FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
Danish: - hvis du får en allergisk reaktion, herunder føler dig svækket, blodtrykfald, vejrtrækningsbesvær, hævelse af ansigt (anafylaksi), hududslæt, kløende udslæt (urticaria), hævelse i ansigt, læber, mund, tunge eller hals (angioødem) og stakåndethed (dyspnø).
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret:
English: • The needle safety guard prevents needle stick injuries after use, so no special precautions for disposal are required.
Danish: - Kanylebeskytteren forhindrer stikulykker efter brug, så yderligere sikkerhedsforanstaltninger ved bortskaffelse er ikke nødvendige.
English: The most serious adverse reactions that may occur during Filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
Danish: De alvorligste bivirkninger, der kan opstå under behandling med Filgrastim, omfatter: anafylaktisk reaktion, alvorlige pulmonale bivirkninger (herunder interstitiel lungebetændelse og ARDS), kapillær lækagesyndrom, alvorlig splenomegali og miltruptur, transformation til myelodysplastisk syndrom eller leukæmi hos SCN-patienter, GvHD hos patienter, der får allogen knoglemarvstransmission eller mobilisering af perifere blodstamceller og seglcellekrise hos patienter med seglcelleanæmi.
English: The needle cover of the pre-filled syringe contains dry natural rubber (see section 4.4).
Danish: Kanylehætten på den fyldte injektionssprøjte indeholder tørt naturgummi (se pkt.4.4).
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 pædiatriske patienter antyder, at filgrastims sikkerhed og virkning er sammenlignelig hos voksne og børn, der får cytotoksisk kemoterapi.
English: Accidental one-time exposure to freezing temperatures does not adversely affect the stability of Accofil.
Danish: En utilsigtet enkelt eksponering over for frostgrader én gang påvirker ikke Accofil s stabilitet.
English: Graft versus Host Diseaseb
Danish: Graft versus hostsygdom b
English: A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal pain or shoulder tip pain.
Danish: Diagnosen miltruptur skal overvejes hos donorer og/eller patienter, som klager over smerter i venstre side af abdomen eller nederste del af skulderbladet.
English: When peripheral blood progenitor cell transplantation is envisaged it is advisable to plan the stem cell mobilization procedure early in the treatment course of the patient.
Danish: Det er tilrådeligt at planlægge proceduren for stamcellemobiliseringen tidligt i behandlingsforløbet af patienten, når en transplantation af perifere blodprogenitorceller kan forudses.
English: Dose reductions of Filgrastim have been noted to slow or stop the progression of splenic enlargement in patients with severe chronic neutropenia, and in 3% of patients a splenectomy was required.
Danish: Det har vist sig, at dosisreduktioner af Filgrastim bremser eller standser udviklingen af miltsvulst hos patienter med alvorlig kronisk neutropeni, og hos 3 % af patienterne var en splenektomi påkrævet.
English: In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Danish: For at forbedre sporbarheden af granulocytkolonistimulerende faktorer (G-CSF), skal handelsnavnet på det administrerede produkt tydeligt fremgå i patientjournalen.
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added.
Danish: F.eks.: Ved en slutvolumen til injektion på 20 ml skal totaltdoser af filgrastim på under 30 ME (300 µg) gives med 0,2 ml 200 mg/ml (20 %) humant albuminopløsning tilsat.
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: Stoffer som melphalan, carmustin (BCNU) og carboplatin kan medføre en reduceret høst af progenitorceller, hvis de gives i lang tid, før det forsøges at foretage mobilisering af progenitorceller.
English: Premature discontinuation of filgrastim therapy, prior to the time of the expected neutrophil nadir, is not recommended.
Danish: Det anbefales ikke at seponere behandlingen med filgrastim før tidspunktet for det forventede neutrofile nadir er nået.
English: Ver y rare
Danish: Sjælden Meget sjælden
English: The recommended dose of filgrastim is 0.5 MU/kg/day (5 micrograms/kg/day).
Danish: Den anbefalede filgrastimdosis er 0,5 ME/kg/dag (5 mikrogram/kg/dag).
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Danish: Der er rapporter i litteraturen, hvor der er påvist passage af filgrastim gennem placenta.
English: - chemotherapy - bone marrow transplantation - severe chronic neutropenia (low number of a type of white blood cells) - neutropenia (low number of a type of white blood cells) in patients with HIV infection - peripheral blood stem cell mobilisation (to stimulate stem cells to enter the blood stream to be collected and used in bone marrow transplantation).
Danish: kemoterapi knoglemarvstransplantation svær kronisk neutropeni (lavt antal af en type hvide blodlegemer) neutropeni (lavt antal af en type hvide blodlegemer) hos patienter med HIV-infektion perifer blodstamcelle mobilisering (for at stimulere dannelse af stamceller til blodet, der indsamles og anvendes i knoglemarvstransplantation).
English: Decreased Appetitee Blood lactate dehydrogenase increased
Danish: Nedsat appetita Forhøjet laktatdehydrog enase i blodet
English: Accofil and neutropenia (low number of a type of white blood cells) in patients with HIV infection
Danish: Accofil og neutropeni (lavt antal af en type hvide blodlegemer) hos patienter med HIV-infektion
English: Bone density decreased Exacerbati on of rheumatoid arthritis
Danish: Fald i knoglet æthed Forværri ng af reumato id artritis
English: Effect of chemotherapy on erythrocytes and thrombocytes Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy.
Danish: Kemoterapis effekt på erythrocytter og trombocytter Behandling med filgrastim alene forhindrer ikke trombocytopeni og anæmi fremkaldt af myelosuppresiv kemoterapi.
English: N Acute Grade II - IV GvHD
Danish: Akut grad IIIV GvHD
English: Thrombocytopenia has been reported very commonly in patients receiving filgrastim .Platelet counts should therefore be monitored closely.
Danish: Der er indberettet tilfælde af trombocytopeni med frekvensen ”meget almindelig” hos patienter, der fik filgrastim.Trombocyttallene bør derfor overvåges tæt.
English: Following subcutaneous administration of recommended doses , serum concentrations were maintained above 10ng/ml for 8 to 16 hours.
Danish: Efter subkutan administration af anbefalede doser forblev serumkoncentrationerne over 10 ng/ml i 8-16 timer.
English: Each ml of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) of filgrastim.
Danish: Hver ml opløsning indeholder 96 millioner enheder (ME) (svarende til 960 mikrogram [μg]) filgrastim.
English: Hold the syringe and gently take the cover from the needle without twisting.
Danish: Hold i injektionssprøjten og træk forsigtigt beskyttelseshætten af kanylen uden at vride.
English: INFORMATION IN BRAILLE Accofil 30 MU/0.5 ml
Danish: Accofil 30 ME/0,5 ml
English: Diarrhoeaa,e Vomitinga,e Nauseaa
Danish: Diarréa,e Opkastninga,e Kvalmea
English: 1 pre-filled syringe (0.5 ml) + 1 alcohol swab “5 pre-filled syringes (0.5 ml) + 5 alcohol swabs” “3 pre-filled syringe (0.5 ml) + 3 alcohol swabs” “10 pre-filled syringe (0.5 ml) + 10 alcohol swabs”
Danish: 1 fyldt injektionssprøjte med 0,5 ml + 1 spritserviet “5 fyldte injektionssprøjter med 0,5 ml + 5 spritservietter” “3 fyldte injektionssprøjter med 0,5 ml + 3 spritservietter” “10 fyldte injektionssprøjter med 0,5 ml + 10 spritservietter”
English: An increased incidence of embryo-loss has been observed in rabbits at high multiples of the clinical exposure and in the presence of maternal toxicity (see section 5.3).
Danish: Hos kaniner er der observeret et øget tab af embryoner ved eksponeringer mange gange højere end den kliniske eksponering og samtidig maternel toksicitet (se pkt.
English: The packs without blister are for syringes without needle safety guard.
Danish: De pakninger uden blisterer for injektionssprøjter uden kanylebeskytter.
English: Each pack contains one, three, five, seven or ten pre-filled syringes, with or without a needle safety guard, and alcohol swab(s).
Danish: Hver pakning indeholdende 1, 3, 5, 7 eller 10 fyldte injektionssprøjter, med eller uden kanylebeskytter og spritserviet(ter).
English: Use of filgrastim in adults with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in ANCs in peripheral blood and a reduction of infection and related events.
Danish: Anvendelsen af filgrastim til børn eller voksne med SCN (alvorlig medfødt, cyklisk og idiopatisk neutropeni) fremkalder en vedvarende øgning af det absolutte neutrofiltal i perifert blod og en reduktion i antallet af infektion og relaterede hændelser.
English: Pseudogout (chondrocalcinosis pyrophosphate)
Danish: Pseudogout (pyrofosfatartropati )
English: Common: ≥ 1/100 to < 1/10
Danish: Almindelig: ≥ 1/100 til <1/10
English: Sickle cells crises, in some cases fatal, have been reported with the use of filgrastim in subjects with sickle cell trait or sickle cell disease.
Danish: Der er indberettet tilfælde af seglcellekriser, som i visse tilfælde var dødbringende, ved behandling af forsøgspersoner med seglcelletræk eller seglcelleanæmi med filgrastim.
English: Acetic acid glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
Danish: Natriumhydroxid Sorbitol (E420) Polysorbat 80
English: The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Danish: Dosisanbefalingerne for pædiatriske patienter er de samme som for voksne, der får myelosuppressiv cytotoksisk kemoterapi.
English: Sweets syndrome (acute febrile neutrophili c dermatosis) Cutaneous
Danish: Sweets syndrom (akut febril ne utrofil dermato se)
English: Do not use Accofil if you notice it is cloudy, or there is discoloration or there are particles in it. Do not put the cover back on used needles, as you may accidentally prick yourself.
Danish: Brug ikke Accofil, hvis du bemærker, at opløsningen er uklar eller der er misfarvning eller den indeholder partikler.
English: Type I glass pre-filled syringe with a permanently attached stainless steel needle in the tip and 1/40 printed markings for graduations from 0.1 mL to 1 mL on the barrel.
Danish: Type-I-glas fyldte injektionssprøjter med en permanent isat kanyle af rustfrit stål i spidsen med 1/40 trykte markeringer for graduering fra 0,1 ml til 1 ml på cylinderen.
English: The most commonly reported adverse reactions are pyrexia, musculoskeletal pain (which includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anaemia, vomiting, and nausea.
Danish: De hyppigst rapporterede bivirkninger er pyreksi, muskuloskeletale smerter (som omfatter knoglesmerter, rygsmerter, artralgi, myalgi, smerte i ekstremitet, muskuloskeletale smerter, muskuloskeletale smerter i brystet, nakkesmerter), anæmi, opkastning og kvalme.
English: The mechanism of vasculitis in patients receiving Filgrastim is unknown.
Danish: Vasculitismekanismen hos patienter, der får Filgrastim, er ukendt.
English: Name and address of the manufacturer(s) of the biological active substance(s) Intas Pharmaceuticals Ltd.
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer)
English: • Experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual (glomerulonephritis).
Danish: - Bliver hævet i ansigtet eller på anklerne, får blod i urinen, eller urinen er brunlig, eller du bemærker, at du tisser mindre end du plejer (glumerulonefritis).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton - Pre-filled syringe with a needle safety guard in blister pack
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton - fyldt sprøjte med sikkerhedsanordning
English: The recommended starting dose of filgrastim is 0.1 MU (1 µg)/kg/day, with titration up to a maximum of 0.4 MU (4 µg)/kg/day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 109/L).
Danish: Den anbefalede filgrastimstartdosis er 0,1 ME (1 µg)/kg/dag med titrering op til højst 0,4 ME (4 µg)/kg/dag indtil en normal neutrofiltal er opnået og kan opretholdes (ANC > 2,0 x 109/l).
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Danish: Der skal udvises særlig forsigtighed, når der gives kemoterapeutiske stoffer, som er kendt for at forårsage svær trombocytopeni både som enkeltstof eller i kombination.
English: The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy.
Danish: Accofils sikkerhed og virkning er den samme hos voksne og børn, der får cytotoksisk kemoterapi.
English: Some cases of splenic rupture were fatal (see section 4.4).
Danish: Nogle tilfælde af miltruptur var dødelige (se pkt.
English: Using the pre-filled syringe with a needle safety guard The needle safety guard covers the needle after injection to prevent needle stick injury.
Danish: Brug af den fyldte injektionssprøjte med kanylebeskytter Kanylebeskytteren dækker kanylen efter injektion for at forhindre stikskader.
English: Respiratory failurea
Danish: Respiration ssvigta
English: 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.A faster schedule of dose escalation may be considered in patients presenting with severe infections.
Danish: Derefter kan dosis justeres individuelt for hver 1-2 ugers behandling for at opretholde et gennemsnitligt neutrofiltal mellem 1,5 x 109/l og 10 x 109/l.
English: In view of the possible risk of microbial contamination, Accofil syringes are for single use only.
Danish: På grund af den mulige risiko for mikrobiologisk kontaminering er Accofil injektionssprøjter kun til engangsbrug.
English: In view of the possible risk of microbial contamination, Accofil pre-filled syringes are for single use only.
Danish: Med tanke på den mulige risiko for mikrobiel kontaminering er Accofil fyldte injektionssprøjter kun beregnet til engangsbrug.
English: Pre-filled syringe with needle safety guard h.
Danish: Fyldt sprøjte med kanylebeskytter h.
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2 °C - 8 °C) Må ikke fryses.
English: 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.
Danish: Filgrastim gives som en intravenøs, kortvarig infusion over 30 minutter eller som en subkutan eller intravenøs, kontinuerlig infusion over 24 timer i hvert tilfælde efter fortynding i 20 ml 50 mg/ml (5 %) isoton glukose til infusion.
English: Take special care with other products that stimulate white blood cells Accofil is one of a group of products that stimulate the production of white blood cells.
Danish: Vær ekstra forsigtig med andre produkter, der stimulerer hvide blodlegemer
English: Constipatione Oral pain
Danish: Forstoppelsee Orale smerter
English: In clinical studies, dosing with 30 MU (300 µg )/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.
Danish: I kliniske studier var det nødvendigt at give 30 ME (300 µg)/dag i 1 til 7 dage pr. uge for at opretholde et ANC > 2,0 x 109/l med en median doseringshyppighed på 3 dage pr. uge.
English: 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 are < 75 x 109/L.
Danish: Hvis det er nødvendigt med mere end én leukaferese, skal man være særlig opmærksom på donorer, som har et trombocyttal <100 x109/l før leukaferesen.
English: - fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation, shortness of breath, extreme pain or discomfort and clammy or sweaty skin.
Danish: - hvis du har en kombination af følgende symptomer: - feber eller kulderystelser eller følelse af at være meget kold, høj puls, forvirring eller desorientering, åndenød, ekstrem smerte eller ubehag og klam eller svedig hud.
English: Put the needle fully into the skin as shown by your nurse or doctor (see picture 7).
Danish: Før kanylen helt ind under huden, sådan som sygeplejersken eller lægen har vist dig (se figur 7).
English: Diluted filgrastim may be adsorbed to glass and plastic materials.
Danish: Hvis filgrastim fortyndes på anden måde end den nedenfor beskrevne, kan det blive adsorberet til glas og plast.
English: The first dose of Accofil should not be administered less than 24 hours following cytotoxic chemotherapy.
Danish: Den første dosis Accofil må tidligst gives 24 timer efter cytotoksisk kemoterapi.
English: Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Danish: Bør ikke anvendes til patienter med hereditær fructoseintolerans.
English: INFORMATION IN BRAILLE Accofil 48 MU/0.5 ml
Danish: Accofil 48 ME/0,5 ml
English: For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MU (10 µg)/kg/day for 4 - 5 consecutive days.
Danish: Til PBPC-mobilisering hos raske donorer før allogen PBPC-transplantation, skal der gives 1,0 ME (10 µg)/kg/dag i 4-5 på hinanden følgende dage.
English: The recommended starting dose is 1.2 MU (12 µg)/kg/day as a single dose or in divided doses.
Danish: Den anbefalede startdosis er 1,2 ME (12 µg)/kg/dag som en enkeltdosis eller i opdelte doser.
English: 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.
Danish: Intermitterende pauser i behandlingen eller nedsættelse af filgrastimdosis bør overvejes hos patienter, der udvikler trombocytopeni, dvs. patienter, der får et vedvarende trombocyttal på < 100 x 109/l.
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)) You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
Danish: Hvis du lider af alvorlig, kronisk neutropeni, kan der være risiko for, at du udvikler kræft i blodet (leukæmi, myelodysplastisk syndrom [MDS]).
English: Discontinue filgrastim
Danish: Seponér filgrastrim
English: - The other ingredients are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.
Danish: - Øvrige indholdsstoffer: Eddikesyre, natriumhydroxid, sorbitol (E420), polysorbat 80 og vand til injektionsvæsker.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på den følgende hjemmeside: Det Europæiske Lægemiddelagentur: http://www.emea.europa.eu/
English: The results of flow cytometric analysis of CD34
Danish: Graden af variation mellem individuelle patienter og laboratorieanalyser af CD34+
English: Individuals receiving filgrastim who report left upper abdominal and/ or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.
Danish: Patienter i behandling med filgrastim, der fortæller om øvre venstre abdominale smerter og/eller smerter yderst på skulderen, skal undersøges for forstørret milt eller miltruptur.
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Danish: Der blev ikke påvist nogen virkning på risikoen for akut GvHD, kronisk GvHD eller tidlig behandlingsrelateret mortalitet i en metaanalyse af allogene transplantationsstudier, som omfattede resultaterne fra 9 prospektive randomiserede studier, 8 retrospektive studier og 1 case-kontrolleret studie.
English: Initial dose adjustment to alternate day dosing with 30 MU (300 µg)/day is recommended.
Danish: Det anbefales indledningsvist at justere dosis til 30 ME(300 µg)/dag hver anden dag.
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Danish: Lægen vil muligvis ønske at overvåge dig nøjere.
English: Respiratory , thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum
English: • transfusion reaction
Danish: Transfusionsre
English: Uncommon: ≥ 1/1,000 to < 1/100 Rare: ≥ 1/10,000 to < 1/1,000
Danish: Ikke almindelig: ≥ 1/1.000 til < 1/100 Sjælden: ≥ 1/10.000 til < 1/1.000
English: 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.
Danish: Tidligere eksponering over for cytotoksiske stoffer Patienter, der tidligere har fået omfattende myelosuppressiv kemoterapi, vil ikke altid opnå tilstrækkelig mobilisering af PBPC til at nå det anbefalede minimumsresultat (2,0 x 106 CD34+
English: For infusions filgrastim should be diluted in 20ml of 5% glucose solution (see section 6.6).
Danish: Ved infusion skal filgrastim fortyndes i 20 ml 5 % glucoseinjektionsvæske (se pkt.
English: Eject unnecessary liquid by pushing the plunger up to the number (mL) on the syringe that matches the prescribed dose.
Danish: Brug skalaen på sprøjtecylinderen til at afmåle den dosis Accofil, som lægen har ordineret, på følgende måde: Pres overskydende væske ud af sprøjten ved at trykke stemplet i til det antal milliliter (ml), der svarer til den ordinerede dosis.
English: • Notice unusual bleeding or bruising that may be (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot.
Danish: - Bemærker blå mærker eller unormale blødninger (det kan være symptomer på en sygdom i blodpladerne (trombocytopeni)), hvor blodet kan have sværere ved at størkne.
English: Acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injection.
Danish: Eddikesyre, natriumhydroxid, sorbitol (E420), polysorbat 80 og vand til injektionsvæske.
English: What should I do before I give myself a subcutaneous injection of Accofil?
Danish: Sådan gør du dig klar til at give dig selv en subkutan injektion af Accofil