FrancophonIA/ELRC3.0 huggingface dataset:
English: Some of the information you require is given at the end of this leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.
Danish: Noget af den information du har brug for er angivet i slutningen af denne indlægsseddel, men korrekt behandling af din sygdom kræver et tæt og konstant samarbejde med din læge.
English: These changes all reversed after discontinuation of treatment.
Danish: Alle disse ændringer svandt efter seponering af behandlingen.
English: You may change the injection site if you notice the area is red or sore.
Danish: Du kan ændre injektionsstedet, hvis du bemærker at området er rødt eller ømt.
English: International Retrospective Study (2006)
Danish: Internationalt retrospektivt studie (2006)
English: The usual dose of Grastofil varies depending on your illness and weight.
Danish: Den sædvanlige dosis varierer afhængigt af din sygdom og vægt.
English: Important: do not try to give yourself an injection unless you have received training from your doctor or nurse.
Danish: Vigtigt: Forsøg ikke at give dig selv en injektion, medmindre du har modtaget undervisning fra din læge eller sygeplejerske.
English: If needed, you may cover the injection site with a plaster.
Danish: Hvis det er nødvendigt, kan du dække injektionsstedet med et plaster.
English: Your healthcare professional should always record the exact medicine you are using.
Danish: Dit sundhedspersonale bør altid registrere det nøjagtige lægemiddel, du anvender.
English: The timing of leukapheresis: one or two leukaphereses on days 5 and 6 which is often sufficient.
Danish: Timing af leukaferese:en eller to leukafereser på dag 5 og 6, hvilket ofte er tilstrækkeligt.
English: Overall, reports were more common after intravenous administration.
Danish: Generelt sås indberetningerne hyppigere efter intravenøs administration.
English: The choice of route should depend on the individual clinical circumstance.
Danish: Valget af administrationsvej bør afhænge af de individuelle kliniske omstændigheder.
English: Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Danish: Vækstfaktorer er proteiner, der produceres naturligt i kroppen, men de kan også fremstilles ved hjælp af bioteknologi til brug som lægemiddel.
English: Dose adjustment is not required in these circumstances.
Danish: Dosisjustering er ikke nødvendig i disse tilfælde.
English: Sarkhej Bavla Highway Moraiya; Taluka: Sanand, Ahmedabad - 382213 Gujarat, India
Danish: Sarkhej Bavla Highway Moraiya; Taluka: Sanand, Ahmedabad - 382213 Gujarat, Indien
English: Do not take a double dose to make up for a forgotten injection.
Danish: Du må ikke tage en dobbelt dosis for at kompensere for en glemt injektion.
English: In some disease types, however, longer treatment lasting up to about one month may be required.
Danish: Ved nogle typer sygdomme kan længere behandling af omkring en måneds varighed dog være påkrævet.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.6.6.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler, skal navnet og batchnummeret for the administrerede præparat tydeligt registreres.
English: This should be considered when interpreting boneimaging results.
Danish: Det bør der tages hensyn til ved tolkning af knoglebilledresultaterne.
English: If you see blood in the syringe, pull the needle out and re-insert it in another place.
Danish: Hvis du ser blod i sprøjten, træk nålen ud og stik den ind et andet sted.
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Danish: Der opstår bindende antistoffer, som det forventes med alle biologiske midler - de har dog aktuelt ikke været forbundet med neutraliserende aktivitet.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 10
Danish: Leukaferese skal startes på dag 5 og fortsættes indtil dag 6, om nødvendigt, for at indsamle 4 x 10
English: Before you inject Grastofil you must do the following:
Danish: Før du injicerer Grastofil skal du gøre følgende:
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Danish: Valget af mobiliseringsmetode bør overvejes i relation til det overordnede formål med behandlingen for hver individuel patient.
English: Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Grastofil).
Danish: Din læge eller sygeplejerske vil give dig instruktioner om, hvordan du gør dette (se nedenfor om vejledning til injektion af Grastofil).
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Danish: Din læge kan ønske at overvåge dig nøje, se punkt 4 i indlægssedlen.
English: • think you may be pregnant, or
Danish: • har mistanke om, at du er gravid, eller
English: Once the number of white cells in your blood has returned to normal it may be possible to reduce the dose frequency to less than once per day.
Danish: Når antallet af hvide blodlegemer i blodet er vendt tilbage til det normale, kan det være muligt at nedsætte hyppigheden af dosis til mindre end en gang om dagen.
English: Regular urinalysis should be performed to monitor this event.
Danish: Der bør udføres regelmæssige urinanalyser for at monitorere denne hændelse.
English: When the response has been obtained, the minimal effective dose to maintain this level should be established.
Danish: Når dette respons er nået, skal den mindste effektive dosis til opretholdelse af dette niveau fastlægges.
English: The only consistently reported adverse event was musculoskeletal pain which is no different from the experience in the adult population.
Danish: Den eneste bivirkning, der vedvarende blev rapporteret, var muskuloskeletale smerter, hvilket ikke er forskelligt fra erfaringen hos den voksne population.
English: After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Danish: Efter en eller to ugers behandling kan den indledende dosis fordobles eller halveres afhængig af patientens respons.
English: The solution should be visually inspected prior to use.
Danish: Opløsningen skal inspiceres visuelt før brug.
English: It is unknown whether filgrastim / metabolites are excreted in human milk.
Danish: Det er ukendt, om filgrastim/metabolitter udskilles i human mælk.
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 ugentligt i de første to uger, og derefter en gang ugentligt eller en gang hver anden uge under vedligeholdelsesbehandlingen.
English: The volume of distribution in blood is approximately 150 mL/kg.
Danish: Fordelingsvoluminet i blod er ca. 150 ml/kg.
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Danish: Find en behagelig, godt oplyst, ren overflade og læg alt det udstyr, du har brug for inden for rækkevidde
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical studies.
Danish: Mulige interaktioner med andre hæmatopoietiske vækstfaktorer og cytokiner er endnu ikke blevet undersøgt i kliniske studier.
English: Your doctor will tell you why you are being treated with Grastofil.
Danish: Din læge vil fortælle dig, hvorfor du bliver behandlet med Grastofil.
English: Put the needle fully into the skin as shown by your nurse or doctor.
Danish: Stik kanylen helt ind i huden, som vist af lægen eller sygeplejersken.
English: Filgrastim should be discontinued and appropriate treatment given.
Danish: Filgrastim bør seponeres og en passende behandling gives.
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 ingen prospektivt randomiserede sammenligninger af de to anbefalede mobiliseringsmetoder (filgrastim alene eller i kombination med myelosuppressiv kemoterapi) i den samme patientpopulation.
English: Grastofil is a biosimilar medicinal product.
Danish: Grastofil er et biosimilært lægemiddel.
English: Absolute neutrophil count (ANC)
Danish: Absolut neutrofiltal (ANC)
English: Contact your doctor to discuss when you should inject the next dose.
Danish: Kontakt din læge for at diskutere hvonår du skal injicere den næste dosis.
English: Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
Danish: Din læge vil regelmæssigt undersøge din urin, hvis du får denne bivirkning, eller hvis der findes protein i din urin (proteinuri).
English: • increase of certain enzymes in the blood
Danish: • forhøjelse af visse enzymer i blodet
English: If you are a stem cell donor, you must be aged between16 and 60 years.
Danish: Hvis du er stamcelledonor, skal du være mellem 16 og 60 år.
English: Subcutaneous and intravenous use.
Danish: Subkutan og intravenøs anvendelse.
English: These collected cells are given back to you after you receive very high doses of treatment for cancer to make your blood counts get back to normal more quickly.
Danish: Du får de høstede celler tilbage, efter du har fået meget høje doser i din kræftbehandling, så dine blodtal hurtigere kan vende tilbage til normalen.
English: Clinical studies with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific posology recommendations cannot be made.
Danish: I kliniske studier med filgrastim indgik et mindre antal ældre patienter, men særlige undersøgelser er ikke udført i denne gruppe, og derfor kan specifikke anbefalinger vedrørende dosering ikke gives
English: cells/kg) or acceleration of platelet recovery to the same degree.
Danish: celler/kg) eller acceleration i gendannelsen af trombocytter i samme omfang.
English: Long-term treatment with Grastofil is required for reduction in neutropenia.
Danish: Langvarig behandling med Grastofil er nødvendig for en reduktion af neutropeni.
English: • before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment.
Danish: • inden højdosis kemoterapi for at få knoglemarven til at producere flere stamceller, som kan høstes og gives tilbage til dig efter behandlingen.
English: If you develop or are likely to develop cancers of the blood, you should not use Grastofil, unless instructed by your doctor.
Danish: Hvis du udvikler, eller det er sandsynligt, at du kan udvikle blodkræft, bør du ikke bruge Grastofil, medmindre det er efter lægens anvisning.
English: This section contains information on how to give yourself an injection of Grastofil.
Danish: Dette punkt indeholder oplysninger om, hvordan du giver dig selv en injektion med Grastofil.
English: Neutropenia may be a long-standing condition where your body does not make enough neutrophils, or it may be caused by drugs used to treat cancer.
Danish: Neutropeni kan være en langvarig tilstand, hvor kroppen ikke danner nok neutrofiler, eller det kan forårsages af lægemidler, der anvendes til at behandle kræft.
English: Urinalysis monitoring is recommended.
Danish: Der anbefales urinanalyse-overvågning.
English: In some cases, your body may make enough neutrophils, but as a part of your treatment for cancer, your doctor may want to increase the number of certain blood cells (CD34 cells) and collect them.
Danish: I nogle tilfælde kan kroppen danne nok neutrofiler, men som en del af din kræftbehandling vil lægen gerne øge antallet af visse blodlegemer (CD34-celler) og høste dem.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: Derfor skal miltstørrelsen nøje overvåges (f.eks. klinisk undersøgelse, ultralyd).
English: The recommendation of a minimum yield of ≥ 2.0 x 10
Danish: Anbefalingen af en minimumshøst på ≥ 2,0 x 10
English: If exposure has been greater than 24 hours or frozen more than once then Grastofil should not be used.
Danish: Hvis eksponeringen overstiger 24 timer, eller hvis opløsningen nedfryses mere end en gang, må Grastofil ikke anvendes.
English: See section 2 “What you need to know before you use Grastofil”.
Danish: Se punkt 2 ”Det skal du vide, før du begynder at bruger Grastofil”.
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 morfologiske og cytogenetiske knoglemarvsundersøgelser hos patienterne med regelmæssige intervaller (ca. hver 12.måned).
English: Telephone +(31) 71.
Danish: Tel:(31) 71.
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 serumkoncentrationen af filgrastim, uanset om det administreres intravenøst eller subkutant.
English: No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Danish: Der er ikke indberettet bivirkninger, der er direkte relateret til denne grad af leukocytose.
English: cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Danish: celler/kg er baseret på publicerede erfaringer, der har medført en adækvat hæmatologisk rekonstitution.
English: If you become pregnant during Grastofil treatment, please inform your doctor.
Danish: Hvis du bliver gravid i løbet af behandlingen med Grastofil, skal du fortælle det til lægen.
English: To give yourself a subcutaneous injection you will need:
Danish: For at give dig selv en subkutan injektion skal du bruge:
English: In other circumstances, additional leukaphereses may be necessary.
Danish: I andre tilfælde kan det blive nødvendigt med flere leukafereser.
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 infusionsopløsningen ikke anvendes med det samme, er opbevaringstiden og de øvrige forhold inden anvendelsen brugerens ansvar og må normalt ikke overstige 24 timer ved 2 °C til 8 °C, medmindre fortynding er foretaget under kontrollerede og godkendte, aseptiske forhold.
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 kemoterapi for solide tumorer, lymfomer og lymfoide leukæmier forventes det, at behandlingsvarigheden for opfyldelse af disse kriterier kan være op til 14 dage.
English: Graft versus Host Disease b
Danish: Graft versus host-sygdom b
English: Veno-occlusive disease d
Danish: Veno-okklusiv sygdom d
English: The safety and efficacy of filgrastim has not been assessed in normal donors less than 16 years or greater than 60 years of age.
Danish: Filgrastims sikkerhed og virkninger er ikke blevet vurderet hos raske donorer under 16 år eller over 60 år.
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 du får dette lægemiddel som subkutan injektion, kan lægen foreslå, at du lærer at tage injektionerne selv.
English: The best places to inject are the top of the thighs and the abdomen.
Danish: De bedste steder at injicere er de øverste steder på forsiden af lårene og maven.
English: Since lithium promotes the release of neutrophils, it is likely to potentiate the effect of filgrastim.
Danish: Da lithium fremmer frigivelsen af neutrofile granulocytter, er det sandsynligt, at det øger filgrastims virkning.
English: The data in the tables below describe adverse reactions reported from clinical studies and spontaneous reporting.
Danish: Data i tabellerne herunder beskriver bivirkninger rapporteret fra kliniske studier og spontane rapporter.
English: For maintenance of normal neutrophil counts
Danish: Til vedligeholdelse af normalt neutrofiltal
English: Do not use Grastofil if you notice it is cloudy, or there is discoloration or there are particles in it.
Danish: Brug ikke Grastofil, hvis du bemærker, at opløsningen er uklar eller der er misfarvning eller den indeholder partikler.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Danish: For det fortyndede lægemiddels opbevaringsforhold, se pkt.6.3.
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02
Danish: Farmakoterapeutisk klassifikation: Immunstimulerende midler, kolonistimulerende faktorer, ATC-kode: L03AA02.
English: Do not touch the needle or push the plunger.
Danish: Rør ikke ved kanylen eller skub ikke til stemplet.
English: Remember: if you have any problems, please ask your doctor or nurse for help and advice.
Danish: Husk: hvis du har nogen problemer, skal du spørge din læge eller sygeplejerske om hjælp og råd.
English: • unusual change in the urine
Danish: • usædvanlige ændringer af urinen
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 aferesecentrene systematisk indsamler data og følger stamcelledonorerne i mindst 10 år mulig for at sikre monitorering af langtidssikkerheden.
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: Inden du får dette lægemiddel, skal du fortælle din læge, hvis du (eller dit barn) har HFI, eller hvis dit barn ikke længere må få sød mad eller drikke, fordi de føler sig syge, kaster op eller får ubehagelige bivirkninger som oppustethed, mavekramper eller diarré.
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Danish: Træk stemplet en anelse tilbage for at kontrollere, at et blodkar ikke er punkteret.
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 lignende virkninger kan ses på nogle non-myeloide celler in vitro.
English: • in patients with advanced HIV infection which will help reduce the risk of infections;
Danish: • til patienter med fremskreden HIV-infektion, hvilket hjælper med at nedsætte risikoen for infektioner.
English: In clinical studies, > 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
Danish: I kliniske studier responderede > 90 % af patienterne på disse doser og opnåede en revertering af neutropeni på 2 dage (median).
English: You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Regular blood tests will be taken to monitor the number of white blood cells in your body.
Danish: Der vil blive taget regelmæssige blodprøver for at overvåge antallet af hvide blodlegemer i kroppen.
English: For reversal of neutropenia
Danish: Revertering af neutropeni
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 granulocytter fra knoglemarven.
English: Grastofil treatment will last for 4 to 5 days.
Danish: Grastofil behandlingen vil fortsætte i 4 til 5 dage.
English: During long-term use cutaneous vasculitis has been reported in 2% of SCN patients.
Danish: Ved langvarig brug er kutan vaskulitis blevet indberettet hos 2 % af SCN-patienter.
English: It is advisable to wait and see how you feel after receiving Grastofil and before driving or operating machinery.
Danish: De tilrådes at vente og se, hvordan du har det, efter at have fået Grastofil og inden du fører motorkøretøj elller betjener maskiner.
English: In patients with severe chronic neutropenia (SCN)
Danish: Hos patienter med svær kronisk neutropeni (SCN)
English: Filgrastim is a recombinant methionyl human granulocyte-colony stimulating factor produced in Escherichia coli (BL21) by recombinant DNA technology.
Danish: Filgrastim er et rekombinant methionyl human granulocytkolonistimulerende faktor produceret i Escherichia coli (BL21) ved rekombinant DNA-teknologi.
English: A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection.
Danish: Et nedsat antal af hvide blodlegemer (neutropeni) kan forekomme af flere grunde og svækker kroppens evne til at bekæmpe infektion.
English: Remove the syringe from the refrigerator.
Danish: Tag injektionssprøjten ud af køleskabet.
English: This observation has only been made in patients with congenital neutropenia.
Danish: Denne observation blev kun gjort hos patienter med medfødt neutropeni.
English: 9/L, with the median dose frequency being 3 days per week.
Danish: 9/l med en mediane doseringshyppighed på 3 dage pr. uge.
English: You do not need to remove the air bubble before injecting.
Danish: Du behøver ikke at fjerne luftboblen inden injektionen.
English: The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Danish: Sikkerheden og virkningen hos nyfødte og patienter med autoimmun neutropeni er ikke fastlagt.
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Danish: Fra et studie med indgift af en enkeltdosis er der nogen evidens for, at intravenøs dosering kan forkorte varigheden af virkningen.
English: Subsequently, the dose may be individually adjusted every 1-2 weeks to maintain the average neutrophil count between 1.5 x 10
Danish: Derefter kan dosis justeres individuelt for hver 1-2 ugers behandling for at opretholde et gennemsnitligt neutrofiltal mellem 1,5 x 10
English: Grastofil can be used:
Danish: Grastofil kan anvendes:
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, der behandles med filgrastim, skal man især være opmærksom på kvantificeringsmetoden.
English: cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Danish: celler/kg af modtagerens kropsvægt hos de fleste donorer efter to leukafereser.
English: There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Danish: Der er ikke tegn på, at patienter med HIV-infektion, der behandles med filgrastim, udviser en øget HIV-replikation.
English: This medicinal product contains 50 mg sorbitol.
Danish: Dette lægemiddel indeholder 50 mg sorbitol.