FrancophonIA/ELRC3.0 huggingface dataset:
English: Effects of filgrastim on pre-natal development have been studied in rats and rabbits.
Danish: Virkningerne af filgrastim på den prænatale udvikling er undersøgt på rotter og kaniner.
English: A risk to the breastfed newborns/infants cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for nyfødte/spædbørn.
English: In clinical studies, > 90 % of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Danish: I kliniske studier responderede > 90 % af patienterne på disse doser og opnåede reversering af neutropeni på 2 dage i gennemsnit.
English: Do not increase the dose your doctor has given you.
Danish: De må ikke øge dosen, som Deres læge har fastsat til Dem.
English: There were no relevant differences between Ratiograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Danish: Der sås ingen relevante forskelle mellem Ratiograstim og referenceproduktet, hvad angår varighed af svær neutropeni og incidens af febril neutropeni.
English: If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine.
Danish: Hvis De (eller Deres barn) har arvelig fructoseintolerans (HFI), som er en sjælden arvelig sygdom, må De (eller Deres barn) ikke få dette lægemiddel.
English: Take special care with other products that stimulate white blood cells
Danish: Vær særlig forsigtig med andre produkter, der stimulerer de hvide blodlegemer
English: Store in a refrigerator.
Danish: Opbevares i køleskab
English: Date of latest renewal: 19 July 2013.
Danish: Dato for første markedsføringstilladelse: 15. september 2008 Dato for seneste fornyelse: 19. juli 2013
English: Regular blood tests will be taken to monitor the number of white blood cells in your body.
Danish: De vil regelmæssigt få taget blodprøver for at måle antallet af hvide blodlegemer i Deres krop.
English: However, you should not attempt this unless you have been properly trained first by your health care provider.
Danish: De må imidlertid ikke forsøge at gøre dette, medmindre De er blevet grundigt instrueret og oplært i det af sundhedspersonalet.
English: This medicine contains 50 mg sorbitol in each mL.
Danish: Dette lægemiddel indeholder 50 mg sorbitol pr. ml.
English: Try to self-inject at approximately the same time every day.
Danish: Forsøg at give indsprøjtningen på omtrent samme tidspunkt hver dag.
English: Uncommon to < 1/100)
Danish: Ikke almindelig til < 1/100)
English: Your healthcare professional should always record the exact product you are using.
Danish: Deres læge skal altid notere præcist, hvilket lægemiddel De bruger.
English: e. Other special populations
Danish: e. Andre specielle populationer
English: Filgrastim for PBPC mobilisation when used alone:
Danish: Filgrastim til PBPC-mobilisering, når det anvendes alene:
English: Decreased appetitee
Danish: Nedsat appetite
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro.
Danish: Granulocyt-kolinistimulerende faktor kan fremme væksten af myoloide celler in vitro, og der kan også ses lignende effekter på nogle non-myoloide celler in vitro.
English: - The safety device prevents needle stick injuries after use, so no special precautions for disposal are required.
Danish: - Sikkerhedsanordningen forebygger skader fra kanylestik efter brug, så der kræves ingen særlige forsigtighedsregler for bortskaffelse.
English: If you develop or are likely to develop cancers of the blood, you should not use Ratiograstim, unless instructed by your doctor.
Danish: Hvis De får eller med sandsynlighed kan udvikle blodkræft, må De ikke bruge Ratiograstim, medmindre lægen siger det.
English: Take your Ratiograstim pre-filled syringe out of the refrigerator.
Danish: Tag medicinsprøjten med Ratiograstim ud af køleskabet.
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Danish: Der var ingen forskelle i sikkerhedsprofilen hos børn, der blev behandlet for SCN.
English: In other circumstances, additional leukapheresis are recommended.
Danish: Under andre omstændigheder anbefales det at give flere leukafereser.
English: Before you inject Ratiograstim you must do the following:
Danish: Før injektion af Ratiograstim skal De foretage følgende:
English: • think you may be pregnant or
Danish: • har mistanke om, at De er gravid eller
English: It can also be given as a daily slow injection into the vein (known as an intravenous infusion).
Danish: Det kan også gives som en daglig langsom indsprøjtning i en vene (kaldes en intravenøs infusion).
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Danish: Graden af variation mellem individuelle patienter og mellem analysemetoder for CD34+ celler betyder, at direkte sammenligning mellem forskellige studier er vanskelig.
English: Do not take a double dose to make up for any missed doses.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: > 1.0 x 109/L for 3 consecutive days
Danish: > 1,0 x 109/l i 3 dage i træk
English: Rates of generation of antibodies against filgrastim is generally low.
Danish: Raterne af produktion af antistoffer mod filgrastim er generelt lave.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke bruges umiddelbart, har brugeren ansvaret for opbevaringstider og forhold før brug, som normalt ikke bør være mere end 24 timer ved 2 °C-8 °C, medmindre fortyndingen er foretaget under kontrollerede og validerede aseptiske forhold.
English: Sweets syndrome (acute febrile neutrophilic dermatosis)
Danish: Sweets syndrom (akut febril neutrofil dermatose)
English: There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone or in combination with myelosuppressive chemotherapy) within the same patient population.
Danish: Der findes ingen prospektive, randomiserede sammenligninger af de to anbefalede mobiliseringsmetoder hos den samme patientpopulation (filgrastim alene eller i kombination med myelosuppressiv kemoterapi).
English: - The active substance is filgrastim.
Danish: - Aktivt stof: filgrastim.
English: If you become pregnant during Ratiograstim treatment, please inform your doctor..
Danish: Hvis De bliver gravid under behandling med Ratiograstim, skal De fortælle det til lægen.
English: Graft versus Host
Danish: Graft versus værtsygdomb
English: No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Danish: Der er ikke rapporteret om bivirkninger, som er direkte relateret til denne sværhedsgrad af leukocytose.
English: Ratiograstim is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Danish: Ratiograstim gives normalt som en daglig indsprøjtning i vævet lige under huden (kaldes en subkutan injektion).
English: Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Danish: Ratiograstim er indiceret til mobilisering af perifere blodstamceller (PBPC).
English: Ratiograstim is a biosimilar medicinal product.
Danish: Ratiograstim er et biosimilært lægemiddel.
English: This section contains information on how to give yourself an injection of Ratiograstim.
Danish: Dette afsnit indeholder oplysninger om, hvordan De kan give Dem selv indsprøjtninger med Ratiograstim.
English: If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim's activity.
Danish: Hvis De ikke reagerer på behandlingen med filgrastim, eller hvis en reaktion på behandlingen ikke kan opretholdes, vil Deres læge undersøge årsagen, herunder om De har udviklet antistoffer, der kan neutralisere aktiviteten af filgrastim.
English: Your doctor will tell you how much Ratiograstim you should take.
Danish: Deres læge vil fortælle Dem, hvor meget Ratiograstim De skal have.
English: Ratiograstim is not recommended during pregnancy.
Danish: Ratiograstim anbefales ikke under graviditet.
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: Den statistiske analyse af forholdet mellem antallet af reinfunderede CD34+ celler og hastigheden af gendannelsen af trombocytter efter højdosis kemoterapi tyder på en kompleks, men kontinuerlig relation.
English: • Inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2
Danish: • Betændelse i aorta (den store pulsåre, der transporterer blod fra hjertet ud i kroppen), se punkt 2
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Ratiograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Danish: Ved fortynding med 50 mg/ml (5 %) glucose infusionsvæske er Ratiograstim kompatibelt med glas og flere plastmaterialer inklusive PVC, polyolefin (et copolymer af polypropylen og polyethylen) og polypropylen.
English: • worsening of rheumatoid arthritis
Danish: Forværring af rheumatoid arthritis
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Danish: Hvis høsten er utilstrækkelig i henhold til de ovennævnte kriterier, bør det overvejes at bruge andre behandlingsformer, som ikke omfatter støttebehandling med progenitorceller.
English: You will need to take Ratiograstim until your white blood cell count is normal.
Danish: De skal tage Ratiograstim, indtil Deres antal af hvide blodlegemer er normalt.
English: How long will I have to take Ratiograstim?
Danish: Hvor længe skal jeg tage Ratiograstim?
English: Ratiograstim should not be diluted with sodium chloride solution.
Danish: Ratiograstim bør ikke fortyndes med natriumchloridopløsning.
English: These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
Danish: Dette kan være symptomer på en tilstand som kaldes ”sepsis” (kaldes også blodforgiftning), som er en alvorlig infektion med inflammatorisk respons i hele kroppen, der kan være livstruende, og kræve akut lægehjælp.
English: How is Ratiograstim given and much should I take?
Danish: Hvordan gives Ratiograstim, og hvor meget skal jeg have?
English: The efficacy and safety of Ratiograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Danish: Ratiograstims sikkerhed og virkning er undersøgt i randomiserede, kontrollerede fase III-studier hos patienter med brystcancer, lungecancer og non-Hodgkin-lymfom.
English: Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 109/L and 10 x 109/L.
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: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Danish: Leukaferese skal indledes på dag 5 og fortsættes efter behov indtil dag 6, så der kan høstes 4 x 106 CD34+ celler/kg legemsvægt hos recipienten.
English: In cancer patients, the pharmacokinetic profile of Ratiograstim and the reference product was comparable after single and repeated subcutaneous administration.
Danish: Hos cancerpatienter var den farmakokinetiske profil af Ratiograstim og referenceproduktet sammenlignelige efter en enkelt og gentagne subkutane doser.
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis De er allergisk over for filgrastim eller et af de øvrige indholdsstoffer i Ratiograstim (angivet i punkt 6).
English: During intermittent dosing with 30 MIU (300 μg)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Danish: Under intermitterende behandling med 30 mio. IE (300 μg) filgrastim/dag kan der ses store udsving i patientens ANC.
English: A faster schedule of dose escalation may be considered in patients presenting with severe infections.
Danish: Hurtigere dosisøgning kan overvejes hos patienter med svære infektioner.
English: (Chondrocal cinosis Pyrophosph ate)
Danish: (chondrocal cinose pyrophosph at)
English: In patients with HIV infection
Danish: Patienter med hiv-infektion
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Ratiograstim was comparable to that of the reference product after subcutaneous and intravenous administration.
Danish: Randomiserede, enkeltblinde, crossover-studier med enkeltdosis, der omfattede 196 raske forsøgspersoner, viste, at Ratiograstims farmakokinetiske profil var sammenlignelig med profilen af referenceproduktet efter subkutan og intravenøs administration.
English: • plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever (Sweets syndrome)
Danish: • Blommefarvede, hævede, smertefulde sår på ben og arme og nogle gange i ansigtet eller på halsen, med feber (Sweets syndrom)
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Danish: Donorer, der får G-CSF til mobilisering af PBPC skal monitoreres, indtil deres hæmatologiske værdier er normale.
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 109/L.
Danish: I perioden med administration af filgrastim til mobilisering af PBPC skal filgrastim seponeres, eller dosis skal reduceres, hvis leukotcyttallet stiger til > 70 x 109/l.
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts
Danish: Der kan komme andre blodcelleforandringer, herunder anæmi og forbigående stigninger af myeloide progenitorceller, som kan nødvendiggøre tæt monitorering af celletal.
English: Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
Danish: Der er indberettet aortisis efter administration af G-CSF hos raske forsøgspersoner og cancerpatienter.
English: Alopeciaa
Danish: Alopecia
English: Reversal of neutropenia or maintaining normal neutrophil counts: Filgrastim should be given by subcutaneous injection.
Danish: Reversering af neutropeni eller opretholdelse af normale neutrofiltal: Filgrastim skal gives som subkutan injektion.
English: MedDRA system organ class
Danish: MedDRA systemorganklasse Meget almindelig
English: Ratiograstim is a white blood cell growth factor (granulocyte colony stimulating factor) and belong to a group of medicines called cytokines.
Danish: Ratiograstim er en vækstfaktor (granulocyt-kolonistimulerende faktor) for hvide blodlegemer og tilhører en gruppe af lægemidler, som kaldes cytokiner.
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, filgrastim should be discontinued immediately.
Danish: Hvis leukocyttallet overstiger 50 x 109/l efter det forventede nadir, skal filgrastim seponeres omgående.
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]).
Danish: Hvis De har svær kronisk neutropeni, kan De være i risiko for at udvikle blodkræft (leukæmi, myelodysplastisk syndrom (MDS)).
English: Congenital, idiopathic or cyclic neutropenia:
Danish: Medfødt, idiopatisk eller cyklisk neutropeni:
English: Pulmonary adverse reactions, in particular interstitial lung disease, have been reported after G-CSF administration.
Danish: Der er rapporteret pulmonale bivirkninger, især interstitiel lungesygdom, efter administration af G-CSF.
English: Special warning and precautions across indications
Danish: Særlige advarsler og forsigtighedsregler på tværs af indikationer
English: The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Danish: Anbefalingen af en minimumshøst på ≥ 2,0 x 106 CD34+ celler/kg er baseret på publicerede erfaringer,
English: Check again to make sure the correct dose of Ratiograstim is in the syringe.
Danish: Tjek en ekstra gang for at sikre, at medicinsprøjten indeholder den korrekte dosis Ratiograstim.
English: Ratiograstim has not been tested in pregnant or breast-feeding women.
Danish: Ratiograstim er ikke blevet testet hos gravide kvinder eller kvinder, der ammer.
English: Ratiograstim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Danish: Ratiograstim indeholder r-metHuG-CSF (filgrastim), og det udvirker markante stigninger i neutrofiltallet i perifert blod i løbet af 24 timer samt mindre stigninger i antallet af monocytter.
English: The stem cells will then go back into the bone marrow and produce blood cells.
Danish: Stamcellerne går bagefter tilbage ind i knoglemarven og producerer blodceller.
English: Ratiograstim is a solution for injection/infusion in a pre-filled syringe with or without safety device.
Danish: Ratiograstim er en injektions-/infusionsvæske, opløsning i en fyldt injektionssprøjte med eller uden sikkerhedsanordning.
English: Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.
Danish: Patienter med heriditær fructoseintolerans (HFI) må ikke få dette lægemiddel, undtagen på tvingende indikation.
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Ratiograstim.
Danish: Utiltænkt nedfrysning af påvirker ikke stabiliteten af Ratiograstim negativt.
English: Ratiograstim may have a minor influence on your ability to drive and use machines.
Danish: Ratiograstim kan i mindre grad påvirke Deres evne til at føre motorkøretøj eller betjene maskiner.
English: Push the plunger up to the number (mL) on the syringe that matches the dose of Ratiograstim that your doctor prescribed.
Danish: Tryk stemplet i til det antal millimeter (ml), der svarer til den ordinerede dosis Ratiograstim.
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with filgrastim.
Danish: Overfølsomhed, herunder anafylaktiske reaktioner, som er opstået ved initial eller efterfølgende behandling, er blevet rapporteret hos patienter i behandling med filgrastim.
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (blood uric acid increased)
Danish: • Høje urinsyreniveauer i blodet der kan medføre gigt (hyperurikæmi) (stigning i urinsyre i blodet)
English: Hepatomeg aly
Danish: Hepatomeg ali
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, som har påvist, at filgrastim passerer placenta hos gravide kvinder.
English: Your doctor will tell you how long you will need to take Ratiograstim.
Danish: Deres læge vil fortælle Dem, hvor længe De skal tage Ratiograstim.
English: Ratiograstim is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia).
Danish: Ratiograstim bruges til at behandle børn, der får kemoterapi, eller som har et meget lavt antal hvide blodlegemer (neutropeni).
English: In clinical studies, dosing with 30 MIU (300 μg)/day on 1 to 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 mio. IE (300 μg)/døgn i 1-7 dage om ugen for at opretholde ANC > 2,0 x 109/l, med en gennemsnitlig doseringshyppighed på 3 dage om ugen.
English: Among these, two cases of platelets < 50 x 109/L were reported and attributed to the leukapheresis procedure.
Danish: Blandt disse blev der rapporteret om to tilfælde af trombocyttal < 50 x 109/l, som var relateret til leukaferesen.
English: Check the appearance of Ratiograstim.
Danish: Kontroller Ratiograstims udseende.
English: Filgrastim may have a minor influence on the ability to drive and use machines.
Danish: Filgrastim kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy: Filgrastim should be given by subcutaneous injection.
Danish: Filgrastim til PBPC-mobilisering efter myelosuppressiv kemoterapi: Filgrastim skal gives som subkutan injektion.
English: Capillary leak syndrome which can be life threatening if treatment is delayed, has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Danish: Der er indberettet kapillær lækage-syndrom, som kan være livstruende, hvis behandling forsinkes, efter indgift af G-CSF, og dette er kendetegnet ved hypotension, hypoalbuminæmi, ødem og hæmokoncentration.
English: Filgrastim was studied in repeated dose toxicity studies up to 1 year in duration which revealed changes attributable to the expected pharmacological actions including increases in leukocytes, myeloid hyperplasia in bone marrow, extramedullary granulopoiesis and splenic enlargement.
Danish: Filgrastim blev undersøgt i studier af toksiciteten efter gentagne doser af op til 1 års varighed, hvor der blev observeret ændringer, som kunne tilskrives de forventede farmakologiske virkninger, herunder stigninger i leukocytter, myeloid hyperplasi i knoglemarv, ekstramedullær granulopoiese og forstørret milt.
English: Based on reported data for another filgrastim product similar to the reference product, comparable findings plus increased foetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Danish: Baseret på de rapporterede data for et andet filgrastim-produkt, der ligner referenceproduktet, blev der observeret sammenlignelige fund samt en stigning i fostermisdannelser ved 100 µg/kg/dag - en maternelt toksisk dosis, der svarede til en systemisk eksponering på cirka 50-90 gange de eksponeringer, der observeres hos patienter, som behandles med den kliniske dosis på 5 µg/kg/dag.
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 acute respiratory distress syndrome (ARDS).
Danish: Lungesymptomer som hoste, feber og dyspnø i forbindelse med radiologiske tegn på lungeinfiltrater og forværring af lungefunktion kan være præliminære tegn på acute respiratory distress syndrome (ARDS).