FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on average Cmin concentrations, a predicted average concentration (Cav) could be calculated for 186 subjects dosed with 300 mg. PK analysis in patients of Cav found that 81 % of the subjects treated with the 300 mg once daily dose attained steady state predicted Cav between 500-2,500 ng/mL.
Danish: På basis af gennemsnitlige Cmin-koncentrationer kunne der udregnes en formodet gennemsnitlig koncentration (Cav) for 186 forsøgspersoner, som havde fået en dosis på 300 mg. Farmakokinetisk analyse hos patienter med Cav konstaterede, at 81 % af forsøgspersonerne behandlet med en dosis på 300 mg en gang dagligt opnåede en formodet Cav ved steady-state på mellem 500-2.500 ng/ml.
English: • adrenal glands not working properly - this may cause weakness, tiredness, loss of appetite, skin discolouration
Danish: • nedsat funktion af binyren - dette kan medføre svaghed, træthed, appetitløshed, misfarvning af huden
English: Co-administration with the HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin (see section 4.5).
Danish: Samtidig administration med HMG-CoA reduktasehæmmerne simvastatin, lovastatin og atorvastatin (se pkt.
English: Study
Danish: Studier
English: The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose.
Danish: De metabolitter, der udskilles i urin og fæces, udgør ca. 17 % af den administerede radioaktivt mærkede dosis.
English: pulmonary embolism, deep vein thrombosis
Danish: pulmonal emboli, dyb venetrombose
English: Posaconazole does not have any major circulating metabolites and its concentrations are unlikely to be altered by inhibitors of CYP450 enzymes.
Danish: Posaconazol har ingen væsentlige cirkulerende metabolitter, og det er ikke sandsynligt, at koncentrationen vil blive påvirket af CYP450 enzymhæmmere.
English: • medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir,
Danish: • lægemidler kaldet proteasehæmmere anvendt i hiv-behandling (inklusive lopinavir og atazanavir der gives sammen med ritonavir)
English: The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose of posaconazole oral suspension.
Danish: De metabolitter, der udskilles i urin og fæces, udgør ca. 17 % af den administrerede radioaktivt mærkede dosis af posaconazol oral suspension.
English: Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following patients:
Danish: Noxafil koncentrat til infusionsvæske, opløsning er også indiceret til forebyggelse af invasive svampeinfektioner hos følgende patienter:
English: Noxafil contains approximately 1.75 g of glucose per 5 mL of suspension.
Danish: Noxafil indeholder cirka 1,75 g glucose per 5 ml suspension.
English: Maximum duration of exposure to the tablet formulation was shorter than with the oral suspension.
Danish: Den maksimale varighed af eksponering for tabletformuleringen var kortere end eksponeringen for den orale suspension.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet, før du tager dette lægemiddel.
English: Noxafil is also available as 40 mg/mL oral suspension and 300 mg concentrate for solution for infusion.
Danish: Noxafil findes også som 40 mg/ml oral suspension og 300 mg koncentrat til infusionsvæske, opløsning.
English: Co-administration of posaconazole with CYP3A4 substrates may result in large increases in exposure to CYP3A4 substrates as exemplified by the effects on tacrolimus, sirolimus, atazanavir and midazolam below.
Danish: Samtidig indtagelse af posaconazol med CYP3A4substrater kan resultere i en stor stigning i eksponering for CYP3A4-substrater som eksemplificeret nedenfor ved virkningen på tacrolimus, sirolimus, atazanavir og midazolam.
English: In healthy volunteers under fasting conditions, dividing the total daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 2.6-fold.
Danish: Hos fastende raske forsøgspersoner gav en opdeling af den totale daglige dosis (800 mg) på 200 mg fire gange dagligt sammenlignet med 400 mg to gange dagligt en øget eksponering for posaconazol med 2,6 gange.
English: H2 receptor antagonists and proton pump inhibitors No clinically relevant effects were observed when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Danish: H2-receptorantagonister og protonpumpehæmmere Ingen klinisk relevant virkning blev observeret, da posaconazol tabletter blev anvendt sammen med syreneutraliserende midler, H2-receptorantagonister og protonpumpehæmmere.
English: See “Other medicines and Noxafil” below for information on other medicines which may interact with Noxafil.
Danish: Læs “Brug af anden medicin sammen med Noxafil” nedenfor for information om andre lægemidler, som kan påvirke virkningen af Noxafil.
English: Co-administration may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes (see section 4.3).
Danish: Samtidig administration kan resultere i forhøjede plasmakoncentrationer af disse lægemidler, som kan medføre QTc-forlængelse og sjældne forekomster af torsades de pointes (se pkt.
English: Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole tablets when given as antifungal prophylaxis.
Danish: Patienterne blev inkluderet i et ikke-sammenlignende farmakokinetisk sikkerhedsstudie med posaconazol tabletter indgivet som profylaktisk antimykotisk behandling.
English: Hyperglycaemia, hypoglycaemia
Danish: hyperglykæmi, hypoglykæmi
English: 200 mg four times daily (hospitalized) then 400 mg twice daily
Danish: 200 mg fire gange dagligt (indlagt), herefter 400 mg to gange dagligt
English: • patients having “high-dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).
Danish: • patienter, som får ”højdosis-immunundertrykkende behandling” efter ”stamcelletransplantation af hæmopoietiske (bloddannende) stamceller” (HSCT).
English: The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical trials.
Danish: Sikkerheden af posaconazol tabletter er vurderet hos 336 patienter og raske frivillige forsøgspersoner i kliniske studier.
English: Following administration of 300 mg posaconazole concentrate for solution for infusion over 90 minutes, mean peak plasma concentration at the end of infusion was 3280 ng/mL (74 % CV).
Danish: Efter administration af 300 mg posaconazol koncentrat til infusionsvæske, opløsning over 90 minutter var den gennemsnitlige peak-plasmakoncentration ved afslutningen af infusionen 3.280 ng/ml (74 % CV (varianskoefficient)).
English: When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes to reduce the likelihood of infusion site reactions (see section 4.8).
Danish: Ved administration via et perifert venekateter skal infusionen gives over ca. 30 minutter for at nedsætte risikoen for reaktioner på infusionsstedet (se pkt.
English: Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during coadministration with posaconazole.
Danish: Der anbefales hyppig monitorering for bivirkninger og toksicitet relateret til antiretrovirale midler, der er CYP3A4-substrater, ved administration samtidig med posaconazol.
English: Fusarium spp.
Danish: Fusarium arter.
English: The other ingredients are: hypromellose acetate succinate; cellulose, microcrystalline; hydroxypropylcellulose (E463); silica dental type; croscarmellose sodium; magnesium stearate, polyvinyl alcohol, macrogol 3350 , titanium dioxide (E171), talc, iron oxide yellow (E172).
Danish: Øvrige indholdsstoffer: hypromelloseacetatsuccinat; mikrokrystallinsk cellulose; hydroxypropylcellulose (E463); silica, kolloid vandfri; croscarmellosenatrium; magnesiumstearat, polyvinylalkohol, macrogol 3350, titandioxid (E171), talcum, gul jernoxid (E172).
English: Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole concentrate for solution for infusion when given as antifungal prophylaxis (Study 5520).
Danish: Patienterne blev inkluderet i et ikke-sammenlignende farmakokinetisk sikkerhedsstudie med posaconazol koncentrat til infusionsvæske, opløsning indgivet som profylaktisk antimykotisk behandling (studie 5520).
English: Posaconazole may increase the plasma concentration of ergot alkaloids (ergotamine and dihydroergotamine), which may lead to ergotism.
Danish: Posaconazol kan øge plasmakoncentrationen af sekalealkaloider (ergotamin og dihydroergotamin), som kan medføre ergotisme.
English: • Glipizide or other “sulfonylureas” (used to treat high blood sugar).
Danish: • glipizid eller andre ”sulfonylurinstoffer” (anvendes til behandling af højt blodsukker).
English: Summary of posaconazole concentrate for solution for infusion bridging study Study 5520 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole concentrate for solution for infusion.
Danish: Sammendrag af bridging-studiet med posaconazol koncentrat til infusionsvæske, opløsning Studie 5520 var et ikke-sammenlignende multicenterstudie, som blev udført for at vurdere de farmakokinetiske egenskaber, sikkerheden og tolerabiliteten af posaconazol koncentrat til infusionsvæske, opløsning.
English: Following single-dose administration of posaconazole oral suspension, there was no effect of mild and moderate renal impairment (n=18, Cl cr ≥ 20 mL/min/1.73 m2) on posaconazole pharmacokinetics; therefore, no dose adjustment is required.
Danish: Efter administration af en enkeltdosis af posaconazol oral suspension, sås ingen påvirkning af posaconazols farmakokinetik ved let og moderat nedsat nyrefunktion (n=18 Cl cr ≥ 20 ml/min/1,73 m2); dosisjustering er således ikke nødvendig.
English: • oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain
Danish: • iltforsyningen til milten er afbrudt (miltinfarkt) - dette kan give svære mavesmerter
English: This medicinal product contains approximately 1.75 g of glucose per 5 mL of suspension.
Danish: Dette lægemiddel indeholder ca. 1,75 g glucose per 5 ml suspension.
English: A non-dose related incidence of thrombus/emboli in the lung was seen in the 1 month repeated dose study in the monkey.
Danish: En ikke dosisrelateret forekomst af blodprop i lungen (lungeemboli) blev konstateret i 1 måneders studiet med gentagne doser til aber.
English: If a central venous catheter is not available, a single infusion may be administered through a peripheral venous catheter.
Danish: Hvis et centralt venekateter ikke er muligt, må der administreres en enkelt infusion gennem et perifert venekateter.
English: No dosage adjustment of posaconazole tablets is required when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Danish: Dosisjusteringer af posaconazol tabletter er ikke nødvendige, når posaconazol tabletter anvendes sammen syreneutraliserende midler, H2-receptorantagonister og protonpumpehæmmere.
English: Overall Response Success by Species All mycologically confirmed Aspergillus spp.
Danish: Samlet respons Virkning per art Alle mykologisk bekræftet Aspergillus arter.
English: • abnormal heart rhythm - shown up on a heart trace (ECG), palpitations, slow or fast heartbeat,
Danish: • unormal hjerterytme - fremgår af et elektrokardiogram (ekg), hjertebanken (palpitationer),
English: For patients with AML or MDS, prophylaxis with Noxafil should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm
Danish: For patienter med AML eller MDS bør forebyggelse med Noxafil påbegyndes flere dage før den forventede optræden af neutropeni og fortsætte i 7 dage, efter at neutrofiltallet stiger til over 500 celler pr. mm
English: Dobutamine hydrochloride Famotidine
Danish: Dobutaminhydrochlorid Famotidin
English: Serial PK samples were collected on Day 1 and at steady-state on Day 8 for all Part 1 subjects and a subset of Part 2 subjects.
Danish: Serielle farmakokinetiske prøver blev udtaget på dag 1 og ved steady-state på dag 8 for alle forsøgspersoner i del 1 og en delgruppe af forsøgspersonerne i del 2.
English: The solution of Noxafil ranges from colourless to pale yellow.
Danish: Noxafil-opløsningens farve kan variere fra farveløs til lysegul.
English: Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections.
Danish: Seksten patienter i alderen 8-17 år blev behandlet med posaconazol oral suspension 800 mg/dag i et studie med invasive svampeinfektioner.
English: Both doses of posaconazole increased Cmax and AUC of oral midazolam (2 mg single oral dose) by 2.2 and 4.5-fold, respectively.
Danish: Begge doser af posaconazol øgede Cmax og AUC for oralt midazolam (2 mg oral enkeltdosis) med henholdsvis 2,2 og 4,5 gange.
English: 200 mg three times daily
Danish: 200 mg tre gange dagligt
English: Co-administration of posaconazole with proton pump inhibitors should be avoided if possible.
Danish: Samtidig administration af posaconazol og protonpumpehæmmere bør om muligt undgås.
English: - The other ingredients in the suspension are polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), artificial cherry flavour containing benzyl alcohol and propylene glycol, and purified water.
Danish: Øvrige indholdsstoffer i suspensionen: polysorbat 80, simeticon, natriumbenzoat (E211), natriumcitratdihydrat, citronsyremonohydrat, glycerol, xanthangummi, flydende glucose, titandioxid (E171), kunstig kirsebæraroma med benzylalkohol og propylenglycol, og renset vand.
English: Posaconazole tablets
Danish: Posaconazol tabletter
English: • digoxin (used to treat heart failure)
Danish: • digoxin (anvendes til behandling af hjertesvigt)
English: Posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Danish: Posaconazol øgede Cmax og AUC for rifabutin med henholdsvis 31 % og 72 %.
English: • swelling of lymph glands (lymphadenopathy)
Danish: • hævede lymfekirtler (lymfadenopati)
English: • loss of appetite, stomach pain or upset stomach, passing wind, dry mouth, changes in your taste
Danish: • appetitløshed, mavesmerter eller dårlig mave, luft i maven, mundtørhed, ændret smagsfornemmelse
English: Noxafil concentrate for solution for infusion should not be given by bolus administration.
Danish: Noxafil koncentrat til infusionsvæske, opløsning må ikke administreres som bolus.
English: Other medicines and Noxafil
Danish: Brug af anden medicin sammen med Noxafil
English: Noxafil contains a medicine called posaconazole.
Danish: Noxafil indeholder et lægemiddelstof, der hedder posaconazol.
English: Two different dosing groups were evaluated: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Part IA) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Part 1B and Part 2).
Danish: To forskellige doseringsgrupper blev vurderet: 200 mg to gange dagligt på dag 1, herefter efterfulgt af 200 mg en gang dagligt (del IA) og 300 mg to gange dagligt på dag 1, herefter efterfulgt af 300 mg en gang dagligt (del 1B og del 2).
English: Safety data at higher exposure levels achieved with posaconazole concentrate for solution for infusion are at present limited.
Danish: Sikkerhedsdata ved højere eksponeringsniveauer med posaconazol koncentrat til infusionsvæske, opløsning er på nuværende tidspunkt begrænset.
English: Concomitant use of posaconazole and rifabutin should be avoided unless the benefit to the patient outweighs the risk (see also above regarding the effect of rifabutin on plasma levels of posaconazole).
Danish: Samtidig administration af posaconazol og rifabutin bør undgås, medmindre fordelen for patienten opvejer risikoen (se også ovenfor vedrørende virkningen af rifabutin på plasmaniveauer af posaconazol).
English: Hypromellose acetate succinate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Silica dental type Croscarmellose sodium Magnesium stearate
Danish: Hypromelloseacetatsuccinat Mikrokrystallinsk cellulose Hydroxypropylcellulose (E463) Silica, kolloid vandfri Croscarmellosenatrium Magnesiumstearat
English: Caution is advised during coadministration of posaconazole with CYP3A4 substrates administered intravenously and the dose of the CYP3A4 substrate may need to be reduced.
Danish: Forsigtighed bør udvises under samtidig administration af posaconazol og CYP3A4-substrater administreret intravenøst, og der kan være behov for at dosis af CYP3A4-substratet reduceres.
English: Adverse reactions by body system and frequency reported in clinical trials and/or postmarketing use *
Danish: Bivirkninger, som er rapporteret i kliniske studier og/eller efter markedsføring, anført efter systemorganklasse og hyppighed*
English: Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections (Study 0041).
Danish: Seksten patienter i alderen 8-17 år blev behandlet med posaconazol oral suspension 800 mg/dag i et studie for invasive svampeinfektioner (studie 0041).
English: Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with serious adverse reactions (see section 4.4).
Danish: Samtidig administration af azol-antimykotika, inklusive posaconazol, og vincristin er blevet associeret med alvorlige bivirkninger (se pkt.
English: • inflammation of the blood vessels
Danish: • betændelse i blodkarrene
English: Posaconazole plasma concentrations following administration of posaconazole concentrate for solution for infusion single dose increased in a greater than dose proportional manner over the range of 50-200 mg; by comparison, dose-dependent increases were observed over a range of 200-300 mg.
Danish: Efter administration af enkeltdosis posaconazol koncentrat til infusionsvæske, opløsning, steg posaconazols plasmakoncentration mere end dosisproportionalt i dosisintervallet 50-200 mg; til sammenligning sås dosisafhængige stigninger i dosisintervallet 200-300 mg.
English: • midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants)
Danish: • midazolam, triazolam, alprazolam og andre ”benzodiazepiner” (anvendes som beroligende eller muskelafslappende midler)
English: • blood clots in your legs (deep vein thrombosis) - signs include intense pain or swelling of the legs
Danish: • blodpropper i benene (dyb venetrombose) - tegn på dette kan være intens smerte eller hævelse i benene
English: • breast pain
Danish: • brystsmerter
English: Since certain adverse reactions (e.g. dizziness, somnolence, etc.) have been reported with posaconazole use, which potentially may affect driving/operating machinery, caution needs to be used.
Danish: Da visse bivirkninger (f.eks. svimmelhed, døsighed osv.), som potentielt kan påvirke evnen til at føre motorkøretøj og betjene maskiner, er set ved anvendelse af posaconazol, skal der udvises forsigtighed.
English: • pain, back or neck pain, pain in arms or legs
Danish: • smerter, ryg- eller nakkesmerter, smerter i arme eller ben
English: Study 1899 was a randomised, evaluator-blinded study of posaconazole oral suspension (200 mg three times a day) versus fluconazole suspension (400 mg once daily) or itraconazole oral solution (200 mg twice a day) in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukaemia or myelodysplastic syndromes.
Danish: Studie 1899 var et randomiseret, evaluator-blindet studie af posaconazol oral suspension (200 mg tre gange dagligt) versus fluconazol suspension (400 mg en gang dagligt) eller itraconazol oral opløsning (200 mg to gange dagligt) hos patienter med neutropeni, der fik cytotoksisk kemoterapi for akut myeloid leukemi eller myelodysplastisk syndrom.
English: • swelling of the mouth
Danish: • hævelser i munden
English: Concomitant use of posaconazole and phenytoin and similar inducers (e.g. carbamazepine, phenobarbital, primidone) should be avoided unless the benefit to the patient outweighs the risk.
Danish: Samtidig administration af posaconazol og phenytoin og lignende induktorer (f.eks. carbamazepin, phenobarbital, primidon) bør undgås, medmindre fordelen for patienten opvejer risikoen.
English: Noxafil concentrate for solution for infusion was investigated in AML and MDS patients and those after HSCT with or at risk for GVHD only.
Danish: Noxafil koncentrat til infusionsvæske, opløsning er udelukkende blevet undersøgt hos patienter med AML og patienter med MDS samt hos patienter efter HSCT med eller uden risiko for graft versus host-sygdom (GVHD).
English: C-posaconazole as oral suspension, radioactivity was predominantly recovered in the faeces (77 % of the radiolabelled dose) with the major component being parent compound (66 % of the radiolabelled dose).
Danish: C-posaconazol som oral suspension blev radioaktiviteten hovedsagelig genfundet i fæces (77 % af den radioaktivt mærkede dosis) heraf hovedparten som uforandret lægemiddel (66 % af den radioaktivt mærkede dosis).
English: Lactated Ringer's solution 5 % dextrose with Lactated Ringer's solution 4.2 % sodium bicarbonate
Danish: Ringer-lactat-infusionsvæske 5 % glucose med Ringer-lactat-infusionsvæske 4,2 % natriumhydrogencarbonat
English: Breast-feeding must be stopped on initiation of treatment with posaconazole.
Danish: Amning skal ophøre ved påbegyndelse af behandling med posaconazol.
English: The blockage will prevent the contents of your intestine from passing through to the lower bowel signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps
Danish: Blokeringen forhindrer indholdet af tarmen i at passere til den nedre del af tarmen, hvilket ofte resulterer i oppustet mave, opkastning, svær forstoppelse, manglende appetit og kramper
English: • inflammation of the pancreas (pancreatitis) - this may cause severe stomach pain
Danish: • betændelse i bugspytkirtlen (pankreatitis) - dette kan give svære mavesmerter
English: cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope
Danish: hjerneblødning, encefalopati, perifer neuropati, synkope
English: electrolyte imbalance, anorexia, decreased appetite, hypokalaemia, hypomagnesaemia
Danish: elektrolytforstyrrelser, anoreksi, nedsat appetit, hypokalæmi, hypomagnesiæmi
English: Posaconazole exhibits dose proportional pharmacokinetics after single and multiple dosing in the therapeutic dose range (200-300 mg).
Danish: Posaconazol udviser dosisproportional farmakokinetik efter administration af enkeltdosis og flergangsdosering i det terapeutiske dosisinterval (200-300 mg).
English: Clinically significant interactions resulting in hospitalisation and/or posaconazole discontinuation were reported in clinical efficacy studies.
Danish: I kliniske effektstudier blev der rapporteret klinisk signifikante interaktioner, som resulterede i hospitalsindlæggelse og/eller afbrydelse af behandling med posaconazol.
English: Two different dosing groups were evaluated in Cohorts 1 and 2: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Cohort 1) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Cohort 2).
Danish: To forskellige doseringsgrupper blev vurderet i kohorte 1 og 2: 200 mg to gange dagligt på dag 1, efterfulgt af 200 mg en gang dagligt (kohorte 1) og 300 mg to gange dagligt på dag 1, efterfulgt af 300 mg en gang dagligt (kohorte 2).
English: There is insufficient data among different races with posaconazole concentrate for solution for infusion.
Danish: Der foreligger ikke tilstrækkelige data blandt forskellige racer med posaconazol koncentrat til infusionsvæske, opløsning.