FrancophonIA/ELRC3.0 huggingface dataset:
English: In the placebo-controlled Phase III studies, the incidence of paraesthesia was 20.6% and 21.2% in the plerixafor and placebo groups, respectively.
Danish: I de placebokontrollerede fase III-studier var forekomsten af paræstesi 20,6 % og 21,2 % i gruppen med henholdsvis plerixafor og placebo.
English: The trial was conducted in patients weighing 70 kg or less (median: 63.7 kg , min: 34.2 kg, max: 70 kg).
Danish: Studiet blev udført hos patienter, som vejede 70 kg eller mindre (median: 63,7 kg, min: 34,2 kg, max: 70 kg).
English: The majority of these events occurred within 1 hour of Mozobil administration.
Danish: Størstedelen af disse hændelser opstod inden for 1 time efter indgivelse af Mozobil.
English: The recommended daily dose of plerixafor by subcutaneous injection (SC) is:
Danish: Voksne Den anbefalede daglige dosis af plerixafor ved subkutan injektion (s.c.) er:
English: Pins and needles and numbness are common in patients being treated for cancers.
Danish: Snurren og prikken og følelsesløshed er almindeligt hos patienter, der behandles for kræft.
English: 37 Hollands Road Haverhill, Suffolk CB9 8PU United Kingdom
Danish: 37 Hollands Road Haverhill, Suffolk CB9 8PU Storbritannien eller
English: • anaphylactic reactions, including anaphylactic shock
Danish: • anafylaktiske reaktioner, herunder anafylaktisk shock
English: male (kg):
Danish: mand (kg):
English: Thrombocytopenia is a known complication of apheresis and has been observed in patients receiving Mozobil.
Danish: Trombocytopeni er en kendt komplikation ved aferese og er observeret hos patienter, der fik Mozobil.
English: Symptoms responded to treatments (e.g., antihistamines, corticosteroids, hydration or supplemental oxygen) or resolved spontaneously.
Danish: Symptomerne reagerede på behandlingerne (fx antihistaminer, kortikosteroider, hydrering eller ekstra ilt) eller forsvandt spontant.
English: This protein “ties” blood stem cells to the bone marrow.
Danish: Dette protein binder blodstamcellerne til knoglemarven.
English: It is not recommended to use Mozobil for stem cell mobilisation if you have leukaemia (a cancer of the blood or bone marrow).
Danish: Det frarådes at bruge Mozobil, hvis du har leukæmi (kræft i blodet eller knoglemarven).
English: You should not use Mozobil if you are pregnant, since there is no experience with Mozobil in pregnant women.
Danish: Du må ikke bruge Mozobil, hvis du er gravid, da der ikke er nogen erfaring med anvendelse af Mozobil til gravide.
English: Based on limited data at doses above the recommended dose and up to 0.48 mg/kg the frequency of gastrointestinal disorders, vasovagal reactions, orthostatic hypotension, and/or syncope may be higher.
Danish: På grund af de begrænsede oplysninger om doser højere end den anbefalede dosis og op til 0,48 mg/kg kan hyppigheden af gastrointestinale lidelser, vasovagale reaktioner, ortostatisk hypotension og/eller synkope være højere.
English: Exposure margins in the juvenile rat study at the maximum tolerated dose (MTD) were ≥18 fold when compared with the highest clinical paediatric dose in children up to 18 years of age.
Danish: Eksponeringsmarginer i studiet med unge rotter ved den maksimalt tolerede dosis (MTD) var ≥18 gange højere end den højeste, kliniske, pædiatriske dosis hos børn op til 18 år.
English: • abnormal dreams, nightmares
Danish: • unormale drømme, mareridt
English: • you have pain in the upper left abdomen (belly) or your left shoulder
Danish: • du får smerter i øverste venstre del af maven eller i din venstre skulder.
English: Safety pharmacology studies with intravenously administered plerixafor in rats showed respiratory and cardiac depressant effects at systemic exposure slightly above the human clinical exposure, whilst subcutaneous administration elicited respiratory and cardiovascular effects only at higher systemic levels.
Danish: Farmakologiske sikkerhedsmæssige studier med intravenøst administreret plerixafor til rotter viste depression af åndedræt og hjerte ved systemiske eksponeringer, der var lidt højere end den humane kliniske eksponering, mens subkutant administreret plerixafor udelukkende viste respiratoriske og kardiovaskulære effekter ved højere systemiske niveauer.
English: In Mozobil clinical studies of oncology patients, there have been rare reports of severe gastrointestinal events, including diarrhoea, nausea, vomiting, and abdominal pain.
Danish: I kliniske studier af Mozobil til onkologiske patienter har der været sjældne indberetninger af svære gastrointestinale hændelser, herunder diaré, nausea, opkastning og abdominalsmerter.
English: Based on population pharmacokinetic modeling and similar to adults, µg/kg-based dosage results in increase in plerixafor exposure with increasing body weight in paediatric patients.
Danish: Baseret på farmakokinetisk populationsmodellering og tilsvarende voksne medførte µg/kg-baseret dosering en stigning i plerixafor-eksponering i takt med stigende legemsvægt hos pædiatriske patienter.
English: One of these events occurred 4 days after last Mozobil administration.
Danish: Den ene af disse hændelser opstod 4 dage efter sidste indgivelse af Mozobil.
English: In clinical studies, the dose of plerixafor has been calculated based on body weight in patients up to 175% of ideal body weight.
Danish: Dosis af plerixafor har i kliniske studier været beregnet på baggrund af legemsvægten hos patienter på op til 175 % af den ideelle legemsvægt.
English: Vials should be inspected visually prior to administration and not used if there is particulate matter or discolouration.
Danish: Hætteglassene skal inspiceres visuelt inden indgivelse og må ikke anvendes, hvis der er partikler eller misfarvning.
English: Platelet counts should be monitored in all patients receiving Mozobil and undergoing apheresis.
Danish: Trombocyttallet bør overvåges hos alle patienter, der får Mozobil og gennemgår aferese.
English: The results of the dose range-finding study in juvenile miniature pigs and the range-finding and definitive studies in juvenile rats were similar to those observed in adult mice, rats, and dogs.
Danish: Resultaterne af det dosisbestemmende studie med unge minigrise og af dosisbestemmende studier samt definitive studier med unge rotter var sammenlignelige med de resultater, der blev observeret hos voksne mus, rotter og hunde.
English: • if you have low platelet counts.
Danish: • hvis du har et lavt antal blodplader.
English: Fertility The effects of plerixafor on male and female fertility are not known (see section 5.3).
Danish: Fertilitet Plerixafors virkning på fertiliteten hos mænd og kvinder kendes ikke (se pkt.
English: It should be administered by subcutaneous injection 6 to 11 hours prior to initiation of each apheresis following 4 day pre-treatment with G-CSF.
Danish: Præparatet skal administreres ved subkutan injektion 6 til 11 timer inden påbegyndelse af hver aferese og efter 4 dages præmedicinering med G-CSF.
English: Mozobil therapy should be initiated and supervised by a physician experienced in oncology and/or haematology.
Danish: Behandling med Mozobil skal indledes og overvåges af en læge med erfaring inden for onkologi og/eller hæmatologi.
English: Breast-feeding should be discontinued during treatment with Mozobil.
Danish: Amning bør ophøre under behandling med Mozobil.
English: Lack of temporal relationship in 8 of 9 patients coupled with the risk profile of patients with myocardial infarction does not suggest Mozobil confers an independent risk for myocardial infarction in patients who also receive G-CSF.
Danish: Grundet den manglende tidsmæssige forbindelse hos 8 ud af 9 patienter samt risikoprofilen for patienter med myokardieinfarkt tyder dette ikke på, at Mozobil giver en uafhængig risiko for myokardieinfarkt hos patienter, der også får G-CSF.
English: Plerixafor was not genotoxic in an adequate battery of genotoxicity tests.
Danish: Plerixafor var ikke genotoksisk i en fyldestgørende gruppe af genotoksicitetstest.
English: Mozobil may cause dizziness and fatigue.
Danish: Mozobil kan forårsage svimmelhed og træthed.
English: Data from animal models also suggest modulation of foetal haematopoiesis, vascularisation, and cerebellar development by SDF-1α and CXCR4.
Danish: Data fra dyrestudier tyder desuden på modulation af føtal hæmatopoiese, vaskularisering og cerebellar udvikling fra SDF-1α og CXCR4.
English: Women of childbearing potential Women of childbearing potential have to use effective contraception during treatment.
Danish: Kvinder i den fertile alder Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen.
English: The median PB CD34+ cell counts at baseline were 15 cells/µl in the Mozobil arm versus 35 cells/µl in control arm.
Danish: Median PB CD34+ celletal ved baseline var 15 celler/μl i Mozobil-armen versus 35 celler/μl i kontrolarmen.
English: Mean (SD)
Danish: Median Middel (SD)
English: Adverse reactions are listed by System Organ Class and frequency.
Danish: Tabuleret liste over bivirkninger Bivirkningerne er opstillet efter systemorganklasse og frekvens.
English: Following a 0.24 mg/kg dose in healthy volunteers with normal renal function, approximately 70% of the dose was excreted unchanged in urine during the first 24 hours following administration.
Danish: Efter en dosis på 0,24 mg/kg til raske frivillige med normal nyrefunktion blev cirka 70 % af dosis udskilt uændret i urinen inden for de første 24 timer efter indgivelse.
English: Mozobil is given by subcutaneous injection (under your skin).
Danish: Mozobil gives med en injektion under huden (subkutan injektion).
English: Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an osmolality of 260 - 320 mOsm/kg.
Danish: Klar, farveløs til lysegul opløsning med en pH-værdi på 6,0-7,5 og en osmolalitet på 260-320 mOsm/kg.
English: Events included one or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnoea (n = 1) or hypoxia (n = 1).
Danish: Bivirkningerne omfattede et eller flere af følgende: urticaria (n = 2), periorbital hævelse (n = 2), dyspnø (n
English: The primary analysis showed that 80% of patients in the Mozobil arm experienced at least a doubling of the PB CD34+ count, observed from the morning of the day preceding the first planned apheresis to the morning prior to apheresis, versus, 28.6 % of patients in the control arm (p=0.0019).
Danish: Den primære analyse viste, at 80 % af patienterne i Mozobil-armen som minimum opnåede en fordobling af PB CD34+ tallet, der blev observeret morgenen efter den første planlagte aferese i forhold til morgenen inden den første planlagte aferese versus 28,6 % af patienterne i kontrolarmen (p=0,0019).
English: Paraesthesia is commonly observed in oncology patients undergoing autologous transplantation following multiple disease interventions.
Danish: Paræstesi ses ofte hos onkologiske patienter, der gennemgår autolog transplantation efter flere indgreb.
English: Plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an in vitro study.
Danish: Plerixafor fungerede ikke som substrat for eller inhibitor af P-glykoprotein i et in vitro studie.
English: Cases of anaphylactic reactions, including anaphylactic shock, have been reported from world-wide post-marketing experience.
Danish: Der er blevet indberettet tilfælde af anafylaktiske reaktioner herunder anafylaktisk shock efter markedsføring på verdensplan.
English: Geometric Mean AUC
Danish: Geometrisk middelværdi AUC
English: Effect on the spleen
Danish: Effekt på milten
English: In in vitro studies with human hepatocytes, plerixafor does not induce CYP1A2, CYP2B6, and CYP3A4 enzymes.
Danish: I in vitro-studier med humane hepatocytter inducerer plerixafor ikke CYP1A2-, CYP2B6- og CYP3A4-enzymer.
English: Histopathology findings of extramedullary haematopoiesis were observed in the liver and spleen of rats and/or dogs.
Danish: Histopatologiske fund af ekstramedullær hæmatopoiese blev observeret i lever og milt hos rotter og/eller hunde.
English: Plerixafor is a bicyclam derivative, a selective reversible antagonist of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1 (SDF-1), also known as CXCL12.
Danish: Plerixafor er et bicyclam-derivat, en selektiv, reversibel antagonist, som binder til CXCR4 kemokinreceptoren og blokerer bindingen af dets kognate ligand, SDF-1α (stromal cell-derived factor-1α), også kendt som CXCL12.
English: The efficacy and safety of Mozobil were evaluated in an open label, multi-center, controlled study in paediatric patients with solid tumors (including neuroblastoma, sarcoma, Ewing sarcoma) or lymphoma who were eligible for autologous hematopoietic stem cell transplantation (DFI12860).
Danish: Mozobils sikkerhed og virkning er blevet undersøgt i et kontrolleret, åbent, multicenterstudie med pædiatriske patienter med solide tumorer (inklusive neuroblastom, sarkom, Ewings sarkom) eller lymfom, som var egnet til autolog stamcelletransplantation (DFI12860).
English: Additional effects of plerixafor consistently noted in repeated dose animal studies included increased levels of circulating white blood cells and increased urinary excretion of calcium and magnesium in rats and dogs, slightly higher spleen weights in rats, and diarrhoea and tachycardia in dogs.
Danish: Andre effekter af plerixafor, der konsekvent blev bemærket i dyrestudier med gentagne doser, omfattede forhøjede niveauer af cirkulerende hvide blodlegemer og øget udskillelse af calcium og magnesium i urinen hos rotter og hunde, let forhøjet miltvægt hos rotter samt diaré og takykardi hos hunde.
English: CD34+ cells/kg was 3 days for both treatment groups, and the safety profile between the groups was similar.
Danish: Mediantiden for at nå ≥ 5 × 106 CD34+ celler/kg var 3 dage for begge behandlingsgrupper, og sikkerhedsprofilen var tilsvarende mellem grupperne.
English: For low weight patients, up to 45 kg of body weight, 1 ml syringes for use in infant patients can be used.
Danish: Til patienter med en lav kropsvægt på op til 45 kg kan der anvendes 1 ml børneinjektionssprøjter.
English: Plerixafor is not metabolised in vitro using human liver microsomes or human primary hepatocytes and does not exhibit inhibitory activity in vitro towards the major drug-metabolising CYP450 enzymes (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5).
Danish: Plerixafor metaboliseres ikke in vitro med anvendelse af humane levermikrosomer eller humane primære hepatocytter og udviser ikke hæmmende aktivitet in vitro i retning mod de vigtigste lægemiddelmetaboliserende CYP450-enzymer (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4/5).
English: There was an imbalance between treatment arms in peripheral blood CD34+ counts on the day prior to first apheresis (i.e. prior to administration of plerixafor), with less circulating PB CD34+ in the plerixafor arm.
Danish: Der sås en ubalance mellem behandlingsarmene i CD34+ celletallet i perifert blod dagen før den første aferese (dvs. før administration af plerixafor) med mindre cirkulerende PB CD34+ i plerixafor-armen.
English: This type of syringe has major graduations for 0.1 ml and minor graduations for 0.01 ml and therefore is suitable to administer plerixafor, at a dose of 240 µg/kg, to paediatric patients of at least 9 kg body weight.
Danish: Denne type injektionssprøjte har hovedopdelinger for hver 0,1 ml og underopdelinger for hver 0,01 ml og er derfor egnet til at administrere plerixafor i en dosis på 240 µg/kg til pædiatriske patienter med en legemsvægt på mindst 9 kg.
English: White blood cell counts should be monitored during Mozobil therapy.
Danish: Antallet af hvide blodlegemer bør overvåges under behandling med Mozobil.
English: The results from single dose subcutaneous studies in rats and mice showed plerixafor can induce transient but severe neuromuscular effects (uncoordinated movement), sedative-like effects (hypoactivity), dyspnoea, ventral or lateral recumbency, and/or muscle spasms.
Danish: Resultaterne fra studier med subkutane enkeltdoser til rotter og mus viste, at plerixafor kan inducere forbigående, men alvorlige neuromuskulære effekter (ukoordineret bevægelse), sedativ-lignende effekter (hypoaktivitet), dyspnø, ventral eller lateral tilbagelænethed og/eller muskelspasmer.
English: Plerixafor-induced leukocytosis and elevations in circulating haematopoietic progenitor cell levels are thought to result from a disruption of CXCR4 binding to its cognate ligand, resulting in the appearance of both mature and pluripotent cells in the systemic circulation.
Danish: Plerixafor-induceret leukocytose og stigninger i niveauet af cirkulerende hæmatopoietiske stamceller menes at være resultatet af afbrydelse af CXCR4's binding til dets kognate ligand, hvilket medfører forekomst af både modne og pluripotente celler i det systemiske kredsløb.
English: During that 24-hour period, the first dose of plerixafor 0.24 mg/kg or placebo was administered 10-11 hours prior to apheresis.
Danish: I denne 24-timers periode blev den første dosis plerixafor 0,24 mg/kg eller placebo indgivet 10-11 timer inden aferese.
English: Other medicines and Mozobil
Danish: Brug af anden medicin sammen med Mozobil
English: Safety data for Mozobil in conjunction with G-CSF in oncology patients with lymphoma and multiple myeloma were obtained from 2 placebo-controlled Phase III studies (301 patients) and 10 uncontrolled Phase II studies (242 patients).
Danish: Sikkerhedsdata for anvendelse af Mozobil sammen med G-CSF til onkologiske patienter med lymfom og multipelt myelom blev indsamlet fra 2 placebokontrollerede fase III-studier (301 patienter) og 10 ikke-kontrollerede fase II-studier (242 patienter).
English: An in vitro general receptor activity screen showed that plerixafor, at a concentration (5 µg/ml) several fold higher than the maximum human systemic level, has moderate or strong binding affinity for a number of different receptors predominantly located on pre-synaptic nerve endings in the central nervous system (CNS) and/or the peripheral nervous system (PNS) (N-type calcium channel, potassium channel SKCA, histamine H3, acetylcholine muscarinic M1 and M2, adrenergic α1B and α2C, neuropeptide Y/Y1 and glutamate NMDA polyamine receptors).
Danish: En in vitro-screening af generel receptoraktivitet viste, at plerixafor ved en koncentration (5 µg/ml), der er adskillige gange højere end det maksimale systemiske niveau hos mennesker, har en moderat eller stærk bindingsaffinitet for et antal forskellige receptorer, der hovedsageligt er placeret på præsynaptiske nerveender i centralnervesystemet (CNS) og/eller det perifere nervesystem (PNS) (Ntype-calciumkanal, kaliumkanal SKCA, histamin H3, acetylkolinmuskarin M1 and M2, adrenerge α1B og α2C, neuropeptid Y/Y1 og glutamat NMDA polyamin-receptorer).
English: Body weight of 83 kg was selected as the cut-off point to transition patients from fixed to weight based dosing (83 kg x 0.24 mg = 19.92 mg/kg).
Danish: Legemsvægt på 83 kg blev valgt som skillepunkt for overførsel af patienter fra fast til vægtbaseret dosis (83 kg x 0,24 mg = 19,92 mg/kg).
English: • difficulty in sleeping
Danish: • søvnbesvær
English: Fixed 20 mg (n=30) 0.24 mg/kg (n=31) Ratio (90% CI)
Danish: Fast 20 mg (n=30) 0,24 mg/kg (n=31) Forhold (90% KI)
English: In rat distribution studies concentrations of radiolabelled plerixafor was detected in reproductive organs (testes, ovaria, uterus) two weeks after single or 7 daily repeated doses in males and after 7 daily repeated doses in females.
Danish: I studier af distributionen hos rotter blev der påvist koncentrationer af radiomærket plerixafor i forplantningsorganerne (testis, ovaria, uterus) 2 uger efter enkeltdoser eller 7 daglige gentagne doser til hanner og efter 7 daglige gentagne doser til hunner.
English: Patients were primarily treated with daily doses of 0.24 mg/kg plerixafor by subcutaneous injection.
Danish: Patienterne blev fortrinsvis behandlet med daglige doser på 0,24 mg/kg plerixafor administreret subkutant.
English: Plerixafor has been shown to cause increased resorptions, decreased foetal weights, retarded skeletal development and increased foetal abnormalities in rats and rabbits.
Danish: Det er påvist, at plerixafor kan medføre forhøjet resorption, nedsat fostervægt, forsinket knoglevækst og stigning i fosteranomalier hos rotter og kaniner.
English: Vasovagal reactions, orthostatic hypotension, and/or syncope can occur following subcutaneous injections (see section 4.8).
Danish: Vasovagale reaktioner, ortostatisk hypotension og/eller synkope kan opstå efter subkutane injektioner (se pkt.
English: How is Mozobil given?
Danish: Hvordan gives Mozobil?
English: • stomach symptoms such as pain, swelling or discomfort
Danish: • symptomer i maven såsom smerter, hævelse eller ubehag
English: For transplanted patients in the Phase III studies, median time to neutrophil engraftment (10-11 days), median time to platelet engraftment (18-20 days) and graft durability up to 12 months post-transplantation were similar across the Mozobil and placebo groups.
Danish: For transplanterede patienter i fase III-studier var mediantiden indtil engraftment af neutrofiler (10-11 dage), mediantiden indtil engraftment af trombocytter (18-20 dage) og transplantatets funktionalitet indtil 12 måneder efter transplantationen ens på tværs af grupperne på Mozobil og placebo.
English: Common Vomiting, abdominal pain, stomach discomfort, dyspepsia, abdominal distention, constipation, flatulence, hypoaesthesia oral, dry mouth
Danish: Meget almindelig Diaré, nausea Almindelig Opkastning, abdominalsmerter, ubehag i maven, dyspepsi, abdominal distention, obstipation, flatulens, oral hypoæstesi, mundtørhed
English: • shortly after receiving Mozobil, you experience rash, swelling around the eyes, shortness of breath or lack of oxygen, feeling lightheaded on standing or sitting, feeling faint or fainting
Danish: • du kort tid efter at have fået Mozobil får udslæt, hævelse omkring øjnene, stakåndethed eller åndenød, eller du føler dig ør, når du står op eller sidder ned, eller føler, at du skal besvime, eller du besvimer.
English: Danmark sanofi A/S Tlf: +45 45 16 70 00
Danish: Sanofi A/S Tlf: +45 45 16 70 00
English: • allergic reactions such as skin rash, swelling around the eyes, shortness of breath
Danish: • allergiske reaktioner såsom udslæt i huden, hævelse omkring øjnene, stakåndethed
English: The fixed 20 mg dose showed 1.43-fold higher exposure (AUC0-10h) than the 0.24 mg/kg dose (Table 2).
Danish: Den faste 20 mg-dosis viste 1,43 gange højere eksponering (AUC0-10t) end 0,24 mg/kg dosen (Tabel 2).
English: • if you have a history of feeling faint or lightheaded on standing or sitting or have fainted before upon injections.
Danish: • hvis du tidligere har haft en følelse af at skulle besvime, eller du er blevet svimmel, når du rejser eller sætter dig op, eller du er besvimet i forbindelse med en injektion.
English: Of these patients, 100% (7 out of 7) mobilised ≥ 2 x10 6/kg CD34+ cells and had successful engraftment.
Danish: Ud af disse patienter mobiliserede 100 % (7 ud af 7) ≥ 2 x106/kg CD34+ celler og gennemgik transplantation med vellykket resultat.
English: Tumour cell mobilisation in leukaemia patients
Danish: Mobilisering af tumorceller hos leukæmipatienter
English: Plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an in vitro study with MDCKII and MDCKII-MDR1 cell models.
Danish: Plerixafor fungerede ikke som substrat for eller inhibitor af P-glykoprotein i en in vitro undersøgelse med MDCKII- og MDCKII-MDR1-celletyper.
English: The potential effects of plerixafor on male fertility and postnatal development have not been evaluated in non-clinical studies.
Danish: De mulige virkninger af plerixafor på fertiliteten hos hanner og på den postnatale udvikling er ikke undersøgt i prækliniske studier.
English: In clinical studies of patients with Non-Hodgkin's lymphoma, the addition of rituximab to a mobilisation regimen of plerixafor and G-CSF did not impact patient safety or CD34+ cell yield.
Danish: I kliniske studier af patienter med non-Hodgkins lymfom havde samtidig behandling med rituximab i et mobiliseringsregimen med plerixafor og G-CSF ingen betydning for patienternes sikkerhed eller udbytte af CD34+-celler.