FrancophonIA/ELRC3.0 huggingface dataset:
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Danish: Som med andre hæmatopoietiske vækstfaktorer har G-CSF in vitro vist stimulerende egenskaber på humane endotelceller.
English: The aim of this patient alert card is to help prevent medication errors including underdose resulting in lack of efficacy with the on-body injector device.
Danish: Formålet med dette patientkort er at forebygge medicineringsfejl, blandt andet underdosering, som fører til manglende effekt ved anvendelse af on-body-injektoren.
English: Step 1: Monitor your on-body injector A For the next 27 hours, occasionally check the status light for at least 10 seconds.
Danish: Trin 1: Hold øje med on-body-injektoren A Kontrollér jævnligt statuslampen i mindst 10 sekunder i de næste 27 timer.
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta.
Danish: Der er rapporteret om alvorlige hudreaktioner (Stevens-Johnsons syndrom) ved brug af Neulasta.
English: The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Danish: Pegfilgrastims sikkerhed og virkning hos de novo AML-patienter < 55 år med cytogenetik t(15;17) er ikke klarlagt.
English: If you see the status light is flashing red, your on-body injector is not functioning properly.
Danish: Hvis statuslampen blinker rødt, virker on-bodyinjektoren ikke korrekt.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Median Absolute Neutrophil Count (cells x 109/l)
Danish: Median absolut neutrofiltal [ANC] (celler x 109/l)
English: • Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role.
Danish: • Sweet's syndrom (blommefarvede, hævede og smertefulde læsioner på lemmer og nogle gange i ansigtet og på halsen i forbindelse med feber) er forekommet, men kan være forårsaget af andre faktorer.
English: Consistent with a self-regulating clearance mechanism, the serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see figure 1).
Danish: I overensstemmelse med en selvregulerende clearancemekanisme falder serumkoncentrationen af pegfilgrastim hurtigt ved begyndelsen af neutrofil gendannelse (se Figur 1).
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Danish: Pegfilgrastim er et kovalent konjugat af rekombinant human G-CSF (r-metHuG-CSF) med et enkelt 20 kDa polyethylen glykol (PEG) molekyle.
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of GCSF.
Danish: Aortitis blev i de fleste tilfælde konstateret ved hjælp af CT-scanning og fortog sig generelt efter seponering af G-CSF.
English: Activity
Danish: Aktivitet
English: Where should I give my injection?
Danish: Hvor skal jeg foretage indsprøjtningen?
English: • If the status light is flashing red, you may not have received your full dose and you may need a replacement dose.
Danish: • Hvis statuslampen blinker rødt, har De muligvis ikke fået hele Deres dosis og skal muligvis have en erstatningsdosis.
English: Medication error as a result of device failure
Danish: Medicineringsfejl på grund af fejl ved injektoren
English: Thrombocytopenia1 Leukocytosis
Danish: Trombocytopeni1 Leukocytose1
English: Check the expiry date on the pre-filled syringe label (EXP).
Danish: Kontroller udløbsdatoen på den fyldte injektionssprøjtes etiket (EXP).
English: Pegfilgrastim appears to be mainly eliminated by neutrophil mediated clearance, which becomes saturated at higher doses.
Danish: Pegfilgrastim bliver tilsyneladende hovedsagligt elimineret ved neutrofilmedieret clearance, som bliver mættet ved højere doser.
English: After use
Danish: Efter brug
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg Deres læge eller apoteket til råds, før De bruger nogen form for medicin.
English: Plan to be in a place where you or your caregiver can appropriately monitor the on-body injector for Neulasta during the approximately 45 minute Neulasta delivery and for an hour after the delivery.
Danish: Sørg for at være på et sted, hvor De eller en plejeperson kan overvåge on-body-injektoren ordentligt i de cirka 45 minutter, hvor Neulasta tilføres, og i en time efter tilførslen.
English: Before use, Neulasta solution should be inspected visually for particulate matter.
Danish: Før anvendelse bør Neulasta injektionsvæsken undersøges visuelt for partikler.
English: If you have an allergic reaction during the delivery of Neulasta, remove the on-body injector by grabbing the edge of the adhesive pad and peeling off the on-body injector.
Danish: Hvis De får en allergisk reaktion under tilførslen af Neulasta, skal De fjerne on-body-injektoren ved at tage fat i kanten af klæbepuden og trække injektoren af.
English: Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Danish: Behandling med pegfilgrastim alene forhindrer ikke thrombocytopeni og anæmi forårsaget af, at fuld dosis myelosuppressiv kemoterapi opretholdes efter foreskrevet skema.
English: No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.
Danish: Dosisændring anbefales ikke til patienter med nedsat nyrefunktion, herunder patienter med terminal nyresygdom.
English: • during the monitoring of your on-body injector you are concerned that it is leaking; or
Danish: • De ved en kontrol af on-body-injektoren er bekymret for, at den er utæt, eller
English: Clean your skin by using an alcohol wipe.
Danish: Rengør Deres hud ved at benytte en afspritningsserviet.
English: On-body injector becomes loose or falls off
Danish: On-body-injektoren løsriver sig eller falder af
English: The safety and efficacy of Neulasta for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Danish: Sikkerhed og effekt af Neulasta til mobilisering af blod stamceller er ikke blevet tilstrækkeligt undersøgt hos patienter eller raske donorer.
English: • general aches and pains in the joints and muscles.
Danish: • generel ømhed og smerter i led og muskler.
English: Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance.
Danish: Pegfilgrastim er en form af filgrastim med forlænget varighed på grund af nedsat renal clearance.
English: Medicine
Danish: Medicin
English: The pre-filled syringe (with or without blister wrapping) may also be provided with an automatic needle guard.
Danish: Den fyldte injektionssprøjte (med eller uden blisterpakning) kan også fås med en automatisk kanylebeskyttelse.
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk (see section 4.8).
Danish: Patienter med nylig forekomst af pulmonale infiltrater eller pneumoni kan have større risiko (se pkt.
English: Medicines should be disposed of in accordance with local requirements.
Danish: Medicin skal bortskaffes i overensstemmelse med lokale retningslinjer.
English: • Do not expose the on-body injector to the following because the on-body injector may be damaged and you could be injured: - Diagnostic imaging (e.g. CT scan, MRI, ultrasound, x-ray).
Danish: • On-body-injektoren må ikke udsættes for nedenstående, da det kan ødelægge injektoren og skade Dem: - Diagnostiske billeder (f.eks. CT-scanninger, MR-scanninger, ultralydsundersøgelser, røntgenoptagelser).
English: Nine hundred and twenty eight patients were randomised to receive either a single dose of pegfilgrastim or placebo approximately 24 hours (day 2) after chemotherapy in each cycle.
Danish: 928 patienter blev randomiseret til at modtage enten en enkelt dosis af pegfilgrastim eller placebo ca. 24 timer (dag 2) efter kemoterapibehandlingen i hver cyklus.
English: Neulasta has no or negligible effect on the ability to drive or use machines.
Danish: Neulasta har ingen eller kun ubetydelig virkning på evnen til at køre bil og betjene maskiner.
English: • what action to take in a suspected case of failed delivery or incomplete delivery of the dose and if symptoms of serious infection that may indicate a missed dose present.
Danish: • information om, hvad man skal gøre ved mistanke om manglende tilførsel eller ufuldstændig tilførsel af dosen, og hvad man skal gøre, hvis der er symptomer på en alvorlig infektion, som kan tyde på manglende dosering.
English: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Danish: Nedenstående tabel beskriver bivirkninger, der er indberettet fra kliniske studier og ved spontan rapportering.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body.
Danish: Dette kan være symptomer på en tilstand, der kaldes for “kapillær lækage-syndrom”, som får blodet til at lække fra de små blodkar ud i kroppen.
English: In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
Danish: I sådanne tilfælde bør behandling med pegfilgrastim afbrydes efter lægens vurdering og den rette behandling gives (se pkt.
English: If you have any problems, please ask your doctor or nurse for help and advice.
Danish: Hvis De har problemer, spørg Deres læge eller sygeplejerske om hjælp og råd.
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Danish: Granulocytkolonistimulerende faktorer kan fremme væksten af myeloide celler in vitro, og lignende effekter kan ses på visse non-myeloide celler in vitro.
English: Push all the way down through the snap.
Danish: Pres hele vejen ned gennem “klikket”.
English: Study Day
Danish: Forsøgsdag
English: 0% (empty)
Danish: 0% (tom)
English: In clinical trials, Neulasta has been safely administered 14 days before chemotherapy.
Danish: I kliniske studier er Neulasta blevet givet uden risiko 14 dage før kemoterapi.
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
Danish: Øget hæmatopoietisk aktivitet i knoglemarven som følge af vækstfaktorbehandling er forbundet med forbigående positive knogleskanningsfund.
English: Your doctor may decide that it would be more convenient for you to use Neulasta with the on-body injector.
Danish: Deres læge vil muligvis beslutte, at det er mere praktisk, hvis De bruger Neulasta sammen med on-body-injektoren.
English: G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Danish: G-CSF kan fremme vækst af myeloide celler, også maligne celler, in vitro, og lignende effekter kan ses på nogle ikke-myeloide celler in vitro.
English: B Open the tray, peeling away the cover.
Danish: B Åbn bakken og træk emballagen af.
English: It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Danish: Det er vigtigt, at De kontakter lægen med det samme, hvis De får smerter i den øverste venstre side af maven eller op mod venstre skulder, da dette kan skyldes problemer med milten.
English: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Danish: Prækliniske data fra konventionelle studier med gentaget dosistoksicitet viste de forventede farmakologiske effekter inklusive stigning i leukocyttallet, myeloid hyperplasi i knoglemarven, ekstramedullær hæmatopoiese og forstørrelse af milten.
English: Step 3: Remove your on-body injector when dose delivery is complete A After the beep, check the colour of the status light.
Danish: Trin 3: Tag injektoren af, når tilførslen af dosen er færdig A Kontrollér statuslampens farve efter biptonen.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS
English: Check to see if the status light is SOLID GREEN or has switched off.
Danish: Kontrollér, om statuslampen er HELT GRØN eller slukket.
English: StevensJohnson syndrome
Danish: StevensJohnsons syndrom
English: The on-body injector is working properly.
Danish: On-body-injektoren virker korrekt.
English: • Tell your healthcare provider if you have had severe skin reactions to acrylic adhesives.
Danish: • Fortæl det til sundhedspersonalet, hvis De før har haft alvorlige reaktioner i huden over for akrylklæbemidler.
English: * Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Danish: * Produceret i Escherichia coli-celler vha. rekombinant DNA-teknologi efterfulgt af konjugation med polyethylenglykol (PEG).
English: Do not touch the needle or push the plunger.
Danish: Rør ikke ved kanylen, og skub ikke til stemplet.
English: • damage to the tiny filters inside your kidneys (glomerulonephritis).
Danish: • beskadigelse af de bittesmå filtre i nyrerne (glomerulonefritis).
English: Call your doctor or healthcare provider if you have any questions.
Danish: Kontakt Deres læge eller sundhedspersonalet, hvis De har spørgsmål.
English: The adhesive pad is water-resistant but you are advised to avoid submerging the on-body injector in water.
Danish: Klæbepuden er vandtæt, men det tilrådes, at De undgår at nedsænke on-body-injektoren i vand.
English: Neulasta contains the active substance pegfilgrastim.
Danish: Neulasta indeholder det aktive stof pegfilgrastim.
English: Elevations in lactate dehydrogenase and alkaline phosphatase1;
Danish: Forhøjet laktatdehydrogenase og alkalisk fosfatase1
English: Check to see if your on-body injector is empty.
Danish: Kontrollér, at on-body-injektoren er tom.
English: Do not try to do this yourself, as you may accidently move it and dislodge the cannula from your skin leading to a missed or incomplete dose of Neulasta.
Danish: Forsøg ikke at gøre det selv, da De kan komme til at flytte og løsne kanylen fra huden, så dosis af Neulasta mangler eller ikke er fuldstændig.
English: • a pre-filled syringe for manual administration; or
Danish: • en fyldt injektionssprøjte til manuel administration eller
English: The on-body injector is worn for 27 hours after placement and is programmed to make sure you do not receive Neulasta any sooner than 24 hours after your chemotherapy.
Danish: On-body-injektoren bæres i 27 timer, efter den er sat på, og er programmeret til at sikre, at De ikke får Neulasta før 24 timer efter Deres kemoterapi.
English: The MAH shall ensure that in each Member State where Neulasta on-body injector is marketed, all patients/carers who are expected to use Neulasta on-body injector are provided with a patient alert card to be disseminated through the prescribing physicians.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at der i hvert medlemsland, hvor on-bodyinjektoren med Neulasta markedsføres, udleveres et patientkort, som skal distribueres gennem de ordinerende læger til alle patienter/omsorgspersoner, der forventes at anvende on-body-injektoren.
English: Leukocytosis
Danish: Leukocytose
English: • If the adhesive becomes saturated with fluid, or you see dripping, your medicine may have leaked out.
Danish: • Hvis klæbemidlet bliver gennemblødt af væske, eller man kan se, at det drypper, kan medicinen være sivet ud.
English: What you need to know before you use Neulasta
Danish: Det skal De vide, før De begynder at bruge Neulasta
English: It is important to keep the skin pinched when injecting.
Danish: Det er vigtigt, at huden også klemmes sammen under injektionen.
English: • are planning to have a baby.
Danish: • planlægger at blive gravid.
English: Then LIFT the syringe off skin.
Danish: LØFT derefter sprøjten væk fra huden.
English: • When dose delivery is complete, a long beep will sound and the status light will be solid green.
Danish: • Når tilførslen af Deres dosis er færdig, aktiveres en lang biptone, og statuslampen bliver grøn.
English: Red flashing status light
Danish: Blinkende rød statuslampe
English: • if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia).
Danish: • er klar over, at De har ændrede blodtal (for eksempel en stigning i hvide blodlegemer eller anæmi) eller fald i antallet af blodplader, hvilket reducerer blodets evne til at størkne (trombocytopeni).
English: Marketing Authorisation Holder and Manufacturer Amgen Europe B.V.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Amgen Europe B.V.
English: The least-squares geometric mean ratios (90% CIs) (on-body injector to manual injection) were 0.97 (0.83, 1.14) for Cmax and 1.00 (0.84, 1.20) for AUC0-inf within the pre-specified bioequivalence limit of 0.80 to 1.25, and established bioequivalence between the two delivery methods of a single 6 mg dose of pegfilgrastim.
Danish: De geometriske gennemsnitsforhold (90 % CI'er) (on-body-injektor til manual injection), beregnet med mindste kvadraters metode, var 0,97 (0,83; 1,14) for Cmax og 1,00 (0,84; 1,20) for AUC0-inf inden for den foruddefinerede bioækvivalensgrænse på 0,80 til 1,25 og var grundlag for, at bioækvivalens mellem de to tilførselsmetoder for en enkelt 6 mg dosis pegfilgrastim kunne konstateres.
English: Your healthcare provider will fill the on-body injector with Neulasta and then apply it directly to your skin using an adhesive pad.
Danish: Sundhedspersonalet vil fylde on-body-injektoren med Neulasta og derefter sætte den direkte på Deres hud ved hjælp af en klæbepude.
English: Do not use the pre-filled syringe if it has been dropped on a hard surface.
Danish: Brug ikke den fyldte injektionssprøjte, hvis De har tabt den på en hård overflade.
English: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Danish: Reduktion i varigheden af neutropeni og forekomsten af febril neutropeni hos voksne patienter behandlet med cytotoksisk kemoterapi for malignitet (med undtagelse af kronisk myeloid leukæmi og myelodysplastiske syndromer).
English: Important: If at any time you hear beeping, check the status light.
Danish: Vigtigt: Kontrollér altid statuslampen, hvis De hører biptonen.
English: Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Danish: Amgen NV Telecomlaan 5-7 1831 Diegem Belgien
English: pegfilgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Pegfilgrastim bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: • Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Danish: • Stevens-Johnsons syndrom, som kan vise sig som rødlige pletter, der ligner målskiver eller cirkler og ofte har blærer i midten, hudafskalning, sår i munden, svælget, næsen, øjnene eller på kønsorganerne, og som eventuelt starter med feber eller influenzalignende symptomer.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med pegfilgrastim skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Step 4: Finish A Discard the used pre-filled syringe and other supplies in a sharps disposal container.
Danish: Trin 4: Afslut A Kassér den brugte injektionssprøjte og andre materialer i en kanylebøtte.
English: On-body injector placement Important: Contact your healthcare provider immediately if you have severe pain or skin discomfort around your on-body injector.
Danish: Placering af on-body-injektoren Vigtigt: Kontakt straks Deres læge eller sundhedspersonalet, hvis De får kraftige smerter eller ubehag i huden omkring injektoren.
English: Nausea and headaches were very commonly observed in patients receiving chemotherapy.
Danish: Kvalme og hovedpine blev observeret som meget almindelige bivirkninger hos patienter, der fik kemoterapi.
English: Neulasta is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Danish: Neulasta anvendes til at reducere varigheden af neutropeni (få hvide blodlegemer) og forekomsten af febergivende neutropeni (få hvide blodlegemer og feber), der kan forårsages af anvendelsen af cytotoksisk kemoterapi (lægemiddel der ødelægger hurtigt voksende celler).
English: Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).
Danish: Pegfilgrastim påvirkede ikke reproduktionsevnen eller fertiliteten hos han- og hunrotter ved kumulative ugentlige doser, der var cirka 6-9 gange højere end den anbefalede dosis til mennesker (baseret på legemsoverfladeareal) (se pkt.
English: • the top of your thighs; and
Danish: • højt oppe på låret, og
English: Common cases of thrombocytopenia have been reported.
Danish: Der er indberettet almindelige tilfælde af trombocytopeni.
English: In an open-label, single dose study (n = 31) various stages of renal impairment, including end-stage renal disease, had no impact on the pharmacokinetics of pegfilgrastim.
Danish: I et åbent enkeltdosisforsøg (n = 31) havde forskellige stadier af nedsat nyrefunktion, herunder terminal nyresygdom, ingen virkning på pegfilgrastims farmakokinetik.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.
Danish: I det øjeblik en injektionssprøjte tages ud af køleskabet, og har nået stuetemperatur (ikke over 30 °C), skal den anvendes indenfor 3 dage eller bortskaffes.
English: • Do not use baths, hot tubs, whirlpool baths, or saunas while wearing the on-body injector.
Danish: • Tag ikke brusebad, badekar, boblebad eller sauna, mens on-body-injektoren er sat på.
English: Back of upper arm
Danish: Bagsiden af overarm
English: Pegfilgrastim has no or negligible influence on the ability to drive and use machines.
Danish: Pegfilgrastim påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: This may affect the on-body injector's performance.
Danish: Det kan påvirke injektorens funktion.
English: • cutaneous vasculitis (inflammation of the blood vessels in the skin).
Danish: • kutan vaskulitis (irritation eller betændelse i blodkarrene i huden).
English: “BEEPS”
Danish: “BIPPER”