FrancophonIA/ELRC3.0 huggingface dataset:
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Danish: Donorer, der har modtaget G-CFS'er til mobilisering af perifere blodstamceller, skal monitoreres, indtil deres hæmatologiske værdier er normale.
English: • if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Danish: • hvis du får hoste, feber og vejrtrækningsproblemer (dyspnø), da det kan være et tegn på shocklunge (akut respiratorisk distress-syndrom, ARDS).
English: Leukocytosis (WBC > 50 x 109/l) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors (see section 4.4).
Danish: Leukocytose (leukocytter > 50 x 109/l) blev observeret hos 41 % af donorerne, og forbigående trombocytopeni (trombocytter < 100 x 109/l) efter filgrastim og leukaferese blev observeret hos 35 % af donorerne (se pkt.
English: Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Danish: Nogle cytotoksiske stoffer er særligt toksiske over for den hæmatopoietiske stamcellepool og kan have en negativ virkning på stamcellemobiliseringen.
English: Filgrastim HEXAL may have a minor influence on your ability to drive and use machines.
Danish: Filgrastim HEXAL kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Danish: • betændelse af blodkarrene i huden (kutan vaskulitis)
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: Der er indberettet kapillærlækage-syndrom, som kan være livstruende ved forsinket behandling, efter indgift af granulocytkoloni-stimulerende faktor, kendetegnet ved hypotension, hypoalbuminæmi, ødem og hæmokoncentration.
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Danish: Myelodysplastisk syndrom og leukæmi er naturlige komplikationer af lidelsen, og forbindelsen til behandlingen med filgrastim er usikker.
English: If you forget to use Filgrastim HEXAL
Danish: Hvis du har glemt at bruge Filgrastim HEXAL
English: Discontinuation of filgrastim therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to normal levels in 1 to 7 days.
Danish: Seponering af behandling med filgrastim fører normalt til en 50 % reduktion i cirkulerende neutrofiler i løbet af 1 til 2 dage, og en tilbagevending til normale niveauer i løbet af 1 til 7 dage.
English: Filgrastim should not be administered to patients with severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution.
Danish: Filgrastim bør ikke gives til patienter med svær medfødt neutropeni, som udvikler leukæmi eller har evidens for leukæmisk evolution.
English: Please tell your doctor before starting treatment if you have: - osteoporosis (bone disease); - sickle cell anaemia, as Filgrastim HEXAL may cause sickle cell crisis.
Danish: Fortæl det til din læge, før du påbegynder behandlingen, hvis du: - har knogleskørhed (knoglesygdom), - har seglcelleanæmi, da Filgrastim HEXAL kan forårsage seglcellekrise.
English: For patients treated with filgrastim diluted to concentrations < 1.5 MU/ml (15 μg/ml), human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Danish: Hos patienter behandlet med filgrastim fortyndet til koncentrationer på < 1,5 mill. E/ml (15 μg/ml) bør der tilføjes humant serumalbumin (HSA) til en slutkoncentration på 2 mg/ml.
English: Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/l to > 5.0 x 109/l.
Danish: Leukaferese bør udføres i det tidsrum, hvor det absolutte neutrofiltal øges fra < 0,5 x 109/l til > 5,0 x 109/l.
English: Dilution to a final concentration < 0.2 MU/ml (2 μg/ml) is not recommended at any time.
Danish: Fortynding til en slutkoncentration < 0,2 MU/ml (2 μg/ml) frarådes.
English: • to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;
Danish: • til at øge antallet af hvide blodlegemer, hvis du lider af svær, kronisk neutropeni, for at hjælpe med at forebygge infektioner,
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 behandle med højere doser af kemoterapi (f.eks. fulde doser ved behandlingsplanen) kan patienter have større risiko for at udvikle trombocytopeni og anæmi.
English: The mechanism of vasculitis in patients receiving filgrastim is unknown.
Danish: Mekanismen for vaskulitis hos patienter, som får filgrastim, kendes ikke.
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6).
Danish: Filgrastim kan gives som en daglig subkutan injektion eller som en daglig intravenøs infusion fortyndet med 5 % glucoseinfusionsvæske og givet over 30 minutter (se pkt.
English: Filgrastim HEXAL contains sorbitol (E420).
Danish: Filgrastim HEXAL indeholder sorbitol (E420).
English: If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Danish: Hvis du føler dig usikker, eller hvis du har spørgsmål, skal du bede lægen eller sundhedspersonalet om hjælp.
English: Please tell your doctor immediately during treatment with Filgrastim HEXAL, if you: - get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder [these may be symptoms of an enlarged spleen (splenomegaly), or possibly rupture of the spleen].
Danish: Du skal straks fortælle det til din læge, hvis du i løbet af behandlingen med Filgrastim HEXAL - får smerter i den øverste venstre side af maven (abdomen), smerter under de venstre ribben eller smerter i venstre skulder [det kan være symptomer på en forstørret milt (splenomegali) eller en mulig sprængt milt].
English: • enlargement of the liver (hepatomegaly)
Danish: • leverforstørrelse (hepatomegali)
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Filgrastim HEXAL 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 HEXAL skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/l.
Danish: Ved administration til perifer blodstamcellemobilisering bør filgrastim seponeres eller dosis reduceres, hvis leukocyttallet stiger til > 70 x 109/l.
English: Filgrastim may have a 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: These could be symptoms of a 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 tilstand, der kaldes for “kapillærlækage-syndrom”, som medfører, at der siver blod fra de små blodkar ud i kroppen.
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Danish: Der blev ikke påvist forskelle i sikkerhedsprofilen for pædiatriske patienter behandlet for svær kronisk neutropeni.
English: Filgrastim should be discontinued and appropriate treatment given in these cases.
Danish: I sådanne tilfælde bør behandlingen med filgrastim seponeres, og relevant behandling indledes.
English: Filgrastim HEXAL is available in packs containing 1, 3, 5 or 10 pre-filled syringes with injection needle and with or without a needle safety guard.
Danish: Filgrastim HEXAL fås i pakninger med 1, 3, 5 eller 10 fyldte injektionssprøjter med eller uden kanylebeskyttelse.
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 vedvarende terapeutisk respons bør behandlingen dog ikke afbrydes, før det forventede nadir er passeret, og neutrofiltallet er normaliseret.
English: Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Danish: Trombocyttallet bør monitoreres nøje især i de første uger af behandlingen med filgrastim.
English: If leukocyte counts exceed 50 x 109/l after the expected nadir, filgrastim should be discontinued immediately.
Danish: Hvis leukocyttallet overstiger 50 109/l efter forventet nadir, bør behandlingen med filgrastim straks seponeres.
English: Filgrastim HEXAL is a clear, colourless to slightly yellowish solution for injection or infusion in prefilled syringe.
Danish: Filgrastim HEXAL er en klar, farveløs til let gullig opløsning til injektion eller infusion i fyldt injektionssprøjte.
English: If the ANC decreases to < 1.0 x 109/l during the treatment period, the dose of filgrastim should be re-escalated according to the above steps ANC = absolute neutrophil count
Danish: Såfremt ANC falder til < 1,0 x 109/l under behandlingen, bør dosis af filgrastim igen øges ved at følge ovenstående procedure.
English: In a small number of patients (< 10%), doses up to 1.0 MU/kg/day (10 μg/kg/day) were required to achieve reversal of neutropenia.
Danish: Hos et lille antal patienter (< 10 %) var det nødvendigt med doser på 1,0 mill. E/kg/dag (10 μg/kg/dag) for at opnå normale neutrofilværdier.
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: Daglig dosering med filgrastim bør fortsættes, indtil det forventede neutrofile nadir er passeret, og neutrofiltallet igen ligger inden for normalområdet.
English: Recipients of allogeneic PBPCs mobilised with filgrastim experienced significantly more rapid haematological recovery, leading to a significant decrease in time to unsupported platelet recovery when compared with allogeneic bone marrow transplantation.
Danish: Modtagere af allogene 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.
English: The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Danish: Doseringsanbefalingerne for pædiatriske patienter er de samme som for voksne i myelosuppressiv cytotoksisk kemoterapi.
English: Excipients: glutamic acid, polysorbate 80, water for injections and sorbitol (E420).
Danish: Hjælpestoffer: glutaminsyre, polysorbat 80, vand til injektionsvæske og sorbitol (E420).
English: • if you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Danish: • hvis du får en eller flere af følgende bivirkninger: hævelse eller opsvulmethed, der kan være forbundet med mindre hyppig vandladning, åndedrætsbesvær, opsvulmet mave og mæthedsfølelse samt en generel følelse af træthed.
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 reduceret knogledensitet og osteoporose er blevet rapporteret hos pædiatriske patienter med svær, kronisk neutropeni, der fik kronisk behandling med filgrastim.
English: Example: In a final volume of 20 ml, total doses of filgrastim less than 30 MU (300 μg) should be given with 0.2 ml of human serum albumin 200 mg/ml (20%) solution Ph. Eur.
Danish: Eksempel: I en slutvolumen på 20 ml bør totale doser filgrastim på mindre end 30 mill. E (300 μg) gives med 0,2 ml tilsat humant serumalbumin 200 mg/ml (20 %) opløsning Ph. Eur.
English: • if you have a combination of any of the following symptoms: fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation, shortness of breath, extreme pain or discomfort and clammy or sweaty skin.
Danish: • hvis du har en kombination af nogle af følgende symptomer: feber eller kulderystelser, fryser meget, forhøjet puls, forvirring eller desorientering, stakåndethed, ekstreme smerter eller ekstremt ubehag, og klam eller svedende hud.
English: This should be considered when interpreting boneimaging results.
Danish: Dette bør tages i betragtning ved tolkning af billeddiagnostik af knogler.
English: Remove one syringe from the pack and remove the protective cap from the injection needle.
Danish: Tag en injektionssprøjte fra pakningen og fjern beskyttelseshætten fra kanylen, der skal bruges til indsprøjtning.
English: Put the used syringe in the disposal container.
Danish: Læg den brugte injektionssprøjte i den punktérfri affaldsbeholder.
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 behandling med kemoterapeutika (alene eller i kombination), som vides at forårsage svær trombocytopeni.
English: In patients treated with myeloablative therapy followed by bone marrow transplantation
Danish: Hos patienter i myeloablativ behandling efterfulgt af knoglemarvstransplantation
English: White blood cell counts of 100 x 109/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: Der er påvist leukocyttal på 100 x 109/l eller derover hos mindre end 5 % af de cancerpatienter, der behandles med filgrastim ved doser over 0,3 mill. E/kg/dag (3 μg/kg/dag).
English: The effects of filgrastim on neutropenia due to bone marrow-infiltrating infection or malignancy have not been well established.
Danish: Filgrastims virkning på neutropeni, der er forårsaget af en knoglemarvsinfiltrerende infektion eller malignitet, kendes ikke.
English: Filgrastim HEXAL is one of a group of products that stimulate the production of white blood cells.
Danish: Filgrastim HEXAL tilhører en gruppe lægemidler, der stimulerer produktionen af hvide blodlegemer.
English: Congenital, idiopathic or cyclic neutropenia: Filgrastim should be given by subcutaneous injection.
Danish: Medfødt, idiopatisk eller cyklisk neutropeni: Filgrastim gives som subkutan injektion.
English: - 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 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: - Reduktion i varigheden af neutropeni og i forekomsten af febril neutropeni hos patienter behandlet med etableret cytotoksisk kemoterapi ved malignitet (med undtagelse af kronisk myeloid leukæmi og myelodysplastiske syndromer) samt til reduktion i varigheden af neutropeni hos patienter i myeloablativ behandling, der efterfølges af knoglemarvstransplantation, og som menes at have øget risiko for langvarig, alvorlig neutropeni.
English: • decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
Danish: • nedsat antal blodplader, som nedsætter blodets evne til at størkne (trombocytopeni)
English: Pre-filled syringe (type I glass) with injection needle (stainless steel), with or without a needle safety guard, containing 0.5 ml solution.
Danish: Fyldt injektionssprøjte (type I-glas) med kanyle (rustfrit stål) med eller uden kanylebeskytter, indeholdende 0,5 ml opløsning.
English: - notice unusual bleeding or bruising [these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot].
Danish: - bemærker usædvanlige blødninger eller blå mærker [det kan være symptomer på et nedsat antal blodplader (trombocytopeni) og nedsat koagulationsevne (blodet har sværere ved at størkne)].
English: Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.
Danish: Ring straks til lægen, hvis du får hævelser i ansigt, eller dine ankler hæver, hvis du får blod i urinen eller brunfarvet urin, eller hvis du bemærker, at du ikke lader vandet så hyppigt som normalt.
English: • pain and swelling of the joints, similar to gout (pseudogout)
Danish: • smerter og hævelse i led, der ligner podagra (pseudopodagra)
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
Danish: • hvis du oplever en allergisk reaktion, herunder svaghed, blodtryksfald, vejrtrækningsbesvær, hævelser i ansigtet (anafylakse), hududslæt, kløende udslæt (urticaria), hævelse af ansigtet, læber, mund, tunge eller hals (angioødem) og stakåndethed (dyspnø).
English: Medicines (containing sorbitol/fructose) given intravenously may be lifethreatening and should be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.
Danish: Babyer og småbørn (under 2 år) kan have hereditær fructoseintolerans (HFI) uden at være diagnosticeret for det. Lægemidler (indeholdende sorbitol / fructose) givet intravenøst kan være livstruende og bør være kontraindiceret for denne population, medmindre der er et overvældende klinisk behov, og der ikke findes andet alternativ.
English: Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation may reduce progenitor yield.
Danish: Når præparater som melphalan, carmustin (BCNU) og carboplatin administreres over lang tid, før det forsøges at foretage stamcellemobilisering, kan det medføre nedsat stamcellehøst.
English: Treatment with filgrastim significantly reduces the duration of febrile neutropenia, antibiotic use and hospitalisation after induction chemotherapy for acute myelogenous leukaemia or myeloablative therapy followed by bone marrow transplantation.
Danish: Behandling med filgrastim reducerer i signifikant grad varigheden af febril neutropeni, brug af antibiotika samt hospitalsindlæggelse efter induktionskemoterapi mod akut myeloid leukæmi eller myeloablativ behandling efterfulgt af knoglemarvstransplantation.
English: • pain in your mouth and throat (oropharyngeal pain)
Danish: • smerter i mund og svælg (orofaryngeale smerter)
English: The most serious adverse reactions that may occur during filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
Danish: De mest alvorlige bivirkninger, der kan forekomme under behandling med filgrastim, omfatter: anafylaktisk reaktion, svære pulmonale bivirkninger (herunder interstitiel pneumoni og ARDS), kapillærlækage-syndrom, svær splenomegali/miltruptur, transformation til myelodysplastisk syndrom eller leukæmi hos patienter med SCN, GvHD hos patienter, der får allogen knoglemarvstransplantation eller transplantation af perifere blodstamceller samt seglcellekrise hos patienter med seglcellesygdom.
English: Long-term administration may be required to maintain the ANC > 2.0 x 109/l.
Danish: Langtidsadministration kan være nødvendigt for at fastholde et absolut neutrofiltal > 2,0 x 109/l.
English: 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.
Danish: Hos patienter med påvist knoglemarvsinfiltrerende infektion eller malignitet bør det overvejes at behandle den underliggende tilstand samtidig med at neutropenien behandles med filgrastim.
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 potentielle risiko i forbindelse med svær leukocytose tilrådes det imidlertid at kontrollere leukocyttallet med regelmæssige intervaller under behandling med filgrastim.
English: Some cases of splenic rupture were fatal (see section 4.4).
Danish: I nogle tilfælde var miltruptur dødelig (se pkt.
English: The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Danish: Virkningen af filgrastim hos patienter med udtalt nedsættelse af myeloide stamceller er ikke undersøgt.
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 stærkt nedsat nyre- eller leverfunktion viser, at filgrastim har en farmakokinetisk og farmakodynamisk profil, som ligner den, man ser hos raske personer.
English: • to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;
Danish: • til at øge antallet af hvide blodlegemer efter behandling med kemoterapi for at hjælpe med at forebygge infektioner,
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 - 2 days, and to normal levels within 1 - 7 days.
Danish: Efter seponering af filgrastim falder antallet af cirkulerende neutrofiler med 50 % inden for 1-2 døgn og normaliseres inden for 1-7 døgn.
English: Glomerulonephritis has been reported in patients receiving filgrastim or pegfilgrastim.
Danish: Der er indberettet glomerulonefritis hos patienter, der fik filgrastim eller pegfilgrastim.
English: Filgrastim dose adjustment
Danish: Filgrastim-dosisjustering
English: Filgrastim HEXAL must not be diluted with sodium chloride solutions.
Danish: Filgrastim HEXAL må ikke fortyndes med natriumchloridopløsninger.
English: Filgrastim may be given as a 30 minute or 24 hour intravenous infusion or given by continuous 24 hour subcutaneous infusion.
Danish: Filgrastim kan gives som intravenøs infusion over 30 minutter eller 24 timer eller som kontinuerlig subkutan infusion over 24 timer.
English: - experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual (glomerulonephritis).
Danish: - får hævelser i ansigt, eller dine ankler hæver, får blod i urinen eller brunfarvet urin, eller du bemærker, at du ikke lader vandet så hyppigt som normalt (glomerulonefritis).
English: Contents of the pack and other information What Filgrastim HEXAL contains
Danish: Pakningsstørrelser og yderligere oplysninger Filgrastim HEXAL indeholder