FrancophonIA/ELRC3.0 huggingface dataset:
English: ANC should be monitored closely, especially during the first few weeks of filgrastim therapy.
Danish: ANC bør monitoreres nøje, især i de første ugers behandling med filgrastim.
English: Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i.e. platelets consistently < 100,000/mm
Danish: Det bør overvejes at indstille behandlingen midlertidigt eller nedsætte dosis af filgrastim hos patienter, der får trombocytopeni, dvs. trombocyttal vedvarende < 100.000/mm3.
English: Type I glass pre-filled syringe with a permanently attached stainless steel needle with or without safety device to prevent needle stick injury and re-use.
Danish: Fyldt injektionssprøjte af type I-glas med fastmonteret kanyle af rustfrit stål med eller uden sikkerhedsanordning for at undgå stikskader og genbrug.
English: During intermittent dosing with 30 MIU (300 μg)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Danish: Under intermitterende administration af 30 mio. IE (300 μg)/døgn kan der med tiden forekomme store udsving i patientens ANC.
English: Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (2.0 x 10
Danish: Patienter, som tidligere har fået meget omfattende myelosuppressiv kemoterapi, vil ikke altid opnå tilstrækkelig mobilisering af perifere blodstamceller til at opnå den anbefalede mindstehøst (2,0 x 106
English: The long-term safety of filgrastim administration above 2.4 MIU (24 μg)/kg/day in patients with SCN has not been established.
Danish: Langtidssikkerhed er ikke påvist for filgrastim ved administration af doser over 2,4 mio. IE (24 μg)/kg/døgn til patienter med SCN.
English: In cancer patients
Danish: Hos kræftpatienter
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.
Danish: Utilsigtet opbevaring ved temperaturer under frysepunktet skader ikke Biograstims stabilitet.
English: Long-term treatment with Biograstim is required for neutropenia.
Danish: Det er nødvendigt at give langtidsbehandling mod neutropeni.
English: Example: In a final injection volume of 20 mL, total doses of filgrastim less than 30 MIU (300 μg) should be given with 0.2 mL of 200 mg/mL (20 %) human albumin solution added.
Danish: Eksempel: Ved et slutvolumen til injektion på 20 ml bør der ved totaldoser af filgrastim på mindre end 30 mio. IE (300 μg) tilsættes 0,2 ml 20 mg/ml (20 %) human albumininfusionsvæske.
English: In normal stem cell donors
Danish: Hos normale stamcelledonorer
English: Transient cytogenic modifications have been observed in normal donors following G-CSF use.
Danish: Der er observeret forbigående cytogene ændringer hos raske donorer efter brug af G-CSF.
English: These autologous PBPCs may be harvested and infused after high-dose cytotoxic therapy, either in place of or in addition to bone marrow transplantation.
Danish: Disse autologe perifere blodstamceller (PBPC) kan høstes og infunderes efter højdosis cytotoksisk kemoterapi - enten i stedet for eller i tilgift til knoglemarvstransplantation.
English: Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50 %, 35 %, 25 %, and 10 % of patients respectively, at recommended doses.
Danish: Reversible, dosisafhængige og sædvanligvis lette til moderate forhøjelser af lactatdehydrogenase (LD), basisk fosfatase, serumurinsyre og gamma-glutamyltransferase (GGT) sås hos henholdsvis ca. 50 %, 35 %, 25 % og 10 % af de patienter, der fik filgrastim i de anbefalede doser.
English: The following undesirable effects and their frequencies have been observed under treatment with filgrastim based on published information.
Danish: Følgende bivirkninger med angivelse af hyppighed som observeret under behandling med filgrastim, er baseret på publicerede oplysninger.
English: Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Danish: Desinficer huden med en spritserviet, og tag godt fat i huden mellem tommel- og pegefinger uden at klemme til (se figur 5).
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Biograstim 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 50 mg/ml (5 %) glucoseinfusionsvæske er Biograstim kompatibelt med glas og flere plastmaterialer inklusive PVC, polyolefin (et copolymer af polypropylen og polyethylen) og polypropylen.
English: However, for a sustained therapeutic response, filgrastim therapy should not be discontinued before the expected nadir has passed and the neutrophil count has recovered to the normal range.
Danish: For at opnå et vedvarende terapeutisk respons må filgrastimterapien dog ikke afbrydes, før det forventede nadir er passeret, og neutrofiltallet atter ligger inden for normalområdet.
English: Yields in excess of this minimum yield appear to correlate with more rapid recovery, those below with slower recovery.
Danish: Større høstudbytte end dette synes at kunne korreleres til hurtigere bedring, mens mindre udbytte giver langsommere bedring.
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Danish: Der bør udvises særlig forsigtighed ved administration af et enkelt kemoterapeutisk middel eller et kombinationspræparat, da de er kendt for at kunne medføre svær trombocytopeni.
English: Thirty-one percent (31 %) of patients in studies were documented as having palpable splenomegaly.
Danish: I kliniske studier havde 31 % af patienterne palpabel splenomegali.
English: Filgrastim should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics (see below).
Danish: Filgrastim bør ikke gives til patienter med svær medfødt neutropeni (Kostmans syndrom) og anormal cytogenetik (se nedenfor).
English: Musculoskeletal pain
Danish: Muskuloskeletale smerter
English: One retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment related mortality (TRM) and mortality when G-CSF was administered.
Danish: Et retrospektivt europæisk studie, der evaluerede anvendelsen af G-CSF efter allogen knoglemarvstransplantation hos patienter med akutte leukæmier, indikerede, at der er en øget risiko for GvHD, behandlingsrelateret mortalitet (BRM) og mortalitet efter indgift af G-CSF.
English: In a separate retrospective international study in patients with acute and chronic myelogenous leukaemias, no effect on the risk of GvHD, TRM and mortality was seen.
Danish: I et separat retrospektivt internationalt studie med patienter med akutte og kroniske myelogene leukæmier blev der ikke observeret nogen indflydelse på risikoen for GvHD, BRM og mortalitet.
English: Undesirable effects reported with equal frequency in patients treated with filgrastim/chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and unspecified pain.
Danish: Bivirkninger, der rapporteredes med samme hyppighed hos patienter, der fik filgrastim/kemoterapi og placebo/kemoterapi, omfattede kvalme og opkastning, alopeci, diarré, træthed, anoreksi, mukosit, hovedpine, hoste, hududslæt, brystsmerter, almen svækkelse, ondt i halsen, forstoppelse og uspecificerede smerter.
English: Some patients may respond very rapidly and with a considerable increase in neutrophil count to the initial dose of filgrastim.
Danish: Nogle patienter kan respondere meget hurtigt på den første dosis filgrastim og med en betragtelig stigning i neutrofiltallet.
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Danish: Donorer, der får G-CSF til mobilisering af perifere blodstamceller, skal monitoreres, indtil deres hæmatologiske værdier atter er normale.
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 inklusive forhøjet leukocyttal, myeloid hyperplasi i knoglemarv, ekstramedullær hæmopoiese og forstørrelse af milten.
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 ved behandling med væksthormoner har været forbundet med forbigående positive knoglescanningsresultater.
English: Inject the liquid slowly and evenly, always keeping your skin pinched.
Danish: Injicer opløsningen støt og roligt, mens De bevarer taget i huden.
English: For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL.
Danish: Til patienter, der behandles med filgrastim, der er fortyndet til en koncentration under 1,5 mio. IE (15 μg) pr. ml, bør der tilsættes humant serumalbumin (HSA) til en slutkoncentration på 2 mg/ml.
English: Continuous infusion with filgrastim over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable elimination half-lives.
Danish: Kontinuerlig infusion af filgrastim over maksimalt 28 døgn hos patienter i restitution efter autolog knoglemarvstransplantation viste sammenlignelige eliminationshalveringstider og ingen tegn på akkumulering.
English: EXP After dilution use within 24 hours.
Danish: EXP Bruges indenfor 24 timer efter fortynding.
English: In all cases this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hypersplenism and no patients underwent splenectomy.
Danish: Ved et objektivt studie viste alle tilfælde sig at være lette til moderate, og det kliniske forløb var godartet, idet ingen af patienterne fik diagnosticeret hypersplenisme, og ingen af dem fik splenektomi.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Multipack Carton - Without Blue Box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Multipakning Yderkarton - uden tekst i "blå boks"
English: It is currently unclear whether long-term treatment of patients with SCN will predispose patients to cytogenetic abnormalities, MDS or leukaemic transformation.
Danish: Det er aktuelt ikke afklaret, om langtidsbehandling af patienter med SCN gør disse patienter disponeret for cytogenetiske anomalier, myelodysplastiske syndromer eller leukæmisk transformation.
English: The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 mL/min/kg.
Danish: Filgrastims eliminationshalveringstid er ca. 3,5 timer med en clearancehastighed på ca. 0,6 ml/min/kg.
English: Biograstim and chemotherapy
Danish: Biograstim og kemoterapi
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Danish: Fortyndet filgrastim kan adsorberes til glas- og plastmaterialer, med mindre det fortyndes som angivet i pkt.
English: Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Danish: Der er indberettet kapillærlækage-syndrom efter indgift af G-CSF, kendetegnet ved hypotension, hypoalbuminæmi, ødem og hæmokoncentration.
English: The treatment will be discontinued when white cells in your blood reach a certain number.
Danish: Behandlingen stoppes, når et passende antal hvide blodceller opnås.
English: Uncommon (may affect up to 1 in 100 people): - blood in the urine; protein in the urine.
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer): - blod i urinen; proteiner i urinen.
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 så bekvem som muligt bør De lade den fyldte injektionssprøjte ligge i 30 minutter ved stuetemperatur eller holde den fyldte injektionssprøjte forsigtigt i hånden i nogle få minutter.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre karton og på den fyldte injektionssprøjte efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: For patients who have not had extensive chemotherapy, one < 0.5 x 10 leukapheresis is often sufficient.
Danish: Hos patienter, som ikke har fået omfattende kemoterapi, er en enkelt leukaferese ofte tilstrækkeligt.
English: Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with bone marrow transplantation.
Danish: Aktuelle data tyder på, at immunologiske interaktioner mellem et allogent transplantat af perifere blodstamceller og recipienten kan være forbundet med en øget risiko for akut og kronisk GvHD sammenlignet med knoglemarvstransplantation.
English: The mechanism of vasculitis in patients receiving filgrastim is unknown.
Danish: Mekanismen bag udvikling af vaskulit hos patienter, der får filgrastim, kendes ikke.
English: Nausea/Vomiting Constipation, anorexia, diarrhoea, mucositis
Danish: Obstipation, anoreksi, diarré, mukosit
English: There was a low frequency (approximately 3 %) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Danish: I kliniske studier observeredes en lav frekvens (ca. 3 %) af myeloplastiske syndromer (MDS) eller leukæmi hos patienter med SCN, der fik filgrastim.
English: You will normally receive your first dose of Biograstim at least 24 hours after your chemotherapy.
Danish: Normalt vil De få den første dosis Biograstim mindst 24 timer efter Deres kemoterapi.
English: In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1 to 2 days after initiation of filgrastim therapy.
Danish: Hos patienter, der får kemoterapi, vil der typisk opstå en forbigående stigning i neutrofiltallet 1-2 dage efter indledning af behandling med filgrastim.
English: As splenic enlargement is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to filgrastim treatment is unclear.
Danish: Da forstørrelse af milten ses hyppigt hos patienter med hiv-infektion og i forskelligt omfang hos de fleste aids-patienter, er det uklart, om der er en sammenhæng med behandling med filgrastim.
English: Other undesirable effects seen include splenic enlargement, which may be progressive in a minority of cases and thrombocytopenia.
Danish: Desuden omfatter de observerede bivirkninger forstørret milt, som kan være progredierende hos et mindretal af tilfældene, og trombocytopeni.
English: Use of filgrastim, either alone or after chemotherapy, mobilises haematopoietic progenitor cells into peripheral blood.
Danish: Brug af filgrastim alene eller efter kemoterapi mobiliserer hæmatopoietiske stamceller til perifert blod.
English: Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Danish: Filgrastim påvirker primært neutrofile forstadier, hvor effekten er en stigning i neutrofiltallet.
English: - Cough, fever and difficult or painful breathing can be signs of serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which may be fatal.
Danish: - Hoste, feber og vanskelig eller smertefuld vejrtrækning kan være tegn på alvorlige bivirkninger i lungerne såsom lungebetændelse og akut lungesvigt, hvilket kan føre til dødsfald.
English: It is unknown whether filgrastim is excreted in human breast milk.
Danish: Det er ukendt, om filgrastim udskilles i human mælk.
English: Once the number of white cells in your blood have returned to normal it may be possible to reduce the dose frequency to less than once per day.
Danish: Når først antallet af hvide blodlegemer er normaliseret, kan doseringen muligvis nedsættes, så injektionen ikke skal gives hver dag.
English: The recommended dose of filgrastim is 0.5 MIU (5 μg)/kg/day.
Danish: Den anbefalede dosis filgrastim er 0,5 mio. IE (5 μg)/kg/døgn.
English: After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
Danish: Efter fortynding: Kemisk og fysisk stabilitet af den fortyndede infusionsvæske er påvist i 24 timer ved 2 °C-8 °C.
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 af filgrastim hos patienter med svært nedsat nyre- eller leverfunktion har vist, at stoffet udviser samme farmakokinetiske og farmakodynamiske profil som hos raske mennesker.
English: Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Danish: Infusion af PBPC accelererer hæmatopoietisk bedring med reduktion af varigheden for risiko for hæmoragiske komplikationer og behov for trombocyttransfusion.
English: A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal pain or shoulder tip pain.
Danish: Diagnosen miltruptur bør overvejes hos donorer og/eller patienter, der klager over smerter i venstre side af øvre abdomen eller ved nederste del af skulderbladet.
English: Undesirable effects related to filgrastim therapy in SCN patients have been reported and for some their frequencies tend to decrease with time.
Danish: Der er rapporteret bivirkninger med forbindelse til filgrastimterapi hos denne patientpopulation, og hos nogle synes hyppigheden at aftage med tiden.
English: Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Danish: Biograstim er indiceret til reduktion af varigheden af neutropeni og incidensen af febril neutropeni hos patienter, der behandles med standard cytotoksisk kemoterapi for malign sygdom (med undtagelse af kronisk myeloid leukæmi og myelodysplastiske syndromer), og til reduktion af neutropeni hos patienter, som behandles med myeloablativ terapi efterfulgt af knoglemarvstransplantation og anses for at have en øget risiko for at få langvarig svær neutropeni.
English: Your doctor will test your blood at regular intervals to see how well the treatment is working.
Danish: Lægen vil tage blodprøver med jævne mellemrum for at undersøge, hvor godt behandlingen virker.
English: With the syringe pointing upwards, expel all air from the syringe by pushing the plunger upwards.
Danish: Hold sprøjten lodret med kanylen opad og fjern al luften fra sprøjten ved at trykke stemplet opad.
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Biograstim; - alcohol wipes or similar.
Danish: For at give Dem selv en subkutan injektion skal De bruge: - en fyldt medicinsprøjte med Biograstim, - spritservietter eller lignende,
English: Filgrastim dose adjustment
Danish: Justering af filgrastimdosis
English: Mobilisation of PBPC does not provide a direct clinical benefit to normal donors and should only be considered for the purposes of allogeneic stem cell transplantation.
Danish: Mobilisering af perifere blodstamceller giver ikke raske donorer en direkte klinisk fordel, og det bør kun anvendes til allogen stamcelletransplantation.
English: In patients with severe chronic neutropenia (SCN) Congenital neutropenia
Danish: Hos patienter med svær kronisk neutropeni (SCN)
English: - The safety device prevents needle stick injuries after use, so no special precautions for disposal are required.
Danish: Bortskaffelse af brugte medicinsprøjter - Sikkerhedsanordningen forebygger skader fra kanylestik efter brug, så der kræves ingen særlige forsigtighedsregler for bortskaffelse.
English: The effects of filgrastim on neutropenia due to bone marrow-infiltrating infection or malignancy have not been well established.
Danish: Filgrastims virkninger på neutropeni, der skylder knoglemarvsinfiltration ved infektion eller malign sygdom er ikke ordentligt fastlagt.
English: Once the neutrophil nadir has been passed the daily dose of filgrastim should be titrated against the neutrophil response as follows:
Danish: Når neutrofiltallets nadir er passeret, bør filgrastims døgndosis atter titreres over for det neutrofile respons som følger:
English: Haematuria, proteinuria
Danish: Hæmaturi, proteinuri
English: As a result of the potential to receive higher doses or a greater number of these medicinal products with filgrastim therapy, the patient may be at higher risk of developing thrombocytopenia and anaemia.
Danish: Som følge af, at patienten kan tåle at få højere doser eller et større antal af disse lægemidler under filgrastimterapien, kan der være en øget risiko for, at patienten udvikler trombocytopeni og anæmi.
English: In clinical studies, > 90 % of patients responded reached and can be maintained (ANC > 2.0 x 10 at these doses, achieving reversal of neutropenia in a median of 2 days.
Danish: I kliniske studier responderede > 90 % af patienterne på disse doser og opnåede reversering af neutropeni på 2 dage i gennemsnit.
English: Normal donors are given a dose of a 10 μg/kg/day, administered subcutaneously for 4 to 5 consecutive days.
Danish: Raske donorer får en dosis på 10 μg/kg/døgn, som administreres subkutant 4-5 dage i træk.
English: The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome or chronic myelogenous leukaemia have not been established.
Danish: Filgrastims sikkerhed og virkning efter administration til patienter med myelodysplastisk syndrom eller kronisk myeloid leukæmi er ikke klarlagt.
English: If patients with SCN develop abnormal cytogenetics, the risks and benefits of continuing filgrastim should be carefully weighed; filgrastim should be discontinued if MDS or leukaemia occur.
Danish: Hvis patienter med SCN udvikler anormal cytogenetik, bør fordele og ulemper ved at fortsætte behandlingen med filgrastim nøje afvejes, og filgrastimbehandlingen bør seponeres, hvis myeloplastisk syndrom eller leukæmi forekommer.
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: Biograstim is a clear and colourless solution.
Danish: Biograstim er en klar og farveløs væske.