FrancophonIA/ELRC3.0 huggingface dataset:
English: Noxafil gastro-resistant tablets are 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.
Danish: 5.1): - 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.
English: Noxafil 300 mg concentrate for solution for infusion posaconazole
Danish: Noxafil 300 mg koncentrat til infusionsvæske, opløsning posaconazol
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, hvis du opdager en eller flere af følgende bivirkninger:
English: Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), and efavirenz.
Danish: Rifamycin antibakterielle midler (rifampicin, rifabutin), visse antiepileptika (phenytoin, carbamazepin, phenobarbital, primidon) og efavirenz Koncentrationen af posaconazol kan være betydeligt nedsat ved kombination.
English: There is no paediatric experience with posaconazole concentrate for solution for infusion (see sections 4.2 and 5.3).
Danish: Der foreligger ingen erfaring med posaconazol koncentrat til infusionsvæske, opløsning til børn (se pkt.
English: Tell your doctor if you are or think you are pregnant before you start to take Noxafil.
Danish: Kontakt straks din læge, hvis du bliver gravid, mens du tager Noxafil.
English: Excipient with known effect: Each vial contains 462 mg (20 mmol) sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder 462 mg (20 mmol) natrium.
English: How to use Noxafil
Danish: Sådan skal du bruge Noxafil
English: • infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;
Danish: • infektioner fremkaldt af svampe af Aspergillus-arten, hvis infektionen ikke er behandlet tilstrækkeligt med et af svampemidlerne amphotericin B eller itraconazol, eller hvis du var nødt til at stoppe behandlingen med disse midler.
English: Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial (Study 0041).
Danish: I et ikke-sammenlignende klinisk studie blev posaconazol oral suspension 800 mg dagligt fordelt på flere doser vurderet som behandling af invasiv aspergillose hos patienter, som var sygdomsrefraktære over for behandling med amphotericin B (inklusive liposomformuleringer) eller itraconazol eller hos patienter, der havde intolerans over for disse lægemidler (studie 0041).
English: Effects of posaconazole on other medicinal products Posaconazole is a potent inhibitor of CYP3A4.
Danish: Posaconazol er en potent hæmmer af CYP3A4.
English: How to take Noxafil
Danish: Sådan skal du tage Noxafil
English: Plasma concentrations following administration of posaconazole intravenous concentrate for solution for infusion are generally higher than those obtained with posaconazole oral suspension.
Danish: Plasmakoncentrationen er generelt højere efter administration af posaconazol intravenøs koncentrat til infusionsvæske, opløsning end efter administration af posaconazol oral suspension.
English: • low potassium levels - shown up in blood tests
Danish: • lavt kaliumniveau (fremgår af dine blodprøver)
English: • have heart rhythm disturbance
Danish: • har hjerterytmeforstyrrelser.
English: oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, infusion site pain, infusion site phlebitis, infusion site thrombosis, mucosal inflammation
Danish: ødem, smerte, kuldegysninger, utilpashed, ubehag i brystet, lægemiddeloverfølsomhed, rastløshed, smerter på infusionsstedet, flebitis på infusionsstedet, trombose på infusionsstedet, slimhindebetændelse
English: Plasma exposure resulting from the solution for infusion was higher than observed with the oral suspension.
Danish: Plasmaeksponeringen fra koncentrat til infusionsvæske, opløsning var højere end den plasmaeksponering, som blev set ved den orale suspension.
English: Repeat dose administration of posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Danish: Gentagen administration af posaconazol oral suspension (400 mg to gange dagligt i 16 dage) øgede Cmax og AUC for sirolimus (2 mg enkeltdosis) med henholdsvis et gennemsnit på 6,7 gange og 8,9 gange (interval 3,1 til 17,5 gange) hos raske forsøgspersoner.
English: Single use vial.
Danish: Hætteglas til engangsbrug.
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir and ritonavir (300/100 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 1.5-fold and 2.5-fold (range 0.9 to 4.1-fold), respectively.
Danish: Efter samtidig administration af posaconazol oral suspension (400 mg to gange dagligt) og atazanavir og ritonavir (300/100 mg en gang dagligt) i 7 dage hos raske forsøgspersoner øgedes Cmax og AUC for atazanavir med et gennemsnit på henholdsvis 1,5 gange og 2,5 gange (interval 0,9 til 4,1 gange).
English: The pharmacokinetics of posaconazole concentration for solution for infusion are comparable in men and women.
Danish: Farmakokinetikken for posaconazol koncentrat til infusionsvæske, opløsning er sammenlignelig hos mænd og kvinder.
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 1.4-fold greater than that achieved therapeutically.
Danish: Ekkokardiografi viste ingen tegn på hjerteinsufficiens i et sikkerhedsfarmakologisk studie med gentagne doser til rotter ved en systemisk eksponering, der var 1,4 gange større end den, der blev opnået terapeutisk.
English: Gender The pharmacokinetics of posaconazole are comparable in men and women.
Danish: Køn Farmakokinetikken for posaconazol er sammenlignelig hos mænd og kvinder.
English: Each mL of oral suspension contains 40 mg of posaconazole.
Danish: 1 ml oral suspension indeholder 40 mg posaconazol.
English: When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes (see section 4.8 and 6.6).
Danish: Ved administration via et perifert venekateter skal infusionen gives over ca. 30 minutter (se pkt.
English: Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Danish: Samlet respons Virkning per art Alle mykotisk bekræftet Aspergillus-arter A. fumigatus A. flavus
English: Tablet coat polyvinyl alcohol macrogol 3350 titanium dioxide (E171) talc iron oxide yellow (E172)
Danish: Tabletovertræk Polyvinylalkohol Macrogol 3350
English: Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial.
Danish: I et ikke-sammenlignende studie med salvage-behandling blev posaconazol oral suspension 800 mg dagligt fordelt på flere doser vurderet som behandling af invasiv aspergillose hos patienter, som var sygdomsrefraktære over for behandling med amphotericin B (inklusive liposomformuleringer) eller itraconazol eller hos patienter, der havde intolerans over for disse lægemidler.
English: nausea vomiting, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence, constipation, anorectal discomfort
Danish: opkastning, abdominalsmerter, diarré, dyspepsi, mundtørhed, flatulens, obstipation, anorektale gener
English: back pain, neck pain, musculoskeletal pain, pain in extremity
Danish: rygsmerter, nakkesmerter, muskuloskeletale smerter, ekstremitetssmerter
English: Noxafil concentrate for solution for infusion will be diluted to the correct concentration by your pharmacist or nurse.
Danish: Apotekspersonalet eller sygeplejersken fortynder Noxafil koncentrat til infusionsvæske, opløsning, så koncentratet får den korrekte koncentration.
English: Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Fortæl straks lægen, apotekspersonalet eller sygeplejersken, hvis du får en eller flere af følgende alvorlige bivirkninger.
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.2-fold greater than that achieved therapeutically.
Danish: Ekkokardiografi viste ingen tegn på hjerteinsufficiens i et sikkerhedsfarmakologisk studie med gentagne doser til rotter ved en systemisk eksponering, der var 2,2 gange større end den, der blev opnået terapeutisk.
English: Eye disorders Uncommon:
Danish: Øjne Ikke almindelig:
English: Taking this medicine
Danish: Indtagelse af dette lægemiddel
English: Noxafil can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm.
Danish: Noxafil kan øge mængden af disse lægemidler i blodet.
English: However, in clinical efficacy trials, the safety profile of posaconazole between the young and elderly patients was similar.
Danish: Sikkerhedsprofilen af posaconazol mellem de unge og ældre patienter, var endvidere tilsvarende i kliniske effektstudier.
English: Gentamicin sulfate
Danish: Morfinsulfat
English: Posaconazole concentrations may be significantly lowered in combination; therefore, concomitant use with posaconazole should be avoided unless the benefit to the patient outweighs the risk (see section 4.5).
Danish: Samtidig behandling med posaconazol bør derfor undgås, medmindre fordelen for patienten opvejer risikoen (se pkt.
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26-fold), respectively.
Danish: Efter samtidig administration af posaconazol oral suspension (400 mg to gange dagligt) og atazanavir (300 mg en gang dagligt) i 7 dage hos raske forsøgspersoner øgedes Cmax og AUC for atazanavir med et gennemsnit på henholdsvis 2,6 gange og 3,7 gange (interval 1,2 til 26 gange).
English: Hepatic impairment
Danish: Invasiv aspergillose
English: What Noxafil is and what it is used for What you need to know before you use Noxafil How to use Noxafil
Danish: Det skal du vide, før du begynder at bruge Noxafil Sådan skal du bruge Noxafil Bivirkninger
English: Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole oral suspension (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years.
Danish: Fra 173 raske mandlige og kvindelige forsøgspersoner i alderen 18 til 85 år blev der før og under administration af posaconazol oral suspension (400 mg to gange dagligt med et fedtrigt måltid) indsamlet flere tidsmæssigt sammenlignelige ekg'er over en periode på 12 timer.
English: There is no paediatric experience with posaconazole tablets.
Danish: Der foreligger ingen erfaring med posaconazol tabletter til børn.
English: Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz and cimetidine Posaconazole concentrations may be significantly lowered in combination; therefore, concomitant use with posaconazole should be avoided unless the benefit to the patient outweighs the risk (see section 4.5).
Danish: Rifamycin antibakterielle midler (rifampicin, rifabutin), visse antiepileptika (phenytoin, carbamazepin, phenobarbital, primidon), efavirenz og cimetidin Koncentrationen af posaconazol kan være betydeligt nedsat ved kombination.
English: Take 200 mg (one 5 mL spoonful) three times a day.
Danish: Tag 200 mg (5 ml måleske) tre gange dagligt.
English: Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the st day, 200 mg twice daily on the 2
Danish: Gentagne doser af fosamprenavir (700 mg to gange dagligt i 10 dage) nedsatte Cmax og AUC for posaconazol oral suspension (200 mg en gang dagligt på dag 1, 200 mg to gange dagligt på dag 2, derefter 400 mg to gange dagligt i 8 dage) med henholdsvis 21% og 23%.
English: • heart rhythm problems
Danish: • hjerterytmeproblemer
English: - The active substance in Noxafil is posaconazole.
Danish: Aktivt stof: posaconazol.
English: What Noxafil contains
Danish: Noxafil indeholder:
English: Each vial contains 300 mg of posaconazole.
Danish: Hvert hætteglas indeholder 300 mg posaconazol.
English: • low levels of “neutrophils” a type of white blood cell (neutropenia) -this can make you more likely to get infections and be shown up in blood tests
Danish: • neutropeni lavt indhold af neutrofile granulocytter, en type hvide blodlegemer (fremgår af dine blodprøver) - dette kan gøre dig mere modtagelig for infektioner
English: Due to the variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough fungal infections (see section 4.2).
Danish: Patienter med svært nedsat nyrefunktion skal monitoreres nøje for tilbagevendende svampeinfektioner på grund af variabilitet i eksponering (se pkt.
English: Famotidine
Danish: Amning
English: Noxafil concentrate for solution for infusion requires dilution (see section 6.6) prior to administration.
Danish: Noxafil koncentrat til infusionsvæske, opløsning skal fortyndes (se pkt.
English: If you become pregnant while you are using Noxafil, contact your doctor straight away.
Danish: Kontakt straks din læge, hvis du bliver gravid, mens du bruger Noxafil.
English: Lorazepam
Danish: Xanthangummi
English: What Noxafil is and what it is used for What you need to know before you take Noxafil How to take Noxafil
Danish: Det skal du vide, før du begynder at tage Noxafil Sådan skal du tage Noxafil Bivirkninger
English: Food The absorption of posaconazole is significantly increased by food (see sections 4.2 and 5.2).
Danish: Føde Føde forøger signifikant absorptionen af posaconazol (se pkt.
English: • tremor
Danish: • opstød
English: Similar recommendations apply to posaconazole concentrate for solution for infusion; however, a specific study has not been conducted with posaconazole concentrate for solution for infusion.
Danish: Tilsvarende anbefalinger gælder for posaconazol koncentrat til infusionsvæske, opløsning.
English: • anaemia - signs include headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests
Danish: • anæmi og et lavt hæmoglobinniveau (fremgår af dine blodprøver) - tegn på dette kan være hovedpine, træthed eller svimmelhed, åndenød eller bleghed
English: Gastrointestinal disorders Very Common:
Danish: Mave-tarm-kanalen Meget almindelig:
English: gastrointestinal haemorrhage, ileus
Danish: blødning i mave/tarm, ileus
English: Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients (see section 5.2).
Danish: Plasmakoncentrationen af posaconazol kan med tiden stige hos nogle patienter, der får posaconazol tabletter (se pkt.
English: Similar recommendations apply to posaconazole tablets; however, a specific study has not been conducted with the posaconazole tablets.
Danish: Tilsvarende anbefalinger gælder for posaconazol tabletter.
English: oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation
Danish: ødem, smerte, kuldegysninger, utilpashed, ubehag i brystet, lægemiddeloverfølsomhed, rastløshed, slimhindebetændelse
English: Noxafil concentrate for solution for infusion will always be prepared and given to you by a healthcare professional.
Danish: Det er altid sygeplejersken, der vil tilberede og give dig Noxafil koncentrat til infusionsvæske, opløsning.
English: • feeling bloated
Danish: • tilstoppet næse
English: • cough, hiccups
Danish: • hoste, hikke
English: Other possible side effects that may occur with the following frequencies are:
Danish: Andre mulige bivirkninger, som kan forekomme med følgende hyppighed, er:
English: Iclusig is for oral use.
Danish: Iclusig er til oral anvendelse.
English: Tell your doctor straight away if you experience any of these symptoms during your treatment with ponatinib, because it could be serious.
Danish: Fortæl det til lægen med det samme, hvis du oplever nogen af disse symptomer under din behandling med ponatinib, da det kan være alvorligt.
English: Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity.
Danish: Behandlingen skal fortsættes, så længe patienten ikke viser tegn på sygdomsprogression eller uacceptabel toksicitet.
English: Baseline demographic characteristics are described in Table 6 below.
Danish: Demografiske karakteristika ved baseline er beskrevet i tabel 6 nedenfor.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, som står på flaskens etiket og kartonen efter “EXP”.
English: Efficacy results are summarized in Table 7, Table 8, and Table 9.
Danish: Effektresultater er opsummeret i tabel 7, tabel 8 og tabel 9.
English: Table 6 Demographics and disease characteristics
Danish: Tabel 6 Demografiske og sygdomsmæssige karakteristika
English: Your doctor may reduce your dose or tell you to temporarily stop taking Iclusig if:
Danish: Din læge kan reducere din dosis eller fortælle dig, at du midlertidigt skal stoppe med at tage Iclusig, hvis:
English: 4879 AC Etten-Leur Netherlands
Danish: 4879 AC Etten-Leur Holland
English: 1105 BP Amsterdam Netherlands
Danish: 1105 BP Amsterdam Holland
English: 93055 Regensburg Germany
Danish: 93055 Regensburg, Tyskland
English: INFORMATION IN BRAILLE Outer Carton:
Danish: INFORMATION I BRAILLESKRIFT Ydre karton:
English: • if you are allergic to ponatinib or any of the other ingredients of this medicine (listed in section
Danish: • hvis du er allergisk over for ponatinib eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD-list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: At the time of reporting, all ongoing patients had a minimum follow-up of 64 months.
Danish: På rapporteringstidspunktet havde alle igangværende patienter en minimumopfølgning på 64 måneder.
English: Persistent grade 2 (longer than 7 days)
Danish: Persisterende grad 2 (mere end 7 dage) Grad 3 eller højere
English: Ponatinib is highly bound (> 99%) to plasma proteins in vitro.
Danish: Ponatinib bindes stærkt (> 99 %) til plasmaproteiner in vitro.
English: Pancreatitis Recommended modifications for pancreatic adverse reactions are summarized in Table 2.
Danish: Pancreatitis Anbefalede modifikationer ved pankreatiske bivirkninger er opsummeret i tabel 2.
English: Poly(vinyl alcohol) Titanium dioxide (E171)
Danish: Polyvinylalkohol Titandioxid (E171)
English: Most patients who had an event of hepatotoxicity had their first event during the first year of treatment.
Danish: De fleste patienter, som havde en hændelse med levertoksicitet, havde den første hændelse i løbet af det første behandlingsår.
English: Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Danish: Hyppighed er inddelt i følgende kategorier: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: No venous occlusive events were fatal.
Danish: Ingen venøse okklusive hændelser havde dødelig udgang.
English: All patients (N=449)
Danish: Alle patienter (N=449)
English: With a minimum follow-up of 48 months, and approximately 2 years after the recommendation for prospective dose reduction, there were 110 CP-CML patients ongoing.
Danish: Med en minimumopfølgning på 48 måneder og ca. 2 år efter anbefalingen om prospektiv dosisreduktion var der 110 igangværende CP-CML-patienter.
English: SPECIAL STORAGE CONDITIONS Store in the original container in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale beholder for at beskytte mod lys.
English: Dose interruption or discontinuation may be required as described in Table 3.
Danish: Det kan være nødvendigt at afbryde eller seponere behandlingen som beskrevet i tabel 3.
English: cytogenetic responses.
Danish: cytogenetisk respons.
English: See section 2 “Iclusig contains lactose”.
Danish: Se afsnit 2 "Iclusig indeholder lactose".
English: Figure 1- Kaplan-Meier estimates for overall survival in the CP-CML population (Treated Population)
Danish: Kaplan-Meier-estimater for generel overlevelse i CP-CML-populationen (behandlet population)
English: *ULN = Upper Limit of Normal for the lab
Danish: *ULN = laboratoriets øvre normalgrænse
English: Most of the patients with grade 3 or 4 platelet count decreased, anaemia or neutropenia, developed it within the first 3 months of treatment.
Danish: De fleste patienter med grad 3 eller 4 nedsat trombocyttal, anæmi eller neutropeni udviklede dette inden for de første 3 behandlingsmåneder.
English: Therefore, clinical medicinal product interactions are unlikely to occur as a result of ponatinib-mediated inhibition of substrates for these transporters.
Danish: Derfor er det usandsynligt, at der vil være kliniske lægemiddelinteraktioner som følge af ponatinibmedieret hæmning af substrater for disse transportører.
English: Hepatic failure (including fatal outcome) has been observed.
Danish: Leversvigt (herunder med dødeligt udfald) er observeret.
English: Very common decreased appetite
Danish: Meget almindelig nedsat appetit