natgillin/translations-raw huggingface dataset:
Sikkerhed og effekt af filgrastim ved administration til patienter under 55 år med de novo- AML og god cytogenetik [t( 8; 21), t( 15; 17) og inv( 16)] er ikke fastlagt.
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.
Andre særlige forsigtighedsregler Kontrol af knogletæthed kan være indiceret hos patienter med samtidig osteoporotisk knoglesygdom, som har været i kontinuerlig behandling med filgrastim i over 6 måneder.
5 Other special precautions 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.
5 Der er rapporteret sjældne pulmonale bivirkninger, især interstitiel pneumoni, efter administration af G- CSF.
Rare pulmonary undesirable effects, in particular interstitial pneumonia, have been reported after G- CSF administration.
IE/ kg/ døgn (3 μg/ kg/ døgn).
Leukocytosis White blood cell counts of 100 x 109/ l or greater have been observed in less than 5% of patients receiving filgrastim at doses above 0.3 MIU/ kg/ day (3 μ g/ kg/ day).
Hvis leukocyttallet ligger over 50 x 109/ l efter det forventede nadir, skal filgrastimbehandlingen omgående seponeres.
If leukocyte counts exceed 50 x 109/ l after the expected nadir, filgrastim should be discontinued immediately.
Ved administration af filgrastim til perifer blodstamcellemobilisering skal filgrastim seponeres eller doseringen af filgrastim reduceres, hvis leukocyttallet stiger til > 70 x 109/ l.
However, during the period of administration of filgrastim for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/ l.
Risici forbundet med øgede doser kemoterapi Der bør udvises særlig forsigtighed ved behandling af patienter med højdosis kemoterapi, da det ikke er påvist, at dette giver øget tumorrespons, og intensiv kemoterapi kan medføre øget toksicitet i form af påvirkning af hjerte, lunger, nervesystem og hud (se produktresumeet for de respektive kemoterapeutiske midler).
Risks associated with increased doses of chemotherapy Special caution should be used when treating patients with high dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the Summary of Product Characteristics of the specific chemotherapy agents used).
På grund af muligheden for behandling med større doser kemoterapi (fx opretholde fuld dosering i behandlingsplanen) kan patienten have en øget risiko for at få trombocytopeni og anæmi.
Because of the potential of receiving higher doses of chemotherapy (e. g. full doses on the prescribed schedule) the patient may be at greater risk of thrombocytopenia and anaemia.
Brug af filgrastim- mobiliserede perifere blodstamceller har vist sig at reducere graden og varigheden af trombocytopeni efter myelosuppressiv eller myeloablativ kemoterapi.
The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Andre særlige forsigtighedsregler Der er ikke foretaget undersøgelser af filgrastims virkninger hos patienter med væsentlig nedsættelse af myeloide stamceller.
Other special precautions The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Filgrastims virkning på graft versus host- sygdom er ikke fastlagt.
The effect of filgrastim on graft versus host disease has not been defined.
Mobilisering Der er ikke foretaget prospektivt randomiserede sammenligninger af de to anbefalede mobiliserings - metoder (filgrastim alene eller i kombination med myelosuppressiv kemoterapi) hos samme patientpopulation.
Mobilisation There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone or in combination with myelosuppressive chemotherapy) within the same patient
Omfanget af forskelle mellem patienterne og mellem forskellige laboratorieundersøgelser af CD34+- celler gør det vanskeligt at udføre direkte sammenligninger af forskellige afprøvninger.
The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Valg af
It is therefore difficult to recommend an optimum method.
6 mobiliseringsmetode bør sammenholdes med de overordnede målsætninger for behandlingen af den enkelte patient.
The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Tidligere eksponering for cytostatika Patienter, som tidligere har fået meget omfattende myelosuppressiv kemoterapi, vil ikke altid opnå tilstrækkelig mobilisering af perifere blodstamceller til at opnå den anbefalede mindstehøst (2, 0 x 106 CD34+- celler/ kg) eller acceleration af trombocytregeneration i samme grad.
Prior exposure to cytotoxic agents Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (2.0 x 106 CD34+ cells/ kg) or acceleration of platelet recovery to the same degree.
Vurdering af stamcellehøst Ved vurdering af antallet af stamceller høstet hos patienter efter behandling med filgrastim er det særlig vigtigt at være opmærksom på kvantificeringsmetoden.
Assessment of progenitor cell yields In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Resultaterne af flowcytometrisk analyse af antallet af CD34+- celler afhænger af den anvendte metodik, og derfor bør rekommandationer af celleantal, der baseres på undersøgelser udført i andre laboratorier, fortolkes med forsigtighed.
The results of flow cytometric analysis of CD34+ 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.
Statistiske analyser af forholdet mellem antallet af reinfunderede CD34+- celler og hastigheden af trombocytøgningen tyder på en kompleks, men sikker sammenhæng.
Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Anbefalingen af en minimumshøst på 2, 0 x 106 CD34+- celler/ kg er baseret på publicerede erfaringer, der medførte tilstrækkelig hæmatologisk rekonstitution.
The recommendation of a minimum yield of 2.0 x 106 CD34+ cells/ kg is based on published experience resulting in adequate haematologic reconstitution.
Der observeredes forbigående trombocytopeni (trombocyttal < 100 x 109/ l) efter administration af filgrastim og leukaferese hos 35% af de undersøgte donorer.
Transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Herunder rapporteredes to tilfælde af trombocyttal < 50 x 109/ l, som tilskrives leukafereseproceduren.
Among these, two cases of platelets < 50 x 109/ l were reported and attributed to the leukapheresis procedure.
Generelt bør leukaferese ikke udføres, hvis trombocyttallet er < 75 x 109/ l.
If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/ l prior to leukapheresis; in general apheresis should not be performed if platelets < 75 x 109/ l.
Hvis leukocyttallet stiger til > 70 x109/ l, bør filgrastim seponeres eller doseringen reduceres.
7 Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x109/ l.
7 Donorer, der får G- CSF til mobilisering af perifere blodstamceller, skal monitoreres, indtil deres hæmatologiske værdier atter er normale.
Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Der er observeret forbigående cytogene ændringer hos raske donorer efter brug af G- CSF.
Transient cytogenic modifications have been observed in normal donors following G-CSF use.
Der er rapporteret om almindelige, men generelt symptomfri tilfælde af splenomegali og meget sjældne tilfælde af miltruptur hos raske donorer og patienter efter administration af G- CSF.
Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs.
Derfor bør miltstørrelsen monitoreres nøje (fx klinisk undersøgelse, ultralyd).
Therefore, spleen size should be carefully monitored (e. g. clinical examination, ultrasound).
Diagnosen miltruptur bør overvejes hos donorer og/ eller patienter, der klager over smerter i venstre side af øvre abdomen eller ved nederste del af skulderbladet.
A diagnosis of splenic rupture should be considered in donors and/ or patients reporting left upper abdominal pain or shoulder tip pain.
Aktuelle data tyder på, at immunologiske interaktioner mellem et allogent transplantat af perifere blodstamceller og recipienten kan være forbundet med en øget risiko for akut og kronisk graft versus host- sygdom sammenlignet med knoglemarvstransplantation.
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 graft versus host disease when compared with bone marrow transplantation.
Hæmatologiske undersøgelser Trombocyttal bør monitoreres nøje, især i de første ugers behandling med filgrastim.
Blood cell counts Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Det bør overvejes at indstille behandlingen midlertidigt eller nedsætte dosis af filgrastim hos patienter, der får trombocytopeni, d. v. s. trombocyttal vedvarende < 100. 000/ mm3.
Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i. e. platelets consistently < 100,000/ mm3.
3%) af myeloplastiske syndromer (MDS) eller leukæmi hos patienter med SCN, der fik filgrastim.
There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
12% af patienterne, som havde normal cytogenetik ved baseline, fik siden konstateret anomalier inklusive monosomi 7 ved en ny rutineundersøgelse.
A subset of approximately 12% of patients who had normal cytogenetic evaluations at baseline were subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
I kliniske undersøgelser havde 31% af patienterne palpabel splenomegali.
Thirty-one percent (31%) of patients in studies were documented as having palpable splenomegaly.
Radiografisk påviste volumenforstørrelser opstod tidligt i filgrastimterapien og stabiliseredes for det meste.
8 radiographically, occurred early during filgrastim therapy and tended to plateau.
Det bemærkedes, at dosisreduktioner nedsatte eller standsede progressionen af miltforstørrelse, og hos 3% af patienterne opstod behov for
Dose reductions were noted to slow or stop the progression of splenic enlargement and in 3% of patients a splenectomy was required.
Hæmaturi/ proteinuri forekom hos et mindre antal patienter.
Haematuria/ proteinuria occurred in a small number of patients.
Særlige forsigtighedsregler hos patienter med hiv- infektion
Special precautions in patients with HIV infection
Hæmatologiske undersøgelser ANC bør monitoreres nøje, især i de første ugers behandling med filgrastim.
Blood cell counts ANC should be monitored closely, especially during the first few weeks of filgrastim therapy.
Det anbefales at måle ANC hver dag i de første 2- 3 dage af filgrastimbehandlingen.
It is recommended that the ANC is measured daily for the first 2 to 3 days of filgrastim administration.
IE (300 μg) / døgn kan der med tiden forekomme store udsving i patientens ANC.
During intermittent dosing with 30 MIU (300 μ g)/ day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
For at bestemme patientens ANC- minimum eller - nadir anbefales det at tage blodprøver til ANC- måling umiddelbart før planlagt indgift af filgrastim.
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.
Infektioner og maligne sygdomme, der forårsager myelosuppression Neutropeni kan forekomme i forbindelse med opportunistiske infektioner, der infiltrerer knoglemarven, såsom Mycobacterium avium- kompleks eller ved maligne sygdomme som lymfom.
Infections and malignancies causing myelosuppression Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Biograstim indeholder sorbitol og bør ikke anvendes til patienter med hereditær fruktoseintolerans.
Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Præliminær dokumentation fra et mindre antal patienter, der blev behandlet samtidig med filgrastim og 5- fluorouracil, tyder på, at sværhedsgraden af neutropeni kan tage til.
Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-Fluorouracil indicates that the severity of neutropenia may be exacerbated.
Mulig interaktion med andre hæmatopoietiske vækstfaktorer og cytokiner er ikke blevet undersøgt i kliniske forsøg.
9 Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
9 Da lithium øger frisætningen af neutrofile granulocytter, vil det sandsynligvis forstærke virkningen af filgrastim.
Since lithium promotes the release of neutrophils, it is likely to potentiate the effect of filgrastim.
En specifik undersøgelse af denne interaktion er ikke udført, men der foreligger ingen dokumentation, der viser, at en sådan interaktion skulle være skadelig.
Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Ved beslutning om at fortsætte/ indstille amningen eller fortsætte/ indstille behandling med filgrastim skal der tages højde for barnets fordele ved amningen og moderens fordele ved filgrastimbehandlingen.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with filgrastim should be made taking into account the benefit of breast- feeding to the child and the benefit of filgrastim therapy to the woman.
I en række kliniske forsøg blev 541 cancerpatienter og 188 raske forsøgspersoner eksponeret for Biograstim.
During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Biograstim.
Sikkerhedsprofilen for Biograstim i disse kliniske forsøg svarede til profilen for det referenceprodukt, der blev anvendt i forsøgene.
The safety profile of Biograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Meget almindelige: ≥1/ 10 Almindelige:
Very common:
≥1/ 100, < 1/ 10 ≥1/ 1, 000, < 1/ 100 ≥1/ 10, 000, < 1/ 1, 000 < 1/ 10, 000 Kan ikke estimeres ud fra forhåndenværende data
≥ 1/ 10 ≥ 1/ 100, < 1/ 10 ≥ 1/ 1,000, < 1/ 100 ≥ 1/ 10,000, < 1/ 1,000 < 1/ 10,000 cannot be estimated from the available data
I kliniske forsøg var de hyppigste bivirkninger, der kunne henføres til filgrastim i den anbefalede dosering, lette til moderate smerter i skeletmuskulaturen, hvilket forekom hos 10%, og svære smerter i skeletmuskulaturen hos 3% af patienterne.
In clinical trials, the most frequent undesirable effects attributable to filgrastim at the recommended dose were mild or moderate musculoskeletal pain, occurring in 10%, and severe musculoskeletal pain in 3% of patients.
Bivirkninger, der rapporteredes med samme hyppighed hos patienter, der fik filgrastim/ kemoterapi og placebo/ kemoterapi, omfattede kvalme og opkastning, alopeci, diarré, træthed, anoreksi, mukosit, hovedpine, hoste, hududslæt, brystsmerter, almen svækkelse, ondt i halsen, forstoppelse og uspecificerede smerter.
Undesirable effects reported with equal frequency in patients treated with filgrastim/ chemotherapy and placebo/ chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and unspecified pain.
50%, 35%, 25% og 10% af de patienter, der fik filgrastim i de anbefalede doser.
10 Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50%, 35%, 25%, and 10% of patients respectively, at recommended doses.
4. 4).
Rare pulmonary undesirable effects including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS) which may be fatal (see section 4.4).
Allergiske reaktioner:
Allergic Reactions:
De omfattede anafylaksi, hududslæt, urticaria, angioødem, dyspnø og hypotension og opstod ved indledning af behandlingen eller under vedligeholdelsesbehandling.
Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea and hypotension, occurring on initial or subsequent treatment, have been reported in patients receiving filgrastim.
4. 4).
Isolated cases of sickle cells crises have been reported in patients with sickle cell disease (see section 4.4).
Systemorganklasse Metabolisme og ernæring
System organ class Metabolism and nutrition disorders
Hyppighed Meget almindelige
Frequency Very common
Bivirkninger Forhøjet basisk fosfatase, forhøjet LDH, forhøjet urinsyre
Undesirable effect Elevated alkaline phosphatase, elevated LDH, elevated uric acid
Nervesystemet Vaskulære sygdomme Luftveje, thorax og mediastinum
Nervous system disorders Vascular disorders Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders
Almindelige Sjældne Almindelige Meget sjældne
Common Rare Common Very rare Very common Common
Kvalme/ opkastning Obstipation, anoreksi, diarré, mukosit
Headache Vascular disorder Cough, sore throat Pulmonary infiltrates Nausea/ Vomiting Constipation, anorexia, diarrhoea, muscositis
Lever og galdeveje Hud og subkutane væv
Hepatobiliary disorders Skin and subcutaneous tissue disorders
Meget almindelige Almindelige Meget sjældne
Very common Common Very rare
Forhøjet GGT Alopeci, hududslæt Sweets syndrom, kutan vaskulit
Elevated GGT Alopecia, skin rash Sweet's syndrome, cutaneous vasculitis
Meget almindelige Meget sjældne
Very common Very rare
Brystsmerter, muskuloskeletale smerter Forværring af reumatoid artrit
Chest pain, musculoskeletal pain Rheumatoid arthritis exacerbation
Nyrer og urinveje Almene symptomer og reaktioner på administrationsstedet
Renal and urinary disorders General disorders and administration site conditions
Meget sjældne Almindelige Ikke almindelige Meget sjældne
Very rare Common Uncommon Very rare
Urinvejsproblemer Træthed, almen svækkelse Uspecificerede smerter Allergisk reaktion
Urinary abnormalities Fatigue, generalised weakness Unspecified pain Allergic reaction
11 De hyppigst rapporterede bivirkninger var lette til moderate forbigående smerter i skeletmuskulaturen.
The most commonly reported undesirable effect was mild to moderate transient musculo-skeletal pain.
Leukocytose (leukocyttal > 50 x 109/ l) observeredes hos 41% af donorer, og forbigående trombocytopeni (trombocyttal < 100 x 109/ l) efter filgrastim og leukaferese observeredes hos 35% af donorerne.
Leukocytosis (WBC > 50 x 109/ l) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim and leukapheresis was observed in 35% of donors.
4. 4)
Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs (see section 4.4).
Systemorganklasse Blod og lymfesystem
System organ class Blood and lymphatic system disorders Metabolism and nutrition disorders
Hyppighed Meget almindelige Ikke almindelige
Frequency Very common Uncommon Common Uncommon
Bivirkninger Leukocytose, trombocytopeni Lidelser i milten
Undesirable effect Leukocytosis, thrombocytopenia Spleen disorder Elevated alkaline phosphatase, elevated LDH SGOT increased, hyperuricaemia
Metabolisme og ernæring
Nervous system disorders Musculoskeletal and connective tissue disorders
Ikke almindelige
Very common Very common Uncommon
Forhøjet ALAT, hyperurikæmi
Headache Musculoskeletal pain Rheumatoid arthritis exacerbation
Nervesystemet Knogler, led, muskler og bindevæv Almene symptomer og reaktioner på administrationsstedet
General disorders and administration site conditions
Meget almindelige Meget almindelige Ikke almindelige Ikke almindelige
Uncommon
Hovedpine Muskuloskeletale smerter Forværring af reumatoid artrit Alvorlig allergisk reaktion
Severe allergic reaction
Hos patienter med SCN
12 In SCN patients
Der er rapporteret hovedpine og diarré kort tid efter indledning af filgrastimterapi – typisk hos færre end 10% af patienterne.
Headache and diarrhoea have been reported shortly after starting filgrastim therapy, typically in less than 10% of patients.
Desuden er der set forbigående, moderate fald i ikke- fastende blodglukose.
Transient, moderate decreases in non-fasting blood glucose have also been seen.
Bivirkninger med mulig forbindelse til filgrastimterapi og typisk en forekomst på < 2% af patienter med svær kronisk neuropati omfattede reaktioner ved injektionsstedet, hepatomegali, artralgi, alopeci, osteoporose og udslæt.
Undesirable effects possibly related to filgrastim therapy and typically occurring in < 2% of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis and rash.
Under langtidsbehandling rapporteredes kutan vaskulit hos 2% af denne patientpopulation.
During long term use, cutaneous vasculitis has been reported in 2% of SCN patients.
Der forekom meget få tilfælde af proteinuri/ hæmaturi.
There have been very few instances of proteinuria/ haematuria.
Systemorganklasse Blod og lymfesystem
System organ class Blood and lymphatic system disorders
Hyppighed Meget almindelige Almindelige
Frequency Very common Common Uncommon
Bivirkninger Anæmi, splenomegali Trombocytopeni
Undesirable effect Anaemia, splenomegaly Thrombocytopenia Spleen disorder
12
Metabolism and nutrition disorders
Ikke almindelige
Very common
Lidelser i milten
Decreased glucose, elevated alkaline phosphatase, elevated LDH, hyperuricaemia
Metabolisme og ernæring
Nervous system disorders Respiratory, thoracic and mediastinal disorders
Meget almindelige
Common Very common
Fald i blodglukose, forhøjet basisk fosfatase, forhøjet LDH, hyperurikæmi
Headache Epistaxis
Nervesystemet Luftveje, thorax og mediastinum Mave- tarmkanalen Lever og galdeveje Hud og subkutane væv
Gastrointestinal disorders Hepatobiliary disorders Skin and subcutaneous tissue disorders
Almindelige Meget almindelige Almindelige Almindelige Almindelige
Common Common Common
Hovedpine Epistaxis Diarré Hepatomegali Alopeci, kutan vaskulit, smerter ved injektionsstedet, udslæt
Diarrhoea Hepatomegaly Alopecia, cutaneous vasculitis, injection site pain, rash
Knogler, led, muskler og bindevæv Nyrer og urinveje
Musculoskeletal and connective tissue disorders Renal and urinary disorders
Meget almindelige Almindelige Ikke almindelige
Very common Common Uncommon
Muskuloskeletale smerter Osteoporose Hæmaturi, proteinuri
Musculoskeletal pain Osteoporosis Haematuria, proteinuria
Patienter med hiv- infektion
In patients with HIV
Forstørrelse af milten rapporteredes at være forbundet med filgrastimterapi hos < 3% af patienterne.
Splenic enlargement was reported to be related to filgrastim therapy in < 3% of patients.