FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use the Nivestim syringe if the liquid has particles floating in it or any of the liquid has leaked out of the syringe.
Danish: Brug ikke Nivestim sprøjten, hvis opløsningen indeholder partikler, eller hvis den lækker ud af sprøjten.
English: Excipient with known effect Each ml of solution contains 50 mg of sorbitol (E420) (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver ml opløsning indeholder 50 mg sorbitol (E420) (se pkt.
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, som skyldes knoglemarvsinfiltrerende infektioner eller maligne sygdomme, kendes ikke.
English: The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome, or chronic myelogenous leukaemia have not been established.
Danish: Filgrastims sikkerhed og virkning hos patienter med myelodysplastisk syndrom eller kronisk myeloid leukæmi er ikke dokumenteret.
English: Hepatomegaly Blood alkaline phosphatase increased
Danish: Hepatomegali Forhøjet alkalisk fosfatase i blodet
English: • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Danish: • Betændelse i blodkarrene i huden (kutan vaskulitis)
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Danish: Der er indberettet glomerulonefritis hos patienter, der får filgrastim og pegfilgrastim.
English: 1 pre-filled syringe with 0.5 ml 5 pre-filled syringes with 0.5 ml 8 pre-filled syringes with 0.5 ml 10 pre-filled syringes with 0.5 ml
Danish: 1 fyldt sprøjte med 0,5 ml 5 fyldte sprøjter med 0,5 ml 8 fyldte sprøjter med 0,5 ml 10 fyldte sprøjter med 0,5 ml
English: Other medicines and Nivestim
Danish: Brug af anden medicin sammen med Nivestim
English: With your other hand, insert the needle at an approximate 45˚ angle.
Danish: Stik kanylen ind under huden i en vinkel på ca. 45 grader med den anden hånd.
English: Aspartate aminotransferase increased
Danish: Forhøjet aspartataminotransferase Forhøjet gammaglutamyltransferase
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 stoppes før, det forventede nadir er passeret, og neutrofiltallet er indenfor referenceintervallet.
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 opstå under behandling med filgrastim omfatter: anafylaktisk reaktion, alvorlige pulmonale bivirkninger (herunder interstitiel pneumoni og ARDS), kapillær lækage-syndrom, alvorlig splenomegali/miltruptur, transformation til myelodysplastisk syndrom eller leukæmi hos SCN-patienter, GvHD hos patienter, der modtager allogen knoglemarvstransplantation eller transplantation af perifere blodstamceller samt seglcellekrise hos patienter med seglcelleanæmi.
English: As a result of the potential to receive higher doses or a greater number of these medications with filgrastim therapy, the patient may be at higher risk of developing thrombocytopenia and anaemia.
Danish: Da de patienter, som er i behandling med filgrastim, har mulighed for at få højere doser og flere kombinationer af disse lægemidler, kan de have større risiko for at udvikle trombocytopeni og anæmi.
English: Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 10
Danish: Afbrydelse af behandlingen eller dosisreduktion af filgrastim bør overvejes hos patienter med alvorlig kronisk neutropeni som udvikler trombocytopeni (trombocyttal < 100 x 10
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 de patienter, som har kendte knoglemarvsinfiltrerende infektioner eller maligne sygdomme, bør det overvejes at behandle den underliggende sygdom på passende måde i tillæg til neutropenibehandlingen med filgrastim.
English: Exacerbation of rheumatoid arthritis
Danish: Nedsat knogletæthed Forværring af reumatoid arthritis
English: 9/L, with the median dose frequency being 3 days per week.
Danish: Den mediane doseringshyppighed var 3 dage pr. uge.
English: Filgrastim 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: Filgrastim 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 (bortset fra 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 øget risiko for langvarig svær neutropeni.
English: • lack of absorption of oxygen in the lung (hypoxia)
Danish: • Manglende optagelse af ilt i lungerne (hypoksi)
English: Diluted filgrastim may be adsorbed to glass and plastic materials unless it is diluted in 5% glucose solution (see section 6.6).
Danish: Fortyndet filgrastim kan adsorberes til glas- og plastmaterialer, medmindre det er fortyndet i 5 % glucoseopløsning (se pkt.
English: Injection site reaction
Danish: Reaktion på injektionsstedet
English: Nivestim contains sodium
Danish: Nivestim indeholder natrium
English: • enlargement of the liver (hepatomegaly)
Danish: • Forstørret leveren (hepatomegali)
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: Stoffer som melphalan, carmustin (BCNU) og carboplatin kan medføre nedsat høst af progenitorceller, hvis de gives i lang tid, før det forsøges at foretage mobilisering af progenitorceller.
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 Nivestim efter den udløbsdato, der står på den ydre pakning og på den fyldte sprøjte efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim.
Danish: Der er indberettet tilfælde af nedsat knogletæthed og osteoporose hos pædiatriske patienter med svær kronisk neutropeni, der fik kronisk behandling med filgrastim.
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
Danish: Efter seponering af filgrastimbehandlingen nedsættes det cirkulerende neutrofiltal med 50 % indenfor 1 til 2 døgn, og normaliseres indenfor 1 til 7 døgn.
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 usædvanlig blødning, eller at du lettere får blå mærker (dette kan være symptomer på et lavere antal blodplader (trombocytopeni), hvor blodet har nedsat evne til at størkne).
English: Nivestim 12 MU/0.2 ml
Danish: Nivestim 12 ME/ 0,2 ml
English: The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Danish: Doseringsrekommendationerne til børn er de samme som til voksne, som får myelosuppressiv cytotoksisk kemoterapi.
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 det kan gives som kontinuerlig, subkutan infusion over 24 timer.
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Danish: Der bør skelnes omhyggeligt mellem diagnoserne blasttransformation af kronisk myeloid leukæmi og akut myeloid leukæmi.
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (> 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Danish: Der blev ikke observeret nogen generelle forskelle for så vidt angår sikkerheden eller effekten hos patienter over 65 år sammenlignet med yngre voksne (> 18 år) patienter, der fik kemoterapi med cytotoksika.
English: Capillary leak syndrome
Danish: Kapillær lækage-syndrom
English: EXP After dilution use within 24 hours.
Danish: EXP Skal bruges senest 24 timer efter fortynding.
English: Nivestim 48 MU/0.5 ml
Danish: Nivestim 48 ME/ 0,5 ml
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: Til patienter, som behandles med filgrastim, som er fortyndet til en koncentration under 1,5 mio E (15 µg) pr. ml, bør der tilføjes humant serumalbumin til en slutkoncentration på 2 mg/ml.
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in patients with cancer treated with filgrastim.
Danish: Der er rapporteret om pseudopodagra (chondrocalcinose pyrophosphat) hos cancerpatienter, som blev behandlet med filgrastim.
English: The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established.
Danish: Filgrastims sikkerhed og virkning er ikke sikkert fastlagt, hvis det gives på samme dag som myelosuppressiv cytotoksisk kemoterapi.
English: Special precautions in patients with HIV infection
Danish: Særlige forsigtighedsregler hos patienter med HIV-infektioner
English: Nivestim works by encouraging the bone marrow to produce more white blood cells.
Danish: Nivestim virker ved at stimulere knoglemarven til at producere flere hvide blodlegemer.
English: There is insufficient data to further evaluate filgrastim use in paediatric subjects.
Danish: Der er ikke tilstrækkelige data til yderligere at evaluere anvendelse af filgrastim til børn.
English: Remove the needle from your skin, then let go of the plunger and allow the syringe to move up until the entire needle is guarded and locks into place.
Danish: Slip derefter stemplet og lad sprøjten flytte sig op over, indtil hele kanylen er beskyttet og låst fast.
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Danish: Der er rapporteret om tilfælde af Sweets syndrom (akut febril neutrofil dermatose) hos patienter, som blev behandlet med filgrastim.
English: After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
Danish: Efter fortynding: Der er vist, at den fortyndede infusionsvæske er kemisk og fysisk stabil i 24 timer ved 2 °C til 8 °C.
English: For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MU (10 µg)/kg/day for 4 to 5 consecutive days.
Danish: Til PBPC-mobilisering hos raske donorer bør filgrastim gives i en dosis på 1,0 ME (10 µg)/kg/dag i 4 til 5 konsekutive dage.
English: Special care should be taken in the diagnosis of SCNs to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia, and myeloid leukaemia.
Danish: Man bør være særlig omhyggelig med at stille diagnosen SCNfor at differentiere fra andre hæmatologiske lidelser som f.eks. aplastisk anæmi, myelodysplasi og myeloid leukæmi.
English: • tingling or numbness of the hands or feet (paraesthesia)
Danish: • Snurren eller følelsesløshed i hænder eller fødder (paræstesi)
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis (see section 4.4).
Danish: Generelt er disse opstået hos patienter med fremskredne maligne sygdomme eller sepsis og hos patienter, der har fået flere kemoterapeutika, eller som har gennemgået aferese (se pkt.
English: The recommended starting dose of filgrastim is 0.1 MU (1 µg)/kg/day with titration up to a maximum of 0.4 MU (4 µg)/kg/day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 10
Danish: Dosis gives med titrering op til højst 0,4 ME (4 µg)/kg/dag, indtil der er opnået et normalt neutrofiltal, som kan opretholdes (ANC > 2,0 x10
English: For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Danish: Mobilisering af perifere blodprogenitorceller (PBPC'er) hos patienter i myelosuppressiv eller myeloablativ behandling efterfulgt af autolog transplantation med PBPC'er.
English: There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Danish: I de kliniske studier var der en lav frekvens af myelodysplastiske syndromer (MDS) eller leukæmi hos patienter med SCN, som blev behandlet med Nivestim (ca. 3 %).
English: When a PBPC transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Danish: Det er tilrådeligt at planlægge proceduren for stamcellemobiliseringen tidligt i behandlingsforløbet af patienten, når en transplantation af PBPC kan forudses.
English: • decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
Danish: • Nedsat blodcelletal som reducerer blodets evne til at størkne (trombocytopeni)
English: Sickle cell crises, in some cases fatal, have been reported with the use of filgrastim in patients with sickle cell trait or sickle cell disease.
Danish: Der er rapporteret om seglcellekrise, som i visse tilfælde var dødbringende, ved behandling med filgrastim hos patienter med seglcelletræk eller seglcelleanæmi.
English: Urinalysis monitoring is recommended.
Danish: Det anbefales, at der tages urinprøver for at monitorere dette.
English: Special warning and precautions associated with co-morbidities
Danish: Særlige advarsler og forholdsregler i forbindelse med komorbiditeter
English: Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Danish: Brug af filgrastim til mobilisering af PBPC hos raske donorer før en allogen PBPC transplantation
English: Permanently discontinue filgrastim in patients with clinically significant hypersensitivity.
Danish: Filgrastim skal seponeres permanent hos patienter med klinisk signifikant overfølsomhed.
English: The most commonly reported adverse reactions are pyrexia, musculoskeletal pain (which includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anaemia, vomiting, and nausea.
Danish: De hyppigst rapporterede bivirkninger er pyreksi, muskuloskeletale smerter (som inkluderer knoglesmerter, rygsmerter, arthralgi, myalgi, smerter i ekstremiterne, muskuloskeletale smerter, muskuloskeletale brystsmerter, nakkesmerter), anæmi, opkastning og kvalme.
English: Uncommon (≥ 1/1,000 to
Danish: Ikke almindelig (≥ 1/1.000 til
English: Injecting the solution with an air bubble present is harmless.
Danish: Det er ikke farligt at indsprøjte opløsningen, selvom der er en luftboble.
English: Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Danish: Filgrastim påvirkede ikke reproduktionsevnen eller fertiliteten hos han- eller hunrotter (se pkt.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: • abnormal x-rays of the lungs (lung infiltration)
Danish: • Unormale røntgenbilleder af lungerne (lungeinfiltration)
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 hævede ankler, blod i urinen eller brun urin, eller hvis du bemærker at du ikke lader vandet så ofte som du plejer (glomerulonefritis).
English: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2°C to 8°C.
Danish: Det er påvist, at den fortyndede infusionsvæske er kemisk og fysisk stabil i 24 timer ved 2 °C-8 °C.
English: An increased incidence of embryo loss has been observed in rabbits at high multiples of the clinical exposure and in the presence of maternal toxicity (see section 5.3).
Danish: I kaniner blev der observeret forhøjet tab af embryoner og maternel toxicitet ved eksponeringer mange gange højere end den kliniske eksponering (se pkt.
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 behandling med filgrastim bør fortsætte, indtil det forventede neutrofile nadir er passeret, og indtil neutrofiltallet er indenfor referenceintervallet.
English: • The other ingredients are acetic acid (glacial), sodium hydroxide, sorbitol E420, polysorbate 80, and water for injections.
Danish: - Øvrige indholdsstoffer: eddikesyre, natriumhydroxid, sorbitol E420, polysorbat 80 og vand til injektionsvæske.
English: Solution for injection/infusion.
Danish: Injektions-/infusionsvæske.
English: In patients treated with myeloablative therapy followed by bone marrow transplantation
Danish: Patienter, som får myeloablativ behandling efterfulgt af knoglemarvstransplantation
English: Please tell your doctor immediately during treatment: - 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: Fortæl det straks til lægen under behandlingen: - hvis du får en allergisk reaktion, herunder svækkelse, blodtryksfald, vejrtrækningsbesvær, hævelse i ansigtet (anafylaksi), hududslæt, kløende udslæt, hævelse af ansigt, læber, mund, tunge eller svælg (angioødem) eller kortåndethed.
English: Physicians should use caution when prescribing filgrastim in patients with sickle cell trait or sickle cell disease.
Danish: Lægen skal udvise forsigtighed ved ordination af filgrastim til patienter med seglcelletræk eller seglcelleanæmi.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy suggesting no age-related differences in the pharmacokinetics of filgrastim.
Danish: Data fra kliniske studier med pædiatriske patienter viser, at sikkerheden og effekten af filgrastim er ens hos voksne og børn, der får kemoterapi med cytotoksika, hvilket tyder på, at der ikke er nogen aldersrelaterede forskelle i farmakokinetikken for filgrastim.
English: In most cases, aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF (see section 4.8).
Danish: Aortitis blev i de fleste tilfælde konstateret ved hjælp af CT-scanning og fortog sig generelt efter seponering af G-CSF.
English: Filgrastim had no observed effect on the fertility of male or female rats.
Danish: Filgrastim havde ingen observeret virkning på han- eller hunrotters fertilitet.
English: The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Danish: Filgrastims virkning hos patienter med udtalt nedsættelse af antallet af myeloide stamceller er ikke undersøgt.
English: Common (≥ 1/100 to
Danish: Almindelig (≥ 1/100 til < 1/10)
English: SYRINGE LABEL
Danish: SPRØJTEETIKET
English: Special precautions in patients undergoing PBPC mobilisation
Danish: Særlige forsigtighedsregler hos patienter, som får foretaget mobilisering af PBPC
English: Acetic acid glacial, sodium hydroxide, polysorbate 80, sorbitol (E420) and water for injections..
Danish: Eddikesyre, natrium hydroxid, polysorbat 80, sorbitol (E420) og vand til injektionsvæsker.
English: For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Danish: Det er ofte tilstrækkeligt med én leukaferese hos patienter, som ikke har fået omfattende kemoterapi.
English: Prior exposure to cytotoxic agents
Danish: Tidligere eksponering for cytotoksiske stoffer
English: The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Danish: Filgrastims sikkerhed og virkning er den samme hos voksne og børn, som får cytotoksisk kemoterapi.
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 ml of 20% human albumin solution Ph. Eur.
Danish: Eksempel: Ved et slutvolumen til injektion på 20 ml bør totaldoser af filgrastim på under 30 mio E (300 µg) gives efter tilsætning af 0,2 ml 20 % human serumalbuminopløsning Ph. Eur.
English: In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 10
Danish: Langtidsbehandling med filgrastim er indiceret til børn eller voksne med svær medfødt, cyklisk eller idiopatisk neutropeni med et absolut neutrofiltal (ANC)  0,5 x 10
English: 9/L) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 10
Danish: 9/l) hos 41 % af donorerne og forbigående trombocytopeni
English: Discontinue filgrastim
Danish: Stop behandlingen med filgrastim
English: Do not administer filgrastim to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Danish: Filgrastim må ikke administreres til patienter med overfølsomhed over for filgrastim eller pegfilgrastim i anamnesen.
English: Each ml contains 60 million units [MU] (600 g) or 96 million units [MU] (960 g) of filgrastim.
Danish: Hver ml indeholder 60 millioner enheder (ME) (600 µg) eller 96 millioner enheder (ME) (960 µg) filgrastim.
English: • 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: - får smerter i øverste venstre side af maven, smerter under brystkassen i venstre side eller yderst på skulderen (dette kan være symptomer på forstørret milt (spenomegali) eller muligvis bristet milt).
English: Filgrastim dose adjustment
Danish: Dosisjustering af filgrastim
English: • swelling in the hands and feet (oedema peripheral)
Danish: • Hævelse af hænder og fødder (perifert ødem)
English: Initial dose adjustment to alternate day dosing with 30 MU (300 µg)/day is recommended.
Danish: Det anbefales initialt at justere dosis til 30 ME (300 µg)/dag hver anden dag.