FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipient: Each ml of solution contains 50 mg of sorbitol.
Danish: Hjælpestof: 1 ml opløsning indeholder 50 mg sorbitol.
English: In randomised, placebo-controlled clinical trials, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
Danish: I randomiserede, placebokontrollerede kliniske forsøg medførte filgrastim ikke stigning i incidensen af de bivirkninger, der forbindes med cytotoksisk kemoterapi.
English: Nausea/Vomiting
Danish: Kvalme/opkastning
English: Particular attention should be paid to haematological values
Danish: Opmærksomheden bør især rettes mod hæmatologi
English: There is no evidence from studies in rats and rabbits that filgrastim is teratogenic.
Danish: Dyreforsøg med rotter og kaniner har ikke vist, at filgrastim er teratogent.
English: Filgrastim ratiopharm should not be diluted with sodium chloride solution.
Danish: Filgrastim ratiopharm bør ikke fortyndes med natriumchloridopløsning.
English: - rejection of transplanted bone marrow (frequency unknown) - elevated levels of some liver or blood enzymes, high blood levels of uric acid, low blood levels
Danish: - afstødning af transplanteret knoglemarv (hyppighed ukendt) - forhøjet niveau af visse lever- eller blodenzymer, højt niveau af urinsyre, lavt blodsukker
English: cannot be estimated from the available data Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Kan ikke estimeres ud fra forhåndenværende data Inden for hver angivet hyppighed angives bivirkningerne i forhold til, hvor alvorlige de er, med de
English: Filgrastim ratiopharm 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: Filgrastim ratiopharm 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: Abdominal palpation should be sufficient to detect
Danish: Abdominal palpation skulle være tilstrækkeligt til at påvise anormale forstørrelser af milten.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with filgrastim should be made taking into account the benefit of breastfeeding to the child and the benefit of filgrastim therapy to the woman.
Danish: Ved beslutning om at fortsætte/indstille amningen eller fortsætte/indstille behandling med filgrastim skal der tages højde for barnets fordele ved amningen og moderens fordele
English: Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of 4 x 106 CD34+ cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Danish: Behandling med filgrastim før allogen PBPC-transplantation til mobilisering af PBPC hos raske donorer gør det muligt at høste 4 x 106 CD34+-celler/kg legemsvægt hos recipienten hos de fleste af donorerne efter to leukafereser.
English: Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50%, 35%, 25%, and 10% of patients respectively, at recommended doses.
Danish: Reversible, dosisafhængige og sædvanligvis lette til moderate forhøjelser af lactatdehydrogenase (LDH), basisk fosfatase, serumurinsyre og gammaglutamyltransferase (GGT) sås hos henholdsvis ca. 50 %, 35 %, 25 % og 10 % af de patienter, der fik filgrastim i de anbefalede doser.
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 forsøg anvendtes en subkutan dosis på 23 mio. IE (230 μg)/m2/døgn (4,0 til 8,4 μg/kg/døgn)
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been
Danish: Mulig interaktion med andre hæmatopoietiske vækstfaktorer og cytokiner er ikke blevet undersøgt i kliniske forsøg.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Danish: Som andre hæmatopoietiske vækstfaktorer har G-CSF udvist in vitro-stimulerende egenskaber i
English: 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.
Danish: Statistiske analyser af forholdet mellem antallet af reinfunderede CD34+-celler og hastigheden af trombocytøgningen tyder på en kompleks, men sikker sammenhæng.
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Danish: For at gøre indsprøjtningen så bekvem som muligt bør De lade den fyldte medicinsprøjte ligge i 30 minutter ved stuetemperatur eller holde den fyldte sprøjte forsigtigt i hånden i nogle få minutter.
English: Thirty-one percent (31%) of patients in studies were documented as having palpable splenomegaly.
Danish: I kliniske studier havde 31 % af patienterne palpabel splenomegali.
English: However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been
Danish: En betydelig procentdel af disse patienter led imidlertid af leukæmi, en lidelse der associeres med Sweets syndrom, og en kausal sammenhæng med filgrastim er derfor ikke påvist.
English: Long term treatment with Filgrastim ratiopharm may be required to maintain a normal number of white cells in your blood.
Danish: Det kan være nødvendigt at give langtidsbehandling med Filgrastim ratiopharm for at opretholde et normalt antal hvide blodlegemer.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstillådelsen (version 1.3, Modul 1.8.1) er på plads og fungerer, før og mens
English: If you have a fever or any of these symptoms, contact your doctor immediately and go straight to
Danish: Kontakt omgående lægen, hvis De får feber eller et af disse symptomer, og tag direkte på hospitalet
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 kliniske forsøg observeredes en lav frekvens (ca. 3 %) af myeloplastiske syndromer (MDS) eller leukæmi hos patienter med SCN, der fik filgrastim.
English: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Danish: Prækliniske data fra konventionelle studier af gentagen dosistoksicitet viste de forventede farmakologiske virkninger inklusive forhøjet leukocyttal, myeloid hyperplasi i knoglemarv, ekstramedullær hæmopoiese og forstørrelse af milten.
English: White blood cell counts of 100 x 109/l or greater have been observed in less than 5% of patients receiving filgrastim at doses above 0.3 MIU/kg/day (3 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: When diluted in glucose 50 mg/ml (5%) solution for infusion, Filgrastim ratiopharm is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Danish: Ved fortynding i 50 mg/ml (5 %) glucose infusionsvæske er Filgrastim ratiopharm kompatibelt med glas og flere plastmaterialer inklusive PVC, polyolefin (et copolymer af polypropylen og polyethylen) og polypropylen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Wrapper Label on Multipacks Wrapped in Transparent Foil - Including the Blue Box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre etiket til multipakning med gennemsigtig folie - med tekst i "blå boks"
English: Do not use Filgrastim ratiopharm if you notice it is cloudy or there are particles in it.
Danish: Brug ikke Filgrastim ratiopharm, hvis opløsningen er uklar eller indeholder partikler.
English: Infections and malignancies causing myelosuppression Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
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: The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 ml/min/kg.
Danish: Filgrastims eliminationshalveringstid er ca. 3,5 timer med en clearancehastighed på ca. 0,6 ml/min/kg.
English: Read
Danish: Læs
English: Increased spleen size and very rare cases of spleen ruptures have been reported.
Danish: Der er indberettet forstørret milt og meget sjældne tilfælde af miltruptur.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Multipack Carton - Without the Blue Box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Multipakning Yderkarton - uden tekst i "blå boks"
English: Do not warm Filgrastim ratiopharm in any other way (for example, do not warm it in a microwave or in hot
Danish: De må ikke opvarme Filgrastim ratiopharm på anden vis (for eksempel hverken ved at
English: Transient, moderate decreases in non-fasting blood glucose have also been
Danish: Desuden er der set forbigående, moderate fald i ikke-fastende blodglukose.
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 effekt efter administration til patienter med myelodysplastisk syndrom eller kronisk myeloid leukæmi er ikke fastlagt.
English: Do not use Filgrastim ratiopharm after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Danish: Brug ikke Filgrastim ratiopharm efter den udløbsdato, der står på den ydre karton og på den fyldte injektionssprøjte efter EXP. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: In view of the possible risk of microbial contamination, Filgrastim ratiopharm syringes are for single use only.
Danish: Da der er risiko for mikrobiel kontaminering, er Filgrastim ratiopharm injektionssprøjter kun til engangsbrug.
English: You should watch for a temperature of 37.8 °C or above, chills or other signs of infection, such as a rash, sore throat, diarrhoea, ear-ache, difficult or painful breathing or problems such as cough or wheezing.
Danish: Vær opmærksom på, om Deres temperatur er over 37,8 °C, eller De har andre tegn på infektion såsom udslæt, ondt i halsen, diarré, ørepine, vejrtrækningsbesvær eller smerter, når De trækker vejret, eller andre problemer såsom hoste, hiven efter vejret.
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: Special precautions in patients with acute myeloid leukaemia
Danish: Særlige forsigtighedsregler hos patienter med akut myeloid leukæmi
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MIU (300 μg) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added.
Danish: Eksempel: Ved et slutvolumen til injektion på 20 ml bør totaldoser af filgrastim på mindre end 30 mio. IE (300 μg) gives efter tilsætning af 0,2 ml 20 mg/ml (20 %) human serumalbuminopløsning.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection or infusion contains 60 million international units [MIU] (600 µg) of filgrastim.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml af opløsning til injektion eller infusion indeholder 60 millioner internationale enheder [mio. IE] (600 µg) af filgrastim.
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: Filgrastim ratiopharm is a clear and colourless solution.
Danish: Filgrastim ratiopharm er en klar og farveløs væske.
English: Filgrastim ratiopharm 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: Filgrastim ratiopharm 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: These symptoms could be signs of severe pulmonary side effects, like pneumonia and respiratory distress syndrome in adults, which may be fatal.
Danish: Disse symptomer kan være tegn på alvorlige bivirkninger i lungerne såsom lungebetændelse og akut lungesvigt hos voksne (adult respiratory distress syndrome), hvilket kan føre til dødsfald.
English: - transient low blood pressure, vascular disorders (which can cause pain, redness and swelling in
Danish: - midlertidigt lavt blodtrykt, forstyrrelser i blodkarrene (som kan give smerter, rødmen og
English: Urinary abnormalities Fatigue, generalised weakness Unspecified pain Allergic reaction
Danish: Forværring af reumatoid artrit Urinvejsproblemer Træthed, almen svækkelse Uspecificerede smerter Allergisk reaktion
English: Risk associated with increased doses of myelosuppressive medicinal products Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medicinal products.
Danish: Risici forbundet med øgede doser af myelosuppressive lægemidler Behandling med filgrastim alene udelukker ikke trombocytopeni og anæmi fremkaldt af myelosuppressive lægemidler.
English: In a small number of patients (< 10%), doses up to 1.0 MIU (10 μg)/kg/day were required to achieve
Danish: Hos et mindre antal patienter (< 10 %) var det nødvendigt at give doser på op til 1,0 mio. IE
English: Leukocytosis (WBC > 50 x 109/l) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors.
Danish: Leukocytose (leukocyttal > 50 x 109/l) observeredes hos 41 % af donorer, og forbigående trombocytopeni (trombocyttal < 100 x 109/l) efter filgrastim og leukaferese observeredes hos 35 % af
English: Dilution to a final concentration less than 0.2 MIU (2 μg) per ml is not recommended at any time.
Danish: Fortynding til en slutkoncentration på under 0,2 mio. IE (2 μg) pr. mil frarådes under alle omstændigheder.
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: 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 forsøg var de hyppigste bivirkninger, der kunne henføres til filgrastim i den anbefalede dosering, lette til moderate smerter i skeletmuskulaturen, hvilket forekom hos 10 %, og svære smerter i skeletmuskulaturen hos 3 % af patienterne.
English: Your doctor will tell you when to stop using Filgrastim ratiopharm.
Danish: Lægen fortæller Dem, når det er tid til at stoppe med Filgrastim ratiopharm.
English: Filgrastim ratiopharm contains the active substance filgrastim.
Danish: Virkning Filgrastim ratiopharm indeholder det aktive stof filgrastim.
English: Check again to make sure the correct dose of Filgrastim ratiopharm is in the syringe.
Danish: Tjek en ekstra gang for at sikre, at medicinsprøjten indeholder den korrekte dosis Filgrastim
English: Isolated cases of sickle cells crises have been reported in patients with sickle cell disease (see section
Danish: Der er rapporteret enkeltstående tilfælde af seglcellekriser hos patienter med seglcellesygdom (se pkt.
English: Cough, sore throat
Danish: Hoste, ondt i halsen
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: If the ANC decreases to < 1.0 x 109/l during the treatment period the dose of filgrastim should be reescalated 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: 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
English: - The other ingredients are: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water
Danish: - Øvrige indholdsstoffer: Natriumhydroxid, eddikesyre, sorbitol, polysorbat 80, vand til
English: 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: aAnalysen omfatter studier med knoglemarvstransplantationer i denne periode; i nogle studier blev GM-CSF (granulocykolonistimulerende faktor) anvendt.
English: The long-term safety of filgrastim administration above 2.4 MIU (24 μg)/kg/day in patients with SCN has not been established.
Danish: Langtidssikkerhed er ikke påvist for filgrastim ved administration af doser over 2,4 mio. IE (24 μg)/kg/døgn til patienter
English: This medicine is given by injection, either through an intravenous infusion (drip) or into the tissue just under the skin.
Danish: Medicinen gives som indsprøjtning - enten som drop (infusion) i en åre eller i vævet lige under huden (som subkutan (SC) injektion).
English: There were no differences in the safety profiles for paediatric patients treated for severe
Danish: Der var ingen forskelle i sikkerhedsprofilen hos børn, der blev behandlet for svær kronisk neutropeni.
English: It is unknown whether filgrastim is excreted in human breast milk.
Danish: Det vides ikke, om filgrastim udskilles i modermælk.
English: Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of severe chronic neutropenias to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia and myeloid leukaemia.
Danish: Transformation til leukæmi eller myelodysplastisk syndrom Der bør udvises særlig forsigtighed, når diagnosen svær kronisk neutropeni stilles, for at differentiere fra andre hæmatopoietiske lidelser såsom aplastisk anæmi, myelodysplasi og myeloid leukæmi.
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
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,
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 forsøg 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: Filgrastim ratiopharm are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Danish: Filgrastim ratiopharm leveres i pakker á 1, 5 eller 10 fyldte injektionssprøjter eller multipakker á 10 (2 pakker á 5) fyldte injektionssprøjter.
English: INFORMATION IN BRAILLE Filgrastim ratiopharm 30 MIU/0.5 ml
Danish: INFORMATION I BRAILLE-SKRIFT Filgrastim ratiopharm 30 mio. IE/ 0,5 ml
English: The most frequent undesirable effects attributable to filgrastim were bone pain, and general
Danish: De hyppigste bivirkninger, der kunne henføres til filgrastim, var knoglesmerter og generelle smerter i
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim ratiopharm.
Danish: Utiltænkt nedfrysning af påvirker ikke stabiliteten af Filgrastim ratiopharm negativt.
English: - inflammation of blood vessels, often with skin rash (very rare); the appearance of plumcoloured, raised, painful lesions on the limbs (sometimes the face and neck) with fever (Sweet's syndrome, very rare); hair loss; pain at the site of injection; rash joint pain; chest pain; worsening of rheumatic conditions; loss of calcium from the bones; pain and swelling of the joints, similar to gout (frequency unknown) - fatigue, generalised weakness, unspecified pain.
Danish: - betændelse i blodkar, ofte med udslet (meget sjælden); der kan opstå blommefarvede, smertefulde hævelser med læsioner på arme og ben (sommetider også i ansigtet og på halsen) ledsaget af feber (Sweets syndrom, meget sjældent); hårtab; smerter ved injektionsstedet, udslæt - ledsmerter, brystsmerter, forværring af reumatiske lidelser, calciumtab fra knoglerne, smerter og hævelse af led, som kan minde om urinsyregigt (hyppighed ukendt)
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 forsøg med børn tyder på, at filgrastim udviser samme sikkerhed og effekt hos voksne og børn, der får cytotoksisk kemoterapi.
English: EU/1/08/449/007 2 x 5 pre-filled syringes
Danish: EU/1/08/449/005 EU/1/08/449/006 EU/1/08/449/007 EU/1/08/449/008
English: Each pre-filled syringe contains 0.5 ml or 0.8 ml of
Danish: Hver fyldt injektionssprøjte indeholder 0,5 ml eller 0,8 ml