FrancophonIA/ELRC3.0 huggingface dataset:
English: No overt cases of pancreatitis have been reported in this patient population.
Danish: Der er ikke blevet rapporteret åbenlyse tilfælde af pankreatitis i denne patientpopulation.
English: Kepivance will be given to you by a doctor or nurse with experience in cancer treatment.
Danish: De vil få Kepivance af en læge eller sygeplejerske med erfaring i kræftbehandling.
English: In a study to assess potential carcinogenicity in transgenic rasH2 mice, no treatment related increases in the incidence of neoplastic lesions were observed.
Danish: I et studie, der havde til formål at vurdere potentiel carcinogenicitet i transgene rasH2-mus, blev der ikke observeret behandlingsrelaterede stigninger i forekomsten af neoplastiske læsioner.
English: Inter-subject variability is high with a CV% of about 50% for CL and 60% for Vss.
Danish: Variansen forsøgspersonerne imellem er høj med en CV% på cirka 50% for CL og 60% for Vss.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Kepivance is a sterile but unpreserved product and is intended for single use only.
Danish: Kepivance er et sterilt produkt, men uden konserveringsmiddel, og er kun beregnet til engangsbrug.
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)
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Once reconstituted, store in a refrigerator and use within 24 hours.
Danish: Rekonstitueret produkt skal opbevares i køleskab og anvendes inden for 24 timer.
English: Non-haematological malignancies
Danish: Ikke-hæmatologiske maligniteter
English: • increase in lipase and amylase levels (digestive enzymes) in the blood (which do not require treatment and usually return to normal after stopping treatment with Kepivance).
Danish: • øget indhold af lipase og amylase (fordøjelsesenzymer) i blodet (kræver ikke behandling og normaliseres sædvanligvis efter, at behandling med Kepivance er ophørt).
English: Lack of efficacy and risk of infection with high dose melphalan conditioning regimen
Danish: Manglende virkning og risiko for infektion med konditionerende behandling med høj dosis melphalan
English: Palifermin is a 140 amino acid protein with a molecular weight of 16.3 kilodaltons.
Danish: Palifermin er et 140 aminosyre-protein med en molekylvægt på 16,3 kilodalton.
English: • darkening of an area of skin (hyperpigmentation);
Danish: • mørkfarvning af et hudområde (hyperpigmentering),
English: It differs from endogenous human KGF in that the first 23 N-terminal amino acids have been deleted to improve
Danish: Det adskiller sig fra endogent humant KGF ved, at de første 23 N-terminale aminosyrer er fjernet for at forbedre proteinstabiliteten.
English: ** WHO Oral Mucositis Scale: Grade 1 = soreness/erythema; Grade 2 = erythema, ulcers, can eat solids; Grade 3 = ulcers, requires liquid diet only; Grade 4 = alimentation not possible
Danish: ** WHO Oral Mucositis-skala: Grad 1 = ømhed/erytem; Grad 2 = erytem, ulcus, kan spise fast føde; Grad 3 = ulcus, kræver udelukkende flydende diæt; Grad 4 = fødeindtagelse ikke mulig
English: Store in a refrigerator
Danish: Opbevares i køleskab.
English: The main efficacy endpoint of the study was the number of days during which patients experienced severe oral mucositis (grade 3/4 on the World Health Organisation (WHO) scale).
Danish: Det vigtigste effektivitetsmål for studiet var antallet af dage, hvorunder patienterne oplevede alvorlig oral mucositis (grad 3/4 på Verdenssundhedsorganisationens (WHO) skala).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Visual acuity was not affected at 6 or 12 months in either treatment group.
Danish: Skarpsynet var ikke påvirket ved måned 6 eller 12 i nogen af behandlingsgrupperne.
English: What you need to know before you use Kepivance
Danish: Det skal De vide, før De begynder at bruge Kepivance
English: Hypersensitivity, including Anaphylactic reactions, has also been associated with palifermin.
Danish: Overfølsomhed, inklusive anafylaktiske reaktioner, er også blevet forbundet med palifermin.
English: As a protein therapeutic, the risk for Kepivance to interact with other medicinal products is low.
Danish: Da Kepivance er et proteinbaseret lægemiddel, er risikoen for, at det interagerer med andre lægemidler, lav.
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03A F08.
Danish: Farmakoterapeutisk klassifikation: Afgiftningsmidler ved cytostatikabehandling, ATC-kode: V03A F08.
English: The safety and efficacy of Kepivance in children aged 0 to 18 years have not been established.
Danish: Kepivances sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt.
English: Due to limited data in patients, heparins should be used with care in patients receiving palifermin and appropriate blood coagulation tests should be carried out to monitor their treatment.
Danish: På grund af de begrænsede data fra patienter skal hepariner anvendes med forsigtighed til patienter, der får palifermin, og passende analyser af blodets koagulation skal udføres for at overvåge behandlingen.
English: However, patients treated with chemotherapy and/or radiotherapy are at higher risk of developing secondary tumours some of which may express KGF receptors, and theoretically, be stimulated by KGF receptor ligands.
Danish: Patienter behandlet med kemoterapi og/eller strålingsterapi er dog udsat for højere risiko for at udvikle sekundære tumorer, hvoraf visse kan udtrykke KGF-receptorer og teoretisk kan stimuleres af KGF-receptorligander.
English: The diluent should be injected slowly into the Kepivance vial.
Danish: Diluenten skal indsprøjtes langsomt i hætteglasset med Kepivance.
English: In this Phase 3 clinical study, palifermin treated patients demonstrated significant benefits in patient-reported outcomes of mouth and throat soreness and its impact on swallowing, drinking, eating and talking.
Danish: I dette fase 3 kliniske studie udviste palifermin-behandlede patienter signifikante fordele i patientrapporteret resultat af mund- og svælg-ømhed og dets indvirken på at synke, drikke, spise og tale.
English: Adverse reactions from clinical trials and spontaneous reporting
Danish: Bivirkninger fra kliniske forsøg og spontan rapportering.
English: Kepivance contains the active substance palifermin which is a protein produced by biotechnology in a bacteria called Escherichia coli.
Danish: Kepivance indeholder det aktive stof palifermin, som er et protein fremstillet ved bioteknologi i en bakterie ved navn Escherichia coli.
English: In two studies in healthy volunteers, co-administration of Kepivance and heparin resulted in approximately 5 times higher systemic exposure to palifermin, due to a lower volume of distribution.
Danish: I to studier med raske frivillige resulterede samtidig administration af Kepivance og heparin i en cirka 5 gange højere systemisk eksponering for palifermin på grund af en lavere distributionsvolumen.
English: It is not known whether Kepivance is present in human milk.
Danish: Det vides ikke, om Kepivance udskilles i human mælk.
English: For information on preparation and administration of Kepivance, please see information for healthcare professionals at the end of this leaflet.
Danish: For information om forberedelse og indgivelse af Kepivance henvises der til oplysningerne til sundhedspersonalet sidst i denne indlægsseddel.
English: 1 Kepivance may cause increased lipase and amylase levels in some patients with or without symptoms of abdominal pain or backache.
Danish: 1Kepivance kan forårsage forhøjede lipase- og amylaseniveauer hos visse patienter med eller uden symptomer på mavesmerter eller rygsmerter.
English: The pharmacodynamic effect of palifermin, as measured by the change in Ki67 expression, tended to be lower when administered with heparin but the clinical relevance of this finding is unclear.
Danish: Palifermins farmakodynamiske effekt, målt ved hjælp af ændringen i Ki67-ekspression, havde en tendens til at være mindre, når det blev administreret sammen med heparin, men den kliniske relevans af dette fund er uklar.
English: Kepivance treatment should be supervised by a physician experienced in the use of anti-cancer
Danish: Behandling med Kepivance skal superviseres af en læge, som har erfaring med brug af anticancerbehandling.
English: Kepivance should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of cytotoxic chemotherapy.
Danish: Kepivance bør ikke indgives inden for 24 timer før, under infusion af, eller inden for 24 timer efter indgivelse af cytotoksisk kemoterapi.
English: Kepivance might interact with a medicine called heparin.
Danish: Kepivance kan interagere med medicin, der indeholder heparin.
English: These NOAEL doses were associated with systemic exposures (based on AUC) up to 9.7 and 2.1 times, respectively, anticipated clinical exposure.
Danish: Disse NOAEL-doser var forbundet med systemisk eksponering (baseret på AUC) på op til henholdsvis 9,7 og 2,1 gange den forventede kliniske eksponering.
English: A single dose of 250 micrograms/kg has been administered intravenously to 8 healthy volunteers without severe or serious adverse effects.
Danish: En enkelt dosis på 250 mikrogram/kg er blevet indgivet intravenøst til 8 raske frivillige uden alvorlige bivirkninger.
English: Kepivance should not be used during pregnancy unless clearly
Danish: Kepivance bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: No gender-related differences were observed in the pharmacokinetics of palifermin.
Danish: Der er ikke observeret nogen kønsrelaterede forskelle i farmakokinetikken for palifermin.
English: However, the administration of palifermin did not affect heparin´s anticoagulant effect in the experimental conditions (single dose, subtherapeutic dose regimen).
Danish: Administration af palifermin påvirkede dog ikke heparins antikoagulerende virkning under de betingelser, der var gældende for studiet (enkeltdosis, subterapeutisk dosisregime).
English: The usual dose of Kepivance is 60 micrograms of Kepivance per kilogram of bodyweight per day.
Danish: Den normale dosis af Kepivance er 60 mikrogram pr. kg legemsvægt pr. dag.
English: In this study (n = 281), patients with multiple myeloma received conditioning with melphalan (200 mg/m2) prior to autologous haematopoietic stem cell transplantation.
Danish: I dette studie (n = 281) fik patienter med multipelt myelom konditionerende behandling med melphalan (200 mg/m2) inden autolog hæmatopoietisk stamcelletransplantation.
English: Treatment with these doses was also associated with maternal effects (clinical signs and/or changes in body weight/food consumption), suggesting that palifermin was not selectively toxic to development in either species.
Danish: Behandling med disse doser var også forbundet med maternelle effekter (kliniske tegn og/eller forandringer i legemsvægt/fødeindtagelse), som tydede på, at palifermin ikke var selektivt toksisk for udvikling hos nogen af arterne.
English: Safety data are based on patients with haematological malignancies enrolled in randomised, placebocontrolled clinical studies, including one pharmacokinetic study, and post marketing experience.
Danish: Sikkerhedsdata er baseret på patienter med hæmatologiske maligniteter, der deltog i randomiserede, placebokontrollerede kliniske studier, inklusive et farmakokinetisk studie og post-marketing erfaring.
English: Fractionation of increased levels of amylase revealed the increase to be predominantly salivary in origin.
Danish: Fraktionering af forhøjede amylaseniveauer afslørede, at forhøjelsen overvejende stammede fra spytkirtlerne.
English: Palifermin should not be used in association with myeloablative chemotherapy-only conditioning.
Danish: Paliferm bør ikke anvendes, hvis det i forbindelse med myeloablativ kemoterapi anvendes som eneste konditionerende behandling.
English: In-vitro and in-vivo data suggest that palifermin binds to unfractionated as well as low molecular weight heparins.
Danish: In vitro og in vivo data tyder på, at palifermin binder til både ufraktionerede hepariner og hepariner med lav molekylvægt.
English: In addition, there was a higher incidence of infections in patients administered palifermin pre- and post-chemotherapy (49.5%) compared with patients who received placebo (24.6%).
Danish: Hertil kommer, at der var en højere forekomst af infektioner hos patienter, der fik palifemin før og efter kemoterapi (49,5%) sammenlignet med patienter, som fik placebo (24,6%).
English: Each pack contains 6 vials.
Danish: Hver pakke indeholder 6 hætteglas.
English: To treat your blood cancer you may be receiving chemotherapy, radiotherapy and autologous hematopoietic stem cell transplantation (cells from your own body that produce blood cells).
Danish: For at behandle Deres blodkræft kan De få kemoterapi, strålebehandling og autolog knoglemarvstransplantation (celler fra Deres egen krop, som producerer blod).
English: Although palifermin was safe at all doses tested the incidence of skin reactions increased with the dose.
Danish: Selvom palifermin var sikkert ved alle afprøvede doser, øgedes forekomsten af hudreaktioner med dosis.
English: Compared with the placebo group, the pre/post-chemotherapy group had a higher incidence of herpes virus infection (9% vs 0%), oral fungal infection (7% vs 2%) and sepsis/septic shock (12% vs 2%).
Danish: Sammenlignet med placebogruppen havde præ/post-kemoterapigruppen en højere forekomst af herpesvirusinfektion (9% mod 0%), svampeinfektion i munden (7% mod 2%) og sepsis/septisk chok (12% mod 2%).
English: KGF is a protein that targets epithelial cells by binding to specific cell-surface receptors thereby stimulating proliferation, differentiation, and upregulation of cytoprotective mechanisms (e.g., induction of antioxidant enzymes).
Danish: KGF er et protein, der retter sig mod epitelceller ved at binde sig til specifikke celle-overfladereceptorer og derved stimulere proliferation, differentiering og opregulering af cytobeskyttende mekanismer (f.eks. induktion af antioxidantenzymer).
English: Cataractogenic effects of palifermin cannot be excluded following results of ophthalmologic examinations in a subset of patients (n = 66; 14 in the placebo group, 52 in the palifermin group) who were followed for 12 months after the acute phase of the above post-approval study.
Danish: Kataraktogene virkninger af palifermin kan ikke udelukkes ifølge resultater fra oftalmologiske undersøgelser i en subgruppe af patienter (n = 66; 14 i placebo-gruppe, 52 i palifermin-gruppen), der blev fulgt i 12 måneder efter den akutte fase i ovennævnte studie efter godkendelsen.
English: Haematologic malignancies do not express the KGF receptor.
Danish: Hæmatologiske maligniteter udtrykker ikke KGF receptoren.
English: Haematopoietic recovery following PBPC infusion was similar between patients who received Kepivance or placebo, and there were no observed differences in disease progression or survival.
Danish: Hæmatopoietisk restitution efter PBPC-infusion var ens blandt patienter, der modtog Kepivance eller placebo, og der observeredes ingen forskelle i sygdomsprogression eller overlevelse.
English: These no observed adverse effect level (NOAEL) doses were associated with systemic exposures up to 2.5 times greater than anticipated clinical exposure.
Danish: Disse doser på ingen-observerede-bivirkninger-niveau (NOAEL) var forbundet med systemisk eksponering på op til 2,5 gange større end den forventede kliniske eksponering.
English: Studies in animals have shown reproductive and developmental toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet og udviklingstoksicitet (se pkt.
English: Kepivance should be reconstituted with 1.2 ml water for injections.
Danish: Kepivance skal rekonstitueres med 1,2 ml vand til brug for injektion.
English: Pain and arthralgia are other common adverse reactions, consistent with Kepivance treated patients having received less opioid analgesia than placebo-treated patients (see Table 2).
Danish: Smerte og artralgi er andre almindelige bivirkninger i overensstemmelse med Kepivance-behandlede patienter, som havde fået mindre opioid analgetika end placebobehandlede patienter (se Tabel 2).
English: There was no evidence of a delay in time to haematopoietic recovery in patients who received palifermin as compared to patients who received placebo.
Danish: Der var ingen tegn på forsinkelse i tid til hæmatopoietisk restitution hos patienter, der modtog palifermin, sammenlignet med patienter, der modtog placebo.
English: The conditioning regimen consisted of total body irradiation (TBI), etoposide and cyclophosphamide.
Danish: Den konditionerende behandling bestod af helkropsbestråling (TBI), etoposid og cyclophosphamid.
English: There was a lower incidence of severe oral mucositis in patients receiving 80 micrograms/kg/day but no effect on the incidence of acute graft-versus-host disease (GVHD).
Danish: Der var en lavere forekomst af alvorlig oral mucositis hos patienter, der fik 80 mikrogram/kg/dag, men ingen indflydelse på forekomsten af akut graft-versus-vært-sygdom (GVHD).
English: Efficacy and safety of palifermin were established in a randomised, double-blind, placebo-controlled study in which patients received high-dose cytotoxic therapy consisting of fractionated total-body irradiation (12 Gy total dose; Day -8 to -5), high-dose etoposide (60 mg/kg; Day -4), and high-dose cyclophosphamide (100 mg/kg; Day -2) followed by PBPC support for the treatment of haematological malignancies ((Non-Hodgkin's Lymphoma (NHL), Hodgkin's disease, Acute Myeloid Leukaemia (AML), Acute Lymphocytic Leukaemia (ALL), Chronic Myeloid Leukaemia (CML), Chronic Lymphocytic Leukaemia (CLL), or multiple myeloma).
Danish: Effektivitet og sikkerhed for palifermin blev fastslået i et randomiseret, dobbeltblindt, placebo kontrolleret studie, hvor patienterne modtog højdosis cytotoksisk behandling bestående af fraktioneret helkropsbestråling (12 Gy total dosis, dag -8 til -5), højdosis etoposid (60 mg/kg, dag -4) og højdosis cyclofosfamid (100 mg/kg, dag -2) efterfulgt af PBPC-understøtning til behandling af hæmatologiske maligniteter (Non-Hodgkins lymfom (NHL), Hodgkin's sygdom, Akut Myeloid Leukæmi (AML), Akut Lymfocytisk Leukæmi (ALL), Kronisk Myeloid Leukæmi (CML), Kronisk Lymfocytisk Leukæmi (CLL) eller multipelt myelom).
English: For the primary endpoint, which was incidence of cataract development or progression at 12 months (defined as an increase of ≥ 0.3 in the LOCS III score), a greater proportion of subjects experienced cataract development in the palifermin group compared with the placebo group (28.6 % in the placebo group vs 48.1% in the palifermin group).
Danish: For det primære endepunkt, der var forekomst af kataraktudvikling eller -progression efter 12 måneder (defineret som en stigning på ≥ 0,3 i LOCS III-scoren), oplevede en større del af patienterne i palifermin-gruppen udvikling af katarakt sammenlignet med placebo-gruppen (28,6 % i placebo-gruppen i forhold til 48,1% i palifermin-gruppen).
English: Kepivance is used to treat oral mucositis (soreness, dryness and inflammation of the mouth) which has occurred as a side effect of treatments for your blood cancer.
Danish: Kepivance benyttes til at behandle oral mucositis (ømhed, tørhed og betændelse i munden), der er opstået som bivirkning ved behandling af Deres blodkræft.
English: Anaphylactic reaction/Hypersensitivity
Danish: Immunsystemet anafylaktisk reaktion/overfølsomhed
English: The pharmacokinetic profile in patients with hepatic insufficiency has not been assessed.
Danish: Den farmakokinetiske profil hos patienter med leverinsufficiens, er ikke blevet vurderet.
English: The study included three treatment arms and was designed to compare each of the palifermin arms (pre- and pre/post-) to
Danish: Studiet omfattede 3 behandlingsarme og var designet til at sammenligne hver palifermin-arm (før og før/efter) med placebo.
English: Do not use Kepivance if you are breast
Danish: Brug ikke Kepivance, hvis De ammer.
English: Kepivance is used to reduce the frequency, duration and severity of oral mucositis symptoms.
Danish: Kepivance benyttes til at reducere hyppigheden, varigheden og sværhedsgraden af symptomerne på oral mucositis.
English: Mild to moderate renal impairment (creatinine clearance 30-80 ml/min) did not influence palifermin pharmacokinetics.
Danish: Let til moderat nyreinsufficiens (kreatinin-clearance 30-80 ml/min) påvirkede ikke palifermins farmakokinetik.
English: • change in colour of the mouth or tongue;
Danish: • ændring af farven i munden eller på tungen,
English: In patients with end-stage renal disease (requiring dialysis) palifermin clearance was decreased by 10% (n = 6).
Danish: Hos patienter med terminal nyrelidelse (dialysekrævende) reduceredes palifermin-clearance med 10% (n = 6).
English: The pharmacokinetics of palifermin were studied in healthy volunteers and patients with haematological malignancies.
Danish: Farmakokinetikken for palifermin blev undersøgt hos raske frivillige og hos patienter med hæmatologiske maligniteter.
English: Other endpoints included the incidence, duration and severity of oral mucositis and the requirement for opioid analgesia.
Danish: Andre mål omfattede forekomst, varighed og grad af oral mucositis og behovet for opioide analgesika.
English: In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in an increased severity and duration of oral mucositis.
Danish: I et klinisk forsøg medførte indgivelse af Kepivance inden for 24 timer fra kemoterapi en øget grad og varighed af oral mucositis.
English: Post- myeloablative radiochemotherapy:
Danish: Post-myeloablativ radiokemoterapi:
English: Palifermin should therefore not be given to patients with known or suspected non-haematological malignancies.
Danish: Palifermin bør derfor ikke gives til patienter med kendte ikke-hæmatologiske maligniteter, eller hvis der er mistanke om ikke-hæmatologiske maligniteter.
English: Before injection‚ Kepivance may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light.
Danish: Før injektion kan Kepivance få lov at nå stuetemperatur i maksimalt 1 time, men det skal beskyttes mod lys.
English: The incidence of ulcerative oral mucositis was 57.9% in the placebo arm, 68.7% in the pre/post CT group and 51.4% in the pre-CT group.
Danish: Forekomsten af ulcerativ mucositits var 57,9% i placebo-armen, 68,7% i før/efter CT-gruppen og 51,4% i før CT-gruppen.
English: • skin rash, itching and redness (pruritus and erythaema);
Danish: • hududslæt, kløe og rødmen (pruritus og erytem),
English: Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous haematopoietic stem cell support.
Danish: Kepivance er indiceret til at mindske forekomst, varighed og grad af oral mucositis hos voksne patienter med hæmatologiske maligniteter, der får myeloablativ radiokemoterapi forbundet med en høj forekomst af alvorlig mucositis, og som behøver autolog hæmatopoietisk stamcellestøtte.