FrancophonIA/ELRC3.0 huggingface dataset:
English: Long-term safety follow-up of donors is ongoing.
Danish: Der foretages langtidsopfølgning af sikkerheden hos donorer.
English: International retrospective study (2006)
Danish: Internationalt retrospektivt studie (2006)
English: Regular monitoring of blood counts is recommended (see above).
Danish: Regelmæssig monitorering af blodværdier anbefales (se ovenfor).
English: Dose adjustment is not required in these circumstances.
Danish: Dosisjustering er ikke nødvendigt under disse omstændigheder.
English: - if you have osteoporosis.
Danish: - Hvis De har osteoporose.
English: Filgrastim should not be used during pregnancy unless clearly necessary.
Danish: Filgrastim bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Your treatment will usually last for about 14 days.
Danish: Behandlingen varer sædvanligvis ca. 14 dage.
English: If there are particles in it, you must not use it.
Danish: Hvis den indeholder partikler, må De ikke bruge den.
English: The recommended dose is...
Danish: Den anbefalede dosis er
English: Do not warm Biograstim in any other way (for example, do not warm it in a microwave or in hot water).
Danish: De må ikke opvarme Biograstim på anden vis (for eksempel hverken ved at lægge den i mikroovnen eller i varmt vand).
English: Ask your doctor which medicine you can take to help with this.
Danish: Spørg deres læge hvilken medicin De kan tage for at afhjælpe dette.
English: The needle will be covered by the protective sleeve so that you cannot prick yourself.
Danish: Nålen vil blive dækket af beskyttelseshætten, så du ikke kan stikke dig selv.
English: This should be considered when interpreting bone-imaging results.
Danish: Der bør tages højde for dette ved fortolkning af knoglescanningsresultater.
English: In some disease types however, longer treatment lasting up to about one month may be required.
Danish: Ved nogle sygdomsformer kan der dog være behov for længere behandling af op til en måneds varighed.
English: You may experience the following additional side effects:
Danish: Yderligere kan De få følgende bivirkninger:
English: You will need to have your injections at about the same time every day.
Danish: De skal have indsprøjtningerne på omtrent samme tidspunkt hver dag.
English: Your doctor or nurse will give you instructions on how to do this.
Danish: Lægen eller sygeplejersken kan vejlede Dem i, hvordan De skal gøre.
English: Date of first authorisation: 15 September 2008.
Danish: Dato for første markedsføringstilladelse: 15. september 2008
English: Spleen size should be evaluated regularly.
Danish: Størrelsen på milten bør vurderes regelmæssigt.
English: The volume of distribution in blood is approximately 150 mL/kg.
Danish: Fordelingsvolumenet i blod er ca. 150 ml/kg.
English: Check the appearance of Biograstim.
Danish: Kontroller Biograstims udseende.
English: Biograstim treatment will last for 4 to 5 days.
Danish: Behandlingen med Biograstim varer i 4-5 dage.
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Danish: Et specifikt studie af denne interaktion er ikke udført, men der foreligger ingen dokumentation, der viser, at en sådan interaktion skulle være skadelig.
English: The solution should be visually inspected prior to use.
Danish: Opløsningen skal kontrolleres visuelt før brug.
English: During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Biograstim.
Danish: I en række kliniske studier blev 541 cancerpatienter og 188 raske forsøgspersoner eksponeret for Biograstim.
English: After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Danish: Efter 1-2 ugers behandling kan initialdosis fordobles eller halveres afhængigt af patientens respons.
English: Some of the information you require is given at the end of this package leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.
Danish: Nogle af de oplysninger, De får brug for, er angivet sidst i denne indlægsseddel, men Deres sygdom kræver et tæt og konstant samarbejde med lægen for at opnå den rette behandling.
English: A risk of promotion of a malignant myeloid clone can not be excluded.
Danish: Risikoen for dannelse af et malignt myeloidt klon kan ikke udelukkes.
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 er ikke foretaget prospektivt randomiserede sammenligninger af de to anbefalede mobiliseringsmetoder (filgrastim alene eller i kombination med myelosuppressiv kemoterapi) hos samme patientpopulation.
English: Sixty-five percent of the patients studied in the SCN trial programme were under 18 years of age.
Danish: 65 % af de patienter, der indgik i SCN-studiesprogrammet, var under 18 år.
English: This section contains information on how to give yourself an injection of Biograstim.
Danish: Dette afsnit indeholder oplysninger om, hvordan De kan give Dem selv indsprøjtninger med Biograstim.
English: Idiopathic or cyclic neutropenia
Danish: Idiopatisk eller cyklisk neutropeni
English: The following information is intended for healthcare professionals only
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale:
English: Biograstim has not been tested in pregnant women.
Danish: Biograstim er ikke undersøgt hos gravide kvinder.
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Danish: Valg af mobiliseringsmetode bør sammenholdes med de overordnede målsætninger for behandlingen af den enkelte patient.
English: Take your Biograstim pre-filled syringe out of the refrigerator.
Danish: Tag medicinsprøjten med Biograstim ud af køleskabet.
English: Thereafter, it is recommended that the ANC is measured at least twice weekly for the first two weeks and subsequently once per week or once every other week during maintenance therapy.
Danish: Derefter anbefales det at måle ANC mindst to gange om ugen i de første to uger og derefter en gang ugentligt eller en gang hver anden uge under vedligeholdelsesbehandlingen.
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 < 16 år eller > 60 år.
English: Only use each syringe for one injection.
Danish: Hver medicinsprøjte må kun bruges til én injektion.
English: Biograstim is a biosimilar medicinal product.
Danish: Biograstim er et biosimilært lægemiddel.
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro.
Danish: Granulocytkolonistimulerende faktor kan fremme væksten af myeloide celler in vitro, og lignende virkninger kan også ses på visse ikke-myeloide celler in vitro.
English: Subcutaneous use and intravenous use.
Danish: Subkutan anvendelse og intravenøs anvendelse.
English: Elevated GGT
Danish: Forhøjet GGT
English: The occurrence of Sweet's syndrome (acute febrile dermatosis) has been reported occasionally.
Danish: Forekomsten af Sweets syndrom (akut febril dermatose) er lejlighedsvist rapporteret.
English: It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body.
Danish: Det hører til en gruppe proteiner, der kaldes cytokiner, og som er meget lig et naturligt protein (granulocytkolonistimulerende faktor [G-CSF]), som produceres af Deres organisme.
English: In other circumstances, additional leukaphereses may be necessary.
Danish: Under andre omstændigheder kan der være behov for flere leukafereser.
English: Your doctor has prescribed Biograstim for you to help your body make more white blood cells.
Danish: Deres læge har ordineret Biograstim til Dem for at hjælpe Deres krop med at producere flere hvide blodceller.
English: You will need to give yourself the injection into the tissue just under the skin.
Danish: De skal give indsprøjtningen i væv lige under huden.
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Danish: Det fremgik af et studie med administration af enkeltdosis, at intravenøs indgift kan afkorte virkningens varighed.
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02
Danish: Farmakoterapeutisk klassifikation: Immunstimulerende midler, kolonistimulerende faktorer, ATC-kode: L03AA02
English: Timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient.
Danish: Tidsplan for leukaferese: Ofte vil 1-2 leukafereser på dag 5 og 6 være tilstrækkeligt.
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 glycoprotein, der regulerer dannelse og frigivelse af funktionelle neutrofile granulocytter fra knoglemarven.
English: No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Danish: Der er ikke rapporteret bivirkninger, der direkte kunne tilskrives denne grad af leukocytose.
English: Do not touch the needle or push the plunger.
Danish: Undgå at berøre kanylen eller skubbe til stemplet.
English: Biograstim treatment will last for up to 2 weeks and in exceptional cases longer.
Danish: Behandlingen med Biograstim varer i op til 2 uger og kan undtagelsesvis vare længere.
English: Orient the needle away from you and others and activate the safety device by firmly pushing the plunger (see picture 8).
Danish: Orienter nålen væk fra dig selv og andre og aktiver sikkerhedsanordningen med et fast tryk på stemplet (se billede 8).
English: Long-term daily administration is required to maintain an adequate neutrophil count.
Danish: Daglig administration over længere tid er nødvendig for at opretholde et tilstrækkeligt neutrofiltal.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De bruger dette lægemiddel.
English: Where should I give my injection?
Danish: Hvor skal indsprøjtningen gives?
English: There were no relevant differences between Biograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Danish: Der sås ingen relevante forskelle mellem Biograstim og referenceproduktet, hvad angår varighed af svær neutropeni og incidens af febril neutropeni.
English: - if you have specific blood disorders (e.g. Kostman's syndrome, myelodysplastic syndrome,
Danish: - Hvis De har specifikke blodsygdomme (f.eks. Kostmans syndrom, myelodysplatisk syndrom,
English: The incidence of these events was similar to that reported in cancer patients.
Danish: Incidensen af disse bivirkninger var den samme som rapporteret for cancerpatienter.
English: The safety profile of Biograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Danish: Sikkerhedsprofilen for Biograstim i disse kliniske studier svarede til profilen for det referenceprodukt, der blev anvendt i studierne.
English: The choice of route should depend on the individual clinical circumstance.
Danish: Valg af administrationsvej bør afhænge af den enkelte patients kliniske situation.
English: Abdominal palpation should be sufficient to detect abnormal increases in splenic volume.
Danish: Abdominal palpation skulle være tilstrækkeligt til at påvise anormale forstørrelser af milten.
English: - if you have sickle cell disease (an inherited disease characterised by sickle-shaped red blood cells).
Danish: - Hvis De har seglcellesygdom (en arvelig sygdom karakteriseret af seglcelleformede røde blodlegemer).
English: Musculoskeletal pain is usually controlled with standard analgesics.
Danish: Smerter i skeletmuskulaturen kan sædvanligvis kontrolleres med standard analgetika.
English: There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously.
Danish: Der er en positiv lineær korrelation mellem dosis og serumkoncentration af filgrastim, uanset om det blev administreret intravenøst eller subkutant.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and local tolerance.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet og lokal tolerans.
English: The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia.
Danish: Der sås en tydelig behandlingseffekt hos denne aldersgruppe, der omfattede de fleste patienter med medfødt neutropeni.
English: Box for the prescribed dose
Danish: Æske til den ordinerede dosis
English: Haematuria/proteinuria occurred in a small number of patients.
Danish: Hæmaturi/proteinuri forekom hos et mindre antal patienter.
English: Check again to make sure the correct dose of Biograstim is in the syringe.
Danish: Tjek en ekstra gang for at sikre, at medicinsprøjten indeholder den korrekte dosis Biograstim.
English: Following established chemotherapy for solid tumours, lymphomas and lymphoid leukaemias, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Danish: Efter standard kemoterapi for solide tumorer, lymfomer og lymfatisk leukæmi forventes det, at den nødvendige behandlingsvarighed for at opfylde disse kriterier vil være op til 14 dage.
English: This observation has only been made in patients with congenital neutropenia.
Danish: Denne observation er kun gjort hos patienter med medfødt neutropeni.
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Danish: Træk stemplet lidt tilbage for at kontrollere, at De ikke har ramt et blodkar.
English: AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Danish: AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm Tyskland
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Danish: Mulig interaktion med andre hæmatopoietiske vækstfaktorer og cytokiner er ikke blevet undersøgt i kliniske studier.
English: An increased incidence of embryo-loss has been observed in rabbits, but no malformation has been seen.
Danish: Der sås en øget incidens af embryonal død hos kaniner, men ingen misdannelser.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below.
Danish: Dette lægemiddel bør ikke blandes med andre lægemidler end dem, som nævnes nedenfor.
English: It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
Danish: Det anbefales at udføre regelmæssige morfologiske og cytogenetiske knoglemarvsstudier hos patienterne (ca. hver 12. måned).
English: Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made.
Danish: I kliniske studier med filgrastim indgik et mindre antal ældre patienter, men der foreligger ingen studier specielt med denne gruppe, hvorfor der ikke kan gives specifikke dosisanbefalinger.
English: For maintaining normal neutrophil counts
Danish: Opretholdelse af normalt neutrofiltal
English: Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Danish: Opmærksomheden bør især rettes mod antallet af stamceller, der mobiliseres hos denne patientgruppe, før administration af højdosis kemoterapi.
English: It is quite normal to have a number of courses of Biograstim treatment.
Danish: Det er helt normalt at få flere behandlingsforløb med Biograstim.
English: Exacerbation of rheumatoid arthritis has been observed in individual cases.
Danish: Forværring af reumatoid artrit er observeret i enkeltstående tilfælde.
English: Possible side effects”).
Danish: Bivirkninger”).
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: Sikkerhed og virkning af filgrastim ved administration til patienter < 55 år med de novo-AML og god cytogenetik [t(8;21), t(15;17) og inv(16)] er ikke klarlagt.
English: It is better to change the injection site every day to avoid the risk of soreness at any one site.
Danish: Det er bedst at give indsprøjtningen et nyt sted hver dag for at undgå risiko for ømhed ved injektionsstedet.
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 De ikke forsøger at tage en indsprøjtning selv, før De har fået den fornødne vejledning af en læge eller sygeplejerske.
English: Filgrastim dosing should be maintained until the last leukapheresis.
Danish: Filgrastim skal gives indtil den sidste leukaferese.
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/mL for 8 to 16 hours.
Danish: Efter subkutan administration af de anbefalede doser opretholdtes en serumkoncentration på over 10 ng/ml i 8-16 timer.
English: Therefore, your doctor may decide that you should not use this medicine.
Danish: Lægen kan derfor beslutte, at De ikke skal have medicinen.
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Danish: Filgrastimbehandlingen skal seponeres permanent hos patienter, der få en alvorlig allergisk reaktion.
English: Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Danish: Biograstim er indiceret til mobilisering af perifere blodstamceller (PBPC).
English: Do not attempt to self-administer without this training.
Danish: Forsøg ikke at gøre det selv uden at have fået vejledningen.
English: Your doctor might check your bone density regularly.
Danish: Deres læge vil muligvis kontrollere Deres knogletæthed regelmæssigt.
English: Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more blood cells, especially certain types of white cells.
Danish: Filgrastim stimulerer knoglemarven (det væv, hvor nye blodlegemer opstår) til at fremstille flere blodlegemer, især visse typer hvide blodlegemer.
English: There are no adequate data from the use of filgrastim in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af filgrastim til gravide kvinder.
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 registrerer data for stamcelledonorer i mindst 10 år af hensyn til langtidssikkerheden.
English: Remove the syringe from the injection site while keeping your finger on the plunger (see picture 7).
Danish: Fjern sprøjten fra injektionsstedet samtidig med, at du holder fingeren på stemplet (se billede 7).
English: If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections.
Danish: Hvis De får medicinen som subkutan injektion, vil lægen muligvis foreslå, at De selv lærer at tage indsprøjtningerne.
English: Therefore, filgrastim is not indicated for use in these conditions.
Danish: Derfor er filgrastim ikke indiceret til behandling af disse tilstande.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF
English: In other circumstances, additional leukaphereses are recommended.
Danish: Under andre omstændigheder anbefales det at give flere leukafereser.
English: Risks associated with increased doses of chemotherapy
Danish: Risici forbundet med øgede doser kemoterapi
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 effektivt til stamcellemobilisering.
English: Filgrastim has minor or moderate influence on the ability to drive and use machines.
Danish: Filgrastim påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: Derfor bør miltstørrelsen monitoreres nøje (fx klinisk studie, ultralyd).
English: Filgrastim is a protein produced by biotechnology in bacteria called Escherichia coli.
Danish: Filgrastim er et protein, der fremstilles ved bioteknologi i bakterien Escherichia coli.
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: Efter induktion og konsoliderende behandling for akut myeloid leukæmi kan behandlingsvarigheden være væsentligt længere (op til 38 dage) afhængigt af den anvendte type kemoterapi, dosering og behandlingsplan.
English: Special precautions in recipients of allogeneic PBPC mobilised with filgrastim
Danish: Særlige forsigtighedsregler hos recipienter af allogene PBPC mobiliseret med filgrastim
English: Particular attention should be paid to haematological values and infectious diseases.
Danish: Opmærksomheden bør især rettes mod hæmatologi og infektionssygdomme.
English: Do not remove the cover from the syringe until you are ready to inject.
Danish: Fjern ikke beskyttelseshætten fra medicinsprøjten, før De er klar til at injicere.
English: Acute grade II-IV GvHD
Danish: Akut grad II-IV GvHD
English: Biograstim should not be diluted with sodium chloride solution.
Danish: Biograstim bør ikke fortyndes med natriumchloridopløsning.
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: Præliminær dokumentation fra et mindre antal patienter, der blev behandlet samtidig med filgrastim og 5-fluorouracil, tyder på, at sværhedsgraden af neutropeni kan tage til.
English: Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Danish: Filgrastim (rekombinant methionyl human granulocytkolonistimulerende faktor) fremstilles i Escherichia coli K802 ved hjælp af rekombinant DNA-teknologi.
English: Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).
Danish: Før kanylen helt ind under huden, som sygeplejersken eller lægen har vist Dem (se figur 6).
English: Check the expiry date on the pre-filled syringe label (EXP).
Danish: Kontroller udløbsdatoen på etiketten på den fyldte injektionssprøjte (EXP).
English: - If you have Sickle Cell Disease, make sure that you tell your doctor before you start taking Biograstim.
Danish: - Hvis De har seglcellesygdom, skal De fortælle det til lægen, før De begynder at få Biograstim.