FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use it if the date has passed the last day of the month shown.
Danish: Brug ikke sprøjten, hvis den sidste dato i den nævnte måned er overskredet.
English: Splenic enlargement is a direct effect of treatment with filgrastim.
Danish: Forstørrelse af milten er en direkte virkning af behandling med filgrastim.
English: 08409 Vilnius Lithuania
Danish: LT-08409 Vilnius Litauen
English: Transient, moderate decreases in non-fasting blood glucose have also been seen.
Danish: Desuden er der set forbigående, moderate fald i ikke-fastende blodglukose.
English: cells/kg) or acceleration of platelet recovery to the same degree.
Danish: CD34+-celler/kg) eller acceleration af trombocytregeneration i samme grad.
English: The most suitable places to inject yourself are: - the top of your thighs; and - the abdomen, except for the area around the navel (see picture 3).
Danish: De mest velegnede steder til indsprøjtningen er: - øverst på hofterne - i maven, undtagen i området omkring navlen (se figur 3).
English: Reduce to 0.5 MIU (5 µg)/kg/day
Danish: Reducer til 0,5 mio. IE (5 µg)/kg/døgn
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2 C-8 C).
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 udvist in vitro-stimulerende egenskaber i humane endotelceller.
English: Headache and diarrhoea have been reported shortly after starting filgrastim therapy, typically in less than 10 % of patients.
Danish: Der er rapporteret hovedpine og diarré kort tid efter indledning af filgrastimterapi - typisk hos færre end 10 % af patienterne.
English: In cancer patients, the pharmacokinetic profile of Biograstim and the reference product was comparable after single and repeated subcutaneous administration.
Danish: Hos cancerpatienter var den farmakokinetiske profil af Biograstim og referenceproduktet sammenlignelige efter en enkelt og gentagne subkutane doser.
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Danish: Patienter med nylig forekomst af lungeinfiltrater eller pneumoni kan have en øget risiko.
English: The efficacy and safety of Biograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Danish: Biograstims sikkerhed og virkning er undersøgt i randomiserede, kontrollerede fase III-studier hos patienter med brystcancer, lungecancer og non-Hodgkin-lymfom.
English: Inject only the dose your doctor has told you.
Danish: Injicer kun den dosis, lægen har ordineret.
English: Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities.
Danish: Filgrastimterapi må kun gives i samarbejde med et onkologisk center, som har erfaring i at behandle med granulocytkolonistimulerende faktorer (G-CSF) og hæmatologi, og som har det nødvendige diagnostiske udstyr.
English: In some SCN patients, filgrastim can also induce a minor increase in the number of circulating eosinophils and basophils relative to baseline; some of these patients may present with eosinophilia or basophilia prior to treatment.
Danish: Hos nogle patienter med SCN kan filgrastim også fremkalde en mindre stigning i antallet af cirkulerende eosinofile og basofile blodlegemer i forhold til baseline, og nogle af disse patienter kan have eosinofili eller basofili før behandlingen.
English: Symptoms suggestive of severe allergic reactions have been reported very rarely.
Danish: Symptomer, der tydede på svære allergiske reaktioner, rapporteredes i meget sjældne tilfælde.
English: Splenic enlargement was reported to be related to filgrastim therapy in < 3 % of patients.
Danish: Forstørrelse af milten rapporteredes at være forbundet med filgrastimterapi hos < 3 % af patienterne.
English: It is important to contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Danish: Det er vigtigt, at De straks kontakter lægen, hvis De får smerter øverst i venstre side af maven eller i venstre skulderparti, da det kan skyldes, at der er noget galt med milten.
English: A subset of approximately 12 % of patients who had normal cytogenetic evaluations at baseline was subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
Danish: En delgruppe på ca. 12 % af patienterne, som havde normal cytogenetik ved baseline, fik siden konstateret anomalier inklusive monosomi 7 ved en ny rutinestudie.
English: Overall, reports were more common after IV administration.
Danish: Generelt sås de hyppigere efter intravenøs administration.
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Danish: I nogle tilfælde genopstod symptomerne efter fornyet provokation, hvilket tyder på en kausal sammenhæng.
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Danish: MDS og leukæmi er naturlige komplikationer til sygdommen, og forbindelse til filgrastimterapi er ikke afklaret.
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Biograstim was comparable to that of the reference product after subcutaneous and intravenous administration.
Danish: Randomiserede, enkeltblinde, crossover-studier med enkeltdosis, der omfattede 196 raske forsøgspersoner, viste, at Biograstims farmakokinetiske profil var sammenlignelig med profilen af referenceproduktet efter subkutan og intravenøs administration.
English: The significance of these changes in terms of the development of haematological malignancy is unknown.
Danish: Det vides ikke, hvilken betydning disse ændringer har for udviklingen af hæmatologisk malign sygdom.
English: cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Danish: Resultaterne af flowcytometrisk analyse af antallet af CD34+-celler afhænger af den anvendte metodik, og derfor bør rekommandationer af celleantal, der baseres på studier udført i andre laboratorier, fortolkes med forsigtighed.
English: Biograstim is a solution for injection or infusion in a pre-filled syringe with or without safety device.
Danish: Biograstim er en injektions- og infusionsvæske i en fyldt injektionssprøjte med eller uden sikkerhedsanordning.
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Danish: Der kan opstå andre forandringer i blodværdier, inklusive anæmi og forbigående øgning af myeloide stamceller, der kræver nøje monitorering af disse værdier.
English: Physicians should exercise caution when considering the use of filgrastim in patients with sickle cell disease and only after careful evaluation of the potential risks and benefits.
Danish: Læger skal udvise forsigtighed, når de overvejer at give filgrastim til patienter med seglcellesygdom, og lægemidler må kun anvendes efter nøje afvejning af potentielle fordele og risici.
English: Long-term treatment with Biograstim may be required to maintain a normal number of white cells in your blood.
Danish: Det kan være nødvendigt at give langtidsbehandling med Biograstim for at opretholde et normalt antal hvide blodlegemer.
English: Since lithium promotes the release of neutrophils, it is likely to potentiate the effect of filgrastim.
Danish: Da lithium øger frisætningen af neutrofile granulocytter, vil det sandsynligvis forstærke virkningen af filgrastim.
English: If the patient is experiencing fatigue, caution is advised when driving a car or operating machines.
Danish: Hvis patienten føler træthed bør forsigtighed udvises ved bilkørsel eller brug af maskiner.
English: The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Danish: Sikkerhed og virkning hos nyfødte og patienter med autoimmun neutropeni er ikke klarlagt.
English: Relative risk (95 % CI) of GvHD and TRM following treatment with G-CSF after bone marrow transplantation
Danish: Relativ risiko (95 % CI) for GvHD og BRM efter behandling med G-CSF efter knoglemarvstransplantation
English: Your doctor will tell you when to stop using Biograstim.
Danish: Lægen fortæller Dem, når det er tid til at stoppe med Biograstim.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens (see below).
Danish: Filgrastim bør ikke anvendes til at øge dosis af cytotoksisk kemoterapi ud over de fastlagte behandlingsplaner (se nedenfor).
English: The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established.
Danish: Filgrastims sikkerhed og virkning, når det gives på samme dag som myelosuppressiv cytotoksisk kemoterapi, er ikke endeligt klarlagt.
English: If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.
Danish: I tilfælde af luftbobler bank let på sprøjten med fingrene, indtil luftboblerne stiger til vejrs.
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 kapillærlækagesyndrom, bør monitoreres nøje og have symptomatisk standardbehandling, inklusive eventuel intensiv behandling efter behov (se pkt.
English: In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, the use of filgrastim is not recommended in the period from 24 hours before to 24 hours after chemotherapy.
Danish: I betragtning af de hurtigtdelende myeloide cellers følsomhed over for myelosuppressiv cytotoksisk kemoterapi bør filgrastim ikke anvendes i tidsrummet fra 24 timer før til 24 timer efter kemoterapi.
English: There were no differences in the safety profiles for paediatric patients treated for severe chronic neutropenia.
Danish: Der var ingen forskelle i sikkerhedsprofilen hos børn, der blev behandlet for svær kronisk neutropeni.
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 vurdering af antallet af stamceller høstet hos patienter efter behandling med filgrastim er det særlig vigtigt at være opmærksom på kvantificeringsmetoden.
English: - It is important to contact your doctor immediately if you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Danish: - Det er vigtigt straks at fortælle det til Deres læge, hvis De får en eller en kombination af følgende bivirkninger: hævelse eller opsvulmethed, der kan være forbundet med mindre hyppig vandladning, åndedrætsbesvær, opsvulmet mave og mæthedsfølelse samt en generel følelse af træthed.
English: - As a very common (may affect more than 1 in 10 people) side effect, filgrastim may cause bone and muscle pain.
Danish: - Som en meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) bivirkning kan filgrastim give knogle- og muskelsmerter.
English: Clearance of filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous and intravenous administration.
Danish: Clearance af filgrastim udviser førsteordens farmakokinetik efter både subkutan og intravenøs administration.
English: Causes of transient neutropenia such as viral infections should be excluded.
Danish: Andre særlige forsigtighedsregler Årsager til forbigående neutropeni såsom virusinfektioner skal udelukkes.
English: It is important that you dispose of used syringes in a puncture-proof container.
Danish: Det er vigtigt, at De kasserer den brugte sprøjte i en særlig beholder til skarpe genstande.
English: The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Danish: Mobiliserings- og afereseprocedurer bør udføres i samarbejde med et onkologisk og hæmatologisk center med tilstrækkelig erfaring inden for dette område og kapacitet til at udføre korrekt monitorering af hæmatopoietiske stamceller.
English: Important side effects
Danish: Vigtige bivirkninger
English: Biograstim contains the active substance filgrastim.
Danish: Biograstim indeholder det aktive stof filgrastim.
English: There is no evidence from studies in rats and rabbits that filgrastim is teratogenic.
Danish: Dyrestudier med rotter og kaniner har ikke vist, at filgrastim er teratogent.
English: Not known (frequency cannot be estimated from the available data): - cough; fever and difficulty breathing or coughing up blood.
Danish: Ikke kendte (hyppighed kan ikke beregnes ud fra forhåndenværende data): - hoste; feber og åndedrætsbesvær eller ophosten af blod.
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Danish: Neutrofile granulocytter dannet ved induktion af filgrastim udviser normal eller forstærket funktion, hvilket kan påvises ved tests af kemotaktisk og fagocytotisk funktion.
English: Monitoring of bone density may be indicated in patients with underlying osteoporotic bone diseases who undergo continuous therapy with filgrastim for more than 6 months.
Danish: Kontrol af knogletæthed kan være indiceret hos patienter med samtidig osteoporotisk knoglesygdom, som har været i kontinuerlig behandling med filgrastim i over 6 måneder.
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Danish: I en metaanalyse af studier med allogene transplantationer, som omfattede resultaterne fra ni prospektive, randomiserede studier, otte retrospektive studier og et case-kontrolleret studie, blev der ikke påvist nogen indflydelse på risikoen for akut GvHD, kronisk GvHD eller tidlig behandlingsrelateret mortalitet.
English: In view of the possible risk of microbial contamination, Biograstim syringes are for single use only.
Danish: Da der er risiko for mikrobiel kontaminering, er Biograstim injektionssprøjter kun til engangsbrug.
English: If someone else is injecting you, they can also use the back of your arms (see picture 4).
Danish: Hvis indsprøjtningen gives af en anden, kan den også gives bag på armene (se figur 4).
English: Dose reductions were noted to slow or stop the progression of splenic enlargement and in 3 % of patients a splenectomy was required.
Danish: Det bemærkedes, at dosisreduktioner nedsatte eller standsede progressionen af miltforstørrelse, og hos 3 % af patienterne opstod behov for splenektomi.
English: Capillary leak syndrome*
Danish: Kapillærlækage-syndrom*
English: In order to determine a patient's trough or nadir ANC, it is recommended that blood samples are taken for ANC measurement immediately prior to any scheduled dosing with filgrastim.
Danish: For at bestemme patientens ANC-minimum eller -nadir anbefales det at tage blodprøver til ANC-måling umiddelbart før planlagt indgift af filgrastim.
English: In clinical trials, 97 % of patients who responded had a complete response at doses of ≤ 2.4 MIU (24 μg)/kg/day.
Danish: I kliniske studier opnåede 97 % af respondenterne fuldstændigt respons ved doser på ≤ 2,4 mio. IE (24 μg)/kg/døgn.
English: No effect was observed on the fertility of male and female rats or gestation in rats.
Danish: Der sås ingen virkning på fertiliteten hos han- og hunrotter eller på graviditet hos rotter.
English: It is recommended that the ANC is measured daily for the first 2 to 3 days of filgrastim administration.
Danish: Det anbefales at måle ANC hver dag i de første 2-3 dage af filgrastimbehandlingen.
English: Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
Danish: Leukaferese bør ikke udføres hos donorer, som får antikoagulationsterapi, eller som har kendte hæmostasedefekter.
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 målt ud fra de ovennævnte kriterier, bør det overvejes at vælge andre behandlingsformer, der ikke kræver supplerende stamcelleterapi.
English: Biograstim does not contain any preservative.
Danish: Biograstim indeholder ingen konserveringsmidler.
English: Use of filgrastim in patients undergoing cytotoxic chemotherapy leads to significant reductions in the incidence, severity and duration of neutropenia and febrile neutropenia.
Danish: Brug af filgrastim til patienter i cytotoksisk kemoterapi medfører signifikant reduktion af incidens, sværhedsgrad og varighed af neutropeni og febril neutropeni.
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation.
Danish: Mobilisering af perifere stamceller bør kun udføres hos donorer, der opfylder normale kliniske og laboratoriemæssige kriterier for stamcelledonation.
English: ● Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Biograstim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Danish: Biograstim indeholder r-metHuG-CSF (filgrastim), og det udvirker markante stigninger i neutrofiltallet i perifert blod i løbet af 24 timer samt mindre stigninger i antallet af monocytter.
English: When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established.
Danish: Efter reversering af neutropeni fastlægges den mindste effektive dosis, der kan opretholde et normalt neutrofiltal.
English: You may notice a small air bubble in the pre-filled syringe.
Danish: Måske kan De se en lille luftboble i den fyldte injektionssprøjte.
English: The amount of Biograstim you need, will depend on the condition you are taking Biograstim for and on your bodyweight.
Danish: Hvor meget Biograstim, De skal have, afhænger af, hvorfor De skal have Biograstim, og hvor meget De vejer.
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 den ikke bruges umiddelbart, har brugeren ansvaret for opbevaringstider og forhold før brug, som normalt ikke bør være mere end 24 timer ved 2-8 °C, medmindre fortyndingen er foretaget under kontrollerede og validerede aseptiske forhold.
English: In a small number of patients (< 10 %), doses up to 1.0 MIU (10 μg)/kg/day were required to achieve reversal of neutropenia.
Danish: Hos et mindre antal patienter (< 10 %) var det nødvendigt at give doser på op til 1,0 mio. IE (10 μg)/kg/døgn for at reversere neutropeni.
English: The clinical relevance of this finding to multiple dose administration is not clear.
Danish: Det står ikke klart, hvad den kliniske relevans af dette fund er ved administration af flere doser.
English: In randomised, placebo-controlled clinical trials, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
Danish: I randomiserede, placebokontrollerede kliniske studier medførte filgrastim ikke stigning i incidensen af de bivirkninger, der forbindes med cytotoksisk kemoterapi.
English: Uncommon (may affect up to 1 in 100 people): - unspecified pain.
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer): - uspecifikke smerter.
English: Talk to your doctor or nurse that you are treated with Biograstim if you are undergoing bone-imaging.
Danish: Fortæl det til Deres læge eller sundhedspersonalet, at De er i behandling med Biograstim, hvis De skal have knoglescanning.
English: In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Danish: Da der foreligger begrænsede data om sikkerhed og virkning hos patienter med sekundær AML, bør der udvises forsigtighed ved administration af filgrastim.
English: Publication Period of study
Danish: Publikation Studieperiode N
English: Push the plunger up to the number (mL) on the syringe that matches the dose of Biograstim that your doctor prescribed.
Danish: Tryk stemplet i til det antal millimeter (ml), der svarer til den ordinerede dosis Biograstim.
English: - Allergic reactions such as skin rash, raised itchy areas of skin and serious allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported.
Danish: - Der er indberettet allergiske reaktioner som f.eks. hududslæt, hævede hudområder med kløe og alvorlige allergiske reaktioner med svækkelse, blodtryksfald, vejrtrækningsbesvær og hævelser i ansigtet.
English: Rare pulmonary undesirable effects, in particular interstitial pneumonia, have been reported after G-CSF administration.
Danish: Der er rapporteret sjældne pulmonale bivirkninger, især interstitiel pneumoni, efter administration af G-CSF.
English: The incidence of fever and documented infections were not reduced in either setting.
Danish: Incidensen af feber og påviste infektioner blev ikke reduceret ved disse behandlinger.
English: When a peripheral blood progenitor cell transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Danish: Ved overvejelse af transplantation af perifere blodstamceller anbefales det at udføre stamcellemobiliseringen tidligt i patientens behandlingsforløb.
English: Regular monitoring of platelet count and haematocrit is recommended.
Danish: Regelmæssig kontrol af trombocyttal og hæmatokrit anbefales.
English: 4.4 Special warnings and precautions for use Special warnings
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Biograstim; - alcohol wipes or similar; - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
Danish: For at give Dem selv en subkutan injektion skal De bruge: - en fyldt medicinsprøjte med Biograstim, - spritservietter eller lignende, - en beholder til skarpe genstande (plastbeholder, der udleveres af hospitalet eller apoteket), så De kan kassere brugte sprøjter på sikker vis.
English: Do not use Biograstim in the 24 hours before or the 24 hours after your chemotherapy.
Danish: Brug ikke Biograstim 24 timer før og 24 timer efter Deres kemoterapi.
English: Dilution to a final concentration less than 0.2 MIU (2 μg) per mL is not recommended at any time.
Danish: Fortynding til en slutkoncentration på under 0,2 mio. IE (2 μg) pr. ml frarådes under alle omstændigheder.
English: However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been established.
Danish: En betydelig procentdel af disse patienter led imidlertid af leukæmi, en lidelse der associeres med Sweets syndrom, og en kausal sammenhæng med filgrastim er derfor ikke påvist.