FrancophonIA/ELRC3.0 huggingface dataset:
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: Procedurerne for mobilisering og aferese skal foretages i samarbejde med et onkologisk-hæmatologisk center med tilstrækkelig erfaring inden for dette område, og hvor der kan foretages korrekt monitorering af hæmatopoietiske progenitorceller.
English: If you have missed an injection, or injected too little, contact your doctor as soon as possible.
Danish: Hvis du har sprunget en indsprøjtning over eller injiceret en for lille dosis, skal du kontakte din læge hurtigst muligt.
English: Do not try to replace the protective cap.
Danish: Sæt ikke beskyttelseshætten på igen.
English: Then, if ANC remains > 1.0 x 10
Danish: Derefter, hvis ANC forbliver > 1,0 x 10
English: In patients with HIV infection
Danish: Patienter med HIV-infektion
English: During long-term use cutaneous vasculitis has been reported in 2% of SCN patients.
Danish: Kutan vasculitis er rapporteret hos 2 % af SCN-patienter under langvarig anvendelse.
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: De kliniske studier med filgrastim har omfattet et mindre antal ældre patienter, men der er ikke foretaget specielle studier hos denne gruppe.
English: When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leucocyte counts rise to > 70 x 10
Danish: Ved administration i forbindelse med PBPC-mobilisering, bør behandlingen med filgrastim afbrydes eller dosis reduceres, hvis leukocyttallet stiger til > 70 x 9/l.
English: Malignant cell growth
Danish: Malign cellevækst
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient abnormal bone scans.
Danish: Øget hæmatopoietisk aktivitet i knoglemarven som reaktion på vækstfaktorbehandling er blevet forbundet med forbigående abnorme knoglescanninger.
English: Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with bone marrow transplantation.
Danish: De nuværende data tyder på, at immunologiske interaktioner mellem det allogene PBPC-transplantat og modtageren kan være forbundet med en øget risiko for akut eller kronisk GvHD, når der sammenlignes med en knoglemarvstransplantation.
English: (mucosal inflammation)
Danish: (slimhindeinflammation)
English: These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Danish: Dette kan være symptomer på en sygdom som kaldes ”kapillær lækage-syndrom,” der medfører, at der lækker blod fra de små blodkar ind i kroppen, og som kræver akut lægehjælp.
English: If exposure has been greater than 24 hours or frozen more than once, then Nivestim should NOT be used.
Danish: Hvis nedfrysningen har varet længere end 24 timer, eller hvis Nivestim er nedfrosset mere end én gang, må Nivestim IKKE bruges.
English: When you have completed the injection, slide the needle guard forward until the needle is completely covered (device ‘clicks' into place).
Danish: Når du har afsluttet indsprøjtningen, skal du skubbe kanylebeskytteren fremad, indtil kanylen er helt dækket (dvs. indtil den er klikket på plads).
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, som tyder på, at neutropeniens sværhedsgrad kan forværres.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: • NEVER put used syringes into your normal household waste bin.
Danish: • Opbevar brugte sprøjter utilgængeligt for børn • Læg ALDRIG brugte sprøjter i den normale affaldsspand med husholdningsaffald
English: Use of filgrastim, either alone, or after chemotherapy, mobilises haematopoietic progenitor cells into the peripheral blood.
Danish: Anvendelse af filgrastim, enten alene eller efter kemoterapi, mobiliserer hæmatopoietiske progenitorceller i det perifere blod.
English: The effects of filgrastim overdosage have not been established.
Danish: Virkningerne efter overdosering af filgrastim er ikke klarlagt.
English: If you do see blood inside the syringe, remove the needle and re-insert it in a different site.
Danish: Hvis der kommer blod i sprøjten, skal du tage kanylen ud og stikke den ind et andet sted.
English: Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥ 20 µg/kg/day) and slightly reduced survival rate (100 µg/kg/day).
Danish: Rotteunger, der fik filgrastim administreret i den perinatale periode og under laktation, udviste forsinkelse i ekstern differentiering og vækstforsinkelse (≥20 µg/kg/dag) og let nedsat overlevelsesrate (100 µg/kg/dag).
English: Pulmonary adverse effects, in particular interstitial lung disease, have been reported after G-CSF administration.
Danish: Der er rapporteret pulmonale bivirkninger, især interstitiel lungesygdom, efter administration af GCSF.
English: 9/L to > 5.0 x 10
Danish: 9/l til > 5,0 x 10
English: Dose adjustment: Filgrastim 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: Justering af dosis: Filgrastim bør gives dagligt som subkutan injektion indtil, neutrofiltallet er nået og kan opretholdes på mere end 1,5 x 10
English: It is also important that you dispose of the syringe in a puncture-proof container.
Danish: Det er også vigtigt, at du bortskaffer sprøjten i en affaldsbeholder, som ikke kan punkteres.
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 mobilisering af PBPC skal monitoreres indtil, deres hæmatologiske værdier er normale.
English: It is recommended that the ANC is measured daily for the first 2-3 days of filgrastim administration.
Danish: Det anbefales at bestemme ANC dagligt i de første 2-3 dage under behandlingen med filgrastim.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid til lægen eller apotekspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin
English: Veno-occlusive disease d
Danish: Veno-okklusiv sygdom
English: Filgrastim dosing should be maintained until the last leukapheresis.
Danish: Behandlingen med filgrastim skal fortsætte indtil den sidste leukaferese.
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Danish: Filgrastim bør seponeres permanent hos patienter, som får en alvorlig allergisk reaktion.
English: Effect of chemotherapy on erythrocytes and thrombocytes
Danish: Kemoterapis virkning på erytrocytter og trombocytter
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 disease.
Danish: Mobilisering af PBPC skal kun udføres hos donorer, der opfylder normale kliniske og laboratoriemæssige kriterier for stamcelledonation, og opmærksomheden skal specielt være rettet mod hæmatologiske værdier og infektionssygdomme.
English: • the front of the thighs, • the abdomen, except for the area around the navel.
Danish: • forsiden af lårene • maven med undtagelse af området omkring navlen
English: Nivestim is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia).
Danish: Nivestim bruges til at behandle børn, der får kemoterapi, eller som har et meget lavt antal hvide blodlegemer (neutropeni).
English: Pack sizes of 1, 5, 8 or 10 pre-filled syringes.
Danish: Pakningsstørrelser på 1, 5, 8 eller 10 fyldte sprøjter.
English: This is known as a subcutaneous injection.
Danish: Det kaldes en subkutan indsprøjtning.
English: Пфайзер Люксембург САРЛ, Клон
Danish: Пфайзер Люксембург САРЛ, Клон България Тел.
English: Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy:
Danish: Filgrastim til PBPC mobilisering efter myelosuppressiv kemoterapi:
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with filgrastim.
Danish: Overfølsomhed, herunder anafylaktiske reaktioner, som er opstået ved initial eller efterfølgende behandling er blevet rapporteret hos patienter i behandling med filgrastim.
English: Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery.
Danish: Et større høstudbytte end dette ser ud til at kunne korreleres til hurtigere bedring, medens mindre udbytte giver langsommere bedring.
English: Special warning and precautions across indications
Danish: Særlige advarsler og forholdsregler på tværs af indikationer
English: • liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)
Danish: • Leverskade grundet blokering af de små blodkar i leveren (veno-okklusiv sygdom)
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: Nivestim contains sorbitol
Danish: Nivestim indeholder sorbitol
English: Long term daily administration is required to maintain an adequate neutrophil count.
Danish: Det er nødvendigt med daglig behandling i længere tid for at opretholde et tilfredsstillende neutrofiltal.
English: Transfusion reaction e a See section c (Description of selected adverse reactions).
Danish: Se afsnit c (Beskrivelse af udvalgte bivirkninger).
English: • inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2
Danish: • Betændelse i aorta (den store pulsåre, der transporterer blod fra hjertet ud i kroppen), se punkt.
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Danish: Fortyndet filgrastim kan adsorberes til glas- og plastmaterialer som nævnt nedenfor.
English: Intravenous (80 µg/kg/day) administration of filgrastim to rabbits during the period of organogenesis was maternally toxic and increased spontaneous abortion, post-implantation loss, and decreased mean live litter size and foetal weight were observed.
Danish: Intravenøs (80 µg/kg/dag) administration af filgrastim til kaniner under organogenese var maternelt toksisk, og der blev observeret øget spontan abort, tab efter implantation og reduceret gennemsnitlig levende kuldstørrelse og fostervægt.
English: Risks associated with increased doses of chemotherapy
Danish: Risiko forbundet med øgede doser kemoterapi
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 et normalt neutrofilniveau, skal den mindste effektive dosis til opretholdelse af et normalt neutrofiltal fastlægges.
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Danish: • Nedsat følesans, særligt i huden (hypoæstesi)
English: Elevations of neutrophil counts are dose dependent at recommended doses.
Danish: Forhøjelsen af neutrofiltallet er dosisafhængigt ved brug af de anbefalede doser.
English: This observation has only been made in patients with congenital neutropenia.
Danish: Det blev kun set hos patienter med congetinal neutropeni.
English: In a small number of patients (< 10%), doses up to 1.0 MU (10 µg)/kg/day were required to achieve reversal of neutropenia.
Danish: Hos et lille antal patienter (< 10 %) var det nødvendigt med doser op til 1,0 ME (10 µg)/kg/dag for at opnå et normalt neutrofiltal.
English: Special precautions in cancer patients
Danish: Særlige forholdsregler hos cancerpatienter
English: • sudden life-threatening allergic reaction (anaphylactic reaction)
Danish: • Pludselig livstruende allergisk reaktion (anafylaktisk reaktion)
English: Analysis includes patients receiving BM transplant during this period.
Danish: Analysen omfatter patienter, som fik knoglemarvstransplantationer i denne periode.
English: Leucocytosis (WBC > 50 x 10
Danish: Der blev set leukocytose (WBC > 50 x 10
English: • A new pre-filled syringe of Nivestim.
Danish: • En ny fyldt sprøjte med Nivestim
English: Mobilisation of PBPC does not provide a direct clinical benefit to normal donors and should only be considered for the purposes of allogeneic stem cell transplantation.
Danish: Mobilisering af PBPC giver ikke nogen direkte klinisk fordel for raske donorer og skal kun anvendes ved allogen stamcelletransplantation.
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: Anvendelsen af filgrastim til patienter, som får cytotoksisk kemoterapi, medfører signifikant reduktion af incidens, sværhedsgrad og varighed af neutropeni og febril neutropeni.
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased)
Danish: • Høje urinsyreniveauer i blodet der kan medføre gigt (hyperurikæmi) (stigning i urinsyre i blodet)
English: Nivestim can be used: - to increase the number of white blood cells after treatment with chemotherapy to help prevent infections; - to increase the number of white blood cells after a bone marrow transplant to help prevent infections; - 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: Nivestim kan bruges: - til at øge antallet af hvide blodelegemer efter behandling med kemoterapi for at hjælpe med at forhindre infektion - til at øge antallet af hvide blodlegemer efter knoglemarvstransplantation for at hjælpe med at forhindre infektion - inden højdosis kemoterapi for at få knoglemarven til at producere flere stamceller, der kan indsamles og gives til dig igen efter behandlingen.
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: Det kan være nødvendigt at monitorere knogletætheden hos patienter med underliggende osteoporotiske knoglesygdomme, som får kontinuerlig behandling med filgrastim i mere end 6 måneder.
English: • rejection of transplanted bone marrow (graft versus host disease)
Danish: • Afstødning af transplanteret knoglemarv (graft versus host-sygdom)
English: Nivestim is one of a group of products that stimulate the production of white blood cells.
Danish: Nivestim er et lægemiddel i en gruppe af produkter, der stimulerer produktionen af de hvide blodlegemer.
English: Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy.
Danish: Bivirkninger med større forekomst hos filgrastim-patienter sammenlignet med placebo er forbundet med sequelae fra den underliggende malignitet eller cytotoksisk kemoterapi.
English: • generalised weakness (asthenia)
Danish: • Generel svækkelse (astheni)
English: Nivestim contains sorbitol (E420).
Danish: Nivestim indeholder sorbitol (E420).
English: Nivestim is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Danish: Nivestim gives normalt som en daglig indsprøjtning i vævet lige under huden (kaldes en subkutan injektion).
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren, der er ansvarlige for batchfrigivelse
English: • The active substance is filgrastim.
Danish: - Aktivt stof: filgrastim.
English: Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Nivestim.
Danish: Uheldig udsættelse for nedfrysningstemperaturer i op til 24 timer påvirker ikke Nivestims holdbarhed.
English: • low blood pressure (hypotension)
Danish: • Lavt blodtryk (hypotension)
English: Cases of capillary leak syndrome have been reported with granulocyte colony-stimulating factor use.
Danish: Der er indberettet tilfælde af kapillær lækage-syndrom i forbindelse med anvendelse af granulocytkolonistimulerende faktor.
English: Rare (≥ 1/10,000 to
Danish: Sjælden (≥ 1/10.000 til
English: The no observed adverse effect level for embryo-foetal toxicity in this study was 10 µg/kg/day, which corresponded to a systemic exposure of approximately 3-5 times the exposures observed in patients treated with the clinical dose.
Danish: NOAEL (no observed adverse effect level) for embryoføtal toksicitet i dette studie var 10 µg/kg/dag, hvilket svarede til en systemisk eksponering på cirka 3-5 gange de eksponeringer, der observeres hos patienter, som behandles med den kliniske dosis.
English: The results of flow cytometric analysis of CD34
Danish: Resultaterne af en flowcytometrisk analyse af antallet af CD34
English: Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or PBPC mobilization.
Danish: Der blev observeret tilfælde efter markedsføring hos patienter, der fik knoglemarvstransplantation eller mobilisering af PBPC.
English: If the ANC decreases to < 1.0 x 10
Danish: Hvis ANC falder til < 1,0 x 10
English: Congenital, idiopathic or cyclic neutropenia: Filgrastim should be given by subcutaneous injection.
Danish: Medfødt, idiopatisk eller cyklisk neutropeni: Filgrastim skal gives som subkutan injektion.
English: 9/L or greater have been observed in less than 5% of cancer patients receiving filgrastim at doses above 0.3 MU/kg/day (3 µg/kg/day).
Danish: 9/l eller derover hos færre end 5 % af de cancerpatienter, som fik filgrastim i doser over 0,3 ME/kg/dag (3 µg/kg/dag).
English: Do not use this medicine if you notice it is cloudy or there are particles in it.
Danish: Brug ikke lægemidlet, hvis du bemærker, opløsningen er uklar eller indeholder partikler.
English: Patients having a bone marrow transplant after chemotherapy:
Danish: Patienter der får knoglemarvstransplantation efter kemoterapi:
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Danish: Symptomerne er i nogle tilfælde vendt tilbage efter gentagen eksponering, hvilket tyder på en kausal sammenhæng.
English: Based on reported data for another filgrastim product similar to the originator, comparable findings plus increased foetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Danish: Baseret på de rapporterede data for et andet filgrastim-produkt, der ligner det originale produkt, blev der observeret sammenlignelige fund samt en stigning i fostermisdannelser ved 100 µg/kg/dag - en maternelt toksisk dosis, der svarede til en systemisk eksponering på cirka 50-90 gange de eksponeringer, der observeres hos patienter, som behandles med den kliniske dosis på 5 µg/kg/dag.
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 elimination half-lives.
Danish: Kontinuerlig infusion af filgrastim i en periode på op til 28 døgn til patienter, som er i restitution efter autolog knoglemarvstransplantation, viste sammenlignelige eliminationshalveringstider og ingen tegn på akkumulation.
English: One retrospective European study evaluating the use of GCSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment related mortality (TRM) and mortality when GCSF was administered.
Danish: Et retrospektivt europæisk studie om brugen af G-CSF efter allogen knoglemarvstransplantation til patienter med akutte leukæmier tydede på en øget risiko for GvHD, behandlingsrelateret mortalitet (BRM) og mortalitet efter indgift af G-CSF.
English: However, in view of the potential risks associated with severe leucocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Danish: På grund af den mulige risiko, som er forbundet med svær leukocytose, bør der foretages leukocyttælling med regelmæssige mellemrum under behandlingen med filgrastim.
English: The dosing in children receiving chemotherapy is the same as for adults.
Danish: Dosering til børn, der får kemoterapi, er den samme som til voksne.
English: The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 15 days (but not above 25°C).
Danish: Sprøjten kan tages ud af køleskabet og opbevares ved stuetemperatur for en enkelt periode på højst 15 døgn (ikke over 25 °C).
English: Relative Risk (95% CI) of GvHD and TRM Following Treatment with GCSF after Bone Marrow Transplantation Publication
Danish: Relativ risiko (95 % sikkerhedsinterval) for GvHD og BRM Efter behandling med G-CSF efter knoglemarvstransplantation
English: Filgrastim was studied in repeated dose toxicity studies up to 1 year in duration which revealed changes attributable to the expected pharmacological actions including increases in leucocytes, myeloid hyperplasia in bone marrow, extramedullary granulopoiesis and splenic enlargement.
Danish: Filgrastim blev undersøgt i studier af toksiciteten efter gentagne doser af op til 1 års varighed, hvor der blev observeret ændringer, som kunne tilskrives de forventede farmakologiske virkninger, herunder stigninger i leukocytter, myeloid hyperplasi i knoglemarv, ekstramedullær granulopoiese og forstørret milt.
English: Filgrastim should not be administered to patients with severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution.
Danish: Filgrastim bør ikke gives til patienter med alvorlig kongenital neutropeni, der udvikler leukæmi eller har tegn på udvikling af leukæmi.
English: The onset of pulmonary signs, such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of acute respiratory distress syndrome (ARDS).
Danish: Lungesymptomer som hoste, feber og dyspnø i forbindelse med radiologiske tegn på lungeinfiltrater og forværrelse af lungefunktionen kan være præliminære tegn på acute respiratory distress syndrome (ARDS).
English: Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 15 days.
Danish: Inden for opbevaringstiden og til ambulante formål må patienterne tage lægemidlet ud af køleskabet og opbevare det ved stuetemperatur (ikke over 25 °C) i en enkelt periode på op til 15 døgn.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Nivestim.
Danish: Hvis lægen ikke giver dig andre anvisninger, skal du stoppe med at amme, hvis du bruger Nivestim,
English: Absolute neutrophil count (ANC) should be monitored closely, especially during the first few weeks of filgrastim therapy.
Danish: Det absolutte neutrofiltal (ANC) skal kontrolleres ofte, specielt i de første uger af behandlingen med filgrastim.