FrancophonIA/ELRC3.0 huggingface dataset:
English: You will need to give yourself the injection into the tissue just under the skin.
Danish: De skal foretage indsprøjtningen i vævet lige under huden.
English: B Carefully pull the grey needle cap straight out and away from your body.
Danish: B Træk forsigtigt den grå kanylehætte af i en lige bevægelse væk fra kroppen.
English: Disposing of used syringes
Danish: Bortskaffelse af brugte sprøjter
English: • if you experience a cough, fever and difficulty breathing.
Danish: • får hoste, feber og åndedrætsbesvær.
English: The on-body injector delivers your Neulasta dose with an under-the-skin (subcutaneous) injection.
Danish: On-body-injektoren leverer Deres Neulasta-dosis med en injektion under huden (subkutant).
English: The mechanism of vasculitis in patients receiving pegfilgrastim is unknown.
Danish: Mekanismen bag vasculitis hos patienter, der får pegfilgrastim, kendes ikke.
English: • Belly, except for a 5 cm (2-inch) area right around your belly button.
Danish: • maven, bortset fra et område på 5 cm omkring navlen
English: • The used syringe should be disposed of in accordance with local requirements.
Danish: • Bortskaf den brugte sprøjte i overensstemmelse med de lokale bestemmelser.
English:  Status light is solid green or the status light has switched off.
Danish:  Statuslampen er helt grøn, eller statuslampen er slukket.
English: It contains important advice on how to monitor your device for medication errors including under dose leading to lack of effect, and when to seek immediate medical attention.
Danish: Kortet indeholder vigtig information om, hvordan man kontrollerer injektoren for medicineringsfejl, for eksempel for lille dosering, som kan medføre manglende virkning, samt information om, hvornår man straks skal søge læge.
English: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Danish: Efter en enkelt subkutan dosis af pegfilgrastim forekommer den maksimale serumkoncentration af pegfilgrastim 16 til 120 timer efter dosering, og serumkoncentrationer af pegfilgrastim opretholdes gennem perioden med neutropeni efter myelosuppressiv kemoterapi.
English: If the status light is flashing green, it is ok.
Danish: Hvis statuslampen blinker grønt, er alt i orden.
English: Injecting the solution with the air bubble is harmless.
Danish: Det er ikke farligt at indsprøjte opløsningen med luftboblen.
English: B Grab the edge of the adhesive pad.
Danish: B Tag fat i kanten af klæbepuden.
English: • if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing these could be signs of a severe allergic reaction.
Danish: • hvis De pludselig får symptomer på allergi, for eksempel udslæt, kløe eller nældefeber på huden, hævelse i ansigt, læber, tunge eller andre dele af kroppen, stakåndethed, hvæsende vejrtrækning eller vejrtrækningsbesvær, kan det være tegn på en alvorlig allergisk reaktion.
English: The healthcare professional must ensure the patient receives appropriate training about the on-body injector and understands that if they suspect a device failure or malfunction the patient must immediately inform a healthcare professional as they may need a replacement dose.
Danish: Sundhedsmedarbejderen skal sikre, at patienten får relevant undervisning i anvendelse af on-body-injektoren og forstår, at en sundhedsmedarbejder straks skal informeres, hvis der er mistanke om fejl eller defekter ved injektoren, da der kan være behov for en erstatningsdosis.
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1,000 to < 1/100]).
Danish: Overfølsomhedslignende reaktioner, herunder hududslæt, urticaria, angioødem, åndenød, erytem, flushing og hypotension, optrådte initialt og under vedligeholdelsesbehandling med pegfilgrastim (ikke almindelig [≥ 1/1.000 til < 1/100]).
English: You may take Neulasta out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days.
Danish: De må tage Neulasta ud af køleskabet og opbevare det ved stuetemperatur (ikke over 30 °C) i højst 3 dage.
English: There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Danish: Der blev ikke observeret nogen negative virkninger hos afkommet fra drægtige rotter, som har fået pegfilgrastim subkutant, men hos kaniner er pegfilgrastim vist at medføre embryo/føtal toksicitet (tab af embryo) ved kumulative doser, der var cirka 4 gange højere end den anbefalede dosis til mennesker.
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with pegfilgrastim.
Danish: Der er rapporteret overfølsomhed, herunder anafylaktiske reaktioner, der er opstået ved den første eller efterfølgende behandlinger hos patienter, der blev behandlet med pegfilgrastim.
English: See also section 2.
Danish: Se også afsnit 2.
English: • Do not put the cap back on used needles.
Danish: • Sæt ikke nålehætten tilbage på brugte kanyler.
English: It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist.
Danish: Det er vigtigt, at De ikke forsøger at give Dem selv indsprøjtningen, med mindre De har modtaget speciel undervisning fra Deres læge eller sygeplejerske eller fra apoteket.
English: Three reported cases show a causal relationship between the adverse drug reaction (ADR) StevensJohnson syndrome and pegfilgrastim.
Danish: Tre indberettede tilfælde viser en kausal sammenhæng mellem bivirkningen Stevens-Johnsons syndrom og pegfilgrastim.
English: The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.
Danish: Sikkerhed og effekt af Neulasta er ikke blevet vurderet hos patienter, der modtager kemoterapi forbundet med forsinket myelosuppression for eksempel nitrosourea.
English: Do not use the pre-filled syringe if:
Danish: Brug ikke den fyldte injektionssprøjte, hvis:
English: On-body injector, the fluid path is made from polypropylene, cyclic olefin copolymer, silicone rubber and fluorinated ethylene propylene (FEP), with a stainless steel 28 gauge needle.
Danish: På on-body-injektoren er væskebanen fremstillet af polypropylen, cyclisk olefin-copolymer, silikonegummi og fluorineret ethylenpropylen (FEP), og den har en 28 gauge kanyle af rustfrit stål.
English: Permanently discontinue pegfilgrastim in patients with clinically significant hypersensitivity.
Danish: Pegfilgrastim skal seponeres permanent hos patienter med klinisk signifikant overfølsomhed.
English: Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
Danish: Rottestudier viste, at reproduktionsevne, fertilitet, brunstcyklus, dage mellem pardannelse og coitus samt intrauterin overlevelse var upåvirket af pegfilgrastim, der blev indgivet subkutant.
English: • The grey needle cap is missing or not securely attached.
Danish: • Den grå kanylehætte mangler eller ikke er sat ordentligt på.
English: Prepare and clean your injection site.
Danish: Klargør og afrens injektionsstedet.
English: The on-body injector contains three silver oxide batteries and includes an adhesive patch made from non-woven polyester tape single coated with a polyacrylate adhesive.
Danish: On-body-injektoren indeholder tre sølvoxidbatterier og en klæbepude, der er fremstillet af uvævet polyesterbånd, belagt med et enkelt lag klæbemiddel af polyakrylat.
English: The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy.
Danish: Pegfilgrastims sikkerhed og virkning er ikke blevet undersøgt hos patienter i behandling med højdosis kemoterapi.
English: A Record the end status of your on-body injector.
Danish: A Registrér on-body-injektorens slutstatus.
English: • pain at the site of injection.
Danish: • smerte ved injektionsstedet.
English: A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Danish: A Tag bakken med den fyldte injektionssprøjte ud af pakningen og saml de ting sammen, der skal bruges til injektionen: afspritningsservietter, vat eller gazekompresser, plaster og en kanylebøtte (følger ikke med).
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Danish: For at gøre indsprøjtningen mere behagelig kan De lade den fyldte injektionssprøjte ligge i 30 minutter og lade den få stuetemperatur, eller De kan holde den fyldte injektionssprøjte forsigtigt i Deres hånd i et par minutter.
English: To give yourself a subcutaneous injection you will need:
Danish: For at foretage en subkutan indsprøjtning skal De bruge:
English: Comprehensive instructions for use for healthcare professionals and patients are given in the package leaflet.
Danish: Indlægssedlen indeholder omfattender instruktioner til anvendelsen for sundhedsmedarbejdere og patienter.
English: Your doctor may decide that it would be more convenient for you to inject Neulasta yourself.
Danish: Deres læge kan beslutte, at det vil være praktisk for Dem, hvis De selv indsprøjter Neulasta.
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy.
Danish: På grund af den potentielle sensivitet af hurtigt delende myeloide celler overfor cytotoksisk kemoterapi bør pegfilgrastim administreres mindst 24 timer efter cytotoksisk kemoterapi.
English: Pinch (without squeezing) the skin using your thumb and forefinger.
Danish: Tag fast i huden (uden at klemme) med tommeltot og pegefinger.
English: Important: read the package leaflet before handling pre-filled syringe.
Danish: Vigtigt: Læs indlægssedlen inden håndtering af den fyldte injektionssprøjte.
English: • a pre-filled syringe with on-body injector for automatic administration.
Danish: • en fyldt injektionssprøjte med on-body-injektor til automatisk administration.
English: What to do if the on-body injector adhesive becomes noticeably wet (saturated) with fluid, or you see dripping.
Danish: Det skal man gøre, hvis on-body-injektorens klæbemiddel bliver synligt vådt (gennemblødt) eller drypper.
English: General disorders and administrative site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: Common (≥ 1/100 to < 1/10)
Danish: Almindelig (≥ 1/100 til
English: Uncommon elevations in liver function tests (LFTs) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Danish: Ikke almindelige tilfælde af forhøjet alanin-aminotransferase (ALAT) eller aspartat-aminotransferase (ASAT) er observeret hos patienter, der var i behandling med pegfilgrastim efter cytotoksisk kemoterapi.
English: How do I prepare my Neulasta injection?
Danish: Hvordan forbereder jeg min Neulasta-indsprøjtning?
English: A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Danish: Diagnosen miltruptur bør overvejes hos patienter, som rapporterer smerter i den øvre venstre side af abdomen eller i nederste del af skulderbladet.
English: Healthcare providers only The trade name of the administered product should be clearly recorded in the patient file.
Danish: Kun for læger og sundhedspersonale Handelsnavnet på det administrerede præparat skal registreres tydeligt i patientjournalen.
English: For subcutaneous use.
Danish: Subkutan anvendelse.
English: *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Danish: *Natriumacetat er dannet ved titrering af koncentret eddikesyre med natriumhydroxid.
English: Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1).
Danish: Begrænsede kliniske data indikerer en lignende indvirkning på helbredelsestiden for alvorlig neutropeni for pegfilgrastim til filgrastim hos patienter med de novo akut myeloid leukæmi (AML) (se pkt.
English: Only a solution that is clear and colourless should be injected.
Danish: Kun en væske, der er klar og farveløs, bør injiceres.
English: Contact dermatitis and local skin reactions such as rash, pruritus, and urticaria have been reported with the use of the on-body injector, possibly indicating a hypersensitivity reaction to the adhesive.
Danish: Der er rapporteret kontaktdermatitis og lokale hudreaktioner såsom udslæt, pruritus og urticaria efter anvendelse af on-body-injektoren, hvilket kan tyde på en overfølsomhedsreaktion på klæbemidlet.
English: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Danish: Der er indberettet kapillærlækage-syndrom efter indgift af granulocytkolonistimulerende faktor, kendetegnet ved hypotension, hypoalbuminæmi, ødem og hæmokoncentration.
English: The overall rate of febrile neutropenia was 9% of patients treated with pegfilgrastim and 18% of patients treated with filgrastim (difference 9%, 95% CI of -16.8%, -1.1%).
Danish: Den samlede forekomst af febril neutropeni var 9% af patienterne behandlet med pegfilgrastim og 18% af patienterne behandlet med filgrastim (forskel på 9%, 95% CI -16,8%; -1,1%).
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemidler samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Danish: Debut af pulmonale symptomer, så som hoste, feber og dyspnø i forbindelse med radiologiske fund af lungeinfiltrater og nedsat lungefunktion sammen med et forhøjet neutrofiltal, kan være begyndende tegn på Acute Respiratory Distress Syndrome (ARDS, shocklunge).
English: Do not use it if the date has passed the last day of the month shown.
Danish: Brug ikke sprøjten, hvis den sidste dag i den påtrykte måned er passeret.
English: The Neulasta pre-filled syringe for manual administration must not be used with the on-body injector.
Danish: Den fyldte injektionssprøjte med Neulasta til manuel administration må ikke bruges sammen med on-body-injektoren.
English: • Inflammation of aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Danish: • Der er indberettet sjældne tilfælde af betændelse i aorta (den store pulsåre, der transporterer blodet fra hjertet ud i kroppen) hos kræftpatienter og raske donorer.
English: You do not have to remove the air bubble before injecting.
Danish: De behøver ikke fjerne luftboblen inden indsprøjtningen.
English: The on-body injector will flash a fast green light.
Danish: On-body-injektoren blinker hurtigt med grønt lys.
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 mcg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy.
Danish: Farmakokinetikken for pegfilgrastim blev undersøgt hos 37 pædiatriske patienter med sarkom, som fik 100 mikrog pegfilgrastim/kg efter VAdriaC/IE-kemoterapi.
English: 9/L) have been reported (see section 4.4).
Danish: 9/l) (almindelig) (se pkt.
English: Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Danish: Fremstiller Amgen NV Telecomlaan 5-7 1831 Diegem Belgien
English: The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers.
Danish: Symptomerne kan omfatte feber, mavesmerter, utilpashed, rygsmerter og øgede betændelsesmarkører.
English: • serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
Danish: • alvorlige allergiske reaktioner, herunder anafylaksi (svaghed, blodtryksfald, åndedrætsbesvær,
English: Push the plunger all the way down as far as it will go to inject all the liquid.
Danish: Tryk stemplet helt i bund for at injicere al væsken.
English: What to do if you hear beeping or when you look at the status light and it is flashing red.
Danish: Det skal man gøre, hvis man hører biplyden, eller statuslampen blinker rødt.
English: C Inspect the medicine and pre-filled syringe.
Danish: C Kontrollér medicinen og den fyldte injektionssprøjte.
English: If the status light is solid green or it has switched off, it is ok.
Danish: Hvis statuslampen er helt grøn, eller den er slukket, er alt i orden.
English: • Avoid knocking or pulling the on-body injector.
Danish: • Undgå at banke på eller trække i on-body-injektoren.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Danish: Glomerulonefritis svandt generelt efter dosisreduktion eller seponering af filgrastim og pegfilgrastim.
English: Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see section 4.4).
Danish: Der kan opstå alvorlige allergiske reaktioner, herunder anafylaksi, hos patienter, der får pegfilgrastim (ikke almindelig) (se pkt.
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Danish: Der er indberettet glomerulonefritis hos patienter, der fik filgrastim og pegfilgrastim.
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8).
Danish: Generelt asymptomatiske tilfælde af splenomegali og tilfælde af miltruptur, herunder enkelte dødelige, er blevet rapporteret efter indgivelse af pegfilgrastim (se pkt.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: What if there is blood at my application site after the on-body injector has been removed?
Danish: Det skal man gøre, hvis der er blod på påsætningsstedet, når on-body-injektoren er taget af.
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg·hr/mL and 29.3 ± 23.2 mcg·hr/mL, respectively) (see section 5.1).
Danish: Den yngste aldersgruppe (0-5 år) havde en højere middeleksponering for pegfilgrastim (AUC) (± standarddeviation) (47,9 ± 22,5 mikrog·t/ml) end ældre børn i alderen 6-11 år og 12-21 år (henholdsvis 22,0 ± 13,1 mikrog·t/ml og 29,3 ± 23,2 mikrog·t/ml) (se pkt.
English: Solution for injection (injection).
Danish: Injektionsvæske, opløsning (injektion).
English: This may be a sign of a problem with your spleen (splenomegaly).
Danish: Det kan være tegn på problemer med milten (forstørret milt).
English: 9/L after the expected nadir, this medicine should be discontinued immediately.
Danish: 9/l efter det forventede nadir.
English: • how to monitor the on-body injector
Danish: • information om, hvordan on-body-injektoren kontrolleres
English: The syringe for use with the on-body injector must either be used within 36 hours after it has reached room temperature (not above 30°C) or disposed of.
Danish: Injektionssprøjten, der skal bruges sammen med on-body-injektoren, skal enten bruges inden for 36 timer, efter den har opnået stuetemperatur (maksimalt 30 °C), eller bortskaffes.
English: The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.
Danish: Bivirkningerne svarede til bivirkningerne hos forsøgsdeltagere, der fik lavere doser af pegfilgrastim.
English: Glomerulonephritis
Danish: Glomerulonefritis
English: In a phase I (n = 253) randomised, single dose, parallel-group study conducted in healthy subjects the exposure (mean serum concentration-time profiles) of pegfilgrastim delivered by manual injection and by the on-body injector were comparable.
Danish: I et randomiseret fase I enkeltdosisstudie (n = 253) med parallelgrupper, der blev gennemført med raske deltagere, var eksponeringen (de gennemsnitlige serumkoncentration-tid profiler) for pegfilgrastim, tilført ved manual injektion og med on-body-injektoren, sammenlignelige.
English: • if you have an allergy to latex.
Danish: • er allergisk over for latex.
English: • Do not expose the on-body injector to direct sunlight.
Danish: • On-body-injektoren må ikke udsættes for direkte sollys.
English: “SNAP”
Danish: “KLIK”
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. c-reactive protein and white blood cell count).
Danish: Symptomerne omfattede feber, mavesmerter, utilpashed, rygsmerter og øgede inflammationsmarkører (f.eks. øget C-reaktivt protein og øget antal hvide blodlegemer).
English: Sodium acetate* Sorbitol (E420) Polysorbate 20
Danish: Natriumacetat* Sorbitol (E420) Polysorbat 20
English: Other medicines and Neulasta
Danish: Brug af anden medicin sammen med Neulasta
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/m every 3 weeks for
Danish: I et placebokontrolleret dobbeltblindet studie hos patienter med brystkræft blev virkningen af pegfilgrastim på incidensen af febril neutropeni evalueret efter administration af et kemoterapiprogram, som er forbundet med en incidens af febril neutropeni på 10-20% (100 mg/m docetaxel hver 3. uge i 4 cykler).
English: Remove from the refrigerator.
Danish: Tag den fyldte injektionssprøjte ud af køleskabet.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Danish: Det kan være symptomer på en ikke almindelig tilstand (kan ramme op til 1 ud af 100 personer), der kaldes for “kapillærlækage-syndrom”, som medfører, at der siver blod fra de små blodkar ud i kroppen.
English: The co-packed pre-filled syringe contains additional solution to compensate for residual liquid retained in the on-body injector after delivery.
Danish: Den medfølgende injektionssprøjte indeholder ekstra opløsning, der skal kompensere for restvæske i on-body-injektoren efter tilførsel.