FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary packaging is an amber glass bottle (Type III) closed with a child-resistant and tamper evident polypropylene cap.
Danish: Primæremballage er en ravfarvet flaske (type III) lukket med børne- og manipulationssikret polypropylenlåg).
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: Pædiatrisk population 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: Neuronal phospholipidosis occurred in dogs dosed for ≥ 3 months at lower systemic exposures than those obtained at therapeutic doses in humans.
Danish: Neuronal fosfolipidose forekom hos hunde behandlet i ≥3 måneder ved lavere systemisk eksponering end den eksponering, der opnås ved terapeutiske doser hos mennesker.
English: neutropenia
Danish: Neutropeni
English: Posaconazole AHCL should be administered with caution to patients with pro-arrhythmic conditions such as: - Congenital or acquired QTc prolongation - Cardiomyopathy, especially in the presence of cardiac failure - Sinus bradycardia - Existing symptomatic arrhythmias - Concomitant use with medicinal products known to prolong the QTc interval (other than those mentioned in section 4.3).
Danish: Posaconazole AHCL bør administreres med forsigtighed til patienter med proarytmiske tilstande såsom: - Kongenital eller erhvervet QTc-forlængelse - Kardiomyopati, især hvis hjerteinsufficiens er til stede - Sinusbradykardi - Eksisterende symptomatiske arytmier - Samtidig behandling med lægemidler, som er kendt for at forlænge QTc-intervallet (ud over dem, der er nævnt under pkt.
English: The active substance is posaconazole.
Danish: - Aktivt stof: posaconazol.
English: Look at the list of medicines given above that must not be taken while you are taking Posaconazole AHCL.
Danish: Se de ovenfor nævnte typer medicin, som ikke må anvendes, mens du tager Posaconazole AHCL.
English: The primary efficacy endpoint was the incidence of proven/probable IFIs at 16 weeks post-randomization as determined by an independent, blinded external expert panel.
Danish: Det primære virkningsendepunkt var forekomst af verificeret/sandsynlig IFI 16 uger efter randomisering bestemt af et uafhængigt, blindet eksternt ekspertpanel.
English: Caution should be used when prescribing Posaconazole AHCL to patients with hypersensitivity to other azoles.
Danish: Der bør udvises forsigtighed, når Posaconazole AHCL ordineres til patienter, som er overfølsomme over for andre azoler.
English: Posaconazole may increase the plasma concentration of ergot alkaloids (ergotamine and dihydroergotamine), which may lead to ergotism.
Danish: Posaconazol kan øge plasmakoncentrationer af sekalealkaloider (ergotamin og dihydroergotamin), som kan medføre ergotisme.
English: breast pain
Danish: Brystsmerter
English: A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomization.
Danish: Et centralt sekundært endepunkt var forekomst af verificeret/sandsynlig IFI 100 dage efter randomisering.
English: Do not take Posaconazole AHCL if you are taking any of the following: - terfenadine (used to treat allergies) - astemizole (used to treat allergies) - cisapride (used to treat stomach problems) - pimozide (used to treat symptoms of Tourette's and mental illness) - halofantrine (used to treat malaria) - quinidine (used to treat abnormal heart rhythms).
Danish: Tag ikke Posaconazole AHCL, hvis du tager et eller flere af følgende lægemidler: - terfenadin (anvendes til behandling af allergier) - astemizol (anvendes til behandling af allergier) - cisaprid (anvendes til behandling af maveproblemer) - pimozid (anvendes til behandling af symptomer ved Tourettes syndrom og psykiske sygdomme) - halofantrin (anvendes til behandling af malaria) - quinidin (anvendes til behandling af unormal hjerterytme).
English: The effect of co-administration with posaconazole on plasma levels of CYP3A4 substrates may also be variable within a patient, unless posaconazole is administered in a strictly standardised way with food, given the large food effect on posaconazole exposure (see section 5.2).
Danish: Virkningen af samtidig administration af posaconazol på plasmaniveauer for CYP3A4substrat kan også variere hos den enkelte patient, medmindre posaconazol administreres på en strengt standardiseret måde sammen med føde på grund af den store virkning af føde på posaconazoleksponering (se pkt.
English: Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (1.7 times the 400 mg twice daily regimen based on steady-state plasma concentrations in healthy volunteers) or female rats at a dose up to 45 mg/kg (2.2 times the 400-mg twice daily regimen).
Danish: Posaconazol havde ingen indvirkning på hanrotters fertilitet ved doser på op til 180 mg/kg (1,7 gange 400 mg to gange dagligt baseret på plasmakoncentrationer ved steady-state hos raske frivillige) eller hunrotter ved en dosis på op til 45 mg/kg (2,2 gange 400 mg to gange dagligt).
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 enkelt oral dosis) med henholdsvis 2,2 og 4,5 gange.
English: Posaconazole is a potent inhibitor of CYP3A4.
Danish: Posaconazol er en potent hæmmer af CYP3A4.
English: - if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin
Danish: - hvis du tager terfenadin, astemizol, cisaprid, pimozid, halofantrin, quinidin, et hvilket som helst lægemiddel, som indeholder “sekalealkaloider” (anvendes til behandling af migræne) såsom ergotamin eller dihydroergotamin, eller et “statin” (kolesterolsænkende lægemiddel) såsom simvastatin, atorvastatin eller lovastatin.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ DEN INDRE EMBALLAGE FLASKEETIKET
English: See “Other medicines and Posaconazole AHCL” below for more information including information on other medicines which may interact with Posaconazole AHCL.
Danish: Læs ”Brug af anden medicin sammen med Posaconazole AHCL” nedenfor for information om andre lægemidler, som kan påvirke virkningen af Posaconazole AHCL.
English: Following administration of 800 mg per day of posaconazole as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8 - 17 years of age (776 ng/mL) were similar to concentrations from 194 patients 18 - 64 years of age (817 ng/mL).
Danish: Efter administration af 800 mg posaconazol 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: After a single oral dose of 400 mg posaconazole oral suspension to patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment (six per group), the mean AUC was 1.3 to 1.6-fold higher compared to that for matched control subjects with normal hepatic function.
Danish: Efter en enkelt oral dosis på 400 mg posaconazol oral suspension til patienter med mild (Child-Pugh klasse A), moderat (Child-Pugh klasse B) eller svær (Child-Pugh klasse C) nedsat leverfunktion (seks pr. gruppe) var den gennemsnitlige AUC 1,3 til 1,6 gange højere sammenlignet med værdien hos forsøgspersoner i kontrolgruppen med normal leverfunktion.
English: Simeticone emulsion (containing polydimethylsiloxane, polyethylene glycol sorbitan tristearate, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid (E200), benzoic acid (E210) and sulfuric acid (E513))
Danish: Simeticon-emulsion (indeholdende polydemetylsiloxan, polyethylenglycolsorbitantristarat, metylcellulose, silicagel, polyetylenglycolstearat, sorbinsyre (E200), benzoesyre (E210) og svovlsyre (E513))
English: Posaconazole AHCL must not be administered with medicinal products that are substrates for CYP3A4 and are known to prolong the QTc interval (see sections 4.3 and 4.5).
Danish: Posaconazole AHCL må ikke administreres sammen med lægemidler, som er substrater for CYP3A4, og som er kendt for at forlænge QTc- intervallet (se pkt.
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 posconazol, skal der udvises forsigtighed.
English: INFORMATION IN BRAILLE Posaconazole AHCL
Danish: INFORMATION I BRAILLESKRIFT Posaconazole AHCL
English: Posaconazole AHCL contains a medicine called posaconazole.
Danish: Posaconazole AHCL indeholder et lægemiddelstof, der hedder posaconazol.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of oral suspension contains 40 mg of posaconazole.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml oral suspension indeholder 40 mg posaconazol.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: If you have missed a dose, take it as soon as you remember and then carry on as before.
Danish: Hvis du har glemt at tage Posaconazole AHCL - Hvis du har glemt en dosis, så tag den, så snart du husker det og fortsæt som før.
English: Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during co-administration 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: Do not breast-feed while taking Posaconazole AHCL.
Danish: Undlad at amme, mens du tager Posaconazole AHCL.
English: 11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole oral suspension 800 mg/day in divided doses for a median of 296 days and up to 460 days.
Danish: 11 ud af 16 patienter var tilfredsstillende behandlet (efter endt behandling fuldstændig eller delvis bedring af alle tegn og symptomer på infektion, der var til stede ved behandlingsstart (baseline)) med posaconazol oral suspension 800 mg dagligt fordelt på flere doser i op til 460 dage med en median på 296 dage.
English: Posaconazole AHCL contains glucose
Danish: Posaconazole AHCL indeholder glucose
English: Strawberry flavour (containing propylene glycol)
Danish: Jordbæraroma (indeholdende propylenglycol)
English: Some patients have also reported feeling confused after taking Posaconazole AHCL, the frequency of this is not known.
Danish: Nogle patienter har også oplevet at føle sig forvirrede efter brug af Posaconazole AHCL.
English: What Posaconazole AHCL looks like and contents of the pack Posaconazole AHCL is a white to off-white free flowing suspension, packaged in amber glass bottle.
Danish: Posaconazole AHCL er en hvid til råhvid letflydende suspension, der er pakket i en ravfarvet glasflaske.
English: b: In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316
Danish: b: I 1899 var det perioden fra randomisering til sidste dosis studiemedicin plus 7 dage; i 316 var det perioden fra første dosis til sidste dosis studiemedicin plus 7 dage.
English: H2 receptor antagonists and proton pump inhibitors Posaconazole plasma concentrations (Cmax and AUC) were reduced by 39 % when posaconazole was administered with cimetidine (400 mg twice a day) due to reduced absorption possibly secondary to a decrease in gastric acid production.
Danish: Posaconazolplasmakoncentrationer (Cmax og AUC) reduceredes med 39 %, da posaconazol blev administreret samtidig med cimetidin (400 mg 2 gange dagligt) på grund af reduceret absorption, som muligvis var sekundær til reduktion af mavesyreproduktionen.
English: haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Danish: Hæmolytisk uræmisk syndrom, thrombotisk trombocytopenisk purpura, pancytopeni, koagulopati, blødning
English: It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens and the effects of food on absorption).
Danish: Det er især vigtigt at forsøge at opnå maksimale plasmaniveauer hos patienter inficeret med Aspergillus (se pkt.
English: - Candida albicans: S ≤0.06 mg/L, R >0.06 mg/L - Candida tropicalis: S ≤0.06 mg/L, R >0.06 mg/L - Candida parapsilosis: S ≤0.06 mg/L, R >0.06 mg/L
Danish: EUCAST-MIC-grænseværdier for posaconazol [følsomme (S); resistente (R)]: - Candida albicans: S ≤0,06 mg/l, R >0,06 mg/l - Candida tropicalis: S ≤0,06 mg/l, R >0,06 mg/l - Candida parapsilosis: S ≤0,06 mg/l, R >0,06 mg/l Der er for tiden utilstrækkelige data til at fastsætte kliniske grænseværdier for andre Candida-arter.
English: If you are not sure, talk to your doctor or pharmacist before taking Posaconazole AHCL.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet, før du tager Posaconazole AHCL.
English: The other ingredients in the suspension are macrogolglycerol hydroxystearate, sodium citrate dihydrate, citric acid monohydrate, simeticone emulsion (containing polydimethylsiloxane, polyethylene glycol sorbitan tristearate, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid (E200), benzoic acid (E210) and sulfuric acid (E513)), xanthan gum (E415), sodium benzoate (E211), liquid glucose, glycerol (E422), titanium dioxide (E171), strawberry flavour (containing propylene glycol) and purified water.
Danish: - Øvrige indholdsstoffer: Macrogolglycerolhydroxystearat, natriumcitratdihydrat, citronsyremonohydrat, simeticon-emulsion (indeholdende polydemetylsiloxan, polyethylenglycolsorbitantristarat, metylcellulose, silicagel, polyetylenglycolstearat, sorbinsyre (E200), benzoesyre (E210) og svovlsyre (E513)), xanthangummi (E415), natriumbenzoat (E211), flydende glucose, glycerol (E211), titandioxid (E171), jordbæraroma (indeholdende propylenglycol), renset vand.
English: The AUC of posaconazole is: 4 times greater when administered with a high fat meal (~ 50 grams fat) and about 2.6 times greater when administered during a non-fat meal or nutritional supplement (14 grams fat) relative to the fasted state (see sections 4.2 and 4.5).
Danish: AUC for posaconazol er sammenlignet med fastende tilstand: 4 gange større, når det administreres med et måltid med højt fedtindhold (~50 gram fedt), og omkring 2,6 gange større, når det administreres sammen med et måltid med lavt fedtindhold eller et ernæringstilskud (14 gram fedt) (se pkt.
English: Posaconazole AHCL 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.
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: 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 på posaconazol med henholdsvis 45 % og 50 %.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Accord Healthcare S.L.U.
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 enkelt dosis) 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: In a study of 136 neutropenic paediatric patients 11 months - 17 years treated with posaconazole oral suspension at doses up to 18 mg/kg/day divided TID, approximately 50% met the pre-specified target (Day 7 Cav between 500 ng/mL-2,500 ng/mL).
Danish: I et studie med 136 pædiatriske patienter med neutropeni i alderen 11 måneder - 17 år, der blev behandlet med posaconazol oral suspension i doser på op til 18 mg/kg/dag fordelt på tre gange dagligt, opfyldte ca. 50 % det præspecificerede mål (gennemsnitlig koncentration (Cav) dag 7 mellem 500 ng/ml-2.500 ng/ml).
English: Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Danish: Studie 316 var et randomiseret, dobbeltblindet studie af posaconazol oral suspension (200 mg tre gange dagligt) versus fluconazolkapsler (400 mg en gang dagligt) til patienter med graft versus host- sygdom (GVHD), der havde gennemgået allogen HSCT.
English: §, electrocardiogram abnormal palpitations, bradycardia, supraventricular extrasystoles, tachycardia
Danish: Langt QT-syndrom§, unormalt elektrokardiogram§, palpitationer, bradykardi, supraventrikulære ekstrasystoler, takykardi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each mL contains 40 mg of posaconazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml indeholder 40 mg posaconazol.
English: Posaconazole AHCL 40 mg/mL oral suspension posaconazole
Danish: Posaconazole AHCL 40 mg/ml oral suspension posaconazol
English: NAME OF THE MEDICINAL PRODUCT Posaconazole AHCL 40 mg/mL oral suspension
Danish: LÆGEMIDLETS NAVN Posaconazole AHCL 40 mg/ml oral suspension
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 stabil dosis af ciclosporin, hvilket medførte behov for dosisnedsættelser.
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du opdager en eller flere af følgende bivirkninger:
English: First time treatment of Thrush
Danish: Førstegangsbehandling af trøske
English: Uncommon: the following may affect up to 1 in 100 people - 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 - low level of platelets (thrombocytopenia) shown in blood tests - this may lead to bleeding - low level of “leukocytes” a type of white blood cell (leukopenia) shown in blood tests - this can make you more likely to get infections - high level of “eosinophils” a type of white blood cell (eosinophilia) - this can happen if you have inflammation - inflammation of the blood vessels - heart rhythm problems
Danish: Ikke almindelige: følgende tilstande kan berøre op til 1 ud af 100 personer - anæmi - tegn på dette kan være hovedpine, træthed eller svimmelhed, åndenød eller bleghed og lavt hæmoglobinniveau i blodprøver - lavt niveau af blodplader (trombocytopeni) i blodprøver) - dette kan medføre blødning - lavt niveau af 'leukocytter' som er en type hvide blodlegemer (leukopeni) i blodprøver - dette kan gøre dig mere modtagelig over for infektioner - højt niveau af 'eosinofiler' som er en type hvide blodlegemer (eosinofili )- dette kan forekomme,
English: Posaconazole AHCL can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them: - 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; - 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; - 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; - infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped.
Danish: Posaconazole AHCL kan anvendes hos voksne til behandling af følgende svampeinfektioner, når andre svampemidler ikke har virket, eller du var nødt til at stoppe med at tage dem: - 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: Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du oplever en eller flere af ovennævnte bivirkninger.