FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use it if the date has passed the last day of the month shown or if it has been kept outside of the refrigerator for more than 15 days or has otherwise expired.
Danish: Brug ikke sprøjten, hvis sidste dato i den nævnte måned er overskredet, eller hvis sprøjten har været opbevaret uden for køleskab i mere end 15 dage, eller brugstiden på anden måde er udløbet.
English: Filgrastim is a protein produced in bacteria called Escherichia coli by recombinant DNA technology.
Danish: Filgrastim er et protein produceret i bakterier Escherichia coli ved rekombinant DNA-teknologi.
English: Filgrastim was studied in repeated dose toxicity studies up to 1 year in duration which revealed changes attributable to the expected pharmacological actions including increases in leukocytes, myeloid hyperplasia in bone marrow, extramedullary granulopoiesis and splenic enlargement.
Danish: Filgrastim blev undersøgt i toksicitetsstudier med gentagne doser af op til 1 års varighed, hvor der blev observeret ændringer, som kunne tilskrives de forventede farmakologiske virkninger, herunder leukocytstigning, myeloid hyperplasi i knoglemarv, ekstramedullær granulopoiese og forstørret milt.
English: You will normally receive your first dose of Accofil at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.
Danish: Du vil normalt modtage din første dosis Accofil mindst 24 timer efter din kemoterapi og mindst 24 timer efter modtagelse af din knoglemarvstransplantation.
English: • low red blood cell count (anaemia)
Danish: - lavt antal røde blodlegemer (anæmi)
English: Using the pre-filled syringe without a needle safety guard Administer the dose as per standard protocol.
Danish: Brug af den fyldte injektionssprøjte uden kanylebeskytter Administrer dosis i henhold til standardprotokollen.
English: These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called Capillary Leak Syndrome which causes the blood to leak from the small blood vessels into your body and needs urgent medical attention.
Danish: Dette kan være symptomer på en ikke almindelig tilstand (kan ramme op til 1 person ud af 100), som kaldes kapillær lækagesyndrom, og som får blodet til at lække fra de små blodkar ud i kroppen og kræver omgående lægehjælp.
English: Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Danish: Accofil er indiceret til behandling af persisterende neutropeni (ANC mindre eller lig med 1,0 x 109/l) hos patienter med fremskreden hiv-infektion for at nedsætte risikoen for bakterielle infektioner, hvis der ikke er anden egnet behandling af neutropeni.
English: Nervous system disorders
Danish: Nervesystemet Hovedpinea
English: White blood cell counts of 100 x 109/L or greater have been observed in less than 5% of patients receiving filgrastim at doses above 0.3 MIU/kg/day (3 µg/kg/day).
Danish: Der er blevet observeret leukocyttal på 100 x 109/l eller derover hos færre end 5 % af de patienter, der fik filgrastim i doser over 0,3 ME/kg/dag (3 µg/kg/dag).
English: If you forget to use Accofil
Danish: Hvis du har glemt at bruge Accofil
English: Capillary leak syndrome has been reported after granulocyte colony-stimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Danish: Kapillær lækagesyndrom er indberettet efter administration af granulocytkoloni-stimulerende faktor og er kendetegnet ved hypotension, hypoalbuminæmi, ødem og hæmokoncentration.
English: Based on reported data for another filgrastim product similar to Accofil, 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 filgrastimpræparat, der ligner Accofil, blev der observeret sammenlignelige fund samt en stigning i fostermisdannelser ved 100 µg/kg/dag, en maternelt toksisk dosis, der svarer til en systemisk eksponering på ca. 50-90 gange de eksponeringer, der ses hos patienter, som behandles med den kliniske dosis på 5 µg/kg/dag.
English: Risks associated with increased doses of chemotherapy 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 udvises særlig forsigtighed, når patienter behandles med højdosis kemoterapi, fordi der ikke er påvist forbedret tumorrespons, og fordi højere doser af kemoterapeutiske stoffer kan medføre forøget toksicitet, herunder kardiale, pulmonale, neurologiske og dermatologiske virkninger (der henvises til ordinationsinformationen for de specifikt anvendte kemoterapeutika).
English: Filgrastim for PBPC mobilisation when used alone Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Danish: Filgrastim til PBPC-mobilisering, når det anvendes alene Filgrastim kan gives som en 24-timers subkutan kontinuerlig infusion eller som en subkutan injektion.
English: • if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Danish: hvis du behandles for svær kronisk neutropeni, og du har blod i urinen (hæmaturi).
English: For further instructions on dilution with glucose 50 mg/ml (5%) solution prior to infusion see section 6.6.
Danish: For yderligere vejledning vedrørende fortynding med isoton glukose 50 mg/ml (5 %) opløsning før infusionen, se pkt.6.6.
English: In randomised, placebo-controlled clinical studies, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
Danish: I randomiserede, placebokontrollerede kliniske studier øgede filgrastim ikke hyppigheden af bivirkninger forbundet med cytotoksisk kemoterapi.
English: Accofil and bone marrow transplantation
Danish: Accofil og knoglemarvstransplantation
English: Special precautions in normal donors undergoing peripheral blood progenitor cell mobilization
Danish: Særlige forsigtighedsregler hos raske donorer, som får foretaget mobilisering af perifere blodprogenitorceller
English: Clearance of filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous or intravenous administration.
Danish: Det er påvist, at filgrastims clearance følger første ordens farmakokinetik efter både subkutan eller intravenøs administration.
English: Accofil and peripheral blood stem cell transplantation (stem cells collected from the blood to use in bone marrow transplantation)
Danish: Accofil og perifer blod stamcelletransplantation (stamceller opsamlet fra blodet til brug ved knoglemarvstransplantation)
English: Disinfect the injection site by using an alcohol swab and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Danish: Desinficer indsprøjtningsstedet med en spritserviet, og tag godt fat i huden medtommel- og pegefingeren uden at klemme til (se figur 5).
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 skal du lade den fyldte injektionssprøjte ligge i 30 minutter ved stuetemperatur eller holde den fyldte injektionssprøjte forsigtigt i hånden i nogle få minutter.
English: Leukocytosis (WBC > 50 x 109/L) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/L) following filgrastim treatment and leukapheresis was observed in 35% of donors.
Danish: Der blev observeret leukocytose (leukocyttal > 50 x 109/l) hos 41 % af donorer og forbigående trombocytopeni (trombocyttal < 100 x 109/l) efter filgrastimbehandling og leukaferese blev observeret hos 35 % af donorer.
English: For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Danish: Ved patienter, der behandles med filgrastim fortyndet til en koncentration under 1,5 mill (15 mikrogram) pr. ml, bør der tilføres humant serumalbumin (HSA) til en slutkoncentration på 2 mg/ml.
English: Thirty-one percent (31%) of patients in studies were documented as having palpable splenomegaly.
Danish: I kliniske studier fandt man, at 31 % af patienterne havde palpabel splenomegali.
English: Special precautions in recipients of allogeneic PBPC mobilised with filgrastim
Danish: Særlige forsigtighedsregler hos modtagere af allogene PBPC'er, der er mobiliseret med filgrastim
English: • diarrhoea
Danish: - diarré
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 bør behandlingen med filgrastim dog ikke seponeres, før det forventede nadir er passeret, og neutrofiltallet igen ligger inden for normalværdiområdet.
English: The long-term safety of administration of filgrastim at doses above 24 µg/kg/day in patients with SCN has not been established.
Danish: Langtidssikkerheden af behandling med filgrastim i doser over 24 µg/kg/dag hos patienter med svær, kronisk neutropeni kendes ikke.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER/ FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Inject only the dose your doctor has told you.
Danish: Injicer kun den dosis, som lægen har ordineret.
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim.
Danish: Tilfælde af nedsat knogletæthed og osteoporose er blevet rapporteret hos pædiatriske patienter med svær kronisk neutropeni, som fik kronisk behandling med filgrastim.
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Danish: Træk let i stemplet for at tjekke, at et blodkar ikke er blevet punkteret.
English: Injury, poisoning and procedural complicatio ns
Danish: Traumer, forgiftninger og behandlingskom plikationer
English: There is insufficient data to further evaluate filgrastim use in paediatric subjects.
Danish: Data er utilstrækkelige til at evaluere anvendelse af filgrastim hos børn yderligere.
English: Increases in volume, measured radiographically occurred early during filgrastim therapy and tended to plateau later in treatment.
Danish: Der forekom radiografisk påviste volumenforstørrelser tidligt under behandlingen med filgrastim, som havde en tendens til at stabilisere sig senere i behandlingen.
English: Filgrastim may be administered as a daily subcutaneous injection or alternatively as a daily intravenous infusion diluted in glucose 50 mg/ml (5%) solution over 30 minutes.
Danish: Filgrastim kan gives som en daglig subkutan injektion eller alternativt som en daglig intravenøs infusion efter fortynding med isoton glukose 50 mg/ml (5 %) over 30 minutter.
English: Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Danish: Trombocyttallene skal monitoreres nøje, især i de første få uger under behandlingen med filgrastim.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Not know n
Danish: Ikke kendt
English: The needle safety guard covers the needle after injection to prevent needle stick injury.
Danish: Kanylebeskytteren dækker kanylen efter injektionen for at forhindre stikskader.
English: In normal donors, dyspnoea has been reported commonly and other pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, and hypoxia) have been reported uncommonly.
Danish: I normale donorer er dyspnø almindeligt rapporteret og andre pulmonale bivirkninger (hæmoptyse, pulmonal blødning, lungeinfiltrater og hypoxi) er blevet rapporteret sjældent.
English: The syringe can be removed from the refrigerator and left at room temperature (not above 25°C) for a single period, that ends within the labelled expiry date, of up to a maximum of 15 days.
Danish: Injektionssprøjten kan tages ud af køleskabet og opbevares ved stuetemperatur (ikke over 25 °C) i en enkelt periode, som slutter inden den anførte udløbsdato og højst må vare 15 dage.
English: The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
Danish: Den første dosis filgrastim bør administreres mindst 24 timer efter cytotoksisk kemoterapi og mindst 24 timer efter knoglemarvsinfusion.
English: Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy Filgrastim should be given by subcutaneous injection.
Danish: Filgrastim til PBPC-mobilisering efter myelosuppressiv kemoterapi Filgrastim skal gives som subkutan injektion.
English: if you experience kidney injury (glomerulonephritis).
Danish: - hvis du får nyreskader (glomerulonefritis).
English: Other medicines and Accofil
Danish: Brug af anden medicin sammen med Accofil
English: The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MU (5 µg)/kg/day given daily 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 myelosuppresiv kemoterapi er 0,5 ME (5 µg)/kg/dag, som gives dagligt som en subkutan injektion fra den første dag efter afsluttet kemoterapi, og indtil tidspunktet for det forventede neutrofile nadir er passeret og neutrofiltallet igen ligger inden for normalværdiområdet.
English: In a small number of patients (< 10%), doses up to 1.0 MU(10 µg)/kg/day were required to achieve reversal of neutropenia.
Danish: I et lille antal patienter (< 10 %), var doser på op til 1,0 MU (10 µg)/kg/dag nødvendige for at opnå revertering af neutropeni.
English: You should not receive Accofil in the 24 hours before and the 24 hours after receiving chemotherapy.
Danish: Du bør ikke få Accofil i 24 timer før og 24 timer efter kemoterapi.
English: f. Find a comfortable, well-lit place and put everything you need where you can reach them (the Accofil pre-filled syringe and alcohol swab).
Danish: Find et bekvemt sted med godt lys, og anbring udstyret, hvor du let kan nå det (den fyldte injektionssprøjte med Accofil og spritserviet).
English: Accofil is available in packs containing 1, 3, 5, 7 and 10 pre-filled syringes, with or without prefixed needle safety guard and alcohol swabs.
Danish: Accofil findes i pakninger, der indeholder 1, 3, 5, 7 eller 10 fyldte injektionssprøjter med eller uden fortil monteret kanylebeskytter samt spritserviet(ter).
English: A decision must be made whether to discontinue breastfeeding 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 afbrydes/ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for kvinden.
English: Dose reductions were noted to slow or stop the progression of splenic enlargement and in 3% of patients a splenectomy was required.
Danish: Det blev bemærket, at dosisreduktion nedsatte eller standsede progressionen af miltforstørrelse, men i 3 % af patienterne, var en splenektomi påkrævet.
English: Accofil 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: Accofil er indiceret til reduktion af varigheden af neutropeni og hyppigheden af febril neutropeni hos patienter, som behandles med etableret cytotoksisk kemoterapi for en malign lidelse (med undtagelse af kronisk myeloid leukæmi og myelodysplastiske syndromer), og til reduktion af varigheden af neutropeni hos patienter, som får myeloablativ behandling efterfulgt af knoglemarvstransplantation, og som anses for at have en øget risiko for langvarig, svær neutropeni.
English: In a small number of patients (< 10%), doses up to 1.0 MU (10 µg) /kg/day were required to achieve reversal of neutropenia.
Danish: I et lille antal patienter (< 10 %), var doser på op til 1,0 ME (10 µg)/kg/dag nødvendige for at opnå revertering af neutropeni.
English: While maintaining pressure on the plunger, remove the syringe from the patient.
Danish: Mens der stadig trykkes på stemplet, trækkes sprøjten ud af patienten.
English: Accofil and severe chronic neutropenia (low number of a type of white blood cells)
Danish: Accofil og svær kronisk neutropeni (lavt antal af en type hvide blodlegemer)
English: However, during the period of administration of filgrastim for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/L.
Danish: Under behandlingen med filgrastim til PBPC-mobilisering, skal behandlingen med filgrastim dog først afbrydes eller dosis reduceres, hvis leukocyttallet stiger til 70 x 109/l.
English: Idiopathic or cyclic neutropenia The recommended starting dose is 0.5 MU (5 µg)/kg/day as a single dose or in divided doses.
Danish: Idiopatisk eller cyklisk neutropeni Den anbefalede startdosis er 0,5 ME (5 µg)/kg/dag som en enkeltdosis eller i opdelte doser.
English: Special precautions in patients undergoing PBPC mobilization
Danish: Særlige forsigtighedsregler hos patienter, der får foretaget PBPC-mobilisering
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: Kontakt straks lægen, hvis du bliver hævet i ansigtet eller på anklerne, får blod i urinen, eller urinen er brunlig, eller du bemærker, at du ikke tisser så ofte, som du plejer.
English: Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).
Danish: Stik kanylen helt ind i huden som demonstreret af sygeplejersken eller lægen (se billede 6).
English: In the post-marketing setting, isolated cases of sickle cell crises have been reported in patients with sickle cell disease (see section 4.4).
Danish: Efter markedsføring er der indberettet isolerede tilfælde af seglcellekriser hos patienter med seglcellesygdom (se pkt.
English: Kidney injury has been seen in patients who received Accofil.
Danish: Der er observeret nyresygdom hos patienter, der fik Accofil.
English: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Danish: Hvis du har problemer, må du endelig bede lægen eller sygeplejersken om hjælp og vejledning.
English: For the reversal of neutropenia and maintenance of normal neutrophil counts in patients with HIV infection, filgrastim is administered subcutaneously.
Danish: For revertering af neutropeni og vedligeholdelse af normale neutrofiltal hos patienter med hivinfektion, administreres filgrastim subkutant.
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis (see section 4.4).
Danish: Disse er generelt forekommet hos patienter med fremskreden malign sygdom, sepsis, som fik flere kemoterapipræparater eller gennemgik aferese (se pkt.
English: 1 pre-filled syringe (0.5 ml) + 1 alcohol swab “3 pre-filled syringe (0.5 ml) + 3 alcohol swabs” “5 pre-filled syringes (0.5 ml) + 5 alcohol swabs” “10 pre-filled syringe (0.5 ml) + 10 alcohol swabs” “7 pre-filled syringe (0.5 ml) + 7 alcohol swabs”
Danish: “3 fyldte injektionssprøjter (0,5 ml) + 3 spritservietter” “5 fyldte injektionssprøjter (0,5 ml) + 5 spritservietter” “10 fyldte injektionssprøjter (0,5 ml) + 10 spritservietter” “7 fyldte injektionssprøjter (0,5 ml) + 7 spritservietter”
English: Filgrastim should not be administered to patients with severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution.
Danish: Filgrastim må ikke gives til patienter med svær medfødt neutropeni, som udvikler leukæmi eller hvor der er bevis for leukæmisk evolution.
English: Pre-filled syringe without needle safety guard b.
Danish: Fyldt sprøjte uden kanylebeskytter b.
English: Risk associated with increased doses of myelosuppressive medicinal products Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medicinal products.
Danish: Risiko forbundet med øgede doser af myelosuppressive lægemidler Behandling med filgrastim alene forhindrer ikke trombocytopeni og anæmi fremkaldt af myelosuppresive lægemidler.
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause an allergic reaction.
Danish: Kanylebeskyttelseshætten på den fyldte injektionssprøjte indeholder tørt naturgummi (et derivat af latex), som kan forårsage en allergisk reaktion.
English: In patients with SCN For congenital, idiopathic or cyclic neutropenia, filgrastim should be given by subcutaneous injection.
Danish: Til medfødt, idiopatisk eller cyklisk neutropeni, filgrastim skal gives som subkutan injektion.
English: Daily dosing with filgrastim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Danish: Den daglige dosering med filgrastim skal fortsætte, indtil den forventede neutrofile nadir er passeret og neutrofiltallet ligger inden for de normale værdier.
English: Disposing of used syringes
Danish: Bortskaffelse af anvendte sprøjter
English: • disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
Danish: - sygdom, der nedsætter knogletætheden, hvilket gør dem svagere, mere porøse og sandsynligvis øger risikoen for brud (osteoporose) - reaktion på injektionsstedet
English: Filgrastim dose adjustment
Danish: Filgrastimdosisjustering
English: What you need to know before you use Accofil Do not use Accofil - If you are allergic (hypersensitive) to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk (overfølsom) over for filgrastim eller et af de øvrige indholdsstoffer i dette lægemiddel (anført i punkt 6).
English: • Have sudden signs of allergy such as rash, itching or hives of skin, swelling of the face, lips,tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be a signs of severe allergic reaction.
Danish: - Får pludselige tegn på allergi som udslæt, kløe eller nældefeber i huden, hævelse i ansigt, læber, tunge eller andre dele af kroppen, stakåndethed, hvæsende vejrtrækning eller vejrtrækningsbesvær, da det kan være tegn på en alvorlig allergisk reaktion.