behandling med posaconazol.
English: haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Danish: hæmolytisk uræmisk syndrom, trombotisk trombocytopenisk purpura, pancytopeni, koagulopati, blødning
English: No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at systemic exposures 4.6-fold greater than the concentrations obtained at therapeutic doses in humans.
Danish: Der blev ikke konstateret virkning på elektrokardiogrammer, inklusive QT- og QTc-intervaller, i et sikkerhedsfarmakologisk studie med gentagne doser til aber ved systemisk eksponering, der var 4,6 gange større end de koncentrationer, der blev opnået ved terapeutiske doser hos mennesker.
English: • high blood levels of creatinine - shown in blood tests
Danish: • højt indhold af kreatinin (fremgår af dine blodprøver)
English: cough, epistaxis, hiccups, nasal congestion, pleuritic pain, tachypnoea pulmonary hypertension, interstitial pneumonia, pneumonitis
Danish: hoste, næseblod, hikke, tilstoppet næse, pleurale smerter, hurtig vejrtrækning pulmonal hypertension, interstitiel pneumoni, pneumonitis
English: These medicines include:
Danish: Disse er:
English: Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Danish: Noxafil gastroresistente tabletter er også indiceret til forebyggelse af invasive svampeinfektioner hos følgende patienter: - Patienter, der får kemoterapi til remissionsinduktion for akut myeloid leukæmi (AML) eller myelodysplastiske syndromer (MDS), der forventes at resultere i langvarig neutropeni og som har høj risiko for at udvikle invasive svampeinfektioner; - Modtagere af hematopoietisk stamcelletransplantation (HSCT), der gennemgår høj-dosis immunsuppressiv behandling for graft versus host-sygdom og som har høj risiko for at udvikle invasive svampeinfektioner.
English: No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at maximal plasma concentrations 8.5-fold greater than the concentrations obtained at therapeutic doses in humans.
Danish: Der blev ikke konstateret virkning på elektrokardiogrammer, inklusive QT- og QTc-intervaller, i et sikkerhedsfarmakologisk studie med gentagne doser til aber ved maksimale plasmakoncentrationer, der var 8,5 gange større end de koncentrationer, der blev opnået ved terapeutiske doser hos mennesker.
English: Paediatric population There is no paediatric experience for posaconazole concentrate for solution for infusion.
Danish: Pædiatrisk population Der foreligger ingen erfaring med posaconazol koncentrat til infusionsvæske, opløsning til børn.
English: hearing impairment
Danish: forringet hørelse
English: In heart transplant patients on stable doses of ciclosporin, posaconazole oral suspension 200 mg once daily increased ciclosporin concentrations requiring dose reductions.
Danish: Posaconazol oral suspension 200 mg en gang dagligt øgede koncentrationerne af ciclosporin hos hjertetransplanterede patienter på en stabil dosis af ciclosporin, hvilket medførte behov for dosisnedsættelser.
English: If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine.
Danish: Hvis du er en kvinde, som kan blive gravid, skal du anvende sikker prævention, mens du tager Noxafil.
English: Each millilitre of oral suspension contains 40 milligrams of posaconazole.
Danish: Hver milliliter oral suspension indeholder 40 milligram posaconazol.
English: Sirolimus concentrations should be measured upon initiation, during co-administration, and at discontinuation of posaconazole treatment, with sirolimus doses adjusted accordingly.
Danish: Koncentrationer af sirolimus bør måles ved initiering af behandling, under samtidig administration og ved seponering af behandling med posaconazol.
English: Excipient with known effect: This medicinal product contains approximately 1.75 g of glucose per 5 mL of suspension.
Danish: Hjælpestof, som behandleren skal være opmærksom på Dette lægemiddel indeholder ca. 1,75 g glucose per 5 ml suspension.
English: • low level of “leukocytes” a type of white blood cell (leukopenia) shown in blood tests - this can make you more likely to get infections
Danish: • leukopeni lavt niveau af leukocytter, en type hvide blodlegemer (fremgår af dine blodprøver) - dette kan gøre dig mere modtagelig over for infektioner
English: • pneumonia - signs include feeling short of breath and producing discoloured phlegm
Danish: • lungebetændelse (pneumoni) - tegn på dette kan være åndenød og misfarvet slim
English: The usual dose is 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day, thereafter.
Danish: Den almindelige dosis er 300 mg (tre 100 mg tabletter) to gange dagligt på den første dag, herefter 300 mg (tre 100 mg tabletter) en gang dagligt.
English: Each gastro-resistant tablet contains 100 mg of posaconazole.
Danish: Hver gastroresistent tablet indeholder 100 mg posaconazol.
English: Posaconazole plasma concentrations following administration of posaconazole may increase over time in some patients (see section 5.2).
Danish: Plasmakoncentrationen af posaconazol efter administration af posaconazol kan med tiden stige hos nogle patienter (se pkt.
English: What Noxafil contains The active substance is posaconazole.
Danish: Noxafil indeholder: Aktivt stof: posaconazol.
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 2.2-fold and 8.9-fold greater, respectively, than those achieved with the human therapeutic doses.
Danish: Forhøjet systolisk og arterielt blodtryk (op til 29 mmHg) blev målt hos rotter og aber ved systemisk eksponering, der var henholdsvis 2,2 gange og 8,9 gange større end den, der blev opnået med terapeutiske doser hos mennesker.
English: The recommended dose is 300 mg twice a day on the first day, then 300 mg once a day, thereafter.
Danish: Den anbefalede dosis er 300 mg to gange dagligt på den første dag og herefter 300 mg en gang dagligt.
English: The pharmacokinetics of posaconazole tablets are comparable in young and elderly subjects.
Danish: Farmakokinetikken for posaconazol tabletter er sammenlignelig hos unge og ældre forsøgspersoner.
English: Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients.
Danish: Efter administration af posaconazol tabletter kan plasmakoncentrationen af posaconazol øges over tid hos nogle patienter.
English: Loading dose of 300 mg Noxafil twice a day on the first day, then 300 mg once a day thereafter.
Danish: Initialdosis på 300 mg Noxafil to gange dagligt på den første dag, herefter 300 mg en gang dagligt.
English: • abnormal skin sensations, such as numbness, tingling, itching, creeping, pricking or burning
Danish: • unormale hudreaktioner, f.eks. følelsesløshed, prikkende, kløende, krybende, stikkende eller brændende fornemmelse på huden
English: Monitoring of patients with severe renal impairment Due to the variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough fungal infections (see sections 4.2 and 5.2).
Danish: Monitorering af patienter med svært nedsat nyrefunktion Patienter med svært nedsat nyrefunktion skal monitoreres nøje for tilbagevendende svampeinfektioner på grund af variabilitet i eksponering (se pkt.
English: Betadex Sulfobutyl Ether Sodium (SBECD) Disodium edetate
Danish: Sulfobutylether beta cyclodextrinnatrium (SBECD) Dinatriumedetat
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 2.1-fold and 8.5-fold greater, respectively, than those achieved with the human therapeutic doses.
Danish: Forhøjet systolisk og arterielt blodtryk (op til 29 mmHg) blev målt hos rotter og aber ved systemisk eksponering, der var henholdsvis 2,1 gange og 8,5 gange større end den, der blev opnået med terapeutiske doser hos mennesker.
English: The clinical significance of this finding is unknown; therefore, the use of posaconazole concentrate for solution for infusion to patients under 18 years of age is not recommended (see section 4.2).
Danish: Posaconazol koncentrat til infusionsvæske, opløsning bør derfor ikke anvendes til patienter under 18 år (se pkt.
English: • feeling weak, dizzy, tired or sleepy
Danish: • følelse af svaghed, svimmelhed, træthed eller søvnighed
English: • infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped;
Danish: • infektioner fremkaldt af svampe af Fusarium-arten, hvis infektionen ikke er behandlet tilstrækkeligt med amphotericin B, eller hvis du var nødt til at stoppe behandlingen med dette middel.
English: Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products; - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.
Danish: - Invasiv aspergillose hos patienter med sygdom, hvor behandling med amphotericin B eller itraconazol har været utilstrækkelig, eller hos patienter med intolerans over for disse lægemidler; - Fusariose hos patienter med sygdom, hvor behandling med amphotericin B har været utilstrækkelig, eller hos patienter med intolerans over for amphotericin B; - Chromoblastomykose og mycetoma hos patienter med sygdom, hvor behandling med itraconazol har været utilstrækkelig, eller hos patienter med intolerans over for itraconazol; - Coccidioidomykose hos patienter med sygdom, hvor behandling med amphotericin B, itraconazol eller fluconazol har været utilstrækkelig, eller hos patienter med intolerans over for disse lægemidler; - Oropharyngeal candidiasis: som first-line behandling hos patienter, der har alvorlig sygdom eller har nedsat immunforsvar, hos hvem respons på lokal behandling forventes at være dårlig.
English: If you develop severe diarrhoea or vomiting (being sick) while taking Noxafil, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly.
Danish: Tal straks med lægen, apotekspersonalet eller sygeplejersken, hvis du får alvorlig diarré eller kaster op, mens du tager Noxafil, da dette kan medføre, at det ikke virker ordentligt.
English: Treatment of refractory Fungal Infections (Invasive aspergillosis, Fusariosis,
Danish: Behandling af refraktære svampeinfektioner (invasiv aspergillosis, Fusariosis, Chromoblastomycosis/Mycetoma, Coccidioidomycosis)
English: • fits (convulsions)
Danish: • væskeophobning (ødemer)
English: • a blockage in your gut (intestinal obstruction) especially in the “ileum”.
Danish: • tarmblokering (mekanisk ileus) især i en del af tyndtarmen, som kaldes ”ileum”.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Almindelig:
English: Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, hvis du oplever et eller flere af ovennævnte bivirkninger.
English: pancreatitis, abdominal distension, enteritis, epigastric discomfort, eructation, gastrooesophageal reflux disease, oedema mouth
Danish: pankreatitis, oppustethed, enteritis, epigastriske gener, opstød, gastroøsofageal reflukssygdom, ødem i munden
English: The pharmacokinetics of posaconazole concentrate for solution for infusion are comparable in young and elderly subjects.
Danish: Farmakokinetikken for posaconazol koncentrat til infusionsvæske, opløsning er sammenlignelig hos unge og ældre forsøgspersoner.
English: Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
Danish: Initialdosis på 300 mg (tre 100 mg tabletter) to gange dagligt på den første dag, herefter 300 mg (tre 100 mg tabletter) en gang dagligt.
English: Noxafil 300 mg concentrate for solution for infusion
Danish: Noxafil 300 mg koncentrat til infusionsvæske, opløsning
English: First time treatment of Thrush On the first day of treatment take 200 mg (one 5 mL spoonful) once.
Danish: Førstegangsbehandling af trøske Tag 200 mg (5 ml måleske) en gang den første behandlingsdag.
English: • pituitary gland not working properly - this may cause low blood levels of some hormones that affect the function of the male or female sex organs
Danish: • nedsat funktion af hypofysen - dette kan medføre lave niveauer af nogle hormoner i blodet,
English: Morphine sulphate Norepinephrine bitartrate Potassium chloride Vancomycin hydrochloride
Danish: Norepinephrinbitartrat Kaliumchlorid Vancomycinhydrochlorid
English: hepatocellular damage, hepatitis, jaundice, hepatomegaly, cholestasis, hepatic toxicity, hepatic function abnormal
Danish: hepatocellulær ødelæggelse, hepatitis, gulsot, hepatomegali, kolestase, levertoksicitet, unormal leverfunktion
English: Discontinuation of Noxafil should be considered if clinical signs and symptoms are consistent with development of liver disease.
Danish: Hvis der er kliniske tegn og symptomer på udvikling af leversygdom, bør seponering af Noxafil overvejes.
English: Noxafil should be administered via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow intravenous (IV) infusion over approximately 90 minutes (see sections 4.2, 4.4, and 4.8).
Danish: Noxafil bør administreres via en infusionsslange med et centralt venekateter (CVK) eller et perifert anlagt centralt venekateter (PICC-line) som en langsom intravenøs (iv) infusion over ca. 90 minutter (se pkt.