FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of filgrastim, either alone, or after chemotherapy, mobilises haematopoietic progenitor cells into peripheral blood.
Danish: Anvendelse af filgrastim, enten alene eller efter kemoterapi, mobiliserer hæmatopoietiske progenitorceller i perifert blod.
English: • increase in white blood cells (leukocytosis)
Danish: • forhøjet antal hvide blodlegemer (leukocytosis)
English: Do not attempt to self-administer without this training.
Danish: Forsøg ikke at tage injektionerne selv uden denne træning.
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 PBPC giver ikke nogen direkte klinisk fordel for raske donorer og må kun overvejes at blive anvendt ved allogen stamcelletransplantation.
English: In a small number of patients (< 10%), doses up to 1.0 MU/kg/day (10 micrograms/kg/day) were required to achieve reversal of neutropenia.
Danish: I et lille antal patienter (< 10 %), var doser på op til 1,0 MU/kg/dag (10 mikrogram/kg/dag) nødvendige for at opnå revertering af neutropeni.
English: How do I prepare my Grastofil injection?
Danish: Hvordan forbereder jeg min Grastofil indsprøjtning?
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 dette lægemiddel efter den udløbsdato, der står på yderkartonen og på den fyldte injektionssprøjte efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: EG LABO-Laboratoires Eurogenerics SAS Telephone +33/1-46.94.86.86
Danish: EG LABO-Laboratoires Eurogenerics SAS Tél:+33/1-46.94.86.86
English: Only use each syringe for one injection.
Danish: Brug kun en injektionssprøjte til en indsprøjtning.
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 meget hurtigt og med en udtalt stigning i neutrofiltallet allerede ved den første filgrastimdosis.
English: Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.
Danish: Bør ikke anvendes til patienter med hereditær fructoseintolerans medmindre det er strengt nødvendigt.
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post-marketing experience.
Danish: Overfølsomhed-lignende reaktioner, inklusiv anafylaksi, udslæt, urticaria, angioødem, dyspnø og hypotension der forekom ved den initiale eller efterfølgende behandling er blevet rapporteret i kliniske studier og efter markedsføring.
English: Tell your doctor immediately during treatment if:
Danish: Fortæl straks din læge under behandlingen, hvis:
English: A diluted solution of Grastofil for infusion should be used within 24 hours when stored at 2 °C to 8 °C.
Danish: En fortyndet opløsning af Grastofil, infusionsvæske, skal anvendes inden for 24 timer ved opbevaring ved 2 °C til 8 °C.
English: Pulmonary adverse reactions, in particular interstitial lung disease, have been reported after G-CSF administration.
Danish: Der er blevet indberettet pulmonale bivirkninger, særligt interstitiel lungesygdom, efter administration af G-CSF.
English: Cases of capillary leak syndrome have been reported with granulocyte colony-stimulating factor use.
Danish: Tilfælde af kapillær lækagesyndrom er blevet indberettet ved brug af granulocytkoloni-stimulerende faktor.
English: Some cases of splenic rupture were fatal.
Danish: Visse tilfælde af miltruptur var dødelige.
English: Grastofil is available in packs containing 1 and 5 pre-filled syringes.
Danish: Grastofil findes i pakninger, der indeholder 1 og 5 fyldte injektionssprøjter.
English: • are pregnant, or breast-feeding;
Danish: • er gravid eller ammer,
English: Grastofil and peripheral blood stem cell transplantation (stem cells collected from the blood to use in bone marrow transplantation)
Danish: Grastofil og perifer blod stamcelletransplantation (stamceller opsamlet fra blodet til brug ved knoglemarvstransplantation)
English: Please tell your doctor immediately during treatment with Grastofil, if you:
Danish: Fortæl det straks til din læge i løbet af behandlingen med Grastofil, hvis du:
English: Your treatment with Grastofil will usually last for about 14 days.
Danish: Din behandling med Grastofil vil normalt vare i ca 14 dage.
English: Grastofil therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities.
Danish: Der må kun gives behandling med Grastofil i samarbejde med et onkologisk center, som har erfaring med behandling med granulocytkolonistimulerende faktor (G-CSF), og som også har hæmatologisk erfaring og de nødvendige diagnostiske faciliteter.
English: It is recommended that the ANC is measured daily for the first 2 to 3 days of filgrastim administration.
Danish: Det anbefales at måle ANC dagligt i de første 2-3 dage under behandlingen med filgrastim.
English: Pregnancy and breast-feeding Grastofil has not been tested in pregnant or breast-feeding women.
Danish: Graviditet, amning og fertilitet Grastofil er ikke blevet undersøgt hos gravide eller ammende kvinder.
English: • liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)
Danish: • leverskade forårsaget af blokering af de små vener i leveren (veno-okklusiv sygdom)
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 et resultat af muligheden for at modtage højere doser eller et større antal af disse lægemidler med filgrastimbehandling, kan patienten have større risiko for at udvikle trombocytopeni og anæmi.
English: The subcutaneous route is preferred in most cases.
Danish: I de fleste tilfælde fortrækkes den subkutane administrationsvej.
English: Your doctor may then test your blood to see how well your treatment with Grastofil is working and to find the dose that is best for you.
Danish: Din læge kan derefter teste dit blod for at se, hvor godt behandlingen med Grastofil fungerer, og for at finde den dosis, der er bedst for dig.
English: • sudden life-threatening allergic reaction (anaphylactic reaction)
Danish: • pludselig livstruende allergisk reaktion (anafylaktisk reaktion)
English: Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥20 μg/kg/day) and slightly reduced survival rate (100 μg/kg/day).
Danish: Rotteunger, der fik filgrastim administreret i den perinatale periode og under laktation, udviste forsinkelse i ekstern differentiering og vækstforsinkelse (≥20 µg/kg/dag) og let nedsat overlevelsesrate (100 µg/kg/dag).
English: Because of the potential of receiving higher doses of chemotherapy (e.g. full doses on the prescribed schedule) the patient may be at greater risk of thrombocytopenia and anaemia.
Danish: På grund af muligheden for at modtage højere doser kemoterapi (f.eks. fulde doser i det foreskrevne ordineringsskema) kan patienten have højere risiko for trombocytopeni og anæmi.
English: These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
Danish: Det kan være symptomer på en tilstand, der kaldes ”sepsis” (kaldes også "blodforgiftning"), en svær infektion med en betændelsesreaktion i hele kroppen, som kan være livstruende og hvor akut lægehjælp er nødvendig.
English: Your doctor may then test your blood to see how well the treatment is working and how long it should last.
Danish: Din læge kan derefter teste dit blod for at se, hvor godt behandlingen virker, og hvor længe den skal fortsætte.
English: Grastofil is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Danish: Grastofil gives normalt som en daglig injektion i vævet lige under huden (en såkaldt subkutan injektion).
English: In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 2.4 MU/kg/day (24 micrograms/kg/day).
Danish: I kliniske studier havde 97 % % af de patienter, der responderede, komplet respons efter doser ≤ 2,4 ME/kg/dag (24 mikrogram/kg/dag).
English: Use of filgrastim in patients undergoing cytotoxic chemotherapy leads to significant reductions in the incidence, severity and duration of neutropenia and febrile neutropenia.
Danish: Anvendelsen af filgrastim hos patienter, som får cytotoksisk kemoterapi medfører signifikant reduktion af incidensen, sværhedsgraden og varigheden af neutropeni og febril neutropeni.
English: 9/L) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 10
Danish: 9/l) hos 41 % af normale donorer og forbigående trombocytopeni (trombocyttal < 100 x 10
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 10
Danish: Hvis det er nødvendigt med mere end én leukaferese, skal man være særlig opmærksom på donorer, som har et trombocyttal < 100 x 10
English: Common (≥ 1/100 to <
Danish: Almindelig (≥ 1/100 til
English: • trouble sleeping (insomnia)
Danish: • søvnbesvær (insomni)
English: Decreased appetite a
Danish: Nedsat appetit a
English: Injecting the solution with the air bubble is harmless.
Danish: Injektion af opløsningen med luftboblen er uskadeligt.
English: • Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Danish: • Betændelse i aorta (den store pulsåre, der transporterer blod fra hjertet ud i kroppen), se pkt.
English: Exacerbation of rheumatoid arthritis
Danish: Forværring af rheumatoid artritis
English: Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells that help fight infection.
Danish: Filgrastim stimulerer knoglemarven (det væv, som producerer nye blodlegemer) til at producere flere hvide blodlegemer, der bekæmper infektioner.
English: • changes in blood chemistry
Danish: • ændringer i blodsammensætning
English: Pack sizes: Cartons containing 1 or 5 pre-filled syringes.
Danish: Pakningsstørrelser: Kartoner indeholdende 1 eller 5 fyldte injektionssprøjter.
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 hemoconcentration.
Danish: Kapillær lækagesyndrom, som kan være livstruende, hvis behandlingen forsinkes, er indberettet efter administration af granulocytkoloni-stimulerende faktor og er kendetegnet ved hypotension, hypoalbuminæmi, ødem og hæmokoncentration.
English: To avoid bending the needle, gently pull the cover from the needle without twisting.
Danish: For at undgå at bøje kanylen, træk forsigtigt hætten af kanylen uden at vride.
English: Filgrastim has minor influence on the ability to drive and use machines.
Danish: Filgrastim påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: For the mobilisation of peripheral blood progenitor cells (PBPC) in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Danish: For mobiliseringen af perifere blodprogenitorceller (PBPC) i hos patienter i myelosuppressiv eller myeloablativ behandling efterfulgt af autolog PBPC-transplantation
English: Your doctor will tell you how long you will need to take Grastofil.
Danish: Din læge vil fortælle dig, hvor længe du skal tage Grastofil.
English: Intravenous (80 μg/kg/day) administration of filgrastim to rabbits during the period of organogenesis was maternally toxic and increased spontaneous abortion, post-implantation loss, and decreased mean live litter size and fetal weight were observed.
Danish: Intravenøs (80 μg/kg/dag) administration af filgrastim til kaniner under organogenese var maternelt toksisk, og der blev observeret øget spontan abort, tab efter implantation og reduceret gennemsnitlig levende kuldstørrelse og fostervægt.
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 virkning på risikoen for GvHD, BRM og mortalitet.
English: Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/or other myelosuppressive treatments.
Danish: Anvendelse af filgrastim til patienter med HIV-infektion opretholder et normalt neutrofiltal og muliggør planlagt dosering af antivirale og/eller andre myelosuppressive behandlinger.
English: • low blood pressure (hypotension)
Danish: • lavt blodtryk (hypotension)
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased)
Danish: • høje niveauer af urinsyre i blodet, hvilket kan forårsage podagra (hyperurikæmi) (forhøjet urinsyre i blodet)
English: Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
Danish: Leukaferese må ikke udføres hos donorer, der er i antikoagulansbehandling, eller som har kendte hæmostatiske defekter.
English: If you notice a spot of blood you may gently dab it away with a cotton ball or tissue.
Danish: Hvis du bemærker en plet blod, kan du forsigtigt duppe den væk med en tot vat eller serviet.
English: Special warning and precautions associated with co-morbidities
Danish: Særlige advarsler og forsigtighedsregler forbundet med komorbiditeter
English: Dilution to a final concentration less than 0.2 MU (2 µg) per mL is not recommended at any time.
Danish: Fortynding til en slutkoncentration mindre end 0,2 mill (2 mikrogram) pr. ml anbefales ikke på noget tidspunkt.
English: Special precautions in patients undergoing PBPC mobilisation
Danish: Særlige forsigtighedsregler hos patienter, der får foretaget PBPC-mobilisering
English: • unusual hair loss or thinning (alopecia)
Danish: • usædvanligt hårtab eller -udtynding (alopeci)
English: • rejection of transplanted bone marrow (graft versus host disease)
Danish: • afstødning af transplanteret knoglemarv (graft versus host-sygdom)
English: In normal donors, a 10 micrograms/kg/day dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 10
Danish: Hos normale donorer muliggør en dosis på 10 mikrogram/kg/dag administreret subkutant i 4-5 på hinanden følgende dage en indsamling af ≥ 4 x 10
English: Grastofil contains 50 mg sorbitol in each ml.
Danish: Grastofil indeholder 50 mg sorbitol i hver ml.
English: Other special populations
Danish: Andre særlige befolkningsgrupper
English: Grastofil contains sorbitol
Danish: Grastofil indeholder sorbitol
English: Grastofil 48 MU/0.5 mL
Danish: Grastofil 48 ME/0,5 ml
English: cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Danish: Derfor skal anbefalinger af antal, som er baseret på undersøgelser i andre laboratorier, tolkes med forsigtighed.
English: • have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction (hypersensitivity).
Danish: • har pludselige tegn på allergi, såsom udslæt, kløe eller nældefeber på huden, hævelse i ansigt, på læberne, tungen eller i andre dele af kroppen, åndenød, hvæsende eller besværet vejrtrækning, da disse kan være tegn på en alvorlig allergisk reaktion (overfølsomhed).
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 may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Danish: Lyngesymptomer som f.eks. hoste, feber og dyspnø i forbindelse med radiologiske tegn på lungeinfiltrater og forværring af lungefunktionen kan være tidlige tegn på Acute Respiratory Distress Syndrome (ARDS).
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Danish: Generelt forsvandt hændelserne med glomerulonefritis efter en dosisreduktion eller seponering af filgrastim og pegfilgrastim.
English: • pain in your mouth and throat (oropharyngeal pain)
Danish: • smerter i munden og halsen (orofaryngeale smerter)
English: 9/L or greater have been observed in less than 5% of cancer patients receiving filgrastim at doses above 0.3 MU/kg/day (3 µg/kg/day).
Danish: 9/l eller derover hos færre end 5 % af de cancerpatienter, der fik filgrastim i doser over 0,3 ME/kg/dag (3 µg/kg/dag).
English: Take special care with other medicines that stimulate white blood cells Grastofil is one of a group of medicines that stimulate the production of white blood cells.
Danish: Vær ekstra forsigtig med andre lægemidler, der stimulerer hvide blodlegemer Grastofil tilhører en gruppe lægemidler, der stimulerer produktionen af hvide blodlegemer.
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 indberettet generelt asymptomatiske tilfælde af splenomegali og tilfælde af miltruptur hos patienter og normale donorer efter administration af filgrastim.
English: CLONMEL Healthcare Ltd. Telephone +353/52.61.77.777
Danish: CLONMEL Healthcare Ltd. Tel:+ 353/52.61.77.777
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, tydede på en øget risiko for GvHD, behandlingsrelateret mortalitet (BRM) og mortalitet efter administration af G-SCF.
English: Grastofil may have a minor influence on your ability to drive and use machines.
Danish: Grastofil kan påvirke din evne til at føre motorkøretøj og betjene maskiner i mindre grad.
English: Special precautions in cancer patients
Danish: Særlige forsigtighedsregler hos cancerpatienter
English: The no observed adverse effect level for embryo-fetal toxicity in this study was 10 μg/kg/day, which corresponded to a systemic exposure of approximately 3-5 times the exposures observed in patients treated with the clinical dose.
Danish: NOAEL (no observed adverse effect level) for embryoføtal toksicitet i dette studie var 10 μg/kg/dag, hvilket svarede til en systemisk eksponering på cirka 3-5 gange de eksponeringer, der observeres hos patienter, som behandles med den kliniske dosis.
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Danish: Der er blevet observeret forbigående cytogenetiske abnormaliteter hos raske donorer efter brug af G-CSF.
English: The recommended starting dose of Grastofil is 0.1 MU/kg/day (1 micrograms/kg/day) with titration up to a maximum of 0.4 MU/kg/day (4 micrograms/kg/day) until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 10
Danish: Den anbefalede Grastofil startdosis er 0,1 ME/kg/dag (1 mikrogram/kg/dag) med titrering op til højst 0,4 ME/kg/dag (4 mikrogram/kg/dag) indtil en normalt neutrofiltal er opnået og kan opretholdes (ANC > 2,0 x 10
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Danish: Filgrastim skal seponeres permanent hos patienter, der får alvorlige, allergiske reaktioner.
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Danish: I visse tilfælde kom symptomerne igen ved fornyet administration, som tyder på en mulig sammenhæng.
English: STADA Nordic ApS Telephone +45/44.85.99.99
Danish: STADA Nordic ApS Tel:+45/44.85.99.99
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Danish: Der kan komme andre blodcelleforandringer, herunder anæmi og forbigående stigninger i myeloide progenitorceller, som kan nødvendiggøre tæt monitorering af celletal.
English: Special precautions in recipients of allogeneic PBPC mobilised with filgrastim 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: Særlige forsigtighedsregler hos modtagere af allogene PBPC'er, der er mobiliseret med filgrastim De nuværende data tyder på, at immunologiske interaktioner mellem det allogene PBPC-transplantat og modtageren kan være forbundet med en øget risiko for akut eller kronisk graft versus host-sygdom (GvHD), når der sammenlignes med en knoglemarvstransplantation.
English: The dosing in children and adolescents receiving chemotherapy is the same as for adults.
Danish: Doseringen for børn og unge, der får kemoterapi, er den samme som for voksne.
English: Grastofil 30 MU/0.5 mL
Danish: Grastofil 30 ME/0,5 ml
English: 9/L were reported and attributed to the leukapheresis procedure.
Danish: 9/l, som var relateret til leukafereseproceduren.
English: You will need to take Grastofil until your white blood cell count is normal.
Danish: Du skal tage Grastofil, indtil antallet af hvide blodlegemer er normalt.
English: Special precautions in normal donors undergoing peripheral blood progenitor cell mobilisation
Danish: Særlige forsigtighedsregler hos raske donorer, som får foretaget mobilisering af perifere blodprogenitorceller
English: (fluidvolume disturbances)
Danish: (forstyrrelser af væskebalancen)
English: Based on reported data for another filgrastim product similar to Grastofil, comparable findings plus increased fetal malformations were observed at 100 μg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 μg/kg/day.
Danish: Baseret på de rapporterede data for et andet filgrastim-præparat, der ligner Grastofil, blev der observeret sammenlignelige fund samt en stigning i fostermisdannelser ved 100 μg/kg/dag - en maternelt toksisk dosis, der svarede til en systemisk eksponering på cirka 50-90 gange de eksponeringer, der observeres hos patienter, som behandles med den kliniske dosis på 5 μg/kg/dag.
English: However, in view of the potential risks associated with severe leukocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Danish: På grund af den mulige risiko, som er forbundet med svær leukocytose, bør der derfor foretages leukocyttælling med regelmæssige mellemrum under behandlingen med filgrastim.
English: Relative risk (95% CI) of GvHD and TRM following treatment with G-CSF after bone marrow (BM) transplantation
Danish: Relativ risiko (95 % CI) for GvHD og BRM efter behandling med G-CSF efter knoglemarvstransplantation Publikation Studieperiode Antal
English: Grastofil is used to treat children and adolescents who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia).
Danish: Grastofil anvendes til at behandle børn og unge, der får kemoterapi og lider af et svært nedsat antal hvide blodlegemer (neutropeni).