FrancophonIA/ELRC3.0 huggingface dataset:
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 AML-patienter, som er < 55 år, og som har god cytogenetik [t (8; 21), t (15; 17), og inv (16)] er ikke klarlagt.
English: If you have missed an injection, contact your doctor as soon as possible.
Danish: Hvis du har sprunget en injektion over, skal du kontakte lægen hurtigst muligt.
English: Elevations of neutrophil counts are dose-dependent at recommended doses.
Danish: Forhøjelserne af neutrofiltallene er dosisafhængige ved de anbefalede doser.
English: Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Danish: Grastofil er indiceret til mobilisering af perifere blodprogenitorceller (PBPC).
English: Push the plunger up slowly to the number (given in mL) that matches the dose of Grastofil which your doctor has prescribed.
Danish: Tryk stemplet langsomt op til det tal (antal ml) på skalaen, der svarer til den dosis Grastofil, som din læge har ordineret.
English: In pregnant rats, no maternal or fetal 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 g/kg/dag.
English: However, the administration of melphalan, carboplatin or carmustine (BCNU) together with filgrastim has been shown to be effective for progenitor mobilisation.
Danish: Administration af melphalan, carboplatin eller carmustin (BCNU) sammen med filgrastim har imidlertid vist sig at være virkningsfuld til mobilisering af progenitorceller.
English: Your doctor will tell you how much Grastofil you should take.
Danish: Din læge vil fortælle dig, hvor meget Grastofil, du skal tage.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Danish: Filgrastim må ikke anvendes til at forhøje dosis af cytotoksisk kemoterapi ud over de etablerede dosisregimer.
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 er ikke observeret nogen overordnede forskelle i sikkerhed eller effekt mellem personer over 65 år i forhold til yngre voksne (> 18 år) patienter i cytotoksisk kemoterapi, og klinisk erfaring har ikke identificeret forskelle i respons mellem ældre og yngre voksne patienter.
English: This is known as a subcutaneuous injection.
Danish: Dette kaldes en subkutan injektion.
English: Among these, two cases of platelets < 50 x 10
Danish: Blandt disse blev der indberettet to tilfælde af trombocyttal < 50 x 10
English: • disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
Danish: • sygdom, som gør knoglerne mindre kompakte og gør dem svagere, mere skrøbelige og mere tilbøjelige til at brække (osteoporose)
English: (Sweets syndrome)
Danish: (Sweets syndrom)
English: In view of the possible risk of microbial contamination, Grastofil pre-filled syringes are for single use only.
Danish: Med tanke på den mulige risiko for mikrobiel kontaminering er Grastofil fyldte injektionssprøjter kun beregnet til engangsbrug.
English: • a change in how your body regulates fluids within your body and may result in puffiness
Danish: • en ændring af, hvordan din krop regulerer væskerne i din krop, hvilket kan føre til hævelser
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Danish: • nedsat følsomhed, især i huden (hypoæstesi)
English: It is important to tell your doctor if you:
Danish: Det er vigtigt at fortælle lægen, hvis du:
English: Loss of response to filgrastim
Danish: Manglende respons på filgrastim
English: Κορίνθου 12, Ν. Ψυχικό, 15451, Αθήνα Telephone +30/2106776550
Danish: Κορίνθου 12, Ν. Ψυχικό, 15451, Αθήνα Τηλ:+30/2106776550
English: • plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever
Danish: • blommefarvede, hævede, smertefulde sår på arme og ben, og til tider i ansigt og hals med feber
English: • lungs do not function as they should, causing breathlessness (respiratory failure)
Danish: • lungerne virker ikke som de skal, og forårsager åndenød (åndedrætssvigt)
English: The incidence of fever and documented infections were not reduced in either setting.
Danish: Hyppigheden af feber og dokumenterede infektioner blev ikke reduceret uanset situation.
English: At the end of this period, Grastofil should not be put back in the refrigerator and should be disposed of in accordance with local requirements.
Danish: Ved afslutningen af denne periode må Grastofil ikke sættes tilbage i køleskabet, men skal bortskaffes i henhold til lokale retningslinjer.
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Danish: De neutrofile granulocytter, der dannes som respons på filgrastim, viser normal eller forstærket funktion, som påvist ved tests af kemotaktisk og fagocytotisk funktion.
English: Long term treatment with Grastofil may be required to maintain a normal number of white cells in your blood.
Danish: Langvarig behandling med Grastofil kan være nødvendig for at opretholde et normalt antal hvide blodlegemer i blodet.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Grastofil.
Danish: Medmindre lægen fortæller dig andet, skal du holde op med at amme, hvis du bruger Grastofil.
English: In patients with HIV infection
Danish: Hos patienter med HIV-infektion
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHT AND REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
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 lækagesyndrom, bør monitoreres nøje og have standard symptomatisk behandling, som kan omfatte behov for intensiv pleje (se pkt.
English: Haematuria was common and proteinuria occurred in a small number of patients.
Danish: Hæmaturi var almindeligt, og proteinuri forekom hos et mindre antal patienter.
English: In other circumstances, additional leukaphereses are recommended.
Danish: I andre tilfælde anbefales det at udføre flere leukafereser.
English: Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 10
Danish: Grastofil er indiceret til behandling af persisterende neutropeni (ANC mindre eller lig med 1,0 x 10
English: Once Grastofil has been out at room temperature it should not be put back into the refrigerator.
Danish: Når Grastofil har været opbevaret ved stuetemperatur, må det ikke sættes tilbage i køleskabet.
English: Grastofil is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of medicines called cytokines.
Danish: Grastofil er en vækstfaktor for hvide blodlegemer (granylocytkoloni-stimulerende faktor) og tilhører en gruppe lægemidler betegnet cytokiner.
English: What Grastofil is used for
Danish: Hvad Grastofil bruges til
English: Patients with a recent history of lung infiltrates or pneumonia may be at higher risk.
Danish: Patienter med en nylig anamnese med lungeinfiltrater eller pneumoni kan have en højere risiko.
English: Grastofil is a clear colourless solution for injection or infusion.
Danish: Grastofil er en klar, farveløs opløsning til injektion eller infusion.
English: Do not warm Grastofil in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Varm ikke Grastofil på nogen anden måde (opvarm for eksempel ikke injektionssprøjten i mikrobølgeovn eller i varmt vand) Ryst ikke den fyldte injektionssprøjte
English: The effects of Grastofil overdose have not been established.
Danish: Virkningerne efter overdosering af Grastofil er ikke klarlagt.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Grastofil.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Grastofil.
English: If you use more Grastofil than you should, contact your doctor or pharmacist as soon as possible.
Danish: Hvis du har brugt mere Grastofil end du bør, skal du kontakte din læge eller apotekspersonalet så hurtigt som muligt.
English: Do not use Grastofil
Danish: Brug ikke Grastofil
English: • you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Danish: • du behandles for svær kronisk neutropeni, og du har blod i urinen (hæmaturi).
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: Do not put the cover back on used needles, as you may accidentally prick yourself.
Danish: Sæt ikke beskyttelseshætten tilbage på brugte kanyler, da du ved et uheld kan komme til at stikke dig selv.
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Danish: MDS og leukæmier er naturlige komplikationer ved sygdommen, og forbindelsen til behandlingen med filgrastim er usikker.
English: Do not use any Grastofil that may be left in the syringe.
Danish: Brug ikke det Grastofil der eventuelt måtte være tilbage i sprøjten.
English: 9/L for 3 more consecutive days
Danish: 9/l i yderligere 3 på hinanden følgende dage
English: Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.
Danish: Tryk på stemplet med et langsomt, konstant tryk, mens du hele tiden holder din hud klemt sammen, indtil injektionssprøjten er tom.
English: Accidental one-time exposure to freezing temperatures does not adversely affect the stability of Grastofil.
Danish: En utilsigtet enkelt eksponering over for frostgrader én gang påvirker ikke Grastofils stabilitet.
English: Grastofil dosing should be maintained until the last leukapheresis.
Danish: Grastofil doseringen skal fortsætte indtil den sidste leukaferese.
English: Grastofil contains the active substance filgrastim.
Danish: Grastofil indeholder det aktive stof filgrastim.
English: Other special precautions Causes of transient neutropenia such as viral infections should be excluded.
Danish: Andre særlige forsigtighedsregler Årsager til forbigående neutropeni, som f.eks. virusinfektioner, skal udelukkes.
English: If you forget to use Grastofil
Danish: Hvis du har glemt at bruge Grastofil
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 have en risiko for at udvikle blodkræft (leukæmi, myelodysplastisk syndrom (MDS)).
English: 9/L) following filgrastim treatment and leukapheresis was observed in 35% of donors (see section 4.4).
Danish: 9/l) efter filgrastimbehandling og leukaferese blev observeret hos 35 % af donorer (se pkt.
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Danish: Der er rapporter i litteraturen hvor der er demonstreret passage af filgrastim gennem placenta hos gravide kvinder.
English: The impact of filgrastim on human fertility is not known.
Danish: Filgrastims indvirkning på human fertilitet er ukendt.
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 rettet mod antallet af mobiliserede progenitorceller før administration af højdosis kemoterapi.
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'er kan høstes og infunderes efter højdosis cytotoksisk behandling, enten i stedet for eller som tillæg til knoglemarvstransplantationen.
English: Dose adjustment: Grastofil should be administered daily by subcutaneous injection until the neutrophil count has reached and can be maintained at more than 1.5 x 10
Danish: Dosisjusteringer: Grastofil skal gives dagligt ved subkutan injektion indtil neutrofiltallet er nået og kan opretholdes på mere end 1,5 x 10
English: Continuous infusion with filgrastim over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable half-lives.
Danish: Kontinuerlig infusion af filgrastim i en periode på op til 28 døgn til patienter, som restituerer efter autolog knoglemarvstransplantation, resulterede i intet tegn på akkumulation og sammenlignelige halveringstider.
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 injektion i venen (en såkaldt intravenøs infusion).
English: Grastofil treatment will last for up to 2 weeks.
Danish: Grastofil behandlingen vil fortsætte i op til 2 uger.
English: In clinical studies in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Danish: I kliniske studier hos cancerpatienter var de muskuloskeletale smerter lette til moderate hos 10 %, og svære hos 3 % af patienterne.
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 svær kronisk neutropeni vil prædisponere patienterne til cytogenetiske abnormiteter, MDS eller leukæmisk transformation.
English: Grastofil containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Danish: Grastofil, som indeholder r-metHuG-CSF (filgrastim) forårsager signifikante stigninger af neutrofiltallet i perifert blod inden for 24 timer med mindre stigninger af monocyttallet.
English: Leave the syringe at room temperature (15ºC to 25 ºC) for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes.
Danish: Lad injektionssprøjten ligge ved stuetemperatur (15 ºC til 25 ºC) i cirka 30 minutter eller hold den fyldte injektionssprøjte forsigtigt i hånden et par minutter.
English: 9/L during the treatment period, the dose of Grastofil should be reescalated according to the above steps ANC = absolute neutrophil count
Danish: 9/l under behandlingen, skal Grastofil dosis igen øges i henhold til ovenstående skema ANC = absolut neutrofiltal
English: Grastofil is injected into the tissue just under the skin.
Danish: Grastofil injiceres i vævet lige under huden.
English: The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia.
Danish: Virkningen af behandlingen var tydelig hos patienterne i denne aldersgruppe, hvoraf flertallet havde medfødt neutropeni.
English: You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
Danish: Du kan kontakte lægen vedrørende din risiko for at udvikle blodkræft, og hvilke undersøgelser der bør udføres.
English: There is insufficient data to evaluate filgrastim use in elderly subjects for other approved Grastofil indications.
Danish: Der er ikke tilstrækkelige data til at vurdere brug af filgrastim til ældre patienter hvad angår andre godkendte indikationer for Grastofil.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Danish: Donorer, der får G-CSF til mobolisering af PBPC skal monitoreres, indtil deres hæmatologiske værdier vender tilbage til normalen.
English: Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
Danish: Der er indberettet aortitis efter administration af G-CSF hos raske forsøgspersoner og kræftpatienter.
English: Grastofil for PBPC mobilisation when used alone
Danish: Grastofil til PBPC-mobilisering, når det anvendes alene:
English: Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.
Danish: Desinficer huden med en spritserviet, og tag fat (uden at klemme) i huden mellem tommel- og pegefinger.
English: The clinical relevance of this finding to multiple dose administration is not clear.
Danish: Den kliniske relevans af dette fund i sammenligning med indgift af multiple doser er uklar.
English: When diluted in 5% glucose, Grastofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Danish: Ved fortynding i 5 % glucose, er Grastofil forligeligt med glas og en række plasttyper, herunder PVC, polyolefin (en co-polymer af polypropylen og polyethylen) og polypropylen.
English: Clearance of filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous and intravenous administration.
Danish: Det er påvist, at filgrastims clearance følger førsteordens farmakokinetik efter både subkutan og intravenøs administration.
English: 9/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: 9/l) hos patienter med fremskreden hiv-infektion for at nedsætte risikoen for bakterielle infektioner, hvis der ikke er anden egnet behandling af neutropeni.
English: A common side effect of Grastofil 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 under brug af Grastofil er smerter i dine muskler eller knogler (muskuloskeletale smerter), som kan afhjælpes ved at tage smertestillende lægemidler (analgetika).
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 oplever et manglende respons på eller ikke kan opretholde et respons på behandlingen med filgrastim, vil lægen undersøge årsagen hertil, herunder om du har udviklet antistoffer, som neutraliserer filgrastims aktivitet.
English: Musculoskeletal pain c
Danish: Muskuloskeletale smerter c
English: If leukocyte counts exceed 50 x 10
Danish: Hvis leukocyttallet overstiger 50 x 10
English: Instructions for injecting Grastofil
Danish: Vejledning til injektion af Grastofil
English: If someone else is injecting you, they can also use the back of your arms.
Danish: Hvis en anden person foretager injektionen, kan vedkommende injicere på bagsiden af dine arme.
English: Filgrastim is not recommended during pregnancy.
Danish: Filgrastim bør ikke anvendes under graviditeten.
English: Any Grastofil syringes that have been out of the refrigerator for longer than 15 days should not be used and should be disposed of in accordance with local requirements.
Danish: Ingen injektionssprøjter med Grastofil, der har været ude af køleskabet i mere end 15 dage må anvendes, men skal bortskaffes i henhold til lokale retningslinjer.
English: During intermittent dosing with 30 MU (300 microgram)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Danish: Under intermitterende behandling med 30 ME (300 mikrogram) filgrastim/dag, kan der ses store udsving i patientens ANC over tid.
English: The stem cells will then go back into the bone marrow and produce blood cells.
Danish: Stamcellerne vil så nå tilbage i knoglemarven og producere blodlegemer.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Danish: Som andre hæmatopoietiske vækstfaktorer har G-CSF vist stimulerende egenskaber på humane endotelceller in vitro.
English: Once the neutrophil nadir has been passed, the daily dose of Grastofil should be titrated against the neutrophil response as follows:
Danish: Når det neutrofile nadir er passeret, skal den daglige Grastofil dosis titreres i forhold til det neutrofile respons, som følger:
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation with special attention to haematological values and infectious diseases.
Danish: Mobilisering af PBPC må kun udføres hos donorer, der opfylder normale kliniske og laboratoriemæssige egnethedskriterier for stamcelledonation med speciel opmærksomhed på hæmatologiske værdier og smittefarlige sygdomme.
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 i dette lægemiddel
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/mL for 8 - 16 hours.
Danish: Efter subkutan administration af anbefalede doser forblev serumkoncentrationerne over 10 ng/ml i 8-16 timer.
English: You may notice a small air bubble in the pre-filled syringe.
Danish: Du kan se en lille luftboble i den fyldte injektionssprøjte.
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: Der er præliminær evidens fra et mindre antal patienter, som blev behandlet samtidigt med filgrastim og 5-fluorouracil, der tyder på, at neutropeniens sværhedsgrad kan forværres.
English: When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established.
Danish: Når der er opnået revertering af neutropeni, skal den mindste effektive dosis til opretholdelse af et normalt neutrofiltal fastlægges.
English: • The active substance is filgrastim.
Danish: • Aktivt stof: filgrastim.
English: Some cytotoxic medicinal products exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Danish: Visse cytotoksiske lægemidler er særligt toksiske over for den hæmatopoietiske progenitorpool, og kan have en negativ virkning på mobilisering af progenitorceller.
English: When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 10
Danish: Når det administreres til PBPC-mobilisering, skal behandlingen med filgrastim dog først afbrydes eller dosis reduceres, hvis leukocyttallet stiger til 70 x 10
English: The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 mL/min/kg.
Danish: Eliminationshalveringstiden af filgrastim i serum er ca. 3,5 timer, med en clearancerate på ca. 0,6 ml/min/kg.
English: World Trade Center Moll de Barcelona s/n, Edifici Est 6ª planta 08039 Barcelona Spain
Danish: World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta,
English: A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal or shoulder tip pain.
Danish: Diagnosen miltruptur bør overvejes hos donorer og/eller patienter, der indberetter smerter i øvre venstre side af abdomen eller skulderbladet.