FrancophonIA/ELRC3.0 huggingface dataset:
English: Step 4: Finish
Danish: Trin 4: Afslutning
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: • Sweets syndrom (blommefarvede, hævede, smertefulde læsioner på arme og ben og undertiden i ansigtet og på halsen, ledsaget af feber) er set, men andre faktorer kan være medvirkende.
English: • cutaneous vasculitis (inflammation of the blood vessels in the skin).
Danish: • kutan vaskulitis (betændelse i blodkarrene i huden).
English: Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Danish: Knoglesmerter var generelt af mild til moderat sværhedsgrad og forbigående, og de kunne kontrolleres med standard-analgetika hos de fleste patienter.
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40 % incidence of febrile neutropenia.
Danish: Ved fravær af støttebehandling med vækstfaktor har dette regime vist sig at resultere i en gennemsnitlig varighed af grad 4-neutropeni på 5-7 dage og i en forekomst af febril neutropeni på 30-40 %.
English: Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
Danish: Der er rapporteret om aortitis efter administration af G-CSF hos raske forsøgsdeltagere og hos cancerpatienter.
English: If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why, including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Danish: Hvis du oplever nedsat virkning, eller hvis virkningen ikke kan opretholdes, vil lægen undersøge hvorfor, herunder om du har udviklet antistoffer, som neutraliserer pegfilgrastims virkning.
English: Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Danish: Kraftig omrysten kan forårsage aggregation af pegfilgrastim, så det bliver biologisk inaktivt.
English: 100 μg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy.
Danish: 100 μg/kg pegfilgrastim efter afslutning af VAdriaC/IE-kemoterapi.
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: at du kontakter lægen med det samme, hvis du får smerter i øvre venstre side af maven eller smerter i venstre skulder, da det kan være tegn på miltproblemer.
English: Important Before you use a Grasustek pre-filled syringe with automatic needle guard, read this important information:
Danish: Inden du bruger en Grasustek fyldt injektionssprøjte med automatisk kanylesikring, skal du læse disse vigtige oplysninger:
English: You may take Grasustek out of the refrigerator and keep it at room temperature (not above 30 °C) for no longer than 3 days.
Danish: Du kan tage Grasustek ud af køleskabet og opbevare det ved rumtemperatur (ikke over 30 °C) i højst 3 dage.
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Danish: Patienter, der udvikler symptomer på kapillærlækagesyndrom, bør monitoreres nøje og have symptomatisk standardbehandling, hvilket kan omfatte intensiv behandling (se pkt.
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 kd polyethylenglycol (PEG)-molekyle.
English: • If you have sickle cell anaemia.
Danish: • hvis du har seglcelleanæmi.
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 neutrofil restitution (se figur 1).
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of GCSF.
Danish: I de fleste tilfælde blev aortitis diagnosticeret ved CT-scanning og forsvandt som regel efter seponering af G-CSF.
English: • if you experience a cough, fever and difficulty breathing.
Danish: • hvis du oplever hoste, feber og vejrtrækningsbesvær.
English: Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Danish: Det er påvist, at pegfilgrastim og filgrastim har identiske virkningsmekanismer, som forårsager en markant stigning i antallet af neutrofiler i perifert blod i løbet af 24 timer med mindre stigninger i monocytter og/eller lymfocytter.
English: Do not use the pre-filled syringe if it has been dropped on a hard surface.
Danish: Brug ikke den fyldte injektionssprøjte, hvis den er blevet tabt på en hård overflade.
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim.
Danish: Leukocyttal (WBC) på 100 x 109/l eller derover er set hos færre end 1 % af de patienter, der behandles med pegfilgrastim.
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Danish: Der er rapporteret om pulmonale bivirkninger, især interstitiel pneumoni, efter administration af G-CSF.
English: • are pregnant or breast-feeding
Danish: • er gravid eller ammer
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
Danish: Der bør udvises nøje omhu for at skelne mellem diagnoserne blasttransformation af kronisk myeloid leukæmi og AML.
English: • The grey needle cap is missing or not securely attached.
Danish: • Den grå kanylehætte mangler eller ikke sidder ordentligt fast.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Danish: *Fremstillet i Escherichia coli-celler ved rekombinant DNA-teknologi efterfulgt af konjugering med polyethylenglycol (PEG).
English: Urinalysis monitoring is recommended.
Danish: Det anbefales at udføre monitorering ved hjælp af urinanalyser.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Grasustek 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 skal ophøre eller behandling med Grasustek seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Grasustek may be exposed to room temperature (not above 30 °C) for a maximum single period of up to 72 hours.
Danish: Grasustek kan udsættes for rumtemperatur (ikke over 30 °C) i en enkeltperiode på højst 72 timer.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Grasustek.
Danish: Medmindre lægen har anvist andet, skal du stoppe med at amme, hvis du bruger Grasustek.
English: Grasustek may be used if it is accidentally frozen for a single period of less than 24 hours.
Danish: Grasustek kan anvendes, hvis det ved en fejl er blevet nedfrosset i en enkelt periode på højst 24 timer.
English: Specific interaction or metabolism studies have not been performed; however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.
Danish: Der er ikke udført specifikke interaktions- eller metabolismestudier; i kliniske forsøg er der imidlertid ikke set interaktioner mellem pegfilgrastim og andre lægemidler.
English: Grasustek 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: Grasustek anvendes til at reducere varigheden af neutropeni (lavt antal hvide blodlegemer) og forekomsten af febril neutropeni (lavt antal hvide blodlegemer med feber), som kan skyldes brug af cytotoksisk kemoterapi (lægemidler, der ødelægger hurtigt voksende celler).
English: • think you may be pregnant or
Danish: • har mistanke om, at du er gravid
English: The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.
Danish: Bivirkningerne var de samme som dem, der er set hos patienter, der har fået lavere doser af pegfilgrastim.
English: The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients.
Danish: Pegfilgrastim sikkerhed og virkning er ikke blevet undersøgt hos patienter med myelodysplastisk syndrom, kronisk myeloid leukæmi og patienter med sekundær AML; derfor bør det ikke anvendes hos sådanne patienter.
English: Call your doctor or healthcare provider if you have any questions.
Danish: Kontakt lægen eller sundhedspersonalet, hvis du har spørgsmål.
English: Your doctor may want to monitor you more closely
Danish: Lægen vil eventuelt holde dig under tættere kontrol.
English: Rates of generation of antibodies against pegfilgrastim are generally low.
Danish: Hyppigheden af dannelse af antistoffer mod pegfilgrastim er generelt lav.
English: Pinch your injection site to create a firm surface.
Danish: Klem fat om injektionsstedet for at danne en fast overflade.
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 faktor kan fremme vækst af myeloide celler in vitro, og der kan eventuelt ses lignende virkninger på visse non-myeloide celler in vitro.
English: Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Danish: Behandlingen med pegfilgrastim bør iværksættes og overvåges af læger med erfaring i onkologi og/eller hæmatologi.
English: • Belly, except for a 5 cm (2-inch) area right around your belly button.
Danish: • Maven, undtagen i en omkreds på ca. 5 cm omkring navlen.
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 af toksicitet efter gentagne doser viste de forventede farmakologiske virkninger, herunder øgede leukocyttal, myeloid hyperplasi i knoglemarven, ekstramedullær hæmatopoiese og miltforstørrelse.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Danish: Ligesom andre hæmatopoietiske vækstfaktorer har G-CSF udvist stimulerende egenskaber på humane endotelceller in vitro.
English: The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Danish: Sikkerheden og virkningen af pegfilgrastim til mobilisering af blodprogenitorceller hos patienter eller raske donorer er ikke blevet tilstrækkeligt evalueret.
English: Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia.
Danish: Der bør udvises særlig forsigtighed ved administration af kemoterapeutiske mono- eller kombinationspræparater, som vides at forårsage svær trombocytopeni.
English: 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: Tag bakken med den fyldte injektionssprøjte ud af pakningen, og find de ting, du skal bruge til injektionen, frem: alkoholservietter, en vatkugle eller et gazestykke, et plaster og en kanylebeholder (medfølger ikke).
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, herunder maligne celler, in vitro, og lignende virkninger kan eventuelt ses på visse non-myeloide celler in vitro.
English: The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Danish: Eliminationen af pegfilgrastim er nonlineær med hensyn til dosis; pegfilgrastims serum-clearance falder i takt med, at dosis øges.
English: Grasustek 6 mg pegfilgrastim SC
Danish: Grasustek 6 mg pegfilgrastim s.c.
English: Thrombocytopenia Leukocytosis1
Danish: Trombocytopeni1 Leukocytose1
English: Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance.
Danish: Pegfilgrastim er en form af filgrastim med langvarig virkning på grund af nedsat renal clearance.
English: Warning/Precaution: If the guard is not activated or only partially activated, discard the syringe without replacing the needle cover.
Danish: Advarsel/forsigtighedsregel: Hvis sikringen ikke bliver aktiveret, eller hvis den kun bliver delvist aktiveret, skal du bortskaffe sprøjten uden at sætte kanylehætten på.
English: Your doctor will check your blood and urine regularly as Grasustek can harm the tiny filters inside your kidneys (glomerulonephritis).
Danish: Lægen vil tage regelmæssige blod- og urinprøver, da Grasustek kan forårsage skade på de bittesmå filtre i nyrerne (glomerulonefritis).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following cytotoxic chemotherapy.
Danish: Reversible, milde til moderate stigninger i urinsyre og basisk fosfatase uden tilknyttede kliniske virkninger var ikke almindelige; reversible, milde til moderate stigninger i laktatdehydrogenase uden tilknyttede kliniske virkninger var ikke almindelige hos patienter, der fik pegfilgrastim efter cytotoksisk kemoterapi.
English: • Any part appears cracked or broken.
Danish: • En eller flere dele er revnede eller itu.
English: -Release the plunger until the needle is covered and then remove the syringe from the injection site
Danish: -Slip stemplet, indtil kanylen er dækket, og fjern så sprøjten fra injektionsstedet.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
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 pegfilgrastim seponeres efter lægens skøn, og der bør gives passende behandling (se pkt.
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: Indtræden af pulmonale tegn såsom hoste, feber og dyspnø ledsaget af radiologiske tegn på lungeinfiltrater samt forværring af lungefunktionen ledsaget af øget neutrofiltal kan være præliminære tegn på akut lungesvigt (ARDS).
English: Dispose of the used medicine immediately in a Sharps container or as instructed by your healthcare provider.
Danish: Bortskaf omgående den brugte medicin i en kanylebeholder, eller som anvist af lægen eller sundhedspersonalet.
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
Danish: Det kan være tegn på akut lungesvigt (ARDS).
English: Pegfilgrastim appears to be mainly eliminated by neutrophil mediated clearance, which becomes saturated at higher doses.
Danish: Pegfilgrastim elimineres tilsyneladende via neutrofilmedieret clearance, som mættes ved højere doser.
English: Pegfilgrastim should be permanently discontinued in patients with clinically significant hypersensitivity.
Danish: Pegfilgrastim bør seponeres permanent hos patienter med klinisk signifikant overfølsomhed.
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 respons på vækstfaktorbehandling har været forbundet med forbigående positive fund i forbindelse med billeddiagnostik af knoglerne.
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 de hurtigt delende myeloide cellers potentielle følsomhed over for cytotoksisk kemoterapi bør pegfilgrastim administreres mindst 24 timer efter administration af cytotoksisk kemoterapi.
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Danish: Der er ikke foretaget specifikke undersøgelser af potentielle interaktioner med lithium, som også fremmer frigivelsen af neutrofiler.
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 trombocytopeni og anæmi, idet den myelosuppressive kemoterapi i fuld dosis fastholdes i henhold til den ordinerede plan.
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 af varigheden af neutropeni og forekomsten af febril neutropeni hos voksne patienter i behandling med cytotoksisk kemoterapi for malignitet (med undtagelse af kronisk myeloid leukæmi og myelodysplastisk syndrom).
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og etiketten på sprøjten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Do not use this medicine if you notice it is cloudy or there are particles in it.
Danish: Brug ikke lægemidlet, hvis opløsningen er uklar eller indeholder partikler.
English: Avoid injecting into areas with scars or stretch marks.
Danish: Undgå områdermed ar eller strækmærker.
English: In case of doubt DO NOT open this pack and take another pack instead.
Danish: Hvis du er i tvivl, skal du IKKE åbne pakken.
English: Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy.
Danish: På baggrund af de kliniske virkninger og risikoen for leukocytose bør der gennemføres regelmæssige leukocyttællinger under behandlingen.
English: Syringe after administration (Guard is released and covers the needle)
Danish: Injektionssprøjte efter administration (Sikringen er blevet aktiveret og dækker kanylen)
English: What Grasustek contains
Danish: Grasustek indeholder:
English: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Danish: Illustration af median serumkoncentration af pegfilgrastim og mediant absolut neutrofiltal (ANC) hos patienter i kemoterapi efter en enkelt 6 mg-injektion
English: Open the blister by peeling back the top layer all the way off the blister as shown.
Danish: Åbn blisterpakningen ved at trække det øverste lag helt af blisterpakningen, som vist.
English: Nausea and headaches were very commonly observed in patients receiving chemotherapy.
Danish: Kvalme og hovedpine blev observeret med hyppigheden meget almindelig hos patienter, der fik kemoterapi.
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 en enkeltdosis pegfilgrastim eller placebo cirka 24 timer (dag 2) efter kemoterapi i hver cyklus.
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 set nogen bivirkninger hos afkommet fra drægtige rotter, som fik pegfilgrastim subkutant, men hos kaniner forårsagede pegfilgrastim embryo-/føtotoksicitet (embryotab) ved kumulative doser, der var cirka 4 gange højere end den anbefalede dosis til mennesker, men ikke når de drægtige kaniner blev eksponeret for den anbefalede dosis til mennesker.
English: OTHER Juta Pharma GmbH
Danish: ANDET Juta Pharma GmbH
English: Other medicines and Grasustek Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Grasustek Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Pull the needle cover straight off as shown, and handle the guard to avoid injuries or bending the needle.
Danish: Træk kanylehætten ret af, som vist, og håndter sprøjten ved sikringen for at undgå skader eller bøjning af kanylen.
English: It is important to keep the skin pinched when injecting.
Danish: Det er vigtigt, at du bliver ved at klemme fat om huden under injektionen.
English: Do not leave the pre-filled syringe exposed to direct sunlight.
Danish: Efterlad ikke den fyldte sprøjte i direkte sollys.
English: • bleeding from the lung (pulmonary haemorrhage)
Danish: • blødning fra lungerne (pulmonal hæmoragi)
English: These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body (see section 4).
Danish: Det kan være symptomer på en tilstand, der kaldes for ”kapillærlækagesyndrom”, hvor blodet siver ud af de små blodkar og ud i kroppen (se punkt 4).
English: Sodium acetate * Sorbitol (E420) Polysorbate 20
Danish: Natriumacetat * Sorbitol (E420) Polysorbat 20
English: Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see section 4.4).
Danish: Alvorlige allergiske reaktioner, herunder anafylaksi, kan forekomme hos patienter, der får pegfilgrastim (ikke almindelig) (se pkt.
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 (kan forekomme hos op til 1 ud af 100 behandlede) tilstand, der kaldes for ”kapillærlækagesyndrom”, hvor blodet siver ud af de små blodkar og ud i kroppen, hvilket kræver omgående lægebehandling.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis på 6 mg, dvs. det er i det væsentlige natrium-frit.