FrancophonIA/ELRC3.0 huggingface dataset:
English: The long-term safety of filgrastim administration above 24 µg/kg/day in patients with SCN has not been established.
Danish: Langtidssikkerheden af behandling med filgrastim i doser over 24 µg/kg/dag hos patienter med SCN kendes ikke.
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Danish: Data i tabellerne nedenfor beskriver bivirkninger, der er indberettet fra kliniske studier og ved spontan indberetning.
English: Pharmacotherapeutic group: Cytokines, ATC code: L03AA02
Danish: Farmakoterapeutisk gruppe: Cytokiner, ATC-kode: L03AA02.
English: • disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
Danish: • Sygdom der forårsager, at knoglerne bliver mindre tætte, gør dem svagere, mere skrøbelige med større sandsynlighed for at brække (osteoporose)
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Danish: Der var ingen forskelle i sikkerhedsprofilen hos børn, som blev behandlet for SCN.
English: It is better to change the injection site every day to avoid the risk of soreness at any one site.
Danish: Du bør skifte indsprøjtningssted hver dag for at undgå risiko for ømhed på indsprøjtningsstedet.
English: The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
Danish: Den eneste konsekvent rapporterede bivirkning var muskel- og knoglesmerter, hvilket ikke adskiller sig fra erfaringen med den voksne population.
English: Granulocyte colony-stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Danish: Granulocyt-kolonistimulerende faktor kan fremme væksten af myeloide celler in vitro, og der kan ses lignende effekter på nogle non-myeloide celler in vitro.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Danish: Det er vigtigt, at du ikke forsøger at give dig selv en indsprøjtning før, du har fået speciel træning af lægen eller sygeplejersken.
English: • lungs do not function as they should, causing breathlessness (respiratory failure)
Danish: • Lungerne fungerer ikke, som de skal, hvilket giver åndenød (respirationssvigt)
English: If you develop or are likely to develop cancers of the blood, you should not use Nivestim, unless instructed by your doctor.
Danish: Hvis du får eller med sandsynlighed kan udvikle blodkræft, må du ikke bruge Nivestim, medmindre lægen siger det.
English: Filgrastim is not recommended during pregnancy.
Danish: Filgrastim er ikke anbefalet under graviditet.
English: It is important to tell your doctor if you: - are pregnant or breast-feeding; - think you may be pregnant; or - are planning to have a baby.
Danish: Det er vigtigt, at du fortæller lægen, hvis du: - er gravid eller ammer - har mistanke om, at du er gravid eller - planlægger at blive gravid.
English: Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Danish: Humant G-CSF er et glykoprotein, som regulerer dannelsen og frigivelsen af funktionelle neutrofile hvide blodlegemer fra knoglemarven.
English: In pregnant rats, no maternal or foetal toxicity was observed at doses up to 575 µg/kg/day.
Danish: Hos drægtige rotter blev der ikke observeret nogen maternel eller føtal toksicitet i doser på op til 575 µg/kg/dag.
English: In other circumstances, additional leukapheresis may be necessary.
Danish: I andre tilfælde kan det blive nødvendigt med flere leukafereser.
English: Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 10
Danish: Der bør udføres leukaferese i den periode, hvor ANC stiger fra < 0,5 x 10
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: Derfor bør størrelsen af milten kontrolleres (f.eks. klinisk undersøgelse, ultralyd).
English: There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously.
Danish: Der var en positiv lineær korrelation mellem dosis og serumkoncentrationen af filgrastim, uanset om det blev indgivet intravenøst eller subkutant.
English: Risk associated with increased doses of myelosuppressive medicinal products
Danish: Risiko forbundet med øgede doser af myelosuppressive lægemidler
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 milde eller moderate hos 10 % og svære hos 3 % af patienterne.
English: It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Danish: Det anbefales, at aferesecentret systematisk indsamler data for stamcelledonorer i mindst 10 år for at monitorere langtidssikkerheden.
English: Mobilisation
Danish: Mobilisering
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Danish: Et studie med administration af enkeltdosis tyder i nogen grad på, at intravenøs dosering kan forkorte virkningens varighed.
English: Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 10
Danish: Derefter kan dosis justeres individuelt hver eller hver anden uge for at opretholde et gennemsnitligt neutrofiltal mellem 1,5 x 10
English: It is currently unclear whether long-term treatment of patients with SCN will predispose patients to cytogenetic abnormalities, MDS or leukaemic transformation.
Danish: Det er på nuværende tidspunkt uklart, om langtidsbehandling af patienter med SCN vil prædisponere for cytogenetiske abnormaliteter, MDS eller leukæmisk transformation.
English: cells/kg recipient body weight in the majority of the donors after two leukapheresis.
Danish: + celler/kg af modtagerens legemsvægt hos de fleste donorer efter to leukafereser.
English: If you forget to use Nivestim
Danish: Hvis du har glemt at bruge Nivestim
English: Acute Grade II - IV GvHD
Danish: Studieperiode N Akut grad II - IV GvHD
English: Sweets syndrome
Danish: Sweets syndrom
English: Your doctor will tell you how long you will need to take Nivestim.
Danish: Din læge vil fortælle dig, hvor længe du skal tage Nivestim.
English: • changes in blood chemistry
Danish: • Ændringer i blodets kemiske sammensætning
English: The passive needle guard will NOT activate unless the ENTIRE dose has been given.
Danish: Den passive kanylebeskytter aktiveres IKKE før, hele dosis er givet.
English: Most people can learn to give themselves a subcutaneous injection, but if you are experiencing a lot of difficulty, please do not be afraid to ask for help and advice from your doctor or nurse.
Danish: De fleste patienter kan lære at give sig selv en subkutan indsprøjtning, men hvis du har vanskeligheder med det, skal du ikke være bange for at bede om hjælp hos lægen eller sygeplejersken.
English: Nivestim has not been tested in pregnant or breast-feeding women.
Danish: Nivestim er ikke blevet testet hos gravide kvinder, eller kvinder der ammer.
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: Ved vurderingen af antallet af progenitorceller, som er høstet hos patienter behandlet med filgrastim, bør man især være opmærksom på kvantificeringsmetoden.
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: Filgrastims sikkerhed og virkning hos de novo patienter med AML, som er under 55 år, og som har god cytogenetik (t(8;21), t(15;17) og inv(16)), er ikke dokumenteret.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Danish: Filgrastim bør ikke bruges til at forhøje dosis af cytotoksisk kemoterapi ud over de etablerede doseringsregimer.
English: Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Danish: Filgrastim er indiceret til mobilisering af perifere blodprogenitorceller (PBPC'er).
English: The solution should be visually inspected prior to use.
Danish: Opløsningen skal undersøges visuelt før brug.
English: Nivestim is usually given once a day by injection, usually into the tissue just under the skin.
Danish: Nivestim gives normalt én gang om dagen som indsprøjtning, sædvanligvis i vævet lige under huden.
English: 4.8 Undesirable effects a.
Danish: 4.8 Bivirkninger a.
English: cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Danish: CD34 + celler/kg er baseret på publicerede erfaringer, der har medført en adækvat hæmatologisk rekonstitution.
English: However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Danish: Det er dog vist, at administration af melphalan, carboplatin eller BCNU sammen med filgrastim er effektiv til at mobilisere progenitorceller.
English: In clinical trials, 97% of patients who responded had a complete response at doses ≤ 24 µg/kg/day.
Danish: I de kliniske studier fik 97 % af de patienter, som responderede, komplet respons efter doser  24 µg/kg/dag.
English: Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary.
Danish: Må ikke anvendes til patienter med hereditær fructoseintolerans (HFI), medmindre det er strengt nødvendigt.
English: Do not take a double dose to make up for any missed doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • decreased appetite
Danish: • Nedsat appetit
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 har svær kronisk neutropeni, kan du være i risiko for at udvikle blodkræft (leukæmi, myelodysplastisk syndrom (MDS)).
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 en vene (kaldes intravenøs infusion).
English: Regular urinalysis should be performed to monitor these events.
Danish: Der bør udføres regelmæssige urinanalyser for at monitorere disse bivirkninger.
English: Talk to your doctor, pharmacist or nurse before using Nivestim.
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du bruger Nivestim:
English: Check the date on the pack to make sure that the medicine has not passed the expiry date.
Danish: Kontroller datoen på pakningen og kontroller, at udløbsdatoen ikke er overskredet.
English: • trouble sleeping (insomnia)
Danish: • Søvnbesvær (insomnia)
English: Long term administration may be required to maintain the ANC > 2.0 x 10
Danish: Det kan være nødvendigt med langtidsadministration for at opretholde et ANC > 2,0 x 10
English: There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone, or in combination with myelosuppressive chemotherapy) within the same patient population.
Danish: Der findes ingen prospektive, randomiserede sammenligninger af de to anbefalede mobiliseringsmetoder hos den samme patientpopulation (filgrastim alene eller i kombination med myelosuppressiv kemoterapi).
English: 9/L during the treatment period the dose of filgrastim should be re-escalated according to the above steps.
Danish: 9/l under behandlingen, bør filgrastimdosis igen øges i henhold til ovenstående skema.
English: Remove the syringe from the blister pack and check that the solution is clear, colourless and practically free from visible particles.
Danish: Tag sprøjten ud af blisterpakningen og kontroller, at opløsningen er klar, farveløs og fri for synlige partikler.
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Danish: Patienter, der udvikler symptomer på kapillær lækage-syndrom, bør monitoreres nøje og have symptomatisk standardbehandling, som kan omfatte behovet for intensiv behandling (se pkt.
English: The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia.
Danish: Der var en klar behandlingseffekt i denne aldersgruppe, som hovedsageligt inkluderede patienter med medfødt neutropeni.
English: • fever (pyrexia)
Danish: • Feber (pyreksi)
English: No undesirable effects directly attributable to this degree of leucocytosis have been reported.
Danish: Der er ikke rapporteret om bivirkninger, som er direkte relateret til denne sværhedsgrad af leukocytose.
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ml for 8 to 16 hours.
Danish: Efter subkutan indgift af anbefalede doser, forblev serumkoncentrationerne over 10 ng/ml i 8 til 16 timer.
English: You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Danish: Du skal fortælle det til lægen, inden du får dette lægemiddel, hvis du (eller dit barn) har HFI, eller hvis dit barn ikke længere kan indtage sukkerholdig mad eller drikke, fordi barnet bliver dårligt, kaster op eller får ubehagelige virkninger som f.eks. oppustethed, mavekramper eller diarré.
English: 9/L for 3 more consecutive days
Danish: 9/l i yderligere 3 konsekutive dage
English: *recombinant methionyl granulocyte colony-stimulating factor G-CSF produced in Escherichia coli (BL21) by recombinant DNA technology.
Danish: *rekombinant methionyl granulocyt-kolonistimulerende faktor G-CSF), som er fremstillet ved hjælp af rekombinant DNA teknologi i Escherichia coli (BL21).
English: cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Danish: + celler og hastigheden af gendannelsen af trombocytter efter højdosis kemoterapi tyder på en kompleks, men kontinuerlig relation.
English: If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim's activity.
Danish: Hvis du ikke reagerer på behandlingen med filgrastim, eller hvis en reaktion på behandlingen ikke kan opretholdelses, vil din læge undersøge årsagen, herunder om du har udviklet antistoffer, der kan neutralisere aktiviteten af filgrastim.
English: A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
Danish: Detaljeret anamnese med henblik på symptomer på HFI skal foretages, før patienten kan anvende lægemidlet.
English: Nivestim does not contain any preservative.
Danish: Nivestim indeholder ikke konserveringsmiddel.
English: 9/L after the expected nadir, filgrastim should be discontinued immediately.
Danish: 9/l efter det forventede nadir, skal filgrastim seponeres omgående.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Danish: Som andre hæmatopoetiske vækstfaktorer har G-CSF vist in vitro stimulerende egenskaber på humane endotelceller.
English: The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Danish: Sikkerheden og effekten hos nyfødte og patienter med autoimmun neutropeni er ikke fastlagt.
English: Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Danish: Hos disse patienter bør opmærksomheden især være henledt på antallet af mobiliserede progenitorceller før administrationen af højdosis kemoterapi.
English: These will be monitored by your doctor.
Danish: Din læge vil overvåge disse symptomer.
English: In view of the possible risk of microbial contamination, Nivestim syringes are for single use only.
Danish: På grund af risikoen for mikrobiel kontamination er Nivestimsprøjter kun til engangsbrug.
English: It is unknown whether filgrastim/metabolites are excreted in human milk.
Danish: Det er uvist, om filgrastim/dets metabolitter udskilles i modermælk.
English: 30 MU (300 µg)/day on 1 to 7 days per week was required to maintain the ANC > 2.0 x 10
Danish: ME (300 µg)/dag i 1 til 7 dage pr. uge for at opretholde et ANC > 2,0 x 10
English: This medicine contains 50 mg sorbitol in each ml.
Danish: Dette lægemiddel indeholder 50 mg sobitol pr. ml.
English: For reversal of neutropenia:
Danish: Behandling af neutropeni:
English: Pull the plunger back slightly to check if any blood appears in the syringe.
Danish: Træk langsomt stemplet tilbage for at kontrollere, om der kommer blod i sprøjten.
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: Dette kan være symptomer på en tilstand som kaldes ”sepsis” (kaldes også ”blodforgiftning”), som er en alvorlig infektion med inflammatorisk respons i hele kroppen, der kan være livstruende, og kræve akut lægehjælp.
English: • transfusion reaction
Danish: • Reaktion på transfusion
English: Haematuria was common and proteinuria occurred in a small number of patients.
Danish: Hæmaturi var almindeligt forekommende og proteinuri forekom hos et mindre antal patienter.
English: These autologous PBPCs may be harvested and infused after high dose cytotoxic therapy, either in place of, or in addition to bone marrow transplantation.
Danish: Disse autologe PBPC kan høstes og infunderes efter højdosis cytotoksisk behandling, enten i stedet for eller i tillæg til knoglemarvstransplantation.
English: Nivestim is a white blood cell growth factor (granulocyte colony-stimulating factor) and belongs to a group of medicines called cytokines.
Danish: Nivestim er en vækstfaktor (granulocyt-kolonistimulerende faktor) for hvide blodlegemer og tilhører en gruppe af lægemidler, som kaldes cytokiner.
English: Filgrastim for PBPC mobilisation when used alone:
Danish: Filgrastim til PBPC mobilisering, når det anvendes alene:
English: In patients with severe chronic neutropenia (SCN)
Danish: Patienter med svær kronisk neutropeni (SCN)
English: The degree of variation between individual patients and between laboratory assays of CD34
Danish: Graden af variation mellem individuelle patienter og mellem analysemetoder for CD34
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Danish: Filgrastims sikkerhed og virkning er ikke undersøgt hos raske donorer under 16 år og over 60 år.
English: cell numbers vary depending on the precise methodology used and recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Danish: Anbefalinger af antal, som er baseret på undersøgelser i andre laboratorier, bør tolkes med forsigtighed.
English: The incidence of fever and documented infections were not reduced in either setting.
Danish: Incidensen af febertilfælde og dokumenterede infektioner blev ikke reduceret ved disse behandlinger.
English: After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Danish: Begyndelsesdosis kan fordobles eller halveres efter en til to ugers behandling afhængig af patienters respons.
English: Make sure you have your sharps container nearby.
Danish: Kontroller, at du har affaldsbeholderen i nærheden.
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 der anvendt en subkutan dosis på 230 µg/m2/dag (4,0 til 8,4 µg/kg/dag).
English: 9/L and 10 x 10
Danish: 9/l og 10 x 10
English: Pseudogout (chondrocalcinosis pyrophosphate)
Danish: Pseudopodagra (chondrocalcinose pyrophosphat)
English: A faster schedule of dose escalation may be considered in patients presenting with severe infections.
Danish: Det kan overvejes at øge dosis hurtigere hos patienter med svære infektioner.
English: For maintaining normal neutrophil counts:
Danish: Vedligeholdelse af normale neutrofiltal:
English: There are no or limited amount of data from the use of filgrastim in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af filgrastim til gravide kvinder.
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 henhold til de ovennævnte kriterier, bør det overvejes at bruge andre behandlingsformer, som ikke omfatter støttebehandling med progenitorceller.
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 brugen brugerens ansvar, og opbevaringstiden bør normalt ikke overstige 24 timer ved 2 °C til 8 °C, medmindre fortyndingen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Danish: Der kan komme andre blodcelleforandringer, herunder anæmi og forbigående stigninger af myeloide progenitorceller, som kan nødvendiggøre tæt monitorering af celletal.
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section
Danish: - hvis du er allergisk over for filgrastim eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Nivestim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within twenty four hours, with minor increases in monocytes.
Danish: Nivestim, som indeholder r-metHuG-CSF (filgrastim), øger neutrofiltallet i perifert blod kraftigt indenfor 24 timer, med en mindre øgning af antallet af monocytter.
English: Find a comfortable well lit working place to give your injection and check the dose that you have been prescribed.
Danish: Find et godt oplyst sted, hvor du kan foretage indsprøjtningen og kontroller, at det er den dosis, som lægen har ordineret.
English: If leucocyte counts exceed 50 x 10
Danish: Hvis leukocyttallet overstiger 50 x 10
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Danish: MDS-syndromer og leukæmier er naturlige komplikationer til sygdommen, og forbindelsen til behandlingen med filgrastim er usikker.
English: Statistical analysis of the relationship between the number of CD34
Danish: Den statistiske analyse af forholdet mellem antallet af reinfunderede CD34
English: During intermittent dosing with 30 MU (300 µg)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Danish: Under intermitterende behandling med 30 mio enheder (300 µg) filgrastim/dag kan der ses store udsving i patientens ANC.