FrancophonIA/ELRC3.0 huggingface dataset:
English: You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea
Danish: De skal fortælle det til lægen, inden De får dette lægemiddel, hvis De (eller Deres barn) har HFI, eller hvis Deres barn ikke længere kan indtage sukkerholdig mad eller drikke, fordi barnet bliver dårligt, kaster op eller får ubehagelige virkninger som f.eks. oppustethed, mavekramper eller diarré.
English: During long term use cutaneous vasculitis has been reported in 2% of SCN patients.
Danish: Kutan vaskulitis er rapporteret hos 2 % af SCN-patienter under langvarig anvendelse.
English: In view of the possible risk of microbial contamination, Ratiograstim syringes are for single use only.
Danish: Da der er risiko for mikrobiel kontaminering, er Ratiograstim injektionssprøjter kun til engangsbrug.
English: 1995-2000b aAnalysis includes studies involving bone marrow transplant during this period; some studies used GM-CSF (granulocyte-macrophage-colony stimulating factor) bAnalysis includes patients receiving bone marrow transplant during this period
Danish: 1995-2000b aAnalysen omfatter studier med knoglemarvstransplantationer i denne periode; i nogle studier blev GM-CSF (granulocykolonistimulerende faktor) anvendt.
English: Ratiograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Danish: Ratiograstim er indiceret til behandling af vedvarende neutropeni (ANC ≤ 1,0 x 109/l) hos patienter med fremskreden hiv-infektion for at reducere risikoen for bakterielle infektioner, når andre behandlingsmuligheder ved neutropeni ikke er hensigtsmæssige.
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 skal iagttages særlig forsigtighed, når patienterne behandles med højdosis kemoterapi, fordi der ikke er dokumenteret forbedret tumorrespons og fordi højere doser af kemoterapeutiske stoffer kan medføre forøget toksicitet, herunder kardiale, pulmonale, neurologiske og dermatologiske effekter (der henvises til produktresumeerne for de enkelte kemoterapeutika).
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Danish: Der er set forbigående cytogenetiske abnormaliteter hos raske donorer efter brug af G-CSF.
English: It is recommended that the ANC is measured daily for the first 2 to 3 days of filgrastim administration.
Danish: Det anbefales at bestemme ANC dagligt i de første 2-3 dage under behandlingen med filgrastim.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Ratiograstim
Danish: Hvis lægen ikke giver Dem andre anvisninger, skal De stoppe med at amme, hvis De bruger Ratiograstim.
English: • increase in white blood cells (leukocytosis)
Danish: • Stigning i antallet af hvide blodlegemer (lekocytose)
English: Ratiograstim contains sorbitol (E420).
Danish: Ratiograstim indeholder sorbitol (E420).
English: Myelodysplastic syndrome or Chronic myeloid leukemia
Danish: Myelodysplastisk syndrom eller kronisk myeloid leukæmi
English: However, in view of the potential risks associated with severe leukocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Danish: På grund af den mulige risiko for svær leukocytose, bør der foretages leukocyttælling med regelmæssige mellemrum under behandlingen med filgrastim.
English: If you forget to use Ratiograstim
Danish: Hvis De har glemt at bruge Ratiograstim
English: Talk to your doctor, pharmacist or nurse before using Ratiograstim.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De bruger Ratiograstim.
English: Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Danish: Nogle cytostatika er særligt toksiske overfor den hæmatopoietiske progenitorpool, og kan have en negativ effekt på mobilisering af progenitorceller.
English: Ratiograstim is one of a group of products that stimulate the production of white blood cells.
Danish: Ratiograstim er et lægemiddel i en gruppe af produkter, der stimulerer produktionen af de hvide blodlegemer.
English: You will normally receive your first dose of Ratiogratsim at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.
Danish: De vil normalt få Deres første dosis Ratiograstim mindst 24 timer efter kemoterapi og mindst 24 timer efter knogletransplantationen.
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by transplantation.
Danish: Der er indimellem indberettet vaskulære sygdomme, inklusive veno-okklusiv sygdom og forstyrrelser i væskevolumen, hos patienter, der får højdosis kemoterapi efterfulgt af transplantation.
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Ratiograstim; - alcohol wipes or similar; - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
Danish: For at give Dem selv en subkutan injektion skal De bruge: - en fyldt medicinsprøjte med Ratiograstim, - spritservietter eller lignende, - en beholder til skarpe genstande (plastbeholder, der udleveres af hospitalet eller apoteket), så De kan kassere brugte sprøjter på sikker vis.
English: Talk to your doctor immediately during treatment with Ratiograstim, if you: - have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips,tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction (hypersensitivity).
Danish: Tal straks med lægen under behandling med Ratiograstim, hvis De: - får pludselige tegn på allergi, såsom udslæt, kløe eller nældefeber på huden, hævelse i ansigt, læber, tunge eller andre dele af kroppen, stakåndethed, hvæsende vejrtrækning eller vejrtrækningsbesvær, da det kan være tegn på en alvorlig allergisk reaktion (overfølsomhed).
English: The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MIU (5 μg)/kg/day from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Danish: Den anbefalede dosis filgrastim til perifer blodstamcellemobilisering efter myelosuppressiv kemoterapi er 0,5 mio. IE (5 μg)/kg/døgn fra den første dag efter afslutning af kemoterapien og indtil det forventede neutrofilnadir passeres, og neutrofiltallet atter ligger inden for normalområdet.
English: - if you experience kidney injury (glomerulonephritis).
Danish: - hvis De får nyreskade (glomerulonefritis).
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution for infusion given over 30 minutes (see section 6.6).
Danish: Filgrastim kan gives som en daglig, subkutan injektion eller som en daglig, intravenøs infusion fortyndet i 5 % glucoseinfusionsvæske, opløsning givet over 30 minutter (se pkt.
English: White blood cell counts of 100 x 109/L or greater have been observed in less than 5 % of cancer patients receiving filgrastim at doses above 0.3 MIU/kg/day (3 μg/kg/day).
Danish: Der er påvist leukocyttal på 100 x 109/l eller derover hos færre end 5 % af de cancerpatienter, som fik filgrastim i doser over 0,3 mio. IE/kg/dag (3 µg/kg/dag).
English: Inflammation of aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Danish: - Der er indberettet sjældne tilfælde af betændelse i aorta (den store pulsåre, der transporterer blod fra hjertet ud i kroppen) hos kræftpatienter og raske donorer.
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Ratiograstim; - alcohol wipes or similar.
Danish: For at give Dem selv en subkutan injektion skal De bruge: - en fyldt medicinsprøjte med Ratiograstim, - spritservietter eller lignende,
English: Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has reached and can be maintained at more than 1.5 x 109/L.
Danish: Filgrastim bør administreres dagligt som subkutan injektion, indtil neutrofiltallet er over 1,5 x 109/l og kan fastholdes på dette niveau.
English: Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/L.
Danish: Der kan opstå behov for yderligere dosisjustering afhængigt af patientens ANC for at opretholde et neutrofiltal på > 2.0 x 109/l.
English: What you need to know before you use Ratiograstim Do not use Ratiograstim
Danish: Det skal De vide, før De begynder at bruge Ratiograstim Brug ikke Ratiograstim
English: A common side effect of Ratiograstim use is pain in your muscles or bones (musculoskeletal pain), which could be relieved by taking standard pain relief medicines (analgesics).
Danish: En almindelig bivirkning ved Ratiograstim er smerter i muskler eller knogler, hvilket kan lindres med almindelig smertestillende medicin.
English: Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Danish: Neutropeni kan skyldes opportunistiske infektioner i knoglemarven som f. eks. Mycobacterium avium kompleks eller maligne sygdomme som f. eks. lymfomer.
English: Special precautions in recipients of allogeneic PBPCs mobilised with filgrastim
Danish: Særlige forholdsregler hos modtagere af allogene PBPC'er, som er mobiliseret med filgrastim
English: Ratiograstim does not contain any preservative.
Danish: Ratiograstim indeholder ingen konserveringsmidler.
English: Complete blood cell counts with differential and platelet counts and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
Danish: Før behandlingen bør der foretages fuldstændig blodcelletælling, herunder differentialtælling og trombocyttælling, og knoglemarvsmorfologi og karyotype bør evalueres før behandlingen.
English: Injury, poisoning and procedural complicatio ns
Danish: Traumer, forgiftninger og behandlingskomplika tioner
English: Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/or other myelosuppressive medication.
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: Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Danish: Trombocyttallet bør monitoreres nøje, især i de første få ugers behandling med filgrastim.
English: - if you have a combination of any of the following symptoms: - 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 De får en kombination af de følgende symptomer: feber eller kulderystelser eller kuldefølelse, høj hjertefrekvens, forvirring eller desorientering, stakåndethed, ekstreme smerter eller ubehag, og klam eller svedende hud.
English: - if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Danish: - hvis De får hoste, feber og vejrtrækningsbesvær (dyspnø), da dette kan være tegn på akut lungesvigt (Acute Respiratory Distress Syndrome (ARDS)).
English: Contents of the pack and other information What Ratiograstim contains
Danish: Pakningsstørrelser og yderligere oplysninger Ratiograstim indeholder:
English: If the ANC decreases to < 1.0 x 109/L during the treatment period the dose of filgrastim should be re-escalated according to the above steps
Danish: Hvis det absolutte neutrofiltal falder til < 1,0 x 109/l i løbet af behandlingen, bør doseringen af filgrastim øges igen ved at følge ovennævnte procedure i omvendt rækkefølge.
English: Ratiograstim 48 MIU/0.8 mL
Danish: Ratiograstim 48 mio. IE/0,8 ml
English: If you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Danish: - hvis De får en eller en kombination af følgende bivirkninger: hævelse eller opsvulmethed, der kan være forbundet med mindre hyppig vandladning, åndedrætsbesvær, opsvulmet mave og mæthedsfølelse samt en generel følelse af træthed.
English: • enlargement of the liver (hepatomegaly)
Danish: • Forstørret lever (hepatomegali)
English: Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 109/l).
Danish: Afbrydelse af behandlingen eller dosisreduktion af filgrastim bør overvejes hos patienter med alvorlig kronisk neutropeni som udvikler trombocytopeni (trombocyttal < 100 x 109/l).
English: Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/L to > 5.0 x 109/L.
Danish: Der bør gives leukaferese, mens det absolutte neutrofiltal stiger fra < 0,5 x 109/l til > 5,0 x 109/l.
English: Ratiograstim 30 MIU/0.5 mL
Danish: Ratiograstim 30 mio. IE/ 0,5 ml
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF.
Danish: Aortitis blev i de fleste tilfælde konstateret ved hjælp af CT-scanning og fortog sig generelt efter seponering af G-CSF (se også pkt.
English: - Do not put the cover back on used needles.
Danish: - Sæt ikke beskyttelseshætten på igen efter brug af kanylen.
English: Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Danish: Ratiograstim er indiceret til reduktion af varigheden af neutropeni og incidensen af febril neutropeni hos patienter, der behandles med standard cytotoksisk kemoterapi for malign sygdom (med undtagelse af kronisk myeloid leukæmi og myelodysplastiske syndromer), og til reduktion af neutropeni hos patienter, som behandles med myeloablativ terapi efterfulgt af knoglemarvstransplantation og anses for at have en øget risiko for at få langvarig svær neutropeni.
English: Ratiograstim is a clear and colourless solution.
Danish: Ratiograstim er en klar og farveløs væske.
English: 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.
Danish: Man bør være særlig omhyggelig med at stille diagnosen SCN for at differentiere fra andre hæmatologiske lidelser som f. eks. aplastisk anæmi, myelodysplasi og myeloid leukæmi.
English: In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Danish: Hos patienter, såvel børn som voksne, med svær kongenit cyklisk eller idiopatisk neutropeni med et absolut neutrofiltal (ANC) på ≤ 0,5 x 109/l og svære eller recidiverende infektioner i anamnesen er langtidsbehandling med Ratiograstim indiceret for at øge neutrofiltallet og reducere forekomst og varighed af hændelser relateret til infektionen.
English: For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Danish: Til mobilisering af perifere blodstamceller(PBPC) hos patienter i myelosuppressiv eller myeloablativ terapi efterfulgt af autolog transplantation med PBPC'er
English: This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. fyldt injektionssprøjte, d.v.s. den er i det væsentlige 'natriumfri'.
English: The effects of filgrastim on neutropenia due to bone marrow-infiltrating infection or malignancy have not been well established.
Danish: Filgrastims virkning på neutropeni, som skyldes knoglemarvsinfiltrerende infektioner eller maligne sygdomme, kendes ikke.
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 de patienter, som har kendte knoglemarvsinfiltrerende infektioner eller maligne sygdomme, bør det overvejes at behandle den underliggende sygdom på passende måde i tillæg til neutropenibehandlingen med filgrastim.
English: Filgrastim may be given as a 30 minute or 24 hour intravenous infusion or given by continuous 24 hour subcutaneous infusion.
Danish: Filgrastim kan gives som intravenøs infusion over 30 minutter eller 24 timer, eller det kan gives som kontinuerlig subkutan infusion over 24 timer.
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 nedsat høst af progenitorceller, hvis de gives i lang tid, før det forsøges at foretage mobilisering af progenitorceller.
English: Haematuria was common andproteinuria occurred in a small number of patients.
Danish: Hæmaturi var almindeligt forekommende og proteinuri forekom hos et mindre antal patienter.
English: Leukocytosis (WBC > 50 x 109/l) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors (see section 4.4).
Danish: Der blev set leukocytose (WBC > 50 x 109/l) hos 41 % af donorerne og forbigående trombocytopeni (trombocyttal < 100 x 109/l) hos 35 % af donorerne efter filigrastimbehandling og leukaferese (se pkt.
English: The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome or chronic myelogenous leukaemia have not been established.
Danish: Filgrastims sikkerhed og virkning hos patienter med myelodysplastisk syndrom eller kronisk myeloid leukæmi er ikke dokumenteret.
English: Fertility Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Danish: Fertilitet Filgrastim påvirkede ikke reproduktionsevnen eller fertiliteten hos han- eller hunrotter (se pkt.
English: In randomised clinical trials, a subcutaneous dose of 23 MIU (230 μg)/m2/day (4.0 to 8.4 μg/kg/day) was used.
Danish: I randomiserede kliniske studier anvendtes en subkutan dosis på 23 mio. IE (230 μg)/m2/døgn (4,0 til
English: Ratiograstim stimulates the bone marrow to produce new white cells quickly.
Danish: Ratiograstim stimulerer knoglemarven til at producere nye, hvide blodlegemer hurtigt.
English: Special precautions in patients with HIV infection
Danish: Særlige forsigtighedsregler hos patienter med hiv-infektion
English: General disorders and administratio n site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: notice unusual bleeding or bruising (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot).
Danish: - bemærker usædvanlig blødning, eller at De lettere får blå mærker (dette kan være symptomer på et lavere antal blodplader (trombocytopeni), hvor blodet har nedsat evne til at størkne).
English: If required, Ratiograstim may be diluted in glucose 50 mg/mL (5 %) solution for infusion.
Danish: Hvis det er nødvendigt, kan Ratiograstim fortyndes med 50 mg/ml (5 %) glucose infusionsvæske.
English: As a result of the potential to receive higher doses or a greater number of these medicinal products with filgrastim therapy, the patient may be at higher risk of developing thrombocytopenia and anaemia.
Danish: Da de patienter, som er i behandling med filgrastim, har mulighed for at få højere doser og flere kombinationer af disse lægemidler, kan de have større risiko for at udvikle trombocytopeni og anæmi.
English: In patients with severe chronic neutropenia (SCN) Posology
Danish: Hos patienter med svær kronisk neutropeni (SCN)
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Danish: Der blev ikke observeret nogen generelle forskelle for så vidt angår sikkerheden eller effekten hos patienter over 65 år sammenlignet med yngre voksne (> 18 år) patienter, der fik kemoterapi med cytotoksika.
English: Sepsis Bronchitis Upper respiratory tract infection Urinary tract infection
Danish: Sepsis Bronkitis Infektion i øvre luftveje Urinvejsinfe ktion
English: Other medicines and Ratiograstim
Danish: Brug af anden medicin sammen med Ratiograstim
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: - får hævelser i ansigt eller hævede ankler, blod i urinen eller brun urin, eller hvis De bemærker, at De ikke lader vandet så ofte, som De plejer (glomerulonefritis).
English: Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.
Danish: Ring straks til lægen, hvis De bliver hævet i ansigtet eller anklerne, hvis der er blod i Deres urin, eller urinen er brun, eller hvis De skal lade vandet mindre hyppigt end normalt.
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: Patienter, som tidligere har fået omfattende myelosuppressiv kemoterapi, vil ikke altid opnå tilstrækkelig mobilisering af PBPC til at opnå den anbefalede minimumshøst (≥ 2,0 x 106/CD34+
English: There was a low frequency (approximately 3 %) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Danish: I de kliniske studier var der en lav frekvens af myelodysplastiske syndromer (MDS) eller leukæmi hos patienter med SCN, som blev behandlet med filgrastim (ca. 3 %).
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient abnormal bone scans This should be considered when interpreting bone-imaging results.
Danish: Øget hæmatopoietisk aktivitet i knoglemarven som reaktion på vækstfaktorbehandling er blevet forbundet med forbigående abnorme knoglescanninger.