FrancophonIA/ELRC3.0 huggingface dataset:
English: Strains with MIC values above the Susceptible (S) breakpoint are rare, or not yet reported.
Danish: Stammer med MIC-værdier højere end følsomheds-grænseværdien er sjældne eller endnu ikke rapporteret.
English: If you or your child are taking VFEND for prevention of fungal infections, your doctor may stop giving VFEND if you or your child develop treatment related side effects.
Danish: Hvis De eller Deres barn tager VFEND til forebyggelse af svampeinfektioner, kan lægen stoppe behandlingen med VFEND, hvis De eller Deres barn får behandlingsrelaterede bivirkninger.
English: • Serious dermatological adverse reactions (including SCC) The frequency of phototoxicity reactions is higher in the paediatric population.
Danish: Alvorlige dermatologiske bivirkninger (herunder CSS) Hyppigheden af fototoksiske reaktioner er højere hos den pædiatriske population.
English: Add 46 ml of water and shake vigorously for about 1 minute.
Danish: Tilsæt 46 ml vand og omryst kraftigt i ca. 1 minut.
English: • Congenital or acquired QTc-prolongation.
Danish: • Kongenital eller erhvervet QTc-forlængelse.
English: 6c Prime the IV line according to the manufacturer's guidelines.
Danish: 6c I.v.-slangen forberedes i henhold til fremstillerens vejledning.
English: Depending on the severity of symptoms, consideration should be given to stopping treatment (see section 4.8).
Danish: Afhængigt af sværhedsgraden af symptomerne, bør det overvejes at standse behandlingen (se pkt.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In the combined data from three bioequivalence studies using the powder for oral suspension formulation, treatment-related taste perversion was recorded in 12 (14%) of subjects.
Danish: Ud fra de samlede data fra 3 bioækvivalensstudier, hvor formuleringen pulver til oral suspension blev anvendt, sås behandlingsrelateret smagsændring hos 12 (14%) af forsøgspersonerne.
English: The adaptor is provided so that you can fill the oral syringe with medicine from the bottle.
Danish: Adaptoren er i pakningen, så De kan fylde doseringssprøjten med medicinen fra flasken.
English: Side effects with frequency not known: Freckles and pigmented spots
Danish: Bivirkninger med ikke kendt hyppighed: • Fregner og pigmentpletter.
English: Constituted suspension: Do not store above 30°C; do not refrigerate or freeze.
Danish: Færdigblandet suspension: Må ikke opbevares over 30°C, må ikke opbevares i køleskab eller nedfryses.
English: If you stop taking VFEND
Danish: Hvis De holder op med at tage VFEND
English: Following constitution, the total volume of the suspension must be 75 ml.
Danish: Efter sammenblanding skal den samlede mængde suspension være 75 ml.
English: Remove the syringe.
Danish: Fjern sprøjten.
English: The interactions in the table are presented in the following order: contraindications, those requiring dose adjustment and careful clinical and/or biological monitoring, and finally those that have no significant pharmacokinetic interaction but may be of clinical interest in this therapeutic field.
Danish: Interaktionerne i skemaet er listet i følgende orden: kontraindikationer, interaktioner der kræver justering af dosis og omhyggelig klinisk og/eller biologisk monitorering og sluttelig interaktioner, der ikke har farmakologisk relevans, men kan være af klinisk interesse.
English: Total parenteral nutrition: Total parenteral nutrition (TPN) need not be discontinued when prescribed with VFEND, but does need to be infused through a separate line.
Danish: Total parenteral ernæring (TPN) behøver ikke at blive afbrudt, når der udskrives VFEND, men de skal infunderes i hver sin dropslange.
English: The major metabolite of voriconazole is the N-oxide, which accounts for 72% of the circulating radiolabelled metabolites in plasma.
Danish: Hovedmetabolitten af voriconazol er N-oxid, der står for 72% af de cirkulerende radioaktivt mærkede metabolitter i plasma.
English: In light of these data the duration of treatment with the intravenous formulation should be no longer than 6 months.
Danish: I lyset af disse data bør behandlingsvarigheden af den intravenøse lægemiddelform ikke overstige 6 måneder.
English: VFEND, is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
Danish: VFEND er et bredspektret triazol-antimykotikum, som er indiceret til følgende hos voksne samt børn over 2 år:
English: It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine.
Danish: Det er blevet påvist, at når man tager alle doser regelmæssigt, forhøjes medicinens virkning.
English: When the VFEND infusion is complete, the line may be used for administration of other intravenous products.
Danish: Når VFEND-infusionen er tilendebragt, kan dropslangen anvendes til administration af andre intravenøse produkter.
English: In a secondary analysis, which utilised DRC assessments at the latest evaluable time point (EOT, or 2, 6, or 12 weeks after EOT) voriconazole and the regimen of amphotericin B followed by fluconazole had successful response rates of 65% and 71%, respectively.
Danish: I en anden analyse, hvor DRCs vurderinger anvendes ved det seneste evaluerbare tidspunkt (EOT eller 2, 6 eller 12 uger efter EOT) havde voriconazol og amphotericin B efterfulgt af fluconazol en succesfuld responsrate på henholdsvis 65 % og 71 %.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt i
English: The reduced dose and/or frequency of voriconazole and fluconazole that would eliminate this effect have not been established.
Danish: Evt. reduceret dosis og/eller frekvens af voriconazol og fluconazol, der ville eliminere denne virkning er ikke fastlagt.
English: If you forget to take VFEND
Danish: Hvis De har glemt at tage VFEND
English: Each bottle contains 45 g of powder providing 70 ml of suspension when constituted with water as recommended.
Danish: Hver flaske indeholder 45 g pulver, der giver 70 ml suspension, når den er sammenblandet med den mængde vand, der er anbefalet.
English: Serious side effects - Stop taking VFEND and see a doctor immediately
Danish: Alvorlige bivirkninger - stop med at tage VFEND og søg læge øjeblikkeligt
English: Dose reduction of methadone may be needed.
Danish: Dosisreduktion af methadone kan være nødvendig.
English: Instructions for reconstitution and use:
Danish: Vejledning til rekonstitution og anvendelse:
English: VFEND must not be administered simultaneously with any blood product or any short-term infusion of concentrated solutions of electrolytes, even if the two infusions are running in separate lines.
Danish: VFEND må ikke gives samtidigt med andre blodprodukter eller andre korttidsinfusioner af elektrolytter, selv om de to infusioner gives i hver sin dropslange.
English: To measure the dose accurately, the top edge of the black ring should be lined up with the graduated mark on the oral syringe.
Danish: For at afmåle den nøjagtige dosis, skal den øverste kant af den sorte ring være ud for markeringen på doseringssprøjten.
English: Other additives should not be introduced into the infusion bag.
Danish: Der må ikke tilføres andre stoffer i infusionsposen.
English: Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation [HSCT]), should be monitored closely during VFEND treatment.
Danish: Patienter, især børn med risikofaktorer for akut pancreatitis (f.eks. nylig kemoterapi, hæmatopoietisk stamcelletransplantation (HSCT)) bør monitoreres tæt under VFEND-behandling.
English: The recommended dose for adults (including elderly patients) is as follows: Intravenous
Danish: Den anbefalede dosis til voksne (også ældre patienter) er: Intravenøst
English: Breast-feeding must be stopped on initiation of treatment with VFEND.
Danish: Amning skal ophøre ved initiering af behandling med VFEND.
English: The safety profile of voriconazole in adults is based on an integrated safety database of more than 2,000 subjects (including 1,603 adult patients in therapeutic trials) and an additional 270 adults in prophylaxis trials.
Danish: Sikkerhedsprofilen for voriconazol hos voksne er baseret på en integreret sikkerhedsdatabase med data fra mere end 2.000 personer (herunder 1.603 voksne patienter i terapeutiske studier) og yderligere 270 voksne i profylaksestudier.
English: The connected syringe and vial are then gently swirled to ensure that the VFEND powder has completely dissolved and no particulates are visible (do not shake).
Danish: Hætteglasset med engangssprøjten roteres forsigtigt for at sikre, at VFEND pulveret opløses helt, og der ikke er synlige partikler til stede (må ikke rystes).
English: This should be taken into consideration for patients on a controlled sodium diet.
Danish: Dette skal der tages hensyn til, hvis patienter er på en kontrolleret natriumdiæt.
English: After administration of a radiolabelled dose of voriconazole, approximately 80% of the radioactivity is recovered in the urine after multiple intravenous dosing and 83% in the urine after multiple oral dosing.
Danish: Efter administration af en radioaktivt mærket dosis af voriconazol bliver næsten 80% af radioaktiviteten genfundet i urinen efter gentagne intravenøse doser, og 83% i urinen efter gentagne orale doser.
English: Sealed Pack Do not use if box has been opened.
Danish: Forseglet pakning Må ikke bruges, hvis pakningen har været åbnet.
English: Successful response was seen in 24 patients (15 complete, 9 partial responses).
Danish: Succesrigt respons er set hos 24 patienter (15 med fuldstændigt, 9 med delvist respons).
English: Women of child-bearing potential Women of child-bearing potential must always use effective contraception during treatment.
Danish: Kvinder i den fertile alder Kvinder i den fertile alder bør altid anvende effektiv antikonception under behandlingen.
English: VFEND must not be infused into the same line or cannula concomitantly with other intravenous products.
Danish: VFEND må ikke infunderes i samme dropslange eller kanyle samtidigt med andre intravenøse produkter.
English: VFEND must not be diluted with 4.2% Sodium Bicarbonate Infusion.
Danish: VFEND må ikke fortyndes med 4,2% natriumcarbonat infusion.
English: • The syringe may then be removed and the contents of the infusion bag mixed gently by inverting the bag several times.
Danish: • Engangssprøjten fjernes derefter, og indholdet i infusionsposen blandes forsigtigt ved at vende posen på hovedet flere gange.
English: • you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
Danish: • De ved, at De har problemer i hjertemuskulaturen (kardiomyopati), uregelmæssig puls, langsom puls eller et unormalt elektrokardiogram (ekg), et såkaldt ”forlænget QTc-syndrom”.
English: For storage conditions after constitution, see section 6.3.
Danish: Opbevaringsbetingelser efter rekonstituering, se pkt.6.3.
English: Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or VFEND are still having the desired effect:
Danish: Fortæl det til lægen, hvis De tager følgende medicin, da det kan være nødvendigt at justere dosis og kontrollere, om medicinen og/eller VFEND stadig har den ønskede virkning:
English: Maximum increase in prothrombin time was approximately 2-fold.
Danish: Protrombintid blev maksimalt øget ca. 2 gange.
English: Clinical management should include laboratory evaluation of hepatic function (specifically AST and ALT) at the initiation of treatment with VFEND and at least weekly for the first month of treatment.
Danish: Den kliniske overvågning bør omfatte laboratorievurdering af leverfunktionen (specifikt ASAT og ALAT) ved initiering af VFEND-behandling og mindst én gang om ugen i den første behandlingsmåned.
English: No subject experienced an interval exceeding the potentially clinically-relevant threshold of 500 msec.
Danish: Ingen forsøgspersoner oplevede et interval, der oversteg den potentielle kliniske relevante grænse på 500 msek.
English: Nine subjects in the voriconazole group and 5 in the amphotericin B followed by fluconazole group also had mycologically proven infection in deep tissue.
Danish: 9 forsøgspersoner i voriconazolgruppen og 5 forsøgspersoner i amphotericin B efterfulgt af fluconazolgruppen havde også mykologisk påvist infektion i dybtliggende væv.
English: • serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).
Danish: • alvorlige svampeinfektioner forårsaget af Scedosporium- eller Fusarium-arter (to andre typer svamp).
English: Altered taste perception
Danish: Ændret smagsopfattelse
English: Following constitution, the volume of the suspension is 75 ml, providing a usable volume of 70 ml.
Danish: Efter færdigblanding er volumen af suspensionen 75 ml; det giver et brugbart volumen på 70 ml.
English: A 4-hour haemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment.
Danish: En hæmodialysesession på 4 timer fjerner ikke en tilstrækkelig mængde voriconazol til at berettige en dosisjustering.
English: Push and screw the syringe securely onto Blue port. 2c Withdraw exactly 19 mL of the solution and unscrew the syringe.
Danish: Tryk og drej sprøjten ind i den blå port. 2c Udtag nøjagtigt 19 ml af opløsningen og afmontér sprøjten.
English: Voriconazole has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and must only be used in patients with severe hepatic impairment if the benefit outweighs the potential risk.
Danish: Voriconazol har været forbundet med forhøjede levertal og kliniske tegn på leverskade, såsom gulsot og må kun anvendes til patienter med svær leverinsufficiens, hvis fordelen opvejer den potentielle risiko.
English: Non-Steroidal AntiInflammatory Drugs (NSAIDs) [CYP2C9 substrates]
Danish: Non-Steroidal AntiInflammatory Drugs (NSAIDs) [CYP2C9-substrater]
English: The combination of voriconazole with rifabutin should, if possible be avoided.
Danish: Kombination af voriconazol og rifabutin skal om muligt undgås.
English: Includes dyspnoea and dyspnoea exertional.
Danish: Inkluderer dyspnø og belastningsdyspnø.
English: Voriconazole should be administered with caution to patients with potentially proarrhythmic conditions, such as:
Danish: Voriconazol bør indgives med forsigtighed hos patienter med potentiel proarytmiske tilstande, såsom:
English: If large bubbles can be seen, slowly push the plunger back into the syringe.
Danish: Hvis der ses store bobler, skal stemplet skubbes langsomt tilbage i doseringssprøjten.
English: VFEND must not be taken during pregnancy, unless indicated by your doctor.
Danish: De må ikke tage VFEND under graviditet, medmindre det er foreskrevet af Deres læge.
English: In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole.
Danish: In vivo studier antyder, at CYP2C19 er signifikant involveret i voriconazols metabolisme.
English: If any particles are seen, discard the infusion bag.
Danish: Hvis der ses partikler i opløsningen, skal infusionsposen kasseres.
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C03
Danish: Farmakoterapeutisk klassifikation: Antimykotika til systemisk anvendelse - triazolderivater, ATC-kode: J02A C03
English: Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikke VFEND efter den udløbsdato, der står på pakningen.
English: Candida species
Danish: Candida-arter
English: Your doctor should also monitor your liver function while you are being treated with VFEND by doing blood tests.
Danish: Deres læge vil også kontrollere Deres leverfunktion under behandling med VFEND ved at tage blodprøver.
English: R-methadone (active) Cmax  31% R-methadone (active) AUC  47% S-methadone Cmax  65% S-methadone AUC  103%
Danish: R-methadon (aktiv) Cmax  31% R-methadone (aktiv) AUC  47% S-methadon Cmax  65% S-methadon AUC  103%
English: As an evolution towards SCC has been reported, stringent measures for the photoprotection are warranted in this population of patients.
Danish: Da der er rapporteret en udvikling i retning af planocellulært karcinom (SCC), kan strenge beskyttelsesforanstaltninger mod lys være påkrævet for denne patientpopulation.
English: The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C. tropicalis, C. glabrata and C. krusei, all of which usually exhibit minimal inhibitory concentration (MICs) of less than 1 mg/L for voriconazole.
Danish: De arter, der oftest forårsager infektioner hos mennesker, omfatter C. albicans, C. parapsilosis, C. tropicalis, C. glabrata og C. krusei, der alle typisk har mindste hæmmende koncentrations(MIC)værdier på mindre end 1 mg/l for voriconazol.
English: In addition VFEND has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Danish: Derudover har VFEND været forbundet med fototoksicitet, herunder reaktioner som efelider, lentigo, aktinisk keratose og pseudoporfyri.
English: VFEND suspension contains 0.54g sucrose per ml of suspension.
Danish: VFEND suspension indeholder 0,54 g saccharose pr. ml suspension.
English: Scedosporium and Fusarium infections Voriconazole was shown to be effective against the following rare fungal pathogens:
Danish: Scedosporium og Fusarium-infektioner Voriconazol har vist sig effektivt over for følgende sjældne patogene svampe:
English: Reconstitute and dilute before use - see leaflet.
Danish: Rekonstitueres og fortyndes før brug - se indlægsseddel.
English: An impurity present in SBECD has been shown to be an alkylating mutagenic agent with evidence for carcinogenicity in rodents.
Danish: En urenhed i SBECD har vist sig at være et alkylerende mutagent stof med tegn på karcinogenicitet hos gnavere.
English: Treatment of candidaemia in non-neutropenic patients.
Danish: Behandling af candidæmi hos non-neutropene patienter.
English: Swallow the tablet whole with some water.
Danish: Tabletterne synkes hele sammen med vand.
English: The visual impairments were generally mild, rarely resulted in discontinuation and were not associated with long-term sequelae.
Danish: Synsnedsættelsen er generelt mild, og resulterer sjældent i afbrydelse af behandling og har ikke været forbundet med langtidsvirkninger.
English: Ciclosporin (in stable renal transplant recipients receiving chronic ciclosporin therapy)
Danish: Ciclosporin (hos stabile nyretransplanterede patienter, der er i kronisk ciclosporinbehandling)
English: Voriconazole is eliminated via hepatic metabolism with less than 2% of the dose excreted unchanged in the urine.
Danish: Voriconazol udskilles ved levermetabolisme, hvor mindre end 2% af dosis udskilles uforandret i urinen.
English: Required Volumes of 10 mg/ml VFEND Concentrate
Danish: Nødvendig mængde af 10 mg/ml VFEND koncentrat
English: The safety and efficacy of VFEND in children below 2 years has not been established.
Danish: Sikkerhed og virkning af VFEND til børn under 2 år er ikke fastlagt.
English: Only clear solutions without particulates should be used.
Danish: Der må kun anvendes klare opløsninger uden partikler.
English: There is a small chance that skin cancer could develop with long-term use of VFEND.
Danish: Der er en lille risiko for, at langvarig brug af VFEND kan forårsage hudkræft.
English: There is limited data on the safety of VFEND in patients with abnormal liver function tests (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], or total bilirubin >5 times the upper limit of normal).
Danish: Der findes begrænsede data om sikkerheden af VFEND til patienter med unormale leverfunktionsværdier (aspartat-aminotransferase (ASAT), alanin-aminotransferase (ALAT), alkalisk fosfatase (AP) eller total-bilirubin > 5 gange den øvre normalgrænse).
English: It is estimated that, on average, increasing the oral dose from 200 mg twice daily to 300 mg twice daily leads to a 2.5-fold increase in exposure (AUCτ).
Danish: Det er skønnet, at en gennemsnitlig stigning i den orale dosis fra 200 mg 2 gange dagligt til 300 mg 2 gange dagligt fører til en 2,5 gange stigning i eksponering (AUC).
English: Therapy could then be switched to the oral formulation at a dose of 200 mg every 12 hours.
Danish: Behandlingen kan derefter skiftes til orale doser på 200 mg hver 12. time.
English: Place the vial on a flat surface.
Danish: Placér hætteglasset på en plan overflade.
English: Use the oral syringe provided in the pack to measure the correct dose.
Danish: Doseringssprøjten, der ligger i pakningen, bruges til at afmåle den korrekte dosis.
English: 5.3 Preclinical safety data
Danish: 5.3 Præklinisk sikkerhedsdata
English: The compatibility of VFEND with diluents other than listed above (or listed below under ‘Incompatibilities') is unknown.
Danish: VFENDs egnethed med andre fortyndingsmidler, end dem der specielt er nævnt oven for (eller er nævnt under ”Uforligeligheder”), er ikke kendt.
English: Store in the original container
Danish: Opbevares i original beholder.
English: Write the date of expiration of the constituted suspension on the bottle label (the shelf-life of the constituted suspension is 14 days).
Danish: Skriv udløbsdato for den færdigblandede suspension på flaskeetiketten (opbevaringstid for færdigblandet suspension er 14 dage)
English: What you need to know before you take VFEND
Danish: Det skal De vide, før De begynder at tage VFEND
English: Frequent monitoring for opiateassociated adverse reactions may be necessary.
Danish: Hyppig monitorering for opioidrelaterede bivirkninger kan være nødvendig.
English: Tell your doctor if you are taking the following medicine, as treatment with VFEND at the same time should be avoided if possible:
Danish: Fortæl det til lægen, hvis De tager følgende medicin, da behandling samtidig med VFEND bør undgås, hvis det er muligt:
English: The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to <18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Danish: Sikkerheden af voriconazol er undersøgt hos 288 pædiatriske patienter i alderen 2 til <12 år (169) og 12 til <18 år (119), som fik voriconazol-profylakse (183) og til terapeutisk brug (105) i kliniske studier.
English: Inflammation of the tissue surrounding the bone
Danish: • Betændelse i vævet omkring knoglen
English: • Oxycodone and other long-acting opiates such as hydrocodone (used for moderate to severe pain)
Danish: • Oxycodon og andre langtidsvirkende opiater, såsom hydrocodon (bruges mod moderate og stærke smerter)
English: Patients less than 40 kg*
Danish: Patienter under 40 kg*
English: If you are already being treated with phenytoin your blood concentration of phenytoin will need to be monitored during your treatment with VFEND and your dose may be adjusted.
Danish: Hvis De allerede er i behandling med phenytoin er det nødvendigt, at måle mængden af phenytoin i Deres blod under Deres behandling med VFEND og det kan være nødvendigt at justere dosis.
English: VFEND should be discontinued if premalignant skin lesions or squamous cell carcinoma are identified (see below the section under Long-term treatment).
Danish: VFEND bør seponeres, hvis der påvises præmaligne hudlæsioner eller planocellulært karcinom (se afsnittet ”Langtidsbehandling” nedenfor).