FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Danish: Hvis du er i tvivl om, hvordan du skal foretage indsprøjtningen, eller hvis du har spørgsmål, skal du bede lægen eller sygeplejersken om hjælp.
English: • pain and swelling of the joints, similar to gout (pseudogout)
Danish: • Smerter og hævelse af led, der minder om gigt (pseudopodagra)
English: Please tell your doctor before starting treatment if you have: - sickle cell anaemia, as Nivestim may cause sickle cell crisis.
Danish: Fortæl det til lægen, inden du starter på behandlingen, hvis du har: seglcelleanæmi, da Nivestim kan forårsage seglcellekrise osteoporose (knoglesygdom).
English: Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
Danish: Leukaferese bør ikke udføres hos donorer, der er i antikoagulansbehandling, eller som har andre kendte hæmostatiske defekter.
English: Clearance of filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous and intravenous administration.
Danish: Det er vist, at filgrastims clearance følger første ordens farmakokinetik efter både subkutan og intravenøs indgift.
English: Pulmonary adverse effects
Danish: Pulmonale bivirkninger
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Danish: Der er set forbigående cytogenetiske abnormaliteterhos raske donorer efter brug af G-CSF.
English: What you need to know before you use Nivestim
Danish: Det skal du vide, før du begynder at bruge Nivestim
English: • increase in white blood cells (leucocytosis)
Danish: • Stigning i antallet af hvide blodlegemer (lekocytose)
English: • unusual hair loss or thinning (alopecia)
Danish: • Usædvanligt hårtab eller udtynding af håret (alopeci)
English: You will normally receive your first dose of Nivestim at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.
Danish: Du vil normalt få din første dosis Nivestim mindst 24 timer efter kemoterapi og mindst 24 timer efter knogletransplantationen.
English: Other special precautions
Danish: Andre særlige forsigtighedsregler
English: cells/kg recipient bodyweight.
Danish: + celler/kg af modtagerens legemsvægt.
English: Nivestim stimulates the bone marrow to produce new white cells quickly.
Danish: Nivestim stimulerer knoglemarven til at producere nye, hvide blodlegemer hurtigt.
English: If required, Nivestim may be diluted in 5% glucose solution.
Danish: Nivestim kan om nødvendigt fortyndes med en 5 % glucoseopløsning.
English: Established cytotoxic chemotherapy
Danish: Etableret cytotoksisk kemoterapi
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus
Danish: • Ømhed og hævelse i mave-tarm-kanalens indvendige lag, som går fra munden til anus
English: Nivestim should not be diluted with sodium chloride solutions.
Danish: Nivestim skal ikke fortyndes med natriumchloridopløsninger.
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported after granulocyte colony-stimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Danish: Der er indberettet kapillær lækage-syndrom, som kan være livstruende, hvis behandling forsinkes, efter indgift af granulocyt-kolonistimulerende faktor, og dette er kendetegnet ved hypotension, hypoalbuminæmi, ødem og hæmokoncentration.
English: Osteoporosis
Danish: Osteoporose
English: Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in absolute neutrophil counts in peripheral blood and a reduction of infection and related events.
Danish: Anvendelse af filgrastim til patienter, børn eller voksne, med SCN (svær medfødt, cyklisk og idiopatisk neutropeni) inducerer en vedvarende øgning af det absolutte neutrofiltal i perifert blod og en reduktion i antallet af infektioner og relaterede episoder.
English: Nivestim may have a minor influence on your ability to drive and use machines.
Danish: Nivestim kan i mindre grad påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: • allergic reaction (hypersensitivity)
Danish: • Allergisk reaktion (overfølsomhed)
English: • plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever
Danish: • Blommefarvede, hævede, smertefulde sår på ben og arme og nogle gange i ansigtet eller på halsen, med feber (Sweets syndrom)
English: Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/or other myelosuppressive medication.
Danish: Brug af filgrastim til HIV inficerede patienter fastholder et normalt antal neutrofile granulocytter og tillader dermed at give den planlagte dosis af antiviral og/eller anden myelosuppressiv medicin.
English: Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool, and may adversely affect progenitor mobilisation.
Danish: Nogle cytostatika er særligt toksiske overfor den hæmatopoietiske progenitorpool, og kan have en negativ effekt på mobilisering af progenitorceller.
English: Nivestim may have a minor influence on the ability to drive and use machines.
Danish: Nivestim kan i mindre grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Transformation to leukaemia or myelodysplastic syndrome
Danish: Transformation til leukæmi eller myelodysplastisk syndrom
English: Special caution should be used when treating patients with high dose chemotherapy, because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic, and dermatologic effects (please refer to the prescribing information of the specific chemotherapy agents used).
Danish: Der skal iagttages særlig forsigtighed, når patienterne behandles med højdosis kemoterapi, fordi der ikke er dokumenteret forbedret tumorrespons og fordi højere doser af kemoterapeutiske stoffer kan medføre forøget toksicitet, herunder kardiale, pulmonale, neurologiske og dermatologiske effekter (der henvises til produktresumeerne for de enkelte kemoterapeutika).
English: Depress the plunger while grasping the finger flange until the entire dose has been given.
Danish: Tryk stemplet ned, mens du holder fast i sprøjten med fingrene, indtil hele dosis er givet.
English: The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MU (5 µg)/kg/day from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Danish: Den anbefalede filgrastimdosis til PBPC-mobilisering efter myelosuppressiv kemoterapi er 0,5 ME (5 µg)/kg/dag fra den første dag efter afsluttet kemoterapi, og indtil tidspunktet for det forventede nadir er passeret og neutrofiltallet er indenfor referenceintervallet.
English: Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Danish: Neutropeni kan skyldes opportunistiske infektioner i knoglemarven som f.eks. Mycobakterium avium kompleks eller maligne sygdomme som f.eks. lymfomer.
English: Sweets syndrome (acute febrile neutrophilic dermatosis)
Danish: Kutan vaskulitis Sweets syndrom (akut febril neutrofil dermatose)
English: Leucocytosis
Danish: Leukocytose
English: Inflammation of the 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 blod fra hjertet ud i kroppen) hos kræftpatienter og raske donorer.
English: Myelodysplastic syndrome or Chronic myeloid leukaemia
Danish: Myelodysplastisk syndrom eller kronisk myleoid leukæmi
English: • redness of the skin (erythema)
Danish: • Rødmen i huden (erytem)
English: Studies of filgrastim in patients with severe impairment of renal or hepatic function demonstrate that it exhibits a similar pharmacokinetic and pharmacodynamic profile to that seen in normal individuals.
Danish: Studier med filgrastim hos patienter med svær nedsat nyre- eller leverfunktion har vist, at filgrastim har en farmakokinetisk og farmakodynamisk profil, som ligner den, man ser hos normale personer.
English: A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal or shoulder tip pain.
Danish: Diagnosen miltruptur bør overvejes hos donorer og/eller patienter, som klager over smerter i øvre venstre side af abdomen eller smerter yderst på skulderen.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Bivirkningerne er anført inden for hver hyppighedsgruppering efter faldende alvorlighedsgrad.
English: Recipients of allogeneic PBPCs mobilised with filgrastim experienced significantly more rapid haematological recovery, leading to a significant decrease in time to unsupported platelet recovery when compared with allogeneic bone marrow transplantation.
Danish: Modtagere af allogene PBPC'er, som er mobiliseret med filgrastim, fik en signifikant hurtigere hæmatologisk restitution, som medførte et signifikant fald i tiden til ikke-understøttet trombocytrestitution sammenlignet med allogen knoglemarvstransplantation.
English: Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim.
Danish: Der er indberettet tilfælde af splenomegali og miltruptur efter administration af filgrastim.
English: Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in G-CSF treatment and haematology and has the necessary diagnostic facilities.
Danish: Der må kun gives behandling med filgrastim i samarbejde med et onkologisk center, som har erfaring med behandling med G-CSF, og som også har hæmatologisk erfaring.
English: Reversal of neutropenia or maintaining normal neutrophil counts: filgrastim should be given by subcutaneous injection.
Danish: Behandling af neutropeni eller opretholdelse af normale neutrofiltal: Filgrastim skal gives som subkutan injektion.
English: Chronic GvHD
Danish: Kronisk GvHD
English: • low red blood cell count (anaemia)
Danish: • Lavt antal røde blodlegemer (anæmi)
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by transplantation.
Danish: Der er indimellem indberettet vasculære sygdomme, inklusive veno-okklusiv sygdom og forstyrrelser i væskevolumen, hos patienter, der får højdosis kemoterapi efterfulgt af transplantation.
English: The duration of fever was not reduced in patients undergoing myeloablative therapy followed by bone marrow transplantation.
Danish: Varigheden af feber blev ikke reduceret hos patienter, der gennemgik myeloablativ terapi efterfulgt af knoglemarvstransplantation.
English: - if you have any of the following or combination of the following side effects: o swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Danish: - hvis du får en af de følgende eller kombination af følgende bivirkninger: o hævelse eller oppustethed, som kan være forbundet med mindre hyppig vandladning, vejrtrækningsbesvær, oppustethed i maven og følelse af mæthed, og en overordnet følelse af træthed.
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6).
Danish: Filgrastim kan gives som en daglig, subkutan injektion eller som en daglig, intravenøs infusion fortyndet i 5 % glucose-opløsning givet over 30 minutter (se pkt.
English: Reduce to 0.5 MU (5 µg)/kg/day
Danish: Reducer dosis til 0,5 ME (5 µg)/kg/dag
English: Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Danish: Trombocyttallet bør monitoreres nøje, især i de første få ugers behandlingen med filgrastim.
English: Discontinuation of filgrastim therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to normal levels in 1 to 7 days.
Danish: Afbrydelse af behandlingen med filgrastim resulterer normalt i et fald på 50 % i antallet af cirkulerende neutrofile granulocytter indenfor 1-2 dage med tilbagevenden til normalt niveau i løbet af 1-7 dage.
English: Filgrastim is not indicated for use in these conditions.
Danish: Filgrastim er ikke indiceret til disse sygdomme.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Danish: Generelt forsvinder glomerulonefritis efter dosisnedsættelse eller seponering af filgrastim og pegfilgrastim.
English: • high blood pressure (hypertension)
Danish: • Højt blodtryk (hypertension)
English: Dose reductions of filgrastim have been noted to slow or stop the progression of splenic enlargement in patients with severe chronic neutropenia, and in 3% of patients a splenectomy was required.
Danish: Dosisreduktioner af filgrastim kunne nedsætte eller stoppe progressionen af miltforstørrelsen hos patienter med alvorlig kronisk neutropeni, og hos 3 % af patienterne blev det nødvendigt med splenektomi.
English: In normal donors, a 10 µg/kg/day dose administered subcutaneously for 4 to 5 consecutive days allows a collection of ≥ 4 x 10
Danish: Hos raske donorer tillader en dosis på10 µg/kg/dag adminstreret subkutant i 4 til 5 på hinanden følgende dage indsamling af ≥ 4 x 10
English: A randomised, open-label, single-dose, comparator-controlled, two-way crossover study in 46 healthy volunteers showed that the pharmacokinetic profile of Nivestim was comparable to that of the reference product after subcutaneous and intravenous administration.
Danish: Det er vist i et randomiseret, åbent, enkeltdosis-, komparator-kontrolleret to-vejs overkrydsningsstudie med 46 raske frivillige forsøgspersoner, at Nivestims farmakokinetiske profil var sammenlignelig med referencepræparatets profil efter subkutan og intravenøs administration.
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Danish: Opbevar den fyldte sprøjte i den ydre pakning for at beskytte mod lys.
English: Dizziness may occur following the administration of filgrastim (see section 4.8).
Danish: Der kan forekomme svimmelhed efter administration af filgrastim (se pkt.
English: Another randomised, double-blind, multiple-dose, comparator-controlled, two-way crossover study in 50 healthy volunteers showed that the pharmacokinetic profile of Nivestim was comparable to that of the reference product after subcutaneous administration.
Danish: I et andet randomiseret, dobbeltblindt, kontrolleret, to-vejs overkrydsningsstudie med multiple doser med 50 raske frivillige forsøgspersoner er det vist, at Nivestims farmakokinetiske profil var sammenlignelig med referencepræparatets profil efter subkutan administration.
English: When diluted in 5% glucose solution, filgrastim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Danish: Ved fortynding med 5 % glucoseopløsning er filgrastim kompatibelt med glas og flere plastmaterialer, herunder PVC, polyolefin (en co-polymer af polypropylen og polyethylen) og polypropylen.
English: The Nivestim syringe plunger stopper and needle cover are not made with natural rubber latex.
Danish: Stopmekanismen på sprøjtestemplet og nålebeskytteren på Nivestim er ikke fremstillet med naturligt gummilatex.
English: Special precautions in recipients of allogeneic PBPCs mobilised with filgrastim
Danish: Særlige forholdsregler hos modtagere af allogene PBPC, som er mobiliseret med filgrastim
English: - if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Danish: - hvis du får hoste, feber og vejrtrækningsbesvær (dyspnø), da dette kan være tegn på akut lungesvigt (Acute Respiratory Distress Syndrome (ARDS).
English: Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Danish: Filgrastim kan gives som en 24-timers subkutan, kontinuerlig infusion eller subkutan injektion.
English: • a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
Danish: • Ændring i hvordan kroppen regulerer væske i kroppen, som kan medføre oppustethed
English: Complete blood cell counts with differential and platelet counts, and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
Danish: Før behandlingen bør der foretages fuldstændig blodcelletælling, herunder differentialtælling og trombocyttælling, og knoglemarvsmorfologi og karyotype bør evalueres før behandlingen.
English: - if you have a combination of any of the following symptoms: o fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation, shortness of breath, extreme pain or discomfort and clammy or sweaty skin.
Danish: - hvis du får en kombination af de følgende symptomer: o feber eller kulderystelser eller kuldefølelse, høj hjertefrekvens, forvirring eller desorientering, stakåndethed, ekstreme smerter eller ubehag, og klam eller svedende hud.
English: Ensure the needle guard covers the needle according to the instructions for active needle guard or passive needle guard below.
Danish: Forvis dig om, at kanylebeskytteren dækker kanylen, som angivet nedenfor i instrukserne for den aktive eller passive kanylebeskytter.
English: Filgrastim should be given by subcutaneous injection.
Danish: Filgrastim bør gives som subkutan injektion.
English: Therefore, in patients with reduced precursors neutrophil response may be diminished (such as those treated with extensive radiotherapy or chemotherapy, or those with bone marrow infiltration by tumour).
Danish: Den neutrofile effekt kan derfor være formindsket hos patienter med et nedsat antal prækursorer (f.eks. patienter, som er behandlet med intensiv stråle- eller kemoterapi, eller patienter med tumorinfiltration i knoglemarven).
English: Loss of response to filgrastim
Danish: Manglende reaktion på filgrastim
English: This medicine contains less than 1 mmol sodium (23 mg) per 0.6 mg/ml or 0.96 mg/ml dose, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis med 0,6 mg/ml eller 0,96 mg/ml, dvs. det er i det væsentlige natriumfrit.
English: Nivestim is not recommended during pregnancy.
Danish: Nivestim bør ikke anvendes under graviditeten.
English: Infusion of PBPC accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Danish: Infusion af PBPC fremmer den hæmatopoietiske restitution, idet perioden med risiko for hæmoragiske komplikationer og behovet for trombocyttransfusioner forkortes.
English: 9/L, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Danish: 9/l, som tidligere har haft svære eller tilbagevendende infektioner, med henblik på at øge neutrofiltallet og for at nedsætte hyppigheden og varigheden af infektionsrelaterede hændelser.
English: Once the neutrophil nadir has been passed, the daily dose of filgrastim should be titrated against the neutrophil response as follows:
Danish: Når det neutrofile nadir er passeret, bør den daglige filgrastimdosis titreres i forhold til det neutrofile respons, som vist i tabellen nedenfor:
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from filgrastim 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 filgrastim skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: In clinical studies, > 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Danish: I de kliniske studier responderede mere end 90 % af patienterne på denne dosis og opnåede normale neutrofilværdier efter mediant 2 dage.
English: A common side effect of filgrastim use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics).
Danish: En almindelig bivirkning ved filgrastim er smerter i muskler eller knogler, hvilket kan lindres med almindelig smertestillende medicin.
English: Medicines (containing sorbitol/fructose) given intravenously may be life-threatening and should be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.
Danish: Spædbørn og småbørn (under 2 år) kan have hereditær fructoseintolerans (HFI) uden at være diagnosticeret med det. Lægemidler (indeholdende sorbitol/fructose) givet intravenøst kan være livstruende og bør være kontraindiceret for denne population, medmindre der er et overvældende klinisk behov, og der ikke findes noget alternativ.
English: The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy.
Danish: Den første dosis filgrastim bør gives mindst 24 timer efter cytotoksisk kemoterapi.
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture have been reported in patients and normal donors following administration of filgrastim.
Danish: Der er generelt rapporteret om asymptomatiske tilfælde af splenomegali og tilfælde af miltruptur hos patienter og raske donorer efter administration af filgrastim.
English: Nivestim is a clear colourless solution for injection/infusion in a glass pre-filled syringe with an injection needle (stainless steel) with a needle guard.
Danish: Nivestim er en klar farveløs injektions-/infusionsvæske i en fyldt sprøjte af glas med kanyle (rustfrit stål) med en kanylebeskytter.
English: How do I give my subcutaneous Nivestim injection?
Danish: Hvordan giver jeg mig selv en indsprøjtning med Nivestim?
English: Some patients may respond very rapidly and with a considerable increase in neutrophil count to the initial dose of filgrastim.
Danish: Nogle patienter responderer med en hurtig stigning i neutrofiltallet allerede efter den første filgrastimdosis.
English: • pain in your mouth and throat (oropharyngeal pain)
Danish: • Smerter i mund og svælg (orofaryngeale smerter)
English: Place the syringe into the sharps container.
Danish: Anbring kanylen i affaldsbeholderen.
English: There is insufficient data to evaluate filgrastim use in geriatric subjects for other approved filgrastim indications.
Danish: Der er ikke tilstrækkelige data til at evaluere anvendelsen af filgrastim til ældre patienter i andre godkendte indikationer for filgrastim.
English: Treatment with filgrastim significantly reduces the durations of febrile neutropenia, antibiotic use and hospitalisation after induction chemotherapy for acute myelogenous leukaemia or myeloablative therapy followed by bone marrow transplantation.
Danish: Behandling med filgrastim reducerer signifikant varigheden af febril neutropeni, antibiotikaforbruget og hospitalisering efter induktionskemoterapi for akut myeloid leukæmi eller myeloablativ terapi efterfulgt af knoglemarvstransplantation.
English: Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.
Danish: Ring straks til lægen, hvis du bliver hævet i ansigtet eller anklerne, hvis der er blod i din urin, eller urinen er brun, eller hvis du skal lade vandet mindre hyppigt end normalt.