FrancophonIA/ELRC3.0 huggingface dataset:
English: The duration of fever was not reduced in patients undergoing myeloablative therapy followed by bone marrow transplantation.
Danish: Feberens varighed blev ikke reduceret hos patienter, der fik myeloablativ terapi efterfulgt af knoglemarvstransplantation.
English: In patients treated with myeloablative therapy followed by bone marrow transplantation
Danish: Patienter, der behandles med myeloablativ terapi efterfulgt af knoglemarvstransplantation
English: During long term use, cutaneous vasculitis has been reported in 2 % of SCN patients.
Danish: Under langtidsbehandling rapporteredes kutan vaskulit hos 2 % af denne patientpopulation.
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 Adult Respiratory Distress Syndrome (ARDS).
Danish: Debut af pulmonale symptomer som hoste, feber og dyspnø i forbindelse med radiologiske fund af lungeinfiltrater og nedsat lungefunktion kan være tidlige tegn på adult respiratory distress syndrome (ARDS).
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50 % within 1 to 2 days, and to normal levels within 1 to 7 days.
Danish: Efter seponering af filgrastimbehandling falder det cirkulerende neutrofiltal med 50 % i løbet af 1-2 dage og normaliseres inden for 1-7 dage.
English: White cells are important as they help your body fight infection.
Danish: Hvide blodlegemer spiller en vigtig rolle i bekæmpelse af infektioner.
English: Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/or other myelosuppressive medicinal product.
Danish: Når filgrastim gives til patienter med hiv-infektion, fastholdes et normalt neutrofiltal, hvilket øger muligheden for at give den planlagte dosis af antiviral og/eller myelosuppressiv medicin.
English: Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Danish: Visse cytostatika udviser især toksicitet over for de hæmatopoietiske stamceller og kan påvirke mobilisering af stamceller negativt.
English: 9/L individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 10
Danish: Efterfølgende kan dosis justeres individuelt hver eller hver anden uge for at opretholde et gennemsnitligt neutrofiltal mellem 1,5 x 109/l og 10 x 109/l.
English: ≥ 1/1,000 to < 1/100
Danish: ≥ 1/1.000 til < 1/100
English: In patients with known bone marrow-infiltrating infections or malignancy, consider appropriate therapy for treatment of the underlying condition in addition to administration of filgrastim for treatment of neutropenia.
Danish: Hos patienter med infektioner, der vides at infiltrere knoglemarven, eller maligne sygdomme bør en passende behandling af den tilgrundliggende sygdom overvejes ud over administration af filgrastim til behandling af neutropeni.
English: The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Danish: Filgrastims sikkerhed og virkning er den samme hos voksne og børn, der får cytotoksisk kemoterapi.
English: Anaemia, splenomegaly
Danish: Bivirkninger Anæmi, splenomegali
English: Recipients of allogeneic PBPCs mobilised with filgrastim experienced significantly more rapid haematological recovery, leading to a significant decrease in time to unsupported platelet recovery, when compared with allogeneic bone marrow transplantation.
Danish: Modtagere af allogene PBPC mobiliseret med filgrastim oplevede signifikant hurtigere hæmatopoietisk bedring, hvilket førte til et signifikant fald i behandlingstiden med trombocytter sammenlignet med allogen knoglemarvstransplantation.
English: Filgrastim should be discontinued and appropriate treatment given in these cases.
Danish: I så fald bør filgrastim seponeres, og der gives passende behandling.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Fyldt injektionssprøjte
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Wrapper Label on Multipacks With Blue Box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre etiket til multipakning med tekst i "blå boks"
English: Transient decreases in blood pressure, not requiring clinical treatment, have been reported occasionally.
Danish: Der er lejlighedsvist rapporteret om forbigående, ikke behandlingskrævende blodtryksfald.
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Danish: Litteraturen omfatter rapporter, der viser, at filgrastim passerer placenta hos gravide kvinder.
English: 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.
Danish: 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.
English: In case of suspected or confirmed pulmonary adverse events, discontinuation of treatment with filgrastim should be considered and appropriate medical care given.
Danish: I tilfælde af mistænkte eller bekræftede bivirkninger i lungerne bør seponering af filgrastim overvejes og passende behandling iværksættes.
English: This leaflet was last revised in .
Danish: Denne indlægsseddel blev senest ændret .
English: Do not use a double dose to make up for a forgotten injection.
Danish: Hvis De har glemt at bruge Biograstim De må ikke tage en dobbeltdosis som erstatning for en glemt indsprøjtning.
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation.
Danish: Vaskulære sygdomme, der omfatter veneokklusion og forstyrrelser i væskebalancen, er lejlighedsvist rapporteret hos patienter, der blev behandlet med højdosis kemoterapi efterfulgt af autolog knoglemarvstransplantation.
English: 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.
Danish: 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.
English: There have been very few instances of proteinuria/haematuria.
Danish: Der forekom meget få tilfælde af proteinuri/hæmaturi.
English: Before you stop using Biograstim, talk to your doctor.
Danish: Hvis De holder op med at bruge Biograstim Tal med lægen, før De stopper behandlingen.
English: You will normally receive your first dose of Biograstim at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Danish: Normalt vil De få den første dosis Biograstim mindst 24 timer efter Deres kemoterapi, men inden for 24 timer efter at De får knoglemarvstransfusion.
English: Increases in volume, measured radiographically, occurred early during filgrastim therapy and tended to plateau.
Danish: Radiografisk påviste volumenforstørrelser opstod tidligt i filgrastimterapien og stabiliseredes for det meste.
English: 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.
Danish: I kliniske studier 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.
English: Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation, may reduce progenitor yield.
Danish: Når midler som melphalan, carmustin (BCNU) og carboplatin gives over længere perioder før indledning af stamcellemobilisering, kan de reducere høsten af stamceller.
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. fyldt injektionssprøjte, d.v.s. den er i det væsentlige 'natriumfri'.
English: The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Danish: Dosisrekommandationerne til børn er de samme som til voksne, der får myelosuppressiv cytotoksisk kemoterapi.
English: Very rare events of cutaneous vasculitis have been reported in patients treated with filgrastim.
Danish: Der er rapporteret meget sjældne tilfælde af kutan vaskulit hos patienter i behandling med filgrastim.
English: For the mobilisation of PBPC in patients undergoing myelosuppressive or myeloablative therapy followed by autologous peripheral blood progenitor cell transplantation
Danish: Til mobilisering af perifere blodstamceller(PBPC) hos patienter i myelosuppressiv eller myeloablativ terapi efterfulgt af autolog perifer blodstamcelletransfusion
English: - The other ingredients are: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections.
Danish: - Øvrige indholdsstoffer: Natriumhydroxid, eddikesyre, sorbitol, polysorbat 80, vand til injektionsvæsker.
English: Biograstim and bone marrow transplantation
Danish: Biograstim og knoglemarvstransplantation
English: Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Danish: Trombocyttal bør monitoreres nøje, især i de første ugers behandling med filgrastim.
English: Rheumatoid arthritis exacerbation
Danish: Forværring af reumatoid artrit
English: Your doctor will tell you why you are being treated with Biograstim.
Danish: Lægen kan forklare Dem nærmere om, hvorfor De får Biograstim.
English: 9/L or greater have been observed in less than 5 % of patients White blood cell counts of 100 x 10 receiving filgrastim at doses above 0.3 MIU/kg/day (3 μg/kg/day).
Danish: Der er observeret leukocyttal på 100 x 109/l eller større hos færre end 5 % af de patienter, der fik filgrastim i doser større end 0,3 mio. IE/kg/døgn (3 μg/kg/døgn).
English: In clinical studies, the only undesirable effects that were consistently considered to be related to filgrastim administration were musculoskeletal pain, predominantly mild to moderate bone pain and myalgia.
Danish: I kliniske studier var de eneste bivirkninger, som konsekvent ansås for at være forbundet med indgift af filgrastim, muskuloskeletale smerter, hovedsageligt lette til moderate knoglesmerter og myalgi.
English: 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).
Danish: 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).
English: The most commonly reported undesirable effect was mild to moderate transient musculo-skeletal pain.
Danish: De hyppigst rapporterede bivirkninger var lette til moderate forbigående smerter i skeletmuskulaturen.
English: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Danish: Hvis De har problemer, må De endelig bede lægen eller sygeplejersken om hjælp og vejledning.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy.
Danish: Data fra kliniske studier med børn tyder på, at filgrastim udviser samme sikkerhed og virkning hos voksne og børn, der får cytotoksisk kemoterapi.
English: The first dose of filgrastim should not be administered less than 24 hours following cytotoxic chemotherapy.
Danish: Den første dosis filgrastim må ikke administreres inden for de første 24 timer efter cytotoksisk kemoterapi.
English: Find a comfortable, well-lit place and put everything you need where you can reach them (the Biograstim pre-filled syringe, alcohol wipes and the puncture-proof container).
Danish: Find et bekvemt og veloplyst sted og anbring udstyret, hvor De let kan nå det (den fyldte injektionssprøjte med Biograstim, spritservietter og beholderen til affald).
English: 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.
Danish: 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.
English: SGOT increased, hyperuricaemia
Danish: Forhøjet ALAT, hyperurikæmi
English: Daily dosing with filgrastim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Danish: Daglig administration af filgrastim bør fortsætte, indtil det forventede neutrofilnadir passeres, og neutrofiltallet atter ligger inden for normalområdet.
English: Common (may affect up to 1 in 10 people): - elevated levels of some blood enzymes.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer): - forhøjet niveau af visse blodenzymer.
English: Find a comfortable, well-lit place and put everything you need where you can reach them (the Biograstim pre-filled syringe and alcohol wipes).
Danish: Find et bekvemt og veloplyst sted og anbring udstyret, hvor De let kan nå det (den fyldte injektionssprøjte med Biograstim og spritservietter).
English: Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Danish: 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.
English: If you are acting as a stem cell donor for another person, the usual dose is 1 million international units (MIU) per kilogram bodyweight each day.
Danish: Hvis De donerer stamceller til en anden person, er den sædvanlige dosis 1 million internationale enheder (mio. IE) pr. kg legemsvægt om dagen.
English: Treatment with filgrastim significantly reduces the duration of febrile neutropenia, antibiotic use and hospitalisation after induction chemotherapy for acute myelogenous leukaemia or myeloablative therapy followed by bone marrow transplantation.
Danish: Ligeledes medfører behandling med filgrastim signifikant reduktion af varigheden af febril neutropeni, brug af antibiotika og hospitalsindlæggelse efter behandling af akut myeloid leukæmi med induktionskemoterapi eller myeloablativ terapi efterfulgt af knoglemarvstransplantation.
English: For example, if you weigh 60 kg your daily dose will be 30 million international units (MIU).
Danish: Hvis De for eksempel vejer 60 kg, vil Deres daglige dosis være 30 mio. IE.
English: The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Danish: Brug af filgrastim-mobiliserede perifere blodstamceller har vist sig at reducere graden og varigheden af trombocytopeni efter myelosuppressiv eller myeloablativ kemoterapi.
English: For example, if you weigh 60 kg your daily dose will be 60 million international units (MIU).
Danish: Hvis De for eksempel vejer 60 kg, vil Deres daglige dosis være 60 mio. IE.
English: Dispose of syringes with safety device as instructed by your doctor, nurse or pharmacist.
Danish: Kasser injektionssprøjter med sikkerhedsanordningen som anvist af lægen, sygeplejersken eller apoteket.
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Biograstim - hvis De er allergisk over for filgrastim eller et af de øvrige indholdsstoffer i Biograstim (angivet i punkt 6).
English: Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in absolute neutrophil counts in peripheral blood and a reduction of infection and related events.
Danish: Når filgrastim gives til børn eller voksne med SCN (svær medfødt, cyklisk og idiopatisk neutropeni), opnås en vedvarende stigning i det absolutte neutrofiltal i perifert blod og en reduktion af forekomsten af infektioner og lignende hændelser.
English: Less frequent undesirable effects include urinary abnormalities predominantly mild or moderate dysuria.
Danish: Blandt de mindre hyppige bivirkninger sås urinvejsproblemer, herunder især let til moderat dysuri.
English: Isolated cases of sickle cells crises have been reported in patients with sickle cell disease (see section 4.4).
Danish: Der er rapporteret enkeltstående tilfælde af seglcellekriser hos patienter med seglcellesygdom (se pkt.
English: The causal association with filgrastim has not been established.
Danish: Der er dog ikke påvist en kausal sammenhæng med filgrastim.
English: This will tell your doctor how well the treatment is working and will also indicate if treatment needs to be continued.
Danish: Derved kan lægen se, hvordan behandlingen virker, og om der er grund til at afbryde den.
English: Biograstim contains sorbitol.
Danish: Biograstim indeholder sorbitol og natrium.
English: This medicine is given by injection, either through an intravenous (IV) infusion (drip) or a subcutaneous (SC) injection (into the tissue just under the skin).
Danish: infusion) i en åre eller i vævet lige under huden (som subkutan (SC) injektion).
English: - if you get left upper abdominal pain or pain at the tip of your shoulder.
Danish: - Hvis De får ondt øverst til venstre i maven eller under skulderbladet.
English: Discontinue filgrastim
Danish: Seponer filgrastim
English: Excipients: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections.
Danish: Hjælpestoffer: Natriumhydroxid, eddikesyre, sorbitol, polysorbat 80, vand til injektionsvæsker.
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy.
Danish: Behandling med filgrastim alene udelukker ikke trombocytopeni og anæmi fremkaldt af myelosuppressiv kemoterapi.
English: If you see blood in the syringe, remove the needle and re-insert it in another place.
Danish: Fjern kanylen, hvis der er blod i sprøjten, og giv injektionen et andet sted.
English: The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Danish: Der er ikke foretaget studier af filgrastims virkninger hos patienter med væsentlig nedsættelse af myeloide stamceller.
English: 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 10
Danish: Ved administration af filgrastim til perifer blodstamcellemobilisering skal filgrastim seponeres eller doseringen af filgrastim reduceres, hvis leukocyttallet stiger til > 70 x 109/l.
English: It could be a consequence of a pulmonary disorder (see section “4.
Danish: Det kan skyldes en lungelidelse (se pkt.
English: Biograstim is useful in several different conditions, which are: - chemotherapy; - bone marrow transplantation; - severe chronic neutropenia (low white blood cell count); - neutropenia in patients with HIV infection; - peripheral blood stem cell mobilisation (for blood stem cell donation).
Danish: Biograstim kan bruges ved følgende lidelser: - Kemoterapi; - Knoglemarvstransplantation; - Almen sløjhed på grund af et lavt antal hvide blodlegemer (svær kronisk neutropeni); - Neutropeni hos patienter med hiv-infektion; - Til at fremme dannelsen af stamceller i blodet (mobilisering af perifere blodstamceller).
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis (see section 4.4).
Danish: Generelt er disse opstået i forbindelse med fremskredne maligne sygdomme, eller sepsis hos patienter, der har fået flere kemoterapeutika, eller som har gennemgået aferese (se pkt.
English: How to use Biograstim
Danish: Sådan skal De bruge Biograstim
English: What you need to know before you use Biograstim Do not use Biograstim
Danish: Det skal De vide, før De begynder at bruge Biograstim
English: 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).
Danish: Der er rapporteret sjældne pulmonale bivirkninger, herunder interstitiel pneumoni, lungeødem og lungeinfiltrater, som i nogle tilfælde førte til respirationssvigt eller adult respiratory distress syndrome, som kan være letalt (se pkt.
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in glucose 50 mg/mL (5 %) solution for infusion given over 30 minutes (see section 6.6 for instructions on dilution).
Danish: Filgrastim kan gives som en daglig subkutan injektion eller som en daglig intravenøs infusion efter fortynding med 50 mg/ml (5 %) glucose infusionsvæske over 30 minutter (se fortyndingsvejledningen i pkt.
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets
Danish: Hvis der kræves mere end én leukaferese, er det særlig vigtigt før leukaferesen at være opmærksom på donorer med trombocyttal < 100 x 109/l.
English: Not known (frequency cannot be estimated from the available data): - rejection of transplanted bone marrow; - transient low blood pressure; - pain and swelling of the joints, similar to gout.
Danish: Ikke kendte (hyppighed kan ikke beregnes ud fra forhåndenværende data): - afstødning af transplanteret knoglemarv; - midlertidigt lavt blodtrykt; - smertefulde og hævede led, som kan minde om urinsyregigt.
English: You will need to have regular blood tests whilst being treated with Biograstim to count the number of neutrophils and other white blood cells in your blood.
Danish: Under behandlingen med Biograstim skal De have regelmæssige blodprøver for at tælle antallet af hvide blodlegemer, blandt andet den type, der hedder neutrofilocytter.
English: If leukocyte counts exceed 50 x 10 should be discontinued immediately.
Danish: Hvis leukocyttallet ligger over 50 x 109/l efter det forventede nadir, skal filgrastimbehandlingen omgående seponeres.
English: For the mobilisation of PBPC in normal donors prior to allogeneic peripheral blood progenitor cell transplantation
Danish: Mobilisering af PBPC hos raske donorer før allogen perifer blodstamcelletransplantation
English: 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).
Danish: 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 (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Yderkarton