FrancophonIA/ELRC3.0 huggingface dataset:
English: The storage times and conditions for reconstitution, dilution, and administration of BESPONSA are shown below.
Danish: Opbevaringstider og -forhold for rekonstitueret og fortyndet BESPONSA opløsning.
English: [4.5 to 7.9]
Danish: 4.8 og 5.2).
English: Median OS; months [95% CI]
Danish: Gennemsnitlig OS, måneder [95 % CI]
English: CD22 expression prior to treatment, had a worse OS outcome following treatment with BESPONSA or Investigator's choice of chemotherapy.
Danish: Patienter med MLL-genrearrangement (mixed lineage leukemia), inklusive t(4;11), der generelt havde lavere CD22 ekspression inden behandlingen, havde et dårligere OS-resultat efter behandling med BESPONSA eller investigators valg af kemoterapi.
English: Dosing regimen for Cycle 1 All patients: Dose (mg/m2) Cycle length
Danish: Dosis (mg/m Længde på cyklus
English: The QT interval should be monitored in case of combinations of such medicinal products (see sections 4.4, 4.8, and 5.2).
Danish: QT-intervallet skal observeres, når disse lægemidler administreres samtidigt (se pkt.
English: SN:
Danish: i.v.
English: 28 dayse
Danish: 28 dage
English: a With ≤4 hours between reconstitution and dilution.
Danish: Med ≤ 4 timer mellem rekonstituering og fortynding.
English: a With ≤ 4 hours between reconstitution and dilution.
Danish: med ≤4 timer i mellem rekonstituering og fortynding.
English: In patients receiving inotuzumab ozogamicin, infusion related reactions were reported (see section 4.8).
Danish: Der er indberettet infusionsrelaterede reaktioner hos patienter, der fik inotuzumab ozogamicin (se pkt.
English: 4 hours between reconstitution and dilution.
Danish: ≤ 4 timer mellem rekonstituering og fortynding.
English: Median PFSe, f; months [95% CI]
Danish: Gennemsnitlig DoR f, måneder [95% CI]
English: c CR is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109/L and ANC ≥ 1 × 109/L) and resolution of any extramedullary disease.
Danish: CR defineres som < 5% blaster i knoglemarven og fravær af leukæmiske blaster i perifert blod, fuld restitution af perifere blodtal (trombocytter ≥ 100 × 109/l og ANC ≥ 1 × 109/l) og resolution af eventuel ekstramedullær sygdom.
English: Of the 49 (15%) patients with Ph+ ALL, 4 patients did not receive a prior TKI, 28 patients received 1 prior TKI, and 17 patients received 2 prior TKIs.
Danish: 28 patienter havde fået 1 TKI tidligere og 17 patienter havde fået 2 TKI'ere tidligere.
English: For the first cycle, the recommended total dose of BESPONSA for all patients is 1.8 mg/m2 per cycle, given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2).
Danish: I første cyklus anbefales en samlet dosis til alle patienter på 1,8 mg/m 2 pr. forløb, givet som 3 opdelte doser på dag 1 (0,8 mg/m 2), 8 (0,5 mg/m 2) og 15 (0,5 mg/m 2).
English: No patients had an increase in QTcF interval > 500 msec. Grade 2 QT interval prolongation was reported in 2/164 (1%) patients.
Danish: Ingen patienter havde en stigning i QTcF-intervallet på > 500 msek.
English: You must avoid becoming pregnant or fathering a child. Women must use effective contraception during treatment and for at least 8 months after the last dose of treatment.
Danish: Kvinder skal bruge sikker prævention under behandlingen og i mindst 8 måneder efter sidste dosis.
English: In patients receiving inotuzumab ozogamicin, TLS, which may be life-threatening or fatal, was reported (see section 4.8).
Danish: Der er indberettet TLS, som kan være livstruende eller dødelig, hos patienter, der fik inotuzumab ozogamicin (se pkt.
English: CRa; n (%) [95% CI]
Danish: CR a, n (%) [95% CI]
English: Alternatively, CD22 expression was assessed using immunohistochemistry in patients with an inadequate bone marrow aspirate and insufficient circulating blasts.
Danish: Hos patienter med både utilstrækkeligt knoglemarvsaspirat og utilstrækkelige cirkulerende blaster blev CD22ekspression vurderet ved hjælp af immunhistokemi.
English: b CRi, per EAC, was defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, partial recovery of peripheral blood counts (platelets < 100 × 109/L and/or ANC < 1 × 109/L) and resolution of any extramedullary disease.
Danish: CRi defineres som < 5% blaster i knoglemarven og fravær af leukæmiske blaster i perifert blod, delvis restitution af perifere blodtal (trombocytter < 100 × 109/l og/eller ANC < 1 × 109/l) og resolution af eventuel ekstramedullær sygdom.
English: In patients receiving inotuzumab ozogamicin, prolonged QT interval was observed (see section 4.4).
Danish: Der er observeret forlængelse af QT-intervallet hos patienter, der fik inotuzumab ozogamicin (se pkt.
English: CRa/CRib; n (%) [95% CI] CRa; n (%) [95% CI] CRib; n (%) [95% CI] Median DoRf; months [95% CI]
Danish: MRD-negativitet c for patienter, som opnåede CR/CRi, frekvens d (%) [95% CI] Gennemsnitlig PFS e, måneder [95% CI]
English: CRa/CRib; n (%) [95% CI]
Danish: CR a/CRi b, n (%) [95 % CI]
English: - Use immediately or store at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Danish: - Bruges straks eller opbevares ved stuetemperatur (20-25 °C) eller i køleskab (2-8 °C).
English: In patients receiving inotuzumab ozogamicin, increases in amylase and lipase have been reported (see section 4.8).
Danish: Der er indberettet stigninger i amylase og lipase hos patienter, der fik inotuzumab ozogamicin (se pkt.
English: Eligible patients were ≥ 18 years of age with Philadelphia chromosome negative (Ph-) or Ph+ relapsed or refractory B-cell CD22-positive precursor ALL.
Danish: Egnede patienter var ≥ 18 år og havde Philadelphia-kromosomnegativ (Ph
English: Patients who have not achieved a CRc or CRid: Dose (mg/m2)
Danish: Patienter, der ikke har opnået CR c eller CRi
English: What BESPONSA looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: • The diluted solution must be used immediately, stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Danish: • Den fortyndede opløsning skal bruges straks, opbevares ved stuetemperatur (20-25 °C) eller i køleskab (2-8 °C).
English: The diluted solution must be used immediately or stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Danish: Den fortyndede opløsning skal bruges straks eller opbevares ved stuetemperatur (20-25 °C) eller i køleskab (2-8 °C).
English: In clinical studies in patients with relapsed or refractory ALL, the maximum single and multiple doses of inotuzumab ozogamicin were 0.8 mg/m2 and 1.8 mg/m2, respectively, per cycle, given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) (see section 4.2).
Danish: I kliniske studier hos patienter med recidiverende eller refraktær ALL var den maksimale enkeltdosis og gentagne doser inotuzumab ozogamicin hhv. 0,8 mg/m 2 og 1,8 mg/m 2 pr. cyklus, givet som
English: CRib; n (%) [95% CI]
Danish: CRi b, n (%) [95 % CI]
English: PC:
Danish: Ph
English: d CRi is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts,
Danish: CRi blev ifølge EAC defineret som < 5 % blaster i knoglemarven og fravær af leukæmiske blaster i perifert blod, delvis restitution af perifere blodtal (trombocytter < 100 × 10
English: For subsequent cycles, the recommended total dose is 1.5 mg/m2 per cycle administered as 3 divided doses on Days 1 (0.5 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who achieve a CR/CRi or 1.8 mg/m2 per cycle given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who do not achieve a CR/CRi.
Danish: I de efterfølgende cyklusser er den anbefalede, samlede dosis 1,5 mg/m 2 pr. cyklus givet som 3 opdelte doser på dag 1 (0,5 mg/m 2), 8 (0,5 mg/m 2) og 15 (0,5 mg/m 2) til patienter, der opnår CR/CRi, eller
English: Use diluted solution immediately or after being stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Danish: Den fortyndede opløsning skal bruges straks eller efter opbevaring ved stuetemperatur (20-25 °C) eller i køleskab (2-8 °C).
English: Slight foetal growth retardation in rats also occurred at approximately 0.4 times the human clinical exposure based on AUC (see section 4.6).
Danish: 0,4 gange den kliniske eksponering hos mennesker baseret på AUC.
English: Due to the risk of VOD/SOS, for patients proceeding to HSCT, the recommended duration of treatment with inotuzumab ozogamicin is 2 cycles; a third cycle may be considered for those patients who do not achieve a CR or CRi and MRD negativity after 2 cycles (see section 4.2).
Danish: For patienter, der forsætter med HSCT, anbefales en behandlingsvarighed med inotuzumab ozogamicin på 2 cyklusser for at mindske risikoen for VOD/SOS.
English: For subsequent cycles, the recommended total dose of BESPONSA is 1.5 mg/m2 per cycle given as 3 divided doses on Days 1 (0.5 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who achieve a CR/CRi or 1.8 mg/m2 per cycle given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who do not achieve a CR/CRi.
Danish: 1,8 mg/m 2 pr. forløb givet som 3 opdelte doser på dag 1 (0,8 mg/m 2), 8 (0,5 mg/m 2) og 15 (0,5 mg/m til patienter, der ikke opnår CR/CRi.
English: What BESPONSA contains
Danish: BESPONSA indeholder:
English: These events have often been transitory.
Danish: Disse hændelser har ofte været forbigående.
English: The follow-up time was up to 24 weeks of age.
Danish: Opfølgningstiden var op til 24 ugers alderen.
English: a Number of patients evaluable.
Danish: a Antal af evaluerbare patienter.
English: Instructions for preparation, see section 6.6.
Danish: Instruktioner for tilberedelse, se pkt 6.6.
English: In antiretroviral naive patients
Danish: Hos antiretroviralt naive patienter
English: For this reason, it is important that you inform your doctor of any change in your health.
Danish: Det er derfor vigtigt, at du informerer din læge om enhver ændring i din helbredstilstand.
English: Interaction studies have only been performed in adults.
Danish: Interaktionsstudier har kun været udført hos voksne.
English: This rare, but very serious side effect occurs more often in women, particularly if very overweight.
Danish: Denne sjældne men meget alvorlige bivirkning optræder hyppigere hos kvinder, specielt hvis de er meget overvægtige.
English: Patient age and/or weight
Danish: Patientens alder og/eller vægt
English: Zerit with food and drink
Danish: Brug af Zerit sammen med mad og drikke
English: Your doctor has defined your daily dose based on your weight and individual characteristics.
Danish: Lægen har beregnet din daglige dosis på baggrund af din vægt og individuelle forhold.
English: Only the data from the marketed formulation are presented.
Danish: Kun data fra den markedsførte formulering er vist.
English: The number of reports in older infants was too small to identify a pattern.
Danish: Antallet af rapporter hos ældre spædbørn var for lille til at identificere et mønster.
English: It also increases CD4 cell counts.
Danish: Samtidig øger det antallet af CD4-celler.
English: There have been no formal interaction studies with other medicinal products.
Danish: Der er ikke foretaget nogen formelle interaktionsstudier med andre lægemidler.
English: These will require specific and sometimes preventive treatment.
Danish: Disse infektioner kræver speciel og i nogle tilfælde forebyggende behandling.
English: Both studies were designed to compare two formulations of Zerit, one of which was the marketed formulation dosed as currently approved in product labelling.
Danish: Begge studier var designet til at sammenligne to formuleringer af Zerit, hvoraf den ene var den markedsførte formulering doseret som den nuværende godkendte produktmærkning.
English: Experience in adults treated with up to 12 times the recommended daily dosage revealed no acute toxicity.
Danish: Erfaring hos voksne behandlet med op til 12 gange den anbefalede daglige dosis medførte ingen akut toksicitet.
English: Zerit should not be used during pregnancy unless clearly necessary.
Danish: Zerit skal ikke anvendes under graviditeten undtaget det er klart nødvendigt.
English: The clinical significance of this is unknown.
Danish: Den kliniske signifikans af dette er ukendt.
English: Contact your doctor if you notice such changes.
Danish: Kontakt lægen, hvis du bemærker sådanne forandringer.
English: Use in children
Danish: Brug hos børn
English: No significant accumulation of stavudine is observed with repeated administration every 6, 8, or 12 hours.
Danish: Ingen signifikant akkumulation af stavudin observeredes efter gentagen administration hver 6., 8., eller 12. time.
English: Date of last renewal: 20 April 2011
Danish: Dato for seneste fornyelse: 20. april 2011
English: ≤ 25 ml/min (including dialysis dependence*)
Danish: ≤ 25 ml/min (inklusive dialysepatienter*)
English: If you have taken Zerit during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis du har taget Zerit under graviditeten, kan din læge tilråde regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge dit barns udvikling.
English: Zerit may also be administered by carefully opening the hard capsule and mixing the contents with food.
Danish: Zerit kan også administreres ved forsigtigt at åbne den hårde kapsel og blande indholdet med føde.
English: The absolute bioavailability is 86±18%.
Danish: Den absolutte biotilgængelighed er 86±18%.
English: Stavudine distributes equally between red blood cells and plasma.
Danish: Stavudin distribueres ligeligt mellem røde blodlegemer og plasma.
English: Do not change the dose on your own.
Danish: Du må ikke selv ændre doseringen.
English: The AUC(inf) for stavudine was 61% of the AUC(inf) of the total circulating radioactivity.
Danish: AUC(inf) for stavudin var 61% af AUC(inf) af den totale cirkulerende radioaktivitet.
English: These CD4 cells play an important role in maintaining a healthy immune system to help fight infection.
Danish: Disse CD4-celler spiller en vigtig rolle i opretholdelsen af et sundt immunforsvar, der skal medvirke til at bekæmpe infektioner.
English: Patients treated with Zerit have reported the following side effects:
Danish: Patienter, som har været behandlet med Zerit, har indberettet følgende bivirkninger:
English: Clinical experience in pregnant women is limited, but congenital anomalies and abortions have been reported.
Danish: Klinisk erfaring hos gravide kvinder er begrænset, men medfødte anomalier og aborter er blevet rapporteret.
English: No notable differences in the frequency of adverse drug reactions were seen between treatment groups.
Danish: Der blev ikke set nogen væsentlig forskelle i frekvensen af bivirkningsreaktioner mellem behandlingsgrupperne.
English: The patient should be instructed to shake the bottle well prior to measuring each dose.
Danish: Patienten skal instrueres i at ryste flasken godt før afmåling af hver dosis.
English: Elderly: Zerit has not been specifically investigated in patients over the age of 65.
Danish: Ældre: Zerit er ikke blevet specifikt testet på patienter over 65 år.
English: The HIV status for the newborns and infants ≤ 3 months of age was negative, for older infants it tended to be positive.
Danish: HIV-status for de nyfødte og spædbørn ≤ 3 måneder var negativ, for ældre spædbørn havde den en tendens til at være positiv.
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Danish: For de børn, hvis mødre har taget NRTI'er i løbet af graviditeten, opvejede fordelen ved beskyttelsen mod hiv risikoen for at få bivirkninger.
English: Zerit may improve your condition, but it is not a cure for your HIV infection.
Danish: Zerit kan forbedre din tilstand, men kan ikke helbrede dig for din hiv-infektion.
English: Please follow these recommendations closely as they will give you the best chance to delay development of a resistance to the medicinal product.
Danish: Du skal nøje overholde anvisningerne, da dette er den bedste mulighed for at udskyde udvikling af resistens over for lægemidlet.
English: Your doctor will therefore be monitoring the effectiveness of your treatment.
Danish: Lægen vil derfor kontrollere, hvor effektivt behandlingen virker på dig.
English: Whether such neurological disorders are transient or permanent is currently unknown.
Danish: Om sådanne neurologiske forstyrrelser er forbigående eller permanente vides ikke på nuværende tidspunkt.
English: Similar effects have been observed with other nucleoside analogues.
Danish: Lignende effekter er observeret med andre nukleosidanaloger.
English: Warnings and precautions Talk to your doctor before taking Zerit.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Zerit.
English: Patient weight
Danish: Patientens vægt
English: The contribution of this to the total elimination in an overdose situation is unknown.
Danish: Betydningen af dette for den totale elimination ved overdosering er ukendt.
English: Do not worry if the solution remains slightly hazy after mixing with water; this is normal.
Danish: Du skal ikke bekymre dig om, at opløsningen godt kan være en smule grumset efter tilsætning af vand; det er helt normalt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 May 1996
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSE Dato for første tilladelse: 8. maj 1996
English: The data available on stavudine excretion into human breast milk are insufficient to assess the risk to the infant.
Danish: De tilgængelige data på udskillelse af stavudin i human modermælk er ikke tilstrækkelige til at vurdere risikoen for spædbarnet.
English: Zerit dosage (according to creatinine clearance)
Danish: Zerit dosis (i henhold til kreatinin-clearance)
English: Stable for 30 days after reconstitution, when stored in a refrigerator.
Danish: Holdbar i 30 dage efter tilberedning ved opbevaring i køleskab.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier om virkninger på evnen til at føre motorkøretøj eller betjene maskiner.
English: However, you should contact your doctor or the nearest hospital for advice.
Danish: Du bør dog kontakte din læge eller nærmeste hospital og spørge om råd.
English: The pharmacokinetics of stavudine was independent of time, since the ratio between AUC(ss) at steady state and the AUC(0-t) after the first dose was approximately 1.
Danish: Stavudins farmakokinetik var uafhængig af tid, fordi forholdet mellem AUC(ss) ved steady state og AUC(0-t) efter første dosis var ca. 1.
English: Lactose intolerance: the hard capsule contains lactose.
Danish: Lactoseintolerans: Den hårde kapsel indeholder lactose.
English: Table 1: Efficacy Outcomes at Week 48 (Studies AI455-099 and AI455-096)
Danish: Tabel 1: Effektresultater i uge 48 (Studie AI455-099 og AI455-096)
English: Because stavudine is not protein-bound, it is not expected to affect the pharmacokinetics of protein-bound medicines.
Danish: Da stavudin ikke er proteinbundet, kan det ikke forventes at indvirke på farmakokinetikken hos proteinbundne lægemidler.
English: It is not known whether stavudine is removed by peritoneal dialysis.
Danish: Det er uvist, om stavudin bliver fjernet ved peritoneal dialyse.
English: This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Danish: Dette er til dels forbundet med forbedret helbredstilstand og livsstil, og for blodlipidernes vedkommende sommetider med selve hiv-medicinen.
English: Patient weight 26-50 ml/min
Danish: 26-50 ml/min
English: The safety and efficacy of stavudine has not been established in patients with significant underlying liver disorders.
Danish: Sikkerhed og effekt af stavudin er ikke fastlagt hos patienter med signifikant underliggende leversygdomme.
English: Adult patients that have problems swallowing capsules should ask their doctor about the possibility of changing to the powder formulation of this medicine.
Danish: Voksne patienter, som har problemer med at sluge kapslerne, kan spørge deres læge om muligheden for at skifte til pulverformuleringen af dette lægemiddel.
English: No evidence of impaired fertility was seen in rats at high exposure levels (up to 216 times that observed at the recommended clinical dose).
Danish: Der blev ikke fundet beviser på nedsat fertilitet hos rotter ved høje eksponeringsniveauer på (op til 216 gange den anbefalede kliniske dosis).
English: The mean terminal elimination half-life of stavudine is 1.3 to 2.3 hours following single or multiple doses, and is independent of dose.
Danish: Den gennemsnitlige terminale eliminationshalveringstid af stavudin er 1,3 til 2,3 timer efter en enkelt eller multiple doser og er uafhængig af dosis.
English: The bottle should be shaken well, until the powder dissolves completely.
Danish: Flasken skal rystes godt, indtil pulveret er fuldstændigt opløst.
English: Do not take Zerit
Danish: Tag ikke Zerit
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Danish: Disse fund påvirker ikke aktuelle nationale anbefalinger vedrørende anvendelse af antiretroviral behandling til gravide kvinder for at forebygge vertikal HIV-transmission.
English: Approximately 70% of the orally administered stavudine dose was excreted as an unchanged drug in urine.
Danish: Omkring 70% af den oralt administrerede stavudindosis blev udskilt som uomdannet lægemiddel i urinen.
English: Peripheral neuropathy: up to 20% of patients treated with Zerit will develop peripheral neuropathy, often starting after some months of treatment.
Danish: Perifer neuropati: Op til 20% af patienter, behandlet med Zerit, vil udvikle perifer neutropati, der som oftest begynder efter nogle måneders behandling.
English: Dublin 15, D15 T867
Danish: D15 T867
English: Dosing recommendations are not available for neonates with a gestational age < 37 weeks.
Danish: Der foreligger ikke anbefalinger af dosis til nyfødte med en svangerskabsalder < 37 uger.
English: Purified Water
Danish: Renset vand
English: Although there are insufficient data to recommend a specific dosage adjustment of Zerit in this patient population, a reduction in the dose and/or an increase in the interval between doses proportional to the reduction for adults should be considered.
Danish: Selvom der ikke foreligger sufficiente data til at anbefale en specifik dosisjustering af Zerit til denne patientgruppe, skal der overvejes en dosisreduktion og/eller øgning af intervallet mellem doser i forhold til reduktionen for voksne.
English: What you need to know before you take Zerit 3.
Danish: Det skal du vide, før du begynder at tage Zerit 3.
English: This medicinal product, in combination with other antiretrovirals, reduces the HIV viral load and keeps it at a low level.
Danish: I kombination med andre antiretrovirale stoffer nedsætter dette lægemiddel hiv-mængden og holder den på et lavt niveau.
English: Infants under the age of 3 months: safety data are available from clinical trials up to 6 weeks of treatment in 179 newborns and infants < 3 months of age (see section 4.8).
Danish: Spædbørn under 3 måneder: Der foreligger sikkerhedsdata fra kliniske studier for op til 6 ugers behandling hos 179 nyfødte og spædbørn < 3 måneder (se pkt 4.8).
English: An ex vivo study using a term human placenta model demonstrated that stavudine reaches the foetal circulation by simple diffusion.
Danish: Et ex vivo studie, der anvendte en human placenta model ved fødslen viste, at stavudin når den føtale cirkulation ved simpel diffusion.
English: Stavudine treatment can select for and/or maintain thymidine analogue mutations (TAMs) associated with zidovudine resistance.
Danish: Stavudinbehandling kan udvælge og/eller opretholde thymidinanaloge mutationer (TAM'er) forbundet med zidovudinresistens.
English: Outer carton PC:
Danish: Ydre karton PC: