FrancophonIA/ELRC3.0 huggingface dataset:
English: A subset of approximately 12% of patients who had normal cytogenetic evaluations at baseline was subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
Danish: Hos en undergruppe på ca. 12 % af patienterne, som havde normal cytogenetik ved baseline, blev der senere fundet abnormiteter, inklusive monosomi 7, ved gentagne rutineundersøgelser.
English: In clinical trials, 97% of patients who responded had a complete response at doses ≤ 24 μg/kg/day.
Danish: I kliniske studier havde 97 % af de responderende patienter fuld respons ved doser ≤ 24 μg/kg/dag.
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Danish: Sikkerheden og virkningen af administration af filgrastim hos de novo-AML-patienter i alderen < 55 år med god cytogenetik [t(8;21), t(15;17) og inv(16)] er ikke fastlagt.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes omgående, er opbevaringstid og -betingelser før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2 °C til 8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: It can also be given as a daily slow injection into the vein (known as an intravenous infusion).
Danish: Det kan også gives som en daglig langsom indsprøjtning i venen (som kaldes en intravenøs infusion).
English: Regular urinalysis should be performed to monitor these events.
Danish: Der bør tages regelmæssige urinprøver for at monitorere eventuel disse hændelser.
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Danish: • nedsat fornemmelse af følsomhed, især i huden (hypæstesi)
English: The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Danish: Den anbefalede minimumshøst på ≥ 2,0 x 106 CD34+-celler/kg er baseret på publicerede erfaringer, der har medført adækvat hæmatologisk rekonstitution.
English: This section contains information on how to give yourself an injection of Filgrastim HEXAL.
Danish: Dette afsnit indeholder information om, hvordan du kan give dig selv en indsprøjtning med Filgrastim
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome [MDS]).
Danish: Hvis du er en patient med svær kronisk neutropeni, kan du have risiko for at udvikle blodkræft (leukæmi, myelodysplastisk syndrom [MDS]).
English: Risk associated with increased doses of myelosuppressive medicinal products
Danish: Risici forbundet med øgede doser af myelosuppressive lægemidler
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Danish: Data fra et studie med administration af en enkelt dosis tyder på, at intravenøs indgift afkorter virkningsvarigheden.
English: Elevations of neutrophil counts are dose-dependent at recommended doses.
Danish: Stigningen i neutrofiltallene er dosisafhængig ved de anbefalede doser.
English: This observation has only been made in patients with congenital neutropenia.
Danish: Denne observation er kun foretaget hos patienter med medfødt neutropeni.
English: Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
Danish: Ved induktions- og konsolideringsbehandling ved akut myeloid leukæmi kan behandlingstiden være betydeligt længere (op til 38 dage) afhængig af type, dosis og plan for den anvendte cytotoksiske kemoterapi.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Danish: Filgrastim bør ikke anvendes til at forhøje dosis af cytotoksisk kemoterapi ud over de etablerede dosisregimer.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Rates of generation of antibodies against filgrastim is generally low.
Danish: Hyppigheden af generering af antistoffer mod filgrastim er generelt lav.
English: The incidence of fever and documented infections were not reduced in either setting.
Danish: Forekomsten af feber og dokumenterede infektioner blev ikke reduceret i nogen af behandlingsregimenerne.
English: Your doctor will tell you how much Filgrastim HEXAL you should take.
Danish: Din læge vil fortælle dig, hvor meget Filgrastim HEXAL du skal tage.
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Danish: Graden af variation mellem de enkelte patienter og mellem laboratorieanalyser af CD34+-celler vanskeliggør en direkte sammenligning af forskellige studier.
English: Filgrastim HEXAL is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of proteins called cytokines.
Danish: Filgrastim HEXAL er en vækstfaktor for hvide blodlegemer (granulocytkoloni-stimulerende faktor) og tilhører en gruppe proteiner ved navn cytokiner.
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for filgrastim eller et af de øvrige indholdsstoffer i Filgrastim HEXAL (angivet i punkt 6).
English: Each graduation ring corresponds to a volume of 0.1 ml.
Danish: Hver ring på skalaen svarer til et volumen på 0,1 ml.
English: The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established.
Danish: Sikkerheden og virkningen af filgrastim givet samme dag som myelosuppressiv cytotoksisk kemoterapi er ikke definitivt fastlagt.
English: Cutaneous vasculitisa Sweets syndrome (acute febrile neutrophilic dermatosis)
Danish: Kutan vaskulitisa Sweets syndrom (akut febril neutrofil dermatose)
English: Geriatric use
Danish: Geriatrisk anvendelse
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Danish: Filgrastim bør seponeres permanent hos patienter, der oplever en alvorlig allergisk reaktion.
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 din urin (hæmaturi).
English: Relative Risk (95% CI) of GvHD and TRM Following treatment with G-CSF after bone marrow transplantation Publication
Danish: Relativ risiko (95 % CI) for GvHD og TRM Efter behandling med G-CSF efter knoglemarvstransplantation Publikation
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Danish: Neutrofiler, der er dannet som respons på filgrastim, udviser normal eller forøget funktion påvist ved test af kemotaktisk og fagocytisk funktion.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Danish: Som med andre hæmatopoietiske vækstfaktorer har G-CSF udvist in vitro-stimulerende egenskaber på humane endotelceller.
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Danish: Hvis høsten er utilstrækkelig i forhold til ovennævnte kriterier, bør alternative behandlingsformer uden stamcellestøtte overvejes.
English: In patients with HIV infection
Danish: Hos patienter med hiv-infektion
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 samlet forskel i sikkerhed og virkning hos personer over 65 år, sammenlignet med yngre voksne (> 18 år) personer, der fik cytotoksisk kemoterapi, og klinisk erfaring har ikke identificeret nogen forskelle i respons mellem ældre og yngre voksne patienter.
English: How long will I have to take Filgrastim HEXAL?
Danish: Hvor længe skal jeg tage Filgrastim HEXAL?
English: In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Danish: Når det skal vurderes, hvor mange stamceller der er blevet høstet hos patienter i filgrastimbehandling, bør man især være opmærksom på kvantificeringsmetoden.
English: Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-fluorouracil indicates that the severity of neutropenia may be exacerbated.
Danish: Præliminære oplysninger fra et mindre antal patienter i samtidig behandling med filgrastim og 5-fluorouracil tyder på, at neutropenien kan forværres.
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ml for 8 - 16 hours.
Danish: Efter subkutan administration af de anbefalede doser holdt serumkoncentrationerne sig over 10 ng/ml i 8 - 16 timer.
English: Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery.
Danish: Det lader til, at resultater over dette er forbundet med hurtigere bedring, mens lavere høstningsresultater giver langsommere bedring.
English: Effect of chemotherapy on erythrocytes and thrombocytes
Danish: Virkninger af kemoterapi på erytrocytter og trombocytter
English: However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Danish: Administration af melphalan, carboplatin eller BCNU sammen med filgrastim har vist sig at være effektivt for stamcellemobiliseringen.
English: Loss of response to filgrastim
Danish: Tab af respons på filgrastim
English: In view of limited safety and efficacy data in patients with secondary acute myelogenous leukaemia (AML), filgrastim should be administered with caution.
Danish: I lyset af de begrænsede data vedrørende sikkerhed og virkning hos patienter med sekundær akut myelogen leukæmi (AML) skal filgrastim administreres med forsigtighed.
English: Take special care with other products that stimulate white blood cells.
Danish: Vær ekstra forsigtig med andre lægemidler, der stimulerer hvide blodlegemer.
English: In other circumstances, additional leukaphereses are recommended.
Danish: I alle andre tilfælde anbefales det at gennemføre yderligere leukafereser.
English: A common side effect of filgrastim use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics).
Danish: En almindelig bivirkning ved anvendelsen af filgrastim er smerter i dine muskler eller knogler (muskel- og ledsmerter), som kan afhjælpes ved at tage standard smertelindrende lægemidler (analgetika).
English: In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Danish: For at forbedre sporbarheden af G-CSF-præparater (granulocytkoloni-stimulerende faktorer) skal det indgivne præparats handelsnavn fremgå tydeligt af patientens journal.
English: The effects of filgrastim overdosage have not been established.
Danish: Virkningen af overdosering med filgrastim er ikke fastlagt.
English: Inject the Filgrastim HEXAL solution as you have been shown by your doctor.
Danish: Indsprøjt opløsningen med Filgrastim HEXAL som din læge har vist dig.
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, eight retrospective studies and one case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Danish: En metaanalyse af allogene transplantationsstudier, inklusive resultaterne af ni prospektive randomiserede forsøg, otte retrospektive studier og ét case-kontrolleret studie, påviste ingen virkning på risikoen for akut GvHD, kronisk GvHD eller tidlig behandlingsrelateret mortalitet.
English: The observed adverse effect level for embryo-foetal toxicity in this study was 10 µg/kg/day, which corresponded to a systemic exposure of approximately 3 - 5 times the exposures observed in patients treated with the clinical dose.
Danish: Det observerede bivirkningsniveau for embryoføtal toksicitet i dette studie var 10 µg/kg/dag, hvilket svarer til en systemisk eksponering på ca. 3-5 gange de eksponeringer, der observeres hos patienter i behandling med den kliniske dosis.
English: Clean the skin at the injection site using an alcohol wipe.
Danish: Rens huden på injektionsstedet med en spritserviet.
English: EXP After dilution use within 24 hours.
Danish: EXP Anvendes inden for 24 timer efter fortynding.
English: In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Danish: I kliniske forsøg med cancerpatienter var muskuloskeletale smerter lette til moderate hos 10 % og svære hos 3 % af patienterne.
English: This does not affect normal operation of the syringe.
Danish: Det påvirker ikke injektionssprøjtens normale funktion.
English: • transfusion reaction
Danish: • reaktion på transfusionen
English: • changes in blood chemistry
Danish: • ændringer i blodkemi
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Danish: Der kan forekomme andre blodcelleforandringer, herunder anæmi og forbigående stigninger i antallet af myeloide stamceller, der nødvendiggør tæt monitorering af celletallene.
English: In pregnant rats, no maternal or foetal toxicity was observed at doses up to 575 µg/kg/day.
Danish: Hos drægtige rotter sås der ingen toksicitet hos moderdyret eller føtal toksicitet ved doser på op til 575 µg/kg/dag.
English: Haematuria was common and proteinuria occurred in a small number of patients.
Danish: Hæmaturi var almindelig og proteinuri forekom hos et mindre antal patienter.
English: Only use each syringe for one injection.
Danish: Brug kun injektionssprøjten til én indsprøjtning.
English: Syringes are embossed with graduation rings in order to enable partial use if required.
Danish: Injektionssprøjterne er præget med en skala med ringe for at gøre en delvis anvendelse mulig, hvis det er nødvendigt.
English: Pack sizes of 1, 3, 5 or 10 pre-filled syringes.
Danish: Pakningsstørrelse på 1, 3, 5 eller 10 fyldte injektionssprøjter.
English: - Treatment of persistent neutropenia (ANC ≤ 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: - Behandling af persisterende neutropeni (ANC ≤ 1,0 x 109/l) hos patienter med fremskreden hiv-infektion for at reducere risikoen for bakterielle infektioner, hvis der ikke findes andre muligheder for håndtering af neutropeni.
English: In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, the use of filgrastim is not recommended in the period from 24 hours before to 24 hours after chemotherapy.
Danish: I betragtning af de hurtigt delende myeloide cellers følsomhed over for myelosuppressiv cytotoksisk kemoterapi bør filgrastim ikke anvendes i perioden 24 timer før til 24 timer efter kemoterapi.
English: You will need to take Filgrastim HEXAL until your white blood cell count is normal.
Danish: Du skal tage Filgrastim HEXAL indtil antallet af dine hvide blodlegemer er normalt.
English: Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 72 hours.
Danish: Inden for opbevaringstiden og til ambulante formål kan patienterne tage lægemidlet ud af køleskabet og opbevare det ved stuetemperatur (ikke over 25°C) i en enkelt periode på op til 72 timer.
English: Randomised, double-blind, single and multiple dose, crossover studies in 204 healthy volunteers showed that the pharmacokinetic profile of Filgrastim HEXAL was comparable to that of the reference product after subcutaneous and intravenous administration.
Danish: Randomiserede, dobbeltblindede overkrydsningsstudier med en enkelt og multiple doser med 204 raske frivillige viste, at Filgrastim HEXAL's farmakokinetiske profil var sammenlignelig med referenceproduktets efter subkutan og intravenøs administration.
English: The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 72 hours (but not above 25°C).
Danish: Injektionssprøjten kan tages ud af køleskabet og opbevares ved stuetemperatur for en enkelt periode på højst 72 timer (ikke ved temperaturer over 25 °C).
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Danish: En statistisk analyse af forholdet mellem antallet af reinfunderede CD34+-celler og hastigheden, hvormed trombocytterne gendannes efter højdosis-kemoterapi, tyder på et komplekst, men kontinuerligt forhold.
English: Subsequently the dose may be individually adjusted every 1 - 2 weeks to maintain the average neutrophil count between 1.5 x 109/l and 10 x 109/l.
Danish: Derefter kan doseringen justeres individuelt hver uge eller hver anden uge for at opretholde det gennemsnitlige neutrofiltal på mellem 1,5 x 109/l og 10 x 109/l.
English: Filgrastim HEXAL is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Danish: Filgrastim HEXAL gives normalt som en daglig indsprøjtning i vævet lige under huden (det kaldes en subkutan indsprøjtning).
English: Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has reached and can be maintained at more than 1.5 x 109/l.
Danish: Filgrastim administreres dagligt som subkutan injektion, indtil neutrofiltallet er nået og kan opretholdes på et niveau over 1,5 x 109/l.
English: • disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
Danish: • sygdom, som får knoglerne til at blive mindre tætte, hvilket gør knoglerne svagere og skørere og øger risikoen for knoglebrud (osteoporose)
English: Common (≥ 1/100 to
Danish: (≥1/100 til
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: Når en perifer blodstamcelletransplantation kan forudses, er det tilrådeligt at planlægge proceduren for stamcellemobiliseringen tidligt i patientens behandlingsforløb.
English: However, you should not attempt this unless you have been properly trained first by your health care provider.
Danish: Men du må ikke prøve at gøre dette, medmindre du først har fået grundig instruktion af lægen eller sundhedspersonalet.
English: Transformation to leukaemia or myelodysplastic syndrome
Danish: Transformering til leukæmi eller myelodysplastisk syndrom
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: Der er observeret et øget embryotab hos kaniner ved mange gange den kliniske eksponering og ved tilstedeværelse af toksicitet hos moderdyret (se pkt.
English: These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
Danish: Det kan være symptomer på en lidelse, der kaldes "sepsis" (eller "blodforgiftning"), der er en alvorlig infektion med en betændelsesreaktion i hele kroppen, som kan være livstruende og kræver øjeblikkelig behandling.
English: Some patients may respond very rapidly and with a considerable increase in neutrophil count to the initial dose of filgrastim.
Danish: Nogle patienter responderer meget hurtigt og med en betragtelig stigning i neutrofiltallet allerede på den første dosis filgrastim.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver gruppering over hyppigheder opstilles bivirkninger efter, hvor alvorlige de er.
English: Your healthcare professional should always record the exact product you are using.
Danish: Lægen eller sundhedspersonalet skal altid notere præcist det lægemiddel, du får.
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 påvist kemisk og fysisk stabilitet af opløsningen til infusion i 24 timer ved 2 °C til 8 °C.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Danish: Leukaferese skal startes på dag 5 og fortsættes til dag 6, hvis det er nødvendigt, for at høste 4 x 106 CD34+ celler/kg af modtagerens legemsvægt.
English: In randomised clinical trials, a subcutaneous dose of 230 μg/m2/day (4.0 to 8.4 μg/kg/day) was used.
Danish: I randomiserede kliniske studier blev en subkutan dosis på 230 μg/m2/dag (4,0-8,4 μg/kg/dag) anvendt.
English: The dosing in children receiving chemotherapy is the same as for adults.
Danish: Doseringen til børn, der får kemoterapi, er den samme som for voksne.
English: Absolute neutrophil count (ANC) should be monitored closely, especially during the first few weeks of filgrastim therapy.
Danish: Det absolutte neutrofiltal (ANC) bør monitoreres nøje især i de første få uger af behandlingen med filgrastim.
English: As a result of the potential to receive higher doses or a greater number of these medicinal products with filgrastim therapy, the patient may be at higher risk of developing thrombocytopenia and anaemia.
Danish: På grund af muligheden for at få højere doser eller et større antal af disse lægemidler med behandling med filgrastim kan patienten have højere risiko for at udvikle trombocytopeni og anæmi.
English: Accidental freezing will not harm Filgrastim HEXAL.
Danish: Utilsigtet frysning vil ikke ødelægge Filgrastim HEXAL.
English: Pulmonary adverse effects, in particular interstitial lung disease, have been reported after G-CSF administration.
Danish: Der foreligger indberetninger om pulmonale bivirkninger, særligt interstitiel lungesygdom, efter administration af G-CSF.
English: There is insufficient data to evaluate filgrastim use in geriatric subjects for other approved filgrastim indications.
Danish: Der foreligger utilstrækkelige data til at evaluere anvendelsen af filgrastim hos geriatriske patienter for andre godkendte indikationer af filgrastim.
English: Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥20 µg/kg/day) and slightly reduced survival rate (100 µg/kg/day).
Danish: Afkom af rotter, som fik administreret filgrastim i perinatal- og dieperioderne, udviste en forsinkelse i ekstern differentiering og forsinket vækst (≥20 µg/kg/dag) samt en lille reduktion i overlevelsesraten (100 µg/kg/dag).