FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy
Danish: Uønskede hændelser med en højere forekomst hos filgrastimpatienter, sammenlignet med placebo, og forbundet med sequelae af underliggende malignitet eller cytotoksisk kemoterapi
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: For patienter behandlet 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: • you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Danish: • du får hoste, feber og stakåndethed (dyspnø), da dette kan være tegn på lungesvigt (Acute Respiratory Distress Syndrome ARDS).
English: Telephone +421/2-5262.1933
Danish: Tel: +421/2-5262.1933
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 hvor der er bevis for leukæmisk evolution.
English: Infections and malignancies causing myelosuppression Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Danish: Infektioner og maligne sygdomme, som forårsager myelosuppression Neutropeni kan skyldes opportunistiske knoglemarvsinfiltrerende infektioner som f.eks. Mycobacterium avium eller maligne sygdomme som f.eks. lymfomer.
English: Filgrastim is not indicated for use in these conditions.
Danish: Filgrastim er ikke indiceret ved disse sygdomme.
English: However, for a sustained therapeutic response, Grastofil 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 Grastofil dog ikke seponeres, før det forventede nadir er passeret, og neutrofiltallet igen ligger inden for normalværdiområdet.
English: Special warnings and precautions across indications
Danish: Specielle advarsler og forsigtighedsregler for alle indikationer
English: Your doctor may test your blood at regular intervals to see how well the Grastofil treatment is working.
Danish: Din læge kan tage blodprøver med jævne mellemrum for at se, hvor godt Grastofil behandlingen virker.
English: • sickle cell anaemia, as filgrastim can cause sickle cell crisis.
Danish: • seglcelleanæmi, da filgrastim kan fremkalde seglcellekrise.
English: Grastofil and bone marrow transplantation
Danish: Grastofil og knoglemarvstransplantation
English: What you need to know before you use Grastofil
Danish: Det skal du vide, før du begynder at bruge Grastofil
English: You will normally receive your first dose of Grastofil 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 Grastofil mindst 24 timer efter din kemoterapi og mindst 24 timer efter modtagelse af din knoglemarvstransplantation.
English: Dose reductions of filgrastim have been noted to slow or stop the progression of splenic enlargement in patients with severe chronic neutropenia, and in 3% of patients a splenectomy was required.
Danish: Det blev bemærket, at dosisreduktion af filgrastim nedsatte eller standsede progressionen af miltforstørrelse hos patienter med svær, kronisk neutropeni, og hos 3 % af patienterne var en splenektomi påkrævet.
English: cells/kg recipient bodyweight.
Danish: celler/kg af modtagerens legemsvægt.
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 oppustet ansigt eller hævede ankler, blod i urinen eller brunfarvet urin, eller du lader vandet mindre end normalt (glomerulonefritis).
English: • allergic reaction (hypersensitivity)
Danish: • allergiske reaktioner (overfølsomhed)
English: These could be symptoms of a condition 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 tilstand, som kaldes ”kapillær lækagesyndrom”, og som får blod til at lække fra de små blodkar ud i kroppen og kræver omgående lægehjælp.
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 dit ansigt bliver oppustet eller dine ankler hæver, du får blod i urinen eller din urin bliver brunfarvet og du lægger mærke til, at du ikke lader vandet så tit.
English: • high blood pressure (hypertension)
Danish: • højt blodtryk (hypertension)
English: • nose bleeds (epistaxis)
Danish: • næseblod (epistaxis)
English: Each mL of solution contains 50 mg of sorbitol (E420) (see section 4.4).
Danish: Hver ml opløsning indeholder 50 mg sorbitol (E420) (se pkt.
English: N Acute grade II - IV GvHD
Danish: Akut grad IIIV GvHD
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with filgrastim.
Danish: Der er indberettet overfølsomhed, herunder anafylaktiske reaktioner, som er opstået efter den første eller efterfølgende behandlinger, hos patienter, der blev behandlet med filgrastim.
English: • you have any of the following or a combination of the following side effects: o 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: • du har en eller flere af følgende bivirkninger: Hævelse eller oppustethed, som kan være forbundet med mindre hyppig vandladning, åndedrætsbesvær, oppustet mave og følelse af opfyldning samt en generel følelse af træthed.
English: Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in ANCs in peripheral blood and a reduction of infection and related events.
Danish: Anvendelsen af filgrastim til patienter, børn eller voksne med SCN (alvorlig medfødt, cyklisk og idiopatisk neutropeni) fremkalder en vedvarende øgning af det absolutte neutrofiltal i perifert blod og en reduktion i antallet af infektioner og relaterede hændelser.
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret: MM/ÅÅÅÅ
English: Congenital, idiopathic or cyclic neutropenia: Grastofil should be given by subcutaneous injection.
Danish: Medfødt, idiopatisk eller cyklisk neutropeni: Grastofil skal gives som subkutan injektion.
English: Grastofil works by stimulating the bone marrow to produce more white blood cells.
Danish: Grastofil virker ved at anspore knoglemarven til at producere flere hvide blodlegemer.
English: Within its shelf-life and for the purpose of ambulatory use, the patient may remove Grastofil from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 15 days.
Danish: Inden for opbevaringstiden og til ambulante formål kan patienterne tage Grastofil ud af køleskabet og opbevare det ved stuetemperatur (ikke over 25 °C) i en enkelt periode på op til 15 dage.
English: Acute respiratory distress syndrome a
Danish: Akut respiratorisk distress syndrom a
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 (dette kan være symptomer på et nedsat antal blodplader (trombocytopeni), hvor blodets størkningsevne er nedsat).
English: Rare (≥ 1/10,000 to <
Danish: Sjælden (≥ 1/10.000 til
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Danish: Der fandtes ingen forskelle med hensyn til sikkerhedsprofilerne for pædiatriske patienter behandlet for svær, kronisk neutropeni.
English: Your doctor will perform regular blood tests to determine the best time to collect the stem cells.
Danish: Din læge vil tage regelmæssige blodprøver for at afgøre det bedste tidspunkt til at indsamle stamceller.
English: Reversal of neutropenia or maintaining normal neutrophil counts: Grastofil should be given by subcutaneous injection.
Danish: Behandling af neutropeni eller opretholdelse af normale neutrofiltal: Grastofil skal gives som subkutan injektion.
English: Transfusion reaction e a
Danish: Transfusionsreaktion e
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 PBPC' er, som er mobiliseret med filgrastim, oplevede signifikant hurtigere hæmatologisk restitution, som medførte et signifikant fald i tiden til ikke-understøttet trombocytrestitution sammenlignet med allogen knoglemarvstransplantation.
English: The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Danish: Virkningerne af filgrastim hos patienter med stærkt reduceret antal af myeloide progenitorceller er ikke blevet undersøgt.
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 opløsning til infusion er kemisk og fysisk stabil i 24 timer ved 2 °C til 8 °C.
English: In randomised clinical studies, a subcutaneous dose of 230 micrograms/m2/day (4.0 to 8.4 micrograms/kg/day) was used.
Danish: I randomiserede kliniske studier er en subkutan dosis på 230 µg/m2/dag (4,0-8,4 µg/kg/dag) anvendt.
English: STADA Nordic ApS, Suomen sivuliike Telephone +358/207.416.888
Danish: STADA Nordic ApS, Suomen sivuliike Puh/Tel: +358/207.416.888
English: • you have a combination of any of the following symptoms: o 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: • du har en kombination af nogle af de følgende symptomer: o feber eller kulderystelser, fryser meget, høj puls, forvirring eller desorientering, åndenød, ekstreme smerter eller utilpashed og klam eller svedende hud.
English: Long-term daily administration is required to maintain an adequate neutrophil count.
Danish: Det er nødvendigt med daglig behandling i længere tid for at opretholde et tilfredstillende neutrofiltal.
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 200 mg/mL (20%) human albumin solution added.
Danish: F.eks.: Ved en slutvolumen til injektion på 20 ml skal totaltdoser af filgrastim på under 30 ME (300 µg) gives med 0,2 ml 200 mg/ml (20 %) humant albuminopløsning tilsat.
English: If required, Grastofil may be diluted in 5% glucose.
Danish: Om nødvendigt kan Grastofil fortyndes i en 5 % glucoseopløsning.
English: • you experience kidney injury (glomerulonephritis).
Danish: • du får nyreskade (glomerulonefritis).
English: Yields in excess of this minimum yield appear to correlate with more rapid recovery; those below with slower recovery.
Danish: Et større høstudbytte end dette ser ud til at kunne korreleres til hurtigere bedring og et mindre høstudbytte til en langsommere bedring.
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count).
Danish: Symptomerne omfattede feber, mavesmerter, utilpashed, rygsmerter og øgede inflammationsmarkører (f.eks. C-reaktivt protein og antal hvide blodlegemer).
English: Telephone +39/02-89.421721
Danish: Tel: +39/02-89.421721
English: Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Danish: Infusion af PBPC'er fremmer den hæmatopoietiske restitution, idet perioden med risiko for hæmoragiske komplikationer og behovet for trombocyttransfusioner forkortes.
English: Type I glass pre-filled syringe with permanently attached stainless steel needle in the tip and 1/40 printed markings for graduations from 0.1 mL to 1 mL on the barrel.
Danish: Type I-glas fyldt injektionssprøjte med permanent isat kanyle af rustfrit stål i spidsen og med 1/40 trykte markeringer for graduering fra 0,1 ml til 1 ml på cylinderen.
English: These have generally occurred in patients with advanced malignant diseases, sepsis, using multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Danish: Disse er generelt forekommet hos patienter med fremskreden malign sygdom, sepsis, patienter, som brugte flere kemoterapeutiske lægemidler eller gennemgik aferese (se pkt.
English: Grastofil should be given by subcutaneous injection.
Danish: Grastofil skal gives som subkutan injektion.
English: The first dose of Grastofil should be administered at least 24 hours after cytotoxic chemotherapy.
Danish: Den første dosis Grastofil må administreres mindst 24 timer efter cytotoksisk kemoterapi.
English: Grastofil and severe chronic neutropenia (low number of a type of white blood cells)
Danish: Grastofil og svær kronisk neutropeni (lavt antal af en type hvide blodlegemer)
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 modtog kronisk behandling med filgrastim.
English: In clinical studies, dosing with 30 MU/day (300 micrograms/day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 10
Danish: I kliniske studier var det nødvendigt at give 30 ME/dag (300 mikrogram/dag) i 1 til 7dage pr. uge for at opretholde et ANC > 2,0 x 10
English: The recommended dose of Grastofil for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MU/kg/day (5 micrograms/kg/day) 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 Grastofil dosis til PBPC-mobilisering efter myelosuppresiv kemoterapi er 0,5 ME/kg/dag (5 mikrogram/kg/dag), 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: • enlargement of the liver (hepatomegaly)
Danish: • forstørret lever (hepatomegali)
English: Therefore, in patients with reduced precursors, neutrophil response may be diminished (such as those treated with extensive radiotherapy or chemotherapy, or those with bone marrow infiltration by tumour).
Danish: Det neutrofile respons kan derfor være formindsket hos patienter med et nedsat antal precursor-celler (f.eks. hos patienter, som er behandlet med intensiv stråle- eller kemoterapi, eller patienter med tumorinfiltration i knoglemarven).
English: Dizziness may occur following the administration of filgrastim (see section 4.8).
Danish: Der kan opstå svimmelhed efter administration af filgrastim (se pkt.
English: Grastofil for PBPC mobilisation when used alone Grastofil may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Danish: Grastofil til PBPC-mobilisering, når det anvendes alene Grastofil kan gives som en 24 timers subkutan kontinuerlig infusion eller subkutan injektion.
English: The mechanism of vasculitis in patients receiving filgrastim is unknown.
Danish: Mekanismen bag vaskulitis hos patienter, der får filgrastim er ikke kendt.
English: Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (2.0 x 10
Danish: Tidligere eksponering over for cytotoksiske lægemidler Patienter, der tidligere har fået omfattende myelosuppressiv kemoterapi, vil ikke altid opnå tilstrækkelig mobilisering af PBPC til at nå det anbefalede minimumsresultat (2,0 x 10
English: • lack of absorption of oxygen in the lung (hypoxia)
Danish: • manglende optagelse af ilt i lungerne (hypoxi)
English: You should not receive Grastofil in the 24 hours before and the 24 hours after receiving chemotherapy.
Danish: Du bør ikke få Grastofil i 24 timer før og 24 timer efter kemoterapi.
English: Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Danish: Trombocyttallet skal monitoreres nøje, især for de første få uger under behandlingen med filgrastim.
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus
Danish: • ømhed og hævelse af slimhinden i fordøjelseskanalen, som går fra munden til anus (mucositis)
English: Oral Pain
Danish: Orale smerter
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 med filgrastim hos patienter med svær nedsat nyre- eller leverfunktion har vist, at filgrastim har en farmakokinetisk og farmakodynamisk profil, som ligner den, man ser hos hos raske personer.
English: Medicinal products such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation, may reduce progenitor yield.
Danish: Lægemidler som melphalan, carmustin (BCNU) og carboplatin kan medføre en reduceret høst af progenitorceller, hvis de gives i lang tid, før det forsøges at foretage mobilisering af progenitorceller.
English: The needle cover of the pre-filled syringe contains dry natural rubber (latex, see section 4.4).
Danish: Kanylehætten på den fyldte injektionssprøjte indeholder tørt naturgummi (latex, se pkt.4.4).
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Danish: Tilfælde af Sweets syndrom (akut febril neutrofil dermatose) er blevet indberettet hos patienter behandlet med filgrastim.
English: Grastofil 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: Grastofil 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: Grastofil and neutropenia (low number of a type of white blood cells) in patients with HIV infection
Danish: Grastofil og neutropeni (lavt antal af en type hvide blodlegemer) hos patienter med HIV-infektion
English: • a new pre-filled syringe of Grastofil; and
Danish: • en ny fyldt injektionssprøjte med Grastofil og
English: Daily dosing with Grastofil should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Danish: Den daglige dosering med Grastofil skal fortsætte, indtil den forventede neutrofile nadir er passeret og neutrofiltallet ligger inden for de normale værdier.
English: Splenomegaly a
Danish: Splenomegali a
English: Blood glucose decreased
Danish: Nedsat glucose i blodet
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 infektion eller maligne sygdomme, kendes ikke tilstrækkeligt.
English: Grastofil for PBPC mobilisation after myelosuppressive chemotherapy Grastofil should be given by subcutaneous injection.
Danish: Grastofil til PBPC-mobilisering efter myelosuppressiv kemoterapi Grastofil skal gives som subkutan injektion.
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 til at hjælpe med at forebygge infektioner
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 kliniske forsøg var der en lav frekvens (ca. 3 %) af myelodysplastiske syndromer (MDS) eller leukæmi hos patienter med svær kronisk neutropeni, som blev behandlet med filgrastim.
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, skal det overvejes at behandle den underliggende sygdom på passende måde i tillæg til neutropenibehandlingen med filgrastim.
English: • severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)
Danish: • svære smerter i knoglerne, brystet, tarmen eller leddene (seglcelleanæmi med krise)
English: Telephone +420/257-888.111
Danish: Tel: +420/257-888.111
English: Special precautions in SCN patients
Danish: Særlige forsigtighedsregler hos SCN-patienter
English: In patients treated with myeloablative therapy followed by bone marrow transplantation
Danish: Hos patienter, der får myeloablativ behandling efterfulgt af knoglemarvstransplantation
English: België/Belgique/Belgien Eurogenerics SA/NV Telephone +32/2.479.78.78
Danish: België/Belgique/Belgien Eurogenerics SA/NV Tél/Tel: +32/2.479.78.78
English: The safety and efficacy of Grastofil are similar in adults, children and adolescents receiving cytotoxic chemotherapy.
Danish: Grastofils sikkerhed og virkning er den samme hos voksne, børn og unge, der får cytotoksisk kemoterapi.
English: Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Danish: Filgrastim virker primært på neutrofile precursor-celler og resulterer i forhøjede neutrofiltal.
English: Physicians should use caution when prescribing filgrastim in patients with sickle cell trait or sickle cell disease.
Danish: Læger skal udvise forsigtighed ved ordination af behandling med filgrastim hos patienter med seglcelletræk eller seglcellesygdom.
English: Special precautions in patients with HIV infection
Danish: Særlige forsigtighedsregler hos patienter med HIV-infektion
English: Hold the syringe with the needle pointing up.
Danish: Hold sprøjten med kanylen pegende opad.
English: How do I give my injection?
Danish: Hvordan kan jeg foretage injektionen?
English: Complete blood cell counts with differential and platelet counts and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
Danish: Før behandlingen bør der foretages en fuldstændig blodcelletælling med differential- og trombocyttælling, og der bør udføres en evaluering af knoglemarvsmorfologi og karyotype.