natgillin/translations-raw huggingface dataset:
8 Hæmaturi/ proteinuri forekom hos et mindre antal patienter.
8 Haematuria/ proteinuria occurred in a small number of patients.
Blodværdier Det absolutte neutrofiltal (ANC) bør monitoreres nøje især i de første få uger af behandlingen med filgrastim.
Blood cell counts ANC should be monitored closely, especially during the first few weeks of filgrastim therapy.
E/ dag (300 μg/ dag) filgrastim kan der ses store udsving i patientens ANC.
During intermittent dosing with 30 MU/ day (300 μ g/ day) of filgrastim, there can be wide fluctuations in the patient's ANC over time.
For at fastlægge patientens bundværdi eller nadir ANC anbefales det at tage blodprøver til ANC- måling, umiddelbart før der indgives en ny dosis filgrastim.
In order to determine a patient's trough or nadir ANC, it is recommended that blood samples are taken for ANC measurement immediately prior to any scheduled dosing with filgrastim.
Risici forbundet med øgede doser af myelosuppressive lægemidler Behandling med filgrastim alene forhindrer ikke trombocytopeni og anæmi fremkaldt af myelosuppresive behandlinger.
Risk associated with increased doses of myelosuppressive medicinal products Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive treatments.
Infektioner og maligniteter som forårsager myelosuppression Neutropeni kan være forårsaget af opportunistiske infektioner i knoglemarven, såsom Mycobakterie avium- kompleks, eller maligniteter, såsom lymfomer.
Infections and malignancies causing myelosuppression Neutropenia may be due to bone marrow-infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Hos patienter med påvist knoglemarvs- infiltrerende infektion eller malignitet bør det overvejes at behandle den underliggende tilstand samtidig med at neutropenien behandles med filgrastim.
In patients with known bone marrow-infiltrating infections or malignancy, consider appropriate therapy for treatment of the underlying condition in addition to administration of filgrastim for treatment of neutropenia.
Der foreligger indberetninger om sjældne pulmonære bivirkninger, særligt interstitiel pneumoni, efter administration af G- CSF (se pkt.
Rare pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration (see section 4.8).
Patienter med lungeinfiltrater eller pneumoni i anamnesen kan have øget risiko.
Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Pulmonale symptomer, såsom hoste, feber og dyspnø, i forbindelse med røntgenpåviste tegn på lungeinfiltrater og forringelse af lungefunktionen kan være tidlige tegn på Adult Respiratory Distress Syndrome (ARDS).
The onset of pulmonary signs, such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS).
Seglcellekriser, i nogle tilfælde fatale, er rapporteret ved brug af filgrastim hos patienter med seglcelleanæmi.
Sickle cells crises, in some cases fatal, have been reported with the use of filgrastim in subjects with sickle cell disease.
Lægen bør udvise forsigtighed med at ordinere filgrastimbehandling hos patienter med seglcelleanæmi og kun benytte filgrastim efter nøje vurdering af potentielle risici og fordele.
Physicians should exercise caution when considering the use of filgrastim in patients with sickle cell disease, and only after careful evaluation of the potential risks and benefits.
Øget hæmatopoietisk aktivitet i knoglemarven som reaktion på vækstfaktorbehandling er blevet forbundet med forbigående positive fund ved billeddiagnosticering af knoglerne.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
Dette bør tages i betragtning ved tolkning af billeddiagnostik af knogler.
This should be considered when interpreting bone imaging results.
Filgrastim HEXAL indeholder sorbitol og bør ikke anvendes hos patienter med hereditær fructose - intolerans.
Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
9 4. 5 Interaktion med andre lægemidler og andre former for interaktion
9 4.5 Interaction with other medicinal products and other forms of interaction
Præliminære oplysninger fra et mindre antal patienter i samtidig behandling med filgrastim og 5- fluorouracil tyder på, at neutropenien kan forværres.
Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-fluorouracil indicates that the severity of neutropenia may be exacerbated.
Mulige interaktioner med andre hæmatopoietiske vækstfaktorer og cytokiner er ikke undersøgt i kliniske forsøg.
Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical studies.
Der foreligger ikke tilstrækkelige data om brugen af filgrastim hos gravide.
There are no adequate data from the use of filgrastim in pregnant women.
Dyreforsøg med rotter og kaniner har ikke påvist tegn på teratogent potentiale.
There is no evidence from studies in rats and rabbits that filgrastim is teratogenic.
Der er observeret en øget abortfrekvens hos kaniner, men der er ikke observeret misdannelser.
An increased incidence of embryo-loss has been observed in rabbits, but no malformation has been seen.
I tilfælde af graviditet bør den eventuelle risiko for fosteret vejes op mod de forventede terapeutiske fordele.
In pregnancy, the possible risk of filgrastim use to the foetus must be weighed against the expected therapeutic benefit.
Derfor bør filgrastim ikke anvendes til ammende kvinder.
It is not known whether filgrastim is excreted in human milk, therefore it is not recommended for use in breast-feeding women.
Filgrastim påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
Filgrastim has no influence on the ability to drive and use machines.
De mest almindeligt rapporterede bivirkninger af filgrastim er lette til moderate muskel - og ledsmerter, hvilket forekommer hos mere end 10% af patienterne.
The most commonly reported adverse reactions to filgrastim are mild to moderate musculoskeletal pain occurring in more than 10% of patients.
Muskel - og ledsmerter kan almindeligvis kontrolleres med standard analgetika.
Musculoskeletal pain is usually controlled with standard analgesics.
De nedenfor opførte bivirkninger er klassificeret ifølge hyppighed og organklasse.
Adverse reactions listed below are classified according to frequency and system organ class.
Hyppighederne er defineret som følger:
Frequency groupings are defined according to the following convention:
Meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 til < 1/ 10), ikke almindelig (≥ 1/ 1. 000 til < 1/ 100), sjælden ≥ 1/ 10. 000, til < 1/ 1. 000), meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
10 Tabel 1.
10 Table 1.
Bivirkninger i kliniske undersøgelser hos cancerpatienter Immunsystemet
Adverse reactions in clinical trials in cancer patients Immune system disorders
Allergiske reaktioner *, inklusive anafylakse, hududslæt, urticaria, angioødem, dyspnø og hypotension.
Allergic-type reactions*, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea and hypotension
Vaskulære sygdomme
Hypotension (transient)
Hypotension (forbigående) Vaskulære sygdomme * inklusive venookklusiv sygdom og forstyrrelser i væskevolumen.
Vascular disorders* including venoocclusive disease and fluid volume disturbances
Lungeødem *, interstitiel pneumoni *, lungeinfiltrater *.
Pulmonary oedema*, interstitial pneumonia*, pulmonary infiltrates*
Sweets Syndrom *, kutan vasculitis.
Sweet's Syndrome*, cutaneous vasculitis
Knogler, led, muskler og bindevæv Meget almindelig:
Musculoskeletal, connective tissue and bone disorders Very common:
Muskel - og ledsmerter (lette til moderate).
Musculoskeletal pain (mild or moderate)
Forværring af rheumatoid arthritis.
Musculoskeletal pain (severe) Rheumatoid arthritis exacerbation
Vandladningsforstyrrelser (primært dysuri).
Micturition disorders (predominantly dysuria)
Forhøjet alkalisk fosfatase, forhøjet laktatdehydrogenase (LDH), gamma- glutamyltransferase (GGT) og øget urinsyre i blodet (reversibelt, dosisafhængigt, let eller moderat). * se nedenfor
Blood alkaline phosphatase, blood lactate dehydrogenase (LDH), gamma-glutamyltransferase (GGT) and blood uric acid increased (reversible, dose-dependent, mild or moderate) * see below
Bivirkninger i kliniske undersøgelser hos raske donorer, som gennemgår mobilisering af perifere blodstamceller Immunsystemet
Adverse reactions in clinical trials in normal donors undergoing PBPC mobilisation Immune system disorders Uncommon:
Anafylakse, angioødem, urticaria, udslæt.
Severe allergic reaction: anaphylaxis, angioedema, urticaria, rash Blood and the lymphatic system disorders Very common:
Leukocytose (WBC > 50 x 109/ l), trombocytopeni (trombocytter < 100 x 109/ l forbigående).
Splenomegaly (generally asymptomatic, also in patients)
Ikke almindelig:
Spleen disorder
Miltruptur (også hos patienter).
Splenic rupture (also in patients)
Luftveje, thorax og mediastinum
Headache Respiratory, thoracic and mediastinal disorders
Hæmoptyse *, blødning i lungen *, lungeinfiltrater *, dyspnø *, hypoxia *
Haemoptysis*, pulmonary haemorrhage*, pulmonary infiltrates*, dyspnoea*, hypoxia*
Muskel - og ledsmerter (lette til moderate, forbigående).
Musculoskeletal pain (mild to moderate, transient) Uncommon:
Forværring af rheumatoid arthritis og symptomer på arthritis.
Rheumatoid arthritis and arthritic symptoms exacerbation Investigations
Øget alkalisk fosfatase og LDH (forbigående, mindre).
Blood alkaline phosphatase and LDH increased (transient, minor)
nedenfor
Uncommon:
11 Tabel 3.
11 Table 3.
Bivirkninger i kliniske undersøgelser med patienter med svær kronisk neutropeni Blod og lymfesystem Meget almindelig:
Adverse reactions in clinical trials in SCN patients Blood and the lymphatic system disorders Very common:
Anæmi, splenomegali (kan i enkelte tilfælde være progressiv).
Anaemia, splenomegaly (may be progressive in a minority of cases)
Sygdomme i milten.
Thrombocytopenia
Nervesystemet
Uncommon:
Mave- tarm- kanalen
Epistaxis Gastrointestinal disorders
Lever og galdeveje Hud
Hepato-biliary disorders
Almindelig: og subkutane væv Almindelig:
Common:
Hepatomegali.
Hepatomegaly
Knogler, led, muskler og bindevæv Meget almindelig:
Skin and subcutaneous tissue disorders
Osteoporose, artralgi.
Cutaneous vasculitis (during long term use), alopecia, rash
Nyrer og urinveje
General musculoskeletal pain, bone pain
Hæmaturi, proteinuri.
Osteoporosis, arthralgia
Almene symptomer og reaktioner på administrationsstedet
Haematuria, proteinuria General disorders and administration site conditions
Smerter ved injektionsstedet.
Injection site pain
Øget alkalisk fosfatas, LDH og urinsyre i blodet (forbigående), reduceret blodglucose (forbigående, moderat).
Blood alkaline phosphatase, LDH and blood uric acid increased (transient), blood glucose decreased (transient, moderate)
Bivirkninger i kliniske undersøgelser med patienter med HIV- infektion Blod og lymfesystem
Adverse reactions in clinical trials in HIV Patients Blood and lymphatic system disorders
Sygdomme i milten, splenomegali *.
Spleen disorder, splenomegaly*
Muskel - og ledsmerter (lette til moderate). * se nedenfor
Musculoskeletal pain (mild to moderate) * see below
I randomiserede, placebokontrollerede kliniske forsøg øgede filgrastim ikke forekomsten af bivirkninger forbundet med cytotoksisk kemoterapi.
In randomised, placebo-controlled clinical studies, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
Blandt de bivirkninger, der blev rapporteret med lige stor frekvens hos patienter behandlet med filgrastim/ kemoterapi og placebo/ kemoterapi, var kvalme og opkastning, alopeci, diarré, træthed, anoreksi, mucositis, hovedpine, hoste, udslæt, brystsmerter, generel svækkelse, ondt i halsen, forstoppelse og uspecificeret smerte.
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.
Allergiske reaktioner forekom ved initial eller efterfølgende behandling hos patienter, som fik filgrastim.
Allergic reactions occurred on initial or subsequent treatment in patients receiving filgrastim.
Generelt var indberetningerne mere almindelige efter intravenøs- administration.
Overall, reports were more common after intravenous administration.
I nogle tilfælde er symptomerne forekommet igen efter genoptaget behandling, hvilket tyder på en mulig sammenhæng.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Filgrastim bør seponeres permanent hos patienter, som oplever en alvorlig allergisk reaktion.
Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Der er indberetninger om vaskulære lidelser hos patienter, som får højdosis- kemoterapi efterfulgt af autolog knoglemarvstransplantation.
Vascular disorders have been reported in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation.
Den årsagsmæssige sammenhæng med filgrastim er ikke fastlagt.
The causal association with filgrastim has not been established.
Dette kan være fatalt.
Pulmonary adverse reactions have in some cases been reported with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS), which may be fatal.
4. 4).
In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, pulmonary infiltrates, dyspnoea and hypoxia) have been reported very rarely in post marketing experience (see section 4.4).
Der er rapporteret om tilfælde af Sweets syndrom (akut febril neutrofil dermatose) hos cancerpatienter.
The occurrence of Sweet's syndrome (acute febrile neutrophilic dermatosis) has been reported occasionally in cancer patients.
Selvom en signifikant procentdel af disse patienter havde leukæmi, en lidelse, som man ved optræder sammen med Sweets syndrom, er en kausal forbindelse med filgrastim imidlertid ikke fastlagt.
However, since a significant percentage of these patients were
12 Der er rapporteret om isolerede tilfælde af seglcellekriser hos patienter med seglcellesygdom (se pkt.
12 suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been established.
Ingen patienter fik diagnosticeret hypersplenisme eller foretaget splenektomi.
In all cases of splenic enlargement in HIV patients 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.
Da forstørret milt er almindeligt forekommende hos patienter med HIV- infektion og forekommer i forskellig grad hos de fleste patienter med AIDS, er sammenhængen med behandlingen med filgrastim ikke fastlagt.
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.
I fire kliniske forsøg udviklede ingen af de raske frivillige eller cancerpatienter anti- rhG- CSF- antistoffer (hverken bindende eller neutraliserende) ved behandling med Filgrastim HEXAL.
In four clinical studies none of the healthy volunteers or cancer patients developed anti-rhG-CSF antibodies (neither binding nor neutralising) upon treatment with Filgrastim HEXAL.
Effekten af overdosering med filgrastim er ikke dokumenteret.
The effects of filgrastim overdose have not been established.
Kolonistimulerende faktorer, ATC- kode:
Colony stimulating factors, ATC Code:
Humant G- CSF er et glykoprotein, som regulerer dannelsen og frigivelsen af funktionelle neutrofiler fra knoglemarven.
Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Filgrastim HEXAL indeholder r- metHuG- CSF (filgrastim) og forårsager udtalte stigninger i neutrofiltallene inden for 24 timer ledsaget af en mindre stigning i antallet af monocytter.
Filgrastim HEXAL containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Efter seponering af filgrastim falder det cirkulerende neutrofiltal med 50% inden for 1- 2 døgn og normaliseres inden for 1- 7 døgn.
Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 - 2 days, and to normal levels within 1 - 7 days.
Som med andre hæmatopoietiske vækstfaktorer har G- CSF udvist in vitro- stimulerende egenskaber på humane endotelceller med specifikke receptorer for G- CSF.
As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells, which have specific receptors for G-CSF.
Dermed har G- CSF vist sig at inducere endotelcellefunktioner i forbindelse med angiogenese.
Accordingly, G-CSF has been shown to induce endothelial cell functions related to angiogenesis.
Derudover har G- CSF vist sig at øge neutrofil migration gennem det vaskulære endotel.
Additionally, G-CSF has been shown to increase neutrophil migration across the vascular endothelium.
Brug af filgrastim, alene eller efter kemoterapi mobiliserer hæmatopoietiske stamceller i perifert blod.
Use of filgrastim, either alone, or after chemotherapy, mobilises haematopoietic progenitor cells into peripheral blood.
Infusion af perifere blodstamceller fremmer den hæmatopoietiske restitutering og forkorter perioden med risiko for blødningskomplikationer og behovet for trombocyttransfusioner.
Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Et retrospektivt europæisk forsøg, som vurderede brugen af G- CSF efter allogen knoglemarvstransplantation hos patienter med akut leukæmi, tydede på en øget risiko for GvHD, behandlingsrelateret mortalitet (TRM) og mortalitet, når G- CSF blev administreret.
13 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.
En metaanalyse af allogene
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.
13 transplantationsforsøg, inklusive resultaterne af ni prospektive randomiserede forsøg, 8 retrospektive forsøg og 1 case- kontrolleret forsøg, påviste ingen effekt på risikoen for akut GvHD, kronisk GvHD eller tidlig behandlingsrelateret mortalitet.
A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Relativ risiko (95% CI) for GvHD og TRM Efter behandling med G- CSF efter knoglemarvstransplantation Publikation
Relative Risk (95% CI) of GvHD and TRM Following treatment with G-CSF after bone marrow transplantation
Undersøgelses -
Period of
N
Acute Grade Chronic
Akut grad
Publication
Kronisk
Study
TRM
N
II - IV GvHD GvHD
II - IV GvHD GvHD
Meta- analyse
TRM
a
Meta-Analysis
1, 08 1, 02
1.08 1.02
(2003) Europæisk retrospektiv
(2003) European
1986 - 2001
1986 - 2001a
(0, 87; 1, 33) (0, 82; 1, 26)
(0.87, 1.33) (0.82, 1.26)
(0, 38; 1, 31)
(0.38, 1.31)
undersøgelse
Retrospective
1, 33 1, 29
1.33 1.29
1, 73
1.73
(2004) International retrospektive
Study (2004) International
1992 - 2002b
1992 - 2002b
(1, 08; 1, 64) (1, 02; 1, 61)
(1.08, 1.64) (1.02, 1.61)
(1, 30; 2, 32)
(1.30, 2.32)
1, 11 1, 10
1.11 1.10
(2006) a
Study (2006) a
1995 - 2000b
1995 - 2000b
(0, 86; 1, 42) (0, 86; 1, 39)
(0.86, 1.42) (0.86, 1.39)
(0, 95; 1, 67)
(0.95, 1.67)
I nogle undersøgelser blev GM- CSF benyttet. b Analysen inkluderer patienter som fik knoglemarvstransplantater i perioden.
Analysis includes studies involving BM transplant during this period; some studies used GM-CSF b Analysis includes patients receiving BM transplant during this period
E/ kg/ dag (10 μg/ kg/ dag) administreret subkutant i 4 - 5 på hinanden følgende dage tilstrækkeligt til at indsamle ≥ 4 x 106 CD34+ celler/ kg af modtagerens legemsvægt hos størstedelen af donorer efter to leukafereser.
Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation In normal donors, a 1 MU/ kg/ day (10 μ g/ kg/ day) dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 106 CD34+ cells/ kg recipient BW in the majority of the donors after two leukaphereses.
Modtagere af allogene perifere blodstamceller mobiliseret med filgrastim oplevede signifikant hurtigere hæmatologisk restitution, hvilket førte til en signifikant reduktion i tiden til ikke- understøttet trombocytrestitution sammenlignet med allogen knoglemarvstransplantation.
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.
Brug af filgrastim hos 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 af infektioner og relaterede episoder.
Use of filgrastim in children or adults with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in ACNs in peripheral blood and a reduction of infection and related events.
Brug af filgrastim hos patienter med HIV- infektion fastholder et normalt neutrofiltal og øger derved muligheden for at give den planlagte dosis af antiviral og/ eller myelosuppressiv behandling.
Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/ or other myelosuppressive treatments.
Der er ikke påvist øget HIV- replikation hos patienter i filgrastim- behandling.
There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Randomiserede, dobbeltblindede overkrydsningsforsøg med en enkelt og multiple doser med 146 raske frivillige viste, at Filgrastim HEXALs farmakokinetiske profil var sammenlignelig med referenceproduktets efter subkutan og intravenøs administration.
Randomised, double-blind, single and multiple dose, crossover studies in 146 healthy volunteers showed that the pharmacokinetic profile of Filgrastim HEXAL was comparable to that of the reference product after subcutaneous and intravenous administration.
E/ kg (5 µg/ kg) resulterede i en maksimal serumkoncentration efter en tmax på 4, 5 ± 0, 9 timer (middel ± SD).
A single subcutaneous dose of 0.5 MU/ kg (5 µg/ kg) resulted in maximum serum concentrations after a tmax of 4.5 ± 0.9 hours (mean ± SD).
Distributionsvolumen i blodet er cirka 150 ml/ kg.
The volume of distribution in blood is approximately 150 ml/ kg.
Efter subkutan administration af de anbefalede doser holdt serumkoncentrationerne sig over 10 ng/ ml i 8 - 16 timer.
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ ml for 8 - 16 hours.
14 Eliminering
14 Elimination
Serumclearance falder, når dosis øges.
The elimination of filgrastim is non-linear with respect to dose, the serum clearance decreases with increasing dose.