natgillin/translations-raw huggingface dataset:
Normale donorer før allogen perifer blodstamcelletransplantation Ved mobilisering af perifere blodstamceller hos raske donorer før allogen perifer blodstamcelle - transplantation skal filgrastim administeres med 1, 0 mill.
Normal donors prior to allogeneic PBPC transplantation For PBPC mobilisation in normal donors prior to allogeneic PBPC transplantation, filgrastim should be administered at 1.0 MU/ kg/ day (10 μ g/ kg/ day) for 4 - 5 consecutive days.
Leukaferese skal startes på dag 5 og fortsættes til dag 6, hvis det er nødvendigt, for at høste 4 x 106 CD34+ celler/ kg af modtagerens legemsvægt.
Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/ kg recipient bodyweight (BW).
Svær kronisk neutropeni (SCN)
Severe chronic neutropenia (SCN)
E/ kg/ dag (12 μg/ kg/ dag) som enkeltdosis eller fordelt på flere doser.
Congenital neutropenia The recommended starting dose is 1.2 MU/ kg/ day (12 μ g/ kg/ day) as a single dose or in divided doses.
E/ kg/ dag (5 μg/ kg/ dag) som enkeltdosis eller fordelt på flere doser.
Idiopathic or cyclic neutropenia The recommended starting dose is 0.5 MU/ kg/ day (5 μ g/ kg/ day) as a single dose or in divided doses.
Dosisjusteringer Filgrastim bør administreres dagligt, indtil neutrofiltallet er nået og kan opretholdes på et niveau over 1, 5 x 109/ l.
Dose adjustments Filgrastim should be administered daily until the neutrophil count has reached and can be maintained at more than 1.5 x 109/ l.
Afhængigt af patientens respons kan den initiale dosis fordobles eller halveres efter 1– 2 ugers behandling.
After 1 - 2 weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Derefter kan doseringen justeres individuelt hver uge eller hver anden uge for at opretholde det gennemsnitlige neutrofiltal på mellem 1, 5 x 109/ l og 10 x 109/ l.
Subsequently the dose may be individually adjusted every 1 - 2 weeks to maintain the average neutrophil count between 1.5 x 109/ l and 10 x 109/ l.
I kliniske undersøgelser havde 97% af de responderende patienter fuld respons ved doser på ≤ 2, 4 mill.
In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 2.4 MU/ kg/ day (24 μ g/ kg/ day).
Langtidssikkerheden af administration af filgrastim i doser på mere end 2, 4 mill.
The long-term safety of filgrastim administration above 2.4 MU/ kg/ day (24 μ g/ kg/ day) in patients with SCN has not been established.
HIV- infektion
HIV infection
E/ kg/ dag (4 μg/ kg/ dag), indtil et normalt neutrofiltal er nået og kan vedligeholdes (absolut neutrofiltal > 2, 0 x 109/ l).
Reversal of neutropenia The recommended starting dose of filgrastim is 0.1 MU/ kg/ day (1 μ g/ kg/ day) given daily with titration up to a maximum of 0.4 MU/ kg/ day (4 μ g/ kg/ day) until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 109/ l).
E/ kg/ dag (10 μg/ kg/ dag) for at opnå normale neutrofilværdier.
In a small number of patients (< 10%), doses up to 1.0 MU/ kg/ day (10 μ g/ kg/ day) were required to achieve reversal of neutropenia.
Fastholdelse af normale neutrofiltal Når et stabilt neutrofilniveau er opnået, bør den lavest effektive dosis til fastholdelse af et normalt neutrofiltal fastlægges.
Maintenance of normal neutrophil counts When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established.
E/ dag (300 μg/ dag) hver anden dag anbefales.
Initial dose adjustment to alternate day dosing with 30 MU/ day (300 μ g/ day) is recommended.
Afhængigt af patientens absolutte neutrofiltal kan det blive nødvendigt med yderligere dosisjustering for at bevare neutrofiltallet på > 2, 0 x 109/ l.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/ l.
E/ dag (300 μg/ dag) i 1- 7 dage om ugen for at opretholde et ANC > 2, 0 x 109/ l med en median- dosisfrekvens på 3 gange ugentligt.
In clinical studies, dosing with 30 MU/ day (300 μ g/ day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 109/ l, with the median dose frequency being 3 days per week.
Langtidsadministration kan være nødvendigt for at fastholde et absolut neutrofiltal > 2, 0 x 109/ l.
Long-term administration may be required to maintain the ANC > 2.0 x 109/ l.
Patienter med nyre - / leverinsufficiens Undersøgelser af filgrastim hos patienter med stærkt nedsat nyre - eller leverfunktion viser, at filgrastim har en farmakokinetisk og farmakodynamisk profil, som ligner den, man ser hos raske personer.
Patients with renal/ hepatic impairment Studies of filgrastim in patients with severe impairment of renal or hepatic function demonstrate that it exhibits a similar pharmacokinetic and pharmacodynamic profile to that seen in normal individuals.
4 Pædiatriske patienter med svær kronisk neutropeni (SCN) og cancer I kliniske forsøg var 65% af de patienter, der blev behandlet for SCN, under 18 år.
4 Paediatric patients in the SCN and cancer settings In clinical studies 65% of patients treated for SCN were younger than 18 years.
I denne aldersgruppe, der hovedsageligt omfatter patienter med medfødt neutropeni, blev der påvist effekt.
For this age-group, which mostly includes patients with congenital neutropenia, efficacy was proven.
Der blev ikke påvist forskelle i sikkerhedsprofilen for pædiatriske patienter behandlet for svær kronisk neutropeni sammenlignet med voksne patienter.
There were no differences in the safety profiles for paediatric patients treated for SCN in comparison to adults.
Ældre patienter De kliniske undersøgelser med filgrastim inkluderede et lille antal ældre patienter.
Elderly patients In clinical investigations with filgrastim a small number of elderly patients was included.
Der er ikke foretaget nogen specifikke undersøgelser hos denne patientpopulation.
No specific studies have been performed for this patient population.
Derfor foreligger der ingen specifikke doseringsanbefalinger for disse patienter.
Therefore, specific posology recommendations for these patients cannot be made.
Dosering og indgivelsesmåde
Method of administration
Etableret cytotoksisk kemoterapi Filgrastim kan gives som en daglig subkutan injektion eller som en daglig intravenøs infusion over 30 minutter.
Established cytotoxic chemotherapy Filgrastim may be administered as a daily subcutaneous injection or alternatively as a daily intravenous infusion over 30 minutes.
6. 6 for yderligere instruktioner om fortynding med 50 mg/ ml (5%) glucoseopløsning før infusionen.
For further instructions on dilution with glucose 50 mg/ ml (5%) solution prior to infusion see section 6.6.
Data fra en undersøgelse med administration af en enkelt dosis tyder på, at intravenøs indgift afkorter virkningens varighed.
There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Den kliniske relevans af dette fund angående administration af flere doser er ikke klarlagt.
The clinical relevance of this finding to multiple dose administration is not clear.
Valget af administrationsvej afhænger af de individuelle kliniske forhold.
The choice of route should depend on the individual clinical circumstance.
E/ kg/ dag (4 – 8, 4 μg/ kg/ dag) anvendt.
In randomised clinical studies, a subcutaneous dose of 23 MU/ m2/ day (230 μ g/ m2/ day) or rather 0.4 - 0.84 MU/ kg/ day (4 - 8.4 μ g/ kg/ day) was used.
I begge tilfælde efter opløsning i 20 ml glucoseopløsning 50 mg/ ml (5%).
Patients treated with myeloablative therapy followed by bone marrow transplantation Filgrastim is administered as an intravenous short-term infusion over 30 minutes or as a subcutaneous or intravenous continuous infusion over 24 hours, in each case after dilution in 20 ml of glucose 50 mg/ ml (5%) solution.
Mobilisering af perifere blodstamceller Subkutan injektion.
Mobilisation of PBPC Subcutaneous injection.
Til mobilisering af perifere blodstamceller hos patienter, der gennemgår myelosuppressiv eller myeloablativ behandling efterfulgt af autolog transplantation af perifere blodstamceller, kan den anbefalede dosis filgrastim også administreres som en 24 timers subkutan kontinuerlig infusion.
For the mobilisation of PBPC in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation the recommended dose of filgrastim may also be administered as a 24 hour subcutaneous continuous infusion.
Til infusion skal filgrastim fortyndes i 20 ml 50 mg/ ml (5%) glucoseopløsning.
For infusions filgrastim should be diluted in 20 ml of glucose 50 mg/ ml (5%) solution.
SCN/ HIV- infektion Subkutan injektion.
SCN/ HIV infection Subcutaneous injection.
Filgrastim bør ikke anvendes til at forhøje dosis af cytotoksisk kemoterapi ud over de etablerede dosisregimer (se nedenfor).
Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established posology regimens (see below).
5 Filgrastim bør ikke gives til patienter med svær medfødt neutropeni (Kostmann' s syndrom) med abnorm cytogenetik (se nedenfor).
5 Filgrastim should not be administered to patients with severe congenital neutropenia (Kostmann's syndrome) with abnormal cytogenetics (see below).
Malign cellevækst Da undersøgelser har vist, at granulocyt- kolonistimulerende faktorer kan fremme væksten af myeloide celler in vitro, skal følgende advarsler tages i betragtning.
Malignant cell growth Since investigations showed that G-CSF can promote growth of myeloid cells in vitro the following warnings should be considered.
Derfor er filgrastim ikke indiceret til disse lidelser.
Therefore filgrastim is not indicated for use in these conditions.
Da der foreligger begrænsede data for sikkerheden og virkningen hos patienter med sekundær AML, bør filgrastim administreres med forsigtighed.
In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Sikkerheden og virkningen af administration af filgrastim hos de novo- AML- patienter i alderen < 55 år med 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.
E/ kg/ dag (3 μg/ kg/ dag).
Leucocytosis 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 MU/ kg/ day (3 μ g/ kg/ day).
Der er ikke rapporteret om nogen bivirkninger, som direkte kan tilskrives denne grad af leukocytose.
No undesirable effects directly attributable to this degree of leucocytosis have been reported.
På grund af den potentielle risiko i forbindelse med svær leukocytose tilrådes det imidlertid at kontrollere leukocyttallet med regelmæssige intervaller under behandlingen med filgrastim.
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.
Hvis leukocyttallet overstiger 50 x 109/ l efter forventet nadir, bør behandlingen med filgrastim straks 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 bør filgrastim seponeres eller dosis reduceres, hvis leukocyttallet stiger til > 70 x 109/ l.
However, during the period of administration of filgrastim for PBPC mobilisation, it should be discontinued or its dose should be reduced if the leukocyte counts rise to > 70 x 109/ l.
(Der henvises til produktresumeerne for de pågældende kemoterapi- præparater).
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 at behandle med højere doser af kemoterapi (f. eks. fulde doser ved den ordinerede terapi) kan patienter have større risiko for at udvikle 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.
Det er påvist, at anvendelsen af filgrastim- mobiliserede perifere blodstamceller reducerer graden og varigheden af trombocytopeni efter myelosuppresiv 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 Effekten af filgrastim hos patienter med udtalt nedsættelse af myeloide stamceller er ikke undersøgt.
Other special precautions The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Hos patienter med nedsat antal prækursorer kan den neutrofile effekt derfor være formindsket (f. eks. patienter behandlet med omfattende stråle - eller kemoterapi eller patienter med tumorinfiltration i knoglemarven).
Therefore, in patients with reduced precursors, neutrophil response may be diminished (such as those treated with extensive radiotherapy or chemotherapy, or those with bone marrow infiltration by tumour).
5. 1).
There have been reports of Graft versus Host Disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 5.1).
6 Mobilisering af perifere blodstamceller
6 Mobilisation of PBPC
Forudgående eksponering for cytotoksiske midler Hos patienter, som tidligere har fået omfattende myelosuppressiv behandling efterfulgt af administration af filgrastim for at mobilisere perifere blodstamceller, vil disse blodlegemer muligvis ikke mobiliseres i tilstrækkelig grad til at opnå den anbefalede minimumshøst (≥ 2, 0 x 106 CD34+ celler/ kg) eller gendannelsen af trombocytter ikke fremskyndes i samme grad.
Prior exposure to cytotoxic agents Patients who have undergone very extensive prior myelosuppressive therapy, followed by administration of filgrastim for mobilisation of PBPCs, may not show sufficient mobilisation of these blood cells to achieve the recommended minimum yield (≥ 2.0 x 106 CD34+ cells/ kg) or acceleration of platelet recovery to the same degree.
Når en perifer blodstamcelle - transplantation kan forudses, er det tilrådeligt at planlægge proceduren for stamcellemobiliseringen tidligt i patientens behandlingsforløb.
When a PBPC transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Antallet af mobiliserede stamceller hos disse patienter bør nøje undersøges, inden der administreres højdosis- kemoterapi.
Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Vurdering af stamcellehøst Når det skal vurderes, hvor mange stamceller der er blevet høstet hos patienter i filgrastimbehandling, bør man især 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.
Derfor skal tællinger fra undersøgelser i andre laboratorier tolkes 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.
En statistisk analyse af forholdet mellem antallet af reinfunderede CD34+- celler og hastigheden, hvormed trombocytterne gendannes efter højdosis kemoterapi, tyder på et komplekst, men kontinuerligt forhold.
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.
Den anbefalede minimumshøst på ≥ 2, 0 x 106 CD34+- celler/ kg er baseret på publicerede erfaringer, der har medført adækvat hæmatologisk rekonstituering.
The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/ kg is based on published experience resulting in adequate haematologic reconstitution.
Raske donorer før allogen perifer blodstamcelle- transplantation Mobilisering af perifere blodstamceller giver ikke nogen direkte klinisk fordel for raske donorer og bør kun anvendes ved allogen stamcelletransplantation.
Normal donors prior to allogeneic PBPC transplantation 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.
Sikkerheden og effekten af filgrastim er ikke undersøgt hos raske donorer < 16 år eller > 60 år.
The safety and efficacy of filgrastim have not been assessed in normal donors< 16 years or > 60 years.
Der er set forbigående trombocytopeni (trombocytter < 100 x 109/ l) efter administration af filgrastim og leukaferese hos 35% af de undersøgte forsøgspersoner.
Transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Blandt disse blev der rapporteret om to tilfælde af trombocytter < 50 x 109/ l.
Among these, two cases of platelets < 50 x 109/ l were reported and attributed to the leukapheresis procedure.
Hvis det er nødvendigt med mere end en leukaferese, bør der udvises særlig opmærksomhed over for donorer med trombocytter < 100 x 109/ l før leukaferese.
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 x 109/ l, skal filgrastim seponeres, eller dosis nedsættes.
Filgrastim administration should be discontinued or its posology should be reduced if the leukocyte counts rise to > 70 x 109/ l.
Donorer, der har modtaget G- CFS’ er til mobilisering af perifere blodstamceller, skal monitoreres, indtil deres hæmatologiske værdier er normale.
Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Der er igangværende langsigtet sikkerhedsopfølgning af donorer.
Long-term safety follow-up of donors is ongoing.
I op til 4 år er der ikke indrapporteret unormal hæmatopoiese hos raske donorer.
For up to 4 years, there have been no reports of abnormal haematopoiesis in normal donors.
Det kan dog ikke udelukkes, at der er en risiko for udvikling af en malign myeloidklon.
7 malignant myeloid clone can not be excluded.
Det anbefales, at aferesecenteret systematisk indsamler data på dets stamcelledonorer med henblik på monitorering af den langsigtede sikkerhed.
It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors to ensure monitoring of long-term safety.
7 Der er set forbigående cytogene modifikationer hos raske donorer efter brug af G- CSF.
Transient cytogenic modifications have been observed in normal donors following G-CSF use.
Betydningen af disse ændringer med hensyn til udvikling af hæmatologisk malignitet er ikke klarlagt.
The significance of these changes in terms of the development of haematological malignancy is unknown.
Der er rapporteret om almindeligt forekommende tilfælde af splenomegali, der dog oftest er asymptomatiske, samt om meget sjældne tilfælde af miltruptur hos raske donorer og patienter efter administration af G- CSF' er.
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 omhyggeligt (f. eks. ved klinisk undersøgelse og ultralyd).
Therefore, spleen size should be carefully monitored (e. g. clinical examination, ultrasound).
Hvis donorer og/ eller patienter klager over smerter i øvre venstre side af maven eller nederste del af skulderbladet, bør diagnosen miltruptur overvejes.
A diagnosis of splenic rupture should be considered in donors and/ or patients reporting left upper abdominal pain or shoulder tip pain.
Hos normale donorer er der meget sjældent rapporteret om pulmonale uønskede hændelser (hæmoptyse, blødning i lungen, lungeinfiltrater, dyspnø og hypoxia) ved anvendelse efter markedsføringen.
In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, pulmonary infiltrates, dyspnoea and hypoxia) have been reported very rarely in post marketing experience.
Modtagere af allogene perifere blodstamceller mobiliseret med filgrastim Aktuelle data tyder på, at immunologiske interaktioner mellem det allogene PBPC- transplantat og modtageren kan være forbundet med en øget risiko for akut eller kronisk ” Graft versus Host Disease ” (GvHD) sammenlignet med en knoglemarvstransplantation.
Recipients of allogeneic PBPCs mobilised with filgrastim 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.
Blodværdier Trombocyttallet bør monitoreres nøje især i de første uger af behandlingen med filgrastim.
Blood cell counts Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Hos patienter, der udvikler trombocytopeni, d. v. s. trombocyttal som konstant ligger under 100. 000/ mm3, bør intermitterende behandling eller dosisnedsættelse overvejes.
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.
Transformering til leukæmi eller myelodysplastisk syndrom Der bør udvises særlig omhu ved diagnosticering af svære kroniske neutropenier for at differentiere dem fra andre hæmatopoietiske lidelser, såsom aplastisk anæmi, myelodysplasi og myeloid leukæmi.
Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of SCNs to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia, and myeloid leukaemia.
I kliniske forsøg med svær kronisk neutropeni behandlet med filgrastin blev der observeret en lav frekvens (cirka 3%) af myelodysplastiske syndromer (MDS) eller leukæmi hos patienter.
There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical study patients with SCN treated with filgrastim.
12% af patienterne, som havde normal cytogenetik ved baseline, blev der senere fundet abnormaliteter, inklusive monosomi 7, ved gentagne rutineundersøgelser.
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.
Filgrastim skal seponeres, hvis der opstår myelodysplastisk syndrom eller leukæmi.
If patients with SCN develop abnormal cytogenetics, the risks and benefits of continuing filgrastim should be carefully weighed; Filgrastim should be discontinued if MDS or leukaemia occurs.
Andre særlige forsigtighedsregler Årsager til forbigående neutropeni, såsom virusinfektioner, bør udelukkes.
Other special precautions Causes of transient neutropenia, such as viral infections should be excluded.
Forstørrelse af milten er en direkte effekt af behandlingen med filgrastim.
Splenic enlargement is a direct effect of treatment with filgrastim.
I kliniske undersøgelser blev der påvist palpabel splenomegali hos 31% af patienterne.
31% of patients in studies were documented as having palpable splenomegaly.
Radiografisk påviste volumenforstørrelser forekom tidligt i filgrastimbehandlingen og havde en tendens til at nå et plateau.
Increases in volume, measured radiographically, occurred early during Filgrastim therapy and tended to plateau.